Sample records for program phase iii

  1. 76 FR 52658 - State Program Requirements; Approval of Application for Program Revision to the National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... (ADEC) in four phases. Phases I-III have been transferred from the EPA to ADEC. In March 2011, ADEC made a submission for approval for a one year extension of the transfer of Phase IV of the APDES program... facilities not previously transferred in Phases I-III. The EPA approved the one year extension for Phase IV...

  2. 75 FR 30385 - Defense Transportation Regulation, Part IV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... extensions will be considered due to the timelines associated with funding and programming future Phase III... extensions will be considered due to the timelines associated with funding and programming future Phase III...

  3. 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…

  4. 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

  5. 78 FR 18325 - Defense Transportation Regulation, Part IV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... received in connection with the Defense Personal Property Program (DP3) Phase III Direct Procurement Method... at http://www.transcom.mil/dtr/part-iv/phaseiii.cfm (DPM SECTION). All identified changes will be... Defense Personal Property System (DPS) Phase III programming projected for FY17. FOR FURTHER INFORMATION...

  6. 76 FR 36095 - Defense Transportation Regulation, Part IV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... with the Defense Personal Property Program (DP3) Phase III Domestic Small Shipments (dS2) and... Regulation, Part IV Web site at http://www.transcom.mil/dtr/part-iv/phaseiii.cfm . All identified changes... based on completion of Defense Personal Property System (DPS) Phase III programming projected for FY15...

  7. 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. |

  8. The Mississippi Catalog of Competencies for Public Elementary and Secondary Physical Education.

    ERIC Educational Resources Information Center

    Mississippi State Dept. of Education, Jackson.

    Phase III of a five-phase project which has implications for the improvement of instructional programs in Mississippi's elementary and secondary schools is described. In phase III, specifically stated objectives or competencies in physical education, designed to accomplish the objectives stated in phase II, are cataloged. The competencies are…

  9. General Improvement of Reading Instruction, Grades 1-12, Teacher Training Program of Title III, P.L. 89-10. Evaluation of Second Phase of Program, Summer 1968.

    ERIC Educational Resources Information Center

    Brookland-Cayce Schools, West Columbia, SC.

    An evaluation of the second phase of a projected 3-year Title III inservice reading instruction program for teaching personnel is presented after one and one-half years of operation in 16 Cayce-West Columbia, South Carolina, schools. Included is an evaluation prepared by each of the 11 elementary supervisors which includes objectives and how they…

  10. A Sequenced Instructional Program in Physical Education for the Handicapped, Phase III. Producing and Disseminating Demonstration Packages. Final Report.

    ERIC Educational Resources Information Center

    Carr, Dorothy B.; Avance, Lyonel D.

    Presented is a sequenced instructional program in physical education which constitutes the third of a three-phase, 4-year project, funded by Title III, for handicapped children, preschool through high school levels, in the Los Angeles Unified School District. Described are the project setting and the following accomplishments: a curriculum guide…

  11. Chattanooga SmartBus Project : phase III evaluation report

    DOT National Transportation Integrated Search

    2009-12-01

    This report presents the results of Phase III of the national evaluation of the Chattanooga Area Regional Transportation Authoritys (CARTA) SmartBus Project. The SmartBus Project is a comprehensive transit ITS program for the city of Chattanooga, ...

  12. Army Enlisted Personnel Competency Assessment Program: Phase III Pilot Tests

    DTIC Science & Technology

    2007-03-01

    Officer’s Representatives and Subject Matter POCs: Tonia Heffner and Peter Greenston Contract for Manpower, Personnel, Leader Development, and Training ...3926 March 2007 Army Project Number Personnel Performance 622785A790 and Training Technology Approved for public release; distribution is unlimited. 111...8217 ARMY ENLISTED PERSONNEL COMPETENCY ASSESSMENT PROGRAM: PHASE III PILOT TESTS EXECUTIVE SUMMARY Research Requirement: The Army Training and Leader

  13. Analysis of Wake VAS Benefits Using ACES Build 3.2.1: VAMS Type 1 Assessment

    NASA Technical Reports Server (NTRS)

    Smith, Jeremy C.

    2005-01-01

    The FAA and NASA are currently engaged in a Wake Turbulence Research Program to revise wake turbulence separation standards, procedures, and criteria to increase airport capacity while maintaining or increasing safety. The research program is divided into three phases: Phase I near term procedural enhancements; Phase II wind dependent Wake Vortex Advisory System (WakeVAS) Concepts of Operations (ConOps); and Phase III farther term ConOps based on wake prediction and sensing. The Phase III Wake VAS ConOps is one element of the Virtual Airspace Modelling and Simulation (VAMS) program blended concepts for enhancing the total system wide capacity of the National Airspace System (NAS). This report contains a VAMS Program Type 1 (stand-alone) assessment of the expected capacity benefits of Wake VAS at the 35 FAA Benchmark Airports and determines the consequent reduction in delay using the Airspace Concepts Evaluation System (ACES) Build 3.2.1 simulator.

  14. Individualized Inservice Teacher Education (Project In-Step). Evaluation Report. Phase III.

    ERIC Educational Resources Information Center

    Thurber, John C.

    This is a report on the third phase of Project IN-STEP, which was intended to develop a viable model for individualized, multi-media in-service teacher education programs. (Phase I and II are reported in ED 033 905, and ED 042 709). The rationale for Phase III was to see if the model could be successfully transferred to an area other than teaching…

  15. 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

  16. Clinical Investigation Program Report, RCS MED-300 (R-1).

    DTIC Science & Technology

    1985-10-31

    Patients with Locally Advanced Gastric Adenocarcinoma, Phase III. (C) 63 1982 SWOG 8006, Preoperative Reductive Chemotherapy for Stage III or IV Operable...Mesothelioma Localized to One Hemithorax, Phase III. (C) 81 1984 SWOG 8104, Treatment of Advanced Seminoma (Stage cII (4) + clII) with Combined...of Locally or Regionally Recurrent but Surgically Resectable Breast Cancer. (C) 99 1984 SWOG 8300, Treatment of Limited Non-Small Cell Lung Cancer

  17. 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 - ...

  18. Analysis of WakeVAS Benefits Using ACES Build 3.2.1

    NASA Technical Reports Server (NTRS)

    Smith, Jeremy C.

    2005-01-01

    The FAA and NASA are currently engaged in a Wake Turbulence Research Program to revise wake turbulence separation standards, procedures, and criteria to increase airport capacity while maintaining or increasing safety. The research program is divided into three phases: Phase I near term procedural enhancements; Phase II wind dependent Wake Vortex Advisory System (WakeVAS) Concepts of Operations (ConOps); and Phase III farther term ConOps based on wake prediction and sensing. This report contains an analysis that evaluates the benefits of a closely spaced parallel runway (CSPR) Phase I ConOps, a single runway and CSPR Phase II ConOps and a single runway Phase III ConOps. A series of simulation runs were performed using the Airspace Concepts Evaluation System (ACES) Build 3.21 air traffic simulator to provide an initial assessment of the reduction in delay and cost savings obtained by the use of a WakeVAS at selected U.S. airports. The ACES simulator is being developed by NASA Ames Research Center as part of the Virtual Airspace Modelling and Simulation (VAMS) program.

  19. About the Lung and Upper Aerodigestive Cancer Research Group | Division of Cancer Prevention

    Cancer.gov

    The Lung and Upper Aerodigestive Cancer Research Group conducts and supports research on the prevention and early detection of lung and head and neck cancers, as well as new approaches to clinical prevention studies including cancer immunoprevention.Phase 0/I/II Cancer Prevention Clinical Trials ProgramThe group jointly administers the Phase 0/I/II Cancer Prevention Clinical

  20. Army Enlisted Personnel Competency Assessment Program: Phase 2 Report

    DTIC Science & Technology

    2006-01-01

    benefit analysis of a notional Army program will be conducted. v Findings: The prototype Army core assessment was successfully administered to over 600...about competency assessment. They will also be incorporated into a cost and benefit analysis to be conducted in Phase III. vi CONTENTS Page Chapter 1...Conduct a Cost- Benefit Analysis, and Make System Recommendations Phase I of PerformM21 resulted in program design recommendations that included such

  1. Advanced Natural Gas Reciprocating Engines(s)

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

    Zurlo, James

    The ARES program was initiated in 2001 to improve the overall brake thermal efficiency of stationary, natural gas, reciprocating engines. The ARES program is a joint award that is shared by Dresser, Inc., Caterpillar and Cummins. The ARES program was divided into three phases; ARES I (achieve 44% BTE), ARES II (achieve 47% BTE) and ARES III (achieve 50% BTE). Dresser, Inc. completed ARES I in March 2005 which resulted in the commercialization of the APG1000 product line. ARES II activities were completed in September 2010 and the technology developed is currently being integrated into products. ARES III activities beganmore » in October 2010. The ARES program goal is to improve the efficiency of natural gas reciprocating engines. The ARES project is structured in three phases with higher efficiency goals in each phase. The ARES objectives are as follows: 1. Achieve 44% (ARES I), 47% (ARES II), and 50% brake thermal efficiency (BTE) as a final ARES III objective 2. Achieve 0.1 g/bhp-hr NOx emissions (with after-treatment) 3. Reduce the cost of the produced electricity by 10% 4. Improve or maintain reliability, durability and maintenance costs« less

  2. USING LANDFILL GAS IN FUEL CELLS - A STEP CLOSER TO COMMERICAL REALITY

    EPA Science Inventory

    The article discusses Phase II and Phase III results of a U.S. EPA program underway at International Fuel Cells Corporation. The program involves controlling methane emissions from landfills using a fuel cell. The fuel cell would reduce air emissions affecting global warming, aci...

  3. Federal Programs Supporting Educational Change, Vol. VII: Factors Affecting Implementation and Continuation.

    ERIC Educational Resources Information Center

    Berman, Paul; And Others

    This report is one of three volumes that describe the second phase of a study that examined the implementation of four federal change agent programs related to education. Phase 2 of the study focused on what happens to local projects in the two largest change agent programs--ESEA Title III and ESEA Title VII--when federal funding stops. This…

  4. Design of Training Systems, Phase II Report, Volume III; Model Program Descriptions and Operating Procedures. TAEG Report No. 12-2.

    ERIC Educational Resources Information Center

    Naval Training Equipment Center, Orlando, FL. Training Analysis and Evaluation Group.

    The Design of Training Systems (DOTS) project was initiated by the Department of Defense (DOD) to develop tools for the effective management of military training organizations. Volume 3 contains the model and data base program descriptions and operating procedures designed for phase 2 of the project. Flow charts and program listings for the…

  5. Evidence to Support Peer Tutoring Programs at the Undergraduate Level

    ERIC Educational Resources Information Center

    Colver, Mitchell; Fry, Trevor

    2016-01-01

    The present study examined undergraduate peer tutoring in three phases. Phase I qualitatively surveyed students' perceptions about the effectiveness of tutoring. Phase II examined the usefulness of promoting regular use of services through a tutoring contract. Phase III utilized an archival, quasi-experimental approach to estimate the effect of…

  6. 40 CFR 76.12 - Phase I NOX compliance extension.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.12 Phase I NOX compliance extension. (a... outage. (iii) Fuel and energy balance summaries and power and other consumption requirements (including...

  7. 40 CFR 76.12 - Phase I NOX compliance extension.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.12 Phase I NOX compliance extension. (a... outage. (iii) Fuel and energy balance summaries and power and other consumption requirements (including...

  8. 40 CFR 76.12 - Phase I NOX compliance extension.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.12 Phase I NOX compliance extension. (a... outage. (iii) Fuel and energy balance summaries and power and other consumption requirements (including...

  9. 40 CFR 76.12 - Phase I NOX compliance extension.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.12 Phase I NOX compliance extension. (a... outage. (iii) Fuel and energy balance summaries and power and other consumption requirements (including...

  10. 40 CFR 76.12 - Phase I NOX compliance extension.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.12 Phase I NOX compliance extension. (a... outage. (iii) Fuel and energy balance summaries and power and other consumption requirements (including...

  11. A Model System for the Design and Maintenance of Related Instruction Curriculum for Approved U.S. Department of Labor Apprenticeship Programs; Phase III. Final Report and Final Evaluation Report.

    ERIC Educational Resources Information Center

    Lane Community Coll., Eugene, OR.

    A final report and final evaluation report of Phase III are provided for a project to establish a national clearinghouse for apprenticeship-related instructional materials. The final report provides a summary and a narrative account of these project activities: identification of materials; identification of apprenticeship curriculum needs;…

  12. Installation Restoration Program Records Search for Westover Air Force Base, Massachusetts.

    DTIC Science & Technology

    1982-04-01

    Phase III (not part of this contract) consists of a technology base development study to support the development of project plans for controlling...determine the extent and magnitude of the contaminant migration. Phase III (not part of this contract) consists of a technology base development study to...number of vegetation studies have attempted to classify the potential climax vegetation within the region of Westover AFB (Braun, 1972; Kuchler, 1975

  13. 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.

  14. KSC SBIR/STTR 2004 Program Year Report

    NASA Technical Reports Server (NTRS)

    2005-01-01

    The Kennedy Space Center Level III SBIR/STTR management staff is under the Technology Transfer Office within the Spaceport Engineering and Technology Directorate. The SBIR and STTR programs provide an opportunity for small high technology companies and research institutions to participate in Government-sponsored research and development (R&D) programs in key technology areas. The SBIR program was established by Congress in 1982 to provide increased opportunities for small businesses to participate in R&D programs, increase employment, and improve U.S. competitiveness. The program's specific objectives are to stimulate U.S. technological innovation, use small businesses to meet Federal research and development needs, increase private sector commercialization of innovations, and foster and encourage participation by socially disadvantaged businesses. Legislation enacted in December 2000 reauthorized the program and strengthened emphasis on pursuing commercial applications of SBIR projects. An SBIR Phase I contract is the opportunity to establish the feasibility and technical merit of a proposed innovation. Selected competitively, the Phase I contract lasts for 6 months and is funded up to $70,000. SBIR Phase II contracts continue the most promising Phase I projects based on scientific! technical merit, expected value to NASA, company capability, and commercial potential. Phase II contracts are usually for a period of 24 months and may not exceed $600,000. NASA usually selects approximately 40 percent of Phase I projects to continue to the Phase II level. Phase III is the process of furthering the development of a product to make it commercially available. The STTR program awards contracts to small business concerns for cooperative R&D with a nonprofit research institution. Research institutions include nonprofit research organizations, Federal laboratories, or universities. The goal of the program established by Congress is to facilitate the transfer of technology developed by a research institution through the entrepreneurship of a small business. The STIR program is smaller in funding than the SBIR program. While the proposal is submitted by the small business concern, at least 30 percent of the funding and work must originate with the research institution. STTR Phase I projects receive up to $100K for a one-year effort, and a Phase II contract receives up to $600K for two years.

  15. DEMONSTRATION OF FUEL CELLS TO RECOVER ENERGY FROM LANDFILL GAS - PHASE III. DEMONSTRATION TESTS - PHASE IV. GUIDELINES AND RECOMMENDATIONS- VOLUME 1. TECHNICAL REPORT

    EPA Science Inventory

    The report summarizes the results of a four-phase program to demonstrate that fuel cell energy recovery using a commercial phosphoric acid fuel cell is both environmentally sound and commercially feasible. Phase I, a conceptual design and evaluation study, addressed the technical...

  16. DEMONSTRATION OF FUEL CELLS TO RECOVER ENERGY FROM LANDFILL GAS - PHASE III. DEMONSTRATION TESTS - PHASE IV. GUIDELINES AND DEMONSTRATIONS - VOLUME 2. APPENDICES

    EPA Science Inventory

    The report summarizes the results of a four-phase program to demonstrate that fuel cell energy recovery using a commercial phosphoric acid fuel cell is both environmentally sound and commercially feasible. Phase I, a conceptual design and evaluation study, addressed the technical...

  17. Cement study : phases I, II, and III.

    DOT National Transportation Integrated Search

    1970-06-01

    This report is the result of a three phase research program in which cements and aggregates from various supplier were studied in an effort to evaluate and improve various constitutents in concrete mixes. The major emphasis of this study has been on ...

  18. Immune Checkpoint Inhibition in Hepatocellular Carcinoma: Basics and Ongoing Clinical Trials.

    PubMed

    Kudo, Masatoshi

    2017-01-01

    Clinical trials of antibodies targeting the immune checkpoint inhibitors programmed cell death 1 (PD-1), programmed cell death ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) for the treatment of advanced hepatocellular carcinoma (HCC) are ongoing. Expansion cohorts of a phase I/II trial of the anti-PD-1 antibody nivolumab in advanced HCC showed favorable results. Two phase III studies are currently ongoing: a comparison of nivolumab and sorafenib in the first-line setting for advanced HCC, and a comparison of the anti-PD-1 antibody pembrolizumab and a placebo in the second-line setting for patients with advanced HCC who progressed on sorafenib therapy. The combination of anti-PD-1/PD-L1 and anti-CTLA-4 antibodies is being evaluated in other phase I/II trials, and the results suggest that an anti-PD-1 antibody combined with locoregional therapy or other molecular targeted agents is an effective treatment strategy for HCC. Immune checkpoint inhibitors may therefore open new doors to the treatment of HCC. © 2017 S. Karger AG, Basel.

  19. Project 8, Phase III Design: Placing an eV-Scale Limit on the Neutrino Mass using Cyclotron Radiation Emission Spectroscopy

    NASA Astrophysics Data System (ADS)

    Oblath, Noah; Project 8 Collaboration

    2016-09-01

    We report on the design concept for Phase III of the Project 8 experiment. In the third phase of Project 8 we aim to place a limit on the neutrino mass that is similar to the current limits set by tritium beta-decay experiments, mν < 2eV . From the first two phases of Project 8 we move to a novel design consisting of a 100cm3 cylindrical volume of tritium gas instrumented with two 30-element rings of inward-facing antennas. Beam-forming techniques similar to those used in radioastronomy will be employed to search for and track electron signals in the fiducial volume. This talk will present the quantitative design concept for the phased-array receiver, and illustrate how we are progressing towards the Phase IV experiment, which will have sensitivity to the neutrino mass scale allowed by the inverted mass hierarchy. This work is supported by the DOE Office of Science Early Career Research Program, and the Laboratory Directed Research and Development Program at Pacific Northwest National Laboratory.

  20. Facilitating the implementation of the American College of Surgeons/Association of Program Directors in Surgery phase III skills curriculum: training faculty in the assessment of team skills.

    PubMed

    Hull, Louise; Arora, Sonal; Stefanidis, Dimitrios; Sevdalis, Nick

    2015-11-01

    Effective teamwork is critical to safety in the operating room; however, implementation of phase III of the American College of Surgeons (ACS) and Association of Program Directors in Surgery (APDS) Curriculum that focuses on team-based skills remains worryingly low. Training and assessing the complexities of teamwork is challenging. The objective of this study was to establish guidelines and recommendations for training faculty in assessing/debriefing team skills. A multistage survey-based consensus study was completed by 108 experts responsible for training and assessing surgical residents from the ACS Accredited Educational Institutes. Experts agreed that a program to teach faculty to assess team-based skills should include training in the recognition of teamwork skills, practice rating these skills, and training in the provision of feedback/debriefing. Agreement was reached that faculty responsible for conducting team-based skills assessment should be revalidated every 2 years and stringent proficiency criteria should be met. Faculty development is critical to ensure high-quality, standardized training and assessment. Training faculty to assess team-based skills has the potential to facilitate the effective implementation of phase III of the ACS and APDS Curriculum. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Installation Restoration Program. Phase II. Confirmation/Quantification Stage 1 for George Air Force Base, California.

    DTIC Science & Technology

    1985-08-30

    technology for objective assessment of adverse effects. A Phase III requirement can be identified at any time during the program. 4. Phase IV - Operations...earth’s field can be asso- ciated with naturally occurring materials, or buried iron objects and remnant cultural features associated with man’s...for as * adequately as that of its own personnel.I 2. Obviously, such objectives can be attained only by the cooperation of all concerned. Therefore, it

  2. Joint probability of statistical success of multiple phase III trials.

    PubMed

    Zhang, Jianliang; Zhang, Jenny J

    2013-01-01

    In drug development, after completion of phase II proof-of-concept trials, the sponsor needs to make a go/no-go decision to start expensive phase III trials. The probability of statistical success (PoSS) of the phase III trials based on data from earlier studies is an important factor in that decision-making process. Instead of statistical power, the predictive power of a phase III trial, which takes into account the uncertainty in the estimation of treatment effect from earlier studies, has been proposed to evaluate the PoSS of a single trial. However, regulatory authorities generally require statistical significance in two (or more) trials for marketing licensure. We show that the predictive statistics of two future trials are statistically correlated through use of the common observed data from earlier studies. Thus, the joint predictive power should not be evaluated as a simplistic product of the predictive powers of the individual trials. We develop the relevant formulae for the appropriate evaluation of the joint predictive power and provide numerical examples. Our methodology is further extended to the more complex phase III development scenario comprising more than two (K > 2) trials, that is, the evaluation of the PoSS of at least k₀ (k₀≤ K) trials from a program of K total trials. Copyright © 2013 John Wiley & Sons, Ltd.

  3. Project Vitality; Phase III. A Program for the Handicapped.

    ERIC Educational Resources Information Center

    Santa Ana Unified School District, CA.

    The 1972-73 school year Project VITALITY is described to provide coordinated work study career development for students in grades seven through 12 or equivalent ages who are legally assigned to the special programs, students in the Teen Mothers program, and those students dismissed from the educable mentally retarded program after August 1, 1969.…

  4. Department of the Navy Advocacy Program: Service Heed and Service Response. Phase III Report: Conclusions

    DTIC Science & Technology

    1983-10-01

    child abuse and spouse abuse, and describe the evolvement of military family advocacy programs. By providing a ready resource for briefings and community presentations, these resource papers should be particularly helpful to Navy and Marine Corps family advocacy

  5. Revised Study Design for Final Phase of the Change Agent Study. Study of Change Agent Programs: A Working Note.

    ERIC Educational Resources Information Center

    Bass, G.; And Others

    The Rand change agent study was designed to determine the factors for successful implementation and continuation of selected federal programs--the Elementary and Secondary Education Act, Title III, Innovation Projects; ESEA Title VII, Bilingual Projects; Vocational Education Part D, Exemplary Programs; and the Right-to-Read program. This report…

  6. The Annual Report of the National Shipbuilding Research Program (The Naval Shipbuilding Research Program)

    DTIC Science & Technology

    1986-08-29

    Abrasives Work Planning for Shipyard SP&C Training Overcoating of Zinc Primers Citric Acid Cleaning - Phase II - Waterborne Coatings Economics of...members workout organizational problems with minimum government involvement a set of strong, committed, and sometimes fiercely independent panels and...01 Manual of Welding Planning and Design Guidelines - Phase III PANEL SP-3 Ship Design Considerations: Adaptation of Japanese Pre - 7 9 79 81 82 83 83

  7. Rotary engine research

    NASA Astrophysics Data System (ADS)

    1992-06-01

    A development history is presented for NASA's 1983-1991 Rotary Engine Enablement Program, emphasizing the CFD approaches to various problems that were instituted from 1987 to the end of the program. In phase I, a test rig was built to intensively clarify and characterize the stratified-charge rotary engine concept. In phase II, a high pressure, electronically controlled fuel injection system was tested. In phase III, the testing of improved fuel injectors led to the achievement of the stipulated 5 hp/cu inch specific power goal. CFD-aided design of advanced rotor-pocket shapes led to additional performance improvements.

  8. 76 FR 22118 - Notice of Submission of Proposed Information Collection to OMB; Disaster Assistance Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-20

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5480-N-34] Notice of Submission of... subject proposal. The U.S. Department of Housing and Urban Development (HUD) is conducting an important... rents (i.e., Phase I) and $0 rent (i.e., Phase II/Phase III) to market rate or assisted housing and...

  9. Early Program Development

    NASA Image and Video Library

    1969-01-01

    This 1969 artist's concept illustrates the use of three major elements of NASA's Integrated program, as proposed by President Nixon's Space Task Group. In Phases I and II, a Space Tug with a manipulator-equipped crew module removes a cargo module from an early Space Shuttle Orbiter and docks with it. In Phases III and IV, the Space Tug with attached cargo module flys toward a Nuclear Shuttle. As a result of the Space Task Group's recommendations for more commonality and integration in the American space program, Marshall Space Flight Center engineers studied many of the spacecraft depicted here.

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

    ERIC Educational Resources Information Center

    Southwestern Cooperative Educational Lab., Albuquerque, NM.

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

  11. Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review.

    PubMed

    Jardim, Denis L; Groves, Eric S; Breitfeld, Philip P; Kurzrock, Razelle

    2017-01-01

    We aimed to describe the reasons for failure of experimental anticancer drugs in late-stage clinical development. We searched the PharmaProjects database (https://citeline.com/products/pharmaprojects/) for anticancer drugs discontinued between 01/01/2009 and 06/30/2014. Drug programs that reached phase III trials, but never gained Food and Drug Administration (FDA) approval were compared to 37 anti-cancer drugs achieving FDA approval in this time period. Forty-two drugs fit our criteria for development failures. These failed drugs (49% targeted, 23% cytotoxics, and 28% other) were tested in 43 cancer indications (drug programs). Only 16% (7/43) of failed drug programs adopted a biomarker-driven rationale for patient selection versus 57% (21/37) of successful drug programs (P<0.001). Phase II trial information was available in 32 of 43 failed drug programs and in 32 of 37 successful programs. Nine of the 32 trials (28%) of failed drugs versus 28 of 32 trials (87%) of successful drugs (P<0.001) achieved proof of concept (single agent response rate (RR) ⩾20% or combination therapy showing a ⩾20% RR increase above the median historical RR without the experimental agent (with a minimal absolute increase of 5%) or a randomized phase II trial showing significance (P⩽0.05) for its primary outcome). No pattern of study sites, trial design or funding characteristics emerged from the failed drug analysis. For drugs that reached Phase III, lack of a biomarker-driven strategy and failure to attain proof of concept in phase II are potential risk factors for later discontinuation, especially for targeted agents. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Effect of Laughter Yoga on Psychological Well-being and Physiological Measures.

    PubMed

    Miles, Cindy; Tait, Elizabeth; Schure, Marc B; Hollis, Marianne

    2016-01-01

    In 2014, laughter yoga (LY) achieved the intermediate level, tier 2, under the Title III-D Evidence-based Disease Prevention and Health Promotion Program through the Administration on Aging (AOA). Further research is needed to qualify LY under the criteria for the highest tier, tier 3, to assure continued funding for LY classes at senior centers. The study intended to demonstrate further the benefits of LY and to qualify LY as tier 3 under Title III-D. Using a quasi-experimental design, the research team conducted a preintervention/postintervention study in 3 phases. The study was done in a variety of community centers. Phase 1, a pilot phase, was limited to North Carolina, and phase 2 was conducted in multiple states. Phase 3 was held at the North Carolina Area Agency on Aging's annual Volunteer Appreciation meeting. Participants in phases 1 (n = 109) and 2 (n = 247) enrolled in LY classes. Classes were advertised by fliers posted in community and in retirement centers. The ability of participants to participate in a class was based solely on their desire to participate, regardless of age, ability, health status, or physical impairment. Phase 3 (n = 23) was a convenience sample only. All phases were voluntary. The pre- and posttests for all 3 phases were Likert-scale surveys, 10 questions on the Psychological Outcomes of Well-being (POWB) survey. Pulse and other physiological measurements were also assessed pre- and postintervention. Analysis included a t test on each of the 10 POWB and physiological measures for all phases. All 10 POWB measures for phases 1 and 2 showed significant improvements between the pre- and postintervention testing (P < .001). Phase 3, the control, showed no significant improvement. The initial study demonstrated that LY meets the criteria to qualify for tier 3 under the Title III-D Evidence-based Disease Prevention and Health Promotion Program and that a large number of Americans, regardless of age and physical ability, could benefit from LY.

  13. 7 CFR 3403.8 - Proposal format for phase II applications.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... FOOD AND AGRICULTURE SMALL BUSINESS INNOVATION RESEARCH GRANTS PROGRAM Preparation of Proposals § 3403... of the innovation. (iii) Market. Milestone, target dates, analyses of market size, and estimated...

  14. 7 CFR 3403.8 - Proposal format for phase II applications.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... FOOD AND AGRICULTURE SMALL BUSINESS INNOVATION RESEARCH GRANTS PROGRAM Preparation of Proposals § 3403... of the innovation. (iii) Market. Milestone, target dates, analyses of market size, and estimated...

  15. 7 CFR 3403.8 - Proposal format for phase II applications.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... FOOD AND AGRICULTURE SMALL BUSINESS INNOVATION RESEARCH GRANTS PROGRAM Preparation of Proposals § 3403... of the innovation. (iii) Market. Milestone, target dates, analyses of market size, and estimated...

  16. 7 CFR 3403.8 - Proposal format for phase II applications.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... FOOD AND AGRICULTURE SMALL BUSINESS INNOVATION RESEARCH GRANTS PROGRAM Preparation of Proposals § 3403... of the innovation. (iii) Market. Milestone, target dates, analyses of market size, and estimated...

  17. 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.

  18. Vapor Phase Catalytic Ammonia Reduction

    NASA Technical Reports Server (NTRS)

    Flynn, Michael T.; Harper, Lynn D. (Technical Monitor)

    1994-01-01

    This paper discusses the development of a Vapor Phase Catalytic Ammonia Reduction (VPCAR) teststand and the results of an experimental program designed to evaluate the potential of the technology as a water purification process. In the experimental program the technology is evaluated based upon product water purity, water recovery rate, and power consumption. The experimental work demonstrates that the technology produces high purity product water and attains high water recovery rates at a relatively high specific power consumption. The experimental program was conducted in 3 phases. In phase I an Igepon(TM) soap and water mixture was used to evaluate the performance of an innovative Wiped-Film Rotating-Disk evaporator and associated demister. In phase II a phenol-water solution was used to evaluate the performance of the high temperature catalytic oxidation reactor. In phase III a urine analog was used to evaluate the performance of the combined distillation/oxidation functions of the processor.

  19. Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial.

    PubMed

    Vieira, Ágata; Melo, Cristina; Machado, Jorge; Gabriel, Joaquim

    2018-02-01

    To analyse the effect of a six-month home-based phase III cardiac rehabilitation (CR) specific exercise program, performed in a virtual reality (Kinect) or conventional (booklet) environment, on executive function, quality of life and depression, anxiety and stress of subjects with coronary artery disease. A randomized controlled trial was conducted with subjects, who had completed phase II, randomly assigned to intervention group 1 (IG1), whose program encompassed the use of Kinect (n = 11); or intervention group 2 (IG2), a paper booklet (n = 11); or a control group (CG), only subjected to the usual care (n = 11). The three groups received education on cardiovascular risk factors. The assessed parameters, at baseline (M0), 3 (M1) and 6 months (M2), were executive function, control and integration in the implementation of an adequate behaviour in relation to a certain objective, specifically the ability to switch information (Trail Making Test), working memory (Verbal Digit Span test), and selective attention and conflict resolution ability (Stroop test), quality of life (MacNew questionnaire) and depression, anxiety and stress (Depression, Anxiety and Stress Scale 21). Descriptive and inferential statistical measures were used, significance level was set at .05. The IG1 revealed significant improvements, in the selective attention and conflict resolution ability, in comparison with the CG in the variable difference M0 - M2 (p = .021) and in comparison with the IG2 in the variable difference M1 - M2 and M0 - M2 (p = .001 and p = .002, respectively). No significant differences were found in the quality of life, and depression, anxiety and stress. The virtual reality format had improved selective attention and conflict resolution ability, revealing the potential of CR, specifically with virtual reality exercise, on executive function. Implications for Rehabilitation In cardiac rehabilitation, especially in phase III, it is important to develop and to present alternative strategies, as virtual reality using the Kinect in a home context. Taking into account the relationship between the improvement of the executive function with physical exercise, it is relevant to access the impact of a cardiac rehabilitation program on the executive function. Enhancing the value of the phase III of cardiac rehabilitation.

