The use of robotics for nondestructive inspection of steel highway bridges and structures: interim report.

DOT National Transportation Integrated Search

1998-01-01

This interim report describes the progress during the first year of a project to develop robotics hardware for nondestructive evaluation of steel structures. The project objectives are to (1) develop and test an improved prototype (POLECAT-II) crawli...

Making the Most of Interim Assessment Data. Lessons from Philadelphia

ERIC Educational Resources Information Center

Christman, Jolley Bruce; Neild, Ruth Curran; Bulkley, Katrina; Blanc, Suzanne; Liu, Roseann; Mitchell, Cecily; Travers, Eva

2009-01-01

Under No Child Left Behind, urban school districts have increasingly turned to interim assessments, administered at regular intervals, to help gauge student progress in advance of annual state exams. These assessments have spawned growing debate among educators, assessment experts, and the testing industry: are they worth the significant…

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…

Grant Closeout Requirements and Reports

Cancer.gov

Requirements and reports to comply with grant closeout, including Final Federal Financial Report (FFR, SF425); Final Research Performance Progress Report (FRPPR); Interim Research Performance Progress Report (IRPPR); Final Invention Statement (FIS, HHS

Progress and future direction for the interim safe storage and disposal of Hanford high-level waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kinzer, J.E.; Wodrich, D.D.; Bacon, R.F.

This paper describes the progress made at the largest environmental cleanup program in the United States. Substantial advances in methods to start interim safe storage of Hanford Site high-level wastes, waste characterization to support both safety- and disposal-related information needs, and proceeding with cost-effective disposal by the U.S. Department of Energy (DOE) and its Hanford Site contractors, have been realized. Challenges facing the Tank Waste Remediation System (TWRS) Program, which is charged with the dual and parallel missions of interim safe storage and disposal of the high-level tank waste stored at the Hanford Site, are described. In these times ofmore » budget austerity, implementing an ongoing program that combines technical excellence and cost effectiveness is the near-term challenge. The technical initiatives and progress described in this paper are made more cost effective by DOE`s focus on work force productivity improvement, reduction of overhead costs, and reduction, integration and simplification of DOE regulations and operations requirements to more closely model those used in the private sector.« less

33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

33 CFR 385.39 - Evaluating progress towards other water-related needs of the region provided for in the Plan.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROGRAMMATIC REGULATIONS... other. (3) The Department of the Army shall include these interim targets in appropriate Corps of... provided for in the Plan. These interim targets shall reflect the incremental accomplishment of the...

78 FR 67442 - Congestion Mitigation and Air Quality Improvement Program Interim Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... the CMAQ Program as a result of the enactment of the Moving Ahead for Progress in the 21st Century Act (MAP-21). The Interim Guidance also contains changes to clarify the 2008 CMAQ Program Guidance. Because... Act for the 21st Century (TEA-21) (Pub. L. 105-178; Oct. 1998) and the Safe, Accountable, Flexible...

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...

Elder Abuse Demonstration Project. Third Interim Report to the Illinois General Assembly on Public Acts 83-1259 and 83-1432.

ERIC Educational Resources Information Center

Illinois State Dept. on Aging, Springfield.

This document contains the third annual interim report of the Illinois Elder Abuse Demonstration Program. It discusses the overall intent of the demonstration program, trends and changes in the third year of the demonstration program compared with the results from the first two years of the program, and achievements and recommendations for a…

NASA Electronic Library System (NELS) optimization

NASA Technical Reports Server (NTRS)

Pribyl, William L.

1993-01-01

This is a compilation of NELS (NASA Electronic Library System) Optimization progress/problem, interim, and final reports for all phases. The NELS database was examined, particularly in the memory, disk contention, and CPU, to discover bottlenecks. Methods to increase the speed of NELS code were investigated. The tasks included restructuring the existing code to interact with others more effectively. An error reporting code to help detect and remove bugs in the NELS was added. Report writing tools were recommended to integrate with the ASV3 system. The Oracle database management system and tools were to be installed on a Sun workstation, intended for demonstration purposes.

2015 NWEA Measures of Academic Progress Normative Data

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2015

2015-01-01

By using carefully constructed measurement scales that span grades, Measures of Academic Progress (MAP) interim assessments from Northwest Evaluation Association™ (NWEA™) offer educators efficient and very accurate estimates of student achievement status within a subject. Before achievement test scores can be useful to educators, however, they…

Baltimore Community Schools: Promise & Progress

ERIC Educational Resources Information Center

Durham, Rachel E.; Connolly, Faith

2016-01-01

This report documents the interim progress of the Baltimore Community School (CommSch) strategy by examining outcomes for the 2014-15 school year. Results show that CommSch parents more often reported being connected with community resources by school staff compared to parents at other schools. They also were more likely to report that school…

Pewaukee School District, Wisconsin. Case Study: Measures of Academic Progress

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2015

2015-01-01

For more than a decade, Pewaukee School District Superintendent JoAnn Sternke has watched her district get better and better at its mission: opening the door to each student's future. The Wisconsin district began using Measures of Academic Progress® (MAP®) computer adaptive interim assessments from Northwest Evaluation Association™ (NWEA™) in 2004…

Progress Report 2013. Turnaround Arts Initiative

ERIC Educational Resources Information Center

Stoelinga, Sara Ray; Joyce, Katie; Silk, Yael

2013-01-01

This interim progress report provides a look at Turnaround Arts schools in their first year, including: (1) a summary of the evaluation design and research questions; (2) a preliminary description of strategies used to introduce the arts in Turnaround Arts schools; and (3) a summary of school reform indicators and student achievement data at…

An Evaluation of the Individual Training Account/Eligible Training Provider Demonstration. Final Interim Report.

ERIC Educational Resources Information Center

D'Amico, Ronald; Martinez, Alexandria; Salzman, Jeffrey; Wagner, Robin

In March 2000, thirteen grants were awarded as part of the Individual Training Account/Eligible Training Provider (ITA/ETP) Demonstration. In summer and fall of 2000, the grant recipients' activities were subjected to an interim evaluation. Site visits were made to each grantee to determine what ITA policies and practices were being formulated,…

Emulytics for Cyber-Enabled Physical Attack Scenarios: Interim LDRD Report of Year One Results.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Clem, John; Urias, Vincent; Atkins, William Dee

Sandia National Laboratories has funded the research and development of a new capability to interactively explore the effects of cyber exploits on the performance of physical protection systems. This informal, interim report of progress summarizes the project’s basis and year one (of two) accomplishments. It includes descriptions of confirmed cyber exploits against a representative testbed protection system and details the development of an emulytics capability to support live, virtual, and constructive experiments. This work will support stakeholders to better engineer, operate, and maintain reliable protection systems.

Pembrolizumab for Ipilimumab-Resistant Melanoma

Cancer.gov

KEYNOTE-002 was designed to test the safety and efficacy of two doses of pembrolizumab compared with chemotherapy in patients with ipilimumab-resistant melanoma; interim results show that pembrolizumab improves progression-free survival for these patients

CT-based texture analysis potentially provides prognostic information complementary to interim fdg-pet for patients with hodgkin's and aggressive non-hodgkin's lymphomas.

PubMed

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.

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

Cancer.gov

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.

LANDFILLS AS BIOREACTORS: RESEARH AT THE OUTER LOOP LANDFILL, LOUISVILLE, KENTUCKY; FIRST INTERIM REPORT

EPA Science Inventory

Interim report resulting from a cooperative research and development agreement (CRADA) between US EP A's Officeof Research and Development - National Risk Management Research Laboratory and a n ongoing field demonstration
of municipal waste landfills being operated as bioreact...

Quantum Manybody Physics with Rydberg Polaritons

DTIC Science & Technology

2016-06-22

report, such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED...for public release. Over the course of this grant, we have seen tremendous progress, both theoretically and experimentally , in our control of photonic...shown in multiple stages of construction at left and below, spans three optical tables in two rooms: One for the experimental control system

75 FR 8412 - Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... NUCLEAR REGULATORY COMMISSION [NRC-2010-0047] Office of New Reactors: Interim Staff Guidance on Assessing Ground Water Flow and Transport of Accidental Radionuclide Releases; Solicitation of Public... ground water flow and transport of accidental radionuclide releases necessary to demonstrate compliance...

Contractors Road Heavy Equipment Area SWMU 055 Corrective Measures Implementation Progress Report Kennedy Space Center, Florida

NASA Technical Reports Server (NTRS)

Johnson, Jill W. (Compiler)

2015-01-01

This Corrective Measures Implementation (CMI) Progress Report documents: (i) activities conducted as part of supplemental assessment activities completed from June 2009 through November 2014; (ii) Engineering Evaluation (EE) Advanced Data Packages (ADPs); and (iii) recommendations for future activities related to corrective measures at the Site. Applicable meeting minutes are provided as Appendix A. The following EE ADPs for CRHE are included with this CMI Progress Report: center dot Supplemental Site Characterization ADP (Step 1 EE) (Appendix B) center dot Site Characterization ADP (Step 1 EE) for Hot Spot 1 (HS1) (Appendix C) center dot Remedial Alternatives Evaluation (Step 2 EE) ADP for HS1 (Appendix D) center dot Interim Measures Work Plan (Step 3 EE) ADP for HS1 (Appendix E) center dot Site Characterization ADP (Step 1 EE) ADP for Hot Spot 2 (HS2), High Concentration Plume (HCP), and Low Concentration Plume (LCP) (Appendix F) A summary of direct-push technology (DPT) and groundwater monitoring well sampling results are provided in Appendices G and H, respectively. The Interim Land Use Control Implementation Plan (LUCIP) is provided as Appendix I. Monitoring well completion reports, other applicable field forms, survey data, and analytical laboratory reports are provided as Appendices J through M, respectively, in the electronic copy of this document. Selected Site photographs are provided in Appendix N. The interim groundwater monitoring plan and document revision log are included as Appendices O and P, respectively. KSC Electronic Data Deliverable (KEDD) files are provided on the attached compact disk.

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

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.

A pavement management research program for Oregon highways : interim report.

DOT National Transportation Integrated Search

1985-03-01

This is the first in a series of reports documenting progress on a statewide pavement management research project. The overall project is conducting research into pavement life cycles of different rehabilitation treatment; the cost-effectiveness of e...

Shale embankment construction criteria : experimental feature interim report.

DOT National Transportation Integrated Search

1985-06-01

The research was conducted in the summer of 1983 during the realignment construction of the Mystic Creek - Camas Valley section on the Coos Bay - Roseburg Highway. Construction is still in progress. As outlined in the experimental features work plan ...

Dip-coating process: Silicon sheet growth development for the large-area silicon sheet task of the low-cost silicon solar array project

NASA Technical Reports Server (NTRS)

Zook, J. D.; Heaps, J. D.; Maciolek, R. B.; Koepke, B. G.; Gutter, C. D.; Schuldt, S. B.

1977-01-01

The objective of this research program is to investigate the technical and economic feasibility of producing solar-cell-quality sheet silicon by coating one surface of carbonized ceramic substrates with a thin layer of large-grain polycrystalline silicon from the melt. The past quarter demonstrated significant progress in several areas. Seeded growth of silicon-on-ceramic (SOC) with an EFG ribbon seed was demonstrated. Different types of mullite were successfully coated with silicon. A new method of deriving minority carrier diffusion length, L sub n from spectral response measurements was evaluated. ECOMOD cost projections were found to be in good agreement with the interim SAMIS method proposed by JPL. On the less positive side, there was a decrease in cell performance which we believe to be due to an unidentified source of impurities.

Region 5: Ohio Canton - Massilon Adequate Letter (2/10/2010)

EPA Pesticide Factsheets

This is a letter from John Mooney, Chief, to Jenifer Hunter regarding Ohio's SIP for the Establishment of Interim Progress for the Fine Particle National Ambient Air Quality and early fine particulate (PM2.5) transportation conformity emission budgets.

77 FR 24952 - Agency Information Collection Activities; Proposed Collection; Comment Request; Regional Haze...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

....regulations.gov Web site is an ``anonymous access'' system, which means the EPA will not know your identity or... and the states will be shifting their focus to development of interim progress reports required by the...

Vibratory roller evaluation study : interim report No. 1.

DOT National Transportation Integrated Search

1974-08-01

The Louisiana Department of Highways has in progress a two phase program to evaluate the use of vibratory rollers in the compaction of asphaltic concrete pavements. Phase one on the first construction project is now complete with eight different vibr...

Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

PubMed

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 Process Evaluation of Project Developmental Continuity, Interim Report VI: Recommendations for Continuing the Impact Study.

ERIC Educational Resources Information Center

Granville, Arthur; And Others

This interim report re-examines data on instrument suitability, comparability of groups, and adequacy of sample size in Year III of the process evaluation of Project Developmental Continuity (PDC) and offers preliminary recommendations concerning the feasibility of continuing the impact study. PDC is a Head Start demonstration program aimed at…

A Process Evaluation of Project Developmental Continuity. Interim Report VI: Executive Summary. Recommendations for Continuing the Impact Study.

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…

A Process Evaluation of Project Developmental Continuity. Interim Report IV, Volume 2: Development of the Implementation and Cost Studies.

ERIC Educational Resources Information Center

Smith, Allen G.; And Others

This interim report describes the development of program implementation and cost studies for Year II of the process evaluation of Project Developmental Continuity (PDC), a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and primary school experiences. Specific areas focused…

Study of New Youth Initiatives in Apprenticeship. Interim Report. Volume 1: Summary and Issues.

ERIC Educational Resources Information Center

CSR, Inc., Washington, DC.

This first volume of the interim report on the Study of New Youth Initiatives in Apprenticeship presents a discussion of site visit findings and implementation issues related to the United States Department of Labor's Apprenticeship-School Linkage Demonstrations. (Volume 2, site visit reports, is available separately as CE 032 792.) Chapter 1…

National Home Start Evaluation. Interim Report V: Case Studies.

ERIC Educational Resources Information Center

Jerome, Chris H.; And Others

One of a series of documents on the evaluation of the National Home Start (NHS) program this third year interim report of case studies describes program efforts and successes with 16 Home Start families throughout the nation. A federally funded demonstration program, NHS is aimed at providing home-based services (such as health, education,…

Environmental Quality Technology Demonstration, Evaluation and Transfer Activities

DTIC Science & Technology

1996-12-02

and Appropriate Requirements) and ARAR support documentation for interim and final Installation Restoration Program (IRP) remedial actions . During the...Relevant and Appropriate Requirements (ARARs) for Fort Devens , Massachusetts. Delivered Federal Environmental Legislative Power Curve in hard copy and... Remedial Actions . Delivered revised tables for Desk Guide on Interpretation of Applicable or Relevant and Appropriate Requirements — Interim Draft

2016 Lake Michigan Lake Trout Working Group Report

USGS Publications Warehouse

Madenjian, Charles P.; Breidert, Brian; Boyarski, David; Bronte, Charles R.; Dickinson, Ben; Donner, Kevin; Ebener, Mark P.; Gordon, Roger; Hanson, Dale; Holey, Mark; Janssen, John; Jonas, Jory; Kornis, Matthew; Olsen, Erik; Robillard, Steve; Treska, Ted; Weldon, Barry; Wright, Greg D.

2017-01-01

This report provides a review on the progression of lake trout rehabilitation towards meeting the Salmonine Fish Community Objectives (FCOs) for Lake Michigan (Eshenroder et. al. 1995) and the interim goal and evaluation objectives articulated in A Fisheries Management Implementation Strategy for the Rehabilitation of Lake Trout in Lake Michigan (Dexter et al. 2011); we also include data describing lake trout stocking and mortality to portray the present state of progress towards lake trout rehabilitation.

National Assessment of Title I: Interim Report. Volume II: Closing the Reading Gap: First Year Findings from a Randomized Trial of Four Reading Interventions for Striving Readers

ERIC Educational Resources Information Center

Torgesen, Joseph; Myers, David; Schirm, Allen; Stuart, Elizabeth; Vartivarian, Sonya; Mansfield, Wendy; Stancavage, Fran; Durno, Donna; Javorsky, Rosanne; Haan, Cinthia

2006-01-01

According to the National Assessment of Educational Progress, nearly 4 in 10 fourth graders read below the basic level. These literacy problems get worse as students advance through school and are exposed to progressively more complex concepts and courses. The purpose of this study was to assess the effectiveness of four remedial reading programs…

Progression-free survival of early interim PET-positive patients with advanced stage Hodgkin's lymphoma treated with BEACOPPescalated alone or in combination with rituximab (HD18): an open-label, international, randomised phase 3 study by the German Hodgkin Study Group.

PubMed

Borchmann, Peter; Haverkamp, Heinz; Lohri, Andreas; Mey, Ulrich; Kreissl, Stefanie; Greil, Richard; Markova, Jana; Feuring-Buske, Michaela; Meissner, Julia; Dührsen, Ulrich; Ostermann, Helmut; Keller, Ulrich; Maschmeyer, Georg; Kuhnert, Georg; Dietlein, Markus; Kobe, Carsten; Eich, Hans; Baues, Christian; Stein, Harald; Fuchs, Michael; Diehl, Volker; Engert, Andreas

2017-04-01

Advanced stage Hodgkin's lymphoma represents a heterogeneous group of patients with different risk profiles. Data suggests that interim PET assessment during chemotherapy is superior to baseline international prognostic scoring in terms of predicting long-term treatment outcome in patients with Hodgkin's lymphoma. We therefore hypothesised that early interim PET-imaging after two courses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) might be suitable for guiding treatment in patients with advanced stage Hodgkin's lymphoma. We aimed to assess whether intensifying standard chemotherapy (BEACOPP escalated ) by adding rituximab would improve progression-free survival in patients with positive PET after two courses of chemotherapy. In this open-label, international, randomised, phase 3 study, we recruited patients aged 18-60 years with newly diagnosed, advanced stage Hodgkin's lymphoma from 160 hospitals and 77 private practices in Germany, Switzerland, Austria, the Netherlands, and the Czech Republic. Interim PET-imaging was done after two cycles of BEACOPP escalated and centrally assessed by an expert panel. Patients with a positive PET after 2 cycles of BEACOPP escalated chemotherapy (PET-2) were randomly assigned (1:1) to receive six additional courses of either BEACOPP escalated (BEACOPP escalated group) or BEACOPP escalated plus rituximab (R-BEACOPP escalated group). PET-2 was assessed using a 5-point scale with 18 FDG uptake higher than the mediastinal blood pool (corresponding to Deauville scale 3) defined as positive. BEACOPP escalated was given as previously described; rituximab was given intravenously at a dose of 375 mg/m 2 (maximum total dose 700 mg), the first administration starting 24 h before starting the fourth cycle of BEACOPP escalated (day 0 and day 3 in cycle 4, day 1 in cycles 5-8). Randomisation was done centrally and used the minimisation method including a random component, stratified according to centre, age, stage, international prognostic score, and sex. The primary efficacy endpoint was 5 year progression-free survival, analysed in the intention-to-treat population. We are reporting this second planned interim analysis as the final report of the trial. The trial is registered with ClinicalTrials.gov, number NCT00515554. Between May 14, 2008, and May 31, 2011, we enrolled 1100 patients. 440 patients had a positive PET-2 and were randomly assigned to either the BEACOPP escalated group (n=220) or the R-BEACOPP escalated group (n=220). With a median follow-up of 33 months (IQR 25-42) for progression-free survival, estimated 3 year progression-free survival was 91·4% (95% CI 87·0-95·7) for patients in the BEACOPP escalated group and 93·0% (89·4-96·6) for those in the R-BEACOPP escalated group (difference 1·6%, 95% CI -4·0 to 7·3; log rank p=0·99). Common grade 3-4 adverse events were leucopenia (207 [95%] of 218 patients in the BEACOPP escalated group vs 211 [96%] of 220 patients in the R-BEACOPP escalated group), and severe infections (51 [23%] vs 43 [20%] patients). Based on a futility analysis, the independent data monitoring committee recommended publication of this second planned interim analysis as the final result. Six (3%) of 219 patients in the BEACOPP escalated group and ten (5%) of 220 in the R-BEACOPP escalated group died; fatal treatment-related toxic effects occurred in one (<1%) patient in the BEACOPP escalated group and three (1%) in the R-BEACOPP escalated group, all of them due to infection. The addition of rituximab to BEACOPP escalated did not improve the progression-free survival of PET-2 positive patients with advanced stage Hodgkin's lymphoma. However, progression-free survival for PET-2 positive patients was much better than expected, exceeding even the outcome of PET-2-unselected patients in the previous HD15 trial. Thus, PET-2 cannot identify patients at high-risk for treatment failure in the context of the very effective German Hodgkin Study Group standard treatment for advanced stage Hodgkin's lymphoma. Deutsche Krebshilfe; Swiss State Secretariat for Education, Research and Innovation (SERI); and Roche Pharma. Copyright © 2017 Elsevier Ltd. All rights reserved.

Recruitment failure and futility were the most common reasons for discontinuation of clinical drug trials. Results of a nationwide inception cohort study in the Netherlands.

PubMed

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.

Proficiency Guidance on New State Summative Assessments from NWEA

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2015

2015-01-01

Measures of Academic Progress® (MAP®) computer adaptive interim assessments serve many purposes, from informing instruction to identifying students for intervention to projecting proficiency on state accountability assessments. To make sure its flagship product does the latter, Northwest Evaluation Association™ (NWEA™) routinely conducts studies…

40 CFR 52.134 - Compliance schedules.

Code of Federal Regulations, 2013 CFR

2013-07-01

... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

40 CFR 52.134 - Compliance schedules.

Code of Federal Regulations, 2010 CFR

2010-07-01

... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

40 CFR 52.134 - Compliance schedules.

Code of Federal Regulations, 2012 CFR

2012-07-01

... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

40 CFR 52.134 - Compliance schedules.

Code of Federal Regulations, 2014 CFR

2014-07-01

... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

40 CFR 52.134 - Compliance schedules.

Code of Federal Regulations, 2011 CFR

2011-07-01

... beyond July 31, 1975, shall apply any reasonable interim measures of control designed to reduce the... progress shall include, but not be limited to: Submittal of the final control plan to the Administrator... of component parts to accomplish emission control equipment or process modification; completion of...

Evaluation of the healthy schools program: Part I. Interim progress.

PubMed

Beam, Margaret; Ehrlich, Ginny; Donze Black, Jessica; Block, Audrey; Leviton, Laura C

2012-01-01

Federal and state policies identify schools as a setting to prevent childhood obesity, but schools need better health-promoting strategies. The objective of this study was to evaluate interim progress in schools receiving hands-on training from the Healthy Schools Program, the nation's largest school-based program aimed at preventing childhood obesity. The 4-year program targets schools with predominantly low-income, African American, or Hispanic students. In 2010 we assessed schools that enrolled in the 2007-2008 and 2008-2009 school years. School representatives completed an inventory of 8 content areas: policy and systems, school meals, competitive foods and beverages, health education, physical education, physical activity outside of physical education, before- and after-school programs, and school employee wellness. Schools' baseline inventory was compared by t test with the most recent inventory available. Schools made significant changes in all content areas, and effect sizes were moderate to large. Participating schools improved environmental policies and practices to prevent childhood obesity. The program is a resource to implement recent federal and state policies.

A Process Evaluation of Project Developmental Continuity. Interim Report III, Executive Summary: Preliminary Recommendations for the Study of Child Impact.

ERIC Educational Resources Information Center

Granville, Arthur C.; And Others

This executive summary presents the major findings of Interim Report III, which reports preliminary evaluation of Project Developmental Continuity (PDC). A Head Start demonstration program, PDC is aimed at promoting greater educational and developmental continuity as children make the transition from preschool to school. The report addresses three…

A Process Evaluation of Project Developmental Continuity. Interim Report IV, Volume I: Pilot Year Impact Study--Instrument Characteristics and Attrition Trends.

ERIC Educational Resources Information Center

Granville, Arthur C.; And Others

This interim report of a pilot year impact study on evaluation methodology is part of a series of documents on the evaluation of Project Developmental Continuity, a Head Start demonstration program aimed at promoting educational and developmental continuity between children's Head Start and primary school experiences. This report deals with…

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…

Challenging Medical Students with an Interim Assessment: A Positive Effect on Formal Examination Score in a Randomized Controlled Study

ERIC Educational Resources Information Center

Bekkink, Marleen Olde; Donders, Rogier; van Muijen, Goos N. P.; Ruiter, Dirk J.

