40 CFR 94.12 - Interim provisions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... differences in testing will not affect NOX emission rates. (g) Flexibility for engines over 560kW...) CONTROL OF EMISSIONS FROM MARINE COMPRESSION-IGNITION ENGINES General Provisions for Emission Regulations for Compression-Ignition Marine Engines § 94.12 Interim provisions. This section contains provisions...

40 CFR 94.12 - Interim provisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... differences in testing will not affect NOX emission rates. (g) Flexibility for engines over 560kW...) CONTROL OF EMISSIONS FROM MARINE COMPRESSION-IGNITION ENGINES General Provisions for Emission Regulations for Compression-Ignition Marine Engines § 94.12 Interim provisions. This section contains provisions...

Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study

NASA Astrophysics Data System (ADS)

Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas

2017-03-01

Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.

The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study

PubMed Central

Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol

2012-01-01

Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377

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.

42 CFR 413.350 - Periodic interim payments for skilled nursing facilities receiving payment under the skilled...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 2 2013-10-01 2013-10-01 false Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A...-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING...

42 CFR 413.350 - Periodic interim payments for skilled nursing facilities receiving payment under the skilled...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 2 2012-10-01 2012-10-01 false Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A...-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING...

42 CFR 413.350 - Periodic interim payments for skilled nursing facilities receiving payment under the skilled...

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A...-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING...

42 CFR 413.350 - Periodic interim payments for skilled nursing facilities receiving payment under the skilled...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 2 2011-10-01 2011-10-01 false Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A...-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING...

42 CFR 413.350 - Periodic interim payments for skilled nursing facilities receiving payment under the skilled...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 2 2014-10-01 2014-10-01 false Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A...-STAGE RENAL DISEASE SERVICES; OPTIONAL PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING...

Frequency and Type of Prosthetic Complications Associated with Interim, Immediately Loaded Full-Arch Prostheses: A 2-Year Retrospective Chart Review.

PubMed

Drago, Carl

2016-08-01

The purpose of this report was to retrospectively evaluate implant and immediate full-arch prosthesis survival rates over a 24-month period; patients were consecutively treated with immediate occlusal loading. Dental arch, gender, and implant orientation (vertical vs. tilted) were also noted. All Brånemark System implants (Nobel Active) and interim, all-acrylic resin prostheses placed in patients following an All-on-Four™ protocol, in a single private practice were assessed by retrospective patient chart review. The amount of space provided surgically for implant restorative components and prostheses was determined from measurements of the vertical heights of the interim prostheses in the right/left anterior and posterior segments. These measurements were made in the laboratory. Interim prosthetic repairs (type, frequency, length of time from insertion) were analyzed by type, arch, gender, and implant orientation. Implant survival and insertion torque values were also measured. Inclusion criteria consisted of all Brånemark System implants placed with the All-on-Four protocol from September 1, 2011, until August 31, 2013. Specific dietary instructions were given for the first 7 days immediately postoperatively and for the weeks prior to insertion of the definitive prostheses. One hundred twenty-nine patients, comprising 191 arches (766 implants) from September 1, 2011, until August 31, 2013, were included in the study. One patient experienced implant failure yielding an overall implant survival rate (SR) of 99.5% (762 of 766). Four hundred twenty-six of 430 maxillary implants and 336 of 336 mandibular implants survived for SRs of 99.1% and 100%, respectively. Regarding implant orientation, 415 of 417 tilted implants (SR 99.5%) and 343 of 345 (CSR 95.6%) vertical implants were noted to be clinically stable. Interim, all-acrylic resin prostheses were in place for a mean of 199.2 days; mandibular prostheses were in place for an average of 195.4 days; maxillary prostheses were in place for an average of 202.0 days. Thirty four of the 191 interim prostheses (17.8%) warranted at least one repair during the treatment period. The average overall implant insertion torque value was 60.74 Ncm; mandibular torque values averaged 63.08 Ncm; maxillary torque values averaged 59.00 Ncm. The results from this study suggest that dental arch, gender, and implant orientation for implants placed and immediately restored with interim, all-acrylic resin, full-arch prostheses per the All-on-Four protocol did not have significant statistical or clinical effects on prosthetic complications of the interim prostheses or implant survival. Only one of the 129 patients experienced implant failures, indicating that the All-on-Four treatment protocol used in this study is a viable alternative to other protocols for rehabilitating edentulous patients. © 2015 by the American College of Prosthodontists.

The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.

PubMed

Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol

2013-05-01

Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.

Interim analysis of postoperative chemoradiotherapy with capecitabine and oxaliplatin versus capecitabine alone for pathological stage II and III rectal cancer: a randomized multicenter phase III trial.

PubMed

Feng, Yan-Ru; Zhu, Yuan; Liu, Lu-Ying; Wang, Wei-Hu; Wang, Shu-Lian; Song, Yong-Wen; Wang, Xin; Tang, Yuan; Liu, Yue-Ping; Ren, Hua; Fang, Hui; Zhang, Shi-Ping; Liu, Xin-Fan; Yu, Zi-Hao; Li, Ye-Xiong; Jin, Jing

2016-05-03

The aim of this study is to present an interim analysis of a phase III trial (NCT00714077) of postoperative concurrent capecitabine and radiotherapy with or without oxaliplatin for pathological stage II and III rectal cancer. Patients with pathologically confirmed stage II and III rectal cancer were randomized to either radiotherapy with concurrent capecitabine (Cap-RT group) or with capecitabine and oxaliplatin (Capox-RT group). The primary endpoint was 3-year disease-free survival rate (DFS). The 3-year DFS rate was 73.9% in the Capox-RT group and 71.6% in the Cap-RT group (HR 0.92, p = 0.647), respectively. No significant difference was observed in overall survival, cumulative incidence of local recurrence and distant metastasis between the two groups (p > 0.05). More grade 3-4 acute toxicity was observed in the Capox-RT group than in the Cap-RT group (38.1% vs. 29.2%, p = 0.041). Inclusion of oxaliplatin in the capecitabine-based postoperative regimen did not improve DFS but increased toxicities for pathological stage II and III rectal cancer in this interim analysis.

38 CFR 3.813 - Interim benefits for disability or death due to chloracne or porphyria cutanea tarda.

Code of Federal Regulations, 2010 CFR

2010-07-01

... rates that dependency and indemnity compensation would be payable if the death were service-connected... disability or death due to chloracne or porphyria cutanea tarda. 3.813 Section 3.813 Pensions, Bonuses, and... Indemnity Compensation Special Benefits § 3.813 Interim benefits for disability or death due to chloracne or...

38 CFR 3.813 - Interim benefits for disability or death due to chloracne or porphyria cutanea tarda.

Code of Federal Regulations, 2013 CFR

2013-07-01

... rates that dependency and indemnity compensation would be payable if the death were service-connected... disability or death due to chloracne or porphyria cutanea tarda. 3.813 Section 3.813 Pensions, Bonuses, and... Indemnity Compensation Special Benefits § 3.813 Interim benefits for disability or death due to chloracne or...

38 CFR 3.813 - Interim benefits for disability or death due to chloracne or porphyria cutanea tarda.

Code of Federal Regulations, 2011 CFR

2011-07-01

... rates that dependency and indemnity compensation would be payable if the death were service-connected... disability or death due to chloracne or porphyria cutanea tarda. 3.813 Section 3.813 Pensions, Bonuses, and... Indemnity Compensation Special Benefits § 3.813 Interim benefits for disability or death due to chloracne or...

38 CFR 3.813 - Interim benefits for disability or death due to chloracne or porphyria cutanea tarda.

Code of Federal Regulations, 2012 CFR

2012-07-01

... rates that dependency and indemnity compensation would be payable if the death were service-connected... disability or death due to chloracne or porphyria cutanea tarda. 3.813 Section 3.813 Pensions, Bonuses, and... Indemnity Compensation Special Benefits § 3.813 Interim benefits for disability or death due to chloracne or...

38 CFR 3.813 - Interim benefits for disability or death due to chloracne or porphyria cutanea tarda.

Code of Federal Regulations, 2014 CFR

2014-07-01

... rates that dependency and indemnity compensation would be payable if the death were service-connected... disability or death due to chloracne or porphyria cutanea tarda. 3.813 Section 3.813 Pensions, Bonuses, and... Indemnity Compensation Special Benefits § 3.813 Interim benefits for disability or death due to chloracne or...

The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter.

PubMed

Stavropoulos, S William; Sing, Ronald F; Elmasri, Fakhir; Silver, Mitchell J; Powell, Alex; Lynch, Frank C; Aal, Ahmed Kamel Abdel; Lansky, Alexandra J; Settlage, Richard A; Muhs, Bart E

2014-10-01

To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE). Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt. Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5-632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up. In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications. Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.

Settlement study : interim report No. 1.

DOT National Transportation Integrated Search

1980-07-01

This report covers methods of procedure used in the field and in the laboratory in computing the amounts and rates of settlement of several high embankments along I-20 and I-12 in Louisiana. It includes examples of a rather new calculation procedure ...

46 CFR 153.481 - Stripping quantities and interim standards for Category B NLS tanks on ships built before July 1...

Code of Federal Regulations, 2011 CFR

2011-10-01

... LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Design and Equipment for Pollution Control § 153.481 Stripping quantities and interim standards for Category B NLS tanks on... paragraph (b)(1) of this section and does not automatically control the flow rate must have— (i) Manual...

46 CFR 153.481 - Stripping quantities and interim standards for Category B NLS tanks on ships built before July 1...

Code of Federal Regulations, 2012 CFR

2012-10-01

... LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Design and Equipment for Pollution Control § 153.481 Stripping quantities and interim standards for Category B NLS tanks on... paragraph (b)(1) of this section and does not automatically control the flow rate must have— (i) Manual...

46 CFR 153.481 - Stripping quantities and interim standards for Category B NLS tanks on ships built before July 1...

Code of Federal Regulations, 2010 CFR

2010-10-01

... LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Design and Equipment for Pollution Control § 153.481 Stripping quantities and interim standards for Category B NLS tanks on... paragraph (b)(1) of this section and does not automatically control the flow rate must have— (i) Manual...

46 CFR 153.481 - Stripping quantities and interim standards for Category B NLS tanks on ships built before July 1...

Code of Federal Regulations, 2014 CFR

2014-10-01

... LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Design and Equipment for Pollution Control § 153.481 Stripping quantities and interim standards for Category B NLS tanks on... paragraph (b)(1) of this section and does not automatically control the flow rate must have— (i) Manual...

46 CFR 153.481 - Stripping quantities and interim standards for Category B NLS tanks on ships built before July 1...

Code of Federal Regulations, 2013 CFR

2013-10-01

... LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Design and Equipment for Pollution Control § 153.481 Stripping quantities and interim standards for Category B NLS tanks on... paragraph (b)(1) of this section and does not automatically control the flow rate must have— (i) Manual...

Adaptive graph-based multiple testing procedures

PubMed Central

Klinglmueller, Florian; Posch, Martin; Koenig, Franz

2016-01-01

Multiple testing procedures defined by directed, weighted graphs have recently been proposed as an intuitive visual tool for constructing multiple testing strategies that reflect the often complex contextual relations between hypotheses in clinical trials. Many well-known sequentially rejective tests, such as (parallel) gatekeeping tests or hierarchical testing procedures are special cases of the graph based tests. We generalize these graph-based multiple testing procedures to adaptive trial designs with an interim analysis. These designs permit mid-trial design modifications based on unblinded interim data as well as external information, while providing strong family wise error rate control. To maintain the familywise error rate, it is not required to prespecify the adaption rule in detail. Because the adaptive test does not require knowledge of the multivariate distribution of test statistics, it is applicable in a wide range of scenarios including trials with multiple treatment comparisons, endpoints or subgroups, or combinations thereof. Examples of adaptations are dropping of treatment arms, selection of subpopulations, and sample size reassessment. If, in the interim analysis, it is decided to continue the trial as planned, the adaptive test reduces to the originally planned multiple testing procedure. Only if adaptations are actually implemented, an adjusted test needs to be applied. The procedure is illustrated with a case study and its operating characteristics are investigated by simulations. PMID:25319733

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.

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…

Testing a Model of Participant Retention in Longitudinal Substance Abuse Research

ERIC Educational Resources Information Center

Gilmore, Devin; Kuperminc, Gabriel P.

2014-01-01

Longitudinal substance abuse research has often been compromised by high rates of attrition, thought to be the result of the lifestyle that often accompanies addiction. Several studies have used strategies including collection of locator information at the baseline assessment, verification of the information, and interim contacts prior to…

Differential impact of antiepileptic drugs on the effects of contraceptive methods on seizures: Interim findings of the epilepsy birth control registry.

PubMed

Herzog, Andrew G

2015-05-01

To present the interim findings of the Epilepsy Birth Control Registry (EBCR) regarding the impact of various contraceptive methods on seizures, stratified by antiepileptic drug (AED) type. This is an observational study that reports interim findings on the first 750 subjects. There are significantly greater relative risks (RR) for both seizure increase and decrease with hormonal contraception (HC) than with non-hormonal contraception (NHC). The rates of HC experiences associated with seizure increase (21.0%) are greater than with NHC (3.9%) (RR=5.39 [95% CI=3.77-7.73, p<0.0001]). The rates of HC experiences associated with seizure decrease (10.3%) are greater than with NHC (5.6%) (RR=1.85 [95% CI=1.30-2.62, p=0.0006]). While differences can reflect biological effects or reporting bias, the finding of a greater RR for seizure increase with hormonal patch than with combined oral contraceptive, perhaps related to the delivery of substantially higher concentrations of hormones, and a greater RR for seizure decrease with depomedroxyprogesterone, known to reduce seizure frequency when used in dosages which produce amenorrhea, support biological effects. All AED categories showed significantly higher frequencies of reports of seizure increase when combined with HC than with NHC. RR for seizure increase with HC was higher with valproate than with any other AED category. There were no significant differences among AEDs for seizure decrease with HC at this juncture of the study. Overall, NEIAEDs had the most favorable profile with regard to reports of seizure increase and decrease when used with HC. Interim EBCR findings suggest that contraception category and interactions between contraception category and AED category are predictive factors for changes in seizure frequency in WWE. Copyright © 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test.

PubMed

Hsueh, Eddy C; DeBloom, James R; Lee, Jonathan; Sussman, Jeffrey J; Covington, Kyle R; Middlebrook, Brooke; Johnson, Clare; Cook, Robert W; Slingluff, Craig L; McMasters, Kelly M

2017-08-29

A 31-gene expression profile (GEP) test that provides risk classification of cutaneous melanoma (CM) patients has been validated in several retrospective studies. The objective of the reported study was a prospective evaluation of the GEP performance in patients enrolled in two clinical registries. Three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries met the criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis. Primary endpoints were recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS). Median follow-up was 1.5 years for event-free patients. Median age for subjects was 58 years (range 18-87) and median Breslow thickness was 1.2 mm (range 0.2-12.0). Eighty-eight percent (282/322) of cases had stage I/II disease and 74% (237/322) had a SLN biopsy. Seventy-seven percent (248/322) had class 1 molecular profiles. 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each). Multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01), while tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis. Interim analysis of patient outcomes from a combined prospective cohort supports the 31-gene GEP's ability to stratify early-stage CM patients into two groups with significantly different metastatic risk. RFS outcomes in this real-world cohort are consistent with previously published analyses with retrospective specimens. GEP testing complements current clinicopathologic features and increases identification of high-risk patients. ClinicalTrials.gov, NCT02355574  and NCT02355587.

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…

Immunogenicity, efficacy and safety of Nuwiq® (human-cl rhFVIII) in previously untreated patients with severe haemophilia A-Interim results from the NuProtect Study.

PubMed

Liesner, R J; Abashidze, M; Aleinikova, O; Altisent, C; Belletrutti, M J; Borel-Derlon, A; Carcao, M; Chambost, H; Chan, A K C; Dubey, L; Ducore, J; Fouzia, N A; Gattens, M; Gruel, Y; Guillet, B; Kavardakova, N; El Khorassani, M; Klukowska, A; Lambert, T; Lohade, S; Sigaud, M; Turea, V; Wu, J K M; Vdovin, V; Pavlova, A; Jansen, M; Belyanskaya, L; Walter, O; Knaub, S; Neufeld, E J

2018-03-01

Nuwiq ® (Human-cl rhFVIII) is a fourth generation recombinant FVIII, produced in a human cell line, without chemical modification or protein fusion. No inhibitors developed in studies with Nuwiq ® in 201 previously treated patients with haemophilia A (HA). The immunogenicity, efficacy and safety of Nuwiq ® in previously untreated patients (PUPs) with severe HA are being assessed in the ongoing NuProtect study. The study, conducted across 38 centres worldwide, is evaluating 110 true PUPs of all ages and ethnicities enrolled for study up to 100 exposure days (EDs) or 5 years maximum. The primary objective is to assess the immunogenicity of Nuwiq ® (inhibitor activity ≥0.6 BU) using the Nijmegen-modified Bethesda assay at a central laboratory. Data for 66 PUPs with ≥20 EDs from a preplanned interim analysis were analysed. High-titre (HT) inhibitors developed in 8 of 66 patients after a median of 11.5 EDs (range 6-24). Five patients developed low-titre inhibitors (4 transient). The cumulative incidence (95% confidence interval) was 12.8% (4.5%, 21.2%) for HT inhibitors and 20.8% (10.7%, 31.0%) for all inhibitors. During inhibitor-free periods, median annualized bleeding rates during prophylaxis were 0 for spontaneous bleeds and 2.40 for all bleeds. Efficacy was rated as "excellent" or "good" in treating 91.8% of bleeds. Efficacy of surgical prophylaxis was "excellent" or "good" for 8 (89%) procedures and "moderate" for 1 (11%). No tolerability concerns were evident. These interim data show a cumulative incidence of 12.8% for HT inhibitors and convincing efficacy and tolerability in PUPs treated with Nuwiq ® . © 2017 The Authors. Haemophilia published by John Wiley & Sons Ltd.

Characterization of the radiation environment for a large-area interim spent-nuclear-fuel storage facility

NASA Astrophysics Data System (ADS)

Fortkamp, Jonathan C.

Current needs in the nuclear industry and movements in the political arena indicate that authorization may soon be given for development of a federal interim storage facility for spent nuclear fuel. The initial stages of the design work have already begun within the Department of Energy and are being reviewed by the Nuclear Regulatory Commission. This dissertation addresses the radiation environment around an interim spent nuclear fuel storage facility. Specifically the dissertation characterizes the radiation dose rates around the facility based on a design basis source term, evaluates the changes in dose due to varying cask spacing configurations, and uses these results to define some applicable health physics principles for the storage facility. Results indicate that dose rates from the facility are due primarily from photons from the spent fuel and Co-60 activation in the fuel assemblies. In the modeled cask system, skyshine was a significant contribution to dose rates at distances from the cask array, but this contribution can be reduced with an alternate cask venting system. With the application of appropriate health physics principles, occupation doses can be easily maintained far below regulatory limits and maintained ALARA.

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.

Project Student Concerns: A Study of Minority Student Suspensions. Interim Report.

ERIC Educational Resources Information Center

Bickel, Frank; Qualls, Robert

This report is a summary of research completed during the 1978-79 school year concerning the causes of disproportionate minority student suspensions in the Jefferson County public schools. A review of related literature is presented to illustrate that factors other than student behavior may contribute to school disruptions and high rates of…

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...

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

Success of Two-Stage Reimplantation in Patients Requiring an Interim Spacer Exchange.

PubMed

George, Jaiben; Miller, Evan M; Curtis, Gannon L; Klika, Alison K; Barsoum, Wael K; Mont, Michael A; Higuera, Carlos A

2018-03-23

Some patients undergoing a 2-stage revision for a periprosthetic joint infection require a repeat spacer in the interim (removal of existing spacer with insertion of a new spacer or spacer exchange) due to persistent infection. The objectives of this study are to (1) determine the factors associated with patients who receive a repeat spacer and (2) compare the infection-free survival (overall and stratified by joint type) of reimplantation in patients who did or did not receive a repeat spacer. From 2001 to 2014, 347 hip or knee 2-stage revisions that finally underwent reimplantation and had a minimum 2-year follow-up were identified. An interim spacer exchange was performed in 59 (17%) patients (exchange cohort). Patient-related and organism-related factors were compared between the exchange and non-exchange cohorts. Kaplan-Meier survival curves were performed to assess the success (absence of signs of infection, reoperation for infection, periprosthetic joint infection-related mortality) of both cohorts. Patients in the exchange group had higher comorbidity score (P = .020), prolonged time to reimplantation (P < .001), and higher prevalence of resistant organisms, though not statistically significant (P = .091). The 5-year infection-free survival rates were 64% (knee 62%, hip 64%) in the exchange cohort, and 78% (knee 77%, hip 78%) in the non-exchange cohort (P = .020). Patients requiring an interim spacer exchange were found to have more comorbidities, prolonged treatment period, and were more likely to be infected with a resistant organism. About one-third of such patients became reinfected within 5 years compared to only one-fifth of the patients without an interim spacer exchange. Copyright © 2018 Elsevier Inc. All rights reserved.

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.

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.

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…

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.

10 CFR 903.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... (h) Power Marketing Administration or PMA means the Alaska Power Administration, Southeastern Power... been confirmed, approved, and placed in effect on an interim basis by the Deputy Secretary. (l) Rate... means sales that last for no longer than one year. (p) Substitute Rate means a rate which has been...

10 CFR 903.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... (h) Power Marketing Administration or PMA means the Alaska Power Administration, Southeastern Power... been confirmed, approved, and placed in effect on an interim basis by the Deputy Secretary. (l) Rate... means sales that last for no longer than one year. (p) Substitute Rate means a rate which has been...

5 CFR 870.204 - Annual rates of pay.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Annual rates of pay. 870.204 Section 870... rates of pay. (a) (1) An insured employee's annual pay is his/her annual rate of basic pay as fixed by law or regulation. (2) Annual pay for this purpose includes the following: (i) Interim geographic...

Age of air and heating rates: comparison of ERA-40 with ERA-Interim

NASA Astrophysics Data System (ADS)

Legras, B.; Fueglistaler, S.

2009-04-01

The age of air in the stratosphere is often used as a test for the good representation of the Brewer-Dobson circulation by atmospheric models. This is a critical requirement to modelize the distribution of long-lived species in chemical models. It is often advocated that using heating rates for vertical transport in the stratosphere performs better that standard analysed velocities from weather centers. This work is based on an extensive comparison of the age of air using 5 years of heating rates from the ERA-40 reanalysis and from the new ERA-interim reanalysis built with 4D-Var assimilation. The ERA-40 exhibits both too young ages with analyzed velocities and too old ages with heating rates. The reason for too young ages is spurious transport associated with too noisy wind, as a result of 3D-Var assimilation. Heating rates provide a much less noisy meridional circulation and preserve transport barriers and polar vortex confinement. However, excessive cooling near 30 hPa in the tropics blocks the ascending motion within the tropical pipe over extended periods of time inducing very old ages. This effect is usually corrected by an empirical correction which can exceed in some regions the calculated heating rate in magnitude, with opposite sign. We relate this correction to the assimilation temperature increment that is required to compensate the bias of the model, notably the excessive negative heat transport due to the noisy vertical velocities and the lack of mass conservation in the isentropic frame. The new ERA-interim exhibits much reduced noise in the vertical velocity and is ten times less diffusive than the ERA-40 in the tropics. Age of air is then found to be slightly older than given by the observations. The biases in the heating rate have also been considerably reduced with respect to ERA-40 and the assimilation increment is now only a fraction of the heating rate. The age of air is in fairly good aggreement with the observations at 20 km and higher altitudes. Further improvements combining heating rates and a filtered version of the assimilation increment for vertical transport in the stratosphere are discussed. We study the effect of restoring the mass conservation by recalculating a mass divergence balancing the modified heating rates. The new velocity dataset generated in isentropic coordinates is then used to study the interranual variability of the Brewer-Dobson and of heating rate, in relation with the QBO cycle.

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…

Statistical controversies in clinical research: building the bridge to phase II-efficacy estimation in dose-expansion cohorts.

PubMed

Boonstra, P S; Braun, T M; Taylor, J M G; Kidwell, K M; Bellile, E L; Daignault, S; Zhao, L; Griffith, K A; Lawrence, T S; Kalemkerian, G P; Schipper, M J

2017-07-01

Regulatory agencies and others have expressed concern about the uncritical use of dose expansion cohorts (DECs) in phase I oncology trials. Nonetheless, by several metrics-prevalence, size, and number-their popularity is increasing. Although early efficacy estimation in defined populations is a common primary endpoint of DECs, the types of designs best equipped to identify efficacy signals have not been established. We conducted a simulation study of six phase I design templates with multiple DECs: three dose-assignment/adjustment mechanisms multiplied by two analytic approaches for estimating efficacy after the trial is complete. We also investigated the effect of sample size and interim futility analysis on trial performance. Identifying populations in which the treatment is efficacious (true positives) and weeding out inefficacious treatment/populations (true negatives) are competing goals in these trials. Thus, we estimated true and false positive rates for each design. Adaptively updating the MTD during the DEC improved true positive rates by 8-43% compared with fixing the dose during the DEC phase while maintaining false positive rates. Inclusion of an interim futility analysis decreased the number of patients treated under inefficacious DECs without hurting performance. A substantial gain in efficiency is obtainable using a design template that statistically models toxicity and efficacy against dose level during expansion. Design choices for dose expansion should be motivated by and based upon expected performance. Similar to the common practice in single-arm phase II trials, cohort sample sizes should be justified with respect to their primary aim and include interim analyses to allow for early stopping. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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…

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...

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.

Different predictive values of interim 18F-FDG PET/CT in germinal center like and non-germinal center like diffuse large B-cell lymphoma.