  20. 75 FR 70217 - Defense Transportation Regulation, Part IV

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... comments received in connection with the Defense Personal Property Program (DP3), Phase III Final-Draft.... Any subsequent changes will be published in a Federal Register Announcement and incorporated into the...

  1. School Information: Phase III of Quality Assessment Program. Appendix B.

    ERIC Educational Resources Information Center

    Burson, William W.

    This questionnaire, used in the Educational Quality Assessment Program in Pennsylvania, was designed to be filled out by school administrators. It requests information about staff size, enrollment size, library books available, hours of paraprofessionals, and quality of housing in school district. It also includes a checklist to show the extent of…

  2. Hawaii Integrated Biofuels Research Program: Final Subcontract Report, Phase III

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

    Not Available

    1992-05-01

    This report is a compilation of studies done to develop an integrated set of strategies for the production of energy from renewable resources in Hawaii. Because of the close coordination between this program and other ongoing DOE research, the work will have broad-based applicability to the entire United States.

  3. Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.

    PubMed

    Thayabaranathan, Tharshanah; Cadilhac, Dominique A; Srikanth, Velandai K; Fitzgerald, Sharyn M; Evans, Roger G; Kim, Joosup; Gerraty, Richard P; Phan, Thanh G; Bladin, Christopher F; Nelson, Mark R; Frayne, Judith H; Thrift, Amanda G

    2016-06-01

    Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  4. Phase 0/I/II Cancer Prevention Clinical Trials Program (Consortia) | Division of Cancer Prevention

    Cancer.gov

    Five cancer research centers lead multiple collaborative networks to assess potential cancer preventive agents and to conduct early clinical development of promising preventive agents. Also called the Consortia for Early Phase Prevention Trials, the studies require extensive biomarker analysis, investigation of the biologic effects of the cancer preventive agents on their

  5. Ceftaroline Fosamil for the Treatment of Community-Acquired Pneumonia: from FOCUS to CAPTURE.

    PubMed

    Carreno, Joseph J; Lodise, Thomas P

    2014-12-01

    Ceftaroline fosamil (ceftaroline hereafter) is the latest addition to the armamentarium for the treatment of patients with community-acquired pneumonia (CAP). It is currently approved by the Food and Drug Administration (FDA) for community-acquired bacterial pneumonia (CABP), which is a recent FDA indication that centers on individuals with documented bacterial pneumonias that arise in the community setting. The purpose of this review is to summarize and discuss the major findings from the Phase III CAP clinical trials as well as the clinical experience with ceftaroline among patients with CAP in the "Ceftaroline Assessment Program and Teflaro(®) Utilization Registry" (CAPTURE). In its two Phase III CAP trials, ceftaroline was compared to ceftriaxone among adults with radiographically confirmed CAP requiring hospitalization who were classified as Pneumonia Outcomes Research Team (PORT) risk class III or IV. Among patients with CAP, clinical success at test of cure was 84.3% vs 77.7% (difference 6.6%, 95% confidence interval [CI]: 1.6-11.8%) in those treated with ceftaroline and ceftriaxone, respectively, across the two Phase III clinical trials. Among patients with a culture-confirmed CABP, day 4 response rates were numerically higher, albeit non-significant, among patients that received ceftaroline vs. ceftriaxone (69.5% for ceftaroline vs. 59.4% for ceftriaxone, difference 10.1%, 95% CI, -0.6% to 20.6%). The efficacy of ceftaroline is supported by real-world observational data from CAPTURE for patients with both CAP and CABP. In addition, the CAPTURE program afforded an opportunity to assess the outcomes of patients who were excluded or limited in the original Phase III trials in a non-comparative fashion. These underrepresented patient populations with CAP included: patients that received prior antibiotics, patients in the ICU, patients with severe renal dysfunction, and those with methicillin-resistant Staphylococcus aureus (MRSA) isolated from respiratory or blood culture. As CAPTURE is a retrospective, non-comparator convenience sample registry, all the findings need to be interpreted with caution.

  6. Environmental, health, and safety issues of fuel cells in transportation. Volume 1: Phosphoric acid fuel-cell buses

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

    Ring, S

    1994-12-01

    The U.S. Department of Energy (DOE) chartered the Phosphoric Acid Fuel-Cell (PAFC) Bus Program to demonstrate the feasibility of fuel cells in heavy-duty transportation systems. As part of this program, PAFC- powered buses are being built to meet transit industry design and performance standards. Test-bed bus-1 (TBB-1) was designed in 1993 and integrated in March 1994. TBB-2 and TBB-3 are under construction and should be integrated in early 1995. In 1987 Phase I of the program began with the development and testing of two conceptual system designs- liquid- and air-cooled systems. The liquid-cooled PAFC system was chosen to continue, throughmore » a competitive award, into Phase H, beginning in 1991. Three hybrid buses, which combine fuel-cell and battery technologies, were designed during Phase III. After completing Phase II, DOE plans a comprehensive performance testing program (Phase HI) to verify that the buses meet stringent transit industry requirements. The Phase III study will evaluate the PAFC bus and compare it to a conventional diesel bus. This NREL study assesses the environmental, health, and safety (EH&S) issues that may affect the commercialization of the PAFC bus. Because safety is a critical factor for consumer acceptance of new transportation-based technologies the study focuses on these issues. The study examines health and safety together because they are integrally related. In addition, this report briefly discusses two environmental issues that are of concern to the Environmental Protection Agency (EPA). The first issue involves a surge battery used by the PAFC bus that contains hazardous constituents. The second issue concerns the regulated air emissions produced during operation of the PAFC bus.« less

  7. E.E.C. 2000: A Study of Environmental Education Centers. Part I and Parts II & III.

    ERIC Educational Resources Information Center

    Minnesota State Dept. of Natural Resources, St. Paul.

    This report of Environmental Education Centers (EECs) presents recommendations development of long range plans for the development and program coordination of EECs in Minnesota. The plan focuses on identifying programming needs, geographic areas to locate facilities, and capital costs for development and creation of a phased-in implementation…

  8. 40 CFR 63.175 - Quality improvement program for valves.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... improvement program for valves. (a) In Phase III, an owner or operator may elect to comply with one of the... use one of these alternative provisions to comply with the requirements of § 63.168(d)(1)(ii) of this... exceeds 2 percent leaking valves, and in such case, monthly monitoring will be required. (d) The following...

  9. 40 CFR 63.175 - Quality improvement program for valves.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... improvement program for valves. (a) In Phase III, an owner or operator may elect to comply with one of the... use one of these alternative provisions to comply with the requirements of § 63.168(d)(1)(ii) of this... exceeds 2 percent leaking valves, and in such case, monthly monitoring will be required. (d) The following...

  10. Induction chemotherapy followed by alternating chemo-radiotherapy in non-endemic undifferentiated carcinoma of the nasopharynx: optimal compliance and promising 4-year results.

    PubMed

    Ponzanelli, Anna; Vigo, Viviana; Marcenaro, Michela; Bacigalupo, Almalina; Gatteschi, Beatrice; Ravetti, Jean-Luis; Corvò, Renzo; Benasso, Marco

    2008-08-01

    Concomitant chemo-radiotherapy is the standard treatment for advanced nasopharyngeal carcinoma (NPC). Induction chemotherapy may improve the results further by enhancing both loco-regional and distant control. Fifty patients with untreated, stage IV (UICC 1992) undifferentiated NPC were initially treated with three courses of epidoxorubicin, 90 mg/m(2), day 1 and cisplatin, 40 mg/m(2), days 1 and 2, every three weeks and then underwent three courses of cisplatin, 20 mg/m(2)/day, days 1-4 and fluorouracil, 200mg/m(2)/day, days 1-4 (weeks 1, 4, 7), alternated to three splits of radiation (week 2-3, 5-6, 8-9-10) up to 70 Gy. All patients but one received 3 cycles of induction chemotherapy. Toxicities from induction chemotherapy were grade III or IV mucositis (2%), grade III or IV nausea/vomiting (22%), grade III or IV hematological toxicity (6%). At the end of induction phase 12% of CRs, 84% of PRs were recorded. Toxicities from alternating chemo-radiotherapy were grade III or IV mucositis (30%), grade III or IV nausea/vomiting (8%), grade III or IV hematological toxicity (24%). Overall, 86% of CRs and 14% of PRs were observed. Four-year progression free survival and overall survival rates are 71% and 81%, respectively. In a small number of patients studied, no correlation between the level of EGFR overexpression and outcomes was detected. In locally advanced UNPC our combined program including induction chemotherapy followed by alternating chemo-radiotherapy is active and gives promising long-term outcomes with acceptable toxicity and optimal patients' compliance. This program merits to be tested in a phase III trial.

  11. 42 CFR 414.410 - Phased-in implementation of competitive bidding programs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... largest MSAs by total population based on 2009 population estimates, and not already phased in as of June 1, 2008). CMS may subdivide any of the 91 MSAs with a population of greater than 8,000,000 into... population of less than 250,000. (iii) An area with low population density within an MSA not selected under...

  12. 42 CFR 414.410 - Phased-in implementation of competitive bidding programs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... largest MSAs by total population based on 2009 population estimates, and not already phased in as of June 1, 2008). CMS may subdivide any of the 91 MSAs with a population of greater than 8,000,000 into... population of less than 250,000. (iii) An area with low population density within an MSA not selected under...

  13. 42 CFR 414.410 - Phased-in implementation of competitive bidding programs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... largest MSAs by total population based on 2009 population estimates, and not already phased in as of June 1, 2008). CMS may subdivide any of the 91 MSAs with a population of greater than 8,000,000 into... population of less than 250,000. (iii) An area with low population density within an MSA not selected under...

  14. [Long-term physical activity after a myocardial infarction : a permanent challenge].

    PubMed

    Tessitore, Elena; Sigaud, Philippe; Meyer, Philippe; Mach, François

    2017-05-24

    Cardiac rehabilitation is a well-defined multidisciplinary program with the objective to reduce mortality and morbidity, while also improving the exercise capacity and quality of life of the patient following a myocardial infarction. Despite the fact that a cardiovascular rehabilitation program is now recommended by international guidelines for all patients who have suffered from an acute coronary syndrome, only half of all patients actually participate to such a program in Switzerland. Even worse, especially when taking into consideration the population in Geneva, less than 5 % of patients follow a long-term cardiac maintenance program (phase III). Since 2015, our project has been to encourage patients who have completed a phase II cardiac rehabilitation program, to resume regular physical activity in the long term.

  15. Defense Small Business Innovation Research Program (SBIR). Abstracts of Phase I Awards. 1986.

    DTIC Science & Technology

    1986-01-01

    RELATIVE HUMIDITY AT TEMPERATURES FOUND IN ARCTIC ENVIRONMENTS. IT IS BASED ON THE OBSERVATION THAT CERTAIN FLUORESCENT AND PHOSPHORESCENT COMPOUNDS ...FREEDMAN TITLE: III-V COMPOUNDS TRACE ELEMENT PROFILE ANALYSIS USING LASER ASSISTED S PECTROSCOPY T 55 OFFICE: RADC/DOR A NOVEL MICROPROBE ANALYSIS...AND II-VI AND III-V COMPOUNDS . THESE ADVANTAGES MAKE THE LSCE TECHNIQUE PARTICULARY WELL SUITED TO THE DEPOSITION OF QUANTUM WELL AND SUPERLATT ICE

  16. Human factors phase III : effects of train control technology on operator performance

    DOT National Transportation Integrated Search

    2005-01-01

    This report describes a study evaluating the effects of train control technology on locomotive engineer performance. Several types : of train control systems were evaluated: partial automation (cruise control and programmed stop) and full automation ...

  17. Human factors phase III : effects of train control technology on operator performance.

    DOT National Transportation Integrated Search

    2005-01-31

    This report describes a study evaluating the effects of train control technology on locomotive engineer performance. Several types of train control systems were evaluated: partial automation (cruise control and programmed stop) and full automation we...

  18. On-line high-speed rail defect detection, phase III : research results.

    DOT National Transportation Integrated Search

    2005-10-01

    The Federal Railroad Administration (FRA) Office of Research and Developments Track and Structures Program sponsored a study for developing and testing a rail defect detection system based on ultrasonic guided waves and non-contact probing. Curren...

  19. Water-quality data-collection activities in Colorado and Ohio; Phase III, evaluation of existing data for use in assessing regional water-quality conditions and trends

    USGS Publications Warehouse

    Norris, J. Michael; Hren, Janet; Myers, Donna N.; Chaney, Thomas H.; Childress, Carolyn J. Oblinger

    1990-01-01

    During the past several years, a growing number of questions have been raised by members of Congress and others about the status of current waterquality conditions in the Nation, trends in water quality, and the major factors that affect water-quality conditions and trends. One area of particular interest and concern has been the suitability of existing water-quality data for addressing these types of questions at regional and national scales. In response to these questions and concerns, the U.S. Geological Survey began a pilot study in Colorado and Ohio to (1) determine the characteristics of current water-quality data-collection activities of Federal, State, regional, and local agencies and universities; and (2) determine how well the data from these activities, collected for various purposes and using different procedures, can be used to improve our ability to address the aforementioned questions.Colorado and Ohio were chosen for the pilot study because they represent regions with different types of water-quality issues and programs. The results of the study are specific to the two States and are not intended to be extrapolated to other States.The study was divided into three phases whose objectives were:Phase I Identify and inventory 1984 water-quality data-collection programs, including costs, in Colorado and Ohio, and identify those programs that meet a set of broad criteria for producing data that potentially are appropriate for water-quality assessments of regional and national scope. Phase II Evaluate the quality assurance of field and laboratory procedures used to produce the data from programs that met the broad criteria of Phase I. Phase III Compile the qualifying data from Phase II and evaluate the extent to which the resulting data base can be used to address selected water-quality questions for the two States.This report presents the results of Phase III, focusing on (1) the number of measurements made at each data-collection site for selected constituents, (2) the areal distribution of those sites that have sufficient data for selected types of analyses, and (3) the availability of key ancillary information such as streamflow to address broad-scope questions such as:What are existing water-quality conditions?Has the water quality changed? andHow do existing water-quality conditions and changes in these conditions relate to natural factors and human-induced activities?

  20. 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.

  1. The Department of Defense Small Business Innovation Research and Small Business Technology Transfer Programs: Implementation of the Commercialization Pilot Program and Related Reforms

    DTIC Science & Technology

    2011-06-01

    testing and evaluation of SBIR and STTR technologies in SBIR and STTR Phases II and III. The implementation requirements were specified in the text of...manufacturing technologies through the SBIR and STTR programs. Fourth, Congress clarified the authority to conduct testing and evaluation of SBIR and STTR...17  A.  SURVEY GOALS ..........................................................................................17  B.  SURVEY DESIGN

  2. NCTN/NCORP Data Archive: Expanding Access to Clinical Trial Data

    Cancer.gov

    NCI is launching the NCTN/NCORP Data Archive, a centralized repository of patient-level data from phase III clinical trials conducted by NCI’s NCTN and NCORP trials programs and the National Cancer Institute of Canada-Clinical Trials Group.

  3. Intersection collision avoidance using ITS countermeasures. Task 9, Intersection collision avoidance system performance guidelines

    DOT National Transportation Integrated Search

    2000-09-01

    Phase III of the Intersection Collision Avoidance Using ITS Countermeasures program developed testbed systems, implemented the systems on a vehicle, and performed testing to determine the potential effectiveness of this system in preventing intersect...

  4. CHAP III- CHARRING ABLATOR PROGRAM FOR ADVANCED INVESTIGATION OF THERMAL PROTECTION SYSTEMS FOR ENTRY

    NASA Technical Reports Server (NTRS)

    Stroud, C. W.

    1994-01-01

    The transient response of a thermal protection material to heat applied to the surface can be calculated using the CHAP III computer program. CHAP III can be used to analyze pyrolysis gas chemical kinetics in detail and examine pyrolysis reactions-indepth. The analysis includes the deposition of solid products produced by chemical reactions in the gas phase. CHAP III uses a modelling technique which can approximate a wide range of ablation problems. The energy equation used in CHAP III incorporates pyrolysis (both solid and gas reactions), convection, conduction, storage, work, kinetic energy, and viscous dissipation. The chemically reacting components of the solid are allowed to vary as a function of position and time. CHAP III employs a finite difference method to approximate the energy equations. Input values include specific heat, thermal conductivity, thermocouple locations, enthalpy, heating rates, and a description of the chemical reactions expected. The output tabulates the temperature at locations throughout the ablator, gas flow within the solid, density of the solid, weight of pyrolysis gases, and rate of carbon deposition. A sample case is included, which analyzes an ablator material containing several pyrolysis reactions subjected to an environment typical of entry at lunar return velocity. CHAP III is written in FORTRAN IV for batch execution and has been implemented on a CDC CYBER 170 series computer operating under NOS with a central memory requirement of approximately 102K (octal) of 60 bit words. This program was developed in 1985.

  5. Phase III of Early Restoration | NOAA Gulf Spill Restoration

    Science.gov Websites

    information about this phase of Early Restoration, including fact sheets on each project. The final Phase III 44 projects are documented in a final Record of Decision. Information about Phase III of Early Archive Home Phase III of Early Restoration Phase III of Early Restoration Beach habitat would be restored

  6. Performance evaluation of two black nickel and two black chrome solar collectors

    NASA Technical Reports Server (NTRS)

    Losey, R.

    1977-01-01

    The test program was based on the evaluation of four unique solar collectors described below: (1) black nickel collector surface with a desiccant drying bed, (2) black nickel collector surface without a desiccant drying bed, (3) black chrome collector surface with a dessicant drying bed, and (4) black chrome collector surface without a desiccant drying bed. The test program included three distinct phases: Initial performance evaluation, natural environmental aging, and post-aging performance evaluation. Results of Phase III testing conclusively indicated a higher normalized efficiency for Black Chrome surfaces when compared to Black Nickel.

  7. Post-Master's Education for Middle and Upper-Level Personnel in Libraries and Information Centers. Final Report, Phase I.

    ERIC Educational Resources Information Center

    Kortendick, James J.; Stone, Elizabeth W.

    A major way of upgrading the profession of librarianship is through a post-master's education program. This data base for the curriculum development of such a program utilized two data-gathering instruments: (1) a questionnaire and (2) interviews. The data are presented under three-headings: (1) questionnaire results, Chapters III, IV, V and VI;…

  8. Bridging the Technology Valley of Death in Joint Medical Development

    DTIC Science & Technology

    2015-11-01

    Force lieutenant colonel, is the Air Force Medical Support Agency Advanced Development Liaison Field Engineer in Falls Church, Virginia. Prusaczyk is...Awareness, communication and coordination may be mini - mal among Service S&T and AD programs. Joint Transition Planning Process A Joint Transition...Human Proof of Phase III NDA/BLA ling Approval, Launch Concept*** Launch Review Program Initiation Materiel Technology Engineering & Production

  9. Safety and efficacy of a nurse-led clinic for post-operative coronary artery bypass grafting patients.

    PubMed

    Broers, Carla; Hogeling-Koopman, Jeanne; Burgersdijk, Cees; Cornel, Jan H; van der Ploeg, J; Umans, Victor A

    2006-01-04

    New opportunities are emerging for nurses as sovereign health care specialists. In accordance with British and American experience, several universities on the European Continent started Advance Nursing Practice programs for nurses to become certified nurse specialists, functioning as intermediates between the consultant, the ward nurse and the patient. This observational study was conducted to evaluate safety and efficacy of a nurse-led clinic for patients recovering after a successful coronary artery bypass grafting operation. From April 1999 to June 2002, 584 consecutive patients underwent a coronary artery bypass graft operation after which they were admitted to the cardiology ward. Subsequently, these patients were treated either by a certified nurse practitioner or by a resident. Both were supervised by an attending cardiologist. The study elapses three time phases: phase I (1999) first control period, phase II (2000-2002) the nurse practitioner was in charge, and phase III (2002) the second control period. A total of 584 patients were admitted at a mean of 5.5 and 6.3 days after the operation (phase II vs I+III, respectively). Typically these patients were men (79%) with a mean age of 67+/-11 years. During the observation period, 349 patients were treated by the nurse practitioner and 235 by a resident (89 in phase I and 146 in phase III). Two patients suddenly died while admitted. All other patients recovered and were discharged. The nurse-treated patients (phase II) were discharged significantly sooner than those treated by the regular staff (11.5 vs 14.7 days; p<0.001, respectively). The 30-day mortality rate was 0.4% and did not differ between the respective patient or time-phase groups. A nurse-led clinic for patients recovering from a coronary artery bypass graft operation was safely and efficaciously introduced in a large Dutch non-cardiac surgery hospital. This study protocol may serve as a preamble for upcoming nurse-led programs to developed and implement the sovereign care by nurse practitioners for various diseases and in different settings.

  10. Decision-theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta-binomial distribution.

    PubMed

    Hee, Siew Wan; Parsons, Nicholas; Stallard, Nigel

    2018-03-01

    The motivation for the work in this article is the setting in which a number of treatments are available for evaluation in phase II clinical trials and where it may be infeasible to try them concurrently because the intended population is small. This paper introduces an extension of previous work on decision-theoretic designs for a series of phase II trials. The program encompasses a series of sequential phase II trials with interim decision making and a single two-arm phase III trial. The design is based on a hybrid approach where the final analysis of the phase III data is based on a classical frequentist hypothesis test, whereas the trials are designed using a Bayesian decision-theoretic approach in which the unknown treatment effect is assumed to follow a known prior distribution. In addition, as treatments are intended for the same population it is not unrealistic to consider treatment effects to be correlated. Thus, the prior distribution will reflect this. Data from a randomized trial of severe arthritis of the hip are used to test the application of the design. We show that the design on average requires fewer patients in phase II than when the correlation is ignored. Correspondingly, the time required to recommend an efficacious treatment for phase III is quicker. © 2017 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Everglades Ecosystem Assessment: Water Management and Quality, Eutrophication, Mercury Contamination, Soils and Habitat - EPA 904-R-07-001, August 2007

    EPA Pesticide Factsheets

    This report summarizes the results for the Program and 2005 Phase III biogeochemical sampling. This survey documented ecological condition for the 2,063-square-mile freshwater portion of the Everglades Protection Area.

  12. Oregon regional intelligent transportation systems (ITS) integration program. Final phase III report, transit tracker information displays

    DOT National Transportation Integrated Search

    2003-11-14

    Transit Tracker uses global positioning system (GPS) technology to track how far a bus is along its scheduled route. This document presents the evaluation strategies and objectives, the data collection methodologies, and the results of the evaluation...

  13. Phase III Advanced Anodes and Cathodes Utilized in Energy Efficient Aluminum Production Cells

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

    R.A. Christini; R.K. Dawless; S.P. Ray

    2001-11-05

    During Phase I of the present program, Alcoa developed a commercial cell concept that has been estimated to save 30% of the energy required for aluminum smelting. Phase ii involved the construction of a pilot facility and operation of two pilots. Phase iii of the Advanced Anodes and Cathodes Program was aimed at bench experiments to permit the resolution of certain questions to be followed by three pilot cells. All of the milestones related to materials, in particular metal purity, were attained with distinct improvements over work in previous phases of the program. NiO additions to the ceramic phase andmore » Ag additions to the Cu metal phase of the cermet improved corrosion resistance sufficiently that the bench scale pencil anodes met the purity milestones. Some excellent metal purity results have been obtained with anodes of the following composition: Further improvements in anode material composition appear to be dependent on a better understanding of oxide solubilities in molten cryolite. For that reason, work was commissioned with an outside consultant to model the MeO - cryolite systems. That work has led to a better understanding of which oxides can be used to substitute into the NiO-Fe2O3 ceramic phase to stabilize the ferrites and reduce their solubility in molten cryolite. An extensive number of vertical plate bench electrolysis cells were run to try to find conditions where high current efficiencies could be attained. TiB2-G plates were very inconsistent and led to poor wetting and drainage. Pure TiB2 did produce good current efficiencies at small overlaps (shadowing) between the anodes and cathodes. This bench work with vertical plate anodes and cathodes reinforced the importance of good cathode wetting to attain high current efficiencies. Because of those conclusions, new wetting work was commissioned and became a major component of the research during the third year of Phase III. While significant progress was made in several areas, much work needs to be done. The anode composition needs further improvements to attain commercial purity targets. At the present corrosion rate, the vertical plate anodes will wear too rapidly leading to a rapidly increasing anode-cathode gap and thermal instabilities in the cell. Cathode wetting as a function of both cathode plate composition and bath composition needs to be better understood to ensure that complete drainage of the molten aluminum off the plates occurs. Metal buildup appears to lead to back reaction and low current efficiencies.« less

  14. Herpes Zoster and Tofacitinib Therapy in Patients With Rheumatoid Arthritis

    PubMed Central

    Winthrop, Kevin L; Yamanaka, Hisashi; Valdez, Hernan; Mortensen, Eric; Chew, Robert; Krishnaswami, Sriram; Kawabata, Thomas; Riese, Richard

    2014-01-01

    Objective Patients with rheumatoid arthritis (RA) are at increased risk for herpes zoster (HZ) (i.e., shingles). The aim of this study was to determine whether treatment with tofacitinib increases the risk of HZ in patients with RA. Methods HZ cases were identified as those reported by trial investigators from the databases of the phase II, phase III, and long-term extension (LTE) clinical trials in the Tofacitinib RA Development Program. Crude incidence rates (IRs) of HZ per 100 patient-years (with 95% confidence intervals [95% CIs]) were calculated by exposure group. Logistic regression analyses were performed to evaluate potential risk factors for HZ (e.g., age, prednisone use). Results Among 4,789 participants, 239 were identified as having tofacitinib-associated HZ during the phase II, phase III, and LTE trials, of whom 208 (87%) were female and whose median age was 57 years (range 21–75 years). One HZ case (0.4%) was multidermatomal; none of the cases involved visceral dissemination or death. Twenty-four patients with HZ (10%) permanently discontinued treatment with tofacitinib, and 16 (7%) were either hospitalized or received intravenous antiviral drugs. The crude HZ IR across the development program was 4.4 per 100 patient-years (95% CI 3.8–4.9), but the IR was substantially higher within Asia (7.7 per 100 patient-years, 95% CI 6.4–9.3). Older age was associated with HZ (odds ratio 1.9, 95% CI 1.5–2.6), and IRs for HZ were similar between patients receiving 5 mg tofacitinib twice daily (4.4 per 100 patient-years, 95% CI 3.2–6.0) and those receiving 10 mg twice daily (4.2 per 100 patient-years, 95% CI 3.1–5.8). In the phase III trials among placebo recipients, the incidence of HZ was 1.5 per 100 patient-years (95% CI 0.5–4.6). Conclusion In the Tofacitinib RA Development Program, increased rates of HZ were observed in patients treated with tofacitinib compared with those receiving placebo, particularly among patients within Asia. Complicated HZ among tofacitinib-treated patients was rare. PMID:24943354

  15. High-intensity interval training in patients with coronary heart disease: Prescription models and perspectives.

    PubMed

    Ribeiro, Paula A B; Boidin, Maxime; Juneau, Martin; Nigam, Anil; Gayda, Mathieu

    2017-01-01

    Recently, high-intensity interval training (HIIT) has emerged as an alternative and/or complementary exercise modality to continuous aerobic exercise training (CAET) in CHD patients. However, the literature contains descriptions of many HIIT protocols with different stage durations, nature of recovery and intensities. In this review, we discuss the most recent forms of validated HIIT protocols in patients with coronary heart disease (CHD) and how to prescribe and use them during short- and long-term (phase II and III) cardiac rehabilitation programs. We also compare the superior and/or equivalent short- and long-term effects of HIIT versus CAET on aerobic fitness, cardiovascular function, and quality of life; their efficiency, safety, and tolerance; and exercise adherence. Short interval HIIT was found beneficial for CHD patients with lower aerobic fitness and would ideally be used in initiation and improvement stages. Medium and/or long interval HIIT protocols may be beneficial for CHD patients with higher aerobic fitness, and would be ideally used in the improvement and maintenance stages because of their high physiological stimulus. Finally, we propose progressive individualized models of HIIT programs (phase II to III) for patients with CHD and how to ideally use them according to the clinical status of patients and phase of the cardiac rehabilitation program. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  16. Phase III Early Restoration Public Meetings | NOAA Gulf Spill Restoration

    Science.gov Websites

    Archive Home Phase III Early Restoration Public Meetings Phase III Early Restoration Public Meetings share Posted on December 6, 2013 | Assessment and Early Restoration Restoration Area Title: Phase III Early on the draft plan for the third phase of Early Restoration, which proposes more than $625 million in

  17. Problems in Decentralized Decision making and Computation.

    DTIC Science & Technology

    1984-12-01

    systesis being referred to. Findeisen [1982] clarifies this distinction by talking about the "programing" and "execution" phases.) 5. The lower and higher...n ... *iii... -258- Findeisen , W., (1982), "Decentralized and Hierarchical Control Under Consistency or Disagreement of Interest," Automatica, Vol. 18

  18. National Evaluation Program CapWIN: the capital wireless integrated net phase III final report.

    DOT National Transportation Integrated Search

    2008-04-01

    The Capital Area Wireless Integrated Net (CapWIN) is comprised of first responder agencies in the Washington, DC metropolitan area. Through the use of the CapWIN application, responders are able to: 1. Exchange messages with other users at roadside l...

  19. 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.

  20. Meta-analyses and adaptive group sequential designs in the clinical development process.

    PubMed

    Jennison, Christopher; Turnbull, Bruce W

    2005-01-01

    The clinical development process can be viewed as a succession of trials, possibly overlapping in calendar time. The design of each trial may be influenced by results from previous studies and other currently proceeding trials, as well as by external information. Results from all of these trials must be considered together in order to assess the efficacy and safety of the proposed new treatment. Meta-analysis techniques provide a formal way of combining the information. We examine how such methods can be used in combining results from: (1) a collection of separate studies, (2) a sequence of studies in an organized development program, and (3) stages within a single study using a (possibly adaptive) group sequential design. We present two examples. The first example concerns the combining of results from a Phase IIb trial using several dose levels or treatment arms with those of the Phase III trial comparing the treatment selected in Phase IIb against a control This enables a "seamless transition" from Phase IIb to Phase III. The second example examines the use of combination tests to analyze data from an adaptive group sequential trial.

  1. Oregon regional intelligent transportation systems (ITS) integration program. Final phase III report, I-5/Barbur Boulevard Parallel Corridor Traffic Management Demonstration Project

    DOT National Transportation Integrated Search

    2005-07-01

    This report presents the results of the evaluation of the I-5/Barbur Boulevard Parallel Corridor Traffic Management Demonstration Project, a cooperative project between the Oregon Department of Transportation (ODOT) and the City of Portland to integr...

  2. Development of a Medical Humanities Program at Dalhousie University Faculty of Medicine, Nova Scotia, Canada, 1992-2003.

    PubMed

    Murray, Jock

    2003-10-01

    The Medical Humanities Program at Dalhousie University Faculty of Medicine in Nova Scotia, Canada, was initiated in 1992 to incorporate the medical humanities into the learning and experiences of medical students. The goal of the program was to gain acceptance as an integral part of the medical school. The program assumed a broad concept of the medical humanities that includes medical history, literature, music, art, multiculturalism, philosophy, epistemology, theology, anthropology, professionalism, history of alternative therapies, writing, storytelling, health law, international medicine, and ethics. Phase I of the program has provided the same elective and research opportunities in the medical humanities that are available to the students in clinical and basic sciences, and has encouraged and legitimized the involvement of the humanities in the life and learning of the medical student through a wide array of programs and activities. Phase II will focus on further incorporation of the humanities into the curriculum. Phase III will be the development of a graduate program in medical humanities to train more faculty who will incorporate the humanities into their teaching and into the development of education programs.

