Literature Review. Aquatic Resources Investigation, Rocky Mountain Arsenal. Phase I

DTIC Science & Technology

1987-08-26

COMPOSITION , AND PAST MANAGEMENT RESOURCES 2. ASSESS THE CONTAMINATION HISTORY OF THOSE RESOURCES 3. PROVIDE A BASIS FOR DESIGNING MORE DETAILED PHASE II...terms of habitat, species composition , and past management practices, (2) assess the contamination history of those resources, and (3) provide a basis for...governmental documents from the Rocky Mountain Arsenal, U.S. Fish and Wildlife Service, and Army Corps of Engineers; Shell Oil Company documents; and

Central State University: Phase III Report

ERIC Educational Resources Information Center

Ohio Board of Regents, 2013

2013-01-01

This document is the final report on Central State University's implementation of Section 371 of Ohio Amended Substitute House Bill 153. Implementation of Phase I action items required that deliverables and timelines be shifted to give Central State the best opportunity for early success. In Phase II, Central State responded aggressively to a…

Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

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

Pugliese, S.M.

1977-02-01

In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

Preparation, Properties, and Development of Calcium Lanthanum Sulfide as an 8- to 12-micrometer Transmitting Ceramic

DTIC Science & Technology

1989-09-01

Advanced Optical Ceramics Phase "O," by S. Musikant , R. A. Tanzilli, R. J. Charles, G. A. Slack, W. White, and R. M. Cannon. Philadelphia, Penna...1977-February 15, 1978, GE Document No. 78SDR2195.) 2. -----.- Advanced Optical Ceramics, Phase II, by S. Musikant , R. M. Cannon, Jr., C. E. Dulka, J...Document DIN:80SDR2172.) 3. - .....- Advanced Optical Ceramics, Phase I, by S. Musikant , R. M. Cannon, Jr., C. E. Dulka, A. Gatti, J. J. Gebhardt, W. A

SEDIMENT TOXICITY IDENTIFICATION EVALUATION (TIE)PHASE I,II,III GUIDANCE DOCUMENT

EPA Science Inventory

Sediment contamination in the United States has been amply documented and, in order to comply with the 1972 Clean Water Act, the U.S. Environmental Protection Agency must address the issue of toxic sediments. Contaminated sediments from a number of freshwater and marine sites hav...

Alabama Coronary Artery Bypass Grafting Project

PubMed Central

Holman, William L.; Sansom, Monique; Kiefe, Catarina I.; Peterson, Eric D.; Hubbard, Steve G.; Delong, James F.; Allman, Richard M.

2004-01-01

Objective/Background: This report describes the first round of results for Phase II of the Alabama CABG Project, a regional quality improvement initiative. Methods: Charts submitted by all hospitals in Alabama performing CABG (ICD-9 codes 36.10–36.20) were reviewed by a Clinical Data Abstraction Center (CDAC) (preintervention 1999–2000; postintervention 2000–2001). Variables that described quality in Phase I were abstracted for Phase II and data describing the new variables of β-blocker use and lipid management were collected. Data samples collected onsite by participating hospitals were used for rapid cycle improvement in Phase II. Results: CDAC data (n = 1927 cases in 1999; n = 2001 cases in 2000) showed that improvements from Phase I in aspirin prescription, internal mammary artery use, and duration of intubation persisted in Phase II. During Phase II, use of β-blockers before, during, or after CABG increased from 65% to 76% of patients (P < 0.05). Appropriate lipid management, an aggregate variable, occurred in 91% of patients before and 91% after the educational intervention. However, there were improvements in 3 of 5 subcategories for lipid management (documenting a lipid disorder [52%–57%], initiating drug therapy [45%–53%], and dietary counseling [74%–91%]; P < 0.05). Conclusions: In Phase II, this statewide process-oriented quality improvement program added two new measures of quality. Achievements of quality improvement from Phase I persisted in Phase II, and improvements were seen in the new variables of lipid management and perioperative use of β-blockers. PMID:14685107

77 FR 76435 - Connect America Fund

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-28

... excluding Phase I fiber from Phase II support is that the Bureau would not likely receive information... carriers should be restricted in building fiber, what information carriers should be required to provide... additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document...

Validation and refinement of mixture volumetric material properties identified in superpave monitoring project II : phase II : [summary].

DOT National Transportation Integrated Search

2015-02-01

Superpave is a set of methods and materials for asphalt paving and the primary method : used by the Florida Department of Transportation. It is well documented that performance : of asphalt mixtures is strongly affected by size composition of aggrega...

Thermodynamic, crystallographic, and dielectric study of the nature of glass transitions in cyclo-octanol

NASA Astrophysics Data System (ADS)

Puertas, Ricardo; Rute, Maria A.; Salud, Josep; López, David O.; Diez, Sergio; van Miltenburg, J. Kees; Pardo, Luis C.; Tamarit, Josep Ll.; Barrio, Maria; Pérez-Jubindo, Miguel A.; de La Fuente, Maria R.

2004-06-01

The stable solid polymorphism of cyclooctanol (C8H16O, for short C8 OH) is revealed to be a complex problem and only two stable solid phases, denoted on cooling from the liquid as phases I and II, are found using static (thermodynamic and x-ray diffraction) as well as dynamic (dielectric spectroscopy) experimental techniques. Both solid phases are known to exhibit glass transitions if they are cooled down fast enough to prevent transition to ordered crystalline states. Although glass transitions corresponding to both phases had been well documented by means of specific heat measurements, x-ray measurements constitute, as far as we know, the first evidence from the structural point of view. In addition, a great amount of dielectric works devoted to phase I and its glass transition, were published in the past but next to nothing relating to the dielectric properties of phase II and its glass transition. The nature of the disorder of phase II will be discussed.

Design specifications for NALDA (Naval Aviation Logistics Data Analysis) CAI (computer aided instruction): Phase 2, Interim report

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

Twitty, A.F.; Handler, B.H.; Duncan, L.D.

Data Systems Engineering Organization (DSEO) personnel are developing a prototype computer aided instruction (CAI) system for the Naval Aviation Logistics Data Analysis (NALDA) system. The objective of this project is to provide a prototype for implementing CAI as an enhancement to existing NALDA training. The CAI prototype project is being performed in phases. The task undertaken in Phase I was to analyze the problem and the alternative solutions and to develop a set of recommendations on how best to proceed. In Phase II a structured design and specification document was completed that will provide the basis for development and implementationmore » of the desired CAI system. Phase III will consist of designing, developing, and testing a user interface which will extend the features of the Phase II prototype. The design of the CAI prototype has followed a rigorous structured analysis based on Yourdon/DeMarco methodology and Information Engineering tools. This document includes data flow diagrams, a data dictionary, process specifications, an entity-relationship diagram, a curriculum description, special function key definitions, and a set of standards developed for the NALDA CAI Prototype.« less

Acid Rain Guidance On Phase II Permitting NOx And Opt-ins

EPA Pesticide Factsheets

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

PubMed Central

Butler, Javed; Hamo, Carine E.; Udelson, James E.; O’Connor, Christopher; Sabbah, Hani N.; Metra, Marco; Shah, Sanjiv J.; Kitzman, Dalane W.; Teerlink, John; Bernstein, Harold S.; Brooks, Gabriel; Depre, Christophe; DeSouza, Mary M.; Dinh, Wilfried; Donovan, Mark; Frische-Danielson, Regina; Frost, Robert J.; Garza, Dahlia; Gohring, Udo-Michael; Hellawell, Jennifer; Hsia, Judith; Ishihara, Shiro; Kay-Mugford, Patricia; Koglin, Joerg; Kozinn, Marc; Larson, Christopher J.; Mayo, Martha; Gan, Li-Ming; Mugnier, Pierrre; Mushonga, Sekayi; Roessig, Lothar; Russo, Cesare; Salsali, Afshin; Satler, Carol; Shi, Victor; Ticho, Barry; van der Laan, Michael; Yancy, Clyde; Stockbridge, Norman; Gheorghiade, Mihai

2017-01-01

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue regarding the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17th 2016 represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions. PMID:28356300

Malignant pleural mesothelioma: a phase II trial with docetaxel.

PubMed

Vorobiof, D A; Rapoport, B L; Chasen, M R; Abratt, R P; Cronje, N; Fourie, L; McMichael, G; Hacking, D

2002-03-01

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

Goals of patient care system change with video-based education increases rates of advance cardiopulmonary resuscitation decision-making and discussions in hospitalised rehabilitation patients.

PubMed

Johnson, Claire E; Chong, Jeffrey C; Wilkinson, Anne; Hayes, Barbara; Tait, Sonia; Waldron, Nicholas

2017-07-01

Advance cardiopulmonary resuscitation (CPR) discussions and decision-making are not routine clinical practice in the hospital setting. Frail older patients may be at risk of non-beneficial CPR. To assess the utility and safety of two interventions to increase CPR decision-making, documentation and communication for hospitalised older patients. A pre-post study tested two interventions: (i) standard ward-based education forums with CPR content; and (ii) a combined, two-pronged strategy with 'Goals of Patient Care' (GoPC) system change and a structured video-based workshop; against usual practice (i.e. no formal training). Participants were a random sample of patients in a hospital rehabilitation unit. The outcomes were the proportion of patients documented as: (i) not for resuscitation (NFR); and (ii) eligible for rapid response team (RRT) calls, and rates of documented discussions with the patient, family and carer. When compared with usual practice, patients were more likely to be documented as NFR following the two-pronged intervention (adjusted odds ratio (aOR): 6.4, 95% confidence interval (CI): 3.0; 13.6). Documentation of discussions with patients was also more likely (aOR: 3.3, 95% CI:1.8; 6.2). Characteristics of patients documented NFR were similar between the phases, but were more likely for RRT calls following Phase 3 (P 0.03). An increase in advance CPR decisions occurred following GoPC system change with education. This appears safe as NFR patients had the same level of frailty between phases but were more likely to be eligible for RRT review. Increased documentation of discussions suggests routine use of the GoPC form may improve communication with patients about their care. © 2017 Royal Australasian College of Physicians.

Benefits and Sustainability of a Learning Collaborative for Implementation of Treat to Target in Rheumatoid Arthritis: Results of the TRACTION Trial Phase II.

PubMed

Solomon, Daniel H; Lu, Bing; Yu, Zhi; Corrigan, Cassandra; Harrold, Leslie R; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N; Losina, Elena

2018-01-05

We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence. We recruited 11 rheumatology sites and randomized them to either receive the LC during Phase I or to a wait-list control group that received the LC intervention during Phase II. The outcome was change in TTT implementation score (0 to 100, 100 is best) from pre- to post-intervention. TTT implementation score is defined as a percent of components documented in visit notes. Analyses examined: 1) the extent that the Phase I intervention teams sustained improvement in TTT; and, 2) predictors of TTT improvement. The analysis included 636 RA patients. At baseline, mean TTT implementation score was 11% in Phase I intervention sites and 13% in Phase II sites. After the intervention, TTT implementation score improved to 57% in the Phase I intervention sites and to 58% in the Phase II sites. Intervention sites from Phase I sustained the improvement during the Phase II (52%). Predictors of greater TTT improvement included only having rheumatologist providers at the site, academic affiliation of the site, fewer providers per site, and the rheumatologist provider being a trainee. Improvement in TTT remained relatively stable over a post-intervention period. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

(Environmental investigation of ground water contamination at Wright-Patterson Air Force Base, Ohio)

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

Not Available

1992-04-01

This Removal Action System Design has been prepared as a Phase I Volume for the implementation of the Phase II removal action at Wright-Patterson Air Force Base (WPAFB) near Dayton, Ohio. The objective of the removal action is to prevent, to the extent practicable, the migration of ground water contaminated with chlorinated volatile organic compounds (VOCS) across the southwest boundary of Area C. The Phase 1, Volume 9 Removal Action System Design compiles the design documents prepared for the Phase II Removal Action. These documents, which are presented in Appendices to Volume 9, include: Process Design, which presents the 30more » percent design for the ground water treatment system (GWTS); Design Packages 1 and 2 for Earthwork and Road Construction, and the Discharge Pipeline, respectively; no drawings are included in the appendix; Design Package 3 for installation of the Ground Water Extraction Well(s); Design Package 4 for installation of the Monitoring Well Instrumentation; and Design Package 5 for installation of the Ground Water Treatment System; this Design Package is incorporated by reference because of its size.« less

Arterial signal timing optimization using PASSER II-87

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

Chang, E.C.P.; Messer, C.J.; Garza, R.U.

1988-11-01

PASSER is the acronym for the Progression Analysis and Signal System Evaluation Routine. PASSER II was originally developed by the Texas Transportation Institute (TTI) for the Dallas Corridor Project. The Texas State Department of Highways and Public Transportation (SDHPT) has sponsored the subsequent program development on both mainframe computers and microcomputers. The theory, model structure, methodology, and logic of PASSER II have been evaluated and well documented. PASSER II is widely used because of its ability to easily select multiple-phase sequences by adjusting the background cycle length and progression speeds to find the optimal timing plants, such as cycle, greenmore » split, phase sequence, and offsets, that can efficiently maximize the two-way progression bands.« less

Phase I and II feasibility study report for the 300-FF-5 operable unit

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

NONE

1993-12-31

The purpose of this Phase I/II feasibility study is to assemble and screen a list of alternatives for remediation of the 300-FF-5 operable site on the Hanford Reservation. This screening is based on information gathered in the Phase I Remedial Investigation (RI) and on currently available information on remediation technologies. The alternatives remaining after screening provide a range of response actions for remediation. In addition, key data needs are identified for collection during a Phase II RI (if necessary). This Phase I/II FS represents a primary document as defined by the Tri-Party Agreement, but will be followed by a Phasemore » III FS that will further develop the alternatives and provide a detailed evaluation of them. The following remedial action objectives were identified for the 300-FF-5 operable unit: Limit current human exposure to contaminated groundwater in the unit; Limit discharge of contaminated groundwater to the Columbia River; Reduce contaminant concentrations in groundwater below acceptable levels by the year 2018.« less

Documents for SBAR Panel: NPDES Comprehensive Storm Water Phase II Regulations

EPA Pesticide Factsheets

SBAR panel on proposed regulations to address currently unregulated discharges of storm water and provide regulatory relief to industrial facilities where industrial materials and activities are not exposed to storm water

Correlation of patient entry rates and physician documentation errors in dictated and handwritten emergency treatment records.

PubMed

Dawdy, M R; Munter, D W; Gilmore, R A

1997-03-01

This study was designed to examine the relationship between patient entry rates (a measure of physician work load) and documentation errors/omissions in both handwritten and dictated emergency treatment records. The study was carried out in two phases. Phase I examined handwritten records and Phase II examined dictated and transcribed records. A total of 838 charts for three common chief complaints (chest pain, abdominal pain, asthma/chronic obstructive pulmonary disease) were retrospectively reviewed and scored for the presence or absence of 11 predetermined criteria. Patient entry rates were determined by reviewing the emergency department patient registration logs. The data were analyzed using simple correlation and linear regression analysis. A positive correlation was found between patient entry rates and documentation errors in handwritten charts. No such correlation was found in the dictated charts. We conclude that work load may negatively affect documentation accuracy when charts are handwritten. However, the use of dictation services may minimize or eliminate this effect.

Practice versus knowledge when it comes to pressure ulcer prevention.

PubMed

Provo, B; Piacentine, L; Dean-Baar, S

1997-09-01

This study was completed to determine the current knowledge and documentation patterns of nursing staff in the prevention of pressure ulcers and to identify the prevalence of pressure ulcers. This pre-post intervention study was carried out in three phases. In phase 1, 67 nursing staff members completed a modified version of Bostrom's Patient Skin Integrity Survey. A Braden Scale score, the presence of actual skin breakdown, and the presence of nursing documentation were collected for each patient (n = 43). Phase II consisted of a 20-minute educational session to all staff. In phase III, 51 nursing staff completed a second questionnaire similar to that completed in phase I. Patient data (n = 49) were again collected using the same procedure as phase I. Twenty-seven staff members completed questionnaires in both phase I and phase III of the study. No statistically significant differences were found in the knowledge of the staff before or after the educational session. The number of patients with a documented plan of care showed a statistically significant difference from phase I to phase III. The number of patients with pressure ulcers or at risk for pressure ulcer development (determined by a Braden Scale score of 16 or less) did not differ statistically from phase I to phase III. Knowledge about pressure ulcers in this sample of staff nurses was for the most part current and consistent with the recommendations in the Agency for Health Care Policy and Research guideline. Documentation of pressure ulcer prevention and treatment improved after the educational session. Although a significant change was noted in documentation, it is unclear whether it reflected an actual change in practice.

Plug-and-play initiative : phase II : final report.

DOT National Transportation Integrated Search

2017-01-01

Clear Roads has undertaken an initiative to establish a Plug-and-Play protocol that fosters interoperability between various winter maintenance equipment and a point location (central office). This report documents the data types and communication me...

Rigid Polyurethane Foam (RPF) Technology for Countermines (Sea) Program Phase II

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

WOODFIN,RONALD L.; FAUCETT,DAVID L.; HANCE,BRADLEY G.

This Phase II report documents the results of one subtask initiated under the joint Department of Energy (DOE)/Department of Defense (DoD) Memorandum of Understanding (MOU) for Countermine Warfare. The development of Rigid Polyurethane Foams for neutralization of mines and barriers in amphibious assault was the objective of the tasking. This phase of the program concentrated on formation of RPF in water, explosive mine simulations, and development of foam and fabric pontoons. Field experimentation was done primarily at the Energetic Materials Research and Testing Center (EMRTC) of the New Mexico Institute of Mining and Technology, Socorro, NM between February 1996 andmore » September 1998.« less

Lower Colorado River Proposed General Permit Main Report and Final Environmental Impact Statement.

DTIC Science & Technology

1982-04-01

developed in two phases. Phase I consisted of the compilation of a data base establishing pertinent environmental parameters and inventorying resources...The result of Phase 1 investigations was a document entitled "Preliminary Enviornmental Resources Inventory Report (PERIR), Vols. I and II", dated...upstream just belo-1arker Dam, and river access is limited. Further, fewer pleasure boaters and water skiers are present. For these reasons, fishing is more

Aircrew Training Devices: Utility and Utilization of Advanced Instructional Features (Phase II-Air Training Command, Military Airlift Command, and Strategic Air Command [and] Phase III-Electronic Warfare Trainers).

ERIC Educational Resources Information Center

Polzella, Donald J.; Hubbard, David C.

This document consists of an interim report and a final report which describe the second and third phases of a project designed to determine the utility and utilization of sophisticated hardware and software capabilities known as advanced instructional features (AIFs). Used with an aircrew training device (ATD), AIFs permit a simulator instructor…

[Environmental investigation of ground water contamination at Wright-Patterson Air Force Base, Ohio]. Volume 9, Removal action system design

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

Not Available

1992-04-01

This Removal Action System Design has been prepared as a Phase I Volume for the implementation of the Phase II removal action at Wright-Patterson Air Force Base (WPAFB) near Dayton, Ohio. The objective of the removal action is to prevent, to the extent practicable, the migration of ground water contaminated with chlorinated volatile organic compounds (VOCS) across the southwest boundary of Area C. The Phase 1, Volume 9 Removal Action System Design compiles the design documents prepared for the Phase II Removal Action. These documents, which are presented in Appendices to Volume 9, include: Process Design, which presents the 30more » percent design for the ground water treatment system (GWTS); Design Packages 1 and 2 for Earthwork and Road Construction, and the Discharge Pipeline, respectively; no drawings are included in the appendix; Design Package 3 for installation of the Ground Water Extraction Well(s); Design Package 4 for installation of the Monitoring Well Instrumentation; and Design Package 5 for installation of the Ground Water Treatment System; this Design Package is incorporated by reference because of its size.« less

Subsonic Ultra Green Aircraft Research Phase II: N+4 Advanced Concept Development

NASA Technical Reports Server (NTRS)

Bradley, Marty K.; Droney, Christopher K.

2012-01-01

This final report documents the work of the Boeing Subsonic Ultra Green Aircraft Research (SUGAR) team on Task 1 of the Phase II effort. The team consisted of Boeing Research and Technology, Boeing Commercial Airplanes, General Electric, and Georgia Tech. Using a quantitative workshop process, the following technologies, appropriate to aircraft operational in the N+4 2040 timeframe, were identified: Liquefied Natural Gas (LNG), Hydrogen, fuel cell hybrids, battery electric hybrids, Low Energy Nuclear (LENR), boundary layer ingestion propulsion (BLI), unducted fans and advanced propellers, and combinations. Technology development plans were developed.

Phase II Study Proposal Briefs.

ERIC Educational Resources Information Center

National Center for the Study of Postsecondary Educational Supports, Honolulu, HI.

This document collects 23 study proposal briefs presented to the National Center for the Study of Postsecondary Educational Supports. The proposals address the following topics concerned with postsecondary services for students with disabilities: cultural empowerment, longitudinal analysis of postsecondary students' experience, effective models of…

A stable isotope tracer study of the influences of adjacent land use and riparian condition on fates of nitrate in streams

Treesearch

Daniel J. Sobota; Sherri L. Johnson; Stan V. Gregory; Linda R. Ashkenas

2012-01-01

The influence of land use on potential fates of nitrate in stream ecosystems, ranging from denitrification to storage in organic matter, has not been documented extensively. Here, we describe the Pacific Northwest component of Lotic Intersite Nitrogen eXperiment, phase II (LINX II) to examine how land-use setting influences fates of nitrate in streams.

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

Noel, Donna

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

On-Line Retrieval II.

ERIC Educational Resources Information Center

Kurtz, Peter; And Others

This report is concerned with the implementation of two interrelated computer systems: an automatic document analysis and classification package, and an on-line interactive information retrieval system which utilizes the information gathered during the automatic classification phase. Well-known techniques developed by Salton and Dennis have been…

Robust Requirements Tracing via Internet Search Technology: Improving an IV and V Technique. Phase 2

NASA Technical Reports Server (NTRS)

Hayes, Jane; Dekhtyar, Alex

2004-01-01

There are three major objectives to this phase of the work. (1) Improvement of Information Retrieval (IR) methods for Independent Verification and Validation (IV&V) requirements tracing. Information Retrieval methods are typically developed for very large (order of millions - tens of millions and more documents) document collections and therefore, most successfully used methods somewhat sacrifice precision and recall in order to achieve efficiency. At the same time typical IR systems treat all user queries as independent of each other and assume that relevance of documents to queries is subjective for each user. The IV&V requirements tracing problem has a much smaller data set to operate on, even for large software development projects; the set of queries is predetermined by the high-level specification document and individual requirements considered as query input to IR methods are not necessarily independent from each other. Namely, knowledge about the links for one requirement may be helpful in determining the links of another requirement. Finally, while the final decision on the exact form of the traceability matrix still belongs to the IV&V analyst, his/her decisions are much less arbitrary than those of an Internet search engine user. All this suggests that the information available to us in the framework of the IV&V tracing problem can be successfully leveraged to enhance standard IR techniques, which in turn would lead to increased recall and precision. We developed several new methods during Phase II; (2) IV&V requirements tracing IR toolkit. Based on the methods developed in Phase I and their improvements developed in Phase II, we built a toolkit of IR methods for IV&V requirements tracing. The toolkit has been integrated, at the data level, with SAIC's SuperTracePlus (STP) tool; (3) Toolkit testing. We tested the methods included in the IV&V requirements tracing IR toolkit on a number of projects.

Joint Test Report For Validation of Alternatives to Aliphatic Isocyanate Polyurethanes

NASA Technical Reports Server (NTRS)

Lewis, Pattie

2007-01-01

National Aeronautics and Space Administration (NASA) and Air Force Space Command (AFSPC) have similar missions and therefore similar facilities and structures in similar environments. The standard practice for protecting metallic substrates in atmospheric environments is the application of an applied coating system. The most common topcoats used in coating systems are polyurethanes that contain isocyanates. Isocyanates are classified as potential human carcinogens and are known to cause cancer in animals. The primary objective of this effort was to demonstrate and validate alternatives to aliphatic isocyanate polyurethanes resulting in one or more isocyanate-free coatings qualified for use at AFSPC and NASA installations participating in this project. This joint Test Report (JTR) documents the results of the laboratory and field testing as well as any test modifications made during the execution of the testing. The technical stakeholders agreed upon test procedure modifications documented in this document. This JTR is made available as a reference for future pollution prevention endeavors by other NASA centers, the Department of Defense and commercial users to minimize duplication of effort. All coating system candidates were tested using approved NASA and AFSPC standard coating systems as experimental controls. This study looked at eight alternative coating systems and two control coating systems and was divided into Phase I Screening Tests, Phase II Tests, and Field Testing. The Phase I Screening Tests were preliminary tests performed on all the selected candidate coating systems. Candidate coating systems that did not meet the acceptance criteria of the screening tests were eliminated from further testing. Phase I Screening Tests included: Ease of Application, Surface Appearance, Dry-To-Touch (Sanding), Accelerated Storage Stability, Pot Life (Viscosity), Cure Time (Solvent Rubs), Cleanability, Knife Test, Tensile (pull-off) Adhesion, and X-Cut Adhesion by Wet Tape After a review of the Phase I test results, four of the alternative coating systems showed substandard performance in relation to the Control Systems and were eliminated from the Phase II testing. Due to the interest of stakeholders and time constraints, however, all eight alternatives were subjected to the following Phase II tests, along with field testing at Stennis Space Center (SSC), Mississippi: Hypergol Compatibility, Liquid Oxygen Compatibility, 18-Month Marine Exposure (Gloss Retention, Color Retention, Blistering, Visual Corrosion, Creepage from Scribe, Heat Adhesion), and Field Exposure (6- and 12-month Evaluation for Coating Condition, Color Retention, Gloss Retention). The remaining four alternative coating systems determined to be the best viable alternatives were carried on to Phase II testing that included: Removability, Repairability, Abrasion Resistance, Gravelometer, Fungus Resistance, Accelerated Weathering, Mandrel Bend Flexibility, and Cyclic Corrosion Resistance. Of the systems that continued to Phase II, three (3) alternative coating systems meet the performance requirements as identified by stakeholders. Two (2) other systems, that were not included in Phase II testing, performed well enough on the 18-Month Marine Exposure, the primary requirement for NASA technical standard NASA-STD-5008, Protective Coating of Carbon Steel, Stainless Steel, and Aluminum on Launch Structures, Facilities, and Ground Support Equipment, that they were also considered to be successful candidates. In total, five (5) alternative coating systems were approved for inclusion in the NASA-STD- 5008 Qualified Products List (QPL). The standard is intended to provide a common framework for consistent practices across NASA and is often used by other entities. The standard's QPL does not connote endorsement of the products by NASA, but lists those products that have been tested and meet the requirements as specified.

Cradle-to-gate life-cycle inventory of U.S. wood products production: CORRIM phase I and phase II products

Treesearch

Maureen E. Puettmann; Richard Bergman; Steve Hubbard; Leonard Johnson; Bruce Lippke; Elaine Oneil; Francis G. Wagner

2010-01-01

This article documents cradle-to-gate life-cycle inventories for softwood lumber, hardwood lumber, and solid-strip hardwood flooring manufacturing from the Inland Northwest and the Northeast–North Central regions of the US. Environmental impacts were measured based on emissions to air and water, solid waste, energy consumption, and resource use. The manufacturing stage...

Mission Connect Mild TBI Translational Research Consortium

DTIC Science & Technology

2010-08-31

symptoms are known to be associated with the study drug, atorvastatin , and they are listed in the Informed Consent document. In this second year of the...confirm that atorvastatin (see note below) given during the acute phase of MTBI has no adverse effects in patients with MTBI NOTE: Due to an...FDA hold on all human studies involving erythropoietin, the neuroprotective agent for this phase II clinical trial was changed to atorvastatin

Field evaluation of asphalt mixture skid resistance and its relationship to aggregate characteristics.

DOT National Transportation Integrated Search

2010-12-01

This report documents the findings from the research that was carried out as part of Phase II of Texas : Department of Transportation (TxDOT) Project 0-5627. The research included measuring and analyzing the : mechanical and physical properties of ag...

Systems to Detect Bacterial Contamination of Banked Blood in a Rapid, Non-Invasive Low Technology Manner. Phase 1.

DTIC Science & Technology

1994-08-25

Department of the Army position, policy or decision unless so designated by other documentation. 94-30800 IIV III !111 IiI I ’ I foron Appr •vedREPORT...copyrighted material is quoted, permission has been obtained to use such material. Where material from documents designated for limited distribution is...Laser Scanning Densitometry for quantitation of the color changes. (6) Narrative: a. Eperimental Methods: 1. Bacteria: Ten bacterial species

Field evaluation of asphalt mixture skid resistance and its relationship to aggregate characteristics.

DOT National Transportation Integrated Search

2011-08-01

This report documents the findings from the research that was carried out as part of Phase II of : TxDOT Project 0-5627. The research included measurements and analysis of mechanical and physical : properties of aggregates used in surface mixes in th...

75 FR 38645 - Standards Improvement Project-Phase III

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

... are specified as ``ID,'' followed by the number of the document. OSHA posts these referenced materials... medical-testing requirement and eliminating an unnecessary and obsolete medical test required in both the... Sec. 1915.1001(h)(4)(ii) requires employers to perform quantitative and qualitative fit testing ``at...

Source Physics Experiment Phase II, Dry Alluvium Geology (DAG) Experiments Using Nitromethane

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

Traeger, Scott R.

Need to provide briefing to the State of Nevada as part of the Permitting process for the Nevada Chemical Accident Prevention Program (CAPP) for use of nitromethane at the NNSS. This document will be accessible to the public as part of the CAPP program.

Meta-Analysis of Human Factors Engineering Studies Comparing Individual Differences, Practice Effects and Equipment Design Variations.

DTIC Science & Technology

1985-02-21

Approvoid foT public 90Ieleol, 2* . tJni7nited " - . - o . - ’--. * . -... . 1 UNCLASSIFIED S, E CURITY CLASSIFICATION OF THIS PAGE-" REPORT DOCUMENTATION...ACCESSION NO. 11. TITLE (Include Security Classification) . Veta -Analysis of Human Factors Engineering Studies Comparing Individual Differences, Practice...Background C Opportunity D Significance E History III. PHASE I FINAL REPORT A Literature Review B Formal Analysis C Results D Implications for Phase II IV

Federal Programs Supporting Educational Change, Vol. VIII: Implementing and Sustaining Innovations.

ERIC Educational Resources Information Center

Berman, Paul; McLaughlin, Milbrey Wallin

This report reviews and synthesizes the findings of a four year, two-phase study conducted by the Rand Corporation to examine and evaluate a national sample of educational innovations funded by Federal programs. Section I of this document provides background information and descriptions of the study. Section II discusses Rand's research approach…

77 FR 38804 - Wireline Competition Bureau Seeks Comment on Model Design and Data Inputs for Phase II of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

...In this document, the Wireline Competition Bureau (the Bureau) seeks comment on a number of threshold decisions regarding the design of and data inputs to the forward looking cost model, and on other assumptions in the cost models currently in the record.

SLURM: Simple Linux Utility for Resource Management

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

Jette, M; Dunlap, C; Garlick, J

2002-04-24

Simple Linux Utility for Resource Management (SLURM) is an open source, fault-tolerant, and highly scalable cluster management and job scheduling system for Linux clusters of thousands of nodes. Components include machine status, partition management, job management, and scheduling modules. The design also includes a scalable, general-purpose communication infrastructure. Development will take place in four phases: Phase I results in a solid infrastructure; Phase II produces a functional but limited interactive job initiation capability without use of the interconnect/switch; Phase III provides switch support and documentation; Phase IV provides job status, fault-tolerance, and job queuing and control through Livermore's Distributed Productionmore » Control System (DPCS), a meta-batch and resource management system.« less

Review of Chemical, Biological, Radiological, and Nuclear (CBRN) Terminology in Technical Guide 316 (TG 316) and Allied Medical Publication 8(C) (AMedP-8(C))

DTIC Science & Technology

2013-05-01

tularensis causing pneumonic tularemia (Aberdeen Proving Ground, MD: USAPHC, January 2012); USAPHC, Technical Guide 316 Supplement F1; USAPHC, Technical...Phase I preliminary BMEGs are completed for anthrax, plague, tularemia , ricin, and Staphylococcal Enterotoxin B (SEB). The Phase II process has been...Exposure to Specified Biological Agents: Brucellosis, Glanders, Q Fever, SEB and Tularemia , IDA Document D-4132 (Alexandria, VA: Institute for Defense

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

Sibbett, B.S.; Nielson, D.L.; Adams, M.C.

This technical report on the Phase II geothermal exploration of Ascension Island documents the data collected during thermal gradient drilling and the subsequent thermal and fluid chemical investigations. It also documents the completion of the Phase II exploration strategy which was proposed at the end of the Phase I--Preliminary Examination of Ascension Island. The thermal gradient drilling resulted in seven holes which range from 206 to 1750 ft (53-533 m) deep, with a cumulative footage of 6563 ft (2000 m). The drilling procedure and the problems encountered during the drilling have been explained in detail to provide information valuable formore » any subsequent drilling program on the island. In addition, the subsurface geology encountered in the holes has been documented and, where possible, correlated with other holes or the geology mapped on the surface of the island. Temperatures measured in the holes reach a maximum of 130 F (54.4 C) at 1285 ft (391.7 m) in hole GH-6. When the temperatures of all holes are plotted against elevation, the holes can be classed into three distinct groups, those which have no thermal manifestations, those with definite geothermal affinities, and one hole which is intermediate between the other two. From consideration of this information, it is clear that the highest geothermal potential on the island is in the Donkey Flat area extending beneath Middleton Ridge, and in the Cricket Valley area. Because of the greater drilling depths and the remote nature of the Cricket Valley area, it is recommended that future exploration concentrate in the area around Middleton Ridge.« less

NALDA (Naval Aviation Logistics Data Analysis) CAI (computer aided instruction)

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

Handler, B.H.; France, P.A.; Frey, S.C.

Data Systems Engineering Organization (DSEO) personnel developed a prototype computer aided instruction CAI system for the Naval Aviation Logistics Data Analysis (NALDA) system. The objective of this project was to provide a CAI prototype that could be used as an enhancement to existing NALDA training. The CAI prototype project was performed in phases. The task undertaken in Phase I was to analyze the problem and the alternative solutions and to develop a set of recommendations on how best to proceed. The findings from Phase I are documented in Recommended CAI Approach for the NALDA System (Duncan et al., 1987). Inmore » Phase II, a structured design and specifications were developed, and a prototype CAI system was created. A report, NALDA CAI Prototype: Phase II Final Report, was written to record the findings and results of Phase II. NALDA CAI: Recommendations for an Advanced Instructional Model, is comprised of related papers encompassing research on computer aided instruction CAI, newly developing training technologies, instructional systems development, and an Advanced Instructional Model. These topics were selected because of their relevancy to the CAI needs of NALDA. These papers provide general background information on various aspects of CAI and give a broad overview of new technologies and their impact on the future design and development of training programs. The paper within have been index separately elsewhere.« less

The Orthopaedic Training Study, Phase II 1968-1972. Final Report Supplement, Psychomotor Skills, Part B.

ERIC Educational Resources Information Center

Olson, Carl J.; And Others

This document, as a supplement to the final report of the Orthopaedic Training Study, presents a discussion of the rationale behind the implementation of a laboratory course in psychomotor skills development for medical students. Medical educators examined resident training in terms of 3 components of cognitive elements of learning: cognitive,…

A Comparative Analysis of Postsecondary Technical Education in Texas. Phase I, Volume II--Appendices.

ERIC Educational Resources Information Center

Groves, Cecil L.; And Others

In response to concerns of unnecessary duplication in programs offered by Texas community/junior colleges and the Texas State Technical College (TSTC) system, TSTC conducted an examination of curricula, enrollments, and outcomes for both systems. This document provides the second volume of the study, containing the data tables used to generate the…

78 FR 50114 - Distribution of 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, and 2009 Satellite...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

... categories of copyrightable content (e.g., movies, music, and sports programming). At Phase II, the royalties... electronic copy in Portable Document Format (PDF) on a Compact Disc, along with the $150 filing fee, to the... request are: Joint Sports Claimants (JSC), Program Suppliers, Devotional Claimants, [[Page 50115...

Long-Range Plan, Phase II: Implementation Plan, 1994-1999. Holyoke Community College.

ERIC Educational Resources Information Center

Holyoke Community Coll., MA.

The Long-Range Planning Committee at Holyoke Community College (HCC) in Massachusetts has devised a 5-year plan to help the college focus on its most important priorities as it seeks to grow and accommodate change. This planning document identifies seven major institutional goals, objectives comprised by each goal, long-range strategies to achieve…

Improving Quality of Seal Leak Test Product using Six Sigma

NASA Astrophysics Data System (ADS)

Luthfi Malik, Abdullah; Akbar, Muhammad; Irianto, Dradjad

2016-02-01

Seal leak test part is a polyurethane material-based product. Based on past data, defect level of this product was 8%, higher than the target of 5%. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control. In the design phase, a Delphi method was used to identify factors that were critical to quality. In the measure phase, stability and process capability was measured. Fault tree analysis (FTA) and failure mode and effect analysis (FMEA) were used in the next phase to analize the root cause and to determine the priority issues. Improve phase was done by compiling, selecting, and designing alternative repair. Some improvement efforts were identified, i.e. (i) making a checklist for maintenance schedules, (ii) making written reminder form, (iii) modifying the SOP more detail, and (iv) performing a major service to the vacuum machine. To ensure the continuity of improvement efforts, some control activities were executed, i.e. (i) controlling, monitoring, documenting, and setting target frequently, (ii) implementing reward and punishment system, (iii) adding cleaning tool, and (iv) building six sigma organizational structure.

A Conserved Nuclear Cyclophilin Is Required for Both RNA Polymerase II Elongation and Co-transcriptional Splicing in Caenorhabditis elegans

PubMed Central

Ahn, Jeong H.; Rechsteiner, Andreas; Strome, Susan; Kelly, William G.

2016-01-01

The elongation phase of transcription by RNA Polymerase II (Pol II) involves numerous events that are tightly coordinated, including RNA processing, histone modification, and chromatin remodeling. RNA splicing factors are associated with elongating Pol II, and the interdependent coupling of splicing and elongation has been documented in several systems. Here we identify a conserved, multi-domain cyclophilin family member, SIG-7, as an essential factor for both normal transcription elongation and co-transcriptional splicing. In embryos depleted for SIG-7, RNA levels for over a thousand zygotically expressed genes are substantially reduced, Pol II becomes significantly reduced at the 3’ end of genes, marks of transcription elongation are reduced, and unspliced mRNAs accumulate. Our findings suggest that SIG-7 plays a central role in both Pol II elongation and co-transcriptional splicing and may provide an important link for their coordination and regulation. PMID:27541139

The Tumor Suppressor Protein p53 and its Physiological Splicing Variant p53as in a Mouse Mammary Cancer Model

DTIC Science & Technology

1997-10-01

and Biomedical Laboratories. PI - Signature Date TABLE OF CONTENTS Report Documentation Page ii Foreword m Introduction 1-2 Experimental Methods...life studies of P53 or p53as in G1, S, and G2/ M was unsuccessful as reported last year. Long cell cycle times may be responsible for lack of separation...of S-phase 5 cells from G2/ M -phase cells by centrifugal elutriation. Attempts to synchronize cells by density arrest and/or serum starvation resulted

Spray Forming Aluminum - Final Report (Phase II)

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

D. D. Leon

1999-07-08

The U.S. Department of Energy - Office of Industrial Technology (DOE) has an objective to increase energy efficient and enhance competitiveness of American metals industries. To support this objective, ALCOA Inc. entered into a cooperative program to develop spray forming technology for aluminum. This Phase II of the DOE Spray Forming Program would translate bench scale spray forming technology into a cost effective world class process for commercialization. Developments under DOE Cooperative Agreement No. DE-FC07-94ID13238 occurred during two time periods due to budgetary constraints; April 1994 through September 1996 and October 1997 and December 1998. During these periods, ALCOA Incmore » developed a linear spray forming nozzle and specific support processes capable of scale-up for commercial production of aluminum sheet alloy products. Emphasis was given to alloys 3003 and 6111, both being commercially significant alloys used in the automotive industry. The report reviews research performed in the following areas: Nozzel Development, Fabrication, Deposition, Metal Characterization, Computer Simulation and Economics. With the formation of a Holding Company, all intellectual property developed in Phases I and II of the Project have been documented under separate cover for licensing to domestic producers.« less

Automation of the Environmental Control and Life Support System

NASA Technical Reports Server (NTRS)

Dewberry, Brandon S.; Carnes, J. Ray

1990-01-01

The objective of the Environmental Control and Life Support System (ECLSS) Advanced Automation Project is to recommend and develop advanced software for the initial and evolutionary Space Station Freedom (SSF) ECLS system which will minimize the crew and ground manpower needed for operations. Another objective includes capturing ECLSS design and development knowledge for future missions. This report summarizes our results from Phase I, the ECLSS domain analysis phase, which we broke down into three steps: 1) Analyze and document the baselined ECLS system, 2) envision as our goal an evolution to a fully automated regenerative life support system, built upon an augmented baseline, and 3) document the augmentations (hooks and scars) and advanced software systems which we see as necessary in achieving minimal manpower support for ECLSS operations. In addition, Phase I included development of an advanced software life cycle testing tools will be used in the development of the software. In this way, we plan in preparation for phase II and III, the development and integration phases, respectively. Automated knowledge acquisition, engineering, verification, and can capture ECLSS development knowledge for future use, develop more robust and complex software, provide feedback to the KBS tool community, and insure proper visibility of our efforts.

The Heliopause Electrostatic Rapid Transit System (HERTS) Design, Trades, and Analyses Performed in the First Year of a Two Year Investigation

NASA Technical Reports Server (NTRS)

Wiegmann, Bruce M.

2016-01-01

The Heliopause Electrostatic Rapid Transit System (HERTS)1 was one of the seven total Phase II NASA Innovative Advanced Concepts (NIAC) that was down-selected in 2015 for continued funding and research. In Phase I we learned that a spacecraft propelled by an Electric Sail (E-Sail) can travel great astronomical distances, such as to the Heliopause region of the solar system (approx.100 to 120 AU) in approximately one quarter of the time (10 years) versus the time it took the Voyager spacecraft launched in 1977 (36 years). The current work within the Phase II NIAC effort builds upon the work that was done in the Phase I NIAC and is focused on: 1) Testing of plasma interaction with a charged wire in a unique MSFC test chamber, 2) Development of a Particle-in-Cell (PIC) models that are validated in the plasma testing and used to extrapolate to the E-Sail propulsion system design. 3) Further down select of a wire deployment and control approach from those narrowed down in the Phase I effort. This paper will document the findings to date (June, 2016) of the above focused areas.

Study of an Audio Playback Machine Storage, Distribution, and Repair System. Options for Machine Operation. Study II, Part 1, Phase 2, Final Report.

ERIC Educational Resources Information Center

ManTech Technical Services Corp., Fairfax, VA.

This report presents the results of a management study of audio playback equipment operations conducted by the National Library Service, Library of Congress, its associated network of state and local machine lending agencies (MLA), and other parties that play a role in current operations. The objectives were to document current operations,…

The Assessment of Business and Industry Needs; Phase II of Multi-County Assessment of Adult Needs Project (MAP).

ERIC Educational Resources Information Center

Ferguson, L. G.; And Others

In order to assess the felt needs and interests of the local population and business community relative to education and training, a survey was designed and implemented in the four-county area surrounding Waco, Texas. This volume, part two of a three part series, documents the work done in developing and conducting the business and industry…

Validation of Student and Parent Reported Data on the Basic Grant Application Form. Pre-Award Validation Analysis Study: Phases I and II Report.

ERIC Educational Resources Information Center

Applied Management Sciences, Inc., Silver Spring, MD.

A Pre-Award Validation Analysis was conducted in 1978-1979 to provide the federal government information about the accuracy of data provided by applicants for Basic Educational Opportunity Grants. New procedures involved: validation of selected applications by college financial aid officers using documentation such as Federal Income Tax forms;…

NHEXAS PHASE I ARIZONA STUDY--STANDARD OPERATING PROCEDURE FOR ANALYSIS OF SOIL OR HOUSE DUST SAMPLES USING CHLORPYRIFOS ELISA SAMPLES (BCO-L-1.0)

EPA Science Inventory

This abstract is included for completeness of documentation, but this SOP was not used in the study.

The purpose of this SOP is to describe the procedures for analyzing both Stage II and Stage III soil and vacuum-cleaner collected house dust samples, and Stage III air samples u...

An audit of growth hormone replacement for GH-deficient adults in Scotland.

PubMed

Philip, Sam; Howat, Isobel; Carson, Maggie; Booth, Anne; Campbell, Karen; Grant, Donna; Patterson, Catherine; Schofield, Christopher; Bevan, John; Patrick, Alan; Leese, Graham; Connell, John

2013-04-01

Guidelines on the clinical use of growth hormone therapy in adults were issued by the UK National Institute for Clinical Excellence (NICE) in August 2003. We conducted a retrospective clinical audit on the use of growth hormone (GH) in Scotland to evaluate the use of these guidelines and their impact on clinical practice. The audit had two phases. In phase I, the impact of NICE criteria on specialist endocrine practice in starting and continuing GH replacement was assessed. In phase II, the reasons why some adults in Scotland with growth hormone deficiency were not on replacement therapy were evaluated. A retrospective cross-sectional case note review was carried out of all adult patients being followed up for growth hormone deficiency during the study period (1 March 2005 to 31 March 2008). Phase I of the audit included 208 patients and phase II 108 patients. Sellar tumours were the main cause of GH deficiency in both phases of the audit. In phase I, 53 patients (77%) had an AGHDA-QoL score >11 documented before commencing GH post-NICE guidance, compared with 35 (25%) pre-NICE guidance. Overall, only 39 patients (18%) met the full NICE criteria for starting and continuing GH (pre-NICE, 11%; post-NICE, 35%). Phase II indicated that the main reasons for not starting GH included perceived satisfactory quality of life (n = 47, 43%), patient reluctance (16, 15%) or a medical contraindication (16, 15%). Although the use of quality of life assessments has increased following publication of the NICE guidelines, most adults on GH in Scotland did not fulfil the complete set of NICE criteria. The main reason for not starting GH therapy in adult GH-deficient patients was perceived satisfactory quality of life. © 2012 Blackwell Publishing Ltd.

Phase 111A Crew Interface Specifications Development for Inflight Maintenance and Stowage Functions

NASA Technical Reports Server (NTRS)

Carl, John G.

1973-01-01

This report presents the findings and data products developed during the Phase IIIA Crew Interface Specification Study for Inflight Maintenance and Stowage Functions, performed by General Electric for the NASA, Johnson Space Center with a set of documentation that can be used as definitive guidelines to improve the present process of defining, controlling and managing flight crew interface requirements that are related to inflight maintenance (including assembly and servicing) and stowage functions. During the Phase IIIA contract period, the following data products were developed: 1) Projected NASA Crew Procedures/Flight Data File Development Process. 2) Inflight Maintenance Management Process Description. 3) Preliminary Draft, General Specification, Inflight Maintenance Management Requirements. 4) Inflight Maintenance Operational Process Description. 5) Preliminary Draft, General Specification, Inflight Maintenance Task and Support Requirements Analysis. 6) Suggested IFM Data Processing Reports for Logistics Management The above Inflight Maintenance data products have been developed during the Phase IIIA study after review of Space Shuttle Program Documentation, including the Level II Integrated Logistics Requirements and other DOD and NASA data relative to Payloads Accommodations and Satellite On-Orbit Servicing. These Inflight Maintenance data products were developed to be in consonance with Space Shuttle Program technical and management requirements.

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

EPA Pesticide Factsheets

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

77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

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

Wu, T.; Griffin, A. M.; Gorski, C. A.