2012-01-01

Until now, positive effects of assessment at a medical curriculum level have not been demonstrated. This study was performed to determine whether an interim assessment, taken during a small group work session of an ongoing biomedical course, results in students' increased performance at the formal course examination. A randomized controlled trial…

The 5 Habits of Effective PLCs

ERIC Educational Resources Information Center

Easton, Lois Brown

2015-01-01

This article describes the knowledge and skills that professional learning community members need to create a habit out of their desire. Habits serve educators as signposts of progress toward achieving their desires. They are interim indicators of a professional learning community's success. Ultimately, of course, professional learning communities…

Predicting analysis time in events-driven clinical trials using accumulating time-to-event surrogate information.

PubMed

Wang, Jianming; Ke, Chunlei; Yu, Zhinuan; Fu, Lei; Dornseif, Bruce

2016-05-01

For clinical trials with time-to-event endpoints, predicting the accrual of the events of interest with precision is critical in determining the timing of interim and final analyses. For example, overall survival (OS) is often chosen as the primary efficacy endpoint in oncology studies, with planned interim and final analyses at a pre-specified number of deaths. Often, correlated surrogate information, such as time-to-progression (TTP) and progression-free survival, are also collected as secondary efficacy endpoints. It would be appealing to borrow strength from the surrogate information to improve the precision of the analysis time prediction. Currently available methods in the literature for predicting analysis timings do not consider utilizing the surrogate information. In this article, using OS and TTP as an example, a general parametric model for OS and TTP is proposed, with the assumption that disease progression could change the course of the overall survival. Progression-free survival, related both to OS and TTP, will be handled separately, as it can be derived from OS and TTP. The authors seek to develop a prediction procedure using a Bayesian method and provide detailed implementation strategies under certain assumptions. Simulations are performed to evaluate the performance of the proposed method. An application to a real study is also provided. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

A Process Evaluation of Project Developmental Continuity, Interim Report VII, Volume 3: Assessment of Program Impact Through the Head Start Year.

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…

Linking the ACT ASPIRE Assessments to NWEA MAP Assessments

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

School, Work and Family Planning. Interim Impacts in Project Redirection.

ERIC Educational Resources Information Center

Polit, Denise F.; And Others

Project Redirection was designed to help pregnant and parenting adolescents progress toward eventual self-sufficiency by linking them with community agencies and volunteers at four geographically and ethnically diverse sites in the United States. Distinctive features of the program include: (1) a broad scope of services including employability…

Capabilities Roadmap Briefings to the National Research Council

NASA Technical Reports Server (NTRS)

2005-01-01

High energy power and propulsion capability roadmap - general background and introduction. Advanced telescopes and observatories and scientific instruments and sensors capability roadmaps - general background and introduction. Space communications capability roadmap interim review. Robotic access to planetary surface capability roadmap. Human health and support systems capability roadmap progress review.

Air traffic control : good progress on interim replacement for outage-plagued system, but risks can be further reduced

DOT National Transportation Integrated Search

1996-10-01

Certain air traffic control(ATC) centers experienced a series of major outages, : some of which were caused by the Display Channel Complex or DCC-a mainframe : computer system that processes radar and other data into displayable images on : controlle...

Consumption Taxes and Economic Efficiency with Idiosyncratic Wage Shocks

ERIC Educational Resources Information Center

Nishiyama, Shinichi; Smetters, Kent

2005-01-01

Fundamental tax reform is examined in an overlapping-generations model in which heterogeneous agents face idiosyncratic wage shocks and longevity uncertainty. A progressive income tax is replaced with a flat consumption tax. If idiosyncratic wage shocks are insurable (i.e., no risk), this reform improves (interim) efficiency, a result consistent…

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.

Commentary: Interim leadership of academic departments at U.S. medical schools.

PubMed

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.

NASA Multidisciplinary Design and Analysis Fellowship Program

NASA Technical Reports Server (NTRS)

1995-01-01

This report is a Year 1 interim report of the progress on the NASA multidisciplinary Design and Analysis Fellowship Program covering the period, January 1, 1995 through September 30, 1995. It summarizes progress in establishing the MDA Fellowship Program at Georgia Tech during the initial year. Progress in the advertisement of the program, recruiting results for the 1995-96 academic year, placement of the Fellows in industry during Summer 1995, program development at the M.S. and Ph.D. levels, and collaboration and dissemination of results are summarized in this report. Further details of the first year's progress will be included in the report from the Year 1 Workshop to be held at NASA Langley on December 7-8, 1995.

Linking the Pennsylvania PSSA Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. Recently, NWEA completed a concordance study to connect the scales of the Pennsylvania System of School Assessment (PSSA) reading and math with those of the…

Linking the Kentucky K-PREP Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the Kansas KAP Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the North Carolina EOG Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. Recently, NWEA completed a concordance study to connect the scales of the North Carolina End-of-Grade (EOG) English language arts (ELA) and math with those…

Linking the PARCC Assessments to NWEA MAP Tests for Illinois

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the Texas STAAR Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the Nebraska NeSA Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the Alaska AMP Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the PARCC Assessments to NWEA MAP Tests for New Mexico

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

Linking the Arizona AZMERIT Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. One important tool is the concordance table between MAP and state summative assessments. Concordance tables have been used for decades to relate scores on…

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…

Psychological and Educational Sequelae of Prematurity. Interim Report No. 11.

ERIC Educational Resources Information Center

Rubin, Rosalyn; And Others

The longitudinal study assessed the psychological and educational sequelae of premature birth through the early elementary school years, to determine whether children born prematurely constitute a high risk population in terms of regular school progress. Subjects included 78 children with birth weights of 2500 grams or less, 78 children of normal…

Linking the Virginia SOL Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. Recently, NWEA completed a concordance study to connect the scales of the Virginia Standards of Learning (SOL) reading and math tests with those of the MAP…

Translating evidence into practice: pursuing perfection in pneumococcal vaccination in a rural community.

PubMed

Doyle, D M; Dauterive, R; Chuang, K H; Ellrodt, A G

2001-11-01

There are many challenges to effectively and efficiently translating evidence into practice. Potential strategies include (1) training more evidence-based practitioners in the art and science of evidence-based medicine, (2) enhancing the quality and availability of systematic reviews, and (3) more effectively linking evidence-based practitioners and evidence users through comprehensive behavioral change initiatives. Herein we explore the third strategy and highlight the key elements of success for a program using behavioral change strategies. We present a clinical model based on clear understanding of the "problem," a systematic approach to diagnosis, selection of scientifically sound treatment options, and effective evaluation with appropriate modification of the treatment plan. A successful program begins with effective team leadership, the expression of a clinically compelling case for change, and commitment to the pursuit of perfection in the delivery of key evidence-based interventions. The team must then diagnose behavioral barriers to change, using a systematic approach based on a published rigorous differential diagnosis framework. This diagnostic step provides the foundation for selection of effective dissemination and implementation strategies (treatments) proven to improve processes of care and clinical outcomes. Finally the team must evaluate progress toward perfection, reviewing interim data and adjusting the treatment regimen to newly diagnosed barriers. We then present a specific project (improving pneumococcal immunization rates in our rural community) and interim results to demonstrate the use of the framework in the real world.

Combined Modality Treatment for PET-Positive Non-Hodgkin Lymphoma: Favorable Outcomes of Combined Modality Treatment for Patients With Non-Hodgkin Lymphoma and Positive Interim or Postchemotherapy FDG-PET

DOE Office of Scientific and Technical Information (OSTI.GOV)

Halasz, Lia M.; Jacene, Heather A.; Catalano, Paul J.

2012-08-01

Purpose: To evaluate outcomes of patients treated for aggressive non-Hodgkin lymphoma (NHL) with combined modality therapy based on [{sup 18}F]fluoro-2-deoxy-2-D-glucose positron emission tomography (FDG-PET) response. Methods and Materials: We studied 59 patients with aggressive NHL, who received chemotherapy and radiation therapy (RT) from 2001 to 2008. Among them, 83% of patients had stage I/II disease. Patients with B-cell lymphoma received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)-based chemotherapy, and 1 patient with anaplastic lymphoma kinase-negative anaplastic T-cell lymphoma received CHOP therapy. Interim and postchemotherapy FDG-PET or FDG-PET/computed tomography (CT) scans were performed for restaging. All patients received consolidated involved-field RT.more » Median RT dose was 36 Gy (range, 28.8-50 Gy). Progression-free survival (PFS) and local control (LC) rates were calculated with and without a negative interim or postchemotherapy FDG-PET scan. Results: Median follow-up was 46.5 months. Thirty-nine patients had negative FDG-PET results by the end of chemotherapy, including 12 patients who had a negative interim FDG-PET scan and no postchemotherapy PET. Twenty patients were FDG-PET-positive, including 7 patients with positive interim FDG-PET and no postchemotherapy FDG-PET scans. The 3-year actuarial PFS rates for patients with negative versus positive FDG-PET scans were 97% and 90%, respectively. The 3-year actuarial LC rates for patients with negative versus positive FDG-PET scans were 100% and 90%, respectively. Conclusions: Patients who had a positive interim or postchemotherapy FDG-PET had a PFS rate of 90% at 3 years after combined modality treatment, suggesting that a large proportion of these patients can be cured with consolidated RT.« less

Data Analysis of GPM Constellation Satellites-IMERG and ERA-Interim precipitation products over West of Iran

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.

Review of nonalcoholic fatty liver disease in women with polycystic ovary syndrome

PubMed Central

Kelley, Carly E; Brown, Ann J; Diehl, Anna Mae; Setji, Tracy L

2014-01-01

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive-aged women. Women with PCOS frequently have metabolic complications including insulin resistance (IR), early diabetes, hypertension and dyslipidemia. Recent studies have demonstrated an association between PCOS and another metabolic complication: nonalcoholic fatty liver disease (NAFLD). NAFLD occurs as a result of abnormal lipid handling by the liver, which sensitizes the liver to injury and inflammation. It can progress to nonalcoholic steatohepatitis (NASH), which is characterized by hepatocyte injury and apoptosis. With time and further inflammation, NASH can progress to cirrhosis. Thus, given the young age at which NAFLD may occur in PCOS, these women may be at significant risk for progressive hepatic injury over the course of their lives. Many potential links between PCOS and NAFLD have been proposed, most notably IR and hyperandrogenemia. Further studies are needed to clarify the association between PCOS and NAFLD. In the interim, clinicians should be aware of this connection and consider screening for NAFLD in PCOS patients who have other metabolic risk factors. The optimal method of screening is unknown. However, measuring alanine aminotransferase and/or obtaining ultrasound on high-risk patients can be considered. First line treatment consists of lifestyle interventions and weight loss, with possible pharmacologic interventions in some cases. PMID:25339805

Linking the New York State NYSTP Assessments to NWEA MAP Tests

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2016

2016-01-01

Northwest Evaluation Association™ (NWEA™) is committed to providing partners with useful tools to help make inferences from the Measures of Academic Progress® (MAP®) interim assessment scores. Recently, NWEA completed a concordance study to connect the scales of the New York State Testing Program (NYSTP) reading and math with those of the MAP…

An Evaluation of ESEA Title III Projects, Fiscal Year 1972. Interim Report.

ERIC Educational Resources Information Center

Wilson, Jerusa; And Others

This report contains descriptions and progress of five projects in the District of Columbia partially or wholly funded by ESEA Title III: (1) The Columbia Road Preschool Pilot Project, a second-year experimental effort designed to serve as a model school providing an experimental setting for early childhood educational programs; (2) The Montessori…

A Computerized Classroom Language Management and Recording System for Deaf and Hard of Hearing Children.

ERIC Educational Resources Information Center

Bornstein, Harry; Casella, Vicki

This interim report describes the development of a networked computerized classroom language management and recording system to assist teachers of children who are deaf or hard-of-hearing. The system will provide storage and access capability for such information as changes in instruction, language learning progress, modifications in communication…

DEBLICOM: Deaf-Blind Communication and Control Systems. Interim Progress Report, August 1974-August 1975.

ERIC Educational Resources Information Center

Kafafian, Haig

Presented is a report on the work of Cybernetics Research Institute (CRI) investigators on the development of deaf-blind communication and control systems (DEBLICOM). Described in Part One is one embodiment of DEBLICOM designed and built by CRI engineers. Reported in Part Two are experimental procedures and human factors considerations of…

Institute for Developmental Studies Interim Progress Report. Part II: Research and Evaluation.

ERIC Educational Resources Information Center

Deutsch, Martin; And Others

The Institute for Developmental Studies (IDS) is engaged in research aimed at specifying what the academic handicaps of deprived children are, what causes these handicaps, and what can be done to overcome them. This IDS report on their research and evaluation program is divided into two sections. The first, "Summaries of Basic Research, Applied…

78 FR 37698 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-67; Small Entity Compliance Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-21

............ Contracting with 2013-010 Morgan. Women-owned Small Business Concerns (Interim). VIII Deletion of Report 2013... panel, consists of senior-level DoD officials from across DoD working to review progress made by DoD to... ensure that CORs understand their duties and responsibilities to survey contractor performance. This...

SNF Interim Storage Canister Corrosion and Surface Environment Investigations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bryan, Charles R.; Enos, David G.

2015-09-01

This progress report describes work being done at Sandia National Laboratories (SNL) to assess the localized corrosion performance of container/cask materials used in the interim storage of spent nuclear fuel (SNF). Of particular concern is stress corrosion cracking (SCC), by which a through-wall crack could potentially form in a canister outer wall over time intervals that are shorter than possible dry storage times. In order for SCC to occur, three criteria must be met. A corrosive environment must be present on the canister surface, the metal must susceptible to SCC, and sufficient tensile stress to support SCC must be presentmore » through the entire thickness of the canister wall. SNL is currently evaluating the potential for each of these criteria to be met.« less

Capitation funding of primary health organisations in New Zealand: are enrolled populations being funded according to need?

PubMed

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.

Use of materials derived from cattle in human food and cosmetics; reopening of the comment period. Interim final rule; reopening of the comment period.

PubMed

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.

Annual Summary Report Calendar Year 2000 for the 100-HR-3, 100-KR-4, and 100-NR-2 Operable Units and Pump-and-Treat Operations

DOE Office of Scientific and Technical Information (OSTI.GOV)

G. B. Mitchem

2001-08-22

This annual progress and performance evaluation report discusses the groundwater remedial actions in the 100 Area, including the interim actions at the 100-HR-3 and 100-KR-4 Operable Units, and also discusses the expedited response action in the 100-NR-2 operable unit.

Cyberspace, the 7th Joint Function for 21st Century Warfare

DTIC Science & Technology

2017-03-31

such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research, special, group study, etc . 3. DATE COVERED...procedures, e.g. RD/FRD, PROPIN, ITAR, etc . Include copyright information. 13. SUPPLEMENTARY NOTES. Enter information not included...elsewhere such as: prepared in cooperation with; translation of; report supersedes; old edition number, etc . 14. ABSTRACT. A brief (approximately

ABE Phase III: Progress and Problems. September 1, 1969-April 1, 1970.

ERIC Educational Resources Information Center

Southwestern Cooperative Educational Lab., Albuquerque, NM.

Interim information concerning the ABE III grants is provided in the three parts of this report. Part 1 (outline) describes the goals and objectives of each component; Part 2 describes accomplishments and problems to date; and Part 3 deals with coordination and supervision activities undertaken by the Lab. The components of the program are: (1)…

SUSTAINABLE ALLOY DESIGN: SEARCHING FOR RARE EARTH ELEMENT ALTERNATIVES THROUGH CRYSTAL ENGINEERING

DTIC Science & Technology

2016-02-26

Property Maps to Guide Materials Design via Statistical Learning Summer Research Group Meeting – Materials by Design Los Alamos National Laboratory, July...Informatics, Rational design , Quantitative correlative spectroscopy and imaging, DFT, In situ high pressure mechanical property measurements, Superalloy...final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED. Indicate the

Some Specifications for an Undergraduate Course in Digital Subsystems. An Interim Report of the Cosine Committee.

ERIC Educational Resources Information Center

Commission on Engineering Education, Washington, DC.

This report describes an undergraduate course in digital subsystems. The course is divided into two major parts. Part I is entitled Electronic Circuits and Functional Units. The material in this part of the course proceeds from simple understandings of circuits to the progressively more complex functional units. Early emphasis is placed on basic…

MFTF-. cap alpha. + T progress report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nelson, W.D.

1985-04-01

Early in FY 1983, several upgrades of the Mirror Fusion Test Facility (MFTF-B) at Lawrence Livermore National Laboratory (LLNL) were proposed to the fusion community. The one most favorably received was designated MFTF-..cap alpha..+T. The engineering design of this device, guided by LLNL, has been a principal activity of the Fusion Engineering Design Center during FY 1983. This interim progress report represents a snapshot of the device design, which was begun in FY 1983 and will continue for several years. The report is organized as a complete design description. Because it is an interim report, some parts are incomplete; theymore » will be supplied as the design study proceeds. As described in this report, MFTF-..cap alpha..+T uses existing facilities, many MFTF-B components, and a number of innovations to improve on the physics parameters of MFTF-B. It burns deuterium-tritium and has a central-cell Q of 2, a wall loading GAMMA/sub n/ of 2 MW/m/sup 2/ (with a central-cell insert module), and an availability of 10%. The machine is fully shielded, allows hands-on maintenance of components outside the vacuum vessel 24 h after shutdown, and has provisions for repair of all operating components.« less

Parallelization of Rocket Engine Simulator Software (P.R.E.S.S.)

NASA Technical Reports Server (NTRS)

Cezzar, Ruknet

1999-01-01

Parallelization of Rocket Engine System Software (PRESS) project is part of a collaborative effort with Southern University at Baton Rouge (SUBR), University of West Florida (UWF), and Jackson State University (JSU). The project has started on October 19, 1995, and after a three-year period corresponding to project phases and fiscal-year funding by NASA Lewis Research Center (now Glenn Research Center), has ended on October 18, 1998. The one-year no-cost extension period was granted on June 7, 1998, until October 19, 1999. The aim of this one year no-cost extension period was to carry out further research to complete the work and lay the groundwork for subsequent research in the area of aerospace engine design optimization software tools. The previous progress for the research has been reported in great detail in respective interim and final research progress reports, seven of them, in all. While the purpose of this report is to be a final summary and an valuative view of the entire work since the first year funding, the following is a quick recap of the most important sections of the interim report dated April 30, 1999.

40 CFR 80.141 - Interim detergent gasoline program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... considered acceptable for demonstration of IVD control performance. Examples of acceptable test procedures... carburetor deposits. Examples of acceptable test procedures for demonstration of carburetor deposit control... ultimate consumer; (ii) All additized post-refinery component (PRC); and (iii) All detergent additives sold...

40 CFR 80.141 - Interim detergent gasoline program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... considered acceptable for demonstration of IVD control performance. Examples of acceptable test procedures... carburetor deposits. Examples of acceptable test procedures for demonstration of carburetor deposit control... ultimate consumer; (ii) All additized post-refinery component (PRC); and (iii) All detergent additives sold...

40 CFR 80.141 - Interim detergent gasoline program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... considered acceptable for demonstration of IVD control performance. Examples of acceptable test procedures... carburetor deposits. Examples of acceptable test procedures for demonstration of carburetor deposit control... ultimate consumer; (ii) All additized post-refinery component (PRC); and (iii) All detergent additives sold...

40 CFR 80.141 - Interim detergent gasoline program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... considered acceptable for demonstration of IVD control performance. Examples of acceptable test procedures... carburetor deposits. Examples of acceptable test procedures for demonstration of carburetor deposit control... ultimate consumer; (ii) All additized post-refinery component (PRC); and (iii) All detergent additives sold...

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.

A two-stage patient enrichment adaptive design in phase II oncology trials.

PubMed

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.

Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors.

PubMed

Strosberg, Jonathan; El-Haddad, Ghassan; Wolin, Edward; Hendifar, Andrew; Yao, James; Chasen, Beth; Mittra, Erik; Kunz, Pamela L; Kulke, Matthew H; Jacene, Heather; Bushnell, David; O'Dorisio, Thomas M; Baum, Richard P; Kulkarni, Harshad R; Caplin, Martyn; Lebtahi, Rachida; Hobday, Timothy; Delpassand, Ebrahim; Van Cutsem, Eric; Benson, Al; Srirajaskanthan, Rajaventhan; Pavel, Marianne; Mora, Jaime; Berlin, Jordan; Grande, Enrique; Reed, Nicholas; Seregni, Ettore; Öberg, Kjell; Lopera Sierra, Maribel; Santoro, Paola; Thevenet, Thomas; Erion, Jack L; Ruszniewski, Philippe; Kwekkeboom, Dik; Krenning, Eric

2017-01-12

Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 ( 177 Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either 177 Lu-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) ( 177 Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the 177 Lu-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the 177 Lu-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the 177 Lu-Dotatate group and 26 in the control group (P=0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the 177 Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. Treatment with 177 Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the 177 Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).

Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.

PubMed

Choueiri, Toni K; Escudier, Bernard; Powles, Thomas; Mainwaring, Paul N; Rini, Brian I; Donskov, Frede; Hammers, Hans; Hutson, Thomas E; Lee, Jae-Lyun; Peltola, Katriina; Roth, Bruce J; Bjarnason, Georg A; Géczi, Lajos; Keam, Bhumsuk; Maroto, Pablo; Heng, Daniel Y C; Schmidinger, Manuela; Kantoff, Philip W; Borgman-Hagey, Anne; Hessel, Colin; Scheffold, Christian; Schwab, Gisela M; Tannir, Nizar M; Motzer, Robert J

2015-11-05

Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR) as well as MET and AXL, each of which has been implicated in the pathobiology of metastatic renal-cell carcinoma or in the development of resistance to antiangiogenic drugs. This randomized, open-label, phase 3 trial evaluated the efficacy of cabozantinib, as compared with everolimus, in patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. We randomly assigned 658 patients to receive cabozantinib at a dose of 60 mg daily or everolimus at a dose of 10 mg daily. The primary end point was progression-free survival. Secondary efficacy end points were overall survival and objective response rate. Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. The rate of progression or death was 42% lower with cabozantinib than with everolimus (hazard ratio, 0.58; 95% confidence interval [CI] 0.45 to 0.75; P<0.001). The objective response rate was 21% with cabozantinib and 5% with everolimus (P<0.001). A planned interim analysis showed that overall survival was longer with cabozantinib than with everolimus (hazard ratio for death, 0.67; 95% CI, 0.51 to 0.89; P=0.005) but did not cross the significance boundary for the interim analysis. Adverse events were managed with dose reductions; doses were reduced in 60% of the patients who received cabozantinib and in 25% of those who received everolimus. Discontinuation of study treatment owing to adverse events occurred in 9% of the patients who received cabozantinib and in 10% of those who received everolimus. Progression-free survival was longer with cabozantinib than with everolimus among patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy. (Funded by Exelixis; METEOR ClinicalTrials.gov number, NCT01865747.).