PubMed

Kim, Jihyun; Lee, Jeong-Ok; Paik, Jin Ho; Lee, Won Woo; Kim, Sang Eun; Song, Yoo Sung

2017-01-01

Diffuse large B-cell lymphoma (DLBCL) is a pathologically heterogeneous disease with different prognoses according to its molecular profiles. Despite the broad usage of 18 F-fluoro-2-dexoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT), previous studies that have investigated the value of interim 18 F-FDG PET/CT in DLBCL have given the controversial results. The purpose of this study was to evaluate the prognostic value of interim 18 F-FDG PET/CT in DLBCL according to germinal center B cell-like (GCB) and non-GCB molecular profiling. We enrolled 118 newly diagnosed DLBCL patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). Interim 18 F-FDG PET/CT scans performed after 2 or 3 cycles of R-CHOP treatment were evaluated based on the Lugano response criteria. Patients were grouped as GCB or non-GCB molecular subtypes according to immunohistochemistry results of CD10, BCL6, and MUM1, based on Hans' algorithm. In total 118 DLBCL patients, 35 % were classified as GCB, and 65 % were classified as non-GCB. Interim PET/CT was negative in 70 %, and positive in 30 %. During the median follow-up period of 23 months, the positive interim 18 F-FDG PET/CT group showed significantly inferior progression free survival (PFS) compared to the negative interim 18 F-FDG PET/CT group (P = 0.0004) in entire patients. A subgroup analysis according to molecular profiling demonstrated significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in GCB subtype of DLBCL (P = 0.0001), but there was no significant difference of PFS between the positive and negative interim 18 F-FDG PET groups in non-GCB subtype of DLBCL. Interim 18 F-FDG PET/CT scanning had a significant predictive value for disease progression in patients with the GCB subtype of DLBCL treated with R-CHOP, but not in those with the non-GCB subtype. Therefore, molecular profiles of DLBCL should be considered for interim 18 F-FDG PET/CT practice.

Annotated Bibliography for Lake Erie. Volume IV. Physical,

DTIC Science & Technology

1974-10-01

Presque Isle Bay, Erie , Pennsylvania - interim report. Environ- mental Sciences Inc. Pittsburg, Pa. 235 P. The factors... Presque Isle Peninsula, Erie , Pennsylvania , indicates apparent correlation of initial high erosion rates of placed beach fill with sand size character...changes since 1854. (CE) 777. U. S. Army Corps of Engineers. 1960. Presque Isle Peninsula, Erie , Pennsylvania , beach erosion con- trol study.

A spacing trial in tropical ash ... an interim report

Treesearch

Robert E. Burgan

1971-01-01

The optimum interval at which to plant tropical ash (Fraxinus uhdei) is being studied on the Waiakea Forest Reserve, island of Hawaii. Four spacing intervals are being tried: 6,8, 10, and 12 feet. Measurements of trial plots in 1969-8 years after plots were set up-suggest that (a) interval had not affected survival rate; (b) spacing had not affected...

Maximum type 1 error rate inflation in multiarmed clinical trials with adaptive interim sample size modifications.

PubMed

Graf, Alexandra C; Bauer, Peter; Glimm, Ekkehard; Koenig, Franz

2014-07-01

Sample size modifications in the interim analyses of an adaptive design can inflate the type 1 error rate, if test statistics and critical boundaries are used in the final analysis as if no modification had been made. While this is already true for designs with an overall change of the sample size in a balanced treatment-control comparison, the inflation can be much larger if in addition a modification of allocation ratios is allowed as well. In this paper, we investigate adaptive designs with several treatment arms compared to a single common control group. Regarding modifications, we consider treatment arm selection as well as modifications of overall sample size and allocation ratios. The inflation is quantified for two approaches: a naive procedure that ignores not only all modifications, but also the multiplicity issue arising from the many-to-one comparison, and a Dunnett procedure that ignores modifications, but adjusts for the initially started multiple treatments. The maximum inflation of the type 1 error rate for such types of design can be calculated by searching for the "worst case" scenarios, that are sample size adaptation rules in the interim analysis that lead to the largest conditional type 1 error rate in any point of the sample space. To show the most extreme inflation, we initially assume unconstrained second stage sample size modifications leading to a large inflation of the type 1 error rate. Furthermore, we investigate the inflation when putting constraints on the second stage sample sizes. It turns out that, for example fixing the sample size of the control group, leads to designs controlling the type 1 error rate. © 2014 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

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.

Relapsed chronic lymphocytic leukemia retreated with rituximab: interim results of the PERLE study.

PubMed

Chaoui, Driss; Choquet, Sylvain; Sanhes, Laurence; Mahé, Béatrice; Hacini, Maya; Fitoussi, Olivier; Arkam, Yazid; Orfeuvre, Hubert; Dilhuydy, Marie-Sarah; Barry, Marly; Jourdan, Eric; Dreyfus, Brigitte; Tempescul, Adrian; Leprêtre, Stéphane; Bardet, Aurélie; Leconte, Pierre; Maynadié, Marc; Delmer, Alain

2017-06-01

This prospective non-interventional study assessed the management of relapsed/refractory CLL after one or two treatments with rituximab, and retreatment with a rituximab-based regimen. An interim analysis was performed at the end of the induction period in 192 evaluable patients. Median age was 72 years [35-89], first relapse (55%), and second relapse (45%). Rituximab administered during first (68%), second (92%), or both treatment lines (20%). R-bendamustine administered in 56% of patients, R-purine analogs (21%), and R-alkylating agents (19%). The overall response rate (ORR) was 74.6%, in favor of R-purine analogs (90%), R-bendamustine (75%), and R-alkylating agents (69%). Lower ORR in Del 17p patients (43%) and third time rituximab (31%). Most frequent adverse events were hematological (23% patients) including neutropenia (11%) and infections (12%); grade 3/4 AEs (23% patients), mainly hematological (18%); death during induction treatment (7%). This first large study focusing on relapsed/refractory CLL patients retreated with rituximab-based regimens is still ongoing.

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.

78 FR 18335 - Central Arizona Project-Rate Order No. WAPA-158

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... Project, reflected in Transmission Service Rate Schedules CAP-FT2, CAP-NFT2, and CAP-NITS2, from January 1... existing Rate Schedules CAP-FT2, CAP-NFT2, CAP-NITS2 under Rate Order No. WAPA-124,\\1\\ were approved for a... Transmission Service Rate Schedules CAP-FT2, CAP-NFT2, and CAP-NITS2 on an interim basis effective as of...

The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease.

PubMed

Pritchett, Yili; Jemiai, Yannis; Chang, Yuchiao; Bhan, Ishir; Agarwal, Rajiv; Zoccali, Carmine; Wanner, Christoph; Lloyd-Jones, Donald; Cannata-Andía, Jorge B; Thompson, Taylor; Appelbaum, Evan; Audhya, Paul; Andress, Dennis; Zhang, Wuyan; Solomon, Scott; Manning, Warren J; Thadhani, Ravi

2011-04-01

Chronic kidney disease is associated with a marked increase in risk for left ventricular hypertrophy and cardiovascular mortality compared with the general population. Therapy with vitamin D receptor activators has been linked with reduced mortality in chronic kidney disease and an improvement in left ventricular hypertrophy in animal studies. PRIMO (Paricalcitol capsules benefits in Renal failure Induced cardia MOrbidity) is a multinational, multicenter randomized controlled trial to assess the effects of paricalcitol (a selective vitamin D receptor activator) on mild to moderate left ventricular hypertrophy in patients with chronic kidney disease. Subjects with mild-moderate chronic kidney disease are randomized to paricalcitol or placebo after confirming left ventricular hypertrophy using a cardiac echocardiogram. Cardiac magnetic resonance imaging is then used to assess left ventricular mass index at baseline, 24 and 48 weeks, which is the primary efficacy endpoint of the study. Because of limited prior data to estimate sample size, a maximum information group sequential design with sample size re-estimation is implemented to allow sample size adjustment based on the nuisance parameter estimated using the interim data. An interim efficacy analysis is planned at a pre-specified time point conditioned on the status of enrollment. The decision to increase sample size depends on the observed treatment effect. A repeated measures analysis model, using available data at Week 24 and 48 with a backup model of an ANCOVA analyzing change from baseline to the final nonmissing observation, are pre-specified to evaluate the treatment effect. Gamma-family of spending function is employed to control family-wise Type I error rate as stopping for success is planned in the interim efficacy analysis. If enrollment is slower than anticipated, the smaller sample size used in the interim efficacy analysis and the greater percent of missing week 48 data might decrease the parameter estimation accuracy, either for the nuisance parameter or for the treatment effect, which might in turn affect the interim decision-making. The application of combining a group sequential design with a sample-size re-estimation in clinical trial design has the potential to improve efficiency and to increase the probability of trial success while ensuring integrity of the study.

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…

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…

Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study.

PubMed

Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Uno, Satoshi

2018-02-01

Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

48 CFR 52.216-7 - Allowable Cost and Payment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... written understanding setting forth the final indirect cost rates. The understanding shall specify (i) the... special terms and the applicable rates. The understanding shall not change any monetary ceiling, contract... not subject to the interest penalty provisions of the Prompt Payment Act. Interim payments made prior...

78 FR 64494 - Southwestern Power Administration; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF14-1-000] Southwestern Power Administration; Notice of Filing Take notice that on October 3, 2013, the Deputy Secretary of the... interim basis in Rate Order SWPA- 66, Southwestern Power Administration Integrated System Rates for the...

78 FR 13999 - Maximum Interest Rates on Guaranteed Farm Loans

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

... loan customers. The existing regulations in 7 CFR 762.124(a)(3) tie the rate to that rate charged an ``average agricultural loan customer,'' as defined in 7 CFR 761.2. This rule would not change the core... charged an average agricultural loan customer. This interim rule follows a proposed rule on the same topic...

43 CFR 38.3 - Administration of adjusted rates of pay.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Administration of adjusted rates of pay. 38.3 Section 38.3 Public Lands: Interior Office of the Secretary of the Interior PAY OF U.S. PARK POLICE-INTERIM GEOGRAPHIC ADJUSTMENTS § 38.3 Administration of adjusted rates of pay. (a) An employee is...

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.

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.

THE DEVELOPMENT OF BEHAVIOR DIMENSIONS FOR EMOTIONALLY DISTURBED CHILDREN--A STUDY OF RELEVANT INDICATORS FOR CLASSROOM TECHNIQUES, THERAPIES METHODS, AND PROGNOSIS. INTERIM REPORT.

ERIC Educational Resources Information Center

CROMWELL, RUE L.

FOUR INSTRUMENTS WERE DEVELOPED AND STANDARDIZED TO MEASURE EARLY EXPERIENCE, CURRENT BEHAVIOR, TREATMENT APPROACHES, AND PROGNOSIS OF EMOTIONALLY DISTURBED CHILDREN--THE RATING/RANKING SCALE OF CHILD BEHAVIOR (R/R SCALE), THE PARENT PRACTICES INVENTORY (PPI), THE SCALE ON PROCEDURES IN DEALING WITH CHILDREN (PDC), AND THE CHILD HISTORY CODE…

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…

78 FR 64494 - Southwestern Power Administration; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF14-2-000] Southwestern Power Administration; Notice of Filing Take notice that on October 3, 2013, the Deputy Secretary of the... interim basis in Rate Order SWPA- 67, Southwestern Power Administration annual rate for the sale of power...

77 FR 65679 - Southwestern Power Administration; Notice of Filing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-30

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF13-1-000] Southwestern Power Administration; Notice of Filing Take notice that on October 18, 2012, the Deputy Secretary of the... an interim basis in Rate Order SWPA-64, Southwestern Power Administration annual rate for the sale of...

78 FR 62616 - Integrated System Power Rates

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

... sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides an additional... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... Deputy Secretary has approved and placed into effect on an interim basis Rate Order No. SWPA-66, which...

76 FR 53813 - Dried Prunes Produced in California; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 993 [Doc. No. AMS-FV-11-0068... Marketing Service, USDA. ACTION: Interim rule with request for comments. SUMMARY: This rule decreases the assessment rate established for the Prune Marketing Committee (Committee) for the 2011-12 and subsequent crop...

78 FR 21520 - Sweet Cherries Grown in Designated Counties in Washington; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 923 [Doc. No. AMS-FV-12-0026... AGENCY: Agricultural Marketing Service, USDA. ACTION: Affirmation of interim rule as final rule. SUMMARY... decreased the assessment rate established for the Washington Cherry Marketing Committee (Committee) for the...

78 FR 28120 - Tomatoes Grown in Florida; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 966 [Doc. No. AMS-FV-12-0051; FV12-966-1 FIR] Tomatoes Grown in Florida; Decreased Assessment Rate AGENCY: Agricultural Marketing... marketing order which regulates the handling of tomatoes grown in Florida. The interim rule was necessary to...

78 FR 21518 - Apricots Grown in Designated Counties in Washington; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 922 [Doc. No. AMS-FV-12-0027...: Agricultural Marketing Service, USDA. ACTION: Affirmation of interim rule as final rule. SUMMARY: The... the assessment rate established for the Washington Apricot Marketing Committee (Committee) for the...

1993 Wholesale Power and Transmission Rate Schedules.

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

US Bonneville Power Administration

1993-10-01

Bonneville Power Administration 1993 Wholesale Power Rate Schedules and General Rate Schedule Provisions and 1993 Transmission Rate Schedules and General Transmission Rate Schedule Provisions, contained herein, were approved on an interim basis effective October 1, 1993. These rate schedules and provisions were approved by the Federal Energy Commission, United States Department of Energy, in September, 1993. These rate schedules and provisions supersede the Administration`s Wholesale Power Rate Schedules and General Rate Schedule Provisions and Transmission Rate Schedules and General Transmission Rate Schedule Provisions effective October 1, 1991.

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.

Interim analyses in 2 x 2 crossover trials.

PubMed

Cook, R J

1995-09-01

A method is presented for performing interim analyses in long term 2 x 2 crossover trials with serial patient entry. The analyses are based on a linear statistic that combines data from individuals observed for one treatment period with data from individuals observed for both periods. The coefficients in this linear combination can be chosen quite arbitrarily, but we focus on variance-based weights to maximize power for tests regarding direct treatment effects. The type I error rate of this procedure is controlled by utilizing the joint distribution of the linear statistics over analysis stages. Methods for performing power and sample size calculations are indicated. A two-stage sequential design involving simultaneous patient entry and a single between-period interim analysis is considered in detail. The power and average number of measurements required for this design are compared to those of the usual crossover trial. The results indicate that, while there is minimal loss in power relative to the usual crossover design in the absence of differential carry-over effects, the proposed design can have substantially greater power when differential carry-over effects are present. The two-stage crossover design can also lead to more economical studies in terms of the expected number of measurements required, due to the potential for early stopping. Attention is directed toward normally distributed responses.

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.

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

77 FR 2521 - Integrated System Power Rates

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... experienced due to a sudden loss of generation or load. 1.1.5. Supplemental Operating Reserve Service provides... Secretary has approved and placed into effect on an interim basis Rate Order No. SWPA-63, which increases...

78 FR 24983 - Domestic Dates Produced or Packed in Riverside County, California; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-29

...://www.ams.usda.gov/MarketingOrdersSmallBusinessGuide ; or by contacting Jeffrey Smutny, Marketing Order... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 987 [Docket No. AMS-FV-12-0035... Rate AGENCY: Agricultural Marketing Service, USDA. ACTION: Affirmation of interim rule as final rule...

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),...

21 CFR 180.30 - Brominated vegetable oil.

Code of Federal Regulations, 2010 CFR

2010-04-01

... million in the finished beverage, pending the outcome of additional toxicological studies on which... INTERIM BASIS PENDING ADDITIONAL STUDY Specific Requirements for Certain Food Additives § 180.30... used on an interim basis as a stabilizer for flavoring oils used in fruit-flavored beverages, for which...

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.

Sample size re-assessment leading to a raised sample size does not inflate type I error rate under mild conditions.

PubMed

Broberg, Per

2013-07-19

One major concern with adaptive designs, such as the sample size adjustable designs, has been the fear of inflating the type I error rate. In (Stat Med 23:1023-1038, 2004) it is however proven that when observations follow a normal distribution and the interim result show promise, meaning that the conditional power exceeds 50%, type I error rate is protected. This bound and the distributional assumptions may seem to impose undesirable restrictions on the use of these designs. In (Stat Med 30:3267-3284, 2011) the possibility of going below 50% is explored and a region that permits an increased sample size without inflation is defined in terms of the conditional power at the interim. A criterion which is implicit in (Stat Med 30:3267-3284, 2011) is derived by elementary methods and expressed in terms of the test statistic at the interim to simplify practical use. Mathematical and computational details concerning this criterion are exhibited. Under very general conditions the type I error rate is preserved under sample size adjustable schemes that permit a raise. The main result states that for normally distributed observations raising the sample size when the result looks promising, where the definition of promising depends on the amount of knowledge gathered so far, guarantees the protection of the type I error rate. Also, in the many situations where the test statistic approximately follows a normal law, the deviation from the main result remains negligible. This article provides details regarding the Weibull and binomial distributions and indicates how one may approach these distributions within the current setting. There is thus reason to consider such designs more often, since they offer a means of adjusting an important design feature at little or no cost in terms of error rate.

Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice.

PubMed

Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Nakamura, Ichiro

2016-10-01

To evaluate the efficacy and safety of ipragliflozin in real-world clinical practice in Japanese patients with type 2 diabetes. We conducted interim analyses at 3 months of a 3-year prospective study of patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015, and whose data were locked by 16 January 2016. Changes in glycemic control, blood pressure, and laboratory variables from baseline, and incidence of adverse drug reactions (ADRs). Of 11,412 patients initially registered, efficacy and safety data were available for 3481 (30.5%) and 4360 (38.2%) patients, respectively. Hemoglobin A1c and fasting plasma glucose decreased by 0.67% and 28.8 mg/dL, respectively, at 3 months/last assessment (both P < .001) from baseline (8.00% and 166.4 mg/dL, respectively). Blood pressure and lipid levels also improved significantly. There were 258 ADRs in 194 patients. The ADRs included 'renal and urinary disorders' (system organ class) in 110 patients (2.5%). These 3-month interim results indicate that ipragliflozin improved glycemic control, lipids, and blood pressure with low rates of ADRs in Japanese patients with type 2 diabetes in real-world clinical practice. The results were consistent with those of placebo-controlled, randomized clinical trials. Clinicaltrials.gov identifier: NCT02479399.

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...

Estimating trends in atmospheric water vapor and temperature time series over Germany

NASA Astrophysics Data System (ADS)

Alshawaf, Fadwa; Balidakis, Kyriakos; Dick, Galina; Heise, Stefan; Wickert, Jens

2017-08-01

Ground-based GNSS (Global Navigation Satellite System) has efficiently been used since the 1990s as a meteorological observing system. Recently scientists have used GNSS time series of precipitable water vapor (PWV) for climate research. In this work, we compare the temporal trends estimated from GNSS time series with those estimated from European Center for Medium-Range Weather Forecasts (ECMWF) reanalysis (ERA-Interim) data and meteorological measurements. We aim to evaluate climate evolution in Germany by monitoring different atmospheric variables such as temperature and PWV. PWV time series were obtained by three methods: (1) estimated from ground-based GNSS observations using the method of precise point positioning, (2) inferred from ERA-Interim reanalysis data, and (3) determined based on daily in situ measurements of temperature and relative humidity. The other relevant atmospheric parameters are available from surface measurements of meteorological stations or derived from ERA-Interim. The trends are estimated using two methods: the first applies least squares to deseasonalized time series and the second uses the Theil-Sen estimator. The trends estimated at 113 GNSS sites, with 10 to 19 years temporal coverage, vary between -1.5 and 2.3 mm decade-1 with standard deviations below 0.25 mm decade-1. These results were validated by estimating the trends from ERA-Interim data over the same time windows, which show similar values. These values of the trend depend on the length and the variations of the time series. Therefore, to give a mean value of the PWV trend over Germany, we estimated the trends using ERA-Interim spanning from 1991 to 2016 (26 years) at 227 synoptic stations over Germany. The ERA-Interim data show positive PWV trends of 0.33 ± 0.06 mm decade-1 with standard errors below 0.03 mm decade-1. The increment in PWV varies between 4.5 and 6.5 % per degree Celsius rise in temperature, which is comparable to the theoretical rate of the Clausius-Clapeyron equation.

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...

40 CFR 92.12 - Interim provisions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... specified in § 92.212(c)(2)(v). (i) Diesel test fuels. Manufacturers and remanufacturers may use LSD or ULSD... determine your cycle-weighted emission rates as specified in subpart B of this part. If you test using LSD...

40 CFR 92.12 - Interim provisions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... specified in § 92.212(c)(2)(v). (i) Diesel test fuels. Manufacturers and remanufacturers may use LSD or ULSD... determine your cycle-weighted emission rates as specified in subpart B of this part. If you test using LSD...

40 CFR 92.12 - Interim provisions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... specified in § 92.212(c)(2)(v). (i) Diesel test fuels. Manufacturers and remanufacturers may use LSD or ULSD... determine your cycle-weighted emission rates as specified in subpart B of this part. If you test using LSD...

40 CFR 92.12 - Interim provisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... specified in § 92.212(c)(2)(v). (i) Diesel test fuels. Manufacturers and remanufacturers may use LSD or ULSD... determine your cycle-weighted emission rates as specified in subpart B of this part. If you test using LSD...

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 ...

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.

THC:CBD Observational Study Data: Evolution of Resistant MS Spasticity and Associated Symptoms.

PubMed

Trojano, Maria

2016-01-01

The prospective observational MObility ImproVEment (MOVE) 2 study is collecting real-life clinical outcomes data on patients with treatment-resistant multiple sclerosis (MS) spasticity treated with THC:CBD oromucosal spray in routine clinical practice. The MOVE 2 study has been ongoing in Italy, involving more than 30 MS centres across the country, since 2013. Web-based real-time data collection techniques are combined with traditional patients' diaries to capture a wide spectrum of outcomes associated with this innovative cannabis-based medication. After surpassing the recruitment threshold of 300 patients, an interim analysis was performed to determine whether the data collected to date align with those from MOVE 2-Germany and the largest phase III randomized controlled trial (RCT) of THC:CBD oromucosal spray. In the Italian cohort, THC:CBD oromucosal spray was added mainly to oral baclofen. Similar to MOVE 2-Germany, during 3 months' observation, treatment discontinuations were limited and patients recorded meaningful improvements on the patient-based 0-10 numerical rating scale and physician-rated modified Ashworth scale at mean daily doses that were about one-third lower than those used in the RCT. Also, similar to MOVE 2-Germany, the proportion of patients reporting adverse events was about one-third of the rate recorded in the RCT. While MOVE 2-Italy continues, this interim analysis has enabled us to better define the place in therapy of THC:CBD oromucosal spray within the context of daily management of our patients with MS spasticity. © 2016 S. Karger AG, Basel.

Dexamethasone and High-Dose Methotrexate Improve Outcome for Children and Young Adults With High-Risk B-Acute Lymphoblastic Leukemia: A Report From Children’s Oncology Group Study AALL0232

PubMed Central

Devidas, Meenakshi; Chen, Si; Salzer, Wanda L.; Raetz, Elizabeth A.; Loh, Mignon L.; Mattano, Leonard A.; Cole, Catherine; Eicher, Alisa; Haugan, Maureen; Sorenson, Mark; Heerema, Nyla A.; Carroll, Andrew A.; Gastier-Foster, Julie M.; Borowitz, Michael J.; Wood, Brent L.; Willman, Cheryl L.; Winick, Naomi J.; Hunger, Stephen P.; Carroll, William L.

2016-01-01

Purpose Survival for children and young adults with high-risk B-acute lymphoblastic leukemia has improved significantly, but 20% to 25% of patients are not cured. Children’s Oncology Group study AALL0232 tested two interventions to improve survival. Patients and Methods Between January 2004 and January 2011, AALL0232 enrolled 3,154 participants 1 to 30 years old with newly diagnosed high-risk B-acute lymphoblastic leukemia. By using a 2 × 2 factorial design, 2,914 participants were randomly assigned to receive dexamethasone (14 days) versus prednisone (28 days) during induction and high-dose methotrexate versus Capizzi escalating-dose methotrexate plus pegaspargase during interim maintenance 1. Results Planned interim monitoring showed the superiority of the high-dose methotrexate regimens, which exceeded the predefined boundary and led to cessation of enrollment in January 2011. At that time, participants randomly assigned to high-dose methotrexate during interim maintenance 1 versus those randomly assigned to Capizzi methotrexate had a 5-year event-free survival (EFS) of 82% versus 75.4% (P = .006). Mature final data showed 5-year EFS rates of 79.6% for high-dose methotrexate and 75.2% for Capizzi methotrexate (P = .008). High-dose methotrexate decreased both marrow and CNS recurrences. Patients 1 to 9 years old who received dexamethasone and high-dose methotrexate had a superior outcome compared with those who received the other three regimens (5-year EFS, 91.2% v 83.2%, 80.8%, and 82.1%; P = .015). Older participants derived no benefit from dexamethasone during induction and experienced excess rates of osteonecrosis. Conclusion High-dose methotrexate is superior to Capizzi methotrexate for the treatment of high-risk B-acute lymphoblastic leukemia, with no increase in acute toxicity. Dexamethasone given during induction benefited younger children but provided no benefit and was associated with a higher risk of osteonecrosis among participants 10 years and older. PMID:27114587

Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial.

PubMed

Shin, Hye Young; Suh, Mina; Baik, Hyung Won; Choi, Kui Son; Park, Boyoung; Jun, Jae Kwan; Hwang, Sang-Hyun; Kim, Byung Chang; Lee, Chan Wha; Oh, Jae Hwan; Lee, You Kyoung; Han, Dong Soo; Lee, Do-Hoon

2016-11-15

We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container). In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia. The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], -3.4 to 25.6) and 12.0% (95% CI, -0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively. The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.

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...

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.

The Viking carbon assimilation experiments - Interim report

NASA Technical Reports Server (NTRS)

Horowitz, N. H.; Hobby, G. L.; Hubbard, J. S.

1976-01-01

A synthesis of organic matter from atmospheric carbon monoxide or carbon dioxide, or both, appears to take place in the surface material of Mars at a low rate. The synthesis appears to be thermolabile and to be inhibited by moisture.

Tracking rare orchids (Orchidaceae) in Arizona

Treesearch

Ronald A. Coleman

2001-01-01

Twenty-six native orchid species occur in Arizona, and 14 are considered rare with fewer than 100 occurrences in the state. The author is conducting three studies covering four of the wild orchids: Stenorrhynchos michuacanum, Hexalectris revoluta, Malaxis porphyry, and M. tenuis. The studies are ongoing so only interim results are available. Interim results indicate...