  3. 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.

  4. The public health impact of malaria vaccine RTS,S in malaria endemic Africa: country-specific predictions using 18 month follow-up Phase III data and simulation models.

    PubMed

    Penny, Melissa A; Galactionova, Katya; Tarantino, Michael; Tanner, Marcel; Smith, Thomas A

    2015-07-29

    The RTS,S/AS01 malaria vaccine candidate recently completed Phase III trials in 11 African sites. Recommendations for its deployment will partly depend on predictions of public health impact in endemic countries. Previous predictions of these used only limited information on underlying vaccine properties and have not considered country-specific contextual data. Each Phase III trial cohort was simulated explicitly using an ensemble of individual-based stochastic models, and many hypothetical vaccine profiles. The true profile was estimated by Bayesian fitting of these models to the site- and time-specific incidence of clinical malaria in both trial arms over 18 months of follow-up. Health impacts of implementation via two vaccine schedules in 43 endemic sub-Saharan African countries, using country-specific prevalence, access to care, immunisation coverage and demography data, were predicted via weighted averaging over many simulations. The efficacy against infection of three doses of vaccine was initially approximately 65 % (when immunising 6-12 week old infants) and 80 % (children 5-17 months old), with a 1 year half-life (exponential decay). Either schedule will avert substantial disease, but predicted impact strongly depends on the decay rate of vaccine effects and average transmission intensity. For the first time Phase III site- and time-specific data were available to estimate both the underlying profile of RTS,S/AS01 and likely country-specific health impacts. Initial efficacy will probably be high, but decay rapidly. Adding RTS,S to existing control programs, assuming continuation of current levels of malaria exposure and of health system performance, will potentially avert 100-580 malaria deaths and 45,000 to 80,000 clinical episodes per 100,000 fully vaccinated children over an initial 10-year phase.

  5. The LOGCAP III to LOGCAP IV Transition in Northern Afghanistan. Contract Services Phase-in and Phase-out on a Grand Scale

    DTIC Science & Technology

    2011-02-01

    Contracting • Engineering and Technology • Logistics • Acquisition Management • Program Management For more information , visit http://clc.dau.mil ...for the collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data...sources, gathering and maintaining the data needed, and completing and reviewing the collection of information . Send comments regarding this burden

  6. Discussion of NAEG distribution and inventory program sampling data in preparation for initiation of phase III

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

    Brady, D.N.; Church, B.W.; White, M.G.

    Soil sampling activities during 1974 were concentrated in Area 5 of the Nevada Test Site (NTS). Area 5 has been assigned the highest priority because of the number of atmospheric test events held and a wide distribution of contaminants. Improved sampling techniques are described. Preliminary data analysis aided in designing a program to infer $sup 239-240$Pu results by Ge(Li) scanning techniques. (auth)

  7. U.S. Air Force Installation Restoration Program. Phase 1. Records Search for Suffolk County Air Force Base (Retired) Landfills 1 and 2. Suffolk County Airport, Westhampton Beach, New York.

    DTIC Science & Technology

    1987-09-20

    of the two study sites (Appendix D). Common species include the herring and ring-billed gull, mourning dove, tree swallow, chimney swift, purple... Species ................... 111-30 III.G ADJACENT LAND USE .................................... 111-31 III.H SUMMARY OF ENVIRONMENTAL FEATURES...methodology, and a list of acronyms/abbreviations used in this report. 1-4 W- x--WW- -- vqwu UV X DECISION TREE Complete List of Locations/Sites I Evaluation

  8. The CTFA Evaluation of Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations.

    PubMed

    Gettings, S D; Lordo, R A; Hintze, K L; Bagley, D M; Casterton, P L; Chudkowski, M; Curren, R D; Demetrulias, J L; Dipasquale, L C; Earl, L K; Feder, P I; Galli, C L; Glaza, S M; Gordon, V C; Janus, J; Kurtz, P J; Marenus, K D; Moral, J; Pape, W J; Renskers, K J; Rheins, L A; Roddy, M T; Rozen, M G; Tedeschi, J P; Zyracki, J

    1996-01-01

    The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation test and comparable data from a selection of promising in vitro eye irritation tests. In Phase III, data from the Draize test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modeling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0-45), where variability in MAS was smallest. This, the confidence with which the MAS of surfactant-based formulations is predicted is greatest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro test results if the purpose is to predict in vivo response using in vitro data.

  9. Los Angeles International Airport Runway Incursion Studies: Phase III--Center-Taxiway Simulation

    NASA Technical Reports Server (NTRS)

    Madson, Michael D.

    2004-01-01

    Phase III of the Los Angeles International Airport Runway Incursion Studies was conducted, under an agreement with HNTB Corporation, at the NASA Ames FutureFlight Central (FFC) facility in June 2003. The objective of the study was the evaluation of a new center-taxiway concept at LAX. This study is an extension of the Phase I and Phase II studies previously conducted at FFC. This report presents results from Phase III of the study, in which a center-taxiway concept between runways 25L and 25R was simulated and evaluated. Phase III data were compared objectively against the Baseline data. Subjective evaluations by participating LAX controllers were obtained with regard to workload, efficiency, and safety criteria. To facilitate a valid comparison between Baseline and Phase III data, the same scenarios were used for Phase III that were tested during Phases I and II. This required briefing participating controllers on differences in airport and airline operations between 2001 and today.

  10. Translation of a Motor Learning Walking Rehabilitation Program Into a Group-Based Exercise Program for Community-Dwelling Older Adults.

    PubMed

    Brach, Jennifer S; Francois, Sara J; VanSwearingen, Jessie M; Gilmore, Sandra; Perera, Subashan; Studenski, Stephanie A

    2016-06-01

    Traditional exercise programs for older adults, which focus on aerobic and strength training, have had only modest effects on walking. Recently, a motor learning exercise program was shown to have greater effects on walking compared with a traditional exercise program. Translating this novel motor learning exercise program into a group exercise program would allow it to be offered as an evidence-based, community-based program for older adults. To translate a walking rehabilitation program based on motor learning theory from one-on-one to group delivery (On the Move) and evaluate multiple aspects of implementation in older adults with impaired mobility. The translation process involved multiple iterations, including meetings of experts in the field (Phase I), focus groups (Phase II), and implementation of the newly developed program (Phase III). Phase III was based on a one-group model of intervention development for feasibility, safety, potential effects, and acceptability. Community sites, including 2 independent living facilities, an apartment building, and a community center. Adults 65 years of age or older who could ambulate independently and who were medically stable. Thirty-one adults, mean age 82.3 ± 5.6 years, were eligible to participate. The group exercise program was held twice a week for 12 weeks. Acceptability of the program was determined by retention and adherence rates and a satisfaction survey. Risk was measured by adverse events and questions on perceived challenge and safety. Mobility was assessed pre- and postintervention by gait speed, Figure of 8 Walk Test, and 6-minute walk test. Modifications to the program included adjustments to format/length, music, education, and group interaction. The 12-week program was completed by 24 of 31 entrants (77%). Adherence was high, with participants attending on average 83% of the classes. Safety was excellent, with only 1 subject experiencing a controlled, noninjurious fall. There was preliminary evidence for improved mobility after the intervention: gait speed improved from 0.76 ± 0.21 to 0.81 ± 0.22 m/s, P = .06; Figure of 8 Walk Test from 13.0 ± 3.9 to 12.0 ± 3.9 seconds, P = .07; and 6-minute walk test from 246 ± 75 to 281 ± 67 m, P = .02. The group-based program was safe and acceptable to older adults with impaired mobility and resulted in potentially clinically meaningful improvements in mobility. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  11. NATO/CCMS PILOT STUDY - EVALUATION OF DEMONSTRATED AND EMERGING TECHNOLOGIES FOR THE TREATMENT OF CONTAMINATED LAND AND GROUNDWATER (PHASE III)

    EPA Science Inventory

    The Council of the North Atlantic Treaty Organization (NATO) established the Committee on the Challenges of Modern Society (CCMS) in 1969. CCMS was charged with developing meaningful programs to share information among countries on environmental and societal issues that complemen...

  12. Repetitively Pulsed Backward-Wave Oscillator Investigations

    DTIC Science & Technology

    1994-03-31

    Sinus-6 High Power BWO Experiments and Theory .................. 6 A . B W O physics .............................................................. 6...B. Experiments with high power output of BWO .............................. 8 Section III. Long Pulse Vacuum BWO Experiments...UNM) has completed its initial phase of research on repetitively pulsed high power backward-wave oscillators (BWOs). The aggressive program that we had

  13. National Dam Inspection Program. Lake of the Four Seasons Dam (NDS-ID Number PA-568, DER-ID Number 40-225) Susquehanna River Basin, Oley Creek, Luzerne County, Pennsylvania. Phase I Inspection Report,

    DTIC Science & Technology

    1980-09-01

    J KIMBALL DACW31-A-C-0020 UNCLASSIFIED NL IIEIIIEEIIIII II/I/ III ////IIfl...f IEEEEEIIIEIIIE SUSQUEHANNA RIVER BASIN OLEY CREEK. LUZERNE COUNTY...IL 21 to10 0 I 6 M . A ka 0 I- * In ~ * .1%fit I aIL a w I iII !i I I .j v IfI a ~ *I f"I :oo -1 o ,* ; i I , 4 -C Zuh U .1 . 1..!! .. "" -w- 4. ’ Z...K -~ / K I~ I I’wTt~y. 4. / I.: .57 /7 uvrt ~1; if, \\ V U 4~ III ~% %(&Ll~~tOOO / Oil, E- L.RBR IBLLSASCAE COSLTN ENGIEER aRHIET TOE~~~. OR- ’A. -l TRE

  14. Space shuttle navigation analysis

    NASA Technical Reports Server (NTRS)

    Jones, H. L.; Luders, G.; Matchett, G. A.; Sciabarrasi, J. E.

    1976-01-01

    A detailed analysis of space shuttle navigation for each of the major mission phases is presented. A covariance analysis program for prelaunch IMU calibration and alignment for the orbital flight tests (OFT) is described, and a partial error budget is presented. The ascent, orbital operations and deorbit maneuver study considered GPS-aided inertial navigation in the Phase III GPS (1984+) time frame. The entry and landing study evaluated navigation performance for the OFT baseline system. Detailed error budgets and sensitivity analyses are provided for both the ascent and entry studies.

  15. Motilin-induced gastric contractions signal hunger in man.

    PubMed

    Tack, J; Deloose, E; Ang, D; Scarpellini, E; Vanuytsel, T; Van Oudenhove, L; Depoortere, I

    2016-02-01

    Hunger is controlled by the brain, which receives input from signals of the GI tract (GIT). During fasting, GIT displays a cyclical motor pattern, the migrating motor complex (MMC), regulated by motilin. To study the relationship between hunger and MMC phases (I-III), focusing on spontaneous and pharmacologically induced phase III and the correlation with plasma motilin and ghrelin levels. The role of phase III was also studied in the return of hunger after a meal in healthy individuals and in patients with loss of appetite. In fasting healthy volunteers, mean hunger ratings during a gastric (62.5±7.5) but not a duodenal (40.4±5.4) phase III were higher (p<0.0005) than during phase I (27.4±4.7) and phase II (37±4.5). The motilin agonist erythromycin, but not the cholinesterase inhibitor neostigmine, induced a premature gastric phase III, which coincided with an increase in hunger scores from 29.2±7 to 61.7±8. The somatostatin analogue octreotide induced a premature intestinal phase III without a rise in hunger scores. Hunger ratings significantly correlated (β=0.05; p=0.01) with motilin plasma levels, and this relationship was lost after erythromycin administration. Motilin, but not ghrelin administration, induced a premature gastric phase III and a rise in hunger scores. In contrast to octreotide, postprandial administration of erythromycin induced a premature gastric phase III accompanied by an early rise in hunger ratings. In patients with unexplained loss of appetite, gastric phase III was absent and hunger ratings were lower. Motilin-induced gastric phase III is a hunger signal from GIT in man. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  16. Initiation of phase III contractions in the jejunum by atropine, hexamethonium and xylocaine in conscious dogs.

    PubMed

    Tohara, K; Uchida, Y; Suzuki, H; Itoh, Z

    2000-02-01

    Mechanisms of initiation of phase III contractions in the jejunum during the digestive state are not well understood. To test whether phase III can be induced by a local injection of various agents in a jejunal segment, a polyethylene tube was chronically placed in a branch of the jejunal artery, and force transducers were chronically placed in the upper jejunum. Local injection of atropine, hexamethonium and xylocaine induced caudal-migrating phase III in the injected segment only in the digestive state, and simultaneous intra-arterial infusions of L-arginine, an NK-1 antagonist, or 5-hydroxytryptamine (5-HT) 1P and 3 antagonists inhibited the induced phase III. Intravenous atropine and hexamethonium also inhibited xylocaine-induced phase III contractions. Atropine and hexamethonium-induced phase III were brought about by inhibition of neural transmission at nicotinic receptors in the inhibitory pathway to NO neurones. NK-1, 5-HT1P and 5-HT3 receptors are present in the excitatory but not the inhibitory pathway to NO neurones. Xylocaine appears to stop neuronal transmission from mechanoreceptors to NO neurones. Thus, the initiation of spontaneous occurrence of phase III in the digestive jejunum is likely to be brought about by transient cessation of postprandial contractions in a segment of the jejunum.

  17. 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

  18. Don't Mess with the NEST

    NASA Astrophysics Data System (ADS)

    Larson, Michael

    2012-03-01

    This presentation will describe the history of the Nuclear Emergency Support Team (NEST) and its evolution over the years. NEST was formed due to a number of nuclear extortion threats received in the early 1970s. From the beginning NEST developed an extensive exercise program to test and expand capabilities. The Nuclear Assessment Program (NAP) was developed, in part, to determine if NEST deployments were required. A major revamp of the NEST program occurred in 1994. Many other organizations work in conjunction with NEST in particular the FBI and DOD. Considerable research and development has been performed in the areas of Access, Search, Diagnostics, Device Assessment, and Disablement. Extensive searches of material appearing in the unclassified literature have been and are being performed to see what is being said about nuclear materials and devices. A comprehensive study of Improvised Nuclear Devices (IND) is ongoing to determine what a terrorist can and cannot do. NEST now consists of four phases with the latest additions of Phase III, Disposition and Phase IV, Nuclear Forensics. LLNL-ABS-521775

  19. Core Engine Noise Program. Volume III. Prediction Methods -- Supplement I. - Extension of Prediction Methods

    DTIC Science & Technology

    1976-03-01

    frequency noise transmission through turbine blade rows and addition of engine and component data to the prediction method for core noise. " Phase VI...lower turbine blade row attenuation for this low bypass engine . When the blade row attenuation is accounted for by means of a turbine work extrac...component and engine data. Currently, an in-depth program to investigate turbine blade row attenuation is underway (NAS3-19435 and DOT-FA75WA-3688). The

  20. A Guide to Computer Simulations of Three Adaptive Instructional Models for the Advanced Instructional System Phases II and III. Final Report.

    ERIC Educational Resources Information Center

    Hansen, Duncan N.; And Others

    Computer simulations of three individualized adaptive instructional models (AIM) were undertaken to determine if these models function as prescribed in Air Force technical training programs. In addition, the project sought to develop a user's guide for effective understanding of adaptive models during field implementation. Successful simulations…

  1. Putting a Medical Library Online: Phase III--Remote Access to CD-ROMs.

    ERIC Educational Resources Information Center

    Kittle, Paul

    1989-01-01

    Describes the implementation of a project that provides dial-up access to MEDLINE on remote optical data disk (CD-ROM) using software that enables callers to use programs like Wordstar, Lotus, and dBase. Highlights include networking CD-ROM databases, hardware considerations, advantages and disadvantages of remote access, and future plans. A…

  2. A Limited Antiballistic Missile System

    DTIC Science & Technology

    1990-12-01

    2.2 ABM Philosophy. .. .. .. .. ... ... ... ...... 2-1 2.3 Ballistic Missile Flight Phases .. .. .. .... ....... 2-3 2.4 Past US Systems...2-7 iii Page 2.4.4 SAFEGUARD .. .. .. .. .. ... ... ..... 2-8 2.4.5 Other Programs. .. .. .. .. ... ... ..... 2-9 2.5 Current ABM ...2.5.6 Summary of ABM Characteristics. .. .. ..... 2-11 2.6 The Threat .. .. .. .. ... ... ... ... ... ... 2-12 2.6.1 The Middle East

  3. 75 FR 47269 - Pilot Program for Waiver of Patent Owner's Statement in Ex Parte Reexamination Proceedings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-05

    ... expected to form a portion of the data used in the decision making processes in phases II and III. Dated... likely to improve efficiency. Such changes may include internal procedural changes, rule making that... notice will take effect on August 5, 2010. FOR FURTHER INFORMATION CONTACT: Robert A. Clarke, Kenneth M...

  4. Development of a Semi-Autonomous Underwater Vehicle for Intervention Missions (SAUVIM Phase III-C)

    DTIC Science & Technology

    2010-01-28

    James Fein from ONR, Mr. Chris Hillenbrand became the ONR Program Officer for the SAUVIM project. In 2002, Dr. David Drumheller became the new ONR...Gary McMurtry, Dr. Song K. Choi & Mr. Oliver T. Easterday Past Personnel: Mr. Yann Douyere, Mr. Alan Parsa & Mr. Max D. Cremer Objectives The

  5. Phase 0/I/II Cancer Prevention Clinical Trials Program Clinical Trials | Division of Cancer Prevention

    Cancer.gov

    The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk. This knowledge is critical to making progress against cancer because risk varies over the lifespan as genetic and epigenetic changes can transform healthy tissue into invasive cancer.

  6. 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.

  7. Quantifying Acoustic Impacts on Marine Mammals and Sea Turtles: Methods and Analytical Approach for Phase III Training and Testing

    DTIC Science & Technology

    2017-06-16

    Acoustic Impacts on Marine Mammals and Sea Turtles: Methods and Analytical Approach for Phase III Training and Testing Sarah A. Blackstock Joseph O...December 2017 4. TITLE AND SUBTITLE Quantifying Acoustic Impacts on Marine Mammals and Sea Turtles: Methods and Analytical Approach for Phase III...Navy’s Phase III Study Areas as described in each Environmental Impact Statement/ Overseas Environmental Impact Statement and describes the methods

  8. 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.

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

    Hoffman, Greg; Marotz, Brian L.; Dunnigan, James

    ''Mitigation for the Construction and Operation of Libby Dam'' is part of the Northwest Power Planning Council's resident fish and wildlife program. The program was mandated by the Northwest Planning Act of 1980, and is responsible for mitigating for damages to fish and wildlife caused by hydroelectric development in the Columbia River Basin. The objective of Phase I of the project (1983 through 1987) was to maintain or enhance the Libby Reservoir fishery by quantifying seasonal water levels and developing ecologically sound operational guidelines. The objective of Phase II of the project (1988 through 1996) was to determine the biologicalmore » effects of reservoir operations combined with biotic changes associated with an aging reservoir. The objectives of Phase III of the project (1996 through present) are to implement habitat enhancement measures to mitigate for dam effects, to provide data for implementation of operational strategies that benefit resident fish, monitor reservoir and river conditions, and monitor mitigation projects for effectiveness.« less

  10. Cilansetron. Solvay.

    PubMed

    Stacher, G

    2001-10-01

    Cilansetron is a 5-HT3 antagonist tinder development by Solvay Pharmaceuticals as a potential treatment for irritable bowel syndrome (IBS). The compound targets non-constipated men and women with IBS. Cilansetron is being evaluated in phase III trials, but up to now, only scarce information has been made available and most publications have appeared in abstract form only. In July 2001, it was reported that regulatory submissions were expected in 2003 [416185]. Also in July 2001, after discussion with the FDA, Solvay initiated a revised phase III program in diarrhea-predominant IBS and signed a five-year 'preferred-provider' clinical services agreement with Quintiles Transnational to conduct the trial. At this time, Solvay was also seeking marketing partners for cilansetron [416185]. By October 1999, Solvay was treating cilansetron as one of its main priorities, as it represented a novel class of compound [342434]. Solvay has predicted peak sales of euro 100 m to euro 1000 m [420654].

  11. Contrave, a bupropion and naltrexone combination therapy for the potential treatment of obesity.

    PubMed

    Padwal, Raj

    2009-10-01

    Contrave, under development by Orexigen Therapeutics Inc for the potential treatment of obesity, is an oral, sustained-release combination of the dopamine and norepinephrine reuptake antagonist bupropion and the opioid antagonist naltrexone. The proposed dual mechanism of action of the compound involves complementary stimulation of central melanocortin pathways, resulting in increased energy expenditure and reduced appetite. At the time of publication, Contrave was being assessed in phase III clinical trials. Preliminary data demonstrated placebo-subtracted weight losses of 3 to 7% and improvements in obesity-related comorbidities and cardiovascular risk factors. The primary adverse effect leading to discontinuation of treatment was nausea. Assuming that the results of the Contrave phase III clinical program reaffirm the efficacy and safety of the drug combination, this agent could be approved and launched to become a market leader in the anti-obesity therapeutic arena.

  12. Microswitch-aided programs to support physical exercise or adequate ambulation in persons with multiple disabilities.

    PubMed

    Lancioni, Giulio E; Singh, Nirbhay N; O'Reilly, Mark F; Sigafoos, Jeff; Alberti, Gloria; Perilli, Viviana; Oliva, Doretta; Buono, Serafino

    2014-09-01

    Three microswitch-aided programs were assessed in three single-case studies to enhance physical exercise or ambulation in participants with multiple disabilities. Study I was aimed at helping a woman who tended to have the head bending forward and the arms down to exercise a combination of appropriate head and arms movements. Study II was aimed at promoting ambulation continuity with a man who tended to have ambulation breaks. Study III was aimed at promoting ambulation with appropriate foot position in a girl who usually showed toe walking. The experimental designs of the studies consisted of a multiple probe across responses (Study I), an ABAB sequence (Study II), and an ABABB(1) sequence (Study III). The last phase of each study was followed by a post-intervention check. The microswitches monitored the target responses selected for the participants and triggered a computer system to provide preferred stimuli contingent on those responses during the intervention phases of the studies. Data showed that the programs were effective with each of the participants who learned to exercise head and arms movements, increased ambulation continuity, and acquired high levels of appropriate foot position during ambulation, respectively. The positive performance levels were retained during the post-intervention checks. The discussion focused on (a) the potential of technology-aided programs for persons with multiple disabilities and (b) the need of replication studies to extend the evidence available in the area. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. The ASPRS Remote Sensing Industry Forecast: Phase II & III - Digital Sensor Compilation

    NASA Technical Reports Server (NTRS)

    Mondello, Charles

    2007-01-01

    In August 1999, ASPRS and NASA's (then) Commercial Remote Sensing Program (CRSP) entered into a 5-year Space Act Agreement (SAA), combining resources and expertise to: (a) Baseline the Remote Sensing Industry (RSI) based on GEIA Model; (b) Develop a 10-Year RSI market forecast and attendant processes; and (c) Provide improved information for decision makers.

  14. A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

    PubMed

    Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

    2007-09-01

    Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

  15. Evaluate fundamental approaches to longwall dust control. Phase III report

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

    Babbitt, C.; Bartlett, P.; Kelly, J.

    1984-03-31

    The overall objective of the contract is to evaluate the effectiveness of available dust control technology for double-drum shearer longwall sections in a coordinated, systematic program at a few longwall test sections and to make the results available to the entire coal mining industry. This program is investigating nine different dust control techniques. These nine subprograms encompass a broad range of dust control measures ranging from administrative controls to new hardware. They span not only presently employed methods but also those recently adopted in the United States and those proposed for the future. This report documents the Phase III effortmore » on each of the subprograms. For clarity, the report is divided in sections by subprogram as follows: Section 2, Subprogram A - passive barriers/spray air movers for dust control; Section 3, Subprogram B - practical aspects of deep cutting; Section 4, Subprogram C - stage loader dust control; Section 5, Subprogram D - longwall automation technology; Section 6, Subprogram E - longwall application of ventilation curtains; Section 7, Subprogram F - reversed drum rotation; Section 8, Subprogram G - reduction of shield generated dust; Section 9, Subprogram H - air canopies for longwalls; and Section 10, Subprogram I - mining practices. 43 figures, 11 tables.« less

  16. Development and functionality of a handheld computer program to improve fruit and vegetable intake among low-income youth

    PubMed Central

    Nollen, Nicole L.; Hutcheson, Tresza; Carlson, Susan; Rapoff, Michael; Goggin, Kathy; Mayfield, Carlene; Ellerbeck, Edward

    2013-01-01

    Mobile technologies hold promise for improving diet and physical activity, but little attention is given to creating programs that adolescents like and will use. This study developed a personal digital assistant (PDA) program to promote increased intake of fruits and vegetables (FV) in predominately low-income, ethnic minority girls. This study used a three-phase community-engaged process, including (i) engagement of a Student Advisory Board (SAB) to determine comfort with PDAs; (ii) early testing of Prototype I and rapid re-design by the SAB and (iii) feasibility testing of Prototype II in a new sample of girls. Phase 1 results showed that girls were comfortable with the PDA. Testing of Prototype I in Phase 2 showed that acceptability was mixed, with girls responding to 47.3% of the prompts. Girls wanted more reminders, accountability in monitoring FV, help in meeting daily goals and free music downloads based on program use. The PDA was reprogrammed and testing of Prototype II in Phase 3 demonstrated marked improvement in use (78.3%), increases in FV intake (1.8 ± 2.6 daily servings) and good overall satisfaction. Findings suggest that mobile technology designed with the early input of youth is a promising way to improve adolescent health behaviors. PMID:22949499

  17. Shuttle: forever young?

    PubMed

    Sietzen, Frank

    2002-01-01

    NASA has started a 4-phase program of upgrades designed to increase safety and extend use of the space shuttles through the year 2020. Phase I is aimed at improving vehicle safety and supporting the space station. Phase II is aimed at combating obsolescence and includes a checkout launch and control system and protection from micrometeoroids and orbital debris. Phase III is designed to expand or enhance the capabilities of the shuttle and includes development of an auxiliary power unit, avionics, a channel-wall nozzle, extended nose landing gear, long-life fuel cells, a nontoxic orbital maneuvering system/reaction control system, and a water membrane evaporator. Phase IV is aimed at design of system changes that would alter the shuttle mold line and configuration; projects include a five-segment solid rocket booster, liquid flyback boosters, and a crew escape module.

  18. 77 FR 40936 - 60-Day Notice of Proposed Information Collection: Passport Demand Forecasting Study Phase III

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-11

    ...: Passport Demand Forecasting Study Phase III ACTION: Notice of request for public comments. SUMMARY: The... of 1995. Title of Information Collection: Passport Demand Forecasting Study Phase III. OMB Control... Consular Affairs/Passport Services (CA/PPT) Form Number: SV-2012-0006. Respondents: A national...

  19. Integrating ADNI Results into Alzheimer’s Disease Drug Development Programs

    PubMed Central

    Cummings, Jeffrey L.

    2010-01-01

    The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is providing critical new information on biomarkers in cognitively normal elderly, persons with mild cognitive impairment (MCI), and patients with mild Alzheimer’s disease (AD). The data provide insights into the progression of the pathology of AD over time, assist in understanding which biomarkers might be most useful in clinical trials, and facilitate development of disease-modifying treatments. ADNI results are intended to support new AD Treatments development; this paper considers how ADNI information can be integrated in AD drug development programs. Cerebrospinal fluid (CSF) amyloid beta protein (Aβ) measures can be used in Phase I studies to detect any short term effects on Aβ levels in the CSF. Phase II studies may benefit most from biomarker measures that can inform decisions about Phase III. CSF Aβ levels, CSF total tau and phospotau measures, fluorodexoyglucose positron emission tomography (FDG PET), Pittsburgh Compound B (PIB) amyloid imaging, or magnetic resonance imaging (MRI) may be employed to select patient in enriched trials or as outcomes for specific disease-modifying interventions. Use of biomarkers may allow Phase II trials to be conducted more efficiently with smaller populations of patients or shorted treatment times. New drug applications (NDA) may include biomarker outcomes of phase III trials. ADNI patients are highly educated and are nearly all of Caucasian ethnicity limiting the generalizability of the results to other populations commonly included in global clinical trials. ADNI has inspired or collaborates with biomarker investigations worldwide and together these studies will provide biomarker information that can reduce development times and costs, improve drug safety, optimize drug efficacy, and bring new treatments to patients with or at risk for AD. PMID:20447734

  20. A seamless phase IIB/III adaptive outcome trial: design rationale and implementation challenges.

    PubMed

    Chen, Y H Joshua; Gesser, Richard; Luxembourg, Alain

    2015-02-01

    The licensed four-valent prophylactic human papillomavirus vaccine is highly efficacious in preventing cervical, vulvar, vaginal, and anal cancers and related precancers caused by human papillomavirus types 6, 11, 16, and 18. These four types account for approximately 70% of cervical cancers. A nine-valent human papillomavirus vaccine, including the four original types (6, 11, 16, and 18) plus the next five most prevalent types in cervical cancer (31, 33, 45, 52, and 58) could provide approximately 90% overall cervical cancer coverage. To expedite the nine-valent human papillomavirus vaccine clinical development, an adaptive, seamless Phase IIB/III outcome trial with ∼ 15,000 subjects was conducted to facilitate dose formulation selection and provide pivotal evidence of safety and efficacy for regulatory registrations. We discuss the design rationale and implementation challenges of the outcome trial, focusing on the adaptive feature of the seamless Phase IIB/III design. Subjects were enrolled in two parts (Part A and Part B). Approximately 1240 women, 16-26 years of age, were enrolled in Part A for Phase IIB evaluation and equally randomized to one of three dose formulations of the nine-valent human papillomavirus vaccine or the four-valent human papillomavirus vaccine (active control). Based on an interim analysis of immunogenicity and safety, one dose formulation of the nine-valent human papillomavirus vaccine was selected for evaluation in the Phase III part of the study. Subjects enrolled in Part A who received the selected dose formulation of the nine-valent human papillomavirus vaccine or four-valent human papillomavirus vaccine continued to be followed up and contributed to the final efficacy and safety analyses. In addition, ∼ 13,400 women 16-26 years of age were enrolled in Part B, randomized to nine-valent human papillomavirus vaccine at the selected dose formulation or four-valent human papillomavirus vaccine, and followed for immunogenicity, efficacy, and safety. A seamless Phase IIB/III design was justified by the extensive pre-existing knowledge of the licensed four-valent human papillomavirus vaccine and the development objectives for the nine-valent human papillomavirus vaccine. Subjects enrolled in Part A who received either the selected nine-valent human papillomavirus formulation or four-valent human papillomavirus vaccine contributed ∼ 10% of person-years of follow-up due to its earlier start-thereby maximizing the overall efficiency of the trial. Some of the challenges encountered in the implementation of the adaptive design included practical considerations during Phase IIB formulation selection by internal and external committees, End-of-Phase II discussion with health authorities and managing changes in the assay for immunological endpoints. Application of the experience and lesson learned from this seamless adaptive design to other clinical programs may depend on case-by-case consideration. A seamless Phase IIB/III adaptive design was successfully implemented in this large outcome study. The development time of the second-generation nine-valent human papillomavirus vaccine was shortened due to improved statistical efficiency. © The Author(s) 2014.

