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
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…
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
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…
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.
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…
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).
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.
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...
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.
To Have and to Hold: Reflections of an Interim Director
ERIC Educational Resources Information Center
Hibl, Lisa M.
2018-01-01
Leading a long-established LLC as an Interim Director poses particular challenges and rewards. Uncertainties abound for the program and for the individual. Professionally speaking, taking on the hybrid role of faculty/ administrator can be both difficult and exciting. Ultimately, the solutions are in the details. Listening carefully to students,…
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.
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...
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...
A Study of the Transitional Adjustment of a Professional Group to its Altered Role. Interim Report.
ERIC Educational Resources Information Center
Daniels, Morris J.
This interim report discusses the adjustments auditing firms are making as a result of the advent of the computer. Data were obtained from (1) a review of the literature, (2) attendance at professional association meetings, and (3) a series of interviews with accountants. The findings to date indicate that the normative patterns governing the…
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...
Analysis of Army Contracting Officer Representative Role in Contingency Operations
2011-12-01
oversight. There may be a shortage of experienced and 12 well-qualified CORs” (Thibault et al., 2011, p. 85). The report also made recommendations to...percent over the same period (Gansler et al., 2007). The shortage of contracting procurement personnel, including CORs, is detrimental to the...According to the Interim Report to Congress in June 2009, There is a critical shortage of qualified contract management personnel in theater and those
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.
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.
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.
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.
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.
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.
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.
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.
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
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 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Weber, M M
2002-11-01
In 1997 the Max Planck Society set up a presidential commission to do research on the historical development of its precursor organization, the Kaiser Wilhelm Society (KWG), during the Third Reich. This paper presents some of the important results given in the interim reports of this commission that are relevant to psychiatry. It focuses on brain research, anthropology, psychiatric genetics, and the role of the well-known biochemist Adolf Butenandt. In general, the interim reports reflect the numerous links between the biomedical research of the KWG and the institutions of the National Socialist (Nazi) state. However, they do not yet allow a final historical assessment as to the complex situation of this field of research during National Socialism.
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...
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.
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.
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.
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.
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.
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…
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.
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.
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.
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…
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.
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.
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.
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.
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.
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.
Mid-latitude storm track variability and its influence on atmospheric composition
NASA Astrophysics Data System (ADS)
Knowland, K. E.; Doherty, R. M.; Hodges, K.
2013-12-01
Using the storm tracking algorithm, TRACK (Hodges, 1994, 1995, 1999), we have studied the behaviour of storm tracks in the North Atlantic basin, using 850-hPa relative vorticity from the ERA-Interim Re-analysis (Dee et al., 2011). We have correlated surface ozone measurements at rural coastal sites in Europe to the storm track data to explore the role mid-latitude cyclones and their transport of pollutants play in determining surface air quality in Western Europe. To further investigate this relationship, we have used the Monitoring Atmospheric Composition Climate (MACC) Re-analysis dataset (Inness et al., 2013) in TRACK. The MACC Re-analysis is a 10-year dataset which couples a chemistry transport model (Mozart-3; Stein 2009, 2012) to an extended version of the European Centre for Medium-Range Weather Forecasts' (ECMWF) Integrated Forecast System (IFS). Storm tracks in the MACC Re-analysis compare well to the storm tracks using the ERA-Interim Re-analysis for the same 10-year period, as both are based on ECMWF IFSs. We also compare surface ozone values from MACC to surface ozone measurements previously studied. Using TRACK, we follow ozone (O3) and carbon monoxide (CO) through the life cycle of storms from North America to Western Europe. Along the storm tracks, we examine the distribution of CO and O3 within 6 degrees of the center of each storm and vertically at different pressure levels in the troposphere. We hope to better understand the mechanisms with which pollution is vented from the boundary layer to the free troposphere, as well as transport of pollutants to rural areas. Our hope is to give policy makers more detailed information on how climate variability associated with storm tracks between 1979-2013 may affect air quality in Northeast USA and Western Europe.
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.
Hill, Suzanne; Freemantle, Nick
2003-01-01
Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.
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.
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.
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
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.
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.
The Decanal Divide: Women in Decanal Roles at U.S. Medical Schools.
Schor, Nina F
2018-02-01
To test the hypotheses that women in medical school dean-level (decanal) positions occupy lower-rank and more image- and education-focused positions than men, and that state and woman-led schools have more women in decanal positions. Data were collected on September 10-18, 2016, from Web sites of 136 allopathic, U.S. medical schools accredited by the Liaison Committee on Medical Education and represented on the roster of accredited MD programs in the United States with full accreditation as of June 22, 2016. Statistical significance of differences between comparison groups was assessed using Student t test with P < .05 indicating significance. Correlation between parameters was determined by Spearman rank correlation test with P < .05 indicating significant correlation. Findings demonstrate that only 15% (22/149) of deans and interim deans are women, and the prevalence of women in decanal positions decreases with ascending professional rank (R = 0.93; P < .05). Women are most prevalent in decanal positions focusing on education and mentoring or institutional public image and least prevalent in those focusing on corporate strategy and policy, finance, or government relations. Schools with a woman as dean or interim dean have a higher percentage of decanal positions occupied by women than those with a man as dean or interim dean (P < .05). State and private medical schools do not differ from one another in this regard. Gender stereotypes and models appear to continue to drive the number and roles of women in decanal positions.
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...
The role of FDG-PET in Hodgkin lymphoma
Hałka, Janusz; Dziuk, Mirosław
2017-01-01
18-fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET)/computed tomography (CT) is currently the most valuable imaging technique in Hodgkin lymphoma. Since its first use in lymphomas in the 1990s, it has become the gold standard in the staging and end-of-treatment remission assessment in patients with Hodgkin lymphoma. The possibility of using early (interim) PET during first-line therapy to evaluate chemosensitivity and thus personalize treatment at this stage holds great promise, and much attention is now being directed toward this goal. With high probability, it is believed that in the near future, the result of interim PET-CT would serve as a compass to optimize treatment. Also the role of PET in pre-transplant assessment is currently evolving. Much controversy surrounds the possibility of detecting relapse after completed treatment with the use of PET in surveillance in the absence of symptoms suggestive of recurrence and the results of published studies are rather discouraging because of low positive predictive value. This review presents current knowledge about the role of 18-FDG-PET/CT imaging at each point of management of patients with Hodgkin lymphoma. PMID:28947879
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.
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.
The Brave New World of the Interim Superintendency
ERIC Educational Resources Information Center
Bigham, Gary D.
2011-01-01
Considering the vital role the superintendent plays in the overall functioning and well-being of any school district, the filling of the top leadership post with a permanent appointment never should be done in haste. The process of advertising, reviewing applications, conducting background checks, interviewing candidates, negotiating contracts,…
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...
McLaren, Susan; Woods, Leslie; Boudioni, Markella; Lemma, Ferew; Tavabie, Abdol
2008-01-01
To identify and explore leadership roles and responsibilities for implementing the workforce development strategy; to identify approaches used to implement and disseminate the strategy; and to identify and explore challenges and achievements in the first 18 months following implementation. A formative evaluation with qualitative methods was used. Documentary analysis, interviews (n = 29) and two focus groups (n = 12) were conducted with a purposive sample of individuals responsible for strategy implementation. Data were transcribed and analysed thematically using framework analysis. Regional health area in Kent, Surrey and Sussex: 24 primary care trusts (PCTs) and 900 general practices. Primary care workforce tutors, lifelong learning advisors, GP tutors, patch associate GP deans and chairs of PCT education committees all had vital leadership roles, some existing and others newly developed. Approaches used to implement the strategy encompassed working within and across organisational boundaries, communication and dissemination of information. Challenges encountered by implementers were resistance to change - evident in some negative attitudes to uptake of training and development opportunities - and role diversity and influence. Achievements included successes in embedding appraisal and protected learning time, and changes in educational practices and services. The use of key leadership roles and change-management approaches had brought about early indications of positive transition in lifelong learning cultures.