Global Spent Fuel Logistics Systems Study (GSFLS). Volume 2A. GSFLS visit findings (appendix). Interim report

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

None

1978-01-31

This appendix is a part of the interim report documentation for the Global Spent Fuel Logistics System (GSFLS) study. This appendix provides the legal/regulatory reference material, supportive of Volume 2 - GSFLS Visit Finding and Evaluations; and certain background material on British Nuclear Fuel Limited (BNFL).

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.).

Determination of rainfall losses in Virginia, phase II : interim report.

DOT National Transportation Integrated Search

1981-01-01

This interim report summarizes results obtained for the project through May 1981. The objective of the study is to develop rainfall loss parameters for localities in Virginia. For this purpose, the state has been divided into eleven hydrologic region...

An Interim Report on the Student Support Services Program: 2002-03 and 2003-04, with Select Data from 1998-2002

ERIC Educational Resources Information Center

Zhang, Yu; Chan, Tsze

2007-01-01

This report describes essential characteristics and key program outcome measures for the Student Support Services (SSS) program grantees and participants in reporting years 2002-03 and 2003-04. The SSS program is designed to increase college persistence and graduation rates for eligible students, increase the transfer rates of eligible students…

43 CFR 38.2 - Computation of hourly, daily, weekly, and biweekly adjusted rates of pay.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Computation of hourly, daily, weekly, and biweekly adjusted rates of pay. 38.2 Section 38.2 Public Lands: Interior Office of the Secretary of the Interior PAY OF U.S. PARK POLICE-INTERIM GEOGRAPHIC ADJUSTMENTS § 38.2 Computation of hourly, daily, weekly...

76 FR 62760 - Foreign-Trade Zone 277-Western Maricopa County, AZ; Application for Temporary/Interim...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

...), fasteners (7318.14, 7318.15, 7318.29), hinges (8302.10), brackets (8302.50), plates (8310.00), compressors..., Sub-Zero would be able to choose the duty rate during customs entry procedures that applies to...

Marine Biochemistry: A New Interdisciplinary Course for the Interim

ERIC Educational Resources Information Center

Goldberg, Arthur S.

1976-01-01

Discusses an undergraduate course which includes lectures, laboratory, and field trips and is designed for the interim winter semester. The course is interdisciplinary, involving a study of the biochemistry, pharmacology, and physiological significance of compounds from marine flora and fauna. (MLH)

Fit of interim crowns fabricated using photopolymer-jetting 3D printing.

PubMed

Mai, Hang-Nga; Lee, Kyu-Bok; Lee, Du-Hyeong

2017-08-01

The fit of interim crowns fabricated using 3-dimensional (3D) printing is unknown. The purpose of this in vitro study was to evaluate the fit of interim crowns fabricated using photopolymer-jetting 3D printing and to compare it with that of milling and compression molding methods. Twelve study models were fabricated by making an impression of a metal master model of the mandibular first molar. On each study model, interim crowns (N=36) were fabricated using compression molding (molding group, n=12), milling (milling group, n=12), and 3D polymer-jetting methods. The crowns were prepared as follows: molding group, overimpression technique; milling group, a 5-axis dental milling machine; and polymer-jetting group using a 3D printer. The fit of interim crowns was evaluated in the proximal, marginal, internal axial, and internal occlusal regions by using the image-superimposition and silicone-replica techniques. The Mann-Whitney U test and Kruskal-Wallis tests were used to compare the results among groups (α=.05). Compared with the molding group, the milling and polymer-jetting groups showed more accurate results in the proximal and marginal regions (P<.001). In the axial regions, even though the mean discrepancy was smallest in the molding group, the data showed large deviations. In the occlusal region, the polymer-jetting group was the most accurate, and compared with the other groups, the milling group showed larger internal discrepancies (P<.001). Polymer-jet 3D printing significantly enhanced the fit of interim crowns, particularly in the occlusal region. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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…

Nonmanufacturing Businesses. U.S. Metric Study Interim Report.

ERIC Educational Resources Information Center

Cornog, June R.; Bunten, Elaine D.

In this fifth interim report on the feasibility of a United States changeover to a metric system stems from the U.S. Metric Study, a primary stratified sample of 2,828 nonmanufacturing firms was randomly selected from 28,184 businesses taken from Social Security files, a secondary sample of 2,258 firms was randomly selected for replacement…

Study of New Youth Initiatives in Apprenticeship. Interim Report. Volume 2: Site Visit Reports.

ERIC Educational Resources Information Center

CSR, Inc., Washington, DC.

This second volume of the interim report provides detailed case study reports on each of the eight Youth Apprenticeship Projects. (Volume 1, an overview of data from the site visits, is available separately as CE 032 791.) Discussion areas covered in each site visit report are local context/operational environment, administrative information,…

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,…

Jet Crackle

DTIC Science & Technology

2015-06-23

DISTRIBUTION/AVAILABILITY STATEMENT DISTRIBUTION A 13. SUPPLEMENTARY NOTES 14. ABSTRACT Fighter jets and other aircraft with high specific thrust engines...interim, memorandum, master’s thesis , progress, quarterly, research, special, group study, etc. 3. DATES COVERED. Indicate the time during which the...State the type of report, such as final, technical, interim, memorandum, master’s thesis , progress, quarterly, research, special, group study, etc

CBVE: A Study to Measure Its Effectiveness in Kentucky. Final Report. Interim Period 1.

ERIC Educational Resources Information Center

Vincent, Roger D.; Cobb, Robert A.

An interim study was conducted in Kentucky to determine the effectiveness of Competency Based Vocational Education (CBVE) and to compare its effectiveness to that of traditional teaching methodologies. Research surveys of those directly involved in the implementation of CBVE were used to ascertain if CBVE is meeting its self-stated goals.…

Second Interim Report on the Installation and Evaluation of Weigh-In-Motion Utilizing Quartz-Piezo Sensor Technology

DOT National Transportation Integrated Search

1999-11-01

The objective of this study is to determine the sensor survivability, accuracy and reliability of quartz-piezoelectric weigh-in-motion (WIM) sensors under actual traffic conditions in Connecticut's environment. This second interim report provides a s...

42 CFR 93.401 - Interaction with other offices and interim actions.

Code of Federal Regulations, 2014 CFR

2014-10-01

... HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC... offices and funding components at any time to permit them to make appropriate interim responses to protect... making decisions about the award or continuation of funding. Research Misconduct Issues ...

42 CFR 93.401 - Interaction with other offices and interim actions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC... offices and funding components at any time to permit them to make appropriate interim responses to protect... making decisions about the award or continuation of funding. Research Misconduct Issues ...

42 CFR 93.401 - Interaction with other offices and interim actions.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC... offices and funding components at any time to permit them to make appropriate interim responses to protect... making decisions about the award or continuation of funding. Research Misconduct Issues ...

42 CFR 93.401 - Interaction with other offices and interim actions.

Code of Federal Regulations, 2011 CFR

2011-10-01

... HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC... offices and funding components at any time to permit them to make appropriate interim responses to protect... making decisions about the award or continuation of funding. Research Misconduct Issues ...

Response Of Iowa pavements to a tracked agricultural vehicle

DOT National Transportation Integrated Search

2000-12-01

The overall objective of the work summarized in this report and in the interim report was to study the effects of targeted implement-of-husbandry loads. This report is to complement Phase I of this work, which was summarized in the interim report, "R...

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.

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...

An Australian Study Comparing the Use of Multiple-Choice Questionnaires with Assignments as Interim, Summative Law School Assessment

ERIC Educational Resources Information Center

Huang, Vicki

2017-01-01

To the author's knowledge, this is the first Australian study to empirically compare the use of a multiple-choice questionnaire (MCQ) with the use of a written assignment for interim, summative law school assessment. This study also surveyed the same student sample as to what types of assessments are preferred and why. In total, 182 undergraduate…

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

75 FR 35672 - Changes in Flood Elevation Determinations

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-23

...This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

77 FR 2699 - Foreign-Trade Zone 267-Fargo, ND; Application for Temporary/Interim Manufacturing Authority, CNH...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

... and locks (HTSUS 8301.20); metal sign plates (HTSUS 8310.00); fans (HTSUS 8414.59); valves (HTSUS 8413... to choose the duty rates during customs entry procedures that apply to the finished subassemblies and...

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.

Internal pilots for a class of linear mixed models with Gaussian and compound symmetric data

PubMed Central

Gurka, Matthew J.; Coffey, Christopher S.; Muller, Keith E.

2015-01-01

SUMMARY An internal pilot design uses interim sample size analysis, without interim data analysis, to adjust the final number of observations. The approach helps to choose a sample size sufficiently large (to achieve the statistical power desired), but not too large (which would waste money and time). We report on recent research in cerebral vascular tortuosity (curvature in three dimensions) which would benefit greatly from internal pilots due to uncertainty in the parameters of the covariance matrix used for study planning. Unfortunately, observations correlated across the four regions of the brain and small sample sizes preclude using existing methods. However, as in a wide range of medical imaging studies, tortuosity data have no missing or mistimed data, a factorial within-subject design, the same between-subject design for all responses, and a Gaussian distribution with compound symmetry. For such restricted models, we extend exact, small sample univariate methods for internal pilots to linear mixed models with any between-subject design (not just two groups). Planning a new tortuosity study illustrates how the new methods help to avoid sample sizes that are too small or too large while still controlling the type I error rate. PMID:17318914

Two-stage phase II oncology designs using short-term endpoints for early stopping.

PubMed

Kunz, Cornelia U; Wason, James Ms; Kieser, Meinhard

2017-08-01

Phase II oncology trials are conducted to evaluate whether the tumour activity of a new treatment is promising enough to warrant further investigation. The most commonly used approach in this context is a two-stage single-arm design with binary endpoint. As for all designs with interim analysis, its efficiency strongly depends on the relation between recruitment rate and follow-up time required to measure the patients' outcomes. Usually, recruitment is postponed after the sample size of the first stage is achieved up until the outcomes of all patients are available. This may lead to a considerable increase of the trial length and with it to a delay in the drug development process. We propose a design where an intermediate endpoint is used in the interim analysis to decide whether or not the study is continued with a second stage. Optimal and minimax versions of this design are derived. The characteristics of the proposed design in terms of type I error rate, power, maximum and expected sample size as well as trial duration are investigated. Guidance is given on how to select the most appropriate design. Application is illustrated by a phase II oncology trial in patients with advanced angiosarcoma, which motivated this research.

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...

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.

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...

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…

Nutrition and Child Growth and Development in Tunisia. Interim Progress Report, (September 1, 1972--February 28, 1973).

ERIC Educational Resources Information Center

Young, Harben Boutourline

This interim report of the Yale Project describes the progress made on the nutrition and growth study of Tunisian children from September 1, 1972 through February 28, 1973. A major part of the report is devoted to the organizational and data collection problems of the longitudinal study, discussed under the following categories: biomedics,…

Testimony of Nationally Representative Groups. U.S. Metric Study Interim Report.

ERIC Educational Resources Information Center

National Bureau of Standards (DOC), Washington, DC.

As the 12th in a series of interim reports prepared for the United States Congress on the metric system, this study was authorized by law to reduce uncertainties concerning the issue of converting to metrication and to provide a better basis upon which the Congress may evaluate and resolve it. The testimony of over 230 nationally representative…

Federal Government: Civilian Agencies. U.S. Metric Study Interim Report.

ERIC Educational Resources Information Center

National Bureau of Standards (DOC), Washington, DC.

This second interim report on the feasibility of a United States changeover to a metric system stems from the U.S. Metric Study, which was authorized by Public Law 90-472, and was prepared by the National Bureau of Standards to provide a better basis for Congressional evaluation of this issue. Participating in this national survey were 55 federal…

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…

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.…

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...

A Continuum Approach for Developing School Leaders in an Urban District

ERIC Educational Resources Information Center

Normore, Anthony

2007-01-01

This study examined a four-staged leadership development continuum for school leaders in a large urban school district in the southeastern United States. The program under examination included: LEAD Program; Interim Assistant Principal Program; Intern Principal Program, and; First Year Principal Support/Interim Principal Program. Qualitative…

42 CFR 93.401 - Interaction with other offices and interim actions.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Interaction with other offices and interim actions. 93.401 Section 93.401 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES PUBLIC...

A study of the usage of LPAs by the North Carolina Division of Motor Vehicles : interim report - phase I.

DOT National Transportation Integrated Search

2014-02-27

This interim report was prepared to assist NCDMV in meeting the requirements of S.B. 402, Sec. 34.17, which mandates that NCDOT in collaboration with NCDMV shall evaluate current contractual models and compensation for license plate agency (LPA...

40 CFR 1043.95 - Interim provisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... ability of an individual vessel to recover capital investments incurred to repower or otherwise modify a... corporations, include the bond ratings of any parent or subsidiary corporations). (iii) Estimated capital investment needed to comply with the requirements of this part by the applicable date. (4) In determining...

Child-Specific Exposure Factors Handbook (2002, Interim Report)

EPA Science Inventory

Children are often more heavily exposed to environmental toxicants than adults. They consume more food and water and have higher inhalation rates per pound of body weight than adults. Young children play close to the ground and come into contact with contaminated soil outdoors ...

48 CFR 1552.242-72 - Financial administrative contracting officer.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) Negotiate advance agreements applicable to treatment of costs and to Independent Research & Development/Bid and Proposal costs. (3) Negotiate changes to interim billing rates and establish final indirect cost... contracting officer. 1552.242-72 Section 1552.242-72 Federal Acquisition Regulations System ENVIRONMENTAL...

78 FR 1 - Prevailing Rate Systems; Abolishment of the Washington, DC, Special Wage Schedule for Printing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... number of the interim rule published on July 13, 2012, in the words of issuance. This document corrects... July 13, 2012, as 41427 instead of 41247 in the words of issuance. The page number is correctly listed...

Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study.

PubMed

von Wolff, M; Rösner, S; Germeyer, A; Jauckus, J; Griesinger, G; Strowitzki, T

2013-12-01

Does intrauterine application of diluted seminal plasma (SP) at the time of ovum pick-up improve the pregnancy rate by ≥14% in IVF treatment? Intrauterine instillation of diluted SP at the time of ovum pick-up is unlikely to increase the pregnancy rate by ≥14% in IVF. SP modulates endometrial function, and sexual intercourse around the time of embryo transfer has been suggested to increase the likelihood of pregnancy. A previous randomized double-blind pilot study demonstrated a strong trend towards increased pregnancy rates following the intracervical application of undiluted SP. As this study was not conclusive and as the finding could have been confounded by sexual intercourse, the intrauterine application of diluted SP was investigated in the present trial. A single-centre, prospective, double-blind, placebo-controlled, randomized, superiority trial on women undergoing IVF was conducted from April 2007 until February 2012 at the University Department of Gynaecological Endocrinology and Reproductive Medicine, Heidelberg, Germany. The study was powered to detect an 14% increase in the clinical pregnancy rate and two sequential tests were planned using the Pocock spending function. At the first interim analysis, 279 women had been randomly assigned to intrauterine diluted SP (20% SP in saline from the patients' partner) (n = 138) or placebo (n = 141) at the time of ovum pick-up. The clinical pregnancy rate per randomized patient was 37/138 (26.8%) in the SP group and 41/141 (29.1%) in the placebo group (difference: -2.3%, 95% confidence interval of the difference: -12.7 to +8.2%; P = 0.69). The live birth rate per randomized patient was 28/138 (20.3%) in the SP group and 33/141 (23.4%) in the placebo group (difference: -3.1%, 95% confidence interval of the difference: -12.7 to +6.6%; P = 0.56). It was decided to terminate the trial due to futility at the first interim analysis, at a conditional power of 62%. The confidence interval of the difference remains wide, thus clinically relevant differences cannot reliably be excluded based on this single study. The results of this study cast doubt on the validity of the concept that SP increases endometrial receptivity and thus implantation in humans. Funding was provided by the department's own research facilities. DRKS00004615.

Atmospheric Effects of Subsonic Aircraft: Interim Assessment Report of the Advanced Subsonic Technology Program

NASA Technical Reports Server (NTRS)

Friedl, Randall R. (Editor)

1997-01-01

This first interim assessment of the subsonic assessment (SASS) project attempts to summarize concisely the status of our knowledge concerning the impacts of present and future subsonic aircraft fleets. It also highlights the major areas of scientific uncertainty, through review of existing data bases and model-based sensitivity studies. In view of the need for substantial improvements in both model formulations and experimental databases, this interim assessment cannot provide confident numerical predictions of aviation impacts. However, a number of quantitative estimates are presented, which provide some guidance to policy makers.

Relationships between High Impact Tropical Rainfall Events and Environmental Conditions

NASA Astrophysics Data System (ADS)

Painter, C.; Varble, A.; Zipser, E. J.

2017-12-01

While rainfall increases as moisture and vertical motion increase, relationships between regional environmental conditions and rainfall event characteristics remain more uncertain. Of particular importance are long duration, heavy rain rate, and significant accumulation events that contribute sizable fractions of overall precipitation over short time periods. This study seeks to establish relationships between observed rainfall event properties and environmental conditions. Event duration, rain rate, and rainfall accumulation are derived using the Tropical Rainfall Measuring Mission (TRMM) 3B42 3-hourly, 0.25° resolution rainfall retrieval from 2002-2013 between 10°N and 10°S. Events are accumulated into 2.5° grid boxes and matched to monthly mean total column water vapor (TCWV) and 500-hPa vertical motion (omega) in each 2.5° grid box, retrieved from ERA-interim reanalysis. Only months with greater than 3 mm/day rainfall are included to ensure sufficient sampling. 90th and 99th percentile oceanic events last more than 20% longer and have rain rates more than 20% lower than those over land for a given TCWV-omega condition. Event duration and accumulation are more sensitive to omega than TCWV over oceans, but more sensitive to TCWV than omega over land, suggesting system size, propagation speed, and/or forcing mechanism differences for land and ocean regions. Sensitivities of duration, rain rate, and accumulation to TCWV and omega increase with increasing event extremity. For 3B42 and ERA-Interim relationships, the 90th percentile oceanic event accumulation increases by 0.93 mm for every 1 Pa/min change in rising motion, but this increases to 3.7 mm for every 1 Pa/min for the 99th percentile. Over land, the 90th percentile event accumulation increases by 0.55 mm for every 1 mm increase in TCWV, whereas the 99th percentile increases by 0.90 mm for every 1 mm increase in TCWV. These changes in event accumulation are highly correlated with changes in event duration. Relationships between 3B42 event properties and ERA-Interim environmental conditions are currently being evaluated using the MERRA-2 reanalysis and two years of 30-minute, 0.1° Integrated Multi-satellitE Retrievals for GPM (IMERG) data. If results remain consistent, they may be valuable for evaluating weather and climate models.

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...

Interim analysis: A rational approach of decision making in clinical trial.

PubMed

Kumar, Amal; Chakraborty, Bhaswat S

2016-01-01

Interim analysis of especially sizeable trials keeps the decision process free of conflict of interest while considering cost, resources, and meaningfulness of the project. Whenever necessary, such interim analysis can also call for potential termination or appropriate modification in sample size, study design, and even an early declaration of success. Given the extraordinary size and complexity today, this rational approach helps to analyze and predict the outcomes of a clinical trial that incorporate what is learned during the course of a study or a clinical development program. Such approach can also fill the gap by directing the resources toward relevant and optimized clinical trials between unmet medical needs and interventions being tested currently rather than fulfilling only business and profit goals.

Middle Level Teachers' Perceptions of Interim Reading Assessments: An Exploratory Study of Data-Based Decision Making

ERIC Educational Resources Information Center

Reed, Deborah K.

2015-01-01

This study explored the data-based decision making of 12 teachers in grades 6-8 who were asked about their perceptions and use of three required interim measures of reading performance: oral reading fluency (ORF), retell, and a benchmark comprised of released state test items. Focus group participants reported they did not believe the benchmark or…

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

ERIC Educational Resources Information Center

What Works Clearinghouse, 2015

2015-01-01

The study authors examined the effects of using "Diagnostic Assessment Tools" ("DAT") on mathematics and reading outcomes for students in Indiana schools during the 2009-10 academic year. "DAT" consists of interim assessment tools--Wireless Generation's mCLASS for students in grades K-2 and CTB/ McGraw-Hill's Acuity…

Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

PubMed

Orenstein, Lauren A V; Orenstein, Evan W; Teguete, Ibrahima; Kodio, Mamoudou; Tapia, Milagritos; Sow, Samba O; Levine, Myron M

2012-01-01

Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa. We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM), low birth weight (LBW), prematurity, and major congenital malformations (MCM) in Sub-Saharan African countries were also performed. Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3) per 1,000 total births, and the most common causes were hemorrhage (34%), dystocia (22%), and severe hypertensive disorders of pregnancy (22%). Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4) or premature (median 15.4%, IQR: 10.6-19.1) were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6), with the musculoskeletal system comprising 30%. Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of adverse pregnancy outcomes will improve safety assessment of interventions during pregnancy.

Seasonal evaluation of evapotranspiration fluxes from MODIS satellite and mesoscale model downscaled global reanalysis datasets

NASA Astrophysics Data System (ADS)

Srivastava, Prashant K.; Han, Dawei; Islam, Tanvir; Petropoulos, George P.; Gupta, Manika; Dai, Qiang

2016-04-01

Reference evapotranspiration (ETo) is an important variable in hydrological modeling, which is not always available, especially for ungauged catchments. Satellite data, such as those available from the MODerate Resolution Imaging Spectroradiometer (MODIS), and global datasets via the European Centre for Medium Range Weather Forecasts (ECMWF) reanalysis (ERA) interim and National Centers for Environmental Prediction (NCEP) reanalysis are important sources of information for ETo. This study explored the seasonal performances of MODIS (MOD16) and Weather Research and Forecasting (WRF) model downscaled global reanalysis datasets, such as ERA interim and NCEP-derived ETo, against ground-based datasets. Overall, on the basis of the statistical metrics computed, ETo derived from ERA interim and MODIS were more accurate in comparison to the estimates from NCEP for all the seasons. The pooled datasets also revealed a similar performance to the seasonal assessment with higher agreement for the ERA interim (r = 0.96, RMSE = 2.76 mm/8 days; bias = 0.24 mm/8 days), followed by MODIS (r = 0.95, RMSE = 7.66 mm/8 days; bias = -7.17 mm/8 days) and NCEP (r = 0.76, RMSE = 11.81 mm/8 days; bias = -10.20 mm/8 days). The only limitation with downscaling ERA interim reanalysis datasets using WRF is that it is time-consuming in contrast to the readily available MODIS operational product for use in mesoscale studies and practical applications.

Predicting clinical trial results based on announcements of interim analyses

PubMed Central

2014-01-01

Background Announcements of interim analyses of a clinical trial convey information about the results beyond the trial’s Data Safety Monitoring Board (DSMB). The amount of information conveyed may be minimal, but the fact that none of the trial’s stopping boundaries has been crossed implies that the experimental therapy is neither extremely effective nor hopeless. Predicting success of the ongoing trial is of interest to the trial’s sponsor, the medical community, pharmaceutical companies, and investors. We determine the probability of trial success by quantifying only the publicly available information from interim analyses of an ongoing trial. We illustrate our method in the context of the National Surgical Adjuvant Breast and Bowel (NSABP) trial, C-08. Methods We simulated trials based on the specifics of the NSABP C-08 protocol that were publicly available. We quantified the uncertainty around the treatment effect using prior weights for the various possibilities in light of other colon cancer studies and other studies of the investigational agent, bevacizumab. We considered alternative prior distributions. Results Subsequent to the trial’s third interim analysis, our predictive probabilities were: that the trial would eventually be successful, 48.0%; would stop for futility, 7.4%; and would continue to completion without statistical significance, 44.5%. The actual trial continued to completion without statistical significance. Conclusions Announcements of interim analyses provide information outside the DSMB’s sphere of confidentiality. This information is potentially helpful to clinical trial prognosticators. ‘Information leakage’ from standard interim analyses such as in NSABP C-08 is conventionally viewed as acceptable even though it may be quite revealing. Whether leakage from more aggressive types of adaptations is acceptable should be assessed at the design stage. PMID:24607270

Retention of long-term interim restorations with sodium fluoride enriched interim cement

NASA Astrophysics Data System (ADS)

Strash, Carolyn

Purpose: Interim fixed dental prostheses, or "provisional restorations", are fabricated to restore teeth when definitive prostheses are made indirectly. Patients undergoing extensive prosthodontic treatment frequently require provisionalization for several months or years. The ideal interim cement would retain the restoration for as long as needed and still allow for ease of removal. It would also avoid recurrent caries by preventing demineralization of tooth structure. This study aims to determine if adding sodium fluoride varnish to interim cement may assist in the retention of interim restorations. Materials and methods: stainless steel dies representing a crown preparation were fabricated. Provisional crowns were milled for the dies using CAD/CAM technology. Crowns were provisionally cemented onto the dies using TempBond NE and NexTemp provisional cements as well as a mixture of TempBond NE and Duraphat fluoride varnish. Samples were stored for 24h then tested or thermocycled for 2500 or 5000 cycles before being tested. Retentive strength of each cement was recorded using a universal testing machine. Results: TempBond NE and NexTemp cements performed similarly when tested after 24h. The addition of Duraphat significantly decreased the retention when added to TempBond NE. NexTemp cement had high variability in retention over all tested time periods. Thermocycling for 2500 and 5000 cycles significantly decreased the retention of all cements. Conclusions: The addition of Duraphat fluoride varnish significantly decreased the retention of TempBond NE and is therefore not recommended for clinical use. Thermocycling significantly reduced the retention of TempBond NE and NexTemp. This may suggest that use of these cements for three months, as simulated in this study, is not recommended.

Traffic and geometric characteristics affecting the involvement of large trucks in accidents : interim report.

DOT National Transportation Integrated Search

1989-07-01

Recent trends indicate that vehicle miles traveled for large trucks is increasing at a higher rate than for other vehicles. The resulting competition between large trucks and other vehicles for highway space can be expected to result in more multi-ve...