  1. 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

  2. Re-defining one's occupational self 2 years after breast cancer: a case study.

    PubMed

    Newman, Robin M

    2013-01-01

    Margaret*, a 56 year-old Caucasian Stage III breast cancer survivor, participated in a 5 week occupational therapy pilot program, called Take Action. This program was designed for breast cancer survivors who self-reported changes in cognitive function following completion of chemotherapy. The goals of the program were to improve participants' knowledge and use of strategies to enhance occupational performance and to improve satisfaction and performance of meaningful daily activities or occupations. Through a client-centered and evidence-based approach, this case study highlights the importance of incorporating the survivors' sense of self into an occupation-based intervention. Occupational therapists play an important role in facilitating exploration of sense of self in the survivorship phase of care to support occupational performance in self care, productivity, work, leisure and social participation. This case study highlights the important work of redefining oneself in the survivorship phase of care. (*denotes name change).

  3. A multiyear assessment of a hospital-school program to promote teen motor vehicle safety.

    PubMed

    Unni, Purnima; Estrada, Cristina M; Chung, Dai H; Riley, Emily B; Worsley-Hynd, Lesley; Stinson, Neil

    2017-08-01

    Motor vehicle crashes are the leading cause of death among teen drivers. The main goal of this program was to reduce texting while driving among high school teens through a unique peer-generated anti-texting campaign. The program consisted of two phases. In phase 1, student leaders participated in a half-day, hospital-based experiential program that emphasized safe teen driving. In phase 2, these students conceptualized and implemented an anti-texting while driving campaign during the school year. The program enrolled 32 schools with 137 student participants in phase 1.This study uses a prospective quasi-experimental pre-post design. A presurvey and a follow-up online survey were used. Response rate was 81%. In phase 2, two rounds of observations of drivers were made near the participating schools at the beginning and end of the phase 2 campaign. The results were analyzed using proportion tests. There was a strong belief (6.49 on a seven-point scale) that texting while driving could result in a crash. About 58% had texted while driving in the previous 7 days in the pre-survey. This proportion decreased significantly to 44% in the follow-up (p < 0.05). Knowledge of Tennessee Graduated Driver Licensing laws and feeling of empowerment to take action with a teen driver who was texting improved significantly (p < 0.05). In phase 2, 12,309 drivers (adults and teens) were observed in the first round, and 13,153 were observed in the second round of observations. Significant reduction in the proportion of drivers texting while driving (from 13% to 9%; p < 0.0001) was observed. Results of driver observations support the effectiveness of this program in meeting the key objective of reducing texting while driving. The program also influenced teenagers' willingness to take positive steps when faced with a driver who was texting. Future efforts should aim to influence social and peer norms. Therapeutic study, level III.

  4. Advances in Electrically Driven Thermal Management

    NASA Technical Reports Server (NTRS)

    Didion, Jeffrey R.

    2017-01-01

    Electrically Driven Thermal Management is a vibrant technology development initiative incorporating ISS based technology demonstrations, development of innovative fluid management techniques and fundamental research efforts. The program emphasizes high temperature high heat flux thermal management required for future generations of RF electronics and power electronic devices. This presentation reviews i.) preliminary results from the Electrohydrodynamic (EHD) Long Term Flight Demonstration launched on STP-H5 payload in February 2017 ii.) advances in liquid phase flow distribution control iii.) development of the Electrically Driven Liquid Film Boiling Experiment under the NASA Microgravity Fluid Physics Program.

  5. The American College of Surgeons/Association of Program Directors in Surgery National Skills Curriculum: adoption rate, challenges and strategies for effective implementation into surgical residency programs.

    PubMed

    Korndorffer, James R; Arora, Sonal; Sevdalis, Nick; Paige, John; McClusky, David A; Stefanidis, Dimitris

    2013-07-01

    The American College of Surgeons/Association of Program Directors in Surgery (ACS/APDS) National Skills Curriculum is a 3-phase program targeting technical and nontechnical skills development. Few data exist regarding the adoption of this curriculum by surgical residencies. This study attempted to determine the rate of uptake and identify implementation enablers/barriers. A web-based survey was developed by an international expert panel of surgical educators (5 surgeons and 1 psychologist). After piloting, the survey was sent to all general surgery program directors via email link. Descriptive statistics were used to determine the residency program characteristics and perceptions of the curriculum. Implementation rates for each phase and module were calculated. Adoption barriers were identified quantitatively and qualitatively using free text responses. Standardized qualitative methodology of emergent theme analysis was used to identify strategies for success and details of support required for implementation. Of the 238 program directors approached, 117 (49%) responded to the survey. Twenty-one percent (25/117) were unaware of the ACS/APDS curriculum. Implementation rates for were 36% for phase I, 19% for phase II, and 16% for phase III. The most common modules adopted were the suturing, knot-tying, and chest tube modules of phase I. Over 50% of respondents identified lack of faculty protected time, limited personnel, significant costs, and resident work-hour restrictions as major obstacles to implementation. Strategies for effective uptake included faculty incentives, adequate funding, administrative support, and dedicated time and resources. Despite the availability of a comprehensive curriculum, its diffusion into general surgery residency programs remains low. Obstacles related to successful implementation include personnel, learner, and administrative issues. Addressing these issues may improve the adoption rate of the curriculum. Copyright © 2013 Mosby, Inc. All rights reserved.

  6. A PHASED REHABILITATION PROTOCOL FOR ATHLETES WITH LUMBAR INTERVERTEBRAL DISC HERNIATION

    PubMed Central

    VanGelder, Leonard H.; Vaughn, Daniel W.

    2013-01-01

    Conservative non-surgical management of a herniated lumbar intervertebral disc (HLD) in athletes is a complex task due to the dramatic forces imparted on the spine during sport participation. The demands placed upon the athlete during rehabilitation and return to sport are unique not only from a sport specific perspective, but also regarding return to the sport strength and conditioning programs utilized for sport preparation. Many prescriptions fail to address postural and motor control faults specific to athletic development, which may prevent full return to sport after suffering a HLD or predispose the athlete to future exacerbations of a HLD. Strength exercises involving squatting, deadlifting, and Olympic power lifts are large components of the typical athlete's conditioning program, therefore some progressions are provided to address potential underlying problems in the athlete's technique that may have contributed to their HLD in the first place. The purpose of this clinical commentary is to propose a framework for rehabilitation that is built around the phases of healing of the disc. Phase I: Non-Rotational/Non-Flexion Phase (Acute Inflammatory Phase), Phase II: Counter rotation/Flexion Phase (Repair Phase), Phase III: Rotational Phase/Power development (Remodeling Phase), and Phase IV: Full return to sport. This clinical commentary provides a theoretical basis for these phases based on available literature as well as reviewing many popular current practice trends in the management of an HLD. The authors recognize the limits of any general exercise rehabilitation recommendation with regard to return to sport, as well as any general strength and conditioning program. It is vital that an individual assessment and prescription is made for every athlete which reviews and addresses movement in all planes of motion under all necessary extrinsic and intrinsic demands to that athlete. Level of Evidence: 5 PMID:24175134

  7. Effect of Porous Media and Fluid Properties on Dense Non-Aqueous Phase Liquid Migration and Dilution Mass Flux

    DTIC Science & Technology

    2005-08-01

    Research and iii Development Program, Department of Defense, who in part funded this research (CU- 1295: Impacts of DNAPL Source Zone Treatment : Experimental...Trichlorosilane Treatment and Retardation Factor ....................... 46 Results and D iscussion... treatments . Water entry rates were then experimentally measured for various media treatments altering contact angle. With all other data known, contact

  8. 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.

  9. Security Quality Requirements Engineering (SQUARE): Case Study Phase III

    DTIC Science & Technology

    2006-05-01

    Security Quality Requirements Engineering (SQUARE): Case Study Phase III Lydia Chung Frank Hung Eric Hough Don Ojoko-Adams Advisor...Engineering (SQUARE): Case Study Phase III CMU/SEI-2006-SR-003 Lydia Chung Frank Hung Eric Hough Don Ojoko-Adams Advisor Nancy R. Mead...1 1.1 The SQUARE Process ............................................................................... 1 1.2 Case Study Clients

  10. Suboptimal Dosing Parameters as Possible Factors in the Negative Phase III Clinical Trials of Progesterone for Traumatic Brain Injury.

    PubMed

    Howard, Randy B; Sayeed, Iqbal; Stein, Donald G

    2017-06-01

    To date, outcomes for all Phase III clinical trials for traumatic brain injury (TBI) have been negative. The recent disappointing results of the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT) and Study of a Neuroprotective Agent, Progesterone, in Severe Traumatic Brain Injury (SyNAPSe) Phase III trials for progesterone in TBI have triggered considerable speculation about the reasons for the negative outcomes of these two studies in particular and for those of all previous Phase III TBI clinical trials in general. Among the factors proposed to explain the ProTECT III and SyNAPSe results, the investigators themselves and others have cited: 1) the pathophysiological complexity of TBI itself; 2) issues with the quality and clinical relevance of the preclinical animal models; 3) insufficiently sensitive clinical endpoints; and 4) inappropriate clinical trial designs and strategies. This paper highlights three critical trial design factors that may have contributed substantially to the negative outcomes: 1) suboptimal doses and treatment durations in the Phase II studies; 2) the strategic decision not to perform Phase IIB studies to optimize these variables before initiating Phase III; and 3) the lack of incorporation of the preclinical and Chinese Phase II results, as well as allometric scaling principles, into the Phase III designs. Given these circumstances and the exceptional pleiotropic potential of progesterone as a TBI (and stroke) therapeutic, we are advocating a return to Phase IIB testing. We advocate the incorporation of dose and schedule optimization focused on lower doses and a longer duration of treatment, combined with the addressing of other potential trial design problems raised by the authors in the recently published trial results.

  11. Similar efficacy for phase I trials in comparison with DTIC for advanced malignant melanoma: an analysis of melanoma outcomes in CTEP-sponsored phase I trials 1995-2011.

    PubMed

    Luke, Jason J; Rubinstein, Lawrence V; Smith, Gary L; Ivy, S Percy; Harris, Pamela J

    2013-04-01

    After ipilimumab, vemurafenib, and interleukin-2, standard of care chemotherapy for melanoma remains dacarbazine (response rate ∼9%). Despite this, many physicians hesitate to refer patients to phase I protocols given a perceived lack of clinical benefit and potential for harm. To better understand the validity of these perceptions, the experience of all patients with melanoma treated on phase I trials sponsored by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) from 1995 to 2011 were analyzed and compared with the pooled results of six contemporary phase III trials of dacarbazine. A total of 937 patients with melanoma were treated in 148 CTEP phase I trials. The majority were men with a median of two prior therapies (46% receiving prior dacarbazine). Response and clinical benefit rates in these trials were not clinically different from those of dacarbazine (phase I: 6.3 and 26.8% vs. dacarbazine: 8.8 and 27.9%) although grades 3 and 4 toxicity was significantly higher (54 vs. 28%). Efficacy and toxicity were generally consistent within phase I subgroups (targeted agents, immunotherapies, or chemotherapeutics) though targeted therapy was associated with a lower response rate, immunotherapy with lower clinical benefit rate, and chemotherapy with higher incidence of grade 4 toxicity. Thus, the perception of limited efficacy of phase I trials for patients with melanoma was disproven, whereas the perception of toxicity was observed. However, this difference in toxicity may have been largely because of the nature of phase I vs. phase III trials (i.e. more heavily pretreated) and because of the phase I trials often being multiagent as opposed to dacarbazine alone. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.

  12. CHEMKIN-III: A FORTRAN chemical kinetics package for the analysis of gas-phase chemical and plasma kinetics

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

    Kee, R.J.; Rupley, F.M.; Meeks, E.

    1996-05-01

    This document is the user`s manual for the third-generation CHEMKIN package. CHEMKIN is a software package whose purpose is to facilitate the formation, solution, and interpretation of problems involving elementary gas-phase chemical kinetics. It provides a 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 a 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 Subroutine Library.more » This library is a collection of about 100 highly modular FORTRAN subroutines that may be called to return information on equations of state, thermodynamic properties, and chemical production rates. CHEMKIN-III includes capabilities for treating multi-fluid plasma systems, that are not in thermal equilibrium. These new capabilities allow researchers to describe chemistry systems that are characterized by more than one temperature, in which reactions may depend on temperatures associated with different species; i.e. reactions may be driven by collisions with electrons, ions, or charge-neutral species. These new features have been implemented in such a way as to require little or no changes to CHEMKIN implementation for systems in thermal equilibrium, where all species share the same gas temperature. CHEMKIN-III now has the capability to handle weakly ionized plasma chemistry, especially for application related to advanced semiconductor processing.« less

  13. 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...

  14. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study.

    PubMed

    Torresi, Joseph; Heron, Leon G; Qiao, Ming; Marjason, Joanne; Chambonneau, Laurent; Bouckenooghe, Alain; Boaz, Mark; van der Vliet, Diane; Wallace, Derek; Hutagalung, Yanee; Nissen, Michael D; Richmond, Peter C

    2015-09-22

    The recombinant yellow fever-17D-dengue virus, live, attenuated, tetravalent dengue vaccine (CYD-TDV) has undergone extensive clinical trials. Here safety and consistency of immunogenicity of phase III manufacturing lots of CYD-TDV were evaluated and compared with a phase II lot and placebo in a dengue-naïve population. Healthy 18-60 year-olds were randomly assigned in a 3:3:3:3:1 ratio to receive three subcutaneous doses of either CYD-TDV from any one of three phase III lots or a phase II lot, or placebo, respectively in a 0, 6, 12 month dosing schedule. Neutralising antibody geometric mean titres (PRNT50 GMTs) for each of the four dengue serotypes were compared in sera collected 28 days after the third vaccination-equivalence among lots was demonstrated if the lower and upper limits of the two-sided 95% CIs of the GMT ratio were ≥0.5 and ≤2.0, respectively. 712 participants received vaccine or placebo and 614 (86%) completed the study; 17 (2.4%) participants withdrew after adverse events. Equivalence of phase III lots was demonstrated for 11 of 12 pairwise comparisons. One of three comparisons for serotype 2 was not statistically equivalent. GMTs for serotype 2 in phase III lots were close to each other (65.9, 44.1 and 58.1, respectively). Phase III lots can be produced in a consistent manner with predictable immune response and acceptable safety profile similar to previously characterised phase II lots. The phase III lots may be considered as not clinically different as statistical equivalence was shown for serotypes 1, 3 and 4 across the phase III lots. For serotype 2, although equivalence was not shown between two lots, the GMTs observed in the phase III lots were consistently higher than those for the phase II lot. As such, in our view, biological equivalence for all serotypes was demonstrated. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Effects of step-feeding and intermittent aeration on organics and nitrogen removal in a horizontal subsurface flow constructed wetland.

    PubMed

    Patil, Sagar; Chakraborty, Saswati

    2017-03-21

    The effect of step feed strategy and intermittent aeration on removal of chemical oxygen demand (COD) and nitrogen was investigated in a laboratory scale horizontal subsurface flow constructed wetland (HSSFCW). Wetland was divided into four zones along the length (zone I to IV), and influent was introduced into first and third zones by step feeding. Continuous study was carried out in four phases. In phases I to III, 30% of influent was bypassed to zone III for denitrification along with organics removal. Intermittent aeration was provided only in zone II at 2.5 L/min for 4 h/day, during phases II, III and IV. In phase I, 87% COD and 43% NH 4 + -N (ammonia-nitrogen) removal were obtained from influents of 331 and 30 mg/L, respectively. In phase II study, external aeration resulted in 97% COD and 71% NH 4 + -N removal in the wetland. In phase IV, 40% of feed was delivered to zone III. Higher supply of organic in zone III resulted in higher denitrification, and total nitrogen removal rate increased to 70% from 56%. In the final effluent, concentration of NO 3 - -N was 9-11 mg/L in phase I to III and decreased to 4 mg/L in phase IV. Batch study showed that COD and NH 4 + -N removal followed first order kinetics in different zones of wetland.

  16. Unraveling the Mystery of the Blue Fog: Structure, Properties, and Applications of Amorphous Blue Phase III.

    PubMed

    Gandhi, Sahil Sandesh; Chien, Liang-Chy

    2017-12-01

    The amorphous blue phase III of cholesteric liquid crystals, also known as the "blue fog," are among the rising stars in materials science that can potentially be used to develop next-generation displays with the ability to compete toe-to-toe with disruptive technologies like organic light-emitting diodes. The structure and properties of the practically unobservable blue phase III have eluded scientists for more than a century since it was discovered. This progress report reviews the developments in this field from both fundamental and applied research perspectives. The first part of this progress report gives an overview of the 130-years-long scientific tour-de-force that very recently resulted in the revelation of the mysterious structure of blue phase III. The second part reviews progress made in the past decade in developing electrooptical, optical, and photonic devices based on blue phase III. The strong and weak aspects of the development of these devices are underlined and criticized, respectively. The third- and-final part proposes ideas for further improvement in blue phase III technology to make it feasible for commercialization and widespread use. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  17. Failures in Phase III: Causes and Consequences.

    PubMed

    Seruga, Bostjan; Ocana, Alberto; Amir, Eitan; Tannock, Ian F

    2015-10-15

    Phase III randomized controlled trials (RCT) in oncology fail to lead to registration of new therapies more often than RCTs in other medical disciplines. Most RCTs are sponsored by the pharmaceutical industry, which reflects industry's increasing responsibility in cancer drug development. Many preclinical models are unreliable for evaluation of new anticancer agents, and stronger evidence of biologic effect should be required before a new agent enters the clinical development pathway. Whenever possible, early-phase clinical trials should include pharmacodynamic studies to demonstrate that new agents inhibit their molecular targets and demonstrate substantial antitumor activity at tolerated doses in an enriched population of patients. Here, we review recent RCTs and found that these conditions were not met for most of the targeted anticancer agents, which failed in recent RCTs. Many recent phase III RCTs were initiated without sufficient evidence of activity from early-phase clinical trials. Because patients treated within such trials can be harmed, they should not be undertaken. The bar should also be raised when making decisions to proceed from phase II to III and from phase III to marketing approval. Many approved agents showed only better progression-free survival than standard treatment in phase III trials and were not shown to improve survival or its quality. Introduction of value-based pricing of new anticancer agents would dissuade the continued development of agents with borderline activity in early-phase clinical trials. When collaborating with industry, oncologists should be more critical and better advocates for cancer patients. ©2015 American Association for Cancer Research.

  18. 76 FR 77982 - Applications for Eligibility Designation; Programs Under Parts A and F of Title III of the Higher...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-15

    ... Title III of the Higher Education Act of 1965, as Amended (HEA), and Programs Under Title V of the HEA...: Programs authorized under Part A, Title III of the HEA: Strengthening Institutions Program (Part A SIP... AANAPISI). Programs authorized under Part F, Title III of the HEA: Hispanic- Serving Institutions Stem and...

  19. 77 FR 67805 - Applications for Eligibility Designation; Programs Under Parts A and F of Title III of the Higher...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-14

    ... Title III of the Higher Education Act of 1965, as Amended (HEA), and Programs Under Title V of the HEA...: Programs authorized under Part A, Title III of the HEA: Strengthening Institutions Program (Part A SIP...). Programs authorized under Part F, Title III of the HEA: Hispanic- Serving Institutions STEM and...

  20. 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.

  1. Ion Implantation with in-situ Patterning for IBC Solar Cells

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

    Graff, John W.

    2014-10-24

    Interdigitated back-side Contact (IBC) solar cells are the highest efficiency silicon solar cells currently on the market. Unfortunately the cost to produce these solar cells is also very high, due to the large number of processing steps required. Varian believes that only the combination of high efficiency and low cost can meet the stated goal of $1/Wp. The core of this program has been to develop an in-situ patterning capability for an ion implantation system capable of producing patterned doped regions for IBC solar cells. Such a patterning capable ion implanter can reduce the number of process steps required tomore » manufacture IBC cells, and therefore significantly reduce the cost. The present program was organized into three phases. Phase I was to select a patterning approach and determine the patterning requirements for IBC cells. Phase II consists of construction of a Beta ion implantation system containing in-situ patterning capability. Phase III consists of shipping and installation of the ion implant system in a customer factory where it will be tested and proven in a pilot production line.« less

  2. Methods for synthesizing semiconductor quality chalcopyrite crystals for nonlinear optical and radiation detection applications and the like

    DOEpatents

    Stowe, Ashley; Burger, Arnold

    2016-05-10

    A method for synthesizing I-III-VI.sub.2 compounds, including: melting a Group III element; adding a Group I element to the melted Group III element at a rate that allows the Group I and Group III elements to react thereby providing a single phase I-III compound; and adding a Group VI element to the single phase I-III compound under heat, with mixing, and/or via vapor transport. The Group III element is melted at a temperature of between about 200 degrees C. and about 700 degrees C. Preferably, the Group I element consists of a neutron absorber and the group III element consists of In or Ga. The Group VI element and the single phase I-III compound are heated to a temperature of between about 700 degrees C. and about 1000 degrees C. Preferably, the Group VI element consists of S, Se, or Te. Optionally, the method also includes doping with a Group IV element activator.

  3. Enantioselective separation of racemic juvenile hormone III by normal-phase high-performance liquid chromatography and preparation of [(2)H(3)]juvenile hormone III as an internal standard for liquid chromatography-mass spectrometry quantification.

    PubMed

    Ichikawa, Akio; Ono, Hiroshi; Furuta, Kenjiro; Shiotsuki, Takahiro; Shinoda, Tetsuro

    2007-08-17

    Juvenile hormone III (JH III) racemate was prepared from methyl (2E,6E)-farnesoate via epoxidation with 3-chloroperbenzoic acid (mCPBA). Enantioselective separation of JH III was conducted using normal-phase high-performance liquid chromatography (HPLC) on a chiral stationary phase. [(2)H(3)]Methyl (2E,6E)-farnesoate was also prepared from (2E,6E)-farnesoic acid and [(2)H(4)]methanol (methanol-d(4)) using 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (EDC) and 4-dimethylaminopyridine (DMAP); the conjugated double bond underwent isomerization to some degree. Epoxidation of [(2)H(3)]methyl (2E,6E)-farnesoate with mCPBA gave a novel deuterium-substituted internal standard [(2)H(3)]JH III (JH III-d(3)). The standard curve was produced by linear regression using the peak area ratios of JH III and JH III-d(3) in liquid chromatography-mass spectrometry (LC-MS).

  4. INTEGRATED PROTECTIVE FABRIC SYSTEM (IPFS) PHASE III PROGRAM: AEROSOL PROTECTION REPORT

    DTIC Science & Technology

    2017-08-16

    one layer control. It was observed that aerosol swatch measurements showed no correlation to aerosol system test performance for the materials and...the BRHA model employed. It was observed that aerosol swatch measurements showed no correlation to aerosol system test performance for the...Testing” (McVeety et al., 2015). This report includes a description of the materials and material controls, a description of the IPFS configurations

  5. Budgetary and Programmatic Fluctuations during the System Development and Demonstration Phase: A Case Study of the Marine Corps H-1 Upgrade Program

    DTIC Science & Technology

    2007-12-01

    impact of economic change might include a closing factory, market manipulation, the signing of international trade 17 treaties, or the global...Refinement System Intergration System Demonstration Concept Decision BA C LRIP Full-Rate Production & Deployment System Development and Demonstration...BLOCK III Concept Exploration Component Advanced Development Concept and Technology Development System Intergration System Demonstration Decision Review

  6. SURFACE CHEMKIN-III: A Fortran package for analyzing heterogeneous chemical kinetics at a solid-surface - gas-phase interface

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

    Coltrin, M.E.; Kee, R.J.; Rupley, F.M.

    1996-05-01

    This document is the user`s manual for the SURFACE CHEMKIN-III package. Together with CHEMKIN-III, this software facilitates the formation, solution, and interpretation of problems involving elementary heterogeneous and gas-phase chemical kinetics in the presence of a solid surface. The package consists of two major software components: an Interpreter and a Surface Subroutine Library. The Interpreter is a program that reads a symbolic description of a user-specified chemical reaction mechanism. One output from the Interpreter is a data file that forms a link to the Surface Subroutine Library, which is a collection of about seventy modular Fortran subroutines that may bemore » called from a user`s application code to return information on chemical production rates and thermodynamic properties. This version of SURFACE CHEMKIN-III includes many modifications to allow treatment of multi-fluid plasma systems, for example modeling the reactions of highly energetic ionic species with a surface. Optional rate expressions allow reaction rates to depend upon ion energy rather than a single thermodynamic temperature. In addition, subroutines treat temperature as an array, allowing an application code to define a different temperature for each species. This version of SURFACE CHEMKIN-III allows use of real (non-integer) stoichiometric coefficients; the reaction order with respect to species concentrations can also be specified independent of the reaction`s stoichiometric coefficients. Several different reaction mechanisms can be specified in the Interpreter input file through the new construct of multiple materials.« less

  7. Overview of the trastuzumab (Herceptin) anti-HER2 monoclonal antibody clinical program in HER2-overexpressing metastatic breast cancer. Herceptin Multinational Investigator Study Group.

    PubMed

    Shak, S

    1999-08-01

    The recombinant humanized anti-HER2 monoclonal antibody trastuzumab (Herceptin; Genentech, San Francisco, CA) was evaluated in human clinical trials for treatment of women with metastatic breast cancer who have tumors that overexpress HER2. The trastuzumab clinical program consisted of a series of phase I, phase II, and phase III clinical trials. Clinical experience with this novel biologic has been obtained in more than 1,000 women with HER2-overexpressing metastatic breast cancer. Two pivotal trials were performed to evaluate trastuzumab efficacy and safety: (1) trastuzumab in combination with chemotherapy as first-line therapy and (2) trastuzumab as a single agent in second- and third-line chemotherapy. Preliminary results of the pivotal clinical trials that have been presented at national meetings are summarized below. The data suggest that trastuzumab will be an important new treatment option for women with HER2-overexpressing metastatic breast cancer.

  8. Comparison of Different Forms of Exercise Training in Patients With Cardiac Disease: Where Does High-Intensity Interval Training Fit?

    PubMed

    Gayda, Mathieu; Ribeiro, Paula A B; Juneau, Martin; Nigam, Anil

    2016-04-01

    In this review, we discuss the most recent forms of exercise training available to patients with cardiac disease and their comparison or their combination (or both) during short- and long-term (phase II and III) cardiac rehabilitation programs. Exercise training modalities to be discussed include inspiratory muscle training (IMT), resistance training (RT), continuous aerobic exercise training (CAET), and high-intensity interval training (HIIT). Particular emphasis is placed on HIIT compared or combined (or both) with other forms such as CAET or RT. For example, IMT combined with CAET was shown to be superior to CAET alone for improving functional capacity, ventilatory function, and quality of life in patients with chronic heart failure. Similarly, RT combined with CAET was shown to optimize benefits with respect to functional capacity, muscle function, and quality of life. Furthermore, in recent years, HIIT has emerged as an alternative or complementary (or both) exercise modality to CAET, providing equivalent if not superior benefits to conventional continuous aerobic training with respect to aerobic fitness, cardiovascular function, quality of life, efficiency, safety, tolerance, and exercise adherence in both short- and long-term training studies. Finally, short-interval HIIT was shown to be useful in the initiation and improvement phases of cardiac rehabilitation, whereas moderate- or longer-interval (or both) HIIT protocols appear to be more appropriate for the improvement and maintenance phases because of their high physiological stimulus. We now propose progressive models of exercise training (phases II-III) for patients with cardiac disease, including a more appropriate application of HIIT based on the scientific literature in the context of a multimodal cardiac rehabilitation program. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  9. The ToxCast Chemical Landscape - Paving the Road to 21st ...

    EPA Pesticide Factsheets

    The ToxCast high-throughput screening (HTS) program within the U.S. Environmental Protection Agency (EPA) was launched in 2007. Phase I of the program screened 310 chemicals, mostly pesticides, across hundreds of ToxCast assay endpoints. In Phase II, the ToxCast library was expanded to 1878 chemicals, culminating in public release of screening data at the end of 2013. Concurrently, a larger EPA library of 3726 chemicals (including the Phase II chemicals) was undergoing screening in the cross-federal agency Tox21 HTS project. Four years later, Phase III of EPA’s ToxCast program is actively screening a diverse library consisting of more than 3800 chemicals, 96% of which are also undergoing Tox21 screening. The majority of ToxCast studies, to date, have focused on using HTS results to build biologically based models for predicting in vivo toxicity endpoints. The focus of the present article, in contrast, is on the EPA chemical library underpinning these efforts. A history of the phased construction of EPA’s ToxCast library is presented, considering factors influencing chemical selection as well as the various quality measures implemented. Next, Chemical Abstracts Service Registry Numbers (CASRN), which were used to compile initial chemical nominations for ToxCast testing, are used to assess overlaps of the current ToxCast library with important toxicity, regulatory, and exposure inventories. Lastly, ToxCast chemicals are described in terms of generaliz

  10. Current report on the interferon program at Roswell Park Memorial Institute.

    PubMed

    Murphy, G P

    1981-01-01

    An overview of the interferon program at Roswell Park Memorial Institute (RPMI), is presented. This program encompasses three interrelated areas of research and new drug development: (a) basic research on purification and characterization of animal and human interferons (leukocyte, fibroblast, and immune); (b) large scale manufacture and preclinical testing of human fibroblast interferon (HFIF); and (c) clinical trials with HFIF to determine its safety of administration as well as antiviral, antitumor, and immunomodulatory activities in patients with neoplastic or viral disease. The antitumor effect of HFIF produced at RPMI as assessed by intralesional injection of various metastatic nodules resulted in an overall 71% local response. Phase I studies in 13 patients demonstrated that HFIF can be administered safely by the subcutaneous, intramuscular, and intravenous routes in doses up to 25 million units per day without any serious untoward effects. Intrathecal administration of HFIF into patients with CNS leukemia was also well tolerated. Pharmacokinetic studies indicated significant levels of HFIF in serum and cerebrospinal fluid after intravenous and intrathecal administration, respectively. Coincidental with the HFIF systemic administration during the Phase I trials, favorable responses in several laboratory, immune, and clinical parameters were observed. These results provide the rationale for conducting phase II and phase III clinical trials with HFIF produced at RPMI.

  11. 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.

  12. Pore-scale characterization of biogeochemical controls on iron and uranium speciation under flow conditions.

    PubMed

    Pearce, Carolyn I; Wilkins, Michael J; Zhang, Changyong; Heald, Steve M; Fredrickson, Jim K; Zachara, John M

    2012-08-07

    Etched silicon microfluidic pore network models (micromodels) with controlled chemical and redox gradients, mineralogy, and microbiology under continuous flow conditions are used for the incremental development of complex microenvironments that simulate subsurface conditions. We demonstrate the colonization of micromodel pore spaces by an anaerobic Fe(III)-reducing bacterial species (Geobacter sulfurreducens) and the enzymatic reduction of a bioavailable Fe(III) phase within this environment. Using both X-ray microprobe and X-ray absorption spectroscopy, we investigate the combined effects of the precipitated Fe(III) phases and the microbial population on uranium biogeochemistry under flow conditions. Precipitated Fe(III) phases within the micromodel were most effectively reduced in the presence of an electron shuttle (AQDS), and Fe(II) ions adsorbed onto the precipitated mineral surface without inducing any structural change. In the absence of Fe(III), U(VI) was effectively reduced by the microbial population to insoluble U(IV), which was precipitated in discrete regions associated with biomass. In the presence of Fe(III) phases, however, both U(IV) and U(VI) could be detected associated with biomass, suggesting reoxidation of U(IV) by localized Fe(III) phases. These results demonstrate the importance of the spatial localization of biomass and redox active metals, and illustrate the key effects of pore-scale processes on contaminant fate and reactive transport.

