Walter, S D; Han, H; Briel, M; Guyatt, G H
2017-04-30
In this paper, we consider the potential bias in the estimated treatment effect obtained from clinical trials, the protocols of which include the possibility of interim analyses and an early termination of the study for reasons of futility. In particular, by considering the conditional power at an interim analysis, we derive analytic expressions for various parameters of interest: (i) the underestimation or overestimation of the treatment effect in studies that stop for futility; (ii) the impact of the interim analyses on the estimation of treatment effect in studies that are completed, i.e. that do not stop for futility; (iii) the overall estimation bias in the estimated treatment effect in a single study with such a stopping rule; and (iv) the probability of stopping at an interim analysis. We evaluate these general expressions numerically for typical trial scenarios. Results show that the parameters of interest depend on a number of factors, including the true underlying treatment effect, the difference that the trial is designed to detect, the study power, the number of planned interim analyses and what assumption is made about future data to be observed after an interim analysis. Because the probability of stopping early is small for many practical situations, the overall bias is often small, but a more serious issue is the potential for substantial underestimation of the treatment effect in studies that actually stop for futility. We also consider these ideas using data from an illustrative trial that did stop for futility at an interim analysis. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.
Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.
Dallas, Michael J
2008-01-01
Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.
2009-01-01
Background Decisions about interim analysis and early stopping of clinical trials, as based on recommendations of Data Monitoring Committees (DMCs), have far reaching consequences for the scientific validity and clinical impact of a trial. Our aim was to evaluate the frequency and quality of the reporting on DMC composition and roles, interim analysis and early termination in pediatric trials. Methods We conducted a systematic review of randomized controlled clinical trials published from 2005 to 2007 in a sample of four general and four pediatric journals. We used full-text databases to identify trials which reported on DMCs, interim analysis or early termination, and included children or adolescents. Information was extracted on general trial characteristics, risk of bias, and a set of parameters regarding DMC composition and roles, interim analysis and early termination. Results 110 of the 648 pediatric trials in this sample (17%) reported on DMC or interim analysis or early stopping, and were included; 68 from general and 42 from pediatric journals. The presence of DMCs was reported in 89 of the 110 included trials (81%); 62 papers, including 46 of the 89 that reported on DMCs (52%), also presented information about interim analysis. No paper adequately reported all DMC parameters, and nine (15%) reported all interim analysis details. Of 32 trials which terminated early, 22 (69%) did not report predefined stopping guidelines and 15 (47%) did not provide information on statistical monitoring methods. Conclusions Reporting on DMC composition and roles, on interim analysis results and on early termination of pediatric trials is incomplete and heterogeneous. We propose a minimal set of reporting parameters that will allow the reader to assess the validity of trial results. PMID:20003383
NASA Astrophysics Data System (ADS)
Vergados, P.; Mannucci, A. J.; Ao, C. O.; Jiang, J. H.; Su, H.
2015-01-01
The spatial variability of the tropical tropospheric relative humidity (RH) throughout the vertical extent of the troposphere is examined using Global Positioning System Radio Occultation (GPSRO) observations from the Constellation Observing System for Meteorology, Ionosphere and Climate (COSMIC) mission. These high vertical resolution observations capture the detailed structure and moisture budget of the Hadley Cell circulation. We compare the COSMIC observations with the European Center for Medium-range Weather Forecast (ECMWF) Re-Analysis Interim (ERA-Interim) and the Modern-Era Retrospective analysis for Research and Applications (MERRA) climatologies. Qualitatively, the spatial pattern of RH in all data sets matches up remarkably well, capturing distinct features of the general circulation. However, RH discrepancies exist between ERA-Interim and COSMIC data sets, which are noticeable across the tropical boundary layer. Specifically, ERA-Interim shows a drier Inter Tropical Convergence Zone (ITCZ) by 15-20% compared both to COSMIC and MERRA data sets, but this difference decreases with altitude. Unlike ECMWF, MERRA shows an excellent agreement with the COSMIC observations except above 400 hPa, where GPSRO observations capture drier air by 5-10%. RH climatologies were also used to evaluate intraseasonal variability. The results indicate that the tropical middle troposphere at ±5-25° is most sensitive to seasonal variations. COSMIC and MERRA data sets capture the same magnitude of the seasonal variability, but ERA-Interim shows a weaker seasonal fluctuation up to 10% in the middle troposphere inside the dry air subsidence regions of the Hadley Cell. Over the ITCZ, RH varies by maximum 9% between winter and summer.
Sun, Libo; Wan, Ying
2018-04-22
Conditional power and predictive power provide estimates of the probability of success at the end of the trial based on the information from the interim analysis. The observed value of the time to event endpoint at the interim analysis could be biased for the true treatment effect due to early censoring, leading to a biased estimate of conditional power and predictive power. In such cases, the estimates and inference for this right censored primary endpoint are enhanced by incorporating a fully observed auxiliary variable. We assume a bivariate normal distribution of the transformed primary variable and a correlated auxiliary variable. Simulation studies are conducted that not only shows enhanced conditional power and predictive power but also can provide the framework for a more efficient futility interim analysis in terms of an improved accuracy in estimator, a smaller inflation in type II error and an optimal timing for such analysis. We also illustrated the new approach by a real clinical trial example. Copyright © 2018 John Wiley & Sons, Ltd.
How well do Reanalysis represent polar lows?
NASA Astrophysics Data System (ADS)
Zappa, G.; Shaffrey, L.; Hodges, K.
2013-12-01
Polar lows are intense maritime mesocyclones forming at high latitudes during polar air outbreaks. The associated high surface winds can be an important cause of coastal damage.They also seem to play a relevant role in the climate system by modulating the oceanic surface heat fluxes. This creates strong interest in understanding whether modern reanalysis datasets are able to represent polar lows, as well as how their representation may be sensitive to the model resolution. In this talk we investigate how ERA-Interim reanalysis represents the polar lows identified by the Norwegian meteorological services and listed in the STARS (Combination of Sea Surface Temperature and AltimeteR Synergy) dataset for the period 2002-2011. The sensitivity to resolution is explored by comparing ERA-Interim to the ECMWF operational analyses (2008-2011), which have three times higher horizontal resolution compared to ERA-Interim. We show that ERAI-Interim has excellent ability to capture the observed polar lows events with up to 90% of the observed events being found in the reanalysis. However, ERA-Interim tends to have polar lows of weaker dynamical intensity, in terms of both winds and vorticity, and with less spatial structure than in the ECMWF operational analyses (See Fig 1). Furthermore, we apply an objective feature tracking algorithm to the 3 hourly vorticity at 850 hPa with constraints on vorticity intensity and atmospheric static stability to objectively identify polar lows in the ERA-Interim reanalysis. We show that for the stronger polar lows the objective climatology shows good agreement with the STARS dataset over the 2002-2011 period. This allows us to extend the polar lows climatology over the whole ERA Interim period. Differences with another reanalysis product (NCEP-CFSR) will be also discussed. Fig 1: Composite of the tangential wind speed at 925 hPa for 34 polar lows observed in the Norwegian sea between 2008-2010 as represented by the ERA-Interim reanalysis (left) and by the ECMWF Operational analysis (right). Positive values indicate cyclonic circulation. The composite is centered on the polar low vorticity maxima and it is presented for a radial cap of 5 degrees of radius on the sphere (~550Km).
Evaluation of ERA-interim and MERRA Cloudiness in the Southern Oceans
NASA Technical Reports Server (NTRS)
Naud, Catherine M.; Booth, James F.; Del Genio, Anthony D.
2014-01-01
The Southern Ocean cloud cover modeled by the Interim ECMWF Re-Analysis (ERA-Interim) and Modern- Era Retrospective Analysis for Research and Applications (MERRA) reanalyses are compared against Moderate Resolution Imaging Spectroradiometer (MODIS) and Multiangle Imaging Spectroradiometer (MISR) observations. ERA-Interim monthly mean cloud amounts match the observations within 5%, while MERRA significantly underestimates the cloud amount. For a compositing analysis of clouds in warm season extratropical cyclones, both reanalyses show a low bias in cloud cover. They display a larger bias to the west of the cyclones in the region of subsidence behind the cold fronts. This low bias is larger for MERRA than for ERA-Interim. Both MODIS and MISR retrievals indicate that the clouds in this sector are at a low altitude, often composed of liquid, and of a broken nature. The combined CloudSat-Cloud-Aerosol Lidar and Infrared Pathfinder Satellite Observations (CALIPSO) cloud profiles confirm these passive observations, but they also reveal that low-level clouds in other parts of the cyclones are also not properly represented in the reanalyses. The two reanalyses are in fairly good agreement for the dynamic and thermodynamic characteristics of the cyclones, suggesting that the cloud, convection, or boundary layer schemes are the problem instead. An examination of the lower-tropospheric stability distribution in the cyclones from both reanalyses suggests that the parameterization of shallow cumulus clouds may contribute in a large part to the problem. However, the differences in the cloud schemes and in particular in the precipitation processes, which may also contribute, cannot be excluded.
Have first-time medical school deans been serving longer than we thought? A 50-year analysis.
Keyes, Joseph A; Alexander, Hershel; Jarawan, Hani; Mallon, William T; Kirch, Darrell G
2010-12-01
To describe the lengths of service of deans at accredited U.S. MD-granting medical schools from academic years 1959 to 2008 and to determine whether the median length of service of deans changed over time. The authors used the database of the Council of Deans of the Association of American Medical Colleges to seek data, from July 1, 1959 to June 30, 2009, on lengths of service of 842 deans and interim deans at all 125 accredited U.S. MD-granting medical schools existing in 2007. All but 8 schools verified their data, which included the date of the beginning of service, the date of the end of service, and whether the individual served in a permanent or interim capacity. Across five-year cohorts of the first-time deans and interim deans studied, the median length of service was 4.4 years. When the authors excluded individuals who were interim deans exclusively and focused the analysis on the 639 persons who were "permanent" deans, the median length of service was 6.0 years across five-year cohorts. Analysis of one-year cohorts of deans showed similar results (median = 6.1 years), although the medians for six of the seven most recent one-year cohorts ranged from 5.0 to 5.7 years. Through cohort analysis, the median length of service of permanent medical school deans was longer than that found in previous studies, and it has remained relatively stable.
NASA Astrophysics Data System (ADS)
Ahmed, F.; Dousa, J.; Hunegnaw, A.; Teferle, F. N.; Bingley, R.
2017-12-01
Integrated water vapor (IWV) derived from climate reanalysis models, such as the European Centre for Medium-range Weather Forecasts (ECMWF) ReAnalysis-Interim (ERA-Interim), is widely used in many atmospheric applications. Therefore, it is of interest to assess the quality of this reanalysis product using available observations. Observations from Global Navigation Satellite Systems (GNSS) are, as of now, available for a period of over 2 decades and their global availability makes it possible to validate the IWV obtained from climate reanalysis models in different geographical and climatic regions. In this study, primarily, three 5-year long homogeneously reprocessed GNSS-derived IWV datasets containing over 400 globally distributed ground-based GNSS stations have been used to validate the IWV estimates obtained from the ERA-Interim climate reanalysis model in 25 different climate zones. The IWV from ERA-Interim has been obtained by vertically integrating the specific humidity at all model levels above the locations of GNSS stations. It has been studied how the difference between the ERA-Interim IWV and the GNSS-derived IWV varies with respect to the different climate zones as well as with respect to the difference in the model orography and latitude. The results show a dependence of the ability of ERA-Interim to model the IWV on difference in climate types and latitude. This dependence, however, is dictated by the concentration of water vapor in different climate zones and at different latitudes. Furthermore, as a secondary focus of this study, the weighted mean atmospheric temperature (Tm) obtained from ERA-Interim has been compared to its equivalent obtained using two widely used approximations globally.
Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.
Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay
2018-04-17
In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.
Kim, Jihyun; Lee, Jeong-Ok; Paik, Jin Ho; Lee, Won Woo; Kim, Sang Eun; Song, Yoo Sung
2017-01-01
Diffuse large B-cell lymphoma (DLBCL) is a pathologically heterogeneous disease with different prognoses according to its molecular profiles. Despite the broad usage of 18 F-fluoro-2-dexoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT), previous studies that have investigated the value of interim 18 F-FDG PET/CT in DLBCL have given the controversial results. The purpose of this study was to evaluate the prognostic value of interim 18 F-FDG PET/CT in DLBCL according to germinal center B cell-like (GCB) and non-GCB molecular profiling. We enrolled 118 newly diagnosed DLBCL patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). Interim 18 F-FDG PET/CT scans performed after 2 or 3 cycles of R-CHOP treatment were evaluated based on the Lugano response criteria. Patients were grouped as GCB or non-GCB molecular subtypes according to immunohistochemistry results of CD10, BCL6, and MUM1, based on Hans' algorithm. In total 118 DLBCL patients, 35 % were classified as GCB, and 65 % were classified as non-GCB. Interim PET/CT was negative in 70 %, and positive in 30 %. During the median follow-up period of 23 months, the positive interim 18 F-FDG PET/CT group showed significantly inferior progression free survival (PFS) compared to the negative interim 18 F-FDG PET/CT group (P = 0.0004) in entire patients. A subgroup analysis according to molecular profiling demonstrated significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in GCB subtype of DLBCL (P = 0.0001), but there was no significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in non-GCB subtype of DLBCL. Interim 18 F-FDG PET/CT scanning had a significant predictive value for disease progression in patients with the GCB subtype of DLBCL treated with R-CHOP, but not in those with the non-GCB subtype. Therefore, molecular profiles of DLBCL should be considered for interim 18 F-FDG PET/CT practice.
NASA Astrophysics Data System (ADS)
Vergados, P.; Mannucci, A. J.; Ao, C. O.; Jiang, J. H.; Su, H.
2015-04-01
The spatial variability of the tropical tropospheric relative humidity (RH) throughout the vertical extent of the troposphere is examined using Global Positioning System Radio Occultation (GPSRO) observations from the Constellation Observing System for Meteorology, Ionosphere, and Climate (COSMIC) mission. These high vertical resolution observations capture the detailed structure and moisture budget of the Hadley Cell circulation. We compare the COSMIC observations with the European Center for Medium-range Weather Forecast (ECMWF) Reanalysis Interim (ERA-Interim) and the Modern-Era Retrospective analysis for Research and Applications (MERRA) climatologies. Qualitatively, the spatial pattern of RH in all data sets matches up remarkably well, capturing distinct features of the general circulation. However, RH discrepancies exist between ERA-Interim and COSMIC data sets that are noticeable across the tropical boundary layer. Specifically, ERA-Interim shows a drier Intertropical Convergence Zone (ITCZ) by 15-20% compared to both COSMIC and MERRA data sets, but this difference decreases with altitude. Unlike ECMWF, MERRA shows an excellent agreement with the COSMIC observations except above 400 hPa, where GPSRO observations capture drier air by 5-10%. RH climatologies were also used to evaluate intraseasonal variability. The results indicate that the tropical middle troposphere at ±5-25° is most sensitive to seasonal variations. COSMIC and MERRA data sets capture the same magnitude of the seasonal variability, but ERA-Interim shows a weaker seasonal fluctuation up to 10% in the middle troposphere inside the dry air subsidence regions of the Hadley Cell. Over the ITCZ, RH varies by maximum 9% between winter and summer.
Palbociclib for Advanced Breast Cancer
An interim analysis of the PALOMA3 trial shows that women with hormone receptor-positive metastatic breast cancer who received palbociclib plus fulvestrant had longer progression-free survival rates than women who received a placebo plus fulvestrant.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-05
... Conservation Program: Availability of the Interim Technical Support Document for High-Intensity Discharge Lamps... high-intensity discharge (HID) lamps energy conservation standards in the Federal Register. This... interim analysis for high- intensity discharge lamps energy conservation standards. The notice provided...
Langton, Jennifer; Crampton, Peter
2008-04-18
To determine whether the three main funding formulas for Primary Health Organisations achieved a stated aim of the Primary Health Care Strategy to fund enrolled populations according to need. National data were obtained from the Ministry of Health for a 12-month period beginning in April 2004: these included demographic characteristics of the enrolled Primary Health Organisation population, plus rates tables for: First-Contact Services, Services to Improve Access, and Health Promotion. Funding for Access and Interim practices for four-quarters was calculated for each of these three funding streams. Analysis of the demographic characteristics of Access and Interim practices was undertaken. Maori and Pacific peoples made up a greater proportion of the Access population than the Interim, had higher rates of deprivation than the non-Maori/non-Pacific population, and demonstrated a younger age distribution. The first quarter (April 2004-June 2004) showed there was preferential funding for Access PHOs and in particular high-needs groups. In quarter two, this level of preferential funding had diminished, coinciding with the introduction of increased government funding for all Interim enrolees aged 65 and over. The greater funding for Access enrolees was notably eroded with the introduction of Access-level funding for those aged 65+ in Interim PHOs. Since these data were analysed all remaining Interim age groups have shifted to Access-level funding, benefiting non-Maori /non-Pacific in Interim PHOs. The rapid shift to Access-level funding for First Contact Services has seen a continued erosion of the redistributive effect of the original needs-based formulas. A system cannot be considered equitable if some members of society are not realising their health potential, and financing of primary care should remain redistributive until such a time as this objective is attained.
NASA Technical Reports Server (NTRS)
Kitzis, J. L.; Kitzis, S. N.
1979-01-01
The brightness temperature data produced by the SMMR final Antenna Pattern Correction (APC) algorithm is discussed. The algorithm consisted of: (1) a direct comparison of the outputs of the final and interim APC algorithms; and (2) an analysis of a possible relationship between observed cross track gradients in the interim brightness temperatures and the asymmetry in the antenna temperature data. Results indicate a bias between the brightness temperature produced by the final and interim APC algorithm.
Symptomatic treatment in multiple sclerosis-interim analysis of a nationwide registry.
Skierlo, S; Rommer, P S; Zettl, U K
2017-04-01
To analyze symptomatic treatment in patients with multiple sclerosis (MS). Multiple sclerosis is a chronic inflammatory disease of the central nervous system, with accumulating disability symptoms like spasticity, voiding disorders, depression, and pain might occur. The nationwide German MS registry was initiated 2001 under guidance of the German MS society (Deutsche MS Gesellschaft). This study was performed as an interim analysis to lay foundation for future work on this topic. A subcohort of 5113 patients was assessed for this interim analysis. The mean age of the patients was 45.3 years; mean EDSS was 4.2. More than two-third of the enrolled patients were females (70.9%). Most frequent symptoms were fatigue (60%), followed by spasticity (52.5%) and voiding disorders (51.7%). The likelihood of treatment was highest for epileptic disorders (68.8%), spasticity (68.5%), pain (60.7%), and depression (58.9%). Multivariate regression analysis showed that retirement was the strongest factor predictive for antispastic treatment (β=.061, P=.005). Almost all patients in this analysis suffer from symptoms due to advanced MS. Treatment for the various symptoms differed tremendously. The likelihood of treatment correlated with the availability of effective therapeutic agents. Clinicians should put more awareness on MS symptoms. Symptomatic treatment may improve quality of life. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-15
... public comments for a planned Environmental Assessment. The Corps is directed to conduct a study of.... The study is structured as a series of interim reports. Interim Report IIIa, limited to the impacts of.... Comments are requested to assist in determining the level of analysis and impacts to be considered for...
NASA Astrophysics Data System (ADS)
González-Rojí, Santos J.; Sáenz, Jon; Ibarra-Berastegi, Gabriel
2016-04-01
A numerical downscaling exercise over the Iberian Peninsula has been run nesting the WRF model inside ERA Interim. The Iberian Peninsula has been covered by a 15km x 15 km grid with 51 vertical levels. Two model configurations have been tested in two experiments spanning the period 2010-2014 after a one year spin-up (2009). In both cases, the model uses high resolution daily-varying SST fields and the Noah land surface model. In the first experiment (N), after the model is initialised, boundary conditions drive the model, as usual in numerical downscaling experiments. The second experiment (D) is configured the same way as the N case, but 3DVAR data assimilation is run every six hours (00Z, 06Z, 12Z and 18Z) using observations obtained from the PREPBUFR dataset (NCEP ADP Global Upper Air and Surface Weather Observations) using a 120' window around analysis times. For the data assimilation experiment (D), seasonally (monthly) varying background error covariance matrices have been prepared according to the parameterisations used and the mesoscale model domain. For both N and D runs, the moisture balance of the model runs has been evaluated over the Iberian Peninsula, both internally according to the model results (moisture balance in the model) and also in terms of the observed moisture fields from observational datasets (particularly precipitable water and precipitation from observations). Verification has been performed both at the daily and monthly time scales. The verification has also been performed for ERA Interim, the driving coarse-scale dataset used to drive the regional model too. Results show that the leading terms that must be considered over the area are the tendency in the precipitable water column, the divergence of moisture flux, evaporation (computed from latent heat flux at the surface) and precipitation. In the case of ERA Interim, the divergence of Qc is also relevant, although still a minor player in the moisture balance. Both mesoscale model runs are more effective at closing the moisture balance over the whole Iberian Peninsula than ERA Interim. The N experiment (no data assimilation) shows a better closure than the D case, as could be expected from the lack of analysis increments in it. This result is robust both at the daily and monthly time scales. Both ERA Interim and the D experiment produce a negative residual in the balance equation (compatible with excess evaporation or increased convergence of moisture over the Iberian Peninsula). This is a result of the data assimilation process in the D dataset, since in the N experiment the residual is mainly positive. The seasonal cycle of evaporation is much closer in the D experiment to the one in ERA Interim than in the N case, with a higher evaporation during summer months. However, both regional climate model runs show a lower evaporation rate than ERA Interim, particularly during summer months.
76 FR 14568 - Federal Acquisition Regulation; Use of Commercial Services Item Authority
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-16
...-AL44 Federal Acquisition Regulation; Use of Commercial Services Item Authority AGENCIES: Department of... interim rule amending the Federal Acquisition Regulation (FAR) to implement section 868 of the Duncan... interim rule. II. Discussion/Analysis The analysis of public comments by the Defense Acquisition...
Interim Terrain Data (ITD) and Vector Product Interim Terrain Data (VITD) user's guide
DOT National Transportation Integrated Search
1996-09-01
This guide is intended to be a convenient reference for users of these types of terrain analysis data. ITD is a digitized version of the standard 1:50,000-scale tactical terrain analysis data base (TTADB) product produced by the Defense Mapping Agenc...
NASA Technical Reports Server (NTRS)
Wei, Jiangfeng; Dirmeyer, Paul A.; Wisser, Dominik; Bosilovich, Michael G.; Mocko, David M.
2013-01-01
Irrigation is an important human activity that may impact local and regional climate, but current climate model simulations and data assimilation systems generally do not explicitly include it. The European Centre for Medium-Range Weather Forecasts (ECMWF) Interim Re-Analysis (ERA-Interim) shows more irrigation signal in surface evapotranspiration (ET) than the Modern-Era Retrospective Analysis for Research and Applications (MERRA) because ERA-Interim adjusts soil moisture according to the observed surface temperature and humidity while MERRA has no explicit consideration of irrigation at the surface. But, when compared with the results from a hydrological model with detailed considerations of agriculture, the ET from both reanalyses show large deficiencies in capturing the impact of irrigation. Here, a back-trajectory method is used to estimate the contribution of irrigation to precipitation over local and surrounding regions, using MERRA with observation-based corrections and added irrigation-caused ET increase from the hydrological model. Results show substantial contributions of irrigation to precipitation over heavily irrigated regions in Asia, but the precipitation increase is much less than the ET increase over most areas, indicating that irrigation could lead to water deficits over these regions. For the same increase in ET, precipitation increases are larger over wetter areas where convection is more easily triggered, but the percentage increase in precipitation is similar for different areas. There are substantial regional differences in the patterns of irrigation impact, but, for all the studied regions, the highest percentage contribution to precipitation is over local land.
Pupil Inquiry Behavior Analysis and Change Activity. Interim Project Report.
ERIC Educational Resources Information Center
Manion, Raymond C.
This interim report discusses progress toward three major goals of the Pupil Inquiry Behavior Analysis and Change Activity: increased pupil inquiry, changed teacher behavior to facilitate pupil inquiry, and the development of a 32-week course of instruction to provide for these behavioral changes. Data currently available deals with the emotional…
Publishing interim results of randomised clinical trials in peer-reviewed journals.
Counsell, Nicholas; Biri, Despina; Fraczek, Joanna; Hackshaw, Allan
2017-02-01
Interim analyses of randomised controlled trials are sometimes published before the final results are available. In several cases, the treatment effects were noticeably different after patient recruitment and follow-up completed. We therefore conducted a literature review of peer-reviewed journals to compare the reported treatment effects between interim and final publications and to examine the magnitude of the difference. We performed an electronic search of MEDLINE from 1990 to 2014 (keywords: 'clinical trial' OR 'clinical study' AND 'random*' AND 'interim' OR 'preliminary'), and we manually identified the corresponding final publication. Where the electronic search produced a final report in which the abstract cited interim results, we found the interim publication. We also manually searched every randomised controlled trial in eight journals, covering a range of impact factors and general medical and specialist publications (1996-2014). All paired articles were checked to ensure that the same comparison between interventions was available in both. In all, 63 studies are included in our review, and the same quantitative comparison was available in 58 of these. The final treatment effects were smaller than the interim ones in 39 (67%) trials and the same size or larger in 19 (33%). There was a marked reduction, defined as a ≥20% decrease in the size of the treatment effect from interim to final analysis, in 11 (19%) trials compared to a marked increase in 3 (5%), p = 0.057. The magnitude of percentage change was larger in trials where commercial support was reported, and increased as the proportion of final events at the interim report decreased in trials where commercial support was reported (interaction p = 0.023). There was no evidence of a difference between trials that stopped recruitment at the interim analysis where this was reported as being pre-specified versus those that were not pre-specified (interaction p = 0.87). Published interim trial results were more likely to be associated with larger treatment effects than those based on the final report. Publishing interim results should be discouraged, in order to have reliable estimates of treatment effects for clinical decision-making, regulatory authority reviews and health economic analyses. Our work should be expanded to include conference publications and manual searches of additional journal publications.
NASA Astrophysics Data System (ADS)
Patra, Anindita; Bhaskaran, Prasad K.
2017-08-01
The head Bay region bordering the northern Bay of Bengal is a densely populated area with a complex geomorphologic setting, and highly vulnerable to extreme water levels along with other factors like sea level rise and impact of tropical cyclones. The influence of climate change on wind-wave regime from this region of Bay of Bengal is not known well and that requires special attention, and there is a need to perform its long-term assessment for societal benefits. This study provides a comprehensive analysis on the temporal variability in domain averaged wind speed, significant wave height (SWH) utilizing satellite altimeter data (1992-2012) and mean wave period using ECMWF reanalysis products ERA-Interim (1992-2012) and ERA-20C (1992-2010) over this region. The SWH derived from WAVEWATCH III (WW3) model along with the ERA-Interim reanalysis supplements the observed variability in satellite altimeter observations. Further, the study performs an extensive error estimation of SWH and mean wave period with ESSO-NIOT wave atlas that shows a high degree of under-estimation in the wave atlas mean wave period. Annual mean and wind speed maxima from altimeter show an increasing trend, and to a lesser extent in the SWH. Interestingly, the estimated trend is higher for maxima compared to the mean conditions. Analysis of decadal variability exhibits an increased frequency of higher waves in the present decade compared to the past. Linear trend analysis show significant upswing in spatially averaged ERA-20C mean wave period, whereas the noticed variations are marginal in the ERA-Interim data. A separate trend analysis for the wind-seas, swell wave heights and period from ERA-20C decipher the fact that distant swells governs the local wind-wave climatology over the head Bay region, and over time the swell activity have increased in this region.
Adams, Hugo J A; Kwee, Thomas C
2016-10-01
This study aimed to systematically review and meta-analyze the prognostic value of interim (18)F-fluoro-2-deoxy-d-glucose positron emission tomography (FDG-PET) in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). MEDLINE and EMBASE were systematically searched for suitable studies. Included studies were methodologically appraised, and results were summarized both descriptively and meta-analytically. Nine studies, comprising a total of 996 R-CHOP-treated DLBCL patients, were included. Overall, studies were of moderate methodological quality. The area under the summary receiver operating curve (AUC) of interim FDG-PET in predicting treatment failure and death were 0.651 and 0.817, respectively. There was no heterogeneity in diagnostic odds ratios across available studies (I(2)=0.0%). At multivariable analysis, 2 studies reported interim FDG-PET to have independent prognostic value in addition to the International Prognostic Index (IPI) in predicting treatment failure, whereas 3 studies reported that this was not the case. One study reported interim FDG-PET to have independent prognostic value in addition to the IPI in predicting death, whereas 2 studies reported that this was not the case. In conclusion, interim FDG-PET in R-CHOP-treated DLBCL has some correlation with outcome, but its prognostic value is homogeneously suboptimal across studies and it has not consistently proven to surpass the prognostic potential of the IPI. Moreover, there is a lack of studies that compared interim FDG-PET to the recently developed and superior National Comprehensive Cancer Network-IPI. Therefore, at present there is no scientific base to support the clinical use of interim FDG-PET in R-CHOP-treated DLBCL. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Interim analysis: A rational approach of decision making in clinical trial.
Kumar, Amal; Chakraborty, Bhaswat S
2016-01-01
Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.
Evaluation of ERA-Interim precipitation data in complex terrain
NASA Astrophysics Data System (ADS)
Gao, Lu; Bernhardt, Matthias; Schulz, Karsten
2013-04-01
Precipitation controls a large variety of environmental processes, which is an essential input parameter for land surface models e.g. in hydrology, ecology and climatology. However, rain gauge networks provides the necessary information, are commonly sparse in complex terrains, especially in high mountainous regions. Reanalysis products (e.g. ERA-40 and NCEP-NCAR) as surrogate data are increasing applied in the past years. Although they are improving forward, previous studies showed that these products should be objectively evaluated due to their various uncertainties. In this study, we evaluated the precipitation data from ERA-Interim, which is a latest reanalysis product developed by ECMWF. ERA-Interim daily total precipitation are compared with high resolution gridded observation dataset (E-OBS) at 0.25°×0.25° grids for the period 1979-2010 over central Alps (45.5-48°N, 6.25-11.5°E). Wet or dry day is defined using different threshold values (0.5mm, 1mm, 5mm, 10mm and 20mm). The correspondence ratio (CR) is applied for frequency comparison, which is the ratio of days when precipitation occurs in both ERA-Interim and E-OBS dataset. The result shows that ERA-Interim captures precipitation occurrence very well with a range of CR from 0.80 to 0.97 for 0.5mm to 20mm thresholds. However, the bias of intensity increases with rising thresholds. Mean absolute error (MAE) varies between 4.5 mm day-1 and 9.5 mm day-1 in wet days for whole area. In term of mean annual cycle, ERA-Interim almost has the same standard deviation of the interannual variability of daily precipitation with E-OBS, 1.0 mm day-1. Significant wet biases happened in ERA-Interim throughout warm season (May to August) and dry biases in cold season (November to February). The spatial distribution of mean annual daily precipitation shows that ERA-Interim significant underestimates precipitation intensity in high mountains and northern flank of Alpine chain from November to March while pronounced overestimate in the southern flank of Alps. The poor topographical and flow related characteristic representation of ERA-Interim model is possibly responsible for the bias. Particularly, the mountain block effect of moisture is weak captured. The comparison demonstrates that ERA-Interim precipitation intensity needs bias correction for further alpine climate studies, although it reasonably captures precipitation frequency. This critical evaluation not only diagnosed the data quality of ERA-Interim, but also provided the evidence for reanalysis products downscaling and bias correction in complex terrain.
Ganeshan, B; Miles, K A; Babikir, S; Shortman, R; Afaq, A; Ardeshna, K M; Groves, A M; Kayani, I
2017-03-01
The purpose of this study was to investigate the ability of computed tomography texture analysis (CTTA) to provide additional prognostic information in patients with Hodgkin's lymphoma (HL) and high-grade non-Hodgkin's lymphoma (NHL). This retrospective, pilot-study approved by the IRB comprised 45 lymphoma patients undergoing routine 18F-FDG-PET-CT. Progression-free survival (PFS) was determined from clinical follow-up (mean-duration: 40 months; range: 10-62 months). Non-contrast-enhanced low-dose CT images were submitted to CTTA comprising image filtration to highlight features of different sizes followed by histogram-analysis using kurtosis. Prognostic value of CTTA was compared to PET FDG-uptake value, tumour-stage, tumour-bulk, lymphoma-type, treatment-regime, and interim FDG-PET (iPET) status using Kaplan-Meier analysis. Cox regression analysis determined the independence of significantly prognostic imaging and clinical features. A total of 27 patients had aggressive NHL and 18 had HL. Mean PFS was 48.5 months. There was no significant difference in pre-treatment CTTA between the lymphoma sub-types. Kaplan-Meier analysis found pre-treatment CTTA (medium feature scale, p=0.010) and iPET status (p<0.001) to be significant predictors of PFS. Cox analysis revealed that an interaction between pre-treatment CTTA and iPET status was the only independent predictor of PFS (HR: 25.5, 95% CI: 5.4-120, p<0.001). Specifically, pre-treatment CTTA risk stratified patients with negative iPET. CTTA can potentially provide prognostic information complementary to iPET for patients with HL and aggressive NHL. • CT texture-analysis (CTTA) provides prognostic information complementary to interim FDG-PET in Lymphoma. • Pre-treatment CTTA and interim PET status were significant predictors of progression-free survival. • Patients with negative interim PET could be further stratified by pre-treatment CTTA. • Provide precision surveillance where additional imaging reserved for patients at greatest recurrence-risk. • Assists in risk-adapted treatment strategy based on interim PET and CTTA.
Hsueh, Eddy C; DeBloom, James R; Lee, Jonathan; Sussman, Jeffrey J; Covington, Kyle R; Middlebrook, Brooke; Johnson, Clare; Cook, Robert W; Slingluff, Craig L; McMasters, Kelly M
2017-08-29
A 31-gene expression profile (GEP) test that provides risk classification of cutaneous melanoma (CM) patients has been validated in several retrospective studies. The objective of the reported study was a prospective evaluation of the GEP performance in patients enrolled in two clinical registries. Three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries met the criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis. Primary endpoints were recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS). Median follow-up was 1.5 years for event-free patients. Median age for subjects was 58 years (range 18-87) and median Breslow thickness was 1.2 mm (range 0.2-12.0). Eighty-eight percent (282/322) of cases had stage I/II disease and 74% (237/322) had a SLN biopsy. Seventy-seven percent (248/322) had class 1 molecular profiles. 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each). Multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01), while tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis. Interim analysis of patient outcomes from a combined prospective cohort supports the 31-gene GEP's ability to stratify early-stage CM patients into two groups with significantly different metastatic risk. RFS outcomes in this real-world cohort are consistent with previously published analyses with retrospective specimens. GEP testing complements current clinicopathologic features and increases identification of high-risk patients. ClinicalTrials.gov, NCT02355574 and NCT02355587.
GPS water vapor and its comparison with radiosonde and ERA-Interim data in Algeria
NASA Astrophysics Data System (ADS)
Namaoui, Houaria; Kahlouche, Salem; Belbachir, Ahmed Hafid; Van Malderen, Roeland; Brenot, Hugues; Pottiaux, Eric
2017-05-01
Remote sensing of atmospheric water vapor using global positioning system (GPS) data has become an effective tool in meteorology, weather forecasting and climate research. This paper presents the estimation of precipitable water (PW) from GPS observations and meteorological data in Algeria, over three stations located at Algiers, Bechar and Tamanrasset. The objective of this study is to analyze the sensitivity of the GPS PW estimates for the three sites to the weighted mean temperature ( T m), obtained separately from two types of T m- T s regression [one general, and one developed specifically for Algeria ( T s stands for surface temperature)], and calculated directly from ERA-Interim data. The results show that the differences in T m are of the order of 18 K, producing differences of 2.01 mm in the final evaluation of PW. A good agreement is found between GPS-PW and PW calculated from radiosondes, with a small mean difference with Vaisala radiosondes. A comparison between GPS and ERA-Interim shows a large difference (4 mm) in the highlands region. This difference is possibly due to the topography. These first results are encouraging, in particular for meteorological applications in this region, with good hope to extend our dataset analysis to a more complete, nationwide coverage over Algeria.
Kadowaki, Takashi; Haneda, Masakazu; Ito, Hiroshi; Ueno, Makoto; Matsukawa, Miyuki; Yamakura, Tomoko; Sasaki, Kazuyo; Kimura, Mayumi; Iijima, Hiroaki
2018-02-01
This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients. We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time. Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups. These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.
Analysis of Transportation Options for Commercial Spent Fuel in the U.S.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Kalinina, Elena; Busch, Ingrid Karin
The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S.more » Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and 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Arzimanoglou, Alexis; Ferreira, Jose A; Satlin, Andrew; Mendes, Shannon; Williams, Betsy; Critchley, David; Schuck, Edgar; Hussein, Ziad; Kumar, Dinesh; Dhadda, Shobha; Bibbiani, Francesco
2016-05-01
A good knowledge of safety and age group-specific pharmacokinetics (PK) of antiepileptic drugs (AEDs) in young pediatric patients is of great importance in clinical practice. This paper presents 6-month interim safety and PK from an ongoing 2-year open-label study (Study 303) of adjunctive rufinamide treatment in pediatric subjects ≥ 1 to < 4 years with inadequately controlled epilepsies of the Lennox-Gastaut syndrome (LGS) spectrum. Subjects (N = 37) were randomized to either rufinamide or any other approved AED chosen by the investigator as adjunctive therapy to the subject's existing regimen of 1-3 AEDs. Interim safety results showed that treatment-emergent adverse events (TEAEs) were similar between the rufinamide (22 [88.0%]) and any-other-AED group (9 [81.8%]), with most events considered mild or moderate. A population PK analysis was conducted including plasma rufinamide concentrations from Study 303 and two other study populations of LGS subjects ≥ 4 years. The rufinamide PK profile was dose independent. The apparent clearance (CL/F) estimated from the PK model was 2.19 L/h; it was found to increase significantly as a function of body weight. Coadministration of valproic acid significantly decreased rufinamide CL/F. CL/F was not significantly affected by other concomitant AEDs, age, gender, race, hepatic function, or renal function. No adjustments to body weight-based rufinamide dosing in subjects ≥ 1 to < 4 years are necessary. Rufinamide was safe and well tolerated in these pediatric subjects. Results from the interim analysis demonstrate that rufinamide's safety and PK profile is comparable in subjects ≥ 1 to < 4 and ≥ 4 years with LGS. Study 303 (clinicaltrials.gov: NCT01405053). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
NASA Astrophysics Data System (ADS)
Wegmann, Martin; Dutra, Emanuel; Jacobi, Hans-Werner; Zolina, Olga
2018-06-01
This study uses daily observations and modern reanalyses in order to evaluate reanalysis products over northern Eurasia regarding the spring snow albedo feedback (SAF) during the period from 2000 to 2013. We used the state-of-the-art reanalyses from ERA-Interim/Land and the Modern-Era Retrospective Analysis for Research and Applications version 2 (MERRA-2) as well as an experimental set-up of ERA-Interim/Land with prescribed short grass as land cover to enhance the comparability with the station data while underlining the caveats of comparing in situ observations with gridded data. Snow depth statistics derived from daily station data are well reproduced in all three reanalyses. However day-to-day albedo variability is notably higher at the stations than for any reanalysis product. The ERA-Interim grass set-up shows improved performance when representing albedo variability and generates comparable estimates for the snow albedo in spring. We find that modern reanalyses show a physically consistent representation of SAF, with realistic spatial patterns and area-averaged sensitivity estimates. However, station-based SAF values are significantly higher than in the reanalyses, which is mostly driven by the stronger contrast between snow and snow-free albedo. Switching to grass-only vegetation in ERA-Interim/Land increases the SAF values up to the level of station-based estimates. We found no significant trend in the examined 14-year time series of SAF, but interannual changes of about 0.5 % K-1 in both station-based and reanalysis estimates were derived. This interannual variability is primarily dominated by the variability in the snowmelt sensitivity, which is correctly captured in reanalysis products. Although modern reanalyses perform well for snow variables, efforts should be made to improve the representation of dynamic albedo changes.
48 CFR 852.236-83 - Payments under fixed-price construction contracts (including NAS).
Code of Federal Regulations, 2013 CFR
2013-10-01
... shall show on the critical path method (CPM) network the total cost of the guarantee period services in... prescribed in 832.111, insert the following clause in contracts that contain a section entitled “Network...) Failure either to meet schedules in Section Network Analysis System (NAS), or to process the Interim Arrow...
48 CFR 852.236-83 - Payments under fixed-price construction contracts (including NAS).
Code of Federal Regulations, 2014 CFR
2014-10-01
... shall show on the critical path method (CPM) network the total cost of the guarantee period services in... prescribed in 832.111, insert the following clause in contracts that contain a section entitled “Network...) Failure either to meet schedules in Section Network Analysis System (NAS), or to process the Interim Arrow...
48 CFR 852.236-83 - Payments under fixed-price construction contracts (including NAS).
Code of Federal Regulations, 2012 CFR
2012-10-01
... shall show on the critical path method (CPM) network the total cost of the guarantee period services in... prescribed in 832.111, insert the following clause in contracts that contain a section entitled “Network...) Failure either to meet schedules in Section Network Analysis System (NAS), or to process the Interim Arrow...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Cumberland, Riley M.; Williams, Kent Alan; Jarrell, Joshua J.
This report evaluates how the economic environment (i.e., discount rate, inflation rate, escalation rate) can impact previously estimated differences in lifecycle costs between an integrated waste management system with an interim storage facility (ISF) and a similar system without an ISF.
78 FR 48503 - Proposed Revision to Missiles Generated by Extreme Winds
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-08
...-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR..., ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants,'' and Interim Staff Guidance DC... and Hurricane Missiles for Nuclear Power Plants'' (ADAMS, Accession No. ML110940300), and Interim...
Fit of interim crowns fabricated using photopolymer-jetting 3D printing.
Mai, Hang-Nga; Lee, Kyu-Bok; Lee, Du-Hyeong
2017-08-01
The fit of interim crowns fabricated using 3-dimensional (3D) printing is unknown. The purpose of this in vitro study was to evaluate the fit of interim crowns fabricated using photopolymer-jetting 3D printing and to compare it with that of milling and compression molding methods. Twelve study models were fabricated by making an impression of a metal master model of the mandibular first molar. On each study model, interim crowns (N=36) were fabricated using compression molding (molding group, n=12), milling (milling group, n=12), and 3D polymer-jetting methods. The crowns were prepared as follows: molding group, overimpression technique; milling group, a 5-axis dental milling machine; and polymer-jetting group using a 3D printer. The fit of interim crowns was evaluated in the proximal, marginal, internal axial, and internal occlusal regions by using the image-superimposition and silicone-replica techniques. The Mann-Whitney U test and Kruskal-Wallis tests were used to compare the results among groups (α=.05). Compared with the molding group, the milling and polymer-jetting groups showed more accurate results in the proximal and marginal regions (P<.001). In the axial regions, even though the mean discrepancy was smallest in the molding group, the data showed large deviations. In the occlusal region, the polymer-jetting group was the most accurate, and compared with the other groups, the milling group showed larger internal discrepancies (P<.001). Polymer-jet 3D printing significantly enhanced the fit of interim crowns, particularly in the occlusal region. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Wu, Wenting; Bot, Brian; Hu, Yan; Geyer, Susan M; Sargent, Daniel J
2013-07-01
Sargent and Goldberg [1] proposed a randomized phase II flexible screening design (SG design) which took multiple characteristics of candidate regimens into consideration in selecting a regimen for further phase III testing. In this paper, we extend the SG design by including provisions for an interim analysis and/or a comparison to a historical control. By including a comparison with a historical control, a modified SG design not only identifies a more promising treatment but also assures that the regimen has a clinically meaningful level of efficacy as compared to a historical control. By including an interim analysis, a modified SG design could reduce the number of patients exposed to inferior treatment regimens. When compared to the original SG design, the modified designs increase the sample size moderately, but expand the utility of the flexible screening design substantially. Copyright © 2013 Elsevier Inc. All rights reserved.
Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study
NASA Astrophysics Data System (ADS)
Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas
2017-03-01
Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.