A Model of Nursing Interim Care.

ERIC Educational Resources Information Center

Thienhaus, Ole J.; Greschel, Jean

In an increasingly cost-conscious health care environment, average length of hospital stay has decreased. Although psychiatric inpatient treatment is largely exempt from the constraints of the Medicare diagnosis related groups (DRG's), length of stay for geropsychiatric hospital services has decreased also. A trend toward higher rates of early…

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.

Non-Formal Education for Rural Development: Strengthening Learning Opportunities for Children and Youth. Interim Report.

ERIC Educational Resources Information Center

United Nations Economic and Social Council, New York, NY.

This interim report, commissioned by UNICEF, emphasizes the value of nonformal educational programs to educationally deprived rural children and youth in developing countries. The first set of basic findings and recommendations arising from this extensive international research study is presented. Organized into five chapters, the text includes…

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...

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

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

Routine interim disease assessment in patients undergoing induction chemotherapy for acute myeloid leukemia: Can we do better?

PubMed

Campuzano-Zuluaga, Germán; Deutsch, Yehuda; Salzberg, Matthew; Gomez, Alexandra; Vargas, Fernando; Elias, Roy; Kwon, Deukwoo; Goodman, Mark; Ikpatt, Offiong F; Chapman, Jennifer R; Watts, Justin; Vega, Francisco; Swords, Ronan

2016-03-01

The presence of >5% blasts at "day 14" (D14), in patients undergoing induction chemotherapy for acute myeloid leukemia (AML) is problematic. It is unclear if a second course of chemotherapy for early persistent disease will alter outcome in these patients. We conducted a retrospective study of AML patients undergoing induction chemotherapy where diagnostic, interim (around day 14), and recovery (days 21-42) bone marrow (BM) evaluations were available for review. Of the 113 patients included in the final analysis, 99 (87.6%) achieved CR at hematologic recovery. At D14, 90 patients (79.6%) had <5% blasts and of these, 87 (96.7%) ultimately achieved CR. At D14, Twenty-three (20.4%) patients had residual leukemia (>5% blasts). Of these, 11 (47.8%) received a second course of chemotherapy (double induction [DI]) and 12 (52.2%) were observed until count recovery (single induction [SI]). No significant difference in CR rates was observed between these two groups (58.3% DI group vs. 45.5% SI group, P value = 0.684). In our analysis, D14 BM evaluation did not uniformly identify patients with primary induction failure. To unequivocally determine the value of a D14 marrow assessment in AML, prospective studies in the context of large cooperative group trials are required. Considering our findings and similar reports from others, we propose that D14 marrow assessment should be individualized, and that other factors, such as cytogenetics and early peripheral blood blast clearance should be considered, to identify patients most likely to benefit from interim disease assessment during AML induction therapy. © 2015 Wiley Periodicals, Inc.

77 FR 72683 - Sweet Cherries Grown in Designated Counties in Washington; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-06

... marketing order now in effect, Washington sweet cherry handlers are subject to assessments. Funds to... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 923 [Doc. No. AMS-FV-12-0026... AGENCY: Agricultural Marketing Service, USDA. ACTION: Interim rule with request for comments. SUMMARY...

43 CFR 38.1 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Lands: Interior Office of the Secretary of the Interior PAY OF U.S. PARK POLICE-INTERIM GEOGRAPHIC... as a whole dollar. Employee means a U.S. Park Police officer whose official duty station is located...) The U.S. Park Police rate of basic pay for the employee's rank and step, exclusive of additional pay...

District-Charter Collaboration Grant Implementation: Final Findings from Interviews and Site Visits. Interim Report

ERIC Educational Resources Information Center

McCullough, Moira; Keating, Betsy; Heinkel, Luke

2016-01-01

In November 2012, the Bill & Melinda Gates Foundation invested in seven innovative district-charter partnerships with "the potential capacity and commitment to accelerate student college ready rates through deep collaboration and sharing of best practices" (District-Charter Collaboration Grant Request for Proposal). These…

42 CFR 413.64 - Payments to providers: Specific rules.

Code of Federal Regulations, 2010 CFR

2010-10-01

... to beneficiaries. Since actual costs of services cannot be determined until the end of the accounting.... This interim rate of payment may be adjusted by the intermediary during an accounting period if the... delay in preparing and submitting bills to the intermediary beyond its normal billing cycle. Any such...

77 FR 39150 - Avocados Grown in South Florida; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

... viewed at: www.ams.usda.gov/MarketingOrdersSmallBusinessGuide . Any questions about the compliance guide... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 915 [Doc. No. AMS-FV-11-0094... Marketing Service, USDA. ACTION: Interim rule with request for comments. SUMMARY: This rule decreases the...

50 CFR 679.25 - Inseason adjustments.

Code of Federal Regulations, 2010 CFR

2010-10-01

... area. (iii) Adjustment of TAC and PSC limits. (iv) Interim closures of statistical areas, or portions... of a statistical area, or portion thereof, under paragraph (a)(1)(iv) of this section, must be based... bycatch rates of prohibited species specified under § 679.21(b) in a statistical area, or portion thereof...

Immunotherapy for recurrent malignant glioma: an interim report on survival.

PubMed

Ingram, M; Buckwalter, J G; Jacques, D B; Freshwater, D B; Abts, R M; Techy, G B; Miyagi, K; Shelden, C H; Rand, R W; English, L W

1990-12-01

We present interim survival data for a group of 83 adult patients with recurrent malignant glioma treated by implanting stimulated autologous lymphocytes into the tumour bed following surgical debulking. The patients were treated 6 months or more prior to data analysis. Fifty-nine patients were male and 24 female. The mean age for the entire group was 48.4 years and the mean Karnofsky rating (KR) was 67.2. Eight of the patients had grade II tumours, 33 had grade III tumours and 42 had grade IV tumours. Statistical analysis focuses on tumour grade, KR and patient age, factors that have been shown to affect survival in previous studies. Multifactorial analyses are employed to identify interrelationships among factors related to survival. Seven patients (8%) did not respond to immunotherapy, 76 (92%) had a good initial response. Twenty-five patients (30.1%) are living and 18 (22%) have shown no evidence of recurrence. Results are evaluated in the light of those obtained in trials of other experimental therapies for recurrent malignant gliomas. It is concluded that the present protocol offers a safe and comparatively effective treatment option.

[Second Interim Report of the Special Committee of the Trustees of Columbia University.

ERIC Educational Resources Information Center

Columbia Univ., New York, NY.

The Special Committee of the Trustees of Columbia University was appointed "to study and recommend changes in the basic structure of the University." The second interim report contains recommendations of the Committee on the participation of faculty and students in university governance through a proposed University Senate that would replace the…

Designing Their Own: Increasing Urban High School Teacher Capacity for Creating Interim Assessments

ERIC Educational Resources Information Center

Ado, Kathryn

2013-01-01

This case study analyzes and documents factors that affect teacher learning and instructional practices in connection to the design your own (DYO) interim or periodic assessment process at one newly developed high school in New York City. Examining these factors through Riggan and Nabors Olah's (2011) conceptual framework offers insights into the…

Interim Assessment Data: A Case Study on Modifying Instruction Based on Benchmark Feedback

ERIC Educational Resources Information Center

Lange, Tracey M.

2014-01-01

The role of data analysis in the jobs of instructional leaders has become as commonplace as teachers creating lesson plans and taking roll in the classroom. Teachers and building leaders routinely use interim assessment data to develop thoughtful and robust instructional plans that address identified areas of student need. The link between the…

An Interim Report on Pennsylvania's Framework for Leadership: Frequently Asked Questions

ERIC Educational Resources Information Center

Bing-ru, Teh; Chiang, Hanley; Lipscomb, Stephen; Gill, Brian

2014-01-01

A new study analyzed data from the 2012/13 pilot of the Framework for Leadership (FFL), Pennsylvania's tool for evaluating the leadership practices of principals and assistant principals. Based on the FFL scores of 336 principals and 69 assistant principals evaluated by their supervisors in the 2012/13 school year, this interim report found that…

Evaluation of the construction and performance of multiple layer polymer concrete overlays : interim report no. 2, condition of the overlays after five years in service.

DOT National Transportation Integrated Search

1987-01-01

This interim report presents the results after 5 years of a study undertaken to evaluate multiple layer polymer concrete overlays over a 10-year period. The report indicates that an overlay of low permeability and high skid resistance can be successf...

Sample size determination in group-sequential clinical trials with two co-primary endpoints

PubMed Central

Asakura, Koko; Hamasaki, Toshimitsu; Sugimoto, Tomoyuki; Hayashi, Kenichi; Evans, Scott R; Sozu, Takashi

2014-01-01

We discuss sample size determination in group-sequential designs with two endpoints as co-primary. We derive the power and sample size within two decision-making frameworks. One is to claim the test intervention’s benefit relative to control when superiority is achieved for the two endpoints at the same interim timepoint of the trial. The other is when the superiority is achieved for the two endpoints at any interim timepoint, not necessarily simultaneously. We evaluate the behaviors of sample size and power with varying design elements and provide a real example to illustrate the proposed sample size methods. In addition, we discuss sample size recalculation based on observed data and evaluate the impact on the power and Type I error rate. PMID:24676799

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...

Evaluation of Hose in Hose Transfer Line Service Life for Hanfords Interim Stabilization Program

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

TORRES, T.D.

RPP-6153, Engineering Task Plan for Hose-in-Hose Transfer System for the Interim Stabilization Program (Torres, 2000a), defines the programmatic goals, functional requirements, and technical criteria for the development and subsequent installation of waste transfer line equipment to support Hanford's Interim Stabilization Program. RPP-6028, Specification for Hose in Hose Transfer Lines for Hanford's Interim Stabilization Program (Torres, 2000b), has been issued to define the specific requirements for the design, manufacture, and verification of transfer line assemblies for specific waste transfer applications associated with Interim Stabilization. Included in RPP-6028 are tables defining the chemical constituents of concern to which transfer lines will bemore » exposed. Current Interim Stabilization Program planning forecasts that the at-grade transfer lines will be required to convey pumpable waste for as much as three years after commissioning, RPP-6028 Section 3.2.7. Performance Incentive Number ORP-05 requires that all the Single Shell Tanks be Interim Stabilized by September 30, 2003. The Tri-Party Agreement (TPA) milestone M-41-00, enforced by a federal consent decree, requires all the Single Shell Tanks to be Interim stabilized by September 30, 2004. By meeting the Performance Incentive the TPA milestone is met. Prudent engineering dictates that the equipment used to transfer waste have a life in excess of the forecasted operational time period, with some margin to allow for future adjustments to the planned schedule. This document evaluates the effective service life of the Hose-in-Hose Transfer Lines, based on information submitted by the manufacturer, published literature and calculations. The effective service life of transfer line assemblies is a function of several factors. Foremost among these are the hose material's resistance to the harmful effects of process fluid characteristics, ambient environmental conditions, exposure to ionizing radiation and the manufacturer's stated shelf life. In order to determine the transfer line service life this evaluation examines the certification of shelf life, the certification of chemical compatibility with waste, catalog information of ambient ratings and published literature on the effects of exposure to ionizing radiation on the mechanical properties of elastomeric materials. During initial hose procurements, the hose-in-hose transfer line vendor River Bend Hose Specialty (RBHS) submitted a letter, dated 6/8/00, which recommended the service and shelf life of the hose to be seven years. In submittals for later hose procurements, RBHS submitted a letter, dated 11/6/00, which recommended the service life of the hose to be three years. This submittal was followed by documentation, on 2/14/01, which submitted new storage requirements and restated the seven year shelf life. RBHS revised their original hose service life estimate to a more conservative three years due to concerns over the effects of chemicals in transferred waste. The above mentioned submittals from RBHS are the primary drivers of the three year service life limit established by this document.« less

Bovine spongiform encephalopathy: the effect of oral exposure dose on attack rate and incubation period in cattle - an update.

PubMed

Konold, Timm; Arnold, Mark E; Austin, Anthony R; Cawthraw, Saira; Hawkins, Steve A C; Stack, Michael J; Simmons, Marion M; Sayers, A Robin; Dawson, Michael; Wilesmith, John W; Wells, Gerald A H

2012-12-05

To provide information on dose-response and aid in modelling the exposure dynamics of the BSE epidemic in the United Kingdom groups of cattle were exposed orally to a range of different doses of brainstem homogenate of known infectious titre from clinical cases of classical bovine spongiform encephalopathy (BSE). Interim data from this study was published in 2007. This communication documents additional BSE cases, which occurred subsequently, examines possible influence of the bovine prion protein gene on disease incidence and revises estimates of effective oral exposure. Following interim published results, two further cattle, one dosed with 100 mg and culled at 127 months post exposure and the other dosed with 10 mg and culled at 110 months post exposure, developed BSE. Both had a similar pathological phenotype to previous cases. Based on attack rate and incubation period distribution according to dose, the dose estimate at which 50% of confirmed cases would be clinically affected was revised to 0.15 g of the brain homogenate used in the experiment, with a 95% confidence interval of 0.03-0.79 g. Neither the full open reading frame nor the promoter region of the prion protein gene of dosed cattle appeared to influence susceptibility to BSE, but this may be due to the sample size. Oral exposure of cattle to a large range of doses of a BSE brainstem homogenate produced disease in all dose groups. The pathological presentation resembled natural disease. The attack rate and incubation period were dependent on the dose.

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.

A Process Evaluation of Project Developmental Continuity, Interim Report VII, Volume 1: Findings from the PDC Implementation Study.

ERIC Educational Resources Information Center

Smith, Allen G.; And Others

This third year interim report, one of a series of documents on the evaluation of Project Developmental Continuity (PDC), presents findings from three major analyses of program implementation; measurement of the extent each program has implemented the basic PDC Guidelines; a description of patterns of that implementation; and analysis of some…

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…

Comparisons of Cooperative and Non-Cooperative Students: An Analysis of Student Accounting System Data. Interim Report, June, 1981.

ERIC Educational Resources Information Center

Frazier, Don

The major purpose of this study was to identify unique effects of cooperative vocational education. This interim report is of results of the analyses of existing data bases. Comparisons of cooperative and non-cooperative vocational programs are made on the following variables: enrollments by age, sex and race, school status, work status,…

A Study of the Transitional Adjustment of a Professional Group to its Altered Role. Interim Report.

ERIC Educational Resources Information Center

Daniels, Morris J.

This interim report discusses the adjustments auditing firms are making as a result of the advent of the computer. Data were obtained from (1) a review of the literature, (2) attendance at professional association meetings, and (3) a series of interviews with accountants. The findings to date indicate that the normative patterns governing the…

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.

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...

78 FR 21521 - Pears Grown in Oregon and Washington; Assessment Rate Decrease for Processed Pears

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-11

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 927 [Doc. No. AMS-FV-12-0031... AGENCY: Agricultural Marketing Service, USDA. ACTION: Affirmation of interim rule as final rule. SUMMARY... Committee locally administers the marketing order that regulates the handling of processed pears grown in...

24 CFR 883.308 - Adjustments to reflect changes in terms of financing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... projected rate of borrowing (net interest cost), based on a reasonable evaluation of market conditions, on obligations issued to provide interim and permanent financing for the project, (2) The projected cost of..., (4) The projected cost of borrowing and the term of the permanent financing to be provided to the...

Interim results from a study of the behavior of juvenile Chinook salmon at Cougar Reservoir and Dam, Oregon, March--August 2011

USGS Publications Warehouse

Beeman, John W.; Hansel, Hal C.; Hansen, Amy C.; Haner, Philip V.; Sprando, Jamie M.; Smith, Collin D.; Evans, Scott D.

2012-01-01

The movements and dam passage of yearling juvenile Chinook salmon implanted with acoustic transmitters and passive integrated transponder tags were studied at Cougar Reservoir and Dam, near Springfield, Oregon. A total of 411 hatchery fish and 26 wild fish were tagged and released between March 7 and May 21, 2011. A series of 16 autonomous hydrophones placed throughout the reservoir were used to determine general fish movements over the life of the acoustic transmitter, which was expected to be 91 days. Movements within the reservoir were directional, and it was common for fish to migrate repeatedly from the head of the reservoir downstream to the dam outlet and back. The dam passage rate was 11.2 percent (95-percent confidence interval 7.8–14.6 percent) for hatchery fish and 15.4 percent (95-percent confidence interval -1.0–31.8 percent) for wild fish within 91 days from release. Most fish passage occurred at night. The median time from release to dam passage was 34.5 days for hatchery fish and 34.2 days for wild fish. A system of hydrophones near the dam outlet, a temperature control tower, was used to estimate positions of fish in three dimensions to enable detailed analyses of fish behavior near the tower. Analyses of these data indicate that hourly averaged depths of fish within a distance of 74 m from the upstream face of the tower ranged from 0.6 to 9.6 meters, with a median depth of 3.6 meters for hatchery fish and 3.4 meters for wild fish. Dam discharge rates and the diurnal period affected the rates of dam passage. Rates of dam passage were similar when the dam discharge rate was less than 1,200 cubic feet per second, but increased sharply at higher discharges. The rate of dam passage at night was 4.4–7.8 times greater than during the day, depending on the distance of fish from the dam. This report is an interim summary of data collected as of August 3, 2011, for planning purposes.

Airland Battle and SOF: A Proposal for an Interim Doctrine for Joint Special Operations

DTIC Science & Technology

1989-05-19

of having to expand forces and create a viable command, control, communications and intelligence (C31) framework while at 3 the same time developing ... technology , not doctrine, and force development and training that is still driven by the parochial differences between service components. This study does...Fondacaro, USA, 51 pages. This study offers the Aimy’s AirLand Battle doctrine as an interim doctrine for SOFgemployment pending the develop - ment of

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.

Clean-burning diesel engines. Interim report, June-December 1985 on Phase 3

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

Dietzmann, H.E.; Smith, L.R.

Gaseous and particulate emissions were measured from diesel forklift engines under a variety of steady-state conditions. An EPA certification fuel was used to determine CO, CO/sub 2/, NOx, HC, particulate, aldehydes, smoke and SO/sub 2/ emission rates from Isuzu C-240, Peugeot XD3P, and Teledyne TMD-20 diesel engines. Emission rates were reported in b/hp-hr, g/hr, and observed concentration, i.e., ppm, percent, or mg/cu. m.

Long-term safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in subjects with haemophilia A.

PubMed

Nolan, B; Mahlangu, J; Perry, D; Young, G; Liesner, R; Konkle, B; Rangarajan, S; Brown, S; Hanabusa, H; Pasi, K J; Pabinger, I; Jackson, S; Cristiano, L M; Li, X; Pierce, G F; Allen, G

2016-01-01

The safety, efficacy and prolonged half-life of recombinant factor VIII Fc fusion protein (rFVIIIFc) in previously treated patients with severe haemophilia A was demonstrated in the phase 3 A-LONG and Kids A-LONG studies. Here, we report interim safety and efficacy data from the rFVIIIFc extension study, ASPIRE (ClinicalTrials.gov #NCT01454739). Eligible subjects could enrol in ASPIRE upon completing A-LONG or Kids A-LONG. There were four treatment groups: individualized prophylaxis; weekly prophylaxis; modified prophylaxis (for subjects in whom optimal treatment could not be achieved with individualized or weekly prophylaxis); and episodic treatment. The primary endpoint was development of inhibitors. A total of 150 A-LONG subjects and 61 Kids A-LONG subjects enrolled in ASPIRE. As of the interim data cut (6 January 2014), the median time on study was 80.9 (A-LONG) and 23.9 (Kids A-LONG) weeks. The majority of subjects (A-LONG, 92.0%; Kids A-LONG, 57.4%) had ≥100 cumulative rFVIIIFc exposure days. No inhibitors were observed. Adverse events were generally consistent with those expected in the general haemophilia A population. Median annualized bleeding rates (ABRs) were low with individualized [A-LONG: 0.66; Kids A-LONG: 0.00 (<6 years old), 1.54 (6 to <12 years old)], weekly (A-LONG: 2.03) and modified (A-LONG: 1.97) prophylaxis. There was no change in prophylactic infusion frequency or total weekly prophylactic dose in the majority of subjects from A-LONG and Kids A-LONG. Interim data from ASPIRE confirm the long-term safety of rFVIIIFc and the maintenance of a low ABR with extended-interval prophylactic dosing in patients with severe haemophilia A. © 2015 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

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.

The Impacts of Upward Bound Math-Science on Postsecondary Outcomes 7-9 Years after Scheduled High School Graduation: Final Report

ERIC Educational Resources Information Center

Seftor, Neil S.; Calcagno, Juan Carlos

2010-01-01

This final report updates the report "Upward Bound Math-Science: Program Description and Interim Impact Estimates" published in 2007 (Olsen et al. 2007). The 2007 interim report contained descriptive findings from a survey of Upward Bound Math-Science (UBMS) grantees from the late 1990s at the time of the study's initiation and impact estimates…

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.

28 CFR 94.41 - Interim emergency payment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

28 CFR 94.41 - Interim emergency payment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

28 CFR 94.41 - Interim emergency payment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

28 CFR 94.41 - Interim emergency payment.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

28 CFR 94.41 - Interim emergency payment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Interim emergency payment. 94.41 Section 94.41 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CRIME VICTIM SERVICES International Terrorism Victim Expense Reimbursement Program Payment of Claims § 94.41 Interim emergency payment...

76 FR 4369 - Special Law Enforcement Commissions

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Special Law Enforcement Commissions AGENCY... of the Interim Special Law Enforcement Commission Policy, Rules and Procedures, the Interim Special Law Enforcement Commission Protocols and the Interim Domestic Violence Waiver that will be used by the...

47 CFR 51.715 - Interim transport and termination pricing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 3 2010-10-01 2010-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...

47 CFR 51.715 - Interim transport and termination pricing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 3 2011-10-01 2011-10-01 false Interim transport and termination pricing. 51... SERVICES (CONTINUED) INTERCONNECTION Reciprocal Compensation for Transport and Termination of Telecommunications Traffic § 51.715 Interim transport and termination pricing. (a) Upon request from a...

33 CFR 385.9 - Implementation principles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

33 CFR 385.9 - Implementation principles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

33 CFR 385.9 - Implementation principles.

Code of Federal Regulations, 2011 CFR

2011-07-01

... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

33 CFR 385.9 - Implementation principles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... of the Plan at specific time intervals during implementation. Interim targets to evaluate progress on... accordance with § 385.39. Interim goals and interim targets shall be consistent with each other. (c... ensure that new information resulting from changed or unforeseen circumstances, new scientific and...

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.

Experimental model: dye penetration of extensive interim restorations used during endodontic treatment while under load in a multiple axis chewing simulator.

PubMed

Jensen, Arna-Lee; Abbott, Paul V

2007-10-01

The purpose of this study was to design an experimental model that allowed extensive endodontic interim restorations to be tested for dye penetration while under simulated masticatory load. Extracted premolar teeth had standardized mesio-occluso-distal cavities prepared, and the root canals were instrumented. A cotton wool pellet was placed in the pulp chamber, and the cavities were restored with Cavit, IRM, Ketac-Fil Plus, Ketac-Silver, or composite resin (Z100). They were subjected to the equivalent of 3 months of clinical load while exposed to methylene blue dye. Results of this study could not support IRM as a suitable interim endodontic restorative material to use in extensive cavities. The dye penetration in the Ketac-Fil Plus and Ketac-Silver specimens was not predictable, and the results suggested Cavit and Z100 composite resin require further investigations as potentially useful materials for this purpose.

42 CFR 417.574 - Interim settlement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 3 2010-10-01 2010-10-01 false Interim settlement. 417.574 Section 417.574 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... PLANS Medicare Payment: Cost Basis § 417.574 Interim settlement. (a) Determination. Within 30 days...

14 CFR 136.41 - Interim operating authority.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...

14 CFR 136.41 - Interim operating authority.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Interim operating authority. 136.41 Section 136.41 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED... technology, as appropriate, and (9) Shall allow for modifications of the interim operating authority based on...

47 CFR 73.404 - Interim hybrid IBOC DAB operation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 4 2012-10-01 2012-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...

47 CFR 73.404 - Interim hybrid IBOC DAB operation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 4 2011-10-01 2011-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...

47 CFR 73.404 - Interim hybrid IBOC DAB operation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 4 2013-10-01 2013-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...

47 CFR 73.404 - Interim hybrid IBOC DAB operation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 4 2014-10-01 2014-10-01 false Interim hybrid IBOC DAB operation. 73.404 Section 73.404 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Digital Audio Broadcasting § 73.404 Interim hybrid IBOC DAB operation. (a) The...

10 CFR 590.403 - Emergency interim orders.

Code of Federal Regulations, 2010 CFR

2010-01-01

... DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS Opinions and Orders § 590.403 Emergency interim... and issue an emergency interim order authorizing the import or export of natural gas. After issuance...

EPA Interim Evaluation of 2016-2017 Milestone Progress in the Chesapeake Bay Watershed

EPA Pesticide Factsheets

This page provides the EPA interim evaluations of the 2016-2017 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2016-2017 milestones, recognizing the achievements made in 2016.

EPA Interim Evaluation of 2012-2013 Milestone Progress in the Chesapeake Bay Watershed

EPA Pesticide Factsheets

This page provides the EPA interim evaluations of the 2012-2013 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2012-2013 milestones, recognizing the achievements made in 2012.

49 CFR 37.193 - Interim service requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Interim service requirements. 37.193 Section 37.193 Transportation Office of the Secretary of Transportation TRANSPORTATION SERVICES FOR INDIVIDUALS WITH DISABILITIES (ADA) Over-the-Road Buses (OTRBs) § 37.193 Interim service requirements. (a) Until...

76 FR 57657 - Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

...] Tetrachlorvinphos; Extension of Time-Limited Interim Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an extension of time-limited interim..., and Cosmetic Act (FFDCA). The time-limited tolerances expire on March 18, 2013. DATES: This regulation...

EPA Interim Evaluation of 2014-2015 Milestone Progress in the Chesapeake Bay Watershed

EPA Pesticide Factsheets

This page provides the EPA interim evaluations of the 2014-2015 milestones for the Chesapeake Bay TMDL. These interim assessments provide a mid-point check on the progress made on the 2014-2015 milestones, recognizing the achievements made in 2014.