  13. Safety and tolerability review of lorcaserin in clinical trials.

    PubMed

    Greenway, F L; Shanahan, W; Fain, R; Ma, T; Rubino, D

    2016-10-01

    Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations. © 2016 World Obesity.

  14. The motilin receptor agonist erythromycin stimulates hunger and food intake through a cholinergic pathway.

    PubMed

    Deloose, Eveline; Vos, Rita; Janssen, Pieter; Van den Bergh, Omer; Van Oudenhove, Lukas; Depoortere, Inge; Tack, Jan

    2016-03-01

    Motilin-induced phase III contractions have been identified as a hunger signal. These phase III contractions occur as part of the migrating motor complex (MMC), a contractility pattern of the gastrointestinal tract during fasting. The mechanism involved in this association between subjective hunger feelings and gastrointestinal motility during the MMC is largely unknown, however, as is its ability to stimulate food intake. We sought to 1) investigate the occurrence of hunger peaks and their relation to phase III contractions, 2) evaluate whether this relation was cholinergically driven, and 3) assess the ability of the motilin receptor agonist erythromycin to induce food intake. An algorithm was developed to detect hunger peaks. The association with phase III contractions was studied in 14 healthy volunteers [50% men; mean ± SEM age: 25 ± 2 y; mean ± SEM body mass index (BMI; in kg/m(2)): 23 ± 1]. The impact of pharmacologically induced phase III contractions on the occurrence of hunger peaks and the involvement of a cholinergic pathway were assessed in 14 healthy volunteers (43% men; age: 29 ± 3 y; BMI: 23 ± 1). Last, the effect of erythromycin administration on food intake was examined in 15 healthy volunteers (40% men; age: 28 ± 3 y; BMI: 22 ± 1). The occurrence of hunger peaks and their significant association with phase III contractions was confirmed (P < 0.0001). Pharmacologically induced phase III contractions were also significantly associated with hunger peaks (P < 0.05), and this association involved a cholinergic pathway. Administering erythromycin significantly stimulated food intake compared with placebo (53% ± 13% compared with 10% ± 5%; P < 0.05). Motilin-induced phase III contractions induced hunger feelings through a cholinergic pathway. Moreover, erythromycin stimulated food intake, suggesting a physiologic role of motilin as an orexigenic signal from the gastrointestinal tract. This trial was registered at www.clinicaltrials.gov as NCT02633579. © 2016 American Society for Nutrition.

  15. ER-2 #809 and DC-8 in Arena Arctica hangar in Kiruna, Sweden prior to the SAGE III Ozone Loss and Validation Experiment (SOLVE)

    NASA Image and Video Library

    2000-01-23

    NASA ER-2 # 809 and its DC-8 shown in Arena Arctica before the SAGE III Ozone Loss and Validation Experiment (SOLVE). The two airborne science platforms were based north of the Arctic Circle in Kiruna, Sweden, during the winter of 2000 to study ozone depletion as part of SOLVE. A large hangar built especially for research, "Arena Arctica" housed the instrumented aircraft and the scientists. Scientists have observed unusually low levels of ozone over the Arctic during recent winters, raising concerns that ozone depletion there could become more widespread as in the Antarctic ozone hole. The NASA-sponsored international mission took place between November 1999 and March 2000 and was divided into three phases. The DC-8 was involved in all three phases returning to Dryden between each phase. The ER-2 flew sample collection flights between January and March, remaining in Sweden from Jan. 9 through March 16. "The collaborative campaign will provide an immense new body of information about the Arctic stratosphere," said program scientist Dr. Michael Kurylo, NASA Headquarters. "Our understanding of the Earth's ozone will be greatly enhanced by this research."

  16. Minicars research safety vehicle program. Phase 3. Volume 1. Technical final report. Report for Jan 1977-Sep 1981

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

    Ausherman, V.K.; Khadikar, A.V.; Syson, S.R.

    1981-09-01

    The objective of the RSV Program was to provide research and test data applicable to the automobile safety performance requirements for the mid-1980s, and to evaluate the compatibility of these requirements with environmental policies, efficient energy utilization, and consumer economic considerations. The RSV Program has demonstrated that it is possible to make cars much safer than they are presently. It has produced automobile designs that are consistent, at affordable cost, with the national objectives for fuel economy and environmental protection. It has indicated, at least to a limited degree, that the technological findings are applicable, at varying levels, to amore » variety of car designs. And it has provided evidence that these findings can be wrapped in a package of considerable appeal to the public. This Final Report is a comprehensive compilation of the findings of the Phase III efforts of Minicars, Inc. It describes the design and testing of the RSV systems, and the performance levels achieved.« less

  17. Monterey-Salinas Transit ITS Augmentation Project : Phase III Evaluation Report

    DOT National Transportation Integrated Search

    2009-12-01

    The purpose of this document is to present the findings from Phase II and Phase III of the Evaluation of the Intelligent Transportation Systems (ITS) Augmentation Project that was implemented at the Monterey-Salinas Transit (MST) in Monterey, Califor...

  18. 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.

  19. Saturn Apollo Program

    NASA Image and Video Library

    1964-11-01

    The Saturn I S-I stages for the SA-8 and SA-10 mission in final assembly phase in a manufacturing building at the Michoud Assembly Facility in New Orleans, Louisiana. The SA-8 mission was launched on May 25, 1965 with the first industry-built booster, and deployed the Pegasus II Micrometeoroid Detection satellite. The SA-10 mission was the last Saturn I mission, launched on July 30, 1965, and carried the Pegasus III Meteoroid Detection satellite.

  20. Method for determining the composition and orientation of III-V {001} semiconductor surfaces

    NASA Astrophysics Data System (ADS)

    Sung, M. M.; Kim, C.; Rabalais, J. W.

    1996-09-01

    A method for determining the composition and orientation of III-V {001} semiconductor surfaces is presented and applications are described. The information is obtained from the techniques of time-of-flight scattering and recoiling spectrometry (TOF-SARS), using the composition from azimuth-specific elemental accessibilities (CASEA) method, and low energy electron diffraction (LEED). The azimuth-specific elemental accessibilities (ASEA) are measured experimentally and calculated from the number of accessible atoms in the unit cell and from three-dimensional trajectory simulations using the SARIC program. The in situ analyses identify the 1st-layer elemental species and determine the orientation of the reconstructed surface symmetry elements with respect to the bulk crystallographic directions. This is demonstrated for the III-V {001} compound semiconductor surfaces of GaAs and InAs in the (4 × 2) and (4 × 2) phases and InP in the (4 × 2) phase. The analyses confirm the missing-row-dimer (MRD) structure for GaAs and InAs in which the missing row direction is parallel to the direction of the 1st-layer multimers (dimers) and the missing-row-trimer-dimer (MRTD) structure for InP in which the missing row direction is perpendicular to the direction of the 1st-layer multimers (trimers).

  1. A new trial design to accelerate tuberculosis drug development: the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP).

    PubMed

    Phillips, Patrick P J; Dooley, Kelly E; Gillespie, Stephen H; Heinrich, Norbert; Stout, Jason E; Nahid, Payam; Diacon, Andreas H; Aarnoutse, Rob E; Kibiki, Gibson S; Boeree, Martin J; Hoelscher, Michael

    2016-03-23

    The standard 6-month four-drug regimen for the treatment of drug-sensitive tuberculosis has remained unchanged for decades and is inadequate to control the epidemic. Shorter, simpler regimens are urgently needed to defeat what is now the world's greatest infectious disease killer. We describe the Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) as a novel hybrid phase II/III trial design to accelerate regimen development. In the Phase IIC STEP trial, the experimental regimen is given for the duration for which it will be studied in phase III (presently 3 or 4 months) and patients are followed for clinical outcomes of treatment failure and relapse for a total of 12 months from randomisation. Operating characteristics of the trial design are explored assuming a classical frequentist framework as well as a Bayesian framework with flat and sceptical priors. A simulation study is conducted using data from the RIFAQUIN phase III trial to illustrate how such a design could be used in practice. With 80 patients per arm, and two (2.5 %) unfavourable outcomes in the STEP trial, there is a probability of 0.99 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.91 that the proportion of unfavourable outcomes would be less than 8 %. With six (7.5 %) unfavourable outcomes, there is a probability of 0.82 that the proportion of unfavourable outcomes in a potential phase III trial would be less than 12 % and a probability of 0.41 that it would be less than 8 %. Simulations using data from the RIFAQUIN trial show that a STEP trial with 80 patients per arm would have correctly shown that the Inferior Regimen should not proceed to phase III and would have had a high chance (0.88) of either showing that the Successful Regimen could proceed to phase III or that it might require further optimisation. Collection of definitive clinical outcome data in a relatively small number of participants over only 12 months provides valuable information about the likelihood of success in a future phase III trial. We strongly believe that the STEP trial design described herein is an important tool that would allow for more informed decision-making and accelerate regimen development.

  2. Cloud point extraction: an alternative to traditional liquid-liquid extraction for lanthanides(III) separation.

    PubMed

    Favre-Réguillon, Alain; Draye, Micheline; Lebuzit, Gérard; Thomas, Sylvie; Foos, Jacques; Cote, Gérard; Guy, Alain

    2004-06-17

    Cloud point extraction (CPE) was used to extract and separate lanthanum(III) and gadolinium(III) nitrate from an aqueous solution. The methodology used is based on the formation of lanthanide(III)-8-hydroxyquinoline (8-HQ) complexes soluble in a micellar phase of non-ionic surfactant. The lanthanide(III) complexes are then extracted into the surfactant-rich phase at a temperature above the cloud point temperature (CPT). The structure of the non-ionic surfactant, and the chelating agent-metal molar ratio are identified as factors determining the extraction efficiency and selectivity. In an aqueous solution containing equimolar concentrations of La(III) and Gd(III), extraction efficiency for Gd(III) can reach 96% with a Gd(III)/La(III) selectivity higher than 30 using Triton X-114. Under those conditions, a Gd(III) decontamination factor of 50 is obtained.

  3. School Improvement Efforts: Qualitative Data from Four Naturally Occurring Experiments in Phase III of the Louisiana School Effectiveness Study.

    ERIC Educational Resources Information Center

    Stringfield, Sam; And Others

    Phase III of the Louisiana School Effectiveness Study (LSES-III) was designed in part to obtain rich, qualitative data on the characteristics of more and less effective schools in the Gulf South. Data were gathered on eight matched outlier pairs of schools during the 1984-1985 school year. Of the eight historically ineffective schools in LSES-III,…

  4. 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

  5. Methodology of clinical trials evaluating the incorporation of new drugs in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL): a critical review.

    PubMed

    Iacoboni, G; Zucca, E; Ghielmini, M; Stathis, A

    2018-05-01

    The first-line treatment of diffuse large B-cell lymphoma (DLBCL) is the combination of rituximab with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, curing approximately 60% of patients. Many clinical trials have been carried out over the last 10 years trying to improve the results of this treatment, but the appropriateness of their planning strategies could be rediscussed. Reports of phase III trials evaluating the addition of molecularly targeted agents or new monoclonal antibodies to the classic R-CHOP backbone in first-line induction or maintenance treatment were reviewed. The trial design, primary end point, number of patients enrolled, patient selection criteria, treatment schedule and results were registered for each one. In addition, the phases I and II trials which preceded these phase III trials were also reviewed. Among six phase III trials with results, only one trial evaluating lenalidomide maintenance after response to R-CHOP induction was positive and reached its primary end point. The other five trials did not show an improved outcome with the addition of the new agent. The preceding phases I and II trials were very heterogeneous in their end points and design. Even though most of these trials were considered positive, thus encouraging further investigation, so far they failed to predict the results of the subsequent phase III trials. The standard of care for DLBCL is still R-CHOP. Phase I/II trials failed to predict the results of subsequent phase III trials evaluating non-chemotherapeutic agents added to R-CHOP. The methodology of phase II trials evaluating new agents in DLBCL needs to be better defined in the future.

  6. 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.

  7. Pore-Scale Characterization of Biogeochemical Controls on Iron and Uranium Speciation under Flow Conditions

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

    Pearce, Carolyn I.; Wilkins, Michael J.; Zhang, Changyong

    2012-09-17

    Etched silicon microfluidic pore network models (micromodels) with controlled chemical and redox gradients, mineralogy, and microbiology under continuous flow conditions are used for the incremental development of complex microenvironments that simulate subsurface conditions. We demonstrate the colonization of micromodel pore spaces by an anaerobic Fe(III)-reducing bacterial species (Geobacter sulfurreducens) and the enzymatic reduction of a bioavailable Fe(III) phase within this environment. Using both X-ray Microprobe and X-ray Absorption Spectroscopy, we investigate the combined effects of the precipitated Fe(III) phases and the microbial population on uranium biogeochemistry under flow conditions. Precipitated Fe(III) phases within the micromodel were most effectively reduced inmore » the presence of an electron shuttle (AQDS), and Fe(II) ions adsorbed onto the precipitated mineral surface without inducing any structural change. In the absence of Fe(III), U(VI) was effectively reduced by the microbial population to insoluble U(IV), which was precipitated in discrete regions associated with biomass. In the presence of Fe(III) phases, however, both U(IV) and U(VI) could be detected associated with biomass, suggesting re-oxidation of U(IV) by localized Fe(III) phases. These results demonstrate the importance of the spatial localization of biomass and redox active metals, and illustrate the key effects of pore-scale processes on contaminant fate and reactive transport.« less

  8. Changing interdigestive migrating motor complex in rats under acute liver injury.

    PubMed

    Liu, Mei; Zheng, Su-Jun; Xu, Weihong; Zhang, Jianying; Chen, Yu; Duan, Zhongping

    2014-01-01

    Gastrointestinal motility disorder is a major clinical manifestation of acute liver injury, and interdigestive migrating motor complex (MMC) is an important indicator. We investigated the changes and characteristics of MMC in rats with acute liver injury. Acute liver injury was created by d-galactosamine, and we recorded the interdigestive MMC using a multichannel physiological recorder and compared the indexes of interdigestive MMC. Compared with normal controls, antral MMC Phase I duration was significantly prolonged and MMC Phase III duration was significantly shortened in the rats with acute liver injury. The duodenal MMC cycle and MMC Phases I and IV duration were significantly prolonged and MMC Phase III duration was significantly shortened in the rats with acute liver injury. The jejunal MMC cycle and MMC Phases I and IV duration were significantly prolonged and MMC Phase III duration was significantly shortened in the rats with acute liver injury compared with normal controls. Compared with the normal controls, rats with acute liver injury had a significantly prolonged interdigestive MMC cycle, related mainly to longer MMC Phases I and IV, shortened MMC Phase III, and MMC Phase II characterized by increased migrating clustered contractions, which were probably major contributors to the gastrointestinal motility disorders.

  9. 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

  10. Phase III Simplified Integrated Test (SIT) results - Space Station ECLSS testing

    NASA Technical Reports Server (NTRS)

    Roberts, Barry C.; Carrasquillo, Robyn L.; Dubiel, Melissa Y.; Ogle, Kathryn Y.; Perry, Jay L.; Whitley, Ken M.

    1990-01-01

    During 1989, phase III testing of Space Station Freedom Environmental Control and Life Support Systems (ECLSS) began at Marshall Space Flight Center (MSFC) with the Simplified Integrated Test. This test, conducted at the MSFC Core Module Integration Facility (CMIF), was the first time the four baseline air revitalization subsystems were integrated together. This paper details the results and lessons learned from the phase III SIT. Future plans for testing at the MSFC CMIF are also discussed.

  11. Review of phase III trial data on IL-23 inhibitors tildrakizumab and guselkumab for psoriasis.

    PubMed

    Amin, M; Darji, K; No, D J; Wu, J J

    2017-10-01

    The development of monoclonal antibodies targeting IL-12 and IL-23 has enhanced the therapeutic options available for psoriasis patients. Recent research suggests that IL-23 alone plays a role in the pathogenesis of psoriasis. The objective was to review the phase III clinical trial data for the anti-IL-23 agents to evaluate the safety and efficacy profile of each agent. We reviewed the results of the phase III clinical trials for the anti-IL-23 agents tildrakizumab and guselkumab. The results of phase III trials on risankizumab have not yet been reported. By week 12, the proportion of patients reaching Psoriasis Area and Severity Index (PASI 75) was >60% among the most efficacious dose of each agent. The percentage of patients achieving PASI 90 at week 16 was the primary endpoint for the phase III trials for guselkumab, which was above 70%. The safety profiles of the agents were comparable, with the most commonly reported adverse events of nasopharyngitis and upper respiratory tract infections. The anti-IL-23 agents demonstrated a rapid clinical improvement that is similar or superior to the improvement seen with currently marketed IL-17 inhibitors with a favourable short-term safety profile. The results of the phase III trials support the notion that IL-23 is a potential target in psoriasis treatment. © 2017 European Academy of Dermatology and Venereology.

  12. Confirmation of model-based dose selection for a Japanese phase III study of rivaroxaban in non-valvular atrial fibrillation patients.

    PubMed

    Kaneko, Masato; Tanigawa, Takahiko; Hashizume, Kensei; Kajikawa, Mariko; Tajiri, Masahiro; Mueck, Wolfgang

    2013-01-01

    This study was designed to confirm the appropriateness of the dose setting for a Japanese phase III study of rivaroxaban in patients with non-valvular atrial fibrillation (NVAF), which had been based on model simulation employing phase II study data. The previously developed mixed-effects pharmacokinetic/pharmacodynamic (PK-PD) model, which consisted of an oral one-compartment model parameterized in terms of clearance, volume and a first-order absorption rate, was rebuilt and optimized using the data for 597 subjects from the Japanese phase III study, J-ROCKET AF. A mixed-effects modeling technique in NONMEM was used to quantify both unexplained inter-individual variability and inter-occasion variability, which are random effect parameters. The final PK and PK-PD models were evaluated to identify influential covariates. The empirical Bayes estimates of AUC and C(max) from the final PK model were consistent with the simulated results from the Japanese phase II study. There was no clear relationship between individual estimated exposures and safety-related events, and the estimated exposure levels were consistent with the global phase III data. Therefore, it was concluded that the dose selected for the phase III study with Japanese NVAF patients by means of model simulation employing phase II study data had been appropriate from the PK-PD perspective.

  13. Inhibition in a microgravity environment of the recovery of Escherichia coli cells damaged by heavy ion beams during the NASDA ISS phase I program of NASA Shuttle/Mir mission no. 6.

    PubMed

    Harada, K; Sugahara, T; Ohnishi, T; Ozaki, Y; Obiya, Y; Miki, S; Miki, T; Imamura, M; Kobayashi, Y; Watanabe, H; Akashi, M; Furusawa, Y; Mizuma, N; Yamanaka, H; Ohashi, E; Yamaoka, C; Yajima, M; Fukui, M; Nakano, T; Takahashi, S; Amano, T; Sekikawa, K; Yanagawa, K; Nagaoka, S

    1998-05-01

    We participated in a space experiment, part of the National Space Development Agency of Japan (NASDA) Phase I Space Radiation Environment Measurement Program, conducted during the National Aeronautics and Space Administration (NASA) Shuttle/Mir Mission No. 6 (S/MM-6) project. The aim of our study was to investigate the effects of microgravity on the DNA repair processes of living organisms in the in orbit. Heavy ion beam radiation- or ç-irradiation-damaged biological samples of Escherichia coli and the radioresistant bacterium Deinococcus radiodurans were prepared and placed in a biospecimen box, which was loaded into the RRMD III sensor unit of the Space Shuttle. Two identical sets of samples were left in the Spacehab's Payload Processing Facility (SPPF) in Florida, USA, as a control. (flight No. STS-84) was launched from NASA John F. Kennedy Space Center (KSC) in Florida, USA, on May 15, 1997. The mission duration was 9.22 days. An astronaut activated the biological samples in the biospecimen box in the Spacehab during orbit in order to start repair of the DNA damaged by heavy ion beams or ç-irradiation and the samples were incubated for 19 h 35 min at about 22ûC, the cabin temperature. The control specimens in the SPPF were subjected to the same treatment under terrestrial gravity. After returned to earth, we investigated cell recovery by comparing the repair of the radiation-damaged DNA of E. coli and D. radiodurans in the microgravity environment in space with that on Earth. The results indicated that the DNA repair process of E. coli, but not of D. radiodurans, cells was inhibited in a microgravity environment.

  14. 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.

  15. The Higher Education Act and Minority Serving Institutions: Towards a Typology of Title III and V Funded Programs

    ERIC Educational Resources Information Center

    Boland, William Casey

    2018-01-01

    To date, there has been little analysis of MSI Title III and V grant-funded programs across all MSI categories. For researchers, practitioners, and policymakers, it is imperative to explore the contributions of MSIs as manifested in Title III and V grant-funded programs. The purpose of this study is to analyze MSI Title III and V programs based on…

  16. Studies on the Inhalation Toxicity of Dyes Present in Colored Smoke Munitions. Phase III, Studies: Four-Week Inhalation Exposures of Rats to Dye Aerosols.

    DTIC Science & Technology

    1984-09-10

    0") AD STUDIES ON THE INHALATION TOXICITY CO• OF DYES PRESENT IN COLORED Ln SMOKE MUNIlIONS U FINAL REPORT FOR PHASE III STUDIES : SFOUR- ELK...3 RECIIEPIT’S CATA6.0G NUMBE.• 4. TITLE (and ,ubiltI.e) S. TYPE OF REPORT & PERIOD COygC r., Studies on the Inhalation Toxicity of Dyes Final: Phase...III Present in Colored Smoke Munitions. Final Report Fh for Phase 111 Studies : FoLr-Week Inhalation G. PERFORMING ORO. REPORT N,’,ER Exposures of Rats

  17. Situational Lightning Climatologies for Central Florida: Phase III

    NASA Technical Reports Server (NTRS)

    Barrett, Joe H., III

    2008-01-01

    This report describes work done by the Applied Meteorology Unit (AMU) to add composite soundings to the Advanced Weather Interactive Processing System (AWIPS). This allows National Weather Service (NWS) forecasters to compare the current atmospheric state with climatology. In a previous phase, the AMU created composite soundings for four rawinsonde observation stations in Florida, for each of eight flow regimes. The composite soundings were delivered to the NWS Melbourne (MLB) office for display using the NSHARP software program. NWS MLB requested that the AMU make the composite soundings available for display in AWIPS. The AMU first created a procedure to customize AWIPS so composite soundings could be displayed. A unique four-character identifier was created for each of the 32 composite soundings. The AMU wrote a Tool Command Language/Tool Kit (TcVTk) software program to convert the composite soundings from NSHARP to Network Common Data Form (NetCDF) format. The NetCDF files were then displayable by AWIPS.

  18. A Community Needs Assessment for the Development of an Interprofessional Palliative Care Training Curriculum.

    PubMed

    Coats, Heather; Paganelli, Tia; Starks, Helene; Lindhorst, Taryn; Starks Acosta, Anne; Mauksch, Larry; Doorenbos, Ardith

    2017-03-01

    There is a known shortage of trained palliative care professionals, and an even greater shortage of professionals who have been trained through interprofessional curricula. As part of an institutional Palliative Care Training Center grant, a core team of interprofessional palliative care academic faculty and staff completed a state-wide palliative care educational assessment to determine the needs for an interprofessional palliative care training program. The purpose of this article is to describe the process and results of our community needs assessment of interprofessional palliative care educational needs in Washington state. We approached the needs assessment through a cross-sectional descriptive design by using mixed-method inquiry. Each phase incorporated a variety of settings and subjects. The assessment incorporated multiple phases with diverse methodological approaches: a preparatory phase-identifying key informants; Phase I-key informant interviews; Phase II-survey; and Phase III-steering committee endorsement. The multiple phases of the needs assessment helped create a conceptual framework for the Palliative Care Training Center and developed an interprofessional palliative care curriculum. The input from key informants at multiple phases also allowed us to define priority needs and to refine an interprofessional palliative care curriculum. This curriculum will provide an interprofessional palliative care educational program that crosses disciplinary boundaries to integrate knowledge that is beneficial for all palliative care clinicians. The input from a range of palliative care clinicians and professionals at every phase of the needs assessment was critical for creating an interprofessional palliative care curriculum.

  19. PLCO Ovarian Phase III Validation Study — EDRN Public Portal

    Cancer.gov

    Our preliminary data indicate that the performance of CA 125 as a screening test for ovarian cancer can be improved upon by additional biomarkers. With completion of one additional validation step, we will be ready to test the performance of a consensus marker panel in a phase III validation study. Given the original aims of the PLCO trial, we believe that the PLCO represents an ideal longitudinal cohort offering specimens for phase III validation of ovarian cancer biomarkers.

  20. Evaluation of the myoelectrical activity of the equine ileum infected with Strongylus vulgaris larvae.

    PubMed

    Berry, C R; Merritt, A M; Burrows, C F; Campbell, M; Drudge, J H

    1986-01-01

    Five weanling ponies were subjected to an intensive 6-week deworming program after which 4 Ag-AgCl bipolar electrodes were implanted surgically on the distal ileum. For 3 hours each day for 5 consecutive days, ileal myoelectrical activity was recorded from fed ponies under 3 sequential conditions: preinoculation, after oral administration of 1,000 killed Strongylus vulgaris infective larvae (3 ponies), and after oral administration of 1,000 live S vulgaris infective larvae. Recordings were analyzed for slow wave frequency, percentage duration of phases I, II, and III of the migrating myoelectrical complex (MMC), and the frequency of distinct, rapidly migrating action-potential complexes within phase 2 of the MMC. After administration of live and killed infected 3rd-stage larvae, there was a marked increase in the number of disrupted phase III complexes, and a significant (P less than 0.001) increase in the number of migrating action-potential complexes. In addition, after inoculation of live 3rd-stage larvae, there was a significant increase (P less than 0.001) in the percentage of time that the MMC was occupied by prolonged periods devoid of spike activity (phase I). The results indicate that S vulgaris larval mucosal penetration and submucosal migration can cause changes in ileal myoelectrical activity that could cause colic, and that larval antigen alone within the lumen may disrupt ileal motility.

  1. Grant Administration Manual for Title III Coordinators.

    ERIC Educational Resources Information Center

    Mathis, Emily Duncan; Ashmore, Frances W.

    Guidelines for coordinators of programs under Title III of the Higher Education Act of 1965 are presented, based on a national survey of Title III program coordinators. The responsibilities of the coordinator and information on administering the Strengthening Developing Institutions Program (SDIP) grant are covered. The program can either be a…

  2. Cost-effectiveness of the U.S. Geological Survey stream-gaging program in Indiana

    USGS Publications Warehouse

    Stewart, J.A.; Miller, R.L.; Butch, G.K.

    1986-01-01

    Analysis of the stream gaging program in Indiana was divided into three phases. The first phase involved collecting information concerning the data need and the funding source for each of the 173 surface water stations in Indiana. The second phase used alternate methods to produce streamflow records at selected sites. Statistical models were used to generate stream flow data for three gaging stations. In addition, flow routing models were used at two of the sites. Daily discharges produced from models did not meet the established accuracy criteria and, therefore, these methods should not replace stream gaging procedures at those gaging stations. The third phase of the study determined the uncertainty of the rating and the error at individual gaging stations, and optimized travel routes and frequency of visits to gaging stations. The annual budget, in 1983 dollars, for operating the stream gaging program in Indiana is $823,000. The average standard error of instantaneous discharge for all continuous record gaging stations is 25.3%. A budget of $800,000 could maintain this level of accuracy if stream gaging stations were visited according to phase III results. A minimum budget of $790,000 is required to operate the gaging network. At this budget, the average standard error of instantaneous discharge would be 27.7%. A maximum budget of $1 ,000,000 was simulated in the analysis and the average standard error of instantaneous discharge was reduced to 16.8%. (Author 's abstract)

  3. Improved Tubulars for Better Economics in Deep Gas Well Drilling Using Microwave Technology

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

    Dinesh Agrawal

    2006-09-30

    The main objective of the entire research program has been to improve the rate-of-penetration in deep hostile environments by improving the life cycle and performance of coiled-tubing, an important component of a deep well drilling system for oil and gas exploration, by utilizing the latest developments in the microwave materials technology. Based on the results of the Phase I and insurmountable difficulties faced in the extrusion and de-waxing processes, the approach of achieving the goals of the program was slightly changed in the Phase II in which an approach of microwave sintering combined with Cold Isostatic Press (CIP) and joiningmore » (by induction or microwave) has been adopted. This process can be developed into a semicontinuous sintering process if the CIP can produce parts fast enough to match the microwave sintering rates. The main objective of the Phase II research program is to demonstrate the potential to economically manufacture microwave processed coiled tubing with improved performance for extended useful life under hostile coiled tubing drilling conditions. After the completion of the Phase II, it is concluded that scale up and sintering of a thin wall common O.D. size tubing that is widely used in the market is still to be proved and further experimentation and refinement of the sintering process is needed in Phase III. Actual manufacturing capability of microwave sintered, industrial quality, full length tubing will most likely require several million dollars of investment.« less

  4. Improved Tubulars for Better Economics in Deep Gas Well Drilling using Microwave Technology

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

    Dinesh Agrawal; Paul Gigl; Mark Hunt

    2007-07-31

    The main objective of the entire research program has been to improve the rate-of-penetration in deep hostile environments by improving the life cycle and performance of coiled-tubing, an important component of a deep well drilling system for oil and gas exploration, by utilizing the latest developments in the microwave materials technology. Based on the results of the Phase I and insurmountable difficulties faced in the extrusion and de-waxing processes, the approach of achieving the goals of the program was slightly changed in the Phase II in which an approach of microwave sintering combined with Cold Isostatic Press (CIP) and joiningmore » (by induction or microwave) has been adopted. This process can be developed into a semicontinuous sintering process if the CIP can produce parts fast enough to match the microwave sintering rates. The main objective of the Phase II research program is to demonstrate the potential to economically manufacture microwave processed coiled tubing with improved performance for extended useful life under hostile coiled tubing drilling conditions. After the completion of the Phase II, it is concluded that scale up and sintering of a thin wall common O.D. size tubing that is widely used in the market is still to be proved and further experimentation and refinement of the sintering process is needed in Phase III. Actual manufacturing capability of microwave sintered, industrial quality, full length tubing will most likely require several million dollars of investment.« less

  5. Advanced Stirling Convertor Update

    NASA Astrophysics Data System (ADS)

    Wood, J. Gary; Carroll, Cliff; Matejczyk, Dan; Penswick, L. B.; Soendker, E.

    2006-01-01

    This paper reports on the 88 We Advanced Stirling Convertor (ASC) currently being developed under Phase II of a NASA NRA program for possible use in advanced high specific power radioisotope space power systems. An early developmental unit, the Frequency Test Bed (FTB) which was built and tested in Phase I demonstrated 36% efficiency. The ASC-1 currently being developed under Phase II, uses a high temperature heater head to allow for operation at 850 °C and is expected to have an efficiency approaching 40% (based on AC electrical out) at a temperature ratio of 3.1. The final lightweight ASC-2 convertor to be developed in Phase III is expected to have a mass of approximately 1 kg. The implementation of the ASC would allow for much higher specific power radioisotope power systems, requiring significantly less radioisotope fuel than current systems. The first run of the ASC-1 occurred in September 2005, and full temperature operation was achieved in early October 2005. Presented is an update on progress on the ASC program as well as the plans for future development. Also presented are efforts being performed to ensure the ASC has the required long life already demonstrated in free-piston Stirling cryocoolers.

  6. Growth of III-V films by control of MBE growth front stoichiometry

    NASA Technical Reports Server (NTRS)

    Grunthaner, Frank J. (Inventor); Liu, John K. (Inventor); Hancock, Bruce R. (Inventor)

    1992-01-01

    For the growth of strain-layer materials and high quality single and multiple quantum wells, the instantaneous control of growth front stoichiometry is critical. The process of the invention adjusts the offset or phase of molecular beam epitaxy (MBE) control shutters to program the instantaneous arrival or flux rate of In and As4 reactants to grow InAs. The interrupted growth of first In, then As4, is also a key feature.