Image guidance improves localization of sonographically occult colorectal liver metastases
NASA Astrophysics Data System (ADS)
Leung, Universe; Simpson, Amber L.; Adams, Lauryn B.; Jarnagin, William R.; Miga, Michael I.; Kingham, T. Peter
2015-03-01
Assessing the therapeutic benefit of surgical navigation systems is a challenging problem in image-guided surgery. The exact clinical indications for patients that may benefit from these systems is not always clear, particularly for abdominal surgery where image-guidance systems have failed to take hold in the same way as orthopedic and neurosurgical applications. We report interim analysis of a prospective clinical trial for localizing small colorectal liver metastases using the Explorer system (Path Finder Technologies, Nashville, TN). Colorectal liver metastases are small lesions that can be difficult to identify with conventional intraoperative ultrasound due to echogeneity changes in the liver as a result of chemotherapy and other preoperative treatments. Interim analysis with eighteen patients shows that 9 of 15 (60%) of these occult lesions could be detected with image guidance. Image guidance changed intraoperative management in 3 (17%) cases. These results suggest that image guidance is a promising tool for localization of small occult liver metastases and that the indications for image-guided surgery are expanding.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Yoon, Dok Hyun; Cho, Yoojin; Kim, Sang Yoon
2011-09-01
Purpose: Induction chemotherapy (ICT) has been used to select patients for organ preservation and determine subsequent treatments in patients with locally advanced squamous cell carcinoma of the head and neck (LASCCHN). Still, the clinical outcomes of LASCCHN patients who showed response to ICT are heterogeneous. We evaluated the efficacy of interim 18-fluoro-2-deoxy-glucose positron emission tomography (FDG-PET) after ICT in this specific subgroup of LASCCHN patients who achieved partial response (PR) after ICT to predict clinical outcomes after concurrent chemoradiotherapy (CCRT). Methods and Materials: Twenty-one patients with LASCCHN who showed PR to ICT by Response Evaluation Criteria In Solid Tumors beforemore » definitive CCRT were chosen in this retrospective analysis. FDG-PET was performed before and 2-4 weeks after ICT to assess the extent of disease at baseline and the metabolic response to ICT, respectively. We examined the correlation of the metabolic response by the percentage decrease of maximum standardized uptake value (SUVmax) on the primary tumor or lymph node after ICT or a specific threshold of SUVmax on interim FDG-PET with clinical outcomes including complete response (CR) rate to CCRT, progression-free survival (PFS), and overall survival (OS). Results: A SUVmax of 4.8 on interim FDG-PET could predict clinical CR after CCRT (100% vs. 20%, p = 0.001), PFS (median, not reached vs. 8.5 mo, p < 0.001), and OS (median, not reached vs. 12.0 months, p = 0.001) with a median follow-up of 20.3 months in surviving patients. A 65% decrease in SUVmax after ICT from baseline also could predict clinical CR after CCRT (100% vs. 33.3%, p = 0.003), PFS (median, not reached vs. 8.9 months, p < 0.001) and OS (median, not reached vs. 24.4 months, p = 0.001) of the patients. Conclusion: These data suggest that interim FDG-PET after ICT might be a useful determinant to predict clinical outcomes in patients with LASCCHN receiving sequential ICT followed by CCRT.« less
Noh, Ji Yun; Lim, Sooyeon; Song, Joon Young; Choi, Won Suk; Jeong, Hye Won; Heo, Jung Yeon; Lee, Jacob; Seo, Yu Bin; Lee, Jin-Soo; Wie, Seong Heon; Kim, Young Keun; Park, Kyung Hwa; Jung, Sook-In; Kim, Shin Woo; Lee, Sun Hee; Lee, Han Sol; Yoon, Young Hoon; Cheong, Hee Jin; Kim, Woo Joo
2017-01-01
In the 2016-2017 season, the A(H3N2) influenza epidemic presented an unusual early peak pattern compared with past seasons in South Korea. The interim vaccine effectiveness (VE) of influenza vaccination in preventing laboratory-confirmed influenza was estimated using test-negative design through the tertiary hospital-based influenza surveillance system in South Korea. From 1 September, 2016 to 7 January, 2017, adjusted VE of influenza vaccination in preventing laboratory-confirmed A(H3N2) was -52.1% (95% confidence interval [CI], -147.2 to 6.4); -70.0% (95% CI, -212.0 to 7.4) in 19-64 years and 4.3% (95% CI, -137.8 to 61.5) in the elderly. Circulating A(H3N2) viruses belonged to the three phylogenetic subclades of 3C.2a, differently to A/Hong Kong/4801/2014, the current vaccine strain. Amino acid substitutions in hemagglutinin of circulating viruses seem to contribute to low VE. In conclusion, interim VE analysis presented that the protection of laboratory-confirmed influenza by seasonal influenza vaccination did not show the statistical significance in South Korea in the 2016-2017 influenza season.
Shimura, Masashi; Maruo, Kazushi; Gosho, Masahiko
2018-04-23
Two-stage designs are widely used to determine whether a clinical trial should be terminated early. In such trials, a maximum likelihood estimate is often adopted to describe the difference in efficacy between the experimental and reference treatments; however, this method is known to display conditional bias. To reduce such bias, a conditional mean-adjusted estimator (CMAE) has been proposed, although the remaining bias may be nonnegligible when a trial is stopped for efficacy at the interim analysis. We propose a new estimator for adjusting the conditional bias of the treatment effect by extending the idea of the CMAE. This estimator is calculated by weighting the maximum likelihood estimate obtained at the interim analysis and the effect size prespecified when calculating the sample size. We evaluate the performance of the proposed estimator through analytical and simulation studies in various settings in which a trial is stopped for efficacy or futility at the interim analysis. We find that the conditional bias of the proposed estimator is smaller than that of the CMAE when the information time at the interim analysis is small. In addition, the mean-squared error of the proposed estimator is also smaller than that of the CMAE. In conclusion, we recommend the use of the proposed estimator for trials that are terminated early for efficacy or futility. Copyright © 2018 John Wiley & Sons, Ltd.
Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis.
Miller, Frank; Björnsson, Marcus; Svensson, Ola; Karlsten, Rolf
2014-03-01
Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase IIa study followed by a Phase IIb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach. Copyright © 2014 Elsevier Inc. All rights reserved.
Code of Federal Regulations, 2011 CFR
2011-01-01
... Definitions. In this part: Student is an individual who is enrolled not less than half-time in a high school, trade school, technical or vocational institute, junior college, college, university or other accredited... interim between school years if the interim is not more than 5 months and if such individual shows to the...
Code of Federal Regulations, 2013 CFR
2013-01-01
... Definitions. In this part: Student is an individual who is enrolled not less than half-time in a high school, trade school, technical or vocational institute, junior college, college, university or other accredited... interim between school years if the interim is not more than 5 months and if such individual shows to the...
Code of Federal Regulations, 2014 CFR
2014-01-01
... Definitions. In this part: Student is an individual who is enrolled not less than half-time in a high school, trade school, technical or vocational institute, junior college, college, university or other accredited... interim between school years if the interim is not more than 5 months and if such individual shows to the...
Code of Federal Regulations, 2012 CFR
2012-01-01
... Definitions. In this part: Student is an individual who is enrolled not less than half-time in a high school, trade school, technical or vocational institute, junior college, college, university or other accredited... interim between school years if the interim is not more than 5 months and if such individual shows to the...
ERIC Educational Resources Information Center
Granville, Arthur C.; Love, John M.
This brief report summarizes the analysis and conclusions presented in detail in Interim Report VI regarding the feasibility of conducting a longitudinal study of Project Developmental Continuity (PDC). This project is a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and…
Interim Assessment Data: A Case Study on Modifying Instruction Based on Benchmark Feedback
ERIC Educational Resources Information Center
Lange, Tracey M.
2014-01-01
The role of data analysis in the jobs of instructional leaders has become as commonplace as teachers creating lesson plans and taking roll in the classroom. Teachers and building leaders routinely use interim assessment data to develop thoughtful and robust instructional plans that address identified areas of student need. The link between the…
Feasibility Analysis and Prototyping of a Fast Autonomous Recon system
2017-06-01
Test and Evaluation Interim Contractor Support System Assessment OPERATIONAL USE AND SYSTEM SUPPORT System Operation in the User Environment...Sustaining Maintenance and Logistics Support Operational Testing System Modifications for Improvement Contractor Support System Assessment...helicopter but has the added benefit of high -speed flight similar to a fixed-wing aircraft. Figure 1 shows the two different flight modes of the V-22
NASA Astrophysics Data System (ADS)
Kishore, P.; Jyothi, S.; Basha, Ghouse; Rao, S. V. B.; Rajeevan, M.; Velicogna, Isabella; Sutterley, Tyler C.
2016-01-01
Changing rainfall patterns have significant effect on water resources, agriculture output in many countries, especially the country like India where the economy depends on rain-fed agriculture. Rainfall over India has large spatial as well as temporal variability. To understand the variability in rainfall, spatial-temporal analyses of rainfall have been studied by using 107 (1901-2007) years of daily gridded India Meteorological Department (IMD) rainfall datasets. Further, the validation of IMD precipitation data is carried out with different observational and different reanalysis datasets during the period from 1989 to 2007. The Global Precipitation Climatology Project data shows similar features as that of IMD with high degree of comparison, whereas Asian Precipitation-Highly-Resolved Observational Data Integration Towards Evaluation data show similar features but with large differences, especially over northwest, west coast and western Himalayas. Spatially, large deviation is observed in the interior peninsula during the monsoon season with National Aeronautics Space Administration-Modern Era Retrospective-analysis for Research and Applications (NASA-MERRA), pre-monsoon with Japanese 25 years Re Analysis (JRA-25), and post-monsoon with climate forecast system reanalysis (CFSR) reanalysis datasets. Among the reanalysis datasets, European Centre for Medium-Range Weather Forecasts Interim Re-Analysis (ERA-Interim) shows good comparison followed by CFSR, NASA-MERRA, and JRA-25. Further, for the first time, with high resolution and long-term IMD data, the spatial distribution of trends is estimated using robust regression analysis technique on the annual and seasonal rainfall data with respect to different regions of India. Significant positive and negative trends are noticed in the whole time series of data during the monsoon season. The northeast and west coast of the Indian region shows significant positive trends and negative trends over western Himalayas and north central Indian region.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mays, S.E.; Poloski, J.P.; Sullivan, W.H.
1982-07-01
This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix C generally describes the methods used to estimate accident sequence frequency values. Information is presented concerning the approach, example collection, failure data, candidate dominant sequences, uncertainty analysis, and sensitivity analysis.
ERIC Educational Resources Information Center
Smith, Allen G.; And Others
This third year interim report, one of a series of documents on the evaluation of Project Developmental Continuity (PDC), presents findings from three major analyses of program implementation; measurement of the extent each program has implemented the basic PDC Guidelines; a description of patterns of that implementation; and analysis of some…
ERIC Educational Resources Information Center
Frazier, Don
The major purpose of this study was to identify unique effects of cooperative vocational education. This interim report is of results of the analyses of existing data bases. Comparisons of cooperative and non-cooperative vocational programs are made on the following variables: enrollments by age, sex and race, school status, work status,…
National Home Start Evaluation Interim Report VII. Twenty-Month Program Analysis and Findings.
ERIC Educational Resources Information Center
Love, John M.; And Others
This interim evaluation report focuses on process (formative) and outcome (summative) data collected in spring 1975 on the National Home Start Program. Home Start, a federally-funded 3-year (1972-1975) home-based demonstration program for low-income families with 3- to 5-year-old children was designed to enhance a mother's skills in dealing with…
Structural Analysis of the Redesigned Ice/Frost Ramp Bracket
NASA Technical Reports Server (NTRS)
Phillips, D. R.; Dawicke, D. S.; Gentz, S. J.; Roberts, P. W.; Raju, I. S.
2007-01-01
This paper describes the interim structural analysis of a redesigned Ice/Frost Ramp bracket for the Space Shuttle External Tank (ET). The proposed redesigned bracket consists of mounts for attachment to the ET wall, supports for the electronic/instrument cables and propellant repressurization lines that run along the ET, an upper plate, a lower plate, and complex bolted connections. The eight nominal bolted connections are considered critical in the summarized structural analysis. Each bolted connection contains a bolt, a nut, four washers, and a non-metallic spacer and block that are designed for thermal insulation. A three-dimensional (3D) finite element model of the bracket is developed using solid 10-node tetrahedral elements. The loading provided by the ET Project is used in the analysis. Because of the complexities associated with accurately modeling the bolted connections in the bracket, the analysis is performed using a global/local analysis procedure. The finite element analysis of the bracket identifies one of the eight bolted connections as having high stress concentrations. A local area of the bracket surrounding this bolted connection is extracted from the global model and used as a local model. Within the local model, the various components of the bolted connection are refined, and contact is introduced along the appropriate interfaces determined by the analysts. The deformations from the global model are applied as boundary conditions to the local model. The results from the global/local analysis show that while the stresses in the bolts are well within yield, the spacers fail due to compression. The primary objective of the interim structural analysis is to show concept viability for static thermal testing. The proposed design concept would undergo continued design optimization to address the identified analytical assumptions and concept shortcomings, assuming successful thermal testing.
Castelnuovo, Gianluca; Manzoni, Gian Mauro; Cuzziol, Paola; Cesa, Gian Luca; Corti, Stefania; Tuzzi, Cristina; Villa, Valentina; Liuzzi, Antonio; Petroni, Maria Letizia; Molinari, Enrico
2011-03-04
Obesity increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private care-costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated. Information and communication technologies (ICT) can help clinicians to deliver treatment in a cost-effective and time-saving manner to a large number of obese individuals with co-morbidities. To examine ad interim effectiveness of a 12-month multidisciplinary telecare intervention for weight loss provided to obese patients with type 2 diabetes. A single-center randomized controlled trial (TECNOB study) started in December 2008. At present, 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. Study is still on-going. All participants attended 1-month inpatient intensive program that involved individualized medical care, diet therapy, physical training and brief psychological counseling. At discharge, participants allocated to the TECNOB program were instructed to use a weight-loss web-site, a web-based videoconference tool, a dietary software installed into their cellular phones and an electronic armband measuring daily steps and energy expenditure. Weight and disordered eating-related behaviors and cognitions (EDI-2) at entry to hospital, at discharge from hospital, at 3,6 and 12 months. Ad interim analysis of data from 34 participants showed no statistically significant difference between groups in weight change at any time-point. However, within-group analysis revealed significant reductions of initial weight at discharge from hospital, at 3 months, at 6 months but not at 12 months. Control group had higher scores in Interpersonal distrust at 12 months. This ad interim findings revealed that the effect of the inpatient treatment was high and probably overwhelmed the effect of the TECNOB intervention. Much statistical power and long-term follow-up may enhance the probability to detect the TECNOB effect over and above the great one exerted by the inpatient program.
ERIC Educational Resources Information Center
Rochester City School District, NY.
This is an interim report of the second full year of the "Fifteen Point Plan." Although majority of comparisons between groups shows no significant statistical differences, differentials in achievement may become more noticeable as the program effects are reinforced with time, and through cumulative experience. From data analyzed after…
NASA Astrophysics Data System (ADS)
Kunstmann, H.; Lorenz, C.
2012-12-01
The three state-of-the-art global atmospheric reanalysis models—namely, ECMWF Interim Re-Analysis (ERA-Interim), Modern-Era Retrospective Analysis for Research and Applications (MERRA; NASA), and Climate Forecast System Reanalysis (CFSR; NCEP)—are analyzed and compared with independent observations (GPCC; GPCP; CRU; CPC; DEL; HOAPS) in the period between 1989 and 2006. Comparison of precipitation and temperature estimates from the three models with gridded observations reveals large differences between the reanalyses and also of the observation datasets. A major source of uncertainty in the observations is the spatial distribution and change of the number of gauges over time. In South America for example, active measuring stations were reduced from 4267 to 390. The quality of precipitation estimates from the reanalyses strongly depends on the geographic location, as there are significant differences especially in tropical regions. The closure of the water cycle in the three reanalyses is analyzed by estimating long-term mean values for precipitation, evapotranspiration, surface runoff, and moisture flux divergence. Major shortcomings in the moisture budgets of the datasets are mainly due to inconsistencies of the net precipitation minus evaporation and evapotranspiration, respectively, (P-E) estimates over the oceans and landmasses. This imbalance largely originates from the assimilation of radiance sounding data from the NOAA-15 satellite, which results in an unrealistic increase of oceanic P-E in the MERRA and CFSR budgets. Overall, ERA-Interim shows both a comparatively reasonable closure of the terrestrial and atmospheric water balance and a reasonable agreement with the observation datasets. The limited performance of the three state-of-the-art reanalyses in reproducing the hydrological cycle, however, puts the use of these models for climate trend analyses and long-term water budget studies into question.
Alpha emitter radium-223 and survival in metastatic prostate cancer.
Parker, C; Nilsson, S; Heinrich, D; Helle, S I; O'Sullivan, J M; Fosså, S D; Chodacki, A; Wiechno, P; Logue, J; Seke, M; Widmark, A; Johannessen, D C; Hoskin, P; Bottomley, D; James, N D; Solberg, A; Syndikus, I; Kliment, J; Wedel, S; Boehmer, S; Dall'Oglio, M; Franzén, L; Coleman, R; Vogelzang, N J; O'Bryan-Tear, C G; Staudacher, K; Garcia-Vargas, J; Shan, M; Bruland, Ø S; Sartor, O
2013-07-18
Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.).
Schrader, M; Zengerling, F; Hakenberg, O W; Protzel, C
2016-09-01
The second-opinion network for testicular cancer is an internet-based platform addressing physicians treating testicular cancer patients. They are offered a second-opinion before determining further therapy after orchiectomy and completion of staging. The high rate of discrepancies between the first and second opinion in more than 30 % supports the assumption of a deficit in the implementation of treatment guidelines. In 2015, approximately 22 % of the newly diagnosed cases with testicular cancer in Germany were covered by this system. According to the present interim analysis, the second-opinion platform helps to avoid overtreatment of testicular cancer patients. The high acceptance of the project and the encouraging results of this interim analysis gave rise to considerations to apply the second-opinion model to penile carcinoma. Data from the UK and the Netherlands show that the second-opinion network for penile cancer could help to improve treatment standards and results in Germany. Current data and the intended further development of the system are discussed.
Tang, Zhongwen
2015-01-01
An analytical way to compute predictive probability of success (PPOS) together with credible interval at interim analysis (IA) is developed for big clinical trials with time-to-event endpoints. The method takes account of the fixed data up to IA, the amount of uncertainty in future data, and uncertainty about parameters. Predictive power is a special type of PPOS. The result is confirmed by simulation. An optimal design is proposed by finding optimal combination of analysis time and futility cutoff based on some PPOS criteria.
Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi
2018-03-01
Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with previous clinical trials in Japan and the rest of the world. Thus, these results provided another corroboration of the tolerability of ambrisentan and we continue to monitor proper use information via the post-marketing surveillance to ensure any new safety signals are identified in a timely manner (ClinTrial.gov: NCT01406327).
Sachpekidis, Christos; Anwar, Hoda; Winkler, Julia; Kopp-Schneider, Annette; Larribere, Lionel; Haberkorn, Uwe; Hassel, Jessica C; Dimitrakopoulou-Strauss, Antonia
2018-07-01
The aim of the present study was to assess the value of interim 18 F-FDG PET/CT performed after the first two cycles of ipilimumab treatment in the prediction of the final clinical response to this type of immunotherapy. The study group comprised 41 patients with unresectable metastatic melanoma scheduled for ipilimumab therapy. Whole-body 18 F-FDG PET/CT was performed before the start of ipilimumab treatment (baseline PET/CT) and after the initial two cycles of ipilimumab treatment (interim PET/CT). Evaluation of patient response to treatment was based on the European Organization for Research and Treatment of Cancer (EORTC) 1999 criteria for PET as well as the recently proposed PET Response Evaluation Criteria for Immunotherapy (PERCIMT). The patients' best clinical response, assessed at a median of 21.4 months (range 6.3-41.9 months) was used as reference. According to their best clinical response, the patients were divided into two groups: those showing clinical benefit (CB) including stable disease, partial response and complete response (31 patients), and those showing no clinical benefit (no-CB including progressive disease (10 patients). According to the EORTC criteria, interim PET/CT demonstrated progressive metabolic disease (PMD) in 20 patients, stable metabolic disease (SMD) in 11 patients, partial metabolic response (PMR) in 8 patients, and complete metabolic response (CMR) in 2 patients. According to the PERCIMT, interim PET/CT demonstrated PMD in 9 patients, SMD in 24 patients, PMR in 6 patients and CMR in 2 patients. On the basis of the interim PET, the patients were divided in a similar manner to the division according to clinical response into those showing metabolic benefit (MB) including SMD, PMR and CMR, and those showing no metabolic benefit (no-MB) including PMD. According to this dichotomization, the EORTC criteria showed a sensitivity (correctly predicting CB) of 64.5%, a specificity (correctly predicting no-CB) of 90.0%, a positive predictive value (PPV) of 95.2%, a negative predictive value (NPV) of 45.0% and an accuracy of 70.7% in predicting best clinical response. The PERCIMT showed a sensitivity of 93.6%, a specificity of 70.0%, a PPV of 90.6%, a NPV of 77.8% and an accuracy of 87.8%. The McNemar test showed that the PERCIMT had a significantly higher sensitivity than EORTC criteria (p = 0.004), while there was no significant difference in specificity (p = 0.5). The agreement between the two sets of criteria was poor (McNemar test p = 0.001, and accordingly kappa = 0.46). The application of the recently proposed PERCIMT to interim 18 F-FDG PET/CT provides a more sensitive predictor of final clinical response to immunotherapy than the application of the EORTC criteria in patients with metastatic melanoma.
ERIC Educational Resources Information Center
Granville, Arthur C.; And Others
This interim report, part of a series of documents examining the feasibility of the longitudinal evaluation of Project Developmental Continuity (PDC), presents the results of an analysis of PDC impact at the Head Start level, using Spring 1977 data. PDC is a Head Start Demonstration Program aimed at providing educational and developmental…
Effectiveness Monitoring Report, MWMF Tritium Phytoremediation Interim Measures.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hitchcock, Dan; Blake, John, I.
2003-02-10
This report describes and presents the results of monitoring activities during irrigation operations for the calendar year 2001 of the MWMF Interim Measures Tritium Phytoremediation Project. The purpose of this effectiveness monitoring report is to provide the information on instrument performance, analysis of CY2001 measurements, and critical relationships needed to manage irrigation operations, estimate efficiency and validate the water and tritium balance model.
Thompson, Geoffrey A; Luo, Qing
2014-09-01
Because polymer-based interim restorative materials are weak, even well-made restorations sometimes fail before the definitive restoration is ready for insertion. Therefore, knowing which fabrication procedures and service conditions affect mechanical properties is important, particularly over an extended period. The purpose of this study was to evaluate the effect of thermal treatment, surface sealing, thermocycling, storage media, storage temperature, and age on autopolymerizing poly(methylmethacrylate) and bis-acryl interim restorative materials. Outcome measures were flexural strength, Vickers surface microhardness, and impact strength. Flexural strength and microhardness of poly(methylmethacrylate) (Jet Acrylic) and 2 bis-acryl-composite resin (Protemp 3 Garant and Integrity) interim restorative materials were evaluated as affected by storage media, storage temperature, storage time, thermocycling, postpolymerization thermal treatment, or application of a surface sealer. In total, 2880 beam specimens (25×2×2 mm) were fabricated. Mechanical property analyses were made at 10 days, 30 days, 6 months, and 1 year after specimen preparation. Flexural strength was determined by using a 3-point bending test in a universal testing machine with a 1 kN load cell at a crosshead speed of 5.0 mm min(-1). Fracture specimens were recovered and used for determining Vickers microhardness. Measurements were made with a 0.1 N load and 15 second dwell time. Three microhardness measurements were made for each specimen, and the mean was used for reporting Vickers microhardness. Notched impact specimens (64×12.7×6.35 mm) were fabricated from Jet, Protemp 3 Garant, and Integrity interim restorative materials, yielding 288 impact specimens. Impact strengths were assessed at 10 days, 30 days, 6 months, and 1 year with a 2 J pendulum. The effects of the various experimental treatments were determined and rank ordered with analysis of variance, F ratios, and least square means differences Student t tests (α=.05). All experimental treatments investigated had significant effects on flexural strength, with material (P<.001) and thermocycling (P<.001) being dominant. Moreover, all experimental treatments investigated had a significant overall impact on Vickers microhardness with material (P<.001) and Palaseal glaze (P<.001) showing large effects. Material (P<.001) and age (P=.010) had a significant effect on impact strength. Mechanical properties of some interim polymeric materials can be improved by postpolymerization heat treatments or surface glazing. This procedure may extend the useful lifetime of some bis-acryl interim restorations. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Tropical cyclone genesis potential index over the western North Pacific simulated by CMIP5 models
NASA Astrophysics Data System (ADS)
Song, Yajuan; Wang, Lei; Lei, Xiaoyan; Wang, Xidong
2015-11-01
Tropical cyclone (TC) genesis over the western North Pacific (WNP) is analyzed using 23 CMIP5 (Coupled Model Intercomparison Project Phase 5) models and reanalysis datasets. The models are evaluated according to TC genesis potential index (GPI). The spatial and temporal variations of the GPI are first calculated using three atmospheric reanalysis datasets (ERA-Interim, NCEP/NCAR Reanalysis-1, and NCEP/DOE Reanalysis-2). Spatial distributions of July-October-mean TC frequency based on the GPI from ERA-interim are more consistent with observed ones derived from IBTrACS global TC data. So, the ERA-interim reanalysis dataset is used to examine the CMIP5 models in terms of reproducing GPI during the period 1982-2005. Although most models possess deficiencies in reproducing the spatial distribution of the GPI, their multimodel ensemble (MME) mean shows a reasonable climatological GPI pattern characterized by a high GPI zone along 20°N in the WNP. There was an upward trend of TC genesis frequency during 1982 to 1998, followed by a downward trend. Both MME results and reanalysis data can represent a robust increasing trend during 1982-1998, but the models cannot simulate the downward trend after 2000. Analysis based on future projection experiments shows that the GPI exhibits no significant change in the first half of the 21st century, and then starts to decrease at the end of the 21st century under the representative concentration pathway (RCP) 2.6 scenario. Under the RCP8.5 scenario, the GPI shows an increasing trend in the vicinity of 20°N, indicating more TCs could possibly be expected over the WNP under future global warming.
NASA Astrophysics Data System (ADS)
Wang, Junhong; Zhang, Liangying; Lin, Po-Hsiung; Bradford, Mark; Cole, Harold; Fox, Jack; Hock, Terry; Lauritsen, Dean; Loehrer, Scot; Martin, Charlie; Vanandel, Joseph; Weng, Chun-Hsiung; Young, Kathryn
2010-11-01
During the THORPEX (The Observing System Research and Predictability Experiment) Pacific Asian Regional Campaign (T-PARC), from 1 August to 30 September 2008, ˜1900 high-quality, high vertical resolution soundings were collected over the Pacific Ocean. These include dropsondes deployed from four aircrafts and zero-pressure balloons in the stratosphere (NCAR's Driftsonde system). The water vapor probability distribution and spatial variability in the northern subtropical Pacific (14°-20°N, 140°E-155°W) are studied using Driftsonde and COSMIC (Constellation Observing System for Meteorology, Ionosphere, and Climate) data and four global reanalysis products. Driftsonde data analysis shows distinct differences of relative humidity (RH) distributions in the free troposphere between the Eastern and Western Pacific (EP and WP, defined as east and west of 180°, respectively), very dry with a single peak of ˜1% RH in the EP and bi-modal distributions in the WP with one peak near ice saturation and one varying with altitude. The frequent occurrences of extreme dry air are found in the driftsonde data with 59% and 19% of RHs less than or equal to 5% and at 1% at 500 hPa in the EP, respectively. RH with respect to ice in the free troposphere exhibits considerable longitudinal variations, very low (<20%) in the EP, but varying from 20% to 100% in the WP. Inter-comparisons of Driftsonde, COSMIC and reanalysis data show generally good agreement among the Driftsonde, COSMIC, ECMWF Reanalysis-Interim (ERA-Interim) and Japanese Reanalysis (JRA) below 200 hPa. The ERA-Interim and JRA are approved to be successful on describing RH frequency distributions and spatial variations in the region. The comparisons also reveal problems in Driftsonde, two National Center for Environmental Prediction (NCEP) reanalyses and COSMIC data. The moist layer at 200-100 hPa in the WP shown in the ERA-Interim, JRA and COSMIC is missing in Driftsonde data. Major problems are found in the RH means and variability over the study region for both NCEP reanalyses. Although the higher-moisture layer at 200-100 hPa in the WP in the COSMIC data agrees well with the ERA-Interim and JRA, it is primarily attributed to the first guess of the 1-Dimensional (1D) variational analysis used in the COSMIC retrieval rather than the refractivity measurements. The limited soundings (total 268) of Driftsonde data are capable of portraying RH probability distributions and longitudinal variability. This implies that Driftsonde system has the potential to become a valuable operational system for upper air observations over the ocean.
Stevens, R B; Wrenshall, L E; Miles, C D; Farney, A C; Jie, T; Sandoz, J P; Rigley, T H; Osama Gaber, A
2016-06-01
A previous nonblinded, randomized, single-center renal transplantation trial of single-dose rabbit anti-thymocyte globulin induction (SD-rATG) showed improved efficacy compared with conventional divided-dose (DD-rATG) administration. The present multicenter, double-blind/double-dummy STAT trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated SD-rATG versus DD-rATG induction for noninferiority in early (7-day) safety and tolerability. Ninety-five patients (randomized 1:1) received 6 mg/kg SD-rATG or 1.5 mg/kg/dose DD-rATG, with tacrolimus-mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12-month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of SD-rATG induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown SD-rATG induction to be noninferior to DD-rATG induction in early tolerability and equivalent in 12-month safety. (Clinical Trials.gov #NCT00906204.). © Copyright 2016 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of the American Society of Transplantation and the American Society of Transplant Surgeons.
Regional Climate Model sesitivity to different parameterizations schemes with WRF over Spain
NASA Astrophysics Data System (ADS)
García-Valdecasas Ojeda, Matilde; Raquel Gámiz-Fortis, Sonia; Hidalgo-Muñoz, Jose Manuel; Argüeso, Daniel; Castro-Díez, Yolanda; Jesús Esteban-Parra, María
2015-04-01
The ability of the Weather Research and Forecasting (WRF) model to simulate the regional climate depends on the selection of an adequate combination of parameterization schemes. This study assesses WRF sensitivity to different parameterizations using six different runs that combined three cumulus, two microphysics and three surface/planetary boundary layer schemes in a topographically complex region such as Spain, for the period 1995-1996. Each of the simulations spanned a period of two years, and were carried out at a spatial resolution of 0.088° over a domain encompassing the Iberian Peninsula and nested in the coarser EURO-CORDEX domain (0.44° resolution). The experiments were driven by Interim ECMWF Re-Analysis (ERA-Interim) data. In addition, two different spectral nudging configurations were also analysed. The simulated precipitation and maximum and minimum temperatures from WRF were compared with Spain02 version 4 observational gridded datasets. The comparison was performed at different time scales with the purpose of evaluating the model capability to capture mean values and high-order statistics. ERA-Interim data was also compared with observations to determine the improvement obtained using dynamical downscaling with respect to the driving data. For this purpose, several parameters were analysed by directly comparing grid-points. On the other hand, the observational gridded data were grouped using a multistep regionalization to facilitate the comparison in term of monthly annual cycle and the percentiles of daily values analysed. The results confirm that no configuration performs best, but some combinations that produce better results could be chosen. Concerning temperatures, WRF provides an improvement over ERA-Interim. Overall, model outputs reduce the biases and the RMSE for monthly-mean maximum and minimum temperatures and are higher correlated with observations than ERA-Interim. The analysis shows that the Yonsei University planetary boundary layer scheme is the most appropriate parameterization in term of temperatures because it better describes monthly minimum temperatures and seems to perform well for maximum temperatures. Regarding precipitation, ERA-Interim time series are slightly higher correlated with observations than WRF, but the bias and the RMSE are largely worse. These results also suggest that CAM V.5.1 2-moment 5-class microphysics schemes should not be used due to the computational cost with no apparent gain with respect to simpler schemes such as WRF single-moment 3-class. For the convection scheme, this study suggests that Betts-Miller-Janjic scheme is an appropriate choice due to its robustness and Kain-Fritsch cumulus scheme should not be used over this region. KEY WORDS: Regional climate modelling, physics schemes, parameterizations, WRF. ACKNOWLEDGEMENTS This work has been financed by the projects P11-RNM-7941 (Junta de Andalucía-Spain) and CGL2013-48539-R (MINECO-Spain, FEDER).
Henderson, Shelley; Purdie, Colin; Michie, Caroline; Evans, Andrew; Lerski, Richard; Johnston, Marilyn; Vinnicombe, Sarah; Thompson, Alastair M
2017-11-01
To investigate whether interim changes in hetereogeneity (measured using entropy features) on MRI were associated with pathological residual cancer burden (RCB) at final surgery in patients receiving neoadjuvant chemotherapy (NAC) for primary breast cancer. This was a retrospective study of 88 consenting women (age: 30-79 years). Scanning was performed on a 3.0 T MRI scanner prior to NAC (baseline) and after 2-3 cycles of treatment (interim). Entropy was derived from the grey-level co-occurrence matrix, on slice-matched baseline/interim T2-weighted images. Response, assessed using RCB score on surgically resected specimens, was compared statistically with entropy/heterogeneity changes and ROC analysis performed. Association of pCR within each tumour immunophenotype was evaluated. Mean entropy percent differences between examinations, by response category, were: pCR: 32.8%, RCB-I: 10.5%, RCB-II: 9.7% and RCB-III: 3.0%. Association of ultimate pCR with coarse entropy changes between baseline/interim MRI across all lesions yielded 85.2% accuracy (area under ROC curve: 0.845). Excellent sensitivity/specificity was obtained for pCR prediction within each immunophenotype: ER+: 100%/100%; HER2+: 83.3%/95.7%, TNBC: 87.5%/80.0%. Lesion T2 heterogeneity changes are associated with response to NAC using RCB scores, particularly for pCR, and can be useful across all immunophenotypes with good diagnostic accuracy. • Texture analysis provides a means of measuring lesion heterogeneity on MRI images. • Heterogeneity changes between baseline/interim MRI can be linked with ultimate pathological response. • Heterogeneity changes give good diagnostic accuracy of pCR response across all immunophenotypes. • Percentage reduction in heterogeneity is associated with pCR with good accuracy and NPV.
Functions and requirements document for interim store solidified high-level and transuranic waste
DOE Office of Scientific and Technical Information (OSTI.GOV)
Smith-Fewell, M.A., Westinghouse Hanford
1996-05-17
The functions, requirements, interfaces, and architectures contained within the Functions and Requirements (F{ampersand}R) Document are based on the information currently contained within the TWRS Functions and Requirements database. The database also documents the set of technically defensible functions and requirements associated with the solidified waste interim storage mission.The F{ampersand}R Document provides a snapshot in time of the technical baseline for the project. The F{ampersand}R document is the product of functional analysis, requirements allocation and architectural structure definition. The technical baseline described in this document is traceable to the TWRS function 4.2.4.1, Interim Store Solidified Waste, and its related requirements, architecture,more » and interfaces.« less
NASA Technical Reports Server (NTRS)
Martinovic, Zoran N.; Cerro, Jeffrey A.
2002-01-01
This is an interim user's manual for current procedures used in the Vehicle Analysis Branch at NASA Langley Research Center, Hampton, Virginia, for launch vehicle structural subsystem weight estimation based on finite element modeling and structural analysis. The process is intended to complement traditional methods of conceptual and early preliminary structural design such as the application of empirical weight estimation or application of classical engineering design equations and criteria on one dimensional "line" models. Functions of two commercially available software codes are coupled together. Vehicle modeling and analysis are done using SDRC/I-DEAS, and structural sizing is performed with the Collier Research Corp. HyperSizer program.
NASA Astrophysics Data System (ADS)
Muhammed Naseef, T.; Sanil Kumar, V.
2017-10-01
An assessment of extreme wave characteristics during the design of marine facilities not only helps to ensure their safety but also assess the economic aspects. In this study, return levels of significant wave height (Hs) for different periods are estimated using the generalized extreme value distribution (GEV) and generalized Pareto distribution (GPD) based on the Waverider buoy data spanning 8 years and the ERA-Interim reanalysis data spanning 38 years. The analysis is carried out for wind-sea, swell and total Hs separately for buoy data. Seasonality of the prevailing wave climate is also considered in the analysis to provide return levels for short-term activities in the location. The study shows that the initial distribution method (IDM) underestimates return levels compared to GPD. The maximum return levels estimated by the GPD corresponding to 100 years are 5.10 m for the monsoon season (JJAS), 2.66 m for the pre-monsoon season (FMAM) and 4.28 m for the post-monsoon season (ONDJ). The intercomparison of return levels by block maxima (annual, seasonal and monthly maxima) and the r-largest method for GEV theory shows that the maximum return level for 100 years is 7.20 m in the r-largest series followed by monthly maxima (6.02 m) and annual maxima (AM) (5.66 m) series. The analysis is also carried out to understand the sensitivity of the number of observations for the GEV annual maxima estimates. It indicates that the variations in the standard deviation of the series caused by changes in the number of observations are positively correlated with the return level estimates. The 100-year return level results of Hs using the GEV method are comparable for short-term (2008 to 2016) buoy data (4.18 m) and long-term (1979 to 2016) ERA-Interim shallow data (4.39 m). The 6 h interval data tend to miss high values of Hs, and hence there is a significant difference in the 100-year return level Hs obtained using 6 h interval data compared to data at 0.5 h interval. The study shows that a single storm can cause a large difference in the 100-year Hs value.
Estimating trends in atmospheric water vapor and temperature time series over Germany
NASA Astrophysics Data System (ADS)
Alshawaf, Fadwa; Balidakis, Kyriakos; Dick, Galina; Heise, Stefan; Wickert, Jens
2017-08-01
Ground-based GNSS (Global Navigation Satellite System) has efficiently been used since the 1990s as a meteorological observing system. Recently scientists have used GNSS time series of precipitable water vapor (PWV) for climate research. In this work, we compare the temporal trends estimated from GNSS time series with those estimated from European Center for Medium-Range Weather Forecasts (ECMWF) reanalysis (ERA-Interim) data and meteorological measurements. We aim to evaluate climate evolution in Germany by monitoring different atmospheric variables such as temperature and PWV. PWV time series were obtained by three methods: (1) estimated from ground-based GNSS observations using the method of precise point positioning, (2) inferred from ERA-Interim reanalysis data, and (3) determined based on daily in situ measurements of temperature and relative humidity. The other relevant atmospheric parameters are available from surface measurements of meteorological stations or derived from ERA-Interim. The trends are estimated using two methods: the first applies least squares to deseasonalized time series and the second uses the Theil-Sen estimator. The trends estimated at 113 GNSS sites, with 10 to 19 years temporal coverage, vary between -1.5 and 2.3 mm decade-1 with standard deviations below 0.25 mm decade-1. These results were validated by estimating the trends from ERA-Interim data over the same time windows, which show similar values. These values of the trend depend on the length and the variations of the time series. Therefore, to give a mean value of the PWV trend over Germany, we estimated the trends using ERA-Interim spanning from 1991 to 2016 (26 years) at 227 synoptic stations over Germany. The ERA-Interim data show positive PWV trends of 0.33 ± 0.06 mm decade-1 with standard errors below 0.03 mm decade-1. The increment in PWV varies between 4.5 and 6.5 % per degree Celsius rise in temperature, which is comparable to the theoretical rate of the Clausius-Clapeyron equation.
NASA Astrophysics Data System (ADS)
Hodges, K.
2010-12-01
Re-analyses are produced using a forecast model, data assimilation system and historical observations. Whilst the observations are common between the re-analyses the way they are assimilated and the forecast model used are often different between the re-analyses which can introduce uncertainty in the representation of particular phenomena between the re-analyses, for example the distribution and properties of weather systems. It is important to inter-compare re-analyses to determine the uncertainty in their representation of the atmosphere, its circulation and weather systems in order to have confidence in their use for studies of the atmosphere and validating climate models. The four recent re-analyses, ERA-Interim, NASA-MERRA, NCEP-CFS and JRA25 are explored and compared for the representation of synoptic scale extra-tropical cyclones. Previous studies of the older re-analyses. ERA40, NCEP-NCAR and DOE has shown that whilst in the NH there was relatively good agreement between the re-analyses in terms of the distribution and properties of extra-tropical cyclones, in the SH there was much larger uncertainty. The newest re-analyses are produced at much higher resolutions than previous re-analyses, in addition more modern data assimilation systems and forecast models have been used. Hence, it would be hoped that the representation of cyclones will be improved to the same extent as that seen in modern NWP systems. This study contrasts extra-tropical cyclones, their distribution and properties, between these new re-analyses and compares them with cyclones in the slightly older though lower resolution JRA25 re-analysis. Results will show that in general in the higher resolution re-analysis more cyclones are identified than in JRA25. In the NH the distribution of storms agrees as well if not better than was the case for the older re-analyses. However, it is in the SH that the largest improvement in agreement is seen for the distribution of storms. For ERA-Interim, NASA-MERRA and NCEP-CFS the agreement in the SH is almost as good as in the NH with the best agreement occurring between ERA-Interim and NCEP-CFS. However, the comparison with JRA25 shows the same level of uncertainty as seen with the older re-analyses. Determining the separation distances of storms using storm matching confirm these results. The biggest differences between the re-analyses occurs for the intensity of storms with the NASA-MERRA having consistently the strongest extreme storms in terms of pressure and winds and JRA25 the weakest, ERA-Interim and NCEP-CFS are very similar in this respect. Using vorticity as an intensity measure shows the greatest sensitivity and goes with resolution. If time permits a comparison of the structure of the storms will also be presented. The approach used only highlights the uncertainty between the re-analyses it does not say which one is right. To try to address this some early results of comparing the re-analyses directly with observations of low level winds from scatterometers in the vicinity of storms will be presented if time permits.
van Beekhuizen, Heleen J; Tarimo, Vincent; Pembe, Andrea B; Fauteck, Heiner; Lotgering, Fred K
2013-09-01
To evaluate the efficacy and safety of misoprostol among patients with retained placenta in a low-resource setting. A prospective, multicenter, randomized, double-blind, placebo-controlled trial was carried out in Tanzania between April 2008 and November 2011. It included patients who delivered at a gestational age of 28 weeks or more and had blood loss of 750 mL or less at 30 minutes after delivery. Sublingual misoprostol (800 μg) was compared with placebo as the primary treatment. Power analysis showed that 117 patients would be required to observe a reduction of 40% in the incidence of manual removal of the placenta (MRP; P=0.05, 80% power), the primary outcome. The secondary outcomes were blood loss and number of blood transfusions. Interim analysis after recruitment of 95 patients showed that incidence of MRP, total blood loss, and incidence of blood transfusions were similar in the misoprostol (MRP, 40%; blood loss, 803 mL; blood transfusion, 15%) and placebo (MRP, 33%, blood loss 787 mL, blood transfusion, 23%) groups. The trial was stopped because continuation would not alter the interim conclusion that misoprostol was ineffective. Treatment with misoprostol was found to have no clinically significant beneficial effect among women with retained placenta. Current Controlled Trials ISRCTN16104753. Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
NASA Astrophysics Data System (ADS)
Vergados, P.; Mannucci, A. J.; Ao, C. O.; Verkhoglyadova, O. P.; Iijima, B.
2017-12-01
This presentation introduces the fundamentals of the Global Positioning System radio occultation (GPS RO) remote sensing technique in retrieving atmospheric temperature and humidity information and presents the use of these observations in climate research. Our objective is to demonstrate and establish the GPS RO remote sensing technique as a complementary data set to existing state-of-the-art space-based platforms for climate studies. We show how GPS RO measurements at 1.2-1.6 GHz frequency band can be used to infer the upper tropospheric water vapor and temperature feedbacks and we present a decade-long specific humidity (SH) record from January 2007 until December 2015. We cross-compare the GPS RO-estimated climate feedbacks and the SH long-record with independent data sets from the Modern-Era Retrospective Analysis for Research and Applications (MERRA), the European Center for Medium-range Weather Forecasts Re-Analysis Interim (ERA-Interim), and the Atmospheric Infrared Sounder (AIRS) instrument. These cross-comparisons serve as a performance guide for the GPS-RO observations with respect to other data sets by providing an independent measure of climate feedbacks and humidity short-term trends.
Interim Air Purity Guidelines for Dry Deck Shelter (DDS) Operations
1990-10-01
The acceptable limits for gaseous contaminants in submarine compressed air for use as diver’s breathing air are derived from the 8-hour Time Weighted...accompanying documentation. Cylinders must be declared as hazardous cargo (" Air , Compressed Non-Flammable Gas") prior to air transport. Analysis of cylinder...capi NAVAL MEDICAL RESEARCH INSTITUTE Bethesda, MD 20889-5055 NMRI 90-109 October 1990 AD-A231 432 INTERIM AIR PURITY GUIDELINES FOR DRY DECK
Terrestrial gravity data analysis for interim gravity model improvement
NASA Technical Reports Server (NTRS)
1987-01-01
This is the first status report for the Interim Gravity Model research effort that was started on June 30, 1986. The basic theme of this study is to develop appropriate models and adjustment procedures for estimating potential coefficients from terrestrial gravity data. The plan is to use the latest gravity data sets to produce coefficient estimates as well as to provide normal equations to NASA for use in the TOPEX/POSEIDON gravity field modeling program.
Graf, Alexandra C; Bauer, Peter
2011-06-30
We calculate the maximum type 1 error rate of the pre-planned conventional fixed sample size test for comparing the means of independent normal distributions (with common known variance) which can be yielded when sample size and allocation rate to the treatment arms can be modified in an interim analysis. Thereby it is assumed that the experimenter fully exploits knowledge of the unblinded interim estimates of the treatment effects in order to maximize the conditional type 1 error rate. The 'worst-case' strategies require knowledge of the unknown common treatment effect under the null hypothesis. Although this is a rather hypothetical scenario it may be approached in practice when using a standard control treatment for which precise estimates are available from historical data. The maximum inflation of the type 1 error rate is substantially larger than derived by Proschan and Hunsberger (Biometrics 1995; 51:1315-1324) for design modifications applying balanced samples before and after the interim analysis. Corresponding upper limits for the maximum type 1 error rate are calculated for a number of situations arising from practical considerations (e.g. restricting the maximum sample size, not allowing sample size to decrease, allowing only increase in the sample size in the experimental treatment). The application is discussed for a motivating example. Copyright © 2011 John Wiley & Sons, Ltd.