45 CFR 1623.6 - Interim funding.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 45 Public Welfare 4 2013-10-01 2013-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...

45 CFR 1623.6 - Interim funding.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 4 2012-10-01 2012-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...

45 CFR 1623.6 - Interim funding.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 45 Public Welfare 4 2011-10-01 2011-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...

45 CFR 1623.6 - Interim funding.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 4 2014-10-01 2014-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...

45 CFR 1623.6 - Interim funding.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 4 2010-10-01 2010-10-01 false Interim funding. 1623.6 Section 1623.6 Public Welfare Regulations Relating to Public Welfare (Continued) LEGAL SERVICES CORPORATION SUSPENSION PROCEDURES § 1623.6 Interim funding. (a) Pending the completion of suspension proceedings under this part...

Modeling Parenting Programs as an Interim Service for Families Waiting for Children's Mental Health Treatment.

PubMed

Cunningham, Charles E; Rimas, Heather; Chen, Yvonne; Deal, Ken; McGrath, Patrick; Lingley-Pottie, Patricia; Reid, Graham J; Lipman, Ellen; Corkum, Penny

2015-01-01

Using a discrete choice conjoint experiment, we explored the design of parenting programs as an interim strategy for families waiting for children's mental health treatment. Latent class analysis yielded 4 segments with different design preferences. Simulations predicted the Fast-Paced Personal Contact segment, 22.1% of the sample, would prefer weekly therapist-led parenting groups. The Moderate-Paced Personal Contact segment (24.7%) preferred twice-monthly therapist-led parenting groups with twice-monthly lessons. The Moderate-Paced E-Contact segment (36.3%), preferred weekly to twice-monthly contacts, e-mail networking, and a program combining therapist-led sessions with the support of a computerized telephone e-coach. The Slow-Paced E-Contact segment (16.9%) preferred an approach combining monthly therapist-led sessions, e-coaching, and e-mail networking with other parents. Simulations predicted 45.3% of parents would utilize an option combining 5 therapist coaching calls with 5 e-coaching calls, a model that could reduce costs and extend the availability of interim services. Although 41.0% preferred weekly pacing, 58% were predicted to choose an interim parenting service conducted at a twice-monthly to monthly pace. The results of this study suggest that developing interim services reflecting parental preferences requires a choice of formats that includes parenting groups, telephone-coached distance programs, and e-coaching options conducted at a flexible pace.

77 FR 20782 - Foreign-Trade Zone 161-Sedgwick County, KS; Application for Temporary/Interim Manufacturing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... County), Kansas. Under T/IM procedures, Siemens has requested authority to produce wind turbine nacelles..., 8544.49), slip rings (8535.90), cable glands (8536.90), electrical panels/boards (8537.10), lamps (8539... to choose the duty rates during customs entry procedures that apply to wind turbine nacelles and hubs...

Brief Intervention for Truant Youth Sexual Risk Behavior and Alcohol Use: A Parallel Process Growth Model Analysis

ERIC Educational Resources Information Center

Dembo, Richard; Briones-Robinson, Rhissa; Ungaro, Rocio; Barrett, Kimberly; Gulledge, Laura; Winters, Ken C.; Belenko, Steven; Karas, Lora M.; Wareham, Jennifer

2014-01-01

Truant youths frequently experience family problems, emotional/psychological issues, substance misuse, and delinquency. They are likely engaging in alcohol use and sexual risk behavior at a higher rate than the general youth population. Early intervention services would benefit them, their families, and society. We present interim findings from an…

42 CFR 412.624 - Methodology for calculating the Federal prospective payment rates.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) Adjustments for teaching hospitals. For discharges on or after October 1, 2005, CMS adjusts the Federal prospective payment on a facility basis by a factor as specified by CMS for facilities that are teaching institutions or units of teaching institutions. This adjustment is made on a claim basis as an interim payment...

Instructional Influence on Human Performance: Insensitivity to Contingencies. Interim Report September 1, 1979 through August 31, 1980.

ERIC Educational Resources Information Center

Shimoff, Eliot H.; Matthews, Byron A.

Five experiments were conducted to determine whether properties inherent in some training procedures may subtly influence the adaptability of skilled performance of complex tasks. The first two experiments assessed the insensitivity of low-rate performances. Examined in the third experiment was the issue of whether instructions that focus…

Development of Physical Demand Profiles for Four Airman Career Ladders. Interim Report for Period 1 July 1972-1 November 1974.

ERIC Educational Resources Information Center

Koym, Kenneth G.

The document investigates certain physical characteristics of airman occupations in terms of the dexterity, muscular coordination, and sensory discrimination required. It examines the feasibility of estimating physical demands in jobs using incumbent ratings and compares physical demand profiles for four career ladders: (1) avionic instrument…

Performance of Retrained Airmen in Air Force Technical Schools (Revised). Interim Report for Period January 1981-August 1982.

ERIC Educational Resources Information Center

Skinner, Mary J.; Alley, William E.

Research was conducted to determine the effect of changing occupational specialties on the performance of Air Force retrained enlistees attending basic technical schools. The academic performance and attrition rates of approximately 20,000 retrainees and 230,000 nonprior-service enlistees (nonretrainees) attending 272 schools were compared.…

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...

Interim results of two-year toxicological studies in rats of vinylidene chloride incorporated in the drinking water or administered by repeated inhalation

PubMed Central

Rampy, L. W.; Quast, J. F.; Humiston, C. G.; Balmer, M. F.; Schwetz, B. A.

1977-01-01

Male and female Sprague-Dawley rats were exposed to vinylidene chloride (VDC) orally or by inhalation in 2-year toxicological studies. Interim results are included in this report. VDC was given in the drinking water at mean ± S.D. concentrations of 0, 68 ± 13, 106 ± 22, and 220 ± 35 ppm which produced mean ± S.D. dosage levels of 0, 5.9 ± 0.6, 10.0 ± 1.2, and 19.3 ± 2.7 mg/kg for male rats and 0, 7.5 ± 0.4, 12.6 ± 1.1, and 25.6 ± 2.4 mg/kg for female rats. Forty-eight rats/sex/VDC level and 80 rats/sex in the control group were used in the 2-year study with an interim kill of an additional 10 rats/sex/level at 90 days. In the inhalation study, rats were exposed to 0, 10, or 40 ppm of VDC vapor 6 hr/day, 5 days/week for 5 weeks, after which the exposure levels were changed to 0, 25, and 75 ppm of VDC. Exposure continued for a total of 18 months and the rats held for observation an additional 6 months. Interim kills occurred at 1, 6 and 12 months. A separate 90-day study using 20 rats/sex/level was conducted at 0, 25, and 75 ppm of VDC vapor. There were 86 rats/sex/level in the 2-year portion of the study. The parameters monitored were: body weight, food and water consumption (drinking water study only), hematology, clinical chemistries, cytogentics of bone marrow cells (inhalation study only), mortality, terminal organ weights, and gross and histopathology. Based on interim kills and gross pathologic observations, the main conclusions are: increased cytoplasmic vacuolation of hepatocytes was seen in the livers of rats given 200 ppm VDC in drinking water or 25 or 75 ppm VDC vapor by inhalation; based on gross tumor count, tumor incidence in VDC-exposed rats was not greater than controls. PMID:612457

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

Engineering report single-shell tank farms interim measures to limit infiltration through the vadose zone

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

HAASS, C.C.

1999-10-14

Identifies, evaluates and recommends interim measures for reducing or eliminating water sources and preferential pathways within the vadose zone of the single-shell tank farms. Features studied: surface water infiltration and leaking water lines that provide recharge moisture, and wells that could provide pathways for contaminant migration. An extensive data base, maps, recommended mitigations, and rough order of magnitude costs are included.

Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

PubMed

Khandhar, Sandeep J; Bowling, Mark R; Flandes, Javier; Gildea, Thomas R; Hood, Kristin L; Krimsky, William S; Minnich, Douglas J; Murgu, Septimiu D; Pritchett, Michael; Toloza, Eric M; Wahidi, Momen M; Wolvers, Jennifer J; Folch, Erik E

2017-04-11

Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

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

Chan, Wanyu R.; Sidheswaran, Meera; sullivan, Douglas

The HZEB research program aims to generate information needed to develop new science-based commercial building ventilation rate (VR) standards that balance the dual objectives of increasing energy efficiency and maintaining acceptable indoor air quality. This interim report describes the preliminary results from one HZEB field study on retail stores. The primary purpose of this study is to estimate the whole-building source strengths of contaminant of concerns (COCs). This information is needed to determine the VRs necessary to maintain indoor concentrations of COCs below applicable health guidelines.The goal of this study is to identify contaminants in retail stores that should bemore » controlled via ventilation, and to determine the minimum VRs that would satisfy the occupant health and odor criteria.« less

Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

PubMed

An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

2014-07-01

The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

Science Opportunities Enabled by NASA's Constellation System: Interim Report

NASA Astrophysics Data System (ADS)

Committee On Science Opportunities Enabled By Nasa'S Constellation System, National Research Council

To begin implementation of the Vision for Space Exploration (recently renamed "United States Space Exploration Policy"), NASA has begun development of new launch vehicles and a human-carrying spacecraft that are collectively called the Constellation System. In November 2007, NASA asked the NRC to evaluate the potential for the Constellation System to enable new space science opportunities. For this interim report, 11 existing "Vision Mission" studies of advanced space science mission concepts inspired by earlier NASA forward-looking studies were evaluated. The focus was to assess the concepts and group them into two categories: more-deserving or less deserving of future study. This report presents a description of the Constellation System and its opportunities for enabling new space science opportunities, and a systematic analysis of the 11 Vision Mission studies. For the final report, the NRC issued a request for information to the relevant communities to obtain ideas for other mission concepts that will be assessed by the study committee, and several issues addressed only briefly in the interim report will be explored more fully.

The cost and impact of the interim federal health program cuts on child refugees in Canada.

PubMed

Evans, Andrea; Caudarella, Alexander; Ratnapalan, Savithiri; Chan, Kevin

2014-01-01

On June 30, 2012, Interim Federal Health Program (IFHP) funding was cut for refugee claimant healthcare. The potential financial and healthcare impacts of these cuts on refugee claimants are unknown. We conducted a one-year retrospective chart review spanning 6 months before and after IFHP funding cuts at The Hospital for Sick Children, a tertiary care children's hospital in Toronto. We analyzed emergency room visits characteristics, admission rates, reasons for admission, and financial records including billing from Medavie Blue Cross. There were 173 refugee children visits to the emergency room in the six months before and 142 visits in the six months after funding cuts. The total amount billed to the IFHP program during the one-year of this study was $131,615. Prior to the IFHP cuts, 46% of the total emergency room bills were paid by IFHP compared to 7% after the cuts (p<0.001). After the cuts to the IFHP, The Hospital for Sick Children was unable to obtain federal health coverage for the vast majority of refugee claimant children registered under the IFHP. This preliminary analysis showed that post-IFHP cuts healthcare costs at the largest tertiary pediatric institution in the country increased.

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…

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...

78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0140] Draft Spent Fuel Storage and Transportation Interim... Spent Fuel Storage and Transportation Interim Staff Guidance No. 24 (SFST-ISG-24), Revision 0, ``The Use of a Demonstration Program as Confirmation of Integrity for Continued Storage of High Burnup Fuel...

75 FR 66553 - Truth in Lending

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

... AGENCY: Board of Governors of the Federal Reserve System. ACTION: Interim final rule; request for public comment. SUMMARY: The Board is publishing for public comment an interim final rule amending Regulation Z (Truth in Lending). The interim rule implements Section 129E of the Truth in Lending Act (TILA), which...

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

A randomized study of contingency management and spirometric lung age for motivating smoking cessation among injection drug users.

PubMed

Drummond, Michael B; Astemborski, Jacquie; Lambert, Allison A; Goldberg, Scott; Stitzer, Maxine L; Merlo, Christian A; Rand, Cynthia S; Wise, Robert A; Kirk, Gregory D

2014-07-28

Even after quitting illicit drugs, tobacco abuse remains a major cause of morbidity and mortality in former injection drug users. An important unmet need in this population is to have effective interventions that can be used in the context of community based care. Contingency management, where a patient receives a monetary incentive for healthy behavior choices, and incorporation of individual counseling regarding spirometric "lung age" (the age of an average healthy individual with similar spirometry) have been shown to improve cessation rates in some populations. The efficacy of these interventions on improving smoking cessation rates has not been studied among current and former injection drug users. In a randomized, factorial design study, we recruited 100 active smokers from an ongoing cohort study of current and former injection drug users to assess the impact of contingency management and spirometric lung age on smoking cessation. The primary outcome was 6-month biologically-confirmed smoking cessation comparing contingency management, spirometric lung age or both to usual care. Secondary outcomes included differences in self-reported and biologically-confirmed cessation at interim visits, number of visits attended and quit attempts, smoking rates at interim visits, and changes in Fagerstrom score and self-efficacy. Six-month biologically-confirmed smoking cessations rates were 4% usual care, 0% lung age, 14% contingency management and 0% for combined lung age and contingency management (p = 0.13). There were no differences in secondary endpoints comparing the four interventions or when pooling the lung age groups. Comparing contingency management to non-contingency management, 6-month cessation rates were not different (7% vs. 2%; p = 0.36), but total number of visits with exhaled carbon monoxide-confirmed abstinence were higher for contingency management than non-contingency management participants (0.38 vs. 0.06; p = 0.03), and more contingency management participants showed reduction in their Fagerstrom score from baseline to follow-up (39% vs. 18%; p = 0.03). While lung age appeared ineffective, contingency management was associated with more short-term abstinence and lowered nicotine addiction. Contingency management may be a useful tool in development of effective tobacco cessation strategies among current and former injection drug users. Clinicaltrials.gov NCT01334736 (April 12, 2011).

Interim Methadone and Patient Navigation in Jail: Rationale and Design of a Randomized Clinical Trial

PubMed Central

Schwartz, Robert P.; Kelly, Sharon M.; Mitchell, Shannon G.; Dunlap, Laura; Zarkin, Gary A.; Sharma, Anjalee; O’Grady, Kevin E.; Jaffe, Jerome H.

2016-01-01

Background Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. Methods This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30 days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. Results We describe the background and rationale for the study, its aims, hypotheses, and study design. Conclusions Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. PMID:27282117

Interim methadone and patient navigation in jail: Rationale and design of a randomized clinical trial.

PubMed

Schwartz, Robert P; Kelly, Sharon M; Mitchell, Shannon G; Dunlap, Laura; Zarkin, Gary A; Sharma, Anjalee; O'Grady, Kevin E; Jaffe, Jerome H

2016-07-01

Methadone maintenance is an effective treatment for opioid dependence but is rarely initiated in US jails. Patient navigation is a promising approach to improve continuity of care but has not been tested in bridging the gap between jail- and community-based drug treatment programs. This is an open-label randomized clinical trial among 300 adult opioid dependent newly-arrested detainees that will compare three treatment conditions: methadone maintenance without routine counseling (termed Interim Methadone; IM) initiated in jail v. IM and patient navigation v. enhanced treatment-as-usual. The two primary outcomes will be: (1) the rate of entry into treatment for opioid use disorder within 30days from release and (2) frequency of opioid positive urine tests over the 12-month follow-up period. An economic analysis will examine the costs, cost-effectiveness, and cost-benefit ratio of the study interventions. We describe the background and rationale for the study, its aims, hypotheses, and study design. Given the large number of opioid dependent detainees in the US and elsewhere, initiating IM at the time of incarceration could be a significant public health and clinical approach to reducing relapse, recidivism, HIV-risk behavior, and criminal behavior. An economic analysis will be conducted to assist policy makers in determining the utility of adopting this approach. ClinicalTrials.gov: NCT02334215. Copyright © 2016 Elsevier Inc. All rights reserved.

The radiative versus entraining effects of overlying humidity on the Lagrangian evolution of subtropical stratocumulus

NASA Astrophysics Data System (ADS)

Eastman, R. M.; Wood, R.

2017-12-01

This study observes the 24-hour Lagrangian evolution of stratocumulus cloud amount and PBL depth in four eastern subtropical ocean basins: the NE Pacific, SE Pacific, SE Atlantic, and E Indian. Nearly 170,000 trajectories are computed using the 2-D wind field at 925mb and cloud properties are sampled along these trajectories twice daily as the A-Train satellite constellation passes overhead. Concurrent measurements of the overlying humidity and temperature profiles are interpolated from the ERA-Interim reanalysis grids. Cloud properties are sampled by MODIS and a measure of planetary boundary layer (PBL) depth is calculated using MODIS cloud top temperatures, CALIPSO lidar observations of cloud top heights, and ERA-Interim sea surface temperatures. High humidity overlying the PBL can reduce cloud top cooling by counteracting radiative cooling and by reducing evaporation within the entrainment zone. Both of these effects can slow the entrainment rate and change cloud evolution. To discern which effect is more important the humidity profile is broken into two distinct components: the specific humidity directly above the inversion, which is entraining into the boundary layer, and the column of specific humidity above that layer, which is radiatively interacting with the PBL, but not directly entraining. These two measures of humidity are compared in the Lagrangian framework. Results suggest that humidity above the PBL has a stronger effect on the Lagrangian PBL deepening rate compared to lower tropospheric stability. A comparison of PBL deepening rates driven by the entraining humidity versus the radiating humidity shows that the radiative effects of overlying humidity are dominant with respect to entrainment. However, the entraining effects of humidity are more important in prolonging cloud lifetime.

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...

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...

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...

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...

The Introduction of Custom Earplugs Aboard LCS-1

DTIC Science & Technology

2016-03-10

reports on the use of foam and custom HPDs, and provides interim recommendations. Custom-molded HPDs were judged by users to be superior in comfort...and able to be worn for longer periods of time than other devices ( foam ). Based on data from LCS and other related studies, the performance...acceptance, and cost of the custom-molded product are comparable, or better, than foam HPDs. The interim recommendation is to provide multiple types of

Alpha emitter radium-223 and survival in metastatic prostate cancer.

PubMed

Parker, C; Nilsson, S; Heinrich, D; Helle, S I; O'Sullivan, J M; Fosså, S D; Chodacki, A; Wiechno, P; Logue, J; Seke, M; Widmark, A; Johannessen, D C; Hoskin, P; Bottomley, D; James, N D; Solberg, A; Syndikus, I; Kliment, J; Wedel, S; Boehmer, S; Dall'Oglio, M; Franzén, L; Coleman, R; Vogelzang, N J; O'Bryan-Tear, C G; Staudacher, K; Garcia-Vargas, J; Shan, M; Bruland, Ø S; Sartor, O

2013-07-18

Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.).

Prognostic Value of Quantitative Metabolic Metrics on Baseline Pre-Sunitinib FDG PET/CT in Advanced Renal Cell Carcinoma

PubMed Central

Minamimoto, Ryogo; Barkhodari, Amir; Harshman, Lauren; Srinivas, Sandy; Quon, Andrew

2016-01-01

Purpose The objective of this study was to prospectively evaluate various quantitative metrics on FDG PET/CT for monitoring sunitinib therapy and predicting prognosis in patients with metastatic renal cell cancer (mRCC). Methods Seventeen patients (mean age: 59.0 ± 11.6) prospectively underwent a baseline FDG PET/CT and interim PET/CT after 2 cycles (12 weeks) of sunitinib therapy. We measured the highest maximum standardized uptake value (SUVmax) of all identified lesions (highest SUVmax), sum of SUVmax with maximum six lesions (sum of SUVmax), total lesion glycolysis (TLG) and metabolic tumor volume (MTV) from baseline PET/CT and interim PET/CT, and the % decrease in highest SUVmax of lesion (%Δ highest SUVmax), the % decrease in sum of SUVmax, the % decrease in TLG (%ΔTLG) and the % decrease in MTV (%ΔMTV) between baseline and interim PET/CT, and the imaging results were validated by clinical follow-up at 12 months after completion of therapy for progression free survival (PFS). Results At 12 month follow-up, 6/17 (35.3%) patients achieved PFS, while 11/17 (64.7%) patients were deemed to have progression of disease or recurrence within the previous 12 months. At baseline, PET/CT demonstrated metabolically active cancer in all cases. Using baseline PET/CT alone, all of the quantitative imaging metrics were predictive of PFS. Using interim PET/CT, the %Δ highest SUVmax, %Δ sum of SUVmax, and %ΔTLG were also predictive of PFS. Otherwise, interim PET/CT showed no significant difference between the two survival groups regardless of the quantitative metric utilized including MTV and TLG. Conclusions Quantitative metabolic measurements on baseline PET/CT appears to be predictive of PFS at 12 months post-therapy in patients scheduled to undergo sunitinib therapy for mRCC. Change between baseline and interim PET/CT also appeared to have prognostic value but otherwise interim PET/CT after 12 weeks of sunitinib did not appear to be predictive of PFS. PMID:27123976

Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix C - sequence quantification

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

Mays, S.E.; Poloski, J.P.; Sullivan, W.H.

1982-07-01

This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix C generally describes the methods used to estimate accident sequence frequency values. Information is presented concerning the approach, example collection, failure data, candidate dominant sequences, uncertainty analysis, and sensitivity analysis.

Moisture balance over the Iberian Peninsula computed using a high resolution regional climate model. The impact of 3DVAR data assimilation.

NASA Astrophysics Data System (ADS)

González-Rojí, Santos J.; Sáenz, Jon; Ibarra-Berastegi, Gabriel

2016-04-01

A numerical downscaling exercise over the Iberian Peninsula has been run nesting the WRF model inside ERA Interim. The Iberian Peninsula has been covered by a 15km x 15 km grid with 51 vertical levels. Two model configurations have been tested in two experiments spanning the period 2010-2014 after a one year spin-up (2009). In both cases, the model uses high resolution daily-varying SST fields and the Noah land surface model. In the first experiment (N), after the model is initialised, boundary conditions drive the model, as usual in numerical downscaling experiments. The second experiment (D) is configured the same way as the N case, but 3DVAR data assimilation is run every six hours (00Z, 06Z, 12Z and 18Z) using observations obtained from the PREPBUFR dataset (NCEP ADP Global Upper Air and Surface Weather Observations) using a 120' window around analysis times. For the data assimilation experiment (D), seasonally (monthly) varying background error covariance matrices have been prepared according to the parameterisations used and the mesoscale model domain. For both N and D runs, the moisture balance of the model runs has been evaluated over the Iberian Peninsula, both internally according to the model results (moisture balance in the model) and also in terms of the observed moisture fields from observational datasets (particularly precipitable water and precipitation from observations). Verification has been performed both at the daily and monthly time scales. The verification has also been performed for ERA Interim, the driving coarse-scale dataset used to drive the regional model too. Results show that the leading terms that must be considered over the area are the tendency in the precipitable water column, the divergence of moisture flux, evaporation (computed from latent heat flux at the surface) and precipitation. In the case of ERA Interim, the divergence of Qc is also relevant, although still a minor player in the moisture balance. Both mesoscale model runs are more effective at closing the moisture balance over the whole Iberian Peninsula than ERA Interim. The N experiment (no data assimilation) shows a better closure than the D case, as could be expected from the lack of analysis increments in it. This result is robust both at the daily and monthly time scales. Both ERA Interim and the D experiment produce a negative residual in the balance equation (compatible with excess evaporation or increased convergence of moisture over the Iberian Peninsula). This is a result of the data assimilation process in the D dataset, since in the N experiment the residual is mainly positive. The seasonal cycle of evaporation is much closer in the D experiment to the one in ERA Interim than in the N case, with a higher evaporation during summer months. However, both regional climate model runs show a lower evaporation rate than ERA Interim, particularly during summer months.

The Coopersmith Self-Esteem Inventory Related to Academic Achievement and School Behavior. Interim Research Report # 23.

ERIC Educational Resources Information Center

Rubin, Rosalyn; And Others

Scores on the Coopersmith Self-Esteem Inventory were related to scores on achievement and intelligence tests, and to socioeconomic level and to teachers' ratings of student behavior, in order to test the hypothesis that student self esteem would have a positive effect on academic achievement. There was a small but statistically significant…

Building a Future: Interim Impact Findings from the YouthBuild Evaluation

ERIC Educational Resources Information Center

Miller, Cynthia; Millenky, Megan; Schwartz, Lisa; Goble, Lisbeth; Stein, Jillian

2016-01-01

Young people have been hit especially hard by changes in the labor market over the past decades. Unemployment among 16- to 24-year-olds increased the most of any age group during the recent recession, and remains more than double that among older adults. The unemployment rate is especially high for young people without high school diplomas.…

Policy Response: Why Don't English Students Care about Money?

ERIC Educational Resources Information Center

Harrison, Neil

2014-01-01

The big news in England as this issue went to press was that the Office for Fair Access (OFFA) had published its interim report on the effect of means-tested student bursaries on university retention rates (OFFA 2014). The finding that presaged a wave of introspection for universities is that OFFA could identify no evidence that bursaries help to…

Drug Abuse Among Indian Children: Inhalant Abuse Among Young Native Americans. Interim Report.

ERIC Educational Resources Information Center

Oetting, E. R.; Goldstein, George S.

Because of the relatively high rate of drug use among American Indian adolescents, this project was planned to survey the use of drugs, especially inhalants, by American Indian children aged 9-12. As a means of gathering data, interviews were rejected in favor of a simply-worded survey administered to over 1000 children in 9 Southwestern tribes.…

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.

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.

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...

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...

Safety, Efficacy, and Persistence of Long-Term Mirabegron Treatment for Overactive Bladder in the Daily Clinical Setting: Interim (1-Year) Report from a Japanese Post-Marketing Surveillance Study.

PubMed

Kato, Daisuke; Tabuchi, Hiromi; Uno, Satoshi

2017-08-01

To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis. Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3 months, 6 months, and 1 year, or at discontinuation (P < 0.001 at each time point). Kaplan-Meier treatment persistence rates were 84.8% at 3 months, 77.6% at 6 months, and 66.0% at 1 year. Treatment persistence rates were similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032). Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years. © 2017 John Wiley & Sons Australia, Ltd.

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

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.