  7. Refinement of Foam Backfill Technology for Expedient Airfield Damage Repair- Phase I: Laboratory Evaluation of Foam Materials

    DTIC Science & Technology

    2016-11-01

    the spring of 2016. Four of these materials were commercially available. The remaining formulations were designed specifically to support this... designated by other authorized documents. DESTROY THIS REPORT WHEN NO LONGER NEEDED. DO NOT RETURN IT TO THE ORIGINATOR. ERDC TR-16-16 iii...The Program Manager was Jeb S. Tingle, ERDC-GSL. This work was performed by the Airfields and Pavements Branch (GMA) of the Engineering Systems

  8. Formal Environmental Assessment for the R-2508 Complex Enhancement Program. P.E. 35126F

    DTIC Science & Technology

    1978-04-01

    PHASE III. A sixth unmanned gap-filler radar sytem will be installed-at Indian Wells Valley and a new long-range radar system may be installed at...SITE TOPCGRAPHiIC ~ao It S. 4.. , I -’ I , ,- I IL? OM " 17291< II - 11 • ~M 1687 , .90~ " , " ,-""/ aBM \\ t 9CI :52 otu I1era!40fet o Al 0o , I, , t

  9. Lexical Link Analysis Application: Improving Web Service to Acquisition Visibility Portal Phase III

    DTIC Science & Technology

    2015-04-30

    It is a supervised learning method but best for Big Data with low dimensions. It is an approximate inference good for Big Data and Hadoop ...Each process produces large amounts of information ( Big Data ). There is a critical need for automation, validation, and discovery to help acquisition...can inform managers where areas might have higher program risk and how resource and big data management might affect the desired return on investment

  10. Preparation of cerium halide solvate complexes

    DOEpatents

    Vasudevan, Kalyan V; Smith, Nickolaus A; Gordon, John C; McKigney, Edward A; Muenchaussen, Ross E

    2013-08-06

    Crystals of a solvated cerium(III) halide solvate complex resulted from a process of forming a paste of a cerium(III) halide in an ionic liquid, adding a solvent to the paste, removing any undissolved solid, and then cooling the liquid phase. Diffusing a solvent vapor into the liquid phase also resulted in crystals of a solvated cerium(III) halide complex.

  11. Effect of amoxicillin/clavulanate on gastrointestinal motility in children.

    PubMed

    Gomez, Roberto; Fernandez, Sergio; Aspirot, Ann; Punati, Jaya; Skaggs, Beth; Mousa, Hayat; Di Lorenzo, Carlo

    2012-06-01

    The aim of the present study was to evaluate the effect of amoxicillin/clavulanate (A/C) on gastrointestinal motility. Twenty consecutive pediatric patients referred for antroduodenal manometry received 20 mg/kg of A/C into the small bowel lumen. In 10 patients (group A), A/C was given 1 hour after and in 10 (group B), 1 hour before ingestion of a meal. Characteristics of the migrating motor complex, including presence, frequency, amplitude, and propagation of duodenal phase III and phase I duration and phase II motility index (MI), were evaluated 30 minutes before and after A/C administration. There were no statistically significant differences in age and sex between the 2 groups. Manometry studies were considered normal in 8 patients in each group. In group A, 2 patients developed duodenal phase III after receiving A/C, and no significant difference was found in the MI before and after the drug administration. In group B, 9 patients developed duodenal phase III (P <0.05 vs group A). All phase III occurred within a few minutes from the medication administration. Most duodenal phase III contractions were preceded by an antral component during fasting but never after the medication was administered in either of the 2 groups (P<0.001 vs fasting). In group B, the duration of duodenal phase I was shorter after drug administration (P<0.05). There was no significant difference in duodenal phase II MI before and after A/C administration for the 2 study groups. In children, administration of A/C directly into the small bowel before a meal induces phase III-type contractions in the duodenum, with characteristics similar to those present in the fasting state. These data suggest the possible use of A/C as a prokinetic agent. Further studies are needed to clarify its specific mechanism of action and the group of patients most likely to benefit from its use.

  12. Edaravone and its clinical development for amyotrophic lateral sclerosis.

    PubMed

    Takei, Koji; Watanabe, Kazutoshi; Yuki, Satoshi; Akimoto, Makoto; Sakata, Takeshi; Palumbo, Joseph

    2017-10-01

    The etiology of amyotrophic lateral sclerosis (ALS) is unknown. Oxidative stress may be one of the major mechanisms involved. In vitro and in vivo data of edaravone suggest that it may possess broad free radical scavenging activity and protect neurons, glia, and vascular endothelial cells against oxidative stress. During the 1980s and 1990s, edaravone was developed for the treatment of acute ischemic stroke. In 2001, a clinical program in ALS was initiated and five clinical studies were conducted in Japan. Phase III studies were designed to rapidly evaluate (within a 24-week double-blind study window) functional changes using the Revised ALS Functional Rating Scale (ALSFRS-R) as a primary endpoint. The study populations were selected according to these considerations and were further refined as the studies proceeded. Although the first phase III study did not meet its primary endpoint, post-hoc analyses showed an apparent effect of edaravone, when additional patient inclusion criteria defined by ALSFRS-R score, pulmonary function, certainty of ALS diagnosis, and duration of disease were applied. This population was hypothesized not only to have retained broad functionality and normal respiratory function at study baseline but also to be likely to show measurable disease progression over 24 weeks. A second confirmatory phase III study applying these refinements in patient selection was prospectively designed and successfully documented a statistically significant difference between the edaravone and placebo groups in the ALSFRS-R primary endpoint. This paper describes and reviews data pertinent to the potential mechanism of action of edaravone, and reviews the development history of edaravone for the treatment of ALS.

  13. Simultaneous separation and determination of six arsenic species in rice by anion-exchange chromatography with inductively coupled plasma mass spectrometry.

    PubMed

    Ma, Li; Yang, Zhaoguang; Tang, Jie; Wang, Lin

    2016-06-01

    The simultaneous separation and determination of arsenite As(III), arsenate As(V), monomethylarsonic acid (MMA), dimethylarsinic acid (DMA), arsenobetaine (AsB), and arsenocholine (AsC) in rice samples have been carried out in one single anion-exchange column run by high-performance liquid chromatography with inductively coupled plasma mass spectrometry. To estimate the effect of variables on arsenic (As) speciation, the chromatographic conditions including type of competing anion, ionic strength, pH of elution buffer, and flow rate of mobile phase have been investigated by a univariate approach. Under the optimum chromatographic conditions, baseline separation of six As species has been achieved within 10 min by gradient elution program using 4 mM NH4 HCO3 at pH 8.6 as mobile phase A and 4 mM NH4 HCO3 , 40 mM NH4 NO3 at pH 8.6 as mobile phase B. The method detection limits for As(III), As(V), MMA, DMA, AsB, and AsC were 0.4, 0.9, 0.2, 0.4, 0.5, and 0.3 μg/kg, respectively. The proposed method has been applied to separation and quantification of As species in real rice samples collected from Hunan Province, China. The main As species detected in all samples were As(III), As(V) and DMA, with inorganic As accounting for over 80% of total As in these samples. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. Neutron imaging systems utilizing lithium-containing semiconductor crystals

    DOEpatents

    Stowe, Ashley C.; Burger, Arnold

    2017-04-25

    A neutron imaging system, including: a plurality of Li-III-VI.sub.2 semiconductor crystals arranged in an array, wherein III represents a Group III element and VI represents a Group VI element; and electronics operable for detecting and a charge in each of the plurality of crystals in the presence of neutrons and for imaging the neutrons. Each of the crystals is formed by: melting the Group III element; adding the Li to the melted Group III element at a rate that allows the Li and Group III element to react, thereby providing a single phase Li-III compound; and adding the Group VI element to the single phase Li-III compound and heating. Optionally, each of the crystals is also formed by doping with a Group IV element activator.

  15. Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer.

    PubMed

    Blair, Hannah A

    2018-05-21

    Atezolizumab (TECENTRIQ™), an immune checkpoint inhibitor, is an immunoglobulin G1 monoclonal antibody that binds to programmed death ligand 1 (PD-L1) and blocks its interactions with programmed death 1 and B7.1 receptors. Atezolizumab is approved as monotherapy in several countries worldwide for the treatment of patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy. Approval was based on its clinical benefit in this setting in the phase II POPLAR and phase III OAK trials. In these studies, atezolizumab significantly prolonged overall survival (OS) relative to docetaxel, regardless of PD-L1 status. Increasing PD-L1 expression was associated with OS improvements. Atezolizumab also demonstrated efficacy in the phase II FIR and BIRCH trials, as assessed by objective response rates (ORRs) in patients with tumours expressing PD-L1. Higher ORRs were seen in patients with high PD-L1 expression. Atezolizumab had an acceptable, manageable tolerability profile, with a low incidence of immune-related adverse events. Therefore, atezolizumab is a valuable treatment option for patients with advanced NSCLC that has progressed during or after chemotherapy.

  16. Rotator Phases of n-Heptane under High Pressure: Raman Scattering and X-ray Diffraction Studies

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

    C Ma; Q Zhou; F Li

    2011-12-31

    We performed high-pressure Raman scattering and angle-dispersive synchrotron X-ray diffraction measurements on n-heptane at room temperature. It has been found that n-heptane undergoes a liquid to rotator phase III (R{sub III}) transition at 1.2 GPa and then transforms into another rotator phase R{sub IV} at about 3 GPa. As the pressure reaches 7.5 GPa, a transition from an orientationally disordered R{sub IV} phase to an ordered crystalline state starts and is completed around 14.5 GPa. Our results clearly present the high-pressure phase transition sequence (liquid-R{sub III}-R{sub IV}-crystal) of n-heptane, similar to that of normal alkanes.

  17. Phase transformation in the alumina-titania system during flash sintering experiments

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

    Jha, S. K.; Lebrun, J. M.; Raj, R.

    2016-02-01

    We show that phase transformation in the alumina–titania system, which produces aluminum-titanate, follows an unusual trajectory during flash sintering. The experiments begin with mixed powders of alumina–titania and end in dense microstructures that are transformed into aluminum-titanate. The sintering and the phase transformation are separated in time, with the sintering occurs during Stage II, and phase transformation during Stage III of the flash sintering experiment. Stage III is the steady-state condition of flash activated state that is established under current control, while Stage II is the period of transition from voltage to current control. The extent of phase transformation increasesmore » with the current density and the hold time in Stage III.« less

  18. Imprinted magnetic graphene oxide for the mini-solid phase extraction of Eu (III) from coal mine area

    NASA Astrophysics Data System (ADS)

    Patra, Santanu; Roy, Ekta; Madhuri, Rashmi; Sharma, Prashant K.

    2017-05-01

    The present work represents the preparation of imprinted magnetic reduced graphene oxide and applied it for the selective removal of Eu (III) from local coal mines area. A simple solid phase extraction method was used for this purpose. The material shows a very high adsorption as well as removal efficiency towards Eu (III), which suggest that the material have potential to be used in future for their real time applications in removal of Eu (III) from complex matrices.

  19. Stirling convertor performance mapping test results

    NASA Astrophysics Data System (ADS)

    Qiu, Songgang; Peterson, Allen A.; White, Maurice A.; Faultersack, Franklyn; Redinger, Darin L.; Petersen, Stephen L.

    2002-01-01

    The Department of Energy (DOE) has selected Free-Piston Stirling Convertors as a technology for future advanced radioisotope space power systems. In August 2000, DOE awarded competitive Phase I, Stirling Radioisotope Generator (SRG) power system integration contracts to three major aerospace contractors, resulting in SRG conceptual designs in February 2001. All three contractors based their designs on the Technology Demonstration Convertor (TDC) developed by Stirling Technology Company (STC) for DOE. The contract award to a single system integration contractor for Phases II and III of the SRG program is anticipated in late 2001. The first potential SRG mission is targeted for a Mars rover. Recent TDC performance data are provided in this paper, together with predictions from Stirling simulation models. .

  20. Job Aids: Descriptive Authoring Flowcharts for Phase III--DEVELOP 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 third 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 III.1 through III.5. The introduction includes definitions;…

  1. Innovative applications of energy storage in a restructured electricity marketplace : Phase III final report : a study for the DOE Energy Storage Systems Program.

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

    Eyer, James M.; Erdman, Bill; Iannucci, Joseph J., Jr.

    2005-03-01

    This report describes Phase III of a project entitled Innovative Applications of Energy Storage in a Restructured Electricity Marketplace. For this study, the authors assumed that it is feasible to operate an energy storage plant simultaneously for two primary applications: (1) energy arbitrage, i.e., buy-low-sell-high, and (2) to reduce peak loads in utility ''hot spots'' such that the utility can defer their need to upgrade transmission and distribution (T&D) equipment. The benefits from the arbitrage plus T&D deferral applications were estimated for five cases based on the specific requirements of two large utilities operating in the Eastern U.S. A numbermore » of parameters were estimated for the storage plant ratings required to serve the combined application: power output (capacity) and energy discharge duration (energy storage). In addition to estimating the various financial expenditures and the value of electricity that could be realized in the marketplace, technical characteristics required for grid-connected distributed energy storage used for capacity deferral were also explored.« less

  2. Development and testing of responder : phase III.

    DOT National Transportation Integrated Search

    2017-06-28

    This report documents the research project Development and Testing of Responder Phase III. Under previous research, a Responder system has been developed to provide relevant and timely information to first responders, allow responders to provid...

  3. Phase III Early Restoration Meeting | NOAA Gulf Spill Restoration

    Science.gov Websites

    Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News Publications Press Releases Story programmatic approach to early restoration planning for Phase III and future early restoration plans. Open

  4. Phase III Early Restoration Meeting - Corpus Christi, TX | NOAA Gulf Spill

    Science.gov Websites

    Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News programmatic approach to early restoration planning for Phase III and future early restoration plans. Open

  5. Phase III Early Restoration Meeting - Pensacola, FL (rescheduled) | NOAA

    Science.gov Websites

    Restoration Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News programmatic approach to early restoration planning for Phase III and future early restoration plans. Open

  6. Motivation and participation in a phase III cardiac rehabilitation programme: an application of the health action process approach.

    PubMed

    Dohnke, Birte; Nowossadeck, Enno; Müller-Fahrnow, Werner

    2010-10-01

    This longitudinal study extends the previous research on low participation rates and high dropout rates in phase III cardiac rehabilitation (CR) exercise programmes. It examines the correlates of motivation and participation 6 months after inpatient phase II CR (T1) and the predictors of dropout 6 months later (T2) using the health action process approach (HAPA). Risk perception, outcome expectancies, self-efficacy, intention (at T1), and participation (at T1 and T2) in relation to phase III CR programmes was assessed in 456 patients. Based on intention and participation at T1, patients were classified as nonintenders (56%), intenders (13%), or actors (31%). Group differences were confirmed in outcome expectancies and self-efficacy. By T2, 21% of T1 actors had dropped out. Dropouts and maintainers differed in intention and self-efficacy (at T1). Results are in line with the HAPA and suggest a perspective for tailoring motivational counselling to improve participation in phase III CR programmes.

  7. 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

  8. ER-2 #809 awaits pilot entry for the third flight of the SAGE III Ozone Loss and Validation Experiment (SOLVE)

    NASA Image and Video Library

    2000-01-28

    ER-2 #809 awaiting pilot entry for the third flight of the SAGE III Ozone Loss and Validation Experiment (SOLVE). The ER-2, a civilian variant of Lockheed's U-2, and another NASA flying laboratory, Dryden's DC-8, were based north of the Arctic Circle in Kiruna, Sweden during the winter of 2000 to study ozone depletion as part of SOLVE. A large hangar built especially for research, "Arena Arctica" housed the instrumented aircraft and the scientists. Scientists have observed unusually low levels of ozone over the Arctic during recent winters, raising concerns that ozone depletion there could become more widespread as in the Antarctic ozone hole. The NASA-sponsored international mission took place between November 1999 and March 2000 and was divided into three phases. The DC-8 was involved in all three phases returning to Dryden between each phase. The ER-2 flew sample collection flights between January and March, remaining in Sweden from Jan. 9 through March 16. "The collaborative campaign will provide an immense new body of information about the Arctic stratosphere," said program scientist Dr. Michael Kurylo, NASA Headquarters. "Our understanding of the Earth's ozone will be greatly enhanced by this research."

  9. Fate of nuclear material during subsequent steps of the kinetin-induced PCD in apical parts of Vicia faba ssp. minor seedling roots.

    PubMed

    Kaźmierczak, Andrzej; Soboska, Kamila

    2018-07-01

    In animals during apoptosis, the best examined type of programmed cell death (PCD), three main phases are distinguished: (i) specification (signaling), (ii) killing and (iii) execution one. It has bean postulated that plant PCD also involves three subsequent phases: (i) transmission of death signals to cells (signaling), (ii) initiation of killing processes and (iii) destruction of cells. One of the most important hallmarks of animal and plant PCD are those regarding nucleus, not thoroughly studied in plants so far. To study kinetin-induced PCD (Kin-PCD) in the context of nuclear material faith, 2-cm apical parts of Vicia faba ssp. minor seedling roots were used. Applied assays involving spectrophotometry, transmission electron microscopy, fluorescence and white light microscopy allowed to examine metabolic and cytomorphologic hallmarks such as changes in DNA content, ssDNA formation and activity of acidic and basic nucleases (DNases and RNases) as well as malformations and fragmentation of nucleoli and nuclei. The obtained results concerning the PCD hallmarks and influence of ZnSO 4 on Kin-PCD allowed us to confirmed presence of specification/signaling, killing and execution/degradation phases of the process and broaden the knowledge about processes affecting nuclei during PCD. Copyright © 2018 Elsevier Ltd. All rights reserved.

  10. Role of regorafenib as second-line therapy and landscape of investigational treatment options in advanced hepatocellular carcinoma

    PubMed Central

    Trojan, Jörg; Waidmann, Oliver

    2016-01-01

    Sorafenib is still the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). In recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development due to either toxicity or lack of benefit. Recently, data of the RESORCE trial, a placebo-controlled Phase III study that evaluated the efficacy and safety of regorafenib in patients with HCC and documented disease progression after systemic first-line treatment with sorafenib, were presented at the ESMO World Congress on Gastrointestinal Cancer, 2016. Regorafenib treatment resulted in a 2.8-month survival benefit compared to placebo (10.6 months vs 7.8 months). Side effects were consistent with the known profile of regorafenib. The approval of regorafenib for this indication is expected in 2017. Further candidate agents in Phase III evaluation for second-line treatment of patients with HCC are the MET inhibitors tivantinib and cabozantinib, the vascular endothelial growth factor receptor-2 antibody ramucirumab, and the programmed death receptor-1 (PD-1) blocking antibody pembrolizumab. Furthermore, results from two first-line trials with either the tyrosine kinase inhibitor lenvatinib or the PD-1 antibody nivolumabin in comparison to sorafenib are awaited in the near future and might further change the treatment sequence of advanced HCC. PMID:27703962

  11. Role of regorafenib as second-line therapy and landscape of investigational treatment options in advanced hepatocellular carcinoma.

    PubMed

    Trojan, Jörg; Waidmann, Oliver

    2016-01-01

    Sorafenib is still the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). In recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development due to either toxicity or lack of benefit. Recently, data of the RESORCE trial, a placebo-controlled Phase III study that evaluated the efficacy and safety of regorafenib in patients with HCC and documented disease progression after systemic first-line treatment with sorafenib, were presented at the ESMO World Congress on Gastrointestinal Cancer, 2016. Regorafenib treatment resulted in a 2.8-month survival benefit compared to placebo (10.6 months vs 7.8 months). Side effects were consistent with the known profile of regorafenib. The approval of regorafenib for this indication is expected in 2017. Further candidate agents in Phase III evaluation for second-line treatment of patients with HCC are the MET inhibitors tivantinib and cabozantinib, the vascular endothelial growth factor receptor-2 antibody ramucirumab, and the programmed death receptor-1 (PD-1) blocking antibody pembrolizumab. Furthermore, results from two first-line trials with either the tyrosine kinase inhibitor lenvatinib or the PD-1 antibody nivolumabin in comparison to sorafenib are awaited in the near future and might further change the treatment sequence of advanced HCC.

  12. Effectiveness of a School-based Academic Asthma Health Education and Counseling Program on Fostering Acceptance of Asthma in Older School-age Students with Asthma

    PubMed Central

    Kintner, Eileen K.; Cook, Gwendolyn; Marti, C. Nathan; Gomes, Melissa; Meeder, Linda; Van Egeren, Laurie A.

    2014-01-01

    Purpose The purpose was to evaluate the effectiveness of the academic asthma education and counseling SHARP program on fostering psychosocial acceptance of asthma. Design and Methods This was a phase III, two-group, cluster randomized, single-blinded, longitudinal study. Students from grades 4 and 5 (N = 205) with asthma and their caregivers completed surveys at pre-intervention and at 1, 12, and 24 months post-intervention. Analysis involved multilevel modeling. Results All students demonstrated significant improvement in aspects of acceptance; students in SHARP demonstrated significant improvement in openness to sharing and connectedness with teachers over students in the control condition. Practice Implications The SHARP program offers a well-tested, effective program for psychosocial acceptance of asthma, which is welcomed by schools. PMID:25443593

  13. Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Hematopoietic Stem Cell Transplant Cope With Late Complications

    ClinicalTrials.gov

    2012-03-05

    Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Atypical Chronic Myeloid Leukemia, BCR-ABL Negative; Blastic Phase Chronic Myelogenous Leukemia; Cancer Survivor; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; de Novo Myelodysplastic Syndromes; Depression; Disseminated Neuroblastoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Fatigue; Long-term Effects Secondary to Cancer Therapy in Adults; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Psychosocial Effects of Cancer and Its Treatment; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Refractory Multiple Myeloma; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Splenic Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Multiple Myeloma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma

  14. 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.

  15. 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.

  16. Raman spectroscopic study of calcite III to aragonite transformation under high pressure and high temperature

    NASA Astrophysics Data System (ADS)

    Liu, Chuanjiang; Zheng, Haifei; Wang, Duojun

    2017-10-01

    In our study, a series of Raman experiments on the phase transition of calcite at high pressure and high temperature were investigated using a hydrothermal diamond anvil cell and Raman spectroscopy technique. It was found that calcite I transformed to calcite II and calcite III at pressures of 1.62 and 2.12 GPa and room temperature. With increasing temperature, the phase transition of calcite III to aragonite occurred. Aragonite was retained upon slowly cooling of the system, indicating that the transition of calcite III to aragonite was irreversible. Based on the available data, the phase boundary between calcite III and aragonite was determined by the following relation: P(GPa) = 0.013 × T(°C) + 1.22 (100°C ≤ T ≤ 170°C). It showed that the transition pressure linearly rose with increasing temperature. A better understanding of the stability of calcite III and aragonite is of great importance to further explore the thermodynamic behavior of carbonates and carbon cycling in the mantle.

  17. Trends in heteroepitaxy of III-Vs on silicon for photonic and photovoltaic applications

    NASA Astrophysics Data System (ADS)

    Lourdudoss, Sebastian; Junesand, Carl; Kataria, Himanshu; Metaferia, Wondwosen; Omanakuttan, Giriprasanth; Sun, Yan-Ting; Wang, Zhechao; Olsson, Fredrik

    2017-02-01

    We present and compare the existing methods of heteroepitaxy of III-Vs on silicon and their trends. We focus on the epitaxial lateral overgrowth (ELOG) method as a means of achieving good quality III-Vs on silicon. Initially conducted primarily by near-equilibrium epitaxial methods such as liquid phase epitaxy and hydride vapour phase epitaxy, nowadays ELOG is being carried out even by non-equilibrium methods such as metal organic vapour phase epitaxy. In the ELOG method, the intermediate defective seed and the mask layers still exist between the laterally grown purer III-V layer and silicon. In a modified ELOG method called corrugated epitaxial lateral overgrowth (CELOG) method, it is possible to obtain direct interface between the III-V layer and silicon. In this presentation we exemplify some recent results obtained by these techniques. We assess the potentials of these methods along with the other existing methods for realizing truly monolithic photonic integration on silicon and III-V/Si heterojunction solar cells.

  18. Effect of 60 degrees head-down tilt on peripheral gas mixing in the human lung.

    PubMed

    Olfert, I Mark; Prisk, G Kim

    2004-09-01

    The phase III slope of sulfur hexafluoride (SF6) in a single-breath washout (SBW) is greater than that of helium (He) under normal gravity (i.e., 1G), thus resulting in a positive SF6-He slope difference. In microgravity (microG), SF6-He slope difference is smaller because of a greater fall in the phase III slope of SF6 than He. We sought to determine whether increasing thoracic fluid volume using 60 degrees head-down tilt (HDT) in 1G would produce a similar effect to microG on phase III slopes of SF6 and He. Single-breath vital capacity (SBW) and multiple-breath washout (MBW) tests were performed before, during, and 60 min after 1 h of HDT. Compared with baseline (SF6 1.050 +/- 0.182%/l, He 0.670 +/- 0.172%/l), the SBW phase III slopes for both SF6 and He tended to decrease during HDT, reaching nadir at 30 min (SF6 0.609 +/- 0.211%/l, He 0.248 +/- 0.138%/l; P = 0.08 and P = 0.06, respectively). In contrast to microG, the magnitude of the phase III slope decrease was similar for both SF6 and He; therefore, no change in SF6-He slope difference was observed. MBW analysis revealed a decrease in normalized phase III slopes at all time points during HDT, for both SF6 (P < 0.01) and He (P < 0.01). This decrease was due to changes in the acinar, and not the conductive, component of the normalized phase III slope. These findings support the notion that changes in thoracic fluid volume alter ventilation distribution in the lung periphery but also demonstrate that the effect during HDT does not wholly mimic that observed in microG.

  19. Phase III Early Restoration Meeting - Lake Charles, LA | NOAA Gulf Spill

    Science.gov Websites

    Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News early restoration planning for Phase III and future early restoration plans. Open House: 5:30pm Public

  20. Extraction equilibrium of indium(III) from nitric acid solutions by di(2-ethylhexyl)phosphoric acid dissolved in kerosene.

    PubMed

    Tsai, Hung-Sheng; Tsai, Teh-Hua

    2012-01-04

    The extraction equilibrium of indium(III) from a nitric acid solution using di(2-ethylhexyl) phosphoric acid (D2EHPA) as an acidic extractant of organophosphorus compounds dissolved in kerosene was studied. By graphical and numerical analysis, the compositions of indium-D2EHPA complexes in organic phase and stoichiometry of the extraction reaction were examined. Nitric acid solutions with various indium concentrations at 25 °C were used to obtain the equilibrium constant of InR₃ in the organic phase. The experimental results showed that the extraction distribution ratios of indium(III) between the organic phase and the aqueous solution increased when either the pH value of the aqueous solution and/or the concentration of the organic phase extractant increased. Finally, the recovery efficiency of indium(III) in nitric acid was measured.

  1. Influence of Al(III) on biofilm and its extracellular polymeric substances in sequencing batch biofilm reactors.

    PubMed

    Hu, Xuewei; Yang, Lei; Lai, Xinke; Yao, Qi; Chen, Kai

    2017-10-03

    This paper presented the influence of Al(III) on biodegradability, micromorphology, composition and functional groups characteristics of the biofilm extracellular polymeric substances (EPS) during different growth phases. The sequencing batch biofilm reactors were developed to cultivate biofilms under different Al(III) dosages. The results elucidated that Al(III) affected biofilm development adversely at the beginning of biofilm growth, but promoted the biofilm mass and improved the biofilm activity with the growth of the biofilm. The micromorphological observation indicated that Al(III) led to a reduction of the filaments and promotion of the EPS secretion in growth phases of the biofilm, also Al(III) could promote microorganisms to form larger colonies for mature biofilm. Then, the analysis of EPS contents and components suggested that Al(III) could increase the protein (PN) of tightly bound EPS (TB-EPS) which alleviated the metal toxicity inhibition on the biofilm during the initial phases of biofilm growth. The biofilm could gradually adapt to the inhibition caused by Al(III) at the biofilm maturation moment. Finally, through the Fourier transform infrared spectroscopy, it was found that Al(III) was beneficial for the proliferation and secretion of TB-EPS functional groups, especially the functional groups of protein and polysaccharides.

  2. National Dam Safety Program. Lake Como Dam (DE 00028), Delaware River Basin, Mill Creek, Kent County, Delaware. Phase I Inspection Report.

    DTIC Science & Technology

    1980-11-01

    STATEMENT (of the abstract antarod in Block 20, It different frm Report) III. SUPPLEMENTARY NOTES Copies are obtainable from National Technical...should employ a professional engineer experienced in operation and maintanance of darns to develop written operating procedures and a periodic...100 YEAR FLOOD WOULD CAUSE A DAM TO bE OVERTOPPED THEREFORE THE OWNER SHOULD ENGAGE A QUALIFIED PkOFEbSIONAL CONSULTANT USING MORE PERCISE METHODS

  3. Naltrexone/bupropion: Contrave(R); naltrexone SR/bupropion SR.

    PubMed

    2010-01-01

    In March 2010, Orexigen(R) Therapeutics submitted a new drug application (NDA) for approval of naltrexone sustained release (SR)/bupropion SR (Contrave(R)) for the treatment of obesity in the US. The tablet contains naltrexone SR 32 mg and bupropion SR 360 mg. The drug has been tested in four randomized, double-blind, placebo-controlled, phase III trials and the co-primary endpoints were met in each case. This review discusses the key development milestones and clinical trial program to date.

  4. Human Factors Assessment of the U.S. Naval Research Laboratory Limb Protection Program (QuadGard Phase 3 Pre-Pilot Production Design)

    DTIC Science & Technology

    2011-09-01

    NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) U.S. Army Research Laboratory ATTN: RDRL- HRM Aberdeen Proving...user’s hand must be inserted toward the elbow area of the QuadGard III sleeve. This issue was overcome by equipment familiarization and practice ...ADELPHI MD 20783-1197 NO. OF NO. OF COPIES ORGANIZATION COPIES ORGANIZATION 17 1 ARMY RSCH LABORATORY – HRED RDRL HRM DW E REDDEN

  5. National SBIR Phase III Commercialization Conference Held in Orlando, Florida on Jun 10 and 11, 1993

    DTIC Science & Technology

    1993-06-01

    design program catted AKCES.BOREVAC, The delivered system will be capable of real gas flows modeling including 3D Navier-Stokes flow, effective...imprrementat’"n of non-thema-l plasma treatment of effluent gases using corona discharge to reduce ermissions of SO2. NGx and other hazardous air...The AWAS is an aircraft mounted sys- tem that provides the flight crew with advance waninq of Low Level Wind Shear (LLWS) and Clear Air Turbulence ( CAT

  6. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program.