Dissimilatory microbial reduction of solid-phase Fe(III)-oxides and Fe(III)-bearing phyllosilicates (Fe(III)-phyllosilicates) is an important process in anoxic soils, sediments, and subsurface materials. Although various studies have documented the relative extent of microbial reduction of single-phase Fe(III)-oxides and Fe(III)-phyllosilicates, detailed information is not available on interaction between these two processes in situations where both phases are available for microbial reduction. The goal of this research was to use the model dissimilatory iron-reducing bacterium (DIRB) Geobacter sulfurreducens to study Fe(III)-oxide vs. Fe(III)-phyllosilicate reduction in a range of subsurface materials and Fe(III)-oxide stripped versions of the materials. Low temperature (12K) Mossbauer spectroscopy was usedmore » to infer changes in the relative abundances of Fe(III)-oxide, Fe(III)-phyllosilicate, and phyllosilicate-associated Fe(II) (Fe(II)-phyllosilicate). A Fe partitioning model was employed to analyze the fate of Fe(II) and assess the potential for abiotic Fe(II)-catalyzed reduction of Fe(III)-phyllosilicates. The results showed that in most cases Fe(III)- oxide utilization dominated (70-100 %) bulk Fe(III) reduction activity, and that electron transfer from oxide-derived Fe(II) played only a minor role (ca. 10-20 %) in Fe partitioning. In addition, the extent of Fe(III)-oxide reduction was positively correlated to surface area-normalized cation exchange capacity and the phyllosilicate-Fe(III)/total Fe(III) ratio, which suggests that the phyllosilicates in the natural sediments promoted Fe(III)-oxide reduction by binding of oxide-derived Fe(II), thereby enhancing Fe(III)-oxide reduction by reducing or delaying the inhibitory effect that Fe(II) accumulation on oxide and DIRB cell surfaces has on Fe(III)-oxide reduction. In general our results suggest that although Fe(III)-oxide reduction is likely to dominate bulk Fe(III) reduction in most subsurface sediments, Fe(II) binding by phyllosilicates is likely to play a key role in controlling the long-term kinetics of Fe(III)-oxide reduction.« less

Modeling and 3D Visualization for Evaluation of Anti-Terrorism/Force Protection Alternatives: Phase II Final Report

DTIC Science & Technology

2006-11-21

SCHOOL Monterey, California 93943-5000 COL David A. Smarsh, USAF Dr. Leonard A. Ferrari Acting President...1.3.6 Planet 9 Studios David Colleen, CEO Chris Greuel, 3D Model Engineer Dan Ancona, Documentation and Training Carlos Newcomb, 3D Imagery...informational forum of M&S professionals working in the service of naval installation security. David Colleen, CEO, Planet 9 Studios, gave a

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

None

The purpose of this document is to provide the technical requirements for operation, inspection and maintenance of a TRUPACT-II Shipping Package and directly related components. This document shall supply the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP) and Certificate of Compliance (C of C) 9218. In the event there is a conflict between this document and the TRUPACT-II SARP (NRC Certificate of Compliance No. 9218), the TRUPACT-II SARP shall govern. This document details the operations, maintenance, repair, replacement of components, as well as the documentation required and the procedures to be followed to maintainmore » the integrity of the TRUPACT-II container. These procedures may be modified for site use, but as a minimum all parameters and format listed herein must be included in any site modified version. For convenience and where applicable steps may be performed out of sequence. Packaging and payload handling equipment and transport trailers have been specifically designed for use with the TRUPACT-II Packaging. This document discusses the minimum required procedures for use of the adjustable center of gravity lift fixture and the TRUPACT-II transport trailer in conjunction with the TRUPACT-II Packaging.« less

Contingency Contractor Optimization Phase 3 Sustainment Requirements Document Contingency Contractor Optimization Tool - Prototype

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

Bandlow, Alisa; Durfee, Justin David; Frazier, Christopher Rawls

2016-05-01

This requirements document serves as an addendum to the Contingency Contractor Optimization Phase 2, Requirements Document [1] and Phase 3 Requirements Document [2]. The Phase 2 Requirements document focused on the high-level requirements for the tool. The Phase 3 Requirements document provided more detailed requirements to which the engineering prototype was built in Phase 3. This document will provide detailed requirements for features and enhancements being added to the production pilot in the Phase 3 Sustainment.

External Payload Carrier (XPC) A Suborbital Research Platform

NASA Technical Reports Server (NTRS)

Schallhorn, Paul; Tatro, Chuck; Kutter, Bernard; Szatkowski, Gerald; Stopnitzky, Ben; Bulk, Tim

2011-01-01

This slide presentation details the concept of an External Payload Carrier (XPC), that can fly on ann unused Solid Rocket Booster (SRB) location on the Atlas V rocket to suborbital environment. The XPC can be used anytime there is sufficient excess lift capability available. The dimensions and possible uses of the XPC are reviewed. The completed Phase 1 study reviewed 57 variations, and arrived at three viable configurations, identified design baselines, subsystems and preliminary testing requirements. Phase II effort is planned to produce the preliminary design (i.e., PDR level), Systems Requirements Document (SRD), identify flight candidates, develop schedule and funding profiles, and identify the risk-reduction activities.

NDE Technology Development Program for Non-Visual Volumetric Inspection Technology; Sensor Effectiveness Testing Report

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

Moran, Traci L.; Larche, Michael R.; Denslow, Kayte M.

The Pacific Northwest National Laboratory (PNNL) located in Richland, Washington, hosted and administered Sensor Effectiveness Testing that allowed four different participants to demonstrate the NDE volumetric inspection technologies that were previously demonstrated during the Technology Screening session. This document provides a Sensor Effectiveness Testing report for the final part of Phase I of a three-phase NDE Technology Development Program designed to identify and mature a system or set of non-visual volumetric NDE technologies for Hanford DST primary liner bottom inspection. Phase I of the program will baseline the performance of current or emerging non-visual volumetric NDE technologies for their abilitymore » to detect and characterize primary liner bottom flaws, and identify candidate technologies for adaptation and maturation for Phase II of the program.« less

Study of Alternate Space Shuttle Concepts. Volume 2, Part 2: Concept Analysis and Definition

NASA Technical Reports Server (NTRS)

1971-01-01

This is the final report of a Phase A Study of Alternate Space Shuttle Concepts by the Lockheed Missiles & Space Company (LMSC) for the National Aeronautics and Space Administration George C. Marshall Space Flight Center (MSFC). The eleven-month study, which began on 30 June 1970, is to examine the stage-and-one-half and other Space Shuttle configurations and to establish feasibility, performance, cost, and schedules for the selected concepts. This final report consists of four volumes as follows: Volume I - Executive Summary, Volume II - Concept Analysis and Definition, Volume III - Program Planning, and Volume IV - Data Cost Data. This document is Volume II, Concept Analysis and Definition.

Phase II. Environmental baseline survey of McCormick Ranch, Kirtland Air Force Base, New Mexico. Part 4. Final report, October 1993-January 1995

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

Hagaraty, G.; Johnson, J.; Middlebrooks, P.

The Phase II EBS results document the extent of environmental contamination believed to be present on McCormick Ranch. Explosive test areas having the greatest potential for containing soil contaminants were identified using several geophysical survey methods: EM 31 terrain conductivity meter, magnetometer/gradiometer, and ground penetrating radar. From the geophysical surveys, five areas selected to conduct further environmental analysis. A total of 310 soil samples were collected from the five areas and 13 specific high explosive test sites. The samples were screened for semi-volatile organic compounds, PETN, TNT, TNT-degradation products, nitrates and radioactivity. Laboratory analyses were performed and no explosives ormore » degradation products were identified. Semi-volatile organic compounds were in 2 samples, manganese was detected in 3 samples, nitrates were discovered below soil action levels, and radiation levels were below background. Consequently, it is unlikely that significant contamination exists.« less

Phase II. Environmental baseline survey of McCormick Ranch, Kirtland Air Force Base, New Mexico. Part 3. Final report, October 1993-January 1995

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

Hagaraty, G.; Johnson, J.; Middlebrooks, P.

The Phase II EBS results document the extent of environmental contamination believed to be present on McCormick Ranch. Explosive test areas having the greatest potential for containing soil contaminants were identified using several geophysical survey methods: EM 31 terrain conductivity meter, magnetometer/gradiometer, and ground penetrating radar. From the geophysical surveys, five areas were selected to conduct further environmental analysis. A total of 310 soil samples were collected from the five areas and 13 specific high explosive test sites. The samples were screened for semi-volatile organic compounds, PETN, TNT, TNT-degradation products, nitrates and radioactivity. Laboratory analyses were and no explosives ormore » degradation products were identified. Semi-volatile organic compounds were in 2 samples, manganese was detected in 3 samples, nitrates were discovered below soil action levels, and radiation levels were below background. Consequently, it is unlikely that significant contamination exists.« less

Phase II. Environmental baseline survey of McCormick Ranch, Kirtland Air Force Base, New Mexico. Part 1. Final report, October 1993-January 1995

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

Hagaraty, G.; Johnson, J.; Middlebrooks, P.

The Phase II EBS results document the extent of environmental contamination believed to be present on McCormick Ranch. Explosive test areas having the greatest potential for containing soil contaminants were identified using several geophysical survey methods: EM 31 terrain conductivity meter, magnetometer/gradiometer, and ground penetrating radar. From the geophysical surveys, five areas were selected to conduct further environmental analysis. A total of 310 soil samples were collected from the and 13 specific high explosive test sites. The samples were screened for semi-volatile organic PETN, TNT, TNT-degradation products, nitrates and radioactivity. Laboratory analyses were and no explosives or degradation products weremore » identified. Semi-volatile organic compounds were in 2 samples, manganese was detected in 3 samples, nitrates were discovered below soil action levels, and radiation levels were below background. Consequently, it is unlikely that significant contamination exists.« less

Phase II. Environmental baseline survey of McCormick Ranch, Kirtland Air Force Base, New Mexico. Part 2. Final report, October 1993-January 1995

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

Hagaraty, G.; Johnson, J.; Middlebrooks, P.

The Phase II EBS results document the extent of environmental contamination believed to be present on McCormick Ranch. Explosive test areas having the greatest potential for containing soil contaminants were identified using several geophysical survey methods: EM 31 terrain conductivity meter, magnetometer/gradiometer, and ground penetrating radar. From the geophysical surveys, five areas were selected to conduct further environmental analysis. A total of 310 soil samples were collected from the five areas and 13 specific high explosive test sites. The samples were screened for semi-volatile organic compounds, PETN, TNT, TNT-degradation products, nitrates and radioactivity. Laboratory analyses were performed and no explosivesmore » or degradation products were identified. Semi-volatile organic compounds were found in 2 samples, manganese was detected in 3 samples, nitrates were discovered below soil action levels, and radiation levels were below background. Consequently, it is unlikely that significant contamination exists.« less

Phase II. Environmental baseline survey of McCormick Ranch, Kirtland Air Force Base, New Mexico. Part 5. Final report, October 1993-January 1995

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

Hagaraty, G.; Johnson, J.; Middlebrooks, P.

The Phase II EBS results document the extent of environmental contamination believed to be present on McCormick Ranch. Explosive test areas having the greatest potential for containing soil contaminants were identified using several geophysical survey methods: EM 31 terrain conductivity meter, magnetometer/gradiometer, and ground penetrating radar. From the geophysical surveys, five areas were selected to conduct further environmental analysis. A total of 310 soil samples were collected from the areas and 13 specific high explosive test sites. The samples were screened for semi-volatile organic compounds, PETN, TNT, TNT-degradation products, nitrates and radioactivity. Laboratory analyses were performed and no explosives ormore » degradation products were identified. Semi-volatile organic compounds were in 2 samples, manganese was detected in 3 samples, nitrates were discovered below soil action levels and radiation levels were below background. Consequently, it is unlikely that significant contamination exists.« less

ATM Technology Demonstration-1 Phase II Boeing Configurable Graphical Display (CGD) Software Design Description

NASA Technical Reports Server (NTRS)

Wilber, George F.

2017-01-01

This Software Description Document (SDD) captures the design for developing the Flight Interval Management (FIM) system Configurable Graphics Display (CGD) software. Specifically this SDD describes aspects of the Boeing CGD software and the surrounding context and interfaces. It does not describe the Honeywell components of the CGD system. The SDD provides the system overview, architectural design, and detailed design with all the necessary information to implement the Boeing components of the CGD software and integrate them into the CGD subsystem within the larger FIM system. Overall system and CGD system-level requirements are derived from the CGD SRS (in turn derived from the Boeing System Requirements Design Document (SRDD)). Display and look-and-feel requirements are derived from Human Machine Interface (HMI) design documents and working group recommendations. This Boeing CGD SDD is required to support the upcoming Critical Design Review (CDR).

Impact of Environmental Issues on the High-Speed Civil Transport

NASA Technical Reports Server (NTRS)

Whitehead, Allen H., Jr.

1998-01-01

This paper provides an overview of the impact of environmental issues on the design and operation of the proposed High-Speed Civil Transport (HSCT). This proposal for a new generation commercial supersonic transport is being pursued by NASA and its US industry partners in the NASA High-Speed Research (HSR) Program. A second related paper describes the overall HSR Program, including a history of supersonic transport development that led to the present program, and a brief outline of the structure of the two-phase program and its management structure. The specific objectives are to address the four major barrier environmental issues and show their impact on the design of the airplane and potentially, its mode of operation. A brief historical perspective shows how HSR Phase I addressed these environmental topics and, with the successful completion of that program, led to the successful advocacy for the Phase II effort that followed. The Phase II program elements were discussed in the earlier paper and addressed technology programs to enhance the economic viability of the HSCT. Since many of the regulations that may effect the certification and operation of the HSCT are either not in place or well documented, a brief treatise is provided to address the status of the rules and the potential impact on the viability of the HSCT.

Chemkin-II: A Fortran chemical kinetics package for the analysis of gas-phase chemical kinetics

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

Kee, R.J.; Rupley, F.M.; Miller, J.A.

1989-09-01

This document is the user's manual for the second-generation Chemkin package. Chemkin is a software package for whose purpose is to facilitate the formation, solution, and interpretation of problems involving elementary gas-phase chemical kinetics. It provides an especially flexible and powerful tool for incorporating complex chemical kinetics into simulations of fluid dynamics. The package consists of two major software components: an Interpreter and Gas-Phase Subroutine Library. The Interpreter is a program that reads a symbolic description of an elementary, user-specified chemical reaction mechanism. One output from the Interpreter is a data file that forms a link to the Gas-Phase Subroutinemore » Library. This library is a collection of about 100 highly modular Fortran subroutines that may be called to return information on equation of state, thermodynamic properties, and chemical production rates.« less

Long-acting rilpivirine for HIV prevention.

PubMed

Jackson, Akil; McGowan, Ian

2015-07-01

Long-acting injectable antiretroviral (ARV) formulations are being developed for the treatment and prevention of HIV infection. The purpose of this review is to summarize recent preclinical and clinical data on TMC278 (rilpivirine), a nonnucleoside reverse transcriptase inhibitor (NNRTI), that is being developed for both a treatment and prevention indication. Long-acting rilpivirine has demonstrated efficacy in preventing HIV acquisition in a humanized mouse model and has been found to be well tolerated and acceptable in several Phase I clinical trials. Pharmacokinetic data from Phase I studies suggest that 1200 mg of long-acting rilpivirine administered every 8 weeks would be associated with plasma and tissue levels of rilpivirine anticipated to be necessary for preventing HIV infection. This regimen is being evaluated in the HPTN-076 Phase II expanded safety study that will enroll women in South Africa, Zimbabwe, and the USA. The HPTN-076 study requires a 4-week run in with oral rilpivirine (25 mg capsules) before receiving 1200 mg of rilpivirine. It is not yet certain whether oral dosing will remain a prerequisite in future trials or post licensure. Long-acting rilpivirine shows promise as a candidate agent for HIV prevention. Preclinical efficacy has been demonstrated in a murine model. Phase I studies have shown good safety and efficacy, but breakthrough infection and resistance have been documented with lower doses of long-acting rilpivirine. Phase II development for a prevention indication is ongoing.

C-Band Airport Surface Communications System Standards Development. Phase II Final Report. Volume 2: Test Bed Performance Evaluation and Final AeroMACS Recommendations

NASA Technical Reports Server (NTRS)

Hall, Edward; Magner, James

2011-01-01

This report is provided as part of ITT s NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: New ATM Requirements-Future Communications, C-Band and L-Band Communications Standard Development and was based on direction provided by FAA project-level agreements for New ATM Requirements-Future Communications. Task 7 included two subtasks. Subtask 7-1 addressed C-band (5091- to 5150-MHz) airport surface data communications standards development, systems engineering, test bed and prototype development, and tests and demonstrations to establish operational capability for the Aeronautical Mobile Airport Communications System (AeroMACS). Subtask 7-2 focused on systems engineering and development support of the L-band digital aeronautical communications system (L-DACS). Subtask 7-1 consisted of two phases. Phase I included development of AeroMACS concepts of use, requirements, architecture, and initial high-level safety risk assessment. Phase II builds on Phase I results and is presented in two volumes. Volume I is devoted to concepts of use, system requirements, and architecture, including AeroMACS design considerations. Volume II (this document) describes an AeroMACS prototype evaluation and presents final AeroMACS recommendations. This report also describes airport categorization and channelization methodologies. The purposes of the airport categorization task were (1) to facilitate initial AeroMACS architecture designs and enable budgetary projections by creating a set of airport categories based on common airport characteristics and design objectives, and (2) to offer high-level guidance to potential AeroMACS technology and policy development sponsors and service providers. A channelization plan methodology was developed because a common global methodology is needed to assure seamless interoperability among diverse AeroMACS services potentially supplied by multiple service providers.

C-Band Airport Surface Communications System Standards Development. Phase II Final Report. Volume 1: Concepts of Use, Initial System Requirements, Architecture, and AeroMACS Design Considerations

NASA Technical Reports Server (NTRS)

Hall, Edward; Isaacs, James; Henriksen, Steve; Zelkin, Natalie

2011-01-01

This report is provided as part of ITT s NASA Glenn Research Center Aerospace Communication Systems Technical Support (ACSTS) contract NNC05CA85C, Task 7: New ATM Requirements-Future Communications, C-Band and L-Band Communications Standard Development and was based on direction provided by FAA project-level agreements for New ATM Requirements-Future Communications. Task 7 included two subtasks. Subtask 7-1 addressed C-band (5091- to 5150-MHz) airport surface data communications standards development, systems engineering, test bed and prototype development, and tests and demonstrations to establish operational capability for the Aeronautical Mobile Airport Communications System (AeroMACS). Subtask 7-2 focused on systems engineering and development support of the L-band digital aeronautical communications system (L-DACS). Subtask 7-1 consisted of two phases. Phase I included development of AeroMACS concepts of use, requirements, architecture, and initial high-level safety risk assessment. Phase II builds on Phase I results and is presented in two volumes. Volume I (this document) is devoted to concepts of use, system requirements, and architecture, including AeroMACS design considerations. Volume II describes an AeroMACS prototype evaluation and presents final AeroMACS recommendations. This report also describes airport categorization and channelization methodologies. The purposes of the airport categorization task were (1) to facilitate initial AeroMACS architecture designs and enable budgetary projections by creating a set of airport categories based on common airport characteristics and design objectives, and (2) to offer high-level guidance to potential AeroMACS technology and policy development sponsors and service providers. A channelization plan methodology was developed because a common global methodology is needed to assure seamless interoperability among diverse AeroMACS services potentially supplied by multiple service providers.

Mineral potential for incompatible element deposits hosted in pegmatites, alkaline rocks, and carbonatites in the Islamic Republic of Mauritania (phase V, deliverable 87): Chapter Q in Second projet de renforcement institutionnel du secteur minier de la République Islamique de Mauritanie (PRISM-II)

USGS Publications Warehouse

Taylor, Cliff D.; Giles, Stuart A.

2015-01-01

USGS review of PRISM-I data suggests that there is abundant documentation of the Bou Naga alkaline complex and to a lesser degree, the Guelb er Richat carbonatite complex, but that all other occurrences of U, Th, REE, and associated elements are poorly described, and poorly understood (Taylor, 2007)

Mercury Phase II Study - Mercury Behavior across the High-Level Waste Evaporator System

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

Bannochie, C. J.; Crawford, C. L.; Jackson, D. G.

2016-06-17

The Mercury Program team’s effort continues to develop more fundamental information concerning mercury behavior across the liquid waste facilities and unit operations. Previously, the team examined the mercury chemistry across salt processing, including the Actinide Removal Process/Modular Caustic Side Solvent Extraction Unit (ARP/MCU), and the Defense Waste Processing Facility (DWPF) flowsheets. This report documents the data and understanding of mercury across the high level waste 2H and 3H evaporator systems.

Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin's Lymphoma

PubMed Central

Younes, Anas; Gopal, Ajay K.; Smith, Scott E.; Ansell, Stephen M.; Rosenblatt, Joseph D.; Savage, Kerry J.; Ramchandren, Radhakrishnan; Bartlett, Nancy L.; Cheson, Bruce D.; de Vos, Sven; Forero-Torres, Andres; Moskowitz, Craig H.; Connors, Joseph M.; Engert, Andreas; Larsen, Emily K.; Kennedy, Dana A.; Sievers, Eric L.; Chen, Robert

2012-01-01

Purpose Brentuximab vedotin is an antibody-drug conjugate (ADC) that selectively delivers monomethyl auristatin E, an antimicrotubule agent, into CD30-expressing cells. In phase I studies, brentuximab vedotin demonstrated significant activity with a favorable safety profile in patients with relapsed or refractory CD30-positive lymphomas. Patients and Methods In this multinational, open-label, phase II study, the efficacy and safety of brentuximab vedotin were evaluated in patients with relapsed or refractory Hodgkin's lymphoma (HL) after autologous stem-cell transplantation (auto-SCT). Patients had histologically documented CD30-positive HL by central pathology review. A total of 102 patients were treated with brentuximab vedotin 1.8 mg/kg by intravenous infusion every 3 weeks. In the absence of disease progression or prohibitive toxicity, patients received a maximum of 16 cycles. The primary end point was the overall objective response rate (ORR) determined by an independent radiology review facility. Results The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea. Conclusion The ADC brentuximab vedotin was associated with manageable toxicity and induced objective responses in 75% of patients with relapsed or refractory HL after auto-SCT. Durable CRs approaching 2 years were observed, supporting study in earlier lines of therapy. PMID:22454421

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

EPA Pesticide Factsheets

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

Fort Hood Solar Total Energy Project. Volume II. Preliminary design. Part 1. System criteria and design description. Final report

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

None,

1979-01-01

This volume documents the preliminary design developed for the Solar Total Energy System to be installed at Fort Hood, Texas. Current system, subsystem, and component designs are described and additional studies which support selection among significant design alternatives are presented. Overall system requirements which form the system design basis are presented. These include program objectives; performance and output load requirements; industrial, statutory, and regulatory standards; and site interface requirements. Material in this section will continue to be issued separately in the Systems Requirements Document and maintained current through revision throughout future phases of the project. Overall system design and detailedmore » subsystem design descriptions are provided. Consideration of operation and maintenance is reflected in discussion of each subsystem design as well as in an integrated overall discussion. Included are the solar collector subsystem; the thermal storage subsystem, the power conversion sybsystem (including electrical generation and distribution); the heating/cooling and domestic hot water subsystems; overall instrumentation and control; and the STES building and physical plant. The design of several subsystems has progressed beyond the preliminary stage; descriptions for such subsystems are therefore provided in more detail than others to provide complete documentation of the work performed. In some cases, preliminary design parameters require specific verificaton in the definitive design phase and are identified in the text. Subsystem descriptions will continue to be issued and revised separately to maintain accuracy during future phases of the project. (WHK)« less

Small Business Innovation Research GRC Phase I, Phase II, and Post-Phase II Opportunity Assessment for 2015

NASA Technical Reports Server (NTRS)

Nguyen, Hung D.; Steele, Gynelle C.

2016-01-01

This report outlines the 2015 Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Phase I, Phase II, and Post-Phase II opportunity contract award results associated with NASA's Aeronautics Research Mission Directorate (ARMD), Human Exploration and Operations Mission Directorate (HEOMD), Science Mission Directorate (SMD), and Space Technology Mission Directorate (STMD) for NASA Glenn Research Center. The report also highlights the number of Phase I, Phase II, and Post-Phase II contracts awarded by mission directorate. The 2015 Phase I contract awards to companies in Ohio and their corresponding technologies are also discussed.

INDEPENDENT REVIEW OF THE X-701B GROUNDWATER REMEDY, PORTSMOUTH, OHIO: TECHNICAL EVALUATION AND RECOMMENDATIONS

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

Looney, B.; Eddy-Dilek, C.; Costanza, J.

2008-12-15

The Department of Energy Portsmouth Paducah Project Office requested assistance from Department of Energy Office of Environmental Management (EM-22) to provide independent technical experts to evaluate past and ongoing remedial activities at the Portsmouth facility that were completed to address TCE contamination associated with the X-701B groundwater plume and to make recommendations for future efforts. The Independent Technical Review team was provided with a detailed and specific charter. The charter requested that the technical team first review the past and current activities completed for the X-701B groundwater remedy for trichloroethene (TCE) in accordance with a Decision Document that was issuedmore » by Ohio EPA on December 8, 2003 and a Work Plan that was approved by Ohio EPA on September 22, 2006. The remedy for X-701B divides the activities into four phases: Phase I - Initial Source Area Treatment, Phase II - Expanded Source Area Treatment, Phase III - Evaluation and Reporting, and Phase IV - Downgradient Remediation and Confirmation of Source Area Treatment. Phase I of the remedy was completed during FY2006, and DOE has now completed six oxidant injection events within Phase II. The Independent Technical Review team was asked to evaluate Phase II activities, including soil and groundwater results, and to determine whether or not the criteria that were defined in the Work Plan for the Phase II end point had been met. The following criteria are defined in the Work Plan as an acceptable Phase II end point: (1) Groundwater samples from the identified source area monitoring wells have concentrations below the Preliminary Remediation Goal (PRG) for TCE in groundwater, or (2) The remedy is no longer effective in removing TCE mass from the source area. In addition, the charter specifies that if the Review Team determines that the Phase II endpoint has not been reached, then the team should address the following issues: (1) If additional injection events are recommended, the team should identify the type of injection and target soil horizon for these injections; (2) Consider the feasibility of declaring Technical Impracticability and proceeding with the RCRA Cap for the X-701B; and (3) Provide a summary of other cost-effective technologies that could be implemented (especially for the lower Gallia). The Independent Technical Review team focused its evaluation solely on the X-701B source zone and contaminant plume. It did not review current or planned remedial activities at other plumes, waste areas, or landfills at the Portsmouth site, nor did it attempt to integrate such activities into its recommendations for X-701B. However, the ultimate selection of a remedy for X-701B by site personnel and regulators should take into account potentially synergistic efforts at other waste areas. Assessment of remedial alternatives in the context of site-wide management practices may reveal opportunities for leveraging and savings that would not otherwise be identified. For example, the cost of source-zone excavation or construction of a permeable reactive barrier at X-701B might be substantially reduced if contaminated soil could be buried on site at an existing or planned landfill. This allowance would improve the feasibility and competitiveness of both remedies. A comprehensive examination of ongoing and future environmental activities across the Portsmouth Gaseous Diffusion Plant is necessary to optimize the selection and timing of X-701B remediation with respect to cleanup efficiency, safety, and economics. A selected group of technical experts attended the technical workshop at the Portsmouth Gaseous Diffusion Plant from November 18 through 21, 2008. During the first day of the workshop, both contractor and DOE site personnel briefed the workshop participants and took them on a tour of the X-701B site. The initial briefing was attended by representatives of Ohio EPA who participated in the discussions. On subsequent days, the team reviewed baseline data and reports, were provided additional technical information from site personnel, evaluated work plans, determined critical issues and uncertainties, and recommended alternatives. This report documents the findings and recommendations of the independent technical review team.« less

40 CFR 52.1490 - Original identification of plan.

Code of Federal Regulations, 2012 CFR

2012-07-01

... measures. (ii) A modeling analysis indicating 1982 attainment. (iii) Documentation of the modeling analysis... agencies, (ii) Additional supporting documentation for the 1982 attainment modeling analysis which included... factors for the model. (iii) A revised 1982 attainment modeling analysis and supporting documentation...

40 CFR 52.1490 - Original identification of plan.

Code of Federal Regulations, 2013 CFR

2013-07-01

... measures. (ii) A modeling analysis indicating 1982 attainment. (iii) Documentation of the modeling analysis... agencies, (ii) Additional supporting documentation for the 1982 attainment modeling analysis which included... factors for the model. (iii) A revised 1982 attainment modeling analysis and supporting documentation...

40 CFR 52.1490 - Original identification of plan.

Code of Federal Regulations, 2014 CFR

2014-07-01

... measures. (ii) A modeling analysis indicating 1982 attainment. (iii) Documentation of the modeling analysis... agencies, (ii) Additional supporting documentation for the 1982 attainment modeling analysis which included... factors for the model. (iii) A revised 1982 attainment modeling analysis and supporting documentation...

Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success?

PubMed

Chan, John K; Ueda, Stefanie M; Sugiyama, Valerie E; Stave, Christopher D; Shin, Jacob Y; Monk, Bradley J; Sikic, Branimir I; Osann, Kathryn; Kapp, Daniel S

2008-03-20

To identify the characteristics of phase II studies that predict for subsequent "positive" phase III trials (those that reached the proposed primary end points of study or those wherein the study drug was superior to the standard regimen investigating targeted agents in advanced tumors. We identified all phase III clinical trials of targeted therapies against advanced cancers published from 1985 to 2005. Characteristics of the preceding phase II studies were reviewed to identify predictive factors for success of the subsequent phase III trial. Data were analyzed using the chi(2) test and logistic regression models. Of 351 phase II studies, 167 (47.6%) subsequent phase III trials were positive and 184 (52.4%) negative. Phase II studies from multiple rather than single institutions were more likely to precede a successful trial (60.4% v 39.4%; P < .001). Positive phase II results were more likely to lead to a successful phase III trial (50.8% v 22.5%; P = .003). The percentage of successful trials from pharmaceutical companies was significantly higher compared with academic, cooperative groups, and research institutes (89.5% v 44.2%, 45.2%, and 46.3%, respectively; P = .002). On multivariate analysis, these factors and shorter time interval between publication of phase II results and III study publication were independent predictive factors for a positive phase III trial. In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial. Investigators should be cognizant of these factors in phase II studies before designing phase III trials.

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

Wang, Meng; Yi, Ming; Tian, Wei

Here, the complex interdigitated phases have greatly frustrated attempts to document the basic features of the superconductivity in the alkali metal intercalated iron chalcogenides. Here, using elastic neutron scattering, energy-dispersive x-ray spectroscopy, and resistivity measurements, we elucidate the relations of these phases in Rb xFe ySe 2-zS z. We find (i) the iron content is crucial in stabilizing the stripe antiferromagnetic (AF) phase with rhombic iron vacancy order (y ≈ 1.5), the block AF phase with root 5 x root 5 iron vacancy order (y ≈ 1.6), and the iron vacancy-free phase (y ≈ 2); and (ii) the iron vacancy-freemore » superconducting phase (z = 0) evolves into an iron vacancy-free metallic phase with sulfur substitution (z > 1.5) due to the progressive decrease of the electronic correlation strength. Both the stripe AF phase and the block AF phase are Mott insulators. The iron-rich compounds (y > 1.6) undergo a first order transition from an iron vacancy disordered phase at high temperatures into the √5 x √5 iron vacancy ordered phase and the iron vacancy-free phase below T s. Our data demonstrate that there are miscibility gaps between these three phases. The existence of the miscibility gaps in the iron content is a key to understanding the relationship between these complicated phases.« less

APT: what it has enabled us to do

NASA Astrophysics Data System (ADS)

Blacker, Brett S.; Golombek, Daniel

2004-09-01

With the development and operations deployment of the Astronomer's Proposal Tool (APT), Hubble Space Telescope (HST) proposers have been provided with an integrated toolset for Phase I and Phase II. This toolset consists of editors for filling out proposal information, an Orbit Planner for determining observation feasibility, a Visit Planner for determining schedulability, diagnostic and reporting tools and an integrated Visual Target Tuner (VTT) for viewing exposure specifications. The VTT can also overlay HST"s field of view on user-selected Flexible Image Transport System (FITS) images, perform bright object checks and query the HST archive. In addition to these direct benefits for the HST user, STScI"s internal Phase I process has been able to take advantage of the APT products. APT has enabled a substantial streamlining of the process and software processing tools, which enabled a compression by three months of the Phase I to Phase II schedule, allowing to schedule observations earlier and thus further benefiting HST observers. Some of the improvements to our process include: creating a compact disk (CD) of Phase I products; being able to print all proposals on the day of the deadline; link the proposal in Portable Document Format (PDF) with a database, and being able to run all Phase I software on a single platform. In this paper we will discuss the operational results of using APT for HST's Cycles 12 and 13 Phase I process and will show the improvements for the users and the overall process that is allowing STScI to obtain scientific results with HST three months earlier than in previous years. We will also show how APT can be and is being used for multiple missions.

Spatial and temporal dependencies of structure II to structure I methane hydrate transformation in porous media under moderate pressure and temperature conditions

NASA Astrophysics Data System (ADS)

Dong, T.; Lin, J. F.; Gu, J. T.; Polito, P. J.; O'Connell, J.; Flemings, P. B.

2017-12-01

We used Raman spectroscopy to monitor methane hydrates transforming from structure II to structure I at the pore scale as a function of space and time. It is well documented that structure I hydrate is the thermodynamically stable phase for pure methane hydrate (<100 MPa, < 20 °C), but due to kinetic limitation, initial methane hydrate formation produces a mixture of structure I and structure II hydrates. We observed that the structure transformation originated around the porous medium grains and over time slowly migrated into the pore space. We synthesized methane hydrates in spherical glass beads (210-297 µm in diameter) in a pressure cell with a sapphire window to integrate optical observations with Raman measurements. We injected CH4 vapor into the cell and supplied only deionized water thereafter to maintain a constant pressure of 14.6 MPa at 3.5 °C, with 14.5 °C subcooling. We used Raman spectroscopy to map the methane hydrates in pore spaces at 5-25 µm resolution, in order to monitor the occupancy ratio of CH4 in large cages to CH4 in small cages, by their Raman peak intensity ratio, i.e., I( 2905 cm-1)/I( 2915 cm-1). We identified 3 stages of hydrate formation at the pore scale: (1) after the initial hydrate formation, Raman mapping revealed that the occupancy ratio ranged from 0.5 to 3, indicating a mixture of structure I and II hydrates; (2) within 1 week, we observed that all structure I hydrates occurred on the glass bead surfaces and structure II hydrates occupied the pore spaces; (3) over the following 2 weeks, structure II hydrates gradually recrystallized into structure I hydrates from glass bead surfaces towards the pore space. These results imply that (1) due to kinetics, the formation of methane hydrate in porous media is more complex than previously thought, and (2) the bulk physical and chemical properties of laboratory-synthesized methane hydrates in porous media may drift over time, as methane hydrates recrystallize from a metastable phase (structure II) to the thermodynamically stable phase (structure I).

Volume I: fluidized-bed code documentation, for the period February 28, 1983-March 18, 1983

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

Piperopoulou, H.; Finson, M.; Bloomfield, D.

1983-03-01

This documentation supersedes the previous documentation of the Fluidized-Bed Gasifier code. Volume I documents a simulation program of a Fluidized-Bed Gasifier (FBG), and Volume II documents a systems model of the FBG. The FBG simulation program is an updated version of the PSI/FLUBED code which is capable of modeling slugging beds and variable bed diameter. In its present form the code is set up to model a Westinghouse commercial scale gasifier. The fluidized bed gasifier model combines the classical bubbling bed description for the transport and mixing processes with PSI-generated models for coal chemistry. At the distributor plate, the bubblemore » composition is that of the inlet gas and the initial bubble size is set by the details of the distributor plate. Bubbles grow by coalescence as they rise. The bubble composition and temperature change with height due to transport to and from the cloud as well as homogeneous reactions within the bubble. The cloud composition also varies with height due to cloud/bubble exchange, cloud/emulsion, exchange, and heterogeneous coal char reactions. The emulsion phase is considered to be well mixed.« less

The Heliopause Electrostatic Rapid Transit System (HERTS) Design, Trades, and Analyses Performed in a Two Year NASA Investigation of Electric Sail Propulsion Systems

NASA Technical Reports Server (NTRS)

Wiegmann, Bruce M.

2017-01-01

The Heliopause Electrostatic Rapid Transit System (HERTS) was one of the seven total Phase II NASA Innovative Advanced Concepts (NIAC) that was down-selected in 2015 for continued funding and research. In Phase I our team learned that a spacecraft propelled by an Electric Sail (E-Sail) can travel great astronomical distances, such as to the Heliopause region of the solar system (approx. 100 to 120 AU) in approximately one quarter of the time (10 years) versus the time it took the Voyager spacecraft launched in 1977 (36 years). The completed work within the Phase II NIAC funded effort builds upon the work that was done in the Phase I NIAC and is focused on: 1) Testing of plasma interaction with a charged wire in a MSFC simulated solar environment vacuum test chamber. 2) Development of a Particle-in-Cell (PIC) models that are validated in the plasma testing and used to extrapolate to the E-Sail propulsion system design. 3) Conceptual design of a Technology Demonstration Mission (TDM) spacecraft developed to showcase E-Sail propulsion systems. 4) Down selection of both: a) Materials for a multi km length conductor and, b) Best configuration of the proposed conductor deployment subsystem. This paper will document the findings to date (June, 2017) of the above focused areas.

Iron cycling under oscillatory redox conditions: from observations to processes

NASA Astrophysics Data System (ADS)

Meile, C. D.; Chen, C.; Barcellos, D.; Wilmoth, J.; Thompson, A.

2017-12-01

Fe oxyhydroxides play a critical role in soils through their role as structural entities, their high sorption capacity, their role as terminal electron acceptors in the respiration of organic matter, as well as their potential to affect the reactivity of that organic matter. In soils that undergo repeated fluctuations in O2 concentrations, soil iron undergoes transformations between reduced and oxidized forms. The rate of Fe(II) oxidation can govern the nature of Fe(III) oxyhydroxides formed, and hence can affect rates of OC mineralization under suboxic conditions. But it remains unclear if this same behavior occurs in soils, where Fe(II) is mainly present as surface complexes. We documented the impact of such redox oscillations on iron cycling through targeted experiments, in which the magnitude and frequency of redox oscillations were varied systematically on soils from the Luquillo Critical Zone Observatory, Puerto Rico. Our observations demonstrated that higher O2 concentrations led to a faster Fe(II) oxidation and resulted in less crystalline Fe(III)-oxyhydroxides than lower O2 concentrations. We further studied the dynamics of iron phases by amending soil slurries with isotopically-labeled 57Fe(II) and developed a numerical model to quantify the individual processes. Our model showed a higher rate of Fe(III) reduction and increased sorption capacity following the oxidation of Fe(II) at high O2 levels than at low O2 levels, and revealed rapid Fe atom exchange between solution and solid phase. Concurrent measurements of CO2 in our oscillation experiments further illustrated the importance O2 fluctuations on coupled Fe-C dynamics.

Army-NASA aircrew/aircraft integration program. Phase 5: A3I Man-Machine Integration Design and Analysis System (MIDAS) software concept document

NASA Technical Reports Server (NTRS)

Banda, Carolyn; Bushnell, David; Chen, Scott; Chiu, Alex; Neukom, Christian; Nishimura, Sayuri; Prevost, Michael; Shankar, Renuka; Staveland, Lowell; Smith, Greg

1992-01-01

This is the Software Concept Document for the Man-machine Integration Design and Analysis System (MIDAS) being developed as part of Phase V of the Army-NASA Aircrew/Aircraft Integration (A3I) Progam. The approach taken in this program since its inception in 1984 is that of incremental development with clearly defined phases. Phase 1 began in 1984 and subsequent phases have progressed at approximately 10-16 month intervals. Each phase of development consists of planning, setting requirements, preliminary design, detailed design, implementation, testing, demonstration and documentation. Phase 5 began with an off-site planning meeting in November, 1990. It is expected that Phase 5 development will be complete and ready for demonstration to invited visitors from industry, government and academia in May, 1992. This document, produced during the preliminary design period of Phase 5, is intended to record the top level design concept for MIDAS as it is currently conceived. This document has two main objectives: (1) to inform interested readers of the goals of the MIDAS Phase 5 development period, and (2) to serve as the initial version of the MIDAS design document which will be continuously updated as the design evolves. Since this document is written fairly early in the design period, many design issues still remain unresolved. Some of the unresolved issues are mentioned later in this document in the sections on specific components. Readers are cautioned that this is not a final design document and that, as the design of MIDAS matures, some of the design ideas recorded in this document will change. The final design will be documented in a detailed design document published after the demonstrations.

Socioeconomic Impact Assessment: Communications Industry. Phase I. Technical Appendix Description and Documentation of the Current State-of-the-Art. Volume II.

DTIC Science & Technology

1979-02-02

R2 = 1.8 nmi (10,940 ft). An analysis of a CAS employing range and range rate indicated that the form of the equation used in ANTC-117 was valid ...interrogations persecond. Preliminary analysis of flight data indicated the system is capable of tracking successfully through garbled situations...ATC simulation, Monte-Carlo simulation of 12 mid-airs and analysis of ARTS III data for ATC interaction. The results of the effort points to the need

Benefit Value to the Air Force of the GIDEP (Government Industry Data Exchange Program) Alert

DTIC Science & Technology

1984-06-15

cost avoidance within that organization is not the result of the ALERT system . 3-1 b) Designed Life - This is the expected life of the item as...Analytics1 Phase II efforts under contract F33615-S3- C-5098. The main findings of the report are: (1) The system set up to handle Government...slow to issue ALERTs. (4) There is no formally documented system for determining that the Air Force’s warranty rights are being enforced on items

Phase II Study of HER-2/neu Intracellular Domain Peptide-Based Vaccine Administered to Stage IV HER2 Positive Breast Cancer Patients Receiving Trastuzumab

DTIC Science & Technology

2007-05-01

the combined approach as well as the immunogenicity of HER2 ICD peptide vaccination. If there is evidence to suggest that the true rate of Grade IV... approach will be evaluated as the ability of the vaccine to elicit HER2 ICD specific T cell immunity, to elicit epitope spreading, and to stimulate...July 2006. Unfortunately, by the time all needed source documents (i.e., imaging, clinical labs, cardiac function tests) were collected, this

Seroprevalence of Brucellosis, Leptospirosis, and Q Fever among Butchers and Slaughterhouse Workers in South-Eastern Iran.

PubMed

Esmaeili, Saber; Naddaf, Saied Reza; Pourhossein, Behzad; Hashemi Shahraki, Abdolrazagh; Bagheri Amiri, Fahimeh; Gouya, Mohammad Mehdi; Mostafavi, Ehsan

2016-01-01

Zoonotic diseases can be occupational hazards to people who work in close contact with animals or their carcasses. In this cross-sectional study, 190 sera were collected from butchers and slaughterhouse workers in different regions of the Sistan va Baluchestan province, in Iran in 2011. A questionnaire was filled for each participant to document personal and behavioural information. The sera were tested for detection of specific IgG antibodies against brucellosis, leptospirosis, and Q fever (phase I and II) using commercial enzyme-linked immunosorbent assays (ELISA). The seroprevalence of brucellosis was 7.9%, leptospirosis 23.4%, and phase I and II of Q fever were 18.1% and 14.4%, respectively. The seroprevalence of Q fever and leptospirosis, but not brucellosis, varied among regions within the province (p = 0.01). Additionally, a significant relationship was found between seropositivity of Q fever and camel slaughtering (p = 0.04). Reduced seropositivity rate of brucellosis was associated with use of personal protective equipment (PPE) (p = 0.004). This study shows that brucellosis, leptospirosis and Q fever occur among butchers and slaughterhouse workers in this area.

7 CFR 1580.301 - Application for trade adjustment assistance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... accordance with 7 CFR 1400.601, for the 3 preceding tax years does not exceed $2,500,000. (6) To comply with... documentation from a certified public accountant or attorney, or (ii) Relevant documentation and other... from a certified public accountant or attorney, (ii) Relevant documentation and other supporting...

Development of a human cadaver model for training in laparoscopic donor nephrectomy.

PubMed

Sutton, Erica R H; Billeter, Adrian; Druen, Devin; Roberts, Henry; Rice, Jonathan

2017-06-01

The organ procurement network recommends a surgeon record 15 cases as surgeon or assistant for laparoscopic donor nephrectomies (LDN) prior to independent practice. The literature suggests that the learning curve for improved perioperative and patient outcomes is closer to 35 cases. In this article, we describe our development of a model utilizing fresh tissue and objective, quantifiable endpoints to document surgical progress, and efficiency in each of the major steps involved in LDN. Phase I of model development focused on the modifications necessary to maintain visualization for laparoscopic surgery in a human cadaver. Phase II tested proposed learner-based metrics of procedural competency for multiport LDN by timing procedural steps of LDN in a novice learner. Phases I and II required 12 and nine cadavers, with a total of 35 kidneys utilized. The following metrics improved with trial number for multiport LDN: time taken for dissection of the gonadal vein, ureter, renal hilum, adrenal and lumbrical veins, simulated warm ischemic time (WIT), and operative time. Human cadavers can be used for training in LDN as evidenced by improvements in timed learner-based metrics. This simulation-based model fills a gap in available training options for surgeons. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Uav Surveying for a Complete Mapping and Documentation of Archaeological Findings. The Early Neolithic Site of Portonovo

NASA Astrophysics Data System (ADS)

Malinverni, E. S.; Conati Barbaro, C.; Pierdicca, R.; Bozzi, C. A.; Tassetti, A. N.

2016-06-01

The huge potential of 3D digital acquisition techniques for the documentation of archaeological sites, as well as the related findings, is almost well established. In spite of the variety of available techniques, a sole documentation pipeline cannot be defined a priori because of the diversity of archaeological settings. Stratigraphic archaeological excavations, for example, require a systematic, quick and low cost 3D single-surface documentation because the nature of stratigraphic archaeology compels providing documentary evidence of any excavation phase. Only within a destructive process each single excavation cannot be identified, documented and interpreted and this implies the necessity of a re- examination of the work on field. In this context, this paper describes the methodology, carried out during the last years, to 3D document the Early Neolithic site of Portonovo (Ancona, Italy) and, in particular, its latest step consisting in a photogrammetric aerial survey by means of UAV platform. It completes the previous research delivered in the same site by means of terrestrial laser scanning and close range techniques and sets out different options for further reflection in terms of site coverage, resolution and campaign cost. With the support of a topographic network and a unique reference system, the full documentation of the site is managed in order to detail each excavation phase; besides, the final output proves how the 3D digital methodology can be completely integrated with reasonable costs during the excavation and used to interpret the archaeological context. Further contribution of this work is the comparison between several acquisition techniques (i.e. terrestrial and aerial), which could be useful as decision support system for different archaeological scenarios. The main objectives of the comparison are: i) the evaluation of 3D mapping accuracy from different data sources, ii) the definition of a standard pipeline for different archaeological needs and iii) the provision of different level of detail according to the user needs.

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

NASA Technical Reports Server (NTRS)

Das, H.; Daniels, V. R.; Vaksman, Z.; Boyd, J. L.; Buckey, J. C.; Locke, J. P.; Putcha, L.

2007-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

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.

Installation-restoration program. Phase 2. Confirmation/quantification. Stage 1 for Shaw Air Force Base, South Carolina. Final report, January 1984-October 1986

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

Alexander, W.J.; Liddle, S.K.

1986-09-01

The primary objectives of this project were to collect and analyze groundwater, surface water, and sediment samples and to perform an initial characterization of the hydrogeochemical regime at potential contamination sites on Shaw Air Force Base near Sumter, South Carolina. This study constituted Phase II of the U.S. Air Force Installation Restoration Program (IRP). Five potential sources of groundwater pollution were studied. The evaluation primarily included the drilling of soil test borings, the installation, development, and sampling of groundwater monitoring wells, and the analyses of soil, surface water, and groundwater samples. Also used in the study were field measurements ofmore » water quality, water-level measurements site observations, published hydrogeologic data and Shaw AFB documents.« less

47 CFR 54.309 - Connect America Fund Phase II Public Interest Obligations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false Connect America Fund Phase II Public Interest Obligations. 54.309 Section 54.309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... Connect America Fund Phase II Public Interest Obligations. (a) A price cap carrier electing Phase II model...