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...
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...
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...
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…
ERIC Educational Resources Information Center
Reis, Fernanda Oliveira
A meeting was held to discuss the findings of case studies examining the role of companies in generating qualifications and the training impact of work organization in Germany, Denmark, Spain, and France. New forms of work organization (NFOT) were identified and examined from the standpoint of sources of organizational change, the main areas of…
ERIC Educational Resources Information Center
Durham Univ. (England). Council for the Advancement of Communication with Deaf People.
The proceedings of a 1999 international symposium on interpreting for deafblind people presents 15 papers and a report of a survey of 20 countries and 5 organizations concerning the roles, training, and rights of interpreters for deafblind people. The papers are: "European Deafblind Comparative Study--Interim Report" (Lynne Hawcroft,…
International Standards. U.S. Metric Study Report.
ERIC Educational Resources Information Center
Huntoon, Robert D.; And Others
In this first interim report on the feasibility of a United States changeover to a metric system stems from the U.S. Metric Study, a series of conclusions and recommendations, based upon a national survey of the role of SI (System's International) units in international trade and other areas of foreign relations, includes the following…
Federal Manpower Legislation and the Academic Health Centers: An Interim Report.
ERIC Educational Resources Information Center
Carter, Grace M.; And Others
Health Manpower Legislation and related research aspects are the topics of this report. The program of the Comprehensive Health Manpower Training Act of 1971 played a major role in the medical school enrollment expansion that occurred between 1971 and 1973. Medical school admissions decisions have been responsible to federal policy objectives and…
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.
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
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...
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.
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 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...
National Aeronautics and Space Administration Exploration Systems Interim Strategy
NASA Technical Reports Server (NTRS)
2004-01-01
Contents include the following: 1. The Exploration Systems Mission Directorate within NASA. Enabling the Vision for Space Exploration. The Role of the Directorate. 2. Strategic Context and Approach. Corporate Focus. Focused, Prioritized Requirements. Spiral Transformation. Management Rigor. 3. Achieving Directorate Objectives. Strategy to Task Process. Capability Development. Research and Technology Development. 4. Beyond the Horizon. Appendices.
Comparison of RCRA SWMU Corrective Action and CERCLA Remedial Action
1991-09-30
4. TITLE AND SUBTITLE 5 . FUNDING NUMBERS Comparison of RCRA SWMU Corrective Action and CERCLA Remedial Action 6. AUTHOR(S) Sam Capps Rupe, Major -1...Interim Status for TSD Facilities .................... 19 5 . Closure and Postclosure Requirements for TSD Facilities ........... 25 D. State Role... 65 1. RCRA Facility Assessment . ............................... 65 2. RCRA Facility Investigation . .............................. 66 3
From Teacher to Day Care Center Director!
ERIC Educational Resources Information Center
De Viteri, Jorge Saenz
This paper addresses the roles and responsibilities of a day care center director, based on the author's personal experience as an interim director during his junior year at college and a survey of other directors. The paper aims to provide insight into the reality of being a day care center director, particularly the acquisition of knowledge,…
Educational Information System for Ontario. Second Interim Report, March 1976-February 1977.
ERIC Educational Resources Information Center
Auster, Ethel; Lawton, Stephen B.
This report of the EISO project, the responsibility of which is the operation of an online bibliographic search service for educators of Ontario, concentrates on research findings collected after EISO had been operational for 16 months. The organization, role, and level of satisfaction of EISO users are treated, the system's impact on a school…
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.
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.
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.
NASA Astrophysics Data System (ADS)
Emanuelsson, B. Daniel; Bertler, Nancy A. N.; Neff, Peter D.; Renwick, James A.; Markle, Bradley R.; Baisden, W. Troy; Keller, Elizabeth D.
2018-01-01
Persistent positive 500-hPa geopotential height anomalies from the ECMWF ERA-Interim reanalysis are used to quantify Amundsen-Bellingshausen Sea (ABS) anticyclonic event occurrences associated with precipitation in West Antarctica (WA). We demonstrate that multi-day (minimum 3-day duration) anticyclones play a key role in the ABS by dynamically inducing meridional transport, which is associated with heat and moisture advection into WA. This affects surface climate variability and trends, precipitation rates and thus WA ice sheet surface mass balance. We show that the snow accumulation record from the Roosevelt Island Climate Evolution (RICE) ice core reflects interannual variability of blocking and geopotential height conditions in the ABS/Ross Sea region. Furthermore, our analysis shows that larger precipitation events are related to enhanced anticyclonic circulation and meridional winds, which cause pronounced dipole patterns in air temperature anomalies and sea ice concentrations between the eastern Ross Sea and the Bellingshausen Sea/Weddell Sea, as well as between the eastern and western Ross Sea.
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...
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
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.
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.
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...
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.
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.
ERIC Educational Resources Information Center
Gephart, William J.
The paper discusses the meaning of value and valuing, their roles in evaluation, and the potency of value systems in problem solving logic. Evaluation is defined as a process for facilitating decision making. A decision making situation occurs when there are options which are impossible to treat equivalently, and there is an impact in the…
2014-07-01
Unified Theory of Acceptance and Use of Technology, Structuration Model of Technology, UNCLASSIFIED DSTO-TR-2992 UNCLASSIFIED 5 Adaptive...Structuration Theory , Model of Mutual Adaptation, Model of Technology Appropriation, Diffusion/Implementation Model, and Tri-core Model, among others [11...simulation gaming essay/scenario writing genius forecasting role play/acting backcasting swot brainstorming relevance tree/logic chart scenario workshop
ERIC Educational Resources Information Center
Martin, Christopher
2014-01-01
In February 2012, Canada's Truth and Reconciliation Commission released an interim report that detailed its findings based on extensive testimony by former students of the nation's residential school system, a system designed to forcibly assimilate aboriginal peoples. The report concludes that the state must play an active role in the restoration…
ERIC Educational Resources Information Center
Ree, Malcolm James; And Others
A study investigated the roles of general ability and specific abilities as predictors of several job performance criteria for Air Force enlistees in eight jobs. Subjects were 1,545 Air Force enlistees entering from 1984 through 1988 who had tested with the Armed Services Vocational Aptitude Battery (ASVAB) parallel forms 11, 12, or 13. Subjects…
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.
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.
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.
The Role of Robots and Automation in Space
NASA Technical Reports Server (NTRS)
Heer, E.
1978-01-01
Advanced space transportation systems based on the shuttle and interim upper stage will open the way to the use of large-scale industrial and commercial systems in space. The role of robot and automation technology in the cost-effective implementation and operation of such systems in the next two decades is discussed. Planning studies initiated by NASA are described as applied to space exploration, global services, and space industrialization, and a forecast of potential missions in each category is presented. The appendix lists highlights of space robot technology from 1967 to the present.
Role Perceptions of Hispanic and Mainstream Navy Recruits.