NASA Astrophysics Data System (ADS)
Georgievski, Goran; Keuler, Klaus
2013-04-01
Water supply and its potential to increase social, economic and environmental risks are among the most critical challenges for the upcoming decades. Therefore, the assessment of the reliability of regional climate models (RCMs) to represent present-day hydrological balance of river basins is one of the most challenging tasks with high priority for climate modelling in order to estimate range of possible socio-economic impacts of the climate change. However, previous work in the frame of 4th IPCC AR and corresponding regional downscaling experiments (with focus on Europe and Danube river basin) showed that even the meteorological re-analyses provide unreliable data set for evaluations of climate model performance. Furthermore, large discrepancies among the RCMs are caused by internal model deficiencies (for example: systematic errors in dynamics, land-soil parameterizations, large-scale condensation and convection schemes), and in spite of higher resolution RCMs do not always improve much the results from GCMs, but even deteriorate it in some cases. All that has a consequence that capturing impact of climate change on hydrological cycle is not an easy task. Here we present state of the art of RCMs in the frame of the CORDEX project for Europe. First analysis shows again that even the up to date ERA-INTERIM re-analysis is not reliable for evaluation of hydrological cycle in major European midlatitude river basins (Seine, Rhine, Elbe, Oder, Vistula, Danube, Po, Rhone, Garonne and Ebro). Therefore, terrestrial water storage, a quasi observed parameter which is a combination of river discharge (from Global River Discharge Centre data set) and atmospheric moisture fluxes from ERA-INTERIM re-analysis, is used for verification. It shows qualitatively good agreement with COSMO-CLM (CCLM) regional climate simulation (abbreviated CCLM_eval) at 0.11 degrees horizontal resolution forced by ERA-INTERIM re-analysis. Furthermore, intercomparison of terrestrial water storage seasonal cycle averaged in Danube river basin for the ten years (1990-1999) overlapping period between CCLM historical experiment (abbreviated CCLM_hist), its forcing GCM (MPI-ESM-LR, here abbreviated MPI_hist) and CCLM_eval is performed. It reveals that CCLM_hist simulation is in better agreement with quasi observed terrestrial water storage than MPI_hist and CCLM_eval. This result seems promising for the assessment of impact of climate change on hydrological cycle. However, evaluation of the whole ensemble of regional climate downscaling experiments participated in CORDEX-Europe project would provide a more robust estimate.
2013-03-04
The Food and Drug Administration (FDA or ``we'') is reopening the comment period for the interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics'' that published in the Federal Register of July 14, 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of September 7, 2005 (70 FR 53063), we amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, we are reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum.
Validation of HOAPS- and ERA-Interim precipitation estimates over the ocean
NASA Astrophysics Data System (ADS)
Bumke, Karl; Schröder, Marc; Fennig, Karsten
2014-05-01
Although precipitation is one of the key parameters of the global hydrological cycle there are still large gaps in the global observation networks, especially over the oceans. But the progress in satellite technology has provided the possibility to retrieve global data sets from space, including precipitation. Levizzani et al. (2007) showed that precipitation over the oceans can be derived with sufficient accuracy from passive microwave radiometry. Advances in analysis techniques have also improved our knowledge of the global precipitation. On the other hand, e.g. Andersson et al. (2011) or Pfeifroth et al. (2012) pointed out that even state-of-the-art satellite retrievals and reanalysis data sets still disagree on global or regional precipitation with respect to amounts, patterns, variability or temporal behavior compared to observations. That creates the need for a validation study over data sparse areas. Within this study, a validation of HOAPS-3.0 (Hamburg Ocean Atmosphere Parameters and fluxes from Satellite Data) based precipitation at pixel-level resolution and of ERA-Interim reanalysis data for 1995-1997 is performed mainly over the Atlantic Ocean using information from ship rain gauges and optical disdrometers mounted onboard of research vessels. The satellite and ERA-Interim data are compared to the in situ measurement by the nearest neighbor approach. Therefore, it must be ensured that both observations are related to each other, which can be determined by the decorrelation lengths in space and time. At least a number of 658 precipitation events are at our disposal including 127 snow events. The statistical analysis follows the recommendations given by the World Meteorological Organization (WMO) for dichotomous or binary forecasts (WWRP/WGNE: http://www.cawcr.gov.au/projects/verification/#Methods_for_dichotomous_forecasts). Based on contingency tables a number of statistical parameters like the accuracy, the bias, the false alarm rate, success ratio or hit rate have been computed. Summarized, the results show that HOAPS data agrees well with observations with respect to the frequency of precipitation events while ERA-Interim overestimates considerably the number of precipitation events. Results are similar for rain and snow events. Although it is difficult to compare rain rates directly due to the limited number of collocated events and different spatial resolution, the results suggest a slight underestimation of precipitation rates by HOAPS and an overestimation by ERA-Interim. References Andersson, A., Klepp, C., Fennig, K., Bakan, S., Graßl, H. and495 co-authors. 2011. Evaluation of HOAPS-3 ocean surface freshwater flux components. J. Appl. Meteorol. Climatol. 50, 379-398, doi:10.1175/2010JAMC2341.1. Levizzani, V., Bauer, P. and Turk, F. J.) 2007. Measuring Precipitation from Space, EURAINSAT and the Future. Advances in Global Change Research, Vol. 28, Springer, 724 p. Pfeifroth,U.,R.Mueller, and B.Ahrens, 2012: Evaluation of Satellite-Based and Reanalysis Precipitation Data in the Tropical Pacific, J. of Appl. Meteorology and Climatology 52, 634-644
Feng, Yan-Ru; Zhu, Yuan; Liu, Lu-Ying; Wang, Wei-Hu; Wang, Shu-Lian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Zhang, Shi-Ping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Ye-Xiong; Jin, Jing
2016-05-03
The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.
Graf, Alexandra C; Bauer, Peter; Glimm, Ekkehard; Koenig, Franz
2014-07-01
Sample size modifications in the interim analyses of an adaptive design can inflate the type 1 error rate, if test statistics and critical boundaries are used in the final analysis as if no modification had been made. While this is already true for designs with an overall change of the sample size in a balanced treatment-control comparison, the inflation can be much larger if in addition a modification of allocation ratios is allowed as well. In this paper, we investigate adaptive designs with several treatment arms compared to a single common control group. Regarding modifications, we consider treatment arm selection as well as modifications of overall sample size and allocation ratios. The inflation is quantified for two approaches: a naive procedure that ignores not only all modifications, but also the multiplicity issue arising from the many-to-one comparison, and a Dunnett procedure that ignores modifications, but adjusts for the initially started multiple treatments. The maximum inflation of the type 1 error rate for such types of design can be calculated by searching for the "worst case" scenarios, that are sample size adaptation rules in the interim analysis that lead to the largest conditional type 1 error rate in any point of the sample space. To show the most extreme inflation, we initially assume unconstrained second stage sample size modifications leading to a large inflation of the type 1 error rate. Furthermore, we investigate the inflation when putting constraints on the second stage sample sizes. It turns out that, for example fixing the sample size of the control group, leads to designs controlling the type 1 error rate. © 2014 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
NASA Astrophysics Data System (ADS)
Huang, J. C.; Wright, W. V.
1982-04-01
The Defense Waste Processing Facility (DWPF) for immobilizing nuclear high level waste (HLW) is scheduled to be built. High level waste is produced when reactor components are subjected to chemical separation operations. Two candidates for immobilizing this HLW are borosilicate glass and crystalline ceramic, either being contained in weld sealed stainless steel canisters. A number of technical analyses are being conducted to support a selection between these two waste forms. The risks associated with the manufacture and interim storage of these two forms in the DWPF are compared. Process information used in the risk analysis was taken primarily from a DWPF processibility analysis. The DWPF environmental analysis provided much of the necessary environmental information.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mays, S.E.; Poloski, J.P.; Sullivan, W.H.
1982-07-01
This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix B provides a description of Browns Ferry, Unit 1, plant systems and the failure evaluation of those systems as they apply to accidents at Browns Ferry. Information is presented concerning front-line system fault analysis; support system fault analysis; human error models andmore » probabilities; and generic control circuit analyses.« less
NASA Astrophysics Data System (ADS)
Belušić, Andreina; Prtenjak, Maja Telišman; Güttler, Ivan; Ban, Nikolina; Leutwyler, David; Schär, Christoph
2018-06-01
Over the past few decades the horizontal resolution of regional climate models (RCMs) has steadily increased, leading to a better representation of small-scale topographic features and more details in simulating dynamical aspects, especially in coastal regions and over complex terrain. Due to its complex terrain, the broader Adriatic region represents a major challenge to state-of-the-art RCMs in simulating local wind systems realistically. The objective of this study is to identify the added value in near-surface wind due to the refined grid spacing of RCMs. For this purpose, we use a multi-model ensemble composed of CORDEX regional climate simulations at 0.11° and 0.44° grid spacing, forced by the ERA-Interim reanalysis, a COSMO convection-parameterizing simulation at 0.11° and a COSMO convection-resolving simulation at 0.02° grid spacing. Surface station observations from this region and satellite QuikSCAT data over the Adriatic Sea have been compared against daily output obtained from the available simulations. Both day-to-day wind and its frequency distribution are examined. The results indicate that the 0.44° RCMs rarely outperform ERA-Interim reanalysis, while the performance of the high-resolution simulations surpasses that of ERA-Interim. We also disclose that refining the grid spacing to a few km is needed to properly capture the small-scale wind systems. Finally, we show that the simulations frequently yield the accurate angle of local wind regimes, such as for the Bora flow, but overestimate the associated wind magnitude. Finally, spectral analysis shows good agreement between measurements and simulations, indicating the correct temporal variability of the wind speed.
Independent Orbiter Assessment (IOA) CIL issues resolution report, volume 3
NASA Technical Reports Server (NTRS)
1988-01-01
The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. This report contains IOA assessment workshets showing resolution of outstanding IOA CIL issues that were summarized in the IOA FMEA/CIL Assessment Interim Report, dated 9 March 1988. Each assessment worksheet has been updated with CIL issue rsolution and rationale. Volume 3 contains the worksheets for the Reaction Control Subsystem and the Communications and Tracking Subsystem.
76 FR 4369 - Interim Deputation Agreements; Interim BIA Adult Detention Facility Guidelines
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-25
... Adult Detention Facility Guidelines AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice. SUMMARY: This notice announces the online publication of the Interim BIA Adult Detention Facility Guidelines and... Indian Affairs Web site. DATES: These Interim BIA Adult Detention Facility Guidelines and Interim Model...
1983-12-01
opportunity existed in the Middle East for the conclusion of an interim settlement in the dispute between Egypt and Israel. Egyptian President Anwar el -Sadat...Richard M. Nixon; Henry A. Kissinger; William P. Rogers; Joseph Sisco; Donald Bergus; Michael Sterner; Golda Meir; Abba Eban; Moshe Dayan; Anwar el ...for the conclusion of an interim settlement in the dispute between Egypt and Israel. Egyptian President Anwar el -Sadat declared his willingness to
NASA Technical Reports Server (NTRS)
Kitzis, J. L.; Kitzis, S. N.
1979-01-01
The brightness temperature data produced by the SMMR Antenna Pattern Correction algorithm are evaluated. The evaluation consists of: (1) a direct comparison of the outputs of the interim, cross, and nominal APC modes; (2) a refinement of the previously determined cos beta estimates; and (3) a comparison of the world brightness temperature (T sub B) map with actual SMMR measurements.
Cunningham, Charles E; Rimas, Heather; Chen, Yvonne; Deal, Ken; McGrath, Patrick; Lingley-Pottie, Patricia; Reid, Graham J; Lipman, Ellen; Corkum, Penny
2015-01-01
Using a discrete choice conjoint experiment, we explored the design of parenting programs as an interim strategy for families waiting for children's mental health treatment. Latent class analysis yielded 4 segments with different design preferences. Simulations predicted the Fast-Paced Personal Contact segment, 22.1% of the sample, would prefer weekly therapist-led parenting groups. The Moderate-Paced Personal Contact segment (24.7%) preferred twice-monthly therapist-led parenting groups with twice-monthly lessons. The Moderate-Paced E-Contact segment (36.3%), preferred weekly to twice-monthly contacts, e-mail networking, and a program combining therapist-led sessions with the support of a computerized telephone e-coach. The Slow-Paced E-Contact segment (16.9%) preferred an approach combining monthly therapist-led sessions, e-coaching, and e-mail networking with other parents. Simulations predicted 45.3% of parents would utilize an option combining 5 therapist coaching calls with 5 e-coaching calls, a model that could reduce costs and extend the availability of interim services. Although 41.0% preferred weekly pacing, 58% were predicted to choose an interim parenting service conducted at a twice-monthly to monthly pace. The results of this study suggest that developing interim services reflecting parental preferences requires a choice of formats that includes parenting groups, telephone-coached distance programs, and e-coaching options conducted at a flexible pace.
24 CFR 35.820 - Interim controls.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Interim controls. 35.820 Section 35...-Possession Multifamily Property § 35.820 Interim controls. HUD shall conduct interim controls in accordance... accordance with § 35.815. Interim controls are considered completed when clearance is achieved in accordance...
24 CFR 35.820 - Interim controls.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Interim controls. 35.820 Section 35...-Possession Multifamily Property § 35.820 Interim controls. HUD shall conduct interim controls in accordance... accordance with § 35.815. Interim controls are considered completed when clearance is achieved in accordance...
Energy policy act transportation study: Interim report on natural gas flows and rates
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-11-17
This report, Energy Policy Act Transportation Study: Interim Report on Natural Gas Flows and Rates, is the second in a series mandated by Title XIII, Section 1340, ``Establishment of Data Base and Study of Transportation Rates,`` of the Energy Policy Act of 1992 (P.L. 102--486). The first report Energy Policy Act Transportation Study: Availability of Data and Studies, was submitted to Congress in October 1993; it summarized data and studies that could be used to address the impact of legislative and regulatory actions on natural gas transportation rates and flow patterns. The current report presents an interim analysis of naturalmore » gas transportation rates and distribution patterns for the period from 1988 through 1994. A third and final report addressing the transportation rates and flows through 1997 is due to Congress in October 2000. This analysis relies on currently available data; no new data collection effort was undertaken. The need for the collection of additional data on transportation rates will be further addressed after this report, in consultation with the Congress, industry representatives, and in other public forums.« less
Flight set 360L007 (STS-33) insulation component. Volume 3: Final release
NASA Technical Reports Server (NTRS)
Hicken, Steve
1990-01-01
Volume 3 of this postfire report deals with the insulation component of the RSRM. The report is released twice for each flight set. The interim release contract date is on or before 60 days after the last field joint or nozzle to case joint is disassembled at KSC and contain the results of the KSC visual evaluation. The data contained in Volume 3 interim release supersedes the insulation data presented in the KSC 10 day report. The final release contract data is on or before 60 days after the last factory joint is disassembled at the Clearfield H-7 facility and contains the results of all visual evaluations and a thermal safety factor analysis. The data contained in the Volume 3 final release supersedes the interim release and the insulation data presented in the Clearfield 10 day report.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-07
... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites AGENCY... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response... interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated using existing, peer...
Predicting clinical trial results based on announcements of interim analyses
2014-01-01
Background Announcements of interim analyses of a clinical trial convey information about the results beyond the trial’s Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial’s stopping boundaries has been crossed implies that the experimental therapy is neither extremely effective nor hopeless. Predicting success of the ongoing trial is of interest to the trial’s sponsor, the medical community, pharmaceutical companies, and investors. We determine the probability of trial success by quantifying only the publicly available information from interim analyses of an ongoing trial. We illustrate our method in the context of the National Surgical Adjuvant Breast and Bowel (NSABP) trial, C-08. Methods We simulated trials based on the specifics of the NSABP C-08 protocol that were publicly available. We quantified the uncertainty around the treatment effect using prior weights for the various possibilities in light of other colon cancer studies and other studies of the investigational agent, bevacizumab. We considered alternative prior distributions. Results Subsequent to the trial’s third interim analysis, our predictive probabilities were: that the trial would eventually be successful, 48.0%; would stop for futility, 7.4%; and would continue to completion without statistical significance, 44.5%. The actual trial continued to completion without statistical significance. Conclusions Announcements of interim analyses provide information outside the DSMB’s sphere of confidentiality. This information is potentially helpful to clinical trial prognosticators. ‘Information leakage’ from standard interim analyses such as in NSABP C-08 is conventionally viewed as acceptable even though it may be quite revealing. Whether leakage from more aggressive types of adaptations is acceptable should be assessed at the design stage. PMID:24607270
NASA Astrophysics Data System (ADS)
Vergados, Panagiotis; Mannucci, Anthony J.; Ao, Chi O.; Verkhoglyadova, Olga; Iijima, Byron
2018-03-01
We construct a 9-year data record (2007-2015) of the tropospheric specific humidity using Global Positioning System radio occultation (GPS RO) observations from the Constellation Observing System for Meteorology, Ionosphere, and Climate (COSMIC) mission. This record covers the ±40° latitude belt and includes estimates of the zonally averaged monthly mean specific humidity from 700 up to 400 hPa. It includes three major climate zones: (a) the deep tropics (±15°), (b) the trade winds belts (±15-30°), and (c) the subtropics (±30-40°). We find that the RO observations agree very well with the European Centre for Medium-Range Weather Forecasts Re-Analysis Interim (ERA-Interim), the Modern-Era Retrospective Analysis for Research and Applications (MERRA), and the Atmospheric Infrared Sounder (AIRS) by capturing similar magnitudes and patterns of variability in the monthly zonal mean specific humidity and interannual anomaly over annual and interannual timescales. The JPL and UCAR specific humidity climatologies differ by less than 15 % (depending on location and pressure level), primarily due to differences in the retrieved refractivity. In the middle-to-upper troposphere, in all climate zones, JPL is the wettest of all data sets, AIRS is the driest of all data sets, and UCAR, ERA-Interim, and MERRA are in very good agreement, lying between the JPL and AIRS climatologies. In the lower-to-middle troposphere, we present a complex behavior of discrepancies, and we speculate that this might be due to convection and entrainment. Conclusively, the RO observations could potentially be used as a climate variable, but more thorough analysis is required to assess the structural uncertainty between centers and its origin.
IUS/TUG orbital operations and mission support study. Volume 2: Interim upper stage operations
NASA Technical Reports Server (NTRS)
1975-01-01
Background data and study results are presented for the interim upper stage (IUS) operations phase of the IUS/tug orbital operations study. The study was conducted to develop IUS operational concepts and an IUS baseline operations plan, and to provide cost estimates for IUS operations. The approach used was to compile and evaluate baseline concepts, definitions, and system, and to use that data as a basis for the IUS operations phase definition, analysis, and costing analysis. Both expendable and reusable IUS configurations were analyzed and two autonomy levels were specified for each configuration. Topics discussed include on-orbit operations and interfaces with the orbiter, the tracking and data relay satellites and ground station support capability analysis, and flight control center sizing to support the IUS operations.
Pritchett, Yili; Jemiai, Yannis; Chang, Yuchiao; Bhan, Ishir; Agarwal, Rajiv; Zoccali, Carmine; Wanner, Christoph; Lloyd-Jones, Donald; Cannata-Andía, Jorge B; Thompson, Taylor; Appelbaum, Evan; Audhya, Paul; Andress, Dennis; Zhang, Wuyan; Solomon, Scott; Manning, Warren J; Thadhani, Ravi
2011-04-01
Chronic kidney disease is associated with a marked increase in risk for left ventricular hypertrophy and cardiovascular mortality compared with the general population. Therapy with vitamin D receptor activators has been linked with reduced mortality in chronic kidney disease and an improvement in left ventricular hypertrophy in animal studies. PRIMO (Paricalcitol capsules benefits in Renal failure Induced cardia MOrbidity) is a multinational, multicenter randomized controlled trial to assess the effects of paricalcitol (a selective vitamin D receptor activator) on mild to moderate left ventricular hypertrophy in patients with chronic kidney disease. Subjects with mild-moderate chronic kidney disease are randomized to paricalcitol or placebo after confirming left ventricular hypertrophy using a cardiac echocardiogram. Cardiac magnetic resonance imaging is then used to assess left ventricular mass index at baseline, 24 and 48 weeks, which is the primary efficacy endpoint of the study. Because of limited prior data to estimate sample size, a maximum information group sequential design with sample size re-estimation is implemented to allow sample size adjustment based on the nuisance parameter estimated using the interim data. An interim efficacy analysis is planned at a pre-specified time point conditioned on the status of enrollment. The decision to increase sample size depends on the observed treatment effect. A repeated measures analysis model, using available data at Week 24 and 48 with a backup model of an ANCOVA analyzing change from baseline to the final nonmissing observation, are pre-specified to evaluate the treatment effect. Gamma-family of spending function is employed to control family-wise Type I error rate as stopping for success is planned in the interim efficacy analysis. If enrollment is slower than anticipated, the smaller sample size used in the interim efficacy analysis and the greater percent of missing week 48 data might decrease the parameter estimation accuracy, either for the nuisance parameter or for the treatment effect, which might in turn affect the interim decision-making. The application of combining a group sequential design with a sample-size re-estimation in clinical trial design has the potential to improve efficiency and to increase the probability of trial success while ensuring integrity of the study.
40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2013 CFR
2013-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...
40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2012 CFR
2012-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...
40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2014 CFR
2014-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...
40 CFR 57.803 - Issuance of tentative determination; notice.
Code of Federal Regulations, 2011 CFR
2011-07-01
... determination. (1) The EPA staff shall formulate and prepare: (i) A “Staff Computational Analysis,” using the... Computational Analysis, discussing the estimated cost of interim controls, and assessing the effect upon the...
Using phase II data for the analysis of phase III studies: An application in rare diseases.
Wandel, Simon; Neuenschwander, Beat; Röver, Christian; Friede, Tim
2017-06-01
Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. A Bayesian meta-analytic approach is used to inform the phase III study with phase II data. It is particularly attractive, since uncertainty of between-trial heterogeneity can be dealt with probabilistically, which is critical if the number of studies is small. Furthermore, it allows quantifying and discounting the phase II data through the predictive distribution relevant for phase III. A phase III design is proposed which uses the phase II data and considers approval based on a phase III interim analysis. The design is illustrated with a non-inferiority case study from a Food and Drug Administration approval in herpetic keratitis (an orphan disease). Design operating characteristics are compared to those of a traditional design, which ignores the phase II data. An analysis of the phase II data reveals good but insufficient evidence for non-inferiority, highlighting the need for a phase III study. For the phase III study supported by phase II data, the interim analysis is based on half of the patients. For this design, the meta-analytic interim results are conclusive and would justify approval. In contrast, based on the phase III data only, interim results are inconclusive and require further evidence. To accelerate drug development for orphan diseases, innovative study designs and appropriate methodology are needed. Taking advantage of randomized phase II data when analyzing phase III studies looks promising because the evidence from phase II supports informed decision-making. The implementation of the Bayesian design is straightforward with public software such as R.
Flight Set 360T004 (STS-30) Insulation Component, Interim Release, Volume 3
NASA Technical Reports Server (NTRS)
Passman, James A.
1989-01-01
The insulation component of the Redesigned Solid Rocket Motor (RSRM) is discussed. The results of all visual evaluations and a thermal safety factor analysis are given. The data contained here supersedes the interim release and the insulation data presented in the Clearfield 10 day report. The objective is to document the postflight condition of the internal and external insulation of nozzle to case joints, the case field joints, the igniter to case joints, and the acreage insulation which made up RSRM-4A and RSRM-4B.
Interim Calibration Report for the SMMR Simulator
NASA Technical Reports Server (NTRS)
Gloersen, P.; Cavalieri, D.
1979-01-01
The calibration data obtained during the fall 1978 Nimbus-G underflight mission with the scanning multichannel microwave radiometer (SMMR) simulator on board the NASA CV-990 aircraft were analyzed and an interim calibration algorithm was developed. Data selected for the analysis consisted of in flight sky, first-year sea ice, and open water observations, as well as ground based observations of fixed targets with varied temperatures of selected instrument components. For most of the SMMR channels, a good fit to the selected data set was obtained with the algorithm.
Comparison of futility monitoring guidelines using completed phase III oncology trials.
Zhang, Qiang; Freidlin, Boris; Korn, Edward L; Halabi, Susan; Mandrekar, Sumithra; Dignam, James J
2017-02-01
Futility (inefficacy) interim monitoring is an important component in the conduct of phase III clinical trials, especially in life-threatening diseases. Desirable futility monitoring guidelines allow timely stopping if the new therapy is harmful or if it is unlikely to demonstrate to be sufficiently effective if the trial were to continue to its final analysis. There are a number of analytical approaches that are used to construct futility monitoring boundaries. The most common approaches are based on conditional power, sequential testing of the alternative hypothesis, or sequential confidence intervals. The resulting futility boundaries vary considerably with respect to the level of evidence required for recommending stopping the study. We evaluate the performance of commonly used methods using event histories from completed phase III clinical trials of the Radiation Therapy Oncology Group, Cancer and Leukemia Group B, and North Central Cancer Treatment Group. We considered published superiority phase III trials with survival endpoints initiated after 1990. There are 52 studies available for this analysis from different disease sites. Total sample size and maximum number of events (statistical information) for each study were calculated using protocol-specified effect size, type I and type II error rates. In addition to the common futility approaches, we considered a recently proposed linear inefficacy boundary approach with an early harm look followed by several lack-of-efficacy analyses. For each futility approach, interim test statistics were generated for three schedules with different analysis frequency, and early stopping was recommended if the interim result crossed a futility stopping boundary. For trials not demonstrating superiority, the impact of each rule is summarized as savings on sample size, study duration, and information time scales. For negative studies, our results show that the futility approaches based on testing the alternative hypothesis and repeated confidence interval rules yielded less savings (compared to the other two rules). These boundaries are too conservative, especially during the first half of the study (<50% of information). The conditional power rules are too aggressive during the second half of the study (>50% of information) and may stop a trial even when there is a clinically meaningful treatment effect. The linear inefficacy boundary with three or more interim analyses provided the best results. For positive studies, we demonstrated that none of the futility rules would have stopped the trials. The linear inefficacy boundary futility approach is attractive from statistical, clinical, and logistical standpoints in clinical trials evaluating new anti-cancer agents.
Coastal Low-Level Wind Jets: A Global Study Based On An Ensemble Of Reanalysis
NASA Astrophysics Data System (ADS)
Cardoso, R. M.; Lima, D. C. A.; Soares, P. M. M.; Semedo, A.
2017-12-01
Reanalyses data are a useful tool for climate and atmospheric studies since they provide physically consistent spatial and temporal information of observable and unobservable atmospheric parameters. Here, we propose the analysis of coastal low-level jets (CLLJs) resorting to three global reanalyses. The six hourly data from the European Centre for Medium-Range Weather Forecasts (ECMWF) Interim Reanalysis (ERA-Interim), the Japanese 55-year Reanalysis (JRA-55) and the Modern Era Retrospective-analysis for Research and Applications (MERRA2), are used to build an ensemble of reanalyses, for a period encompassing 1980-2016. A detailed global climatology of CLLJs is presented based on a reanalyses ensemble. This gives robustness to the CLLJs representation and also reduces uncertainty. The annual and diurnal cycle as well as the inter-annual variability are analysed in order to evaluate the temporal fluctuations of frequency of occurrence of CLLJ. The ensemble mean displays a good representation of their seasonal spatial variability. The Oman and Benguela CLLJs show, respectively, a decrease and increase of frequency of occurrence, which is statistically significant during boreal summer and austral spring for the period of study. The Oman CLLJ is the most intense and occurs in higher altitudes when compared with the other jets occurring during the season where each CLLJs have higher mean incidence.
NASA Astrophysics Data System (ADS)
Chenoli, Sheeba Nettukandy; Ahmad Mazuki, Muhammad Yunus; Turner, John; Samah, Azizan Abu
2017-01-01
We present projected changes in the speed and meridional location of the Subtropical Jet (STJ) during winter using output of the Coupled Model Intercomparison Project Phase 5 (CMIP5) models. We use the ERA-Interim reanalysis dataset to evaluate the historical simulations of the STJ by 18 of the CMIP5 models for the period 1979-2012. Based on the climatology of the STJ from ERA-Interim, we selected the area of study as 70°E-290°E and 20°S-40°S, which is over the Indian and Southern Pacific Oceans, and 300-100 hPa to reduce altitude-related bias. An assessment of the ability of the CMIP5 models in simulating ENSO effects on the jet stream were carried out using standardized zonal wind anomalies at 300-100 hPa. Results show that 47 % of the CMIP5 models used in this study were able to simulate ENSO impacts realistically. In addition, it is more difficult for the models to reproduce the observed intensity of ENSO impacts than the patterns. The historical simulations of the CMIP5 models show a wide range of trends in meridional movement and jet strength, with a multi-model mean of 0.04° decade-1 equatorward and 0.42 ms-1 decade-1 respectively. In contrast to the ERA-Interim analysis, 94 % of the CMIP5 models show a strengthening of the jet in the historical runs. Variability of the jet strength is significantly (5 %) linked to the sea surface temperature changes over the eastern tropical Pacific. The CMIP5 model projections with Representative Concentration Pathways (RCPs) 4.5 and 8.5 were used for analysis of changes of the STJ for the period 2011-2099. Based on the RCP 4.5 (RCP 8.5) scenario the multi-model mean trend of the 18 CMIP5 models project a statistically significant (5 % level) increase in jet strength by the end of the century of 0.29 ms-1 decade-1 (0.60 ms-1 decade-1). Also, the mean meridional location of the jet is projected to shift poleward by 0.006° decade-1 (0.042° decade-1) in 2099 during winter, with the only significant (5 %) trend being with RCP 8.5.
IVHS Countermeasures for Rear-End Collision, Task 1 Vol. V: 1985 NASS Case Analysis
DOT National Transportation Integrated Search
1994-02-15
The Task 1 Interim Report consists of six volumes. This Volume, Volume V, 1985 NASS Analysis, presents the results of the analysis of the 1985 NASS crash data. Data from 1985 was selected for analysis because it provided more insight into roadway var...
Han, Kelong; Claret, Laurent; Sandler, Alan; Das, Asha; Jin, Jin; Bruno, Rene
2016-07-13
Maintenance treatment (MTx) in responders following first-line treatment has been investigated and practiced for many cancers. Modeling and simulation may support interpretation of interim data and development decisions. We aimed to develop a modeling framework to simulate overall survival (OS) for MTx in NSCLC using tumor growth inhibition (TGI) data. TGI metrics were estimated using longitudinal tumor size data from two Phase III first-line NSCLC studies evaluating bevacizumab and erlotinib as MTx in 1632 patients. Baseline prognostic factors and TGI metric estimates were assessed in multivariate parametric models to predict OS. The OS model was externally validated by simulating a third independent NSCLC study (n = 253) based on interim TGI data (up to progression-free survival database lock). The third study evaluated pemetrexed + bevacizumab vs. bevacizumab alone as MTx. Time-to-tumor-growth (TTG) was the best TGI metric to predict OS. TTG, baseline tumor size, ECOG score, Asian ethnicity, age, and gender were significant covariates in the final OS model. The OS model was qualified by simulating OS distributions and hazard ratios (HR) in the two studies used for model-building. Simulations of the third independent study based on interim TGI data showed that pemetrexed + bevacizumab MTx was unlikely to significantly prolong OS vs. bevacizumab alone given the current sample size (predicted HR: 0.81; 95 % prediction interval: 0.59-1.09). Predicted median OS was 17.3 months and 14.7 months in both arms, respectively. These simulations are consistent with the results of the final OS analysis published 2 years later (observed HR: 0.87; 95 % confidence interval: 0.63-1.21). Final observed median OS was 17.1 months and 13.2 months in both arms, respectively, consistent with our predictions. A robust TGI-OS model was developed for MTx in NSCLC. TTG captures treatment effect. The model successfully predicted the OS outcomes of an independent study based on interim TGI data and thus may facilitate trial simulation and interpretation of interim data. The model was built based on erlotinib data and externally validated using pemetrexed data, suggesting that TGI-OS models may be treatment-independent. The results supported the use of longitudinal tumor size and TTG as endpoints in early clinical oncology studies.
NASA Astrophysics Data System (ADS)
Tang, Malcolm S. Y.; Chenoli, Sheeba Nettukandy; Samah, Azizan Abu; Hai, Ooi See
2018-03-01
The study of Antarctic precipitation has attracted a lot of attention recently. The reliability of climate models in simulating Antarctic precipitation, however, is still debatable. This work assess the precipitation and surface air temperature (SAT) of Antarctica (90 oS to 60 oS) using 49 Coupled Model Intercomparison Project phase 5 (CMIP5) global climate models and the European Centre for Medium-range Weather Forecasts "Interim" reanalysis (ERA-Interim); the National Centers for Environmental Prediction Climate Forecast System Reanalysis (CFSR); the Japan Meteorological Agency 55-year Reanalysis (JRA-55); and the Modern Era Retrospective-analysis for Research and Applications (MERRA) datasets for 1979-2005 (27 years). For precipitation, the time series show that the MERRA and JRA-55 have significantly increased from 1979 to 2005, while the ERA-Int and CFSR have insignificant changes. The reanalyses also have low correlation with one another (generally less than +0.69). 37 CMIP5 models show increasing trend, 18 of which are significant. The resulting CMIP5 MMM also has a significant increasing trend of 0.29 ± 0.06 mm year-1. For SAT, the reanalyses show insignificant changes and have high correlation with one another, while the CMIP5 MMM shows a significant increasing trend. Nonetheless, the variability of precipitation and SAT of MMM could affect the significance of its trend. One of the many reasons for the large differences of precipitation is the CMIP5 models' resolution.
5 CFR 772.102 - Interim personnel actions.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Interim personnel actions. 772.102 Section 772.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) INTERIM RELIEF General § 772.102 Interim personnel actions. When an employee or...
5 CFR 772.102 - Interim personnel actions.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Interim personnel actions. 772.102 Section 772.102 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS (CONTINUED) INTERIM RELIEF General § 772.102 Interim personnel actions. When an employee or...
NASA Technical Reports Server (NTRS)
1979-01-01
Structural analysis and certification of the collector system is presented. System verification against the interim performance criteria is presented and indicated by matrices. The verification discussion, analysis, and test results are also given.
ERIC Educational Resources Information Center
Anyaso, Hilary Hurd
2009-01-01
The Registry for College and University Presidents places former executives in interim presidential and other senior-level posts and is familiar with the challenges interim executives and institutions encounter in times of leadership transitions. However, the one big advantage interims bring to institutions, says Registry Vice President Kevin J.…
40 CFR 155.56 - Interim registration review decision.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Interim registration review decision... PROGRAMS REGISTRATION STANDARDS AND REGISTRATION REVIEW Registration Review Procedures § 155.56 Interim registration review decision. The Agency may issue, when it determines it to be appropriate, an interim...
NASA Astrophysics Data System (ADS)
Quintana-Seguí, Pere; Turco, Marco; Herrera, Sixto; Miguez-Macho, Gonzalo
2017-04-01
Offline land surface model (LSM) simulations are useful for studying the continental hydrological cycle. Because of the nonlinearities in the models, the results are very sensitive to the quality of the meteorological forcing; thus, high-quality gridded datasets of screen-level meteorological variables are needed. Precipitation datasets are particularly difficult to produce due to the inherent spatial and temporal heterogeneity of that variable. They do, however, have a large impact on the simulations, and it is thus necessary to carefully evaluate their quality in great detail. This paper reports the quality of two high-resolution precipitation datasets for Spain at the daily time scale: the new SAFRAN-based dataset and Spain02. SAFRAN is a meteorological analysis system that was designed to force LSMs and has recently been extended to the entirety of Spain for a long period of time (1979/1980-2013/2014). Spain02 is a daily precipitation dataset for Spain and was created mainly to validate regional climate models. In addition, ERA-Interim is included in the comparison to show the differences between local high-resolution and global low-resolution products. The study compares the different precipitation analyses with rain gauge data and assesses their temporal and spatial similarities to the observations. The validation of SAFRAN with independent data shows that this is a robust product. SAFRAN and Spain02 have very similar scores, although the latter slightly surpasses the former. The scores are robust with altitude and throughout the year, save perhaps in summer when a diminished skill is observed. As expected, SAFRAN and Spain02 perform better than ERA-Interim, which has difficulty capturing the effects of the relief on precipitation due to its low resolution. However, ERA-Interim reproduces spells remarkably well in contrast to the low skill shown by the high-resolution products. The high-resolution gridded products overestimate the number of precipitation days, which is a problem that affects SAFRAN more than Spain02 and is likely caused by the interpolation method. Both SAFRAN and Spain02 underestimate high precipitation events, but SAFRAN does so more than Spain02. The overestimation of low precipitation events and the underestimation of intense episodes will probably have hydrological consequences once the data are used to force a land surface or hydrological model.
17 CFR 210.8-03 - Interim financial statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (§ 249.308(a) of this chapter) must be reviewed by an independent public accountant using professional... interim financial statements have been reviewed by an independent public accountant, a report of the accountant on the review must be filed with the interim financial statements. Interim financial statements...
24 CFR 35.1330 - Interim controls.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Interim controls. 35.1330 Section... Lead-Paint Hazard Evaluation and Hazard Reduction Activities § 35.1330 Interim controls. Interim controls of lead-based paint hazards identified in a risk assessment shall be conducted in accordance with...
7 CFR 1738.21 - Interim financing.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1738.21 Section 1738.21... Interim financing. (a) Upon notification by RUS that an applicant's application is considered complete, the applicant may enter into an interim financing agreement with a lender other than RUS or use its...
Tropopause sharpening by data assimilation
NASA Astrophysics Data System (ADS)
Pilch Kedzierski, R.; Neef, L.; Matthes, K.
2016-08-01
Data assimilation was recently suggested to smooth out the sharp gradients that characterize the tropopause inversion layer (TIL) in systems that did not assimilate TIL-resolving observations. We investigate whether this effect is present in the ERA-Interim reanalysis and the European Centre for Medium-Range Weather Forecasts (ECMWF) operational forecast system (which assimilate high-resolution observations) by analyzing the 4D-Var increments and how the TIL is represented in their data assimilation systems. For comparison, we also diagnose the TIL from high-resolution GPS radio occultation temperature profiles from the COSMIC satellite mission, degraded to the same vertical resolution as ERA-Interim and ECMWF operational analyses. Our results show that more recent reanalysis and forecast systems improve the representation of the TIL, updating the earlier hypothesis. However, the TIL in ERA-Interim and ECMWF operational analyses is still weaker and farther away from the tropopause than GPS radio occultation observations of the same vertical resolution.
Interim 2001-based national population projections for the United Kingdom and constituent countries.
Shaw, Chris
2003-01-01
This article describes new 2001-based national population projections which were carried out following the publication in September 2002 of the first results of the 2001 Census. These "interim" projections, carried out by the Government Actuary in consultation with the Registrars General, take preliminary account of the results of the Census which showed that the base population used in previous projections was overestimated. The interim projections also incorporate a reduced assumption of net international migration to the United Kingdom, informed by the first results of the 2001 Census and taking account of more recent migration information. The population of the United Kingdom is now projected to increase from an estimated 58.8 million in 2001 to reach 63.2 million by 2026. The projected population at 2026 is about 1.8 million (2.8 per cent) lower than in the previous (2000-based) projections.
An Approach for Evaluating the Technical Quality of Interim Assessments
ERIC Educational Resources Information Center
Li, Ying; Marion, Scott; Perie, Marianne; Gong, Brian
2010-01-01
Increasing numbers of schools and districts have expressed interest in interim assessment systems to prepare for summative assessments and to improve teaching and learning. However, with so many commercial interim assessments available, schools and districts are struggling to determine which interim assessment is most appropriate to their needs.…
47 CFR 51.611 - Interim wholesale rates.
Code of Federal Regulations, 2010 CFR
2010-10-01
... selecting a particular discount rate. The same discount percentage rate shall be used to establish interim... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim wholesale rates. 51.611 Section 51.611... Resale § 51.611 Interim wholesale rates. (a) If a state commission cannot, based on the information...
7 CFR 15a.71 - Interim procedures.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 1 2010-01-01 2010-01-01 false Interim procedures. 15a.71 Section 15a.71 Agriculture Office of the Secretary of Agriculture EDUCATION PROGRAMS OR ACTIVITIES RECEIVING OR BENEFITTING FROM FEDERAL FINANCIAL ASSISTANCE Procedures (Interim) § 15a.71 Interim procedures. For the purposes of...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-07
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0068] Japan Lessons-Learned Project Directorate Interim... Commission (NRC). ACTION: Japan Lessons-Learned Project Directorate interim staff guidance; issuance. SUMMARY...-Learned Project Directorate Interim Staff Guidance (JLD-ISG), JLD-ISG-2012-01, ``Compliance with Order EA...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-07
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0069] Japan Lessons-Learned Project Directorate Interim...-Learned Project Directorate interim staff guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the Final Japan Lessons-Learned Project Directorate Interim...
7 CFR 1735.75 - Interim financing.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 7 Agriculture 11 2010-01-01 2010-01-01 false Interim financing. 1735.75 Section 1735.75... Involving Loan Funds § 1735.75 Interim financing. (a) A borrower may submit a written request for RUS approval of interim financing if it is necessary to close an acquisition before the loan to finance the...
13 CFR 120.890 - Source of interim financing.
Code of Federal Regulations, 2014 CFR
2014-01-01
....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...
13 CFR 120.890 - Source of interim financing.
Code of Federal Regulations, 2010 CFR
2010-01-01
....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...
13 CFR 120.890 - Source of interim financing.
Code of Federal Regulations, 2013 CFR
2013-01-01
....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...
13 CFR 120.890 - Source of interim financing.
Code of Federal Regulations, 2012 CFR
2012-01-01
....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...
13 CFR 120.890 - Source of interim financing.
Code of Federal Regulations, 2011 CFR
2011-01-01
....890 Section 120.890 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION BUSINESS LOANS Development Company Loan Program (504) Interim Financing § 120.890 Source of interim financing. A Project may... experience or qualifications, SBA may require the interim loan to be managed by a third party such as a bank...
Dal-Ré, Rafael; Ross, Joseph S; Marušić, Ana
2016-07-01
To examine compliance with International Committee of Medical Journal Editors' (ICMJE) policy on prospective trial registration along with predictors of compliance. Cross-sectional analysis of all articles reporting trial results published in the six highest-impact general medicine journals in January-June 2014 that were registered in a public trial registry. The main outcome measure was compliance with ICMJE policy. The time frame for trial primary end point ascertainment was used to assess whether retrospective registration could have allowed changing of primary end points following an interim analysis. Forty of 144 (28%) articles did not comply with the ICMJE policy. Trials of non-FDA-regulated interventions were less compliant than trials of FDA-regulated interventions (i.e., medicines, medical devices) (42% vs. 21%; P = 0.016). Twenty-nine of these 40 (72%; 20% overall) were registered before any interim analysis of primary end points could have been conducted; 11 (28%; 8% overall) were registered after primary end point ascertainment, such that investigators could have had the opportunity to conduct an interim analysis before trial registration. Twenty-eight percent of trials published in high-impact journals were retrospectively registered including nearly 10% that were registered after primary end point ascertainment could have had taken place. Prospective registration should be prompted and enforced to ensure transparency and accountability in clinical research. Copyright © 2016 Elsevier Inc. All rights reserved.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
... Staff Guidance on Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic... Seismic Margin Analysis for New Reactors Based on Probabilistic Risk Assessment,'' (Agencywide Documents.../COL-ISG-020 ``Implementation of a Seismic Margin Analysis for New Reactors Based on Probabilistic Risk...
Minamimoto, Ryogo; Barkhodari, Amir; Harshman, Lauren; Srinivas, Sandy; Quon, Andrew
2016-01-01
Purpose The objective of this study was to prospectively evaluate various quantitative metrics on FDG PET/CT for monitoring sunitinib therapy and predicting prognosis in patients with metastatic renal cell cancer (mRCC). Methods Seventeen patients (mean age: 59.0 ± 11.6) prospectively underwent a baseline FDG PET/CT and interim PET/CT after 2 cycles (12 weeks) of sunitinib therapy. We measured the highest maximum standardized uptake value (SUVmax) of all identified lesions (highest SUVmax), sum of SUVmax with maximum six lesions (sum of SUVmax), total lesion glycolysis (TLG) and metabolic tumor volume (MTV) from baseline PET/CT and interim PET/CT, and the % decrease in highest SUVmax of lesion (%Δ highest SUVmax), the % decrease in sum of SUVmax, the % decrease in TLG (%ΔTLG) and the % decrease in MTV (%ΔMTV) between baseline and interim PET/CT, and the imaging results were validated by clinical follow-up at 12 months after completion of therapy for progression free survival (PFS). Results At 12 month follow-up, 6/17 (35.3%) patients achieved PFS, while 11/17 (64.7%) patients were deemed to have progression of disease or recurrence within the previous 12 months. At baseline, PET/CT demonstrated metabolically active cancer in all cases. Using baseline PET/CT alone, all of the quantitative imaging metrics were predictive of PFS. Using interim PET/CT, the %Δ highest SUVmax, %Δ sum of SUVmax, and %ΔTLG were also predictive of PFS. Otherwise, interim PET/CT showed no significant difference between the two survival groups regardless of the quantitative metric utilized including MTV and TLG. Conclusions Quantitative metabolic measurements on baseline PET/CT appears to be predictive of PFS at 12 months post-therapy in patients scheduled to undergo sunitinib therapy for mRCC. Change between baseline and interim PET/CT also appeared to have prognostic value but otherwise interim PET/CT after 12 weeks of sunitinib did not appear to be predictive of PFS. PMID:27123976
Comparative Analysis of Languages for Machine Processing. Interim Report.
ERIC Educational Resources Information Center
Zierer, Ernesto; And Others
This report gives the results obtained in the semantic and syntactic analysis of the Japanese particles "de,""ni,""e," and "wo" in comparison to their equivalents in English, German, and Spanish. The study is based on the so-called "Correlational Analysis" as proposed by Ernst von Glaserfeld. The…
Evaluation of reanalysis datasets against observational soil temperature data over China
NASA Astrophysics Data System (ADS)
Yang, Kai; Zhang, Jingyong
2018-01-01
Soil temperature is a key land surface variable, and is a potential predictor for seasonal climate anomalies and extremes. Using observational soil temperature data in China for 1981-2005, we evaluate four reanalysis datasets, the land surface reanalysis of the European Centre for Medium-Range Weather Forecasts (ERA-Interim/Land), the second modern-era retrospective analysis for research and applications (MERRA-2), the National Center for Environmental Prediction Climate Forecast System Reanalysis (NCEP-CFSR), and version 2 of the Global Land Data Assimilation System (GLDAS-2.0), with a focus on 40 cm soil layer. The results show that reanalysis data can mainly reproduce the spatial distributions of soil temperature in summer and winter, especially over the east of China, but generally underestimate their magnitudes. Owing to the influence of precipitation on soil temperature, the four datasets perform better in winter than in summer. The ERA-Interim/Land and GLDAS-2.0 produce spatial characteristics of the climatological mean that are similar to observations. The interannual variability of soil temperature is well reproduced by the ERA-Interim/Land dataset in summer and by the CFSR dataset in winter. The linear trend of soil temperature in summer is well rebuilt by reanalysis datasets. We demonstrate that soil heat fluxes in April-June and in winter are highly correlated with the soil temperature in summer and winter, respectively. Different estimations of surface energy balance components can contribute to different behaviors in reanalysis products in terms of estimating soil temperature. In addition, reanalysis datasets can mainly rebuild the northwest-southeast gradient of soil temperature memory over China.