Lessons learned from the Siting Process of an Interim Storage Facility in Spain - 12024

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lamolla, Meritxell Martell

2012-07-01

On 29 December 2009, the Spanish government launched a site selection process to host a centralised interim storage facility for spent fuel and high-level radioactive waste. It was an unprecedented call for voluntarism among Spanish municipalities to site a controversial facility. Two nuclear municipalities, amongst a total of thirteen municipalities from five different regions, presented their candidatures to host the facility in their territories. For two years the government did not make a decision. Only in November 30, 2011, the new government elected on 20 November 2011 officially selected a non-nuclear municipality, Villar de Canas, for hosting this facility. Thismore » paper focuses on analysing the factors facilitating and hindering the siting of controversial facilities, in particular the interim storage facility in Spain. It demonstrates that involving all stakeholders in the decision-making process should not be underestimated. In the case of Spain, all regional governments where there were candidate municipalities willing to host the centralised interim storage facility, publicly opposed to the siting of the facility. (author)« less

Online Monitoring Technical Basis and Analysis Framework for Emergency Diesel Generators - Interim Report for FY 2013

DOE Office of Scientific and Technical Information (OSTI.GOV)

Binh T. Pham; Nancy J. Lybeck; Vivek Agarwal

The Light Water Reactor Sustainability program at Idaho National Laboratory is actively conducting research to develop and demonstrate online monitoring capabilities for active components in existing nuclear power plants. Idaho National Laboratory and the Electric Power Research Institute are working jointly to implement a pilot project to apply these capabilities to emergency diesel generators and generator step-up transformers. The Electric Power Research Institute Fleet-Wide Prognostic and Health Management Software Suite will be used to implement monitoring in conjunction with utility partners: Braidwood Generating Station (owned by Exelon Corporation) for emergency diesel generators, and Shearon Harris Nuclear Generating Station (owned bymore » Duke Energy Progress) for generator step-up transformers. This report presents monitoring techniques, fault signatures, and diagnostic and prognostic models for emergency diesel generators. Emergency diesel generators provide backup power to the nuclear power plant, allowing operation of essential equipment such as pumps in the emergency core coolant system during catastrophic events, including loss of offsite power. Technical experts from Braidwood are assisting Idaho National Laboratory and Electric Power Research Institute in identifying critical faults and defining fault signatures associated with each fault. The resulting diagnostic models will be implemented in the Fleet-Wide Prognostic and Health Management Software Suite and tested using data from Braidwood. Parallel research on generator step-up transformers was summarized in an interim report during the fourth quarter of fiscal year 2012.« less

An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non-muscle-invasive bladder cancer: Interim results.

PubMed

Packiam, Vignesh T; Lamm, Donald L; Barocas, Daniel A; Trainer, Andrew; Fand, Benjamin; Davis, Ronald L; Clark, William; Kroeger, Michael; Dumbadze, Igor; Chamie, Karim; Kader, A Karim; Curran, Dominic; Gutheil, John; Kuan, Arthur; Yeung, Alex W; Steinberg, Gary D

2017-07-26

CG0070 is a replication-competent oncolytic adenovirus that targets bladder tumor cells through their defective retinoblastoma pathway. Prior reports of intravesical CG0070 have shown promising activity in patients with high-grade non-muscle invasive bladder cancer (NMIBC) who previously did not respond to bacillus Calmette-Guérin (BCG). However, limited accrual has hindered analysis of efficacy, particularly for pathologic subsets. We evaluated interim results of a phase II trial for intravesical CG0070 in patients with BCG-unresponsive NMIBC who refused cystectomy. At interim analysis (April 2017), 45 patients with residual high-grade Ta, T1, or carcinoma-in-situ (CIS) ± Ta/T1 had evaluable 6-month follow-up in this phase II single-arm multicenter trial (NCT02365818). All patients received at least 2 prior courses of intravesical therapy for CIS, with at least 1 being a course of BCG. Patients had either failed BCG induction therapy within 6 months or had been successfully treated with BCG with subsequent recurrence. Complete response (CR) at 6 months was defined as absence of disease on cytology, cystoscopy, and random biopsies. Of 45 patients, there were 24 pure CIS, 8 CIS + Ta, 4 CIS + T1, 6 Ta, 3 T1. Overall 6-month CR (95% CI) was 47% (32%-62%). Considering 6-month CR for pathologic subsets, pure CIS was 58% (37%-78%), CIS ± Ta/T1 50% (33%-67%), and pure Ta/T1 33% (8%-70%). At 6 months, the single patient that progressed to muscle-invasive disease had Ta and T1 tumors at baseline. No patients with pure T1 had 6-month CR. Treatment-related adverse events (AEs) at 6 months were most commonly urinary bladder spasms (36%), hematuria (28%), dysuria (25%), and urgency (22%). Immunologic treatment-related AEs included flu-like symptoms (12%) and fatigue (6%). Grade III treatment-related AEs included dysuria (3%) and hypotension (1.5%). There were no Grade IV/V treatment-related AEs. This phase II study demonstrates that intravesical CG0070 yielded an overall 47% CR rate at 6 months for all patients and 50% for patients with CIS, with an acceptable level of toxicity for patients with high-risk BCG-unresponsive NMIBC. There is a particularly strong response and limited progression in patients with pure CIS. Copyright © 2017 Elsevier Inc. All rights reserved.

The role and challenges of the food industry in addressing chronic disease

PubMed Central

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

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer-updated results.

PubMed

Kimura, Go; Ueda, Takeshi

2017-03-01

A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28-1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18-0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. © The Author 2016. Published by Oxford University Press.

Post hoc analysis of Japanese patients from the placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer—updated results

PubMed Central

Ueda, Takeshi

2017-01-01

Abstract A post hoc analysis of interim results from PREVAIL, a Phase III, double-blind, placebo-controlled trial of men with metastatic castration-resistant prostate cancer, demonstrated that the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients were generally consistent with those of the overall population. A recent longer term analysis of PREVAIL demonstrated continued benefit of enzalutamide treatment over placebo. Here, we report results from a post hoc analysis of Japanese patients enrolled in PREVAIL at the prespecified number of deaths for the final analysis. In Japanese patients, enzalutamide reduced the risk of death by 35% (hazard ratio, 0.65; 95% confidence interval, 0.28–1.51) and the risk of investigator-assessed radiographic progression or death by 60% (hazard ratio, 0.40; 95% confidence interval, 0.18–0.90). These results show that treatment effects and safety in Japanese patients in the final analysis of PREVAIL continued to be generally consistent with those of the overall population. PMID:28003320

Advanced Materials and Component Development for Lithium-Ion Cells for NASA Missions

NASA Technical Reports Server (NTRS)

Reid, Concha M.

2012-01-01

Human missions to Near Earth Objects, such as asteroids, planets, moons, liberation points, and orbiting structures, will require safe, high specific energy, high energy density batteries to provide new or extended capabilities than are possible with today s state-of-the-art aerospace batteries. The Enabling Technology Development and Demonstration Program, High Efficiency Space Power Systems Project battery development effort at the National Aeronautics and Space Administration (NASA) is continuing advanced lithium-ion cell development efforts begun under the Exploration Technology Development Program Energy Storage Project. Advanced, high-performing materials are required to provide improved performance at the component-level that contributes to performance at the integrated cell level in order to meet the performance goals for NASA s High Energy and Ultra High Energy cells. NASA s overall approach to advanced cell development and interim progress on materials performance for the High Energy and Ultra High Energy cells after approximately 1 year of development has been summarized in a previous paper. This paper will provide an update on these materials through the completion of 2 years of development. The progress of materials development, remaining challenges, and an outlook for the future of these materials in near term cell products will be discussed.

Development studies for a novel wet oxidation process. Phase 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1994-07-01

DETOX{sup SM} is a catalyzed wet oxidation process which destroys organic materials in an acidic water solution of iron at 373 to 473 K. The solution can be used repeatedly to destroy great amounts of organic materials. Since the process is conducted in a contained vessel, air emissions from the process can be well controlled. The solution is also capable of dissolving and concentrating many heavy and radioactive metals for eventual stabilization and disposal. The Phase 2 effort for this project is site selection and engineering design for a DETOX demonstration unit. Site selection was made using a set ofmore » site selection criteria and evaluation factors. A survey of mixed wastes at DOE sites was conducted using the Interim Mixed Waste Inventory Report. Sites with likely suitable waste types were identified. Potential demonstration sites were ranked based on waste types, interest, regulatory needs, scheduling, ability to provide support, and available facilities. Engineering design for the demonstration unit is in progress and is being performed by Jacobs Applied Technology. The engineering design proceeded through preliminary process flow diagrams (PFDs), calculation of mass and energy balances for representative waste types, process and instrumentation diagrams (P and IDs), preparation of component specifications, and a firm cost estimate for fabrication of the demonstration unit.« less

Interim Report: Field Demonstration Of Permeable Reactive Barriers To Remove Dissolved Uranium From Groundwater, Fry Canyon, Utah

EPA Pesticide Factsheets

The Fry Canyon site in southeastern Utah was selected in 1996 as a long-term field demonstration site to assess the performance of selected permeable reactive barriers for the removal of uranium (U) from groundwater.

Data Use "Multi-State" Spotlight: Using Data Fidelity Tools to Improve Data Quality. Transforming State Systems to Improve Outcomes for Children with Disabilities

ERIC Educational Resources Information Center

Ruedel, Kristin; Nelson, Gena; Bailey, Tessie

2018-01-01

To evaluate interim progress toward the State-identified Measurable Result (SIMR), states require access to high-quality data from local education agencies (LEAs) and early intervention service providers. In a review of 2017 Phase III State Systemic Improvement Plans (SSIP), 43 Part C states noted limitations or concerns related to data and…

Combinational Optimal Stopping Problems

DTIC Science & Technology

2016-04-01

such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED...Vinel, A. and P. Krokhmal (2015) Certainty equivalent measures of risk, Annals of Operations Research , DOI:10.1007/s10479-015-1801-0. [3] Chernikov...Operations Research , 50(3):415–423, 2002. [16] I. Ljubi, P. Mutzel, and B. Zey. Stochastic survivable network design problems. Electronic Notes in Discrete

Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

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

MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.

PubMed

Goetz, Matthew P; Toi, Masakazu; Campone, Mario; Sohn, Joohyuk; Paluch-Shimon, Shani; Huober, Jens; Park, In Hae; Trédan, Olivier; Chen, Shin-Cheh; Manso, Luis; Freedman, Orit C; Garnica Jaliffe, Georgina; Forrester, Tammy; Frenzel, Martin; Barriga, Susana; Smith, Ian C; Bourayou, Nawel; Di Leo, Angelo

2017-11-10

Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer.

Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma.

PubMed

Stewart, A Keith; Rajkumar, S Vincent; Dimopoulos, Meletios A; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S; Mihaylov, Georgi G; Goranova-Marinova, Vesselina; Rajnics, Péter; Suvorov, Aleksandr; Niesvizky, Ruben; Jakubowiak, Andrzej J; San-Miguel, Jesus F; Ludwig, Heinz; Wang, Michael; Maisnar, Vladimír; Minarik, Jiri; Bensinger, William I; Mateos, Maria-Victoria; Ben-Yehuda, Dina; Kukreti, Vishal; Zojwalla, Naseem; Tonda, Margaret E; Yang, Xinqun; Xing, Biao; Moreau, Philippe; Palumbo, Antonio

2015-01-08

Lenalidomide plus dexamethasone is a reference treatment for relapsed multiple myeloma. The combination of the proteasome inhibitor carfilzomib with lenalidomide and dexamethasone has shown efficacy in a phase 1 and 2 study in relapsed multiple myeloma. We randomly assigned 792 patients with relapsed multiple myeloma to carfilzomib with lenalidomide and dexamethasone (carfilzomib group) or lenalidomide and dexamethasone alone (control group). The primary end point was progression-free survival. Progression-free survival was significantly improved with carfilzomib (median, 26.3 months, vs. 17.6 months in the control group; hazard ratio for progression or death, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P=0.0001). The median overall survival was not reached in either group at the interim analysis. The Kaplan-Meier 24-month overall survival rates were 73.3% and 65.0% in the carfilzomib and control groups, respectively (hazard ratio for death, 0.79; 95% CI, 0.63 to 0.99; P=0.04). The rates of overall response (partial response or better) were 87.1% and 66.7% in the carfilzomib and control groups, respectively (P<0.001; 31.8% and 9.3% of patients in the respective groups had a complete response or better; 14.1% and 4.3% had a stringent complete response). Adverse events of grade 3 or higher were reported in 83.7% and 80.7% of patients in the carfilzomib and control groups, respectively; 15.3% and 17.7% of patients discontinued treatment owing to adverse events. Patients in the carfilzomib group reported superior health-related quality of life. In patients with relapsed multiple myeloma, the addition of carfilzomib to lenalidomide and dexamethasone resulted in significantly improved progression-free survival at the interim analysis and had a favorable risk-benefit profile. (Funded by Onyx Pharmaceuticals; ClinicalTrials.gov number, NCT01080391.).

Planning for progress, productivity, and performance.

PubMed

Benedict, J M

1983-10-01

A project is described for the interim renovation of a labor intensive existing foodservice facility. The renovated area will provide effective food management during the hospital's redevelopment period, including a new foodservice. Objectives of the interim project were to conserve labor while emphasizing control and centralization, provide economic foodservices with improved quality, and incorporate one tray distribution system throughout the hospital complex. Immediate measures were necessary in order to generate funds to proceed. Renovations had to occur without disrupting food-service to patients. The project was planned over a three year period and included an ingredient control area, two patient tray service centres, a renewed production kitchen and test kitchen facility. Each phase has been financed on the understanding that the costs of construction and equipment will be repaid within one fiscal year of operating the renovated facility. Positive results are being achieved, attributable to the support and encouragement received from staff during the change process.

Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis.

PubMed

Yardley, Denise A; Noguchi, Shinzaburo; Pritchard, Kathleen I; Burris, Howard A; Baselga, José; Gnant, Michael; Hortobagyi, Gabriel N; Campone, Mario; Pistilli, Barbara; Piccart, Martine; Melichar, Bohuslav; Petrakova, Katarina; Arena, Francis P; Erdkamp, Frans; Harb, Wael A; Feng, Wentao; Cahana, Ayelet; Taran, Tetiana; Lebwohl, David; Rugo, Hope S

2013-10-01

Effective treatments for hormone-receptor-positive (HR(+)) breast cancer (BC) following relapse/progression on nonsteroidal aromatase inhibitor (NSAI) therapy are needed. Initial Breast Cancer Trials of OraL EveROlimus-2 (BOLERO-2) trial data demonstrated that everolimus and exemestane significantly prolonged progression-free survival (PFS) versus placebo plus exemestane alone in this patient population. BOLERO-2 is a phase 3, double-blind, randomized, international trial comparing everolimus (10 mg/day) plus exemestane (25 mg/day) versus placebo plus exemestane in postmenopausal women with HR(+) advanced BC with recurrence/progression during or after NSAIs. The primary endpoint was PFS by local investigator review, and was confirmed by independent central radiology review. Overall survival, response rate, and clinical benefit rate were secondary endpoints. Final study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age. The incidence and severity of adverse events were consistent with those reported at the interim analysis and in other everolimus trials. The addition of everolimus to exemestane markedly prolonged PFS in patients with HR(+) advanced BC with disease recurrence/progression following prior NSAIs. These results further support the use of everolimus plus exemestane in this patient population. ClinicalTrials.gov #NCT00863655.

Development of Career Opportunities for Technicians in the Nuclear Medicine Field, Phase I. Interim Report Number 1: Survey of Job Characteristics, Manpower Needs and Training Resources, July 1969.

ERIC Educational Resources Information Center

Technical Education Research Center, Cambridge, MA.

Phase I of a multiphase research program in progress at the Technical Education Research Center, Inc., was conducted to analyze needs and resources in terms of job performance tasks, career opportunities, and training requirements for nuclear medical technicians. Data were gathered through personal interviews with 203 persons, mostly physicians,…

The New Guard: A Service-Equivalent Force

DTIC Science & Technology

2012-06-07

quartermas ter , medical , ordinance and inspector general. The bureaus were designed to be more efficient and deliver cost aving; but. onl y created...2. REPORT TYPE. State the type of report, such as final , technical, interim, memorandum, master’s thesis , progress, quarterly, research ...the report, performing the research , or credited with the content of the report. The form of entry is the last name, first name, middle initial, and

Effect of Alcohol on the Spreading Ability of Sodium Hypochlorite Endodontic Irrigant

DTIC Science & Technology

1982-09-01

Research Progress Sodium Hypochlorite Endodontic Irrigant Report (Interim) 6. PERFORMING ORG. REPORT NUMBER 7. AU THOR(s) 8. CONTRACT OR GRANT NUMBER(s...neceewary and Identify by block nam.ber) Alcohol Sodium hypochlorite Endodontics Root canal 20, ABSTRACT (Continue on reveree side If neceeseay and...depressant significantly increased the ability of the sodium hypochlorite endodontic irrigant to penetrate in vitro. A freshly mixed solution containing 30

Cellular Mechanisms of Transcranial Direct Current Stimulation

DTIC Science & Technology

2016-07-14

REPORT TYPE. State the type of report, such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group ...in fEPSP timing was not resolved. Importantly, grouping across all pathways (e.g. not controlling pathway selectivity), 8 V/m radial positive fields...each signal group during DCS and in control conditions (no electrical stimulation). F) Changes in synaptic strength for each signal group under all

An Advanced Approach to Simultaneous Monitoring of Multiple Bacteria in Space

NASA Technical Reports Server (NTRS)

Eggers, Mitch

1998-01-01

This interim report describes progress on the development of spacecraft-compatible methods of nucleic acid preparation and cleanup. Grantee found that performance of a widely-known protocol could be greatly enhanced by the addition of a sizing step to eliminate acids. Testing of alternative adsorptive methods is underway. Grantee also confirmed and extended observation of precipitation of DNA by condensing agents such a spermine at low ionic strength.

Fundamental Understanding of Propellant/Nozzle Interaction for Rocket Nozzle Erosion Minimization Under Very High Pressure Conditions

DTIC Science & Technology

2005-08-31

conditions; with X-ray radiography for erosion rate measurements. A vortex combustor was also designed to simulate propellant product species and to...DATES COVERED Interim Progress Report, August 1, 2004 to July 31, 2005 4. TITLE AND SUBTITLE Fundamental Understanding of Propellant /Nozzle...nozzle erosion by solid- propellant combustion products. Several processes can affect the nozzle erosion rate at high pressure and temperature

DEVELOPMENT OF IMPROVED FABRICATION METHODS, PROCESS AND TECHNIQUES FOR PRODUCING TYPICAL AIRCRAFT SHAPES FROM BERYLLIUM. Interim Technical Documentary Progress Report for the Period ending October 31, 1962

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jenkins, R.G.; Siergiej, J.M.

1962-12-28

In a program to develop a complete manufacturing process for ihe production of beryllium channels, techniques are being sought for drawing to obtain a flnal product meeting specifications more rigorous than are obtainable by direct extrusion. Progress in designing and procuring the special tooling required to draw complex shapes at elevated temperature is described, and the flrst set of draw dies is evaluated with respect to design and quality. Three experimental draw attempts have been made on U-channels, in addition to draw tests on flats. (auth)

Safety and efficacy of lithium in combination with riluzole for treatment of amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial.

PubMed

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.

An interim report on gill disease

USGS Publications Warehouse

Rucker, R.R.; Johnson, H.E.; Kaydas, G.M.

1952-01-01

GILL DISEASE among fish, a disease which is characterized by a proliferation of the gill epithelium, has been attributed to a number of different causes. Generally, there are two recognized types: the eastern or bacterial type, in which long filamentous bacteria can always be demonstrated; and the western type, in which, by definition, bacteria cannot be demonstrated.

A Case Study of Technical Assistance to Demonstration Programs for Young Handicapped Children. Part I.

ERIC Educational Resources Information Center

Behr, Shirley K.; And Others

The interim report presents an evaluation of TADS (Technical Assistance Development System) through case studies of TADS technical assistance to the staffs of two demonstration programs for preschool handicapped children and their families. Purposes of the study included obtaining indepth descriptions of the technical assistance process to…

Color stability and marginal integrity of interim crowns: An in vitro study

PubMed Central

Elagra, Marwa I.; Rayyan, Mohammad R.; Alhomaidhi, Maisam M.; Alanaziy, Areej A.; Alnefaie, Mona O.

2017-01-01

Objective: Many commercial dental materials are used to fabricate interim restorations. This study aimed to compare the color stability and the marginal integrity of four different interim crown materials. Materials and Methods: An ivorine right maxillary central incisor was prepared for a full coverage all-ceramic restoration. A total of 36 specimens in the form of crowns were fabricated on the master die using four different materials (n = 9); Polymethyl methacrylate (PMMA) resin (TrimPLUS), PMMA computer-aided design, and computer-aided manufacturing (CAD-CAM) blocks (Ceramill TEMP), cold cure bis-acryl resin (Success CD), and bis-acryl resin dual-cure composite (TempSpan). Color change ΔE for each sample was calculated by measuring its color as Commission Internationale de l’Eclairage L* a* b* with a spectrophotometer before and after immersing in a concentrated tea solution for 7 days. Marginal gap was measured at four reference points using stereomicroscope at ×40. One-way ANOVA and the Tukey multiple comparisons test were used to determine any statistically significant difference between the four groups, (α = 0.05). Results: Success CD showed significantly the greatest color change (7.7) among all the tested materials, while no significant difference was found between the other three materials. TempSpan showed significantly the highest marginal gap formation (430.15 μm), while no significant difference was found between the three other materials. Conclusions: Bis-acryl resin composite materials demonstrated clinically noticeable change in color while PMMA materials demonstrated superior color stability. Dual cure interim materials exhibited significantly higher marginal discrepancy in comparison to PMMA and cold cure bis-acrylic resin materials. CAD-CAM PMMA material exhibited the best color stability and marginal integrity. PMID:28932142

Our Lady of Hungary Catholic School, Indiana. School Achieves Double-Digit Growth with the Help of Interim and Classroom Formative Assessment Data. Case Study: Measures of Academic Progress & Professional Development.

ERIC Educational Resources Information Center

Northwest Evaluation Association, 2015

2015-01-01

In 2014, South Bend's Our Lady of Hungary Catholic School welcomed its third principal in four years: Kevin Goralczyk, an Indiana native and seasoned educator. Together with the parish's pastor, Reverend Kevin Bauman, Principal Goralczyk began exploring how OLH could raise its pre-K-8 student achievement and better support teachers and staff…

United States Air Force F-35A Operational Basing Environmental Impact Statement. Appendix E: Comments

DTIC Science & Technology

2013-09-01

such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED...appear in the report, e.g. 001; AFAPL30480105. 6. AUTHOR(S). Enter name(s) of person(s) responsible for writing the report, performing the research ...negatively impacted by the noise] SAFTY ALL NEW military aircraft designs suffer crashes during their initial development peri~ Bringing the F-35

Draft report: Results of stainless steel canister corrosion studies and environmental sample investigations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bryan, Charles R.; Enos, David

2014-09-01

This progress report describes work being done at Sandia National Laboratories (SNL) to assess the localized corrosion performance of container/cask materials used in the interim storage of used nuclear fuel. The work involves both characterization of the potential physical and chemical environment on the surface of the storage canisters and how it might evolve through time, and testing to evaluate performance of the canister materials under anticipated storage conditions.

18 CFR 11.17 - Procedures for payment of charges and costs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... charge is established for a period for which an interim charge was paid, the Commission will apply the... hydrology, development, and other characteristics of the river basin, demonstrate sufficient stability to...

18 CFR 11.17 - Procedures for payment of charges and costs.

Code of Federal Regulations, 2011 CFR

2011-04-01

... charge is established for a period for which an interim charge was paid, the Commission will apply the... hydrology, development, and other characteristics of the river basin, demonstrate sufficient stability to...

Analysis of Transportation Options for Commercial Spent Fuel in the U.S.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kalinina, Elena; Busch, Ingrid Karin

The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S.more » Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage The U.S. Department of Energy (DOE) is laying the groundwork for implementing interim storage and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF) and high and associated transportation of spent nuclear fuel (SNF) high and associated transportation of spent nuclear fuel (SNF) highand associated transportation of spent nuclear fuel (SNF)...« less

ARSENIC REMOVAL FROM DRINKING WATER BY ADSORPTIVE MEDIA. U.S. EPA DEMONSTRATION PROJECT AT SOUTH TRUCKEE MEADOWS GENERAL IMPROVEMENT DISTRICT (STMIG), NV. INTERIM EVALUATION REPORT

EPA Science Inventory

This report documents the activities performed during and the results obtained from the first 32 weeks of operation of an arsenic and antimony removal technology currently being demonstrated at the South Truckee Meadows General Improvement District (STMGID) in Washoe County, NV. ...