Isac Sc-Linac Phase-II Helium Refrigerator Commissioning and First Operational Experience at Triumf

NASA Astrophysics Data System (ADS)

Sekachev, I.; Kishi, D.; Laxdal, R. E.

2010-04-01

ISAC Phase-II is an upgrade of the radioactive isotope superconducting linear accelerator, SC-linac, at TRIUMF. The Phase-I section of the accelerator, medium-beta, is operational and is cooled with a 600 W helium refrigerator, commissioned in March 2005. An identical refrigerator is being used with the Phase-II segment of the accelerator; which is now under construction. The second refrigerator has been commissioned and tested with the Phase-I section of the linac and is used for Phase-II linac development, including new SC-cavity performance tests. The commissioning of the Phase-II refrigeration system and recent operational experience is presented.

Design of Phase II Non-inferiority Trials.

PubMed

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

78 FR 76789 - Additional Connect America Fund Phase II Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445... Phase I to Phase II. 2. Timing of Phase II Support Disbursements. In the USF/ICC Transformation Order... language in paragraph 180 of the USF/ICC Transformation Order. We now seek to more fully develop the record...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

Fabrication of Natural Uranium UO 2 Disks (Phase II): Texas A&M Work for Others Summary Document

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

Gerczak, Tyler J.; Baldwin, Charles A.; Schmidlin, Joshua E.

The steps to fabricate natural UO 2 disks for an irradiation campaign led by Texas A&M University are outlined. The process was initiated with stoichiometry adjustment of parent, U 3O 8 powder. The next stage of sample preparation involved exploratory pellet pressing and sintering to achieve the desired natural UO 2 pellet densities. Ideal densities were achieved through the use of a bimodal powder size blend. The steps involved with disk fabrication are also presented, describing the coring and thinning process executed to achieve final dimensionality.

Maritime Analytics Prototype: Phase 3 Validation

DTIC Science & Technology

2014-01-01

maritim arehouse (GP ported on th sability Sca the training sks, errors m estionnaire, as assessed u the trial was t ” in the scien icant improv...which ed that MVA tools, and th ated the mo e, and becaus lot of prais essels. t - s, e s) n r e e e - e n s, e is P e st e e ii...rapport a environne en raison permet de une bonne navires d’ é ….... t documente n banc d’ess l’analyse de intérêt. Les c iel Widget A DDC) sur l ISTIP

Development of the Corporal: The Embryo of the Army Missile Program, Volume II: Supporting Data. Documents 1 through 31

DTIC Science & Technology

1961-04-01

heads, were used. Flights E-4 through E-6 utilized forged cylinders of SAE 4140 , machined to 0.25- inch wall thickness with machined skirts. The heads...cylindrical portion of the air tank in E-1 was welded of SAE 4130 steel plates 0.50 inch thick. The heads were 0.375 inch thick, whereas the internal...Edward S. Forman, and Weld Arnold. The early phases of the research were financed by a fund of $1,000 from Mr. Weld Arnold. "The first activities of

Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

PubMed Central

Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

2015-01-01

Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

PubMed

Massett, Holly A; Mishkin, Grace; Rubinstein, Larry; Ivy, S Percy; Denicoff, Andrea; Godwin, Elizabeth; DiPiazza, Kate; Bolognese, Jennifer; Zwiebel, James A; Abrams, Jeffrey S

2016-11-15

Accruing patients in a timely manner represents a significant challenge to early phase cancer clinical trials. The NCI Cancer Therapy Evaluation Program analyzed 19 months of corrective action plans (CAP) received for slow-accruing phase I and II trials to identify slow accrual reasons, evaluate whether proposed corrective actions matched these reasons, and assess the CAP impact on trial accrual, duration, and likelihood of meeting primary scientific objectives. Of the 135 CAPs analyzed, 69 were for phase I trials and 66 for phase II trials. Primary reasons cited for slow accrual were safety/toxicity (phase I: 48%), design/protocol concerns (phase I: 42%, phase II: 33%), and eligibility criteria (phase I: 41%, phase II: 35%). The most commonly proposed corrective actions were adding institutions (phase I: 43%, phase II: 85%) and amending the trial to change eligibility or design (phase I: 55%, phase II: 44%). Only 40% of CAPs provided proposed corrective actions that matched the reasons given for slow accrual. Seventy percent of trials were closed to accrual at time of analysis (phase I = 48; phase II = 46). Of these, 67% of phase I and 70% of phase II trials met their primary objectives, but they were active three times longer than projected. Among closed trials, 24% had an accrual rate increase associated with a greater likelihood of meeting their primary scientific objectives. Ultimately, trials receiving CAPs saw improved accrual rates. Future trials may benefit from implementing CAPs early in trial life cycles, but it may be more beneficial to invest in earlier accrual planning. Clin Cancer Res; 22(22); 5408-16. ©2016 AACRSee related commentary by Mileham and Kim, p. 5397. ©2016 American Association for Cancer Research.

Summary of Research through Phase II/Year 2 of Initially Approved 3 Phase/3 Year Project - Establishing the Relationship between Fracture-Related Dolomite and Primary Rock Fabric on the Distribution of Reservoirs in the Michigan Basin

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

G. Grammer

2007-09-30

This final scientific/technical report covers the first 2 years (Phases I and II of an originally planned 3 Year/3 Phase program). The project was focused on evaluating the relationship between fracture-related dolomite and dolomite constrained by primary rock fabric in the 3 most prolific reservoir intervals in the Michigan Basin. The characterization of select dolomite reservoirs was the major focus of our efforts in Phases I and II of the project. Structural mapping and log analysis in the Dundee (Devonian) and Trenton/Black River (Ordovician) suggest a close spatial relationship among gross dolomite distribution and regional-scale, wrench fault-related NW-SE and NE-SWmore » structural trends. A high temperature origin for much of the dolomite in these 2 studied intervals (based upon fluid inclusion homogenization temperatures and stable isotopic analyses,) coupled with persistent association of this dolomite in reservoirs coincident with wrench fault-related features, is strong evidence for these reservoirs being influenced by hydrothermal dolomitization. In the Niagaran (Silurian), there is a general trend of increasing dolomitization shelfward, with limestone predominant in more basinward positions. A major finding is that facies types, when analyzed at a detailed level, are directly related to reservoir porosity and permeability in these dolomites which increases the predictability of reservoir quality in these units. This pattern is consistent with our original hypothesis of primary facies control on dolomitization and resulting reservoir quality at some level. The identification of distinct and predictable vertical stacking patterns within a hierarchical sequence and cycle framework provides a high degree of confidence at this point that the results should be exportable throughout the basin. Much of the data synthesis and modeling for the project was scheduled to be part of Year 3/Phase III, but the discontinuation of funding after Year 2 precluded those efforts. Therefore, the results presented in this document are not final, and in many cases represent a report of 'progress to date' as numerous tasks were scheduled to extend into Year 3.« less

Enhanced Night Visibility Series, Volume XII : Overview of Phase II and Development of Phase III Experimental Plan

DOT National Transportation Integrated Search

2005-12-01

This volume provides an overview of the six studies that compose Phase II of the Enhanced Night Visibility project and the experimental plan for its third and final portion, Phase III. The Phase II studies evaluated up to 12 vision enhancement system...

Seroprevalence of Brucellosis, Leptospirosis, and Q Fever among Butchers and Slaughterhouse Workers in South-Eastern Iran

PubMed Central

Esmaeili, Saber; Naddaf, Saied Reza; Pourhossein, Behzad; Hashemi Shahraki, Abdolrazagh; Bagheri Amiri, Fahimeh; Gouya, Mohammad Mehdi; Mostafavi, Ehsan

2016-01-01

Zoonotic diseases can be occupational hazards to people who work in close contact with animals or their carcasses. In this cross-sectional study, 190 sera were collected from butchers and slaughterhouse workers in different regions of the Sistan va Baluchestan province, in Iran in 2011. A questionnaire was filled for each participant to document personal and behavioural information. The sera were tested for detection of specific IgG antibodies against brucellosis, leptospirosis, and Q fever (phase I and II) using commercial enzyme-linked immunosorbent assays (ELISA). The seroprevalence of brucellosis was 7.9%, leptospirosis 23.4%, and phase I and II of Q fever were 18.1% and 14.4%, respectively. The seroprevalence of Q fever and leptospirosis, but not brucellosis, varied among regions within the province (p = 0.01). Additionally, a significant relationship was found between seropositivity of Q fever and camel slaughtering (p = 0.04). Reduced seropositivity rate of brucellosis was associated with use of personal protective equipment (PPE) (p = 0.004). This study shows that brucellosis, leptospirosis and Q fever occur among butchers and slaughterhouse workers in this area. PMID:26731333

Shuttle unified navigation filter, revision 1

NASA Technical Reports Server (NTRS)

Muller, E. S., Jr.

1973-01-01

Equations designed to meet the navigation requirements of the separate shuttle mission phases are presented in a series of reports entitled, Space Shuttle GN and C Equation Document. The development of these equations is based on performance studies carried out for each particular mission phase. Although navigation equations have been documented separately for each mission phase, a single unified navigation filter design is embodied in these separate designs. The purpose of this document is to present the shuttle navigation equations in a form in which they would most likely be coded-as the single unified navigation filter used in each mission phase. This document will then serve as a single general reference for the navigation equations replacing each of the individual mission phase navigation documents (which may still be used as a description of a particular navigation phase).

Change of motion and localization of cholesterol molecule during L(alpha)-H(II) transition.

PubMed Central

Hayakawa, E; Naganuma, M; Mukasa, K; Shimozawa, T; Araiso, T

1998-01-01

Formation of the inverted hexagonal (H(II)) phase from the lamellar (L(alpha)) phase of bovine brain-extracted phosphatidylcholine (BBPC) and phosphatidylethanolamine (BBPE) was investigated using 31P-NMR with or without cholesterol. When the ratio of BBPC to BBPE was 1:1, the H(II) formation was observed in the presence of 33 mol% cholesterol (i.e., BBPC:BBPE:cholesterol = 1:1:1) at 47 degrees C. The fraction of the H(II) phase in the BBPC/BBPE/cholesterol system could be controlled by the addition of dioleoylglycerol. The change of molecular motion of cholesterol affected by the H(II) formation was measured at various ratios of the L(alpha) to H(II) phase with the time-resolved fluorescence depolarization method, using dehydroergosterol as a fluorescent probe. It is observed that the motion of cholesterol became vigorous in the mixture state of the L(alpha) and the H(II) phases compared to that in the L(alpha) or the H(II) phase only. These facts show that cholesterol has the strong ability to induce the H(II) phase, probably by special molecular motion, which includes change of its location from the headgroup area to the acyl-chain area. PMID:9533700

Development of Geriatric Competencies for Emergency Medicine Residents Using an Expert Consensus Process

PubMed Central

Hogan, Teresita M.; Losman, Eve D.; Carpenter, Christopher R.; Sauvigne, Karen; Irmiter, Cheryl; Emanuel, Linda; Leipzig, Rosanne M.

2011-01-01

Background The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes. Objectives The objective was to develop a consensus document, “Geriatric Competencies for Emergency Medicine Residents,” by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. Methods This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. Results In Phase I, participants (n = 363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n = 24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. Conclusions The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. PMID:20370765

Development of geriatric competencies for emergency medicine residents using an expert consensus process.

PubMed

Hogan, Teresita M; Losman, Eve D; Carpenter, Christopher R; Sauvigne, Karen; Irmiter, Cheryl; Emanuel, Linda; Leipzig, Rosanne M

2010-03-01

The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes. The objective was to develop a consensus document, "Geriatric Competencies for Emergency Medicine Residents," by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. In Phase I, participants (n=363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n=24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. Copyright (c) 2010 by the Society for Academic Emergency Medicine.

21 CFR 880.5440 - Intravascular administration set.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

21 CFR 880.5440 - Intravascular administration set.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

21 CFR 880.5440 - Intravascular administration set.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

21 CFR 880.5440 - Intravascular administration set.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

Flight Test of the F/A-18 Active Aeroelastic Wing Airplane

NASA Technical Reports Server (NTRS)

Voracek, David

2007-01-01

A viewgraph presentation of flight tests performed on the F/A active aeroelastic wing airplane is shown. The topics include: 1) F/A-18 AAW Airplane; 2) F/A-18 AAW Control Surfaces; 3) Flight Test Background; 4) Roll Control Effectiveness Regions; 5) AAW Design Test Points; 6) AAW Phase I Test Maneuvers; 7) OBES Pitch Doublets; 8) OBES Roll Doublets; 9) AAW Aileron Flexibility; 10) Phase I - Lessons Learned; 11) Control Law Development and Verification & Validation Testing; 12) AAW Phase II RFCS Envelopes; 13) AAW 1-g Phase II Flight Test; 14) Region I - Subsonic 1-g Rolls; 15) Region I - Subsonic 1-g 360 Roll; 16) Region II - Supersonic 1-g Rolls; 17) Region II - Supersonic 1-g 360 Roll; 18) Region III - Subsonic 1-g Rolls; 19) Roll Axis HOS/LOS Comparison Region II - Supersonic (open-loop); 20) Roll Axis HOS/LOS Comparison Region II - Supersonic (closed-loop); 21) AAW Phase II Elevated-g Flight Test; 22) Region I - Subsonic 4-g RPO; and 23) Phase II - Lessons Learned

Installation Restoration Program. Phase II--Confirmation/Quantification. Stage 1.

DTIC Science & Technology

1985-03-01

four phases. Phase I, Initial Assessment/ Records Search, is designed to identify possible hazardous waste contami- nated sites and potential...7 71 -. - - IL’ -, 1% 33 AihlIII Is 33 n~iL t iiC UII! ii CL C LU 1-3, Phase II, Confirmation and Quantification, is designed to confirm the...additional monitoring data upon which design of mitigative actions are based. In Phase III, Technology Base Development, appropriate technology is selected and

Installation Restoration Program. Phase II: Stage 1 Problem Confirmation Study, Duluth International Airport, Duluth, Minnesota.

DTIC Science & Technology

1984-10-01

8 iii "i t-. Table of Contents (cont.) Section Title Page -APPENDIX A Acronyms, Definitions, Nomenclature and Units of Measure B Scope of Work, Task...Identification/Records Search Phase II - Problem Confirmation and Quantification Phase III - Technology Base Development Phase IV - Corrective Action Only...Problem Identification/Records Search Phase II - Problem Confirmation and Quantification Phase III - Technology Base Development Phase IV - Corrective

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

PubMed Central

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

Purpose To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. Methods The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Results Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). Conclusion The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China. PMID:27701471

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

PubMed

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

Technology Development Report: CDDF, Dual Use Partnerships, SBIR/STTR: Fiscal Year 2003 Activities

NASA Technical Reports Server (NTRS)

Bailey, John W.

2004-01-01

The FY2003 NASA John C. Stennis Stennis Space Center (SSC) Technology Development Report provides an integrated report of all technology development activities at SSC. This report actually combines three annual reports: the Center Director's Discretionary Fund (CDDF) Program Report, Dual Use Program Report, and the Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program Report. These reports are integrated in one document to summarize all technology development activities underway in support of the NASA missions assigned to SSC. The Dual Use Program Report provides a summary review of the results and status of the nine (9) Dual Use technology development partnership projects funded and managed at SSC during FY2003. The objective of these partnership projects is to develop or enhance technologies that will meet the technology needs of the two NASA SSC Mission Areas: Propulsion Test and Earth Science Applications. During FY2003, the TDTO managed twenty (20) SBIR Phase II Projects and two (2) STTR Phase II Projects. The SBIR contracts support low TRL technology development that supports both the Propulsion Test and the Earth Science Application missions. These projects are shown in the SBIR/STTR Report. In addition to the Phase II contracts, the TDTO managed ten (10) SBIR Phase I contracts which are fixed price, six month feasibility study contracts. These are not listed in this report. Together, the Dual Use Projects and the SBIR/STTR Projects constitute a technology development partnership approach that has demonstrated that success can be achieved through the identification of the technical needs of the NASA mission and using various available partnership techniques to maximize resource utilization to achieve mutual technology goals. Greater use of these partnership techniques and the resource leveraging they provide, is a goal of the TDTO, providing more support to meet the technology development needs of the mission areas at SSC.

Oral Sulforaphane increases Phase II antioxidant enzymes in the human upper airway

PubMed Central

Riedl, Marc A.; Saxon, Andrew; Diaz-Sanchez, David

2009-01-01

Background Cellular oxidative stress is an important factor in asthma and is thought to be the principle mechanism by which oxidant pollutants such as ozone and particulates mediate their pro-inflammatory effects. Endogenous Phase II enzymes abrogate oxidative stress through the scavenging of reactive oxygen species and metabolism of reactive chemicals. Objective We conducted a placebo-controlled dose escalation trial to investigate the in vivo effects of sulforaphane, a naturally occurring potent inducer of Phase II enzymes, on the expression of glutathione-s-transferase M1 (GSTM1), glutathione-s-transferase P1 (GSTP1), NADPH quinone oxidoreductase (NQO1), and hemoxygenase-1 (HO-1) in the upper airway of human subjects. Methods Study subjects consumed oral sulforaphane doses contained in a standardized broccoli sprout homogenate (BSH). RNA expression for selected Phase II enzymes was measured in nasal lavage cells by RT-PCR before and after sulforaphane dosing. Results All subjects tolerated oral sulforaphane dosing without significant adverse events. Increased Phase II enzyme expression in nasal lavage cells occurred in a dose-dependent manner with maximal enzyme induction observed at the highest dose of 200 grams broccoli sprouts prepared as BSH. Significant increases were seen in all sentinel Phase II enzymes RNA expression compared to baseline. Phase II enzyme induction was not seen with ingestion of non-sulforaphane containing alfalfa sprouts. Conclusion Oral sulforaphane safely and effectively induces mucosal Phase II enzyme expression in the upper airway of human subjects. This study demonstrates the potential of antioxidant Phase II enzymes induction in the human airway as a strategy to reduce the inflammatory effects of oxidative stress. Clinical Implications This study demonstrates the potential of enhancement of Phase II enzyme expression as a novel therapeutic strategy for oxidant induced airway disease. Capsule Summary A placebo-controlled dose escalation trial demonstrated that naturally occurring sulforaphane from broccoli sprouts can induce a potent increase in antioxidant Phase II enzymes in airway cells. PMID:19028145

Centrifuge workers study. Phase II, completion report

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

Wooten, H.D.

1994-09-01

Phase II of the Centrifuge Workers Study was a follow-up to the Phase I efforts. The Phase I results had indicated a higher risk than expected among centrifuge workers for developing bladder cancer when compared with the risk in the general population for developing this same type of cancer. However, no specific agent could be identified as the causative agent for these bladder cancers. As the Phase II Report states, Phase I had been limited to workers who had the greatest potential for exposure to substances used in the centrifuge process. Phase II was designed to expand the survey tomore » evaluate the health of all employees who had ever worked in Centrifuge Program Departments 1330-1339 but who had not been interviewed in Phase I. Employees in analytical laboratories and maintenance departments who provided support services for the Centrifuge Program were also included in Phase II. In December 1989, the Oak Ridge Associated Universities (ORAU), now known as Oak Ridge Institute for Science and Education (ORISE), was contracted to conduct a follow-up study (Phase II). Phase H of the Centrifuge Workers Study expanded the survey to include all former centrifuge workers who were not included in Phase I. ORISE was chosen because they had performed the Phase I tasks and summarized the corresponding survey data therefrom.« less

Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

PubMed

2007-02-01

The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Lower Red River Meadow Restoration Project : Biennial Report 1996-97.

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

LRK Communications; Wildlife Habitat Institute; Pocket Water, Inc.

2003-07-01

The Red River has been straightened and the riparian vegetation corridor eliminated in several reaches within the watershed. The river responded by incision resulting in over-steepened banks, increased sedimentation, elevated water temperatures, depressed groundwater levels, reduced floodplain function, and degraded fish habitat. The Lower Red River Meadow Restoration Project is a multi-phase ecosystem enhancement effort that restores natural physical and biological processes and functions to stabilize the stream channel and establish high quality habitats for fish and wildlife. A natural channel restoration philosophy guides the design and on the ground activities, allowing the channel to evolve into a state ofmore » dynamic equilibrium. Two years of planning, two years of restoration in Phases I and II, and one year post-restoration monitoring are complete. By excavating new bends and reconnecting historic meanders, Phase I and II channel realignment increased channel length by 3,060 feet, decreased channel gradient by 25 percent, and increased sinuosity from 1.7 to 2.3. Cross-sectional shapes and point bars were modified to maintain deep pool habitat at low flow and to reconnect the meadow floodplain. Improved soil moisture conditions will help sustain the 31,500 native riparian plantings reestablished within these two phases. Overall, short-term restoration performance was successful. Analyses of long-term parameters document either post-restoration baseline conditions or early stages of evolution toward desired conditions. An adaptive management strategy has helped to improve restoration designs, methods, and monitoring. Lessons learned are being transferred to a variety of audiences to advance the knowledge of ecological restoration and wise management of watersheds.« less

Social support in the post-abortion recovery room: evidence from patients, support persons and nurses in a Vancouver clinic.

PubMed

Veiga, Mariana B; Lam, Melanie; Gemeinhardt, Carla; Houlihan, Edwina; Fitzsimmons, Brian P; Hodgson, Zoë G

2011-03-01

The benefits of social support in post-surgical recovery are well documented; social support decreases preoperative stress and postoperative recovery time. However, a paucity of studies have examined the effect of social support in the context of pregnancy termination. This study is the first to examine the effect of postoperative accompaniment from the patient, support person and nurses' perspective. This study was carried out in two phases. In Phase I, no accompaniment was allowed in the post-anesthesia recovery room (PAR); in Phase II, accompaniment was permitted. All participants completed pre- and postoperative questionnaires. The perception of accompaniment was overwhelmingly positive in patients and support people. Patients in Phase II demonstrated a high (over 95%) acceptance of accompaniment in the recovery room. It was found that 96.8% reported they would choose to be accompanied in the recovery room again if they had to have another abortion. Support persons felt very strongly that their presence was helpful to the patient. The decrease in pre- to postoperative anxiety levels was significantly greater in those women who were accompanied. However, overall, nurses demonstrated a negative attitude towards accompaniment in the recovery room. In summary, the presence of a support person in the PAR was perceived in a positive manner by patients and support people. However, the reasoning behind the negative opinion of nurses requires further study before PAR accompaniment can be considered a possibility in the context of pregnancy termination. Copyright © 2011 Elsevier Inc. All rights reserved.

Department of Defense Index of Specifications and Standards. Part 1. Alphabetical Listing

DTIC Science & Technology

1989-07-01

the Basic DODISS Part II. PART II, Numerical Listing reflects all active documents in document number sequence within document type. The alphabetic...NPFC 106) 5801 Tabor Avenue P ’ - elphia, PA 19120 "The use Index is mandatory on all military activities . This mandatory provision i as thiat the...Class, is also available as follows: Military Activities : Commanding Officer Naval Publications and Forms Center (ATTN: NPODS) 5801 Tabor Avenue

40 CFR 63.1038 - Recordkeeping requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... visual inspections as specified in § 63.1026(b)(4). (ii) Documentation of dual mechanical seal pump... frequency of drips for dual mechanical seal pumps, records of the design criteria and explanations and any...). (ii) Trial evaluation program documentation as specified in § 63.1035(d)(6)(iii). (iii) Engineering...

76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

...: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled, ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen...

76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

...: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the...

76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

...: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration... the guidance entitled, ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document describes a means by which focused ultrasound...

Potentially bioavailable ferrous iron nanoparticles in glacial sediments

NASA Astrophysics Data System (ADS)

Hawkings, J.; Benning, L. G.; Raiswell, R.; Kaulich, B.; Araki, T.; Abyaneh, M.; Koch-Müller, M.; Stockdale, A.; Tranter, M.; Wadham, J.

2017-12-01

Iron (Fe) is an essential nutrient for marine phytoplankton, the primary producers of the ocean. Despite it being the fourth most abundant element in the Earth's crust, it is highly insoluble, due in part to its rapid oxidation from ferric (Fe2+) to ferrous phases (Fe3+), which often leads to the formation of nanoparticulate iron oxyhydroxide phases1. The insoluble nature of Fe in oxygenated waters means Fe limitation of primary producers is prevalent in 30-50% of the world's oceans, including areas of high biological productivity proximal to significant glacial activity (e.g., the Southern Ocean). Glaciers and ice sheets are a significant source of nanoparticulate Fe, which may be important in sustaining the high productivity observed in the near coastal regions proximal to glacial coverage. The reactivity of particulate iron is poorly understood, despite its importance in the ocean Fe inventory. Here we combined geochemical extractions, high-resolution imaging and spectroscopy to investigate the abundance, morphology and valence state of reactive iron in glacial sediments. Our results document the widespread occurrence of amorphous and Fe(II)-rich nanoparticles in glacial meltwaters and icebergs. Fe(II) is thought to be highly bioavailable in marine environments. We argue that glaciers and ice sheets are therefore able to supply potentially bioavailable Fe(II)-containing nanoparticulate material for downstream ecosystems, including those in a marine setting. The flux of bioavailable particulate iron from Arctic glaciers may increase as rising air temperatures lead to higher meltwater export.

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol.

PubMed

Randell, Rebecca; Greenhalgh, Joanne; Hindmarsh, Jon; Dowding, Dawn; Jayne, David; Pearman, Alan; Gardner, Peter; Croft, Julie; Kotze, Alwyn

2014-05-02

Robotic surgery offers many potential benefits for patients. While an increasing number of healthcare providers are purchasing surgical robots, there are reports that the technology is failing to be introduced into routine practice. Additionally, in robotic surgery, the surgeon is physically separated from the patient and the rest of the team, with the potential to negatively impact teamwork in the operating theatre. The aim of this study is to ascertain: how and under what circumstances robotic surgery is effectively introduced into routine practice; and how and under what circumstances robotic surgery impacts teamwork, communication and decision making, and subsequent patient outcomes. We will undertake a process evaluation alongside a randomised controlled trial comparing laparoscopic and robotic surgery for the curative treatment of rectal cancer. Realist evaluation provides an overall framework for the study. The study will be in three phases. In Phase I, grey literature will be reviewed to identify stakeholders' theories concerning how robotic surgery becomes embedded into surgical practice and its impacts. These theories will be refined and added to through interviews conducted across English hospitals that are using robotic surgery for rectal cancer resection with staff at different levels of the organisation, along with a review of documentation associated with the introduction of robotic surgery. In Phase II, a multi-site case study will be conducted across four English hospitals to test and refine the candidate theories. Data will be collected using multiple methods: the structured observation tool OTAS (Observational Teamwork Assessment for Surgery); video recordings of operations; ethnographic observation; and interviews. In Phase III, interviews will be conducted at the four case sites with staff representing a range of surgical disciplines, to assess the extent to which the results of Phase II are generalisable and to refine the resulting theories to reflect the experience of a broader range of surgical disciplines. The study will provide (i) guidance to healthcare organisations on factors likely to facilitate successful implementation and integration of robotic surgery, and (ii) guidance on how to ensure effective communication and teamwork when undertaking robotic surgery.

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

PubMed Central

2014-01-01

Background Robotic surgery offers many potential benefits for patients. While an increasing number of healthcare providers are purchasing surgical robots, there are reports that the technology is failing to be introduced into routine practice. Additionally, in robotic surgery, the surgeon is physically separated from the patient and the rest of the team, with the potential to negatively impact teamwork in the operating theatre. The aim of this study is to ascertain: how and under what circumstances robotic surgery is effectively introduced into routine practice; and how and under what circumstances robotic surgery impacts teamwork, communication and decision making, and subsequent patient outcomes. Methods and design We will undertake a process evaluation alongside a randomised controlled trial comparing laparoscopic and robotic surgery for the curative treatment of rectal cancer. Realist evaluation provides an overall framework for the study. The study will be in three phases. In Phase I, grey literature will be reviewed to identify stakeholders’ theories concerning how robotic surgery becomes embedded into surgical practice and its impacts. These theories will be refined and added to through interviews conducted across English hospitals that are using robotic surgery for rectal cancer resection with staff at different levels of the organisation, along with a review of documentation associated with the introduction of robotic surgery. In Phase II, a multi-site case study will be conducted across four English hospitals to test and refine the candidate theories. Data will be collected using multiple methods: the structured observation tool OTAS (Observational Teamwork Assessment for Surgery); video recordings of operations; ethnographic observation; and interviews. In Phase III, interviews will be conducted at the four case sites with staff representing a range of surgical disciplines, to assess the extent to which the results of Phase II are generalisable and to refine the resulting theories to reflect the experience of a broader range of surgical disciplines. The study will provide (i) guidance to healthcare organisations on factors likely to facilitate successful implementation and integration of robotic surgery, and (ii) guidance on how to ensure effective communication and teamwork when undertaking robotic surgery. PMID:24885669

47 CFR 69.727 - Regulatory relief.

Code of Federal Regulations, 2010 CFR

2010-10-01

... customer. (b) Phase II relief. Upon satisfaction of the Phase II triggers specified in §§ 69.709(c) or 69... Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase I... similarly situated customers; and (ii) The price cap LEC excludes all contract tariff offerings from price...

47 CFR 90.769 - Construction and implementation of Phase II nationwide licenses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Use of Frequencies in the 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide Systems § 90.769 Construction and implementation of Phase II nationwide licenses...

Barriers to participation in a phase II cardiac rehabilitation programme.

PubMed

Mak, Y M W; Chan, W K; Yue, C S S

2005-12-01

To identify barriers to participation in a phase II cardiac rehabilitation programme and measures that may enhance participation. Prospective study. Regional hospital, Hong Kong. Cardiac patients recruited for a phase I cardiac rehabilitation programme from July 2002 to January 2003. Reasons for not participating in a phase II cardiac rehabilitation programme. Of the 193 patients recruited for a phase I cardiac rehabilitation programme, 152 (79%) patients, with a mean age of 70.3 years (standard deviation, 11.9 years), did not proceed to phase II programme. Eleven (7%) deaths occurred before commencement of phase II and 74 (49%) patients were considered physically unfit. Reasons for the latter included fractures, pain, or degenerative changes in the lower limbs (24%), and co-morbidities such as cerebrovascular accident (19%), chronic renal failure (11%), congestive heart failure (9%), and unstable angina (8%). Phase II rehabilitation was postponed until after completion of scheduled cardiac interventions in 13% of patients. Failure of physicians to arrange the pre-phase II exercise stress test as per protocol was reported in 7% of patients. Other reasons were reported: work or time conflicts (16%), non-compliance with cardiac treatment (5%), financial constraints (4%), self-exercise (3%), fear after exercise stress testing (3%), and patients returning to their original cardiologists for treatment (3%). A significant (79%) proportion of patients did not proceed to a phase II cardiac rehabilitation programme for a variety of reasons. These included physical unfitness, work or time conflicts, and need to attend scheduled cardiac interventions. Further studies are required to determine how to overcome obstacles to cardiac rehabilitation.

Commandant's international technical series. Volume 9. International regulations on the prevention of pollution from ships carrying hazardous chemicals in bulk. Final report

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

Not Available

1985-12-01

MARPOL was developed to minimize accidental and operational pollution from ships carrying noxious liquid substances in bulk. Accidental pollution could result from a collision, a grounding, or an overflow of a cargo tank. Operational pollution results from the disposal of cargo tank washings. Major amendments were made to the original Annex II by the International Maritime Organization. The United States and other States party to MARPOL will implement Annex II, as amended, on April 7, 1987. Implementation will affect seagoing ships transporting noxious liquid substances to and from such ships. The attached documents contain internationally agreed requirements, interpretations, and guidelinesmore » necessary for the implementation of Annex II. The documents attached include: (1) MARPOL Annex II as amended by amendments adopted by the twenty-second session of the IMO Marine Environment Protection Committee; (2) Unified Interpretations of Annex II; (3) Standards for the Procedures and Arrangements for the Discharge of Noxious Liquid Substances; (4) Ammendments to the Bulk Chemical Code and the International Bulk Chemical Code to include marine pollution concerns; (5) Guidelines on the Provision of Adequate Reception Facilities in Ports, Part II (Noxious Liquid Substances). The contents of these documents are being placed in regulations. The purpose of this document is to give members of the interested public advance notification of impending regulations.« less

Sundstrand’s Precision Metal Forming Cell. Industrial Modernization Incentive Program (IMIP). Phase 2

DTIC Science & Technology

1991-03-01

1-2 1.4 CONCLUSIONS AND RECOMMENDATIONS ....................... 1-2 20. PHASE II MANAGEMENT PLAN...2-1 2.1 PROGRAM MANAGEMENT ................................... 2-1 2.2 IM IP TEAM...Barbier, reference Section 2.0 (Phase II Management Plan), is complete and this report provides the results of the Phase II study. 1.2 OBJECTIVES The

What Works in Oklahoma Schools: A Comprehensive Needs Assessment of Oklahoma Schools. Phase II State Report

ERIC Educational Resources Information Center

Marzano Research Laboratory, 2010

2010-01-01

Phase II provides a more detailed examination of classroom variables important to achievement in Oklahoma schools. Where Phase I addressed all nine of the Oklahoma essential elements using survey data, Phase II focuses on what occurs in Oklahoma classrooms primarily using data from principal interviews, classroom observations (on-site), and video…

76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

...: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply...

76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...

Market Analysis and Consumer Impacts Source Document. Part II. Review of Motor Vehicle Market and Consumer Expenditures on Motor Vehicle Transportation

DOT National Transportation Integrated Search

1980-12-01

This source document on motor vehicle market analysis and consumer impacts consists of three parts. Part II consists of studies and review on: motor vehicle sales trends; motor vehicle fleet life and fleet composition; car buying patterns of the busi...

76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

...: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact cooling systems for aesthetic use may comply with the...

Central Alaska Network vital signs monitoring plan

USGS Publications Warehouse

MacCluskie, Margaret C.; Oakley, Karen L.; McDonald, Trent; Wilder, Doug

2005-01-01

Denali National Park and Preserve, Wrangell-St. Elias National Park and Preserve, and Yukon-Charley Rivers National Preserve have been organized into the Central Alaska Network (CAKN) for the purposes of carrying out ecological monitoring activities under the National Park Services’ Vital Signs Monitoring program. The Phase III Report is the initial draft of the Vital Signs Monitoring Plan for the Central Alaska Network. It includes updated material from the Phase I and II documents. This report, and draft protocols for 11 of the network’s Vital Signs, were peer reviewed early in 2005. Review comments were incorporated into the document bringing the network to the final stage of having a Vital Signs Monitoring Plan. Implementation of the program will formally begin in FY 2006. The broad goals of the CAKN monitoring program are to: (1) better understand the dynamic nature and condition of park ecosystems; and (2) provide reference points for comparisons with other, altered environments. The focus of the CAKN program will be to monitor ecosystems in order to detect change in ecological components and in the relationships among the components. Water quality monitoring is fully integrated within the CAKN monitoring program. A monitoring program for lentic (non-moving water) has been determined, and the program for lotic systems (moving water) is under development.

25 CFR 900.131 - What role does the Secretary play during the performance of a self-determination construction...

Code of Federal Regulations, 2011 CFR

2011-04-01

... phase activities. The Secretary shall provide the Indian tribe or tribal organization with an opportunity to review the project construction documents at the concept phase, the schematic phase, the design development phase, and the final construction documents phase, or as otherwise negotiated. Upon receipt of...

Oropharyngeal dysphagia in preschool children with cerebral palsy: oral phase impairments.

PubMed

Benfer, Katherine A; Weir, Kelly A; Bell, Kristie L; Ware, Robert S; Davies, Peter S W; Boyd, Roslyn N

2014-12-01

This study aimed to document the prevalence and patterns of oral phase oropharyngeal dysphagia (OPD) in preschool children with cerebral palsy (CP), and its association with mealtime duration, frequency and efficiency. Cross-sectional population-based cohort study of 130 children diagnosed with CP at 18-36 months ca (mean = 27.4 months, 81 males) and 40 children with typical development (mean = 26.2, 18 males). Functional abilities of children with CP were representative of a population sample (GMFCS I = 57, II = 15, III = 23, IV = 12, V = 23). Oral phase impairment was rated from video using the Dyspahgia Disorders Survey, Schedule for Oral Motor Impairment, and Pre-Speech Assessment Scale. Parent-report was collected on a feeding questionnaire. Mealtime frequency, duration and efficiency were calculated from a three day weighed food record completed by parents. Gross motor function was classified using the Gross Motor Function Classification System (GMFCS). Overall, 93.8% of children had directly assessed oral phase impairments during eating or drinking, or in controlling saliva (78.5% with modified cut-points). Directly assessed oral phase impairments were associated with declining gross motor function, with children from GMFCS I having a 2-fold increased likelihood of oral phase impairment compared to the children with TD (OR = 2.0, p = 0.18), and all children from GMFCS II-V having oral phase impairments. Difficulty biting (70%), cleaning behaviours (70%) and chewing (65%) were the most common impairments on solids, and difficulty sipping from a cup (60%) for fluids. OPD severity and GMFCS were not related to mealtime frequency, duration or efficiency, although children on partial tube feeds had significantly reduced mealtime efficiency. Oral phase impairments were common in preschool children with CP, with severity increasing stepwise with declining gross motor function. The prevalence and severity of oral phase impairments were significantly greater for most tasks when compared to children with typical development, even for those with mild CP. Children who were partially tube fed had significantly lower feeding efficiency, so this could be a useful early indicator of children needing supplementation to their nutrition (through increasing energy density of foods/fluids, or tube feeds). Copyright © 2014 Elsevier Ltd. All rights reserved.

45 CFR 164.316 - Policies and procedures and documentation requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... when it last was in effect, whichever is later. (ii) Availability (Required). Make documentation.... (iii) Updates (Required). Review documentation periodically, and update as needed, in response to...

Electric Utility Phase I Acid Rain Compliance Strategies for the Clean Air Act Amendments of 1990

EIA Publications

1994-01-01

The Acid Rain Program is divided into two time periods; Phase I, from 1995 through 1999, and Phase II, starting in 2000. Phase I mostly affects power plants that are the largest sources of SO2 and NOx . Phase II affects virtually all electric power producers, including utilities and nonutilities. This report is a study of the effects of compliance with Phase I regulations on the costs and operations of electric utilities, but does not address any Phase II impacts.

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

DOT National Transportation Integrated Search

1966-12-01

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

Ion Conduction Path and Low-Temperature Form:. Argyrodite-Type Superionic Conductors

NASA Astrophysics Data System (ADS)

Onoda, M.; Wada, H.; Sato, A.; Ishii, M.

2007-01-01

The structures of the orthorhombic room-temperature phase of Cu8GeS6 (phase II) and the monoclinic low-temperature phase of Ag7TaS6 (phase II) have been successfully refined based on X-ray diffraction data from 12-fold twinned (Cu8GeS6 II) and 24-fold twinned (Ag7TaS6 II) crystals. Respectively among 6 major and 6 minor twin domains of Cu8GeS6 II, or among 12 major and 12 minor twin domains of Ag7TaS6 II, the argyrodite-type frameworks, GeS6 or TaS6, can be superposed to each other in principle, and only Cu-Cu or Ag-Ag network directions differ. At higher temperature, the crystals were considered to be 2-fold twinned crystals of superionic-conductor phase I with a space group F 43m. On cooling, each domain transforms into 6 domains of orthorhombic Cu8GeS6 II or 12 domains of monoclinic Ag7TaS6 II. Superposed projections along 6 directions of the structure of Cu8GeS6 II and along 12 directions of the structure of Ag7TaS6 II seem to show approximate expressions for Cu-ion and Ag-ion conduction paths in superionic-conductor phases, Cu8GeS6 I and Ag7TaS6I.

Estimates of general combining ability in Hevea breeding at the Rubber Research Institute of Malaysia : I. Phases II and III A.

PubMed

Tan, H

1977-01-01

Estimates of general combining ability of parents for yield and girth obtained separately from seedlings and their corresponding clonal families in Phases II and IIIA of the RRIM breeding programme are compared. A highly significant positive correlation (r = 0.71***) is found between GCA estimates from seedling and clonal families for yield in Phase IIIA, but not in Phase II (r = -0.03(NS)) nor for girth (r= -0.27(NS)) in Phase IIIA. The correlations for Phase II yield and Phase IIIA girth, however, improve when the GCA estimates based on small sample size or reversed rankings are excluded.When the best selections (based on present clonal and seedling information) are compared, all five of the parents top-ranking for yield are common in Phase IIIA but only two parents are common for yield and girth in Phases II and IIIA respectively. However, only one parent for yield in Phase II and two parents for girth in Phase IIIA would, if selected on clonal performance, have been omitted from the top ranking selections made by previous workers using seedling information.These findings, therefore, justify the choice of parents based on GCA estimates for yield obtained from seedling performance. Similar justification cannot be offered for girth, for which analysis is confounded by uninterpretable site and seasonal effects.

Benzocaine polymorphism: pressure-temperature phase diagram involving forms II and III.

PubMed

Gana, Inès; Barrio, Maria; Do, Bernard; Tamarit, Josep-Lluís; Céolin, René; Rietveld, Ivo B

2013-11-18

Understanding the phase behavior of an active pharmaceutical ingredient in a drug formulation is required to avoid the occurrence of sudden phase changes resulting in decrease of bioavailability in a marketed product. Benzocaine is known to possess three crystalline polymorphs, but their stability hierarchy has so far not been determined. A topological method and direct calorimetric measurements under pressure have been used to construct the topological pressure-temperature diagram of the phase relationships between the solid phases II and III, the liquid, and the vapor phase. In the process, the transition temperature between solid phases III and II and its enthalpy change have been determined. Solid phase II, which has the highest melting point, is the more stable phase under ambient conditions in this phase diagram. Surprisingly, solid phase I has not been observed during the study, even though the scarce literature data on its thermal behavior appear to indicate that it might be the most stable one of the three solid phases. Copyright © 2013 Elsevier B.V. All rights reserved.

Haematopoietic SCT in severe autoimmune diseases: updated guidelines of the European Group for Blood and Marrow Transplantation

PubMed Central

Snowden, J A; Saccardi, R; Allez, M; Ardizzone, S; Arnold, R; Cervera, R; Denton, C; Hawkey, C; Labopin, M; Mancardi, G; Martin, R; Moore, J J; Passweg, J; Peters, C; Rabusin, M; Rovira, M; van Laar, J M; Farge, D

2012-01-01

In 1997, the first consensus guidelines for haematopoietic SCT (HSCT) in autoimmune diseases (ADs) were published, while an international coordinated clinical programme was launched. These guidelines provided broad principles for the field over the following decade and were accompanied by comprehensive data collection in the European Group for Blood and Marrow Transplantation (EBMT) AD Registry. Subsequently, retrospective analyses and prospective phase I/II studies generated evidence to support the feasibility, safety and efficacy of HSCT in several types of severe, treatment-resistant ADs, which became the basis for larger-scale phase II and III studies. In parallel, there has also been an era of immense progress in biological therapy in ADs. The aim of this document is to provide revised and updated guidelines for both the current application and future development of HSCT in ADs in relation to the benefits, risks and health economic considerations of other modern treatments. Patient safety considerations are central to guidance on patient selection and HSCT procedural aspects within appropriately experienced and Joint Accreditation Committee of International Society for Cellular Therapy and EBMT accredited centres. A need for prospective interventional and non-interventional studies, where feasible, along with systematic data reporting, in accordance with EBMT policies and procedures, is emphasized. PMID:22002489

Draft Background Document: Summary of Data on Municipal ...

EPA Pesticide Factsheets

... it •i HI it 221 IM ll HA ii ii HA it ii NA il li NA II 12.' 1*8 1.113 •l Nt ii ii NA •• -.*l UQ • NT .2* «ff .Uj •• HA II -.115 ll N* il • l 1 .91 j •• NA ii .1?.' - tit .mi .112 ...

1 CFR 21.11 - Standard organization of the Code of Federal Regulations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General... (h) Paragraphs, which are designated as follows: level 1(a), (b), (c), etc. level 2(1), (2), (3), etc. level 3(i), (ii), (iii), etc. level 4(A), (B), (C), etc. level 5(1), (2), (3), etc. level 6(i), (ii...

Report of Programme Commission II (Natural Sciences), Annex - Recommendations.

ERIC Educational Resources Information Center

United Nations Educational, Scientific, and Cultural Organization, Paris (France). General Conference.

As the second part of the report of the Programme Commission II, a summary of recommendations on plans for natural sciences and their applications is presented in this document. Resolutions and budgetary appropriations are two major concerns in the document. The topics are related to the 1973-74 draft program and budget, the 1973-78 draft…

Mechanisms of blood pressure alterations in response to the Valsalva maneuver in postural tachycardia syndrome

NASA Technical Reports Server (NTRS)

Sandroni, P.; Novak, V.; Opfer-Gehrking, T. L.; Huck, C. A.; Low, P. A.

2000-01-01

The postural tachycardia syndrome (POTS) is characterized clinically by orthostatic lightheadedness and tachycardia. When these patients perform a Valsalva maneuver, there is an excessive blood pressure increment after cessation of the maneuver (phase IV) that is sometimes associated with headaches. It is not known whether excessive phase IV is due to excessive peripheral vascular tone (an alpha-adrenergic mechanism) or is a manifestation of increased beta-adrenergic tone (hyperadrenergic state). The authors undertook a pharmacologic study evaluating the effect of intravenous phentolamine (alpha-adrenergic antagonist) and propranolol (beta-adrenergic antagonist) on the different phases of the Valsalva maneuver in a group of patients with POTS and age-matched normal control subjects. Patients with POTS had mean phases, when compared with controls, that were characterized by more negative II_E (p = 0.07), smaller II_L (p = 0.04), and significantly larger phase IV (p = 0.001). The effect of phentolamine was qualitatively and quantitatively different in POTS when compared with controls. Ten mg phentolamine in controls resulted in a significant accentuation of phase II_E (p = 0.001), attenuation of phase II_L (p = 0.002), and increase of phase IV (57.6 vs 30.7 mm Hg; p = 0.025). These changes resembled those of patients with POTS at baseline. In patients with POTS, the phase II abnormalities, already present, were further accentuated (p <0.001), and phase IV became smaller (50.6 vs 73.8 mm Hg; p = 0.09). Propranolol had no significant effect on phases II_E and II_L, but significantly reduced phase IV in both controls (p <0.05) and in patients with POTS (p <0.001) and improved the headache symptoms, when present, during and after phase IV. The authors conclude that phase IV is mainly under beta-adrenergic regulation and that the exaggerated phase IV in POTS is a result of a hyperadrenergic state.

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

First results of GERDA Phase II and consistency with background models

NASA Astrophysics Data System (ADS)

Agostini, M.; Allardt, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; Belyaev, S. T.; Benato, G.; Bettini, A.; Bezrukov, L.; Bode1, T.; Borowicz, D.; Brudanin, V.; Brugnera, R.; Caldwell, A.; Cattadori, C.; Chernogorov, A.; D'Andrea, V.; Demidova, E. V.; Di Marco, N.; Domula, A.; Doroshkevich, E.; Egorov, V.; Falkenstein, R.; Frodyma, N.; Gangapshev, A.; Garfagnini, A.; Gooch, C.; Grabmayr, P.; Gurentsov, V.; Gusev, K.; Hakenmüller, J.; Hegai, A.; Heisel, M.; Hemmer, S.; Hofmann, W.; Hult, M.; Inzhechik, L. V.; Janicskó Csáthy, J.; Jochum, J.; Junker, M.; Kazalov, V.; Kihm, T.; Kirpichnikov, I. V.; Kirsch, A.; Kish, A.; Klimenko, A.; Kneißl, R.; Knöpfle, K. T.; Kochetov, O.; Kornoukhov, V. N.; Kuzminov, V. V.; Laubenstein, M.; Lazzaro, A.; Lebedev, V. I.; Lehnert, B.; Liao, H. Y.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Macolino, C.; Majorovits, B.; Maneschg, W.; Medinaceli, E.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Palioselitis, D.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Salamida, F.; Salathe, M.; Schmitt, C.; Schneider, B.; Schönert, S.; Schreiner, J.; Schulz, O.; Schütz, A.-K.; Schwingenheuer, B.; Selivanenko, O.; Shevzik, E.; Shirchenko, M.; Simgen, H.; Smolnikov, A.; Stanco, L.; Vanhoefer, L.; Vasenko, A. A.; Veresnikova, A.; von Sturm, K.; Wagner, V.; Wegmann, A.; Wester, T.; Wiesinger, C.; Wojcik, M.; Yanovich, E.; Zhitnikov, I.; Zhukov, S. V.; Zinatulina, D.; Zuber, K.; Zuzel, G.