The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study
Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol
2012-01-01
Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377
NASA Astrophysics Data System (ADS)
Sharifi, Ehsan; Steinacker, Reinhold; Saghafian, Bahram
2016-04-01
Precipitation is a critical component of the Earth's hydrological cycle. The primary requirement in precipitation measurement is to know where and how much precipitation is falling at any given time. Especially in data sparse regions with insufficient radar coverage, satellite information can provide a spatial and temporal context. Nonetheless, evaluation of satellite precipitation is essential prior to operational use. This is why many previous studies are devoted to the validation of satellite estimation. Accurate quantitative precipitation estimation over mountainous basins is of great importance because of their susceptibility to hazards. In situ observations over mountainous areas are mostly limited, but currently available satellite precipitation products can potentially provide the precipitation estimation needed for meteorological and hydrological applications. One of the newest and blended methods that use multi-satellites and multi-sensors has been developed for estimating global precipitation. The considered data set known as Integrated Multi-satellitE Retrievals (IMERG) for GPM (Global Precipitation Measurement) is routinely produced by the GPM constellation satellites. Moreover, recent efforts have been put into the improvement of the precipitation products derived from reanalysis systems, which has led to significant progress. One of the best and a worldwide used model is developed by the European Centre for Medium Range Weather Forecasts (ECMWF). They have produced global reanalysis daily precipitation, known as ERA-Interim. This study has evaluated one year of precipitation data from the GPM-IMERG and ERA-Interim reanalysis daily time series over West of Iran. IMERG and ERA-Interim yield underestimate the observed values while IMERG underestimated slightly and performed better when precipitation is greater than 10mm. Furthermore, with respect to evaluation of probability of detection (POD), threat score (TS), false alarm ratio (FAR) and probability of false detection (POFD) IMERG yields a better value of POD, TS, FAR and POFD in comparison to era-Interim. Overall, ERA-Interim product produced fewer robust results when compared to IMERG.
Polymer concrete overlay test program : interim report.
DOT National Transportation Integrated Search
1974-11-01
This report describes work done on various combinations of monomers and polymer concrete mixes and identifies the mixes showing the greatest potential for use in bridge deck overlays . Presented are test results showing physical properties of various...
MUC-4 Test Results and Analysis
1992-01-01
PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 MUC3 MUC4 STEMS 15,285 INFLECTED FORMS 14,56 1 TOTALS est at 10,000...34 . As an indication of system development during MUC4 , we can compare our TST3 results with our results on th e MUC-4 interim test (TST2) . The relevant... MUC4 Interim Test) Summary Scores SLOT POS ACT COR PAR INC ICR IPA SPU MIS NON REC PRE OVG inc-total 529 1189 160 63 24 0 23 942 282 718 36 16 79 perp
Andrade, Verónica; Martínez, Alejandra; Rojas, Ninón; Bello-Toledo, Helia; Flores, Paulo; Sánchez-Sanhueza, Gabriela; Catalán, Alfonso
2018-05-01
Interim restorations are occasionally left in the mouth for extended periods and are susceptible to bacterial infiltration. Thus, dental interim cements with antibacterial properties are required. The purpose of this in vitro study was to determine in vitro antibacterial activity against Streptococcus mutans and to compare the diametrical tensile strength (DTSs) of dental interim cement modified with zinc oxide nanoparticles (ZnO-NPs) with that of cement modified with terpenes. Antibacterial properties of ZnO-NPs, terpenes, and dental interim cement modified with ZnO-NPs and cement modified with terpenes against S mutans were tested according to minimum inhibitory concentration (MIC) and direct contact inhibition (DCI). Tensile strength levels were evaluated using DTS. Results were analyzed using the Kolmogorov-Smirnov, ANOVA, and Tamhane tests (α=.05). The MICs of ZnO-NPs and terpenes against S mutans were 61.94 μg/g and 0.25% v/v, respectively. The DCI assay under the cylinders of cement (area of contact with the agar surface) revealed significant bacterial growth inhibition on Temp-Bond NE specimens with ZnO-NPs at MIC of 495.2 μg/g (8× MIC) and with terpenes at MIC 0.999% v/v (4× MIC) (P<.05). The Temp-Bond NE cement cylinder (control group) showed the lowest DTS (1.05 ±0.27 MPa) of all other test groups. In the Zn-NPs group, the greatest increase occurred in the NP8 (8× MIC; 495.2 μg/g) group with a value of 1.50 ±0.23 MPa, a significant increase in DTS compared with the control and terpene groups (P<.05). In the terpene group, the highest increase corresponded to group T2 (2× MIC; 0.4995% v/v) with a value of 1.29 ±0.18 MPa. The addition of terpenes and ZnO-NPs to interim cement showed antibacterial activity when in contact with S. mutans ATCC 25175. Both terpenes and ZnO-NPs antimicrobial agents increased diametral tensile strength. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
12 CFR 552.2-2 - Procedures for organization of interim Federal stock association.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Procedures for organization of interim Federal stock association. (a) Applications for permission to organize... chapter or § 552.2-1(b)(3) of this part. (b) Approval of an application for permission to organize an... the interim was chartered to facilitate. Applications for permission to organize an interim Federal...
NASA Technical Reports Server (NTRS)
Wells, C.; Kolkhorst, H. E.
1971-01-01
The consumables analysis was performed for the Skylab 2, 3, and 4 Preliminary Reference Interim Revision Flight Plan. The analysis and the results are based on the mission requirements as specified in the flight plan and on other available data. The results indicate that the consumables requirements for the Skylab missions allow for remaining margins (percent) of oxygen, nitrogen, and water nominal as follows: 83.5, 90.8, and 88.7 for mission SL-2; 57.1, 64.1, and 67.3 for SL-3; and 30.8, 44.3, and 46.5 for SL-4. Performance of experiment M509 as scheduled in the flight plan results in venting overboard the cluster atmosphere. This is due to the addition of nitrogen for propulsion and to the additional oxygen introduced into the cabin when the experiment is performed with the crewman suited.
Impact evaluation of Morgantown PRT 1975-1976 ridership: Interim Analysis
DOT National Transportation Integrated Search
1977-06-01
An analysis of the ridership levels of the Morgantown PRT system during its : initial period of operation, the 1975-1976 academic year, is presented. PRT ridership : by day, weekly ridership trends in terms of exogeneous events, the influence of : fe...
40 CFR 265.13 - General waste analysis.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 27 2013-07-01 2013-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...
40 CFR 265.13 - General waste analysis.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 26 2011-07-01 2011-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...
40 CFR 265.13 - General waste analysis.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 26 2014-07-01 2014-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...
40 CFR 265.13 - General waste analysis.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 27 2012-07-01 2012-07-01 false General waste analysis. 265.13 Section 265.13 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL...
DOT National Transportation Integrated Search
2004-02-17
This document presents the results of the analysis of baseline, or "pre-enhancement," data describing the operation of the existing 511 telephone traveler information system operated by the Arizona Department of Transportation (ADOT). The model deplo...
MO-F-CAMPUS-I-05: Quantitative ADC Measurement of Esophageal Cancer Before and After Chemoradiation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Yang, L; UT MD Anderson Cancer Center, Houston, TX; Son, JB
2015-06-15
Purpose: We investigated whether quantitative diffusion imaging can be used as an imaging biomarker for early prediction of treatment response of esophageal cancer. Methods: Eight patients with esophageal cancer underwent a baseline and an interim MRI studies during chemoradiation on a 3T whole body MRI scanner with an 8-channel torso phased array coil. Each MRI study contained two axial diffusion-weighted imaging (DWI) series with a conventional DWI sequence and a reduced field-of-view DWI sequence (FOCUS) of varying b-values. ADC maps with two b-values were computed from conventional DWI images using a mono-exponential model. For each of DWI sequences, separate ADCallmore » was computed by fitting the signal intensity of images with all the b-values to a single exponential model. For the FOCUS sequence, a bi-exponential model was used to extract perfusion and diffusion coefficients (ADCperf and ADCdiff) and their contributions to the signal decay. A board-certified radiologist contoured the tumor region and mean ADC values and standard deviations of tumor and muscle ROIs were recorded from different ADC maps. Results: Our results showed that (1) the magnitude of ADCs from the same ROIs by the different analysis methods can be substantially different. (2) For a given method, the change between the baseline and interim muscle ADCs was relatively small (≤10%). In contrast, the change between the baseline and interim tumor ADCs was substantially larger, with the change in ADCdiff by FOCUS DWI showing the largest percentage change of 73.2%. (3) The range of the relative change of a specific parameter for different patients was also different. Conclusion: Presently, we do not have the final pathological confirmation of the treatment response for all the patients. However, for a few patients whose surgical specimen is available, the quantitative ADC changes have been found to be useful as a potential predictor for treatment response.« less
OTVE turbopump condition monitoring, task E.5
NASA Technical Reports Server (NTRS)
Coleman, Paul T.; Collins, J. J.
1989-01-01
Recent work has been carried out on development of isotope wear analysis and optical and eddy current technologies to provide bearing wear measurements and real time monitoring of shaft speed, shaft axial displacement and shaft orbit of the Orbit Transfer Vehicle hydrostatic bearing tester. Results show shaft axial displacement can be optically measured (at the same time as shaft orbital motion and speed) to within 0.3 mils by two fiberoptic deflectometers. Evaluation of eddy current probes showed that, in addition to measuring shaft orbital motion, they can be used to measure shaft speed without having to machine grooves on the shaft surface as is the usual practice for turbomachinery. The interim results of this condition monitoring effort are presented.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-16
... Space Administration (NASA). ACTION: Interim rule. SUMMARY: DoD, GSA, and NASA are issuing an interim..., and NASA are issuing an interim rule amending the FAR, to implement section 811 of the National... meetings, DoD, GSA, and NASA weighed the costs and benefits of publishing this rule as proposed or interim...
Interim Administrators in Higher Education: A National Study
ERIC Educational Resources Information Center
Huff, Marie Thielke; Neubrander, Judy
2015-01-01
The focus of this paper is on the roles and experiences of interim administrators in higher education. A survey was given to current and recent interim administrators in four-year public universities and colleges across the United States. The goals were to identify the advantages and disadvantages of using and serving as interims, and to solicit…
Interim Draft: Biological Sampling and Analysis Plan Outline ...
Standard Operation Procedures This interim sampling and analysis plan (SAP) outline was developed specifically as an outline of the output that will be generated by a developing on-line tool called the MicroSAP. The goal of the MicroSAP tool is to assist users with development of SAPs needed for site characterization, verification sampling, and post decontamination sampling stages of biological sampling and analysis activities in which the EPA would be responsible for conducting sampling. These activities could include sampling and analysis for a biological contamination incident, a research study, or an exercise. The development of this SAP outline did not consider the initial response of an incident, as it is assumed that the initial response would have been previously completed by another agency during the response, or the clearance phase, as it is assumed that separate committee would be established to make decisions regarding clearing a site. This outline also includes considerations for capturing the associated data quality objectives in the SAP.
RESEARCH METHOD FOR SAMPLING AND ANALYSIS OF FIBROUS AMPHIBOLE IN VERMICULITE ATTIC INSULATION
NRMRL hosted a meeting on July 17-18, 2003 entitled, "Analytical Method for Bulk Analysis of Vermiculite." The purpose of this effort was to produce an interim research method for use by U.S. EPA's Office of Research and Development (ORD) for the analysis of bulk vermiculite for...
78 FR 8295 - Guarantees for Bonds Issued for Community or Economic Development Purposes
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-05
.... V. Rulemaking Analysis A. Executive Order (E.O.) 12866; Regulatory Impact Analysis It has been... Budget. The Regulatory Impact Analysis prepared by the CDFI Fund for the interim rule is provided below... Community Investment Impact System (CIIS), which collects data from CDFIs that have received awards from the...
Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao
2017-09-01
To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.
A randomized, controlled trial of oral propranolol in infantile hemangioma.
Léauté-Labrèze, Christine; Hoeger, Peter; Mazereeuw-Hautier, Juliette; Guibaud, Laurent; Baselga, Eulalia; Posiunas, Gintas; Phillips, Roderic J; Caceres, Hector; Lopez Gutierrez, Juan Carlos; Ballona, Rosalia; Friedlander, Sheila Fallon; Powell, Julie; Perek, Danuta; Metz, Brandie; Barbarot, Sebastien; Maruani, Annabel; Szalai, Zsuzsanna Zsofia; Krol, Alfons; Boccara, Olivia; Foelster-Holst, Regina; Febrer Bosch, Maria Isabel; Su, John; Buckova, Hana; Torrelo, Antonio; Cambazard, Frederic; Grantzow, Rainer; Wargon, Orli; Wyrzykowski, Dariusz; Roessler, Jochen; Bernabeu-Wittel, Jose; Valencia, Adriana M; Przewratil, Przemyslaw; Glick, Sharon; Pope, Elena; Birchall, Nicholas; Benjamin, Latanya; Mancini, Anthony J; Vabres, Pierre; Souteyrand, Pierre; Frieden, Ilona J; Berul, Charles I; Mehta, Cyrus R; Prey, Sorilla; Boralevi, Franck; Morgan, Caroline C; Heritier, Stephane; Delarue, Alain; Voisard, Jean-Jacques
2015-02-19
Oral propranolol has been used to treat complicated infantile hemangiomas, although data from randomized, controlled trials to inform its use are limited. We performed a multicenter, randomized, double-blind, adaptive, phase 2-3 trial assessing the efficacy and safety of a pediatric-specific oral propranolol solution in infants 1 to 5 months of age with proliferating infantile hemangioma requiring systemic therapy. Infants were randomly assigned to receive placebo or one of four propranolol regimens (1 or 3 mg of propranolol base per kilogram of body weight per day for 3 or 6 months). A preplanned interim analysis was conducted to identify the regimen to study for the final efficacy analysis. The primary end point was success (complete or nearly complete resolution of the target hemangioma) or failure of trial treatment at week 24, as assessed by independent, centralized, blinded evaluations of standardized photographs. Of 460 infants who underwent randomization, 456 received treatment. On the basis of an interim analysis of the first 188 patients who completed 24 weeks of trial treatment, the regimen of 3 mg of propranolol per kilogram per day for 6 months was selected for the final efficacy analysis. The frequency of successful treatment was higher with this regimen than with placebo (60% vs. 4%, P<0.001). A total of 88% of patients who received the selected propranolol regimen showed improvement by week 5, versus 5% of patients who received placebo. A total of 10% of patients in whom treatment with propranolol was successful required systemic retreatment during follow-up. Known adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) occurred infrequently, with no significant difference in frequency between the placebo group and the groups receiving propranolol. This trial showed that propranolol was effective at a dose of 3 mg per kilogram per day for 6 months in the treatment of infantile hemangioma. (Funded by Pierre Fabre Dermatologie; ClinicalTrials.gov number, NCT01056341.).
Adaptive graph-based multiple testing procedures
Klinglmueller, Florian; Posch, Martin; Koenig, Franz
2016-01-01
Multiple testing procedures defined by directed, weighted graphs have recently been proposed as an intuitive visual tool for constructing multiple testing strategies that reflect the often complex contextual relations between hypotheses in clinical trials. Many well-known sequentially rejective tests, such as (parallel) gatekeeping tests or hierarchical testing procedures are special cases of the graph based tests. We generalize these graph-based multiple testing procedures to adaptive trial designs with an interim analysis. These designs permit mid-trial design modifications based on unblinded interim data as well as external information, while providing strong family wise error rate control. To maintain the familywise error rate, it is not required to prespecify the adaption rule in detail. Because the adaptive test does not require knowledge of the multivariate distribution of test statistics, it is applicable in a wide range of scenarios including trials with multiple treatment comparisons, endpoints or subgroups, or combinations thereof. Examples of adaptations are dropping of treatment arms, selection of subpopulations, and sample size reassessment. If, in the interim analysis, it is decided to continue the trial as planned, the adaptive test reduces to the originally planned multiple testing procedure. Only if adaptations are actually implemented, an adjusted test needs to be applied. The procedure is illustrated with a case study and its operating characteristics are investigated by simulations. PMID:25319733
Interim analyses in 2 x 2 crossover trials.
Cook, R J
1995-09-01
A method is presented for performing interim analyses in long term 2 x 2 crossover trials with serial patient entry. The analyses are based on a linear statistic that combines data from individuals observed for one treatment period with data from individuals observed for both periods. The coefficients in this linear combination can be chosen quite arbitrarily, but we focus on variance-based weights to maximize power for tests regarding direct treatment effects. The type I error rate of this procedure is controlled by utilizing the joint distribution of the linear statistics over analysis stages. Methods for performing power and sample size calculations are indicated. A two-stage sequential design involving simultaneous patient entry and a single between-period interim analysis is considered in detail. The power and average number of measurements required for this design are compared to those of the usual crossover trial. The results indicate that, while there is minimal loss in power relative to the usual crossover design in the absence of differential carry-over effects, the proposed design can have substantially greater power when differential carry-over effects are present. The two-stage crossover design can also lead to more economical studies in terms of the expected number of measurements required, due to the potential for early stopping. Attention is directed toward normally distributed responses.
Multi-method Quantification of Sea-ice Production in Weddell Sea Polynyas (Antarctica)
NASA Astrophysics Data System (ADS)
Heinemann, G.; Zentek, R.; Stulic, L.; Paul, S.; Preusser, A.; Timmermann, R.
2017-12-01
Coastal polynyas occur frequently during winter in the Weddell Sea, which leads to strong sea ice production and to the formation of a highly saline water mass which is considered to be a major source of bottom water and one of the main drivers of the circulation beneath the Filchner-Ronne Ice Shelf. Thus the quantification of sea ice production in Weddell Sea polynyas is of vital interest for understanding water mass modification in this region. We use a multi-method approach to quantify sea ice production. Method 1) is based on the energy balance simulated by the regional climate model COSMO-CLM (CCLM) with 15 / 5 km resolution for the period 2002-2015 (nested in ERA-Interim data). Daily sea ice concentrations were taken from microwave satellite measurements. Method 2) is based on remote sensing using MODIS thermal infrared data at a resolution of 1-2km and a surface energy balance model taking atmospheric data from different reanalyses (ERA-Interim, JRA55, NCEP2) as well as data of CCLM. Method 3) relies on simulations using the Finite Element Sea ice-Ocean Model (FESOM). FESOM is run on a global grid with a resolution of about 5 km along the coast of the Weddell Sea using atmospheric forcing from reanalyses (ERA-Interim (80km) and CFSR (38km)) as well as from CCLM. In addition, an experiment with assimilation of MODIS thin ice retrievals was conducted. Estimates of polynya area (POLA) and sea ice production (IP) from the different methods are presented. The MODIS-based method with ERA-Interim shows the largest POLA as well as the largest IP for the Ronne polynya (RO, POLA / IP = 2800 km² / 29 km³/a) and for the polynya off Brunt Ice Shelf (BR, 3400 km² / 30 km³/a). Sensitivity to the choice of atmosphere data is high. In particular, too low temperatures in JRA55 cause very large ice production events and a strong overestimation of IP rates. Estimates based on CCLM simulations agree generally well with MODIS/ERA-Interim. FESOM yields a generally larger ice production and shows also a pronounced sensitivity to the atmospheric forcing, but the effect on POLA and IP depends on the region. For BR the FESOM simulations show much larger POLA and IP than other methods.
Independent Orbiter Assessment (IOA): CIL issues resolution report, volume 2
NASA Technical Reports Server (NTRS)
1988-01-01
The results of the Independent Orbiter Assessment (IOA) of the Failure Modes And Effects Analysis (FMEA) and Critical Items List (CIL) are presented. This report contains IOA assessment worksheets showing resolution of outstanding IOA CIL issues that were summarized in the IOA FMEA/CIL Assessment Interim Report, dated 9 March 1988. Each assessment worksheet has been updated with CIL issue resolution and rationale. Volume 2 contains the worksheets for the following subsystems: Nose Wheel Steering Subsystem; Remote Manipulator Subsystem; Atmospheric Revitalization Subsystem; Extravehicular Mobility Unit Subsystem; Power Reactant Supply and Distribution Subsystem; Main Propulsion Subsystem; and Orbital Maneuvering Subsystem.
IVHS Countermeasures for Rear-End Collisions, Task 1 Vol. III: 1991 NASS CDS Case Analysis
DOT National Transportation Integrated Search
1994-02-15
This report is from the NHTSA sponsored program, "IVHS Countermeasures for Rear-End Collisions". The Task 1 Interim Report consists of six volumes. This Volume, Volume III, 1991 NASS CDS Clinical Case Analysis presents the results of a clinical case ...
42 CFR 418.307 - Periodic interim payments.
Code of Federal Regulations, 2010 CFR
2010-10-01
... (CONTINUED) MEDICARE PROGRAM HOSPICE CARE Payment for Hospice Care § 418.307 Periodic interim payments... payments. The biweekly interim payment amount is based on the total estimated Medicare payments for the...
[Response to US review rules on patent subject matter of traditional Chinese medicine compositions].
Liu, Pan; Cao, Ya-di; Gong, Rui-Juan; Liu, Wei
2018-02-01
The United States Patent and Trademark Office(USPTO) issued Interim Guidance on Patent Subject Matter Eligibility on December 16, 2014, bringing certain effects to the review rules on patent application of Chinese medicine compositions. Based on the Interim Guidance, cases analysis was used in this paper to analyze the patent subject matter issues of traditional Chinese medicine compositions in the United States. The researches have shown that the application documents should be properly written in the United States when the patent for Chinese medicine compositions is applied, which can improve the probability of authorization. Copyright© by the Chinese Pharmaceutical Association.
Mobile source air toxics mitigation measures.
DOT National Transportation Integrated Search
2013-10-01
In accordance with the Federal Highway Administration (FHWA) Interim Guidance Update on Mobile Source Air Toxic Analysis in NEPA Documents (September 30, 2009), transportation projects subject to the National Environmental Policy Act (NEPA) mus...
Safe Passage Data Analysis: Interim Report
DOT National Transportation Integrated Search
1993-04-01
The purpose of this report is to describe quantitatively the costs and benefits of screener : proficiency evaluation and reporting systems (SPEARS) equipment, particularly computer-based : instruction (CBI) systems, compared to current methods of tra...
The cost and impact of the interim federal health program cuts on child refugees in Canada.
Evans, Andrea; Caudarella, Alexander; Ratnapalan, Savithiri; Chan, Kevin
2014-01-01
On June 30, 2012, Interim Federal Health Program (IFHP) funding was cut for refugee claimant healthcare. The potential financial and healthcare impacts of these cuts on refugee claimants are unknown. We conducted a one-year retrospective chart review spanning 6 months before and after IFHP funding cuts at The Hospital for Sick Children, a tertiary care children's hospital in Toronto. We analyzed emergency room visits characteristics, admission rates, reasons for admission, and financial records including billing from Medavie Blue Cross. There were 173 refugee children visits to the emergency room in the six months before and 142 visits in the six months after funding cuts. The total amount billed to the IFHP program during the one-year of this study was $131,615. Prior to the IFHP cuts, 46% of the total emergency room bills were paid by IFHP compared to 7% after the cuts (p<0.001). After the cuts to the IFHP, The Hospital for Sick Children was unable to obtain federal health coverage for the vast majority of refugee claimant children registered under the IFHP. This preliminary analysis showed that post-IFHP cuts healthcare costs at the largest tertiary pediatric institution in the country increased.
Analysis of the factors that impact the reliability of high level waste canister materials
DOE Office of Scientific and Technical Information (OSTI.GOV)
Boyd, W.K.; Hall, A.M.
1977-09-19
The analysis encompassed identification and analysis of potential threats to canister integrity arising in the course of waste solidification, interim storage at the fuels reprocessing plant, wet and dry shipment, and geologic storage. Fabrication techniques and quality assurance requirements necessary to insure optimum canister reliability were considered taking into account such factors as welding procedure, surface preparation, stress relief, remote weld closure, and inspection methods. Alternative canister materials and canister systems were also considered in terms of optimum reliability in the face of threats to the canister's integrity, ease of fabrication, inspection, handling and cost. If interim storage in airmore » is admissible, the sequence suggested comprises producing a glass-type waste product in a continuous ceramic melter, pouring into a carbon steel or low-alloy steel canister of moderately heavy wall thickness, storing in air upright on a pad and surrounded by a concrete radiation shield, and thereafter placing in geologic storage without overpacking. Should the decision be to store in water during the interim period, then use of either a 304 L stainless steel canister overpacked with a solution-annealed and fast-cooled 304 L container, or a single high-alloy canister, is suggested. The high alloy may be Inconel 600, Incoloy Alloy 800, or Incoloy Alloy 825. In either case, it is suggested that the container be overpacked with a moderately heavy wall carbon steel or low-alloy steel cask for geologic storage to ensure ready retrievability. 19 figs., 5 tables.« less
An interim reference model for the variability of the middle atmosphere H2O vapor distribution
NASA Technical Reports Server (NTRS)
Remsberg, E. E.; Russell, J. M., III; Wu, C. Y.
1989-01-01
Water vapor is an important minor constituent in the studies of the middle atmosphere for a variety of reasons, including its role as a source for active HO(y) chemicals and its use in analysis of transport processes. A number of in situ and remote techniques were employed in the determination of water vapor distributions. Two of the more complete data sets were used to develop an interim reference profile. First, there are the seven months of Nimbus 7 limb infrared monitor of the stratosphere (LIMS) data obtained during Nov. 1978 to May 1979 over the range 64S to 84N latitude and from about 100 to 1 mb in the mid-mesosphere at several fixed Northern Hemisphere mid-latitude sites. These two data sets were combined to give a mid-lattitude, interim reference water vapor profile for the entire vertical range of the middle atmosphere and with accuracies of better than 25 percent. The daily variability of stratospheric water vapor profiles about the monthly mean was also established from these data sets for selected months. Information is also provided on the longitudinal variability of LIMS water vapor profiles about the daily, weekly, and monthly zonal means. Generally, the interim reference water vapor profile and its variability are consistent with prevailing ideas about chemistry and transport.
NASA Astrophysics Data System (ADS)
José González-Rojí, Santos; Wilby, Robert L.; Sáenz, Jon; Ibarra-Berastegi, Gabriel
2017-04-01
Downscaling via the Statistical DownScaling Model (SDSM) version 5.2 and two different configurations of the dynamical WRF model (with and without 3DVAR data assimilation) was evaluated for the estimation of daily precipitation over 21 sites across the Iberian Peninsula during the period 2010-2014. Six different strategies were used to calibrate the SDSM model. These options cover (1) use of NCEP/NCAR R1 Reanalysis and (2) ERA Interim data for downscaling predictor variables calibrated with data from periods (3) 1948-2009 (NCEP/NCAR R1) and (4) 1979-2009 (NCEP/NCAR R1 and ERA Interim). Additionally, for the ERA Interim case, two different grid resolutions have been used, (5) 2.5° and (6) 0.75°. On the other side, for the NCEP/NCAR R1 case, only the 2.5° resolution has been used. Configuring the SDSM model in this way allows testing the sensitivity of the results to different origins of the predictors, fit to different calibration periods and use of different reanalysis resolutions. On the other hand, ERA Interim data at the highest resolution was used as the initial/boundary conditions to run WRF simulations with a 15 km x 15 km horizontal resolution over the Iberian Peninsula, for two different configurations. The first experiment (N) was run using the same configuration typically used for numerical downscaling, with information being fed through the boundaries of the domain. The second experiment (D) was run using 3DVAR data assimilation at 00UTC, 06UTC, 12UTC and 18UTC. In both cases, WRF simulations were run over the period 2009-2014, using the first year (2009) as spin-up for the soil model. Results from the WRF N and D runs and comparable SDSM set up for the period 2010-2014 were evaluated using observations from ECA and E-OBS datasets. In each case, model skill was assessed using seven daily precipitation metrics (absolute mean, wet-day intensity, 90th percentile, maximum 5-day total, maximum number of consecutive dry days, fraction of total from heavy events and number of heavy events defined here as values over the threshold of 90th percentile. Our results show that the SDSM model improves its behaviour when using predictors from the ERA Interim Reanalysis. Improvements are even more impressive when using the 0.75° resolution for ERA Interim. Better results than using WRF D are obtained with this configuration of the SDSM model for mean precipitation and precipitation intensity. Overall, the analysis reveals the extent to which the skill of SDSM can be improved through judicious choice of downscaling predictor source, grid resolution and calibration period. Moreover, the computationally efficient SDSM tool can achieve comparable skill to WRF over a range of precipitation metrics and the contrasting rainfall regimes of the Iberian Peninsula.
Color stability and marginal integrity of interim crowns: An in vitro study
Elagra, Marwa I.; Rayyan, Mohammad R.; Alhomaidhi, Maisam M.; Alanaziy, Areej A.; Alnefaie, Mona O.
2017-01-01
Objective: Many commercial dental materials are used to fabricate interim restorations. This study aimed to compare the color stability and the marginal integrity of four different interim crown materials. Materials and Methods: An ivorine right maxillary central incisor was prepared for a full coverage all-ceramic restoration. A total of 36 specimens in the form of crowns were fabricated on the master die using four different materials (n = 9); Polymethyl methacrylate (PMMA) resin (TrimPLUS), PMMA computer-aided design, and computer-aided manufacturing (CAD-CAM) blocks (Ceramill TEMP), cold cure bis-acryl resin (Success CD), and bis-acryl resin dual-cure composite (TempSpan). Color change ΔE for each sample was calculated by measuring its color as Commission Internationale de l’Eclairage L* a* b* with a spectrophotometer before and after immersing in a concentrated tea solution for 7 days. Marginal gap was measured at four reference points using stereomicroscope at ×40. One-way ANOVA and the Tukey multiple comparisons test were used to determine any statistically significant difference between the four groups, (α = 0.05). Results: Success CD showed significantly the greatest color change (7.7) among all the tested materials, while no significant difference was found between the other three materials. TempSpan showed significantly the highest marginal gap formation (430.15 μm), while no significant difference was found between the three other materials. Conclusions: Bis-acryl resin composite materials demonstrated clinically noticeable change in color while PMMA materials demonstrated superior color stability. Dual cure interim materials exhibited significantly higher marginal discrepancy in comparison to PMMA and cold cure bis-acrylic resin materials. CAD-CAM PMMA material exhibited the best color stability and marginal integrity. PMID:28932142
NASA Astrophysics Data System (ADS)
Renwick, J. A.; Rana, S.; McGregor, J.
2015-12-01
This work addresses the seasonal (winter, pre-monsoon, monsoon and post-monsoon) performance of seven precipitation products from three different data sources: gridded station data, satellite-derived data and reanalyses products over the Indian Subcontinent, for a period of 10 years (1997/98 to 2006/07). Precipitation products evaluated are the Asian Precipitation - Highly Resolved Observational Data Integration Towards Evaluation of Water Resources (APHRODITE), the Climate Prediction Center unified gauge (CPC-uni), the Global Precipitation Climatology project (GPCP), Tropical Rainfall Measuring Mission (TRMM) post real-time research products (3B42-V6 and 3B42-V7), the Climate Forecast System Reanalysis (CFSR) and the European Centre for Medium-Range Weather Forecasts (ECMWF) Interim Re-Analysis (ERA-Interim). Several verification measures are employed to assess the accuracy of the data. All datasets capture the large-scale characteristics of the seasonal mean precipitation distribution, albeit with pronounced seasonal and/or regional differences. Compared to APHRODITE, the gauge-only (CPC-uni) and the satellite-derived precipitation products (GPCP, 3B42-V6 and 3B42-V7) capture the summer monsoon rainfall variability better than CFSR and ERA-Interim. Similar conclusions were drawn for the post-monsoon season, with the exception of 3B42-V7, which underestimates post-monsoon precipitation. Over mountainous regions 3B42-V7 shows an appreciable improvement over 3B42-V6 and other gauge-based precipitation products. Significantly large biases/errors occur during the winter months, which is likely related to the uncertainty in observations that artificially inflate the existing error in reanalyses and satellite retrievals.
Liesner, R J; Abashidze, M; Aleinikova, O; Altisent, C; Belletrutti, M J; Borel-Derlon, A; Carcao, M; Chambost, H; Chan, A K C; Dubey, L; Ducore, J; Fouzia, N A; Gattens, M; Gruel, Y; Guillet, B; Kavardakova, N; El Khorassani, M; Klukowska, A; Lambert, T; Lohade, S; Sigaud, M; Turea, V; Wu, J K M; Vdovin, V; Pavlova, A; Jansen, M; Belyanskaya, L; Walter, O; Knaub, S; Neufeld, E J
2018-03-01
Nuwiq ® (Human-cl rhFVIII) is a fourth generation recombinant FVIII, produced in a human cell line, without chemical modification or protein fusion. No inhibitors developed in studies with Nuwiq ® in 201 previously treated patients with haemophilia A (HA). The immunogenicity, efficacy and safety of Nuwiq ® in previously untreated patients (PUPs) with severe HA are being assessed in the ongoing NuProtect study. The study, conducted across 38 centres worldwide, is evaluating 110 true PUPs of all ages and ethnicities enrolled for study up to 100 exposure days (EDs) or 5 years maximum. The primary objective is to assess the immunogenicity of Nuwiq ® (inhibitor activity ≥0.6 BU) using the Nijmegen-modified Bethesda assay at a central laboratory. Data for 66 PUPs with ≥20 EDs from a preplanned interim analysis were analysed. High-titre (HT) inhibitors developed in 8 of 66 patients after a median of 11.5 EDs (range 6-24). Five patients developed low-titre inhibitors (4 transient). The cumulative incidence (95% confidence interval) was 12.8% (4.5%, 21.2%) for HT inhibitors and 20.8% (10.7%, 31.0%) for all inhibitors. During inhibitor-free periods, median annualized bleeding rates during prophylaxis were 0 for spontaneous bleeds and 2.40 for all bleeds. Efficacy was rated as "excellent" or "good" in treating 91.8% of bleeds. Efficacy of surgical prophylaxis was "excellent" or "good" for 8 (89%) procedures and "moderate" for 1 (11%). No tolerability concerns were evident. These interim data show a cumulative incidence of 12.8% for HT inhibitors and convincing efficacy and tolerability in PUPs treated with Nuwiq ® . © 2017 The Authors. Haemophilia published by John Wiley & Sons Ltd.
Cyclone Activity in the Arctic From an Ensemble of Regional Climate Models (Arctic CORDEX)
NASA Astrophysics Data System (ADS)
Akperov, Mirseid; Rinke, Annette; Mokhov, Igor I.; Matthes, Heidrun; Semenov, Vladimir A.; Adakudlu, Muralidhar; Cassano, John; Christensen, Jens H.; Dembitskaya, Mariya A.; Dethloff, Klaus; Fettweis, Xavier; Glisan, Justin; Gutjahr, Oliver; Heinemann, Günther; Koenigk, Torben; Koldunov, Nikolay V.; Laprise, René; Mottram, Ruth; Nikiéma, Oumarou; Scinocca, John F.; Sein, Dmitry; Sobolowski, Stefan; Winger, Katja; Zhang, Wenxin
2018-03-01
The ability of state-of-the-art regional climate models to simulate cyclone activity in the Arctic is assessed based on an ensemble of 13 simulations from 11 models from the Arctic-CORDEX initiative. Some models employ large-scale spectral nudging techniques. Cyclone characteristics simulated by the ensemble are compared with the results forced by four reanalyses (ERA-Interim, National Centers for Environmental Prediction-Climate Forecast System Reanalysis, National Aeronautics and Space Administration-Modern-Era Retrospective analysis for Research and Applications Version 2, and Japan Meteorological Agency-Japanese 55-year reanalysis) in winter and summer for 1981-2010 period. In addition, we compare cyclone statistics between ERA-Interim and the Arctic System Reanalysis reanalyses for 2000-2010. Biases in cyclone frequency, intensity, and size over the Arctic are also quantified. Variations in cyclone frequency across the models are partly attributed to the differences in cyclone frequency over land. The variations across the models are largest for small and shallow cyclones for both seasons. A connection between biases in the zonal wind at 200 hPa and cyclone characteristics is found for both seasons. Most models underestimate zonal wind speed in both seasons, which likely leads to underestimation of cyclone mean depth and deep cyclone frequency in the Arctic. In general, the regional climate models are able to represent the spatial distribution of cyclone characteristics in the Arctic but models that employ large-scale spectral nudging show a better agreement with ERA-Interim reanalysis than the rest of the models. Trends also exhibit the benefits of nudging. Models with spectral nudging are able to reproduce the cyclone trends, whereas most of the nonnudged models fail to do so. However, the cyclone characteristics and trends are sensitive to the choice of nudged variables.
Graiff, Lorenzo; Vigolo, Paolo
2012-04-01
Placement of a dental implant and an interim restoration in the esthetic zone immediately following tooth extraction is now a common procedure. However, in such clinical situations, the fabrication of an appropriate interim restoration may be challenging. The aim of this article is to present a technique for modifying the extracted tooth so it can be used as an implant-supported interim restoration.
Interim analysis of STR effectiveness
DOT National Transportation Integrated Search
1978-01-01
The present report describes the status of the NHTSA Short Term Rehabilitation Study (STR) as of December, 1977, and summarizes the progress of data collection efforts by the eleven participating ASAP projects. Outcome measures considered as indicati...
Aggarwal, Swati P; Zinman, Lorne; Simpson, Elizabeth; McKinley, Jane; Jackson, Katherine E; Pinto, Hanika; Kaufman, Petra; Conwit, Robin A; Schoenfeld, David; Shefner, Jeremy; Cudkowicz, Merit
2010-05-01
In a pilot study, lithium treatment slowed progression of amyotrophic lateral sclerosis (ALS). We aimed to confirm or disprove these findings by assessing the safety and efficacy of lithium in combination with riluzole in patients with ALS. We did a double-blind, placebo-controlled trial with a time-to-event design. Between January and June, 2009, patients with ALS who were taking a stable dose of riluzole for at least 30 days were randomly assigned (1:1) by a centralised computer to receive either lithium or placebo. Patients, caregivers, investigators, and all site study staff with the exception of site pharmacists were masked to treatment assignment. The primary endpoint was the time to an event, defined as a decrease of at least six points on the revised ALS functional rating scale score or death. Interim analyses were planned for when 84 patients had been allocated treatment, 6 months later or after 55 events, and after 100 events. Analysis was by intention to treat. The stopping boundary for futility at the first interim analysis was a p value of at least 0.68. We used a log-rank test to compare the distributions of the time to an event between the lithium and placebo groups. This trial is registered with ClinicalTrials.gov, NCT00818389. At the first interim analysis, 22 of 40 patients in the lithium group had an event compared with 20 of 44 patients in the placebo group (log rank p=0.51). The hazard ratio of reaching the primary endpoint was 1.13 (95% CI 0.61-2.07). The study was stopped at the first interim analysis because criterion for futility was met (p=0.78). The difference in mean decline in the ALS functional rating scale score between the lithium group and the placebo group was 0.15 (95% CI -0.43 to 0.73, p=0.61). There were no major safety concerns. Falls (p=0.04) and back pain (p=0.05) were more common in the lithium group than in the placebo group. We found no evidence that lithium in combination with riluzole slows progression of ALS more than riluzole alone. The time-to-event endpoint and use of prespecified interim analyses enabled a clear result to be obtained rapidly. This design should be considered for future trials testing the therapeutic efficacy of drugs that are easily accessible to people with ALS. National Institute of Neurological Disorders and Stroke, ALS Association, and ALS Society of Canada. Copyright 2010 Elsevier Ltd. All rights reserved.
Solar cycle modulation of Southern Annular Mode -Energy-momentum analysis-
NASA Astrophysics Data System (ADS)
Kuroda, Y.
2016-12-01
Climate is affected by various factors, including oceanic changes and volcanic eruptions. 11-year solar cycle change is one of such important factors. Observational analysis shows that the Southern Annular Mode (SAM) in late-winter/spring show structural modulation associated with 11-year solar cycle. In fact, SAM-related signal tends to extend from surface to upper stratosphere and persistent longer period in the High Solar (HS) years, whereas it is restricted in the troposphere and not persist in the Low Solar (LS) years. In the present study, we used 35-year record of ERA-Interim reanalysis data and performed wave-energy and momentum analysis on the solar-cycle modulation of the SAM to examine key factors to create such solar-SAM relationship. It is found that enhanced wave-mean flow interaction tends to take place in the middle stratosphere in association with enhanced energy input from diabatic heating on September only in HS years. The result suggests atmospheric and solar conditions on September are keys to create solar-SAM relationship.
The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.
Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol
2013-05-01
Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.
NASA Astrophysics Data System (ADS)
Shi, Chunhua; Huang, Ying; Guo, Dong; Zhou, Shunwu; Hu, Kaixi; Liu, Yu
2018-05-01
The South Asian High (SAH) has an important influence on atmospheric circulation and the Asian climate in summer. However, current comparative analyses of the SAH are mostly between reanalysis datasets and there is a lack of sounding data. We therefore compared the climatology, trends and abrupt changes in the SAH in the Japanese 55-year Reanalysis (JRA-55) dataset, the National Centers for Environmental Prediction Climate Forecast System Reanalysis (NCEP-CFSR) dataset, the European Center for Medium-Range Weather Forecasts Reanalysis Interim (ERA-interim) dataset and radiosonde data from China using linear analysis and a sliding t-test. The trends in geopotential height in the control area of the SAH were positive in the JRA-55, NCEP-CFSR and ERA-interim datasets, but negative in the radiosonde data in the time period 1979-2014. The negative trends for the SAH were significant at the 90% confidence level in the radiosonde data from May to September. The positive trends in the NCEP-CFSR dataset were significant at the 90% confidence level in May, July, August and September, but the positive trends in the JRA-55 and ERA-Interim were only significant at the 90% confidence level in September. The reasons for the differences in the trends of the SAH between the radiosonde data and the three reanalysis datasets in the time period 1979-2014 were updates to the sounding systems, changes in instrumentation and improvements in the radiation correction method for calculations around the year 2000. We therefore analyzed the trends in the two time periods of 1979-2000 and 2001-2014 separately. From 1979 to 2000, the negative SAH trends in the radiosonde data mainly agreed with the negative trends in the NCEP-CFSR dataset, but were in contrast with the positive trends in the JRA-55 and ERA-Interim datasets. In 2001-2014, however, the trends in the SAH were positive in all four datasets and most of the trends in the radiosonde and NCEP-CFSR datasets were significant. It is therefore better to use the NCEP-CFSR dataset than the JRA-55 and ERA-Interim datasets when discussing trends in the SAH.
Zhu, Jay-Jiguang; Demireva, Petya; Kanner, Andrew A; Pannullo, Susan; Mehdorn, Maximilian; Avgeropoulos, Nicholas; Salmaggi, Andrea; Silvani, Antonio; Goldlust, Samuel; David, Carlos; Benouaich-Amiel, Alexandra
2017-12-01
We characterized health-related quality of life (HRQoL), cognitive, and functional status in newly diagnosed glioblastoma (GBM) patients receiving Tumor treating fields (TTFields) with temozolomide (TMZ) versus TMZ alone in a planned interim analysis of a randomized phase III trial [NCT00916409], which showed significant improvement in progression-free and overall survival with TTFields/TMZ. After radiotherapy with concomitant TMZ, newly diagnosed GBM patients were randomized (2:1) to TTFields/TMZ (n = 210) or TMZ (n = 105). Interim analysis was performed in 315 patients with ≥18 months of follow-up. HRQoL, a secondary endpoint, was evaluated in per-protocol patient population and expressed as change from baseline (CFB) at 3, 6, and 9 months for each subscale in the EORTC QLQ-C30/BN20. Karnofsky performance scores (KPS) and Mini-Mental State Examination scores (MMSE) were assessed. CFB in HRQoL was balanced in treatment groups at the 12-month time point. Initially, HRQoL improved in patients treated with TTFields/TMZ (CFB3: 24% and CFB6: 13%) versus TMZ (CFB3: -7% and CFB6: -17%), though this difference was no longer evident at the 9-month point. General scales, including physical and social functioning, showed no difference at 9 and 12 months. TTFields/TMZ group reported higher concerns of "itchy skin". KPS over 12 months was just below 90 in both groups. Cognitive status (MMSE) was stable over time. HRQoL, KPS, and MMSE were balanced in both groups over time. There was no preliminary evidence that HRQoL, cognitive, and functional status is adversely affected by the continuous use of TTFields.
The influence of El Niño-Southern Oscillation on boreal winter rainfall over Peninsular Malaysia
NASA Astrophysics Data System (ADS)
Richard, Sandra; Walsh, Kevin J. E.
2017-09-01
Multi-scale interactions between El Niño-Southern Oscillation and the Boreal Winter Monsoon contribute to rainfall variations over Malaysia. Understanding the physical mechanisms that control these spatial variations in local rainfall is crucial for improving weather and climate prediction and related risk management. Analysis using station observations and European Centre for Medium-Range Weather Forecasts Interim Reanalysis (ERA-Interim) reanalysis reveals a significant decrease in rainfall during El Niño (EL) and corresponding increase during La Niña particularly north of 2°N over Peninsular Malaysia (PM). It is noted that the southern tip of PM shows a small increase in rainfall during El Niño although not significant. Analysis of the diurnal cycle of rainfall and winds indicates that there are no significant changes in morning and evening rainfall over PM that could explain the north-south disparity. Thus, we suggest that the key factor which might explain the north-south rainfall disparity is the moisture flux convergence (MFC). During the December to January (DJF) period of EL years, except for the southern tip of PM, significant negative MFC causes drying as well as suppression of uplift over most areas. In addition, lower specific humidity combined with moisture flux divergence results in less moisture over PM. Thus, over the areas north of 2°N, less rainfall (less heavy rain days) with smaller diurnal rainfall amplitude explains the negative rainfall anomaly observed during DJF of EL. The same MFC argument might explain the dipolar pattern over other areas such as Borneo if further analysis is performed.