    PubMed

    Barret, Juan P; Podmelle, Fred; Lipový, Břetislav; Rennekampff, Hans-Oliver; Schumann, Hauke; Schwieger-Briel, Agnes; Zahn, Tobias R; Metelmann, Hans-Robert

    2017-09-01

    The clinical significance of timely re-epithelialization is obvious in burn care, since delayed wound closure is enhancing the risk of wound site infection and extensive scarring. Topical treatments that accelerate wound healing are urgently needed to reduce these sequelae. Evidence from preliminary studies suggests that betulin can accelerate the healing of different types of wounds, including second degree burns and split-thickness skin graft wounds. The goal of this combined study program consisting of two randomized phase III clinical trials in parallel is to evaluate whether a topical betulin gel (TBG) is accelerating re-epithelialization of split-thickness skin graft (STSG) donor site wounds compared to standard of care. Two parallel blindly evaluated, randomised, controlled, multicentre phase III clinical trials were performed in adults undergoing STSG surgery (EudraCT nos. 2012-003390-26 and 2012-000777-23). Donor site wounds were split into two equal halves and randomized 1:1 to standard of care (a non-adhesive moist wound dressing) or standard of care plus TBG consisting of 10% birch bark extract and 90% sunflower oil (Episalvan, Birken AG, Niefern-Oeschelbronn, Germany). The primary efficacy assessment was the intra-individual difference in time to wound closure assessed from digital photographs by three blinded experts. A total of 219 patients were included and treated in the two trials. Wounds closed faster with TBG than without it (15.3 vs. 16.5 days; mean intra-individual difference=-1.1 days [95% CI, -1.5 to -0.7]; p<0.0001). This agreed with unblinded direct clinical assessment (difference=-2.1 days [95% CI, -2.7 to -1.5]; p<0.0001). Adverse events possibly related to treatment were mild or moderate and mostly at the application site. TBG accelerates re-epithelialization of partial thickness wounds compared to the current standard of care, providing a well-tolerated contribution to burn care in practice. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. TRIO (Triplet Ionospheric Observatory) Mission

    NASA Astrophysics Data System (ADS)

    Lee, D.; Seon, J.; Jin, H.; Kim, K.; Lee, J.; Jang, M.; Pak, S.; Kim, K.; Lin, R. P.; Parks, G. K.; Halekas, J. S.; Larson, D. E.; Eastwood, J. P.; Roelof, E. C.; Horbury, T. S.

    2009-12-01

    Triplets of identical cubesats will be built to carry out the following scientific objectives: i) multi-observations of ionospheric ENA (Energetic Neutral Atom) imaging, ii) ionospheric signature of suprathermal electrons and ions associated with auroral acceleration as well as electron microbursts, and iii) complementary measurements of magnetic fields for particle data. Each satellite, a cubesat for ion, neutral, electron, and magnetic fields (CINEMA), is equipped with a suprathermal electron, ion, neutral (STEIN) instrument and a 3-axis magnetometer of magnetoresistive sensors. TRIO is developed by three institutes: i) two CINEMA by Kyung Hee University (KHU) under the WCU program, ii) one CINEMA by UC Berkeley under the NSF support, and iii) three magnetometers by Imperial College, respectively. Multi-spacecraft observations in the STEIN instruments will provide i) stereo ENA imaging with a wide angle in local times, which are sensitive to the evolution of ring current phase space distributions, ii) suprathermal electron measurements with narrow spacings, which reveal the differential signature of accelerated electrons driven by Alfven waves and/or double layer formation in the ionosphere between the acceleration region and the aurora, and iii) suprathermal ion precipitation when the storm-time ring current appears. In addition, multi-spacecraft magnetic field measurements in low earth orbits will allow the tracking of the phase fronts of ULF waves, FTEs, and quasi-periodic reconnection events between ground-based magnetometer data and upstream satellite data.

  8. Development of a unified web-based national HIV/AIDS information system in China

    PubMed Central

    Mao, Yurong; Wu, Zunyou; Poundstone, Katharine; Wang, Changhe; Qin, Qianqian; Ma, Ye; Ma, Wei

    2010-01-01

    Background In the past, many data collection systems were in operation for different HIV/AIDS projects in China. We describe the creation of a unified, web-based national HIV/AIDS information system designed to streamline data collection and facilitate data use. Methods Integration of separate HIV/AIDS data systems was carried out in three phases. Phase 1, from January 2006 to December 2007, involved creating a set of unified data collection forms that took into account existing program needs and the reporting requirements of various international organizations. Phase 2, from January to October 2007, involved creating a web-based platform to host the integrated HIV/AIDS data collection system. Phase 3, from November to December 2007, involved pilot testing the new, integrated system prior to nationwide application. Results Eight web-based data collection subsystems based on one platform began operation on 1 January 2008. These eight subsystems cover: (i) HIV/AIDS case reporting; (ii) HIV testing and counselling; (iii) antiretroviral treatment (ART) for adults; (iv) ART for children; (v) behavioural interventions for high-risk groups; (vi) methadone maintenance treatment; (vii) sentinel and behavioural surveillance; and (viii) local county background information. The system provides real-time data to monitor HIV testing, prevention and treatment programs across the country. Conclusion China’s new unified, web-based HIV/AIDS information system has improved the efficiency of data collection, reporting, analysis and use, as well as data quality and security. It is a powerful tool to support policy making, program evaluation and implementation of the national HIV/AIDS program and, thus, may serve a model for other countries. PMID:21113041

  9. Recent updates of precision therapy for gastric cancer: Towards optimal tailored management.

    PubMed

    Joo, Moon Kyung; Park, Jong-Jae; Chun, Hoon Jai

    2016-05-21

    Signaling pathways of gastric carcinogenesis and gastric cancer progression are being avidly studied to seek optimal treatment of gastric cancer. Among them, hepatocyte growth factor (HGF)/c-MET, phosphoinositide 3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) and janus kinase 2/signal transducer and activator of transcription 3 (JAK2/STAT3) pathways have been widely investigated. Their aberrant expression or mutation has been significantly associated with advanced stage or poor prognosis of gastric cancer. Recently, aberrations of immune checkpoints including programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) have been suggested as an important step in the formation of a microenvironment favorable for gastric cancer. Accomplishments in basic research have led to the development of novel agents targeting these signaling pathways. However, phase III studies of selective anti-HGF/c-MET antibodies and mTOR inhibitor failed to show significant benefits in terms of overall survival and progression-free survival. Few agents directly targeting STAT3 have been developed. However, this target is still critical issue in terms of chemoresistance, and SH2-containing protein tyrosine phosphatase 1 might be a significant link to effectively inhibit STAT3 activity. Inhibition of PD-1/PD-L1 showed durable efficacy in phase I studies, and phase III evaluation is warranted. Therapeutic strategy to concurrently inhibit multiple tyrosine kinases is a reasonable option, however, lapatinib needs to be further evaluated to identify good responders. Regorafenib has shown promising effectiveness in prolonging progression-free survival in a phase II study. In this topic highlight, we review the biologic roles and outcomes of clinical studies targeting these signaling pathways.

  10. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma

    PubMed Central

    Schadendorf, Dirk; Hodi, F. Stephen; Robert, Caroline; Weber, Jeffrey S.; Margolin, Kim; Hamid, Omid; Patt, Debra; Chen, Tai-Tsang; Berman, David M.; Wolchok, Jedd D.

    2015-01-01

    Purpose To provide a more precise estimate of long-term survival observed for ipilimumab-treated patients with advanced melanoma, we performed a pooled analysis of overall survival (OS) data from multiple studies. Methods The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospective studies of ipilimumab, including two phase III trials. Patients were previously treated (n = 1,257) or treatment naive (n = 604), and the majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706). We also conducted a secondary analysis of OS data (n = 4,846) with an additional 2,985 patients from an expanded access program. OS rates were estimated using the Kaplan-Meier method. Results Among 1,861 patients, median OS was 11.4 months (95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years of survival follow-up. The survival curve began to plateau around year 3, with follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for all patients, treatment-naive patients, and previously treated patients, respectively. Including data from the expanded access program, median OS was 9.5 months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve beginning around year 3. Conclusion To our knowledge, this is the largest analysis of OS to date for ipilimumab-treated patients with advanced melanoma. We observed a plateau in the survival curve, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose. These data add to the evidence supporting the durability of long-term survival in ipilimumab-treated patients with advanced melanoma. PMID:25667295

  11. Analysis of navigation and guidance requirements for commercial VTOL operations

    NASA Technical Reports Server (NTRS)

    Hoffman, W. C.; Zvara, J.; Hollister, W. M.

    1975-01-01

    The paper presents some results of a program undertaken to define navigation and guidance requirements for commercial VTOL operations in the takeoff, cruise, terminal and landing phases of flight in weather conditions up to and including Category III. Quantitative navigation requirements are given for the parameters range, coverage, operation near obstacles, horizontal accuracy, multiple landing aircraft, multiple pad requirements, inertial/radio-inertial requirements, reliability/redundancy, update rate, and data link requirements in all flight phases. A multi-configuration straw-man navigation and guidance system for commercial VTOL operations is presented. Operation of the system is keyed to a fully automatic approach for navigation, guidance and control, with pilot as monitor-manager. The system is a hybrid navigator using a relatively low-cost inertial sensor with DME updates and MLS in the approach/departure phases.

  12. 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...

  13. 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...

  14. 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...

  15. Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains (DTaP-sIPV).

    PubMed

    Okada, Kenji; Miyazaki, Chiaki; Kino, Yoichiro; Ozaki, Takao; Hirose, Mizuo; Ueda, Kohji

    2013-07-15

    Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations. Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable. DTaP-sIPV was shown to be a safe and immunogenic vaccine. JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp).

  16. 24 CFR 8.29 - Homeownership programs (sections 235(i) and 235(j), Turnkey III and Indian housing mutual self...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Homeownership programs (sections 235(i) and 235(j), Turnkey III and Indian housing mutual self-help programs). 8.29 Section 8.29...), Turnkey III and Indian housing mutual self-help programs). Any housing units newly constructed or...

  17. 24 CFR 8.29 - Homeownership programs (sections 235(i) and 235(j), Turnkey III and Indian housing mutual self...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Homeownership programs (sections 235(i) and 235(j), Turnkey III and Indian housing mutual self-help programs). 8.29 Section 8.29...), Turnkey III and Indian housing mutual self-help programs). Any housing units newly constructed or...

  18. 40 CFR 147.650 - State-administrative program-Class I, II, III, IV, and V wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CONTROL PROGRAMS Idaho § 147.650 State-administrative program—Class I, II, III, IV, and V wells. The UIC program for Class I, II, III, IV, and V wells in the State of Idaho, other than those on Indian lands, is the program administered by the Idaho Department of Water Resources, approved by EPA pursuant to...

  19. 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).

  20. Effect of weak magnetic field on arsenate and arsenite removal from water by zerovalent iron: an XAFS investigation.

    PubMed

    Sun, Yuankui; Guan, Xiaohong; Wang, Jianmin; Meng, Xiaoguang; Xu, Chunhua; Zhou, Gongming

    2014-06-17

    In this study, a weak magnetic field (WMF), superimposed with a permanent magnet, was utilized to improve ZVI corrosion and thereby enhance As(V)/As(III) removal by ZVI at pHini 3.0-9.0. The experiment with real arsenic-bearing groundwater revealed that WMF could greatly improve arsenic removal by ZVI even in the presence of various cations and anions. The WMF-induced improvement in As(V)/As(III) removal by ZVI should be primarily associated with accelerated ZVI corrosion, as evidenced by the pH variation, Fe(2+) release, and the formation of corrosion products as characterized with X-ray absorption fine structure spectroscopy. The arsenic species analysis in solution/solid phases at pHini 3.0 revealed that As(III) oxidation to As(V) in aqueous phase preceded its subsequent sequestration by the newly formed iron (hydr)oxides. However, both As(V) adsorption following As(III) oxidation to As(V) in solution and As(III) adsorption preceding its conversion to As(V) in solid phase were observed at pHini 5.0-9.0. The application of WMF accelerated the transformation of As(III) to As(V) in both aqueous and solid phases at pHini 5.0-9.0 and enhanced the oxidation of As(III) to As(V) in solution at pHini 3.0.

  1. Phase III Early Restoration Meeting - Galveston, TX | NOAA Gulf Spill

    Science.gov Websites

    Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News planning for Phase III and future early restoration plans. Open House: 6:00pm Public Meeting: 6:30pm

  2. Phase III Early Restoration Meeting - Port Arthur, TX | NOAA Gulf Spill

    Science.gov Websites

    Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News planning for Phase III and future early restoration plans. Open House: 6:00pm Public Meeting: 6:30pm

  3. Phase III Early Restoration Meeting - Panama City, FL | NOAA Gulf Spill

    Science.gov Websites

    Areas Alabama Florida Louisiana Mississippi Texas Region-wide Open Ocean Data Media & News planning for Phase III and future early restoration plans. Open House: 6:00pm Public Meeting: 6:30pm

  4. 78 FR 65621 - Implementation of Title I/II Program Initiatives; Extension of Public Comment Period; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ... DEPARTMENT OF EDUCATION Implementation of Title I/II Program Initiatives; Extension of Public Comment Period; Correction AGENCY: Department of Education. ACTION: Correction notice. SUMMARY: On October... Title I/II Program Initiatives,'' Docket ID ED- 2013-ICCD-0090. The comment period for this information...

  5. 78 FR 41785 - Agency Information Collection Activities; Comment Request; Implementation of Title I/II Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-11

    ...; Comment Request; Implementation of Title I/II Program Initiatives AGENCY: Institute of Educational... note that written comments received in response to this notice will be considered public records. Title of Collection: Implementation of Title I/II Program Initiatives. OMB Control Number: 1850-New. Type...

  6. North Carolina "Sealed Corridor" Phase I, II, and III Assessment

    DOT National Transportation Integrated Search

    2009-10-01

    The Federal Railroad Administration (FRA) tasked the John A. Volpe National Transportation Systems Center to document the further success of the North Carolina DOT "Sealed Corridor" project through Phases I, II, and III. The Sealed Corridor is the se...

  7. Phase III gross solids removal devices pilot study, 2002-2005.

    DOT National Transportation Integrated Search

    2005-12-01

    The objective of the Phase III Gross Solids Removal Devices (GSRDs) Pilot study was to : evaluate the performance of non-proprietary devices that can capture gross solids and that can be : incorporated into existing highway drainage systems or implem...

  8. Improvement of conspicuity of trailblazing signs, Phase III : evaluation of fluorescent colors.

    DOT National Transportation Integrated Search

    2001-01-01

    This report represents a Phase III effort to design and evaluate a new sign design for incident route trailblazing. The colors evaluated were fluorescent coral, fluorescent purple, fluorescent yellow-green, and non-fluorescent purple. The results ind...

  9. 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.

  10. The Center for Astronomy Education (CAE) and Our NSF Funded CCLI Phase III Collaboration of Astronomy Teaching Scholars (CATS) Program: Updates to Our New Community-Based Model for Astronomy Education Research

    NASA Astrophysics Data System (ADS)

    Brissenden, Gina; Impey, C.; Prather, E. E.; Lee, K. M.; CATS

    2010-01-01

    The Center for Astronomy Education (CAE) has been devoted to improving teaching & learning in Astro 101 by creating research-validated curriculum & assessment instruments for use in Astro 101 & by providing Astro 101 instructors professional development opportunities to increase their pedagogical content knowledge & instructional skills at implementing these curricula & assessment materials. To create sustainability and further expand this work, CAE, in collaboration with other national leaders in astronomy education & research, developed the Collaboration of Astronomy Teaching Scholars (CATS) Program. The primary goals of CATS are to: 1) increase the number of Astro 101 instructors conducting fundamental research in astronomy education 2) increase the amount of research-validated curriculum & assessment instruments available for use in Astro 101 3) increase the number of people prepared to develop & conduct their own CAE Teaching Excellence Workshops In our second year we have concluded a national study assessing the contribution students’ personal characteristics make to student learning gains and the effectiveness of interactive learning strategies. We have results from our classroom research validation study on the use of the "ClassAction” electronic learning system. We have begun creation of an assessment instrument designed specifically for Astro 101 to evaluate the effectiveness of our instruction in improving students’ attitudes & beliefs about science, and which is being informed by several of our studies and community input. We have also begun field-testing of our Solar System Concept Inventory. Additionally research into students’ beliefs and reasoning difficulties on topics in Cosmology is underway. We acknowledge the NSF for funding under Award No. 0715517, a CCLI Phase III Grant for the Collaboration of Astronomy Teaching Scholars (CATS) Program.

  11. Development of an EORTC quality of life phase III module measuring cancer-related fatigue (EORTC QLQ-FA13).

    PubMed

    Weis, Joachim; Arraras, Juan Ignacio; Conroy, Thierry; Efficace, Fabio; Fleissner, Claudia; Görög, Attila; Hammerlid, Eva; Holzner, Bernhard; Jones, Louise; Lanceley, Anne; Singer, Susanne; Wirtz, Markus; Flechtner, Henning; Bottomley, Andrew

    2013-05-01

    European Organisation for Research and Treatment of Cancer (EORTC) has developed a new multidimensional instrument measuring cancer-related fatigue that can be used in conjunction with the quality of life core questionnaire, EORTC QLQ-C30. The paper focuses on the development of the phase III module, collaborating with seven European countries, including a patient sample of 318 patients. The methodology followed the EORTC guidelines for developing phase III modules. Patients were assessed by questionnaires (EORTC QLQ-C30 with the EORTC Fatigue Module FA15) followed by an interview, asking for their opinions on the difficulty in understanding, on annoyance and on intrusiveness. The phase II FA15 was revised on the basis of qualitative analyses (comments of the patients), quantitative results (descriptive statistics) as well as the multi-item response theory analyses. The three dimensions (physical, emotional and cognitive) of the scale could be confirmed. As a result, EORTC QLQ-FA13 is now available as a valid phase III module measuring cancer-related fatigue in clinical trials and will be psychometrically improved in the upcoming phase IV. Copyright © 2012 John Wiley & Sons, Ltd.

  12. Understanding the Mechanism of Magnetic Relaxation in Pentanuclear {MnIVMnIII2LnIII2} Single-Molecule Magnets.

    PubMed

    Vignesh, Kuduva R; Langley, Stuart K; Moubaraki, Boujemaa; Murray, Keith S; Rajaraman, Gopalan

    2018-02-05

    A new family of heterometallic pentanuclear complexes of formulas [Mn IV Mn III 2 Ln III 2 O 2 (benz) 4 (mdea) 3 (NO 3 ) 2 (MeOH)] (Ln = Dy (1-Dy), Tb (2-Tb), Gd (3-Gd), Eu (4-Eu), Sm (5-Sm), Nd (6-Nd), Pr (7-Pr); benz(H) = benzoic acid; mdeaH 2 = N-methyldiethanolamine) and [Mn IV Mn III 2 Ln III 2 O 2 (o-tol) 4 (mdea) 3 (NO 3 ) 2 (MeOH)] (Ln = Gd (8-Gd), Eu (9-Eu); o-tol(H) = o-toluic acid) have been isolated and structurally, magnetically, and theoretically characterized. dc magnetic susceptibility measurements reveal dominant antiferromagnetic magnetic interactions for each complex, except for 2-Tb and 3-Gd, which reveal an upturn in the χ M T product at low temperatures. The magnetic interactions between the spin centers in the Gd derivatives, 3-Gd and 8-Gd, which display markedly different χ M T vs T profiles, were found to be due to the interactions of the Gd III -Gd III ions which change from ferromagnetic (3-Gd) to antiferromagnetic (8-Gd) due to structural differences. ac magnetic susceptibility measurements reveal a nonzero out-of-phase component for 1-Dy and 7-Pr, but no maxima were observed above 2 K (H dc = 0 Oe), which suggests single-molecule magnet (SMM) behavior. Out-of-phase signals were observed for complexes 2-Tb, 4-Eu, 8-Gd, and 9-Eu, in the presence of a static dc field (H dc = 2000, 3000 Oe). The anisotropic nature of the lanthanide ions in the benzoate series (1-Dy, 2-Tb, 5-Sm, 6-Nd, and 7-Pr) were thoroughly investigated using ab initio methods. CASSCF calculations predict that the origin of SMM behavior in 1-Dy and 7-Pr and the applied field SMM behavior in 2-Tb does not solely originate from the single-ion anisotropy of the lanthanide ions. To fully understand the relaxation mechanism, we have employed the Lines model to fit the susceptibility data using the POLY_ANISO program, which suggests that the zero-field SMM behavior observed in complexes 1-Dy and 7-Pr is due to weak Mn III/IV -Ln III and Ln III -Ln III couplings and an unfavorable Ln III /Mn III /Mn IV anisotropy. In complexes 4-Eu, 8-Gd, and 9-Eu ab initio calculations indicate that the anisotropy of the Mn III ions solely gives rise to the possibility of SMM behavior. Complex 7-Pr is a Pr(III)-containing complex that displays zero-field SMM behavior, which is rare, and our study suggests the possibility of coupling weak SOC lanthanide metal ions to anisotropic transition-metal ions to derive SMM characteristics; however, enhancing the exchange coupling in {3d-4f} complexes is still a stubborn hurdle in harnessing new generation {3d-4f} SMMs.

  13. The effects of phase III cardiac rehabilitation in serum and salivary Hs-CRP and anthropometric measurements in patients with coronary artery disease.

    PubMed

    Jamshidpour, Boshra; Moghadam, Behrouz Attarbashi; Vasaghi-Gharamaleki, Behnoosh; Mirzaii-Dizgah, Iraj; Nejatian, Mostafa

    2013-09-01

    Cardiac rehabilitation is a key part in the treatment of coronary artery disease (CAD) by its anti-infammatory effects. However, the effect of exercise training programs on salivary concentrations of high-sensitivity C-reactive protein (hs-CRP) in patients with coronary artery disease has not been well studied. The objective of this study was to evaluate the effect of phase III cardiac rehabilitation on serum and salivary levels of hs-CRP, in relation to the anthropometric measurements of obesity and the relationship between salivary and serum levels of hs-CRP in CAD male patients. Forty male volunteers (45-75 years) with CAD participated in 6 to 8 weeks of moderate intensity aerobic exercise training consisting of 45 minutes sessions of treadmill, stationary bicycle and arm ergometer. Anthropometric measurements of obesity, serum level of hs-CRP, stimulated and nonstimulated salivary level of hs-CRP were measured at the beginning, in the middle and at the end of exercise sessions. All anthropometric measurements increased (p < 0.05) following cardiac rehabilitation except waist-hip ratio. Serum hs-CRP level reduced by 36% independent to the anthropometric measurements changes. Stimulated and nonstimulated salivary hs-CRP level decreased 68 and 54%, respectively, after 24 sessions of cardiac rehabilitation. Nonstimulated salivary hs-CRP levels correlated to serum levels of hs-CRP at baseline and after 24 sessions (p < 0.05). Phase III cardiac rehabilitation seems to be effective to improve serum and salivary hs-CRP concentrations independent of anthropometric measurements. Nonstimulated salivary hs-CRP measurement could be a surrogate for blood measurement of hs-CRP during cardiac rehabilitation in male patients with CAD.

  14. Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis.

    PubMed

    van de Kerkhof, Peter C M; Griffiths, Christopher E M; Reich, Kristian; Leonardi, Craig L; Blauvelt, Andrew; Tsai, Tsen-Fang; Gong, Yankun; Huang, Jiaqing; Papavassilis, Charis; Fox, Todd

    2016-07-01

    Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis. We reviewed safety data from the secukinumab psoriasis phase II/III program. Data were pooled from 10 phase II/III secukinumab psoriasis studies. Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). There was a limited number of patients in comparator groups and the exposure to placebo was short. Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  15. Canadian Phase III Randomized Trial of Stereotactic Body Radiotherapy Versus Conventionally Hypofractionated Radiotherapy for Stage I, Medically Inoperable Non-Small-Cell Lung Cancer - Rationale and Protocol Design for the Ontario Clinical Oncology Group (OCOG)-LUSTRE Trial.

    PubMed

    Swaminath, Anand; Wierzbicki, Marcin; Parpia, Sameer; Wright, James R; Tsakiridis, Theodoros K; Okawara, Gordon S; Kundapur, Vijayananda; Bujold, Alexis; Ahmed, Naseer; Hirmiz, Khalid; Kurien, Elizabeth; Filion, Edith; Gabos, Zsolt; Faria, Sergio; Louie, Alexander V; Owen, Timothy; Wai, Elaine; Ramchandar, Kevin; Chan, Elisa K; Julian, Jim; Cline, Kathryn; Whelan, Timothy J

    2017-03-01

    We describe a Canadian phase III randomized controlled trial of stereotactic body radiotherapy (SBRT) versus conventionally hypofractionated radiotherapy (CRT) for the treatment of stage I medically inoperable non-small-cell lung cancer (OCOG-LUSTRE Trial). Eligible patients are randomized in a 2:1 fashion to either SBRT (48 Gy in 4 fractions for peripherally located lesions; 60 Gy in 8 fractions for centrally located lesions) or CRT (60 Gy in 15 fractions). The primary outcome of the study is 3-year local control, which we hypothesize will improve from 75% with CRT to 87.5% with SBRT. With 85% power to detect a difference of this magnitude (hazard ratio = 0.46), a 2-sided α = 0.05 and a 2:1 randomization, we require a sample size of 324 patients (216 SBRT, 108 CRT). Important secondary outcomes include overall survival, disease-free survival, toxicity, radiation-related treatment death, quality of life, and cost-effectiveness. A robust radiation therapy quality assurance program has been established to assure consistent and high quality SBRT and CRT delivery. Despite widespread interest and adoption of SBRT, there still remains a concern regarding long-term control and risks of toxicity (particularly in patients with centrally located lesions). The OCOG-LUSTRE study is the only randomized phase III trial testing SBRT in a medically inoperable population, and the results of this trial will attempt to prove that the benefits of SBRT outweigh the potential risks. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. 40 CFR 86.109-94 - Exhaust gas sampling system; Otto-cycle vehicles not requiring particulate emission measurements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and...

  17. 40 CFR 86.109-94 - Exhaust gas sampling system; Otto-cycle vehicles not requiring particulate emission measurements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and...

  18. 40 CFR 86.109-94 - Exhaust gas sampling system; Otto-cycle vehicles not requiring particulate emission measurements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and... detection for the HPLC analyzer. Sampling systems for all phases shall be identical. (iii) The methanol and...

  19. Progress in the Development of Metamorphic Multi-Junction III-V Space-Solar Cells at Essential Research Incorporated

    NASA Technical Reports Server (NTRS)

    Sinharoy, Samar; Patton, Martin O.; Valko, Thomas M., Sr.; Weizer, Victor G.

    2002-01-01

    Theoretical calculations have shown that highest efficiency III-V multi-junction solar cells require alloy structures that cannot be grown on a lattice-matched substrate. Ever since the first demonstration of high efficiency metamorphic single junction 1.1 eV and 1.2 eV InGaAs solar cells by Essential Research Incorporated (ERI), interest has grown in the development of multi-junction cells of this type using graded buffer layer technology. ERI is currently developing a dual-junction 1.6 eV InGaP/1.1 eV InGaAs tandem cell (projected practical air-mass zero (AM0), one-sun efficiency of 28%, and 100-sun efficiency of 37.5%) under a Ballistic Missile Defense Command (BMDO) SBIR Phase II program. A second ongoing research effort at ERI involves the development of a 2.1 eV AlGaInP/1.6 eV InGaAsP/1.2 eV InGaAs triple-junction concentrator tandem cell (projected practical AM0 efficiency of 36.5% under 100 suns) under a SBIR Phase II program funded by the Air Force. We are in the process of optimizing the dual-junction cell performance. In case of the triple-junction cell, we have developed the bottom and the middle cell, and are in the process of developing the layer structures needed for the top cell. A progress report is presented in this paper.

  20. Benzyl and Methyl Fatty Hydroxamic Acids Based on Palm Kernel Oil as Chelating Agent for Liquid-Liquid Iron(III) Extraction

    PubMed Central

    Haron, Md Jelas; Jahangirian, Hossein; Silong, Sidik; Yusof, Nor Azah; Kassim, Anuar; Rafiee-Moghaddam, Roshanak; Mahdavi, Behnam; Peyda, Mazyar; Abdollahi, Yadollah; Amin, Jamileh

    2012-01-01

    Liquid-liquid iron(III) extraction was investigated using benzyl fatty hydroxamic acids (BFHAs) and methyl fatty hydroxamic acids (MFHAs) as chelating agents through the formation of iron(III) methyl fatty hydroxamate (Fe-MFHs) or iron(III) benzyl fatty hydroxamate (Fe-BFHs) in the organic phase. The results obtained under optimized conditions, showed that the chelating agents in hexane extract iron(III) at pH 1.9 were realized effectively with a high percentage of extraction (97.2% and 98.1% for MFHAs and BFHAs, respectively). The presence of a large amount of Mg(II), Ni(II), Al(III), Mn(II) and Co(II) ions did affect the iron(III) extraction. Finally stripping studies for recovering iron(III) from organic phase (Fe-MFHs or Fe-BFHs dissolved in hexane) were carried out at various concentrations of HCl, HNO3 and H2SO4. The results showed that the desired acid for recovery of iron(III) was 5 M HCl and quantitative recovery of iron(III) was achieved from Fe(III)-MFHs and Fe(III)-BFHs solutions in hexane containing 5 mg/L of Fe(III). PMID:22408444

  1. Secukinumab in the Treatment of Psoriasis and Psoriatic Arthritis: A Review of the Literature.

    PubMed

    Abrouk, M; Gandy, J; Nakamura, M; Lee, K; Brodsky, M; Singh, R; Zhu, H; Farahnik, B; Bhutani, T; Koo, J

    2017-07-01

    While there are several commercially available treatment options for psoriasis and psoriatic arthritis, there remains a large number of individuals who are refractory to current modalities. In the recent past, there has been increasing evidence that interleukin (IL)-17 plays a vital role in the pathophysiology of psoriasis. Preclinical, phase II, and phase III studies of secukinumab (Cosentyx®) targeting IL-17 and its receptor have thus far proved to be promising. We reviewed the results of phase II and phase III clinical trials for secukinumab in the treatment of psoriasis and psoriatic arthritis. Only published studies were considered in the present review. We also performed an English language literature search from January 2003 to September 2015 using PubMed with any of the following key words: (secukinumab OR AIN457) AND (psoriasis OR psoriatic arthritis). In our review of the literature, seven phase III and five phase II clinical trials, as well as open-label extension studies with unpublished findings were found. Results from phase III clinical trials indicated secukinumab to be efficacious and safe for the treatment of psoriasis and psoriatic arthritis according to Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) scores. The safety profile of this agent was similar across all studies, with the most frequently reported adverse events of nasopharyngitis, upper respiratory infections, headache, and injection site reaction. Secukinumab demonstrates rapid and robust clinical improvement accompanied by a favorable short- term safety profile. The results of the phase III trials continue to reinforce the theory that the IL-17 pathway is an essential target in psoriasis and psoriatic arthritis treatment. Additional extension studies of lower level evidence are needed to further understand the safety profile of the drug.

  2. Malaria burden and treatment targets in Kachin Special Region II, Myanmar from 2008 to 2016: A retrospective analysis

    PubMed Central

    Bi, Yaw

    2018-01-01

    Although drug-based treatment is the primary intervention for malaria control and elimination, optimal use of targeted treatments remains unclear. From 2008 to 2016, three targeted programs on treatment were undertaken in Kachin Special Region II (KR2), Myanmar. Program I (2008–2011) treated all confirmed, clinical and suspected cases; program II (2012–2013) treated confirmed and clinical cases; and program III (2014–2016) targeted confirmed cases only. This study aims to evaluate the impacts of the three programs on malaria burden individually based on the annual parasite incidence (API), slide positivity rate (SPR) and their relative values. The API is calculated from original collected data and the incidence rate ratio (IRR) for each year is calculated by using the first-year API as a reference in each program phase across the KR2. Same method is applied to calculate SPR and risk ratio (RR) at the sentinel hospital too. During program I (2008–2011), malaria burden was reduced by 61% (95%CI: 58%-74%) and the actual API decreased from 9.8 (95%CI: 9.6–10.1) per 100 person-years in 2008 to 3.8 (3.6–4.1) per 100 person-years in 2011. Amid program II (2012–2013), the malaria burden increased by 33% (95%CI: 22%-46%) and the actual API increased from 2.1(95%CI: 2.0–2.3) per 100 person-years in 2012 to 2.8 (95%CI: 2.7–2.9) per 100 person-years in 2013. During program III (2014–2016) the malaria burden increased furtherly by 60% (95%CI: 51% - 69%) and the actual API increased from 3.2(95%CI: 3.0–3.3) per 100 person-years in 2014 to 5.1 (95%CI: 4.9–5.2) per 100 person-years in 2016. Results of the slide positivity of the sentinel hospital also confirm these results. Resurgence of malaria was mainly due to Plasmodium vivax during program II and III. This study indicates that strategy adopted in program I (2008–2011) should be more appropriate for the KR2. Quality-assured treatment of all confirmed, clinical and suspected malaria cases may be helpful for the reduction of malaria burden. PMID:29614088

  3. Remedial Action Report for Operable Units 6-05 and 10-04, Phase III

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

    R. P. Wells

    2007-08-15

    This Phase III remedial action report addresses the remediation of lead-contaminated soils found at the Security Training Facility STF-02 Gun Range at the Idaho National Laboratory Site. Phase I, consisting of developing and implementing institutional controls at Operble Unit 10-04 sites and developing and implementing Idaho National Laboratory Site-wide plans for both institutional controls and ecological monitoring, was addressed in a previous report. Phase II will remediate sites contaminated with trinitrotoluene and Royal Demolition Explosive. Phase IV will remediate hazards from unexploded ordnance.