2017-01-01

The GERDA (GERmanium Detector Array) is an experiment for the search of neutrinoless double beta decay (0νββ) in 76Ge, located at Laboratori Nazionali del Gran Sasso of INFN (Italy). GERDA operates bare high purity germanium detectors submersed in liquid Argon (LAr). Phase II of data-taking started in Dec 2015 and is currently ongoing. In Phase II 35 kg of germanium detectors enriched in 76Ge including thirty newly produced Broad Energy Germanium (BEGe) detectors is operating to reach an exposure of 100 kg·yr within about 3 years data taking. The design goal of Phase II is to reduce the background by one order of magnitude to get the sensitivity for T1/20ν = O≤ft( {{{10}26}} \\right){{ yr}}. To achieve the necessary background reduction, the setup was complemented with LAr veto. Analysis of the background spectrum of Phase II demonstrates consistency with the background models. Furthermore 226Ra and 232Th contamination levels consistent with screening results. In the first Phase II data release we found no hint for a 0νββ decay signal and place a limit of this process T1/20ν > 5.3 \\cdot {1025} yr (90% C.L., sensitivity 4.0·1025 yr). First results of GERDA Phase II will be presented.

Authentic assessment based showcase portfolio on learning of mathematical problem solving in senior high school

NASA Astrophysics Data System (ADS)

Sukmawati, Zuhairoh, Faihatuz

2017-05-01

The purpose of this research was to develop authentic assessment model based on showcase portfolio on learning of mathematical problem solving. This research used research and development Method (R & D) which consists of four stages of development that: Phase I, conducting a preliminary study. Phase II, determining the purpose of developing and preparing the initial model. Phase III, trial test of instrument for the initial draft model and the initial product. The respondents of this research are the students of SMAN 8 and SMAN 20 Makassar. The collection of data was through observation, interviews, documentation, student questionnaire, and instrument tests mathematical solving abilities. The data were analyzed with descriptive and inferential statistics. The results of this research are authentic assessment model design based on showcase portfolio which involves: 1) Steps in implementing the authentic assessment based Showcase, assessment rubric of cognitive aspects, assessment rubric of affective aspects, and assessment rubric of skill aspect. 2) The average ability of the students' problem solving which is scored by using authentic assessment based on showcase portfolio was in high category and the students' response in good category.

Development of a rapidly deployed Department of Energy emergency response element.

PubMed

Tighe, R J; Riland, C A; Hopkins, R C

2000-02-01

The Federal Radiological Emergency Response Plan (FRERP) directs the Department of Energy (DOE) to maintain a viable, timely, and fully documented response option capable of supporting the responsible Lead Federal Agency in the event of a radiological emergency impacting any state or United States territory (e.g., CONUS). In addition, the DOE maintains a response option to support radiological emergencies outside the continental United States (OCONUS). While the OCONUS mission is not governed by the FRERP, this response is operationally similar to that assigned to the DOE by the FRERP The DOE is prepared to alert, activate, and deploy radiological response teams to augment the Radiological Assistance Program and/or local responders. The Radiological Monitoring and Assessment Center (RMAC) is a phased response that integrates with the Federal Radiological Monitoring and Assessment Center (FRMAC) in CONUS environments and represents a stand-alone DOE response for OCONUS environments. The FRMAC/RMAC Phase I was formally "stood up" as an operational element in April 1999. The FRMAC/RMAC Phase II proposed "stand-up" date is midyear 2000.

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

PubMed

Suzuki, Kazuyuki; Endo, Ryujin; Takikawa, Yasuhiro; Moriyasu, Fuminori; Aoyagi, Yutaka; Moriwaki, Hisataka; Terai, Shuji; Sakaida, Isao; Sakai, Yoshiyuki; Nishiguchi, Shuhei; Ishikawa, Toru; Takagi, Hitoshi; Naganuma, Atsushi; Genda, Takuya; Ichida, Takafumi; Takaguchi, Koichi; Miyazawa, Katsuhiko; Okita, Kiwamu

2018-05-01

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia. © 2017 The Japan Society of Hepatology.

Phenomenology of Polymorphism, III: p, TDiagram and Stability of Piracetam Polymorphs

NASA Astrophysics Data System (ADS)

Céolin, R.; Agafonov, V.; Louër, D.; Dzyabchenko, V. A.; Toscani, S.; Cense, J. M.

1996-02-01

The nootropic drug Piracetam is known to crystallize in three phases. In order to obtain their stability hierarchy from sublimation pressure inequalities, the drawing of a topologicalp,Tdiagram was attempted. For such a purpose and also for quality control, crystallographic and thermodynamic data were required. Powder X-ray diffractometry (XRD) and differential scanning calorimetry (DSC) were used. Molecular energy calculations were performed. Phase I melts at 426 K (ΔfusH(I) = +180 J·g-1). Phase II transforms into Phase I at 399 K (Δ(II→I)H= +24 J·g-1). Phase III transforms into phase I at 392 K (Δ(III→I)H= +28 J·g-1) or melts at 412 K (ΔfusH(III) = +210 J·g-1). Thep,Tdiagram shows that phase I is stable at higher temperature and phase II at lower temperature, like phase III, which is stable under high pressure. At room temperature, phase II is the more stable form, and phase I the less stable one. This agrees with the spontaneous I → II transformation observed at 298 K within a few hours, and with lattice energies, calculated previously. Molecular energy calculations and crystal structure comparison show how intermolecular hydrogen bonds and H-bonded dimers, in phases II and III, may stabilize conformations higher in energy than those of the isolated molecule and of phase I.

International Expert Consensus Document on Takotsubo Syndrome (Part II): Diagnostic Workup, Outcome, and Management.

PubMed

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-06-07

The clinical expert consensus statement on takotsubo syndrome (TTS) part II focuses on the diagnostic workup, outcome, and management. The recommendations are based on interpretation of the limited clinical trial data currently available and experience of international TTS experts. It summarizes the diagnostic approach, which may facilitate correct and timely diagnosis. Furthermore, the document covers areas where controversies still exist in risk stratification and management of TTS. Based on available data the document provides recommendations on optimal care of such patients for practising physicians.

International Expert Consensus Document on Takotsubo Syndrome (Part II): Diagnostic Workup, Outcome, and Management

PubMed Central

Ghadri, Jelena-Rima; Wittstein, Ilan Shor; Prasad, Abhiram; Sharkey, Scott; Dote, Keigo; Akashi, Yoshihiro John; Cammann, Victoria Lucia; Crea, Filippo; Galiuto, Leonarda; Desmet, Walter; Yoshida, Tetsuro; Manfredini, Roberto; Eitel, Ingo; Kosuge, Masami; Nef, Holger M; Deshmukh, Abhishek; Lerman, Amir; Bossone, Eduardo; Citro, Rodolfo; Ueyama, Takashi; Corrado, Domenico; Kurisu, Satoshi; Ruschitzka, Frank; Winchester, David; Lyon, Alexander R; Omerovic, Elmir; Bax, Jeroen J; Meimoun, Patrick; Tarantini, Guiseppe; Rihal, Charanjit; Y.-Hassan, Shams; Migliore, Federico; Horowitz, John D; Shimokawa, Hiroaki; Lüscher, Thomas Felix; Templin, Christian

2018-01-01

Abstract The clinical expert consensus statement on takotsubo syndrome (TTS) part II focuses on the diagnostic workup, outcome, and management. The recommendations are based on interpretation of the limited clinical trial data currently available and experience of international TTS experts. It summarizes the diagnostic approach, which may facilitate correct and timely diagnosis. Furthermore, the document covers areas where controversies still exist in risk stratification and management of TTS. Based on available data the document provides recommendations on optimal care of such patients for practising physicians. PMID:29850820

Cellulose-lanthanum hydroxide nanocomposite as a selective marker for detection of toxic copper

PubMed Central

2014-01-01

In this current report, a simple, reliable, and rapid method based on modifying the cellulose surface by doping it with different percentages of lanthanum hydroxide (i.e., 1% La(OH)3-cellulose (LC), 5% La(OH)3-cellulose (LC2), and 10% La(OH)3-cellulose (LC3)) was proposed as a selective marker for detection of copper (Cu(II)) in aqueous medium. Surface properties of the newly modified cellulose phases were confirmed by Fourier transform infrared spectroscopy, field emission scanning electron microscope, energy dispersive X-ray spectroscopy, X-ray diffraction, and X-ray photoelectron spectroscopic analysis. The effect of pH on the adsorption of modified cellulose phases for Cu(II) was evaluated, and LC3 was found to be the most selective for Cu(II) at pH 6.0. Other parameters, influencing the maximum uptake of Cu(II) on LC3, were also investigated for a deeper mechanistic understanding of the adsorption phenomena. Results showed that the adsorption capacity for Cu(II) was improved by 211% on the LC3 phase as compared to diethylaminoethyl cellulose phase after only 2 h contact time. Adsorption isotherm data established that the adsorption process nature was monolayer with a homogeneous adsorbent surface. Results displayed that the adsorption of Cu(II) onto the LC3 phase obeyed a pseudo-second-order kinetic model. Selectivity studies toward eight metal ions, i.e., Cd(II), Co(II), Cr(III), Cr(VI), Cu(II), Fe(III), Ni(II), and Zn(II), were further performed at the optimized pH value. Based on the selectivity study, it was found that Cu(II) is highly selective toward the LC3 phase. Moreover, the efficiency of the proposed method was supported by implementing it to real environmental water samples with adequate results. PMID:25258599

MECHANISM AND KINETICS OF THE FORMATION OF NOX AND OTHER COMBUSTION POLLUTANTS. PHASE II. MODIFIED COMBUSTION

EPA Science Inventory

The report gives Phase II results of a combined experimental/theoretical study to define the mechanisms and kinetics of the formation of NOx and other combustion pollutants. Two experimental devices were used in Phase II. A special flat-flame burner with a controlled-temperature ...

76 FR 3624 - Milford Wind Corridor Phase II, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-2657-000] Milford Wind Corridor Phase II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for... proceeding Milford Wind Corridor Phase II, LLC's application for market-based rate authority, with an...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0465] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... guidance document will serve as the special control for rTMS systems. Section 513(f)(2) of the Federal Food...

Abrupt change of Antarctic moisture origin at the end of Termination II

PubMed Central

Masson-Delmotte, V.; Stenni, B.; Blunier, T.; Cattani, O.; Chappellaz, J.; Cheng, H.; Dreyfus, G.; Edwards, R. L.; Falourd, S.; Govin, A.; Kawamura, K.; Johnsen, S. J.; Jouzel, J.; Landais, A.; Lemieux-Dudon, B.; Lourantou, A.; Marshall, G.; Minster, B.; Mudelsee, M.; Pol, K.; Röthlisberger, R.; Selmo, E.; Waelbroeck, C.

2010-01-01

The deuterium excess of polar ice cores documents past changes in evaporation conditions and moisture origin. New data obtained from the European Project for Ice Coring in Antarctica Dome C East Antarctic ice core provide new insights on the sequence of events involved in Termination II, the transition between the penultimate glacial and interglacial periods. This termination is marked by a north–south seesaw behavior, with first a slow methane concentration rise associated with a strong Antarctic temperature warming and a slow deuterium excess rise. This first step is followed by an abrupt north Atlantic warming, an abrupt resumption of the East Asian summer monsoon, a sharp methane rise, and a CO2 overshoot, which coincide within dating uncertainties with the end of Antarctic optimum. Here, we show that this second phase is marked by a very sharp Dome C centennial deuterium excess rise, revealing abrupt reorganization of atmospheric circulation in the southern Indian Ocean sector. PMID:20566887

Doping-induced disappearance of ice II from water's phase diagram

NASA Astrophysics Data System (ADS)

Shephard, Jacob J.; Slater, Ben; Harvey, Peter; Hart, Martin; Bull, Craig L.; Bramwell, Steven T.; Salzmann, Christoph G.

2018-06-01

Water and the many phases of ice display a plethora of complex physical properties and phase relationships1-4 that are of paramount importance in a range of settings including processes in Earth's hydrosphere, the geology of icy moons, industry and even the evolution of life. Well-known examples include the unusual behaviour of supercooled water2, the emergent ferroelectric ordering in ice films4 and the fact that the `ordinary' ice Ih floats on water. We report the intriguing observation that ice II, one of the high-pressure phases of ice, disappears in a selective fashion from water's phase diagram following the addition of small amounts of ammonium fluoride. This finding exposes the strict topologically constrained nature of the ice II hydrogen-bond network, which is not found for the competing phases. In analogy to the behaviour of frustrated magnets5, the presence of the exceptional ice II is argued to have a wider impact on water's phase diagram, potentially explaining its general tendency to display anomalous behaviour. Furthermore, the impurity-induced disappearance of ice II raises the prospect that specific dopants may not only be able to suppress certain phases but also induce the formation of new phases of ice in future studies.

High Speed Research Program Structural Acoustics Multi-Year Summary Report

NASA Technical Reports Server (NTRS)

Beier, Theodor H.; Bhat, Waman V.; Rizzi, Stephen A.; Silcox, Richard J.; Simpson, Myles A.

2005-01-01

This report summarizes the work conducted by the Structural Acoustics Integrated Technology Development (ITD) Team under NASA's High Speed Research (HSR) Phase II program from 1993 to 1999. It is intended to serve as a reference for future researchers by documenting the results of the interior noise and sonic fatigue technology development activities conducted during this period. For interior noise, these activities included excitation modeling, structural acoustic response modeling, development of passive treatments and active controls, and prediction of interior noise. For sonic fatigue, these activities included loads prediction, materials characterization, sonic fatigue code development, development of response reduction techniques, and generation of sonic fatigue design requirements. Also included are lessons learned and recommendations for future work.

Assessment of Operational Automated Guideway Systems - Airtrans (Phase II)

DOT National Transportation Integrated Search

1980-01-01

This study, Phase II, completes the assessment of AIRTRANS, the automated guideway system located at the Dallas-Fort Worth Airport. The Phase I assessment report: "Assessment of Operational Automated Guideway Systems--AIRTRANS (Phase I)" (PB-261 339)...

Attendance at specialist hepatitis clinics and initiation of antiviral treatment among persons chronically infected with hepatitis C: examining the early impact of Scotland's Hepatitis C Action Plan.

PubMed

McDonald, S A; Hutchinson, S J; Innes, H A; Allen, S; Bramley, P; Bhattacharyya, D; Carman, W; Dillon, J F; Fox, R; Fraser, A; Goldberg, D J; Kennedy, N; Mills, P R; Morris, J; Stanley, A J; Wilks, D; Hayes, P C

2014-05-01

Primary goals of the Hepatitis C Action Plan for Scotland Phase II (May 2008-March 2011) were to increase, among persons chronically infected with the hepatitis C (HCV) virus, attendance at specialist outpatient clinics and initiation on antiviral therapy. We evaluated progress towards these goals by comparing the odds, across time, of (a) first clinic attendance within 12 months of HCV diagnosis (n = 9747) and (b) initiation on antiviral treatment within 12 months of first attendance (n = 5736). Record linkage between the national HCV diagnosis (1996-2009) and HCV clinical (1996-2010) databases and logistic regression analyses were conducted for both outcomes. For outcome (a), 32% and 45% in the respective pre-Phase II (before 1 May 2008) and Phase II periods attended a specialist clinic within 12 months of diagnosis; the odds of attendance within 12 months increased over time (OR = 1.05 per year, 95% CI: 1.04-1.07), but was not significantly greater for persons diagnosed with HCV in the Phase II era, compared with the pre-Phase II era (OR = 1.1, 95% CI: 0.9-1.3), after adjustment for temporal trend. For outcome (b), 13% and 28% were initiated on treatment within 12 months of their first clinic attendance in the pre-Phase II and Phase II periods, respectively. Higher odds of treatment initiation were associated with first clinic attendance in the Phase II (OR = 1.9, 95% CI: 1.5-2.4), compared with the pre-Phase II era. Results were consistent with a positive impact of the Hepatitis C Action Plan on the treatment of chronically infected individuals, but further monitoring is required to confirm a sustained effect. © 2013 John Wiley & Sons Ltd.

Maximizing return on socioeconomic investment in phase II proof-of-concept trials.

PubMed

Chen, Cong; Beckman, Robert A

2014-04-01

Phase II proof-of-concept (POC) trials play a key role in oncology drug development, determining which therapeutic hypotheses will undergo definitive phase III testing according to predefined Go-No Go (GNG) criteria. The number of possible POC hypotheses likely far exceeds available public or private resources. We propose a design strategy for maximizing return on socioeconomic investment in phase II trials that obtains the greatest knowledge with the minimum patient exposure. We compare efficiency using the benefit-cost ratio, defined to be the risk-adjusted number of truly active drugs correctly identified for phase III development divided by the risk-adjusted total sample size in phase II and III development, for different POC trial sizes, powering schemes, and associated GNG criteria. It is most cost-effective to conduct small POC trials and set the corresponding GNG bars high, so that more POC trials can be conducted under socioeconomic constraints. If δ is the minimum treatment effect size of clinical interest in phase II, the study design with the highest benefit-cost ratio has approximately 5% type I error rate and approximately 20% type II error rate (80% power) for detecting an effect size of approximately 1.5δ. A Go decision to phase III is made when the observed effect size is close to δ. With the phenomenal expansion of our knowledge in molecular biology leading to an unprecedented number of new oncology drug targets, conducting more small POC trials and setting high GNG bars maximize the return on socioeconomic investment in phase II POC trials. ©2014 AACR.

Development of advanced blanket performance under irradiation and system integration through JUPITER-II project

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

Abe, Katsunori; Kohyama, Akira; Tanaka, Satoru

This report describes an outline of the activities of the JUPITER-II collaboration (japan-USA program of Irradiation/Integration test for Fusion Research-II), Which has bee carried out through six years (2001-2006) under Phase 4 of the collabroation implemented by Amendment 4 of Annex 1 to the DOE (United States Department of Energy)-MEXT (Ministry of Education ,Culture,Sports,Science and Technology) Cooperation. This program followed the RTNS-II Program (Phase1:1982-4986), the FFTF/MOTA Program (Phase2:1987-1994) and the JUPITER Program (Phase 3: 1995-2000) [1].

Intermediate load modules for test and evaluation

NASA Technical Reports Server (NTRS)

1984-01-01

Photovoltaic modules were tested for qualification. Tests involved the following: (1) delivery of 20 solar cells for use as reference cells; (2) module documentation and inspection plans specifying the 10 Group I modules; (3) design review of module documentation from Group I modules; (4) revise module documentation to overcome any problems of deficiencies associated with the Group I modules; (5) delivery of 10 Group II modules built to revised specifications; (6) testing of Group II modules to the criteria as outlined in qualification specification. It is found that the solarvolt MSP43E40B satisfies the design criteria of qualification specification for intermediate load modules. Design changes were made in the Group I modules to overcome the deficiencies which allowed Group II modules to pass the qualification tests.

Upgrade for Phase II of the Gerda experiment

NASA Astrophysics Data System (ADS)

Agostini, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; Belyaev, S. T.; Benato, G.; Bettini, A.; Bezrukov, L.; Bode, T.; Borowicz, D.; Brudanin, V.; Brugnera, R.; Caldwell, A.; Cattadori, C.; Chernogorov, A.; D'Andrea, V.; Demidova, E. V.; Di Marco, N.; Domula, A.; Doroshkevich, E.; Egorov, V.; Falkenstein, R.; Frodyma, N.; Gangapshev, A.; Garfagnini, A.; Grabmayr, P.; Gurentsov, V.; Gusev, K.; Hakenmüller, J.; Hegai, A.; Heisel, M.; Hemmer, S.; Hiller, R.; Hofmann, W.; Hult, M.; Inzhechik, L. V.; Ioannucci, L.; Janicskó Csáthy, J.; Jochum, J.; Junker, M.; Kazalov, V.; Kermaïdic, Y.; Kihm, T.; Kirpichnikov, I. V.; Kirsch, A.; Kish, A.; Klimenko, A.; Kneißl, R.; Knöpfle, K. T.; Kochetov, O.; Kornoukhov, V. N.; Kuzminov, V. V.; Laubenstein, M.; Lazzaro, A.; Lebedev, V. I.; Lehnert, B.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Macolino, C.; Majorovits, B.; Maneschg, W.; Medinaceli, E.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Nisi, S.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Ransom, C.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Salamida, F.; Salathe, M.; Schmitt, C.; Schneider, B.; Schönert, S.; Schreiner, J.; Schütz, A.-K.; Schulz, O.; Schwingenheuer, B.; Selivanenko, O.; Shevchik, E.; Shirchenko, M.; Simgen, H.; Smolnikov, A.; Stanco, L.; Vanhoefer, L.; Vasenko, A. A.; Veresnikova, A.; von Sturm, K.; Wagner, V.; Wegmann, A.; Wester, T.; Wiesinger, C.; Wojcik, M.; Yanovich, E.; Zhitnikov, I.; Zhukov, S. V.; Zinatulina, D.; Zsigmond, A. J.; Zuber, K.; Zuzel, G.

2018-05-01

The Gerda collaboration is performing a sensitive search for neutrinoless double beta decay of ^{76}Ge at the INFN Laboratori Nazionali del Gran Sasso, Italy. The upgrade of the Gerda experiment from Phase I to Phase II has been concluded in December 2015. The first Phase II data release shows that the goal to suppress the background by one order of magnitude compared to Phase I has been achieved. Gerda is thus the first experiment that will remain "background-free" up to its design exposure (100 kg year). It will reach thereby a half-life sensitivity of more than 10^{26} year within 3 years of data collection. This paper describes in detail the modifications and improvements of the experimental setup for Phase II and discusses the performance of individual detector components.

40 CFR 80.45 - Complex emissions model.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) VOCW% = Percentage change in winter VOC emissions from baseline levels (8) Phase II total VOC emissions... its domain Phase I = The years 1995-1999 Phase II = Year 2000 and beyond (b) Weightings and baselines... appropriate pollutant and Phase: Table 1—Normal and Higher Emitter Weightings for Exhaust Emissions Phase I...

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

Abe Lederman

This report contains the comprehensive summary of the work performed on the SBIR Phase II project (“Distributed Relevance Ranking in Heterogeneous Document Collections”) at Deep Web Technologies (http://www.deepwebtech.com). We have successfully completed all of the tasks defined in our SBIR Proposal work plan (See Table 1 - Phase II Tasks Status). The project was completed on schedule and we have successfully deployed an initial production release of the software architecture at DOE-OSTI for the Science.gov Alliance's search portal (http://www.science.gov). We have implemented a set of grid services that supports the extraction, filtering, aggregation, and presentation of search results from numerousmore » heterogeneous document collections. Illustration 3 depicts the services required to perform QuickRank™ filtering of content as defined in our architecture documentation. Functionality that has been implemented is indicated by the services highlighted in green. We have successfully tested our implementation in a multi-node grid deployment both within the Deep Web Technologies offices, and in a heterogeneous geographically distributed grid environment. We have performed a series of load tests in which we successfully simulated 100 concurrent users submitting search requests to the system. This testing was performed on deployments of one, two, and three node grids with services distributed in a number of different configurations. The preliminary results from these tests indicate that our architecture will scale well across multi-node grid deployments, but more work will be needed, beyond the scope of this project, to perform testing and experimentation to determine scalability and resiliency requirements. We are pleased to report that a production quality version (1.4) of the science.gov Alliance's search portal based on our grid architecture was released in June of 2006. This demonstration portal is currently available at http://science.gov/search30 . The portal allows the user to select from a number of collections grouped by category and enter a query expression (See Illustration 1 - Science.gov 3.0 Search Page). After the user clicks “search” a results page is displayed that provides a list of results from the selected collections ordered by relevance based on the query expression the user provided. Our grid based solution to deep web search and document ranking has already gained attention within DOE, other Government Agencies and a fortune 50 company. We are committed to the continued development of grid based solutions to large scale data access, filtering, and presentation problems within the domain of Information Retrieval and the more general categories of content management, data mining and data analysis.« less

Chesapeake Bay Low Freshwater Inflow Study. Phase II. MAP FOLIO. Biota Assessment.

DTIC Science & Technology

1982-05-01

conditions. These were: 1) Base Average -- average freshwater inflow conditions. by increased water consumption projected for the year 2020. 3) Base Drought...RESOLUTION TEST CHART NATIONAL BUREAU OF STANDARDS. 1963- A TAI m - ii J May 1982 Chesapeake Bay Low Freshwater Inflow Study Phase II Biota Assessment Map...A PERIOD ZOVERED change was found to CIESAPEAKE BAY LOW FRESHWATER INFLOW STUDY FINAL BIOTA ASSESSMENT PHASE II: FINAL REPORT MAP FOLIO s PERFORMING

Effects of Combined Phase III and Phase II Cardiac Exercise Therapy for Middle-aged Male Patients with Acute Myocardial Infarction

PubMed Central

Lee, Chih-Wei; Wang, Ji-Hung; Hsieh, Jen-Che; Hsieh, Tsung-Cheng; Huang, Chien-Hui

2013-01-01

[Purpose] To investigate the effects of cardiac exercise therapy (CET) on exercise capacity and coronary risk factors (CRFs) of patients with acute myocardial infarction (AMI). [Methods] Patients who participated in an 8-week supervised, hospital-based phase II and 6-month home-based phase III CET with monthly telephone and/or home visits were defined as the exercise group (EG) (n=20), while those who did not receive phase II or phase III CET were defined as the no-exercise group (NEG) (n=10). CRFs were evaluated pre- and post-phase II and eight months after discharge. One and two-way repeated measures ANOVA were used to perform intra- and inter-group comparisons. [Results] Thirty men with AMI aged 49.3 ± 8.3 years were studied. EG increased their exercise capacity (METs) (6.8 ± 1.6 vs.10.0 ± 1.9) after phase II CET and was able to maintain it at 8-month follow-up. Both groups had significantly fewer persons who kept on smoking compared to the first examination. High density lipoprotein cholesterol (HDL-C) increased from 38.1 ± 11.0 to 43.7 ± 8.7 mg/dl at follow-up in EG while no significant difference was noted in NEG. [Conclusion] After phase III CET subjects had maintained the therapeutic effects of smoking cessation, and increasing exercise capacity obtained in phase II CET. HDL-C in EG continued to improve during phase III CET. PMID:24396201

47 CFR 54.310 - Connect America Fund for Price Cap Territories-Phase II

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false Connect America Fund for Price Cap Territories... Connect America Fund for Price Cap Territories—Phase II (a) Geographic areas eligible for support. Connect America Phase II support may be made available for census blocks or other areas identified as eligible by...

Phase I/II adaptive design for drug combination oncology trials

PubMed Central

Wages, Nolan A.; Conaway, Mark R.

2014-01-01

Existing statistical methodology on dose finding for combination chemotherapies has focused on toxicity considerations alone in finding a maximum tolerated dose combination to recommend for further testing of efficacy in a phase II setting. Recently, there has been increasing interest in integrating phase I and phase II trials in order to facilitate drug development. In this article, we propose a new adaptive phase I/II method for dual-agent combinations that takes into account both toxicity and efficacy after each cohort inclusion. The primary objective, both within and at the conclusion of the trial, becomes finding a single dose combination with an acceptable level of toxicity that maximizes efficacious response. We assume that there exist monotone dose–toxicity and dose–efficacy relationships among doses of one agent when the dose of other agent is fixed. We perform extensive simulation studies that demonstrate the operating characteristics of our proposed approach, and we compare simulated results to existing methodology in phase I/II design for combinations of agents. PMID:24470329

Raman Frequencies Calculated from the Volume Data as a Function of Temperature at High Pressures for the Disordered Phase II of NH4I

NASA Astrophysics Data System (ADS)

Yurtseven, H.; Kavruk, D.

In this study, we calculate the Raman frequencies as a function of temperature for the fixed pressures of 706, 1080 and 6355 bars using the volume data for phase II of ammonium iodide. The Raman frequencies calculated here are for the translational optic ν5 TOM (125 cm-1) lattice mode that is located at the zone boundary (M point) of the Brillouin zone of phase II for NH4I. For this calculation the volume data obtained at zero pressure, is used through the mode Grüneisen parameter for the disordered phase II (β phase) which has the CsCl structure of NH4I. Our predicted frequencies of the ν5 TOM (125 cm-1) mode can be compared when the Raman data for this lattice mode is available at various temperatures for fixed pressures of 706, 1080 and 6355 bars in the disordered phase II of ammonium iodide.

Adolescent Health. Volume II: Background and the Effectiveness of Selected Prevention and Treatment Services [and] Indexes to Volumes I, II, and III.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. Office of Technology Assessment.

This document, the second of three volumes in the U.S. Congress Office of Technology Assessment's "Adolescent Health" series, provides background information on aspects of adolescents' lives and examines the effectiveness of prevention and treatment interventions. Chapter 1, an introduction to this two-part document, provides a summary of the…

Structured Forms Reference Set of Binary Images II (SFRS2)

National Institute of Standards and Technology Data Gateway

NIST Structured Forms Reference Set of Binary Images II (SFRS2) (Web, free access)   The second NIST database of structured forms (Special Database 6) consists of 5,595 pages of binary, black-and-white images of synthesized documents containing hand-print. The documents in this database are 12 different tax forms with the IRS 1040 Package X for the year 1988.

EARLY ENTRANCE COPRODUCTION PLANT

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

David Storm; Govanon Nongbri; Steve Decanio

2004-01-12

The overall objective of this project is the three phase development of an Early Entrance Coproduction Plant (EECP) which uses petroleum coke to produce at least one product from at least two of the following three categories: (1) electric power (or heat), (2) fuels, and (3) chemicals using ChevronTexaco's proprietary gasification technology. The objective of Phase I is to determine the feasibility and define the concept for the EECP located at a specific site; develop a Research, Development, and Testing (RD&T) Plan to mitigate technical risks and barriers; and prepare a Preliminary Project Financing Plan. The objective of Phase IImore » is to implement the work as outlined in the Phase I RD&T Plan to enhance the development and commercial acceptance of coproduction technology. The objective of Phase III is to develop an engineering design package and a financing and testing plan for an EECP located at a specific site. The project's intended result is to provide the necessary technical, economic, and environmental information needed by industry to move the EECP forward to detailed design, construction, and operation. The partners in this project are Texaco Energy Systems LLC or TES (a subsidiary of ChevronTexaco), General Electric (GE), Praxair, and Kellogg Brown & Root (KBR) in addition to the U.S. Department of Energy (DOE). TES is providing gasification technology and Fischer-Tropsch (F-T) technology developed by Rentech, Inc., GE is providing combustion turbine technology, Praxair is providing air separation technology, and KBR is providing engineering. During Phase I, a design basis for the Fischer-Tropsch Synthesis section was developed based on limited experience with the specified feed gas and operating conditions. The objective of this Task in Phase II RD&T work was to confirm the performance of the F-T reactor at the set design conditions. Although much of the research, development, and testing work were done by TES outside of this project, several important issues were addressed in this phase of the project. They included Rejuvenation/Regeneration of the Fischer-Tropsch Catalyst, online Catalyst Withdrawal and Addition from the synthesis reactor, and the Fischer-Tropsch Design Basis Confirmation. In Phase III the results from these RD&T work will be incorporated in developing the engineering design package. This Topical Report documents the Phase II RD&T work that was completed for this task.« less

The National Geographic Names Data Base: Phase II instructions

USGS Publications Warehouse

Orth, Donald J.; Payne, Roger L.

1987-01-01

not recorded on topographic maps be added. The systematic collection of names from other sources, including maps, charts, and texts, is termed Phase II. In addition, specific types of features not compiled during Phase I are encoded and added to the data base. Other names of importance to researchers and users, such as historical and variant names, are also included. The rules and procedures for Phase II research, compilation, and encoding are contained in this publication.

Use of a pharmacy technician to facilitate postfracture care provided by clinical pharmacy specialists.

PubMed

Irwin, Adriane N; Heilmann, Rachel M F; Gerrity, Theresa M; Kroner, Beverly A; Olson, Kari L

2014-12-01

The ability of a pharmacy technician to support the patient screening and documentation-related functions of a pharmacist-driven osteoporosis management service was evaluated. A two-phase prospective study was conducted within a large integrated health system to assess a pharmacy technician's performance in supporting a multisite team of clinical pharmacy specialists providing postfracture care. In phase I of the study, a specially trained pharmacy technician provided support to pharmacists at five participating medical offices, helping to identify patients requiring pharmacist intervention and, when applicable, collecting patient-specific clinical information from the electronic health record. In phase II of the study, the amount of pharmacist time saved through the use of technician support versus usual care was evaluated. The records of 127 patient cases were reviewed by the pharmacy technician during phase I of the study, and a pharmacist agreed with the technician's determination of the need for intervention in the majority of instances (92.9%). An additional 91 patient cases were reviewed by the technician in phase II of the research. With technician support, pharmacists spent less time reviewing cases subsequently determined as not requiring intervention (mean ± S.D., 5.0 ± 3.8 minutes per case compared with 5.2 ± 4.5 minutes under the usual care model; p = 0.78). In cases requiring intervention, technician support was associated with a reduction in the average pharmacist time spent on care plan development (13.5 ± 7.1 minutes versus 18.2 ± 16.6 minutes with usual care, p = 0.34). The study results suggest that a pharmacy technician can accurately determine if a patient is a candidate for pharmacist intervention and collect clinical information to facilitate care plan development. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Mixed response and time-to-event endpoints for multistage single-arm phase II design.

PubMed

Lai, Xin; Zee, Benny Chung-Ying

2015-06-04

The objective of phase II cancer clinical trials is to determine if a treatment has sufficient activity to warrant further study. The efficiency of a conventional phase II trial design has been the object of considerable debate, particularly when the study regimen is characteristically cytostatic. At the time of development of a phase II cancer trial, we accumulated clinical experience regarding the time to progression (TTP) for similar classes of drugs and for standard therapy. By considering the time to event (TTE) in addition to the tumor response endpoint, a mixed-endpoint phase II design may increase the efficiency and ability of selecting promising cytotoxic and cytostatic agents for further development. We proposed a single-arm phase II trial design by extending the Zee multinomial method to fully use mixed endpoints with tumor response and the TTE. In this design, the dependence between the probability of response and the TTE outcome is modeled through a Gaussian copula. Given the type I and type II errors and the hypothesis as defined by the response rate (RR) and median TTE, such as median TTP, the decision rules for a two-stage phase II trial design can be generated. We demonstrated through simulation that the proposed design has a smaller expected sample size and higher early stopping probability under the null hypothesis than designs based on a single-response endpoint or a single TTE endpoint. The proposed design is more efficient for screening new cytotoxic or cytostatic agents and less likely to miss an effective agent than the alternative single-arm design.

Outcome assessment of patients undergoing maxillofacial procedures for the treatment of sleep apnea: comparison of subjective and objective results.

PubMed

Dattilo, David J; Drooger, Scott A

2004-02-01

The purpose of this study was to compare the subjective findings of the Epworth Sleepiness Scale (ESS) to the objective findings of the overnight sleep study (OSS) in 57 patients who underwent phase I and phase II surgery for the correction of obstructive sleep apnea (OSA). Forty-two patients in phase I category (hyoid suspension, palatal surgery, and/or genioglossus advancement) and 15 patients in phase II category (maxillomandibular advancement) were examined. All patients had an OSS and completion of an ESS preoperatively and at a minimum of 8 weeks postoperatively. The results of each test were evaluated to examine any relationship between the improvements of the findings of the OSS to the changes in the ESS. Using accepted criteria, phase I surgery produced an 80% success rate and phase II surgery produced a greater than 95% success rate in both the respiratory disturbance index and the ESS. 1) Both phase I and phase II procedures are effective in treating OSA. 2) Phase II appears to be more effective in treating OSA using both objective and subjective evaluations. 3) Improvement in ESS scores and excessive daytime sleepiness seems to parallel the improvement in OSS scores in patients undergoing surgical correction of OSA.

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase II: Final Report.

ERIC Educational Resources Information Center

Walker, Bonnie L.

This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…

Single-arm phase II trial design under parametric cure models.

PubMed

Wu, Jianrong

2015-01-01

The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios. Copyright © 2015 John Wiley & Sons, Ltd.

A tool for hearing aid and cochlear implant users to judge the usability of cellular telephones in field conditions

NASA Astrophysics Data System (ADS)

Deer, Maria Soledad

The auditory experience of using a hearing aid or a cochlear implant simultaneously with a cell phone is driven by a number of factors. These factors are: radiofrequency and baseband interference, speech intelligibility, sound quality, handset design, volume control and signal strength. The purpose of this study was to develop a tool to be used by hearing aid and cochlear implant users in retail stores as they try cell phones before buying them. This tool is meant to be an efficient, practical and systematic consumer selection tool that will capture and document information on all the domains that play a role in the auditory experience of using a cell phone with a hearing aid or cochlear implant. The development of this consumer tool involved three steps as follows: preparation, verification and measurement of success according to a predefined criterion. First, the consumer tool, consisting of a comparison chart and speech material, was prepared. Second, the consumer tool was evaluated by groups of subjects in a two-step verification process. Phase I was conducted in a controlled setting and it was followed by Phase II which took place in real world (field) conditions. In order to perform a systematic evaluation of the consumer tool two questionnaires were developed: one questionnaire for each phase. Both questionnaires involved five quantitative variables scored with the use of ratings scales. These ratings were averaged yielding an Overall Consumer Performance Score. A qualitative performance category corresponding to the Mean Opinion Score (MOS) was allocated to each final score within a scale ranging from 1 to 5 (where 5 = excellent and 1 = bad). Finally, the consumer tool development was determined to be successful if at least 80% of the participants in verification Phase II rated the comparison chart as excellent or good according to the qualitative MOS score. The results for verification Phase II (field conditions) indicated that the Overall Consumer Performance score for 92% of the subjects (11/12) was 3.7 and above corresponding to Good and Excellent MOS qualitative categories. It was concluded that this is a practical and efficient tool for hearing aid/cochlear implant users as they approach a cell phone selection process.

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.

PubMed

Elsäßer, Amelie; Regnstrom, Jan; Vetter, Thorsten; Koenig, Franz; Hemmings, Robert James; Greco, Martina; Papaluca-Amati, Marisa; Posch, Martin

2014-10-02

Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of adaptive designs in the regulatory context. Since there is limited experience in the implementation and interpretation of adaptive clinical trials, early interaction with regulators is recommended. The EMA offers such interactions through scientific advice and protocol assistance procedures. We performed a text search of scientific advice letters issued between 1 January 2007 and 8 May 2012 that contained relevant key terms. Letters containing questions related to adaptive clinical trials in phases II or III were selected for further analysis. From the selected letters, important characteristics of the proposed design and its context in the drug development program, as well as the responses of the Committee for Human Medicinal Products (CHMP)/Scientific Advice Working Party (SAWP), were extracted and categorized. For 41 more recent procedures (1 January 2009 to 8 May 2012), additional details of the trial design and the CHMP/SAWP responses were assessed. In addition, case studies are presented as examples. Over a range of 5½ years, 59 scientific advices were identified that address adaptive study designs in phase II and phase III clinical trials. Almost all were proposed as confirmatory phase III or phase II/III studies. The most frequently proposed adaptation was sample size reassessment, followed by dropping of treatment arms and population enrichment. While 12 (20%) of the 59 proposals for an adaptive clinical trial were not accepted, the great majority of proposals were accepted (15, 25%) or conditionally accepted (32, 54%). In the more recent 41 procedures, the most frequent concerns raised by CHMP/SAWP were insufficient justifications of the adaptation strategy, type I error rate control and bias. For the majority of proposed adaptive clinical trials, an overall positive opinion was given albeit with critical comments. Type I error rate control, bias and the justification of the design are common issues raised by the CHMP/SAWP.

10 CFR 2.305 - Service of documents, methods, proof.

Code of Federal Regulations, 2013 CFR

2013-01-01

... optical storage media containing the electronic document. (3) A participant granted an exemption under § 2... certificate of service. (i) If a document is served on participants through only the E-filing system, then the certificate of service must state that the document has been filed through the E-Filing system. (ii) If a...

10 CFR 2.305 - Service of documents, methods, proof.

Code of Federal Regulations, 2014 CFR

2014-01-01

... optical storage media containing the electronic document. (3) A participant granted an exemption under § 2... certificate of service. (i) If a document is served on participants through only the E-filing system, then the certificate of service must state that the document has been filed through the E-Filing system. (ii) If a...

Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

PubMed

Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

2018-01-01

To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

Learning Atomic-Molecular Theory in Secondary School: The Role of Meta-Conceptual Awareness and Modelling Skills

NASA Astrophysics Data System (ADS)

Chan, Chi Keung

The aim of this study was to examine the contribution of students' meta-conceptual awareness and modelling skills to their conceptual change when learning atomic-molecular theory. Instructional materials used in the intervention covered three sub-topics: atomic structure, chemical bonding, and structures and properties. Glynn's (1991) Teaching with Analogy model and Chambliss's (2002) guidelines for constructing scientific texts were used as the frameworks for designing and implementing instructional materials for the intervention. Forty-five Secondary 4 chemistry students from two classes at a secondary school in Hong Kong participated in the study. The two classes were taught by the same teacher. The study consisted of two phases. During Phase I, which lasted for 6 weeks, Class A (n = 13) used the above-mentioned instructional materials to learn the three sub-topics, whereas Class B (n = 32) learned the same sub-topics using traditional textbook materials. To further examine the effects of the intervention, a 2-week switching-replication treatment was implemented in Phase II. Class A used traditional textbook materials for revision whereas Class B used the tailor-made instructional materials. A mixed-methods design was used to assess the effectiveness of the intervention. Based on the student misconceptions documented in the literature, a written test of the three sub-topics was developed. The test comprised 33 two-tier multiple-choice items. The test was administered three times: before Phase I (T1), just after Phase I and before Phase II (T2), and 2 weeks after Phase II (T3). Qualitative data were gathered from semi-structured interviews with five students. Three students from Class A and two students from Class B were interviewed individually after Phase I and Phase II, respectively, to assess students' understanding of the essential theoretical concepts and to assess students' modelling skills. The results of paired-samples t-test showed that there was a significant difference between scores at T1 and T2 in both classes, but the difference between scores at T2 and T3 in both classes was insignificant. The results of independent-samples t-test showed that there were no significant differences in scores between Classes A and B at T1, T2 and T3. The results indicate that explicit presentation of misconceptions and scientific concepts, as suggested by Chambliss (2002), was found to be roughly as effective as traditional textbook instruction in terms of students' meta-conceptual awareness. The semi-structured interviews revealed that the modelling skills of the three students from Class A and the two students from Class B had improved after receiving the interventional treatment in Phase I and the switching-replication treatment in Phase II, respectively. They had achieved modelling skills with the general characteristics of level-2 modelling according to Grosslight et al.'s (1991) framework of epistemological views of models and their use in science. They recognised that each model had its own presentation purposes and its own strengths and limitations. They understood that models are not physical copies of reality. In addition, they were aware that a chemical bond is a force rather than a material. They also knew that ionic bonds are present throughout the whole lattice of sodium chloride. These skills enabled the students to avoid forming or retaining some important misconceptions about atomic-molecular theory. They were able to distinguish between microscopic and macroscopic properties. However, some students retained their original misconceptions such as misinterpretation of electron shells as fixed orbits. Possible reasons to account for the results are suggested. The significance and implications of the findings for chemistry education in secondary school are discussed.

Underground Test Area Subproject Phase I Data Analysis Task. Volume VIII - Risk Assessment Documentation Package

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

None

Volume VIII of the documentation for the Phase I Data Analysis Task performed in support of the current Regional Flow Model, Transport Model, and Risk Assessment for the Nevada Test Site Underground Test Area Subproject contains the risk assessment documentation. Because of the size and complexity of the model area, a considerable quantity of data was collected and analyzed in support of the modeling efforts. The data analysis task was consequently broken into eight subtasks, and descriptions of each subtask's activities are contained in one of the eight volumes that comprise the Phase I Data Analysis Documentation.

Underground Test Area Subproject Phase I Data Analysis Task. Volume VII - Tritium Transport Model Documentation Package

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

None

Volume VII of the documentation for the Phase I Data Analysis Task performed in support of the current Regional Flow Model, Transport Model, and Risk Assessment for the Nevada Test Site Underground Test Area Subproject contains the tritium transport model documentation. Because of the size and complexity of the model area, a considerable quantity of data was collected and analyzed in support of the modeling efforts. The data analysis task was consequently broken into eight subtasks, and descriptions of each subtask's activities are contained in one of the eight volumes that comprise the Phase I Data Analysis Documentation.

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

Starcher, Autumn N.; Elzinga, Evert J.; Sparks, Donald L.