Modified Interim Mandibular Advancement (MIMA) Appliance for Symptomatic Correction of Obstructive Sleep Apnea

PubMed Central

Singh, Harpreet; Mishra, Harsh Ashok; Gupta, Ankur

2016-01-01

Obstructive Sleep Apnea (OSA) is a chronic, progressive, multifactorial, life-threatening disorder that causes significant impact on patient’s life. Patients with OSA [Apnea/Hypopnea Index (AHI)>30] who cannot tolerate Continuous Positive Airway Pressure (CPAP) therapy or are not surgical candidates may benefit from oral appliances. This paper describes interim appliance devised from existing Hawley’s retainer in patients with OSA. A 38-year-old man of athletic built with history of orthodontic treatment six months back due to esthetic concerns and wearing upper Hawley’s retainer, reported with chief complaint of frequent nocturnal awakening along with excessive daytime somnolence. Based on diagnostic aids, he was diagnosed with Class II Division 1 malocclusion with severe mandibular retrusion. Sleep test revealed AHI score of 34, suggestive of severe OSA. With ENT and Oral surgeon concurrence, mandibular advancement of 7mm with Bilateral Sagital Split Osteotomy (BSSO) with distraction was contemplated as a viable functional and curative stable treatment plan. Because of non-adherence and non-compliance with CPAP therapy and on request of patient, an interim anterior positioning appliance was devised to facilitate comfortable sound sleep till the time surgery is impending. After three months of wearing this customized appliance, improved quality of sleep was discernible; both subjectively as reported by patient and objectively using sleep test (AHI=9.8). PMID:27656589

Usefulness of Interim FDG-PET After Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Receiving Sequential Induction Chemotherapy Followed by Concurrent Chemoradiotherapy

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

United States Air Force F-35A Operational Basing Environmental Impact Statement. Appendix E: Comments

DTIC Science & Technology

2013-09-01

studies such as this one, and other research conducted in most recent decade. Of course, the housing designation ("not compatible with residential...such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED...appear in the report, e.g. 001; AFAPL30480105. 6. AUTHOR(S). Enter name(s) of person(s) responsible for writing the report, performing the research

Progress on plutonium stabilization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hurt, D.

1996-05-01

The Defense Nuclear Facilities Safety Board has safety oversight responsibility for most of the facilities where unstable forms of plutonium are being processed and packaged for interim storage. The Board has issued recommendations on plutonium stabilization and has has a considerable influence on DOE`s stabilization schedules and priorities. The Board has not made any recommendations on long-term plutonium disposition, although it may get more involved in the future if DOE develops plans to use defense nuclear facilities for disposition activities.

FY17 Status Report: Research on Stress Corrosion Cracking of SNF Interim Storage Canisters.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schindelholz, Eric John; Bryan, Charles R.; Alexander, Christopher L.

This progress report describes work done in FY17 at Sandia National Laboratories (SNL) to assess the localized corrosion performance of container/cask materials used in the interim storage of spent nuclear fuel (SNF). Of particular concern is stress corrosion cracking (SCC), by which a through-wall crack could potentially form in a canister outer wall over time intervals that are shorter than possible dry storage times. Work in FY17 refined our understanding of the chemical and physical environment on canister surfaces, and evaluated the relationship between chemical and physical environment and the form and extent of corrosion that occurs. The SNL corrosionmore » work focused predominantly on pitting corrosion, a necessary precursor for SCC, and process of pit-to-crack transition; it has been carried out in collaboration with university partners. SNL is collaborating with several university partners to investigate SCC crack growth experimentally, providing guidance for design and interpretation of experiments.« less

Evaluation of rubber-asphalt chip seal in Oregon : interim report.

DOT National Transportation Integrated Search

1977-05-01

The Oregon State Highway Division, in cooperation with the Federal Highway Administration, participated in a demonstration project on the evaluation of rubber-asphalt chip seals. The trial projects were placed in Maintenance District 11, in the vicin...

Marine Natural Product Chemistry and the Interim: A Novel Approach

ERIC Educational Resources Information Center

Bland, Jeffrey S.; Medcalf, Darrell G.

1974-01-01

Describes a course designed to strengthen a student's background in organic chemistry, demonstrate the interfacing of chemistry and biology, expose undergraduates to graduate research, provide familiarity with instrumentation, and provide a novel field experience. (Author/GS)

16 CFR 1209.36 - Production testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.36 Production testing. (a) General... manufactured to demonstrate that the product being manufactured is substantially similar to the product which...

16 CFR 1209.32 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.32 Definitions. In addition to the... samples of the cellulose insulation being produced to demonstrate that the product meets the requirements...

The Time Needed to Implement the Blue Ribbon Commission Recommendation on Interim Storage - 13124

DOE Office of Scientific and Technical Information (OSTI.GOV)

Voegele, Michael D.; Vieth, Donald

2013-07-01

The report of the Blue Ribbon Commission on America's Nuclear Future [1] makes a number of important recommendations to be considered if Congress elects to redirect U.S. high-level radioactive waste disposal policy. Setting aside for the purposes of this discussion any issues related to political forces leading to stopping progress on the Yucca Mountain project and driving the creation of the Commission, an important recommendation of the Commission was to institute prompt efforts to develop one or more consolidated storage facilities. The Blue Ribbon Commission noted that this recommended strategy for future storage and disposal facilities and operations should bemore » implemented regardless of what happens with Yucca Mountain. It is too easy, however, to focus on interim storage as an alternative to geologic disposal. The Blue Ribbon Commission report does not go far enough in addressing the magnitude of the contentious problems associated with reopening the issues of relative authorities of the states and federal government with which Congress wrestled in crafting the Nuclear Waste Policy Act [2]. The Blue Ribbon Commission recommendation for prompt adoption of an interim storage program does not appear to be fully informed about the actions that must be taken, the relative cost of the effort, or the realistic time line that would be involved. In essence, the recommendation leaves to others the details of the systems engineering analyses needed to understand the nature and details of all the operations required to reach an operational interim storage facility without derailing forever the true end goal of geologic disposal. The material presented identifies a number of impediments that must be overcome before the country could develop a centralized federal interim storage facility. In summary, and in the order presented, they are: 1. Change the law, HJR 87, PL 107-200, designating Yucca Mountain for the development of a repository. 2. Bring new nuclear waste legislation to the floor of the Senate, overcoming existing House support for Yucca Mountain; 3. Change the longstanding focus of Congress from disposal to storage; 4. Change the funding concepts embodied in the Nuclear Waste Policy Act to allow the Nuclear Waste fund to be used to pay for interim storage; 5. Reverse the Congressional policy not to give states or tribes veto or consent authority, and to reserve to Congress the authority to override a state or tribal disapproval; 6. Promulgate interim storage facility siting regulations to reflect the new policies after such changes to policy and law; 7. Complete already underway changes to storage and transportation regulations, possibly incorporating changes to reflect changes to waste disposal law; 8. Promulgate new repository siting regulations if the interim storage facility is to support repository development; 9. Identify volunteer sites, negotiate agreements, and get Congressional approval for negotiated benefits packages; 10. Design, License and develop the interim storage facility. The time required to accomplish these ten items depends on many factors. The estimate developed assumes that certain of the items must be completed before other items are started; given past criticisms of the current program, such an assumption appears appropriate. Estimated times for completion of individual items are based on historical precedent. (authors)« less

Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer.

PubMed

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.

Venetoclax for chronic lymphocytic leukaemia progressing after ibrutinib: an interim analysis of a multicentre, open-label, phase 2 trial.

PubMed

Jones, Jeffrey A; Mato, Anthony R; Wierda, William G; Davids, Matthew S; Choi, Michael; Cheson, Bruce D; Furman, Richard R; Lamanna, Nicole; Barr, Paul M; Zhou, Lang; Chyla, Brenda; Salem, Ahmed Hamed; Verdugo, Maria; Humerickhouse, Rod A; Potluri, Jalaja; Coutre, Steven; Woyach, Jennifer; Byrd, John C

2018-01-01

Therapy targeting Bruton's tyrosine kinase (BTK) with ibrutinib has transformed the treatment of chronic lymphocytic leukaemia. However, patients who are refractory to or relapse after ibrutinib therapy have poor outcomes. Venetoclax is a selective, orally bioavailable inhibitor of BCL-2 active in previously treated patients with relapsed or refractory chronic lymphocytic leukaemia. In this study, we assessed the activity and safety of venetoclax in patients with chronic lymphocytic leukaemia who are refractory to or relapse during or after ibrutinib therapy. In this interim analysis of a multicentre, open-label, non-randomised, phase 2 trial, we enrolled patients aged 18 years or older with a documented diagnosis of chronic lymphocytic leukaemia according to the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and an Eastern Cooperative Oncology Group performance score of 2 or lower. All patients had relapsed or refractory disease after previous treatment with a BCR signalling pathway inhibitor. All patients were screened for Richter's transformation and cases confirmed by biopsy were excluded. Eligible patients received oral venetoclax, starting at 20 mg per day with stepwise dose ramp-up over 5 weeks to 400 mg per day. Patients with rapidly progressing disease received an accelerated dosing schedule (to 400 mg per day by week 3). The primary endpoint was overall response, defined as the proportion of patients with an overall response per investigator's assessment according to IWCLL criteria. All patients who received at least one dose of venetoclax were included in the activity and safety analyses. This study is ongoing; data for this interim analysis were collected per regulatory agencies' request as of June 30, 2017. This trial is registered with ClinicalTrials.gov, number NCT02141282. Between September, 2014, and November, 2016, 127 previously treated patients with relapsed or refractory chronic lymphocytic leukaemia were enrolled from 15 sites across the USA. 91 patients had received ibrutinib as the last BCR inhibitor therapy before enrolment, 43 of whom were enrolled in the main cohort and 48 in the expansion cohort recruited later after a protocol amendment. At the time of analysis, the median follow-up was 14 months (IQR 8-18) for all 91 patients, 19 months (9-27) for the main cohort, and 12 months (8-15) for the expansion cohort. 59 (65%, 95% CI 53-74) of 91 patients had an overall response, including 30 (70%, 54-83) of 43 patients in the main cohort and 29 (60%, 43-72) of 48 patients in the expansion cohort. The most common treatment-emergent grade 3 or 4 adverse events were neutropenia (46 [51%] of 91 patients), thrombocytopenia (26 [29%]), anaemia (26 [29%]), decreased white blood cell count (17 [19%]), and decreased lymphocyte count (14 [15%]). 17 (19%) of 91 patients died, including seven because of disease progression. No treatment-related deaths occurred. The results of this interim analysis show that venetoclax has durable clinical activity and favourable tolerability in patients with relapsed or refractory chronic lymphocytic leukaemia whose disease progressed during or after discontinutation of ibrutinib therapy. The durability of response to venetoclax will be assessed in the final analysis in 2019. AbbVie, Genentech. Copyright © 2018 Elsevier Ltd. All rights reserved.

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...

A Process Evaluation of Project Developmental Continuity. Interim Report II, Part A: Program Case Studies. Volume 2.

ERIC Educational Resources Information Center

Spencer, Lynn, Ed.

These 7 case studies are part of a series of documents on the evaluation of Project Developmental Continuity (PDC), a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and primary school experiences. Each case study reviews the planning year at a PDC demonstration site in one…

A Process Evaluation of Project Developmental Continuity. Interim Report II, Part A: Program Case Studies. Volume I.

ERIC Educational Resources Information Center

Spencer, Lynn, Ed.

These 8 case studies are part of a series of documents on the evaluation of Project Developmental Continuity (PDC), a Head Start demonstration program aimed at providing educational and developmental continuity between children's Head Start and primary school experiences. Each case study reviews the planning year at a PDC demonstration site in one…

Arsenic Removal from Drinking Water by Adsorptive Media U.S. EPA Demonstration Project at Upper Bodfish in Lake Isabella, CA Interim Evaluation Report

EPA Science Inventory

This report documents the activities performed during and the results obtained from the first 10 months of system operation of an arsenic (As) and uranium (U) removal technology being demonstrated at Upper Bodfish in Lake Isabella, CA. The objectives of the project are to evalua...

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...

Proof of concept deployment plan.

DOT National Transportation Integrated Search

2008-02-01

The U.S. Department of Transportation (USDOT) Next Generation 9-1-1 (NG9-1-1) : Proof-of-Concept (POC) demonstration is envisioned to test key features and : functionalities of the NG9-1-1 system. The Interim POC System Design Document : defines the ...

Environmental effects of ozone depletion and its interactions with climate change: progress report, 2015.

PubMed

2016-02-01

The Environmental Effects Assessment Panel (EEAP) is one of three Panels that regularly informs the Parties (countries) to the Montreal Protocol on the effects of ozone depletion and the consequences of climate change interactions with respect to human health, animals, plants, biogeochemistry, air quality, and materials. The Panels provide a detailed assessment report every four years. The most recent 2014 Quadrennial Assessment by the EEAP was published as a special issue of seven papers in 2015 (Photochem. Photobiol. Sci., 2015, 14, 1-184). The next Quadrennial Assessment will be published in 2018/2019. In the interim, the EEAP generally produces an annual update or progress report of the relevant scientific findings. The present progress report for 2015 assesses some of the highlights and new insights with regard to the interactive nature of the effects of UV radiation, atmospheric processes, and climate change.

Failsafe automation of Phase II clinical trial interim monitoring for stopping rules.

PubMed

Day, Roger S

2010-02-01

In Phase II clinical trials in cancer, preventing the treatment of patients on a study when current data demonstrate that the treatment is insufficiently active or too toxic has obvious benefits, both in protecting patients and in reducing sponsor costs. Considerable efforts have gone into experimental designs for Phase II clinical trials with flexible sample size, usually implemented by early stopping rules. The intended benefits will not ensue, however, if the design is not followed. Despite the best intentions, failures can occur for many reasons. The main goal is to develop an automated system for interim monitoring, as a backup system supplementing the protocol team, to ensure that patients are protected. A secondary goal is to stimulate timely recording of patient assessments. We developed key concepts and performance needs, then designed, implemented, and deployed a software solution embedded in the clinical trials database system. The system has been in place since October 2007. One clinical trial tripped the automated monitor, resulting in e-mails that initiated statistician/investigator review in timely fashion. Several essential contributing activities still require human intervention, institutional policy decisions, and institutional commitment of resources. We believe that implementing the concepts presented here will provide greater assurance that interim monitoring plans are followed and that patients are protected from inadequate response or excessive toxicity. This approach may also facilitate wider acceptance and quicker implementation of new interim monitoring algorithms.

Parameter identification for nonlinear aerodynamic systems

NASA Technical Reports Server (NTRS)

Pearson, Allan E.

1993-01-01

This final technical report covers a three and one-half year period preceding February 28, 1993 during which support was provided under NASA Grant NAG-1-1065. Following a general description of the system identification problem and a brief survey of methods to attack it, the basic ideas behind the approach taken in this research effort are presented. The results obtained are described with reference to the published work, including the five semiannual progress reports previously submitted and two interim technical reports.

LINER FOR EXTRUSION BILLET CONTAINERS. Interim Technical Documentary Progress Report, June 5, 1962-September 5, 1962

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spachner, S.A.

1962-10-31

A container-sleeve-liner assembly was designed which will provide adequate support for ceramic, ceramic coated metal, or metal liners. The design minimizes mechanical property requirements of liner materials, and permits rapid removal of worn or damaged liners. A high-strength stem was designed and fabricated. Technical literature on high-strength materials was reviewed, and high-strength materials producers were contacted to locate sources and assess applicability of existing materials for refractory metal extrusion liner use. (auth)

United States Air Force F-35A Operational Basing Environmental Impact Statement. Appendix E: Comments

DTIC Science & Technology

2013-09-01

hreatens the well being of our community, whether through noi se and emissions or the risk of accidents from an under- test ed and flawed design . The...such as final, technical, interim, memorandum, master’s thesis, progress, quarterly, research , special, group study, etc. 3. DATES COVERED...appear in the report, e.g. 001; AFAPL30480105. 6. AUTHOR(S). Enter name(s) of person(s) responsible for writing the report, performing the research

Toward Active Control of Noise from Hot Supersonic Jets

DTIC Science & Technology

2012-05-14

was developed that would allow for easy data sharing among the research teams. This format includes the acoustic data along with all calibration ...SUPERSONIC | QUARTERLY RPT. 3 ■ 1 i; ’XZ. "• Tff . w w i — r i (a) Far-Field Array Calibration (b) MHz Rate PIV Camera Setup Figure... Plenoptic camera is a similar setup to determine 3-D motion of the flow using a thick light sheet. 2.3 Update on CFD Progress In the previous interim

Implementing Program Integrity from an HBCU Perspective: Progress, Problems, and Prospects. An Analysis of Part H, Program Integrity - TRIAD of the Higher Education Act and the Final Rules and Related Interim Final Regulations Published in the "Federal Register" on April 29, 1994.

ERIC Educational Resources Information Center

Blakely, William A.

This paper examines the impact and implications for the nation's 104 historically black colleges and universities (HBCUs) of the final regulations published in the April 29, 1994 "Federal Register" and traces both the legislative and regulatory history of Part H of the Higher Education Act provisions. The analysis addresses specific…

NRL EIGHTH CARD Program Interim Progress Report, 1 March 1969 to 30 September 1969

DTIC Science & Technology

1969-12-31

methods to measure the water vapor content of the atmosphere have been inves- tigated. One is based on the psychrometer method of measuring wet and dry bulb...over and under configuration. A shipboard psychrometer consisting of the sensors and blower and an 18.5-foot-high intake stack has been mounted on a...small boat. The intake stack may be partially dismounted to pro- vide a 9-foot intake level. The readout for the psychrometer is a multipoint Leeds and

75 FR 984 - Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites

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...

Laser ablation/ionization characterization of solids: Second interim progress report of the strategic environmental research development program

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hess, W.P.; Bushaw, B.A.; McCarthy, M.I.

1996-10-01

The Department of Energy is undertaking the enormous task of remediating defense wastes and environmental insults which have occurred over 50 years of nuclear weapons production. It is abundantly clear that significant technology advances are needed to characterize, process, and store highly radioactive waste and to remediate contaminated zones. In addition to the processing and waste form issues, analytical technologies needed for the characterization of solids, and for monitoring storage tanks and contaminated sites do not exist or are currently expensive labor-intensive tasks. This report describes progress in developing sensitive, rapid, and widely applicable laser-based mass spectrometry techniques for analysismore » of mixed chemical wastes and contaminated soils.« less

Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial.

PubMed

Demetri, George D; von Mehren, Margaret; Jones, Robin L; Hensley, Martee L; Schuetze, Scott M; Staddon, Arthur; Milhem, Mohammed; Elias, Anthony; Ganjoo, Kristen; Tawbi, Hussein; Van Tine, Brian A; Spira, Alexander; Dean, Andrew; Khokhar, Nushmia Z; Park, Youn Choi; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Patel, Shreyaskumar R

2016-03-10

This multicenter study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and at least one additional systemic regimen. Patients were randomly assigned in a 2:1 ratio to receive trabectedin or dacarbazine intravenously every 3 weeks. The primary end point was overall survival (OS), secondary end points were disease control-progression-free survival (PFS), time to progression, objective response rate, and duration of response-as well as safety and patient-reported symptom scoring. A total of 518 patients were enrolled and randomly assigned to either trabectedin (n = 345) or dacarbazine (n = 173). In the final analysis of PFS, trabectedin administration resulted in a 45% reduction in the risk of disease progression or death compared with dacarbazine (median PFS for trabectedin v dacarbazine, 4.2 v 1.5 months; hazard ratio, 0.55; P < .001); benefits were observed across all preplanned subgroup analyses. The interim analysis of OS (64% censored) demonstrated a 13% reduction in risk of death in the trabectedin arm compared with dacarbazine (median OS for trabectedin v dacarbazine, 12.4 v 12.9 months; hazard ratio, 0.87; P = .37). The safety profiles were consistent with the well-characterized toxicities of both agents, and the most common grade 3 to 4 adverse effects were myelosuppression and transient elevation of transaminases in the trabectedin arm. Trabectedin demonstrates superior disease control versus conventional dacarbazine in patients who have advanced liposarcoma and leiomyosarcoma after they experience failure of prior chemotherapy. Because disease control in advanced sarcomas is a clinically relevant end point, this study supports the activity of trabectedin for patients with these malignancies. © 2015 by American Society of Clinical Oncology.

Cathodic Protection Field Trials on Prestressed Concrete Components, Final Report

DOT National Transportation Integrated Search

1998-01-01

This is the final report in a study to demonstrate the feasibility of using cathodic protection (CP) on concrete bridge structures containing prestressed steel. The interim report, FHWA-RD-95-032, has more details on the installation of selected CP s...

Model Estimation Using Ridge Regression with the Variance Normalization Criterion. Interim Report No. 2. The Education and Inequality in Canada Project.

ERIC Educational Resources Information Center

Lee, Wan-Fung; Bulcock, Jeffrey Wilson

The purposes of this study are: (1) to demonstrate the superiority of simple ridge regression over ordinary least squares regression through theoretical argument and empirical example; (2) to modify ridge regression through use of the variance normalization criterion; and (3) to demonstrate the superiority of simple ridge regression based on the…

Explorative analyses on the value of interim PET for prediction of response in pediatric and adolescent non-Hodgkin lymphoma patients

PubMed Central

2013-01-01

Background This study is to evaluate the predictive value of FDG-PET (PET) in pediatric and adolescent patients suffering from non-Hodgkin lymphoma (pNHL) in comparison to information provided by conventional imaging methods (CIM). Methods Imaging was performed at baseline and at interim (after 2 cycles of chemotherapy). The response assessment in PET was carried out visually and semi-quantitatively, the latter one by use of percentage decrease in SUVmax from baseline to interim (ΔSUVmax). The PET-based results were compared to the findings by CIM. Progression-free survival (PFS) was analyzed using Kaplan-Meier curves (KM) and log-rank test. Results The final study included 16 patients (mean follow-up time, 60.2 months (range, 4.0 to 85.7 months)). Relapse occurred in four patients. Visual PET compared to CIM revealed higher sensitivity (3/4 vs 1/4) and NPV (6/7 vs 10/13), and equal PPV (3/9 vs 1/3), but lower specificity (6/12 vs 10/12) and accuracy (9/16 vs 11/16). False-positive findings in PET at interim were predominantly observed in patients presenting bulky disease (5/6), whereas CIM was true-negative in all of these cases. KM analyses revealed no significant differences in 5-year PFS neither for CIM (76.9% vs 66.7%; p = 0.67) nor for visual PET (85.7% vs 66.7%; p = 0.34) nor for ΔSUVmax (88.9% vs 57.1%; p = 0.12). Conclusions The predictive value of iPET in pediatric patients suffering from NHL was limited due to considerably high amount of false-positive findings, especially in patients suffering from bulky disease. However, due to our limited sample size, final conclusions cannot be drawn and, thus, call for further evaluation of PET in pNHL in larger and more homogenous patient series. PMID:24139528

West Valley demonstration project: Alternative processes for solidifying the high-level wastes

NASA Astrophysics Data System (ADS)

Holton, L. K.; Larson, D. E.; Partain, W. L.; Treat, R. L.

1981-10-01

Two pretreatment approaches and several waste form processes for radioactive wastes were selected for evaluation. The two waste treatment approaches were the salt/sludge separation process and the combined waste process. Both terminal and interim waste form processes were studied.

HARD CHROME POLLUTION PREVENTION DEMONSTRATION PROJECT - INTERIM REPORT

EPA Science Inventory

In the project, five chromium emission prevention/control devices were tested tha cover the spectrum of prevention/control techniques currently in use in small- and large-size hard chromium electroplating job shops. The Project results show that some of the tested devices had ch...

U.S. Food and Drug Administration Approval Summary: Enzalutamide for the Treatment of Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

PubMed

Ning, Yang-Min; Brave, Michael; Maher, V Ellen; Zhang, Lijun; Tang, Shenghui; Sridhara, Rajeshwari; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard

2015-08-01

The U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). At the prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm. The overall benefit-risk profile supports the expanded indication for enzalutamide. On September 10, 2014, the U.S. Food and Drug Administration approved enzalutamide for the treatment of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide was initially approved in 2012 for use in patients with mCRPC who had previously received docetaxel. The current approval was based on the results of a randomized, placebo-controlled, double-blind trial conducted in 1,717 asymptomatic or minimally symptomatic patients with chemotherapy-naïve mCRPC. Patients were assigned to receive either enzalutamide 160 mg or placebo orally once daily. The coprimary endpoints were overall survival (OS) and radiographic progression-free survival (rPFS), which was assessed by independent central radiology review. At the prespecified interim analysis, a statistically significant improvement in OS was demonstrated for patients in the enzalutamide arm compared with patients in the placebo arm (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.60-0.84). The median OS was 32.4 and 30.2 months in the enzalutamide and placebo arms, respectively. A statistically significant prolongation of rPFS was observed in patients in the enzalutamide arm (HR, 0.17; 95% CI, 0.14-0.21). In addition, the time to initiation of cytotoxic chemotherapy was prolonged in the enzalutamide arm (HR, 0.35; 95% CI, 0.30-0.40), with median times of 28.0 and 10.8 months in the enzalutamide and placebo arms, respectively. The safety profile was similar to that previously reported for enzalutamide. Adverse reactions of interest included seizure, hypertension, and falls. Enzalutamide should be discontinued if a seizure occurs during treatment. The overall benefit-risk profile supports the expanded indication for enzalutamide. ©AlphaMed Press.