Biggi, Alberto; Gallamini, Andrea; Chauvie, Stephane; Hutchings, Martin; Kostakoglu, Lale; Gregianin, Michele; Meignan, Michel; Malkowski, Bogdan; Hofman, Michael S; Barrington, Sally F
2013-05-01
At present, there are no standard criteria that have been validated for interim PET reporting in lymphoma. In 2009, an international workshop attended by hematologists and nuclear medicine experts in Deauville, France, proposed to develop simple and reproducible rules for interim PET reporting in lymphoma. Accordingly, an international validation study was undertaken with the primary aim of validating the prognostic role of interim PET using the Deauville 5-point score to evaluate images and with the secondary aim of measuring concordance rates among reviewers using the same 5-point score. This paper focuses on the criteria for interpretation of interim PET and on concordance rates. A cohort of advanced-stage Hodgkin lymphoma patients treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) were enrolled retrospectively from centers worldwide. Baseline and interim scans were reviewed by an international panel of 6 nuclear medicine experts using the 5-point score. Complete scan datasets of acceptable diagnostic quality were available for 260 of 440 (59%) enrolled patients. Independent agreement among reviewers was reached on 252 of 260 patients (97%), for whom at least 4 reviewers agreed the findings were negative (score of 1-3) or positive (score of 4-5). After discussion, consensus was reached in all cases. There were 45 of 260 patients (17%) with positive interim PET findings and 215 of 260 patients (83%) with negative interim PET findings. Thirty-three interim PET-positive scans were true-positive, and 12 were false-positive. Two hundred three interim PET-negative scans were true-negative, and 12 were false-negative. Sensitivity, specificity, and accuracy were 0.73, 0.94, and 0.91, respectively. Negative predictive value and positive predictive value were 0.94 and 0.73, respectively. The 3-y failure-free survival was 83%, 28%, and 95% for the entire population and for interim PET-positive and -negative patients, respectively (P < 0.0001). The agreement between pairs of reviewers was good or very good, ranging from 0.69 to 0.84 as measured with the Cohen kappa. Overall agreement was good at 0.76 as measured with the Krippendorf α. The 5-point score proposed at Deauville for reviewing interim PET scans in advanced Hodgkin lymphoma is accurate and reproducible enough to be accepted as a standard reporting criterion in clinical practice and for clinical trials.
Beckmann, James T; Wylie, James D; Potter, Michael Q; Maak, Travis G; Greene, Thomas H; Aoki, Stephen K
2015-12-16
Heterotopic ossification (HO) is a known complication of hip arthroscopy. Our objective was to determine the effect of postoperative naproxen therapy on the development of HO following arthroscopic surgery for femoroacetabular impingement. Between August 2011 and April 2013, 108 eligible patients were enrolled and randomized to take naproxen or a placebo for three weeks postoperatively. Radiographs were made at routine follow-up visits for one year following surgery. The primary outcome measure was the development of HO, as classified with the Brooker criteria and two-dimensional measurements on radiographs made at least seventy-five days postoperatively (average, 322 days). The primary analysis, performed with a Fisher exact test, compared the proportion of subjects with HO between the treatment and control groups. A single a priori interim analysis was planned at the midpoint of the study. Our data safety and monitoring board stopped this study when the interim analysis showed that the stopping criterion had been met for demonstration of efficacy of the naproxen intervention. The prevalence of HO was 46% (twenty-two of the forty-eight in the final analysis) in the placebo group versus 4% (two of forty-eight) in the naproxen group (p < 0.001). Medication compliance was 69% overall, but it did not differ between the naproxen and placebo groups. Minor adverse reactions to the study medications were reported in 42% of the patients taking naproxen versus 35% of those taking the placebo (p = 0.45). In this trial, prophylaxis with naproxen was effective in reducing the prevalence of HO without medication-related morbidity. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.
Guidance: Interim Municipal Settlement Policy
Interim guidance and fact sheets regarding settlements involving municipalities or municipal waste under Section 122 CERCLA as amended by SARA. Interim policy sets forth the criteria by which EPA generally determines whether to exercise enforcement discretion to pursue MSW generators and transporters as PRPs.
NASA Technical Reports Server (NTRS)
Keuper, H. R.; Peplies, R. W.; Gillooly, R. P.
1977-01-01
The use of machine scanning and/or computer-based techniques to provide greater objectivity in the photomorphic approach was investigated. Photomorphic analysis and its application in regional planning are discussed. Topics included: delineation of photomorphic regions; inadequacies of existing classification systems; tonal and textural characteristics and signature analysis techniques; pattern recognition and Fourier transform analysis; and optical experiments. A bibliography is included.
Science Opportunities Enabled by NASA's Constellation System: Interim Report
NASA Astrophysics Data System (ADS)
Committee On Science Opportunities Enabled By Nasa'S Constellation System, National Research Council
To begin implementation of the Vision for Space Exploration (recently renamed "United States Space Exploration Policy"), NASA has begun development of new launch vehicles and a human-carrying spacecraft that are collectively called the Constellation System. In November 2007, NASA asked the NRC to evaluate the potential for the Constellation System to enable new space science opportunities. For this interim report, 11 existing "Vision Mission" studies of advanced space science mission concepts inspired by earlier NASA forward-looking studies were evaluated. The focus was to assess the concepts and group them into two categories: more-deserving or less deserving of future study. This report presents a description of the Constellation System and its opportunities for enabling new space science opportunities, and a systematic analysis of the 11 Vision Mission studies. For the final report, the NRC issued a request for information to the relevant communities to obtain ideas for other mission concepts that will be assessed by the study committee, and several issues addressed only briefly in the interim report will be explored more fully.
NAVSTAR GPS Simulation and Analysis Program (Interim Report)
DOT National Transportation Integrated Search
1983-10-01
This study assesses the capability of the planned NAVSTAR Global Positioning System (GPS) to meet civil navigation requirements. When it becomes operational in about 1983, NAVSTAR GPS will provide accurate two-dimensional and three-dimensional servic...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-22
...: Lynchburg, Virginia. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of..., Interim Director, Division of Compensation Analysis and Support, National Institute for Occupational...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-29
...: Lawrence Livermore National Laboratory. Location: Livermore, California. Job Titles and/or Job Duties: All... L. Hinnefeld, Interim Director, Office of Compensation Analysis and Support, National Institute for...
Road weather connected vehicle applications : benefit-cost analysis interim report.
DOT National Transportation Integrated Search
2013-01-01
RWMP is currently engaged in a project to evaluate the potential benefits of road weather connected vehicle applications. Of particular interest are the potential improvements in safety, reductions in travel time, improved travel reliability, reducti...
INTERIM ANALYSIS OF THE CONTRIBUTION OF HIGH-LEVEL EVIDENCE FOR DENGUE VECTOR CONTROL.
Horstick, Olaf; Ranzinger, Silvia Runge
2015-01-01
This interim analysis reviews the available systematic literature for dengue vector control on three levels: 1) single and combined vector control methods, with existing work on peridomestic space spraying and on Bacillus thuringiensis israelensis; further work is available soon on the use of Temephos, Copepods and larvivorous fish; 2) or for a specific purpose, like outbreak control, and 3) on a strategic level, as for example decentralization vs centralization, with a systematic review on vector control organization. Clear best practice guidelines for methodology of entomological studies are needed. There is a need to include measuring dengue transmission data. The following recommendations emerge: Although vector control can be effective, implementation remains an issue; Single interventions are probably not useful; Combinations of interventions have mixed results; Careful implementation of vector control measures may be most important; Outbreak interventions are often applied with questionable effectiveness.
Pembrolizumab for Ipilimumab-Resistant Melanoma
KEYNOTE-002 was designed to test the safety and efficacy of two doses of pembrolizumab compared with chemotherapy in patients with ipilimumab-resistant melanoma; interim results show that pembrolizumab improves progression-free survival for these patients
28 CFR 94.41 - Interim emergency payment.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...
28 CFR 94.41 - Interim emergency payment.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...
28 CFR 94.41 - Interim emergency payment.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...
28 CFR 94.41 - Interim emergency payment.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...
28 CFR 94.41 - Interim emergency payment.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...
76 FR 4369 - Special Law Enforcement Commissions
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-25
... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Special Law Enforcement Commissions AGENCY... of the Interim Special Law Enforcement Commission Policy, Rules and Procedures, the Interim Special Law Enforcement Commission Protocols and the Interim Domestic Violence Waiver that will be used by the...
47 CFR 51.715 - Interim transport and termination pricing.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...
47 CFR 51.715 - Interim transport and termination pricing.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 3 2011-10-01 2011-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...
33 CFR 385.9 - Implementation principles.
Code of Federal Regulations, 2013 CFR
2013-07-01
... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...
33 CFR 385.9 - Implementation principles.
Code of Federal Regulations, 2014 CFR
2014-07-01
... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...
33 CFR 385.9 - Implementation principles.
Code of Federal Regulations, 2011 CFR
2011-07-01
... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...
33 CFR 385.9 - Implementation principles.
Code of Federal Regulations, 2012 CFR
2012-07-01
... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...
Investigation of Kelvin wave periods during Hai-Tang typhoon using Empirical Mode Decomposition
NASA Astrophysics Data System (ADS)
Kishore, P.; Jayalakshmi, J.; Lin, Pay-Liam; Velicogna, Isabella; Sutterley, Tyler C.; Ciracì, Enrico; Mohajerani, Yara; Kumar, S. Balaji
2017-11-01
Equatorial Kelvin waves (KWs) are fundamental components of the tropical climate system. In this study, we investigate Kelvin waves (KWs) during the Hai-Tang typhoon of 2005 using Empirical Mode Decomposition (EMD) of regional precipitation, zonal and meridional winds. For the analysis, we use daily precipitation datasets from the Global Precipitation Climatology Project (GPCP) and wind datasets from the European Centre for Medium-Range Weather Forecasts (ECMWF) Interim Re-analysis (ERA-Interim). As an additional measurement, we use in-situ precipitation datasets from rain-gauges over the Taiwan region. The maximum accumulated precipitation was approximately 2400 mm during the period July 17-21, 2005 over the southwestern region of Taiwan. The spectral analysis using the wind speed at 950 hPa found in the 2nd, 3rd, and 4th intrinsic mode functions (IMFs) reveals prevailing Kelvin wave periods of ∼3 days, ∼4-6 days, and ∼6-10 days, respectively. From our analysis of precipitation datasets, we found the Kelvin waves oscillated with periods between ∼8 and 20 days.
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-10
...The Federal Deposit Insurance Corporation (FDIC) is adopting an interim final rule that revises its risk-based and leverage capital requirements for FDIC-supervised institutions. This interim final rule is substantially identical to a joint final rule issued by the Office of the Comptroller of the Currency (OCC) and the Board of Governors of the Federal Reserve System (Federal Reserve) (together, with the FDIC, the agencies). The interim final rule consolidates three separate notices of proposed rulemaking that the agencies jointly published in the Federal Register on August 30, 2012, with selected changes. The interim final rule implements a revised definition of regulatory capital, a new common equity tier 1 minimum capital requirement, a higher minimum tier 1 capital requirement, and, for FDIC-supervised institutions subject to the advanced approaches risk-based capital rules, a supplementary leverage ratio that incorporates a broader set of exposures in the denominator. The interim final rule incorporates these new requirements into the FDIC's prompt corrective action (PCA) framework. In addition, the interim final rule establishes limits on FDIC-supervised institutions' capital distributions and certain discretionary bonus payments if the FDIC-supervised institution does not hold a specified amount of common equity tier 1 capital in addition to the amount necessary to meet its minimum risk-based capital requirements. The interim final rule amends the methodologies for determining risk-weighted assets for all FDIC-supervised institutions. The interim final rule also adopts changes to the FDIC's regulatory capital requirements that meet the requirements of section 171 and section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act. The interim final rule also codifies the FDIC's regulatory capital rules, which have previously resided in various appendices to their respective regulations, into a harmonized integrated regulatory framework. In addition, the FDIC is amending the market risk capital rule (market risk rule) to apply to state savings associations. The FDIC is issuing these revisions to its capital regulations as an interim final rule. The FDIC invites comments on the interaction of this rule with other proposed leverage ratio requirements applicable to large, systemically important banking organizations. This interim final rule otherwise contains regulatory text that is identical to the common rule text adopted as a final rule by the Federal Reserve and the OCC. This interim final rule enables the FDIC to proceed on a unified, expedited basis with the other federal banking agencies pending consideration of other issues. Specifically, the FDIC intends to evaluate this interim final rule in the context of the proposed well- capitalized and buffer levels of the supplementary leverage ratio applicable to large, systemically important banking organizations, as described in a separate Notice of Proposed Rulemaking (NPR) published in the Federal Register August 20, 2013. The FDIC is seeking commenters' views on the interaction of this interim final rule with the proposed rule regarding the supplementary leverage ratio for large, systemically important banking organizations.
Clinical trial of an inhibitor of RAGE-Aβ interactions in Alzheimer disease.
Galasko, Douglas; Bell, Joanne; Mancuso, Jessica Y; Kupiec, James W; Sabbagh, Marwan N; van Dyck, Christopher; Thomas, Ronald G; Aisen, Paul S
2014-04-29
To examine safety, tolerability, and efficacy of PF-04494700, an inhibitor of the receptor for advanced glycation end products (RAGE), in mild to moderate Alzheimer disease (AD). Double-blind, placebo-controlled trial at 40 academic centers (United States). Subjects with AD and Mini-Mental State Examination score 14-26 were randomized to PF-04494700 60 mg/day × 6 days, then 20 mg daily (high dose); 15 mg/day × 6 days, then 5 mg daily (low dose); or placebo, for 18 months. Clinical and laboratory measures were used to evaluate safety and tolerability. The primary efficacy measure was the Alzheimer's Disease Assessment Scale-cognitive (ADAS-cog). Secondary measures assessed clinical stage, function, behavior, MRI, and CSF biomarkers. A total of 399 subjects were randomized. In a prespecified interim analysis, when 50% of subjects had completed the 6-month visit, the high dose was associated with confusion, falls, and greater ADAS-cog decline and was discontinued. A second prespecified analysis compared low-dose and placebo groups for futility and safety approximately 12 months after all subjects were randomized. This analysis met criteria for futility, and treatment was discontinued. There were no safety concerns in the low-dose group. Analyses including post-futility data showed decreased decline on the ADAS-cog in the low-dose group at month 18. Other clinical and biomarker measures showed no differences between low-dose treatment and placebo. PF-04494700 at 20 mg/d was associated with increased adverse events and cognitive decline. At 5 mg/d, PF-04494700 had a good safety profile. A potential benefit for this low dose on the ADAS-cog is not conclusive, because of high dropout and discontinuation rates subsequent to the interim analyses. This study provides Class I evidence that in patients with AD high-dose PF-04494700 increased cognitive decline at 6 months and Class IV evidence that low-dose PF-04494700 slowed cognitive decline at 18 months.
Levin, Bruce; Thompson, John L P; Chakraborty, Bibhas; Levy, Gilberto; MacArthur, Robert; Haley, E Clarke
2011-08-01
TNK-S2B, an innovative, randomized, seamless phase II/III trial of tenecteplase versus rt-PA for acute ischemic stroke, terminated for slow enrollment before regulatory approval of use of phase II patients in phase III. (1) To review the trial design and comprehensive type I error rate simulations and (2) to discuss issues raised during regulatory review, to facilitate future approval of similar designs. In phase II, an early (24-h) outcome and adaptive sequential procedure selected one of three tenecteplase doses for phase III comparison with rt-PA. Decision rules comparing this dose to rt-PA would cause stopping for futility at phase II end, or continuation to phase III. Phase III incorporated two co-primary hypotheses, allowing for a treatment effect at either end of the trichotomized Rankin scale. Assuming no early termination, four interim analyses and one final analysis of 1908 patients provided an experiment-wise type I error rate of <0.05. Over 1,000 distribution scenarios, each involving 40,000 replications, the maximum type I error in phase III was 0.038. Inflation from the dose selection was more than offset by the one-half continuity correction in the test statistics. Inflation from repeated interim analyses was more than offset by the reduction from the clinical stopping rules for futility at the first interim analysis. Design complexity and evolving regulatory requirements lengthened the review process. (1) The design was innovative and efficient. Per protocol, type I error was well controlled for the co-primary phase III hypothesis tests, and experiment-wise. (2a) Time must be allowed for communications with regulatory reviewers from first design stages. (2b) Adequate type I error control must be demonstrated. (2c) Greater clarity is needed on (i) whether this includes demonstration of type I error control if the protocol is violated and (ii) whether simulations of type I error control are acceptable. (2d) Regulatory agency concerns that protocols for futility stopping may not be followed may be allayed by submitting interim analysis results to them as these analyses occur.
42 CFR 417.574 - Interim settlement.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 3 2010-10-01 2010-10-01 false Interim settlement. 417.574 Section 417.574 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... PLANS Medicare Payment: Cost Basis § 417.574 Interim settlement. (a) Determination. Within 30 days...
14 CFR 136.41 - Interim operating authority.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...
14 CFR 136.41 - Interim operating authority.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...
47 CFR 73.404 - Interim hybrid IBOC DAB operation.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 47 Telecommunication 4 2012-10-01 2012-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...
47 CFR 73.404 - Interim hybrid IBOC DAB operation.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 4 2011-10-01 2011-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...
47 CFR 73.404 - Interim hybrid IBOC DAB operation.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 47 Telecommunication 4 2013-10-01 2013-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...
47 CFR 73.404 - Interim hybrid IBOC DAB operation.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 47 Telecommunication 4 2014-10-01 2014-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...
10 CFR 590.403 - Emergency interim orders.
Code of Federal Regulations, 2010 CFR
2010-01-01
... DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS Opinions and Orders § 590.403 Emergency interim... and issue an emergency interim order authorizing the import or export of natural gas. After issuance...
EPA Interim Evaluation of 2016-2017 Milestone Progress in the Chesapeake Bay Watershed
This page provides the EPA interim evaluations of the 2016-2017 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2016-2017 milestones, recognizing the achievements made in 2016.
EPA Interim Evaluation of 2012-2013 Milestone Progress in the Chesapeake Bay Watershed
This page provides the EPA interim evaluations of the 2012-2013 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2012-2013 milestones, recognizing the achievements made in 2012.
49 CFR 37.193 - Interim service requirements.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 1 2010-10-01 2010-10-01 false Interim service requirements. 37.193 Section 37.193 Transportation Office of the Secretary of Transportation TRANSPORTATION SERVICES FOR INDIVIDUALS WITH DISABILITIES (ADA) Over-the-Road Buses (OTRBs) § 37.193 Interim service requirements. (a) Until...
76 FR 57657 - Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
...] Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an extension of time-limited interim..., and Cosmetic Act (FFDCA). The time-limited tolerances expire on March 18, 2013. DATES: This regulation...
EPA Interim Evaluation of 2014-2015 Milestone Progress in the Chesapeake Bay Watershed
This page provides the EPA interim evaluations of the 2014-2015 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2014-2015 milestones, recognizing the achievements made in 2014.
45 CFR 1623.6 - Interim funding.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 45 Public Welfare 4 2013-10-01 2013-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...
45 CFR 1623.6 - Interim funding.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 45 Public Welfare 4 2012-10-01 2012-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...
45 CFR 1623.6 - Interim funding.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 45 Public Welfare 4 2011-10-01 2011-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...
45 CFR 1623.6 - Interim funding.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 45 Public Welfare 4 2014-10-01 2014-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...
45 CFR 1623.6 - Interim funding.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 45 Public Welfare 4 2010-10-01 2010-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...
Gordon, Robert; Magee, Christopher; Frazer, Anna; Evans, Craig; McCosker, Kathryn
2010-06-01
This study compared the outcomes of an interim mechanical prosthesis program for lower limb amputees operated under a public and private model of service. Over a two-year period, 60 transtibial amputees were fitted with an interim prosthesis as part of their early amputee care. Thirty-four patients received early amputee care under a public model of service, whereby a prosthetist was employed to provide the interim mechanical prosthesis service. The remaining 26 patients received early amputee care under a private model of service, where an external company was contracted to provide the interim mechanical prosthesis service. The results suggested comparable clinical outcomes between the two patient groups. However, the public model appeared to be less expensive with the average labour cost per patient being 29.0% lower compared with the private model. The results suggest that a public model of service may provide a more comprehensive and less expensive interim prosthesis program for lower limb amputees.
Jones, Jeffrey A; Mato, Anthony R; Wierda, William G; Davids, Matthew S; Choi, Michael; Cheson, Bruce D; Furman, Richard R; Lamanna, Nicole; Barr, Paul M; Zhou, Lang; Chyla, Brenda; Salem, Ahmed Hamed; Verdugo, Maria; Humerickhouse, Rod A; Potluri, Jalaja; Coutre, Steven; Woyach, Jennifer; Byrd, John C
2018-01-01
Therapy targeting Bruton's tyrosine kinase (BTK) with ibrutinib has transformed the treatment of chronic lymphocytic leukaemia. However, patients who are refractory to or relapse after ibrutinib therapy have poor outcomes. Venetoclax is a selective, orally bioavailable inhibitor of BCL-2 active in previously treated patients with relapsed or refractory chronic lymphocytic leukaemia. In this study, we assessed the activity and safety of venetoclax in patients with chronic lymphocytic leukaemia who are refractory to or relapse during or after ibrutinib therapy. In this interim analysis of a multicentre, open-label, non-randomised, phase 2 trial, we enrolled patients aged 18 years or older with a documented diagnosis of chronic lymphocytic leukaemia according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and an Eastern Cooperative Oncology Group performance score of 2 or lower. All patients had relapsed or refractory disease after previous treatment with a BCR signalling pathway inhibitor. All patients were screened for Richter's transformation and cases confirmed by biopsy were excluded. Eligible patients received oral venetoclax, starting at 20 mg per day with stepwise dose ramp-up over 5 weeks to 400 mg per day. Patients with rapidly progressing disease received an accelerated dosing schedule (to 400 mg per day by week 3). The primary endpoint was overall response, defined as the proportion of patients with an overall response per investigator's assessment according to IWCLL criteria. All patients who received at least one dose of venetoclax were included in the activity and safety analyses. This study is ongoing; data for this interim analysis were collected per regulatory agencies' request as of June 30, 2017. This trial is registered with ClinicalTrials.gov, number NCT02141282. Between September, 2014, and November, 2016, 127 previously treated patients with relapsed or refractory chronic lymphocytic leukaemia were enrolled from 15 sites across the USA. 91 patients had received ibrutinib as the last BCR inhibitor therapy before enrolment, 43 of whom were enrolled in the main cohort and 48 in the expansion cohort recruited later after a protocol amendment. At the time of analysis, the median follow-up was 14 months (IQR 8-18) for all 91 patients, 19 months (9-27) for the main cohort, and 12 months (8-15) for the expansion cohort. 59 (65%, 95% CI 53-74) of 91 patients had an overall response, including 30 (70%, 54-83) of 43 patients in the main cohort and 29 (60%, 43-72) of 48 patients in the expansion cohort. The most common treatment-emergent grade 3 or 4 adverse events were neutropenia (46 [51%] of 91 patients), thrombocytopenia (26 [29%]), anaemia (26 [29%]), decreased white blood cell count (17 [19%]), and decreased lymphocyte count (14 [15%]). 17 (19%) of 91 patients died, including seven because of disease progression. No treatment-related deaths occurred. The results of this interim analysis show that venetoclax has durable clinical activity and favourable tolerability in patients with relapsed or refractory chronic lymphocytic leukaemia whose disease progressed during or after discontinutation of ibrutinib therapy. The durability of response to venetoclax will be assessed in the final analysis in 2019. AbbVie, Genentech. Copyright © 2018 Elsevier Ltd. All rights reserved.
Kahl, L; Patel, J; Layton, M; Binks, M; Hicks, K; Leon, G; Hachulla, E; Machado, D; Staumont-Sallé, D; Dickson, M; Condreay, L; Schifano, L; Zamuner, S; van Vollenhoven, R F
2016-11-01
We aimed to evaluate the pharmacodynamics, efficacy, safety and tolerability of the JAK1 inhibitor GSK2586184 in adults with systemic lupus erythematosus (SLE). In this adaptive, randomized, double-blind, placebo-controlled study, patients received oral GSK2586184 50-400 mg, or placebo twice daily for 12 weeks. Primary endpoints included interferon-mediated messenger RNA transcription over time, changes in Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index score, and number/severity of adverse events. A pre-specified interim analysis was performed when ≥ 5 patients per group completed 2 weeks of treatment. In total, 84-92% of patients were high baseline expressors of the interferon transcriptional biomarkers evaluated. At interim analysis, GSK2586184 showed no significant effect on mean interferon transcriptional biomarker expression (all panels). The study was declared futile and recruitment was halted at 50 patients. Shortly thereafter, significant safety data were identified, including elevated liver enzymes in six patients (one confirmed and one suspected case of Drug Reaction with Eosinophilia and Systemic Symptoms), leading to immediate dosing cessation. Safety of Estrogen in Lupus National Assessment-SLE Disease Activity Index scores were not analysed due to the small number of patients completing the study. The study futility and safety data described for GSK2586184 do not support further evaluation in patients with SLE. Study identifiers: GSK Study JAK115919; ClinicalTrials.gov identifier: NCT01777256.
78 FR 14487 - Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticide Tolerances
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-06
...] Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: This regulation proposes the extension of the time-limited... related to EPA's extension of the time-limited interim tolerances for the combined residues of the...
78 FR 15880 - Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-13
... Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation extends the time-limited interim tolerances for the... . II. Background A detailed summary of the background related to EPA's extension of the time-limited...
24 CFR 115.207 - Consequences of interim certification and certification.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Consequences of interim certification and certification. 115.207 Section 115.207 Housing and Urban Development Regulations Relating to... ENFORCEMENT AGENCIES Certification of Substantially Equivalent Agencies § 115.207 Consequences of interim...
46 CFR 308.203 - Amount insured under interim binder.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 8 2014-10-01 2014-10-01 false Amount insured under interim binder. 308.203 Section 308.203 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.203 Amount insured under interim binder. The...
46 CFR 308.203 - Amount insured under interim binder.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 8 2013-10-01 2013-10-01 false Amount insured under interim binder. 308.203 Section 308.203 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.203 Amount insured under interim binder. The...
46 CFR 308.203 - Amount insured under interim binder.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 8 2011-10-01 2011-10-01 false Amount insured under interim binder. 308.203 Section 308.203 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.203 Amount insured under interim binder. The...
46 CFR 308.203 - Amount insured under interim binder.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 8 2010-10-01 2010-10-01 false Amount insured under interim binder. 308.203 Section 308.203 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.203 Amount insured under interim binder. The...
46 CFR 308.203 - Amount insured under interim binder.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 8 2012-10-01 2012-10-01 false Amount insured under interim binder. 308.203 Section 308.203 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Protection and Indemnity Insurance § 308.203 Amount insured under interim binder. The...
76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-01
... NRC staff's evaluation of the suitability of using Revision 3 of the Nuclear Energy Institute's (NEI... NUCLEAR REGULATORY COMMISSION [NRC-2011-0228] Interim Staff Guidance on Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-24
... Manufacturing. Location: Canonsburg, Pennsylvania. Job Titles and/or Job Duties: All employees who worked in any...: Stuart L. Hinnefeld, Interim Director, Division of Compensation Analysis and Support, National Institute...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-06
.... Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: January 1... INFORMATION CONTACT: Stuart L. Hinnefeld, Interim Director, Division of Compensation Analysis and Support...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-28
.... Location: Albuquerque, New Mexico. Job Titles and/or Job Duties: All employees who worked within the... CONTACT: Stuart L. Hinnefeld, Interim Director, Division of Compensation Analysis and Support, National...
Bartha, Erzsebet; Davidson, Thomas; Brodtkorb, Thor-Henrik; Carlsson, Per; Kalman, Sigridur
2013-07-09
A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation's main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed. A previously developed probabilistic decision analytic cost-effectiveness model was employed to compare the routine fluid treatment to GDHT. Results from the interim analysis, published trials, the meta-analysis, and the registry data were used as model inputs. EVPI was predicted using (1) combined uncertainty of model inputs; (2) threshold value of society's willingness to pay for one, quality-adjusted life-year; and (3) estimated number of future patients exposed to choice between GDHT and routine fluid treatment during the expected lifetime of GDHT. If a decision to use GDHT were based on cost-effectiveness, then the decision would have a substantial degree of uncertainty. Assuming a 5-year lifetime of GDHT in clinical practice, the number of patients who would be subject to future decisions was 30,400. EVPI per patient would be €204 at a €20,000 threshold value of society's willingness to pay for one quality-adjusted life-year. Given a future population of 30,400 individuals, total EVPI would be €6.19 million. If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as 'further research is needed' are replaced with 'further research is cost-effective and 'further funding of a trial is justified'. ClinicalTrials.gov NCT01141894.
Birch, Nick; Graham, Jon; Priestley, Tom; Heywood, Chris; Sakel, Mohamed; Gall, Angela; Nunn, Andrew; Signal, Nada
2017-06-19
The RAPPER II study investigates the feasibility, safety and acceptability of using the REX self-stabilising robotic exoskeleton in people with spinal cord injury (SCI) who are obligatory wheelchair users. Feasibility is assessed by the completion of transfer into the REX device, competency in achieving autonomous control and completion of upper body exercise in an upright position in the REX device. Safety is measured by the occurrence of serious adverse events. Device acceptability is assessed with a user questionnaire. RAPPER II is a prospective, multi-centre, open label, non-randomised, non-comparative cohort study in people with SCI recruited from neurological rehabilitation centres in the United Kingdom, Australia and New Zealand. This is the planned interim report of the first 20 participants. Each completed a transfer into the REX, were trained to achieve machine control and completed Timed Up and Go (TUG) tests as well as upper body exercises in standing in a single first time session. The time to achieve each task as well as the amount of assistance required was recorded. After finishing the trial tasks a User Experience questionnaire, exploring device acceptability, was completed. All participants could transfer into the REX. The mean transfer time was 439 s. Nineteen completed the exercise regime. Eighteen could achieve autonomous control of the REX, 17 of whom needed either no assistance or the help of just one therapist. Eighteen participants completed at least one TUG test in a mean time of 313 s, 15 with the assistance of just one therapist. The questionnaire demonstrated high levels of acceptability amongst users. There were no Serious Adverse Events. This first interim analysis of RAPPER II shows that it is feasible and safe for people with SCI to use the REX powered assisted walking device to ambulate and exercise in. Participants with tetraplegia and paraplegia could walk and perform a functional exercise program when standing needing only modest levels of assistance in most cases. User acceptability was high. ClinicalTrials.gov , NCT02417532 . Registered 11 April 2015.
NASA Astrophysics Data System (ADS)
González-Rojí, Santos J.; Sáenz, Jon; Ibarra-Berastegi, Gabriel; Díaz de Argandoña, Javier
2018-01-01
An analysis of the atmospheric branch of the hydrological cycle by means of a 15 km resolution numerical integration performed using Weather Research and Forecasting (WRF) nested in ERA Interim is presented. Two WRF experiments covering the period 2010-2014 were prepared. The first one (N) was configured as in standard numerical downscaling experiments. The second one (D), with the same parameterizations, included a step of 3DVAR data assimilation every 6 h. Apart from comparing our results with ERA Interim data, several observational data sets were used to validate the precipitable water (radiosondes and MODIS data), precipitation (EOBS, ECA&D, TRMM, and GPCP), or evaporation (GLEAM). The verification results showed that the D experiment systematically performs better than N and in many instances, too, better than the forcing reanalysis. According to the results, the leading terms of the water balance are the tendency of the precipitable water, the divergence of moisture flux, evaporation, and precipitation. No spatial patterns were recognizable for the annual accumulated evaporation, but the effect of the Atlantic fronts was detected in the precipitation patterns. The transboundary moisture fluxes through the contour of the Iberian Peninsula behave differently depending on the season during 2010-2014. During winter, they show a net moisture import through the boundaries. During spring, summer, or autumn moisture is exported specially through the Mediterranean coast, and only during midday, this feature is reversed due to sea breezes.
30 CFR 827.13 - Coal preparation plants: Interim performance standards.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Coal preparation plants: Interim performance...-COAL PREPARATION PLANTS NOT LOCATED WITHIN THE PERMIT AREA OF A MINE § 827.13 Coal preparation plants: Interim performance standards. (a) Persons operating or who have operated coal preparation plants after...
30 CFR 827.13 - Coal preparation plants: Interim performance standards.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Coal preparation plants: Interim performance...-COAL PREPARATION PLANTS NOT LOCATED WITHIN THE PERMIT AREA OF A MINE § 827.13 Coal preparation plants: Interim performance standards. (a) Persons operating or who have operated coal preparation plants after...
30 CFR 827.13 - Coal preparation plants: Interim performance standards.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Coal preparation plants: Interim performance...-COAL PREPARATION PLANTS NOT LOCATED WITHIN THE PERMIT AREA OF A MINE § 827.13 Coal preparation plants: Interim performance standards. (a) Persons operating or who have operated coal preparation plants after...
30 CFR 827.13 - Coal preparation plants: Interim performance standards.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Coal preparation plants: Interim performance...-COAL PREPARATION PLANTS NOT LOCATED WITHIN THE PERMIT AREA OF A MINE § 827.13 Coal preparation plants: Interim performance standards. (a) Persons operating or who have operated coal preparation plants after...
30 CFR 827.13 - Coal preparation plants: Interim performance standards.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Coal preparation plants: Interim performance...-COAL PREPARATION PLANTS NOT LOCATED WITHIN THE PERMIT AREA OF A MINE § 827.13 Coal preparation plants: Interim performance standards. (a) Persons operating or who have operated coal preparation plants after...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
... DEPARTMENT OF COMMERCE [Docket T-1-2010] Foreign-Trade Zones Board Foreign-Trade Zone 22; Temporary/Interim Manufacturing Authority; LG Electronics Mobilecomm USA, Inc. (Cell Phones); Notice of.../ interim manufacturing (T/IM) authority, on behalf of LG Electronics Mobilecomm USA, Inc. (LGEMU), to...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-28
..., GA; Application for Temporary/ Interim Manufacturing Authority; Makita Corporation of America; (Hand- Held Power Tool and Gasoline/Electric-Powered Garden Product Manufacturing); Buford, GA An application... Georgia Foreign-Trade Zone, Inc., grantee of FTZ 26, requesting temporary/interim manufacturing (T/IM...
Interim Action Proposed Plan for the Chemicals, Metals, and Pesticides (CMP) Pits Operable Unit
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bradley, J.
2002-06-18
The purpose of this Interim Action Proposed Plan (IAPP) is to describe the preferred interim remedial action for addressing the Chemicals, Metals, and Pesticides (CMP) Pits Operable Unit and to provide an opportunity for public input into the remedial action selection process.
ERIC Educational Resources Information Center
Nugent, Patricia A.
2011-01-01
The author spent years in central-office administration, most recently in an interim position. Some interim administrators simply see themselves as placeholders until the real deal is hired, giving the organization the opportunity to coast. There are others who see themselves as change agents and cannot wait to undo or redo what their predecessor…
Presidential Transition: The Experience of Two Community College Interim Presidents
ERIC Educational Resources Information Center
Thompson, Matthew D.
2010-01-01
The purpose of this qualitative case study was to understand the experiences of two community college interim presidents, their characteristics, and how they led institutions following an abrupt presidential departure. There were two fundamental questions framing this research study, 1. How do two interim community college presidents lead…
47 CFR 73.404 - Interim hybrid IBOC DAB operation.
Code of Federal Regulations, 2010 CFR
2010-10-01
... RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The... test operation pursuant to § 73.1620, may commence interim hybrid IBOC DAB operation with digital... No. 99-325. FM stations are permitted to operate with hybrid digital effective radiated power equal...
17 CFR 210.10-01 - Interim financial statements.
Code of Federal Regulations, 2010 CFR
2010-04-01
... accountant on the review must be filed with the interim financial statements. (e) Filing of other interim... sheets shall include only major captions (i.e., numbered captions) prescribed by the applicable sections... the date of any material accounting change and the reasons for making it. In addition, for filings on...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-07
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0067] Japan Lessons-Learned Project Directorate Interim...-Learned Project Directorate Interim Staff Guidance; issuance. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the Final Japan Lessons-Learned Project Directorate (JLD...
78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-03
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0140] Draft Spent Fuel Storage and Transportation Interim... Spent Fuel Storage and Transportation Interim Staff Guidance No. 24 (SFST-ISG-24), Revision 0, ``The Use of a Demonstration Program as Confirmation of Integrity for Continued Storage of High Burnup Fuel...
75 FR 66553 - Truth in Lending
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-28
... AGENCY: Board of Governors of the Federal Reserve System. ACTION: Interim final rule; request for public comment. SUMMARY: The Board is publishing for public comment an interim final rule amending Regulation Z (Truth in Lending). The interim rule implements Section 129E of the Truth in Lending Act (TILA), which...
Staff Reactions to Interim Leadership in a Student Affairs Organization
ERIC Educational Resources Information Center
Jones, Robin D.
2011-01-01
Interim leadership appointments in higher education are a common strategy used to fill leadership gaps in executive positions. Because student affairs executives are particularly vulnerable to high turnover rates, interim appointments are becoming more widespread. Even with the prevalence of this trend, little attention has been given to the…
Faculty and Student Views of the Interim Term
ERIC Educational Resources Information Center
Centra, John A.; Sobol, Marion G.
1974-01-01
Evaluations of the interim term or 4-1-4 program at various colleges have been generally favorable. A detailed evaluation of the Rider College interim study program based on faculty and student reports indicated that the more nontraditionally oriented courses were rated higher than the more traditional offerings. (Editor/PG)
12 CFR 541.18 - Interim Federal savings association.
Code of Federal Regulations, 2010 CFR
2010-01-01
... an existing savings and loan holding company or to facilitate any other transaction the Office may... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Interim Federal savings association. 541.18... REGULATIONS AFFECTING FEDERAL SAVINGS ASSOCIATIONS § 541.18 Interim Federal savings association. The term...
15 CFR 904.322 - Interim action.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Interim action. 904.322 Section 904... Sanctions and Denials Permit Sanction for Violations § 904.322 Interim action. (a) To protect marine resources during the pendency of an action under this subpart, in cases of willfulness, or as otherwise...
15 CFR 904.322 - Interim action.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Interim action. 904.322 Section 904... Sanctions and Denials Permit Sanction for Violations § 904.322 Interim action. (a) To protect marine resources during the pendency of an action under this subpart, in cases of willfulness, or as otherwise...
Into the Sunset: Reflections of an Interim Administrator.
ERIC Educational Resources Information Center
Marlowe, John
2000-01-01
One advantage to an interim administrative position is that the public cuts short-timers a little slack. Temporary administrators can learn on the job and become experts on specialized subjects. Personnel issues demand more time than interims possess. Such positions usually do not turn into long-term contracts. (MLH)
2015-09-30
1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. PCoD Lite - Using an Interim PCoD Protocol to Assess...US National Research Council (NRC 2005). Here, we provide an insight into how the Interim PCoD approach (Harwood et al. 2014, King et al. 2015...illustrate how the interim PCoD protocol can be used to inform the process of determining whether or not Navy activities are likely to have an impact on
ERIC Educational Resources Information Center
Lamb, Theodore A.; Chin, Keric B. O.
This paper proposes a conceptual framework based on different levels of analysis using the metaphor of the layers of an onion to help organize and structure thinking on research issues concerning training. It discusses the core of the "analytic onion," the biological level, and seven levels of analysis that surround that core: the individual, the…
Reanalysis Data Evaluation to Study Temperature Extremes in Siberia
NASA Astrophysics Data System (ADS)
Shulgina, T. M.; Gordov, E. P.
2014-12-01
Ongoing global climate changes are strongly pronounced in Siberia by significant warming in the 2nd half of 20th century and recent extreme events such as 2010 heat wave and 2013 flood in Russia's Far East. To improve our understanding of observed climate extremes and to provide to regional decision makers the reliable scientifically based information with high special and temporal resolution on climate state, we need to operate with accurate meteorological data in our study. However, from available 231 stations across Siberia only 130 of them present the homogeneous daily temperature time series. Sparse, station network, especially in high latitudes, force us to use simulated reanalysis data. However those might differ from observations. To obtain reliable information on temperature extreme "hot spots" in Siberia we have compared daily temperatures form ERA-40, ERA Interim, JRA-25, JRA-55, NCEP/DOE, MERRA Reanalysis, HadEX2 and GHCNDEX gridded datasets with observations from RIHMI-WDC/CDIAC dataset for overlap period 1981-2000. Data agreement was estimated at station coordinates to which reanalysis data were interpolated using modified Shepard method. Comparison of averaged over 20 year annual mean temperatures shows general agreement for Siberia excepting Baikal region, where reanalyses significantly underestimate observed temperature behavior. The annual temperatures closest to observed one were obtained from ERA-40 and ERA Interim. Furthermore, t-test results show homogeneity of these datasets, which allows one to combine them for long term time series analysis. In particular, we compared the combined data with observations for percentile-based extreme indices. In Western Siberia reanalysis and gridded data accurately reproduce observed daily max/min temperatures. For East Siberia, Lake Baikal area, ERA Interim data slightly underestimates TN90p and TX90p values. Results obtained allows regional decision-makers to get required high spatial resolution (0,25°×0,25°) climatic information products from the combined ERA data. The authors acknowledge partial financial support for this research from the RFBR (13-05-12034, 14-05-00502), SB RAS Integration projects (131, VIII.80.2.1.) and grant of the President of RF (№ 181).
ERIC Educational Resources Information Center
Watson, William J.
Occupational analysts using Comprehensive Occupational Data Analysis Programs (CODAP) make subjective decisions at various stages in their analysis of an occupation. The possibility exists that two different analysts could reach different conclusions in analyzing an occupation, and thereby provide divergent guidance to management. Two analysts,…
Evaluation of internal fit of interim crown fabricated with CAD/CAM milling and 3D printing system.
Lee, Wan-Sun; Lee, Du-Hyeong; Lee, Kyu-Bok
2017-08-01
This study is to evaluate the internal fit of the crown manufactured by CAD/CAM milling method and 3D printing method. The master model was fabricated with stainless steel by using CNC machine and the work model was created from the vinyl-polysiloxane impression. After scanning the working model, the design software is used to design the crown. The saved STL file is used on the CAD/CAM milling method and two types of 3D printing method to produce 10 interim crowns per group. Internal discrepancy measurement uses the silicon replica method and the measured data are analyzed with One-way ANOVA to verify the statistic significance. The discrepancy means (standard deviation) of the 3 groups are 171.6 (97.4) µm for the crown manufactured by the milling system and 149.1 (65.9) and 91.1 (36.4) µm, respectively, for the crowns manufactured with the two types of 3D printing system. There was a statistically significant difference and the 3D printing system group showed more outstanding value than the milling system group. The marginal and internal fit of the interim restoration has more outstanding 3D printing method than the CAD/CAM milling method. Therefore, the 3D printing method is considered as applicable for not only the interim restoration production, but also in the dental prosthesis production with a higher level of completion.
NASA Astrophysics Data System (ADS)
Alshawaf, Fadwa; Dick, Galina; Heise, Stefan; Balidakis, Kyriakos; Schmidt, Torsten; Wickert, Jens
2017-04-01
Ground-based GNSS (Global Navigation Satellite Systems) have efficiently been used since the 1990s as a meteorological observing system. Recently scientists used GNSS time series of precipitable water vapor (PWV) for climate research although they may not be sufficiently long. In this work, we compare the trend estimated from GNSS time series with that estimated from European Center for Medium-RangeWeather Forecasts Reanalysis (ERA-Interim) data and meteorological measurements.We aim at evaluating climate evolution in Central Europe by monitoring different atmospheric variables such as temperature and PWV. PWV time series were obtained by three methods: 1) estimated from ground-based GNSS observations using the method of precise point positioning, 2) inferred from ERA-Interim data, and 3) determined based on daily surface measurements of temperature and relative humidity. The other variables are available from surface meteorological stations or received from ERA-Interim. The PWV trend component estimated from GNSS data strongly correlates (>70%) with that estimated from the other data sets. The linear trend is estimated by straight line fitting over 30 years of seasonally-adjusted PWV time series obtained using the meteorological measurements. The results show a positive trend in the PWV time series with an increase of 0.2-0.7 mm/decade with a mean standard deviations of 0.016 mm/decade. In this paper, we present the results at three GNSS stations. The temporal increment of the PWV correlates with the temporal increase in the temperature levels.
Remedy Selection and Land Use at Federal Facilities
Analysis of approximately 98 percent of the interim and final source control Records of Decision signed at Federal Facilities on the NPL from the beginning of Superfund through August 1995. PB96-963309. EPA/540/R-96/020. August 1996
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-06
... Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All employees of the Department.... Hinnefeld, Interim Director, Division of Compensation Analysis and Support, National Institute for...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-23
..., Massachusetts. Job Titles and/or Job Duties: All employees who worked in any building or area. Period of..., Interim Director, Division of Compensation Analysis and Support, National Institute for Occupational...
Bevacizumab improves survival for patients with advanced cervical cancer
Patients with advanced, recurrent, or persistent cervical cancer that was not curable with standard treatment who received the drug bevacizumab (Avastin) lived 3.7 months longer than patients who did not receive the drug, according to an interim analysis
Bend case study : indirect land use and growth impacts : interim report
DOT National Transportation Integrated Search
2000-01-01
To improve environmental analysis of indirect land use impacts of highway capacity improvements, this study analyzed the land use and growth patterns of 20 Oregon communities over 20 years. Using a Geographic Information System and aerial photos, gro...