Previous research demonstrated the formation of single divalent metal (Co, Ni, and ZnAl) and mixed divalent metal (NiZnAl) layered double hydroxide (LDH) phases from reactions of the divalent metal with Al-bearing substrates and soils in both laboratory experiments and in the natural environment. Recently Fe(II)-Al-LDH phases have been found in laboratory batch reaction studies, and although they have yet to be found in the natural environment. Potential locations of Fe(II)-Al-LDH phases in nature include areas with suboxic and anoxic conditions. Because these areas can be environments of significant contaminant accumulation, it is important to understand the possible interactions and impactsmore » of contaminant elements on LDH phase formation. One such contaminant, Zn, can also form as an LDH and has been found to form as a mixed divalent layered hydroxide phase. To understand how Zn impacts the formation of Fe(II)-Al-LDH phase formation and kinetics, 3 mM or 0.8 mM Fe(II) and 0.8 mM Zn were batch reacted with either 10 g/L pyrophyllite or 7.5 g/L γ-Al2O3 for up to three months under anoxic conditions. Aqueous samples were analyzed by inductively coupled plasma optical emission spectrometry (ICP-OES) and solid samples were analyzed with X-ray absorption spectroscopy (XAS). Shell-by-shell fits of Fe(II) and co-sorption samples with pyrophyllite show the formation of a mixed divalent metal (Fe(II)-Zn-Al) layered hydroxide phase, while Fe(II) and Zn co-sorption samples with γ-Al2O3 produce Fe(II)-Al-LDH phases and Zn in inner-sphere complexation with the γ-Al2O3. This study demonstrates the formation of a mixed divalent metal layered hydroxide and further iterates the importance of sorbent reactivity on LDH phase formation.« less

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

Bottom, Daniel L.; Simenstad, Charles A.; Campbell, Lance

In 2002 with support from the U.S. Army Corps of Engineers (USACE), an interagency research team began investigating salmon life histories and habitat use in the lower Columbia River estuary to fill significant data gaps about the estuary's potential role in salmon decline and recovery . The Bonneville Power Administration (BPA) provided additional funding in 2004 to reconstruct historical changes in estuarine habitat opportunities and food web linkages of Columbia River salmon (Onchorhynchus spp.). Together these studies constitute the estuary's first comprehensive investigation of shallow-water habitats, including selected emergent, forested, and scrub-shrub wetlands. Among other findings, this research documented themore » importance of wetlands as nursery areas for juvenile salmon; quantified historical changes in the amounts and distributions of diverse habitat types in the lower estuary; documented estuarine residence times, ranging from weeks to months for many juvenile Chinook salmon (O. tshawytscha); and provided new evidence that contemporary salmonid food webs are supported disproportionately by wetland-derived prey resources. The results of these lower-estuary investigations also raised many new questions about habitat functions, historical habitat distributions, and salmon life histories in other areas of the Columbia River estuary that have not been adequately investigated. For example, quantitative estimates of historical habitat changes are available only for the lower 75 km of the estuary, although tidal influence extends 217 km upriver to Bonneville Dam. Because the otolith techniques used to reconstruct salmon life histories rely on detection of a chemical signature (strontium) for salt water, the estuarine residency information we have collected to date applies only to the lower 30 or 35 km of the estuary, where fish first encounter ocean water. We lack information about salmon habitat use, life histories, and growth within the long tidal-fresh reaches of the main-stem river and many tidally-influenced estuary tributaries. Finally, our surveys to date characterize wetland habitats within island complexes distributed in the main channel of the lower estuary. Yet some of the most significant wetland losses have occurred along the estuary's periphery, including shoreline areas and tributary junctions. These habitats may or may not function similarly as the island complexes that we have surveyed to date. In 2007 we initiated a second phase of the BPA estuary study (Phase II) to address specific uncertainties about salmon in tidal-fresh and tributary habitats of the Columbia River estuary. This report summarizes 2007 and 2008 Phase II results and addresses three principal research questions: (1) What was the historic distribution of estuarine and floodplain habitats from Astoria to Bonneville Dam? (2) Do individual patterns of estuarine residency and growth of juvenile Chinook salmon vary among wetland habitat types along the estuarine tidal gradient? (3) Are salmon rearing opportunities and life histories in the restoring wetland landscape of lower Grays River similar to those documented for island complexes of the main-stem estuary? Phase II extended our analysis of historical habitat distribution in the estuary above Rkm 75 to near Bonneville Dam. For this analysis we digitized the original nineteenth-century topographic (T-sheets) and hydrographic (H-sheets) survey maps for the entire estuary. Although all T-sheets (Rkm 0 to Rkm 206) were converted to GIS in 2005 with support for the USACE estuary project, final reconstruction of historical habitats throughout the estuary requires completion of the remaining H-sheet GIS maps above Rkm 75 and their integration with the T-sheets. This report summarizes progress to date on compiling the upper estuary H-sheets above Rkm 75. For the USACE estuary project, we analyzed otoliths from Chinook salmon collected near the estuary mouth in 2003-05 to estimate variability in estuary residence times among juvenile out migrants. In Phase II we expanded these analyses to compare growth and residency among individuals collected in tidal-fresh water wetlands of the lower main-stem estuary. Although no known otolith structural or chemical indicators currently exist to define entry into tidal fresh environments, our previous analyses indicate that otolith barium concentrations frequently increase before individuals encounter salt water. Here we evaluate whether otolith barium levels may provide a valid indicator of tidal fresh water entry by Columbia River Chinook salmon. We also examine otolith growth increments to quantify and compare recent (i.e., the previous 30 d) growth rates among individuals sampled in different wetland habitats along the estuarine tidal gradient.« less

Electronic monitoring and voice prompts improve hand hygiene and decrease nosocomial infections in an intermediate care unit.

PubMed

Swoboda, Sandra M; Earsing, Karen; Strauss, Kevin; Lane, Stephen; Lipsett, Pamela A

2004-02-01

To determine whether electronic monitoring of hand hygiene and voice prompts can improve hand hygiene and decrease nosocomial infection rates in a surgical intermediate care unit. Three-phase quasi-experimental design. Phase I was electronic monitoring and direct observation; phase II was electronic monitoring and computerized voice prompts for failure to perform hand hygiene on room exit; and phase III was electronic monitoring only. Nine-room, 14-bed intermediate care unit in a university, tertiary-care institution. All patient rooms, utility room, and staff lavatory were monitored electronically. All healthcare personnel including physicians, nurses, nursing support personnel, ancillary staff, all visitors and family members, and any other personnel interacting with patients on the intermediate care unit. All patients with an intermediate care unit length of stay >48 hrs were followed for nosocomial infection. Electronic monitoring during all phases, computerized voice prompts during phase II only. We evaluated a total of 283,488 electronically monitored entries into a patient room with 251,526 exits for 420 days (10,080 hrs and 3,549 patient days). Compared with phase I, hand hygiene compliance in patient rooms improved 37% during phase II (odds ratio, 1.38; 95% confidence interval, 1.04-1.83) and 41% in phase III (odds ratio, 1.41; 95% confidence interval, 1.07-1.84). When adjusting for patient admissions during each phase, point estimates of nosocomial infections decreased by 22% during phase II and 48% during phase III; when adjusting for patient days, the number of infections decreased by 10% during phase II and 40% during phase III. Although the overall rate of nosocomial infections significantly decreased when combining phases II and III, the association between nosocomial infection and individual phase was not significant. Electronic monitoring provided effective ongoing feedback about hand hygiene compliance. During both the voice prompt phase and post-intervention phase, hand hygiene compliance and nosocomial infection rates improved suggesting that ongoing monitoring and feedback had both a short-term and, perhaps, a longer-term effect.

TORO II: A finite element computer program for nonlinear quasi-static problems in electromagnetics: Part 2, User`s manual

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

Gartling, D.K.

User instructions are given for the finite element, electromagnetics program, TORO II. The theoretical background and numerical methods used in the program are documented in SAND95-2472. The present document also describes a number of example problems that have been analyzed with the code and provides sample input files for typical simulations. 20 refs., 34 figs., 3 tabs.

Executive overview and introduction to the SMAP information system life-cycle and documentation standards

NASA Technical Reports Server (NTRS)

1989-01-01

An overview of the five volume set of Information System Life-Cycle and Documentation Standards is provided with information on its use. The overview covers description, objectives, key definitions, structure and application of the standards, and document structure decisions. These standards were created to provide consistent NASA-wide structures for coordinating, controlling, and documenting the engineering of an information system (hardware, software, and operational procedures components) phase by phase.

Phase II test plan for the evaluation of the performance of container filling systems

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

BOGER, R.M.

The PHMC will provide tank wastes for final treatment by BNFL from Hanford's waste tanks. Concerns about the ability for ''grab'' sampling to provide large volumes of representative waste samples has led to the development of a nested, fixed-depth sampling system. Preferred concepts for filling sample containers that meet RCRA organic sample criteria were identified by a PHMC Decision Board. These systems will replace the needle based sampling ''T'' that is currently on the sampling system. This test plan document identifies cold tests with simulants that will demonstrate the preferred bottle filling concepts abilities to provide representative waste samples andmore » will meet RCRA criteria. Additional tests are identified that evaluate the potential for cross-contamination between samples and the ability for the system to decontaminate surfaces which have contacted tank wastes. These tests will be performed with kaolid/water and sand/water slurry simulants in the test rig that was used by AEAT to complete Phase 1 tests in FY 1999.« less

First Principles Based Simulation of Reaction-Induced Phase Transition in Hydrogen Storage and Other Materials

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

Ge, Qingfeng

2014-08-31

This major part of this proposal is simulating hydrogen interactions in the complex metal hydrides. Over the period of DOE BES support, key achievements include (i) Predicted TiAl 3Hx as a precursor state for forming TiAl 3 through analyzing the Ti-doped NaAlH 4 and demonstrated its catalytic role for hydrogen release; (ii) Explored the possibility of forming similar complex structures with other 3d transition metals in NaAlH 4 as well as the impact of such complex structures on hydrogen release/uptake; (iii) Demonstrated the role of TiAl 3 in hydriding process; (iv) Predicted a new phase of NaAlH 4 that linksmore » to Na3AlH6 using first-principles metadynamics; (v) Examined support effect on hydrogen release from supported/encapsulated NaAlH 4; and (vi) Expanded research scope beyond hydrogen storage. The success of our research is documented by the peer-reviewed publications.« less

Adsorption of cadmium(II) on waste biomaterial.

PubMed

Baláž, M; Bujňáková, Z; Baláž, P; Zorkovská, A; Danková, Z; Briančin, J

2015-09-15

Significant increase of the adsorption ability of the eggshell biomaterial toward cadmium was observed upon milling, as is evidenced by the value of maximum monolayer adsorption capacity of 329mgg(-1), which is markedly higher than in the case of most "green" sorbents. The main driving force of the adsorption was proven to be the presence of aragonite phase as a consequence of phase transformation from calcite occurring during milling. Cadmium is adsorbed in a non-reversible way, as documented by different techniques (desorption tests, XRD and EDX measurements). The optimum pH for cadmium adsorption was 7. The adsorption process was accompanied by the increase of the value of specific surface area. The course of adsorption has been described by Langmuir, Freundlich and Dubinin-Radushkevich isotherms. The adsorption kinetics was evaluated using three models, among which the best correlation coefficients and the best normalized standard deviation values were achieved for the pseudo-second order model and the intraparticle diffusion model, respectively. Copyright © 2015 Elsevier Inc. All rights reserved.

United Nations Office on Drugs and Crime International Network of Drug Dependence Treatment and Rehabilitation Resource Centres: Treatnet.

PubMed

Tomás-Rosselló, Juana; Rawson, Richard A; Zarza, Maria J; Bellows, Anne; Busse, Anja; Saenz, Elizabeth; Freese, Thomas; Shawkey, Mansour; Carise, Deni; Ali, Robert; Ling, Walter

2010-10-01

Key to the dissemination of evidence-based addiction treatments is the exchange of experiences and mutual support among treatment practitioners, as well as the availability of accurate addiction training materials and effective trainers. To address the shortage of such resources, the United Nations Office on Drugs and Crime (UNODC) created Treatnet, a network of 20 drug dependence treatment resource centers around the world. Treatnet's primary goal is to promote the use of effective addiction treatment practices. Phase I of this project included (1) selecting and establishing a network of geographically distributed centers; (2) conducting a capacity-building program consisting of a training needs assessment, development of training packages, and the training of 2 trainers per center in 1 content area each; and (3) creating good-practice documents. Data on the training activities conducted by the trainers during their first 6 months in the field are presented. Plans for Phase II of the Treatnet project are also discussed.

CMIF ECLS system test findings

NASA Technical Reports Server (NTRS)

Schunk, Richard G.; Carrasquillo, Robyn L.; Ogle, Kathyrn Y.; Wieland, Paul O.; Bagdigian, Robert M.

1989-01-01

During 1987 three Space Station integrated Environmental Control and Life Support System (ECLSS) tests were conducted at the Marshall Space Flight Center (MSFC) Core Module Integration Facility (CMIF) as part of the MSFC ECLSS Phase II test program. The three tests ranged in duration from 50 to 150 hours and were conducted inside of the CMIF module simulator. The Phase II partial integrated system test configuration consisted of four regenerative air revitalization subsystems and one regenerative water reclamation subsystem. This paper contains a discussion of results and lessons learned from the Phase II test program. The design of the Phase II test configuration and improvements made throughout the program are detailed. Future plans for the MSFC CMIF test program are provided, including an overview of planned improvements for the Phase III program.

Investing in Our Nation's Youth. National Youth Anti-Drug Media Campaign: Phase II (Final Report).

ERIC Educational Resources Information Center

Office of National Drug Control Policy, Washington, DC.

This publication presents the findings from an evaluation of Phase II of the National Youth Anti-Drug Media Campaign. The number one goal of the campaign was to educate youth to reject illegal drugs. This report evaluates Phase II and focuses on the effect of paid television advertising on awareness of anti-drug messages among youth, teens, and…

Labeled carbon dioxide (C18O2): an indicator gas for phase II in expirograms.

PubMed

Schulz, Holger; Schulz, Anne; Eder, Gunter; Heyder, Joachim

2004-11-01

Carbon dioxide labeled with 18O (C18O2) was used as a tracer gas for single-breath measurements in six anesthetized, mechanically ventilated beagle dogs. C18O2 is taken up quasi-instantaneously in the gas-exchanging region of the lungs but much less so in the conducting airways. Its use allows a clear separation of phase II in an expirogram even from diseased individuals and excludes the influence of alveolar concentration differences. Phase II of a C18O2 expirogram mathematically corresponds to the cumulative distribution of bronchial pathways to be traversed completely in the course of exhalation. The derivative of this cumulative distribution with respect to respired volume was submitted to a power moment analysis to characterize volumetric mean (position), standard deviation (broadness), and skewness (asymmetry) of phase II. Position is an estimate of dead space volume, whereas broadness and skewness are measures of the range and asymmetry of functional airway pathway lengths. The effects of changing ventilatory patterns and of changes in airway size (via carbachol-induced bronchoconstriction) were studied. Increasing inspiratory or expiratory flow rates or tidal volume had only minor influence on position and shape of phase II. With the introduction of a postinspiratory breath hold, phase II was continually shifted toward the airway opening (maximum 45% at 16 s) and became steeper by up to 16%, whereas skewness showed a biphasic response with a moderate decrease at short breath holding and a significant increase at longer breath holds. Stepwise bronchoconstriction decreased position up to 45 +/- 2% and broadness of phase II up to 43 +/- 4%, whereas skewness was increased up to twofold at high-carbachol concentrations. Under all circumstances, position of phase II by power moment analysis and dead space volume by the Fowler technique agreed closely in our healthy dogs. Overall, power moment analysis provides a more comprehensive view on phase II of single-breath expirograms than conventional dead space volume determinations and may be useful for respiratory physiology studies as well as for the study of diseased lungs.

Phase II Transport Model of Corrective Action Unit 98: Frenchman Flat, Nevada Test Site, Nye County, Nevada, Revision 1

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

Gregg Ruskuaff

This document, the Phase II Frenchman Flat transport report, presents the results of radionuclide transport simulations that incorporate groundwater radionuclide transport model statistical and structural uncertainty, and lead to forecasts of the contaminant boundary (CB) for a set of representative models from an ensemble of possible models. This work, as described in the Federal Facility Agreement and Consent Order (FFACO) Underground Test Area (UGTA) strategy (FFACO, 1996; amended 2010), forms an essential part of the technical basis for subsequent negotiation of the compliance boundary of the Frenchman Flat corrective action unit (CAU) by Nevada Division of Environmental Protection (NDEP) andmore » National Nuclear Security Administration Nevada Site Office (NNSA/NSO). Underground nuclear testing via deep vertical shafts was conducted at the Nevada Test Site (NTS) from 1951 until 1992. The Frenchman Flat area, the subject of this report, was used for seven years, with 10 underground nuclear tests being conducted. The U.S. Department of Energy (DOE), NNSA/NSO initiated the UGTA Project to assess and evaluate the effects of underground nuclear tests on groundwater at the NTS and vicinity through the FFACO (1996, amended 2010). The processes that will be used to complete UGTA corrective actions are described in the “Corrective Action Strategy” in the FFACO Appendix VI, Revision No. 2 (February 20, 2008).« less

Paleoecology of a Northern Michigan Lake and the relationship among climate, vegetation, and Great Lakes water levels

USGS Publications Warehouse

Booth, R.K.; Jackson, S.T.; Thompson, T.A.

2002-01-01

We reconstructed Holocene water-level and vegetation dynamics based on pollen and plant macrofossils from a coastal lake in Upper Michigan. Our primary objective was to test the hypothesis that major fluctuations in Great Lakes water levels resulted in part from climatic changes. We also used our data to provide temporal constraints to the mid-Holocene dry period in Upper Michigan. From 9600 to 8600 cal yr B.P. a shallow, lacustrine environment characterized the Mud Lake basin. A Sphagnum-dominated wetland occupied the basin during the mid-Holocene dry period (???8600 to 6600 cal yr B.P.). The basin flooded at 6600 cal yr B.P. as a result of rising water levels associated with the onset of the Nipissing I phase of ancestral Lake Superior. This flooding event occured contemporaneously with a well-documented regional expansion of Tsuga. Betula pollen increased during the Nipissing II phase (4500 cal yr B.P.). Macrofossil evidence from Mud Lake suggests that Betula alleghaniensis expansion was primarily responsible for the rising Betula pollen percentages. Major regional and local vegetational changes were associated with all the major Holocene highstands of the western Great Lakes (Nipissing I, Nipissing II, and Algoma). Traditional interpretations of Great Lakes water-level history should be revised to include a major role of climate. ?? 2002 University of Washington.

Trust Mines: Legal Documents and Settlements

EPA Pesticide Factsheets

Legal Documents and Settlements related to the Northern Abandoned Uranium Mines Region including the Phase 1 Settlement Agreement and Environmental Response Trust Agreement, Phase 2 Settlement Agreement Removal Site Evaluation (RSE) Trust Agreement.

Generation of phase II in vitro metabolites using homogenized horse liver.

PubMed

Wong, Jenny K Y; Chan, George H M; Leung, David K K; Tang, Francis P W; Wan, Terence S M

2016-02-01

The successful use of homogenized horse liver for the generation of phase I in vitro metabolites has been previously reported by the authors' laboratory. Prior to the use of homogenized liver, the authors' laboratory had been using mainly horse liver microsomes for carrying out equine in vitro metabolism studies. Homogenized horse liver has shown significant advantages over liver microsomes for in vitro metabolism studies as the procedures are much quicker and have higher capability for generating more in vitro metabolites. In this study, the use of homogenized liver has been extended to the generation of phase II in vitro metabolites (glucuronide and/or sulfate conjugates) using 17β-estradiol, morphine, and boldenone undecylenate as model substrates. It was observed that phase II metabolites could also be generated even without the addition of cofactors. To the authors' knowledge, this is the first report of the successful use of homogenized horse liver for the generation of phase II metabolites. It also demonstrates the ease with which both phase I and phase II metabolites can now be generated in vitro simply by using homogenized liver without the need for ultracentrifuges or tedious preparation steps. Copyright © 2015 John Wiley & Sons, Ltd.

Phenotypic variation of Pseudomonas brassicacearum as a plant root-colonization strategy.

PubMed

Achouak, Wafa; Conrod, Sandrine; Cohen, Valérie; Heulin, Thierry

2004-08-01

Pseudomonas brassicacearum was isolated as a major root-colonizing population from Arabidopsis thaliana. The strain NFM421 of P. brassicacearum undergoes phenotypic variation during A. thaliana and Brassica napus root colonization in vitro as well as in soil, resulting in different colony appearance on agar surfaces. Bacteria forming translucent colonies (phase II cells) essentially were localized at the surface of young roots and root tips, whereas wild-type cells (phase I cells) were localized at the basal part of roots. The ability of phase II cells to spread and colonize new sites on root surface correlates with over-production of flagellin as evidenced by sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis of surface proteins and microsequencing. Moreover, phase II cells showed a higher ability to swim and to swarm on semisolid agar medium. Phase I and phase II cells of P. brassicacearum NFM421 were tagged genetically with green fluorescent protein and red fluorescent protein. Confocal scanning laser microscopy was used to localize phase II cells on secondary roots and root tips of A. thaliana, whereas phase I cells essentially were localized at the basal part of roots. These experiments were conducted in vitro and in soil. Phenotypic variation on plant roots is likely to be a colonization strategy that may explain the high colonization power of P. brassicacearum.

Langmuir Probe Spacecraft Potential End Item Specification Document

NASA Technical Reports Server (NTRS)

Gilchrist, Brian; Curtis, Leslie (Technical Monitor)

2001-01-01

This document describes the Langmuir Probe Spacecraft Potential (LPSP) investigation of the plasma environment in the vicinity of the ProSEDS Delta II spacecraft. This investigation will employ a group of three (3) Langmuir Probe Assemblies, LPAs, mounted on the Delta II second stage to measure the electron density and temperature (n(sub e) and T(sub e)), the ion density (n(sub i)), and the spacecraft potential (V(sub s)) relative to the surrounding ionospheric plasma. This document is also intended to define the technical requirements and flight-vehicle installation interfaces for the design, development, assembly, testing, qualification, and operation of the LPSP subsystem for the Propulsive Small Expendable Deployer System (ProSEDS) and its associated Ground Support Equipment (GSE). This document also defines the interfaces between the LPSP instrument and the ProSEDS Delta II spacecraft, as well as the design, fabrication, operation, and other requirements established to meet the mission objectives. The LPSP is the primary measurement instrument designed to characterize the background plasma environment and is a supporting instrument for measuring spacecraft potential of the Delta II vehicle used for the ProSEDS mission. Specifically, the LPSP will use the three LPAs equally spaced around the Delta II body to make measurements of the ambient ionospheric plasma during passive operations to aid in validating existing models of electrodynamic-tether propulsion. These same probes will also be used to measure Delta II spacecraft potential when active operations occur. When the electron emitting plasma contractor is on, dense neutral plasma is emitted. Effective operation of the plasma contactor (PC) will mean a low potential difference between the Delta II second stage and the surrounding plasma and represents one of the voltage parameters needed to fully characterize the electrodynamic-tether closed circuit. Given that the LP already needs to be well away from any near-field disturbances around the Delta II, it is possible to use the same probe with a simple reconfiguration of the electronics to measure potential with respect to the ambient plasma. The LP measurement techniques are outlined in the following text and discussed in detail in the Appendix. The scientific goals of the investigation, the physical and electrical characteristics of the instrument, and the on-orbit measurement requirements are also discussed in this document.

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

PubMed

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

2017-05-01

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

Columbia River Basin Fish and Wildlife Program Annual Implementation Work Plan for Fiscal Year 1994.

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

United States. Bonneville Power Administration; Northwest Power Planning Council; Columbia Basin Fish and Wildlife Authority

1994-02-01

This document is part of Bonneville Power Administration`s program to protect, mitigate, and enhance fish and wildlife affected by the development and operation of hydroelectric facilities on the Columbia River and its tributaries. The Fiscal Year 1994 (FY 1994) Annual Implementation Work Plan (AIWP) presents Bonneville Power Administration`s (BPA`s) plan for implementation of the Columbia River Basin Fish and Wildlife Program (Program). The purpose of the Program is to guide BPA and other federal agencies in carrying out their responsibilities to protect, mitigate, and enhance fish and wildlife in the Columbia River Basin. Phase I began the work of salmonmore » recovery with certain fast-track measures completed in August 1991. Phase II dealt with Snake and Columbia river flow and salmon harvest and was completed in December 1991. Phase III dealt with system-wide habitat and salmon production issues and was completed in September 1992. Phase IV planning, focusing on resident fish and wildlife, began in August 1993, and was finished and adopted in November 1993. This report provides summaries of the ongoing and new projects for FY 1994 within the areas of juvenile migration, adult migration, salmon harvest, production and habitat, coordinated implementation, monitoring and evaluation, resident fish, and wildlife.« less

Spiral chain structure of high pressure selenium-II{sup '} and sulfur-II from powder x-ray diffraction

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

Fujihisa, Hiroshi; Yamawaki, Hiroshi; Sakashita, Mami

2004-10-01

The structure of high pressure phases, selenium-II{sup '} (Se-II{sup '}) and sulfur-II (S-II), for {alpha}-Se{sub 8} (monoclinic Se-I) and {alpha}-S{sub 8} (orthorhombic S-I) was studied by powder x-ray diffraction experiments. Se-II{sup '} and S-II were found to be isostructural and to belong to the tetragonal space group I4{sub 1}/acd, which is made up of 16 atoms in the unit cell. The structure consisted of unique spiral chains with both 4{sub 1} and 4{sub 3} screws. The results confirmed that the structure sequence of the pressure-induced phase transitions for the group VIb elements depended on the initial molecular form. The chemicalmore » bonds of the phases are also discussed from the interatomic distances that were obtained.« less

77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...

EUDISED: European Documentation and Information System for Education. Volume II, National Reports.

ERIC Educational Resources Information Center

Council of Europe, Strasbourg (France). Documentation Center for Education in Europe.

This study briefly describes the documentation and information projects of seven nations, stressing their use in the field of education. The sections are: (1) automated documentation and the human sciences in France, (2) documentation for education and the social sciences in the Federal Republic of Germany, (3) mechanized projects in library work…

ORANGES evaluation phase I risk assessment report : phase I of the US DOT sponsored evaluation of the ORANGES electronic payment system field operational test

DOT National Transportation Integrated Search

2004-03-11

This document is the US DOT evaluation Risk Assessment report for Phase I of the ORANGES field operational test. This document consolidates working papers and incorporates an assessment of issues, risks, mitigation strategies and lessons learned look...

The Origins of [C ii] Emission in Local Star-forming Galaxies

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

Croxall, K. V.; Smith, J. D.; Pellegrini, E.

The [C ii] 158 μ m fine-structure line is the brightest emission line observed in local star-forming galaxies. As a major coolant of the gas-phase interstellar medium, [C ii] balances the heating, including that due to far-ultraviolet photons, which heat the gas via the photoelectric effect. However, the origin of [C ii] emission remains unclear because C{sup +} can be found in multiple phases of the interstellar medium. Here we measure the fractions of [C ii] emission originating in the ionized and neutral gas phases of a sample of nearby galaxies. We use the [N ii] 205 μ m fine-structuremore » line to trace the ionized medium, thereby eliminating the strong density dependence that exists in the ratio of [C ii]/[N ii] 122 μ m. Using the FIR [C ii] and [N ii] emission detected by the KINGFISH (Key Insights on Nearby Galaxies: a Far- Infrared Survey with Herschel ) and Beyond the Peak Herschel programs, we show that 60%–80% of [C ii] emission originates from neutral gas. We find that the fraction of [C ii] originating in the neutral medium has a weak dependence on dust temperature and the surface density of star formation, and has a stronger dependence on the gas-phase metallicity. In metal-rich environments, the relatively cooler ionized gas makes substantially larger contributions to total [C ii] emission than at low abundance, contrary to prior expectations. Approximate calibrations of this metallicity trend are provided.« less

78 FR 69302 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

..., II-T, III-C, I-C, II-U, I-B, I-E, I-G, I-H, I-I, I-J, I-L, I-M, I-P, II-G, II-I, II-P, III-D, I-K, I..., I-H, I-I, I-J, I-L, I-M, I-P, II-G, II-I, II-P, III-D, I-K, I-N, I-O, I-S, II-E, II-L, II-M, II-R, I... 102(h) of CERCLA, to document that all environmental impacts associated with the DON's activities on...

Funding and Strategic Alignment Guidance for Infusing Small Business Innovation Research Technology Into Aeronautics Research Mission Directorate Projects at NASA Glenn Research Center for 2015

NASA Technical Reports Server (NTRS)

Nguyen, Hung D.; Steele, Gynelle C.; Morris, Jessica R.

2015-01-01

This document is intended to enable the more effective transition of NASA Glenn Research Center (GRC) SBIR technologies funded by the Small Business Innovation Research (SBIR) program as well as its companion, the Small Business Technology Transfer (STTR) program into NASA Aeronautics Research Mission Directorate (ARMD) projects. Primarily, it is intended to help NASA program and project managers find useful technologies that have undergone extensive research and development (RRD), through Phase II of the SBIR program; however, it can also assist non-NASA agencies and commercial companies in this process. aviation safety, unmanned aircraft, ground and flight test technique, low emissions, quiet performance, rotorcraft

NREL-Prime Next-Generation Drivetrain Dynamometer Test Report

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

Keller, Jonathan; Erdman, Bill; Blodgett, Douglas

2016-08-01

Advances in wind turbine drivetrain technologies are necessary to improve reliability and reduce the cost of energy for land-based and offshore wind turbines. The NREL-Prime Next-Generation Drivetrain team developed a geared, medium-speed drivetrain that is lighter, more reliable and more efficient than existing designs. One of the objectives of Phase II of the project was to complete the detailed design, fabrication, and dynamometer testing of a 750 kilowatt (kW) drivetrain that includes the key gearbox innovations designed by Romax Technology and power converter innovations designed by DNV Kema Renewables. The purpose of this document is to summarize these tests completedmore » in NREL's National Wind Technology Center 2.5 megawatt (MW) dynamometer.« less

Beginning Teacher Evaluation Study: Phase II, 1973-74, Final Report: Volume III.2. Reading and Mathematics Observation System: Description and Analysis of Time Expenditures.

ERIC Educational Resources Information Center

Calfee, Robert; Calfee, Kathryn Hoover

The Beginning Teacher Evaluation Study (BTES), Phase II, was a research project on effective teaching behavior--what teachers do that significantly affects what and how pupils learn. The purposes of Phase II were to (1) develop an assessment system for measuring teacher and pupil behaviors and other factors which could influence each of them and…

Automatic extraction of numeric strings in unconstrained handwritten document images

NASA Astrophysics Data System (ADS)

Haji, M. Mehdi; Bui, Tien D.; Suen, Ching Y.

2011-01-01

Numeric strings such as identification numbers carry vital pieces of information in documents. In this paper, we present a novel algorithm for automatic extraction of numeric strings in unconstrained handwritten document images. The algorithm has two main phases: pruning and verification. In the pruning phase, the algorithm first performs a new segment-merge procedure on each text line, and then using a new regularity measure, it prunes all sequences of characters that are unlikely to be numeric strings. The segment-merge procedure is composed of two modules: a new explicit character segmentation algorithm which is based on analysis of skeletal graphs and a merging algorithm which is based on graph partitioning. All the candidate sequences that pass the pruning phase are sent to a recognition-based verification phase for the final decision. The recognition is based on a coarse-to-fine approach using probabilistic RBF networks. We developed our algorithm for the processing of real-world documents where letters and digits may be connected or broken in a document. The effectiveness of the proposed approach is shown by extensive experiments done on a real-world database of 607 documents which contains handwritten, machine-printed and mixed documents with different types of layouts and levels of noise.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

Documentation systems for educators seeking academic promotion in U.S. medical schools.

PubMed

Simpson, Deborah; Hafler, Janet; Brown, Diane; Wilkerson, LuAnn

2004-08-01

To explore the state and use of teaching portfolios in promotion and tenure in U.S. medical schools. A two-phase qualitative study using a Web-based search procedure and telephone interviews was conducted. The first phase assessed the penetration of teaching portfolio-like systems in U.S. medical schools using a keyword search of medical school Web sites. The second phase examined the current use of teaching portfolios in 16 U.S. medical schools that reported their use in a survey in 1992. The individual designated as having primary responsibility for faculty appointments/promotions was contacted to participate in a 30-60 minute interview. The Phase 1 search of U.S. medical schools' Web sites revealed that 76 medical schools have Web-based access to information on documenting educational activities for promotion. A total of 16 of 17 medical schools responded to Phase 2. All 16 continued to use a portfolio-like system in 2003. Two documentation categories, honors/awards and philosophy/personal statement regarding education, were included by six more of these schools than used these categories in 1992. Dissemination of work to colleagues is now a key inclusion at 15 of the Phase 2 schools. The most common type of evidence used to document education was learner and/or peer ratings with infrequent use of outcome measures and internal/external review. The number of medical schools whose promotion packets include portfolio-like documentation associated with a faculty member's excellence in education has increased by more than 400% in just over ten years. Among early-responder schools the types of documentation categories have increased, but students' ratings of teaching remain the primary evidence used to document the quality or outcomes of the educational efforts reported.

Effectiveness of safety belt warning and interlock systems

DOT National Transportation Integrated Search

1973-04-01

Rental cars in Fayetteville, N.C., were equipped with four seat belt and warning systems: (Phase I) detachable shoulder and lap belt, no warning system; (Phase II) detachable shoulder and lap belt, warning system (January 1, 1972 standard); (Phase II...

Recent Advances in Understanding of Kinetic Interplay Between Phase II Metabolism and Efflux Transport.

PubMed

Wang, Shuai; Xing, Huijie; Zhao, Mengjing; Lu, Danyi; Li, Zhijie; Dong, Dong; Wu, Baojian

2016-01-01

Mechanistic understanding of the metabolism-transport interplay assumes great importance in pharmaceutical fields because the knowledge can help to interpret drug/xenobiotic metabolism and disposition studies as well as the drug-drug interactions in vivo. About 10 years ago, it started to recognize that cellular phase II metabolism is strongly influenced by the excretion (efflux transport) of generated metabolites, a kinetic phenomenon termed "phase II metabolism-transport interplay". This interplay is believed to have significant effects on the pharmacokinetics (bioavailability) of drugs/chemicals undergoing phase II metabolism. In this article, we review the studies investigating the phase II metabolism-transport interplay using cell models, perfused rat intestine, and intact rats. The potential confounding factors in exploring such interplay is also summarized. Moreover, the mechanism underlying the phase II metabolism-transport interplay is discussed. Various studies with engineered cells and rodents have demonstrated that there is an interaction (interplay) between phase II enzymes and efflux transporters. This type of interplay mainly refers to the dependence of phase II (conjugative) metabolism on the activities of efflux transporters. In general, inhibiting efflux transporters or decreasing their expression causes the reductions in metabolite excretion, apparent excretion clearance (CLapp) and total metabolism (fmet), as well as an increase in the intracellular level of metabolite (Ci). The deconjugation mediated by hydrolase (acting as a "bridge") is essential for the interplay to play out based on pharmacokinetic modeling/simulations, cell and animal studies. The hydrolases bridge the two processes (i.e., metabolite formation and excretion) and enable the interplay thereof (a bridging effect). Without the bridge, metabolite formation is independent on its downstream process excretion, thus impact of metabolite excretion on its formation is impossible. Deconjugation (mediated by hydrolases) plays an essential role in the conjugation-transport interplay. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

8 CFR 1287.6 - Proof of official records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Abolishing the Requirement of Legislation for Foreign Public Document. (1) In any proceeding under this... (ii) Administrative documents dealing directly with commercial or customs operations. (d) Canada. In...

Phase-II trials in osteosarcoma recurrences: A systematic review of past experience.

PubMed

Omer, Natacha; Le Deley, Marie-Cécile; Piperno-Neumann, Sophie; Marec-Berard, Perrine; Italiano, Antoine; Corradini, Nadège; Bellera, Carine; Brugières, Laurence; Gaspar, Nathalie

2017-04-01

The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister.eu and French National Cancer Institute website or referenced in PubMed and American Society of Clinical Oncology websites, between 2003 and 2016, using the following criteria: (osteosarcoma OR bone sarcoma) AND (Phase-II). Among the 99 trials identified, 80 were Phase-II, 17 I/II and 2 II/III, evaluating mostly targeted therapy (n = 40), and chemotherapy alone (n = 26). Results were fully (n = 28) or partially (abstract, n = 6) published. Twenty-four trials were dedicated to osteosarcoma, 22 had an osteosarcoma stratum. Twenty-eight out of 99 trials refer to the age range observed at recurrence (28%). Overall, 65 trials were run in multicentre settings, including 17 international trials. Only 9 trials were randomised. The primary end-point was tumour response in 71 trials (response rate, n = 40 or best response, n = 31), with various definitions (complete + partial ± minor response and stable disease), mainly evaluated with RECIST criteria (n = 69); it was progression-free survival in 24 trials and OS in 3. In single-arm trials evaluating response rate, the null hypothesis tested (when available, n = 12) varied from 5% to 25%. No robust historical data can currently be derived from past efficacy Phase-II trials. There is an urgent need to develop international randomised Phase-II trials across all age ranges with standardised primary end-point. Copyright © 2017 Elsevier Ltd. All rights reserved.

Psychosocial Responses During Different Phases of Sport-Injury Rehabilitation: A Qualitative Study

PubMed Central

Clement, Damien; Arvinen-Barrow, Monna; Fetty, Tera

2015-01-01

Context: Athletic trainers have traditionally conceptualized rehabilitation programs in terms of 3 distinct physiologic phases; however, these phases appear to neglect athletes' psychosocial responses to their injuries. Objective: To document injured athletes' psychosocial responses during the different phases of injury rehabilitation. Design: Qualitative study. Setting: National Collegiate Athletic Association Division II university in the mid-Atlantic region of the United States. Patients or Other Participants: A total of 8 previously injured athletes (4 men and 4 women) participated in the study. Data Collection and Analysis: We collected participant data by using semistructured interviews, transcribed verbatim and analyzed by directed content analysis. Established themes were triangulated to determine trustworthiness. Results: Initially, athletes' cognitive appraisals were predominately negative in nature, leading to negative emotions. These appraisals changed after diagnosis and when moving to the reaction-to-rehabilitation phase and the reaction-to-sport phase. During the reaction-to-rehabilitation phase, athletes reported mixed cognitive appraisals and identified frustration as the main emotional response. When returning to sport, athletes reflected on the lessons learned, yet they expressed some doubts related to their ability to return to play. These cognitive appraisals served as a precursor to the resulting emotional responses of nervousness and reinjury anxiety, as well as excitement. Throughout the various phases of rehabilitation, athletes reported seeking out social support: initially from significant others and then from their athletic trainers during the reaction-to-rehabilitation phase. Conclusions: The results appear to support the use of the integrated model of psychological response to sport injury and the rehabilitation process and the 3 phases of rehabilitation as a framework for understanding how physical and psychosocial factors may interact during sport-injury rehabilitation. Understanding this interaction may help athletic trainers provide better care to their injured athletes. PMID:25322346

The Forest Inventory and Analysis Database: Database description and users manual version 4.0 for Phase 2

Treesearch

Sharon W. Woudenberg; Barbara L. Conkling; Barbara M. O' Connell; Elizabeth B. LaPoint; Jeffery A. Turner; Karen L. Waddell

2010-01-01

This document is based on previous documentation of the nationally standardized Forest Inventory and Analysis database (Hansen and others 1992; Woudenberg and Farrenkopf 1995; Miles and others 2001). Documentation of the structure of the Forest Inventory and Analysis database (FIADB) for Phase 2 data, as well as codes and definitions, is provided. Examples for...

North Atlantic simulations in Coordinated Ocean-ice Reference Experiments phase II (CORE-II). Part II: Inter-annual to decadal variability

NASA Astrophysics Data System (ADS)

Danabasoglu, Gokhan; Yeager, Steve G.; Kim, Who M.; Behrens, Erik; Bentsen, Mats; Bi, Daohua; Biastoch, Arne; Bleck, Rainer; Böning, Claus; Bozec, Alexandra; Canuto, Vittorio M.; Cassou, Christophe; Chassignet, Eric; Coward, Andrew C.; Danilov, Sergey; Diansky, Nikolay; Drange, Helge; Farneti, Riccardo; Fernandez, Elodie; Fogli, Pier Giuseppe; Forget, Gael; Fujii, Yosuke; Griffies, Stephen M.; Gusev, Anatoly; Heimbach, Patrick; Howard, Armando; Ilicak, Mehmet; Jung, Thomas; Karspeck, Alicia R.; Kelley, Maxwell; Large, William G.; Leboissetier, Anthony; Lu, Jianhua; Madec, Gurvan; Marsland, Simon J.; Masina, Simona; Navarra, Antonio; Nurser, A. J. George; Pirani, Anna; Romanou, Anastasia; Salas y Mélia, David; Samuels, Bonita L.; Scheinert, Markus; Sidorenko, Dmitry; Sun, Shan; Treguier, Anne-Marie; Tsujino, Hiroyuki; Uotila, Petteri; Valcke, Sophie; Voldoire, Aurore; Wang, Qiang; Yashayaev, Igor

2016-01-01

Simulated inter-annual to decadal variability and trends in the North Atlantic for the 1958-2007 period from twenty global ocean - sea-ice coupled models are presented. These simulations are performed as contributions to the second phase of the Coordinated Ocean-ice Reference Experiments (CORE-II). The study is Part II of our companion paper (Danabasoglu et al., 2014) which documented the mean states in the North Atlantic from the same models. A major focus of the present study is the representation of Atlantic meridional overturning circulation (AMOC) variability in the participating models. Relationships between AMOC variability and those of some other related variables, such as subpolar mixed layer depths, the North Atlantic Oscillation (NAO), and the Labrador Sea upper-ocean hydrographic properties, are also investigated. In general, AMOC variability shows three distinct stages. During the first stage that lasts until the mid- to late-1970s, AMOC is relatively steady, remaining lower than its long-term (1958-2007) mean. Thereafter, AMOC intensifies with maximum transports achieved in the mid- to late-1990s. This enhancement is then followed by a weakening trend until the end of our integration period. This sequence of low frequency AMOC variability is consistent with previous studies. Regarding strengthening of AMOC between about the mid-1970s and the mid-1990s, our results support a previously identified variability mechanism where AMOC intensification is connected to increased deep water formation in the subpolar North Atlantic, driven by NAO-related surface fluxes. The simulations tend to show general agreement in their temporal representations of, for example, AMOC, sea surface temperature (SST), and subpolar mixed layer depth variabilities. In particular, the observed variability of the North Atlantic SSTs is captured well by all models. These findings indicate that simulated variability and trends are primarily dictated by the atmospheric datasets which include the influence of ocean dynamics from nature superimposed onto anthropogenic effects. Despite these general agreements, there are many differences among the model solutions, particularly in the spatial structures of variability patterns. For example, the location of the maximum AMOC variability differs among the models between Northern and Southern Hemispheres.

North Atlantic Simulations in Coordinated Ocean-Ice Reference Experiments Phase II (CORE-II) . Part II; Inter-Annual to Decadal Variability

NASA Technical Reports Server (NTRS)

Danabasoglu, Gokhan; Yeager, Steve G.; Kim, Who M.; Behrens, Erik; Bentsen, Mats; Bi, Daohua; Biastoch, Arne; Bleck, Rainer; Boening, Claus; Bozec, Alexandra;

Reflective Cracking of Flexible Pavements Phase I and II Final Recommendations

DOT National Transportation Integrated Search

2008-02-02

This report summarizes all the findings and recommendations from the Phase I and Phase II of the Nevada Department of Transportation (NDOT) study initiated in 2006 to mitigate reflective cracking in hot mix asphalt (HMA) overlays. Based on the analys...

Certificates in General Education for Adults. Certificate I (Foundation). Certificate II & Certificate II (Further Study).

ERIC Educational Resources Information Center

National Languages and Literacy Inst. of Australia, Melbourne. Adult Education Resource and Information Service.

This document is intended for adult education providers in Victoria, Australia, who intend to deliver courses leading to one or more of the following certificates in general education for adults: Certificate I in General Education for Adults (Foundation); Certificate II in General Education for Adults; and Certificate II in General Education for…

NASA Processes and Requirements for Conducting Human-in-the-Loop Closed Chamber Tests

NASA Technical Reports Server (NTRS)

Barta, Daniel J.; Montz, Michael E.

2004-01-01

NASA has specific processes and requirements that must be followed for tests involving human subjects to be conducted in a safe and effective manner. There are five distinct phases of test operations. Phase one, the test request phase, consists of those activities related to initiating, processing, reviewing, and evaluating the test request. Phase two, the test preparation phase consists of those activities related to planning, coordinating, documenting, and building up the test. Phase three, the test readiness phase consists of those activities related to verifying and reviewing the planned test operations. Phase four, the test activity phase, consists of all pretest operations, functional checkouts, emergency drills, and test operations. Phase five, the post test activity phase, consists of those activities performed once the test is completed, including briefings, documentation of anomalies, data reduction and archiving, and reporting. Project management processes must be followed for facility modifications and major test buildup, which include six phases: initiation and assessment, requirements evaluation, preliminary design, detailed design, use readiness review (URR) and acceptance. Compliance with requirements for safety and quality assurance are documented throughout the test buildup and test operation processes. Tests involving human subjects must be reviewed by the applicable Institutional Review Board (IRB).

Prostate Cancer Clinical Trials Group: The University of Michigan Site

DTIC Science & Technology

2012-04-01

and fusion-negative strata. UM will be the lead site for this trial with the Univ. of Chicago N01 Phase II consortium as the coordinating center. Ten...sensitive prostate cancer: a University of Chicago Phase II Consortium/Department of Defense Prostate Cancer Clinical Trials Consortium study. JE Ward, T...N01 contract with CTEP (University of Chicago – Early Therapeutics Development with Phase II emphasis group). The Program is committed to creating

The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors.

PubMed

Fleming, Richard M

2002-01-01

Over 60% of Americans are overweight and a number of popular diets have been advocated, often without evidence, to alleviate this public health hazard. This study was designed to investigate the effects of several diets on weight loss, serum lipids, and other cardiovascular disease risk factors. One hundred men and women followed one of four dietary programs for 1 year: a moderate-fat (MF) program without calorie restriction (28 patients); a low-fat (LF) diet (phase I) (16) ; a MF, calorie-controlled (phase II) diet (38 patients); and a high-fat (HF) diet (18 subjects) [corrected]. Weight, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), homocysteine (Ho), and lipoprotein(a) [Lp(a)], were measured every 4th month. The TC/HDL-C ratio was calculated and fibrinogen levels were measured at baseline and after one year. The MF diet resulted in a 2.6% (NS) decrease in weight compared with 18.4% (p=0.045) decrease in patients on phase I, 12.6% (p=0.0085) decrease in patients on phase II, and 13.7% (p=0.025) decrease in those on the HF diet. TC was reduced by 5% (NS) in the MF group, 39.1% (p=0.0005) in the phase I group, and 30.4% (p=0.0001) in the phase II group. HF group had a 4.3% (NS) increase in TC. LDL-C was reduced by 6.1% (NS) on MF, 52.0% (p=0.0001) on phase I, and 38.8% (p=0.0001) on phase II. Patients on HF had a 6.0% (NS) increase in LDL-C. There were nonsignificant reductions in HDL-C in those on MF (-1.5%) and HF (-5.8%). Patients on phase I showed an increase in HDL-C of 9.0% (NS), while those on phase II diet had a 3.6% increase (NS) in HDL-C. TC/HDL-C increased (9.8%) only in patients following the high-fat diets (NS). Patients on MF had a 5.3% (NS) reduction in TC/HDL-C, while those on LF had significant reductions on the phase I ( -45.8%; p=0.0001) diet and phase II diet (-34.7%; p=0.0001). TG levels increased on both the MF (1.0%) and HF (5.5%) diets, although neither was statistically significant. People following the phase I and II diets showed reductions of 37.3% and 36.9%, respectively. Ho levels increased by 9.7% when people followed the MF diet and by 12.4% when they followed the HF diet. Patients following the phase I and phase II diets showed reductions of 13.6% and 14.6%, respectively. Only those following phase II diets showed a tendency toward significant improvement (p=0.061). Lp(a) levels increased by 4.7% following the MF (NS) diet and by 31.0% (NS) on the HF diet. Patients following phase I showed a 7.4% (NS) reduction and a 10.8% reduction (NS) following phase II. Fibrinogen levels increased only in individuals following HF diets (11.9%), while patients following MF (-0.6%), phase I (-11.0%), and phase II (-6.3%) diets showed nonsignificant reductions in fibrinogen. Patients on MF demonstrated nonsignificant reductions in weight, LDL-C, TC, HDL-C, TC/HDL-C ratios, and fibrinogen and nonsignificant increases in TGs, Lp(a), and homocysteine. There was significant weight loss in patients on phase I and II and HF diets after 1 year. Reductions in TC, LDL-C, TGs, and TC/HDL ratios were significant only in patients either following a LF diet or a MF, calorically reduced diet. Only patients following HF diets showed a worsening of each cardiovascular disease risk factor (LDL-C, TG, TC, HDL-C, TC/HDL ratio, Ho, Lp(a), and fibrinogen), despite achieving statistically significant weight loss. Copyright 2002 CHF, Inc.

Research safety vehicle, Phase II. Volume I. Executive summary. Final report jul 75-dec 76

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

Struble, D.

1976-12-01

Volume I summarizes the results of the Minicars Research Safety Vehicle Phase II program, as detailed in Volumes II and III. Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidentialmore » Task Force on Motor Vehicle Goals beyond 1980.« less

The use of dihexyldithiocarbamate in reverse-phase HPLC of metal chelates

NASA Astrophysics Data System (ADS)

Fatimah, S. S.; Bahti, H. H.; Hastiawan, I.; Permanasari, A.

2018-05-01

Dialkyldithiocarbamates have long been used as chelating agents in reverse-phase HPLC of transition metals. In the previous study, an alkyl homolog of this type of ligand, namely dihexyldithiocarbamate (DHDTC), was synthesized and characterized. The use of this particular ligand in the revese-phase HPLC of some selected transition metal ions is now reported for the first time. The mobile phase comprising of the flow rate and of the detection, in the separation of the metal chelates of Cd (II), Fe (III), Cu (II), and Co (III), were investigated on a C-18 column. The results showed that dihexylditiocarbamate could be used for separating Cd (II), Fe(III), Cu(II), and Co(III). Therefore, it could be used in simultaneous analysis.