A web-based endpoint adjudication system for interim analyses in clinical trials.

PubMed

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.

Modeling and simulation of maintenance treatment in first-line non-small cell lung cancer with external validation.

PubMed

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.

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...

40 CFR 1033.150 - Interim provisions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... provisions. The provisions of this section apply instead of other provisions of this part for a limited time... remanufacture system. (iv) The remanufacturer must demonstrate at the time of certification that the system... requested such certificates. The notification should occur at the same time that the remanufacturer submits...

40 CFR 1033.150 - Interim provisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... provisions. The provisions of this section apply instead of other provisions of this part for a limited time... remanufacture system. (iv) The remanufacturer must demonstrate at the time of certification that the system... requested such certificates. The notification should occur at the same time that the remanufacturer submits...

The deep underground science and engineering laboratory at Homestake

NASA Astrophysics Data System (ADS)

Lesko, Kevin T.

2009-06-01

The US National Science Foundation and the US underground science community are well into the campaign to establish a world-class, multi-disciplinary deep underground science and engineering laboratory — DUSEL. The NSF's review committee, following the first two NSF solicitations, selected Homestake as the prime site to be developed into an international, multidisciplinary, world-class research facility. Homestake DUSEL will provide much needed underground research space to help relieve the worldwide shortage, particularly at great depth, and will develop research campuses at different depths to satisfy the research requirements for the coming decades. The State of South Dakota has demonstrated remarkable support for the project and has secured the site with the transfer of the former Homestake Gold Mine and has initiated re-entry and rehabilitation of the facility to host a modest interim science program with state funds and those from a substantial philanthropic donor. I review the scientific case for DUSEL and the progress in developing the preliminary design of DUSEL in Homestake and the initial suite of experiments to be funded along with the facility.

The Deep Underground Science and Engineering Laboratory at Homestake

NASA Astrophysics Data System (ADS)

Lesko, Kevin T.

2009-12-01

The US National Science Foundation and the US underground science community are well into the campaign to establish a world-class, multi-disciplinary deep underground science and engineering laboratory—DUSEL. The NSF's review committee, following the first two NSF solicitations, selected Homestake as the prime site to be developed into an international, multidisciplinary, world-class research facility. Homestake DUSEL will provide much needed underground research space to help relieve the worldwide shortage, particularly at great depth, and will develop research campuses at different depths to satisfy the research requirements for the coming decades. The State of South Dakota demonstrates remarkable support for the project and has secured the site with the transfer of the former Homestake Gold Mine and has initiated re-entry and rehabilitation of the facility to host a modest interim science program with state funds and those from a substantial philanthropic donor. I review the scientific case for DUSEL and the progress in developing the preliminary design of DUSEL in Homestake and the integrated suite of experiments to be funded along with the facility.

Interim Expertise

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...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Balkwill, D.L.; Reeves, R.H.

The present document is an interim technical report in which we describe the research which has been completed during the seven-month period since the start of the grant. Progress is summarized in two main areas. The first is microbiological characterization of subsurface materials from the Hanford reservation and the Idaho National Engineering Laboratory, and the second is phylogenetic characterization of these microorganisms. The major tools used for phylogenetic characterization are RFLP analysis of PCR derived material and 16S rRNA sequencing. A description of manuscripts ready for publication is also provided. 4 refs. (MHB)

Application of the ALE and MBE Methods to the Growth of Layered Hg sub x Cd sub 1-x Te Films.

DTIC Science & Technology

1986-09-26

films / We have studied the applicability of the Atomic Layer Epitaxy (ALE, vee Ref. -1pand Molecular Beam Epitaxy (MBE) ito growth of Hg2 Cdi- ,Te...thin- films throughout the composition range 0 x $ 0.8. The progress of the Contract has been reported periodically in five interim reports. This final...I separate sources) yielded films with high x values. On the grounds of these observations we do not find ALE suitable for growth of HgCdTe. 2) ALE

Radioactive Wastes.

PubMed

Choudri, B S; Charabi, Yassine; Baawain, Mahad; Ahmed, Mushtaque

2017-10-01

Papers reviewed herein present a general overview of radioactive waste related activities around the world in 2016. The current reveiw include studies related to safety assessments, decommission and decontamination of nuclear facilities, fusion facilities, transportation. Further, the review highlights on management solutions for the final disposal of low and high level radioactive wastes (LLW and HLW), interim storage and final disposal options for spent fuel (SF), and tritiated wastes, with a focus on environmental impacts due to the mobility of radionuclides in ecosystem, water and soil alongwith other progress made in the management of radioactive wastes.

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...

77 FR 55230 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-01; Compliance With...

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...

77 FR 55231 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-02; Compliance With...

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...

Antimicrobial Exposure Assessment Task Force II (AEATF II) Volume 5: Governing Document for a Multi-Year Antimicrobial Chemical Exposure Monitoring Program (interim draft document)

EPA Pesticide Factsheets

Describes the overall scope of the AEATF II program, demonstrates the need for additional human exposure monitoring data and explains the proposed methodology for the exposure monitoring studies proposed for conduct by the AEATF II.

Wide Area Recovery and Resiliency Program (WARRP) Interim Clearance Strategy for Environments Contaminated with Cesium-137

DTIC Science & Technology

2012-07-01

Goiania) and those containing 137Cs and other radionuclides ( Chernobyl ). Another group contains documents relevant to site survey 3 procedures...residents of the contaminated areas. Recovery experience from the Chernobyl incident have demonstrated that direct involvement of inhabitants and local

40 CFR 1039.104 - Are there interim provisions that apply only for a limited time?

Code of Federal Regulations, 2013 CFR

2013-07-01

... engine must comply with . . . kW 560 5 0.10 2015-2018 3.5 2015-2018 1 For manufacturers certifying... cap 19 ≤ kW 560 6 0.10 2015-2018 3.5 2015-2018 1 The FEL cap for engines demonstrating compliance with...

Comprehensive Child Development Program--A National Family Support Demonstration. Interim Report to Congress.

ERIC Educational Resources Information Center

Administration for Children, Youth, and Families (DHHS), Washington, DC. Head Start Bureau.

The Comprehensive Child Development Program (CCDP), enacted by Congress in 1988, provides intensive, comprehensive, integrated, and continuous support to preschool children from low-income families to enhance their intellectual, social, and physical development. It also provides needed services to parents and household family members to enhance…

Polymer concrete overlay on Beulah Road Bridge : interim report no. 1--installation and initial condition of overlay.

DOT National Transportation Integrated Search

1982-01-01

The installation of a thin polymer concrete overlay on the Beulah Road bridge demonstrates that an overlay of low permeability and high skid resistance can be successfully installed by maintenance forces with a minimum of disruption to traffic, appro...

CETA Demonstration Provides Lessons On Implementing Youth Programs.

DTIC Science & Technology

1980-12-08

private sector participation, and labor market effects. In addition to a series of reports on specific issues and additional interim reports, MDRC...im, Mr. Gregory J. Ahat 4 1""yDm Director Alian Kotler Human Resources Division IDurid Ihuir U.S. General Accounting Office (.ijbr’E Sfrrw

High Performance Concrete in Washington State SR 18/SR 516 Overcrossing: Interim Report on Girder Monitoring

DOT National Transportation Integrated Search

2000-04-01

In the mid 1990s the Federal Highway Administration (FHWA) established a High Performance Concrete (HPC) program aimed at demonstrating the positive effects of utilizing HPC in bridges. Research on the benefits of using HPC for bridges has shown a nu...

High performance concrete in Washington state SR 18/SR 516 overcrossing : interim report on materials tests

DOT National Transportation Integrated Search

2000-04-01

In the mid 1990s the Federal Highway Administration (FHWA) established a High Performance Concrete (HPC) program aimed at demonstrating the positive effects of utilizing HPC in bridges. Research on the benefits of using HPC for bridges has shown a nu...

Evaluation of the construction and performance of polymer concrete overlays on five bridges : interim report no. 1.

DOT National Transportation Integrated Search

1983-01-01

The installation of thin polymer concrete overlays on five bridges on I-85 near Williamsburg, Virginia, has demonstrated that an overlay of low permeability and high skid resistance can be successfully installed by a contractor with a minimum of disr...

Demonstration/Validation of the Snap Sampler Passive Groundwater Sampling Device at the Former McClellan Air Force Base

DTIC Science & Technology

2011-02-01

and Development Center Fe Iron gpd Gallons per Day HDPE High Density Polyethylene Hg Mercury ICP Inductively Coupled Plasma ICP/MS...Inductively Coupled Plasma Mass Spectrometry IROD Interim Record of Decision ITRC Interstate Technology and Regulatory Council K Potassium Kow...alkaline earth metals, alkali metals, and a metalloid, were sampled. This particular demonstration took place at the McClellan Air Force Base (AFB) in

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...

76 FR 14559 - Federal Acquisition Regulation; Justification and Approval of Sole-Source 8(a) Contracts

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... Space Administration (NASA). ACTION: Interim rule. SUMMARY: DoD, GSA, and NASA are issuing an interim..., and NASA are issuing an interim rule amending the FAR, to implement section 811 of the National... meetings, DoD, GSA, and NASA weighed the costs and benefits of publishing this rule as proposed or interim...

Interim Administrators in Higher Education: A National Study

ERIC Educational Resources Information Center

Huff, Marie Thielke; Neubrander, Judy

2015-01-01

The focus of this paper is on the roles and experiences of interim administrators in higher education. A survey was given to current and recent interim administrators in four-year public universities and colleges across the United States. The goals were to identify the advantages and disadvantages of using and serving as interims, and to solicit…

Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial.

PubMed

Rathkopf, Dana E; Beer, Tomasz M; Loriot, Yohann; Higano, Celestia S; Armstrong, Andrew J; Sternberg, Cora N; de Bono, Johann S; Tombal, Bertrand; Parli, Teresa; Bhattacharya, Suman; Phung, De; Krivoshik, Andrew; Scher, Howard I; Morris, Michael J

2018-05-01

Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS. PREVAIL was a phase 3, randomized, double-blind, placebo-controlled multinational study that enrolled 1717 chemotherapy-naive men with metastatic castration-resistant prostate cancer from September 2010 through September 2012. The data were analyzed in November 2016. Patients were randomized 1:1 to enzalutamide 160 mg or placebo until confirmed radiographic disease progression or a skeletal-related event and initiation of either cytotoxic chemotherapy or an investigational agent for prostate cancer treatment. Sensitivity analyses (SAs) of investigator-assessed rPFS were performed using the final rPFS data cutoff (May 6, 2012; 439 events; SA1) and the interim OS data cutoff (September 16, 2013; 540 events; SA2). Additional SAs using investigator-assessed rPFS from the final rPFS data cutoff assessed the impact of skeletal-related events (SA3), clinical progression (SA4), a confirmatory scan for soft-tissue disease progression (SA5), and all deaths regardless of time after study drug discontinuation (SA6). Correlations between investigator-assessed rPFS (SA2) and OS were calculated using Spearman ρ and Kendall τ via Clayton copula. In the 1717 men (mean age, 72.0 [range, 43.0-93.0] years in enzalutamide arm and 71.0 [range, 42.0-93.0] years in placebo arm), enzalutamide significantly reduced risk of radiographic progression or death in all SAs, with hazard ratios of 0.22 (SA1; 95% CI, 0.18-0.27), 0.31 (SA2; 95% CI, 0.27-0.35), 0.21 (SA3; 95% CI, 0.18-0.26), 0.21 (SA4; 95% CI, 0.17-0.26), 0.23 (SA5; 95% CI, 0.19-0.30), and 0.23 (SA6; 95% CI, 0.19-0.30) (P < .001 for all). Correlations of rPFS and OS in enzalutamide-treated patients were 0.89 (95% CI, 0.86-0.92) by Spearman ρ and 0.72 (95% CI, 0.68-0.77) by Kendall τ. Sensitivity analyses in PREVAIL demonstrated the robustness of the PCWG2 rPFS definition using additional measures of progression. There was concordance between central and investigator review and a positive correlation between rPFS and OS among enzalutamide-treated patients. clinicaltrials.gov Identifier: NCT01212991.

Antimicrobial Exposure Assessment Task Force II (AEATF II) Volume 5: Governing Document for a Multi-Year Antimicrobial Chemical Exposure Monitoring Program (interim draft document with changes)

EPA Pesticide Factsheets

This document describes the overall scope of the AEATF II program, demonstrates the need for additional human exposure monitoring data and explains the proposed methodology for the exposure monitoring studies proposed for conduct by the AEATF II.

40 CFR 600.117 - Interim provisions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... fuel economy values using gasoline test fuel as specified in 40 CFR 86.113-04(a), regardless of any testing with Tier 3 test fuel under paragraph (b) of this section. (b) Manufacturers may demonstrate that... economy measurements using the gasoline test fuel specified in 40 CFR 86.113-04(a), as long as this test...

Performance-Based Scholarships: What Have We Learned? Interim Findings from the PBS Demonstration. Policy Brief

ERIC Educational Resources Information Center

Patel, Reshma; Richburg-Hayes, Lashawn; de la Campa, Elijah; Rudd, Timothy

2013-01-01

In today's economy, employers' demand for an educated workforce is steadily rising. Policymakers, education leaders, and communities across the country recognize the need to improve college attendance and success, but are constrained by the current budgetary environment. Meanwhile students themselves face mounting college costs, and financial aid…

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…

INTERIM REPORT ON THE EVOLUTION AND PERFORMANCE OF THE EICHROM TECHNOLOGIES PROCEPT RAPID DIOXIN ASSAY FOR SOIL AND SEDIMENT SAMPLES

EPA Science Inventory

A demonstration of screening technologies for determining the presence of dioxin and dioxin-like compounds in soil and sediment was conducted under the U.S. Environmental Protection Agency's(EPA's) Superfund Innovative Technology Evaluation Program in Saginaw, Michigan in 2004. T...

40 CFR 96.284 - Opt-in process.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS FOR STATE IMPLEMENTATION PLANS CAIR SO2 Opt-in Units... of interim review, if the plan appears to contain information demonstrating that the SO2 emissions... section, the owner or operator shall monitor and report the SO2 emissions rate and the heat input of the...

76 FR 72006 - Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

.... Discussion Uranium recovery facility licensees, including in-situ recovery facilities and conventional... Recovery Facility Surveys of Radon and Radon Progeny in Air and Demonstrations of Compliance AGENCY... Staff Guidance, ``Evaluations of Uranium Recovery Facility Surveys of Radon and Radon Progeny in Air and...

Diagnostic utility of FDG-PET in the differential diagnosis between different forms of primary progressive aphasia.

PubMed

Bouwman, Femke; Orini, Stefania; Gandolfo, Federica; Altomare, Daniele; Festari, Cristina; Agosta, Federica; Arbizu, Javier; Drzezga, Alexander; Nestor, Peter; Nobili, Flavio; Walker, Zuzana; Morbelli, Silvia; Boccardi, Marina

2018-05-09

A joint effort of the European Association of Nuclear Medicine (EANM) and the European Academy of Neurology (EAN) aims at clinical guidance for the use of FDG-PET in neurodegenerative diseases. This paper addresses the diagnostic utility of FDG-PET over clinical/neuropsychological assessment in the differentiation of the three forms of primary progressive aphasia (PPA). Seven panelists were appointed by the EANM and EAN and a literature search was performed by using harmonized PICO (Population, Intervention, Comparison, Outcome) question keywords. The studies were screened for eligibility, and data extracted to assess their methodological quality. Critical outcomes were accuracy indices in differentiating different PPA clinical forms. Subsequently Delphi rounds were held with the extracted data and quality assessment to reach a consensus based on both literature and expert opinion. Critical outcomes for this PICO were available in four of the examined papers. The level of formal evidence supporting clinical utility of FDG-PET in differentiating among PPA variants was considered as poor. However, the consensual recommendation was defined on Delphi round I, with six out of seven panelists supporting clinical use. Quantitative evidence demonstrating utility or lack thereof is still missing. Panelists decided consistently to provide interim support for clinical use based on the fact that a typical atrophy or metabolic pattern is needed for PPA according to the diagnostic criteria, and the synaptic failure detected by FDG-PET is an earlier phenomenon than atrophy. Also, a normal FDG-PET points to a non-neurodegenerative cause.

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design.

PubMed

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.

Technology demonstration of dedicated compressed natural gas (CNG) original equipment manufacturer (OEM) vehicles at Ft. Bliss, Texas. Interim report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alvarez, R.A.; Yost, D.M.

1995-11-01

A technology demonstration program of dedicated compressed natural gas (CNG) original equipment manufacturer (OEM) vehicles was conducted at FL Bliss, Texas to demonstrate the use of CNG as an alternative fuel. The demonstration program at FL Bliss was the first Army initiative with CNG-fueled vehicles under the legislated Alternative Motor Fuels Act. This Department of Energy (DOE)-supported fleet demonstration consisted of 48 General Services Administration (GSA)-owned, Army-leased 1992 dedicated CNG General Motors (GM) 3/4-ton pickup trucks and four 1993 gasoline-powered Chevrolet 3/4-ton pickup trucks.

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...

Photomask etch system and process for 10nm technology node and beyond

NASA Astrophysics Data System (ADS)

Chandrachood, Madhavi; Grimbergen, Michael; Yu, Keven; Leung, Toi; Tran, Jeffrey; Chen, Jeff; Bivens, Darin; Yalamanchili, Rao; Wistrom, Richard; Faure, Tom; Bartlau, Peter; Crawford, Shaun; Sakamoto, Yoshifumi

2015-10-01

While the industry is making progress to offer EUV lithography schemes to attain ultimate critical dimensions down to 20 nm half pitch, an interim optical lithography solution to address an immediate need for resolution is offered by various integration schemes using advanced PSM (Phase Shift Mask) materials including thin e-beam resist and hard mask. Using the 193nm wavelength to produce 10nm or 7nm patterns requires a range of optimization techniques, including immersion and multiple patterning, which place a heavy demand on photomask technologies. Mask schemes with hard mask certainly help attain better selectivity and hence better resolution but pose integration challenges and defectivity issues. This paper presents a new photomask etch solution for attenuated phase shift masks that offers high selectivity (Cr:Resist > 1.5:1), tighter control on the CD uniformity with a 3sigma value approaching 1 nm and controllable CD bias (5-20 nm) with excellent CD linearity performance (<5 nm) down to the finer resolution. The new system has successfully demonstrated capability to meet the 10 nm node photomask CD requirements without the use of more complicated hard mask phase shift blanks. Significant improvement in post wet clean recovery performance was demonstrated by the use of advanced chamber materials. Examples of CD uniformity, linearity, and minimum feature size, and etch bias performance on 10 nm test site and production mask designs will be shown.

Bonded functional esthetic prototype: an alternative pre-treatment mock-up technique and cost-effective medium-term esthetic solution.

PubMed

McLaren, Edward A

2013-09-01

As the economy has receded in recent years, many patients have been inclined to reject dental treatment beyond what they feel is the minimal amount necessary. Increasingly, there has been reluctance to take on the expense of full-mouth restorations and time-consuming procedures. Consequently, clinicians can benefit from innovative, conservative, interim solutions that enable them to provide segment treatment with long-term stability and esthetics, with lower initial cost. The bonded functional esthetic prototype (BFEP) allows fabrication of up to 14 teeth from composite in 1 hour, providing either a pre-treatment restoration or a long-term provisional solution until further treatment can be completed. As demonstrated herein, the BFEP enables superb function, stability, and esthetics in the interim while dispersing the cost of definitive treatment over time.

Software Safety Progress in NASA

NASA Technical Reports Server (NTRS)

Radley, Charles F.

1995-01-01

NASA has developed guidelines for development and analysis of safety-critical software. These guidelines have been documented in a Guidebook for Safety Critical Software Development and Analysis. The guidelines represent a practical 'how to' approach, to assist software developers and safety analysts in cost effective methods for software safety. They provide guidance in the implementation of the recent NASA Software Safety Standard NSS-1740.13 which was released as 'Interim' version in June 1994, scheduled for formal adoption late 1995. This paper is a survey of the methods in general use, resulting in the NASA guidelines for safety critical software development and analysis.

Structural Tailoring of Advanced Turboprops (STAT)

NASA Technical Reports Server (NTRS)

Brown, Kenneth W.

1988-01-01

This interim report describes the progress achieved in the structural Tailoring of Advanced Turboprops (STAT) program which was developed to perform numerical optimizations on highly swept propfan blades. The optimization procedure seeks to minimize an objective function, defined as either direct operating cost or aeroelastic differences between a blade and its scaled model, by tuning internal and external geometry variables that must satisfy realistic blade design constraints. This report provides a detailed description of the input, optimization procedures, approximate analyses and refined analyses, as well as validation test cases for the STAT program. In addition, conclusions and recommendations are summarized.

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.

Interim Report: 100-NR-2 Apatite Treatability Test: Low Concentration Calcium Citrate-Phosphate Solution Injection for In Situ Strontium-90 Immobilization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Williams, Mark D.; Fritz, Brad G.; Mendoza, Donaldo P.

2008-07-11

Following an evaluation of potential Sr-90 treatment technologies and their applicability under 100-NR-2 hydrogeologic conditions, U.S. Department of Energy, Fluor Hanford, Inc., Pacific Northwest National Laboratory, and the Washington Department of Ecology agreed that the long-term strategy for groundwater remediation at 100-N Area will include apatite sequestration as the primary treatment, followed by a secondary treatment if necessary (most likely phytoremediation). Since then, the agencies have worked together to agree on which apatite sequestration technology has the greatest chance of reducing Sr-90 flux to the river at a reasonable cost. In July 2005, aqueous injection, (i.e., the introduction of apatite-formingmore » chemicals into the subsurface) was endorsed as the interim remedy and selected for field testing. Studies are in progress to assess the efficacy of in situ apatite formation by aqueous solution injection to address both the vadose zone and the shallow aquifer along the 300 ft of shoreline where Sr-90 concentrations are highest. This report describes the field testing of the shallow aquifer treatment.« less

Comparison of futility monitoring guidelines using completed phase III oncology trials.

PubMed

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.

Integrated Occupational Program: Information Manual for Administrators, Counsellors, and Teachers. Interim 1988.

ERIC Educational Resources Information Center

Forest, Jan

The Integrated Occupational Program (IOP) was designed for students in grades 8-12 who have experienced prolonged difficulty with the regular elementary and secondary school programs, who demonstrate a significant lag in one or more of their academic courses, and who typically fall into the intelligence band of 75-95 IQ. The IOP enables students…

Replacement of a hopeless maxillary central incisor: a technique for the fabrication of an immediate implant-supported interim restoration.

PubMed

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.

International validation study for interim PET in ABVD-treated, advanced-stage hodgkin lymphoma: interpretation criteria and concordance rate among reviewers.

PubMed

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.

Publishing interim results of randomised clinical trials in peer-reviewed journals.

PubMed

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.

Guidance: Interim Municipal Settlement Policy

EPA Pesticide Factsheets

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.