1982-12-01
ACCESSION NO- 3. R9C’PI’NT’S CATALOG NUMBER 4. TITLE (and Subttl.e) S . TYPE of REPORT & PERIOO COVERED Role Perceptions of Hispanic and M4ainstream Interim...Technical Report Navy Recruits *. PERFORMING ORG. REPORT NUMBER 7. AUTHOR( s ) 6. CONTRACT OR GRANT NUMUER(a) Harry C. Triandis Judith Li3ansky Gerardo...T NU M E R S A Department of Psycholog~y University of Illinois NR 170-906 603 E. Daniel, Chamva.;vn, IL 6182__ II. CONTROLLING OFFICE NAME AND
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.
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.
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...
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.
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.
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.
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).
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.
Evaluation of Marsh/Estuarine Water Quality and Ecological Models: An Interim Guide
1982-01-01
benthic oxygen demand, benthic scour and deposition, photosynthesis and respiration of aquatic plants, and nitrification (Dobbins 1964; O’Connor 1967... photosynthesis , algal respiration, decom- position, and mixing processes play dominant roles, the understanding and characterization of significant pro...Adams, S. M. 1979. "A Mathematical Model of Trophic Dynamics in Estuarine Seagrass Communities," Marsh-Estuarine Systems Simulation, Dame, R. F., ed
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.
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…
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,…
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,...
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...
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.).
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.).
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.
ERIC Educational Resources Information Center
New York State Interdepartmental Fuel and Energy Committee, Albany.
After presenting the background of the availability of fuel for transportation and the increasing per capita energy consumption, the report examines the State's role in energy conservation. Five proposals are outlined: (1) a coordinated education program designed to increase public awareness of the current energy situation; (2) a pilot program of…
The role and challenges of the food industry in addressing chronic disease
2010-01-01
Summary Increasingly, food companies play an important role in stemming the rising burden of nutrition-related chronic diseases. Concrete actions taken by these companies include global public commitments to address food reformulation, consumer information, responsible marketing, promotion of healthy lifestyles, and public-private partnerships. These actions are reviewed together with eleven specific PepsiCo goals and commitments that address products, the marketplace, and communities at large. Interim progress on these goals and commitments are discussed as well as constraints hampering faster progress. Further disease prevention depends on increasing implementation of private-public initiatives. PMID:20509876
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)
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...
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.
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.
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.
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.
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.
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.
Taipower`s radioactive waste management program
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lee, B.C.C.
1996-09-01
Nuclear safety and radioactive waste management are the two major concerns of nuclear power in Taiwan. Recognizing that it is an issue imbued with political and social-economic concerns, Taipower has established an integrated nuclear backend management system and its associated financial and mechanism. For LLW, the Orchid Island storage facility will play an important role in bridging the gap between on-site storage and final disposal of LLW. Also, on-site interim storage of spent fuel for 40 years or longer will provide Taipower with ample time and flexibility to adopt the suitable alternative of direct disposal or reprocessing. In other words,more » by so exercising interim storage option, Taipower will be in a comfortable position to safely and permanently dispose of radwaste without unduly forgoing the opportunities of adopting better technologies or alternatives. Furthermore, Taipower will spare no efforts to communicate with the general public and make her nuclear backend management activities accountable to them.« less
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.
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...
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.
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.
NASA Astrophysics Data System (ADS)
Hu, Xiaoming; Sejas, Sergio A.; Cai, Ming; Taylor, Patrick C.; Deng, Yi; Yang, Song
2018-05-01
The global-mean surface temperature has experienced a rapid warming from the 1980s to early-2000s but a muted warming since, referred to as the global warming hiatus in the literature. Decadal changes in deep ocean heat uptake are thought to primarily account for the rapid warming and subsequent slowdown. Here, we examine the role of ocean heat uptake in establishing the fast warming and warming hiatus periods in the ERA-Interim through a decomposition of the global-mean surface energy budget. We find the increase of carbon dioxide alone yields a nearly steady increase of the downward longwave radiation at the surface from the 1980s to the present, but neither accounts for the fast warming nor warming hiatus periods. During the global warming hiatus period, the transfer of latent heat energy from the ocean to atmosphere increases and the total downward radiative energy flux to the surface decreases due to a reduction of solar absorption caused primarily by an increase of clouds. The reduction of radiative energy into the ocean and the surface latent heat flux increase cause the ocean heat uptake to decrease and thus contribute to the slowdown of the global-mean surface warming. Our analysis also finds that in addition to a reduction of deep ocean heat uptake, the fast warming period is also driven by enhanced solar absorption due predominantly to a decrease of clouds and by enhanced longwave absorption mainly attributed to the air temperature feedback.
10. international mouse genome conference
DOE Office of Scientific and Technical Information (OSTI.GOV)
Meisler, M.H.
Ten years after hosting the First International Mammalian Genome Conference in Paris in 1986, Dr. Jean-Louis Guenet presided over the Tenth Conference at the Pasteur Institute, October 7--10, 1996. The 1986 conference was a satellite to the Human Gene Mapping Workshop and had approximately 50 attendees. The 1996 meeting was attended by 300 scientists from around the world. In the interim, the number of mapped loci in the mouse increased from 1,000 to over 20,000. This report contains a listing of the program and its participants, and two articles that review the meeting and the role of the laboratory mousemore » in the Human Genome project. More than 200 papers were presented at the conference covering the following topics: International mouse chromosome committee meetings; Mutant generation and identification; Physical and genetic maps; New technology and resources; Chromatin structure and gene regulation; Rate and hamster genetic maps; Informatics and databases; and Quantitative trait analysis.« less
Time Utilization in the Army Dental Corps
1985-09-01
good patient oral hygiene plays an immediate role in the success of periodontal treatment . Also, there is a continuity between periodontal surgery...much of their interim pre- and post-prosthetic > treatment time with procedures in the "general" category. In the case of oral surgeons, half of the...general procedures (such as hospital ward rounds and cellulitis treatment ) are more related to what an oral surgeon does than to any other specialty
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...
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...
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.
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.
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.
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.
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.
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
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.
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…
DOE Office of Scientific and Technical Information (OSTI.GOV)
Simontacchi, Gabriele; Filippi, Andrea Riccardo, E-mail: andreariccardo.filippi@unito.it; Ciammella, Patrizia
Purpose: This multicenter retrospective study was designed to evaluate the prognostic role of interim fluorodeoxyglucose-labeled positron emission tomography (i-FDG-PET) in a cohort of patients affected with early-stage Hodgkin lymphoma (HL) treated initially with adriamycin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy followed by radiation therapy, and to assess the role of chemotherapy continuation plus radiation therapy for i-FDG-PET-positive patients. Methods and Materials: Data from 257 patients were retrieved from 4 hematology and radiation oncology departments. Inclusion criteria were stage I to IIAB HL, “intention-to-treat” AVBD plus radiation therapy, and FDG-PET at diagnosis and after the first 2 ABVD cycles. All i-FDG-PET scans underwentmore » blinded local review by using the Deauville 5-point scoring system; patients were stratified as negative or positive using 2 Deauville score cutoff values, ≥3 or ≥4. Results: Median follow-up time was 56 months (range: 9-163 months); 5-year overall survival (OS) and disease-specific survival (DSS) for the whole cohort were 97.5% and 98.3%, respectively. Five-year progression-free survival (PFS) was 95.6%. After i-FDG-PET revision, 43 of 257 patients (16.7%) had a positive i-FDG-PET (Deauville scores: 3-5). Five-year PFS rates for i-FDG-PET-negative and i-FDG-PET-positive patients were 98.1% and 83.7%, respectively, if using a Deauville score cutoff of 3, and 97.7% and 78.6%, respectively, if using a cutoff of 4 (P=.0001). Five-year OS for i-FDG-PET-negative and i-FDG-PET-positive patients was 98.5% and 93.0%, respectively, if using a cutoff of 3, and 98.6% and 89.3%, respectively, if using a cutoff of 4 (P=.029 and P=.002). At univariate regression analysis, i-FDG-PET positivity was associated with worse OS and PFS. At multivariate analysis, performed only for PFS, i-FDG-PET positivity confirmed its negative impact (P=.002). Conclusions: i-FDG-PET is prognostic for PFS and OS in early-stage HL patients treated with combined modality therapy; the continuation of chemotherapy followed by radiation therapy is able to obtain durable, complete remission in most i-FDG-PET-positive patients.« less
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
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.