Clinical practice guidelines and consensus statements in oncology--an assessment of their methodological quality.

PubMed

Jacobs, Carmel; Graham, Ian D; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

2014-01-01

Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal scored consistently lower than the others over both domains. No journals adhered to all the items related to the transparency of document development. One journal's consensus statements endorsed a product made by the sponsoring pharmaceutical company in 64% of cases. Guidance documents are an essential part of oncology care and should be subjected to a rigorous and validated development process. Consensus statements had lower methodological quality than clinical practice guidelines using AGREE II. At a minimum, journals should ensure that that all consensus statements and clinical practice guidelines adhere to AGREE II criteria. Journals should consider explicitly requiring guidelines to declare pharmaceutical company sponsorship and to identify the sponsor's product to enhance transparency.

15 CFR 758.5 - Conformity of documents and unloading of items.

Code of Federal Regulations, 2010 CFR

2010-01-01

... disposition from BIS. (ii) Contact information. U.S. Department of Commerce, Bureau of Industry and Security... Trade (Continued) BUREAU OF INDUSTRY AND SECURITY, DEPARTMENT OF COMMERCE EXPORT ADMINISTRATION... documents. When a license is issued by BIS, the information entered on related export control documents (e.g...

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

PubMed

Song, James X

2014-01-01

Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular carcinoma (HCC) trial in which progression-free survival (PFS) in two biomarker-defined populations is evaluated at both interim and final analyses. As an extension, a short-term biomarker is used to predict the long-term PFS in a Bayesian model in order to improve the precision of hazard ratio (HR) estimate at the interim analysis. The characteristics of the extended design are examined in a number of scenarios via simulations. The recommended adaptive design is shown to be useful in a phase II setting. When a short-term maker which correlates with the long-term PFS is available, the design can be applied in smaller early phase trials in which PFS requires longer follow-up. In summary, the adaptive design offers flexibility in randomized phase II patient enrichment trials and should be considered in an overall personalized healthcare (PHC) strategy. Copyright © 2013 Elsevier Inc. All rights reserved.

U10 : Trusted Truck(R) II (phase B).

DOT National Transportation Integrated Search

2009-01-01

Phase B of the Trusted Truck II project built on the system developed in Phase A (or Year 1). For the implementation portion of the project, systems were added to the trailer to provide additional diagnostic trailer data that can be sent to the TTM...

Movement Analysis Applied to the Basketball Jump Shot--Part II.

ERIC Educational Resources Information Center

Martin, Thomas P.

1981-01-01

The jump shot is one of the most important shots in the game of basketball. The movement analysis of the jump shot designates four phases: (1) preparatory position; (2) movement phase I (crouch); (3) movement phase II (jump); and (4) follow-through. (JN)

Reliability Programs for Nonelectronic Designs. Volume 1

DTIC Science & Technology

1983-04-01

to the system or component levels or to both and then Its degree of effectiveness. DOCUMENT ID TITLE/SUBJECT APPLICATION EFFECTIVENESS Sys ./Comp/Both...ID TITLE/SUBJECT APPLICATION EFFECTIVENESS ’ Sys ./Comp/Both Exc./Good/Poor MIL-STD-781B Reliability Tests Exponen- 1 1 1 1 Ii II tial Distribution MIL...DOCUMENT ID TITLE/SUBJECT APPLICATION EFFECTIVENESS Sys ./Comp/Both Exc./Good/Poor MIL-STD-1535A Supplier Quality Assurance I 1 I1 I 1 1 I Program

The Setup Phase of Project Open Book: A Report to the Commission on Preservation and Access on the Status of an Effort to Convert Microfilm to Digital Imagery.

ERIC Educational Resources Information Center

Conway, Paul; Weaver, Shari

1994-01-01

This report documents the second phase of Yale University's Project Open Book, which explored the uses of digital technology for preservation of and access to deteriorating documents. Highlights include preconditions for project implementation; quality digital conversion; characteristics of source materials; digital document indexing; workflow…

A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings.

PubMed

Cockle-Hearne, Jane; Barnett, Deborah; Hicks, James; Simpson, Mhairi; White, Isabel; Faithfull, Sara

2018-04-30

Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=-.55; phase II, P=.001, r=-.59. Self-efficacy improved for coping P=.02, r=-.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. ©Jane Cockle-Hearne, Deborah Barnett, James Hicks, Mhairi Simpson, Isabel White, Sara Faithfull. Originally published in JMIR Cancer (http://cancer.jmir.org), 30.04.2018.

A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings

PubMed Central

Barnett, Deborah; Hicks, James; Simpson, Mhairi; White, Isabel; Faithfull, Sara

2018-01-01

Background Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. Objective To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. Methods A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. Results A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=−.55; phase II, P=.001, r=−.59. Self-efficacy improved for coping P=.02, r=−.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. Conclusions The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. PMID:29712628

Deep Bore Storage of Nuclear Waste Using MMW (Millimeter Wave) Technology, STTR Fast Track Project, Phase I Final Report-Revised

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

Oglesby, Kenneth D.; Woskov, Paul; Einstein, Herbert

This report covers the technical work in Phase I of this DOE-Nuclear Program STTR Fast Track project. All key tasks were successfully performed, new tasks were added to utilize DOD-AFRL’s 95 GigaHertz (GHz) gyrotron in Phase II, while other lesser tasks were left for Phase II efforts or were requested to be made optional. This research adds to our understanding of using MMW power to melt and vaporize rocks and steel/ metals and laid plans for future testing in Phase II. This work built upon a prior DOE project DE-EE0005504 that developed the basic waveguide setup, process and instruments. Inmore » this project we were investigating the use of MMW to form rock melt and steel plugs in deep wells to further isolate highly radioactive nuclear waste in ultra-deep basement rocks for long term storage. This technology also has potential for deep well drilling for nuclear storage, geothermal and oil and gas industries. It also has the potential for simultaneously sealing and securing the wellbore with a thick rock melt liner as the wellbore is drilled. This allows for higher levels of safety and protection of the environment during deep drilling operations. The larger purpose of this project was to find answers to key questions in progressing MMW technology for these applications. Phase I of this project continued bench testing using the MIT 10 kilo-Watt (kW), 28 GHz frequency laboratory gyrotron, literature searches, planning and design of equipment for Phase II efforts. Furnace melting and rock testing (Tasks 4 and 5) were deferred to Phase II due to lack of concurrent availability of the furnace and personnel at MIT. That delay and lower temperature furnace (limited to 1650oC) caused rethinking of Task 4 to utilize coordinated rock selection with the DOD testing in Phase II. The high pressure and high power window design work (moved to Phase I Task 3 from Phase II Task 20) and Additive materials and methods (Tasks 7 & 8) performed in Phase I may become patentable and thus little detail can be provided in this public report. A version of that new high pressure, high MMW power window may be built for possible Phase II testing at the DOD site. Most significantly, additional tasks were added for planning the use of the Department of Defense, Air Force Research Laboratory’s (DOD-AFRL’s) System 0 gyrotron in Phase II. Specifically added and accomplished were multiple discussions on DOD and DOE-MIT-Impact goals, timing between ongoing DOD testing, outlining the required equipment and instruments for rock testing, and terms for an agreement. That addition required a visit to Kirtland AFB in Albuquerque, New Mexico to talk to key DOD-AFRL personnel and management. A DOD-Impact-MIT charter (i.e., contract) is now being circulated for signatures. Also added task to Phase I, MIT designed the critical path reflected power isolator screen for Phase II testing. To ensure compatibility, that design was computer simulated for the expected heat load distribution and the resulting temperature increase. Advancing the MMW testing up to the optimum 95 GHz and 100kW (5X higher) power levels was stated in the original proposal to be a key required development step for this technology to achieve prototype drilling, lining, and rock melting/ vaporization for creating sealing plugs.« less

Sulforaphane-stimulated phase II enzyme induction inhibits cytokine production by airway epithelial cells stimulated with diesel extract.

PubMed

Ritz, Stacey A; Wan, Junxiang; Diaz-Sanchez, David

2007-01-01

Airborne particulate pollutants, such as diesel exhaust particles, are thought to exacerbate lung and cardiovascular diseases through induction of oxidative stress. Sulforaphane, derived from cruciferous vegetables, is the most potent known inducer of phase II enzymes involved in the detoxification of xenobiotics. We postulated that sulforaphane may be able to ameliorate the adverse effects of pollutants by upregulating expression of endogenous antioxidant enzymes. Stimulation of bronchial epithelial cells with the chemical constituents of diesel particles result in the production of proinflammatory cytokines. We first demonstrated a role for phase II enzymes in regulating diesel effects by transfecting the airway epithelial cell line (BEAS-2B) with the sentinel phase II enzyme NAD(P)H: quinine oxidoreductase 1 (NQO1). IL-8 production in response to diesel extract was significantly reduced in these compared with untransfected cells. We then examined whether sulforaphane would stimulate phase II induction and whether this would thereby ablate the effect of diesel extracts on cytokine production. We verified that sulforaphane significantly augmented expression of the phase II enzyme genes GSTM1 and NQO1 and confirmed that sulforaphane treatment increased glutathione S-transferase activity in epithelial cells without inducing cell death or apoptosis. Sulforaphane pretreatment inhibited IL-8 production by BEAS-2B cells upon stimulation with diesel extract. Similarly, whereas diesel extract stimulated production of IL-8, granulocyte-macrophage colony-stimulating factor, and IL-1beta from primary human bronchial epithelial cells, sulforaphane pretreatment inhibited diesel-induced production of all of these cytokines. Our studies show that sulforaphane can mitigate the effect of diesel in respiratory epithelial cells and demonstrate the chemopreventative potential of phase II enzyme enhancement.

Study in Parkinson Disease of Exercise (SPARX): Translating high-intensity exercise from animals to humans

PubMed Central

Moore, Charity G.; Schenkman, Margaret; Kohrt, Wendy M.; Delitto, Anthony; Hall, Deborah A.; Corcos, Daniel

2013-01-01

A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as “first-line” or “add-on” therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, Phase II study that we designed to test the feasibility of using high-intensity exercise to modify symptoms of PD and to simultaneously test the nonfutility of achieving a prespecified change in patients’ motor scores on the Unified Parkinson Disease Rating Scale (UPDRS). The trial began in May 2102 and is in the process of screening, enrolling, and randomly assigning 126 patients with early-stage PD to 1 of 3 groups: usual care (wait-listed controls), moderate-intensity exercise (4 days/week at 60%–65% maximal heart rate [HRmax]), or high-intensity exercise (4 days/week at 80%–85% HRmax). At 6-month follow-up, the trial is randomly reassigning usual care participants to a moderate-intensity or high-intensity exercise group for the remaining 6 months. The goals of the Phase II trial are to determine if participants can exercise at moderate and high intensities; to determine if either exercise yields benefits consistent with meaningful clinical change (nonfutility); and to document safety and attrition. The advantage of using a non-futility approach allows us to efficiently determine if moderate- or high-intensity exercise warrants further large-scale investigation in PD. PMID:23770108

The Value of Botox-A in Acute Radiation Proctitis: Results From a Phase I/II Study Using a Three-Dimensional Scoring System

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

Vuong, Te, E-mail: tvuong@jgh.mcgill.ca; Waschke, Kevin; Niazi, Tamim

Purpose: Acute radiation proctitis (ARP) is a common side effect of pelvic radiotherapy, and its management is challenging in daily practice. The present phase I/II study evaluates the safety and efficacy of the botulinum toxin A (BTX-A) in ARP treatment for rectal cancer patients undergoing neoadjuvant high-dose-rate endorectal brachytherapy (HDREBT). Methods and Materials: Fifteen patients, treated with neoadjuvant HDREBT, 26-Gy in 4 fractions, received the study treatment that consisted of a single injection of BTX-A into the rectal wall. The injection was performed post-HDREBT and prior to the development of ARP. The control group, 20 such patients, did not receivemore » the BTX-A injection. Both groups had access to standard treatment with hydrocortisone rectal aerosol foam (Cortifoam) and anti-inflammatory and narcotic medication. The ARP was clinically evaluated by self-administered daily questionnaires using visual analog scores to document frequency and urgency of bowel movements, rectal burning/tenesmus, and pain symptoms before and after HDREBT. Results: At the time of this analysis, there was no observed systemic toxicity. Patient compliance with the self-administered questionnaire was 100% from week 1 to 4, 70% during week 5, and 40% during week 6. The maximum tolerated dose was established at the 100-U dose level, and noticeable mean differences were observed in bowel frequency (p = 0.016), urgency (p = 0.007), and pain (p = 0.078). Conclusions: This study confirms the feasibility and efficacy of BTX-A intervention at 100-U dose level for study patients compared to control patients. A phase III study with this dose level is planned to validate these results.« less

A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

PubMed

Cheng, Steven K; Dietrich, Mary S; Dilts, David M

2010-11-15

Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.

Installation Restoration Program. Remedial Investigation Report. Minnesota Air National Guard Base Duluth International Airport, Duluth, Minnesota. Volume 5

DTIC Science & Technology

1990-01-01

1-20 1-6 Sites Defined and Ranked During IRP Phase I Study. 1-29 1-7 Aerial Photograph of Site 2, April 1988. 1-32 1-8 Site 2 Sampling Locations...Utilized During Phase II Investigations. 1-35 1-9 Aerial Photograph of Site 3, April 1988. 1-38 1-10 Site 3 Sampling Locations Utilized During Phase II...Investigations. 1-47 1-11 Aerial Photograph of Site 4, April 1988. 1-54 1-12 Site 4 Sampling Locations Utilized During Phase II Investigations. 1-57 1-13

ORANGES evaluation test plans : analysis of before data collected for the US DOT sponsored evaluation of the ORANGES electronic payment systems field operational test

DOT National Transportation Integrated Search

2003-10-02

This document is one of a series of working papers that report on progress for the US DOT evaluation for Phase I of the ORANGES field operational test. Each working paper corresponds to a Phase I task. At the conclusion of Phase I, these documents wi...

Final waste forms project: Performance criteria for phase I treatability studies

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

Gilliam, T.M.; Hutchins, D.A.; Chodak, P. III

1994-06-01

This document defines the product performance criteria to be used in Phase I of the Final Waste Forms Project. In Phase I, treatability studies will be performed to provide {open_quotes}proof-of-principle{close_quotes} data to establish the viability of stabilization/solidification (S/S) technologies. This information is required by March 1995. In Phase II, further treatability studies, some at the pilot scale, will be performed to provide sufficient data to allow treatment alternatives identified in Phase I to be more fully developed and evaluated, as well as to reduce performance uncertainties for those methods chosen to treat a specific waste. Three main factors influence themore » development and selection of an optimum waste form formulation and hence affect selection of performance criteria. These factors are regulatory, process-specific, and site-specific waste form standards or requirements. Clearly, the optimum waste form formulation will require consideration of performance criteria constraints from each of the three categories. Phase I will focus only on the regulatory criteria. These criteria may be considered the minimum criteria for an acceptable waste form. In other words, a S/S technology is considered viable only if it meet applicable regulatory criteria. The criteria to be utilized in the Phase I treatability studies were primarily taken from Environmental Protection Agency regulations addressed in 40 CFR 260 through 265 and 268; and Nuclear Regulatory Commission regulations addressed in 10 CFR 61. Thus the majority of the identified criteria are independent of waste form matrix composition (i.e., applicable to cement, glass, organic binders etc.).« less

Small Diameter Bomb Increment II (SDB II)

DTIC Science & Technology

2015-12-01

Selected Acquisition Report ( SAR ) RCS: DD-A&T(Q&A)823-439 Small Diameter Bomb Increment II (SDB II) As of FY 2017 President’s Budget Defense...Acquisition Management Information Retrieval (DAMIR) March 23, 2016 16:19:13 UNCLASSIFIED SDB II December 2015 SAR March 23, 2016 16:19:13 UNCLASSIFIED...Document OSD - Office of the Secretary of Defense O&S - Operating and Support PAUC - Program Acquisition Unit Cost SDB II December 2015 SAR March 23

Piper betle Induced Cytoprotective Genes and Proteins via the Nrf2/ARE Pathway in Aging Mice.

PubMed

Aliahmat, Nor Syahida; Abdul Sani, Nur Fathiah; Wan Hasan, Wan Nuraini; Makpol, Suzana; Wan Ngah, Wan Zurinah; Mohd Yusof, Yasmin Anum

2016-01-01

The objective of this study was to elucidate the underlying antioxidant mechanism of aqueous extract of Piper betle (PB) in aging rats. The nuclear factor erythroid 2-related factor 2 (Nrf2)/ARE pathway involving phase II detoxifying and antioxidant enzymes plays an important role in the antioxidant system by reducing electrophiles and reactive oxygen species through induction of phase II enzymes and proteins. Genes and proteins of phase II detoxifying antioxidant enzymes were analyzed by QuantiGenePlex 2.0 Assay and Western blot analysis. PB significantly induced genes and proteins of phase II and antioxidant enzymes, NAD(P)H quinone oxidoreductase 1, and catalase in aging mice (p < 0.05). The expression of these enzymes were stimulated via translocation of Nrf2 into the nucleus, indicating the involvement of ARE, a cis-acting motif located in the promoter region of nearly all phase II genes. PB was testified for the first time to induce cytoprotective genes through the Nrf2/ARE signaling pathway, thus unraveling the antioxidant mechanism of PB during the aging process. © 2016 S. Karger AG, Basel.

Site preference of alloying elements in DO22-Ni3V phase: Phase-field and first-principles study

NASA Astrophysics Data System (ADS)

Zhang, Ding-Ni; Shangguan, Qian-Qian; Liu, Fu; Zhang, Ming-Yi

2015-07-01

Site preference of alloying elements in DO22-Ni3V phase was investigated using phase-field and first-principles method. The concentrations of alloying elements on sublattices of DO22-Ni3V phase were quantitatively studied using phase-field model based on microscopic diffusion equations. The phase-field computation results demonstrate that the concentration differences of alloying elements on the NiI and NiII site are attributed to the coordination environment difference. Host atoms Ni and substitutional ternary additions Al prefer to occupy NiI site. Antisite atoms V show site preference on the NiII site. Further reason of site preference of alloying elements on the two different Ni sites were studied using first-principles method to calculate the electronic structure of DO22-Ni3V phase. Calculation of density of states, orbitals population and charge population of the optimized Ni3V structure found that the electronic structures of NiI and NiII sites are different. Electronic structure difference, which is caused by coordination environment difference, is the essential reason for site selectivity behaviors of alloying elements on NiI and NiII sites.

Background Document for Capacity Analysis for Newly Listed ...

EPA Pesticide Factsheets

... II II II M •i n". M " " It .1 tt It ..' I!' .. II .1 It \\ tl 0 4 . • • ' i ni process ois&s.F'iCH (It t ... Num&er fen!«r //cm p»s» T) A R Unt Nutnbt ' ' 1 . V 1 1 1 1 1 1 1 1 2 i 2 2 ...

Articulated, Performance-Based Instruction Guide for Drafting II. Final Document. Revised.

ERIC Educational Resources Information Center

Henderson, William Edward, Jr.

Developed during a project designed to provide continuous, performance-based vocational training at the secondary and postsecondary levels, this instructional guide is intended to help teachers implement a laterally and vertically articulated secondary level drafting II program. Introductory materials include a description of Drafting II,…

Computer Simulations of Polytetrafluoroethylene in the Solid State

NASA Astrophysics Data System (ADS)

Holt, D. B.; Farmer, B. L.; Eby, R. K.; Macturk, K. S.

1996-03-01

Force field parameters (Set I) for fluoropolymers were previously derived from MOPAC AM1 semiempirical data on model molecules. A second set (Set II) was derived from the AM1 results augmented by ab initio calculations. Both sets yield reasonable helical and phase II packing structures for polytetrafluoroethylene (PTFE) chains. However, Set I and Set II differ in the strength of van der Waals interactions, with Set II having deeper potential wells (order of magnitude). To differentiate which parameter set provides a better description of PTFE behavior, molecular dynamics simulations have been performed with Biosym Discover on clusters of PTFE chains which begin in a phase II packing environment. Added to the model are artificial constraints which allow the simulation of thermal expansion without having to define periodic boundary conditions for each specific temperature of interest. The preliminary dynamics simulations indicate that the intra- and intermolecular interactions provided by Set I are too weak. The degree of helical disorder and chain motion are high even at temperatures well below the phase II-phase IV transition temperature (19 C). Set II appears to yield a better description of PTFE in the solid state.

The Importance of Longitudinal Studies

NASA Astrophysics Data System (ADS)

Knezek, Patricia

2014-01-01

It has been eight years since the AAS Council unanimously endorsed the document, known as "Equity Now: The Pasadena Recommendations for Gender Equality in Astronomy," in January 2005. This document was the main product of the conference entitled “Women in Astronomy II: Ten Years After” (WIA II), held in June 2003 in Pasadena, CA. One of the key recommendations represented in that document was the need for a longitudinal study of astronomers. It was recognized that in order to understand our own field, how it is evolving, and the impact on individuals, we need to track people over time. I will discuss the fundamental questions that led to the recommendation, and set the stage for the current (ongoing) longitudinal study.

Design, analysis, and test verification of advanced encapsulation systems

NASA Technical Reports Server (NTRS)

Mardesich, N.; Minning, C.

1982-01-01

Design sensitivities are established for the development of photovoltaic module criteria and the definition of needed research tasks. The program consists of three phases. In Phase I, analytical models were developed to perform optical, thermal, electrical, and structural analyses on candidate encapsulation systems. From these analyses several candidate systems will be selected for qualification testing during Phase II. Additionally, during Phase II, test specimens of various types will be constructed and tested to determine the validity of the analysis methodology developed in Phase I. In Phse III, a finalized optimum design based on knowledge gained in Phase I and II will be developed. All verification testing was completed during this period. Preliminary results and observations are discussed. Descriptions of the thermal, thermal structural, and structural deflection test setups are included.

Technology Demonstration of the Zero Emissions Chromium Electroplating System

DTIC Science & Technology

2008-02-01

Phase I trivalent chromium results ................................................................... 23 18 Phase II total chromium in PRD fluid results...0 xa B D F H J L Sam pies Figure 16. Phase II iron results. ERDC/CERL TR-05-35, Vol. 1 23 Trivalent Chromium Phase I Analysis for Phase I was...with the samples. Each sample was analyzed twice, and an average was computed. Figure 17 shows the results. ANAD has specified that Trivalent Chromium

Managing la malilla: Exploring drug treatment experiences among injection drug users in Tijuana, Mexico, and their implications for drug law reform

PubMed Central

Syvertsen, Jennifer; Pollini, Robin A.; Lozada, Remedios; Vera, Alicia; Rangel, Gudelia; Strathdee, Steffanie A.

2012-01-01

Background In August 2009, Mexico reformed its drug laws and decriminalized small quantities of drugs for personal use; offenders caught three times will be mandated to enter drug treatment. However, little is known about the quality or effectiveness of drug treatment programs in Mexico. We examined injection drug users’ (IDUs) experiences in drug treatment in Tijuana, Mexico, with the goal of informing program planning and policy. Methods We examined qualitative and quantitative data from Proyecto El Cuete, a multi-phased research study on HIV risk among IDUs in Tijuana. Phase I consisted of 20 in-depth interviews and Phase II employed respondent-driven sampling to recruit 222 IDUs for a quantitative survey. We also reviewed national drug policy documents, surveillance data, and media reports to situate drug users’ experiences within the broader sociopolitical context. Results Participants in the qualitative study were 50% male with a mean age of 32; most injected heroin (85.0%) and methamphetamine (60.0%). The quantitative sample was 91.4% male with a mean age of 35; 98.2% injected heroin and 83.7% injected heroin and methamphetamine together. The majority of participants reported receiving treatment: residential treatment was most common, followed by methadone; other types of services were infrequently reported. Participants’ perceptions of program acceptability and effectiveness were mixed. Mistreatment emerged as a theme in the qualitative interviews and was reported by 21.6% of Phase II participants, primarily physical (72.0%) and verbal (52.0%) abuse. Conclusions Our results point to the need for political, economic, and social investment in the drug treatment system before offenders are sentenced to treatment under the revised national drug law. Resources are needed to strengthen program quality and ensure accountability. The public health impact of the new legislation that attempts to bring drug treatment to the forefront of national drug policy should be systematically evaluated. PMID:20800464

Laboratory modeling of energy dissipation in broken-back culverts - phase II.

DOT National Transportation Integrated Search

2011-05-01

This report represents Phase II of broken-back culverts with a drop of 6 feet. The first phase of this research was performed for a drop of 24 feet. This research investigates the reduction in scour downstream of a broken-back culvert by forming a hy...

DEVELOPMENT OF A SCALABLE, LOW-COST, ULTRANANOCRYSTALLINE DIAMOND ELECTROCHEMICAL PROCESS FOR THE DESTRUCTION OF CONTAMINANTS OF EMERGING CONCERN (CECS) - PHASE II

EPA Science Inventory

This Small Business Innovation Research (SBIR) Phase II project will employ the large scale; highly reliable boron-doped ultrananocrystalline diamond (BD-UNCD®) electrodes developed during Phase I project to build and test Electrochemical Anodic Oxidation process (EAOP)...

78 FR 18305 - Notice of Request for Extension of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... Identity Verification (PIV) Request for Credential, the USDA Homeland Security Presidential Directive 12... consists of two phases of implementation: Personal Identity Verification phase I (PIV I) and Personal Identity Verification phase II (PIV II). The information requested must be provided by Federal employees...

A two-step spin crossover mononuclear iron(II) complex with a [HS-LS-LS] intermediate phase.

PubMed

Bonnet, Sylvestre; Siegler, Maxime A; Costa, José Sánchez; Molnár, Gábor; Bousseksou, Azzedine; Spek, Anthony L; Gamez, Patrick; Reedijk, Jan

2008-11-21

The two-step spin crossover of a new mononuclear iron(ii) complex is studied by magnetic, crystallographic and calorimetric methods revealing two successive first-order phase transitions and an ordered intermediate phase built by the repetition of the unprecedented [HS-LS-LS] motif.

The effectiveness and safety of traffic and non-traffic related messages presented on changeable message signs : phase II.

DOT National Transportation Integrated Search

2008-08-01

In Phase II of this investigation, we used a fully interactive PC-based STISIM driving simulator, to conduct two : experiments which were similar to experiments in Phase I. The participants were 120 licensed drivers from three : age groups18-24, 3...

Tipster Text Phase 2 Architecture Design

DTIC Science & Technology

1996-06-19

TIPSTER Text Phase II Architecture Design Version 2.1p 19 June 1996 Ralph Grishman New York University grishman @cs.nyu.edu and the TIPSTER...1996 2. REPORT TYPE 3. DATES COVERED 00-00-1996 to 00-00-1996 4. TITLE AND SUBTITLE TIPSTER Text Phase II Architecture Design 5a. CONTRACT

Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807)

PubMed Central

Hironaka, Shuichi; Tsubosa, Yasuhiro; Mizusawa, Junki; Kii, Takayuki; Kato, Ken; Tsushima, Takahiro; Chin, Keisho; Tomori, Akihisa; Okuno, Tatsuya; Taniki, Toshikatsu; Ura, Takashi; Matsushita, Hisayuki; Kojima, Takashi; Doki, Yuichiro; Kusaba, Hitoshi; Fujitani, Kazumasa; Taira, Koichi; Seki, Shiko; Nakamura, Tsutomu; Kitagawa, Yuko

2014-01-01

We carried out a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil (CF) therapy (2-weekly DCF regimen) in esophageal cancer patients to investigate its safety and antimetastatic activity. Patients received 2-weekly docetaxel (30 mg/m2 [dose level (DL)1] or 40 mg/m2 [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed-dose CF (80 mg/m2 cisplatin, day 1; 800 mg/m2 fluorouracil, days 1–5) repeated every 4 weeks. The primary endpoint was dose-limiting toxicity (DLT) in phase I and central peer review-based response rate in phase II. At least 22 responders among 50 patients were required to satisfy the primary endpoint with a threshold of 35%. Sixty-two patients were enrolled in phase I and II. In phase I, 10 patients were enrolled with DLT of 0/3 at DL1 and 2/7 in DL2. Considering DLT and treatment compliance, the recommended phase II dose was determined as DL1. In phase II, the response rate was 62% (P < 0.0001; 95% confidence interval, 48–75%); median overall survival and progression-free survival were 11.1 and 5.8 months, respectively. Common grade 3/4 adverse events were neutropenia (25%), anemia (36%), hyponatremia (29%), anorexia (24%), and nausea (11%). No febrile neutropenia was observed. Pneumonitis caused treatment-related death in one patient. The 2-weekly DCF regimen showed promising antimetastatic activity and tolerability. A phase III study comparing this regimen with CF therapy is planned by the Japan Clinical Oncology Group. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001737. PMID:25041052

Unusual Enhancement of Magnetization by Pressure in the Antiferro-Quadrupole-Ordered Phase in CeB6

NASA Astrophysics Data System (ADS)

Ikeda, Suguru; Sera, Masafumi; Hane, Shingo; Uwatoko, Yoshiya; Kosaka, Masashi; Kunii, Satoru

2007-06-01

The effect of pressure on CeB6 was investigated by the measurement of the magnetization (M) under pressure, and we obtained the following results. The effect of pressure on M in phase I is very small. By applying pressure, TQ is enhanced, but TN and the critical field from the antiferromagnetic (AFM) phase III to the antiferro-quadrupole (AFQ) phase II (HcIII--II) are suppressed, as previously reported. The magnetization curve in phase III shows the characteristic shoulder at H˜ HcIII--II/2 at ambient pressure. This shoulder becomes much more pronounced by applying pressure. Both HcIII--II and the magnetic field, where a shoulder is seen in the magnetization curve in phase III, are largely suppressed by pressure. In phase II, the M-T curve at a low magnetic field exhibits an unusual concave temperature dependence below TQ down to TN. Thus, we found that the lower the magnetic field, the larger the enhancement of M in both phases III and II. To clarify the origin of the unusual pressure effect of M, we performed a mean-field calculation for the 4-sublattice model using the experimental results of dTQ/dP>0 and dTN/dP<0 and assuming the positive pressure dependence of the Txyz-antiferro-octupole (AFO) interaction. The characteristic features of the pressure effect of M obtained by the experiments could be reproduced well by the mean-field calculation. We found that the origin of the characteristic effect of pressure on CeB6 is the change in the subtle balance between the AFM interaction and the magnetic field-induced-effective FM interaction induced by the coexistence of the Oxy-AFQ and Txyz-AFO interactions under pressure.

32 CFR 2700.33 - Mandatory review for declassification.

Code of Federal Regulations, 2012 CFR

2012-07-01

... made more specific, no further action will be taken. (4) Subject to paragraph (b)(7) of this section... one hour. (ii) Reproduction of documents: Documents will be reproduced at a rate of $.25 per page for all copying of four pages or more. No fee shall be assessed for reproducing documents which are three...

32 CFR 2700.33 - Mandatory review for declassification.

Code of Federal Regulations, 2013 CFR

2013-07-01

... made more specific, no further action will be taken. (4) Subject to paragraph (b)(7) of this section... one hour. (ii) Reproduction of documents: Documents will be reproduced at a rate of $.25 per page for all copying of four pages or more. No fee shall be assessed for reproducing documents which are three...

32 CFR 2700.33 - Mandatory review for declassification.

Code of Federal Regulations, 2014 CFR

2014-07-01

... made more specific, no further action will be taken. (4) Subject to paragraph (b)(7) of this section... one hour. (ii) Reproduction of documents: Documents will be reproduced at a rate of $.25 per page for all copying of four pages or more. No fee shall be assessed for reproducing documents which are three...

50 CFR 600.315 - National Standard 2-Scientific Information.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) SAFE Report. (1) The SAFE report is a document or set of documents that provides Councils with a... responsibility to assure that a SAFE report or similar document is prepared, reviewed annually, and changed as..., Federal, university, or other sources to acquire and analyze data and produce the SAFE report. (ii) The...

76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...

75 FR 10182 - Approval and Promulgation of Implementation Plans; State of Iowa

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... INFORMATION: Throughout this document ``we,'' ''us,'' or ``our'' refer to the EPA. Table of Contents I. What is being addressed in this document? II. What revisions is EPA approving? III. What action is EPA taking? IV. Statutory and Executive Order Reviews I. What is being addressed in this document? The State...

High level waste storage tank farms/242-A evaporator standards/requirements identification document phase 1 assessment report

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

Biebesheimer, E., Westinghouse Hanford Co.

This document, the Standards/Requirements Identification Document (S/RID) Phase I Assessment Report for the subject facility, represents the results of an Administrative Assessment to determine whether S/RID requirements are fully addressed by existing policies, plans or procedures. It contains; compliance status, remedial actions, and an implementing manuals report linking S/RID elements to requirement source to implementing manual and section.

Evapotranspiration information reporting: II. Recommended documentation

USDA-ARS?s Scientific Manuscript database

Researchers and journal authors, reviewers, and readers can benefit from more complete documentation of published evapotranspiration (ET) information, including a description of field procedures, instrumentation, data filtering, model parameterization, and site review. This information is important ...

Denver area post-World War II suburbs.

DOT National Transportation Integrated Search

2011-02-01

Historic Residential Subdivisions of Metropolitan Denver, 1940-1965, documents the development of : mid-century suburbs in CDOT Region 6. The report follows the National Register of Historic Places : format for multiple property documentation, and is...

Integration, acceptance testing, and clinical operation of the Medical Information, Communication and Archive System, phase II.

PubMed

Smith, E M; Wandtke, J; Robinson, A

1999-05-01

The Medical Information, Communication and Archive System (MICAS) is a multivendor incremental approach to picture archiving and communications system (PACS). It is a multimodality integrated image management system that is seamlessly integrated with the radiology information system (RIS). Phase II enhancements of MICAS include a permanent archive, automated workflow, study caches, Microsoft (Redmond, WA) Windows NT diagnostic workstations with all components adhering to Digital Information Communications in Medicine (DICOM) standards. MICAS is designed as an enterprise-wide PACS to provide images and reports throughout the Strong Health healthcare network. Phase II includes the addition of a Cemax-Icon (Fremont, CA) archive, PACS broker (Mitra, Waterloo, Canada), an interface (IDX PACSlink, Burlington, VT) to the RIS (IDXrad) plus the conversion of the UNIX-based redundant array of inexpensive disks (RAID) 5 temporary archives in phase I to NT-based RAID 0 DICOM modality-specific study caches (ImageLabs, Bedford, MA). The phase I acquisition engines and workflow management software was uninstalled and the Cemax archive manager (AM) assumed these functions. The existing ImageLabs UNIX-based viewing software was enhanced and converted to an NT-based DICOM viewer. Installation of phase II hardware and software and integration with existing components began in July 1998. Phase II of MICAS demonstrates that a multivendor open-system incremental approach to PACS is feasible, cost-effective, and has significant advantages over a single-vendor implementation.

Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE).

PubMed

Servagi-Vernat, Stéphanie; Créhange, Gilles; Bonnetain, Franck; Mertens, Cécile; Brain, Etienne; Bosset, Jean François

2017-07-13

The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older. This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO). This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older. Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.

FutureGen 2.0 Pipeline and Regional Carbon Capture Storage Project - Final Report

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

Burger, Chris; Wortman, David; Brown, Chris

The U.S. Department of Energy’s (DOE) FutureGen 2.0 Program involves two projects: (1) the Oxy-Combustion Power Plant Project and (2) the CO2 Pipeline and Storage Project. This Final Technical Report is focused on the CO2 Pipeline and Storage Project. The FutureGen 2.0 CO2 Pipeline and Storage Project evolved from an initial siting and project definition effort in Phase I, into the Phase II activity consisting permitting, design development, the acquisition of land rights, facility design, and licensing and regulatory approvals. Phase II also progressed into construction packaging, construction procurement, and targeted early preparatory activities in the field. The CO2 Pipelinemore » and Storage Project accomplishments were significant, and in some cases unprecedented. The engineering, permitting, legal, stakeholder, and commercial learnings substantially advance the nation’s understanding of commercial-scale CO2 storage in deep saline aquifers. Voluminous and significant information was obtained from the drilling and the testing program of the subsurface, and sophisticated modeling was performed that held up to a wide range of scrutiny. All designs progressed to the point of securing construction contracts or comfort letters attesting to successful negotiation of all contract terms and willing execution at the appropriate time all major project elements – pipeline, surface facilities, and subsurface – as well as operations. While the physical installation of the planned facilities did not proceed in part due to insufficient time to complete the project prior to the expiration of federal funding, the project met significant objectives prior to DOE’s closeout decision. Had additional time been available, there were no known, insurmountable obstacles that would have precluded successful construction and operation of the project. Due to the suspension of the project, site restoration activities were developed and the work was accomplished. The site restoration efforts are also documented in this report. All permit applications had been submitted to all agencies for those permits or approvals required prior to the start of project construction. Most of the requisite permits were received during Phase II. This report includes information on each permitting effort. Successes and lessons learned are included in this report that will add value to the next generation of carbon storage efforts.« less

Geraniol modulates tongue and hepatic phase I and phase II conjugation activities and may contribute directly to the chemopreventive activity against experimental oral carcinogenesis.

PubMed

Madankumar, Arumugam; Jayakumar, Subramaniyan; Gokuladhas, Krishnan; Rajan, Balan; Raghunandhakumar, Subramanian; Asokkumar, Selvamani; Devaki, Thiruvengadam

2013-04-05

Xenobiotic metabolizing enzymes are chief determinants in both the susceptibility to mutagenic effect of chemical carcinogens and in the response of tumors to chemotherapy. The present study was aimed to analyze the effect of geraniol administration on the activity of phase I and phase II carcinogen metabolizing enzymes through the nuclear factor erythroid 2-related factor-2 (Nrf2) activation against 4-niroquinoline-1-oxide (4NQO) induced oral carcinogenesis. The well-known chemical carcinogen 4NQO (50 ppm) was used to induce oral carcinogenesis through drinking water for 4, 12, and 20 weeks. The degree of cancer progression at each stage was confirmed by histological examination. At the end of the experimental period, 100% tumor formation was observed in the oral cavity of 4NQO induced animals with significant (P<0.05) alteration in the status of tumor markers, tongue and liver phase I and phase II drug metabolizing enzymes indicating progression of disease. Oral administration of geraniol at the dose of 200 mg/kg b.wt., thrice a week to 4NQO induced animals was able to inhibit tumor formation and thereby delayed the progression of oral carcinogenesis by modulating tongue and liver phase I and phase II drug metabolizing enzymes, as substantiated further by the histological and transmission electron microscopic studies. Our results demonstrate that geraniol exerts its chemopreventive potential by altering activities of phases I and II drug metabolizing enzymes to achieve minimum bioactivation of carcinogen and maximum detoxification. Copyright © 2013 Elsevier B.V. All rights reserved.

Polymorphism of paracetamol: relative stabilities of the monoclinic and orthorhombic phases inferred from topological pressure-temperature and temperature-volume phase diagrams.

PubMed

Espeau, Philippe; Céolin, René; Tamarit, Josep-Lluis; Perrin, Marc-Antoine; Gauchi, Jean-Pierre; Leveiller, Franck

2005-03-01

The thermodynamic relationships between the two known polymorphs of paracetamol have been investigated, and the subsequent pressure-temperature and temperature-volume phase diagrams were constructed using data from crystallographic and calorimetric measurements as a function of the temperature. Irrespective of temperature, monoclinic Form I and orthorhombic Form II are stable phases at ordinary and high pressures, respectively. The I and II phase regions in the pressure-temperature diagram are bordered by the I-II equilibrium curve, for which a negative slope (dp/dT approximately -0.3 MPa x K(-1)) was determined although it was not observed experimentally. This curve goes through the I-II-liquid triple point whose coordinates (p approximately 234 MPa, T approximately 505 K) correspond to the crossing point of the melting curves, for which dp/dT values of +3.75 MPa x K(-1) (I) and +3.14 MPa x K(-1) (II) were calculated from enthalpy and volume changes upon fusion. More generally, this case exemplifies how the stability hierarchy of polymorphs may be inferred from the difference in their sublimation curves, as topologically positioned with respect to each other, using the phase rule and simple inferences resorting to Gibbs equilibrium thermodynamics. Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.

An early oral health care program starting during pregnancy: results of a prospective clinical long-term study.

PubMed

Meyer, Karen; Geurtsen, Werner; Günay, Hüsamettin

2010-06-01

This study covers phase IV of a prospective clinical long-term study. Objective of this clinical investigation was to analyze the effects of a long-term prevention program on dental and oral health of teenagers at the age of 13 to 14 years. The entire study was subdivided into four phases. Phase I comprised an individual preventive care during pregnancy ("primary-primary prevention"); phase II assessed mothers and their young children until the age of 3 years ("primary prevention"); and in phase III, mothers and children at the age of 6 years were investigated. In phase IV of the study, the oral health of 13- to 14-year-old teenagers was examined (13.4 +/- 0.5 years; n = 29). All phases consisted of an examination, education about oral health care, and treatment based on the concept of an early oral health care promotion. The control group consisted of randomly selected adolescents at the same age (n = 30). The following clinical parameters were assessed: decayed/missing/filled teeth (DMF-T)/decayed, missing, and filled surface teeth index, hygiene index, papilla bleeding index, Periodontal Screening Index, and Streptococcus mutans/Lactobacillus concentration in saliva. The teenagers of the "prevention" group of phase IV of our prospective study revealed a share of 89.7% caries-free dentitions (65.5% sound; 24.2% caries-free with fillings). Mean DMF-T was 0.55 +/- 1.0. The control group showed a significantly higher mean DMF-T of 1.5 +/- 1.5 (p < 0.05) and revealed 56.7% of caries-free dentitions (30% sound, 26.7% caries-free with restorations). Our data clearly document that an early oral health care promotion starting during pregnancy may cause a sustained and long-term improvement of the oral health of children.

Applied Meteorology Unit (AMU) Quarterly Report - Fourth Quarter FY-10

NASA Technical Reports Server (NTRS)

Bauman, William; Crawford, Winifred; Barrett, Joe; Watson, Leela; Wheeler, Mark

2010-01-01

Three AMU tasks were completed in this Quarter, each resulting in a forecast tool now being used in operations and a final report documenting how the work was done. AMU personnel completed the following tasks (1) Phase II of the Peak Wind Tool for General Forecasting task by delivering an improved wind forecasting tool to operations and providing training on its use; (2) a graphical user interface (GUI) she updated with new scripts to complete the ADAS Update and Maintainability task, and delivered the scripts to the Spaceflight Meteorology Group on Johnson Space Center, Texas and National Weather Service in Melbourne, Fla.; and (3) the Verify MesoNAM Performance task after we created and delivered a GUI that forecasters will use to determine the performance of the operational MesoNAM weather model forecast.

Year 6 Post-Remediation Biomonitoring and Phase II Source Investigation at the United Heckathorn Superfund Site, Richmond, California

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

Kohn, Nancy P.; Evans, Nathan R.

The Heckathorn Superfund Site in Richmond, California, encompasses the property of the former United Heckathorn pesticide packaging plant and the adjacent waterway, Lauritzen Channel. The site was used from 1945 to 1966 by several operators to produce various agricultural chemicals. The site was placed on the National Priorities List of Superfund sites in 1990, which resulted in the removal of pesticide-contaminated soil from the upland portion of the site and dredging the marine portion of the site. Post-remediation marine monitoring and associated studies conducted through 2002 indicate that the contamination in the channel continues to pose a significant risk tomore » biota and human health. This report documents continued marine monitoring and source investigation studies conducted in 2003.« less

Medical devices; radiology devices; reclassification of full-field digital mammography system. Final rule.

PubMed

2010-11-05

The Food and Drug Administration (FDA) is announcing the reclassification of the full-field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce planar digital x-ray images of the entire breast; this generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." FDA is reclassifying the device into class II (special controls) because general controls along with special controls will provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

NHEXAS PHASE I MARYLAND STUDY--LIST OF AVAILABLE DOCUMENTS: PROTOCOLS AND SOPS

EPA Science Inventory

This document lists available protocols and SOPs for the NHEXAS Phase I Maryland study. It identifies protocols and SOPs for the following study components: (1) Sample collection and field operations, (2) Sample analysis and general laboratory procedures, (3) Data Analysis Proced...

GeoGIS : phase II.

DOT National Transportation Integrated Search

2009-12-01

A new web-based geotechnical Geographic Information System (GeoGIS) was developed and tested for the Alabama Department of Transportation (ALDOT) during Phase II of this research project. This web-based system stores geotechnical information about tr...

Railroad Classification Yard Technology Manual: Volume II : Yard Computer Systems

DOT National Transportation Integrated Search

1981-08-01

This volume (Volume II) of the Railroad Classification Yard Technology Manual documents the railroad classification yard computer systems methodology. The subjects covered are: functional description of process control and inventory computer systems,...

Hazardous Materials Routing Study Phase II: Analysis of Hazardous Materials Truck Routes in Proximity to the Dallas Central Business District

DOT National Transportation Integrated Search

1985-10-01

This report summarizes the findings from the second phase of a two-part analysis of hazardous materials truck routes in the Dallas-Fort Worth area. Phase II of this study analyzes the risk of transporting hazardous materials on freeways and arterial ...

75 FR 4894 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

... activity.\\5\\ There will also be an increase in the monthly fee for the mutual fund Profile Phase II Service.... Profile Phase I transmits mutual fund price and rate information. Profile Phase II stores data elements such as accumulation, breakpoints, and commission eligibility that relate to mutual fund processing...

DEMONSTRATION OF FUEL CELLS TO RECOVER ENERGY FROM LANDFILL GAS: PHASE II. PRETREATMENT SYSTEM PERFORMANCE MEASUREMENT

EPA Science Inventory

The report describes Phase II of a demonstration of the utilization of commercial phosphoric acid fuel cells to recover energy from landfill gas. This phase consisted primarily of the construction and testing of a Gas Pretreatment Unit (GPU) whose function is to remove those impu...

Characterization of unpaved road condition through the use of remote sensing project - phase II, deliverable 8-D: final report.

DOT National Transportation Integrated Search

2016-03-07

Building on the success of developing a UAV based unpaved road assessment system in Phase I, the project team was awarded a Phase II project by the USDOT to focus on outreach and implementation. The project team added Valerie Lefler of Integrated Glo...

A Reliability Simulator for Radiation-Hard Microelectronics Development

DTIC Science & Technology

1991-07-01

1 3.0 PHASE II WORK PLANS ................................................................ 2... plan . The correlation experimental details including the devices utilized, the hot-carrier stressing and the wafer-level radiation correlation procedure...channel devices, and a new lifetime extrapolation method is demonstrated for p-channel devices. 3.0 PHASE II WORK PLANS The Phase 1I program consisted of

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

New York State Educational Information System (NYSEIS) Systems Design. Volume I, Phase II. Final Report.

ERIC Educational Resources Information Center

Price Waterhouse and Co., New York, NY.

This volume on Phase II of the New York State Educational Information System (NYSEIS) describes the Gross Systems Analysis and Design, which includes the general flow diagram and processing chart for each of the student, personnel, and financial subsystems. Volume II, Functional Specifications, includes input/output requirements and file…

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

NASA Technical Reports Server (NTRS)

Crawford, Winifred C.

2010-01-01

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

A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN).

PubMed

Bellmunt, J; Kerst, J M; Vázquez, F; Morales-Barrera, R; Grande, E; Medina, A; González Graguera, M B; Rubio, G; Anido, U; Fernández Calvo, O; González-Billalabeitia, E; Van den Eertwegh, A J M; Pujol, E; Perez-Gracia, J L; González Larriba, J L; Collado, R; Los, M; Maciá, S; De Wit, R

2017-07-01

Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously. NCT01830231. © 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.

Phase I to II cross-induction of xenobiotic metabolizing enzymes: a feedforward control mechanism for potential hormetic responses.