Efficacy and safety of cisplatin, dexamethasone, gemcitabine and pegaspargase (DDGP) regimen in newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma: interim analysis of a phase 4 study NCT01501149

PubMed Central

Li, Ling; Li, Xin; Wang, Xinhua; Fu, Xiaorui; Ma, Wang; Qin, Yanru; Li, Wencai; Wu, Jingjing; Sun, Zhenchang; Zhang, Xudong; Nan, Feifei; Chang, Yu; Li, Zhaoming; Zhang, Dandan; Wang, Guannan; Yan, Jiaqin; Su, Liping; Wang, Jinghua; Xue, Hongwei; Young, Ken H.; Zhang, Mingzhi

2016-01-01

To explore a more effective treatment for newly diagnosed, advanced-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), we conducted a phase 4 study of the cisplatin, dexamethasone, gemcitabine, pegaspargase (DDGP) regimen. The primary end point was the 2-year progression-free survival (PFS) after the protocol treatment. Secondary endpoints included response rate (RR), overall survival (OS) and median survival time (MST). The interim analysis included data only from March 2011 to September 2013, who received six cycles of DDGP chemotherapy. A total of 25 eligible patients were enrolled. Seventeen patients (17/24, 70.83%) achieved complete response (CR) and four (4/24, 16.67%) achieved partial response (PR), three (3/24, 12.50%) had progressive disease (PD). The RR after treatment was 87.50%. After a median follow-up duration of 24.67 months (range 4-48 months). The 2-year PFS and OS rate were 61.80% (95% CI, 42.00% to 81.60%) and 68.50 % (95% CI, 48.70% to 88.30%), respectively. The MST was 36.55 months (95% CI, 29.41 months to 43.70 months). Grade 3/4 leukopenia occurred in fourteen patients (58.33%) and grade 3/4 thrombocytopenia occurred in eleven patients (45.83%). Twelve patients (50.00%) experienced Activated Partial Phromboplastin Ptime (APTT) elongation and fourteen patients (58.33%) experienced hypofibrinogenemia. In conclusion, DDGP regimen is an effective and tolerated treatment for newly diagnosed, advanced-stage ENKTL. This trial was registered at www.ClinicalTrials.gov as #NCT01501149. PMID:27384676

Remediation management of complex sites using an adaptive site management approach.

PubMed

Price, John; Spreng, Carl; Hawley, Elisabeth L; Deeb, Rula

2017-12-15

Complex sites require a disproportionate amount of resources for environmental remediation and long timeframes to achieve remediation objectives, due to their complex geologic conditions, hydrogeologic conditions, geochemical conditions, contaminant-related conditions, large scale of contamination, and/or non-technical challenges. A recent team of state and federal environmental regulators, federal agency representatives, industry experts, community stakeholders, and academia worked together as an Interstate Technology & Regulatory Council (ITRC) team to compile resources and create new guidance on the remediation management of complex sites. This article summarizes the ITRC team's recommended process for addressing complex sites through an adaptive site management approach. The team provided guidance for site managers and other stakeholders to evaluate site complexities and determine site remediation potential, i.e., whether an adaptive site management approach is warranted. Adaptive site management was described as a comprehensive, flexible approach to iteratively evaluate and adjust the remedial strategy in response to remedy performance. Key aspects of adaptive site management were described, including tools for revising and updating the conceptual site model (CSM), the importance of setting interim objectives to define short-term milestones on the journey to achieving site objectives, establishing a performance model and metrics to evaluate progress towards meeting interim objectives, and comparing actual with predicted progress during scheduled periodic evaluations, and establishing decision criteria for when and how to adapt/modify/revise the remedial strategy in response to remedy performance. Key findings will be published in an ITRC Technical and Regulatory guidance document in 2017 and free training webinars will be conducted. More information is available at www.itrc-web.org. Copyright © 2017 Elsevier Ltd. All rights reserved.

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...

A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials

PubMed Central

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

78 FR 55339 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

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.

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...

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...

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...

An interim prosthesis program for lower limb amputees: comparison of public and private models of service.

PubMed

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.

Providing More Cash for College: Interim Findings from the Performance-Based Scholarship Demonstration in California

ERIC Educational Resources Information Center

Richburg-Hayes, Lashawn; Patel, Reshma; Brock, Thomas; de la Campa, Elijah; Rubb, Timothy; Valenzuela, Ireri

2015-01-01

One of the original purposes of student financial aid was to ensure fairer access to post-secondary education to those least able to afford it and to those traditionally underrepresented. Various federal and state programs were put in place to achieve this goal, including the federal Pell Grant and state aid programs. Yet policymakers and…

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...

78 FR 20503 - Energy Conservation Program: Availability of the Interim Technical Support Document for High...

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...

Stability of Beriplast P fibrin sealant: storage and reconstitution.

PubMed

Eberhard, Ulrich; Broder, Martin; Witzke, Günther

2006-04-26

This study was performed to investigate the stability of Beriplast P fibrin sealant (FS) across a range of storage conditions, both pre- and post-reconstitution. Storage stability of the FS was evaluated during long-term refrigeration (24 months) with or without interim storage at elevated temperatures (40 degrees C for 1 week and 25 degrees C for 1 and 3 months). Stability of individual FS components was assessed by measuring: fibrinogen content, Factor XIII activity (FXIII), thrombin activity and aprotinin potency. The package integrity of each component was also checked (sterility testing, moisture content and pH). Storage stability was also evaluated by testing the reconstituted product for adhesion (tearing force testing after mixing the solutions) and sterility. Reconstitution stability was evaluated following 3-months' storage, for up to 50 h post-reconstitution using the same tests as for the storage stability investigations. Pre-defined specifications were met for fibrinogen content, Factor XIII activity, and thrombin activity, demonstrating storage stability. Package integrity and the functionality and sterility of the reconstituted product were confirmed throughout. Reconstitution stability was demonstrated for up to 50 h following reconstitution, in terms of both tearing force and sterility tests. In conclusion, the storage stability of Beriplast P was demonstrated over a range of 24-month storage schedules including interim exposure to elevated temperature, and the reconstituted product was stable for up to 50 h.

Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer

PubMed Central

Rathkopf, Dana E.; Beer, Tomasz M.; Loriot, Yohann; Higano, Celestia S.; Armstrong, Andrew J.; Sternberg, Cora N.; de Bono, Johann S.; Tombal, Bertrand; Parli, Teresa; Bhattacharya, Suman; Phung, De; Krivoshik, Andrew; Scher, Howard I.

2018-01-01

Importance Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. Objective To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS. Design, Setting, and Participants PREVAIL was a phase 3, randomized, double-blind, placebo-controlled multinational study that enrolled 1717 chemotherapy-naive men with metastatic castration-resistant prostate cancer from September 2010 through September 2012. The data were analyzed in November 2016. Interventions Patients were randomized 1:1 to enzalutamide 160 mg or placebo until confirmed radiographic disease progression or a skeletal-related event and initiation of either cytotoxic chemotherapy or an investigational agent for prostate cancer treatment. Main Outcomes and Measures Sensitivity analyses (SAs) of investigator-assessed rPFS were performed using the final rPFS data cutoff (May 6, 2012; 439 events; SA1) and the interim OS data cutoff (September 16, 2013; 540 events; SA2). Additional SAs using investigator-assessed rPFS from the final rPFS data cutoff assessed the impact of skeletal-related events (SA3), clinical progression (SA4), a confirmatory scan for soft-tissue disease progression (SA5), and all deaths regardless of time after study drug discontinuation (SA6). Correlations between investigator-assessed rPFS (SA2) and OS were calculated using Spearman ρ and Kendall τ via Clayton copula. Results In the 1717 men (mean age, 72.0 [range, 43.0-93.0] years in enzalutamide arm and 71.0 [range, 42.0-93.0] years in placebo arm), enzalutamide significantly reduced risk of radiographic progression or death in all SAs, with hazard ratios of 0.22 (SA1; 95% CI, 0.18-0.27), 0.31 (SA2; 95% CI, 0.27-0.35), 0.21 (SA3; 95% CI, 0.18-0.26), 0.21 (SA4; 95% CI, 0.17-0.26), 0.23 (SA5; 95% CI, 0.19-0.30), and 0.23 (SA6; 95% CI, 0.19-0.30) (P < .001 for all). Correlations of rPFS and OS in enzalutamide-treated patients were 0.89 (95% CI, 0.86-0.92) by Spearman ρ and 0.72 (95% CI, 0.68-0.77) by Kendall τ. Conclusions and Relevance Sensitivity analyses in PREVAIL demonstrated the robustness of the PCWG2 rPFS definition using additional measures of progression. There was concordance between central and investigator review and a positive correlation between rPFS and OS among enzalutamide-treated patients. Trial Registration clinicaltrials.gov Identifier: NCT01212991 PMID:29522174

Stakeholder consultation insights on the future of genomics at the clinical-public health interface.

PubMed

Modell, Stephen M; Kardia, Sharon L R; Citrin, Toby

2014-05-01

In summer 2011, the Centers for Disease Control and Prevention Office of Public Health Genomics conducted a stakeholder consultation, administered by the University of Michigan Center for Public Health and Community Genomics, and Genetic Alliance, to recommend priorities for public health genomics from 2012 through 2017. Sixty-two responses from health professionals, administrators, and members of the public were pooled with 2 sets of key informant interviews and 3 discussion groups. NVivo 9 and manual methods were used to organize themes. This review offers an interim analysis of progress with respect to the final recommendations, which demonstrated a strong interest in moving genomic discoveries toward implementation and comparative effectiveness (T3/T4) translational research. A translational research continuum exists with familial breast and ovarian cancer at one end and prostate cancer at the other. Cascade screening for inherited arrhythmia syndromes and hypercholesterolemia lags stakeholder recommendations in the United States but not in Europe; implementation of health service-based screening for Lynch syndrome, and integration into electronic health information systems, is on pace with the recommended timeline. A number of options exist to address deficits in the funding of translational research, particularly for oncogenomic gene expression profiling. The goal of personalized risk assessment necessitates both research progress (eg, in whole genome sequencing, as well as provider education in the differentiation of low- vs high-risk status. The public health approach supports an emphasis on genetic test validation while endorsing clinical translation research inclusion of an environmental and population-based perspective. Copyright © 2014 Mosby, Inc. All rights reserved.

Rapid effects of essential fatty acid deficiency on growth and development parameters and transcription of key fatty acid metabolism genes in juvenile barramundi (Lates calcarifer).

PubMed

Salini, Michael J; Turchini, Giovanni M; Wade, Nicholas M; Glencross, Brett D

2015-12-14

Barramundi (Lates calcarifer), a catadromous teleost of significant and growing commercial importance, are reported to have limited fatty acid bioconversion capability and therefore require preformed long-chain PUFA (LC-PUFA) as dietary essential fatty acid (EFA). In this study, the response of juvenile barramundi (47·0 g/fish initial weight) fed isolipidic and isoenergetic diets with 8·2% added oil was tested. The experimental test diets were either devoid of fish oil (FO), and thus with no n-3 LC-PUFA (FO FREE diet), or with a low inclusion of FO (FO LOW diet). These were compared against a control diet containing only FO (FO CTRL diet) as the added lipid source, over an 8-week period. Interim samples and measurements were taken fortnightly during the trial in order to define the aetiology of the onset and progression of EFA deficiency. After 2 weeks, the fish fed the FO FREE and FO LOW diets had significantly lower live-weights, and after 8 weeks significant differences were detected for all performance parameters. The fish fed the FO FREE diet also had a significantly higher incidence of external abnormalities. The transcription of several genes involved in fatty acid metabolism was affected after 2 weeks of feeding, showing a rapid nutritional regulation. This experiment documents the aetiology of the onset and the progression of EFA deficiency in juvenile barramundi and demonstrates that such deficiencies can be detected within 2 weeks in juvenile fish.

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...

75 FR 13484 - Foreign-Trade Zone 22; Temporary/Interim Manufacturing Authority; LG Electronics Mobilecomm USA...

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...

76 FR 37781 - Foreign-Trade Zone 26; Atlanta, GA; Application for Temporary/Interim Manufacturing Authority...

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.

The Intentional Interim

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...

77 FR 55232 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-03; Compliance With...

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...

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)

PCoD Lite - Using an Interim PCoD Protocol to Assess the Effects of Disturbance Associated with US Navy Exercises on Marine Mammal Populations

DTIC Science & Technology

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

KDHE Project Code: C6-074-00002: Progress and Monitoring Report for the LDB/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2015

DOE Office of Scientific and Technical Information (OSTI.GOV)

LaFreniere, Lorraine M.

In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparge (AS) systems. The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

KDHE Project Code: C6-074-00002: Progress and Monitoring Report for the LDB/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2013

DOE Office of Scientific and Technical Information (OSTI.GOV)

LaFreniere, Lorraine

In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparging (AS). The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

KDHE POroject Code: C6-074-00002: Progress and Monitoring Report for the LBD/SVE/AS System at the Former CCC/USDA Grain Storage Facility, Agra, Kansas, in January-June 2016

DOE Office of Scientific and Technical Information (OSTI.GOV)

LaFreniere, Lorraine M.

In 2008-2009, to address the carbon tetrachloride contamination detected on its former property, the CCC/USDA implemented a source area cleanup in accord with the document Interim Measure Work Plan/Design for Agra, Kansas (IMWP/D; Argonne 2008). The cleanup involves five large-diameter boreholes (LDBs) coupled with soil vapor extraction (SVE) and air sparge (AS) systems. The work plan was approved by the Kansas Department of Health and Environment (KDHE) in November 2008 (KDHE 2008b), and operation began in May 2009.

Benchmarking of MCNP for calculating dose rates at an interim storage facility for nuclear waste.

PubMed

Heuel-Fabianek, Burkhard; Hille, Ralf

2005-01-01

During the operation of research facilities at Research Centre Jülich, Germany, nuclear waste is stored in drums and other vessels in an interim storage building on-site, which has a concrete shielding at the side walls. Owing to the lack of a well-defined source, measured gamma spectra were unfolded to determine the photon flux on the surface of the containers. The dose rate simulation, including the effects of skyshine, using the Monte Carlo transport code MCNP is compared with the measured dosimetric data at some locations in the vicinity of the interim storage building. The MCNP data for direct radiation confirm the data calculated using a point-kernel method. However, a comparison of the modelled dose rates for direct radiation and skyshine with the measured data demonstrate the need for a more precise definition of the source. Both the measured and the modelled dose rates verified the fact that the legal limits (<1 mSv a(-1)) are met in the area outside the perimeter fence of the storage building to which members of the public have access. Using container surface data (gamma spectra) to define the source may be a useful tool for practical calculations and additionally for benchmarking of computer codes if the discussed critical aspects with respect to the source can be addressed adequately.

RH-TRU Waste Shipments from Battelle Columbus Laboratories to the Hanford Nuclear Facility for Interim Storage

DOE Office of Scientific and Technical Information (OSTI.GOV)

Eide, J.; Baillieul, T. A.; Biedscheid, J.

2003-02-26

Battelle Columbus Laboratories (BCL), located in Columbus, Ohio, must complete decontamination and decommissioning (D&D) activities for nuclear research buildings and grounds by 2006, as directed by Congress. Most of the resulting waste (approximately 27 cubic meters [m3]) is remote-handled (RH) transuranic (TRU) waste destined for disposal at the Waste Isolation Pilot Plant (WIPP). The BCL, under a contract to the U.S. Department of Energy (DOE) Ohio Field Office, has initiated a plan to ship the TRU waste to the DOE Hanford Nuclear Facility (Hanford) for interim storage pending the authorization of WIPP for the permanent disposal of RH-TRU waste. Themore » first of the BCL RH-TRU waste shipments was successfully completed on December 18, 2002. This BCL shipment of one fully loaded 10-160B Cask was the first shipment of RH-TRU waste in several years. Its successful completion required a complex effort entailing coordination between different contractors and federal agencies to establish necessary supporting agreements. This paper discusses the agreements and funding mechanisms used in support of the BCL shipments of TRU waste to Hanford for interim storage. In addition, this paper presents a summary of the efforts completed to demonstrate the effectiveness of the 10-160B Cask system. Lessons learned during this process are discussed and may be applicable to other TRU waste site shipment plans.« less

Hematopoietic Stem-Cell Gene Therapy for Cerebral Adrenoleukodystrophy.

PubMed

Eichler, Florian; Duncan, Christine; Musolino, Patricia L; Orchard, Paul J; De Oliveira, Satiro; Thrasher, Adrian J; Armant, Myriam; Dansereau, Colleen; Lund, Troy C; Miller, Weston P; Raymond, Gerald V; Sankar, Raman; Shah, Ami J; Sevin, Caroline; Gaspar, H Bobby; Gissen, Paul; Amartino, Hernan; Bratkovic, Drago; Smith, Nicholas J C; Paker, Asif M; Shamir, Esther; O'Meara, Tara; Davidson, David; Aubourg, Patrick; Williams, David A

2017-10-26

In X-linked adrenoleukodystrophy, mutations in ABCD1 lead to loss of function of the ALD protein. Cerebral adrenoleukodystrophy is characterized by demyelination and neurodegeneration. Disease progression, which leads to loss of neurologic function and death, can be halted only with allogeneic hematopoietic stem-cell transplantation. We enrolled boys with cerebral adrenoleukodystrophy in a single-group, open-label, phase 2-3 safety and efficacy study. Patients were required to have early-stage disease and gadolinium enhancement on magnetic resonance imaging (MRI) at screening. The investigational therapy involved infusion of autologous CD34+ cells transduced with the elivaldogene tavalentivec (Lenti-D) lentiviral vector. In this interim analysis, patients were assessed for the occurrence of graft-versus-host disease, death, and major functional disabilities, as well as changes in neurologic function and in the extent of lesions on MRI. The primary end point was being alive and having no major functional disability at 24 months after infusion. A total of 17 boys received Lenti-D gene therapy. At the time of the interim analysis, the median follow-up was 29.4 months (range, 21.6 to 42.0). All the patients had gene-marked cells after engraftment, with no evidence of preferential integration near known oncogenes or clonal outgrowth. Measurable ALD protein was observed in all the patients. No treatment-related death or graft-versus-host disease had been reported; 15 of the 17 patients (88%) were alive and free of major functional disability, with minimal clinical symptoms. One patient, who had had rapid neurologic deterioration, had died from disease progression. Another patient, who had had evidence of disease progression on MRI, had withdrawn from the study to undergo allogeneic stem-cell transplantation and later died from transplantation-related complications. Early results of this study suggest that Lenti-D gene therapy may be a safe and effective alternative to allogeneic stem-cell transplantation in boys with early-stage cerebral adrenoleukodystrophy. Additional follow-up is needed to fully assess the duration of response and long-term safety. (Funded by Bluebird Bio and others; STARBEAM ClinicalTrials.gov number, NCT01896102 ; ClinicalTrialsRegister.eu number, 2011-001953-10 .).

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.

PubMed

Soria, Jean-Charles; Ohe, Yuichiro; Vansteenkiste, Johan; Reungwetwattana, Thanyanan; Chewaskulyong, Busyamas; Lee, Ki Hyeong; Dechaphunkul, Arunee; Imamura, Fumio; Nogami, Naoyuki; Kurata, Takayasu; Okamoto, Isamu; Zhou, Caicun; Cho, Byoung Chul; Cheng, Ying; Cho, Eun Kyung; Voon, Pei Jye; Planchard, David; Su, Wu-Chou; Gray, Jhanelle E; Lee, Siow-Ming; Hodge, Rachel; Marotti, Marcelo; Rukazenkov, Yuri; Ramalingam, Suresh S

2018-01-11

Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). In this double-blind, phase 3 trial, we randomly assigned 556 patients with previously untreated, EGFR mutation-positive (exon 19 deletion or L858R) advanced NSCLC in a 1:1 ratio to receive either osimertinib (at a dose of 80 mg once daily) or a standard EGFR-TKI (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily). The primary end point was investigator-assessed progression-free survival. The median progression-free survival was significantly longer with osimertinib than with standard EGFR-TKIs (18.9 months vs. 10.2 months; hazard ratio for disease progression or death, 0.46; 95% confidence interval [CI], 0.37 to 0.57; P<0.001). The objective response rate was similar in the two groups: 80% with osimertinib and 76% with standard EGFR-TKIs (odds ratio, 1.27; 95% CI, 0.85 to 1.90; P=0.24). The median duration of response was 17.2 months (95% CI, 13.8 to 22.0) with osimertinib versus 8.5 months (95% CI, 7.3 to 9.8) with standard EGFR-TKIs. Data on overall survival were immature at the interim analysis (25% maturity). The survival rate at 18 months was 83% (95% CI, 78 to 87) with osimertinib and 71% (95% CI, 65 to 76) with standard EGFR-TKIs (hazard ratio for death, 0.63; 95% CI, 0.45 to 0.88; P=0.007 [nonsignificant in the interim analysis]). Adverse events of grade 3 or higher were less frequent with osimertinib than with standard EGFR-TKIs (34% vs. 45%). Osimertinib showed efficacy superior to that of standard EGFR-TKIs in the first-line treatment of EGFR mutation-positive advanced NSCLC, with a similar safety profile and lower rates of serious adverse events. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125 .).

Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer.

PubMed

Swain, Sandra M; Baselga, José; Kim, Sung-Bae; Ro, Jungsil; Semiglazov, Vladimir; Campone, Mario; Ciruelos, Eva; Ferrero, Jean-Marc; Schneeweiss, Andreas; Heeson, Sarah; Clark, Emma; Ross, Graham; Benyunes, Mark C; Cortés, Javier

2015-02-19

In patients with metastatic breast cancer that is positive for human epidermal growth factor receptor 2 (HER2), progression-free survival was significantly improved after first-line therapy with pertuzumab, trastuzumab, and docetaxel, as compared with placebo, trastuzumab, and docetaxel. Overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached. We report final prespecified overall survival results with a median follow-up of 50 months. We randomly assigned patients with metastatic breast cancer who had not received previous chemotherapy or anti-HER2 therapy for their metastatic disease to receive the pertuzumab combination or the placebo combination. The secondary end points of overall survival, investigator-assessed progression-free survival, independently assessed duration of response, and safety are reported. Sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis. The median overall survival was 56.5 months (95% confidence interval [CI], 49.3 to not reached) in the group receiving the pertuzumab combination, as compared with 40.8 months (95% CI, 35.8 to 48.3) in the group receiving the placebo combination (hazard ratio favoring the pertuzumab group, 0.68; 95% CI, 0.56 to 0.84; P<0.001), a difference of 15.7 months. This analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative. Results of sensitivity analyses after adjustment for crossover were consistent. Median progression-free survival as assessed by investigators improved by 6.3 months in the pertuzumab group (hazard ratio, 0.68; 95% CI, 0.58 to 0.80). Pertuzumab extended the median duration of response by 7.7 months, as independently assessed. Most adverse events occurred during the administration of docetaxel in the two groups, with long-term cardiac safety maintained. In patients with HER2-positive metastatic breast cancer, the addition of pertuzumab to trastuzumab and docetaxel, as compared with the addition of placebo, significantly improved the median overall survival to 56.5 months and extended the results of previous analyses showing the efficacy of this drug combination. (Funded by F. Hoffmann-La Roche and Genentech; CLEOPATRA ClinicalTrials.gov number, NCT00567190.).

75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

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...

75 FR 54526 - Defense Federal Acquisition Regulation Supplement; Payment of Costs Prior to Definitization...

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...

76 FR 43260 - Foreign-Trade Zone 72-Indianapolis, IN; Application for Temporary/Interim Manufacturing Authority...

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...

75 FR 60436 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1

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...

75 FR 24667 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1

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...

75 FR 10476 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1

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...

75 FR 15420 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) NO. 1

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...

76 FR 59119 - Interim Change to the Military Freight Traffic Unified Rules Publication (MFTURP) No. 1

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...

76 FR 15028 - Airport Improvement Program (AIP): Interim Policy Regarding Access to Airports From Residential...

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...

78 FR 5830 - Draft Environmental Assessment and Proposed Habitat Conservation Plan for the Interim Operations...

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....

75 FR 65528 - Membership of the National Science Board's Senior Executive Service Performance Review Board

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...

77 FR 15818 - License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience

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...

A Conservative Method of Retaining an Interim Obturator for a Total Maxillectomy Patient

PubMed Central

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.

PubMed

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.

Analysis of phase II methodologies for single-arm clinical trials with multiple endpoints in rare cancers: An example in Ewing's sarcoma.