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.
Understanding Organics in Meteorites and the Pre-Biotic Environment
NASA Technical Reports Server (NTRS)
Zare, Richard N.
2003-01-01
(1) Refinement of the analytic capabilities of our experiment via characterization of molecule-specific response and the effects upon analysis of the type of sample under investigation; (2) Measurement of polycyclic aromatic hydrocarbons (PAHs) with high sensitivity and spatial resolution within extraterrestrial samples; (3) Investigation of the interstellar reactions of PAHs via the analysis of species formed in systems modeling dust grains and ices; (4) Investigations into the potential role of PAHs in prebiotic and early biotic chemistry via photoreactions of PAHs under simulated prebiotic Earth conditions. To meet these objectives, we use microprobe laser-desorption, laser-ionization mass spectrometry (MuL(exp 2)MS), which is a sensitive, selective, and spatially resolved technique for detection of aromatic compounds. Appendix A presents a description of the MuL(exp 2)MS technique. The initial grant proposal was for a three-year funding period, while the award was given for a one-year interim period. Because of this change in time period, emphasis was shifted from the first research goal, which was more development-oriented, in order to focus more on the other analysis-oriented goals. The progress made on each of the four research areas is given below.
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.
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
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.
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
The evolving story of information assurance at the DoD.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Campbell, Philip LaRoche
2007-01-01
This document is a review of five documents on information assurance from the Department of Defense (DoD), namely 5200.40, 8510.1-M, 8500.1, 8500.2, and an ''interim'' document on DIACAP [9]. The five documents divide into three sets: (1) 5200.40 & 8510.1-M, (2) 8500.1 & 8500.2, and (3) the interim DIACAP document. The first two sets describe the certification and accreditation process known as ''DITSCAP''; the last two sets describe the certification and accreditation process known as ''DIACAP'' (the second set applies to both processes). Each set of documents describes (1) a process, (2) a systems classification, and (3) a measurement standard.more » Appendices in this report (a) list the Phases, Activities, and Tasks of DITSCAP, (b) note the discrepancies between 5200.40 and 8510.1-M concerning DITSCAP Tasks and the System Security Authorization Agreement (SSAA), (c) analyze the DIACAP constraints on role fusion and on reporting, (d) map terms shared across the documents, and (e) review three additional documents on information assurance, namely DCID 6/3, NIST 800-37, and COBIT{reg_sign}.« less
75 FR 10645 - Low Pathogenic Avian Influenza; Voluntary Control Program and Payment of Indemnity
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-09
...We are adopting as a final rule, with changes, an interim rule that amended the regulations by establishing, under the auspices of the National Poultry Improvement Plan, a voluntary program for the control of the H5/H7 subtypes of low pathogenic avian influenza in commercial poultry. As amended by this document, the rule provides that the amount of indemnity for which contract growers are eligible will be reduced by any payment they have already received on their contracts when poultry in their care are destroyed, clarifies the roles of cooperating State agencies with respect to H5/H7 low pathogenic avian influenza outbreaks, provides that consistency with humane euthanasia guidelines will be considered when selecting a method for the destruction of poultry, and provides additional guidance for cleaning and disinfecting an affected premises. The control program and indemnity provisions established by the interim rule are necessary to help ensure that the H5/H7 subtypes of low pathogenic avian influenza are detected and eradicated when they occur within the United States.
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
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.
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.
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.
2015-12-01
the MIS System/Subsystem Specification ( SSS ), and supplementary BAA document. On June 26, 2014, the SEI provided a draft interim report of the...findings and issues. The SEI team also received July 3, 2014, versions of the MIS Stakeholder Requirements, MIS SSS , and build plan and July 17, 2014...versions of the MIS SSS together with the MIS system model. On July 14–15, 2014, the SEI presented a summary of the issues at the two contractors
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...
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.
Michaelson, M Dror; Oudard, Stephane; Ou, Yen-Chuan; Sengeløv, Lisa; Saad, Fred; Houede, Nadine; Ostler, Peter; Stenzl, Arnulf; Daugaard, Gedske; Jones, Robert; Laestadius, Fredrik; Ullèn, Anders; Bahl, Amit; Castellano, Daniel; Gschwend, Juergen; Maurina, Tristan; Chow Maneval, Edna; Wang, Shaw-Ling; Lechuga, Maria Jose; Paolini, Jolanda; Chen, Isan
2014-01-10
We evaluated angiogenesis-targeted sunitinib therapy in a randomized, double-blind trial of metastatic castration-resistant prostate cancer (mCRPC). Men with progressive mCRPC after docetaxel-based chemotherapy were randomly assigned 2:1 to receive sunitinib 37.5 mg/d continuously or placebo. Patients also received oral prednisone 5 mg twice daily. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS). Two interim analyses were planned. Overall, 873 patients were randomly assigned to receive sunitinib (n = 584) or placebo (n = 289). The independent data monitoring committee stopped the study for futility after the second interim analysis. After a median overall follow-up of 8.7 months, median OS was 13.1 months and 11.8 months for sunitinib and placebo, respectively (hazard ratio [HR], 0.914; 95% CI, 0.762 to 1.097; stratified log-rank test, P = .168). PFS was significantly improved in the sunitinib arm (median 5.6 v 4.1 months; HR, 0.725; 95% CI, 0.591 to 0.890; stratified log-rank test, P < .001). Toxicity and rates of discontinuations because of adverse events (AEs; 27% v 7%) were greater with sunitinib than placebo. The most common treatment-related grade 3/4 AEs were fatigue (9% v 1%), asthenia (8% v 2%), and hand-foot syndrome (7% v 0%). Frequent treatment-emergent grade 3/4 hematologic abnormalities were lymphopenia (20% v 11%), anemia (9% v 8%), and neutropenia (6% v < 1%). The addition of sunitinib to prednisone did not improve OS compared with placebo in docetaxel-refractory mCRPC. The role of antiangiogenic therapy in mCRPC remains investigational.
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.
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.
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.
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.
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.
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
Interim Guidance: Municipal Solid Waste Exemption under Superfund
Interim guidance discusses the statutory provisions of CERCLA § 107(p) and identifies some factors to be considered by EPA and DOJ staff in exercising their enforcement discretion of MSW at an NPL site.
Interim report : a non-overlay cathodic protection system.
DOT National Transportation Integrated Search
1983-01-01
This interim report describes Virginia's experience in installing its first cathodic protection system for a bridge deck. The installation was completed with practically no problems. Very minor problems have been encountered with the rectifier/contro...