McMinnville case study : indirect land use and growth impacts : interim report
DOT National Transportation Integrated Search
1999-12-01
To improve environmental analysis of indirect land use impacts of highway capacity improvements, this study analyzed : the land use and growth patterns of 20 Oregon communities over 20 years. Using a Geographic Information System and : aerial photos,...
Determination of zenith hydrostatic delay and its impact on GNSS-derived integrated water vapor
NASA Astrophysics Data System (ADS)
Wang, Xiaoming; Zhang, Kefei; Wu, Suqin; He, Changyong; Cheng, Yingyan; Li, Xingxing
2017-08-01
Surface pressure is a necessary meteorological variable for the accurate determination of integrated water vapor (IWV) using Global Navigation Satellite System (GNSS). The lack of pressure observations is a big issue for the conversion of historical GNSS observations, which is a relatively new area of GNSS applications in climatology. Hence the use of the surface pressure derived from either a blind model (e.g., Global Pressure and Temperature 2 wet, GPT2w) or a global atmospheric reanalysis (e.g., ERA-Interim) becomes an important alternative solution. In this study, pressure derived from these two methods is compared against the pressure observed at 108 global GNSS stations at four epochs (00:00, 06:00, 12:00 and 18:00 UTC) each day for the period 2000-2013. Results show that a good accuracy is achieved from the GPT2w-derived pressure in the latitude band between -30 and 30° and the average value of 6 h root-mean-square errors (RMSEs) across all the stations in this region is 2.5 hPa. Correspondingly, an error of 5.8 mm and 0.9 kg m-2 in its resultant zenith hydrostatic delay (ZHD) and IWV is expected. However, for the stations located in the mid-latitude bands between -30 and -60° and between 30 and 60°, the mean value of the RMSEs is 7.3 hPa, and for the stations located in the high-latitude bands from -60 to -90° and from 60 to 90°, the mean value of the RMSEs is 9.9 hPa. The mean of the RMSEs of the ERA-Interim-derived pressure across at the selected 100 stations is 0.9 hPa, which will lead to an equivalent error of 2.1 mm and 0.3 kg m-2 in the ZHD and IWV, respectively, determined from this ERA-Interim-derived pressure. Results also show that the monthly IWV determined using pressure from ERA-Interim has a good accuracy - with a relative error of better than 3 % on a global scale; thus, the monthly IWV resulting from ERA-Interim-derived pressure has the potential to be used for climate studies, whilst the monthly IWV resulting from GPT2w-derived pressure has a relative error of 6.7 % in the mid-latitude regions and even reaches 20.8 % in the high-latitude regions. The comparison between GPT2w and seasonal models of pressure-ZHD derived from ERA-Interim and pressure observations indicates that GPT2w captures the seasonal variations in pressure-ZHD very well.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-22
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-SFUND-2009-0907; FRL-9114-6] RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites; Extension of... Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response...
Do Interim Assessments Reduce the Race and SES Achievement Gaps?
ERIC Educational Resources Information Center
Konstantopoulos, Spyros; Li, Wei; Miller, Shazia R.; van der Ploeg, Arie
2017-01-01
The authors examined differential effects of interim assessments on minority and low socioeconomic status students' achievement in Grades K-6. They conducted a large-scale cluster randomized experiment in 2009-2010 to evaluate the impact of Indiana's policy initiative introducing interim assessments statewide. The authors used 2-level models to…
31 CFR 50.7 - Special Rules for Interim Guidance Safe Harbors.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 31 Money and Finance: Treasury 1 2013-07-01 2013-07-01 false Special Rules for Interim Guidance Safe Harbors. 50.7 Section 50.7 Money and Finance: Treasury Office of the Secretary of the Treasury TERRORISM RISK INSURANCE PROGRAM General Provisions § 50.7 Special Rules for Interim Guidance Safe Harbors...
31 CFR 50.7 - Special Rules for Interim Guidance Safe Harbors.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 31 Money and Finance: Treasury 1 2014-07-01 2014-07-01 false Special Rules for Interim Guidance Safe Harbors. 50.7 Section 50.7 Money and Finance: Treasury Office of the Secretary of the Treasury TERRORISM RISK INSURANCE PROGRAM General Provisions § 50.7 Special Rules for Interim Guidance Safe Harbors...
31 CFR 50.7 - Special Rules for Interim Guidance Safe Harbors.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 31 Money and Finance: Treasury 1 2012-07-01 2012-07-01 false Special Rules for Interim Guidance Safe Harbors. 50.7 Section 50.7 Money and Finance: Treasury Office of the Secretary of the Treasury TERRORISM RISK INSURANCE PROGRAM General Provisions § 50.7 Special Rules for Interim Guidance Safe Harbors...
31 CFR 50.7 - Special Rules for Interim Guidance Safe Harbors.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 31 Money and Finance: Treasury 1 2011-07-01 2011-07-01 false Special Rules for Interim Guidance Safe Harbors. 50.7 Section 50.7 Money and Finance: Treasury Office of the Secretary of the Treasury TERRORISM RISK INSURANCE PROGRAM General Provisions § 50.7 Special Rules for Interim Guidance Safe Harbors...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-08
... in 48 CFR Part 217 Government procurement. Ynette R. Shelkin, Editor, Defense Acquisition Regulations...). ACTION: Final rule. SUMMARY: DoD is adopting as final, without change, an interim rule amending the... interim rule. Therefore, DoD is finalizing the interim rule without change. This rule was not subject to...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-20
...--Indianapolis, IN; Application for Temporary/Interim Manufacturing Authority; Brevini Wind USA, Inc. (Wind... temporary/interim manufacturing (T/IM) authority within FTZ 72 at the Brevini Wind USA, Inc. (Brevini... requested authority to produce wind turbine gear boxes (HTSUS 8483.40, duty rate: 2.5%). Foreign components...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-30
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it is releasing an interim...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it released an interim change...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-08
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it released an interim change...
76 FR 776 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) NO. 1
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-06
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) NO. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it is releasing an interim...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-29
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) NO. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it will release an interim...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-23
... DEPARTMENT OF DEFENSE Department of the Army Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1 AGENCY: Department of the Army, DoD. SUMMARY: The Military Surface Deployment and Distribution Command (SDDC) is providing notice that it has released an interim...
Can Interim Assessments Be Used for Instructional Change? Policy Brief. RB-51
ERIC Educational Resources Information Center
Goertz, Margaret E.; Olah, Leslie Nabors; Riggan, Matthew
2009-01-01
The purpose of this exploratory study was to examine the use of interim assessments and the policy supports that promote their use to change instruction, focusing on elementary school mathematics. The authors use the term "interim assessments" to refer to assessments that: a) evaluate student knowledge and skills, typically within a…
40 CFR Appendix III to Part 265 - EPA Interim Primary Drinking Water Standards
Code of Federal Regulations, 2011 CFR
2011-07-01
...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT... 40 Protection of Environment 26 2011-07-01 2011-07-01 false EPA Interim Primary Drinking Water... Water Standards Parameter Maximum level (mg/l) Arsenic 0.05 Barium 1.0 Cadmium 0.01 Chromium 0.05...
40 CFR Appendix III to Part 265 - EPA Interim Primary Drinking Water Standards
Code of Federal Regulations, 2010 CFR
2010-07-01
...) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT... 40 Protection of Environment 25 2010-07-01 2010-07-01 false EPA Interim Primary Drinking Water... Water Standards Parameter Maximum level (mg/l) Arsenic 0.05 Barium 1.0 Cadmium 0.01 Chromium 0.05...
33 CFR 96.360 - Interim Safety Management Certificate: what is it and when can it be used?
Code of Federal Regulations, 2010 CFR
2010-07-01
... section, when— (1) The company's valid Document of Compliance certificate or Interim Document of Compliance certificate applies to that vessel type; (2) The company's safety management system for the vessel... to the responsible person or their company. (b) An Interim Safety Management Certificate is valid for...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-18
... resolution. The goal of the interim policy is to strike a careful balance by accommodating residential... will allow the agency to complete a separate, ongoing general aviation airport study that is analyzing the federally assisted general aviation airport system. The interim policy adopts the changes proposed...
18 CFR 300.20 - Interim acceptance and review of Bonneville Power Administration rates.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Interim acceptance and review of Bonneville Power Administration rates. 300.20 Section 300.20 Conservation of Power and Water... Director of the Office of Energy Market Regulation; or (ii) Deny the Administrator's interim rate request...
42 CFR 417.572 - Budget and enrollment forecast and interim reports.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 3 2010-10-01 2010-10-01 false Budget and enrollment forecast and interim reports... PLANS, AND HEALTH CARE PREPAYMENT PLANS Medicare Payment: Cost Basis § 417.572 Budget and enrollment forecast and interim reports. (a) Annual submittal. The HMO or CMP must submit an annual operating budget...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-28
... Operations of PacifiCorp's Klamath Hydroelectric Project on the Klamath River, Klamath County, OR, and... Environmental Policy Act (NEPA) for the interim operations of the Klamath Hydroelectric Project in [[Page 5831... habitats upon which they depend, resulting from the interim operations of the Klamath Hydroelectric Project...
40 CFR Appendix III to Part 265 - EPA Interim Primary Drinking Water Standards
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 26 2014-07-01 2014-07-01 false EPA Interim Primary Drinking Water Standards III Appendix III to Part 265 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND DISPOSAL FACILITIES Pt....
Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-25
...: Comments should be addressed to Interim Director, Division of Human Resource Management and Chief Human.... Judith S. Sunley, Interim Director, Division of Human Resource Management and Chief Human Capital Officer..., Interim Director, Division of Human Resource Management and Chief Human Capital Officer. [FR Doc. 2010...
46 CFR 308.6 - Period of interim binders, updating application information and new applications.
Code of Federal Regulations, 2013 CFR
2013-10-01
... information and new applications. 308.6 Section 308.6 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.6 Period of interim binders, updating... interim binders are required to notify the American War Risk Agency annually, by June 30th, of any change...
46 CFR 308.6 - Period of interim binders, updating application information and new applications.
Code of Federal Regulations, 2011 CFR
2011-10-01
... information and new applications. 308.6 Section 308.6 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.6 Period of interim binders, updating... interim binders are required to notify the American War Risk Agency annually, by June 30th, of any change...
46 CFR 308.6 - Period of interim binders, updating application information and new applications.
Code of Federal Regulations, 2012 CFR
2012-10-01
... information and new applications. 308.6 Section 308.6 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.6 Period of interim binders, updating... interim binders are required to notify the American War Risk Agency annually, by June 30th, of any change...
46 CFR 308.6 - Period of interim binders, updating application information and new applications.
Code of Federal Regulations, 2010 CFR
2010-10-01
... information and new applications. 308.6 Section 308.6 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.6 Period of interim binders, updating... interim binders are required to notify the American War Risk Agency annually, by June 30th, of any change...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-16
...-05: Ongoing Review of Operating Experience AGENCY: Nuclear Regulatory Commission. ACTION: Interim... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience... industry-wide operating experience as an attribute of aging management programs used at nuclear power...
31 CFR 50.7 - Special Rules for Interim Guidance Safe Harbors.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Special Rules for Interim Guidance Safe Harbors. 50.7 Section 50.7 Money and Finance: Treasury Office of the Secretary of the Treasury TERRORISM RISK INSURANCE PROGRAM General Provisions § 50.7 Special Rules for Interim Guidance Safe Harbors...
Improved survival with vemurafenib in melanoma with BRAF V600E mutation.
Chapman, Paul B; Hauschild, Axel; Robert, Caroline; Haanen, John B; Ascierto, Paolo; Larkin, James; Dummer, Reinhard; Garbe, Claus; Testori, Alessandro; Maio, Michele; Hogg, David; Lorigan, Paul; Lebbe, Celeste; Jouary, Thomas; Schadendorf, Dirk; Ribas, Antoni; O'Day, Steven J; Sosman, Jeffrey A; Kirkwood, John M; Eggermont, Alexander M M; Dreno, Brigitte; Nolop, Keith; Li, Jiang; Nelson, Betty; Hou, Jeannie; Lee, Richard J; Flaherty, Keith T; McArthur, Grant A
2011-06-30
Phase 1 and 2 clinical trials of the BRAF kinase inhibitor vemurafenib (PLX4032) have shown response rates of more than 50% in patients with metastatic melanoma with the BRAF V600E mutation. We conducted a phase 3 randomized clinical trial comparing vemurafenib with dacarbazine in 675 patients with previously untreated, metastatic melanoma with the BRAF V600E mutation. Patients were randomly assigned to receive either vemurafenib (960 mg orally twice daily) or dacarbazine (1000 mg per square meter of body-surface area intravenously every 3 weeks). Coprimary end points were rates of overall and progression-free survival. Secondary end points included the response rate, response duration, and safety. A final analysis was planned after 196 deaths and an interim analysis after 98 deaths. At 6 months, overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. In the interim analysis for overall survival and final analysis for progression-free survival, vemurafenib was associated with a relative reduction of 63% in the risk of death and of 74% in the risk of either death or disease progression, as compared with dacarbazine (P<0.001 for both comparisons). After review of the interim analysis by an independent data and safety monitoring board, crossover from dacarbazine to vemurafenib was recommended. Response rates were 48% for vemurafenib and 5% for dacarbazine. Common adverse events associated with vemurafenib were arthralgia, rash, fatigue, alopecia, keratoacanthoma or squamous-cell carcinoma, photosensitivity, nausea, and diarrhea; 38% of patients required dose modification because of toxic effects. Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation. (Funded by Hoffmann-La Roche; BRIM-3 ClinicalTrials.gov number, NCT01006980.).
Johnson, John R.; Justice, Robert; Pazdur, Richard
2011-01-01
On April 30, 2010, the U.S. Food and Drug Administration converted letrozole (Femara®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal women with hormone receptor–positive early breast cancer. The initial accelerated approvals of letrozole for adjuvant and extended adjuvant treatment on December 28, 2005 and October 29, 2004, respectively, were based on an analysis of the disease-free survival (DFS) outcome of patients followed for medians of 26 months and 28 months, respectively. Both trials were double-blind, multicenter studies. Both trials were unblinded early when an interim analysis showed a favorable letrozole effect on DFS. In updated intention-to-treat analyses of both trials, the risk for a DFS event was lower with letrozole than with tamoxifen (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.77–0.99; p = .03) in the adjuvant trial and was lower than with placebo (HR, 0.89; 95% CI, 0.76–1.03; p = .12) in the extended adjuvant trial. The latter analysis ignores the interim switch of 60% of placebo-treated patients to letrozole. Bone fractures and osteoporosis were reported more frequently following treatment with letrozole whereas tamoxifen was associated with a higher risk for endometrial proliferation and endometrial cancer. Myocardial infarction was more frequently reported with letrozole than with tamoxifen, but the incidence of thromboembolic events was higher with tamoxifen than with letrozole. Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen. PMID:22089970
Cohen, Martin H; Johnson, John R; Justice, Robert; Pazdur, Richard
2011-01-01
On April 30, 2010, the U.S. Food and Drug Administration converted letrozole (Femara®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal women with hormone receptor-positive early breast cancer. The initial accelerated approvals of letrozole for adjuvant and extended adjuvant treatment on December 28, 2005 and October 29, 2004, respectively, were based on an analysis of the disease-free survival (DFS) outcome of patients followed for medians of 26 months and 28 months, respectively. Both trials were double-blind, multicenter studies. Both trials were unblinded early when an interim analysis showed a favorable letrozole effect on DFS. In updated intention-to-treat analyses of both trials, the risk for a DFS event was lower with letrozole than with tamoxifen (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.77-0.99; p = .03) in the adjuvant trial and was lower than with placebo (HR, 0.89; 95% CI, 0.76-1.03; p = .12) in the extended adjuvant trial. The latter analysis ignores the interim switch of 60% of placebo-treated patients to letrozole. Bone fractures and osteoporosis were reported more frequently following treatment with letrozole whereas tamoxifen was associated with a higher risk for endometrial proliferation and endometrial cancer. Myocardial infarction was more frequently reported with letrozole than with tamoxifen, but the incidence of thromboembolic events was higher with tamoxifen than with letrozole. Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen.
A Conservative Method of Retaining an Interim Obturator for a Total Maxillectomy Patient
Bettie, Nirmal Famila
2017-01-01
Interim obturators are indicated during the postsurgical phases. It promotes surgical healing and serves as a temporary prosthesis to rehabilitate a patient with intra-oral surgical defect. Retention is gained by wiring, surgical suturing, and other noninvasive methods to enable functional rehabilitation and easy replacement with a permanent obturator. Interim obturators serve as an easy guide for replacing with definitive obturators by indicating prosthesis extensions and the required method of retention. A more conservative and noninvasive method of retaining an interim obturator for a maxillectomy patient is described in this case report. PMID:29284985
A Conservative Method of Retaining an Interim Obturator for a Total Maxillectomy Patient.
Bettie, Nirmal Famila
2017-11-01
Interim obturators are indicated during the postsurgical phases. It promotes surgical healing and serves as a temporary prosthesis to rehabilitate a patient with intra-oral surgical defect. Retention is gained by wiring, surgical suturing, and other noninvasive methods to enable functional rehabilitation and easy replacement with a permanent obturator. Interim obturators serve as an easy guide for replacing with definitive obturators by indicating prosthesis extensions and the required method of retention. A more conservative and noninvasive method of retaining an interim obturator for a maxillectomy patient is described in this case report.
Code of Federal Regulations, 2010 CFR
2010-01-01
... means the pro forma financial analysis prepared by the applicant, and acceptable to RUS, to determine... years estimated in the feasibility study for completion of the construction covered by the loan... the RE Act to each eligible entity. Interim construction means the construction, improvement, or...
Code of Federal Regulations, 2011 CFR
2011-01-01
... means the pro forma financial analysis prepared by the applicant, and acceptable to RUS, to determine... years estimated in the feasibility study for completion of the construction covered by the loan... the RE Act to each eligible entity. Interim construction means the construction, improvement, or...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-25
.... Job Titles and/or Job Duties: Extruders and Shapes Specialists who worked in the Rod and Shape Mill... L. Hinnefeld, Interim Director, Division of Compensation Analysis and Support, National Institute...
Grants Pass case study : indirect land use and growth impacts : interim report
DOT National Transportation Integrated Search
1999-08-01
To improve environmental analysis of indirect land use impacts of highway capacity improvements, this study analyzed the land use and growth patterns of 20 Oregon communities over 20 years. Using a Geographic Information System and aerial photos, gro...
40 CFR 265.113 - Closure; time allowed for closure.
Code of Federal Regulations, 2010 CFR
2010-07-01
... includes an amended waste analysis plan, ground-water monitoring and response program, human exposure....113 Section 265.113 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) INTERIM STATUS STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE TREATMENT, STORAGE, AND...
Land Use Management for Solid Waste Programs
ERIC Educational Resources Information Center
Brown, Sanford M., Jr.
1974-01-01
The author discusses the problems of solid waste disposal and examines various land use management techniques. These include the land use plan, zoning, regionalization, land utilities, and interim use. Information concerning solid waste processing site zoning and analysis is given. Bibliography included. (MA)
Improving Science Achievement and Attitudes of Students With and Without Learning Disabilities
NASA Astrophysics Data System (ADS)
Sanders-White, Pamela
The primary purpose of this study was to investigate the effect of structured note-taking compared to traditional note-taking on the acquisition of scientific knowledge for students with and without learning disabilities (LD) and students with reading difficulties (RD). An additional purpose was to examine whether the two note-taking methods affected students' attitudes toward science. The sample population consisted of 203 fifth grade students across four public schools in the southern area of the United States. A standardized instrument aligned to Florida's science standards was used to measure the acquisition of scientific knowledge and the Test of Science-Related Attitudes (TOSRA) was used to measure seven distinct science-related attitudes. For meaningful analyses, students with LD and students with RD were collapsed to form a single group due to the small numbers of participants in each of the subgroups; the collapsed group was referred to as "low achievers." A three-way repeated measures ANOVA was conducted to determine the effects of the pretest-posttest Science Interim assessment by group, type of student, and gender. The pretest-posttest Science Interim assessment scores were the within-group factor, while group, type of student, and gender were the between-groups factors. Results revealed that there was a significant interaction between the pretest-posttest Science Interim assessment and group, F(1, 191) = 9.320, p = .003, indicating that scientific knowledge scores increased for the experimental group, but decreased for the control group. Results also indicated that there was a significant three-way interaction between the pretest-posttest Science Interim assessment, group, and gender, F(1, 191) = 5.197, p = .024, showing that all participants in the experimental group improved their scores; while in the control group, female scores decreased and male scores increased. Participants in the experimental and control groups did not show improved attitudes toward science, as measured by the pretest-posttest TOSRA constructs.
Wave energy resource of Brazil: An analysis from 35 years of ERA-Interim reanalysis data
Araújo, Alex Maurício
2017-01-01
This paper presents a characterization of the wave power resource and an analysis of the wave power output for three (AquaBuoy, Pelamis and Wave Dragon) different wave energy converters (WEC) over the Brazilian offshore. To do so it used a 35 years reanalysis database from the ERA-Interim project. Annual and seasonal statistical analyzes of significant height and energy period were performed, and the directional variability of the incident waves were evaluated. The wave power resource was characterized in terms of the statistical parameters of mean, maximum, 95th percentile and standard deviation, and in terms of the temporal variability coefficients COV, SV e MV. From these analyses, the total annual wave power resource available over the Brazilian offshore was estimated in 89.97 GW, with largest mean wave power of 20.63 kW/m in the southernmost part of the study area. The analysis of the three WEC was based in the annual wave energy output and in the capacity factor. The higher capacity factor was 21.85% for Pelamis device at the southern region of the study area. PMID:28817731
Wave energy resource of Brazil: An analysis from 35 years of ERA-Interim reanalysis data.
Espindola, Rafael Luz; Araújo, Alex Maurício
2017-01-01
This paper presents a characterization of the wave power resource and an analysis of the wave power output for three (AquaBuoy, Pelamis and Wave Dragon) different wave energy converters (WEC) over the Brazilian offshore. To do so it used a 35 years reanalysis database from the ERA-Interim project. Annual and seasonal statistical analyzes of significant height and energy period were performed, and the directional variability of the incident waves were evaluated. The wave power resource was characterized in terms of the statistical parameters of mean, maximum, 95th percentile and standard deviation, and in terms of the temporal variability coefficients COV, SV e MV. From these analyses, the total annual wave power resource available over the Brazilian offshore was estimated in 89.97 GW, with largest mean wave power of 20.63 kW/m in the southernmost part of the study area. The analysis of the three WEC was based in the annual wave energy output and in the capacity factor. The higher capacity factor was 21.85% for Pelamis device at the southern region of the study area.
50 CFR 660.720 - Interim protection for sea turtles.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 50 Wildlife and Fisheries 13 2012-10-01 2012-10-01 false Interim protection for sea turtles. 660... Migratory Fisheries § 660.720 Interim protection for sea turtles. (a) Until the effective date of §§ 660.707... harvest of swordfish (Xiphias gladius) using longline gear deployed on the high seas of the Pacific Ocean...
50 CFR 660.720 - Interim protection for sea turtles.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 50 Wildlife and Fisheries 13 2013-10-01 2013-10-01 false Interim protection for sea turtles. 660... Migratory Fisheries § 660.720 Interim protection for sea turtles. (a) Until the effective date of §§ 660.707... harvest of swordfish (Xiphias gladius) using longline gear deployed on the high seas of the Pacific Ocean...
50 CFR 660.720 - Interim protection for sea turtles.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 50 Wildlife and Fisheries 11 2011-10-01 2011-10-01 false Interim protection for sea turtles. 660... Migratory Fisheries § 660.720 Interim protection for sea turtles. (a) Until the effective date of §§ 660.707... harvest of swordfish (Xiphias gladius) using longline gear deployed on the high seas of the Pacific Ocean...
50 CFR 660.720 - Interim protection for sea turtles.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 50 Wildlife and Fisheries 13 2014-10-01 2014-10-01 false Interim protection for sea turtles. 660... Migratory Fisheries § 660.720 Interim protection for sea turtles. (a) Until the effective date of §§ 660.707... harvest of swordfish (Xiphias gladius) using longline gear deployed on the high seas of the Pacific Ocean...
49 CFR 37.169 - Interim requirements for over-the-road bus service operated by private entities.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 1 2010-10-01 2010-10-01 false Interim requirements for over-the-road bus service... Interim requirements for over-the-road bus service operated by private entities. (a) Private entities operating over-the-road buses, in addition to compliance with other applicable provisions of this part...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-08
... assessable professional reported or required to be reported by a municipal advisor to the MSRB on Form A-11... Assessment and Form A-11- Interim. For purposes of the interim assessment, an assessable professional of a...-Interim as an assessable professional any associated person (i) Who otherwise qualifies as an assessable...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-28
... ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2013-0534; FRL-9900-36-Region 9.... Environmental Protection Agency (EPA). ACTION: Interim final rule. SUMMARY: EPA is making an interim [email protected] . Mail or deliver: Frances Wicher (AIR-2), U.S. Environmental Protection Agency Region 9...
Longitudinal joint treatment : first interim report.
DOT National Transportation Integrated Search
2000-11-01
Maine highways have been showing signs of longitudinal joint failure for a number of : years. In an effort to reduce the amount of joint failures the Maine Department of : Transportation (MDOT) is currently evaluating two projects. One project is mon...
Longitudinal joint treatment : second interim report.
DOT National Transportation Integrated Search
2001-09-01
Maine highways have been showing signs of longitudinal joint failure for a : number of years. In an effort to reduce the amount of joint failures the Maine : Department of Transportation (MDOT) is currently evaluating two projects. One : project is m...
An Adaptive Staggered Dose Design for a Normal Endpoint.
Wu, Joseph; Menon, Sandeep; Chang, Mark
2015-01-01
In a clinical trial where several doses are compared to a control, a multi-stage design that combines both the selection of the best dose and the confirmation of this selected dose is desirable. An example is the two-stage drop-the-losers or pick-the-winner design, where inferior doses are dropped after interim analysis. Selection of target dose(s) can be based on ranking of observed effects, hypothesis testing with adjustment for multiplicity, or other criteria at interim stages. A number of methods have been proposed and have made significant gains in trial efficiency. However, many of these designs started off with all doses with equal allocation and did not consider prioritizing the doses using existing dose-response information. We propose an adaptive staggered dose procedure that allows explicit prioritization of doses and applies error spending scheme that favors doses with assumed better responses. This design starts off with only a subset of the doses and adaptively adds new doses depending on interim results. Using simulation, we have shown that this design performs better in terms of increased statistical power than the drop-the-losers design given strong prior information of dose response.
A two-stage patient enrichment adaptive design in phase II oncology trials.
Song, James X
2014-01-01
Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular carcinoma (HCC) trial in which progression-free survival (PFS) in two biomarker-defined populations is evaluated at both interim and final analyses. As an extension, a short-term biomarker is used to predict the long-term PFS in a Bayesian model in order to improve the precision of hazard ratio (HR) estimate at the interim analysis. The characteristics of the extended design are examined in a number of scenarios via simulations. The recommended adaptive design is shown to be useful in a phase II setting. When a short-term maker which correlates with the long-term PFS is available, the design can be applied in smaller early phase trials in which PFS requires longer follow-up. In summary, the adaptive design offers flexibility in randomized phase II patient enrichment trials and should be considered in an overall personalized healthcare (PHC) strategy. Copyright © 2013 Elsevier Inc. All rights reserved.
In vitro evaluation of the marginal integrity of CAD/CAM interim crowns.
Kelvin Khng, Kwang Yong; Ettinger, Ronald L; Armstrong, Steven R; Lindquist, Terry; Gratton, David G; Qian, Fang
2016-05-01
The accuracy of interim crowns made with computer-aided design and computer-aided manufacturing (CAD/CAM) systems has not been well investigated. The purpose of this in vitro study was to evaluate the marginal integrity of interim crowns made by CAD/CAM compared with that of conventional polymethylmethacrylate (PMMA) crowns. A dentoform mandibular left second premolar was prepared for a ceramic crown and scanned for the fabrication of 60 stereolithical resin dies, half of which were scanned to fabricate 15 Telio CAD-CEREC and 15 Paradigm MZ100-E4D-E4D crowns. Fifteen Caulk and 15 Jet interim crowns were made on the remaining resin dies. All crowns were cemented with Tempgrip under a 17.8-N load, thermocycled for 1000 cycles, placed in 0.5% acid fuschin for 24 hours, and embedded in epoxy resin before sectioning from the mid-buccal to mid-lingual surface. The marginal discrepancy was measured using a traveling microscope, and dye penetration was measured as a percentage of the overall length under the crown. The mean vertical marginal discrepancy of the conventionally made interim crowns was greater than for the CAD/CAM crowns (P=.006), while no difference was found for the horizontal component (P=.276). The mean vertical marginal discrepancy at the facial surface of the Caulk crowns was significantly greater than that of the other 3 types of interim crowns (P<.001). At the facial margin, the mean horizontal component of the Telio crowns was significantly larger than that of the other 3 types, with no difference at the lingual margins (P=.150). The mean percentage dye penetration for the Paradigm MZ100-E4D crowns was significantly greater and for Jet crowns significantly smaller than for the other 3 crowns (P<.001). However, the mean percentage dye penetration was significantly correlated with the vertical and horizontal marginal discrepancies of the Jet interim crowns at the facial surface and with the horizontal marginal discrepancies of the Caulk interim crowns at the lingual surface (P<.01 in each instance). A significantly smaller vertical marginal discrepancy was found with the interim crowns fabricated by CAD/CAM as compared with PMMA crowns; however, this difference was not observed for the horizontal component. The percentage dye penetration was correlated with vertical and horizontal discrepancies at the facial surface for the Jet interim crowns and with horizontal discrepancies at the lingual surface for the Caulk interim crowns. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Boeck, Stefan; Vehling-Kaiser, Ursula; Waldschmidt, Dirk; Kettner, Erika; Märten, Angela; Winkelmann, Cornelia; Klein, Stefan; Kojouharoff, Georgi; Gauler, Thomas; Fischer von Weikersthal, Ludwig; Clemens, Michael R; Geissler, Michael; Greten, Tim F; Hegewisch-Becker, Susanna; Neugebauer, Sascha; Heinemann, Volker
2010-01-01
To date, only limited toxicity data are available for the combination of erlotinib with either capecitabine or gemcitabine as front-line therapy for advanced pancreatic cancer. Within a randomized phase III trial, 281 treatment-naive patients were randomly assigned between capecitabine (2000 mg/m/day, for 14 days, once every 3 weeks) plus erlotinib (150 mg/day, arm A) and gemcitabine (1000 mg/m as a 30-min infusion) plus erlotinib (150 mg/day, arm B). In case of treatment failure, patients were crossed over to a second-line treatment with the comparator cytostatic drug without erlotinib. The primary study endpoint was the time to treatment failure of second-line therapy (TTF2). This interim analysis of toxicity contains safety data from the first 127 randomized patients. During first-line therapy, patients received a median number of three treatment cycles (range 0-13) in both the arms. Regarding chemotherapy, a treatment delay was observed in 12% of the cycles in arm A and in 22% of the cycles in arm B. Dose reductions of the cytostatic drug were performed in 18 and 27% of treatment cycles, respectively. Erlotinib dose reductions were performed in 6 and 11% of all cycles. Grade 3/4 hematological toxicity was <10% in both the arms; major grade 3/4 toxicities in arms A and B were diarrhea (9 vs. 7%), skin rash (4 vs. 12%), and hand-foot syndrome (7 vs. 0%). No treatment-related death was observed. In conclusion, this interim safety analysis suggests that treatment with erlotinib 150 mg/day is feasible in combination with capecitabine or gemcitabine.
Araki, Eiichi; Onishi, Yukiko; Asano, Michiko; Kim, Hyosung; Ekholm, Ella; Johnsson, Eva; Yajima, Toshitaka
2016-07-01
Dapagliflozin treatment when added to insulin therapy in Japanese patients with type 2 diabetes remains to be evaluated. This was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate efficacy (at 16 weeks) and long-term safety (at 52 weeks) of dapagliflozin in addition to insulin therapy. The interim analysis was carried out at week 16 to assess the efficacy and safety profiles. The patients receiving insulin (n = 182) were randomized to either dapagliflozin 5 mg or a placebo at a 2:1 ratio. The primary efficacy end-point was the change in hemoglobin A1c (HbA1c) from baseline at week 16. Patients in the dapagliflozin group showed an adjusted decrease in HbA1c of -0.55% from baseline, whereas the placebo showed a marginal increase of 0.05%. The placebo-corrected mean change of HbA1c from baseline to week 16 in dapagliflozin was -0.60% (P < 0.0001). In addition, the placebo-corrected mean change of fasting plasma glucose and bodyweight from baseline to week 16 in the dapagliflozin group was -22.7 mg/dL (P < 0.0001) and -1.21 kg (P < 0.0001), respectively. The placebo-corrected mean daily insulin dose in the dapagliflozin group was numerically decreased (treatment difference: -0.72 IU/day; P = 0.0743). No major episodes or discontinuations as a result of hypoglycemia were reported during the study period. Dapagliflozin used as add-on treatment to insulin therapy showed significantly greater reduction of HbA1c, fasting plasma glucose and bodyweight without severe hypoglycemia compared with the placebo at week 16. These results show the clinical benefit of prescribing dapagliflozin for Japanese patients with insufficient glycemic control even with insulin therapy. © 2015 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.
2008-07-10
The Drug Enforcement Administration (DEA) is finalizing, without change, the Interim Rule with Request for Comment published in the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule removed the Controlled Substances Act (CSA) exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent. Upon the effective date of the Interim Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, became subject to the regulatory provisions of the CSA. DEA regulated the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. No comments to the Interim Rule were received. This Final Rule finalizes the Interim Rule without change.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1979-03-01
The certification and verification of the Northrup Model NSC-01-0732 Fresnel lens tracking solar collector are presented. A certification statement is included with signatures and a separate report on the structural analysis of the collector system. System verification against the Interim Performance Criteria are indicated by matrices with verification discussion, analysis, and enclosed test results.
Hybrid Wing-Body (HWB) Pressurized Fuselage Modeling, Analysis, and Design for Weight Reduction
NASA Technical Reports Server (NTRS)
Mukhopadhyay, Vivek
2012-01-01
This paper describes the interim progress for an in-house study that is directed toward innovative structural analysis and design of next-generation advanced aircraft concepts, such as the Hybrid Wing-Body (HWB) and the Advanced Mobility Concept-X flight vehicles, for structural weight reduction and associated performance enhancement. Unlike the conventional, skin-stringer-frame construction for a cylindrical fuselage, the box-type pressurized fuselage panels in the HWB undergo significant deformation of the outer aerodynamic surfaces, which must be minimized without significant structural weight penalty. Simple beam and orthotropic plate theory is first considered for sizing, analytical verification, and possible equivalent-plate analysis with appropriate simplification. By designing advanced composite stiffened-shell configurations, significant weight reduction may be possible compared with the sandwich and ribbed-shell structural concepts that have been studied previously. The study involves independent analysis of the advanced composite structural concepts that are presently being developed by The Boeing Company for pressurized HWB flight vehicles. High-fidelity parametric finite-element models of test coupons, panels, and multibay fuselage sections, were developed for conducting design studies and identifying critical areas of potential failure. Interim results are discussed to assess the overall weight/strength advantages.
FRAPCON analysis of cladding performance during dry storage operations
DOE Office of Scientific and Technical Information (OSTI.GOV)
Richmond, David J.; Geelhood, Kenneth J.
There is an increasing need in the U.S. and around the world to move used nuclear fuel from wet storage in fuel pools to dry storage in casks stored at independent spent fuel storage installations (ISFSI) or interim storage sites. The NRC limits cladding temperature to 400°C while maintaining cladding hoop stress below 90 MPa in an effort to avoid radial hydride reorientation. An analysis was conducted with FRAPCON-4.0 on three modern fuel designs with three representative used nuclear fuel storage temperature profiles that peaked at 400 °C. Results were representative of the majority of U.S. LWR fuel. They conservativelymore » showed that hoop stress remains below 90 MPa at the licensing temperature limit. Results also show that the limiting case for hoop stress may not be at the highest rod internal pressure in all cases but will be related to the axial temperature and oxidation profiles of the rods at the end of life and in storage.« less
40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...
49 CFR 1152.29 - Prospective use of rights-of-way for interim trail use and rail banking.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 8 2010-10-01 2010-10-01 false Prospective use of rights-of-way for interim trail... Governing Notice, Applications, Financial Assistance, Acquisition for Public Use, and Trail Use § 1152.29 Prospective use of rights-of-way for interim trail use and rail banking. (a) If any state, political...
Temps at the Top: Factors Related to the Appointment of Interim Community College Presidents
ERIC Educational Resources Information Center
Goff, Susan L.
2012-01-01
The appointment of interim community college presidents, the topic of this study, is a little understood phenomenon. A growing shortage of community college presidents coupled with a lack of replacements suggests the appointment of interims will continue well into the future. This study, with a purpose of looking at the factors related to the…
2008-07-17
OIG is adopting in final form, without change, an interim final rule published on March 26, 2008 (73 FR 15937). We received no comments to the interim final rule. The interim final rule revised the process for advisory opinion requestors to submit payments for advisory opinion costs.
ERIC Educational Resources Information Center
Goertz, Margaret E.; Olah, Leslie Nabors; Riggan, Matthew
2009-01-01
The purpose of this exploratory study is to examine the use of interim assessments and the policy supports that promote use to improve instruction, focusing on elementary school mathematics. The authors use the term "interim assessments" to refer to assessments that a) evaluate student knowledge and skills, typically within a limited…
40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...
40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...
40 CFR 52.243 - Interim approval of the Carbon Monoxide plan for the South Coast.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Interim approval of the Carbon Monoxide plan for the South Coast. 52.243 Section 52.243 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS California § 52.243 Interim approval of the Carbon...
76 FR 5564 - Grant of Interim Extension of the Term of U.S. Patent No. 4,971,802; MIFAMURTIDE
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-01
... DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No. PTO-P-2011-0001] Grant of Interim... Office, Commerce. ACTION: Notice of interim patent term extension. SUMMARY: The United States Patent and... States Patent and Trademark Office. [FR Doc. 2011-2088 Filed 1-31-11; 8:45 am] BILLING CODE 3510-16-P ...
Interim Testing, Socio-Economic Status, and the Odds of Passing Grade 8 State Tests in New Jersey
ERIC Educational Resources Information Center
Babo, Gerard; Tienken, Christopher H.; Gencarelli, Maria A.
2014-01-01
A review of the literature pertaining to the effect and influence of commercially-prepared interim assessments in mathematics and language arts literacy reveals a lack of quantitative data to determine the value of these products for school reform. This study examined the ability of commercially-prepared interim pretest and posttest assessments in…
47 CFR 51.715 - Interim transport and termination pricing.
Code of Federal Regulations, 2013 CFR
2013-10-01
... shall set interim transport and termination rates either at the default ceilings specified in § 51.705(c) or in accordance with a bill-and-keep methodology as defined in § 51.713. (3) In a state in which the... minute of use), and transport (as described in § 51.707(b)(2)). (c) An interim arrangement shall cease to...
47 CFR 51.715 - Interim transport and termination pricing.
Code of Federal Regulations, 2014 CFR
2014-10-01
... shall set interim transport and termination rates either at the default ceilings specified in § 51.705(c) or in accordance with a bill-and-keep methodology as defined in § 51.713. (3) In a state in which the... minute of use), and transport (as described in § 51.707(b)(2)). (c) An interim arrangement shall cease to...
47 CFR 51.715 - Interim transport and termination pricing.
Code of Federal Regulations, 2012 CFR
2012-10-01
... shall set interim transport and termination rates either at the default ceilings specified in § 51.705(c) or in accordance with a bill-and-keep methodology as defined in § 51.713. (3) In a state in which the... minute of use), and transport (as described in § 51.707(b)(2)). (c) An interim arrangement shall cease to...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-11
...-indicator of the Capital Fund indicator to all PHAs for the Capital Fund Indicator under the PHAS interim... transition to the scoring system implemented by the PHAS interim rule, especially as relates to the indicator that assesses occupancy rate. The 5 points for the occupancy sub-indicator will be awarded for fiscal...
Lin, Wei-Shao; Harris, Bryan T; Pellerito, John; Morton, Dean
2018-04-30
This report describes a proof of concept for fabricating an interim complete removable dental prosthesis with a digital light processing 3-dimensional (3D) printer. Although an in-office 3D printer can reduce the overall production cost for an interim complete removable dental prosthesis, the process has not been validated with clinical studies. This report provided a preliminary proof of concept in developing a digital workflow for the in-office additively manufactured interim complete removable dental prosthesis. Copyright © 2018 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.
Code of Federal Regulations, 2010 CFR
2010-01-01
.... Feasibility study means the pro forma financial analysis performed by RUS to determine the economic... RUS to the borrower's construction fund. Borrower means any organization which has an outstanding loan... percent per year. Initial loan means the first loan made to a borrower. Interim construction means the...
Code of Federal Regulations, 2014 CFR
2014-01-01
.... Feasibility study means the pro forma financial analysis performed by RUS to determine the economic... RUS to the borrower's construction fund. Borrower means any organization which has an outstanding loan... percent per year. Initial loan means the first loan made to a borrower. Interim construction means the...
Code of Federal Regulations, 2013 CFR
2013-01-01
.... Feasibility study means the pro forma financial analysis performed by RUS to determine the economic... RUS to the borrower's construction fund. Borrower means any organization which has an outstanding loan... percent per year. Initial loan means the first loan made to a borrower. Interim construction means the...
Code of Federal Regulations, 2012 CFR
2012-01-01
.... Feasibility study means the pro forma financial analysis performed by RUS to determine the economic... RUS to the borrower's construction fund. Borrower means any organization which has an outstanding loan... percent per year. Initial loan means the first loan made to a borrower. Interim construction means the...
Code of Federal Regulations, 2011 CFR
2011-01-01
.... Feasibility study means the pro forma financial analysis performed by RUS to determine the economic... RUS to the borrower's construction fund. Borrower means any organization which has an outstanding loan... percent per year. Initial loan means the first loan made to a borrower. Interim construction means the...
Aeromedical Airlift -- Do the Pieces Fit?
1988-01-01
architecture analysis. feasibility study, and system design phase. To save money and time associated with unforeseen down-line modifications that may... loand Redietribution of Patients in CONUS. Draft Interim; Report No. IX-h. Maximnus, Inc., McLean Va.: Prepared for Office of the Assistant.Secretary of
78 FR 10269 - National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-13
... agencies incur the remaining costs. Abbreviations Used in This Document AGI--Acute Gastrointestinal Illness AIDS--Acquired Immune Deficiency Syndrome AIP--Agreement in Principle AWWA--American Water Works... Analysis HUS--Hemolytic Uremic Syndrome ICR--Information Collection Request IESWTR--Interim Enhanced...
DOT National Transportation Integrated Search
1994-02-01
THE ATTACHED REPORT IS FROM THE NHTSA SPONSORED PROGRAM, "IVHS COUNTERMEASURES FOR REAR-END COLLISIONS," CONTRACT #DTNH22-93-C-07326. THE PROGRAM'S PRIMARY OBJECTIVE IS TO DEVELOP PRACTICAL PERFORMANCE GUIDELINES OR SPECIFICATIONS FOR REAR-END COLLIS...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-01
... emissions, (applicants are encouraged to provide quantitative information regarding expected reductions in...). Applicants are encouraged to provide quantitative information that validates the existence of substantial... infrastructure investments on systematic analysis of expected benefits and costs, including both quantitative and...
Longitudinal joint treatment, interim report - third year, March 2004.
DOT National Transportation Integrated Search
2004-03-01
Maine highways have been showing signs of longitudinal joint failure for a number of years. In an effort : to reduce the amount of joint failures the Maine Department of Transportation (MDOT) is currently : evaluating two projects. One project is mon...
Longitudinal joint treatment, interim report - fourth year, March 2005.
DOT National Transportation Integrated Search
2005-03-01
Maine highways have been showing signs of longitudinal joint failure for a number of years. In an effort : to reduce the amount of joint failures the Maine Department of Transportation (MDOT) is currently : evaluating two projects. One project is mon...
2016-07-29
This rule adopts as final, with some modifications, the National School Lunch Program and School Breakfast Program regulations set forth in the interim final rule published in the Federal Register on June 28, 2013. The requirements addressed in this rule conform to the provisions in the Healthy, Hunger-Free Kids Act of 2010 regarding nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs. Most provisions of this final rule were implemented on July 1, 2014, a full year subsequent to publication of the interim final rule. This was in compliance with section 208 of the Healthy, Hunger-Free Kids Act of 2010, which required that State and local educational agencies have at least one full school year from the date of publication of the interim final rule to implement the competitive food provisions. Based on comments received on the interim final rule and implementation experience, this final rule makes a few modifications to the nutrition standards for all foods sold in schools implemented on July 1, 2014. In addition, this final rule codifies specific policy guidance issued after publication of the interim rule. Finally, this rule retains the provision related to the standard for total fat as interim and requests further comment on this single standard.