Terrestrial gravity data analysis for interim gravity model improvement

NASA Technical Reports Server (NTRS)

1987-01-01

This is the first status report for the Interim Gravity Model research effort that was started on June 30, 1986. The basic theme of this study is to develop appropriate models and adjustment procedures for estimating potential coefficients from terrestrial gravity data. The plan is to use the latest gravity data sets to produce coefficient estimates as well as to provide normal equations to NASA for use in the TOPEX/POSEIDON gravity field modeling program.

Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application.

PubMed

Jiang, Yu; Guarino, Peter; Ma, Shuangge; Simon, Steve; Mayo, Matthew S; Raghavan, Rama; Gajewski, Byron J

2016-07-22

Subject recruitment for medical research is challenging. Slow patient accrual leads to increased costs and delays in treatment advances. Researchers need reliable tools to manage and predict the accrual rate. The previously developed Bayesian method integrates researchers' experience on former trials and data from an ongoing study, providing a reliable prediction of accrual rate for clinical studies. In this paper, we present a user-friendly graphical user interface program developed in R. A closed-form solution for the total subjects that can be recruited within a fixed time is derived. We also present a built-in Android system using Java for web browsers and mobile devices. Using the accrual software, we re-evaluated the Veteran Affairs Cooperative Studies Program 558- ROBOTICS study. The application of the software in monitoring and management of recruitment is illustrated for different stages of the trial. This developed accrual software provides a more convenient platform for estimation and prediction of the accrual process.

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...

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.

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 ...

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.

Interim heterogeneity changes measured using entropy texture features on T2-weighted MRI at 3.0 T are associated with pathological response to neoadjuvant chemotherapy in primary breast cancer.

PubMed

Henderson, Shelley; Purdie, Colin; Michie, Caroline; Evans, Andrew; Lerski, Richard; Johnston, Marilyn; Vinnicombe, Sarah; Thompson, Alastair M

2017-11-01

To investigate whether interim changes in hetereogeneity (measured using entropy features) on MRI were associated with pathological residual cancer burden (RCB) at final surgery in patients receiving neoadjuvant chemotherapy (NAC) for primary breast cancer. This was a retrospective study of 88 consenting women (age: 30-79 years). Scanning was performed on a 3.0 T MRI scanner prior to NAC (baseline) and after 2-3 cycles of treatment (interim). Entropy was derived from the grey-level co-occurrence matrix, on slice-matched baseline/interim T2-weighted images. Response, assessed using RCB score on surgically resected specimens, was compared statistically with entropy/heterogeneity changes and ROC analysis performed. Association of pCR within each tumour immunophenotype was evaluated. Mean entropy percent differences between examinations, by response category, were: pCR: 32.8%, RCB-I: 10.5%, RCB-II: 9.7% and RCB-III: 3.0%. Association of ultimate pCR with coarse entropy changes between baseline/interim MRI across all lesions yielded 85.2% accuracy (area under ROC curve: 0.845). Excellent sensitivity/specificity was obtained for pCR prediction within each immunophenotype: ER+: 100%/100%; HER2+: 83.3%/95.7%, TNBC: 87.5%/80.0%. Lesion T2 heterogeneity changes are associated with response to NAC using RCB scores, particularly for pCR, and can be useful across all immunophenotypes with good diagnostic accuracy. • Texture analysis provides a means of measuring lesion heterogeneity on MRI images. • Heterogeneity changes between baseline/interim MRI can be linked with ultimate pathological response. • Heterogeneity changes give good diagnostic accuracy of pCR response across all immunophenotypes. • Percentage reduction in heterogeneity is associated with pCR with good accuracy and NPV.

78 FR 1130 - Domestic Dates Produced or Packed in Riverside County, CA; Decreased Assessment Rate

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... issued in past years; and (4) this interim final rule provides a 60-day comment period, and all comments... (Committee) for the 2012-13 and subsequent crop years from $1.00 to $0.90 per hundredweight of dates handled... reasonable and necessary expenses of the program. The crop year begins October 1 and ends September 30. The...

Update to the Propagation and Establishment of Aquatic Plants Handbook

DTIC Science & Technology

2005-03-01

decades or even longer. In the interim these reservoirs provide relatively poor aquatic habitat and water quality. Unvegetated aquatic ecosystems are also...establishment or reestab- lishment of aquatic plant communities. Many reservoirs without aquatic plants suffer from poor water quality (high nutrients...serve as a food source for waterfowl and other aquatic wildlife, improve water clarity and quality (James and Barko 1990), reduce rates of

76 FR 21109 - Rural Energy for America Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

...The Rural Business-Cooperative Service (Agency) is establishing an interim rule for the Rural Energy for America Program (REAP), which is authorized under the Food, Conservation, and Energy Act of 2008. This interim rule modifies the existing grant and guaranteed loan program for renewable energy systems and energy efficiency improvements. In addition, it adds a grant program for feasibility studies for renewable energy systems and a grant program for energy audits and renewable energy development assistance, as provided in the Food, Conservation, and Energy Act of 2008.

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...

Basic Parameters of Metal Behavior under High Rate Forming

DTIC Science & Technology

1962-03-01

1ii PHOTOGRAPH THIS SHEET II LEVELr• At-ký W •I)-_) -N INVENTORY z DOCUMENT IDENTIFICATION may. 6•t S]/ tp i - 0~o- o’•5,,? 3 ’ \\NAL- TR-/I. -a I .. ~1...TR 111.2/20- 3 BASIC PARAMETERS OF METAL BEHAVIOUR "> UNDER HIGH RATE FORMING L L j Fourth Interim Report to ell- L’,I I U. S. ARMY MATERIALS...RESEARCH AGENCY 1• I iiC::Ur:ui i 1,,i .:1 ’•:, 1 r/ n od I P,101c rolcso. Filing Subjects: I. Explosive forming 2. Dynamic behavior of metals 3 . High rate

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.

Multi-method Quantification of Sea-ice Production in Weddell Sea Polynyas (Antarctica)

NASA Astrophysics Data System (ADS)

Heinemann, G.; Zentek, R.; Stulic, L.; Paul, S.; Preusser, A.; Timmermann, R.

2017-12-01

Coastal polynyas occur frequently during winter in the Weddell Sea, which leads to strong sea ice production and to the formation of a highly saline water mass which is considered to be a major source of bottom water and one of the main drivers of the circulation beneath the Filchner-Ronne Ice Shelf. Thus the quantification of sea ice production in Weddell Sea polynyas is of vital interest for understanding water mass modification in this region. We use a multi-method approach to quantify sea ice production. Method 1) is based on the energy balance simulated by the regional climate model COSMO-CLM (CCLM) with 15 / 5 km resolution for the period 2002-2015 (nested in ERA-Interim data). Daily sea ice concentrations were taken from microwave satellite measurements. Method 2) is based on remote sensing using MODIS thermal infrared data at a resolution of 1-2km and a surface energy balance model taking atmospheric data from different reanalyses (ERA-Interim, JRA55, NCEP2) as well as data of CCLM. Method 3) relies on simulations using the Finite Element Sea ice-Ocean Model (FESOM). FESOM is run on a global grid with a resolution of about 5 km along the coast of the Weddell Sea using atmospheric forcing from reanalyses (ERA-Interim (80km) and CFSR (38km)) as well as from CCLM. In addition, an experiment with assimilation of MODIS thin ice retrievals was conducted. Estimates of polynya area (POLA) and sea ice production (IP) from the different methods are presented. The MODIS-based method with ERA-Interim shows the largest POLA as well as the largest IP for the Ronne polynya (RO, POLA / IP = 2800 km² / 29 km³/a) and for the polynya off Brunt Ice Shelf (BR, 3400 km² / 30 km³/a). Sensitivity to the choice of atmosphere data is high. In particular, too low temperatures in JRA55 cause very large ice production events and a strong overestimation of IP rates. Estimates based on CCLM simulations agree generally well with MODIS/ERA-Interim. FESOM yields a generally larger ice production and shows also a pronounced sensitivity to the atmospheric forcing, but the effect on POLA and IP depends on the region. For BR the FESOM simulations show much larger POLA and IP than other methods.

Route-Specific Passage Proportions and Survival Rates for Fish Passing through John Day Dam, The Dalles Dam, and Bonneville Dam in 2010 and 2011

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

Ploskey, Gene R.; Weiland, Mark A.; Carlson, Thomas J.

This report fulfills a request of the U.S. Army Engineer District, Portland, Oregon, to produce an interim report of estimates of route-specific fish passage proportions and survival rates for lower Columbia River dams in 2010 and 2011. The estimates are needed to update the Compass Model for the Columbia River Treaty and the new Biological Opinion before detail technical reports are published in late 2012. This report tabulates route-specific fish-passage proportions and survival rates for steelhead and Chinook salmon smolts passing through various sampled routes at John Day Dam, The Dalles Dam, and Bonneville Dam in 2010 and 2011. Resultsmore » were compiled from analyses of data acquired in spring 2010 and 2011 studies that were specifically designed to estimate dam-passage and forebay-to-tailrace survival rates, travel time metrics, and spill passage efficiency, as stipulated by the 2008 Federal Columbia River Power System Biological Opinion and the Columbia Basin Fish Accords. The study designs allowed for estimation of route-specific fish passage proportions and survival rates as well as estimation of forebay-passage survival, all of which are summarized herein.« less

A modified varying-stage adaptive phase II/III clinical trial design.

PubMed

Dong, Gaohong; Vandemeulebroecke, Marc

2016-07-01

Conventionally, adaptive phase II/III clinical trials are carried out with a strict two-stage design. Recently, a varying-stage adaptive phase II/III clinical trial design has been developed. In this design, following the first stage, an intermediate stage can be adaptively added to obtain more data, so that a more informative decision can be made. Therefore, the number of further investigational stages is determined based upon data accumulated to the interim analysis. This design considers two plausible study endpoints, with one of them initially designated as the primary endpoint. Based on interim results, another endpoint can be switched as the primary endpoint. However, in many therapeutic areas, the primary study endpoint is well established. Therefore, we modify this design to consider one study endpoint only so that it may be more readily applicable in real clinical trial designs. Our simulations show that, the same as the original design, this modified design controls the Type I error rate, and the design parameters such as the threshold probability for the two-stage setting and the alpha allocation ratio in the two-stage setting versus the three-stage setting have a great impact on the design characteristics. However, this modified design requires a larger sample size for the initial stage, and the probability of futility becomes much higher when the threshold probability for the two-stage setting gets smaller. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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.

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...

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.

Using phase II data for the analysis of phase III studies: An application in rare diseases.

PubMed

Wandel, Simon; Neuenschwander, Beat; Röver, Christian; Friede, Tim

2017-06-01

Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. A Bayesian meta-analytic approach is used to inform the phase III study with phase II data. It is particularly attractive, since uncertainty of between-trial heterogeneity can be dealt with probabilistically, which is critical if the number of studies is small. Furthermore, it allows quantifying and discounting the phase II data through the predictive distribution relevant for phase III. A phase III design is proposed which uses the phase II data and considers approval based on a phase III interim analysis. The design is illustrated with a non-inferiority case study from a Food and Drug Administration approval in herpetic keratitis (an orphan disease). Design operating characteristics are compared to those of a traditional design, which ignores the phase II data. An analysis of the phase II data reveals good but insufficient evidence for non-inferiority, highlighting the need for a phase III study. For the phase III study supported by phase II data, the interim analysis is based on half of the patients. For this design, the meta-analytic interim results are conclusive and would justify approval. In contrast, based on the phase III data only, interim results are inconclusive and require further evidence. To accelerate drug development for orphan diseases, innovative study designs and appropriate methodology are needed. Taking advantage of randomized phase II data when analyzing phase III studies looks promising because the evidence from phase II supports informed decision-making. The implementation of the Bayesian design is straightforward with public software such as R.

Have first-time medical school deans been serving longer than we thought? A 50-year analysis.

PubMed

Keyes, Joseph A; Alexander, Hershel; Jarawan, Hani; Mallon, William T; Kirch, Darrell G

2010-12-01

To describe the lengths of service of deans at accredited U.S. MD-granting medical schools from academic years 1959 to 2008 and to determine whether the median length of service of deans changed over time. The authors used the database of the Council of Deans of the Association of American Medical Colleges to seek data, from July 1, 1959 to June 30, 2009, on lengths of service of 842 deans and interim deans at all 125 accredited U.S. MD-granting medical schools existing in 2007. All but 8 schools verified their data, which included the date of the beginning of service, the date of the end of service, and whether the individual served in a permanent or interim capacity. Across five-year cohorts of the first-time deans and interim deans studied, the median length of service was 4.4 years. When the authors excluded individuals who were interim deans exclusively and focused the analysis on the 639 persons who were "permanent" deans, the median length of service was 6.0 years across five-year cohorts. Analysis of one-year cohorts of deans showed similar results (median = 6.1 years), although the medians for six of the seven most recent one-year cohorts ranged from 5.0 to 5.7 years. Through cohort analysis, the median length of service of permanent medical school deans was longer than that found in previous studies, and it has remained relatively stable.

Antibacterial activity against Streptococcus mutans and diametrical tensile strength of an interim cement modified with zinc oxide nanoparticles and terpenes: An in vitro study.

PubMed

Andrade, Verónica; Martínez, Alejandra; Rojas, Ninón; Bello-Toledo, Helia; Flores, Paulo; Sánchez-Sanhueza, Gabriela; Catalán, Alfonso

2018-05-01

Interim restorations are occasionally left in the mouth for extended periods and are susceptible to bacterial infiltration. Thus, dental interim cements with antibacterial properties are required. The purpose of this in vitro study was to determine in vitro antibacterial activity against Streptococcus mutans and to compare the diametrical tensile strength (DTSs) of dental interim cement modified with zinc oxide nanoparticles (ZnO-NPs) with that of cement modified with terpenes. Antibacterial properties of ZnO-NPs, terpenes, and dental interim cement modified with ZnO-NPs and cement modified with terpenes against S mutans were tested according to minimum inhibitory concentration (MIC) and direct contact inhibition (DCI). Tensile strength levels were evaluated using DTS. Results were analyzed using the Kolmogorov-Smirnov, ANOVA, and Tamhane tests (α=.05). The MICs of ZnO-NPs and terpenes against S mutans were 61.94 μg/g and 0.25% v/v, respectively. The DCI assay under the cylinders of cement (area of contact with the agar surface) revealed significant bacterial growth inhibition on Temp-Bond NE specimens with ZnO-NPs at MIC of 495.2 μg/g (8× MIC) and with terpenes at MIC 0.999% v/v (4× MIC) (P<.05). The Temp-Bond NE cement cylinder (control group) showed the lowest DTS (1.05 ±0.27 MPa) of all other test groups. In the Zn-NPs group, the greatest increase occurred in the NP8 (8× MIC; 495.2 μg/g) group with a value of 1.50 ±0.23 MPa, a significant increase in DTS compared with the control and terpene groups (P<.05). In the terpene group, the highest increase corresponded to group T2 (2× MIC; 0.4995% v/v) with a value of 1.29 ±0.18 MPa. The addition of terpenes and ZnO-NPs to interim cement showed antibacterial activity when in contact with S. mutans ATCC 25175. Both terpenes and ZnO-NPs antimicrobial agents increased diametral tensile strength. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Diffuse Large B-Cell Lymphoma: Prospective Multicenter Comparison of Early Interim FLT PET/CT versus FDG PET/CT with IHP, EORTC, Deauville, and PERCIST Criteria for Early Therapeutic Monitoring

PubMed Central

Minamimoto, Ryogo; Fayad, Luis; Advani, Ranjana; Vose, Julie; Macapinlac, Homer; Meza, Jane; Hankins, Jordan; Mottaghy, Felix; Juweid, Malik

2016-01-01

Purpose To compare the performance characteristics of interim fluorine 18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) (after two cycles of chemotherapy) by using the most prominent standardized interpretive criteria (including International Harmonization Project [IHP] criteria, European Organization for Research and Treatment of Cancer [EORTC] criteria, and PET Response Criteria in Solid Tumors (PERCIST) versus those of interim 18F fluorothymidine (FLT) PET/CT and simple visual interpretation. Materials and Methods This HIPAA-compliant prospective study was approved by the institutional review boards, and written informed consent was obtained. Patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) underwent both FLT and FDG PET/CT 18–24 days after two cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone or rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin. For FDG PET/CT interpretation, IHP criteria, EORTC criteria, PERCIST, Deauville criteria, standardized uptake value, total lesion glycolysis, and metabolic tumor volume were used. FLT PET/CT images were interpreted with visual assessment by two reviewers in consensus. The interim (after cycle 2) FDG and FLT PET/CT studies were then compared with the end-of-treatment FDG PET/CT studies to determine which interim examination and/or criteria best predicted the result after six cycles of chemotherapy. Results From November 2011 to May 2014, there were 60 potential patients for inclusion, of whom 46 patients (24 men [mean age, 60.9 years ± 13.7; range, 28–78 years] and 22 women [mean age, 57.2 years ± 13.4; range, 25–76 years]) fulfilled the criteria. Thirty-four patients had complete response, and 12 had residual disease at the end of treatment. FLT PET/CT had a significantly higher positive predictive value (PPV) (91%) in predicting residual disease than did any FDG PET/CT interpretation method (42%–46%). No difference in negative predictive value (NPV) was found between FLT PET/CT (94%) and FDG PET/CT (82%–95%), regardless of the interpretive criteria used. FLT PET/CT showed statistically higher (P < .001–.008) or similar NPVs than did FDG PET/CT. Conclusion Early interim FLT PET/CT had a significantly higher PPV than standardized FDG PET/CT–based interpretation for therapeutic response assessment in DLBCL. © RSNA, 2016 Online supplemental material is available for this article. PMID:26854705

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.

Leadership trends in academic pediatric departments.

PubMed

Stapleton, F Bruder; Jones, Douglas; Fiser, Debra H

2005-08-01

To examine recent turnover trends among chairs of academic pediatric departments. Membership data for the 150 institutions represented by the Association of Medical School Pediatric Department Chairs in the United States, Canada, and Puerto Rico were reviewed for the time period of 1993-2003. From 1993 to 2003, 278 individuals (250 men and 28 women) held the position of chair. The mean time of service was 5.58 +/- 3.2 years (median: 5 years). Twenty-nine individuals served continuously as chairs during the 11-year period. Seventy-two individuals served as interim chairs. Twenty-eight women were appointed either chairs or interim chairs during the 11 years. The number of female chairs decreased from 13 in 1993 to 11 in 2003. Female chairs were in office 3.42 +/- 2.72 years. A total of 123 departments had a change in leadership, with a mean annual turnover rate of 17% (range: 4.6-24%). Three departments had 5 different leaders as either interim chair or chair and 6 departments had 4 different leaders during this time period. Neonatology was the most common subspecialty represented by recent pediatric chairs, although nephrology was the subspecialty with the greatest proportional representation. Departments of pediatrics have high turnover of leadership. Women, in particular, serve for relatively short periods and appear to be under-represented within the leadership of pediatrics. Efforts should be made to ascertain personal qualities that allow sustained leadership and to attract more women into leadership positions.

An intercomparison of multidecadal observational and reanalysis data sets for global total ozone trends and variability analysis

NASA Astrophysics Data System (ADS)

Bai, Kaixu; Chang, Ni-Bin; Shi, Runhe; Yu, Huijia; Gao, Wei

2017-07-01

A four-step adaptive ozone trend estimation scheme is proposed by integrating multivariate linear regression (MLR) and ensemble empirical mode decomposition (EEMD) to analyze the long-term variability of total column ozone from a set of four observational and reanalysis total ozone data sets, including the rarely explored ERA-Interim total ozone reanalysis, from 1979 to 2009. Consistency among the four data sets was first assessed, indicating a mean relative difference of 1% and root-mean-square error around 2% on average, with respect to collocated ground-based total ozone observations. Nevertheless, large drifts with significant spatiotemporal inhomogeneity were diagnosed in ERA-Interim after 1995. To emphasize long-term trends, natural ozone variations associated with the solar cycle, quasi-biennial oscillation, volcanic aerosols, and El Niño-Southern Oscillation were modeled with MLR and then removed from each total ozone record, respectively, before performing EEMD analyses. The resulting rates of change estimated from the proposed scheme captured the long-term ozone variability well, with an inflection time of 2000 clearly detected. The positive rates of change after 2000 suggest that the ozone layer seems to be on a healing path, but the results are still inadequate to conclude an actual recovery of the ozone layer, and more observational evidence is needed. Further investigations suggest that biases embedded in total ozone records may significantly impact ozone trend estimations by resulting in large uncertainty or even negative rates of change after 2000.

Research study on materials processing in space Skylab experiment M553 - sphere forming

NASA Technical Reports Server (NTRS)

Johnson, P. C.; Peters, E. T.; Wechsler, A. E.

1973-01-01

A research program was conducted to study the solidification of metals in the form of small spheres both in the one gravity environment of the earth laboratory and the low gravity environment of KC-135 trajectory flights and the Skylab 1/2 mission. The program had three phases. The details of the results of this program are contained in interim reports prepared at the conclusion of each of the three phases. This final report is intended to summarize the efforts and results described in detail in each of these interim reports, with particular emphasis on the differences observed between the ground-based and Skylab flight specimens.

Lagrangian large eddy simulations of boundary layer clouds on ERA-Interim and ERA5 trajectories

NASA Astrophysics Data System (ADS)

Kazil, J.; Feingold, G.; Yamaguchi, T.

2017-12-01

This exploratory study examines Lagrangian large eddy simulations of boundary layer clouds along wind trajectories from the ERA-Interim and ERA5 reanalyses. The study is motivated by the need for statistically representative sets of high resolution simulations of cloud field evolution in realistic meteorological conditions. The study will serve as a foundation for the investigation of biomass burning effects on the transition from stratocumulus to shallow cumulus clouds in the South-East Atlantic. Trajectories that pass through a location with radiosonde data (St. Helena) and which exhibit a well-defined cloud structure and evolution were identified in satellite imagery, and sea surface temperature and atmospheric vertical profiles along the trajectories were extracted from the reanalysis data sets. The System for Atmospheric Modeling (SAM) simulated boundary layer turbulence and cloud properties along the trajectories. Mean temperature and moisture (in the free troposphere) and mean wind speed (at all levels) were nudged towards the reanalysis data. Atmospheric and cloud properties in the large eddy simulations were compared with those from the reanalysis products, and evaluated with satellite imagery and radiosonde data. Simulations using ERA-Interim data and the higher resolution ERA5 data are contrasted.

Treatability Study in Support of Intrinsic Remediation for Site ST41. Elmendorf Air Force Base, Anchorage, Alaska

DTIC Science & Technology

1995-10-01

BTEX on the shallow groundwater system at the site. Site history and the results of soil and groundwater investigations conducted previously are also...or predicted future, concentrations and distribution. Whether in conjunction with the interim 1 remedial action system already in place or not...L:\\45007\\st4 I rept\\st41 finl.doc D 0 • 0 • 0 0 0 0 • 6 FINAL 4 22 years, depending upon the effectiveness of the interim remedial action (IRA) system

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.

Evaluation of heat conduction in dental implants after exposure to hot beverages.

PubMed

Livne, Shiri; Harel, Noga; Piek, Dana; Ormianer, Zeev

2014-03-01

It is unknown if the consumption of hot beverages after implant placement poses a danger of overheating at the bone-implant interface. The purpose of this study was to investigate the effect of simulated consumption of hot beverages on the heat transfer to different dental implant types, implant sizes, and the presence of an interim restoration. A model that consisted of 2 plastic containers was constructed to simulate the oral cavity and endosseous region of the jaw. One-piece and 2-piece implants with abutments were placed into a block of bovine mandibular bone without any healing tissue, surrounded by water maintained at 37°C in the lower compartment. The abutments, which extended into the upper container, were covered with water heated to 60°C to simulate consumption of a hot substance and then were cooled down spontaneously to 37°C during 100 to 600 seconds. Five thermocouple electrodes with an accuracy of ±0.1°C were attached to each test specimen and to a computer with data recording and analysis software to record temperature changes. Repeated measures ANOVA (α=.05)was performed to determine the effect of each major factor. Heat conduction from the abutment exposed to hot liquid was significantly higher in the cervical as opposed to the apical areas of the implants. Implant type (1 piece), diameter (wider), and the absence of an interim coping had a significant effect on the maximum temperature measured and on the temperature change rate. Abutment exposure to hot liquids resulted in heat conduction to the cervical region of the implant, which could be biologically harmful in healing tissues. Heat conduction was mitigated by implant design and diameter, and by the presence of an interim prosthesis. Results may differ in clinical models. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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.

Chronic toxicity studies on 1,3,5-trinitrobenzene in Fischer 344 rats. Final report, 1 May 1993-30 April 1995

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

Reddy, T.V.; Daniel, F.B.; Olson, G.R.

1996-02-01

Chronic toxic effects of I ,3,5-tnnitriotrobenzene (TNB) in male and female Fischer rats were evaluated by feeding certified powdered laboratory chow diet supplemented with varied concentrations of TNB (0, 5, 60 and 300 mg/kg diet). The study was designed to accommodate three interim sacrifices (10 rats/group/sex) at 90, 180 and 365 days. The final sacrifice was performed after two years. All data related to these interim sacrifices are presented independently in appendices J to L. The calculated average TNB consumption for females was 0.23, 2.68 and 13.31 mg/kg/day and was 0.22, 2.64 and 13.44 mg/kg/day for males. Terminal body weightsmore » were significantly decreased in both sexes in the 300 mg/kg group. Relative spleen weights were decreased in both sexes in the 300 mg/kg group while brain weights were increased in females in this same group. Methemoglobin was increased in both sexes in the 300 mg/kg group while other hematological effects noted at the interim sacrifice times were not evident at two years. Histopathological examinations suggested treatment related changes in both sexes involving the kidneys (cytoplasmic/hyaline droplets) in the 60 and 300 mg/kg groups and the spleen (erythroid cell hyperplasia and pigment deposition) in the 300 mg/kg group. The cytoplasmic/hyaline droplets were characterized by immunohistochemistry as alpha-2u-globulin. These renal droplets were also noted at the interim sacrifice times. A no observed adverse effect level (NOAEL) was established in this study at 2.68 mg/kg b.w./day for F-344 rats administered TNB for two years.« less

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

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.