Babbush, Charles A; Kanawati, Ali; Kotsakis, Georgios A; Hinrichs, James E
2014-04-01
Patient-related variables such as cost of treatment, length of the treatment period, and comfort provided by the interim prosthesis when treatment planning for full-arch rehabilitation are often neglected in dental publications. Two patient cohorts were followed up longitudinally in this study: the "All-on-4 treatment concept group" and the "historical group." The number of implants, total treatment time, number of surgical procedures, number of sinus grafts, necessity for immediate provisional implants, adjusted cost associated for treatment in each group, and the quality of interim prosthesis were compared. The total adjusted cost for patients receiving All-on-4 treatment concept averaged at $42,422 ± 3860 (&OV0556;31,392 ± 2856), whereas the mean total adjusted cost for the historical group was $57,944 ± 20,198 (&OV0556;42,879 ± 2113) (P = 0.01). The difference in cost had a mean value of $7307 (&OV0556;5407) per jaw. Factors associated with complexity of treatment and patient comfort, such as the quality of interim prosthesis, number of surgeries, and duration of treatment time, all significantly favored the All-on-4 treatment concept group in comparison with conventional treatment modalities. When implant rehabilitation of the total jaw is sought, the All-on-4 treatment concept should be considered the least costly and least time consuming treatment option.
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).
2010-11-17
This document contains an amendment to interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding status as a grandfathered health plan; the amendment permits certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status.
2014-09-30
1 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. PCoD Lite - Using an Interim PCoD Protocol to Assess...Skookum Tom Road Friday Harbor, WA, USA phone: 1-360-370-5493 email: jw@smrullc.com Award Number: N000141410406 http://www.smrumarine.com/ pcod ...DATE 30 SEP 2014 2. REPORT TYPE 3. DATES COVERED 00-00-2014 to 00-00-2014 4. TITLE AND SUBTITLE PCoD Lite - Using an Interim PCoD Protocol to
2002-03-01
9045 4 8985 4 9001 5 8804 5 8893 Mean: 8788.8 Mean: 8925.4 Expected S.D.: 93.7 Expected S.D.: 94.5 Standard Dev.: 136.9 Standard Dev.: 107.4 Variance...subject to lit]) severe criminal penalties. Dissemination in 200204 5 042accordance with DoD Directive 5230.25" Air Force Institute for Environment...COVERED March 2002 INTERIM (2001 - 2002) 4. TITLE AND SUBTITLE 5 . FUNDING NUMBERS Interim Radiological Scoping and Characterization Survey Report, 1963
Interim Land Use Control Implementation Plan
NASA Technical Reports Server (NTRS)
Applegate, Joseph L.
2014-01-01
This Interim Land Use Control Implementation Plan (LUCIP) has been prepared to inform current and potential future users of the Kennedy Space Center (KSC) Contractors Road Heavy Equipment (CRHE) Area (SWMU 055; "the Site") of institutional controls that have been implemented at the Site1. Although there are no current unacceptable risks to human health or the environment associated with the CRHE Area, an interim institutional land use control (LUC) is necessary to prevent human health exposure to volatile organic compound (VOC)-affected groundwater at the Site. Controls will include periodic inspection, condition certification, and agency notification.
Integrated waste management system costs in a MPC system
DOE Office of Scientific and Technical Information (OSTI.GOV)
Supko, E.M.
1995-12-01
The impact on system costs of including a centralized interim storage facility as part of an integrated waste management system based on multi-purpose canister (MPC) technology was assessed in analyses by Energy Resources International, Inc. A system cost savings of $1 to $2 billion occurs if the Department of Energy begins spent fuel acceptance in 1998 at a centralized interim storage facility. That is, the savings associated with decreased utility spent fuel management costs will be greater than the cost of constructing and operating a centralized interim storage facility.
ERIC Educational Resources Information Center
Bailey, Jon S.; Hughes, Ronald G.
Research developments in learning theory over the past fifty years have led to principles of behavior which have been shown in innumerable applied settings to be valuable in analyzing and modifying human behavior. When applied to flying training using simulators, these principles suggest that a significant contribution could be made in improving…
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-22
... (see FAR 25.408). II. Discussion and Analysis This interim rule adds Colombia to the definition of...,000 for construction. Because the Colombia FTA construction threshold of $7,777,000 is the same as the... states that acquisitions that do not exceed $150,000 (with some exceptions) are automatically reserved...
76 FR 28885 - Brucellosis in Swine; Add Texas to List of Validated Brucellosis-Free States
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-19
... movement of breeding swine from Texas. DATES: This interim rule is effective on May 19, 2011. We will..., bison, and swine, but goats, sheep, horses, and even humans are susceptible. In its principal animal... analysis. Breeding swine originating from a validated brucellosis-free State or herd may be moved...
Code of Federal Regulations, 2014 CFR
2014-07-01
... characteristics of anisotropic particles. Quantitative analysis involves the use of point counting. Point counting... 0.004. • Refractive Index Liquids for Dispersion Staining: high-dispersion series, 1.550, 1.605, 1... hand. Repeat the series. Collect the dispersed solids by centrifugation at 1000 rpm for 5 minutes. Wash...
Code of Federal Regulations, 2010 CFR
2010-07-01
... characteristics of anisotropic particles. Quantitative analysis involves the use of point counting. Point counting... 0.004. • Refractive Index Liquids for Dispersion Staining: high-dispersion series, 1.550, 1.605, 1... hand. Repeat the series. Collect the dispersed solids by centrifugation at 1000 rpm for 5 minutes. Wash...
Code of Federal Regulations, 2011 CFR
2011-07-01
... characteristics of anisotropic particles. Quantitative analysis involves the use of point counting. Point counting... 0.004. • Refractive Index Liquids for Dispersion Staining: high-dispersion series, 1.550, 1.605, 1... hand. Repeat the series. Collect the dispersed solids by centrifugation at 1000 rpm for 5 minutes. Wash...
Code of Federal Regulations, 2012 CFR
2012-07-01
... characteristics of anisotropic particles. Quantitative analysis involves the use of point counting. Point counting... 0.004. • Refractive Index Liquids for Dispersion Staining: high-dispersion series, 1.550, 1.605, 1... hand. Repeat the series. Collect the dispersed solids by centrifugation at 1000 rpm for 5 minutes. Wash...
Code of Federal Regulations, 2013 CFR
2013-07-01
... characteristics of anisotropic particles. Quantitative analysis involves the use of point counting. Point counting... 0.004. • Refractive Index Liquids for Dispersion Staining: high-dispersion series, 1.550, 1.605, 1... hand. Repeat the series. Collect the dispersed solids by centrifugation at 1000 rpm for 5 minutes. Wash...
ERIC Educational Resources Information Center
Dembo, Richard; Briones-Robinson, Rhissa; Ungaro, Rocio; Barrett, Kimberly; Gulledge, Laura; Winters, Ken C.; Belenko, Steven; Karas, Lora M.; Wareham, Jennifer
2014-01-01
Truant youths frequently experience family problems, emotional/psychological issues, substance misuse, and delinquency. They are likely engaging in alcohol use and sexual risk behavior at a higher rate than the general youth population. Early intervention services would benefit them, their families, and society. We present interim findings from an…
ERIC Educational Resources Information Center
Crawshaw, Robert
An examination of the principles and techniques of oral testing in British university-level final examinations in modern languages discusses: (1) the shortcomings of present oral testing procedures; (2) the theoretical controversy surrounding the design and value of oral proficiency tests, arising from research in English as a second language…
Home Start Evaluation Study. Interim Report II: Program Analysis. Revised Draft.