PubMed

Zhang, Qiang; Pi, Jingbo; Woods, Courtney G; Andersen, Melvin E

2009-06-15

Hormetic responses to xenobiotic exposure likely occur as a result of overcompensation by the homeostatic control systems operating in biological organisms. However, the mechanisms underlying overcompensation that leads to hormesis are still unclear. A well-known homeostatic circuit in the cell is the gene induction network comprising phase I, II and III metabolizing enzymes, which are responsible for xenobiotic detoxification, and in many cases, bioactivation. By formulating a differential equation-based computational model, we investigated in this study whether hormesis can arise from the operation of this gene/enzyme network. The model consists of two feedback and one feedforward controls. With the phase I negative feedback control, xenobiotic X activates nuclear receptors to induce cytochrome P450 enzyme, which bioactivates X into a reactive metabolite X'. With the phase II negative feedback control, X' activates transcription factor Nrf2 to induce phase II enzymes such as glutathione S-transferase and glutamate cysteine ligase, etc., which participate in a set of reactions that lead to the metabolism of X' into a less toxic conjugate X''. The feedforward control involves phase I to II cross-induction, in which the parent chemical X can also induce phase II enzymes directly through the nuclear receptor and indirectly through transcriptionally upregulating Nrf2. As a result of the active feedforward control, a steady-state hormetic relationship readily arises between the concentrations of the reactive metabolite X' and the extracellular parent chemical X to which the cell is exposed. The shape of dose-response evolves over time from initially monotonically increasing to J-shaped at the final steady state-a temporal sequence consistent with adaptation-mediated hormesis. The magnitude of the hormetic response is enhanced by increases in the feedforward gain, but attenuated by increases in the bioactivation or phase II feedback loop gains. Our study suggests a possibly common mechanism for the hormetic responses observed with many mutagens/carcinogens whose activities require bioactivation by phase I enzymes. Feedforward control, often operating in combination with negative feedback regulation in a homeostatic system, may be a general control theme responsible for steady-state hormesis.

Bank of Standardized Stimuli (BOSS) phase II: 930 new normative photos.

PubMed

Brodeur, Mathieu B; Guérard, Katherine; Bouras, Maria

2014-01-01

Researchers have only recently started to take advantage of the developments in technology and communication for sharing data and documents. However, the exchange of experimental material has not taken advantage of this progress yet. In order to facilitate access to experimental material, the Bank of Standardized Stimuli (BOSS) project was created as a free standardized set of visual stimuli accessible to all researchers, through a normative database. The BOSS is currently the largest existing photo bank providing norms for more than 15 dimensions (e.g. familiarity, visual complexity, manipulability, etc.), making the BOSS an extremely useful research tool and a mean to homogenize scientific data worldwide. The first phase of the BOSS was completed in 2010, and contained 538 normative photos. The second phase of the BOSS project presented in this article, builds on the previous phase by adding 930 new normative photo stimuli. New categories of concepts were introduced, including animals, building infrastructures, body parts, and vehicles and the number of photos in other categories was increased. All new photos of the BOSS were normalized relative to their name, familiarity, visual complexity, object agreement, viewpoint agreement, and manipulability. The availability of these norms is a precious asset that should be considered for characterizing the stimuli as a function of the requirements of research and for controlling for potential confounding effects.

A phase IB study of the pharmacokinetics of gemcitabine and pemetrexed, when administered in rapid sequence to patients with advanced solid tumors.

PubMed

Dy, Grace K; Suri, Ajit; Reid, Joel M; Sloan, Jeff A; Pitot, Henry C; Alberts, Steven R; Goldberg, Richard M; Atherton, Pamela J; Hanson, Lorelei J; Burch, Patrick A; Rubin, Joseph; Erlichman, Charles; Adjei, Alex A

2005-06-01

We have previously demonstrated that pemetrexed is clinically active when administered 90 min after gemcitabine in a phase I study. The present study was undertaken to evaluate the efficacy, toxicity, and pharmacokinetics of gemcitabine and pemetrexed when pemetrexed is administered immediately after gemcitabine. A total of 14 patients received 84 cycles of treatment. Gemcitabine 1250 mg/m(2) was administered on days 1 and 8 of each 21-day cycle, and pemetrexed 500 mg/m(2) on day 8 immediately following gemcitabine administration. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria and recorded as maximum grade per patient for all treatment cycles. Pharmacokinetic analyses of plasma gemcitabine and pemetrexed concentrations were performed. Neutropenia was the most common severe toxicity. Non-hematologic toxicities, which included nausea, vomiting, fatigue, diarrhea, rash, and elevated transaminases were of mild-to-moderate severity. No increased toxicity was observed with this schedule in comparison to the previous phase I schedule. There was no pharmacokinetic interaction between the two drugs. One partial response was documented in a patient with non-small-cell lung cancer. Eight patients had disease stabilization for five or more cycles. Gemcitabine immediately followed by pemetrexed is well tolerated and clinically active, and deserves further evaluation in phase II trials.

Fe(II) sorption on pyrophyllite: Effect of structural Fe(III) (impurity) in pyrophyllite on nature of layered double hydroxide (LDH) secondary mineral formation

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

Starcher, Autumn N.; Li, Wei; Kukkadapu, Ravi K.

Fe(II)-Al(III)-LDH (layered double hydroxide) phases have been shown to form from reactions of aqueous Fe(II) with Fe-free Al-bearing minerals (phyllosilicate/clays and Al-oxides). To our knowledge, the effect of small amounts of structural Fe(III) impurities in “neutral” clays on such reactions, however, were not studied. In this study to understand the role of structural Fe(III) impurity in clays, laboratory batch studies with pyrophyllite (10 g/L), an Al-bearing phyllosilicate, containing small amounts of structural Fe(III) impurities and 0.8 mM and 3 mM Fe(II) (both natural and enriched in 57Fe) were carried out at pH 7.5 under anaerobic conditions (4% H2 – 96%more » N2 atmosphere). Samples were taken up to 4 weeks for analysis by Fe-X-ray absorption spectroscopy and 57Fe Mössbauer spectroscopy. In addition to the precipitation of Fe(II)-Al(III)-LDH phases as observed in earlier studies with pure minerals (no Fe(III) impurities in the minerals), the analyses indicated formation of small amounts of Fe(III) containing solid(s), most probably hybrid a Fe(II)-Al(III)/Fe(III)-LDH phase. The mechanism of Fe(II) oxidation was not apparent but most likely was due to interfacial electron transfer from the sorbed Fe(II) to the structural Fe(III) and/or surface-sorption-induced electron-transfer from the sorbed Fe(II) to the clay lattice. Increase in the Fe(II)/Al ratio of the LDH with reaction time further indicated the complex nature of the samples. This research provides evidence for the formation of both Fe(II)-Al(III)-LDH and Fe(II)-Fe(III)/Al(III)-LDH-like phases during reactions of Fe(II) in systems that mimic the natural environments. Better understanding Fe phase formation in complex laboratory studies will improve models of natural redox systems.« less

Memo, "Incorporation of HLW Glass Shell V2.0 into the Flowsheets," to ED Lee, CCN: 184905, October 20, 2009

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

Gimpel, Rodney F.; Kruger, Albert A.

2013-12-18

Efforts are being made to increase the efficiency and decrease the cost of vitrifying radioactive waste stored in tanks at the U.S. Department of Energy Hanford Site. The compositions of acceptable and processable high-level waste (HL W) glasses need to be optimized to minimize the waste-form volume and, hence, to reduce cost. A database of glass properties of waste glass and associated simulated waste glasses was collected and documented in PNNL 18501, Glass Property Data and Models for Estimating High-Level Waste Glass Volume and glass property models were curve-fitted to the glass compositions. A routine was developed that estimates HLmore » W glass volumes using the following glass property models: II Nepheline, II One-Percent Crystal Temperature (T1%), II Viscosity (11) II Product Consistency Tests (PCT) for boron, sodium, and lithium, and II Liquidus Temperature (TL). The routine, commonly called the HL W Glass Shell, is presented in this document. In addition to the use of the glass property models, glass composition constraints and rules, as recommend in PNNL 18501 and in other documents (as referenced in this report) were incorporated. This new version of the HL W Glass Shell should generally estimate higher waste loading in the HL W glass than previous versions.« less

A Science Plan for a Comprehensive Regional Assessment of the Atlantic Coastal Plain Aquifer System in Maryland

USGS Publications Warehouse

Shedlock, Robert J.; Bolton, David W.; Cleaves, Emery T.; Gerhart, James M.; Nardi, Mark R.

2007-01-01

The Maryland Coastal Plain region is, at present, largely dependent upon ground water for its water supply. Decades of increasing pumpage have caused ground-water levels in parts of the Maryland Coastal Plain to decline by as much as 2 feet per year in some areas of southern Maryland. Continued declines at this rate could affect the long-term sustainability of ground-water resources in Maryland's heavily populated Coastal Plain communities and the agricultural industry of the Eastern Shore. In response to a recommendation in 2004 by the Advisory Committee on the Management and Protection of the State's Water Resources, the Maryland Geological Survey and the U.S. Geological Survey have developed a science plan for a comprehensive assessment that will provide new scientific information and new data management and analysis tools for the State to use in allocating ground water in the Coastal Plain. The comprehensive assessment has five goals aimed at improving the current information and tools used to understand the resource potential of the aquifer system: (1) document the geologic and hydrologic characteristics of the aquifer system in the Maryland Coastal Plain and appropriate areas of adjacent states; (2) conduct detailed studies of the regional ground-water-flow system and water budget for the aquifer system; (3) improve documentation of patterns of water quality in all Coastal Plain aquifers, including the distribution of saltwater; (4) enhance ground-water-level, streamflow, and water-quality-monitoring networks in the Maryland Coastal Plain; and (5) develop science-based tools to facilitate sound management of the ground-water resources in the Maryland Coastal Plain. The assessment, as designed, will be conducted in three phases and if fully implemented, is expected to take 7 to 8 years to complete. Phase I, which was initiated in January 2006, is an effort to assemble all the information and investigation tools needed to do a more comprehensive assessment of the aquifer system. The work will include updating the hydrogeologic framework, developing a Geographic Information System-based aquifer information system, refinement of water-use information, assessment of existing water-quality data, and development of detailed plans for ground-water-flow and management models. Phase II is an intensive study phase during which a regional ground-water-flow model will be developed and calibrated for the entire region of Maryland in the Atlantic Coastal Plain as well as appropriate areas of Delaware and Virginia. The model will be used to simulate flow and water levels in the aquifer system and to study the water budget of the system. The model analysis will be based on published information but will be supplemented with field investigations of recharge and leakage in the aquifer system. Localized and finely discretized ground-water-flow models that are embedded in the regional model will be developed for selected areas of heavy withdrawals. Other modeling studies will be conducted to better understand flow in the unconfined parts of the aquifer system and to support the recharge studies. Phase II will also include selected water-quality studies and a study to determine how hydrologic and water-quality-monitoring networks need to be enhanced to appropriately assess the sustainability of the Coastal Plain aquifer system. Phase III will be largely devoted to the development and application of a ground-water optimization model. This model will be linked to the ground-water-flow model to create a model package that can be used to test different water-management scenarios. The management criteria that will be used to develop these scenarios will be determined in consultation with a variety of state and local stakeholders and policy makers in Phases I and II of the assessment. The development of the aquifer information system is a key component of the assessment. The system will store all relevant aquifer data

Anal Cancer: An Examination of Radiotherapy Strategies

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

Glynne-Jones, Rob; Lim, Faye

2011-04-01

The Radiation Therapy Oncology Group 9811, ACCORD-03, and ACT II Phase III trials in anal cancer showed no benefit for cisplatin-based induction and maintenance chemotherapy, or radiation dose-escalation >59 Gy. This review examines the efficacy and toxicity of chemoradiation (CRT) in anal cancer, and discusses potential alternative radiotherapy strategies. The evidence for the review was compiled from randomized and nonrandomized trials of radiation therapy and CRT. A total of 103 retrospective/observational studies, 4 Phase I/II studies, 16 Phase II prospective studies, 2 randomized Phase II studies, and 6 Phase III trials of radiotherapy or chemoradiation were identified. There are nomore » meta-analyses based on individual patient data. A 'one-size-fits-all' approach for all stages of anal cancer is inappropriate. Early T1 tumors are probably currently overtreated, whereas T3/T4 lesions might merit escalation of treatment. Intensity-modulated radiotherapy or the integration of biological therapy may play a role in future.« less

Internment of Japanese Americans. Documents from the National Archives Series.

ERIC Educational Resources Information Center

National Archives and Records Administration, Washington, DC.

This booklet provides samples of documents relating to the internment of some 122,000 Japanese Americans during World War II by Executive Order 9066. The documents cover the time span from the Executive Order in 1942 to 1988 when the U.S. government formally acknowledged the injustice of the internment and provided restitution to the victims. The…

Requirements Analysis Study for Master Pump Shutdown System Project Development Specification [SEC 1 and 2

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

BEVINS, R.R.

This study is a requirements document that presents analysis for the functional description for the master pump shutdown system. This document identifies the sources of the requirements and/or how these were derived. Each requirement is validated either by quoting the source or an analysis process involving the required functionality, performance characteristics, operations input or engineering judgment. The requirements in this study apply to the first phase of the W314 Project. This document has been updated during the definitive design portion of the first phase of the W314 Project to capture additional software requirements and is planned to be updated duringmore » the second phase of the W314 Project to cover the second phase of the project's scope.« less

Group II metabotropic glutamate receptor activation attenuates peripheral sensitization in inflammatory states

PubMed Central

Du, Junhui; Zhou, Shengtai; Carlton, Susan M.

2008-01-01

Several lines of evidence indicate that Group II metabotropic glutamate receptor (mGluR) activation can depress sensory transmission. We have reported the expression of Group II mGluRs on unmyelinated axons, many of which were presumed to be nociceptors, in the rat digital nerve (Carlton et al., 2001b). The goals of the present study are to further our understanding of Group II modulation of nociceptor processing in the periphery, documenting behavioral changes using inflammatory models and documenting, for the first time, cutaneous single fiber activity following exposure to a Group II agonist (2R,4R)-4-aminopyrrolidine-2,4-dicarboxylate (APDC) and antagonist LY341495 (LY). The data indicate that peripheral Group II mGluR activation does not depress nociceptive behaviors or nociceptor fiber responses in the non-sensitized state (i.e. following brief nociceptive mechanical or thermal stimulation) but can depress these responses when nociceptors are sensitized by exposure to formalin or inflammatory soup. Group II mGluR agonist-induced inhibition can be blocked by a selective Group II antagonist. Peripheral Group II mGluR-induced inhibition evoked in these studies occurs through activation of local receptors and not through spinal or supraspinal mechanisms. The data indicate that administration of selective Group II agonists may be potent therapeutic agents for prevention of peripheral sensitization and for treatment of inflammatory pain. PMID:18487022

Structures and phase transitions in a new ferroelectric -- pyridinium chlorochromate -- studied by X-ray diffraction, DSC and dielectric methods.

PubMed

Małuszyńska, Hanna; Czarnecki, Piotr; Czarnecka, Anna; Pająk, Zdzisław

2012-04-01

Pyridinium chlorochromate, [C(5)H(5)NH](+)[ClCrO(3)](-) (hereafter referred to as PyClCrO(3)), was studied by X-ray diffraction, differential scanning calorimetry (DSC) and dielectric methods. Studies reveal three reversible phase transitions at 346, 316 and 170 K with the following phase sequence: R ̅3m (I) → R3m (II) → Cm (III) → Cc (IV), c' = 2c. PyClCrO(3) is the first pyridinium salt in which all four phases have been successfully characterized by a single-crystal X-ray diffraction method. Structural results together with dielectric and calorimetric studies allow the classification of the two intermediate phases (II) and (III) as ferroelectric with the Curie point at 346 K, and the lowest phase (IV) as most probably ferroelectric. The ferroelectric hysteresis loop was observed only in phase (III). The high ionic conductivity hindered its observation in phase (II).

Connected Vehicle Pilot Deployment Program phase 1 : deployment readiness summary : New York City : final report.

DOT National Transportation Integrated Search

2016-09-09

This document describes the Deployment Readiness Summary for the New York City (NYC) Connected Vehicle Pilot Deployment (CVPD) Project. It demonstrates the completion of Task 1-12 deliverables of Phase 1 by the NYC team. The document also addresses h...

40 CFR 300.315 - Phase IV-Documentation and cost recovery.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 28 2014-07-01 2014-07-01 false Phase IV-Documentation and cost recovery. 300.315 Section 300.315 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS NATIONAL OIL AND HAZARDOUS SUBSTANCES...

40 CFR 300.315 - Phase IV-Documentation and cost recovery.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 29 2013-07-01 2013-07-01 false Phase IV-Documentation and cost recovery. 300.315 Section 300.315 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS NATIONAL OIL AND HAZARDOUS SUBSTANCES...

40 CFR 300.315 - Phase IV-Documentation and cost recovery.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 29 2012-07-01 2012-07-01 false Phase IV-Documentation and cost recovery. 300.315 Section 300.315 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SUPERFUND, EMERGENCY PLANNING, AND COMMUNITY RIGHT-TO-KNOW PROGRAMS NATIONAL OIL AND HAZARDOUS SUBSTANCES...

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.

Whom and where are we not vaccinating? Coverage after the introduction of a new conjugate vaccine against group A meningococcus in Niger in 2010.

PubMed

Kim, Sung Hye; Pezzoli, Lorenzo; Yacouba, Harouna; Coulibaly, Tiekoura; Djingarey, Mamoudou H; Perea, William A; Wierzba, Thomas F

2012-01-01

MenAfriVac is a new conjugate vaccine against Neisseria meningitidis serogroup A developed for the African "meningitis belt". In Niger, the first two phases of the MenAfriVac introduction campaign were conducted targeting 3,135,942 individuals aged 1 to 29 years in the regions of Tillabéri, Niamey, and Dosso, in September and December 2010. We evaluated the campaign and determined which sub-populations or areas had low levels of vaccination coverage in the regions of Tillabéri and Niamey. After Phase I, conducted in the Filingué district, we estimated coverage using a 30×15 cluster-sampling survey and nested lot quality assurance (LQA) analysis in the clustered samples to identify which subpopulations (defined by age 1-14/15-29 and sex) had unacceptable vaccination coverage (<70%). After Phase II, we used Clustered Lot Quality Assurance Sampling (CLQAS) to assess if any of eight districts in Niamey and Tillabéri had unacceptable vaccination coverage (<75%) and estimated overall coverage. Estimated vaccination coverage was 77.4% (95%CI: 84.6-70.2) as documented by vaccination cards and 85.5% (95% CI: 79.7-91.2) considering verbal history of vaccination for Phase I; 81.5% (95%CI: 86.1-77.0) by card and 93.4% (95% CI: 91.0-95.9) by verbal history for Phase II. Based on vaccination cards, in Filingué, we identified both the male and female adult (age 15-29) subpopulations as not reaching 70% coverage; and we identified three (one in Tillabéri and two in Niamey) out of eight districts as not reaching 75% coverage confirmed by card. Combined use of LQA and cluster sampling was useful to estimate vaccination coverage and to identify pockets with unacceptable levels of coverage (adult population and three districts). Although overall vaccination coverage was satisfactory, we recommend continuing vaccination in the areas or sub-populations with low coverage and reinforcing the social mobilization of the adult population.

IDC Re-Engineering Phase 2 System Specification Document Version 1.5

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

Satpathi, Meara Allena; Burns, John F.; Harris, James M.

This document contains the system specifications derived to satisfy the system requirements found in the IDC System Requirements Document for the IDC Re-Engineering Phase 2 project. This System Specification Document (SSD) defines waveform data processing requirements for the International Data Centre (IDC) of the Comprehensive Nuclear Test Ban Treaty Organization (CTBTO). The routine processing includes characterization of events with the objective of screening out events considered to be consistent with natural phenomena or non-nuclear, man-made phenomena. This document does not address requirements concerning acquisition, processing and analysis of radionuclide data but does include requirements for the dissemination of radionuclide datamore » and products.« less

The Systems Approach to Functional Job Analysis. Task Analysis of the Physician's Assistant: Volume II--Curriculum and Phase I Basic Core Courses and Volume III--Phases II and III--Clinical Clerkships and Assignments.

ERIC Educational Resources Information Center

Wake Forest Univ., Winston Salem, NC. Bowman Gray School of Medicine.

This publication contains a curriculum developed through functional job analyses for a 24-month physician's assistant training program. Phase 1 of the 3-phase program is a 6-month basic course program in clinical and bioscience principles and is required of all students regardless of their specialty interest. Phase 2 is a 6 to 10 month period of…

47 CFR 90.765 - Licenses term for Phase II licenses.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide...(a), EA and Regional licenses authorized pursuant to § 90.761, and non-nationwide licenses authorized...

47 CFR 90.765 - Licenses term for Phase II licenses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide...(a), EA and Regional licenses authorized pursuant to § 90.761, and non-nationwide licenses authorized...

Planning Targets for Phase II Watershed Implementation Plans

EPA Pesticide Factsheets

On August 1, 2011, EPA provided planning targets for nitrogen, phosphorus and sediment for the Phase II Watershed Implementation Plans (WIPs) of the Chesapeake Bay TMDL. This page provides the letters containing those planning targets.

Sears Point Tidal Marsh Restoration Project: Phase II

EPA Pesticide Factsheets

Information about the SFBWQP Sears Point Tidal Marsh Restoration Project: Phase II, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic resources.

Nintedanib (OFEV) in the treatment of idiopathic pulmonary fibrosis.

PubMed

Fukihara, Jun; Kondoh, Yasuhiro

2016-12-01

Nintedanib is a new anti-fibrosis agent that is an intracellular tyrosine kinase inhibitor targeting platelet derived growth factor receptor, fibroblast growth factor receptor and vascular endothelial growth factor receptor. Although nintedanib is attracting much attention as a new treatment option for patients with idiopathic pulmonary fibrosis (IPF), the clinical evidence is limited mainly to the results from the dose-deciding phase II TOMORROW trial and phase III INPULSIS trials, which evaluated efficacy and safety of nintedanib for patients with IPF, prespecified subgroup analyses, pooled analyses and meta-analyses derived from those trials. Areas covered: In this document, we mainly reviewed reports on working mechanisms of nintedanib, and efficacy and safety of nintedanib for patients with IPF. The literature search was undertaken using Pub Med. Expert commentary: It is unknown whether the efficacy of nintedanib in patients enrolled in the clinical trials will be the same for the entire spectrum of patients, including patients unfit for the clinical trials due to age, severity, timing of IPF diagnosis or diagnosis of interstitial pneumonias other than IPF. Sufficient consideration should be given when selecting candidates for nintedanib in the real world.

Dental and skeletal changes in patients with mandibular retrognathism following treatment with Herbst and pre-adjusted fixed appliance

PubMed Central

Vigorito, Fabio de Abreu; Dominguez, Gladys Cristina; Aidar, Luís Antônio de Arruda

2014-01-01

Objective To assess the dentoskeletal changes observed in treatment of Class II, division 1 malocclusion patients with mandibular retrognathism. Treatment was performed with the Herbst orthopedic appliance during 13 months (phase I) and pre-adjusted orthodontic fixed appliance (phase II). Methods Lateral cephalograms of 17 adolescents were taken in phase I onset (T1) and completion (T2); in the first thirteen months of phase II (T3) and in phase II completion (T4). Differences among the cephalometric variables were statistically analyzed (Bonferroni variance and multiple comparisons). Results From T1 to T4, 42% of overall maxillary growth was observed between T1 and T2 (P < 0.01), 40.3% between T2 and T3 (P < 0.05) and 17.7% between T3 and T4 (n.s.). As for overall mandibular movement, 48.2% was observed between T1 and T2 (P < 0.001) and 51.8% between T2 and T4 (P < 0.01) of which 15.1% was observed between T2 and T3 (n.s.) and 36.7% between T3 and T4 (P < 0.01). Class II molar relationship and overjet were properly corrected. The occlusal plane which rotated clockwise between T1 and T2, returned to its initial position between T2 and T3 remaining stable until T4. The mandibular plane inclination did not change at any time during treatment. Conclusion Mandibular growth was significantly greater in comparison to maxillary, allowing sagittal maxillomandibular adjustment. The dentoalveolar changes (upper molar) that overcorrected the malocclusion in phase I, partially recurred in phase II, but did not hinder correction of the malocclusion. Facial type was preserved. PMID:24713559

Preconcentration of trace lead and iron on activated carbon functionalized by o-Anisic acid derivatives prior to their determination in environmental samples.

PubMed

Tian, Hua; Hu, Zheng; He, Qun; Liu, Xueliang; Zhang, Li; Chang, Xijun

2012-07-01

Two solid-phase adsorbents (phase I and phase II) were synthesized successfully that o-Anisic acid derivatives were evenly functionalized on the surface of activated carbon. It was certified that the two adsorbents were applied to preconcentrate and separate trace levels of Pb(II) and Fe(III) from natural liquid samples with satisfactory results. It can be found that the adsorption capacity of the ions adsorbed on phase I and phase II was 48.3 and 85.7 mg g(-1) for Pb(II), 39.5 and 72.5 mg g(-1) for Fe(III), respectively. The detection limit (3σ) of the method separated on phase I and phase II was 0.12 and 0.09 ng mL(-1) for Pb(II), 0.23 and 0.17 ng mL(-1) for Fe(III), respectively. The relative standard deviation (R.S.D.) of the method was lower than 3.0%. The adsorption and desorption property of two kinds of adsorbents was comparatively studied, respectively. The adsorption selectivity of heavy metal ions at certain pH, the adsorption kinetics, the condition of complete elution, the effect of coexisting ions, the adsorption capacity and adsorption isotherm modes were examined. Based on the experimental datum determined by inductively coupled plasma optical emission spectrometry (ICP-OES), it was certified that the adsorption on the surface of adsorbents was in strict accordance with the monolayer adsorption principle. The structural features of series of multidentate ligand modified on adsorption matrix had been obtained. These conclusions can provide reference for synthesizing an efficient adsorbent which is specific to remove a particular kind of contaminant. Copyright © 2012 Elsevier B.V. All rights reserved.

US/UK Loan Account Project Status PMOD477

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

Stevens, Patrice A.

2012-07-12

The viewgraphs describe the status of PMOD477 for LANL. The meeting will occur at DOE-HQ with NA-11 and Military Applications personnel in attendance. Serves to repatriate material with a balance to zero by December 2012. Phase 1 -- Establish formality of operations for War Reserve (WR): Complete surrogate taskings to A90 through a Materials Channel and perform US/UK lessons learned; Complete the US/UK agreed Quality Acceptance Plan, Materials Plan, Shipping procedure, and establish the formal UK/US point of contacts. Phase 2 -- Metal Manufacture (WR): Process material and store material as electrorefined metal (ER) rings, with initial assay and isotopicmore » analysis, prior to manufacturing. Material is cast into accepted configuration and appropriate acceptance document for each aliquot will be generated. Phase 3 -- Intermediate Material Manufacture, Packaging and Shipping (WR): Continue processing of the material in accepted configuration with appropriate acceptance documentation for each aliquot. Provide an initial tasking of the material owed to UK including appropriate quality acceptance documentation. Phase 4 -- Complete Tasking (WR). Phase 5 -- Residue Processing (Non-WR): Complete processing of residue material and waste into accepted configuration with appropriate acceptance document for disposal.« less

Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.

PubMed

Lee, Cindy; Vather, Ryash; O'Callaghan, Anne; Robinson, Jackie; McLeod, Briar; Findlay, Michael; Bissett, Ian

2013-12-01

Malignant bowel obstruction (MBO) is common in patients with advanced cancer. To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.

Chronic Iron Limitation Confers Transient Resistance to Oxidative Stress in Marine Diatoms.

PubMed

Graff van Creveld, Shiri; Rosenwasser, Shilo; Levin, Yishai; Vardi, Assaf

2016-10-01

Diatoms are single-celled, photosynthetic, bloom-forming algae that are responsible for at least 20% of global primary production. Nevertheless, more than 30% of the oceans are considered "ocean deserts" due to iron limitation. We used the diatom Phaeodactylum tricornutum as a model system to explore diatom's response to iron limitation and its interplay with susceptibility to oxidative stress. By analyzing physiological parameters and proteome profiling, we defined two distinct phases: short-term (<3 d, phase I) and chronic (>5 d, phase II) iron limitation. While at phase I no significant changes in physiological parameters were observed, molecular markers for iron starvation, such as Iron Starvation Induced Protein and flavodoxin, were highly up-regulated. At phase II, down-regulation of numerous iron-containing proteins was detected in parallel to reduction in growth rate, chlorophyll content, photosynthetic activity, respiration rate, and antioxidant capacity. Intriguingly, while application of oxidative stress to phase I and II iron-limited cells similarly oxidized the reduced glutathione (GSH) pool, phase II iron limitation exhibited transient resistance to oxidative stress, despite the down regulation of many antioxidant proteins. By comparing proteomic profiles of P. tricornutum under iron limitation and metatranscriptomic data of an iron enrichment experiment conducted in the Pacific Ocean, we propose that iron-limited cells in the natural environment resemble the phase II metabolic state. These results provide insights into the trade-off between optimal growth rate and susceptibility to oxidative stress in the response of diatoms to iron quota in the marine environment. © 2016 American Society of Plant Biologists. All Rights Reserved.

Evaluation of phase II toxicity identification evaluation methods for freshwater whole sediment and interstitial water.

PubMed

Phillips, Bryn M; Anderson, Brian S; Hunt, John W; Clark, Sara L; Voorhees, Jennifer P; Tjeerdema, Ron S; Casteline, Jane; Stewart, Margaret

2009-02-01

Phase I whole sediment toxicity identification evaluation (TIE) methods have been developed to characterize the cause of toxicity as organic chemicals, metals, or ammonia. In Phase II identification treatments, resins added to whole sediment to reduce toxicity caused by metals and organics can be separated and eluted much like solid-phase extraction (SPE) columns are eluted for interstitial water. In this study, formulated reference sediments spiked with toxic concentrations of copper, fluoranthene, and nonylphenol were subjected to whole sediment and interstitial water TIE treatments to evaluate Phase I and II TIE procedures for identifying the cause of toxicity to Hyalella azteca. Phase I TIE treatments consisted of adding adsorbent resins to whole sediment, and using SPE columns to remove spiked chemicals from interstitial water. Phase II treatments consisted of eluting resins and SPE columns and the preparation and testing of eluates for toxicity and chemistry. Whole sediment resins and SPE columns significantly reduced toxicity, and the eluates from all treatments contained toxic concentrations of the spiked chemical except for interstitial water fluoranthene. Toxic unit analysis based on median lethal concentrations (LC50s) allowed for the comparison of chemical concentrations among treatments, and demonstrated that the bioavailability of some chemicals was reduced in some samples and treatments. The concentration of fluoranthene in the resin eluate closely approximated the original interstitial water concentration, but the resin eluate concentrations of copper and nonylphenol were much higher than the original interstitial water concentrations. Phase II whole sediment TIE treatments provided complementary lines of evidence to the interstitial water TIE results.

Chronic Iron Limitation Confers Transient Resistance to Oxidative Stress in Marine Diatoms1

PubMed Central

Graff van Creveld, Shiri; Rosenwasser, Shilo; Vardi, Assaf

2016-01-01

Diatoms are single-celled, photosynthetic, bloom-forming algae that are responsible for at least 20% of global primary production. Nevertheless, more than 30% of the oceans are considered “ocean deserts” due to iron limitation. We used the diatom Phaeodactylum tricornutum as a model system to explore diatom’s response to iron limitation and its interplay with susceptibility to oxidative stress. By analyzing physiological parameters and proteome profiling, we defined two distinct phases: short-term (<3 d, phase I) and chronic (>5 d, phase II) iron limitation. While at phase I no significant changes in physiological parameters were observed, molecular markers for iron starvation, such as Iron Starvation Induced Protein and flavodoxin, were highly up-regulated. At phase II, down-regulation of numerous iron-containing proteins was detected in parallel to reduction in growth rate, chlorophyll content, photosynthetic activity, respiration rate, and antioxidant capacity. Intriguingly, while application of oxidative stress to phase I and II iron-limited cells similarly oxidized the reduced glutathione (GSH) pool, phase II iron limitation exhibited transient resistance to oxidative stress, despite the down regulation of many antioxidant proteins. By comparing proteomic profiles of P. tricornutum under iron limitation and metatranscriptomic data of an iron enrichment experiment conducted in the Pacific Ocean, we propose that iron-limited cells in the natural environment resemble the phase II metabolic state. These results provide insights into the trade-off between optimal growth rate and susceptibility to oxidative stress in the response of diatoms to iron quota in the marine environment. PMID:27503604

SH-2F LAMPS Instructional Systems Development: Phase II. Final Report.

ERIC Educational Resources Information Center

Gibbons, Andrew S.; Hymes, Jonah P.

This project was one of four aircrew training development projects in a continuing study of the methodology, effectiveness, and resource requirements of the Instructional Systems Development (ISD) process. This report covers the Phase II activities of a two-phase project for the development of aircrew training for SH-2F anti-submarine warfare…

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2013 CFR

2013-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2012 CFR

2012-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2014 CFR

2014-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

An Experimental Evaluation of Hyperactivity and Food Additives. 1977-Phase II.

ERIC Educational Resources Information Center

Harley, J. Preston; And Others

Phase II of a study on the effectiveness of B. Feingold's recommended diet for hyperactive children involved the nine children (mean age 9 years) who had shown the "best" response to diet manipulation in Phase I. Each child served as his own control and was challenged with specified amounts of placebo and artificial color containing food…

Connected vehicle pilot deployment program phase 1 : human use approval summary – Tampa.

DOT National Transportation Integrated Search

2016-07-18

This document presents the Human Use Approval (HUA) Summary for the THEA Connected Vehicle (CV) Pilot Deployment. The purpose of this report is to document the process used by THEA in the Tampa CV Pilot Deployment as required in Phase 1, Task 8 in pr...

The Vocational Education Component of the Rhode Island Educational Management Information System.

ERIC Educational Resources Information Center

Galamaga, Donald P.; Bartolomeo, Paul A.

The document describes the implementation (Phase Two) of the Vocational Educational module--one component of an educational management information system. Phase Two entails the technical effort of final system design, final output specifications, edit specifications, system software selection, computer programing, systems documentation and the…

Job Aids: Descriptive Authoring Flowcharts for Phase II--DESIGN of the Instructional Systems Development Model.

ERIC Educational Resources Information Center

Schulz, Russel E.; Farrell, Jean R.

This resource guide for the use of job aids ("how-to-do-it" guidance) for activities identified in the second phase of the Instructional Systems Development Model (ISD) contains an introduction to the use of job aids, as well as descriptive authoring flowcharts for Blocks II.1 through II.4. The introduction includes definitions;…

Thermal, spectroscopic and structural characterization of isostructural phase transition in 4-hydroxybenzaldehyde

NASA Astrophysics Data System (ADS)

Panicker, Lata

2018-05-01

Polycrystalline samples of 4-hydroxybenzaldehyde (4-HOBAL) were investigated using differential scanning calorimeter (DSC), Raman spectroscopy and X-ray powder diffraction. The DSC data indicated that 4-HOBAL on heating undergoes a polymorphic transformation from polymorph I to polymorph II. The polymorph II formed remains metastable at ambient condition and transforms to polymorph I when annealed at ambient temperature for more than seven days. The structural information of polymorphs I and II obtained using its X-ray powder diffraction patterns indicated that 4-HOBAL undergoes an isostructural phase transition from polymorph I (monoclinic, P21/c) to polymorph II (monoclinic, P21/c). Raman data suggest that this structural change is associated with some change in its molecular interactions. Thus, in 4-HOBAL the polymorphic phase transformation (II to I) even though energetically favoured is kinetically hindered.

Phase I/II Study of Erlotinib Combined With Cisplatin and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

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

Herchenhorn, Daniel, E-mail: herchenhorn@hotmail.co; Dias, Fernando L.; Viegas, Celia M.P.

Purpose: Erlotinib, an oral tyrosine kinase inhibitor, is active against head-and-neck squamous cell carcinoma (HNSCC) and possibly has a synergistic interaction with chemotherapy and radiotherapy. We investigated the safety and efficacy of erlotinib added to cisplatin and radiotherapy in locally advanced HNSCC. Methods and Materials: In this Phase I/II trial 100 mg/m{sup 2} of cisplatin was administered on Days 8, 29, and 50, and radiotherapy at 70 Gy was started on Day 8. During Phase I, the erlotinib dose was escalated (50 mg, 100 mg, and 150 mg) in consecutive cohorts of 3 patients, starting on Day 1 and continuingmore » during radiotherapy. Dose-limiting toxicity was defined as any Grade 4 event requiring radiotherapy interruptions. Phase II was initiated 8 weeks after the last Phase I enrollment. Results: The study accrued 9 patients in Phase I and 28 in Phase II; all were evaluable for efficacy and safety. No dose-limiting toxicity occurred in Phase I, and the recommended Phase II dose was 150 mg. The most frequent nonhematologic toxicities were nausea/vomiting, dysphagia, stomatitis, xerostomia and in-field dermatitis, acneiform rash, and diarrhea. Of the 31 patients receiving a 150-mg daily dose of erlotinib, 23 (74%; 95% confidence interval, 56.8%-86.3%) had a complete response, 3 were disease free after salvage surgery, 4 had inoperable residual disease, and 1 died of sepsis during treatment. With a median 37 months' follow-up, the 3-year progression-free and overall survival rates were 61% and 72%, respectively. Conclusions: This combination appears safe, has encouraging activity, and deserves further studies in locally advanced HNSCC.« less

Preparation and characterization of magnetic nanocomposite of Schiff base/silica/magnetite as a preconcentration phase for the trace determination of heavy metal ions in water, food and biological samples using atomic absorption spectrometry.

PubMed

Bagheri, Hasan; Afkhami, Abbas; Saber-Tehrani, Mohammad; Khoshsafar, Hosein

2012-08-15

A versatile and robust solid phase with both magnetic property and a very high adsorption capacity is presented on the basis of modification of iron oxide-silica magnetic particles with a newly synthesized Schiff base (Fe(3)O(4)/SiO(2)/L). The structure of the resulting product was confirmed by Fourier transform infrared (FT-IR) spectra, X-ray diffraction (XRD) spectrometry and transmission electron microscopy (TEM). We developed an efficient and cost-effective method for the preconcentration of trace amounts of Pb(II), Cd(II) and Cu(II) in environmental and biological samples using this novel magnetic solid phase. Prepared magnetic solid phase is an ideal support because it has a large surface area, good selectivity and can be easily retrieved from large volumes of aqueous solutions. The possible parameters affecting the enrichment were optimized. Under the optimal conditions, the method detection limit was 0.14, 0.19 and 0.12 μg L(-1) for Pb(II), Cd(II) and Cu(II) ions, respectively. The established method has been successfully applied to analyze real samples, and satisfactory results were obtained. All these indicated that this magnetic phase had a great potential in environmental and biological fields. Copyright © 2012 Elsevier B.V. All rights reserved.

Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer.

PubMed

Lee, Keun-Wook; Lee, Kyung Hee; Zang, Dae Young; Park, Young Iee; Shin, Dong Bok; Kim, Jin Won; Im, Seock-Ah; Koh, Sung Ae; Yu, Kyung-Sang; Cho, Joo-Youn; Jung, Jin-A; Bang, Yung-Jue

2015-08-01

Oraxol consists of paclitaxel and HM30181A, a P-glycoprotein inhibitor, to increase the oral bioavailability of paclitaxel. This phase I/II study (HM-OXL-201) was conducted to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Oraxol. In addition, we investigated the efficacy and safety of Oraxol as second-line chemotherapy for metastatic or recurrent gastric cancer (GC). In the phase I component, paclitaxel was orally administered at escalating doses (90, 120, or 150 mg/m(2) per day) with a fixed dose (15 mg/day) of HM30181A. Oraxol was administrated 6 times per cycle (days 1, 2, 8, 9, 15, and 16) every 4 weeks. In the phase II component, the efficacy and safety of Oraxol were evaluated. In the phase I component, the MTD could not be determined. Based on toxicity and pharmacokinetic data, the RP2D of oral paclitaxel was determined to be 150 mg/m(2). In the phase II component, 4 of 43 patients (9.3%) achieved partial responses. Median progression-free survival and overall survival were 2.6 and 10.7 months, respectively. Toxicity profiles were favorable, and the most common drug-related adverse events (grade ≥3) were neutropenia and diarrhea. Oraxol exhibited modest efficacy and favorable toxicity profiles as second-line chemotherapy for GC. ©AlphaMed Press; the data published online to support this summary is the property of the authors.

Growth-differentiation factor-15, endoglin and N-terminal pro-brain natriuretic peptide induction in athletes participating in an ultramarathon foot race.

PubMed

Tchou, Isabelle; Margeli, Alexandra; Tsironi, Maria; Skenderi, Katerina; Barnet, Marc; Kanaka-Gantenbein, Christina; Papassotiriou, Ioannis; Beris, Photis

2009-09-01

We investigated the actions of growth-differentiation factor (GDF)-15, endoglin and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) in 15 male athletes who participated in the ultradistance foot race of the 246 km 'Sparthathlon'. Measurements were performed before (phase I), at the end of the race (phase II) and 48 h post-race (phase III). GDF-15 and endoglin serum concentrations were determined with enzyme-linked immunosorbent assay and NT-pro-BNP plasma levels by electrochemiluminescence. GDF-15 levels were increased from phase I (563.9 +/- 57.1 pg ml(-1)) to phase II (2311.1 +/- 462.3 pg ml(-1)) and decreased at phase III (862.0 +/- 158.0 pg ml(-1)) (p < 0.0002). NT-pro-BNP levels followed a similar pattern to that of GDF-15 from 38.1 +/- 4.8 pg ml(-1) at phase I to 1280.6 +/- 259.0 pg ml(-1) at phase II and 89.8 +/- 13.6 pg ml(-1) at phase III (p < 0.0001) and at the same time points, endoglin levels were 4.7 +/- 0.2 ng ml(-1) at phase I, 5.8 +/- 0.2 ng ml(-1) at phase II and 4.3 +/- 0.2 ng ml(-1) at phase III (p < 0.002). These findings indicate that circulating GDF-15, endoglin and NT-pro-BNP levels reflect a transient endothelial dysfunction in these athletes who participated in a foot race consisting of continuous, prolonged and brisk exercise.

South Bay Salt Pond Restoration, Phase II at Ravenswood

EPA Pesticide Factsheets

Information about the South Bay Salt Pond Restoration Project: Phase II Construction at Ravenswood, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic resources.

Carbon footprint estimator, phase II : volume II - technical appendices.

DOT National Transportation Integrated Search

2014-03-01

The GASCAP model was developed to provide a software tool for analysis of the life-cycle GHG : emissions associated with the construction and maintenance of transportation projects. This phase : of development included techniques for estimating emiss...

Morristown Alternative Transportation Study Phase II.

DOT National Transportation Integrated Search

2005-10-14

This report summarizes the Phase II planning effort conducted by the park and the US Department of Transportation's Volpe Center (the Volpe Center) to articulate a viable park-community pilot transit service for Morristown National Historical Park. M...

The topological pressure-temperature phase diagram of ritonavir, an extraordinary case of crystalline dimorphism.

PubMed

Céolin, R; Rietveld, I B

2015-01-01

A topological pressure-temperature phase diagram involving the phase relationships of ritonavir forms I and II has been constructed using experimental calorimetric and volumetric data available from the literature. The triple point I-II-liquid is located at a temperature of about 407 K and a pressure as extraordinarily small as 17.5 MPa (175 bar). Thus, the less soluble solid phase (form II) will become metastable on increasing pressure. At room temperature, form I becomes stable around 100 MPa indicating that form II may turn into form I at a relatively low pressure of 1000 bar, which may occur under processing conditions such as mixing or grinding. This case is a good example for which a proper thermodynamic evaluation trumps "rules of thumb" such as the density rule. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Detailed validation of the bidirectional effect in various Case I and Case II waters.

PubMed

Gleason, Arthur C R; Voss, Kenneth J; Gordon, Howard R; Twardowski, Michael; Sullivan, James; Trees, Charles; Weidemann, Alan; Berthon, Jean-François; Clark, Dennis; Lee, Zhong-Ping

2012-03-26

Simulated bidirectional reflectance distribution functions (BRDF) were compared with measurements made just beneath the water's surface. In Case I water, the set of simulations that varied the particle scattering phase function depending on chlorophyll concentration agreed more closely with the data than other models. In Case II water, however, the simulations using fixed phase functions agreed well with the data and were nearly indistinguishable from each other, on average. The results suggest that BRDF corrections in Case II water are feasible using single, average, particle scattering phase functions, but that the existing approach using variable particle scattering phase functions is still warranted in Case I water.

Mechanochemical induced structural changes in sucrose using the rotational diamond anvil cell

NASA Astrophysics Data System (ADS)

Ciezak-Jenkins, Jennifer A.; Jenkins, Timothy A.

2018-02-01

The response of sucrose to high-pressure and shear conditions has been studied in a rotational diamond anvil cell. Previous experiments conducted by Bridgman and Teller showed divergent behavior in regard to the existence of a rheological explosion under mechanochemical stimuli. Raman spectroscopy confirmed the existence of the isostructural Phase I to Phase II transition near 5 GPa. When subjected to high-pressure and shear, Raman spectra of Phase I showed evidence that while the sucrose molecule underwent significant molecular deformation, there was no evidence of a complete chemical reaction. In contrast, Phase II showed a near-total loss of the in-situ Raman signal in response to shear, suggesting the onset of amorphization or decomposition. The divergent behaviors of Phase I and Phase II are examined in light of the differences in the hydrogen bonding and plasticity of the material.

40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

Code of Federal Regulations, 2011 CFR

2011-07-01

... transformation; (v) The date on which the class II controlled substances were imported; (vi) The port of entry.... Customs entry form; (xiv) Dated records documenting the sale or transfer of class II controlled substances... source facility; (vii) The U.S. port of entry for the import, the expected date of shipment and the...

40 CFR 82.24 - Recordkeeping and reporting requirements for class II controlled substances.

Code of Federal Regulations, 2014 CFR

2014-07-01

... transformation; (v) The date on which the class II controlled substances were imported; (vi) The port of entry.... Customs entry form; (xiv) Dated records documenting the sale or transfer of class II controlled substances... source facility; (vii) The U.S. port of entry for the import, the expected date of shipment and the...

Managing Information Technology: Facing the Issues. Track II: Funding and Accountability Issues.

ERIC Educational Resources Information Center

CAUSE, Boulder, CO.

Eight papers making up Track II of the 1989 conference of the Professional Association for the Management of Information Technology in Higher Education (known as CAUSE, an acronym for the association's former name) are presented in this document. The focus of Track II is on funding and accountability issues, and the papers include: "A…

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

In vitro enzymatic reduction kinetics of mineral oxides by membrane fractions from Shewanella oneidensis MR-1

NASA Astrophysics Data System (ADS)

Ruebush, Shane S.; Icopini, Gary A.; Brantley, Susan L.; Tien, Ming

2006-01-01

This study documents the first example of in vitro solid-phase mineral oxide reduction by enzyme-containing membrane fractions. Previous in vitro studies have only reported the reduction of aqueous ions. Total membrane (TM) fractions from iron-grown cultures of Shewanella oneidensis MR-1 were isolated and shown to catalyze the reduction of goethite, hematite, birnessite, and ramsdellite/pyrolusite using formate. In contrast, nicotinamide adenine dinucleotide (NADH) and succinate cannot function as electron donors. The significant implications of observations related to this cell-free system are: (i) both iron and manganese mineral oxides are reduced by the TM fraction, but aqueous U(VI) is not; (ii) TM fractions from anaerobically grown, but not aerobically grown, cells can reduce the mineral oxides; (iii) electron shuttles and iron chelators are not needed for this in vitro reduction, documenting conclusively that reduction can occur by direct contact with the mineral oxide; (iv) electron shuttles and EDTA stimulate the in vitro Fe(III) reduction, documenting that exogenous molecules can enhance rates of enzymatic mineral reduction; and (v) multiple membrane components are involved in solid-phase oxide reduction. The membrane fractions, consisting of liposomes of cytoplasmic and outer membrane segments, contain at least 100 proteins including the enzyme that oxidizes formate, formate dehydrogenase. Mineral oxide reduction was inhibited by the addition of detergent Triton X-100, which solubilizes membranes and their associated proteins, consistent with the involvement of multiple electron carriers that are disrupted by detergent addition. In contrast, formate dehydrogenase activity was not inhibited by Triton X-100. The addition of anthraquinone-2,6-disulfonate (AQDS) and menaquinone-4 was unable to restore activity; however, menadione (MD) restored 33% of the activity. The addition of AQDS and MD to reactions without added detergent increased the rate of goethite reduction. The Michaelis-Menten Km values of 71 ± 22 m 2/L for hematite and 50 ± 16 m 2/L for goethite were calculated as a function of surface area of the two insoluble minerals. Vmax was determined to be 123 ± 14 and 156 ± 13 nmol Fe(II)/min/mg of TM protein for hematite and goethite, respectively. These values are consistent with in vivo rates of reduction reported in the literature. These observations are consistent with our conclusion that the enzymatic reduction of mineral oxides is an effective probe that will allow elucidation of molecular chemistry of the membrane-mineral interface where electron transfer occurs.