PubMed

Dutton, P; Love, S B; Billingham, L; Hassan, A B

2018-05-01

Trials run in either rare diseases, such as rare cancers, or rare sub-populations of common diseases are challenging in terms of identifying, recruiting and treating sufficient patients in a sensible period. Treatments for rare diseases are often designed for other disease areas and then later proposed as possible treatments for the rare disease after initial phase I testing is complete. To ensure the trial is in the best interests of the patient participants, frequent interim analyses are needed to force the trial to stop promptly if the treatment is futile or toxic. These non-definitive phase II trials should also be stopped for efficacy to accelerate research progress if the treatment proves to be particularly promising. In this paper, we review frequentist and Bayesian methods that have been adapted to incorporate two binary endpoints and frequent interim analyses. The Eurosarc Trial of Linsitinib in advanced Ewing Sarcoma (LINES) is used as a motivating example and provides a suitable platform to compare these approaches. The Bayesian approach provides greater design flexibility, but does not provide additional value over the frequentist approaches in a single trial setting when the prior is non-informative. However, Bayesian designs are able to borrow from any previous experience, using prior information to improve efficiency.

A longitudinal medical Spanish program at one US medical school.

PubMed

Reuland, Daniel S; Frasier, Pamela Y; Slatt, Lisa M; Alemán, Marco A

2008-07-01

Policymakers have recommended recruiting or training (or both) more US physicians who can provide care in Spanish. Few longitudinal medical Spanish programs have been described and evaluated. This study aims to describe development and evaluation of the preclinical phase of a 4-y program designed to graduate physicians who can provide language-concordant care in Spanish. Study was done in one public medical school in southeastern USA. The program targeted intermediate/advanced Spanish speakers. Standardized fluency assessments were used to determine eligibility and evaluate participants' progress. Curriculum included didactic coursework, simulated patients, socio-cultural seminars, clinical skills rotations at sites serving Latinos, service-learning, and international immersion. For the first two cohorts (n = 45) qualitative evaluation identified program improvement opportunities and found participants believed the program helped them maintain their Spanish skills. Mean interim (2-y) speaking proficiency scores were unchanged from baseline: 9.0 versus 8.7 at baseline on 12-point scale (p = 0.15). Mean interim listening comprehension scores (second cohort only, n = 25) increased from a baseline of 77 to 86% (p = 0.003). Proportions "passing" the listening comprehension test increased from 72 to 92% (p = 0.06). We describe development of a longitudinal Spanish program within a medical school. Participation was associated with improved Spanish listening comprehension and no change in speaking proficiency.

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...

76 FR 48197 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

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...

75 FR 12217 - Notice of Availability for Comments Regarding the Planned Environmental Assessment Interim Report...

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...

78 FR 53038 - Interim Final Determination to Stay and Defer Sanctions; California; San Joaquin Valley

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...

In vitro evaluation of the marginal integrity of CAD/CAM interim crowns.

PubMed

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.

Prognostic value of interim FDG-PET in R-CHOP-treated diffuse large B-cell lymphoma: Systematic review and meta-analysis.

PubMed

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.

Quantifying the bias in the estimated treatment effect in randomized trials having interim analyses and a rule for early stopping for futility.

PubMed

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.

A global validation of ERA-Interim integrated water vapor estimates using ground-based GNSS observations

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.

Elimination of exemptions for chemical mixtures containing the list I chemicals ephedrine and/or pseudoephedrine. Final rule.

PubMed

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.

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…

Office of Inspector General; Medicare and state health care programs: fraud and abuse; issuance of advisory opinions by the OIG. Final rule.

PubMed

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.

From Testing to Teaching: The Use of Interim Assessments in Classroom Instruction. CPRE Research Report # RR-65

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...

77 FR 34399 - Public Housing Assessment System (PHAS): Capital Fund Interim Scoring Notice; Request for Comment

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...

Fabrication of an interim complete removable dental prosthesis with an in-office digital light processing three-dimensional printer: A proof-of-concept technique.

PubMed

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.

Group sequential designs for stepped-wedge cluster randomised trials

PubMed Central

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.

PubMed

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.

Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study.

PubMed

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.

The Homestake Interim Laboratory and Homestake DUSEL

NASA Astrophysics Data System (ADS)

Lesko, Kevin T.

2011-12-01

The former Homestake gold mine in Lead South Dakota is proposed for the National Science Foundation's Deep Underground Science and Engineering Laboratory (DUSEL). The gold mine provides expedient access to depths in excess of 8000 feet below the surface (>7000 mwe). Homestake's long history of promoting scientific endeavours includes the Davis Solar Neutrino Experiment, a chlorine-based experiment that was hosted at the 4850 Level for more than 30 years. As DUSEL, Homestake would be uncompromised by competition with mining interests or other shared uses. The facility's 600-km of drifts would be available for conversion for scientific and educational uses. The State of South Dakota, under Governor Rounds' leadership, has demonstrated exceptionally strong support for Homestake and the creation of DUSEL. The State has provided funding totalling $46M for the preservation of the site for DUSEL and for the conversion and operation of the Homestake Interim Laboratory. Motivated by the strong educational and outreach potential of Homestake, the State contracted a Conversion Plan by world-recognized mine-engineering contractor to define the process of rehabilitating the facility, establishing the appropriate safety program, and regaining access to the facility. The State of South Dakota has established the South Dakota Science and Technology Authority to oversee the transfer of the Homestake property to the State and the rehabilitation and preservation of the facility. The Homestake Scientific Collaboration and the State of South Dakota's Science and Technology Authority has called for Letters of Interest from scientific, educational and engineering collaborations and institutions that are interested in hosting experiments and uses in the Homestake Interim Facility in advance of the NSF's DUSEL, to define experiments starting as early as 2007. The Homestake Program Advisory Committee has reviewed these Letters and their initial report has been released. Options for developing the Homestake Interim Laboratory and evolving this facility into DUSEL are presented.

National School Lunch Program and School Breakfast Program: Nutrition Standards for All Foods Sold in School as Required by the Healthy, Hunger-Free Kids Act of 2010. Final rule and interim final rule.

PubMed

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.

DOUBLE TRACKS Test Site interim corrective action plan

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The DOUBLE TRACKS site is located on Range 71 north of the Nellis Air Force Range, northwest of the Nevada Test Site (NTS). DOUBLE TRACKS was the first of four experiments that constituted Operation ROLLER COASTER. On May 15, 1963, weapons-grade plutonium and depleted uranium were dispersed using 54 kilograms of trinitrotoluene (TNT) explosive. The explosion occurred in the open, 0.3 m above the steel plate. No fission yield was detected from the test, and the total amount of plutonium deposited on the ground surface was estimated to be between 980 and 1,600 grams. The test device was composed primarilymore » of uranium-238 and plutonium-239. The mass ratio of uranium to plutonium was 4.35. The objective of the corrective action is to reduce the potential risk to human health and the environment and to demonstrate technically viable and cost-effective excavation, transportation, and disposal. To achieve these objectives, Bechtel Nevada (BN) will remove soil with a total transuranic activity greater then 200 pCI/g, containerize the soil in ``supersacks,`` transport the filled ``supersacks`` to the NTS, and dispose of them in the Area 3 Radioactive Waste Management Site. During this interim corrective action, BN will also conduct a limited demonstration of an alternative method for excavation of radioactive near-surface soil contamination.« less

Environmental effects of ozone depletion and its interactions with climate change: progress report, 2008.

PubMed

Andrady, Anthony; Aucamp, Pieter J; Bais, Alkiviadis; Ballaré, Carlos L; Björn, Lars Olof; Bornman, Janet F; Caldwell, Martyn; Cullen, Anthony P; Erickson, David J; de Gruijl, Frank R; Häder, Donat-P; Ilyas, Mohammad; Kulandaivelu, G; Kumar, H D; Longstreth, Janice; McKenzie, Richard L; Norval, Mary; Paul, Nigel; Redhwi, Halim Hamid; Smith, Raymond C; Solomon, Keith R; Sulzberger, Barbara; Takizawa, Yukio; Tang, Xiaoyan; Teramura, Alan H; Torikai, Ayako; van der Leun, Jan C; Wilson, Stephen R; Worrest, Robert C; Zepp, Richard G

2009-01-01

After the enthusiastic celebration of the 20th Anniversary of the Montreal Protocol on Substances that Deplete the Ozone Layer in 2007, the work for the protection of the ozone layer continues. The Environmental Effects Assessment Panel is one of the three expert panels within the Montreal Protocol. This EEAP deals with the increase of the UV irradiance on the Earth's surface and its effects on human health, animals, plants, biogeochemistry, air quality and materials. For the past few years, interactions of ozone depletion with climate change have also been considered. It has become clear that the environmental problems will be long-lasting. In spite of the fact that the worldwide production of ozone depleting chemicals has already been reduced by 95%, the environmental disturbances are expected to persist for about the next half a century, even if the protective work is actively continued, and completed. The latest full report was published in Photochem. Photobiol. Sci., 2007, 6, 201-332, and the last progress report in Photochem. Photobiol. Sci., 2008, 7, 15-27. The next full report on environmental effects is scheduled for the year 2010. The present progress report 2008 is one of the short interim reports, appearing annually.

Progress toward Global Interruption of Wild Poliovirus Transmission, 2010–2013 and Tackling the Challenges to Complete Eradication

PubMed Central

Wassilak, Steven G.F.; Oberste, M. Steven; Tangermann, Rudolph H.; Diop, Ousmane M.; Jafari, Hamid S.; Armstrong, Gregory L.

2015-01-01

Despite substantial progress, global polio eradication has remained elusive. Indigenous wild poliovirus (WPV) transmission in four endemic countries (Afghanistan, India, Nigeria, and Pakistan) persisted into 2010 and outbreaks from imported WPV continued. By 2013, most outbreaks in the interim were promptly controlled. The number of polio-affected districts globally has declined by74% (from 481 in 2009 to 126 in 2013), including a 79% decrease in the number of affected districts in endemic countries (from 304 to 63). India is now polio-free. The challenges to success in the remaining polio-endemic countries include 1) threats to the security of vaccinators in each country and a ban on polio vaccination in areas of Afghanistan and Pakistan; 2) a risk of decreased government commitment; and 3) remaining surveillance gaps. Coordinated efforts under the International Health Regulations and efforts to mitigate the challenges provide a clear opportunity to soon secure global eradication. PMID:25316873

Procedures for Handling Retaliation Complaints Under Section 31307 of the Moving Ahead for Progress in the 21st Century Act (MAP-21). Final rule.

PubMed

2016-12-14

On March 16, 2016, the Occupational Safety and Health Administration (OSHA) of the U.S. Department of Labor (Department) issued an interim final rule (IFR) that provided procedures for the Department's processing of complaints under the employee protection (retaliation or whistleblower) provisions of Section 31307 of the Moving Ahead for Progress in the 21st Century Act (MAP-21). The IFR established procedures and time frames for the handling of retaliation complaints under MAP-21, including procedures and time frames for employee complaints to OSHA, investigations by OSHA, appeals of OSHA determinations to an administrative law judge (ALJ) for a hearing de novo, hearings by ALJs, review of ALJ decisions by the Administrative Review Board (ARB) (acting on behalf of the Secretary of Labor) and judicial review of the Secretary's final decision. It also set forth the Department's interpretations of the MAP-21 whistleblower provisions on certain matters. This final rule adopts, without change, the IFR.

A Summary on Progress in Materials Development for Advanced Lithium-ion Cells for NASA's Exploration Missions

NASA Technical Reports Server (NTRS)

Reid, Concha M.

2011-01-01

Vehicles and stand-alone power systems that enable the next generation of human missions to the moon will require energy storage systems that are safer, lighter, and more compact than current state-of-the-art (SOA) aerospace quality lithium-ion (Li-ion) batteries. NASA is developing advanced Li-ion cells to enable or enhance future human missions to Near Earth Objects, such as asteroids, planets, moons, libration points, and orbiting structures. Advanced, high-performing materials are required to provide component-level performance that can offer the required gains at the integrated cell level. Although there is still a significant amount of work yet to be done, the present state of development activities has resulted in the synthesis of promising materials that approach the ultimate performance goals. This paper on interim progress of the development efforts will present performance of materials and cell components and will elaborate on the challenges of the development activities and proposed strategies to overcome technical issues.

Progress in Materials and Component Development for Advanced Lithium-ion Cells for NASA's Exploration Missions

NASA Technical Reports Server (NTRS)

Reid, Concha, M.; Reid, Concha M.

2011-01-01

Vehicles and stand-alone power systems that enable the next generation of human missions to the Moon will require energy storage systems that are safer, lighter, and more compact than current state-of-the- art (SOA) aerospace quality lithium-ion (Li-ion) batteries. NASA is developing advanced Li-ion cells to enable or enhance the power systems for the Altair Lunar Lander, Extravehicular Activities spacesuit, and rovers and portable utility pallets for Lunar Surface Systems. Advanced, high-performing materials are required to provide component-level performance that can offer the required gains at the integrated cell level. Although there is still a significant amount of work yet to be done, the present state of development activities has resulted in the synthesis of promising materials that approach the ultimate performance goals. This report on interim progress of the development efforts will elaborate on the challenges of the development activities, proposed strategies to overcome technical issues, and present performance of materials and cell components.

WWC Review of the Report "The Impact of Indiana's System of Interim Assessments on Mathematics and Reading." What Works Clearinghouse Single Study Review

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…

The Predictive Validity of Interim Assessment Scores Based on the Full-Information Bifactor Model for the Prediction of End-of-Grade Test Performance

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…

25 CFR 39.1100 - Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously...

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...

25 CFR 39.1100 - Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously...

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...

25 CFR 39.1100 - Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously...

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...

25 CFR 39.1100 - Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously...

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...

25 CFR 39.1100 - Interim fiscal year 1980 and fiscal year 1981 funding for pre-kindergarten programs previously...

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...

Diesel Emission Control -- Sulfur Effects (DECSE) Program; Phase I Interim Data Report No. 2: NO{sub x} Adsorber Catalysts

DOE Office of Scientific and Technical Information (OSTI.GOV)

DOE; ORNL; NREL

1999-10-15

The Diesel Emission Control-Sulfur Effects (DECSE) is a joint government/industry program to determine the impact of diesel fuel sulfur levels on emission control systems whose use could lower emissions of nitrogen oxides (NOx) and particulate matter (PM) from on-highway trucks in the 2002--2004 model years. Phase 1 of the program was developed with the following objectives in mind: (1) evaluate the effects of varying the level of sulfur content in the fuel on the emission reduction performance of four emission control technologies; and (2) measure and compare the effects of up to 250 hours of aging on selected devices formore » multiple levels of fuel sulfur content. This interim report discusses the results of the DECSE test program that demonstrates the potential of NOx adsorber catalyst technology across the range of diesel engine operation with a fuel economy penalty less than 4%.« less

Education and career progression of imaging administrators.

PubMed

South-Winter, Carole

2014-01-01

The advancement into leadership positions for many administrators began as staff technologists moving up via interim management opportunities. New managers must develop supervisory skills while simultaneously assuming responsibility for the operation of the department. Mobility today is based primarily on a formal educational background. A transferable set of skills must be augmented with higher education. Those in the imaging sciences realize that an administrative position requires business and management acumen as well as technical skills. A shortage of imaging administrators is predicted due to an aging population and the rapid advancement of technology in healthcare. Institutes of higher education need to address and support the curricula and programs needed, which includes the CRA credential, for this growing field.

Laboratory evaluation of advanced battery technologies for electric vehicle applications

NASA Astrophysics Data System (ADS)

Deluca, W. H.; Kulaga, J. E.; Hogrefe, R. L.; Tummilo, A. F.; Webster, C. E.

1989-03-01

During 1988, battery technology evaluations were performed for the Department of Energy and Electric Power Research Institute at the Argonne Analysis and Diagnostic Laboratory. Cells and multicell modules from four developers were examined to determine their performance and life characteristics for electric vehicle propulsion applications. The results provide an interim measure of the progress being made in battery R and D programs, a comparison of battery technologies, and a source of basic data for modeling and continuing R and D. This paper summarizes the performance and life characterizations of twelve single cells and six 3- to 24-cell modules that encompass four technologies (Na/S, Ni/Fe, lead-acid, and Fe/Air).

Spacelab experiment definition study on phase transition and critical phenomena in fluids: Interim report on experimental justification

NASA Technical Reports Server (NTRS)

Moldover, M. R.; Hocken, M. R.; Gammon, R. W.; Sengers, J. V.

1976-01-01

Pure fluids and fluid mixtures near critical points are identified and are related to the progress of several disciplines. Consideration is given to thermodynamic properties, transport properties, and the complex nonlinear phenomena which occur when fluids undergo phase transitions in the critical region. The distinction is made between practical limits which may be extended by advances in technology and intrinsic ones which arise from the modification of fluid properties by the earth's gravitational field. The kinds of experiments near critical points which could best exploit the low gravity environment of an orbiting laboratory are identified. These include studies of the index of refraction, constant volume specific heat, and phase separation.

Benefit-Risk Summary of Nivolumab for Patients With Metastatic Squamous Cell Lung Cancer After Platinum-Based Chemotherapy: A Report From the US Food and Drug Administration.

PubMed

Kazandjian, Dickran; Khozin, Sean; Blumenthal, Gideon; Zhang, Lijun; Tang, Shenghui; Libeg, Meredith; Kluetz, Paul; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard

2016-01-01

Metastatic squamous non-small-cell lung cancer (SQ NSCLC) is a serious and life-threatening malignant condition with unmet medical need. In late December 2014, the US Food and Drug Administration (FDA) obtained the data monitoring committee report of a planned interim analysis of a trial in second-line SQ NSCLC (CM017) that demonstrated an overall survival benefit for patients treated with nivolumab compared with docetaxel. In that trial, 272 patients with metastatic SQ NSCLC patients had been randomized to receive nivolumab (n = 135) or docetaxel (n = 137). Median overall survival was 9.2 months for patients randomized to nivolumab and 6.0 months for those randomized to docetaxel (hazard ratio, 0.59; 95% CI, 0.44-0.79; P < .001). The safety of nivolumab was evaluated in a single-arm trial of 117 patients in previously treated metastatic SQ NSCLC and was consistent with the safety profile in melanoma, with rare but serious immune-mediated adverse events managed with corticosteroids and dose interruption. The FDA granted nivolumab traditional approval on March 4, 2015, for treatment of metastatic SQ NSCLC with progression during or after platinum-based chemotherapy. The approval provides an important treatment option for these patients, affecting routine care and clinical trials.

Understanding the development of a regulated market approach to new psychoactive substances (NPS) in New Zealand using Punctuated Equilibrium Theory.

PubMed

Rychert, Marta; Wilkins, Chris

2018-05-09

The short-lived regulated legal market for new psychoactive substances (NPS) in New Zealand marked a radical departure from the traditional prohibition-based approach to drugs. This paper aimed to enhance understanding of this policy change using Punctuated Equilibrium Theory (PET). The analysis draws on 3 years of evaluative research, including interviews with key stakeholders, analysis of legislation and policy documents and academic and grey literature. The reframing of the NPS issue from one of drug control to the need for stricter market regulation was achieved by the efforts of strategic policy entrepreneurs, including the legal high industry, drug law reform advocates, influential politicians and an independent legal advisory institution. This reframing was aided by the perceived saliency of the NPS problem and ineffectiveness of previous prohibition-based responses. In the absence of any political opposition to the regulatory approach, the Psychoactive Substances Act rapidly progressed through the Parliament. However, once the interim legal market was established, portrayal of the issues shifted away from experts and lobbyists to critique from local communities, local government, animal rights activists and the media, who viewed the new regime as a source of social and health problems. The mobilization of criticism ('Schattschneider mobilization') drew on ideas of animal welfare and community safety. With a looming national election, the government responded by ending the interim market with the urgent passage of amendment legislation. Punctuated Equilibrium Theory (PET) helps explain how New Zealand's Psychoactive Substances Act (PSA) policy first emerged on the political agenda and how the initial positive tone of expert support for reform shifted to a tide of popular criticism during the interim regime. However, with its emphasis on explaining agenda-setting, PET does not account for the legislative design shortcomings of the PSA. © 2018 Society for the Study of Addiction.

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

The Decanal Divide: Women in Decanal Roles at U.S. Medical Schools.

PubMed

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.

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials

PubMed Central

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.

Introduction to TETHYS—an interdisciplinary GIS database for studying continental collisions

NASA Astrophysics Data System (ADS)

Khan, S. D.; Flower, M. F. J.; Sultan, M. I.; Sandvol, E.

2006-05-01

The TETHYS GIS database is being developed as a way to integrate relevant geologic, geophysical, geochemical, geochronologic, and remote sensing data bearing on Tethyan continental plate collisions. The project is predicated on a need for actualistic model 'templates' for interpreting the Earth's geologic record. Because of their time-transgressive character, Tethyan collisions offer 'actualistic' models for features such as continental 'escape', collision-induced upper mantle flow magmatism, and marginal basin opening, associated with modern convergent plate margins. Large integrated geochemical and geophysical databases allow for such models to be tested against the geologic record, leading to a better understanding of continental accretion throughout Earth history. The TETHYS database combines digital topographic and geologic information, remote sensing images, sample-based geochemical, geochronologic, and isotopic data (for pre- and post-collision igneous activity), and data for seismic tomography, shear-wave splitting, space geodesy, and information for plate tectonic reconstructions. Here, we report progress on developing such a database and the tools for manipulating and visualizing integrated 2-, 3-, and 4-d data sets with examples of research applications in progress. Based on an Oracle database system, linked with ArcIMS via ArcSDE, the TETHYS project is an evolving resource for researchers, educators, and others interested in studying the role of plate collisions in the process of continental accretion, and will be accessible as a node of the national Geosciences Cyberinfrastructure Network—GEON via the World-Wide Web and ultra-high speed internet2. Interim partial access to the data and metadata is available at: http://geoinfo.geosc.uh.edu/Tethys/ and http://www.esrs.wmich.edu/tethys.htm. We demonstrate the utility of the TETHYS database in building a framework for lithospheric interactions in continental collision and accretion.

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.

Validation of HOAPS- and ERA-Interim precipitation estimates over the ocean

NASA Astrophysics Data System (ADS)

Bumke, Karl; Schröder, Marc; Fennig, Karsten

2014-05-01

Although precipitation is one of the key parameters of the global hydrological cycle there are still large gaps in the global observation networks, especially over the oceans. But the progress in satellite technology has provided the possibility to retrieve global data sets from space, including precipitation. Levizzani et al. (2007) showed that precipitation over the oceans can be derived with sufficient accuracy from passive microwave radiometry. Advances in analysis techniques have also improved our knowledge of the global precipitation. On the other hand, e.g. Andersson et al. (2011) or Pfeifroth et al. (2012) pointed out that even state-of-the-art satellite retrievals and reanalysis data sets still disagree on global or regional precipitation with respect to amounts, patterns, variability or temporal behavior compared to observations. That creates the need for a validation study over data sparse areas. Within this study, a validation of HOAPS-3.0 (Hamburg Ocean Atmosphere Parameters and fluxes from Satellite Data) based precipitation at pixel-level resolution and of ERA-Interim reanalysis data for 1995-1997 is performed mainly over the Atlantic Ocean using information from ship rain gauges and optical disdrometers mounted onboard of research vessels. The satellite and ERA-Interim data are compared to the in situ measurement by the nearest neighbor approach. Therefore, it must be ensured that both observations are related to each other, which can be determined by the decorrelation lengths in space and time. At least a number of 658 precipitation events are at our disposal including 127 snow events. The statistical analysis follows the recommendations given by the World Meteorological Organization (WMO) for dichotomous or binary forecasts (WWRP/WGNE: http://www.cawcr.gov.au/projects/verification/#Methods_for_dichotomous_forecasts). Based on contingency tables a number of statistical parameters like the accuracy, the bias, the false alarm rate, success ratio or hit rate have been computed. Summarized, the results show that HOAPS data agrees well with observations with respect to the frequency of precipitation events while ERA-Interim overestimates considerably the number of precipitation events. Results are similar for rain and snow events. Although it is difficult to compare rain rates directly due to the limited number of collocated events and different spatial resolution, the results suggest a slight underestimation of precipitation rates by HOAPS and an overestimation by ERA-Interim. References Andersson, A., Klepp, C., Fennig, K., Bakan, S., Graßl, H. and495 co-authors. 2011. Evaluation of HOAPS-3 ocean surface freshwater flux components. J. Appl. Meteorol. Climatol. 50, 379-398, doi:10.1175/2010JAMC2341.1. Levizzani, V., Bauer, P. and Turk, F. J.) 2007. Measuring Precipitation from Space, EURAINSAT and the Future. Advances in Global Change Research, Vol. 28, Springer, 724 p. Pfeifroth,U.,R.Mueller, and B.Ahrens, 2012: Evaluation of Satellite-Based and Reanalysis Precipitation Data in the Tropical Pacific, J. of Appl. Meteorology and Climatology 52, 634-644

Flight effects on exhaust noise for turbojet and turbofan engines: Comparison of experimental data with prediction

NASA Technical Reports Server (NTRS)

Stone, J. R.