ERIC Educational Resources Information Center
Deloria, Dennis; And Others
This document is the second in a series of evaluative reports directed to evaluation needs of Home Start planners and administrators. It focuses on implementation data about programs gathered during local site visits conducted in the spring and fall of 1972. The two basic evaluative questions asked are: (1) What was Home Start intended by its…
Response Surface Analysis. National Consortium for Humanizing Education, Interim Report No. 3.
ERIC Educational Resources Information Center
Roebuck, Flora N.; Aspy, D. N.
One of the major studies conducted by the Consortium involved examining the inter-relationships of various aspects of teacher and student classroom functioning to determine what happens to a particular class of teacher or student behavior as the quantity and/or quality of other aspects of classroom interaction change. This examination occurred in…
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...
A web-based endpoint adjudication system for interim analyses in clinical trials.
Nolen, Tracy L; Dimmick, Bill F; Ostrosky-Zeichner, Luis; Kendrick, Amy S; Sable, Carole; Ngai, Angela; Wallace, Dennis
2009-02-01
A data monitoring committee (DMC) is often employed to assess trial progress and review safety data and efficacy endpoints throughout a trail. Interim analyses performed for the DMC should use data that are as complete and verified as possible. Such analyses are complicated when data verification involves subjective study endpoints or requires clinical expertise to determine each subject's status with respect to the study endpoint. Therefore, procedures are needed to obtain adjudicated data for interim analyses in an efficient manner. In the past, methods for handling such data included using locally reported results as surrogate endpoints, adjusting analysis methods for unadjudicated data, or simply performing the adjudication as rapidly as possible. These methods all have inadequacies that make their sole usage suboptimal. For a study of prophylaxis for invasive candidiasis, adjudication of both study eligibility criteria and clinical endpoints prior to two interim analyses was required. Because the study was expected to enroll at a moderate rate and the sponsor required adjudicated endpoints to be used for interim analyses, an efficient process for adjudication was required. We created a web-based endpoint adjudication system (WebEAS) that allows for expedited review by the endpoint adjudication committee (EAC). This system automatically identifies when a subject's data are complete, creates a subject profile from the study data, and assigns EAC reviewers. The reviewers use the WebEAS to review the subject profile and submit their completed review form. The WebEAS then compares the reviews, assigns an additional review as a tiebreaker if needed, and stores the adjudicated data. The study for which this system was originally built was administratively closed after 10 months with only 38 subjects enrolled. The adjudication process was finalized and the WebEAS system activated prior to study closure. Some website accessibility issues presented initially. However, once these issues were resolved, the reviewers found the system user-friendly and easy to navigate. Web-based data adjudication depends upon expeditious data collection and verification. Further, ability to use web-based technologies, in addition to clinical expertise, must be considered in selecting EAC members. The automated nature of this system makes it a practical mechanism for ensuring timely endpoint adjudication. The authors believe a similar approach could be useful for handling endpoint adjudication for future clinical trials.
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.
A randomized controlled trial of interim methadone maintenance.
Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J
2006-01-01
Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (P<.001). Overall, in the past 30 days at follow-up, interim participants reported significantly fewer days of heroin use (P<.001), had a significant reduction in heroin-positive drug test results (P<.001), reported spending less money on drugs (P<.001), and received less illegal income (P<.02) than the waiting list participants. Interim methadone maintenance results in a substantial increase in the likelihood of entry into comprehensive treatment, and is an effective means of reducing heroin use and criminal behavior among opioid-dependent individuals awaiting entry into a comprehensive methadone treatment program.
5th ESA Workshop on Joint Interim Approaches to NAS Recommendations
EPA and its federal partners, Fish and Wildlife Service and National Marine Fisheries Service, held a two-day meeting that provided a forum for stakeholder suggestions for refining some of the interim scientific methods
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-25
... through the HEARTH Act. The statutory provisions and the implementing interim regulations that govern RHSP... HEARTH Act. The statutory provisions and the implementing interim regulations that govern RHSP require...
Intelligent cruise control field operational test : interim report
DOT National Transportation Integrated Search
1997-03-01
This interim document reports on a cooperative agreement between NHTSA and UMTRI entitled Intelligent Cruise Control (ICC) Field Operational Test (FOT). The overarching goal of the work is to characterize safety and comfort issues that are fundamenta...
Computerization of material test data reporting system : interim report.
DOT National Transportation Integrated Search
1973-09-01
This study was initiated to provide an integrated system of reporting, storing, and retrieving of construction and material test data using computerized (storage-retrieval) and quality control techniques. The findings reported in this interim report ...
2005 Annual Operations Report for INTEC Operable Unit 3-13, Group 1, Tank Farm Interim Action
DOE Office of Scientific and Technical Information (OSTI.GOV)
D. Shanklin
2006-07-19
This annual operations report describes the requirements followed and activities conducted to inspect, monitor, and maintain the items installed during performance of the Waste Area Group 3, Operable Unit 3-13, Group 1, Tank Farm Interim Action, at the Idaho Nuclear Technology and Engineering Center. This report describes inspection and monitoring activities fro the surface-sealed areas within the tank farm, concrete-lined ditches and culverts in and around the tank farm, the lift station, and the lined evaporation pond. These activities are intended to assure that the interim action is functioning adequately to meet the objectives stated in the Operable Unit 3-13,more » Record of Decision for the Group 1, Tank Farm Interim Action, (DOE/ID-10660) and as amended by the agreement to resolve dispute, which was effective in February 2003.« less
2006 Annual Operations Report for INTEC Operable Unit 3-13, Group 1, Tank Farm Interim Action
DOE Office of Scientific and Technical Information (OSTI.GOV)
D. E. Shanklin
2007-02-14
This annual operations report describes the requirements followed and activities conducted to inspect, monitor, and maintain the items installed during performance of the Waste Area Group 3, Operable Unit 3-13, Group 1, Tank Farm Interim Action, at the Idaho Nuclear Technology and Engineering Center. This report covers the time period from January 1 through December 31, 2006, and describes inspection and monitoring activities for the surface-sealed areas within the tank farm, concrete-lined ditches and culverts in and around the tank farm, the lift station, and the lined evaporation pond. These activities are intended to assure that the interim action ismore » functioning adequately to meet the objectives stated in the Operable Unit 3-13, Record of Decision for the Group 1, Tank Farm Interim Action (DOE/ID-10660) as described in the Group 1 Remedial Design/Remedial Action Work Plan (DOE/ID-10772).« less
Using ERA-Interim reanalysis for creating datasets of energy-relevant climate variables
NASA Astrophysics Data System (ADS)
Jones, Philip D.; Harpham, Colin; Troccoli, Alberto; Gschwind, Benoit; Ranchin, Thierry; Wald, Lucien; Goodess, Clare M.; Dorling, Stephen
2017-07-01
The construction of a bias-adjusted dataset of climate variables at the near surface using ERA-Interim reanalysis is presented. A number of different, variable-dependent, bias-adjustment approaches have been proposed. Here we modify the parameters of different distributions (depending on the variable), adjusting ERA-Interim based on gridded station or direct station observations. The variables are air temperature, dewpoint temperature, precipitation (daily only), solar radiation, wind speed, and relative humidity. These are available on either 3 or 6 h timescales over the period 1979-2016. The resulting bias-adjusted dataset is available through the Climate Data Store (CDS) of the Copernicus Climate Change Data Store (C3S) and can be accessed at present from ftp://ecem.climate.copernicus.eu. The benefit of performing bias adjustment is demonstrated by comparing initial and bias-adjusted ERA-Interim data against gridded observational fields.