Corals Use Similar Immune Cells and Wound-Healing Processes as Those of Higher Organisms

PubMed Central

Palmer, Caroline V.; Traylor-Knowles, Nikki G.; Willis, Bette L.; Bythell, John C.

2011-01-01

Sessile animals, like corals, frequently suffer physical injury from a variety of sources, thus wound-healing mechanisms that restore tissue integrity and prevent infection are vitally important for defence. Despite the ecological importance of reef-building corals, little is known about the cells and processes involved in wound healing in this group or in phylogenetically basal metazoans in general. A histological investigation into wound healing of the scleractinian coral Porites cylindrica at 0 h, 6 h, 24 h and 48 h after injury revealed differences in cellular components between injured and healthy tissues. Cell counts of the obligate endosymbiont, Symbiodinium, and melanin volume fraction analysis revealed rapid declines in both Symbiodinium abundance and tissue cross-sectional area occupied by melanin-containing granular cells after injury. Four phases of wound healing were identified, which are similar to phases described for both vertebrates and invertebrates. The four phases included (i) plug formation via the degranulation of melanin-containing granular cells; (ii) immune cell infiltration (inflammation); (iii) granular tissue formation (proliferation); and (iv) maturation. This study provides detailed documentation of the processes involved in scleractinian wound healing for the first time and further elucidates the roles of previously-described immune cells, such as fibroblasts. These results demonstrate the conservation of wound healing processes from anthozoans to humans. PMID:21887359

Establishing a good dentist-patient relationship: skills defined from the dental faculty perspective.

PubMed

Orsini, Cesar A; Jerez, Oscar M

2014-10-01

The importance of developing good dentist-patient relationships has been well documented, but previous studies have focused on social techniques, not considering the psychological and behavioral characteristics of patients, and have used definitions and instruments that were not dental-specific. Therefore, the aims of this study were to propose a definition of dentist-patient relationship skills, derived from dental faculty members' criteria and informed by Emotional Intelligence concepts, and to propose a preliminary dental-specific, face-valid, and reliable self-assessment instrument. The study was conducted in three phases. Phases I and II defined dentist-patient relationship competence through literature analysis and semi-structured interviews with expert key informants, establishing the outcome skills. In Phase III, the instrument was constructed and piloted. Communication skills and basic psychological tools resulted in core topics for use in practice. The definition both specifies and broadens social interactions in dentistry by including dental faculty members' criteria and topics such as psychological tools and pre-, intra-, and postoperative topics appropriate for use during consultation, examination, and treatment. The instrument was found suitable, reasonable, and accessible with a Cronbach's alpha level of 0.95. Future studies are needed to confirm the definition, as well as the instrument's validity, reliability, transference, and sensitivity to the dental educational environment.

12 CFR 217.122 - Qualification requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... related processes; (ii) Have and document a process (which must capture business environment and internal... current business activities, risk profile, technological processes, and risk management processes; and (ii... assessment systems. (D) Business environment and internal control factors. The Board-regulated institution...

12 CFR 324.122 - Qualification requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... related processes; (ii) Have and document a process (which must capture business environment and internal... current business activities, risk profile, technological processes, and risk management processes; and (ii... assessment systems. (D) Business environment and internal control factors. The FDIC-supervised institution...

Our Documents: A National Initiative on American History, Civics, and Service. Teacher Sourcebook, Volume II

ERIC Educational Resources Information Center

Mazzenga, Maria, Ed.; McCullough, Julie, Ed.

2003-01-01

What do Matthew Brady, Carrie Chapman Catt, Ansel Adams, Orson Welles, and J. Howard Miller have to do with the 100 milestone documents? A few hints: Matthew Brady created the first photographic documentation of a war. Carrie Chapman Catt was the president of the National American Woman Suffrage Association in 1920. Orson Welles produced plays for…

38 CFR 17.501 - Confidential and privileged documents.

Code of Federal Regulations, 2012 CFR

2012-07-01

... facility: (i) Medical records reviews, (ii) Drug usage evaluations, (iii) Blood usage reviews, (iv... quality assurance reviews. (e) Documents which are confidential and privileged may be in written, computer... of Boards of Investigations; (5) Completed patient satisfaction survey questionnaires and findings...

38 CFR 17.501 - Confidential and privileged documents.

Code of Federal Regulations, 2014 CFR

2014-07-01

... facility: (i) Medical records reviews, (ii) Drug usage evaluations, (iii) Blood usage reviews, (iv... quality assurance reviews. (e) Documents which are confidential and privileged may be in written, computer... of Boards of Investigations; (5) Completed patient satisfaction survey questionnaires and findings...

38 CFR 17.501 - Confidential and privileged documents.

Code of Federal Regulations, 2010 CFR

2010-07-01

... facility: (i) Medical records reviews, (ii) Drug usage evaluations, (iii) Blood usage reviews, (iv... quality assurance reviews. (e) Documents which are confidential and privileged may be in written, computer... of Boards of Investigations; (5) Completed patient satisfaction survey questionnaires and findings...

38 CFR 17.501 - Confidential and privileged documents.

Code of Federal Regulations, 2011 CFR

2011-07-01

... facility: (i) Medical records reviews, (ii) Drug usage evaluations, (iii) Blood usage reviews, (iv... quality assurance reviews. (e) Documents which are confidential and privileged may be in written, computer... of Boards of Investigations; (5) Completed patient satisfaction survey questionnaires and findings...

38 CFR 17.501 - Confidential and privileged documents.

Code of Federal Regulations, 2013 CFR

2013-07-01

... facility: (i) Medical records reviews, (ii) Drug usage evaluations, (iii) Blood usage reviews, (iv... quality assurance reviews. (e) Documents which are confidential and privileged may be in written, computer... of Boards of Investigations; (5) Completed patient satisfaction survey questionnaires and findings...

7 CFR 2.90 - Chief Financial Officer.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., documents, papers, recommendations, or other material that are the property of the Department or that are... under any other law to records, reports, audits, reviews, documents, papers, recommendations, or other... perform such services; and (ii) Procurement, property management, space management, communications...

7 CFR 2.90 - Chief Financial Officer.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., documents, papers, recommendations, or other material that are the property of the Department or that are... under any other law to records, reports, audits, reviews, documents, papers, recommendations, or other... perform such services; and (ii) Procurement, property management, space management, communications...

7 CFR 2.90 - Chief Financial Officer.

Code of Federal Regulations, 2014 CFR

2014-01-01

..., documents, papers, recommendations, or other material that are the property of the Department or that are... under any other law to records, reports, audits, reviews, documents, papers, recommendations, or other... perform such services; and (ii) Procurement, property management, space management, communications...

7 CFR 2.90 - Chief Financial Officer.

Code of Federal Regulations, 2012 CFR

2012-01-01

..., documents, papers, recommendations, or other material that are the property of the Department or that are... under any other law to records, reports, audits, reviews, documents, papers, recommendations, or other... perform such services; and (ii) Procurement, property management, space management, communications...

46 CFR 11.301 - Requirements for STCW officer endorsements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... specialist. (vii) Workshop skills training: Documentation of successful completion of assessments or... engineering—as appropriate. (ii) Training ship experience: Documentation of successful completion of an approved training program involving formal training and assessment onboard a training ship. (iii) Simulator...

50 CFR 23.25 - What additional information is required on a non-Party CITES document?

Code of Federal Regulations, 2010 CFR

2010-10-01

....25 What additional information is required on a non-Party CITES document? (a) Purpose. Under Article... Certification (1) Export (i) For Appendix-I and -II specimens, the Scientific Authority has advised that the...

Pavement performance evaluation, phase II : data collection.

DOT National Transportation Integrated Search

2008-12-01

Phase I and II of this study tested approximately 1500 rehabilitated pavements (asphalt and PCC) : throughout the State. These pavements ranged from 5 to 15 years old and were intended to develop a : snapshot of how various rehabilitations were perfo...

Improving traffic safety culture in Iowa : phase II.

DOT National Transportation Integrated Search

2013-07-01

Phase II of Improving Traffic Safety Culture in Iowa focuses on producing actions that will improve the traffic safety culture across the state, and involves collaboration among the three large public universities in Iowa: Iowa State University, Univ...

South Bay Salt Pond Tidal Wetland Restoration Phase II Planning

EPA Pesticide Factsheets

Information about the SFBWQP South Bay Salt Pond Tidal Wetland Restoration Phase II Planning project, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic re

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

PubMed

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PubMed Central

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Background Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles. PMID:29216190

Characterization of pH dependent Mn(II) oxidation strategies and formation of a bixbyite-like phase by Mesorhizobium australicum T-G1

USGS Publications Warehouse

Bohu, Tsing; Santelli, Cara M; Akob, Denise M.; Neu, Thomas R; Ciobota, Valerian; Rösch, Petra; Popp, Jürgen; Nietzsche, Sándor; Küsel, Kirsten

2015-01-01

Despite the ubiquity of Mn oxides in natural environments, there are only a few observations of biological Mn(II) oxidation at pH < 6. The lack of low pH Mn-oxidizing bacteria (MOB) isolates limits our understanding of how pH influences biological Mn(II) oxidation in extreme environments. Here, we report that a novel MOB isolate, Mesorhizobium australicum strain T-G1, isolated from an acidic and metalliferous uranium mining area, can oxidize Mn(II) at both acidic and neutral pH using different enzymatic pathways. X-ray diffraction, Raman spectroscopy, and scanning electron microscopy with energy dispersive X-ray spectroscopy revealed that T-G1 initiated bixbyite-like Mn oxide formation at pH 5.5 which coincided with multi-copper oxidase expression from early exponential phase to late stationary phase. In contrast, reactive oxygen species (ROS), particularly superoxide, appeared to be more important for T-G1 mediated Mn(II) oxidation at neutral pH. ROS was produced in parallel with the occurrence of Mn(II) oxidation at pH 7.2 from early stationary phase. Solid phase Mn oxides did not precipitate, which is consistent with the presence of a high amount of H2O2 and lower activity of catalase in the liquid culture at pH 7.2. Our results show that M. australicum T-G1, an acid tolerant MOB, can initiate Mn(II) oxidation by varying its oxidation mechanisms depending on the pH and may play an important role in low pH manganese biogeochemical cycling.

Characterization of pH dependent Mn(II) oxidation strategies and formation of a bixbyite-like phase by Mesorhizobium australicum T-G1.

PubMed

Bohu, Tsing; Santelli, Cara M; Akob, Denise M; Neu, Thomas R; Ciobota, Valerian; Rösch, Petra; Popp, Jürgen; Nietzsche, Sándor; Küsel, Kirsten

2015-01-01

Despite the ubiquity of Mn oxides in natural environments, there are only a few observations of biological Mn(II) oxidation at pH < 6. The lack of low pH Mn-oxidizing bacteria (MOB) isolates limits our understanding of how pH influences biological Mn(II) oxidation in extreme environments. Here, we report that a novel MOB isolate, Mesorhizobium australicum strain T-G1, isolated from an acidic and metalliferous uranium mining area, can oxidize Mn(II) at both acidic and neutral pH using different enzymatic pathways. X-ray diffraction, Raman spectroscopy, and scanning electron microscopy with energy dispersive X-ray spectroscopy revealed that T-G1 initiated bixbyite-like Mn oxide formation at pH 5.5 which coincided with multi-copper oxidase expression from early exponential phase to late stationary phase. In contrast, reactive oxygen species (ROS), particularly superoxide, appeared to be more important for T-G1 mediated Mn(II) oxidation at neutral pH. ROS was produced in parallel with the occurrence of Mn(II) oxidation at pH 7.2 from early stationary phase. Solid phase Mn oxides did not precipitate, which is consistent with the presence of a high amount of H2O2 and lower activity of catalase in the liquid culture at pH 7.2. Our results show that M. australicum T-G1, an acid tolerant MOB, can initiate Mn(II) oxidation by varying its oxidation mechanisms depending on the pH and may play an important role in low pH manganese biogeochemical cycling.

Specific threonine-4 phosphorylation and function of RNA polymerase II CTD during M phase progression

PubMed Central

Hintermair, Corinna; Voß, Kirsten; Forné, Ignasi; Heidemann, Martin; Flatley, Andrew; Kremmer, Elisabeth; Imhof, Axel; Eick, Dirk

2016-01-01

Dynamic phosphorylation of Tyr1-Ser2-Pro3-Thr4-Ser5-Pro6-Ser7 heptad-repeats in the C-terminal domain (CTD) of the large subunit coordinates progression of RNA polymerase (Pol) II through the transcription cycle. Here, we describe an M phase-specific form of Pol II phosphorylated at Thr4, but not at Tyr1, Ser2, Ser5, and Ser7 residues. Thr4 phosphorylated Pol II binds to centrosomes and midbody and interacts with the Thr4-specific Polo-like kinase 1. Binding of Pol II to centrosomes does not require the CTD but may involve subunits of the non-canonical R2TP-Prefoldin-like complex, which bind to and co-localize with Pol II at centrosomes. CTD Thr4 mutants, but not Ser2 and Ser5 mutants, display severe mitosis and cytokinesis defects characterized by multipolar spindles and polyploid cells. We conclude that proper M phase progression of cells requires binding of Pol II to centrosomes to facilitate regulation of mitosis and cytokinesis in a CTD Thr4-P dependent manner. PMID:27264542

Specific threonine-4 phosphorylation and function of RNA polymerase II CTD during M phase progression.

PubMed

Hintermair, Corinna; Voß, Kirsten; Forné, Ignasi; Heidemann, Martin; Flatley, Andrew; Kremmer, Elisabeth; Imhof, Axel; Eick, Dirk

2016-06-06

Dynamic phosphorylation of Tyr1-Ser2-Pro3-Thr4-Ser5-Pro6-Ser7 heptad-repeats in the C-terminal domain (CTD) of the large subunit coordinates progression of RNA polymerase (Pol) II through the transcription cycle. Here, we describe an M phase-specific form of Pol II phosphorylated at Thr4, but not at Tyr1, Ser2, Ser5, and Ser7 residues. Thr4 phosphorylated Pol II binds to centrosomes and midbody and interacts with the Thr4-specific Polo-like kinase 1. Binding of Pol II to centrosomes does not require the CTD but may involve subunits of the non-canonical R2TP-Prefoldin-like complex, which bind to and co-localize with Pol II at centrosomes. CTD Thr4 mutants, but not Ser2 and Ser5 mutants, display severe mitosis and cytokinesis defects characterized by multipolar spindles and polyploid cells. We conclude that proper M phase progression of cells requires binding of Pol II to centrosomes to facilitate regulation of mitosis and cytokinesis in a CTD Thr4-P dependent manner.

Implementation of a Proficiency-Based Diploma System in Maine: Phase II--District Level Analysis

ERIC Educational Resources Information Center

Silvernail, David L.; Stump, Erika K.; McCafferty, Anita Stewart; Hawes, Kathryn M.

2014-01-01

This report describes the findings from Phase II of a study of Maine's implementation of a proficiency-based diploma system. At the request of the Joint Standing Committee on Education and Cultural Affairs of the Maine Legislature, the Maine Policy Research Institute (MEPRI) has conducted a two-phased study of the implementation of Maine law…

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

Extension and Public Service in the University of Illinois. Phase II Report.

ERIC Educational Resources Information Center

Illinois Univ., Urbana.

Phase II of the report on the problem outlined in Phase I deals with specific recommendations for expanding and improving the extension and public service functions of the University of Illinois. To be effective, the university needs a master plan in which the four essential ingredients must be (1) broad, strong and explicit policy commitments by…

Impact of interventions for patients refusing emergency medical services transport.

PubMed

Alicandro, J; Hollander, J E; Henry, M C; Sciammarella, J; Stapleton, E; Gentile, D

1995-06-01

To evaluate the effect of a documentation checklist and on-line medical control contact on ambulance transport of out-of-hospital patients refusing medical assistance. Consecutive patients served by four suburban ambulance services who initially refused emergency medical services (EMS) transport to the hospital were prospectively enrolled. In phase 1 (control phase), all patients who initially refused medical attention or transport had an identifying data card completed. In phase 2 (documentation phase), out-of-hospital providers completed a similar data card that contained a checklist of high-risk criteria for a poor outcome if not transported. In phase 3 (intervention phase), a data card similar to that used in phase 2 was completed, and on-line medical control was contacted for all patients with high-risk criteria who refused transport. The primary endpoint was the percentage of patients transported to the hospital. A total of 361 patients were enrolled. Transport rate varied by phase: control, 17 of 144 (12%); documentation, 11 of 150 (7%); and intervention, 12 of 67 (18%) (chi-square, p = 0.023). Transport of high-risk patients improved with each intervention: control, two of 60 (3%); documentation, seven of 70 (10%); and intervention, 12 of 34 (35%) (chi-square, p = 0.00003). Transport of patients without high-risk criteria decreased with each intervention: control, 15 of 84 (18%); documentation, four of 80 (5%); and intervention, 0 of 33 (0%) (p = 0.0025). Of the 28 patients for whom medical control was contacted, 12 (43%) were transported to the hospital, and only three of these 12 patients (25%) were released from the ED. Contact with on-line medical control increased the likelihood of transport of high-risk patients who initially refused medical assistance. The appropriateness of the decreased transport rate of patients not meeting high-risk criteria needs further evaluation.

Is a Wood Waste Gasification Project at Norbord South Carolina, Inc. a Fuel Conversion Plant, Part II

EPA Pesticide Factsheets

This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

Order Denying Petition to Object to Operating Permit for Wygen II Power Plant

EPA Pesticide Factsheets

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

Petition for the Administrator to Object to Operating Permit for Wygen II Station

EPA Pesticide Factsheets

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Petition Database available at www2.epa.gov/title-v-operating-permits/title-v-petition-database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

A Report on the Navy SBIR Program: Best Practices, Roadblocks and Recommendations for Technology Transition

DTIC Science & Technology

2008-04-01

a recommendation to the Phase I Sponsor, the NAVSEA SBIR Program Manager, and the PCO between 90 and 180 days after Phase I contract execution...determine eligibility for Phase II and send recommendations to sponsor Between 90 and 180 days after contract execution PCO Invites Phase II Proposals...manning study to evaluate the claim of inadequate numbers of contracting personnel. Although there were symptoms that contract delays were in part

Comparison between the phase I and phase II 6 m coke oven batteries of C. Still type in China Steel Corporation

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

Chiao-Hwa, H.; Tai-Heng, C.; Cheng-Hwa, L.

1983-01-01

The 98 ovens built for phase II batteries at China Steel Corporation show significant improvements over those of phase I, although they are operated in series with these. Improvements discussed in this paper include those associated with the single collection main, water sealing for the ascension pipe, aspiration by high pressure flushing liquor, self-sealing doors, wall head armour structures, waste gas flues and thermal efficiency.

Removal and recovery of mercury(II) from hazardous wastes using 1-(2-thiazolylazo)-2-naphthol functionalized activated carbon as solid phase extractant.

PubMed

Starvin, A M; Rao, T Prasada

2004-09-10

As a part of removal of toxic heavy metals from hazardous wastes, solid phase extraction (SPE) of mercury(II) at trace and ultra trace levels was studied using 1-(2-thiazolylazo)-2-naphthol (TAN) functionalized activated carbon (AC). The SPE material removes traces of mercury(II) quantitatively in the pH range 6.0 +/- 0.2. Other parameters that influence quantitative recovery of mercury(II), viz. percent concentration of TAN in AC, amount of TAN-AC, preconcentration time and volume of aqueous phase were varied and optimized. The possible means of removal of Hg(II) from other metal ions that are likely to be present in the wastes of the chloroalkali industry is discussed. The potential of TAN-functionalized AC SPE material for decontaminating mercury from the brine sludge and cell house effluent of a chloralkali plant has been evaluated.

Caltrans WeatherShare Phase II System: An Application of Systems and Software Engineering Process to Project Development

DOT National Transportation Integrated Search

2009-08-25

In cooperation with the California Department of Transportation, Montana State University's Western Transportation Institute has developed the WeatherShare Phase II system by applying Systems Engineering and Software Engineering processes. The system...

Roadway lighting and safety : phase II--monitoring quality, durability and efficiency.

DOT National Transportation Integrated Search

2011-10-01

This Phase II project follows a previous project titled Strategies to Address Nighttime Crashes at Rural, Unsignalized Intersections. Based on the results of the previous study, the Iowa Highway Research Board (IHRB) indicated interest in pursuing fu...

Final report of evaluation of masonry coatings : phase II.

DOT National Transportation Integrated Search

1972-11-01

This research project was undertaken to evaluate several coating systems for concrete masonry to replace the presently used Class 2 rubbed finish. This is the report of Phase II, the field evaluation, of that project. : In early October 1970, applica...

Evaluation of Phase II of the SmarTraveler advanced traveler information system : operational test

DOT National Transportation Integrated Search

1994-07-31

Under contract to the Massachusetts Highway Department, the Central Transportation : Planning Staff (technical staff to the Boston MPO) chose Multisystems, Inc. of : Cambridge, Massachusetts, to perform an evaluation of Phase II of the SmarTraveler :...

Research safety vehicle. Phase II. Volume II. comprehensive technical results. Final report July 1975--December 1976

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

DiNapoli, N.; Fitzpatrick, M.; Strother, C.

1977-11-01

Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidential Task Force on Motor Vehicle Goals beyond 1980.

Portable microfluidic platform for real-time, high sensitive detection and identification of trichloroethylene and other organochloride compounds

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

Jensen, Erik

In this successful SBIR Phase II effort, HJ Science & Technology, Inc. has designed and built a novel portable instrument capable of performing automated aqueous organochloride (chlorinated solvent) speciation analysis for environmental monitoring at DoE sites. Our technique employs performing organochloride conjugation, labeling the conjugate with an efficient fluorophore, and performing on-chip capillary electrophoresis separation with laser induced fluorescence detection. The key component of the portable instrument is a novel microfluidic chip capable of complete “end-to-end” automation of sample preparation, conjugation, labeling, and μCE separation and detection. In addition, the Phase II prototype includes key supporting instrumentation such as themore » optical module, pneumatic manifold, electronics, software, etc. As such, we have achieved all of the following 4 Phase II technical objectives: 1) Further refine and optimize the “on-chip” automation of the organochloride conjugation and labeling protocol, 2) Further improve the microfluidic chip fabrication process and the pneumatic manifold design in order to address issues related to performance consistency, product yield, performance reliability, and user friendliness, 3) Design and build the supporting components of the Phase II prototype including optical module, electronics, and software, and 4) Assemble the Phase II prototype hardware.« less

Weather Avoidance Using Route Optimization as a Decision Aid: An AWIN Topical Study. Phase 1

NASA Technical Reports Server (NTRS)

1998-01-01

The aviation community is faced with reducing the fatal aircraft accident rate by 80 percent within 10 years. This must be achieved even with ever increasing, traffic and a changing National Airspace System. This is not just an altruistic goal, but a real necessity, if our growing level of commerce is to continue. Honeywell Technology Center's topical study, "Weather Avoidance Using Route Optimization as a Decision Aid", addresses these pressing needs. The goal of this program is to use route optimization and user interface technologies to develop a prototype decision aid for dispatchers and pilots. This decision aid will suggest possible diversions through single or multiple weather hazards and present weather information with a human-centered design. At the conclusion of the program, we will have a laptop prototype decision aid that will be used to demonstrate concepts to industry for integration into commercialized products for dispatchers and/or pilots. With weather a factor in 30% of aircraft accidents, our program will prevent accidents by strategically avoiding weather hazards in flight. By supplying more relevant weather information in a human-centered format along with the tools to generate flight plans around weather, aircraft exposure to weather hazards can be reduced. Our program directly addresses the NASA's five year investment areas of Strategic Weather Information and Weather Operations (simulation/hazard characterization and crew/dispatch/ATChazard monitoring, display, and decision support) (NASA Aeronautics Safety Investment Strategy: Weather Investment Recommendations, April 15, 1997). This program is comprised of two phases, Phase I concluded December 31, 1998. This first phase defined weather data requirements, lateral routing algorithms, an conceptual displays for a user-centered design. Phase II runs from January 1999 through September 1999. The second phase integrates vertical routing into the lateral optimizer and combines the user interface into a prototype software testbed. Phase II concludes with a dispatcher and pilot evaluation of the route optimizer decision aid. This document describes work completed in Phase I in contract with NASA Langley August 1998 - December 1998. This report includes: (1) Discuss how weather hazards were identified in partnership with experts, and how weather hazards were prioritized; (2) Static representations of display layouts for integrated planning function (3) Cost function for the 2D route optimizer; (4) Discussion of the method for obtaining, access to raw data of, and the results of the flight deck user information requirements definition; (5) Itemized display format requirements identified for representing weather hazards in a route planning aid.

Improvement of medication event interventions through use of an electronic database.

PubMed

Merandi, Jenna; Morvay, Shelly; Lewe, Dorcas; Stewart, Barb; Catt, Char; Chanthasene, Phillip P; McClead, Richard; Kappeler, Karl; Mirtallo, Jay M

2013-10-01

Patient safety enhancements achieved through the use of an electronic Web-based system for responding to adverse drug events (ADEs) are described. A two-phase initiative was carried out at an academic pediatric hospital to improve processes related to "medication event huddles" (interdisciplinary meetings focused on ADE interventions). Phase 1 of the initiative entailed a review of huddles and interventions over a 16-month baseline period during which multiple databases were used to manage the huddle process and staff interventions were assigned via manually generated e-mail reminders. Phase 1 data collection included ADE details (e.g., medications and staff involved, location and date of event) and the types and frequencies of interventions. Based on the phase 1 analysis, an electronic database was created to eliminate the use of multiple systems for huddle scheduling and documentation and to automatically generate e-mail reminders on assigned interventions. In phase 2 of the initiative, the impact of the database during a 5-month period was evaluated; the primary outcome was the percentage of interventions documented as completed after database implementation. During the postimplementation period, 44.7% of assigned interventions were completed, compared with a completion rate of 21% during the preimplementation period, and interventions documented as incomplete decreased from 77% to 43.7% (p < 0.0001). Process changes, education, and medication order improvements were the most frequently documented categories of interventions. Implementation of a user-friendly electronic database improved intervention completion and documentation after medication event huddles.

14 CFR 121.915 - Continuing qualification curriculum.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in all tasks, procedures and subjects required in accordance with the approved program documentation, as follows: (i) For pilots in command, seconds in command, and flight engineers, First Look in accordance with the certificate holder's FAA-approved program documentation. (ii) For pilots in command...

Airport Performance Model : Volume 2 - User's Manual and Program Documentation

DOT National Transportation Integrated Search

1978-10-01

Volume II contains a User's manual and program documentation for the Airport Performance Model. This computer-based model is written in FORTRAN IV for the DEC-10. The user's manual describes the user inputs to the interactive program and gives sample...

Religious Education and the Media in the Elementary School.

ERIC Educational Resources Information Center

Riordan, Sister Mary

1981-01-01

This discussion of positive and negative aspects of media in religious education is based on Church documents, including and following the Documents of Vatican II, and on the author's own experiences as an elementary school teacher. Eleven references are listed. (Author/LLS)

Brominated flame retardants in Chinese air before and after the phase out of polybrominated diphenyl ethers

NASA Astrophysics Data System (ADS)

Li, Wen-Long; Qi, Hong; Ma, Wan-Li; Liu, Li-Yan; Zhang, Zhi; Mohammed, Mohammed O. A.; Song, Wei-Wei; Zhang, Zifeng; Li, Yi-Fan

2015-09-01

Brominated flame retardants (BFRs), including polybrominated diphenyl ethers (PBDEs) and novel non-BDE flame retardants (NBFRs), were analyzed in Chinese air during China's POPs Soil and Air Monitoring Program Phase I (SAMP-I) and Phase II (SAMP-II). The levels of Σ12PBDEs and Σ6NBFRs in urban sites were significantly higher than those in rural sites and background sites. The higher detection rate and concentrations of high molecular weight PBDEs and NBFRs in Phase II indicated the changing of the commercial pattern of BFRs after the phase out of PBDEs in China. Temperature was the major factor affecting the seasonal variations of molecular weight BFRs in atmosphere. A significant correlation between BFRs concentration and gross domestic product (GDP) was observed, with the GDP parameter explained 59.4% and 72.7% of the total variability for Octa-BDEs and low molecular weight NBFRs, respectively. Our findings indicated an evolving commercial usage of BFRs from SAMP-I to SAMP-II, i.e. shifting from lower molecular weight to higher molecular weight congeners in China.

Corrective Action Investigation Plan for Corrective Action Unit 165: Areas 25 and 26 Dry Well and Washdown Areas, Nevada Test Site, Nevada (including Record of Technical Change Nos. 1, 2, and 3) (January 2002, Rev. 0)

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

U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 165 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 165 consists of eight Corrective Action Sites (CASs): CAS 25-20-01, Lab Drain Dry Well; CAS 25-51-02, Dry Well; CAS 25-59-01, Septic System; CAS 26-59-01, Septic System; CAS 25-07-06, Train Decontamination Area; CAS 25-07-07, Vehicle Washdown; CAS 26-07-01, Vehicle Washdown Station; and CAS 25-47-01, Reservoir and French Drain. All eight CASsmore » are located in the Nevada Test Site, Nevada. Six of these CASs are located in Area 25 facilities and two CASs are located in Area 26 facilities. The eight CASs at CAU 165 consist of dry wells, septic systems, decontamination pads, and a reservoir. The six CASs in Area 25 are associated with the Nuclear Rocket Development Station that operated from 1958 to 1973. The two CASs in Area 26 are associated with facilities constructed for Project Pluto, a series of nuclear reactor tests conducted between 1961 to 1964 to develop a nuclear-powered ramjet engine. Based on site history, the scope of this plan will be a two-phased approach to investigate the possible presence of hazardous and/or radioactive constituents at concentrations that could potentially pose a threat to human health and the environment. The Phase I analytical program for most CASs will include volatile organic compounds, semivolatile organic compounds, Resource Conservation and Recovery Act metals, total petroleum hydrocarbons, polychlorinated biphenyls, and radionuclides. If laboratory data obtained from the Phase I investigation indicates the presence of contaminants of concern, the process will continue with a Phase II investigation to define the extent of contamination. Based on the results of Phase I sampling, the analytical program for Phase II investigation may be reduced. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Understanding decomposition and encapsulation energies of structure I and II clathrate hydrates

NASA Astrophysics Data System (ADS)

Alavi, Saman; Ohmura, Ryo

2016-10-01

When compressed with water or ice under high pressure and low temperature conditions, some gases form solid gas hydrate inclusion compounds which have higher melting points than ice under those pressures. In this work, we study the balance of the guest-water and water-water interaction energies that lead to the formation of the clathrate hydrate phases. In particular, molecular dynamics simulations with accurate water potentials are used to study the energetics of the formation of structure I (sI) and II (sII) clathrate hydrates of methane, ethane, and propane. The dissociation enthalpy of the clathrate hydrate phases, the encapsulation enthalpy of methane, ethane, and propane guests in the corresponding phases, and the average bonding enthalpy of water molecules are calculated and compared with accurate calorimetric measurements and previous classical and quantum mechanical calculations, when available. The encapsulation energies of methane, ethane, and propane guests stabilize the small and large sI and sII hydrate cages, with the larger molecules giving larger encapsulation energies. The average water-water interactions are weakened in the sI and sII phases compared to ice. The relative magnitudes of the van der Waals potential energy in ice and the hydrate phases are similar, but in the ice phase, the electrostatic interactions are stronger. The stabilizing guest-water "hydrophobic" interactions compensate for the weaker water-water interactions and stabilize the hydrate phases. A number of common assumptions regarding the guest-cage water interactions are used in the van der Waals-Platteeuw statistical mechanical theory to predict the clathrate hydrate phase stability under different pressure-temperature conditions. The present calculations show that some of these assumptions may not accurately reflect the physical nature of the interactions between guest molecules and the lattice waters.

Understanding decomposition and encapsulation energies of structure I and II clathrate hydrates.

PubMed

Alavi, Saman; Ohmura, Ryo

2016-10-21

When compressed with water or ice under high pressure and low temperature conditions, some gases form solid gas hydrate inclusion compounds which have higher melting points than ice under those pressures. In this work, we study the balance of the guest-water and water-water interaction energies that lead to the formation of the clathrate hydrate phases. In particular, molecular dynamics simulations with accurate water potentials are used to study the energetics of the formation of structure I (sI) and II (sII) clathrate hydrates of methane, ethane, and propane. The dissociation enthalpy of the clathrate hydrate phases, the encapsulation enthalpy of methane, ethane, and propane guests in the corresponding phases, and the average bonding enthalpy of water molecules are calculated and compared with accurate calorimetric measurements and previous classical and quantum mechanical calculations, when available. The encapsulation energies of methane, ethane, and propane guests stabilize the small and large sI and sII hydrate cages, with the larger molecules giving larger encapsulation energies. The average water-water interactions are weakened in the sI and sII phases compared to ice. The relative magnitudes of the van der Waals potential energy in ice and the hydrate phases are similar, but in the ice phase, the electrostatic interactions are stronger. The stabilizing guest-water "hydrophobic" interactions compensate for the weaker water-water interactions and stabilize the hydrate phases. A number of common assumptions regarding the guest-cage water interactions are used in the van der Waals-Platteeuw statistical mechanical theory to predict the clathrate hydrate phase stability under different pressure-temperature conditions. The present calculations show that some of these assumptions may not accurately reflect the physical nature of the interactions between guest molecules and the lattice waters.

Phase I, open-cycle absorption solar cooling. Part IV. Executive summary analysis and resolution of critical issues and recommendations for Phase II. Final report

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

Wood, B.D.

The objective of this project is to advance lower cost solar cooling technology with the feasibility analysis, design and evaluation of proof-of-concept open cycle solar cooling concepts. The work is divided into three phases, with planned completion of each phase before proceeding with the following phase: Phase I - performance/economic/environmental related analysis and exploratory studies; Phase II - design and construction of an experimental system, including evaluative testing; Phase III - extended system testing during operation and engineering modifications as required. For Phase I, analysis and resolution of critical issues were completed with the objective of developing design specifications formore » an improved prototype OCA system.« less

Evaluation of hydrothermal resources of North Dakota. Phase II. Final technical report

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

Harris, K.L.; Howell, F.L.; Winczewski, L.M.

1981-06-01

This evaluation of the hydrothermal resources of North Dakota is based on existing data on file with the North Dakota Geological Survey (NDGS) and other state and federal agencies, and field and laboratory studies conducted. The principal sources of data used during the Phase II study were WELLFILE, the computer library of oil and gas well data developed during the Phase I study, and WATERCAT, a computer library system of water well data assembled during the Phase II study. A field survey of the shallow geothermal gradients present in selected groundwater observation holes was conducted. Laboratory determinations of the thermalmore » conductivity of core samples is being done to facilitate heat-flow calculations on those hole-of-convenience cased.« less

Effects of extracellular polymeric substances on the bioaccumulation of mercury and its toxicity toward the cyanobacterium Microcystis aeruginosa.

PubMed

Chen, Ho-Wen; Huang, Winn-Jung; Wu, Ting-Hsiang; Hon, Chen-Lin

2014-01-01

This investigation examines how extracellular polymeric substances (EPSs) and environmental factors affect the bioaccumulation and toxicity of inorganic mercury (+2 oxidation state, Hg(II)) using a culture of Microcystis aeruginosa, which dominates eutrophic reservoir populations. The identified EPSs were classified as carbohydrates and proteins. Evaluation of the bioaccumulation of Hg(II) in cells by multiple regression analysis reveals that the concentration of EPSs in filtrate, the initial concentration of Hg(II) in medium, and the culture age significantly affected the amount of Hg(II) accumulated. Composition profiles revealed that the concentrations of soluble carbohydrates were significantly higher in Hg(II)-accumulated cells than in the control ones. Preliminary results based on scanning electron microscopic (SEM) map investigations suggest that most of the Hg(II) was accumulated in the cytoplasm (intracellular). Additionally, the effective concentrations (EC50) of Hg(II) that inhibit the growth of M. aeruginosa were 38.6 μg L(-1) in the logarithmic phase and 17.5 μg L(-1) in the stationary phase. As expected, the production of more EPSs in the logarithmic phase typically implies higher EC50 values because EPSs may be regarded as a protective barrier of cells against an external Hg(II) load, enabling them to be less influenced by Hg(II).

Review article: novel oral-targeted therapies in inflammatory bowel disease.

PubMed

White, J R; Phillips, F; Monaghan, T; Fateen, W; Samuel, S; Ghosh, S; Moran, G W

2018-06-01

There is a great unmet clinical need for efficacious, tolerable, economical and orally administrated drugs for the treatment of inflammatory bowel disease (IBD). New therapeutic avenues have become possible including the development of medications that target specific genetic pathways found to be relevant in other immune mediated diseases. To provide an overview of recent clinical trials for new generation oral targeted medications that may have a future role in IBD management. Pubmed and Medline searches were performed up to 1 March 2018 using keywords: "IBD", "UC", "CD", "inflammatory bowel disease" "ulcerative colitis", "Crohn's disease" in combination with "phase", "study", "trial" and "oral". A manual search of the clinical trial register, article reference lists, abstracts from meetings of Digestive Disease Week, United European Gastroenterology Week and ECCO congress were also conducted. In randomised controlled trials primary efficacy endpoints were met for tofacitinib (JAK 1/3 inhibitor-phase III), upadacitinib (JAK 1 inhibitor-phase II) and AJM300 (α4-integrin antagonist-phase II) in ulcerative colitis. Ozanimod (S1P receptor agonist-phase II) also demonstrated clinical remission. For Crohn's disease, filgotinib (JAK1 inhibitor-phase II) met primary endpoints and laquinimod (quinolone-3-carboxide small molecule-phase II) was also efficacious. Trials using mongersen (SMAD7 inhibitor) and vidofludimus (dihydroorotate dehydrogenase inhibitor) have been halted. This is potentially the start of an exciting new era in which multiple therapeutic options are at the disposal of physicians to treat IBD on an individualised basis. Head-to-head studies with existing treatments and longer term safety data are needed for this to be possible. © 2018 John Wiley & Sons Ltd.

Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

PubMed

2004-03-16

The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

Regular Topologies for Gigabit Wide-Area Networks: Congestion Avoidance Testbed Experiments. Volume 3

NASA Technical Reports Server (NTRS)

Denny, Barbara A.; McKenney, Paul E., Sr.; Lee, Danny

1994-01-01

This document is Volume 3 of the final technical report on the work performed by SRI International (SRI) on SRI Project 8600. The document includes source listings for all software developed by SRI under this effort. Since some of our work involved the use of ST-II and the Sun Microsystems, Inc. (Sun) High-Speed Serial Interface (HSI/S) driver, we have included some of the source developed by LBL and BBN as well. In most cases, our decision to include source developed by other contractors depended on whether it was necessary to modify the original code. If we have modified the software in any way, it is included in this document. In the case of the Traffic Generator (TG), however, we have included all the ST-II software, even though BBN performed the integration, because the ST-II software is part of the standard TG release. It is important to note that all the code developed by other contractors is in the public domain, so that all software developed under this effort can be re-created from the source included here.

The Face of War: A Study Guide for the Exhibition at the National Archives. March 1994 - September 1995.

ERIC Educational Resources Information Center

National Archives and Records Administration, Washington, DC.

This document is a study guide to "The Face of War," an exhibition of documents and photographs from the vast World War II holdings of the National Archives. This brochure contains reproductions of selected documents from the exhibit as well as discussion questions. The guide can be used by individuals, families, or school groups while…

Revenue cycle management, Part II.

PubMed

Crew, Matt

2007-01-01

The proper management of your revenue cycle requires the application of "best practices" and the continual monitoring and measuring of the entire cycle. The correct technology will enable you to gain the insight and efficiencies needed in the ever-changing healthcare economy. The revenue cycle is a process that begins when you negotiate payor contracts, set fees, and schedule appointments and continues until claims are paid in full. Every single step in the cycle carries equal importance. Monitoring all phases and a commitment to continually communicating the results will allow you to achieve unparalleled success. In part I of this article, we explored the importance of contracting, scheduling, and case management as well as coding and clinical documentation. We will now take a closer look at the benefits charge capture, claim submission, payment posting, accounts receivable follow-up, and reporting can mean to your practice.

Clinch River - Environmental Restoration Program (CR-ERP) pilot study, ambient water toxicity

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

Simbeck, D.J.

1997-06-01

Clinch River - Environmental Restoration Program (CR-ERP) personnel and Tennessee Valley Authority (TVA) personnel conducted a pilot study during the week of April 22-29, 1993, prior to initiation of CR-ERP Phase II Sampling and Analysis activities as described in the Statement of Work (SOW) document. The organisms specified for testing were larval fathead minnows, Pimephales promelas, and the daphnid, Ceriodaphnia dubia. Surface water samples were collected by TVA Field Engineering personnel from Clinch River Mile 9.0 and Poplar Creek Kilometer 1.6 on April 21, 23, and 26. Samples were split and provided to the CR-ERP and TVA toxicology laboratories formore » testing. Exposure of test organisms to these samples resulted in no toxicity (survival, growth, or reproduction) to either species in testing conducted by TVA.« less

75 FR 62530 - Eagle Creek Hydro Power, LLC; Laredo Ridge Wind, LLC; RRI Energy West, Inc.; Goshen Phase II LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

...; EG10-52-000; EG10-53-000; EG10- 54-000; EG10-55-000; EG10-56-000] Eagle Creek Hydro Power, LLC; Laredo Ridge Wind, LLC; RRI Energy West, Inc.; Goshen Phase II LLC; Solar Partners I, LLC; Solar Partners II, LLC; Solar Partners VIII, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status October 1...

Project 1946: Phase II

DTIC Science & Technology

2010-07-01

History (Project 1946 - Phase II),” for the National Intelligence Council. The views, opinions, and findings should not be construed as representing...29 Section 1: Senior Leadership  Foreign Assistance  Officer Corps  Saddam‘s Personality ...45 Section 3: Personal Interactions with Saddam  Senior Leadership

Magnetic sensor for nondestructive evaluation of deteriorated prestressing strand : phase II.

DOT National Transportation Integrated Search

2011-08-01

This report gives an account of the execution and achievements in Phase II of the project completed through August 2011. The main objective of this project is to advance the practical development of a nondestructive testing and evaluation method usin...

New Round of Studies Begin in Phase 0/I/II Cancer Prevention Clinical Trials Program | Division of Cancer Prevention

Cancer.gov

The NCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials, is beginning a new round of studies in the effort toward systematic early clinical development of promising preventive agents for people at increased risk of developing cancer. |

Chronology and pyroclastic stratigraphy of the May 18, 1980, eruption of Mount St. Helens, Washington

NASA Technical Reports Server (NTRS)

Criswell, C. William

1987-01-01

The eruption of Mount St. Helens on May 18, 1980 can be subdivided into six phases: the paroxysmal phase I, the early Plinian phase II, the early ash flow phase III, the climactic phase IV, the late ash flow phase V, and phase VI, the activity of which consisted of a low-energy ash plume. These phases are correlated with stratigraphic subunits of ash-fall tephra and pyroclastic flow deposits. Sustained vertical discharge of phase II produced evolved dacite with high S/Cl ratios. Ash flow activity of phase III is attributed to decreases in gas content, indicated by reduced S/Cl ratios and increased clast density of the less evolved gray pumice. Climactic events are attributed to vent clearing and exhaustion of the evolved dacite.

Expendable Air Vehicles/High Altitude Balloon Technology. Phase 1.

DTIC Science & Technology

1991-08-02

CHR/91 -2750 I I I I I THIS PAGE INTENTIONALLY LEFT BLANK 3 I I U I I I I I I I I I CHR/91 -2750 PREFACE The work described in this Phase II SBIR...Final Technical Report is the implementation of a capability which Coleman Research Corporation demon- strated during a Phase I SBIR (contract number...CRC) has developed a Balloon Drift Pattern Simulation 1BDPS). CRC developed this simulation software for digital computers as a product of a Phase II

A Guidance Document for Kentucky's Oil and Gas Operations

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

None, None

1998-11-10

This technical report is a summary of the progress made for "A Guidance Document for Kentucky's Oil and Gas Operators". During this quarter, the document received continued review and editing in an elec-tronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (USEPA) to develop an addendum section to provide better explanation of USEPA requirements for Class II injection wells in Kentucky.

A green separation strategy for neodymium (III) from cobalt (II) and nickel (II) using an ionic liquid-based aqueous two-phase system.

PubMed

Chen, Yuehua; Wang, Huiyong; Pei, Yuanchao; Wang, Jianji

2018-05-15

It is significant to develop sustainable strategies for the selective separation of rare earth from transition metals from fundamental and practical viewpoint. In this work, an environmentally friendly solvent extraction approach has been developed to selectively separate neodymium (III) from cobalt (II) and nickel (II) by using an ionic liquid-based aqueous two phase system (IL-ATPS). For this purpose, a hydrophilic ionic liquid (IL) tetrabutylphosphonate nitrate ([P 4444 ][NO 3 ]) was prepared and used for the formation of an ATPS with NaNO 3 . Binodal curves of the ATPSs have been determined for the design of extraction process. The extraction parameters such as contact time, aqueous phase pH, content of phase-formation components of NaNO 3 and the ionic liquid have been investigated systematically. It is shown that under optimal conditions, the extraction efficiency of neodymium (III) is as high as 99.7%, and neodymium (III) can be selectively separated from cobalt (II) and nickel (II) with a separation factor of 10 3 . After extraction, neodymium (III) can be stripped from the IL-rich phase by using dilute aqueous sodium oxalate, and the ILs can be quantitatively recovered and reused in the next extraction process. Since [P 4444 ][NO 3 ] works as one of the components of the ATPS and the extractant for the neodymium, no organic diluent, extra etractant and fluorinated ILs are used in the separation process. Thus, the strategy described here shows potential in green separation of neodymium from cobalt and nickel by using simple IL-based aqueous two-phase system. Copyright © 2018 Elsevier B.V. All rights reserved.

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

21 CFR 870.3450 - Vascular graft prosthesis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

EPA Science Inventory

THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

Susan M. Cormier, ORD/NRMRL, Susan B. Norton, ORD/NCEA, Glenn W. Suter, II ORD/NCEA, William Swietlik, OW lOST

Science Question(s):

MYP Science Question: How can multiple and possibly related causes of biological ...

10 CFR 431.75 - Materials incorporated by reference.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INDUSTRIAL EQUIPMENT Commercial Warm Air Furnaces Test Procedures § 431.75 Materials incorporated by.../bookshop.htm. (ii) The ANSI Standard from Global Engineering Documents, 15 Inverness Way East, Englewood... from Global Engineering Documents, 15 Inverness Way East, Englewood, CO 80112, or http://global.ihs.com...

10 CFR 431.75 - Materials incorporated by reference.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INDUSTRIAL EQUIPMENT Commercial Warm Air Furnaces Test Procedures § 431.75 Materials incorporated by.../bookshop.htm. (ii) The ANSI Standard from Global Engineering Documents, 15 Inverness Way East, Englewood... from Global Engineering Documents, 15 Inverness Way East, Englewood, CO 80112, or http://global.ihs.com...