1976-01-01

It was demonstrated that static and in flight jet engine exhaust noise can be predicted with reasonable accuracy when the multiple source nature of the problem is taken into account. Jet mixing noise was predicted from the interim prediction method. Provisional methods of estimating internally generated noise and shock noise flight effects were used, based partly on existing prediction methods and partly on recent reported engine data.

Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302

PubMed Central

Saad, Fred; Shore, Neal; Van Poppel, Hendrik; Rathkopf, Dana E.; Smith, Matthew R.; de Bono, Johann S.; Logothetis, Christopher J.; de Souza, Paul; Fizazi, Karim; Mulders, Peter F.A.; Mainwaring, Paul; Hainsworth, John D.; Beer, Tomasz M.; North, Scott; Fradet, Yves; Griffin, Thomas A.; De Porre, Peter; Londhe, Anil; Kheoh, Thian; Small, Eric J.; Scher, Howard I.; Molina, Arturo; Ryan, Charles J.

2016-01-01

Background Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy. Objective Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients. Design, setting, and participants This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial. Intervention Patients were grouped by concomitant BTT use or no BTT use. Outcome measurements and statistical analysis Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models. Results and limitations While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p = 0.01) and increased the time to ECOG deterioration (HR 0.75; p < 0.001) and time to opiate use for cancer-related pain (HR 0.80; p = 0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients. Conclusions AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT. Patient summary Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone. Trial registration ClinicalTrials.gov NCT00887198. PMID:25985882

Hazardous waste management programs; Florida: authorization for interim authorization phase I--Environmental Protection Agency. Notice of final determination.

PubMed

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).

DTIC Science & Technology

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

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Interim final rule with comment period.

PubMed

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.

Analysis of phase II methodologies for single-arm clinical trials with multiple endpoints in rare cancers: An example in Ewing’s sarcoma

PubMed Central

Dutton, P; Love, SB; Billingham, L; Hassan, AB

2016-01-01

Trials run in either rare diseases, such as rare cancers, or rare sub-populations of common diseases are challenging in terms of identifying, recruiting and treating sufficient patients in a sensible period. Treatments for rare diseases are often designed for other disease areas and then later proposed as possible treatments for the rare disease after initial phase I testing is complete. To ensure the trial is in the best interests of the patient participants, frequent interim analyses are needed to force the trial to stop promptly if the treatment is futile or toxic. These non-definitive phase II trials should also be stopped for efficacy to accelerate research progress if the treatment proves to be particularly promising. In this paper, we review frequentist and Bayesian methods that have been adapted to incorporate two binary endpoints and frequent interim analyses. The Eurosarc Trial of Linsitinib in advanced Ewing Sarcoma (LINES) is used as a motivating example and provides a suitable platform to compare these approaches. The Bayesian approach provides greater design flexibility, but does not provide additional value over the frequentist approaches in a single trial setting when the prior is non-informative. However, Bayesian designs are able to borrow from any previous experience, using prior information to improve efficiency. PMID:27587590

FY2017 Defense Spending Under an Interim Continuing Resolution (CR): In Brief

DTIC Science & Technology

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

Interim overdentures.

PubMed

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.

Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

PubMed

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.

How the University of Texas system responded to the need for interim storage of low-level radioactive waste materials.

PubMed

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.

US Intergroup Trial of Response-Adapted Therapy for Stage III to IV Hodgkin Lymphoma Using Early Interim Fluorodeoxyglucose–Positron Emission Tomography Imaging: Southwest Oncology Group S0816

PubMed Central

Li, Hongli; Schöder, Heiko; Straus, David J.; Moskowitz, Craig H.; LeBlanc, Michael; Rimsza, Lisa M.; Bartlett, Nancy L.; Evens, Andrew M.; Mittra, Erik S.; LaCasce, Ann S.; Sweetenham, John W.; Barr, Paul M.; Fanale, Michelle A.; Knopp, Michael V.; Noy, Ariela; Hsi, Eric D.; Cook, James R.; Lechowicz, Mary Jo; Gascoyne, Randy D.; Leonard, John P.; Kahl, Brad S.; Cheson, Bruce D.; Fisher, Richard I.; Friedberg, Jonathan W.

2016-01-01

Purpose Four US National Clinical Trials Network components (Southwest Oncology Group, Cancer and Leukemia Group B/Alliance, Eastern Cooperative Oncology Group, and the AIDS Malignancy Consortium) conducted a phase II Intergroup clinical trial that used early interim fluorodeoxyglucose positron emission tomography (FDG-PET) imaging to determine the utility of response-adapted therapy for stage III to IV classic Hodgkin lymphoma. Patients and Methods The Southwest Oncology Group S0816 (Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV Hodgkin Lymphoma) trial enrolled 358 HIV-negative patients between July 1, 2009, and December 2, 2012. A PET scan was performed after two initial cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) and was labeled PET2. PET2-negative patients (Deauville score 1 to 3) received an additional four cycles of ABVD, whereas PET2-positive patients (Deauville score 4 to 5) were switched to escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) for six cycles. Among 336 eligible and evaluable patients, the median age was 32 years (range, 18 to 60 years), with 52% stage III, 48% stage IV, 49% International Prognostic Score 0 to 2, and 51% score 3 to 7. Results Three hundred thirty-six of the enrolled patients were evaluable. Central review of the interim PET2 scan was performed in 331 evaluable patients, with 271 (82%) PET2-negative and 60 (18%) PET2-positive. Of 60 eligible PET2-positive patients, 49 switched to eBEACOPP as planned and 11 declined. With a median follow-up of 39.7 months, the Kaplan-Meier estimate for 2-year overall survival was 98% (95% CI, 95% to 99%), and the 2-year estimate for progression-free survival (PFS) was 79% (95% CI, 74% to 83%). The 2-year estimate for PFS in the subset of patients who were PET2-positive after two cycles of ABVD was 64% (95% CI, 50% to 75%). Both nonhematologic and hematologic toxicities were greater in the eBEACOPP arm than in the continued ABVD arm. Conclusion Response-adapted therapy based on interim PET imaging after two cycles of ABVD seems promising with a 2-year PFS of 64% for PET2-positive patients, which is much higher than the expected 2-year PFS of 15% to 30%. PMID:27069074

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

JT9D ceramic outer air seal system refinement program

NASA Technical Reports Server (NTRS)

Gaffin, W. O.

1982-01-01

The abradability and durability characteristics of the plasma sprayed system were improved by refinement and optimization of the plasma spray process and the metal substrate design. The acceptability of the final seal system for engine testing was demonstrated by an extensive rig test program which included thermal shock tolerance, thermal gradient, thermal cycle, erosion, and abradability tests. An interim seal system design was also subjected to 2500 endurance test cycles in a JT9D-7 engine.

North Atlantic storm driving of extreme wave heights in the North Sea

NASA Astrophysics Data System (ADS)

Bell, R. J.; Gray, S. L.; Jones, O. P.

2017-04-01

The relationship between storms and extreme ocean waves in the North Sea is assessed using a long-period wave data set and storms identified in the Interim ECMWF Re-Analysis (ERA-Interim). An ensemble sensitivity analysis is used to provide information on the spatial and temporal forcing from mean sea-level pressure and surface wind associated with extreme ocean wave height responses. Extreme ocean waves in the central North Sea arise due to intense extratropical cyclone winds from either the cold conveyor belt (northerly-wind events) or the warm conveyor belt (southerly-wind events). The largest wave heights are associated with northerly-wind events which tend to have stronger wind speeds and occur as the cold conveyor belt wraps rearward round the cyclone to the cold side of the warm front. The northerly-wind events provide a larger fetch to the central North Sea to aid wave growth. Southerly-wind events are associated with the warm conveyor belts of intense extratropical cyclones that develop in the left upper tropospheric jet exit region. Ensemble sensitivity analysis can provide early warning of extreme wave events by demonstrating a relationship between wave height and high pressure to the west of the British Isles for northerly-wind events 48 h prior. Southerly-wind extreme events demonstrate sensitivity to low pressure to the west of the British Isles 36 h prior.

Evaluative studies in nuclear medicine research. Interim progress report, July 1, 1975--June 30, 1976. [Diagnostic value of brain scans

DOE Office of Scientific and Technical Information (OSTI.GOV)

Potchen, E.J.

Data relating to the determination of the efficacy of radionuclide brain scanning have been analyzed. The data were gathered at a teaching hospital by use of a prospective questionnaire followed by a retrospective study of the result of the brain scan examination. Data analysis was accomplished using a method of pattern discovery which relates selected outcomes such as normal and abnormal brain scans to patient attributes (signs, symptoms, history, and previous test results). The objective of the analysis was the identification of patterns or clusters of patient attributes which have a high probability of acting as predictors of the outcomemore » of the brain scan.« less

Progress report on CCIR studies for guaranteeing access to the geostationary satellite orbit

NASA Astrophysics Data System (ADS)

Reinhart, E. E.

Overall responsibility for preparing a report on the technical information necessary for the World Administrative Radio Conference to be held in the spring of 1984 is vested in the Interim Working Party (IWP) 4/1. The various approaches being considered by the IWP 4/1 to guarantee orbital access are described, along with the criteria that the party has proposed for evaluating and comparing the approaches. These approaches include the following: a regional detailed long-term (10-20 years) a priori allotment plan, a periodically revised (3-5 years) regional detailed allotment plan, a regional or subregional allotment plan with guaranteed access, guaranteed access by means of multilateral coordination, and coordination procedures and technical factors that are revised periodically.

Performance evaluation of advanced battery technologies for electric vehicle applications

NASA Astrophysics Data System (ADS)

Deluca, W. H.; Tummillo, A. F.; Kulaga, J. E.; Webster, C. E.; Gillie, K. R.; Hogrefe, R. L.

1990-01-01

At the Argonne Analysis and Diagnostic Laboratory, advanced battery technology evaluations are performed under simulated electric vehicle operating conditions. During 1989 and the first quarter of 1990, single cell and multicell modules from seven developers were examined for the Department of Energy and Electric Power Research Institute. The results provide battery users, developers, and program managers with an interim measure of the progress being made in battery R&D programs, a comparison of battery technologies, and a source of basic data for modeling and continuing R&D. This paper summarizes the performance and life characterizations of two single cells and seven 3- to 960-cell modules that encompass six technologies (Na/S, Ni/Fe, Ni/Cd, Ni-metal hydride, lead-acid, and Zn/Br).

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.

Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Interim final rule with request for comments.

PubMed

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.

Evaluation and analysis of Seasat-A scanning multichannel Microwave Radiometer (SMMR) Antenna Pattern Correction (APC) algorithm

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.

French Interim MALE UAV Program

DTIC Science & Technology

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

Conceptual design statement of work for the immobilized low-activity waste interim storage facility project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carlson, T.A., Fluor Daniel Hanford

1997-02-06

The Immobilized Low-Activity Waste Interim Storage subproject will provide storage capacity for immobilized low-activity waste product sold to the U.S. Department of Energy by the privatization contractor. This statement of work describes the work scope (encompassing definition of new installations and retrofit modifications to four existing grout vaults), to be performed by the Architect-Engineer, in preparation of a conceptual design for the Immobilized Low-Activity Waste Interim Storage Facility.

22 CFR 127.8 - Interim suspension.

Code of Federal Regulations, 2010 CFR

2010-04-01

... world peace or the security or foreign policy of the United States. The interim suspension orders... Trade Controls will issue an appropriate order disposing of the motion or petition and will promptly...

How well do Reanalysis represent polar lows?

NASA Astrophysics Data System (ADS)

Zappa, G.; Shaffrey, L.; Hodges, K.

2013-12-01

Polar lows are intense maritime mesocyclones forming at high latitudes during polar air outbreaks. The associated high surface winds can be an important cause of coastal damage.They also seem to play a relevant role in the climate system by modulating the oceanic surface heat fluxes. This creates strong interest in understanding whether modern reanalysis datasets are able to represent polar lows, as well as how their representation may be sensitive to the model resolution. In this talk we investigate how ERA-Interim reanalysis represents the polar lows identified by the Norwegian meteorological services and listed in the STARS (Combination of Sea Surface Temperature and AltimeteR Synergy) dataset for the period 2002-2011. The sensitivity to resolution is explored by comparing ERA-Interim to the ECMWF operational analyses (2008-2011), which have three times higher horizontal resolution compared to ERA-Interim. We show that ERAI-Interim has excellent ability to capture the observed polar lows events with up to 90% of the observed events being found in the reanalysis. However, ERA-Interim tends to have polar lows of weaker dynamical intensity, in terms of both winds and vorticity, and with less spatial structure than in the ECMWF operational analyses (See Fig 1). Furthermore, we apply an objective feature tracking algorithm to the 3 hourly vorticity at 850 hPa with constraints on vorticity intensity and atmospheric static stability to objectively identify polar lows in the ERA-Interim reanalysis. We show that for the stronger polar lows the objective climatology shows good agreement with the STARS dataset over the 2002-2011 period. This allows us to extend the polar lows climatology over the whole ERA Interim period. Differences with another reanalysis product (NCEP-CFSR) will be also discussed. Fig 1: Composite of the tangential wind speed at 925 hPa for 34 polar lows observed in the Norwegian sea between 2008-2010 as represented by the ERA-Interim reanalysis (left) and by the ECMWF Operational analysis (right). Positive values indicate cyclonic circulation. The composite is centered on the polar low vorticity maxima and it is presented for a radial cap of 5 degrees of radius on the sphere (~550Km).

Evaluation of reanalysis datasets against observational soil temperature data over China

NASA Astrophysics Data System (ADS)

Yang, Kai; Zhang, Jingyong

2018-01-01

Soil temperature is a key land surface variable, and is a potential predictor for seasonal climate anomalies and extremes. Using observational soil temperature data in China for 1981-2005, we evaluate four reanalysis datasets, the land surface reanalysis of the European Centre for Medium-Range Weather Forecasts (ERA-Interim/Land), the second modern-era retrospective analysis for research and applications (MERRA-2), the National Center for Environmental Prediction Climate Forecast System Reanalysis (NCEP-CFSR), and version 2 of the Global Land Data Assimilation System (GLDAS-2.0), with a focus on 40 cm soil layer. The results show that reanalysis data can mainly reproduce the spatial distributions of soil temperature in summer and winter, especially over the east of China, but generally underestimate their magnitudes. Owing to the influence of precipitation on soil temperature, the four datasets perform better in winter than in summer. The ERA-Interim/Land and GLDAS-2.0 produce spatial characteristics of the climatological mean that are similar to observations. The interannual variability of soil temperature is well reproduced by the ERA-Interim/Land dataset in summer and by the CFSR dataset in winter. The linear trend of soil temperature in summer is well rebuilt by reanalysis datasets. We demonstrate that soil heat fluxes in April-June and in winter are highly correlated with the soil temperature in summer and winter, respectively. Different estimations of surface energy balance components can contribute to different behaviors in reanalysis products in terms of estimating soil temperature. In addition, reanalysis datasets can mainly rebuild the northwest-southeast gradient of soil temperature memory over China.

Registration Review Schedules

EPA Pesticide Factsheets

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.

Documentation of medication changes in inpatient clinical notes: an audit to support quality improvement.

PubMed

Peusschers, Elsie; Twine, Jaryth; Wheeler, Amanda; Moudgil, Vikas; Patterson, Sue

2015-04-01

To describe completeness and accuracy of recording medication changes in progress notes during psychiatric inpatient admissions. A retrospective audit of records of 54 randomly selected psychiatric admissions at a metropolitan tertiary hospital. Medication changes recorded on National Inpatient Medication Chart (NIMC) were compared to documentation in the clinical progress records and assessed for completeness against seven quality criteria. With between one and 32 medication changes per admission, a total of 519 changes were recorded in NIMCs. Just over half were documented in progress notes. Psychotropic and regular medications were more frequently charted than 'other' and 'if required' medications. Documentation was seldom comprehensive. Medication name was most frequently documented; desired therapeutic effect or potential adverse effects were rarely documented. Evidence of patient involvement in, and an explicit rationale for, a change were infrequently recorded. Revealing substantial gaps in communication about medication changes during psychiatric admission, this audit sheds light on a previously undescribed source of medication error, warranting attention. Further research is needed to examine barriers to best practice, to support design and implementation of quality improvement activities but in the interim, attention should be addressed to development and articulation of content and procedures for documentation. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

PubMed

Lonial, Sagar; Dimopoulos, Meletios; Palumbo, Antonio; White, Darrell; Grosicki, Sebastian; Spicka, Ivan; Walter-Croneck, Adam; Moreau, Philippe; Mateos, Maria-Victoria; Magen, Hila; Belch, Andrew; Reece, Donna; Beksac, Meral; Spencer, Andrew; Oakervee, Heather; Orlowski, Robert Z; Taniwaki, Masafumi; Röllig, Christoph; Einsele, Hermann; Wu, Ka Lung; Singhal, Anil; San-Miguel, Jesus; Matsumoto, Morio; Katz, Jessica; Bleickardt, Eric; Poulart, Valerie; Anderson, Kenneth C; Richardson, Paul

2015-08-13

Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma. In this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival. Overall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% in the control group (P<0.001). Common grade 3 or 4 adverse events in the two groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 or 2 in 29 patients. Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death. (Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-2 ClinicalTrials.gov number, NCT01239797.).

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

EPA Pesticide Factsheets

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.

75 FR 47444 - Amendments to the Informal and Other Procedures, Rules of Organization and Program Management...

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

EPA Pesticide Factsheets

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 Pesticide Factsheets

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.

Plutonium storage criteria

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

The skill of ECMWF long range Forecasting System to drive impact models for health and hydrology in Africa

NASA Astrophysics Data System (ADS)

Di Giuseppe, F.; Tompkins, A. M.; Lowe, R.; Dutra, E.; Wetterhall, F.

2012-04-01

As the quality of numerical weather prediction over the monthly to seasonal leadtimes steadily improves there is an increasing motivation to apply these fruitfully to the impacts sectors of health, water, energy and agriculture. Despite these improvements, the accuracy of fields such as temperature and precipitation that are required to drive sectoral models can still be poor. This is true globally, but particularly so in Africa, the region of focus in the present study. In the last year ECMWF has been particularly active through EU research founded projects in demonstrating the capability of its longer range forecasting system to drive impact modeling systems in this region. A first assessment on the consequences of the documented errors in ECMWF forecasting system is therefore presented here looking at two different application fields which we found particularly critical for Africa - vector-born diseases prevention and hydrological monitoring. A new malaria community model (VECTRI) has been developed at ICTP and tested for the 3 target regions participating in the QWECI project. The impacts on the mean malaria climate is assessed using the newly realized seasonal forecasting system (Sys4) with the dismissed system 3 (Sys3) which had the same model cycle of the up-to-date ECMWF re-analysis product (ERA-Interim). The predictive skill of Sys4 to be employed for malaria monitoring and forecast are also evaluated by aggregating the fields to country level. As a part of the DEWFORA projects, ECMWF is also developing a system for drought monitoring and forecasting over Africa whose main meteorological input is precipitation. Similarly to what is done for the VECTRI model, the skill of seasonal forecasts of precipitation is, in this application, translated into the capability of predicting drought while ERA-Interim is used in monitoring. On a monitoring level, the near real-time update of ERA-Interim could compensate the lack of observations in the regions. However, ERA-Interim suffers from biases and drifts that limit its application for drought monitoring purposes in some regions.

75 FR 73169 - Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

...This final rule with comment period addresses changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It finalizes the calendar year (CY) 2010 interim relative value units (RVUs) and issues interim RVUs for new and revised procedure codes for CY 2011. It also addresses, implements, or discusses certain provisions of both the Affordable Care Act (ACA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). In addition, this final rule with comment period discusses payments under the Ambulance Fee Schedule (AFS), the Ambulatory Surgical Center (ASC) payment system, and the Clinical Laboratory Fee Schedule (CLFS), payments to end-stage renal disease (ESRD) facilities, and payments for Part B drugs. Finally, this final rule with comment period also includes a discussion regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for durable medical equipment, prosthetics, orthotics, and supplies (CBP DMEPOS), and provider and supplier enrollment issues associated with air ambulances.

A Novel Approach for Determining Source–Receptor Relationships in Model Simulations: A Case Study of Black Carbon Transport in Northern Hemisphere Winter

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ma, Po-Lun; Gattiker, J. R.; Liu, Xiaohong

2013-06-27

A Gaussian process (GP) emulator is applied to quantify the contribution of local and remote emissions of black carbon (BC) on the BC concentrations in different regions using a Latin Hypercube sampling strategy for emission perturbations in the offline version of the Community Atmosphere Model Version 5.1 (CAM5) simulations. The source-receptor relationships are computed based on simulations constrained by a standard free-running CAM5 simulation and the ERA-Interim reanalysis product. The analysis demonstrates that the emulator is capable of retrieving the source-receptor relationships based on a small number of CAM5 simulations. Most regions are found susceptible to their local emissions. Themore » emulator also finds that the source-receptor relationships retrieved from the model-driven and the reanalysis-driven simulations are very similar, suggesting that the simulated circulation in CAM5 resembles the assimilated meteorology in ERA-Interim. The robustness of the results provides confidence for applying the emulator to detect dose-response signals in the climate system.« less

The role and meaning of interim housing in housing first programs for people experiencing homelessness and mental illness.

PubMed

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

PubMed Central

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

Interim Guidance: Municipal Solid Waste Exemption under Superfund

EPA Pesticide Factsheets

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...

Amendment to the interim final rules for group health plans and health insurance coverage relating to status as a grandfathered health plan under the Patient Protection and Affordable Care Act. Amendment to interim final rules with request for comments.

PubMed

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.

PCoD Lite - Using an Interim PCoD Protocol to Assess the Effects of Disturbance Associated with US Navy Exercises on Marine Mammal Populations

DTIC Science & Technology

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

Interim Radiological Scoping and Characterization Survey Report, 1963 Igloo 572 Accident (Former Medina Base), Lackland Training Annex, Lackland AFB, Texas

DTIC Science & Technology

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.

Potential System Integration Issues in the Joint Multi-Role (JMR) Joint Common Architecture (JCA) Demonstration System

DTIC Science & Technology

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

A randomized controlled trial of interim methadone maintenance.

PubMed

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 Pesticide Factsheets

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

77 FR 31374 - Notice of Submission of Proposed Information Collection to OMB; Rural Housing Stability Program...

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

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.

Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL.

PubMed

Howard, D R; Munir, T; McParland, L; Rawstron, A C; Milligan, D; Schuh, A; Hockaday, A; Allsup, D J; Marshall, S; Duncombe, A S; O'Dwyer, J L; Smith, A F; Longo, R; Varghese, A; Hillmen, P

2017-11-01

ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. A total of 200 patients were recruited to assess the primary end point of complete remission (CR) rates according to IWCLL criteria. Secondary end points were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness. The trial closed following a pre-planned interim analysis. At final analysis, CR rates were 76 FCR vs 55% FCM-miniR (adjusted odds ratio: 0.37; 95% confidence interval: 0.19-0.73). MRD-negativity rates were 54 FCR vs 44% FCM-miniR. More participants experienced serious adverse reactions with FCM-miniR (49%) compared to FCR (41%). There are no significant differences between the treatment groups for PFS and OS. FCM-miniR is not expected to be cost-effective over a lifetime horizon. In summary, FCM-miniR is less well tolerated than FCR with an inferior response and MRD-negativity rate and increased toxicity, and will not be taken forward into a confirmatory trial. The trial demonstrated that oral FCR yields high response rates compared to historical series with intravenous chemotherapy.

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....

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...

78 FR 53183 - Request for Public Comments Regarding the Interim Environmental Review of the Trans-Pacific...

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...