The WFIRST Interim Design Reference Mission: Capabilities, Constraints, and Open Questions
NASA Technical Reports Server (NTRS)
Kruk, Jeffrey W.
2012-01-01
The Project Office and Science Definition Team for the Wide-Field Infrared Survey Telescope (WFIRST) are in the midst of a pre-Phase A study to establish a Design Reference Mission (DRM). An Interim report was released in June 2011, with a final report due later in 2012. The predicted performance of the Interim DRM Observatory will be described, including optical quality, observing efficiency, and sensitivity for representative observing scenarios. Observing constraints and other limitations on performance will also be presented, with an emphasis on potential Guest Observer programs. Finally, a brief status update will be provided on open trade studies of interest to the scientific community. The final DRM may differ from the Interim DRM presented here. However, the underlying requirements of the scientific programs are not expected to change, hence the capabilities of the IDRM are likely to be maintained even if the implementation changes in significant ways.
1986-05-01
AD-ft?l 552 TIGHT BOUNDS FOR NININAX GRID MATCHING WITH i APPLICATIONS TO THE AVERAGE C.. (U) MASSACHUSETTS INST OF TECH CAMBRIDGE LAS FOR COMPUTER...MASSACHUSETTS LABORATORYFORNSTITUTE OF COMPUTER SCIENCE TECHNOLOGY MIT/LCS/TM-298 TIGHT BOUNDS FOR MINIMAX GRID MATCHING, WITH APPLICATIONS TO THE AVERAGE...PERIOD COVERED Tight bounds for minimax grid matching, Interim research with applications to the average case May 1986 analysis of algorithms. 6
2010-05-01
textiles include “soft” body armor; spall liners for combat vehicles; flame protection garments; and protective braided sleeves for hoses and cable...summarizes the results of an Interim Base Case analysis of those materials as well. Chapter Four offers IDA’s initial ideas regarding opportunities that...process in the requirements analysis process by which the department determines the NDS goals, or stockpile requirements, it will recommend to the
Interim reliability evaluation program, Browns Ferry 1
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mays, S.E.; Poloski, J.P.; Sullivan, W.H.
1981-01-01
Probabilistic risk analysis techniques, i.e., event tree and fault tree analysis, were utilized to provide a risk assessment of the Browns Ferry Nuclear Plant Unit 1. Browns Ferry 1 is a General Electric boiling water reactor of the BWR 4 product line with a Mark 1 (drywell and torus) containment. Within the guidelines of the IREP Procedure and Schedule Guide, dominant accident sequences that contribute to public health and safety risks were identified and grouped according to release categories.
An evaluation of very large airplanes and alternative fuels. Interim report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Mikolowsky, W.T.; Noggle, L.W.; Hederman, W.F.
1976-12-01
Very large airplanes using alternative fuels are examined in the context of existing and possible future Air Force missions. Synthetic jet fuel (JP), liquid methane, liquid hydrogen, and nuclear propulsion are the fuel alternatives selected for detailed analysis. Conceptual designs of airplanes using each of these fuels were developed and estimates were made of their lifecycle cost and life-cycle energy consumption. Mission analyses were performed to determine the effectiveness of the alternative airplanes in strategic airlift specifically and in the station-keeping role in general. Results indicate that for most military applications airplanes with gross weights in excess of one millionmore » pounds promise to be superior to any comtemporary airplanes in terms of cost-effectiveness and energy-hydrocarbon jet fuel, whether manufactured from oil shale, coal or crude oil, remains the most attractive aviation fuel for future Air Force use. Policy recommendations are made pertaining both to alternative fuels and to advanced-technology large airplanes. Future research and developments are also identified.« less
A Humidity-Driven Prediction System for Influenza Outbreaks
NASA Astrophysics Data System (ADS)
Thrastarson, H. T.; Teixeira, J.
2015-12-01
Recent studies have highlighted the role of absolute (or specific) humidity conditions as a leading explanation for the seasonal behavior of influenza outbreaks in temperate regions. If the timing and intensity of seasonal influenza outbreaks can be forecast, this would be of great value for public health response efforts. We have developed and implemented a SIRS (Susceptible-Infectious-Recovered-Susceptible) type numerical prediction system that is driven by specific humidity to predict influenza outbreaks. For the humidity, we have explored using both satellite data from the AIRS (Atmospheric Infrared Sounder) instrument as well as ERA-Interim re-analysis data. We discuss the development, testing, sensitivities and limitations of the prediction system and show results for influenza outbreaks in the United States during the years 2010-2014 (modeled in retrospect). Comparisons are made with other existing prediction systems and available data for influenza outbreaks from Google Flu Trends and the CDC (Center for Disease Control), and the incorporation of these datasets into the forecasting system is discussed.
Latex and microsilica modified concrete bridge deck overlays in Oregon : interim report.
DOT National Transportation Integrated Search
1994-08-01
This interim report presented information collected from 24 bridge deck overlays constructed in Oregon between 1989 and 1993. Decks were placed on a variety of existing structures using hydroblasting, milling and diamond grinding surface preparation....
Autonomy Level Specification for Intelligent Autonomous Vehicles
2003-09-01
Autonomy Level Specification for Intelligent Autonomous Vehicles : Interim Progress Report Hui-Min Huang, Elena Messina, James Albus...Level Specification for Intelligent Autonomous Vehicles : Interim Progress Report 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6
Evaluation of experimental rumble strip areas in Louisiana : interim report No. 1.
DOT National Transportation Integrated Search
1985-03-01
This interim report was prepared to provide a review of nineteen rumble strip areas installed experimentally in Louisiana between August 1982 and September 1983. Situated randomly throughout central and southern Louisiana, construction of these coars...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-28
... Agreement (TPP). The interim environmental review will be available at: http://www.ustr.gov/trade-topics... available at: http://www.ustr.gov/trade-topics/environment/environmental-reviews . The purpose of...
Interim Assessment of the VAL Automated Guideway Transit System.
DOT National Transportation Integrated Search
1981-11-01
This report describes an interim assessment of the VAL (Vehicules Automatiques Legers or Light Automated Vehicle) AGT system which is currently under construction in Lille, France, and which is to become fully operational in December 1983. This repor...
Group sequential designs for stepped-wedge cluster randomised trials
Grayling, Michael J; Wason, James MS; Mander, Adrian P
2017-01-01
Background/Aims: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Methods: Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. Results: We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial’s type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. Conclusion: The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into stepped-wedge cluster randomised trials according to the needs of the particular trial. PMID:28653550
Group sequential designs for stepped-wedge cluster randomised trials.
Grayling, Michael J; Wason, James Ms; Mander, Adrian P
2017-10-01
The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into stepped-wedge cluster randomised trials according to the needs of the particular trial.
2014-02-01
a 0.18 in thick polymer interlayer between two layers of 0.5 in tempered silica based “ soda lime ” glass . A 0.08 in shatter resistant film was...AFCEC-CX-TY-TR-2014-0005 ANALYSIS OF MULTIPLE-IMPACT BALLISTIC PERFORMANCE OF A TEMPERED GLASS LAMINATE WITH A STRIKE FACE FILM Michael A. Magrini...Interim Technical Report 3 JAN 2012 to 2 JAN 2013 Analysis of Multiple-Impact Ballistic Performance of A Tempered Glass Laminate with a Strike Face Film
Sources and Nature of Cost Analysis Data Base Reference Manual.