Fast Charge Battery Electric Transit Bus In-Use Fleet Evaluation
DOE Office of Scientific and Technical Information (OSTI.GOV)
Prohaska, Robert; Kelly, Kenneth; Eudy, Leslie
2016-07-25
The focus of this interim fleet evaluation is to characterize and evaluate the operating behavior of Foothill Transit's fast charge battery electric buses (BEBs). Future research will compare the BEBs' performance to conventional vehicles. In an effort to better understand the impacts of drive cycle characteristics on advanced vehicle technologies, researchers at the National Renewable Energy Laboratory analyzed over 148,000 km of in-use operational data, including driving and charging events. This analysis provides an unbiased evaluation of advanced vehicle technologies in real-world operation demonstrating the importance of understanding the effects of road grade and heating, ventilating and air conditioning requirementsmore » when deploying electric vehicles. The results of this analysis show that the Proterra BE35 demonstrated an operating energy efficiency of 1.34 kWh/km over the data reporting period.« less
Fast Charge Battery Electric Transit Bus In-Use Fleet Evaluation: Preprint
DOE Office of Scientific and Technical Information (OSTI.GOV)
Prohaska, Robert; Eudy, Leslie; Kelly, Kenneth
2016-05-06
The focus of this interim fleet evaluation is to characterize and evaluate the operating behavior of Foothill Transit's fast charge battery electric buses (BEBs). Future research will compare the BEBs' performance to conventional vehicles. In an effort to better understand the impacts of drive cycle characteristics on advanced vehicle technologies, researchers at the National Renewable Energy Laboratory analyzed over 148,000 km of in-use operational data, including driving and charging events. This analysis provides an unbiased evaluation of advanced vehicle technologies in real-world operation demonstrating the importance of understanding the effects of road grade and heating, ventilating and air conditioning requirementsmore » when deploying electric vehicles. The results of this analysis show that the Proterra BE35 demonstrated an operating energy efficiency of 1.34 kWh/km over the data reporting period.« less
Booth, James F; Naud, Catherine M; Willison, Jeff
2018-03-01
The representation of extratropical cyclones (ETCs) precipitation in general circulation models (GCMs) and a weather research and forecasting (WRF) model is analyzed. This work considers the link between ETC precipitation and dynamical strength and tests if parameterized convection affects this link for ETCs in the North Atlantic Basin. Lagrangian cyclone tracks of ETCs in ERA-Interim reanalysis (ERAI), the GISS and GFDL CMIP5 models, and WRF with two horizontal resolutions are utilized in a compositing analysis. The 20-km resolution WRF model generates stronger ETCs based on surface wind speed and cyclone precipitation. The GCMs and ERAI generate similar composite means and distributions for cyclone precipitation rates, but GCMs generate weaker cyclone surface winds than ERAI. The amount of cyclone precipitation generated by the convection scheme differs significantly across the datasets, with GISS generating the most, followed by ERAI and then GFDL. The models and reanalysis generate relatively more parameterized convective precipitation when the total cyclone-averaged precipitation is smaller. This is partially due to the contribution of parameterized convective precipitation occurring more often late in the ETC life cycle. For reanalysis and models, precipitation increases with both cyclone moisture and surface wind speed, and this is true if the contribution from the parameterized convection scheme is larger or not. This work shows that these different models generate similar total ETC precipitation despite large differences in the parameterized convection, and these differences do not cause unexpected behavior in ETC precipitation sensitivity to cyclone moisture or surface wind speed.
2012-02-01
AFRL-RX-TY-TR-2012-0022 ANALYSIS OF COMMERCIALLY AVAILABLE HELMET AND BOOT OPTIONS FOR THE JOINT FIREFIGHTER INTEGRATED RESPONSE ENSEMBLE...Interim Technical Report 01-SEP-2010 -- 31-JAN-2011 Analysis of Commercially Available Firefighting Helmet and Boot Options for the Joint Firefighter...ensemble. A requirements correlation matrix was generated and sent to industry detailing objective and threshold measurements for both the helmet
ERIC Educational Resources Information Center
What Works Clearinghouse, 2015
2015-01-01
The study, "The Impact of Indiana's System of Interim Assessments on Mathematics and Reading," examined the effects of using Diagnostic Assessment Tools (DAT) on mathematics and reading outcomes for students in 59 Indiana schools during the 2009-10 academic year. DAT consists of interim assessment tools--Wireless Generation's mCLASS for…
ERIC Educational Resources Information Center
Immekus, Jason C.; Atitya, Ben
2016-01-01
Interim tests are a central component of district-wide assessment systems, yet their technical quality to guide decisions (e.g., instructional) has been repeatedly questioned. In response, the study purpose was to investigate the validity of a series of English Language Arts (ELA) interim assessments in terms of dimensionality and prediction of…
Code of Federal Regulations, 2014 CFR
2014-04-01
... 25 Indians 1 2014-04-01 2014-04-01 false Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously funded by the Bureau. 39.1100 Section 39.1100 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION THE INDIAN SCHOOL EQUALIZATION PROGRAM Pre-kindergarten Programs § 39.1100 Interim fiscal year...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 25 Indians 1 2012-04-01 2011-04-01 true Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously funded by the Bureau. 39.1100 Section 39.1100 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION THE INDIAN SCHOOL EQUALIZATION PROGRAM Pre-kindergarten Programs § 39.1100 Interim fiscal year...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 25 Indians 1 2010-04-01 2010-04-01 false Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously funded by the Bureau. 39.1100 Section 39.1100 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION THE INDIAN SCHOOL EQUALIZATION PROGRAM Pre-kindergarten Programs § 39.1100 Interim fiscal year...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 25 Indians 1 2013-04-01 2013-04-01 false Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously funded by the Bureau. 39.1100 Section 39.1100 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION THE INDIAN SCHOOL EQUALIZATION PROGRAM Pre-kindergarten Programs § 39.1100 Interim fiscal year...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 25 Indians 1 2011-04-01 2011-04-01 false Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously funded by the Bureau. 39.1100 Section 39.1100 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR EDUCATION THE INDIAN SCHOOL EQUALIZATION PROGRAM Pre-kindergarten Programs § 39.1100 Interim fiscal year...
NASA Astrophysics Data System (ADS)
Rasmussen, K. L.; Prein, A. F.; Rasmussen, R. M.; Ikeda, K.; Liu, C.
2017-11-01
Novel high-resolution convection-permitting regional climate simulations over the US employing the pseudo-global warming approach are used to investigate changes in the convective population and thermodynamic environments in a future climate. Two continuous 13-year simulations were conducted using (1) ERA-Interim reanalysis and (2) ERA-Interim reanalysis plus a climate perturbation for the RCP8.5 scenario. The simulations adequately reproduce the observed precipitation diurnal cycle, indicating that they capture organized and propagating convection that most climate models cannot adequately represent. This study shows that weak to moderate convection will decrease and strong convection will increase in frequency in a future climate. Analysis of the thermodynamic environments supporting convection shows that both convective available potential energy (CAPE) and convective inhibition (CIN) increase downstream of the Rockies in a future climate. Previous studies suggest that CAPE will increase in a warming climate, however a corresponding increase in CIN acts as a balancing force to shift the convective population by suppressing weak to moderate convection and provides an environment where CAPE can build to extreme levels that may result in more frequent severe convection. An idealized investigation of fundamental changes in the thermodynamic environment was conducted by shifting a standard atmospheric profile by ± 5 °C. When temperature is increased, both CAPE and CIN increase in magnitude, while the opposite is true for decreased temperatures. Thus, even in the absence of synoptic and mesoscale variations, a warmer climate will provide more CAPE and CIN that will shift the convective population, likely impacting water and energy budgets on Earth.
DOT National Transportation Integrated Search
1994-02-01
THE ATTACHED REPORT IS FROM THE NHTSA SPONSORED PROGRAM, "IVHS COUNTERMEASURES FOR REAR-END COLLISIONS," CONTRACT #DTNH22-93-C-07326. THE PROGRAM'S PRIMARY OBJECTIVE IS TO DEVELOP PRACTICAL PERFORMANCE GUIDELINES OR SPECIFICATIONS FOR REAR-END COLLIS...
Transportation Systems Center Bibliography of Technical Reports, July 1970 - December 1976,
1977-04-01
Systems Center. AD-733-763 Judith Gertler, Herbert Glynn, Vivian Hobbs, Frederick Interim Report. June 1971. 16p. Woolfall. AD-733-764 Air Traffic Control...of Deployment Cost Analysis .. .......... FAA-76-20 Airspace Control Environmnent Simulator - Final Report.... ............ .. TSC-131.3 *All- Wether
Locomotive cab design development. volume III: design application analysis - Interim report
DOT National Transportation Integrated Search
1976-10-01
In Volume II of this service of reports on Locomotive Cab Design Development, changes were recommended in the layout and equipment content of locomotive cabs. This report studies the impact of these changes on the interface of the cab with the rest o...
Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Kameda, Hiroyuki; Tamura, Masahiro; Mihara, Hanako; Kaku, Kohei
2016-09-01
Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest. The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected. Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P < 0.0001). This interim analysis characterized the safety profile of tofogliflozin in Japanese elderly patients with type 2 diabetes mellitus during the early post-marketing period. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.
NASA Astrophysics Data System (ADS)
Balidakis, Kyriakos; Nilsson, Tobias; Heinkelmann, Robert; Glaser, Susanne; Zus, Florian; Deng, Zhiguo; Schuh, Harald
2017-04-01
The quality of the parameters estimated by global navigation satellite systems (GNSS) and very long baseline interferometry (VLBI) are distorted by erroneous meteorological observations applied to model the propagation delay in the electrically neutral atmosphere. For early VLBI sessions with poor geometry, unsuitable constraints imposed on the a priori tropospheric gradients is a source of additional hassle of VLBI analysis. Therefore, climate change indicators deduced from the geodetic analysis, such as the long-term precipitable water vapor (PWV) trends, are strongly affected. In this contribution we investigate the impact of different modeling and parameterization of the propagation delay in the troposphere on the estimates of long-term PWV trends from geodetic VLBI analysis results. We address the influence of the meteorological data source, and of the a priori non-hydrostatic delays and gradients employed in the VLBI processing, on the estimated PWV trends. In particular, we assess the effect of employing temperature and pressure from (i) homogenized in situ observations, (ii) the model levels of the ERA Interim reanalysis numerical weather model and (iii) our own blind model in the style of GPT2w with enhanced parameterization, calculated using the latter data set. Furthermore, we utilize non-hydrostatic delays and gradients estimated from (i) a GNSS reprocessing at GeoForschungsZentrum Potsdam, rigorously considering tropospheric ties, and (ii)) direct ray-tracing through ERA Interim, as additional observations. To evaluate the above, the least-squares module of the VieVS@GFZ VLBI software was appropriately modified. Additionally, we study the noise characteristics of the non-hydrostatic delays and gradients estimated from our VLBI and GNSS analyses as well as from ray-tracing. We have modified the Theil-Sen estimator appropriately to robustly deduce PWV trends from VLBI, GNSS, ray-tracing and direct numerical integration in ERA Interim. We disseminate all our solutions in the latest Tropo-SINEX format.
PROJECT W-551 INTERIM PRETREATMENT SYSTEM PRECONCEPTUAL CANDIDATE TECHNOLOGY DESCRIPTIONS
DOE Office of Scientific and Technical Information (OSTI.GOV)
MAY TH
The Office of River Protection (ORP) has authorized a study to recommend and select options for interim pretreatment of tank waste and support Waste Treatment Plant (WTP) low activity waste (LAW) operations prior to startup of all the WTP facilities. The Interim Pretreatment System (IPS) is to be a moderately sized system which separates entrained solids and 137Cs from tank waste for an interim time period while WTP high level waste vitrification and pretreatment facilities are completed. This study's objective is to prepare pre-conceptual technology descriptions that expand the technical detail for selected solid and cesium separation technologies. This revisionmore » includes information on additional feed tanks.« less
Sensitivity Analysis for Multidisciplinary Systems (SAMS)
2016-12-01
support both mode-based structural representations and time-dependent, nonlinear finite element structural dynamics. This interim report describes...Adaptation, & Sensitivity Toolkit • Elasticity, heat transfer, & compressible flow • Adjoint solver for sensitivity analysis • High-order finite elements ...PROGRAM ELEMENT NUMBER 62201F 6. AUTHOR(S) Richard D. Snyder 5d. PROJECT NUMBER 2401 5e. TASK NUMBER N/A 5f. WORK UNIT NUMBER Q1FS 7
Surface Acoustic Wave Transducer Study.
1978-05-01
B. Network Analysis 48 C. Experimental Results 53 D. Conc lusions 56 VI. Analysis of SAW Propagation in Layered Structures . . . 56 A. Introduction...unLdtrect1ona~ transducer and the associated matching networks . The capacity weighted transducer consists of a layered structure in which the lower...CAPACITIVELY WEIGHTED TRANSDUCERS A. Introduction The capacitive tap weight network transducer (CNN) has been pre- .5 sented in the interim as an
The utility of Bayesian predictive probabilities for interim monitoring of clinical trials
Connor, Jason T.; Ayers, Gregory D; Alvarez, JoAnn
2014-01-01
Background Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. Purpose We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods. Results For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. Limitations Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval. Conclusions The use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision making process. PMID:24872363
INTERIM -- Starlink Software Environment
NASA Astrophysics Data System (ADS)
Pearce, Dave; Pavelin, Cliff; Lawden, M. D.
Early versions of this paper were based on a number of other papers produced at a very early stage of the Starlink project. They contained a description of a specific implementation of a subroutine library, speculations on the desirable attributes of a software environment, and future development plans. They reflected the experimental nature of the Starlink software environment at that time. Since then, the situation has changed. The implemented subroutine library, INTERIM_DIR:INTERIM.OLB, is now a well established and widely used piece of software. A completely new Starlink software environment (ADAM) has been developed and distributed. Thus the library released in 1980 as `STARLINK' and now called `INTERIM' has reached the end of its development cycle and is now frozen in its current state, apart from bug corrections. This paper has, therefore, been completely rewritten and restructured to reflect the new situation. Its aim is to describe the facilities of the INTERIM subroutine library as clearly and concisely as possible. It avoids speculation, discussion of design decisions, and announcements of future plans.
Pioglitazone (Actos) and bladder cancer: Legal system triumphs over the evidence.
Davidson, Mayer B
2016-08-01
In preclinical studies, pioglitazone was associated with bladder cancer in male rats (but not in female rats, mice dogs or monkeys). Because of this association, the Federal Drug Administration requested a large 10year epidemiological study to evaluate whether there was an association between bladder cancer and exposure to pioglitazone in patients. A 5-year interim report published in 2011 showed no significant association between ever vs never exposure to the drug but a significant association in patients exposed to pioglitazone for >2years. Importantly, the final 10year report did not confirm the 5year interim report finding no association between bladder cancer and pioglitazone, even after >4years of exposure to the drug. However, as would be expected, following the 5-year interim report, many epidemiological studies were carried out and civil litigation lawsuits began to be filed. Of the 23 epidemiological studies that have been published to date, 18 showed no association between bladder cancer and pioglitazone (5 with a combination of rosiglitazone and pioglitazone). Of the five that did show a significant association with pioglitazone, three could not be confirmed in the same population and in one of them there were significantly more risk factors for bladder cancer in the patients exposed to pioglitazone. In the fourth one, a significant association became non-significant when patients >79years were included. In the fifth one, detection bias was a major flaw. Currently, >11,000 legal cases have been filed, many of which claim emotional distress due to the fear of bladder cancer. To limit their legal costs, the pharmaceutical company has established a 2.4 billion dollar settlement pool. So much for evidence-based medicine. Copyright © 2016 Elsevier Inc. All rights reserved.
NASA Astrophysics Data System (ADS)
Xie, Jin; Yu, Ye; Li, Jiang-lin; Ge, Jun; Liu, Chuan
2018-02-01
Surface sensible and latent heat fluxes (SH and LE) over the Tibetan Plateau (TP) have been under research since 1950s, especially for recent several years, by mainly using observation, reanalysis, and satellite data. However, the spatiotemporal changes are not consistent among different studies. This paper focuses on the spatiotemporal variation of SH and LE over the TP from 1981 to 2013 using reanalysis data sets (ERA-Interim, JRA-55, and MERRA) and observations. Results show that the spatiotemporal changes from the three reanalysis data sets are significantly different and the probable causes are discussed. Averaged for the whole TP, both SH and LE from MERRA are obviously higher than the other two reanalysis data sets. ERA-Interim shows a significant downward trend for SH and JRA-55 shows a significant increase of LE during the 33 years with other data sets having no obvious changes. By comparing the heat fluxes and some climate factors from the reanalysis with observations, it is found that the differences of heat fluxes among the three reanalysis data sets are closely related to their differences in meteorological conditions as well as the different parameterizations for surface transfer coefficients. In general, the heat fluxes from the three reanalysis have a better representation in the western TP than that in the eastern TP under inter-annual scale. While in terms of monthly variation, ERA-Interim may have better applicability in the eastern TP with dense vegetation conditions, while SH of JRA-55 and LE of MERRA are probably more representative for the middle and western TP with poor vegetation conditions.
17 CFR 402.2a - Appendix A-Calculation of market risk haircut for purposes of § 402.2(g)(2).
Code of Federal Regulations, 2014 CFR
2014-04-01
... larger in absolute value of the two residual position interim haircuts being netted, and (ii) zero, in... category of the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in... the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in the...
17 CFR 402.2a - Appendix A-Calculation of market risk haircut for purposes of § 402.2(g)(2).
Code of Federal Regulations, 2011 CFR
2011-04-01
... larger in absolute value of the two residual position interim haircuts being netted, and (ii) zero, in... category of the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in... the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in the...
17 CFR 402.2a - Appendix A-Calculation of market risk haircut for purposes of § 402.2(g)(2).
Code of Federal Regulations, 2012 CFR
2012-04-01
... larger in absolute value of the two residual position interim haircuts being netted, and (ii) zero, in... category of the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in... the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in the...
17 CFR 402.2a - Appendix A-Calculation of market risk haircut for purposes of § 402.2(g)(2).
Code of Federal Regulations, 2010 CFR
2010-04-01
... larger in absolute value of the two residual position interim haircuts being netted, and (ii) zero, in... category of the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in... the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in the...
17 CFR 402.2a - Appendix A-Calculation of market risk haircut for purposes of § 402.2(g)(2).
Code of Federal Regulations, 2013 CFR
2013-04-01
... larger in absolute value of the two residual position interim haircuts being netted, and (ii) zero, in... category of the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in... the larger (in absolute value) of the two interim haircuts that were netted, and (2) a zero in the...
Interim Report by Asia International Grid Connection Study Group
NASA Astrophysics Data System (ADS)
Omatsu, Ryo
2018-01-01
The Asia International Grid Connection Study Group Interim Report examines the feasibility of developing an international grid connection in Japan. The Group has investigated different cases of grid connections in Europe and conducted research on electricity markets in Northeast Asia, and identifies the barriers and challenges for developing an international grid network including Japan. This presentation introduces basic contents of the interim report by the Study Group.
Commentary: Interim leadership of academic departments at U.S. medical schools.
Grigsby, R Kevin; Aber, Robert C; Quillen, David A
2009-10-01
Medical schools and teaching hospitals are experiencing more frequent turnover of department chairs. Loss of a department chair creates instability in the department and may have a negative effect on the organization at large. Interim leadership of academic departments is common, and interim chairs are expected to immediately demonstrate skills and leadership abilities. However, little is known about how persons are prepared to assume the interim chair role. Newer competencies for effective leadership include an understanding of the business of medicine, interpersonal and communication skills, the ability to deal with conflict and solve adaptive challenges, and the ability to build and work on teams. Medical schools and teaching hospitals need assistance to meet the unique training and support needs of persons serving as interim leaders. For example, the Association of American Medical Colleges and individual chair societies can develop programs to allow current chairs to reflect on their present positions and plan for the future. Formal leadership training, mentorship opportunities, and conscientious succession planning are good first steps in preparing to meet the needs of academic departments during transitions in leadership. Also, interim leadership experience may be useful as a means for "opening the door" to underrepresented persons, including women, and increasing the diversity of the leadership team.
Reinforcement of a PMMA resin for interim fixed prostheses with silica nanoparticles.
Topouzi, Marianthi; Kontonasaki, Eleana; Bikiaris, Dimitrios; Papadopoulou, Lambrini; Paraskevopoulos, Konstantinos M; Koidis, Petros
2017-05-01
Fractures in long span provisional/interim restorations are a common complication. Adequate fracture toughness is necessary to resist occlusal forces and crack propagation, so these restorations should be constructed with materials of improved mechanical properties. The aim of this study was to investigate the possible reinforcement of neat silica nanoparticles and trietoxyvinylsilane-modified silica nanoparticles in a PMMA resin for fixed interim restorations. Composite PMMA-Silica nanoparticles powders were mixed with PMMA liquid and compact bar shaped specimens were fabricated according to the British standard BS EN ISO 127337:2005. The single-edge notched method was used to evaluate fracture toughness (three-point bending test), while the dynamic thermomechanical properties (Storage Modulus, Loss Modulus, tanδ) of a series of nanocomposites with different amounts of nanoparticles (0.25%, 0.50%, 0.75%, 1% w.t.) were evaluated. Statistical analysis was performed and the statistically significant level was set to p<0.05. The fracture toughness of all experimental composites was remarkably higher compared to control. There was a tendency to decrease of fracture toughness, by increasing the concentration of the filler. No statistically significant differences were detected among the modified/unmodified silica nanoparticles. Dynamic mechanical properties were also affected. By increasing the silica nanoparticles content an increase in Storage Modulus was recorded, while Glass Transition Temperature was shifted at higher temperatures. Under the limitations of this in-vitro study, it can be suggested that both neat silica nanoparticles and trietoxyvinylsilane-modified silica nanoparticles, especially at low concentrations, may enhance the overall performance of fixed interim prostheses, as can effectively increase the fracture toughness, the elastic modulus and the Glass Transition Temperature of PMMA resins used in fixed provisional restorations. Copyright © 2017 Elsevier Ltd. All rights reserved.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-25
..., 2011. Three respondents provided comments on the interim rule. II. Discussion and Analysis A summary of... Comment: Three respondents provided comments supporting the idea that establishing an effective system of... by reiterating this language in the DFARS. C. Clarity of Definitions Comment: One respondent...
75 FR 40925 - National Primary Drinking Water Regulations: Revisions to the Total Coliform Rule
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-14
... discussion on docket. Abbreviations Used in This Document ADWR Airline Drinking Water Rule AGI Acute Gastrointestinal Illness AIDS Acquired Immune Deficiency Syndrome AIP Agreement in Principle AWWA American Water... Cost Analysis HUS Hemolytic Uremic Syndrome ICR Information Collection Request IESWTR Interim Enhanced...
76 FR 79767 - Truth in Lending (Regulation Z)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-22
... analysis of potential benefits, costs, and impacts.\\14\\ The Bureau believes that the interim final rule... obligations on consumers or covered persons and is not expected to have any impact on consumers' access to... potential reduction of access by consumers to consumer financial products or services; the impact on...
Curricular Change: A Model for Analysis.
ERIC Educational Resources Information Center
Axelrod, Joseph
This interim report on 1 project at the Berkeley Center for Research and Development in Higher Education deals with the construction of a theoretical model of the curricular-instructional subsystem. The relationship between student unrest and the poor quality of education in American colleges has long been evident to educational researchers. The…
75 FR 36715 - Advisory Committee on Reactor Safeguards; Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-28
... Seismic Input for Site Response and Soil Structure Interaction Analyses'' (Open)--The Committee will hold... Seismic Input for Site Response and Soil Structure Interaction Analyses.'' 9:30 a.m.-10:30 a.m.: Interim Staff Guidance (ISG) DC/COL-ISG-020, ``Implementation of Seismic Margin Analysis for New Reactors Based...
Linear Programming for Vocational Education Planning. Interim Report.
ERIC Educational Resources Information Center
Young, Robert C.; And Others
The purpose of the paper is to define for potential users of vocational education management information systems a quantitative analysis technique and its utilization to facilitate more effective planning of vocational education programs. Defining linear programming (LP) as a management technique used to solve complex resource allocation problems…
HARD CHROME POLLUTION PREVENTION DEMONSTRATION PROJECT - INTERIM REPORT
In the project, five chromium emission prevention/control devices were tested tha cover the spectrum of prevention/control techniques currently in use in small- and large-size hard chromium electroplating job shops. The Project results show that some of the tested devices had ch...
DOT National Transportation Integrated Search
1979-07-01
This study is to determined by physical, chemical, and biological means, the effects of bridged highway construction techniques on water quality in wetlands. Water quality was monitored before, during, and after construction. The data shows the incre...
Kimura, Go; Ueda, Takeshi
2017-03-01
A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.
Ueda, Takeshi
2017-01-01
Abstract A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28–1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18–0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. PMID:28003320
Recent decadal trends in Iberian water vapour: GPS analysis and WRF process study
NASA Astrophysics Data System (ADS)
Miranda, Pedro M. A.; Nogueira, Miguel; Semedo, Alvaro; Benevides, Pedro; Catalao, Joao; Costa, Vera
2016-04-01
A 24-year simulation of the recent Iberian climate, using the WRF model at 9km resolution forced by ERA-Interim reanalysis (1989-2012), is analysed for the decadal evolution of the upwelling forcing coastal wind and for column integrated Precipitable water vapour (PWV). Results indicate that, unlike what was found by Bakun et al. (2009) for the Peruvian region, a statistically significant trend in the upwelling favourable (northerly) wind has been accompanied by a corresponding decrease in PWV, not only inland but also over the coastal waters. Such increase is consistent with a reinforced northerly coastal jet in the maritime boundary layer contributing to atmospheric Ekman pumping of dry continental air into the coastal region. Diagnostics of the prevalence of the Iberian thermal low following Hoinka and Castro (2003) also show a positive trend in its frequency during an extended summer period (April to September). These results are consistent with recent studies indicating an upward trend in the frequency of upwelling in SW Iberia (Alves and Miranda 2013), and may be relevant for climate change applications as an increase in coastal upwelling (Miranda et al 2013) may lead to substantial regional impacts in the subtropics. The same analysis with ERA-Interim reanalysis data, which was used to force the WRF simulations, does not reveal the same signal in PWV, and indeed correlates poorly with the GPS observations, indicating that the data assimilation process makes the water vapour data in reanalysis unusable for climate change purposes. The good correlation between the WRF simulated data and GPS observations allow for a detailed analysis of the processes involved in the evolution of the PWV field. Akcnowledgements: Study done within FCT Grant RECI/GEO-MET/0380/2012, financially supported by FCT Grant UID/ GEO/50019/2013-IDL Alves JMR, Miranda PMA (2013) Variability of Iberian upwelling implied by ERA-40 and ERA-Interim reanalyses, Tellus A 2013, http://dx.doi.org/10.3402/tellusa.v65i0.19245. Bakun et al (2010) Greenhouse gas, upwelling-favorable winds, and the future of coastal ocean upwelling ecosystems, Global Change Biology, doi: 10.1111/j.1365-2486.2009.02094.x Hoinka KP, Castro M (2003) The Iberian Peninsula thermal low. QJRMS, 129, 1491- 1511, doi: 10.1256/qj.01.189. Miranda et al (2013) Climate change and upwelling: response of Iberian upwelling to atmospheric forcing in a regional climate scenario. Climate Dynamics, doi: 10.1007/s00382-012-1442-9.
1983-09-01
AD-Ali33 592 ARTIFICIAL INTELLIGENCE: AN ANALYSIS OF POTENTIAL 1/1 APPLICATIONS TO TRAININ..(U) DENVER RESEARCH INST CO JRICHARDSON SEP 83 AFHRL-TP...83-28 b ’ 3 - 4. TITLE (aied Suhkie) 5. TYPE OF REPORT & PERIOD COVERED ARTIFICIAL INTEL11GENCE: AN ANALYSIS OF Interim POTENTIAL APPLICATIONS TO...8217 sde if neceseamy end ides*f by black naumber) artificial intelligence military research * computer-aided diagnosis performance tests computer
South Asia river flow projections and their implications for water resources
NASA Astrophysics Data System (ADS)
Mathison, C.; Wiltshire, A. J.; Falloon, P.; Challinor, A. J.
2015-06-01
South Asia is a region with a large and rising population and a high dependance on industries sensitive to water resource such as agriculture. The climate is hugely variable with the region relying on both the Asian Summer Monsoon (ASM) and glaciers for its supply of fresh water. In recent years, changes in the ASM, fears over the rapid retreat of glaciers and the increasing demand for water resources for domestic and industrial use, have caused concern over the reliability of water resources both in the present day and future for this region. The climate of South Asia means it is one of the most irrigated agricultural regions in the world, therefore pressures on water resource affecting the availability of water for irrigation could adversely affect crop yields and therefore food production. In this paper we present the first 25 km resolution regional climate projections of river flow for the South Asia region. ERA-Interim, together with two global climate models (GCMs), which represent the present day processes, particularly the monsoon, reasonably well are downscaled using a regional climate model (RCM) for the periods; 1990-2006 for ERA-Interim and 1960-2100 for the two GCMs. The RCM river flow is routed using a river-routing model to allow analysis of present day and future river flows through comparison with river gauge observations, where available. In this analysis we compare the river flow rate for 12 gauges selected to represent the largest river basins for this region; Ganges, Indus and Brahmaputra basins and characterize the changing conditions from east to west across the Himalayan arc. Observations of precipitation and runoff in this region have large or unknown uncertainties, are short in length or are outside the simulation period, hindering model development and validation designed to improve understanding of the water cycle for this region. In the absence of robust observations for South Asia, a downscaled ERA-Interim RCM simulation provides a benchmark for comparison against the downscaled GCMs. On the basis that these simulations are among the highest resolution climate simulations available we examine how useful they are for understanding the changes in water resources for the South Asia region. In general the downscaled GCMs capture the seasonality of the river flows, with timing of maximum river flows broadly matching the available observations and the downscaled ERA-Interim simulation. Typically the RCM simulations over-estimate the maximum river flows compared to the observations probably due to a positive rainfall bias and a lack of abstraction in the model although comparison with the downscaled ERA-Interim simulation is more mixed with only a couple of the gauges showing a bias compared with the downscaled GCM runs. The simulations suggest an increasing trend in annual mean river flows for some of the river gauges in this analysis, in some cases almost doubling by the end of the century; this trend is generally masked by the large annual variability of river flows for this region. The future seasonality of river flows does not change with the future maximum river flow rates still occuring during the ASM period, with a magnitude in some cases, greater than the present day natural variability. Increases in river flow during peak flow periods means additional water resource for irrigation, the largest usage of water in this region, but also has implications in terms of inundation risk. Low flow rates also increase which is likely to be important at times of the year when water is historically more scarce. However these projected increases in resource from rivers could be more than countered by changes in demand due to reductions in the quantity and quality of water available from groundwater, increases in domestic use due to a rising population or expansion of other industries such as hydro-electric power generation.
SWSA 6 interim corrective measures environmental monitoring: FY 1991 results
DOE Office of Scientific and Technical Information (OSTI.GOV)
Clapp, R.B.; Marshall, D.S.
1992-06-01
In 1988, interim corrective measures (ICMs) were implemented at Solid Waste Storage Area (SWSA) 6 at Oak Ridge National Laboratory. The SWSA 6 site was regulated under the Resource Conservation and Recovery Act (RCRA). The ICMs consist of eight large high-density polyethylene sheets placed as temporary caps to cover trenches known to contain RCRA-regulated materials. Environmental monitoring for FY 1991 consisted of collecting water levels at 13 groundwater wells outside the capped areas and 44 wells in or near the capped areas in order to identify any significant loss of hydrologic isolation of the wastes. Past annual reports show thatmore » the caps are only partially effective in keeping the waste trenches dry and that many trenches consistently or intermittently contain water.« less
DOE Office of Scientific and Technical Information (OSTI.GOV)
Clapp, R.B.; Marshall, D.S.
1992-06-01
In 1988, interim corrective measures (ICMs) were implemented at Solid Waste Storage Area (SWSA) 6 at Oak Ridge National Laboratory. The SWSA 6 site was regulated under the Resource Conservation and Recovery Act (RCRA). The ICMs consist of eight large high-density polyethylene sheets placed as temporary caps to cover trenches known to contain RCRA-regulated materials. Environmental monitoring for FY 1991 consisted of collecting water levels at 13 groundwater wells outside the capped areas and 44 wells in or near the capped areas in order to identify any significant loss of hydrologic isolation of the wastes. Past annual reports show thatmore » the caps are only partially effective in keeping the waste trenches dry and that many trenches consistently or intermittently contain water.« less
1982-05-07
The State of Florida has applied for interim Authorization Phase I. EPA has reviewed Florida's application for Phase I and has determined that Florida's hazardous waste program is substantially equivalent to the Federal program covered by Phase I. The State of Florida is, hereby, granted Interim Authorization for Phase I to operate the State 's hazardous waste program, in lieu of the Federal program.
The Archaeology of Coralville Lake, Iowa. Volume 4. Recreation Area Survey. (Interim Report 2).
1985-09-01
THE ARCHAEOLOGY OF CORALVILLE LAKE, IOWA VOLUME IV: RECREATION AREA SURVEY (INTERIM REPORT II) p - [ JAN 1 4 1986 WAUWATOSA. WISCONSIN 86 1.13 117...THE ARCHAEOLOGY OF CORALVILLE LAKE, IOWA ; VOLUME IV: RECREATION AREA SURVEY (INTERIM REPORT II) Submitted To: Rock Island District Corps of Engineers...presents the results of intensive archaeological and geomorphic investigations at 14 special use or recreation areas at Coralville Lake, Iowa . The
2005-03-25
This interim final rule with comment period adopts the substance of the April 15, 2004 temporary interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment will allow certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This interim final rule with comment period also requires that nursing facilities install smoke detectors in resident rooms and public areas if they do not have a sprinkler system installed throughout the facility or a hard-wired smoke detection system in those areas.
Job Analysis of the Medical Service Career Field. Interim Report. August 1, 1972-June 1, 1973.
ERIC Educational Resources Information Center
McFarland, Barry P.
The purpose of this study was to complete a job analysis of the Air Force's Medical Service Career Field. This is the first in a series of reports designed to compare and make recommendations concerning the role of the Nurse and Medical Corpsman in the Air Force's health care delivery system. A sample of 1,996 airmen in the Medical Service Career…
NASA Astrophysics Data System (ADS)
Gruzdev, A. N.
2017-07-01
Using the data of the ERA-Interim reanalysis, we have obtained estimates of changes in temperature, the geopotential and its large-scale zonal harmonics, wind velocity, and potential vorticity in the troposphere and stratosphere of the Northern and Southern hemispheres during the 11-year solar cycle. The estimates have been obtained using the method of multiple linear regression. Specific features of response of the indicated atmospheric parameters to the solar cycle have been revealed in particular regions of the atmosphere for a whole year and depending on the season. The results of the analysis indicate the existence of a reliable statistical relationship of large-scale dynamic and thermodynamic processes in the troposphere and stratosphere with the 11-year solar cycle.
NASA Astrophysics Data System (ADS)
José González-Rojí, Santos; Sáenz, Jon; Ibarra-Berastegi, Gabriel
2017-04-01
GLEAM dataset was presented a few years ago and since that moment, it has just been used for validation of evaporation in a few places of the world (Australia and Africa). The Iberian Peninsula is composed of different soil types and it is affected by different weather regimes, with different climate regions. It is this feature which makes it a very interesting zone for the study of the meteorological cycle, including evaporation. For that purpose, a numerical downscaling exercise over the Iberian Peninsula was run nesting the WRF model inside ERA Interim. Two model configurations were tested in two experiments spanning the period 2010-2014 after a one-year spin-up (2009). In the first experiment (N), boundary conditions drive the model. The second experiment (D) is configured the same way as the N case, but 3DVAR data assimilation is run every six hours (00Z, 06Z, 12Z and 18Z) using observations obtained from the PREPBUFR dataset. For both N and D runs and ERA Interim, the evaporation of the model runs was compared to GLEAM v3.0b and v3.0c datasets over the Iberian Peninsula, both at the daily and monthly time scales. GLEAM v3.0a was not used for validation as it uses for forcing radiation and air temperature data from ERA Interim. Results show that the experiment with data assimilation (D) improve the results obtained for N experiment. Moreover, correlations values are comparable to the ones obtained with ERA Interim. However, some negative correlation values are observed at Portuguese and Mediterranean coasts for both WRF runs. All of these problematic points are considered as urban sites by the NOAH land surface model. Because of that, the model is not able to simulate a correct evaporation value. Even with these discrepancies, better results than for ERA Interim are observed for seasonal Biases and daily RMSEs over Iberian Peninsula, obtaining the best values inland. Minimal differences are observed for the two GLEAM datasets selected.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-20
... States-Panama Trade Promotion Agreement Implementation Act (the ``Act'') [Pub. L. 112-43] implements the... Promotion Agreement (the ``Agreement''). This safeguard mechanism applies when, as a result of the...) all data available to the requestor showing changes in productivity, utilization of capacity...
DOT National Transportation Integrated Search
1984-01-01
Results of usual tests for specification compliance and special tests to show viscosity-temperature susceptibility and ductility penetration relationships for asphalts supplied for use by the Virginia Department of Highways and Transportation in 1983...
Comparison of measured and calculated dynamic loads for the Mod-2 2.5 mW wind turbine system
NASA Technical Reports Server (NTRS)
Zimmerman, D. K.; Shipley, S. A.; Miller, R. D.
1995-01-01
The Boeing Company, under contract to the Electric Power Research Institute (EPRI), has completed a test program on the Mod-2 wind turbines at Goodnoe Hills, Washington. The objectives were to update fatigue load spectra, discern site and machine differences, measure vortex generator effects, and to evaluate rotational sampling techniques. This paper shows the test setup and loads instrumentation, loads data comparisons and test/analysis correlations. Test data are correlated with DYLOSAT predictions using both the NASA interim turbulence model and rotationally sampled winds as inputs. The latter is demonstrated to have the potential to improve the test/analysis correlations. The paper concludes with an assessment of the importance of vortex generators, site dependence, and machine differences on fatigue loads. The adequacy of prediction techniques used are evaluated and recommendations are made for improvements to the methodology.
Pressure sores following elective total hip arthroplasty: pitfalls of misinterpretation.
Keong, Nicole; Ricketts, David; Alakeson, Nuki; Rust, Philippa
2004-01-01
OBJECTIVE: To assess the reliability of reporting protocols regarding pressure sores. METHODS: Retrospective data were collected regarding pressure sore rates following total hip arthroplasty operations carried out during 2001 at two orthopaedic units in an NHS hospital (Princess Royal Hospital) and in a local private hospital. RESULTS: Preliminary results presented in audit and interim reports indicated an alarmingly high pressure sore rate across the two sites (17/172 [9.9%] NHS, 23/71 [32.4%] private hospital). On analysis, the data collection system was revealed to be flawed. Grade 1 areas (erythema with no ulceration) were included, leading to a dramatic discrepancy between reported and confirmed pressure sores. Re-analysis showed the confirmed pressure sore rates to be much lower (2.3% NHS, 1.0% private hospital). CONCLUSIONS: This audit suggests that both poor data collection and education lead to inaccurate audit. This may lead to subsequent inappropriate management and inappropriate NHS star ratings. PMID:15140301
DOE Office of Scientific and Technical Information (OSTI.GOV)
Bush, David A., E-mail: dbush@llu.edu; Smith, Jason C.; Slater, Jerry D.
2016-05-01
Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractionsmore » over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are significantly fewer hospitalization days after proton treatment, which may indicate reduced toxicity with proton beam therapy.« less
Minamimoto, Ryogo; Fayad, Luis; Advani, Ranjana; Vose, Julie; Macapinlac, Homer; Meza, Jane; Hankins, Jordan; Mottaghy, Felix; Juweid, Malik
2016-01-01
Purpose To compare the performance characteristics of interim fluorine 18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) (after two cycles of chemotherapy) by using the most prominent standardized interpretive criteria (including International Harmonization Project [IHP] criteria, European Organization for Research and Treatment of Cancer [EORTC] criteria, and PET Response Criteria in Solid Tumors (PERCIST) versus those of interim 18F fluorothymidine (FLT) PET/CT and simple visual interpretation. Materials and Methods This HIPAA-compliant prospective study was approved by the institutional review boards, and written informed consent was obtained. Patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) underwent both FLT and FDG PET/CT 18–24 days after two cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone or rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin. For FDG PET/CT interpretation, IHP criteria, EORTC criteria, PERCIST, Deauville criteria, standardized uptake value, total lesion glycolysis, and metabolic tumor volume were used. FLT PET/CT images were interpreted with visual assessment by two reviewers in consensus. The interim (after cycle 2) FDG and FLT PET/CT studies were then compared with the end-of-treatment FDG PET/CT studies to determine which interim examination and/or criteria best predicted the result after six cycles of chemotherapy. Results From November 2011 to May 2014, there were 60 potential patients for inclusion, of whom 46 patients (24 men [mean age, 60.9 years ± 13.7; range, 28–78 years] and 22 women [mean age, 57.2 years ± 13.4; range, 25–76 years]) fulfilled the criteria. Thirty-four patients had complete response, and 12 had residual disease at the end of treatment. FLT PET/CT had a significantly higher positive predictive value (PPV) (91%) in predicting residual disease than did any FDG PET/CT interpretation method (42%–46%). No difference in negative predictive value (NPV) was found between FLT PET/CT (94%) and FDG PET/CT (82%–95%), regardless of the interpretive criteria used. FLT PET/CT showed statistically higher (P < .001–.008) or similar NPVs than did FDG PET/CT. Conclusion Early interim FLT PET/CT had a significantly higher PPV than standardized FDG PET/CT–based interpretation for therapeutic response assessment in DLBCL. © RSNA, 2016 Online supplemental material is available for this article. PMID:26854705
FY2017 Defense Spending Under an Interim Continuing Resolution (CR): In Brief
2016-09-16
rated based on the fraction of a year for which the interim CR is in effect . In recent fiscal years, the referenced funding level on which interim or...of the Federal Government: Causes, Processes, and Effects , coordinated by Clinton T. Brass. 8 Typically, such funding is specified as an annualized...congressional consideration of a CR to fund the federal government through the opening months of the fiscal year is widely anticipated. This report
Fenton, A H
1976-07-01
The construction of an interim overdenture using existing removable partial dentures with natural tooth crowns and artificial teeth can be a simple and economical method of providing patients with dentures while tissues heal and teeth are prepared and restored. A more definite prognosis for both the patient and his remaining dentition can be established before the final overdenture is completed. The procedures necessary to provide three types of interim overdentures have been outlined. Patients tolerate this method of changing their dentitions extremely well.
Emery, Robert J
2012-11-01
Faced with the prospect of being unable to permanently dispose of low-level radioactive wastes (LLRW) generated from teaching, research, and patient care activities, component institutions of the University of Texas System worked collaboratively to create a dedicated interim storage facility to be used until a permanent disposal facility became available. Located in a remote section of West Texas, the University of Texas System Interim Storage Facility (UTSISF) was licensed and put into operation in 1993, and since then has provided safe and secure interim storage for up to 350 drums of dry solid LLRW at any given time. Interim storage capability provided needed relief to component institutions, whose on-site waste facilities could have possibly become overburdened. Experiences gained from the licensing and operation of the site are described, and as a new permanent LLRW disposal facility emerges in Texas, a potential new role for the storage facility as a surge capacity storage site in times of natural disasters and emergencies is also discussed.
CMM Interim Check Design of Experiments (U)
DOE Office of Scientific and Technical Information (OSTI.GOV)
Montano, Joshua Daniel
2015-07-29
Coordinate Measuring Machines (CMM) are widely used in industry, throughout the Nuclear Weapons Complex and at Los Alamos National Laboratory (LANL) to verify part conformance to design definition. Calibration cycles for CMMs at LANL are predominantly one year in length and include a weekly interim check to reduce risk. The CMM interim check makes use of Renishaw’s Machine Checking Gauge which is an off-the-shelf product simulates a large sphere within a CMM’s measurement volume and allows for error estimation. As verification on the interim check process a design of experiments investigation was proposed to test a couple of key factorsmore » (location and inspector). The results from the two-factor factorial experiment proved that location influenced results more than the inspector or interaction.« less
Planning applications in image analysis
NASA Technical Reports Server (NTRS)
Boddy, Mark; White, Jim; Goldman, Robert; Short, Nick, Jr.
1994-01-01
We describe two interim results from an ongoing effort to automate the acquisition, analysis, archiving, and distribution of satellite earth science data. Both results are applications of Artificial Intelligence planning research to the automatic generation of processing steps for image analysis tasks. First, we have constructed a linear conditional planner (CPed), used to generate conditional processing plans. Second, we have extended an existing hierarchical planning system to make use of durations, resources, and deadlines, thus supporting the automatic generation of processing steps in time and resource-constrained environments.
On the Statistical Analysis of the Radar Signature of the MQM-34D
1975-01-31
target drone for aspect angles near normal to the roll axis for a vertically polarized measurements system. The radar cross section and glint are... drone . The raw data from RATSCAT are reported in graphical form in an AFSWC three-volume report.. The results reported here are a statistical analysis of...Ta1get Drones , AFSWC-rR.74-0l, January 1974. 2James W. Wright, On the Statistical Analysis of the Radar Signature of the MQM-34D, Interim Report
Midcycle survey of Mississippi's forest resources
Charles E. Thomas; William H. McWilliams
1985-01-01
To provide current forest resource data, the Forest Inventory and Analysis Unit of the U.S. Forest Service Southern Forest Experiment Station has conducted interim surveys within the regular 10-year survey cycles. This report summarizes the findings of a midcycle survey of Mississippi forest resources. Field work for the survey was completed in 1983....
The Responsiveness of Public Schools to Their Clientele. Milestone 1: Report of Progress.
ERIC Educational Resources Information Center
Zeigler, L. Harmon; And Others
An analysis of the literature dealing with the responsiveness of public institutions to their clientele constitutes the main body of this interim project report. The analysts adopted Dahl and Lindblom's classification of political decision-making processes for summarizing the range of governing systems possible in public education. These four…
Federal Programs Supporting Educational Change, Vol. 2: Factors Affecting Change Agent Projects.
ERIC Educational Resources Information Center
Berman, Paul; Pauly, Edward W.
This second volume in the change-agent series reports the interim results of an exploratory statistical analysis of a survey of a nationwide sample of 293 change-agent projects funded by four federal demonstration programs--Elementary Secondary Education Act (ESEA) Title III, Innovative Projects; ESEA Title VII, Bilingual Projects; Vocational…
76 FR 9213 - Small Business Jobs Act: 504 Loan Program Debt Refinancing
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-17
... negative impact on the availability of financing for small businesses. SBA finds that good cause exists to... 27, 2012 and would have less impact if delayed until notice and comment rulemaking could be completed... requiring Regulatory Impact Analysis as set forth below. A. Regulatory Objective of the Interim Final Rule...