[A pilot clinical study of immediate provisionalization with a chairside computer aided design and computer aided manufacture monolithic crown for single tooth immediate implant placement].

PubMed

Tian, J H; Di, P; Lin, Y; Zhang, Y; Wei, D H; Cui, H Y

2017-01-09

Objective: To evaluate the primary clinical outcomes of immediate provisionalization with a monolithic crown utilizing a novel chairside computer aided design and computer aided manufacture (CAD/CAM) workflow for single tooth immediate implant placement. Methods: This pilot study was a prospective within-subjects design. Thirteen consecutive patients were included and diagnosed with untreatable single incisor or premolar with fine general and local anatomical conditions. The trial was conducted at Department of Implantology, Peking University School and Hospital of Stomatology, Beijing, between January 2016 and June 2016. The teeth were extracted atraumatically and implants were immediately placed in the fresh sockets. Two screw-retained interim crowns were fabricated for the same site utilizing different workflows, a monolithic lithium disilicate (LS2) crown produced by CEREC (Sirona, Germany) chairside CAD/CAM system (CER group) and a manually fabricated resin crown utilizing conventional workflow (CONV group) respectively. The patients were blinded to the group allocation of the two interim crowns. After the clinical try-in for both crowns in a randomized sequence, the patients ' level of satisfaction was assessed with a virtual analogue scale (VAS) questionnaire. The restorations chosen by patients themselves were seated in the implants by one experienced prosthodontist. The accuracy, aesthetic effect and clinical time consumption of both groups were compared. Statistical analyses were performed with the Wilcoxon signed rank test. Results: All patients were treated with atraumatic tooth extraction, immediate implant placement using flapless surgery and immediate provisionalization in a single visit. The interim crowns of both groups could be fitted with or without slight adjustments. For each patient, the interim crown of CER group was chosen to be seated with a relatively higher VAS result. The white esthetic score (WES) results demonstrated no statistically significant difference between CER group (7.5±1.1) and CONV group (7.9±0.9) ( P> 0.05). The mean total work time was significantly different resulting in (131.9±5.0) min for CER group and (205.2±6.3) min( P< 0.05). The major difference lied in the laboratory work time, resulting in (113.5±6.3) min for CER group which was significantly shorter than (185.6±6.6) min for CONV group. As for impression taking time, the CER group (7.5±0.8) min was significantly shorter than CONV group (11.7± 1.1) min ( P< 0.05). However, analysis for clinical adjustment time showed a significantly longer time for CER group [(11.0±2.1) min vs (8.0±2.8) min, P< 0.05]. After 3-6 months of observation, the overall survival rate was 100%. Screw loosening occurred in 4 patients and was tightened again. No other major complication soccurred. Conclusions: The full digital workflow utilizing CEREC chairside CAD/CAM system to fabricate interim crowns after immediate implant placement in one single visit was feasible. It was more time-efficient and could effectively shorten the laboratory work time compared to the conventional workflow. Patients demonstrated high satisfaction and there was no statistical difference in WES results compared to the conventional workflow. Favorable clinical outcomes were gained in this short-term follow-up study.

A 20-Year Prospective Study of Childbearing and Incidence of Diabetes in Young Women, Controlling for Glycemia Before Conception

PubMed Central

Gunderson, Erica P.; Lewis, Cora E.; Tsai, Ai-Lin; Chiang, Vicky; Carnethon, Mercedes; Quesenberry, Charles P.; Sidney, Stephen

2010-01-01

OBJECTIVE We sought to determine whether childbearing increases incidence of type 2 diabetes after accounting for preconception glycemia and gestational glucose intolerance. RESEARCH DESIGN AND METHODS A prospective, biracial cohort was examined up to five times during 1985–2006 in the multicenter, U.S. population–based Coronary Artery Risk Development in Young Adults Study. The analysis included 2,408 women (1,226 black and 1,182 white) aged 18–30 years who were free of diabetes and had a fasting plasma glucose (FPG) <126 mg/dl at baseline. Incident diabetes was diagnosed by self-report, diabetes medication use, FPG ≥126 mg/dl, and/or plasma glucose ≥200 mg/dl after a 2-h oral glucose load. Time-dependent interim birth groups were those with zero and those with one or more births with or without gestational diabetes mellitus (GDM), stratified by baseline parity. Complementary log-log models estimated relative hazards of incident diabetes by interim births adjusted for age, race, family history of diabetes, and baseline covariates (FPG, BMI, education, smoking, and physical activity). RESULTS Of 193 incident diabetes cases in 42,782 person-years (4.5 cases/1,000 person-years), 84 (44%) had one or more interim births. Among nulliparas at baseline, incident rates per 1,000 person-years were 3.2 (95% CI 2.4–4.1) for those with no births, 2.9 (1.8 –3.9) for one or more births without GDM, and 18.4 (10.9 –25.9) for one or more births with GDM; adjusted relative hazards (95% CI) were 0.9 (0.6 –1.4) for one or more births without GDM and 3.8 (2.2– 6.6) for one or more births with GDM versus no births. CONCLUSIONS Childbearing did not elevate diabetes incidence among those with normal glucose tolerance during pregnancy (without GDM). GDM conferred the highest risk of developing diabetes independent of family history of diabetes and preconception glycemia and obesity. PMID:17898128

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.

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.).

EFFECTS OF EXTREME AND UNUSUAL CONDITIONS ON LANA ALLOYS: INTERIM REPORT, FY14 (U)

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

Shanahan, Kirk L.

2014-04-25

The TTP proposed research aimed at determining: a) the rate at which these changes occurred and the effect of initial conditions, especially in the early phases of Hydrogen Heat Treatment (HHT), b) whether or not different LANA alloys would show similar effects, and c) whether common contaminants/poisons impacted LANA alloy hydride chemistry similarly to what had been found for Pd and Pd-alloy hydride chemistry.

836: Developing a Cooperative Communication System for Safe, Effective, and Efficient Patient Care

DTIC Science & Technology

2014-01-01

since tool institution. There was an average rate of 40 positive sepsis identification tool (SIT) triggers per 1000 patient days. In a 6 month...period 28% of patients with a positive SIT had sepsis and 6% had severe sepsis. Interim review showed 67% received first fluid bolus within 20 minutes...for ulcer prevention, including changing the practice of positioning mechanically ventilated and sedated patients , rethinking the use of extended

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).

Interim report on nuclear waste depository thermal analysis

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

Altenbach, T.J.

1978-07-25

A thermal analysis of a deep geologic depository for spent nuclear fuel is being conducted. The TRUMP finite difference heat transfer code is used to analyze a 3-dimensional model of the depository. The model uses a unit cell consisting of one spent fuel canister buried in salt beneath a ventilated room in the depository. A base case was studied along with several parametric variations. It is concluded that this method is appropriate for analyzing the thermal response of the system, and that the most important parameter in determining the maximum temperatures is the canister heat generation rate. The effects ofmore » room ventilation and different depository media are secondary.« less

Contribution of postpolymerization conditioning and storage environments to the mechanical properties of three interim restorative materials.

PubMed

Thompson, Geoffrey A; Luo, Qing

2014-09-01

Because polymer-based interim restorative materials are weak, even well-made restorations sometimes fail before the definitive restoration is ready for insertion. Therefore, knowing which fabrication procedures and service conditions affect mechanical properties is important, particularly over an extended period. The purpose of this study was to evaluate the effect of thermal treatment, surface sealing, thermocycling, storage media, storage temperature, and age on autopolymerizing poly(methylmethacrylate) and bis-acryl interim restorative materials. Outcome measures were flexural strength, Vickers surface microhardness, and impact strength. Flexural strength and microhardness of poly(methylmethacrylate) (Jet Acrylic) and 2 bis-acryl-composite resin (Protemp 3 Garant and Integrity) interim restorative materials were evaluated as affected by storage media, storage temperature, storage time, thermocycling, postpolymerization thermal treatment, or application of a surface sealer. In total, 2880 beam specimens (25×2×2 mm) were fabricated. Mechanical property analyses were made at 10 days, 30 days, 6 months, and 1 year after specimen preparation. Flexural strength was determined by using a 3-point bending test in a universal testing machine with a 1 kN load cell at a crosshead speed of 5.0 mm min(-1). Fracture specimens were recovered and used for determining Vickers microhardness. Measurements were made with a 0.1 N load and 15 second dwell time. Three microhardness measurements were made for each specimen, and the mean was used for reporting Vickers microhardness. Notched impact specimens (64×12.7×6.35 mm) were fabricated from Jet, Protemp 3 Garant, and Integrity interim restorative materials, yielding 288 impact specimens. Impact strengths were assessed at 10 days, 30 days, 6 months, and 1 year with a 2 J pendulum. The effects of the various experimental treatments were determined and rank ordered with analysis of variance, F ratios, and least square means differences Student t tests (α=.05). All experimental treatments investigated had significant effects on flexural strength, with material (P<.001) and thermocycling (P<.001) being dominant. Moreover, all experimental treatments investigated had a significant overall impact on Vickers microhardness with material (P<.001) and Palaseal glaze (P<.001) showing large effects. Material (P<.001) and age (P=.010) had a significant effect on impact strength. Mechanical properties of some interim polymeric materials can be improved by postpolymerization heat treatments or surface glazing. This procedure may extend the useful lifetime of some bis-acryl interim restorations. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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.).

Conditional power and predictive power based on right censored data with supplementary auxiliary information.

PubMed

Sun, Libo; Wan, Ying

2018-04-22

Conditional power and predictive power provide estimates of the probability of success at the end of the trial based on the information from the interim analysis. The observed value of the time to event endpoint at the interim analysis could be biased for the true treatment effect due to early censoring, leading to a biased estimate of conditional power and predictive power. In such cases, the estimates and inference for this right censored primary endpoint are enhanced by incorporating a fully observed auxiliary variable. We assume a bivariate normal distribution of the transformed primary variable and a correlated auxiliary variable. Simulation studies are conducted that not only shows enhanced conditional power and predictive power but also can provide the framework for a more efficient futility interim analysis in terms of an improved accuracy in estimator, a smaller inflation in type II error and an optimal timing for such analysis. We also illustrated the new approach by a real clinical trial example. Copyright © 2018 John Wiley & Sons, Ltd.

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.

An interim reference model for the variability of the middle atmosphere H2O vapor distribution

NASA Technical Reports Server (NTRS)

Remsberg, E. E.; Russell, J. M., III; Wu, C. Y.

1989-01-01

Water vapor is an important minor constituent in the studies of the middle atmosphere for a variety of reasons, including its role as a source for active HO(y) chemicals and its use in analysis of transport processes. A number of in situ and remote techniques were employed in the determination of water vapor distributions. Two of the more complete data sets were used to develop an interim reference profile. First, there are the seven months of Nimbus 7 limb infrared monitor of the stratosphere (LIMS) data obtained during Nov. 1978 to May 1979 over the range 64S to 84N latitude and from about 100 to 1 mb in the mid-mesosphere at several fixed Northern Hemisphere mid-latitude sites. These two data sets were combined to give a mid-lattitude, interim reference water vapor profile for the entire vertical range of the middle atmosphere and with accuracies of better than 25 percent. The daily variability of stratospheric water vapor profiles about the monthly mean was also established from these data sets for selected months. Information is also provided on the longitudinal variability of LIMS water vapor profiles about the daily, weekly, and monthly zonal means. Generally, the interim reference water vapor profile and its variability are consistent with prevailing ideas about chemistry and transport.

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.

Conditional estimation using prior information in 2-stage group sequential designs assuming asymptotic normality when the trial terminated early.

PubMed

Shimura, Masashi; Maruo, Kazushi; Gosho, Masahiko

2018-04-23

Two-stage designs are widely used to determine whether a clinical trial should be terminated early. In such trials, a maximum likelihood estimate is often adopted to describe the difference in efficacy between the experimental and reference treatments; however, this method is known to display conditional bias. To reduce such bias, a conditional mean-adjusted estimator (CMAE) has been proposed, although the remaining bias may be nonnegligible when a trial is stopped for efficacy at the interim analysis. We propose a new estimator for adjusting the conditional bias of the treatment effect by extending the idea of the CMAE. This estimator is calculated by weighting the maximum likelihood estimate obtained at the interim analysis and the effect size prespecified when calculating the sample size. We evaluate the performance of the proposed estimator through analytical and simulation studies in various settings in which a trial is stopped for efficacy or futility at the interim analysis. We find that the conditional bias of the proposed estimator is smaller than that of the CMAE when the information time at the interim analysis is small. In addition, the mean-squared error of the proposed estimator is also smaller than that of the CMAE. In conclusion, we recommend the use of the proposed estimator for trials that are terminated early for efficacy or futility. Copyright © 2018 John Wiley & Sons, Ltd.

Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix B - system descriptions and fault trees

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

Mays, S.E.; Poloski, J.P.; Sullivan, W.H.

1982-07-01

This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix B provides a description of Browns Ferry, Unit 1, plant systems and the failure evaluation of those systems as they apply to accidents at Browns Ferry. Information is presented concerning front-line system fault analysis; support system fault analysis; human error models andmore » probabilities; and generic control circuit analyses.« less

Reforming primary health care: is New Zealand's primary health care strategy achieving its early goals?

PubMed

Cumming, Jacqueline; Mays, Nicholas; Gribben, Barry

2008-11-06

In 2001, the New Zealand government introduced its Primary Health Care Strategy (PHCS), aimed at strengthening the role of primary health care, in order to improve health and to reduce inequalities in health. As part of the Strategy, new funding was provided to reduce the fees that patients pay when they use primary health care services in New Zealand, to improve access to services and to increase service use. In this article, we estimate the impact of the new funding on general practitioner and practice nurse visit fees paid by patients and on consultation rates. The analyses involved before-and-after monitoring of fees and consultation rates in a random sample of 99 general practices and covered the period from June 2001 (pre-Strategy) to mid-2005. Fees fell particularly in Access (higher need, higher per capita funded) practices over time for doctor and nurse visits. Fees increased over time for many in Interim (lower need, lower per capita funded) practices, but they fell for patients aged 65 years and over as new funding was provided for this age group. There were increases in consultation rates across almost all age, funding model (Access or Interim), socio-demographic and ethnic groups. Increases were particularly high in Access practices. The Strategy has resulted in lower fees for primary health care for many New Zealanders, and consultation rates have also increased over the past few years. However, fees have not fallen by as much as expected in government policy given the amount of extra public money spent since there are limited requirements for practices to reduce patients' fees in line with increases in public funding for primary care.

Reforming primary health care: is New Zealand's primary health care strategy achieving its early goals?

PubMed Central

Cumming, Jacqueline; Mays, Nicholas; Gribben, Barry

2008-01-01

Background In 2001, the New Zealand government introduced its Primary Health Care Strategy (PHCS), aimed at strengthening the role of primary health care, in order to improve health and to reduce inequalities in health. As part of the Strategy, new funding was provided to reduce the fees that patients pay when they use primary health care services in New Zealand, to improve access to services and to increase service use. In this article, we estimate the impact of the new funding on general practitioner and practice nurse visit fees paid by patients and on consultation rates. The analyses involved before-and-after monitoring of fees and consultation rates in a random sample of 99 general practices and covered the period from June 2001 (pre-Strategy) to mid-2005. Results Fees fell particularly in Access (higher need, higher per capita funded) practices over time for doctor and nurse visits. Fees increased over time for many in Interim (lower need, lower per capita funded) practices, but they fell for patients aged 65 years and over as new funding was provided for this age group. There were increases in consultation rates across almost all age, funding model (Access or Interim), socio-demographic and ethnic groups. Increases were particularly high in Access practices. Conclusion The Strategy has resulted in lower fees for primary health care for many New Zealanders, and consultation rates have also increased over the past few years. However, fees have not fallen by as much as expected in government policy given the amount of extra public money spent since there are limited requirements for practices to reduce patients' fees in line with increases in public funding for primary care. PMID:18990236

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...

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

Controlling the type I error rate in two-stage sequential adaptive designs when testing for average bioequivalence.

PubMed

Maurer, Willi; Jones, Byron; Chen, Ying

2018-05-10

In a 2×2 crossover trial for establishing average bioequivalence (ABE) of a generic agent and a currently marketed drug, the recommended approach to hypothesis testing is the two one-sided test (TOST) procedure, which depends, among other things, on the estimated within-subject variability. The power of this procedure, and therefore the sample size required to achieve a minimum power, depends on having a good estimate of this variability. When there is uncertainty, it is advisable to plan the design in two stages, with an interim sample size reestimation after the first stage, using an interim estimate of the within-subject variability. One method and 3 variations of doing this were proposed by Potvin et al. Using simulation, the operating characteristics, including the empirical type I error rate, of the 4 variations (called Methods A, B, C, and D) were assessed by Potvin et al and Methods B and C were recommended. However, none of these 4 variations formally controls the type I error rate of falsely claiming ABE, even though the amount of inflation produced by Method C was considered acceptable. A major disadvantage of assessing type I error rate inflation using simulation is that unless all possible scenarios for the intended design and analysis are investigated, it is impossible to be sure that the type I error rate is controlled. Here, we propose an alternative, principled method of sample size reestimation that is guaranteed to control the type I error rate at any given significance level. This method uses a new version of the inverse-normal combination of p-values test, in conjunction with standard group sequential techniques, that is more robust to large deviations in initial assumptions regarding the variability of the pharmacokinetic endpoints. The sample size reestimation step is based on significance levels and power requirements that are conditional on the first-stage results. This necessitates a discussion and exploitation of the peculiar properties of the power curve of the TOST testing procedure. We illustrate our approach with an example based on a real ABE study and compare the operating characteristics of our proposed method with those of Method B of Povin et al. Copyright © 2018 John Wiley & Sons, Ltd.

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 .).

IUS/TUG orbital operations and mission support study. Volume 2: Interim upper stage operations

NASA Technical Reports Server (NTRS)

1975-01-01

Background data and study results are presented for the interim upper stage (IUS) operations phase of the IUS/tug orbital operations study. The study was conducted to develop IUS operational concepts and an IUS baseline operations plan, and to provide cost estimates for IUS operations. The approach used was to compile and evaluate baseline concepts, definitions, and system, and to use that data as a basis for the IUS operations phase definition, analysis, and costing analysis. Both expendable and reusable IUS configurations were analyzed and two autonomy levels were specified for each configuration. Topics discussed include on-orbit operations and interfaces with the orbiter, the tracking and data relay satellites and ground station support capability analysis, and flight control center sizing to support the IUS operations.

The role of interim 18F-FDG PET/CT in prediction of response to ipilimumab treatment in metastatic melanoma.

PubMed

Sachpekidis, Christos; Anwar, Hoda; Winkler, Julia; Kopp-Schneider, Annette; Larribere, Lionel; Haberkorn, Uwe; Hassel, Jessica C; Dimitrakopoulou-Strauss, Antonia

2018-07-01

The aim of the present study was to assess the value of interim 18 F-FDG PET/CT performed after the first two cycles of ipilimumab treatment in the prediction of the final clinical response to this type of immunotherapy. The study group comprised 41 patients with unresectable metastatic melanoma scheduled for ipilimumab therapy. Whole-body 18 F-FDG PET/CT was performed before the start of ipilimumab treatment (baseline PET/CT) and after the initial two cycles of ipilimumab treatment (interim PET/CT). Evaluation of patient response to treatment was based on the European Organization for Research and Treatment of Cancer (EORTC) 1999 criteria for PET as well as the recently proposed PET Response Evaluation Criteria for Immunotherapy (PERCIMT). The patients' best clinical response, assessed at a median of 21.4 months (range 6.3-41.9 months) was used as reference. According to their best clinical response, the patients were divided into two groups: those showing clinical benefit (CB) including stable disease, partial response and complete response (31 patients), and those showing no clinical benefit (no-CB including progressive disease (10 patients). According to the EORTC criteria, interim PET/CT demonstrated progressive metabolic disease (PMD) in 20 patients, stable metabolic disease (SMD) in 11 patients, partial metabolic response (PMR) in 8 patients, and complete metabolic response (CMR) in 2 patients. According to the PERCIMT, interim PET/CT demonstrated PMD in 9 patients, SMD in 24 patients, PMR in 6 patients and CMR in 2 patients. On the basis of the interim PET, the patients were divided in a similar manner to the division according to clinical response into those showing metabolic benefit (MB) including SMD, PMR and CMR, and those showing no metabolic benefit (no-MB) including PMD. According to this dichotomization, the EORTC criteria showed a sensitivity (correctly predicting CB) of 64.5%, a specificity (correctly predicting no-CB) of 90.0%, a positive predictive value (PPV) of 95.2%, a negative predictive value (NPV) of 45.0% and an accuracy of 70.7% in predicting best clinical response. The PERCIMT showed a sensitivity of 93.6%, a specificity of 70.0%, a PPV of 90.6%, a NPV of 77.8% and an accuracy of 87.8%. The McNemar test showed that the PERCIMT had a significantly higher sensitivity than EORTC criteria (p = 0.004), while there was no significant difference in specificity (p = 0.5). The agreement between the two sets of criteria was poor (McNemar test p = 0.001, and accordingly kappa = 0.46). The application of the recently proposed PERCIMT to interim 18 F-FDG PET/CT provides a more sensitive predictor of final clinical response to immunotherapy than the application of the EORTC criteria in patients with metastatic melanoma.

[Multicentric prospective randomized study evaluating the interest of intravaginal electro-stimulation at home for urinary incontinence after prior perineal reeducation. Interim analysis].

PubMed

Lopès, P; Levy-Toledano, R; Chiarelli, P; Rimbault, F; Marès, P

2014-03-01

Perineal reeducation of stress urinary incontinence is beneficial in 80% of cases. However, patients have to perform self-retraining exercises of the perineal muscles at home, in order to maintain the benefit of the physiotherapy. The aim of this study is to assess the benefit of GYNEFFIK(®), a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI) that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK(®) electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained (defined as non-worsening ICIQ and Ditrovie scales' score). According to the protocol, an interim analysis was performed on 95 patients (i.e. almost half of the expected sample size) who had had at least one evaluation under treatment, among which 44 patients had finished the study. The therapeutic benefit of the initial perineal reeducation was maintained in 87.8% of the GYNEFFIK(®) patient group, while it was maintained in 52.2% (P=0.0001) in the usual care group (i.e. who did not use electro-stimulation). Likewise, patient had a more favorable subjective impression when using GYNEFFIK(®) (83.7% versus 60.0% in the usual care group) as they felt that they improved during the study. In the GYNEFFIK(®) group, no increase in symptoms was reported, whereas almost one out of five patients in the usual care group felt that their condition had worsened. Copyright © 2014. Published by Elsevier SAS.

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...

Evaluation of Cloud Physical Properties of ECMWF Analysis and Re-Analysis (ERA-40 and ERA Interim) against CERES Tropical Deep Convective Cloud Object Observations

NASA Technical Reports Server (NTRS)

Xu, Kuan-Man

2008-01-01

This study presents an approach that converts the vertical profiles of grid-averaged cloud properties from large-scale models to probability density functions (pdfs) of subgrid-cell cloud physical properties measured at satellite footprints. Cloud physical and radiative properties, rather than just cloud and precipitation occurrences, of assimilated cloud systems by the European Center for Medium-range Weather Forecasts (ECMWF) operational analysis (EOA) and ECMWF Re-Analyses (ERA-40 and ERA Interim) are validated against those obtained from Earth Observing System satellite cloud object data for January-August 1998 and March 2000 periods. These properties include ice water path (IWP), cloud-top height and temperature, cloud optical depth and solar and infrared radiative fluxes. Each cloud object, a contiguous region with similar cloud physical properties, is temporally and spatially matched with EOA and ERA-40 data. Results indicate that most pdfs of EOA and ERA-40 cloud physical and radiative properties agree with those of satellite observations of the tropical deep convective cloud-object type for the January-August 1998 period. There are, however, significant discrepancies in selected ranges of the cloud property pdfs such as the upper range of EOA cloud top height. A major discrepancy is that the dependence of the pdfs on the cloud object size for both EOA and ERA-40 is not as strong as in the observations. Modifications to the cloud parameterization in ECMWF that occurred in October 1999 eliminate the clouds near the tropopause but shift power of the pdf to lower cloud-top heights and greatly reduce the ranges of IWP and cloud optical depth pdfs. These features persist in ERA-40 due to the use of the same cloud parameterizations. The downgrade of data assimilation technique and the lack of snow water content information in ERA-40, not the coarser horizontal grid resolution, are also responsible for the disagreements with observed pdfs of cloud physical properties although the detection rates of cloud object occurrence are improved for small size categories. A possible improvement to the convective parameterization is to introduce a stronger dependence of updraft penetration heights with grid-cell dynamics. These conclusions will be rechecked using the ERA Interim data, due to recent changes in the ECMWF convective parameterization (Bechtold et al. 2004, 2008). Results from the ERA Interim will be presented at the meeting.

Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study.

PubMed

van der Heijde, Désirée; Tanaka, Yoshiya; Fleischmann, Roy; Keystone, Edward; Kremer, Joel; Zerbini, Cristiano; Cardiel, Mario H; Cohen, Stanley; Nash, Peter; Song, Yeong-Wook; Tegzová, Dana; Wyman, Bradley T; Gruben, David; Benda, Birgitta; Wallenstein, Gene; Krishnaswami, Sriram; Zwillich, Samuel H; Bradley, John D; Connell, Carol A

2013-03-01

The purpose of this 24-month phase III study was to examine structural preservation with tofacitinib in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Data from a planned 12-month interim analysis are reported. In this double-blind, parallel-group, placebo-controlled study, patients receiving background MTX were randomized 4:4:1:1 to tofacitinib at 5 mg twice daily, tofacitinib at 10 mg twice daily, placebo to tofacitinib at 5 mg twice daily, and placebo to tofacitinib at 10 mg twice daily. At month 3, nonresponder placebo-treated patients were advanced in a blinded manner to receive tofacitinib as indicated above; remaining placebo-treated patients were advanced at 6 months. Four primary efficacy end points were all analyzed in a step-down procedure. At month 6, response rates according to the American College of Rheumatology 20% improvement criteria for tofacitinib at 5 mg and 10 mg twice daily were higher than those for placebo (51.5% and 61.8%, respectively, versus 25.3%; both P < 0.0001). At month 6, least squares mean (LSM) changes in total modified Sharp/van der Heijde score for tofacitinib at 5 mg and 10 mg twice daily were 0.12 and 0.06, respectively, versus 0.47 for placebo (P = 0.0792 and P ≤ 0.05, respectively). At month 3, LSM changes in the Health Assessment Questionnaire disability index score for tofacitinib at 5 mg and 10 mg twice daily were -0.40 (significance not declared due to step-down procedure) and -0.54 (P < 0.0001), respectively, versus -0.15 for placebo. At month 6, rates of remission (defined as a value <2.6 for the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate) for tofacitinib at 5 mg and 10 mg twice daily were 7.2% (significance not declared due to step-down procedure) and 16.0% (P < 0.0001), respectively, versus 1.6% for placebo. The safety profile was consistent with findings in previous studies. Data from this 12-month interim analysis demonstrate that tofacitinib inhibits progression of structural damage and improves disease activity in patients with RA who are receiving MTX. Copyright © 2013 by the American College of Rheumatology.