1983-07-01
COVERED Sources and Nature of Cost Analysis Data Base Interim Report (Update) Reference Manual 6 . PERFORMING ORG. REPORT NUMBER USAAVRADCOM TM 83-F-3 7 ...SECTION 6 - DATA FOR MULTIPLE APPLICATIONS 6.0.0 7.0.0 SECTION 7 - GLOSSARY OF COST ANALYSIS TERMS SECTION 8 - REFERENCES 8.0.0 SECTION 9 - BIBLIOGRAPHY...Relationsh-;ips Manual for the Army 1.14. 1 Yateri ci Command, TP-449, Mla; 1912 ( 7 21 RACKFORS JiR 1CO(PTER, INC. xlB.Aii- 6 -4A 1.15. 1 Z FNE>:THj MUNSON
Acoustic emission monitoring of steel bridge members : interim report.
DOT National Transportation Integrated Search
1995-01-01
This interim report describes the current status of acoustic emission (AE) monitoring of steel bridge members. The report includes a brief introduction to the theory of acoustic emission and a comprehensive summary of previous efforts to apply AE mon...
33 CFR 385.38 - Interim goals.
Code of Federal Regulations, 2010 CFR
2010-07-01
.... (ii) Improvement in water quality; including: (A) Total phosphorus concentrations in the Everglades...) Increases in total spatial extent of restored wetlands; (B) Improvement in habitat quality; and (C... implementation process. In addition, interim goals will facilitate adaptive management and allow the Corps of...
16 CFR 1209.1 - Scope and application.
Code of Federal Regulations, 2014 CFR
2014-01-01
... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM... part 1209, an interim consumer product safety standard, prescribes flame resistance and corrosiveness requirements for cellulose insulation that is a consumer product. These requirements are intended to reduce or...
16 CFR 1209.1 - Scope and application.
Code of Federal Regulations, 2011 CFR
2011-01-01
... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM... part 1209, an interim consumer product safety standard, prescribes flame resistance and corrosiveness requirements for cellulose insulation that is a consumer product. These requirements are intended to reduce or...
16 CFR 1209.1 - Scope and application.
Code of Federal Regulations, 2012 CFR
2012-01-01
... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM... part 1209, an interim consumer product safety standard, prescribes flame resistance and corrosiveness requirements for cellulose insulation that is a consumer product. These requirements are intended to reduce or...
Determination of rainfall losses in Virginia, phase II : interim report.
DOT National Transportation Integrated Search
1981-01-01
This interim report summarizes results obtained for the project through May 1981. The objective of the study is to develop rainfall loss parameters for localities in Virginia. For this purpose, the state has been divided into eleven hydrologic region...
75 FR 77733 - Federal Acquisition Regulation; Preventing Abuse of Interagency Contracts
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-13
... DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE... Aeronautics and Space Administration (NASA). ACTION: Interim rule with request for comments. SUMMARY: The..., including economies and efficiencies and the ability to leverage resources. This interim rule, which...
76 FR 12550 - Lavatory Oxygen Systems
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-08
... Lavatory Oxygen Systems AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Interim final rule... related to the provisioning of supplemental oxygen inside lavatories. This action is necessitated by other mandatory actions that temporarily render such oxygen systems inoperative. DATES: This interim rule is...
75 FR 7955 - Changes in Flood Elevation Determinations
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 65 [Docket ID FEMA...: Federal Emergency Management Agency, DHS. ACTION: Interim rule. SUMMARY: This interim rule lists..., Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street SW...
76 FR 49674 - Changes in Flood Elevation Determinations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-11
... in their floodplain management requirements. The community may at any time enact stricter... DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 65 [Docket ID FEMA...: Federal Emergency Management Agency, DHS. ACTION: Interim rule. SUMMARY: This interim rule lists...
Lessons for outsourcing and interim management relationships.
Macko, W; Kostyack, P T
1999-01-01
Few decisions can affect an organization more than the selection of an outsourcing or interim management partner. More and more health care organizations face such decisions in today's competitive market in order to face new business needs. Making these relationships successful can be important for health care organizations seeking competitive advantages or seeking immediately accessible management support. These relationships, however, require careful partner selection and development. Success in outsourcing and interim management relationships is contingent upon a thorough selection process, a strong contract that has clearly and explicitly detailed responsibilities and a culture-sensitive business rapport between the client and selected partner.
NASA Technical Reports Server (NTRS)
Friedl, Randall R. (Editor)
1997-01-01
This first interim assessment of the subsonic assessment (SASS) project attempts to summarize concisely the status of our knowledge concerning the impacts of present and future subsonic aircraft fleets. It also highlights the major areas of scientific uncertainty, through review of existing data bases and model-based sensitivity studies. In view of the need for substantial improvements in both model formulations and experimental databases, this interim assessment cannot provide confident numerical predictions of aviation impacts. However, a number of quantitative estimates are presented, which provide some guidance to policy makers.
2005-03-16
This interim final rule establishes requirements and procedures for implementation of TRICARE Reserve Select. It also revises requirements and procedures for the Transitional Assistance Management Program. In addition, it establishes requirements and procedures for implementation of the earlier TRICARE eligibility for certain reserve component members. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates.
Seasonal and Interannual Variations of Heat Fluxes in the Barents Sea Region
NASA Astrophysics Data System (ADS)
Bashmachnikov, I. L.; Yurova, A. Yu.; Bobylev, L. P.; Vesman, A. V.
2018-03-01
Seasonal and interannual variations in adjective heat fluxes in the ocean ( dQ oc) and the convergence of advective heat fluxes in the atmosphere ( dQ atm) in the Barents Sea region have been investigated over the period of 1993-2012 using the results of the MIT regional eddy-permitting model and ERA-Interim atmospheric reanalysis. Wavelet analysis and singular spectrum analysis are used to reveal concealed periodicities. Seasonal 2- to 4- and 5- to 8-year cycles are revealed in the dQ oc and dQ atm data. It is also found that seasonal variations in dQ oc are primarily determined by the integrated volume fluxes through the western boundary of the Barents Sea, whereas the 20-year trend is determined by the temperature variation of the transported water. A cross-wavelet analysis of dQ oc and dQ atm in the Barents Sea region shows that the seasonal variations in dQ oc and dQ atm are nearly in-phase, while their interannual variations are out-of-phase. It is concluded that the basin of the Barents Sea plays an important role in maintaining the feedback mechanism (the Bjerknes compensation) of the ocean-atmosphere system in the Arctic region.
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.
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.
Analysis of Syllabi Intending to Prepare Teachers to Be Data Literate: An Interim Report
ERIC Educational Resources Information Center
WestEd, 2013
2013-01-01
This report documents the work of one component of a larger research effort. The objective of the project is to understand what schools of education are doing to prepare teachers to use data in their practice. The issue is multifaceted, complex, and systemic. Schools of education do not act alone to suddenly introduce courses on data-driven…
Solar Market Research and Analysis Publications | Solar Research | NREL
lifespan, and saving costs. The report is an expanded edition of an interim report published in 2015. Cost achieving the SETO 2030 residential PV cost target of $0.05 /kWh by identifying and quantifying cost reduction opportunities. Distribution Grid Integration Unit Cost Database: This database contains unit cost
Code of Federal Regulations, 2010 CFR
2010-07-01
... emissions analysis as listed in § 93.127 need not be explicitly considered): (1) All in-place regionally... must include the project with its original design concept and scope, and the ‘Action’ scenario must include the project with its new design concept and scope. [62 FR 43801, Aug. 15, 1997, as amended at 69...