ERIC Educational Resources Information Center
Jung, Steven M.; And Others
Survey activities are reported which were designed to provide the foundation for a national evaluation of the effectiveness of programs assisted under the Career Education Incentive Act of 1977 (PL 95-207). The methodology described, called "program evaluability assessment," focuses on detailed analysis of program assumptions in order to…
The Costs and Benefits of High Speed Vessels Relative to Traditional C-17 Military Airlift
2003-12-01
37 APPENDIX D SWOT Analysis...Port Action Officers Group IBCT Interim Brigade Combat Team LCS Littoral Combat Ship LST Landing ship tank LSV Logistics Support Vessel... SWOT Strength Weakness Opportunity Threat TACOM Tank and Automotive Command TSV Theater Support Vessel USS United States Ship USTRANSCOM
Why Did Principals and Teachers Respond Differently to Curriculum Reform?
ERIC Educational Resources Information Center
Ng, Shun Wing
2009-01-01
This article presents the finding of an interim evaluation survey commissioned by the Education Bureau of Hong Kong on the effectiveness of the curriculum reform initiated in 2001. Drawing upon change theories for analysis of the study, the article examines the perceptions of both principals and teachers on the effectiveness of short-term…
FY 1987 current fiscal year work plan
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
This Current Year Work Plan presents a detailed description of the activities to be performed by the Joint Integration Office during FY87. It breaks down the activities into two major work areas: Program Management and Program Analysis. Program Management is performed by the JIO by providing technical planning and guidance for the development of advanced TRU waste management capabilities. This includes equipment/facility design, engineering, construction, and operations. These functions are integrated to allow transition from interim storage to final disposition. JIO tasks include program requirements identification, long-range technical planning, budget development, program planning document preparation, task guidance, task monitoring, informationmore » gathering and task reporting to DOE, interfacing with other agencies and DOE lead programs, integrating public involvement with program efforts, and preparation of program status reports for DOE. Program Analysis is performed by the JIO to support identification and assessment of alternatives, and development of long-term TRU waste program capabilities. This work plan includes: system analyses, requirements analyses, interim and procedure development, legislative and regulatory analyses, dispatch and traffic analyses, and data bases.« less
Immunotherapy for recurrent malignant glioma: an interim report on survival.
Ingram, M; Buckwalter, J G; Jacques, D B; Freshwater, D B; Abts, R M; Techy, G B; Miyagi, K; Shelden, C H; Rand, R W; English, L W
1990-12-01
We present interim survival data for a group of 83 adult patients with recurrent malignant glioma treated by implanting stimulated autologous lymphocytes into the tumour bed following surgical debulking. The patients were treated 6 months or more prior to data analysis. Fifty-nine patients were male and 24 female. The mean age for the entire group was 48.4 years and the mean Karnofsky rating (KR) was 67.2. Eight of the patients had grade II tumours, 33 had grade III tumours and 42 had grade IV tumours. Statistical analysis focuses on tumour grade, KR and patient age, factors that have been shown to affect survival in previous studies. Multifactorial analyses are employed to identify interrelationships among factors related to survival. Seven patients (8%) did not respond to immunotherapy, 76 (92%) had a good initial response. Twenty-five patients (30.1%) are living and 18 (22%) have shown no evidence of recurrence. Results are evaluated in the light of those obtained in trials of other experimental therapies for recurrent malignant gliomas. It is concluded that the present protocol offers a safe and comparatively effective treatment option.
Kikui, Miki; Kokubo, Yoshihiro; Ono, Takahiro; Kida, Momoyo; Kosaka, Takayuki; Yamamoto, Masaaki; Watanabe, Makoto; Maeda, Yoshinobu; Miyamoto, Yoshihiro
2017-05-01
A positive association between metabolic syndrome (MetS) and periodontal status has recently been noted. However, no study has evaluated the relationship by sex and in a general urban population using the uniform definition proposed in the 2009 Joint Interim Statement. The aim of this study was to clarify the relationship between MetS and periodontal status using the uniform definition in a general urban Japanese population. A total of 1,856 Japanese men and women (mean age: 66.4 years) were studied using data from the Suita study. Periodontal status was evaluated by the Community Periodontal Index (CPI). MetS was defined using the 2009 Joint Interim Statement. The associations of the MetS and its components with periodontal disease were investigated using multiple logistic regression analysis adjusting for age, drinking, and smoking. Among the components of the MetS, low HDL cholesterol level was significantly associated with periodontal disease in men and women [odds ratios (OR)=2.39 and 1.53; 95% confidence intervals=1.36-4.19 and 1.06-2.19]. Furthermore, the risk of periodontal disease showed 1.43-, 1.42-, and 1.89-fold increases in those with 2, 3, and ≥4 components, respectively, compared with those having no components (P trend <0.001). For the analysis by sex, the risk of periodontal disease was increased 2.27- and 1.76-fold in those with ≥4 components in men and women, respectively (both P trend =0.001). These findings suggest that MetS and lower HDL cholesterol are associated with periodontal disease. Subjects with two or more MetS components had a significantly higher prevalence of periodontal disease.
Kikui, Miki; Kokubo, Yoshihiro; Kida, Momoyo; Kosaka, Takayuki; Yamamoto, Masaaki; Watanabe, Makoto; Maeda, Yoshinobu; Miyamoto, Yoshihiro
2017-01-01
Aim: A positive association between metabolic syndrome (MetS) and periodontal status has recently been noted. However, no study has evaluated the relationship by sex and in a general urban population using the uniform definition proposed in the 2009 Joint Interim Statement. The aim of this study was to clarify the relationship between MetS and periodontal status using the uniform definition in a general urban Japanese population. Methods: A total of 1,856 Japanese men and women (mean age: 66.4 years) were studied using data from the Suita study. Periodontal status was evaluated by the Community Periodontal Index (CPI). MetS was defined using the 2009 Joint Interim Statement. The associations of the MetS and its components with periodontal disease were investigated using multiple logistic regression analysis adjusting for age, drinking, and smoking. Results: Among the components of the MetS, low HDL cholesterol level was significantly associated with periodontal disease in men and women [odds ratios (OR) = 2.39 and 1.53; 95% confidence intervals = 1.36–4.19 and 1.06–2.19]. Furthermore, the risk of periodontal disease showed 1.43-, 1.42-, and 1.89-fold increases in those with 2, 3, and ≥ 4 components, respectively, compared with those having no components (Ptrend < 0.001). For the analysis by sex, the risk of periodontal disease was increased 2.27- and 1.76-fold in those with ≥ 4 components in men and women, respectively (both Ptrend = 0.001). Conclusion: These findings suggest that MetS and lower HDL cholesterol are associated with periodontal disease. Subjects with two or more MetS components had a significantly higher prevalence of periodontal disease. PMID:27725400
Kolinski, Martin; Hess, Pablo; Leziy, Sonia; Friberg, Bertil; Bellucci, Gionata; Trisciuoglio, Davide; Wagner, Wilfried; Moergel, Maximilian; Pozzi, Alessandro; Wiltfang, Jörg; Behrens, Eleonore; Zechner, Werner; Vasak, Christoph; Weigl, Paul
2018-07-01
The aim of this interim analysis of a 5-year prospective multicenter study is to evaluate clinical and radiological performance of immediately provisionalized 3.0-mm-diameter tapered implants. Patients needing implant rehabilitation of maxillary lateral incisors or mandibular lateral and central incisors were treated with 3.0-mm-diameter implants placed in extraction or healed sites and immediately provisionalized. Clinical and radiographic examinations were performed at implant insertion, 6 months thereafter, and are ongoing. Marginal bone levels and changes, complications, the papilla, plaque, and bleeding indices, and the pink esthetic score (PES) were evaluated at each follow-up visit. Of 112 enrolled patients, 77 patients (91 implants) met the inclusion criteria. Seventy-one patients with 82 implants completed the 1-year follow-up. Three implants failed yielding a CSR of 96.7%. All failures occurred within the first 3 months after implant insertion. Marginal bone level changes from insertion to 6 months was - 0.57 ± 1.30 mm (n = 75) and from insertion to 12 months - 0.25 ± 1.38 mm (n = 72). Fifteen non-serious complications were recorded. Papilla index score and PES improved at the 1-year follow-up. Plaque formation and bleeding-on-probing showed no statistically significant differences between the 6-month and the 1-year visit. This 1-year analysis demonstrated high survival, stable bone levels, and healthy soft tissue with 3.0-mm-diameter implants. Narrow diameter implants are a safe and predictable treatment option in patients with limited bone volume and/or limited interdental space and eligible for immediate loading protocols.
The high-resolution regional reanalysis COSMO-REA6
NASA Astrophysics Data System (ADS)
Ohlwein, C.
2016-12-01
Reanalyses gain more and more importance as a source of meteorological information for many purposes and applications. Several global reanalyses projects (e.g., ERA, MERRA, CSFR, JMA9) produce and verify these data sets to provide time series as long as possible combined with a high data quality. Due to a spatial resolution down to 50-70km and 3-hourly temporal output, they are not suitable for small scale problems (e.g., regional climate assessment, meso-scale NWP verification, input for subsequent models such as river runoff simulations). The implementation of regional reanalyses based on a limited area model along with a data assimilation scheme is able to generate reanalysis data sets with high spatio-temporal resolution. Within the Hans-Ertel-Centre for Weather Research (HErZ), the climate monitoring branch concentrates efforts on the assessment and analysis of regional climate in Germany and Europe. In joint cooperation with DWD (German Meteorological Service), a high-resolution reanalysis system based on the COSMO model has been developed. The regional reanalysis for Europe matches the domain of the CORDEX EURO-11 specifications, albeit at a higher spatial resolution, i.e., 0.055° (6km) instead of 0.11° (12km) and comprises the assimilation of observational data using the existing nudging scheme of COSMO complemented by a special soil moisture analysis with boundary conditions provided by ERA-Interim data. The reanalysis data set covers the past 20 years. Extensive evaluation of the reanalysis is performed using independent observations with special emphasis on precipitation and high-impact weather situations indicating a better representation of small scale variability. Further, the evaluation shows an added value of the regional reanalysis with respect to the forcing ERA Interim reanalysis and compared to a pure high-resolution dynamical downscaling approach without data assimilation.
A high-resolution regional reanalysis for Europe
NASA Astrophysics Data System (ADS)
Ohlwein, C.
2015-12-01
Reanalyses gain more and more importance as a source of meteorological information for many purposes and applications. Several global reanalyses projects (e.g., ERA, MERRA, CSFR, JMA9) produce and verify these data sets to provide time series as long as possible combined with a high data quality. Due to a spatial resolution down to 50-70km and 3-hourly temporal output, they are not suitable for small scale problems (e.g., regional climate assessment, meso-scale NWP verification, input for subsequent models such as river runoff simulations). The implementation of regional reanalyses based on a limited area model along with a data assimilation scheme is able to generate reanalysis data sets with high spatio-temporal resolution. Within the Hans-Ertel-Centre for Weather Research (HErZ), the climate monitoring branch concentrates efforts on the assessment and analysis of regional climate in Germany and Europe. In joint cooperation with DWD (German Meteorological Service), a high-resolution reanalysis system based on the COSMO model has been developed. The regional reanalysis for Europe matches the domain of the CORDEX EURO-11 specifications, albeit at a higher spatial resolution, i.e., 0.055° (6km) instead of 0.11° (12km) and comprises the assimilation of observational data using the existing nudging scheme of COSMO complemented by a special soil moisture analysis with boundary conditions provided by ERA-Interim data. The reanalysis data set covers the past 20 years. Extensive evaluation of the reanalysis is performed using independent observations with special emphasis on precipitation and high-impact weather situations indicating a better representation of small scale variability. Further, the evaluation shows an added value of the regional reanalysis with respect to the forcing ERA Interim reanalysis and compared to a pure high-resolution dynamical downscaling approach without data assimilation.
Rolling out of kangaroo mother care in secondary level facilities in Bihar-Some experiences.
Neogi, Sutapa B; Chauhan, Monika; Sharma, Jyoti; Negandhi, Preeti; Sethy, Ghanshyam
2016-01-01
Preterm birth is one of the leading causes of under-five child deaths worldwide and in India. Kangaroo mother care (KMC) is a powerful and easy-to-use method to promote health and well-being and reduce morbidity and mortality in preterm/low birth weight (LBW) babies. As the part of the roll-out of India Newborn Action Plan interventions, we implemented KMC in select facilities with an objective to assess the responsiveness of public health system to roll out KMC. KMC intervention was implemented in two select high priority districts, Gaya and Purnea in Bihar over the duration of 8 months from August 2015 to March 2016. The implementation of intervention was phased out into; situation analysis, implementation of intervention, and interim assessment. KMC model, as envisaged keeping in mind the building blocks of health system, was established in 6 identified health-care facilities. A pretested simple checklist was used to assess the awareness, knowledge, skills, and practice of KMC during baseline situational analysis and interim assessment phases for comparison. The intervention clearly seemed to improve the awareness among auxiliary nurse midwives/nurses about KMC. Improvements were also observed in the availability of infrastructure required for KMC and support logistics like facility for manual expression of breast milk, cups/suitable devices such as paladi cups for feeding small babies and digital weighing scale. Although the recording of information regarding LBW babies and KMC practice improved, still there is scope for much improvement. There is a commitment at the national level to promote KMC in every facility. The present experience shows the possibility of rolling out KMC in secondary level facilities with support from government functionaries.
Third year interim report on experimental utilization of tire shreds to enhance highway drainage.
DOT National Transportation Integrated Search
2003-04-01
In the summer of 2000 shredded tires were used in an experimental project on a full highway : reconstruction project in the town of Rome. Shredded tires were used to construct a subgrade drain in the : ditch profile. The picture at right shows the co...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-26
... Promotion Agreement (``U.S.-Colombia TPA''). Title III, Subtitle B, Section 321 through Section 328 of the United States-Colombia Trade Promotion Agreement Implementation Act (``Implementation Act'') [Pub. L. 112... requester showing changes in productivity, utilization of capacity, inventories, exports, wages, employment...
Implementation of EPA criminal enforcement strategy for RCRA interim status facilities
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1985-11-15
The directive discusses criminal enforcement priorities and procedures related to the RCRA section 3007(e)(2) Loss of Interim Status (LOIS) provision, including: (1) identifying/targeting facilities with violations, (2) verifying receipt of RCRA 3007 letters, and (3) inspections of facilities. The directive supplements directive no. 9930.0-1 RCRA LOIS Enforcement Strategy, dated October 15, 1985. The directive is supplemented by directive no. 9930.0-2a, Accepting Nonhazardous Waste After Losing Interim Status, dated December 20, 1986.
2009-04-06
The Ryan Haight Online Pharmacy Consumer Protection Act, which was enacted on October 15, 2008, amended the Controlled Substances Act and Controlled Substances Import and Export Act by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. DEA is hereby issuing an interim rule to amend its regulations to implement the legislation and is requesting comments on the interim rule.
French Interim MALE UAV Program
2003-09-02
MINISTÈRE DE LA DÉFENSE June, 13th 2002 Lcl Monsterleet FAF Staff J. Caron EADS S&DE-ISR FRENCH INTERIM MALE UAV PROGRAM 4 INDUSTRIAL STATUS Report...2003 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE French Interim Male UAV Program 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c...PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) EADS
DOE Office of Scientific and Technical Information (OSTI.GOV)
Carlson, T.A., Fluor Daniel Hanford
1997-02-06
The Immobilized Low-Activity Waste Interim Storage subproject will provide storage capacity for immobilized low-activity waste product sold to the U.S. Department of Energy by the privatization contractor. This statement of work describes the work scope (encompassing definition of new installations and retrofit modifications to four existing grout vaults), to be performed by the Architect-Engineer, in preparation of a conceptual design for the Immobilized Low-Activity Waste Interim Storage Facility.
22 CFR 127.8 - Interim suspension.
Code of Federal Regulations, 2010 CFR
2010-04-01
... world peace or the security or foreign policy of the United States. The interim suspension orders... Trade Controls will issue an appropriate order disposing of the motion or petition and will promptly...
Lanthanum carbonate: safety data after 10 years.
Hutchison, Alastair J; Wilson, Rosamund J; Garafola, Svetlana; Copley, John Brian
2016-12-01
Despite 10 years of post-marketing safety monitoring of the phosphate binder lanthanum carbonate, concerns about aluminium-like accumulation and toxicity persist. Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5-year observational database study (SPD405-404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminated via the hepatobiliary pathway, whereas aluminium shows appreciable absorption and is eliminated by the kidneys. Randomised prospective studies of paired bone biopsies revealed no evidence of accumulation or toxicity in patients treated with lanthanum carbonate. Patients treated with lanthanum carbonate for up to 6 years showed no clinically relevant changes in liver enzyme or bilirubin levels. Lanthanum does not cross the intact blood-brain barrier. The most common adverse effects are mild/moderate nausea, diarrhoea and flatulence. An interim Kaplan-Meier analysis of SPD405-404 data from the United States Renal Data System revealed that the median 5-year survival was 51.6 months (95% CI: 49.1, 54.2) in patients who received lanthanum carbonate (test group), 48.9 months (95% CI: 47.3, 50.5) in patients treated with other phosphate binders (concomitant therapy control group) and 40.3 months (95% CI: 38.9, 41.5) in patients before the availability of lanthanum carbonate (historical control group). Bone fracture rates were 5.9%, 6.7% and 6.4%, respectively. After more than 850 000 person-years of worldwide patient exposure, there is no evidence that lanthanum carbonate is associated with adverse safety outcomes in patients with end-stage renal disease. © 2016 Shire Development LLC. Nephrology published by John Wiley & Sons Australia, Ltd on behalf of Asian Pacific Society of Nephrology.
NASA Astrophysics Data System (ADS)
Song, Xiangzhou; Yu, Lisan
2017-05-01
This study provides an analysis of the Mediterranean Sea surface energy budget using nine surface heat flux climatologies. The ensemble mean estimation shows that the net downward shortwave radiation (192 ± 19 W m-2) is balanced by latent heat flux (-98 ± 10 W m-2), followed by net longwave radiation (-78 ± 13 W m-2) and sensible heat flux (-13 ± 4 W m-2). The resulting net heat budget (Qnet) is 2 ± 12 W m-2 into the ocean, which appears to be warm biased. The annual-mean Qnet should be -5.6 ± 1.6 W m-2 when estimated from the observed net transport through the Strait of Gibraltar. To diagnose the uncertainty in nine Qnet climatologies, we constructed Qnet from the heat budget equation by using historic hydrological observations to determine the heat content changes and advective heat flux. We also used the Qnet from a data-assimilated global ocean state estimation as an additional reference. By comparing with the two reference Qnet estimates, we found that seven products (NCEP 1, NCEP 2, CFSR, ERA-Interim, MERRA, NOCSv2.0, and OAFlux+ISCCP) overestimate Qnet, with magnitude ranging from 6 to 27 W m-2, while two products underestimate Qnet by -6 W m-2 (JRA55) and -14 W m-2 (CORE.2). Together with the previous warm pool work of Song and Yu (2013), we show that CFSR, MERRA, NOCSv2.0, and OAFlux+ISCCP are warm-biased not only in the western Pacific warm pool but also in the Mediterranean Sea, while CORE.2 is cold-biased in both regions. The NCEP 1, 2, and ERA-Interim are cold-biased over the warm pool but warm-biased in the Mediterranean Sea.
On the presence of equatorial waves in the lower stratosphere of a general circulation model
NASA Astrophysics Data System (ADS)
Maury, P.; Lott, F.
2014-02-01
To challenge the hypothesis that equatorial waves in the lower stratosphere are essentially forced by convection, we use the LMDz atmospheric model extended to the stratosphere and compare two versions having very different convection schemes but no quasi-biennial oscillation (QBO). The two versions have realistic time mean precipitation climatologies but very different precipitation variabilities. Despite these differences, the equatorial stratospheric Kelvin waves at 50 hPa are almost identical in the two versions and quite realistic. The Rossby gravity waves are also very similar but significantly weaker than in observations. We demonstrate that this bias on the Rossby gravity waves is essentially due to a dynamical filtering occurring because the model zonal wind is systematically westward. During a westward phase of the QBO, the ERA-Interim Rossby gravity waves compare well with those in the model. These results suggest that (i) in the model the effect of the convection scheme on the waves is in part hidden by the dynamical filtering, and (ii) the waves are produced by other sources than equatorial convection. For the Kelvin waves, this last point is illustrated by an Eliassen and Palm flux analysis, showing that in the model they come more from the subtropics and mid-latitude regions, whereas in the ERA-Interim reanalysis the sources are more equatorial. We show that non-equatorial sources are also significant in reanalysis data sets as they explain the presence of the Rossby gravity waves in the stratosphere. To illustrate this point, we identify situations with large Rossby gravity waves in the reanalysis middle stratosphere for dates selected when the stratosphere is dynamically separated from the equatorial troposphere. We refer to this process as a stratospheric reloading.
On the presence of equatorial waves in the lower stratosphere of a general circulation model
NASA Astrophysics Data System (ADS)
Maury, P.; Lott, F.
2013-08-01
To challenge the hypothesis that equatorial waves in the lower stratosphere are essentially forced by convection, we use the LMDz atmospheric model extended to the stratosphere and compare two versions having very different convection schemes but no quasi biennial oscillation (QBO). The two versions have realistic time mean precipitation climatologies but very different precipitation variabilities. Despite these differences, the equatorial stratospheric Kelvin waves at 50 hPa are almost identical in the two versions and quite realistic. The Rossby-gravity waves are also very close but significantly weaker than in observations. We demonstrate that this bias on the Rossby-gravity waves is essentially due to a dynamical filtering occurring because the model zonal wind is systematically westward: during a westward phase of the QBO, the Rossby-gravity waves in ERA-Interim compare well with those in the model. These results suggest that in the model the effect of the convection scheme on the waves is in part hidden by the dynamical filtering and the waves are produced by other sources than equatorial convection. For the Kelvin waves, this last point is illustrated by an Eliassen and Palm flux analysis, showing that in the model they come more from the subtropics and mid-latitude regions whereas in the ERA-Interim reanalysis the sources are more equatorial. We also show that non-equatorial sources are significant in reanalysis data, and we consider the case of the Rossby-gravity waves. We identify situations in the reanalysis where here are large Rossby-gravity waves in the middle stratosphere, and for dates when the stratosphere is dynamically separated from the equatorial troposphere. We refer to this process as a "stratospheric reloading".
A comparison of Loon balloon observations and stratospheric reanalysis products
NASA Astrophysics Data System (ADS)
Friedrich, Leon S.; McDonald, Adrian J.; Bodeker, Gregory E.; Cooper, Kathy E.; Lewis, Jared; Paterson, Alexander J.
2017-01-01
Location information from long-duration super-pressure balloons flying in the Southern Hemisphere lower stratosphere during 2014 as part of X Project Loon are used to assess the quality of a number of different reanalyses including National Centers for Environmental Prediction Climate Forecast System version 2 (NCEP-CFSv2), European Centre for Medium-Range Weather Forecasts (ERA-Interim), NASA Modern Era Retrospective-Analysis for Research and Applications (MERRA), and the recently released MERRA version 2. Balloon GPS location information is used to derive wind speeds which are then compared with values from the reanalyses interpolated to the balloon times and locations. All reanalysis data sets accurately describe the winds, with biases in zonal winds of less than 0.37 m s-1 and meridional biases of less than 0.08 m s-1. The standard deviation on the differences between Loon and reanalyses zonal winds is latitude-dependent, ranging between 2.5 and 3.5 m s-1, increasing equatorward. Comparisons between Loon trajectories and those calculated by applying a trajectory model to reanalysis wind fields show that MERRA-2 wind fields result in the most accurate simulated trajectories with a mean 5-day balloon-reanalysis trajectory separation of 621 km and median separation of 324 km showing significant improvements over MERRA version 1 and slightly outperforming ERA-Interim. The latitudinal structure of the trajectory statistics for all reanalyses displays marginally lower mean separations between 15 and 35° S than between 35 and 55° S, despite standard deviations in the wind differences increasing toward the equator. This is shown to be related to the distance travelled by the balloon playing a role in the separation statistics.
Magnan, Sindy; Tota, Joseph E; El-Zein, Mariam; Burchell, Ann N; Schiller, John T; Ferenczy, Alex; Tellier, Pierre-Paul; Coutlée, François; Franco, Eduardo L
2018-04-20
We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up. Assessments were done at 0·5, 1, 3, 6, 9, and 12 months. The primary outcome was incidence of a new infection by an HPV type that was not present at baseline. Analyses were performed by intention-to-treat. Between January 2013 and June 2017, 280 participants were randomly assigned to the carrageenan (n=141) or the placebo (n=139) arm. All participants were included in safety analyses, but 3 (1%) were excluded from efficacy analyses (HPV results unavailable: carrageenan=2, placebo=1). The median follow-up time was 9·2 months (inter-quartile range: 1·9-13·2). 59 (42%) of 139 participants in the carrageenan arm and 78 (57%) of 138 participants in the placebo arm got infected by at least one new HPV type (hazard ratio=0·64, 95% confidence interval=0·45-0·89, p=0·009). 62 (44%) of 141 participants in the carrageenan arm versus 43 (31%) of 139 participants in the placebo arm reported an adverse event (p=0.02); none of which were deemed related to the gels. Our trial's interim analysis suggests that using a carrageenan-based lubricant gel can reduce the risk of genital HPV infections in women. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.
This schedule indicates plans for completion of risk assessments, proposed interim decisions and interim decisions for pesticides in the Registration Review program, EPA reviews all registered pesticides at least every 15 years as required by FIFRA.
Maywood interim storage site. Annual site environmental report, calendar year 1985
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1986-05-01
During 1985, the environmental monitoring program was continued at the Maywood Interim Storage Site (MISS), a US Department of Energy (DOE) facility located in the Borough of Maywood and the Township of Rochelle Park, New Jersey. The MISS is presently used for the storage of low-level radioactively contaminated soils. Monitoring results show that the MISS is in compliance with DOE concentration guides and radiation protection standards. Derived Concentration Guides (DCGs) represent the concentrations of radionuclides in air or water that would limit the radiation dose to 100 mrem/yr. The applicable guides have been revised since the 1984 environmental monitoring reportmore » was published. The guides applied in 1984 were based on a radiation protection standard of 500 mrem/yr; the guides applied for 1985 are based on a standard of 100 mrem/yr.« less
van den Bogert, Cornelis A; Souverein, Patrick C; Brekelmans, Cecile T M; Janssen, Susan W J; Koëter, Gerard H; Leufkens, Hubert G M; Bouter, Lex M
2017-08-01
The objective of the study was to identify the reasons for discontinuation of clinical drug trials and to evaluate whether efficacy-related discontinuations were adequately planned in the trial protocol. All clinical drug trials in the Netherlands, reviewed by institutional review boards in 2007, were followed until December 2015. Data were obtained through the database of the Dutch competent authority (Central Committee on Research Involving Human Subjects [CCMO]) and a questionnaire to the principal investigators. Reasons for trial discontinuation were the primary outcome of the study. Three reasons for discontinuation were analyzed separately: all cause, recruitment failure, and efficacy related (when an interim analysis had demonstrated futility or superiority). Among the efficacy-related discontinuations, we examined whether the data monitoring committee, the stopping rule, and the moment of the interim analysis in the trial progress were specified in the trial protocol. Of the 574 trials, 102 (17.8%) were discontinued. The most common reasons were recruitment failure (33 of 574; 5.7%) and solely efficacy related (30 of 574; 5.2%). Of the efficacy-related discontinuations, 10 of 30 (33.3%) of the trial protocols reported all three aspects in the trial protocol, and 20 of 30 (66.7%) reported at least one aspect in the trial protocol. One out of five clinical drug trials is discontinued before the planned trial end, with recruitment failure and futility as the most common reasons. The target sample size of trials should be feasible, and interim analyses should be adequately described in trial protocols. Copyright © 2017 Elsevier Inc. All rights reserved.
Campuzano-Zuluaga, Germán; Deutsch, Yehuda; Salzberg, Matthew; Gomez, Alexandra; Vargas, Fernando; Elias, Roy; Kwon, Deukwoo; Goodman, Mark; Ikpatt, Offiong F; Chapman, Jennifer R; Watts, Justin; Vega, Francisco; Swords, Ronan
2016-03-01
The presence of >5% blasts at "day 14" (D14), in patients undergoing induction chemotherapy for acute myeloid leukemia (AML) is problematic. It is unclear if a second course of chemotherapy for early persistent disease will alter outcome in these patients. We conducted a retrospective study of AML patients undergoing induction chemotherapy where diagnostic, interim (around day 14), and recovery (days 21-42) bone marrow (BM) evaluations were available for review. Of the 113 patients included in the final analysis, 99 (87.6%) achieved CR at hematologic recovery. At D14, 90 patients (79.6%) had <5% blasts and of these, 87 (96.7%) ultimately achieved CR. At D14, Twenty-three (20.4%) patients had residual leukemia (>5% blasts). Of these, 11 (47.8%) received a second course of chemotherapy (double induction [DI]) and 12 (52.2%) were observed until count recovery (single induction [SI]). No significant difference in CR rates was observed between these two groups (58.3% DI group vs. 45.5% SI group, P value = 0.684). In our analysis, D14 BM evaluation did not uniformly identify patients with primary induction failure. To unequivocally determine the value of a D14 marrow assessment in AML, prospective studies in the context of large cooperative group trials are required. Considering our findings and similar reports from others, we propose that D14 marrow assessment should be individualized, and that other factors, such as cytogenetics and early peripheral blood blast clearance should be considered, to identify patients most likely to benefit from interim disease assessment during AML induction therapy. © 2015 Wiley Periodicals, Inc.
Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov
Bothwell, Laura E; Avorn, Jerry; Khan, Nazleen F; Kesselheim, Aaron S
2018-01-01
Objectives This review investigates characteristics of implemented adaptive design clinical trials and provides examples of regulatory experience with such trials. Design Review of adaptive design clinical trials in EMBASE, PubMed, Cochrane Registry of Controlled Clinical Trials, Web of Science and ClinicalTrials.gov. Phase I and seamless Phase I/II trials were excluded. Variables extracted from trials included basic study characteristics, adaptive design features, size and use of independent data monitoring committees (DMCs) and blinded interim analyses. We also examined use of the adaptive trials in new drug submissions to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) and recorded regulators’ experiences with adaptive designs. Results 142 studies met inclusion criteria. There has been a recent growth in publicly reported use of adaptive designs among researchers around the world. The most frequently appearing types of adaptations were seamless Phase II/III (57%), group sequential (21%), biomarker adaptive (20%), and adaptive dose-finding designs (16%). About one-third (32%) of trials reported an independent DMC, while 6% reported blinded interim analysis. We found that 9% of adaptive trials were used for FDA product approval consideration, and 12% were used for EMA product approval consideration. International regulators had mixed experiences with adaptive trials. Many product applications with adaptive trials had extensive correspondence between drug sponsors and regulators regarding the adaptive designs, in some cases with regulators requiring revisions or alterations to research designs. Conclusions Wider use of adaptive designs will necessitate new drug application sponsors to engage with regulatory scientists during planning and conduct of the trials. Investigators need to more consistently report protections intended to preserve confidentiality and minimise potential operational bias during interim analysis. PMID:29440155
Boonstra, P S; Braun, T M; Taylor, J M G; Kidwell, K M; Bellile, E L; Daignault, S; Zhao, L; Griffith, K A; Lawrence, T S; Kalemkerian, G P; Schipper, M J
2017-07-01
Regulatory agencies and others have expressed concern about the uncritical use of dose expansion cohorts (DECs) in phase I oncology trials. Nonetheless, by several metrics-prevalence, size, and number-their popularity is increasing. Although early efficacy estimation in defined populations is a common primary endpoint of DECs, the types of designs best equipped to identify efficacy signals have not been established. We conducted a simulation study of six phase I design templates with multiple DECs: three dose-assignment/adjustment mechanisms multiplied by two analytic approaches for estimating efficacy after the trial is complete. We also investigated the effect of sample size and interim futility analysis on trial performance. Identifying populations in which the treatment is efficacious (true positives) and weeding out inefficacious treatment/populations (true negatives) are competing goals in these trials. Thus, we estimated true and false positive rates for each design. Adaptively updating the MTD during the DEC improved true positive rates by 8-43% compared with fixing the dose during the DEC phase while maintaining false positive rates. Inclusion of an interim futility analysis decreased the number of patients treated under inefficacious DECs without hurting performance. A substantial gain in efficiency is obtainable using a design template that statistically models toxicity and efficacy against dose level during expansion. Design choices for dose expansion should be motivated by and based upon expected performance. Similar to the common practice in single-arm phase II trials, cohort sample sizes should be justified with respect to their primary aim and include interim analyses to allow for early stopping. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.
NASA Technical Reports Server (NTRS)
Reichle, Rolf; Koster, Randal; DeLannoy, Gabrielle; Forman, Barton; Liu, Qing; Mahanama, Sarith; Toure, Ally
2011-01-01
The Modern-Era Retrospective analysis for Research and Applications (MERRA) is a state-of-the-art reanalysis that provides. in addition to atmospheric fields. global estimates of soil moisture, latent heat flux. snow. and runoff for J 979-present. This study introduces a supplemental and improved set of land surface hydrological fields ('MERRA-Land') generated by replaying a revised version of the land component of the MERRA system. Specifically. the MERRA-Land estimates benefit from corrections to the precipitation forcing with the Global Precipitation Climatology Project pentad product (version 2.1) and from revised parameters in the rainfall interception model, changes that effectively correct for known limitations in the MERRA land surface meteorological forcings. The skill (defined as the correlation coefficient of the anomaly time series) in land surface hydrological fields from MERRA and MERRA-Land is assessed here against observations and compared to the skill of the state-of-the-art ERA-Interim reanalysis. MERRA-Land and ERA-Interim root zone soil moisture skills (against in situ observations at 85 US stations) are comparable and significantly greater than that of MERRA. Throughout the northern hemisphere, MERRA and MERRA-Land agree reasonably well with in situ snow depth measurements (from 583 stations) and with snow water equivalent from an independent analysis. Runoff skill (against naturalized stream flow observations from 15 basins in the western US) of MERRA and MERRA-Land is typically higher than that of ERA-Interim. With a few exceptions. the MERRA-Land data appear more accurate than the original MERRA estimates and are thus recommended for those interested in using '\\-tERRA output for land surface hydrological studies.
NASA Technical Reports Server (NTRS)
Xu, Kuan-Man
2008-01-01
This study presents an approach that converts the vertical profiles of grid-averaged cloud properties from large-scale models to probability density functions (pdfs) of subgrid-cell cloud physical properties measured at satellite footprints. Cloud physical and radiative properties, rather than just cloud and precipitation occurrences, of assimilated cloud systems by the European Center for Medium-range Weather Forecasts (ECMWF) operational analysis (EOA) and ECMWF Re-Analyses (ERA-40 and ERA Interim) are validated against those obtained from Earth Observing System satellite cloud object data for January-August 1998 and March 2000 periods. These properties include ice water path (IWP), cloud-top height and temperature, cloud optical depth and solar and infrared radiative fluxes. Each cloud object, a contiguous region with similar cloud physical properties, is temporally and spatially matched with EOA and ERA-40 data. Results indicate that most pdfs of EOA and ERA-40 cloud physical and radiative properties agree with those of satellite observations of the tropical deep convective cloud-object type for the January-August 1998 period. There are, however, significant discrepancies in selected ranges of the cloud property pdfs such as the upper range of EOA cloud top height. A major discrepancy is that the dependence of the pdfs on the cloud object size for both EOA and ERA-40 is not as strong as in the observations. Modifications to the cloud parameterization in ECMWF that occurred in October 1999 eliminate the clouds near the tropopause but shift power of the pdf to lower cloud-top heights and greatly reduce the ranges of IWP and cloud optical depth pdfs. These features persist in ERA-40 due to the use of the same cloud parameterizations. The downgrade of data assimilation technique and the lack of snow water content information in ERA-40, not the coarser horizontal grid resolution, are also responsible for the disagreements with observed pdfs of cloud physical properties although the detection rates of cloud object occurrence are improved for small size categories. A possible improvement to the convective parameterization is to introduce a stronger dependence of updraft penetration heights with grid-cell dynamics. These conclusions will be rechecked using the ERA Interim data, due to recent changes in the ECMWF convective parameterization (Bechtold et al. 2004, 2008). Results from the ERA Interim will be presented at the meeting.
45 CFR 689.8 - Interim administrative actions.
Code of Federal Regulations, 2011 CFR
2011-10-01
... RESEARCH MISCONDUCT § 689.8 Interim administrative actions. (a) After an inquiry or during an external or... misconduct. Such an order will normally be issued on recommendation from OIG and in consultation with the...
45 CFR 689.8 - Interim administrative actions.
Code of Federal Regulations, 2012 CFR
2012-10-01
... RESEARCH MISCONDUCT § 689.8 Interim administrative actions. (a) After an inquiry or during an external or... misconduct. Such an order will normally be issued on recommendation from OIG and in consultation with the...
45 CFR 689.8 - Interim administrative actions.
Code of Federal Regulations, 2010 CFR
2010-10-01
... RESEARCH MISCONDUCT § 689.8 Interim administrative actions. (a) After an inquiry or during an external or... misconduct. Such an order will normally be issued on recommendation from OIG and in consultation with the...
45 CFR 689.8 - Interim administrative actions.
Code of Federal Regulations, 2013 CFR
2013-10-01
... RESEARCH MISCONDUCT § 689.8 Interim administrative actions. (a) After an inquiry or during an external or... misconduct. Such an order will normally be issued on recommendation from OIG and in consultation with the...
45 CFR 689.8 - Interim administrative actions.
Code of Federal Regulations, 2014 CFR
2014-10-01
... RESEARCH MISCONDUCT § 689.8 Interim administrative actions. (a) After an inquiry or during an external or... misconduct. Such an order will normally be issued on recommendation from OIG and in consultation with the...
7 CFR 1710.109 - Reimbursement of general funds and interim financing.
Code of Federal Regulations, 2010 CFR
2010-01-01
... be limited, except in cases of extreme financial hardship as determined by the Administrator, to the...) Policies for reimbursement of general funds and interim financing following certain mergers, consolidations...
Preventive maintenance study : interim report.
DOT National Transportation Integrated Search
2017-09-01
This interim report details the performance of 69 test sites treated with various preventive maintenance treatments. The maintenance treatments applied included crack sealing, full lane chip sealing, wheel path chip sealing, dig outs (mill and fill),...
Interim Open Source Software (OSS) Policy
This interim Policy establishes a framework to implement the requirements of the Office of Management and Budget's (OMB) Federal Source Code Policy to achieve efficiency, transparency and innovation through reusable and open source software.
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... Practice; Interim Commission Review of Public Company Accounting Oversight Board Inspection Reports and... facilitate interim Commission review of Public Company Accounting Oversight Board [[Page 47445
Interim Policy for Evaluation of Stereoisomeric Pesticides
An interim approach for determining data requirements for non-racemic mixtures of stereoisomeric pesticides. These data are needed in order to assess the risk posed to ecosystems and drinking water sources by these mixtures.
EPA's Revised Interim Financial Assistance Conflict of Interest Policy
EPA has established the following revised interim policy governing disclosure of actual and potential conflicts of interest (COI Policy) by applicants for, and recipients of, federal financial assistance awards from EPA.
An allowable cladding peak temperature for spent nuclear fuels in interim dry storage
NASA Astrophysics Data System (ADS)
Cha, Hyun-Jin; Jang, Ki-Nam; Kim, Kyu-Tae
2018-01-01
Allowable cladding peak temperatures for spent fuel cladding integrity in interim dry storage were investigated, considering hydride reorientation and mechanical property degradation behaviors of unirradiated and neutron irradiated Zr-Nb cladding tubes. Cladding tube specimens were heated up to various temperatures and then cooled down under tensile hoop stresses. Cool-down specimens indicate that higher heat-up temperature and larger tensile hoop stress generated larger radial hydride precipitation and smaller tensile strength and plastic hoop strain. Unirradiated specimens generated relatively larger radial hydride precipitation and plastic strain than did neutron irradiated specimens. Assuming a minimum plastic strain requirement of 5% for cladding integrity maintenance in interim dry storage, it is proposed that a cladding peak temperature during the interim dry storage is to keep below 250 °C if cladding tubes are cooled down to room temperature.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Chung, D.; Ascanio, X.
1996-05-01
The Department of Energy has issued a technical standard for long-term (>50 years) storage and will soon issue a criteria document for interim (<20 years) storage of plutonium materials. The long-term technical standard, {open_quotes}Criteria for Safe Storage of Plutonium Metals and Oxides,{close_quotes} addresses the requirements for storing metals and oxides with greater than 50 wt % plutonium. It calls for a standardized package that meets both off-site transportation requirements, as well as remote handling requirements from future storage facilities. The interim criteria document, {open_quotes}Criteria for Interim Safe Storage of Plutonium-Bearing Solid Materials{close_quotes}, addresses requirements for storing materials with less thanmore » 50 wt% plutonium. The interim criteria document assumes the materials will be stored on existing sites, and existing facilities and equipment will be used for repackaging to improve the margin of safety.« less
Transport across the tropical tropopause layer and convection
NASA Astrophysics Data System (ADS)
Tissier, Ann-Sophie; Legras, Bernard; Tzella, Alexandra
2015-04-01
We investigate how air parcels detrained from convective sources enter the TTL. The approach is based on the comparison of unidimensional trajectories and Lagrangian backward and forward trajectories, using TRACZILLA and ERA-Interim. Backward trajectories are launched at 380K and run until they hit a deep convective cloud. Forward trajectories are launched at the top of high convective clouds identified by brightness temperature from CLAUS dataset. 1D trajectories are computed using Gardiner's method. Results show that the warm pool region during winter and the Bay of Bengal / Sea of China during summer are the prevalent sources as already identified in many previous studies and we quantify the respective role of the various regions. We show that the 1D model explains qualitatively and often quantitatively the 3d results. We also show that in spite of generating very high convection, Africa is quite ineffective as providing air that remains in the TTL while on the opposite the Tibetan Plateau is the most effective region in this respect although its total contribution is minor. Finally, we compare ERA-Interim, JRA-55 and MERRA reanalysis and find large similarities between the two formers.
Analysis of extreme summers and prior late winter/spring conditions in central Europe
NASA Astrophysics Data System (ADS)
Träger-Chatterjee, C.; Müller, R. W.; Bendix, J.
2013-05-01
Drought and heat waves during summer in mid-latitudes are a serious threat to human health and agriculture and have negative impacts on the infrastructure, such as problems in energy supply. The appearance of such extreme events is expected to increase with the progress of global warming. A better understanding of the development of extremely hot and dry summers and the identification of possible precursors could help improve existing seasonal forecasts in this regard, and could possibly lead to the development of early warning methods. The development of extremely hot and dry summer seasons in central Europe is attributed to a combined effect of the dominance of anticyclonic weather regimes and soil moisture-atmosphere interactions. The atmospheric circulation largely determines the amount of solar irradiation and the amount of precipitation in an area. These two variables are themselves major factors controlling the soil moisture. Thus, solar irradiation and precipitation are used as proxies to analyse extreme sunny and dry late winter/spring and summer seasons for the period 1958-2011 in Germany and adjacent areas. For this purpose, solar irradiation data from the European Center for Medium Range Weather Forecast 40-yr and interim re-analysis dataset, as well as remote sensing data are used. Precipitation data are taken from the Global Precipitation Climatology Project. To analyse the atmospheric circulation geopotential data at 850 hPa are also taken from the European Center for Medium Range Weather Forecast 40-yr and interim re-analysis datasets. For the years in which extreme summers in terms of high solar irradiation and low precipitation are identified, the previous late winter/spring conditions of solar irradiation and precipitation in Germany and adjacent areas are analysed. Results show that if the El Niño-Southern Oscillation (ENSO) is not very intensely developed, extremely high solar irradiation amounts, together with extremely low precipitation amounts during late winter/spring, might serve as precursor of extremely sunny and dry summer months to be expected.
Zerger, Suzanne; Francombe Pridham, Katherine; Jeyaratnam, Jeyagobi; Connelly, Jolynn; Hwang, Stephen; O'Campo, Patricia; Stergiopoulos, Vicky
2014-07-01
The housing first (HF) model for individuals experiencing homelessness and mental illness differs by design from traditional models that require consumers to achieve "housing readiness" by meeting program or treatment prerequisites in transitional housing settings prior to permanent housing placement. Given a growing body of evidence for its favorable outcomes and cost effectiveness, HF is increasingly seen as an alternative to and argument against these traditional programs. As such, it is important that the elements and implementation challenges of the HF model be clearly understood and articulated. This qualitative study explored a largely unexamined aspect of the HF model-the need for and meaning of temporary residential settings (interim housing), a place to stay while waiting to secure permanent housing-using interviews and focus groups with service providers and consumers who experienced interim housing during implementation of HF in a large urban center. Although interim housing may not be necessary for all programs implementing the model, our study revealed numerous reasons and demands for safe, flexible interim housing options, and illustrated how they influence the effectiveness of consumer recovery, continuous service engagement, and housing stability.
What a Difference a Day Makes: Change in Memory for Newly Learned Word Forms Over 24 Hours
McGregor, Karla K.
2014-01-01
Purpose This study explored the role of time and retrieval experience in the consolidation of word forms. Method Participants were 106 adults trained on 16 novel word-referent pairs, then tested immediately and 24 hr later for recognition and recall of word forms. In the interim, tests were repeated 2 hr or 12 hr after training, or not at all, thus varying the amount and timing of retrieval experience. Results Recognition accuracy was stable and speed improved over the 24-hr period. But these manifestations of consolidation did not depend on interim retrieval experience; in fact, the 2-hr interim test interfered with improvements in speed. In contrast, the number of word forms recalled increased only with interim retrieval experiences, and the 12-hr interim test was more advantageous to recall than the 2-hr test. Conclusions After a word form is encoded, it can become stronger with time. Retrieval experience can also strengthen the trace, but, if retrieval occurs when the memory is still labile, it can be disruptive. This complex interplay between retrieval experience and time holds implications for measuring learning outcomes and for scheduling practice in classrooms and clinics. PMID:24845578