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.

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.

Observed surface wind speed declining induced by urbanization in East China

NASA Astrophysics Data System (ADS)

Li, Zhengquan; Song, Lili; Ma, Hao; Xiao, Jingjing; Wang, Kuo; Chen, Lian

2018-02-01

Monthly wind data from 506 meteorological stations and ERA-Interim reanalysis during 1991-2015, are used to examine the surface wind trend over East China. Furthermore, combining the urbanization information derived from the DMSP/OLS nighttime light data during 1992-2013, the effects of urbanization on surface wind change are investigated by applying the observation minus reanalysis (OMR) method. The results show that the observed surface wind speed over East China is distinctly weakening with a rate of -0.16 m s-1 deca-1 during 1991-2015, while ERA-Interim wind speed does not have significant decreasing or increasing trend in the same period. The observed surface wind declining is mainly attributed to underlying surface changes of stations observational areas that were mostly induced by the urbanization in East China. Moreover, the wind declining intensity is closely related to the urbanization rhythms. The OMR annual surface wind speeds of Rhythm-VS, Rhythm-S, Rhythm-M, Rhythm-F and Rhythm-VF, have decreasing trends with the rates of -0.02 to -0.09, -0.16 to -0.26, -0.22 to -0.30, -0.26 to -0.36 and -0.33 to -0.51 m s-1 deca-1, respectively. The faster urbanization rhythm is, the stronger wind speed weakening presents. Additionally urban expansion is another factor resulted in the observed surface wind declining.

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...

2005 Annual Operations Report for INTEC Operable Unit 3-13, Group 1, Tank Farm Interim Action

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

D. Shanklin

2006-07-19

This annual operations report describes the requirements followed and activities conducted to inspect, monitor, and maintain the items installed during performance of the Waste Area Group 3, Operable Unit 3-13, Group 1, Tank Farm Interim Action, at the Idaho Nuclear Technology and Engineering Center. This report describes inspection and monitoring activities fro the surface-sealed areas within the tank farm, concrete-lined ditches and culverts in and around the tank farm, the lift station, and the lined evaporation pond. These activities are intended to assure that the interim action is functioning adequately to meet the objectives stated in the Operable Unit 3-13,more » Record of Decision for the Group 1, Tank Farm Interim Action, (DOE/ID-10660) and as amended by the agreement to resolve dispute, which was effective in February 2003.« less

2006 Annual Operations Report for INTEC Operable Unit 3-13, Group 1, Tank Farm Interim Action

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

D. E. Shanklin

2007-02-14

This annual operations report describes the requirements followed and activities conducted to inspect, monitor, and maintain the items installed during performance of the Waste Area Group 3, Operable Unit 3-13, Group 1, Tank Farm Interim Action, at the Idaho Nuclear Technology and Engineering Center. This report covers the time period from January 1 through December 31, 2006, and describes inspection and monitoring activities for the surface-sealed areas within the tank farm, concrete-lined ditches and culverts in and around the tank farm, the lift station, and the lined evaporation pond. These activities are intended to assure that the interim action ismore » functioning adequately to meet the objectives stated in the Operable Unit 3-13, Record of Decision for the Group 1, Tank Farm Interim Action (DOE/ID-10660) as described in the Group 1 Remedial Design/Remedial Action Work Plan (DOE/ID-10772).« less

Using ERA-Interim reanalysis for creating datasets of energy-relevant climate variables

NASA Astrophysics Data System (ADS)

Jones, Philip D.; Harpham, Colin; Troccoli, Alberto; Gschwind, Benoit; Ranchin, Thierry; Wald, Lucien; Goodess, Clare M.; Dorling, Stephen

2017-07-01

The construction of a bias-adjusted dataset of climate variables at the near surface using ERA-Interim reanalysis is presented. A number of different, variable-dependent, bias-adjustment approaches have been proposed. Here we modify the parameters of different distributions (depending on the variable), adjusting ERA-Interim based on gridded station or direct station observations. The variables are air temperature, dewpoint temperature, precipitation (daily only), solar radiation, wind speed, and relative humidity. These are available on either 3 or 6 h timescales over the period 1979-2016. The resulting bias-adjusted dataset is available through the Climate Data Store (CDS) of the Copernicus Climate Change Data Store (C3S) and can be accessed at present from ftp://ecem.climate.copernicus.eu. The benefit of performing bias adjustment is demonstrated by comparing initial and bias-adjusted ERA-Interim data against gridded observational fields.

Production of aluminum-silicon alloy and ferrosilicon and commercial purity aluminum by the direct reduction process. Third interim technical report, Phase C for the period 1980 July 1-1980 September 30

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

Bruno, M.J.

1980-10-01

Pilot reactor VSR-3 operation in the third quarter was directed to tapping molten alloy product. Modifications to the hearth region included a tapping furnace to maintain taphole temperature, a graphite ring filter to separate carbides from matal and an alumina liner to eliminate carbiding from reaction of alloy with the graphite hearth walls. Tapping was not successful, however, due to high alloy viscosity from a large concentration of carbides. Three runs were made on the pilot crystallizer to determine the effects of alloy composition, cooling rate, tamping rate, remelt temperature and rate on eutectic Al-Si yield.

Reinforcement of a PMMA resin for interim fixed prostheses with silica nanoparticles.

PubMed

Topouzi, Marianthi; Kontonasaki, Eleana; Bikiaris, Dimitrios; Papadopoulou, Lambrini; Paraskevopoulos, Konstantinos M; Koidis, Petros

2017-05-01

Fractures in long span provisional/interim restorations are a common complication. Adequate fracture toughness is necessary to resist occlusal forces and crack propagation, so these restorations should be constructed with materials of improved mechanical properties. The aim of this study was to investigate the possible reinforcement of neat silica nanoparticles and trietoxyvinylsilane-modified silica nanoparticles in a PMMA resin for fixed interim restorations. Composite PMMA-Silica nanoparticles powders were mixed with PMMA liquid and compact bar shaped specimens were fabricated according to the British standard BS EN ISO 127337:2005. The single-edge notched method was used to evaluate fracture toughness (three-point bending test), while the dynamic thermomechanical properties (Storage Modulus, Loss Modulus, tanδ) of a series of nanocomposites with different amounts of nanoparticles (0.25%, 0.50%, 0.75%, 1% w.t.) were evaluated. Statistical analysis was performed and the statistically significant level was set to p<0.05. The fracture toughness of all experimental composites was remarkably higher compared to control. There was a tendency to decrease of fracture toughness, by increasing the concentration of the filler. No statistically significant differences were detected among the modified/unmodified silica nanoparticles. Dynamic mechanical properties were also affected. By increasing the silica nanoparticles content an increase in Storage Modulus was recorded, while Glass Transition Temperature was shifted at higher temperatures. Under the limitations of this in-vitro study, it can be suggested that both neat silica nanoparticles and trietoxyvinylsilane-modified silica nanoparticles, especially at low concentrations, may enhance the overall performance of fixed interim prostheses, as can effectively increase the fracture toughness, the elastic modulus and the Glass Transition Temperature of PMMA resins used in fixed provisional restorations. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Spatiotemporal Evaluation of Reanalysis and In-situ Surface Air Temperature over Ethiopia

NASA Astrophysics Data System (ADS)

Tesfaye, T.

2017-12-01

Tewodros Woldemariam Tesfaye*1, C.T. Dhanya 2,and A.K. Gosain3 1Research Scholar, Department of Civil Engineering, Indian Institute of Technology Delhi, New Delhi-110016, India 2Assistant Professor, Department of Civil Engineering, Indian Institute of Technology Delhi, New Delhi-110016, India 3 Professor, Department of Civil Engineering, Indian Institute of Technology Delhi, New Delhi-110016, India, *e-mail: tewodros2002@gmail.com Abstract: Water resources management and modelling studies are often constrained by the scarcity of observed data, especially of the two major variables i.e., precipitation and temperature. Modellers, hence, rely on reanalysis datasets as a substitute; though its performance heavily vary depending on the data availability and regional characteristics. The present study aims at examining the ability of frequently used reanalysis datasets in capturing the spatiotemporal characteristics of maximum and minimum surface temperatures over Ethiopia and to highlight the biases, if any, in these over Ethiopian region. We considered ERA-Interim, NCEP 2, MERRA and CFSR reanalysis datasets and compared these with temperature observations from 15 synoptic stations spread over Ethiopia. In addition to the long term averages and annual cycle, a critical comparison of various extreme indices such as diurnal temperature range, warm days, warm nights, cool days, cool nights, summer days and tropical nights are also undertaken. Our results indicate that, the performance of CFSR followed by NCEP 2 is better in capturing majority of the aspects. ERA-Interim suffers a huge additive bias in the simulation of various aspects of minimum temperature in all the stations considered; while its performance is better for maximum temperature. The inferior performance of ERA-Interim is noted to be only because of the difficulty in simulating minimum temperature. Key words: ERA Interim; NCEP Reanalysis; MERRA; CFSR; Diurnal temperature range; reanalysis performance.

[German national second-opinion network for testicular cancer and penile carcinoma : Two sources for evidence-based information].

PubMed

Schrader, M; Zengerling, F; Hakenberg, O W; Protzel, C

2016-09-01

The second-opinion network for testicular cancer is an internet-based platform addressing physicians treating testicular cancer patients. They are offered a second-opinion before determining further therapy after orchiectomy and completion of staging. The high rate of discrepancies between the first and second opinion in more than 30 % supports the assumption of a deficit in the implementation of treatment guidelines. In 2015, approximately 22 % of the newly diagnosed cases with testicular cancer in Germany were covered by this system. According to the present interim analysis, the second-opinion platform helps to avoid overtreatment of testicular cancer patients. The high acceptance of the project and the encouraging results of this interim analysis gave rise to considerations to apply the second-opinion model to penile carcinoma. Data from the UK and the Netherlands show that the second-opinion network for penile cancer could help to improve treatment standards and results in Germany. Current data and the intended further development of the system are discussed.

Efficacy and safety of sublingual ramelteon as an adjunctive therapy in the maintenance treatment of bipolar I disorder in adults: A phase 3, randomized controlled trial.

PubMed

Mahableshwarkar, Atul R; Calabrese, Joseph R; Macek, Thomas A; Budur, Kumar; Adefuye, Adedeji; Dong, Xinxin; Hanson, Elizabeth; Sachs, Gary S

2017-10-15

The optimal long-term management strategy for bipolar I disorder patients is not yet established. Evidence supports the rationale for circadian rhythm regulation to prevent mood episode relapse in bipolar patients. This study evaluated the efficacy and safety of a new sublingual formulation of the melatonin receptor agonist ramelteon (ramelteon SL) as adjunctive therapy in the maintenance treatment of bipolar I patients. In a double-blinded trial in the United States and Latin America, adult bipolar I disorder patients stable for ≥ 8 weeks before baseline and with a mood episode 8 weeks to 9 months before screening, were randomized to once-daily ramelteon SL 0.1mg (n = 164), 0.4mg (n = 160), or 0.8mg (n = 154), or placebo (n = 164), in addition to their existing treatment. The primary endpoint was time from randomization to relapse of symptoms. The prespecified futility criterion in a planned, unblinded, independent interim analysis was the failure of all ramelteon SL doses to achieve a conditional power ≥ 30% compared with placebo. No significant differences between any dose of ramelteon SL and placebo were observed. The study was terminated after meeting the futility criteria. Ramelteon SL was well tolerated, with a safety profile consistent with that for oral ramelteon. A low rate of relapse events precluded detection of any statistically significant difference between groups. The study failed to demonstrate the efficacy of ramelteon SL as adjunctive maintenance therapy for bipolar disorder. Interim analyses for futility in clinical studies are valuable in preventing unnecessary exposure of subjects to interventions. Copyright © 2017. Published by Elsevier B.V.

Early Outcomes Of Decentralized Care for Rifampicin-Resistant Tuberculosis in Johannesburg, South Africa: An Observational Cohort Study.

PubMed

Berhanu, Rebecca; Schnippel, Kathryn; Mohr, Erika; Hirasen, Kamban; Evans, Denise; Rosen, Sydney; Sanne, Ian

2016-01-01

We describe baseline characteristics, time to treatment initiation and interim patient outcomes at a decentralized, outpatient treatment site for rifampicin-resistant TB (RR-TB). Prospective observational cohort study of RR-TB patients from March 2013 until December 2014. Study subjects were followed until completion of the intensive phase of treatment (6 months), transfer out, or a final outcome (loss from treatment (LFT) or death). 214 patients with RR-TB were enrolled in the study. Xpert MTB/RIF was the diagnostic test of rifampicin resistance for 87% (n = 186), followed by direct PCR on AFB positive specimen in 14 (7%) and indirect PCR on cultured isolate in 5 (2%). Median time between sputum testing and treatment initiation was 10 days (IQR 6-21). Interim outcomes were available in 148 patients of whom 78% (n = 115) were still on treatment, 9% (n = 13) had died, and 14% (n = 20) were LFT. Amongst 131 patients with culture positive pulmonary TB, 85 (64.9%) were culture negative at 6 months, 12 were still sputum culture positive (9.2%) and 34 had no culture documented or contaminated culture (26%). Patients who initiated as outpatients within 1 week of sputum collection for diagnosis of RR-TB had a significantly lower incidence of LFT (IRR 0.30, 95% CI: 0.09-0.98). HIV co-infection occurred in 178 patients (83%) with a median CD4 count 88 cells/ml3 (IQR 27-218). Access to decentralized treatment coupled with the rapid diagnosis of RR-TB has resulted in short time to treatment initiation. Despite the lack of treatment delays, early treatment outcomes remain poor with high rates of death and loss from care.

Early Outcomes Of Decentralized Care for Rifampicin-Resistant Tuberculosis in Johannesburg, South Africa: An Observational Cohort Study

PubMed Central

Schnippel, Kathryn; Mohr, Erika; Hirasen, Kamban; Evans, Denise; Rosen, Sydney; Sanne, Ian

2016-01-01

Objective We describe baseline characteristics, time to treatment initiation and interim patient outcomes at a decentralized, outpatient treatment site for rifampicin-resistant TB (RR-TB). Methods Prospective observational cohort study of RR-TB patients from March 2013 until December 2014. Study subjects were followed until completion of the intensive phase of treatment (6 months), transfer out, or a final outcome (loss from treatment (LFT) or death). Results 214 patients with RR-TB were enrolled in the study. Xpert MTB/RIF was the diagnostic test of rifampicin resistance for 87% (n = 186), followed by direct PCR on AFB positive specimen in 14 (7%) and indirect PCR on cultured isolate in 5 (2%). Median time between sputum testing and treatment initiation was 10 days (IQR 6–21). Interim outcomes were available in 148 patients of whom 78% (n = 115) were still on treatment, 9% (n = 13) had died, and 14% (n = 20) were LFT. Amongst 131 patients with culture positive pulmonary TB, 85 (64.9%) were culture negative at 6 months, 12 were still sputum culture positive (9.2%) and 34 had no culture documented or contaminated culture (26%). Patients who initiated as outpatients within 1 week of sputum collection for diagnosis of RR-TB had a significantly lower incidence of LFT (IRR 0.30, 95% CI: 0.09–0.98). HIV co-infection occurred in 178 patients (83%) with a median CD4 count 88 cells/ml3 (IQR 27–218). Conclusions Access to decentralized treatment coupled with the rapid diagnosis of RR-TB has resulted in short time to treatment initiation. Despite the lack of treatment delays, early treatment outcomes remain poor with high rates of death and loss from care. PMID:27812140

Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years

PubMed Central

Li, David K; Freedman, Mark S; Truffinet, Philippe; Benzerdjeb, Hadj; Wang, Dazhe; Bar-Or, Amit; Traboulsee, Anthony L; Reiman, Lucy E; O’Connor, Paul W

2012-01-01

Background: Teriflunomide, an oral disease-modifying therapy in development for patients with relapsing forms of multiple sclerosis (RMS), was well tolerated and effective in reducing magnetic resonance imaging (MRI) lesions in 179 RMS patients in a phase 2 36-week, placebo-controlled study. Methods: A total of 147 patients who completed the core study entered an open-label extension. Teriflunomide patients continued their assigned dose, and placebo patients were re-allocated to teriflunomide, 7 mg/day or 14 mg/day. An interim analysis was performed at a cut-off on January 8 2010. Results: The mean and median duration of study treatment, including both the core and extension phase, from baseline to the interim cut-off, was 5.6 years (standard deviation: 2.7 years) and 7.1 years (range: 0.05–8.5 years), respectively. Of 147 patients, 62 (42.2%) discontinued (19% due to treatment-emergent adverse events (TEAEs)). The most common TEAEs were mild infections, fatigue, sensory disturbances and diarrhoea. No serious opportunistic infections occurred, with no discontinuations due to infection. Asymptomatic alanine aminotransferase increases (≤3× upper limit of normal (ULN)) were common (7 mg, 64.2%; 14 mg, 62.1%); increases >3×ULN were similar across groups (7 mg, 12.3%; 14 mg, 12.1%). Mild decreases in neutrophil counts occurred; none led to discontinuation. The incidence of malignancies was comparable to that of the general population, and cases were not reminiscent of those observed in immunocompromised patients. Annualised relapse rates remained low, minimal disability progression was observed, with a dose-dependent benefit with teriflunomide 14 mg for several MRI parameters. Conclusion: Teriflunomide had a favourable safety profile for up to 8.5 years. PMID:22307384

Experiences with an adaptive design for a dose-finding study in patients with osteoarthritis.

PubMed

Miller, Frank; Björnsson, Marcus; Svensson, Ola; Karlsten, Rolf

2014-03-01

Dose-finding studies in non-oncology areas are usually conducted in Phase II of the development process of a new potential medicine and it is key to choose a good design for such a study, as the results will decide if and how to proceed to Phase III. The present article has focus on the design of a dose-finding study for pain in osteoarthritis patients treated with the TRPV1 antagonist AZD1386. We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis. Three alternatives were proposed: one single dose-finding study with parallel design, a programme with a smaller Phase IIa study followed by a Phase IIb dose-finding study, and an adaptive dose-finding study. We describe these alternatives in detail and explain why the adaptive design was chosen for the study. We give insights in design aspects of the adaptive study, which need to be pre-planned, like interim decision criteria, statistical analysis method and setup of a Data Monitoring Committee. Based on the interim analysis it was recommended to stop the study for futility since AZD1386 showed no significant pain decrease based on the primary variable. We discuss results and experiences from the conduct of the study with the novel design approach. Huge cost savings have been done compared to if the option with one dose-finding design for Phase II had been chosen. However, we point out several challenges with this approach. Copyright © 2014 Elsevier Inc. All rights reserved.

Latex and microsilica modified concrete bridge deck overlays in Oregon : interim report.

DOT National Transportation Integrated Search

1994-08-01

This interim report presented information collected from 24 bridge deck overlays constructed in Oregon between 1989 and 1993. Decks were placed on a variety of existing structures using hydroblasting, milling and diamond grinding surface preparation....

Autonomy Level Specification for Intelligent Autonomous Vehicles

DTIC Science & Technology

2003-09-01

Autonomy Level Specification for Intelligent Autonomous Vehicles : Interim Progress Report Hui-Min Huang, Elena Messina, James Albus...Level Specification for Intelligent Autonomous Vehicles : Interim Progress Report 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6

Evaluation of experimental rumble strip areas in Louisiana : interim report No. 1.

DOT National Transportation Integrated Search

1985-03-01

This interim report was prepared to provide a review of nineteen rumble strip areas installed experimentally in Louisiana between August 1982 and September 1983. Situated randomly throughout central and southern Louisiana, construction of these coars...

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...

Effects of highway deicing chemicals on shallow unconsolidated aquifers in Ohio, interim report, 1988-93

USGS Publications Warehouse

Jones, A.L.; Sroka, B.N.

1997-01-01

Effects of the application of highway deicing chemicals during winter months on ground- water quality are being studied by the U.S. Geological Survey in cooperation with the Ohio Department of Transportation and the Federal Highway Administration. Eight sites throughout the State were selected along major undivided highways where drainage is by open ditches and ground-water flow is approximately perpendicular to the highway. At these sites, records of deicer application rates are being kept and apparent movement of deicing chemicals through shallow, unconsolidated aquifers is being monitored by means of periodic measurements of specific con ductance and concentrations of dissolved sodium, calcium, and chloride. The counties and corre sponding sections of state routes being monitored are the following: State Route (SR) 3 in Ashland County, SR 84 in Ashtabula County, SR 29 in Champaign County, SR 4 in Clark County, SR 2 in Lucas County, SR 104 in Pickaway County, SR 14 in Portage County, and SR 97 in Richland County. The study began in January 1988 with background data collection, extensive literature review, and site selection. This process, including drilling of wells at the eight selected sites, lasted 3 years. Routine ground-water sampling at 4- to 6-week intervals began in January 1991. A relatively new type of multilevel, passive flow ground-water sampling device was constructed and used. Other conditions monitored on a regular basis included ground-water level (monitored con tinuously), specific conductance, air and soil temperature, precipitation, chloride concentration in soil samples, ground conductivity, and deicing chemical application times and rates. For the interim reporting period, water samples were collected from January 1991 through September 1993. Evidence from water analysis, specific conductance measurements, and surface geophysical measurements indicates that four of the eight sites (Ashtabula County, Lucas County, Portage County, and Richland County sites) are potentially affected by direct application of deic ing chemicals. Climatic data from the period January 1991 through September 1993 show that cold weather, and therefore deicing chemical application rates, varied widely across the State. As a consequence, only minor traces of dissolved chloride above background concentrations (mean, 12-25 mg/L) were determined in ground-water samples from the Pickaway County, Clark County, and Champaign County sites. At the Ashland and Richland County sites, dissolved chlo ride concentrations increased above background concentrations (from the upgradient well, pre sumably unaffected by road salt) only intermittently (mean background concentrations of 3-25 mg/L, rising to a mean of 49-77 mg/L). For the interim reporting period, the mean dissolved chloride concentration for all downgradient wells was about 2 times the background concentra tion (25mg/L) at the Ashland County site (50 mg/L) and 14 times the background concentration (3 mg/L) at the Richland County site (40 mg/L). At the Lucas County, Portage County, and Ash tabula County sites, deicing-chemical application was consistent throughout the winter, and downgradient dissolved chloride concentrations rarely returned to background concentrations (mean 6-32 mg/L) throughout the period. For the interim reporting period, the mean dissolved chloride concentration for all downgradient wells was about 3 times the background concentra tion at the Lucas County site (92 mg/L), 72 times the background concentration at the Portage County site (432 mg/L, 2 downgradient wells), and 21 times the background concentration at the Ashtabula County site (279 mg/L). Other factors that may affect the movement of deicing chemicals through the aquifer were examined, such as precipitation amounts; the types of subsurface materials; ground-water velocity and gradient; hydraulic conductivity; soil type; land use; and ODOT deicing priority. A final report is planned for 2001 afte

Evaluation of internal fit of interim crown fabricated with CAD/CAM milling and 3D printing system.

PubMed

Lee, Wan-Sun; Lee, Du-Hyeong; Lee, Kyu-Bok

2017-08-01

This study is to evaluate the internal fit of the crown manufactured by CAD/CAM milling method and 3D printing method. The master model was fabricated with stainless steel by using CNC machine and the work model was created from the vinyl-polysiloxane impression. After scanning the working model, the design software is used to design the crown. The saved STL file is used on the CAD/CAM milling method and two types of 3D printing method to produce 10 interim crowns per group. Internal discrepancy measurement uses the silicon replica method and the measured data are analyzed with One-way ANOVA to verify the statistic significance. The discrepancy means (standard deviation) of the 3 groups are 171.6 (97.4) µm for the crown manufactured by the milling system and 149.1 (65.9) and 91.1 (36.4) µm, respectively, for the crowns manufactured with the two types of 3D printing system. There was a statistically significant difference and the 3D printing system group showed more outstanding value than the milling system group. The marginal and internal fit of the interim restoration has more outstanding 3D printing method than the CAD/CAM milling method. Therefore, the 3D printing method is considered as applicable for not only the interim restoration production, but also in the dental prosthesis production with a higher level of completion.

Acoustic emission monitoring of steel bridge members : interim report.

DOT National Transportation Integrated Search

1995-01-01

This interim report describes the current status of acoustic emission (AE) monitoring of steel bridge members. The report includes a brief introduction to the theory of acoustic emission and a comprehensive summary of previous efforts to apply AE mon...

33 CFR 385.38 - Interim goals.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... (ii) Improvement in water quality; including: (A) Total phosphorus concentrations in the Everglades...) Increases in total spatial extent of restored wetlands; (B) Improvement in habitat quality; and (C... implementation process. In addition, interim goals will facilitate adaptive management and allow the Corps of...

16 CFR 1209.1 - Scope and application.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM... part 1209, an interim consumer product safety standard, prescribes flame resistance and corrosiveness requirements for cellulose insulation that is a consumer product. These requirements are intended to reduce or...

16 CFR 1209.1 - Scope and application.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM... part 1209, an interim consumer product safety standard, prescribes flame resistance and corrosiveness requirements for cellulose insulation that is a consumer product. These requirements are intended to reduce or...