  4. A phase II clinical trial of a dental health education program delivered by aboriginal health workers to prevent early childhood caries.

    PubMed

    Blinkhorn, Fiona; Brown, Ngiare; Freeman, Ruth; Humphris, Gerry; Martin, Andrew; Blinkhorn, Anthony

    2012-08-21

    Early Childhood Caries (ECC) is a widespread problem in Australian Aboriginal communities causing severe pain and sepsis. In addition dental services are difficult to access for many Aboriginal children and trying to obtain care can be stressful for the parents. The control of dental caries has been identified as a key indictor in the reduction of Indigenous disadvantage. Thus, there is a need for new approaches to prevent ECC, which reflect the cultural norms of Aboriginal communities. This is a Phase II single arm trial designed to gather information on the effectiveness of a dental health education program for Aboriginal children aged 6 months, followed over 2 years. The program will deliver advice from Aboriginal Health Workers on tooth brushing, diet and the use of fluoride toothpaste to Aboriginal families. Six waves of data collection will be conducted to enable estimates of change in parental knowledge and their views on the acceptability of the program. The Aboriginal Health Workers will also be interviewed to record their views on the acceptability and program feasibility. Clinical data on the child participants will be recorded when they are 30 months old and compared with a reference population of similar children when the study began. Latent variable modeling will be used to interpret the intervention effects on disease outcome. The research project will identify barriers to the implementation of a family centered Aboriginal oral health strategy, as well as the development of evidence to assist in the planning of a Phase III cluster randomized study. ACTRN12612000712808.

  5. Student Perceptions of Elementary School Climates in the Louisiana School Effectiveness Study: A Comparison of Phase III and Phase IV.

    ERIC Educational Resources Information Center

    Roberts, Sharon Pol; Heroman, Deborah S.

    A 5-year study examined third-graders' perceptions of school climate in 16 Louisiana schools. Part of the Louisiana School Effectiveness Study (LSES), Phase III and IV examined student perceptions in 1984-85 and 1989-90, respectively, and also gathered demographic data and multiple measures of student outcomes through student surveys and classroom…

  6. Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules.

    PubMed

    Robertson, David S; Prevost, A Toby; Bowden, Jack

    2016-09-30

    Seamless phase II/III clinical trials offer an efficient way to select an experimental treatment and perform confirmatory analysis within a single trial. However, combining the data from both stages in the final analysis can induce bias into the estimates of treatment effects. Methods for bias adjustment developed thus far have made restrictive assumptions about the design and selection rules followed. In order to address these shortcomings, we apply recent methodological advances to derive the uniformly minimum variance conditionally unbiased estimator for two-stage seamless phase II/III trials. Our framework allows for the precision of the treatment arm estimates to take arbitrary values, can be utilised for all treatments that are taken forward to phase III and is applicable when the decision to select or drop treatment arms is driven by a multiplicity-adjusted hypothesis testing procedure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  7. 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.

  8. Integrating an HTLV-III Screening Program into a Community Based Family Health Service Agency.

    ERIC Educational Resources Information Center

    Klausmeier, Walter W.; Henshaw, Beverly

    Acquired Immune Deficiency Syndrome (AIDS) has become one of the most serious epidemic disease problems in recent years. In 1985 the Public Health Service recommended establishment of test sites where individuals might be tested for Human T Lymphotropic Virus III (HTLV-III) antibody. An HTLV-III antibody screening program was integrated into a…

  9. Development of a central data warehouse for statewide ITS and transportation data in Florida phase III : final report.

    DOT National Transportation Integrated Search

    2009-12-15

    This report documents Phase III of the development and operation of a prototype for the Statewide Transportation : Engineering Warehouse for Archived Regional Data (STEWARD). It reflects the progress on the development and : operation of STEWARD sinc...

  10. Application of Δ- and λ-isomerism of octahedral metal complexes for inducing chiral nematic phases.

    PubMed

    Sato, Hisako; Yamagishi, Akihiko

    2009-11-20

    The Delta- and Lambda-isomerism of octahedral metal complexes is employed as a source of chirality for inducing chiral nematic phases. By applying a wide range of chiral metal complexes as a dopant, it has been found that tris(beta-diketonato)metal(III) complexes exhibit an extremely high value of helical twisting power. The mechanism of induction of the chiral nematic phase is postulated on the basis of a surface chirality model. The strategy for designing an efficient dopant is described, together with the results using a number of examples of Co(III), Cr(III) and Ru(III) complexes with C(2) symmetry. The development of photo-responsive dopants to achieve the photo-induced structural change of liquid crystal by use of photo-isomerization of chiral metal complexes is also described.

  11. Application of Δ- and Λ-Isomerism of Octahedral Metal Complexes for Inducing Chiral Nematic Phases

    PubMed Central

    Sato, Hisako; Yamagishi, Akihiko

    2009-01-01

    The Δ- and Λ-isomerism of octahedral metal complexes is employed as a source of chirality for inducing chiral nematic phases. By applying a wide range of chiral metal complexes as a dopant, it has been found that tris(β-diketonato)metal(III) complexes exhibit an extremely high value of helical twisting power. The mechanism of induction of the chiral nematic phase is postulated on the basis of a surface chirality model. The strategy for designing an efficient dopant is described, together with the results using a number of examples of Co(III), Cr(III) and Ru(III) complexes with C2 symmetry. The development of photo-responsive dopants to achieve the photo-induced structural change of liquid crystal by use of photo-isomerization of chiral metal complexes is also described. PMID:20057959

  12. 40 CFR 52.1771 - Classification of regions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 4 2013-07-01 2013-07-01 false Classification of regions. 52.1771 Section 52.1771 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... III III III III Eastern Piedmont Intrastate I III III III III Northern Coastal Intrastate I III III...

  13. 40 CFR 52.1771 - Classification of regions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 4 2014-07-01 2014-07-01 false Classification of regions. 52.1771 Section 52.1771 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... III III III III Eastern Piedmont Intrastate I III III III III Northern Coastal Intrastate I III III...

  14. 40 CFR 52.1771 - Classification of regions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 4 2011-07-01 2011-07-01 false Classification of regions. 52.1771 Section 52.1771 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... III III III III Eastern Piedmont Intrastate I III III III III Northern Coastal Intrastate I III III...

  15. 40 CFR 52.1771 - Classification of regions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 4 2010-07-01 2010-07-01 false Classification of regions. 52.1771 Section 52.1771 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... III III III III Eastern Piedmont Intrastate I III III III III Northern Coastal Intrastate I III III...

  16. 40 CFR 52.1771 - Classification of regions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 4 2012-07-01 2012-07-01 false Classification of regions. 52.1771 Section 52.1771 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... III III III III Eastern Piedmont Intrastate I III III III III Northern Coastal Intrastate I III III...

  17. The Design of a Primary Flight Trainer using Concurrent Engineering Concepts

    NASA Technical Reports Server (NTRS)

    Ladesic, James G.; Eastlake, Charles N.; Kietzmann, Nicholas H.

    1993-01-01

    Concurrent Engineering (CE) concepts seek to coordinate the expertise of various disciplines from initial design configuration selection through product disposal so that cost efficient design solutions may be achieve. Integrating this methodology into an undergraduate design course sequence may provide a needed enhancement to engineering education. The Advanced Design Program (ADP) project at Embry-Riddle Aeronautical University (EMU) is focused on developing recommendations for the general aviation Primary Flight Trainer (PFT) of the twenty first century using methods of CE. This project, over the next two years, will continue synthesizing the collective knowledge of teams composed of engineering students along with students from other degree programs, their faculty, and key industry representatives. During the past year (Phase I). conventional trainer configurations that comply with current regulations and existing technologies have been evaluated. Phase I efforts have resulted in two baseline concepts, a high-wing, conventional design named Triton and a low-wing, mid-engine configuration called Viper. In the second and third years (Phases II and III). applications of advanced propulsion, advanced materials, and unconventional airplane configurations along with military and commercial technologies which are anticipated to be within the economic range of general aviation by the year 2000, will be considered.

  18. Zwitterion-functionalized polymer microspheres as a sorbent for solid phase extraction of trace levels of V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) prior to their determination by ICP-MS.

    PubMed

    Jia, Xiaoyu; Gong, Dirong; Zhao, Junyi; Ren, Hongyun; Wang, Jiani; Zhang, Xian

    2018-03-19

    This paper describes the preparation of zwitterion-functionalized polymer microspheres (ZPMs) and their application to simultaneous enrichment of V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) from environmental water samples. The ZPMs were prepared by emulsion copolymerization of ethyl methacrylate, 2-diethylaminoethyl methacrylate and triethylene glycol dimethyl acrylate followed by modification with 1,3-propanesultone. The components were analyzed by elemental analyses as well as Fourier transform infrared spectroscopy, and the structures were characterized by scanning electron microscopy and transmission electron microscopy. The ZPMs were packed into a mini-column for on-line solid-phase extraction (SPE) of the above metal ions. Following extraction with 40 mM NH 4 NO 3 and 0.5 M HNO 3 solution, the ions were quantified by ICP-MS. Under the optimized conditions, the enrichment factors (from a 40 mL sample) are up to 60 for the ions V(V), As(III), Sb(III) and Hg(II), and 55 for Cr(III) and Sn(IV). The detection limits are 1.2, 3.4, 1.0, 3.7, 2.1 and 1.6 ng L -1 for V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II), respectively, and the relative standard deviations (RSDs) are below 5.2%. The feasibility and accuracy of the method were validated by successfully analyzing six certified reference materials as well as lake, well and river waters. Graphical abstract Zwitterion-functionalized polymer microspheres (ZPMs) were prepared and packed into a mini-column for on-line solid-phase extraction (SPE) via pump 1. Then V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) ions in environmental waters were eluted and submitted to ICP-MS via pump 2.

  19. Reliable, Practical Kilowatt-class Cryogenics for Superconducting Devices

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

    Spoor, Philip

    2016-12-15

    Following the successful development of a Flexibly-Attached Remote cryocooler for ~200W at 80K under a Phase II DOE grant, Clever Fellows Innovation Consortium, Inc. (dba CFIC-Qdrive; acquired by Chart Industries in 2012) was invited by the DOE to scale up this technology to ~1000W/80K in a Phase III program. This target is responsive to the “Cryogenics Roadmap” developed by the DOE to accelerate the development of cryogenic cooling necessary to support the emerging superconducting power applications. Mirroring the Roadmap, our proposal included a capacity target (1000W at 80K) and a cost target (<$40/watt, at 80K), but unlike the Roadmap, wemore » did not formally propose to meet a specific efficiency target. We achieved 75% of the capacity target, with a record-size coaxial “pulse-tube” coldfinger, but only by working on the project well beyond the original “period of performance” on unfunded extension. We believe 100% of the capacity target was within reach, but our own budget and time constraints forbade additional effort. We were less successful in meeting the cost targets. Ultimately, the specific configuration that was the subject of Phase III was not commercialized, largely because the market for superconducting devices has not been nearly as robust as was expected at the advent of the Roadmap.« less

  20. 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

  1. Hexafluorobenzene under Extreme Conditions.

    PubMed

    Pravica, Michael; Sneed, Daniel; Wang, Yonggang; Smith, Quinlan; White, Melanie

    2016-03-17

    We report the results from three high pressure experiments on hexafluorobenzene (C6F6). In the first experiment, Raman spectra were recorded up to 34.4 GPa. A phase transition from I → II was observed near 2 GPa. Near 8.8 GPa, a phase transition to an unreported phase (III) commenced. Above 20.6 GPa, yet another phase was observed (IV). Pressure cycling was employed to determine that, below 25.6 GPa, all pressure-induced alterations were reversible. However, at pressures above 20 GPa, dramatic spectral changes and broadening were observed at 25.6 and 34.4 GPa. The sample irreversibly changed into a soft solid with waxlike consistency when pressure was reduced to ambient and was recoverable. In the second experiment, IR spectra were collected up to 14.6 GPa. The phase transition (II → III) near 8.8 GPa was confirmed. An angular dispersive X-ray diffraction experiment was conducted to 25.6 GPa. Phase transitions above 1.4 GPa (I → II), above 5.5 GPa (II → III), above 10 GPa (III → IV), and above 15.5 GPa (IV → V) were observed. Near 25.6 GPa, long-range crystalline order was lost as the X-ray diffraction spectrum presented evidence of an amorphous solid.

  2. Changes of Polyphenolic Substances in the Anatomical Parts of Buckwheat (Fagopyrum esculentum Moench.) during Its Growth Phases

    PubMed Central

    Bystricka, Judita; Musilova, Janette; Tomas, Jan; Vollmannova, Alena; Lachman, Jaromir; Kavalcova, Petra

    2014-01-01

    In this study the changes of total polyphenolics in different anatomical parts (stems, leaves, flowers and seeds) of common buckwheat (Fagopyrum esculentum Moench.) during vegetation period were analysed. The content of total polyphenolics was evaluated in growth phase I (formation of buds), phase II (at the beginning of flowering), phase III (full blossoming) and phase IV (full ripeness). In all growth phases (GP) the stems and leaves were evaluated and statistically significant differences in polyphenolics content between the two parts were confirmed. Statistically significant differences (p < 0.01) in polyphenolics content (in GP II and III) between stems and leaves; and between stems and flowers were found. In flowers an average of 13.8 times higher and in leaves 6 times higher concentration of polyphenolics in comparison with stems was measured. In GP III the content of polyphenolics in common buckwheat was following: flowers > leaves > achene > stems. In flowers an average of 11.9 times higher, in leaves 8.3 times higher and in achenes 5.9 times higher contents of polyphenolics compared with stems were found. In GP III and IV (leaves, achenes, stems) the leaves contained in average 20 times higher and achenes 5.6 times higher polyphenolics than stems. PMID:28234337

  3. Renaissance of antibiotics against difficult infections: Focus on oritavancin and new ketolides and quinolones.

    PubMed

    Van Bambeke, Françoise

    2014-11-01

    Lipoglycopeptide, ketolide, and quinolone antibiotics are currently in clinical development, with specific advantages over available molecules within their respective classes. The lipoglycopeptide oritavancin is bactericidal against MRSA, vancomycin-resistant enterococci, and multiresistant Streptococcus pneumoniae, and proved effective and safe for the treatment of acute bacterial skin and skin structure infection (ABSSSI) upon administration of a single 1200 mg dose (two completed phase III trials). The ketolide solithromycin (two phase III studies recruiting for community-acquired pneumonia) shows a profile of activity similar to that of telithromycin, but in vitro data suggest a lower risk of hepatotoxicity, visual disturbance, and aggravation of myasthenia gravis due to reduced affinity for nicotinic receptors. Among quinolones, finafloxacin and delafloxacin share the unique property of an improved activity in acidic environments (found in many infection sites). Finafloxacin (phase II completed; activity profile similar to that of ciprofloxacin) is evaluated for complicated urinary tract and Helicobacter pylori infections. The other quinolones (directed towards Gram-positive pathogens) show improved activity on MRSA and multiresistant S. pneumoniae compared to current molecules. They are in clinical evaluation for ABSSSI (avarofloxacin (phase II completed), nemonoxacin and delafloxacin (ongoing phase III)), respiratory tract infections (zabofloxacin and nemonoxacin (ongoing phase III)), or gonorrhea (delafloxacin).

  4. Environmental Technology Verification (ETV) Program Case Studies: Demonstrating Program Outcomes, Volume III

    EPA Science Inventory

    This booklet, ETV Program Case Studies: Demonstrating Program Outcomes, Volume III contains two case studies, addressing verified environmental technologies for decentalized wastewater treatment and converting animal waste to energy. Each case study contains a brief description ...

  5. Reward, cost, and self-evaluation procedures for disruptive adolescents in a psychiatric hospital school1

    PubMed Central

    Kaufman, Kenneth F.; O'Leary, K. Daniel

    1972-01-01

    Sixteen pupils in a psychiatric hospital were assigned to two tutorial reading classes and balanced on six pupil characteristics and teacher preferences for the children. The effects of reward and cost procedures in a token program were assessed using both within- and between-subject comparisons in the following phases: (1) Baseline; (2) Token I, teacher evaluated and reinforced children for appropriate behavior; (3) Withdrawal of Tokens; (4) Token II, same as Token I; (5) Token III, same as Token I and II, but switched order of class meeting time; and (6) Self-Evaluation, students rated their own behavior and received prizes based on their rating, rather than the teacher's rating. The token program was markedly successful in reducing disruptive behavior and in increasing reading skills in both the Reward and Cost Classes, but there were no significant differences in the effects of the reward versus the cost procedure. While cost may be seen as a punishment procedure, there were no adverse side effects observed in the Cost Class at any time when the token program was in effect. The order of the classes was unrelated to the level of disruptive behavior or academic progress. The Self-Evaluative Phase, in which the students rated their own behavior, was included as an alternative to the abrupt withdrawal of tokens. In this phase, disruptive behavior remained at the previous low level. PMID:16795351

  6. 75 FR 14575 - Voting Equipment Evaluations Phase III

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ..., Human Performance-Based Standards and Usability Testing. NIST Phase III research is designed to: (1... vendor equipment will not be released. Comparative information may be released in a blind manner... electronic poll book systems as well as software used for ballot design and creation. Dated: March 23, 2010...

  7. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals. Job Profiles

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

    O'Neil, Lori Ross; Conway, T. J.; Tobey, D. H.

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Job Profiles. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  8. 76 FR 53704 - 30-Day Notice of Proposed Information Collection: Passport Demand Forecasting Study Phase III...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ...: Passport Demand Forecasting Study Phase III, OMB Number 1405-0177 ACTION: Notice of request for public... approval in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Passport... Passport Services CA/PPT. Form Number: SV2011-0010. [[Page 53705

  9. 76 FR 33398 - 60-Day Notice of Proposed Information Collection; Passport Demand Forecasting Study Phase III...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ...; Passport Demand Forecasting Study Phase III, 1405-0177 ACTION: Notice of request for public comments... the Paperwork Reduction Act of 1995. Title of Information Collection: Passport Demand Forecasting... Approved Collection. Originating Office: Bureau of Consular Affairs, Passport Services Office: CA/PPT. Form...

  10. [Efficacy of nebulizer therapy with acetylcystein in outpatients with chronic obstructive lung disease].

    PubMed

    Stepanishcheva, L A; Ignatova, G L; Blinova, E V

    2005-01-01

    Chronic obstructive lung disease (COLD) is a widespread illness with constantly growing mortality. Mucolytic therapy plays a significant role in treatment of patients with COLD. The paper contains the results of nebulization with acetyl-cystein as part of rehabilitation program in outpatients with stable clinical course of I-II stage of COLD. The results demonstrated significant clinical improvement, as well as positive changes in external respiration parameters (1 sforced expiratory volume), increase of physical activity tolerance, and disappearance of acute inflammation phase reactants in saliva.

  11. [Prospect and Current Situation of Immune Checkpoint Inhibitors 
in First-line Treatment in Advanced Non-small Cell Lung Cancer Patients].

    PubMed

    Wang, Haiyang; Yu, Xiaoqing; Fan, Yun

    2017-06-20

    With the breakthroughs achieved of programmed death-1 (PD-1)/PD-L1 inhibitors monotherapy as first-line and second-line treatment in advanced non-small cell lung cancer (NSCLC), the treatment strategy is gradually evolving and optimizing. Immune combination therapy expands the benefit population and improves the curative effect. A series of randomized phase III trials are ongoing. In this review, we discuss the prospect and current situation of immune checkpoint inhibitors in first-line treatment in advanced NSCLC patients.

  12. An Analysis of Department of Defense Financial and Acquisition Policies in Support of Military Contingency Requirements.

    DTIC Science & Technology

    1984-03-01

    Pledge, Company Newspaper, Attendance Contest, Posters Are High Spots in Successful Program." PRINTERS INK 199 (May 22, 1942): 17-18. 14 Baxter, William ...August 6, 4 1965): 75. 42 Bunker, John. "Redoubt-Phase III." AIR RESERVIST 31 (August-September 1979): 12-15. 43 Bunker, William B. "Another Job for...Flexible." AIR V. FORCE 64 (October 1981): 45-49. 53 Chadwell, Paul A. "Exclusive Interview with Dr. William J. Perry." NATIONAL DEFENSE 65 (October

  13. Flight Test of an Intelligent Flight-Control System

    NASA Technical Reports Server (NTRS)

    Davidson, Ron; Bosworth, John T.; Jacobson, Steven R.; Thomson, Michael Pl; Jorgensen, Charles C.

    2003-01-01

    The F-15 Advanced Controls Technology for Integrated Vehicles (ACTIVE) airplane (see figure) was the test bed for a flight test of an intelligent flight control system (IFCS). This IFCS utilizes a neural network to determine critical stability and control derivatives for a control law, the real-time gains of which are computed by an algorithm that solves the Riccati equation. These derivatives are also used to identify the parameters of a dynamic model of the airplane. The model is used in a model-following portion of the control law, in order to provide specific vehicle handling characteristics. The flight test of the IFCS marks the initiation of the Intelligent Flight Control System Advanced Concept Program (IFCS ACP), which is a collaboration between NASA and Boeing Phantom Works. The goals of the IFCS ACP are to (1) develop the concept of a flight-control system that uses neural-network technology to identify aircraft characteristics to provide optimal aircraft performance, (2) develop a self-training neural network to update estimates of aircraft properties in flight, and (3) demonstrate the aforementioned concepts on the F-15 ACTIVE airplane in flight. The activities of the initial IFCS ACP were divided into three Phases, each devoted to the attainment of a different objective. The objective of Phase I was to develop a pre-trained neural network to store and recall the wind-tunnel-based stability and control derivatives of the vehicle. The objective of Phase II was to develop a neural network that can learn how to adjust the stability and control derivatives to account for failures or modeling deficiencies. The objective of Phase III was to develop a flight control system that uses the neural network outputs as a basis for controlling the aircraft. The flight test of the IFCS was performed in stages. In the first stage, the Phase I version of the pre-trained neural network was flown in a passive mode. The neural network software was running using flight data inputs with the outputs provided to instrumentation only. The IFCS was not used to control the airplane. In another stage of the flight test, the Phase I pre-trained neural network was integrated into a Phase III version of the flight control system. The Phase I pretrained neural network provided realtime stability and control derivatives to a Phase III controller that was based on a stochastic optimal feedforward and feedback technique (SOFFT). This combined Phase I/III system was operated together with the research flight-control system (RFCS) of the F-15 ACTIVE during the flight test. The RFCS enables the pilot to switch quickly from the experimental- research flight mode back to the safe conventional mode. These initial IFCS ACP flight tests were completed in April 1999. The Phase I/III flight test milestone was to demonstrate, across a range of subsonic and supersonic flight conditions, that the pre-trained neural network could be used to supply real-time aerodynamic stability and control derivatives to the closed-loop optimal SOFFT flight controller. Additional objectives attained in the flight test included (1) flight qualification of a neural-network-based control system; (2) the use of a combined neural-network/closed-loop optimal flight-control system to obtain level-one handling qualities; and (3) demonstration, through variation of control gains, that different handling qualities can be achieved by setting new target parameters. In addition, data for the Phase-II (on-line-learning) neural network were collected, during the use of stacked-frequency- sweep excitation, for post-flight analysis. Initial analysis of these data showed the potential for future flight tests that will incorporate the real-time identification and on-line learning aspects of the IFCS.

  14. A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A.

    PubMed

    Yoneyama, Koichiro; Schmitt, Christophe; Kotani, Naoki; Levy, Gallia G; Kasai, Ryu; Iida, Satofumi; Shima, Midori; Kawanishi, Takehiko

    2017-12-06

    Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I-I/II studies, emicizumab reduced the bleeding frequency in patients with severe hemophilia A, regardless of the presence of factor VIII inhibitors, at once-weekly subcutaneous doses of 0.3, 1, and 3 mg/kg. Using the phase I-I/II study data, population pharmacokinetic and repeated time-to-event (RTTE) modeling were performed to quantitatively characterize the relationship between the pharmacokinetics of emicizumab and reduction in bleeding frequency. Simulations were then performed to identify the minimal exposure expected to achieve zero bleeding events for 1 year in at least 50% of patients and to select the dosing regimens to be tested in phase III studies. The RTTE model adequately predicted the bleeding onset over time as a function of plasma emicizumab concentration. Simulations suggested that plasma emicizumab concentrations of ≥  45 μg/mL should result in zero bleeding events for 1 year in at least 50% of patients. This efficacious exposure provided the basis for selecting previously untested dosing regimens of 1.5 mg/kg once weekly, 3 mg/kg every 2 weeks, and 6 mg/kg every 4 weeks for phase III studies. A pharmacometric approach guided the phase III dose selection of emicizumab in hemophilia A, without conducting a conventional dose-finding study. Phase III studies with the selected dosing regimens are currently ongoing. This case study indicates that a pharmacometric approach can substitute for a conventional dose-finding study in rare diseases and will streamline the drug development process.

  15. Stability hierarchy between Piracetam forms I, II, and III from experimental pressure-temperature diagrams and topological inferences.

    PubMed

    Toscani, Siro; Céolin, René; Minassian, Léon Ter; Barrio, Maria; Veglio, Nestor; Tamarit, Josep-Lluis; Louër, Daniel; Rietveld, Ivo B

    2016-01-30

    The trimorphism of the active pharmaceutical ingredient piracetam is a famous case of polymorphism that has been frequently revisited by many researchers. The phase relationships between forms I, II, and III were ambiguous because they seemed to depend on the heating rate of the DSC and on the history of the samples or they have not been observed at all (equilibrium II-III). In the present paper, piezo-thermal analysis and high-pressure differential thermal analysis have been used to elucidate the positions of the different solid-solid and solid-liquid equilibria. The phase diagram, involving the three solid phases, the liquid phase and the vapor phase, has been constructed. It has been shown that form III is the high-pressure, low-temperature form and the stable form at room temperature. Form II is stable under intermediary conditions and form I is the low pressure, high temperature form, which possesses a stable melting point. The present paper demonstrates the strength of the topological approach based on the Clapeyron equation and the alternation rule when combined with high-pressure measurements. Copyright © 2015 Elsevier B.V. All rights reserved.

  16. 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.

  17. 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.

  18. Community shift of biofilms developed in a full-scale drinking water distribution system switching from different water sources.

    PubMed

    Li, Weiying; Wang, Feng; Zhang, Junpeng; Qiao, Yu; Xu, Chen; Liu, Yao; Qian, Lin; Li, Wenming; Dong, Bingzhi

    2016-02-15

    The bacterial community of biofilms in drinking water distribution systems (DWDS) with various water sources has been rarely reported. In this research, biofilms were sampled at three points (A, B, and C) during the river water source phase (phase I), the interim period (phase II) and the reservoir water source phase (phase III), and the biofilm community was determined using the 454-pyrosequencing method. Results showed that microbial diversity declined in phase II but increased in phase III. The primary phylum was Proteobacteria during three phases, while the dominant class at points A and B was Betaproteobacteria (>49%) during all phases, but that changed to Holophagae in phase II (62.7%) and Actinobacteria in phase III (35.6%) for point C, which was closely related to its water quality. More remarkable community shift was found at the genus level. In addition, analysis results showed that water quality could significantly affect microbial diversity together, while the nutrient composition (e.g. C/N ration) of the water environment might determine the microbial community. Furthermore, Mycobacterium spp. and Pseudomonas spp. were detected in the biofilm, which should give rise to attention. This study revealed that water source switching produced substantial impact on the biofilm community. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Effects of Mg/Ga and V/III source ratios on hole concentration of N-polar (000\\bar{1}) p-type GaN grown by metalorganic vapor phase epitaxy

    NASA Astrophysics Data System (ADS)

    Nonoda, Ryohei; Shojiki, Kanako; Tanikawa, Tomoyuki; Kuboya, Shigeyuki; Katayama, Ryuji; Matsuoka, Takashi

    2016-05-01

    The effects of growth conditions such as Mg/Ga and V/III ratios on the properties of N-polar (000\\bar{1}) p-type GaN grown by metalorganic vapor phase epitaxy were studied. Photoluminescence spectra from Mg-doped GaN depended on Mg/Ga and V/III ratios. For the lightly doped samples, the band-to-acceptor emission was observed at 3.3 eV and its relative intensity decreased with increasing V/III ratio. For the heavily doped samples, the donor-acceptor pair emission was observed at 2.8 eV and its peak intensity monotonically decreased with V/III ratio. The hole concentration was maximum for the Mg/Ga ratio. This is the same tendency as in group-III polar (0001) growth. The V/III ratio also reduced the hole concentration. The higher V/III ratio reduced the concentration of residual donors such as oxygen by substituting nitrogen atoms. The surface became rougher with increasing V/III ratio and the hillock density increased.

  20. IMPROVED TUBULARS FOR BETTER ECONOMICS IN DEEP GAS WELL DRILLING USING MICROWAVE TECHNOLOGY

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

    Dinesh Agrawal; Paul Gigl; Mahlon Dennis

    2005-03-01

    The main objective of the research program has been to improve the rate-of-penetration in deep hostile environments by improving the life cycle and performance of coiled-tubing, an important component of a deep well drilling system for oil and gas exploration, by utilizing the latest developments in the microwave materials technology. Originally, it was proposed to accomplish this by developing an efficient and economically viable continuous microwave process to sinter continuously formed/extruded steel powder for the manufacture of seamless coiled tubing and other tubular products. However, based on the results and faced with insurmountable difficulties in the extrusion and de-waxing processes,more » the approach of achieving the goals of the program has been slightly changed. In the continuation proposal an approach of microwave sintering combined with Cold Isostatic Press (CIP) and joining (by induction or microwave) is adopted. This process can be developed into a semi-continuous sintering process if the CIP can produce parts fast enough to match the microwave sintering rates. Originally, the entire program was spread over three phases with the following goals: Phase I: Demonstration of the feasibility concept of continuous microwave sintering process for tubular steel products. Phase II: Design, building and testing of a prototype microwave system which shall be combined with a continuous extruder for steel tubular objects. Phase III: Execution of the plan for commercialization of the technology by one of the industrial partners. However, since some of the goals of the phase I were not completed, an extension of nine months was granted and we continued extrusion experiments, designed and built semicontinuous microwave sintering unit.« less

  1. 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.

  2. Structural and phase transformation of A{sup III}B{sup V}(100) semiconductor surface in interaction with selenium

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

    Bezryadin, N. N.; Kotov, G. I., E-mail: giktv@mail.ru; Kuzubov, S. V., E-mail: kuzub@land.ru

    2015-03-15

    Surfaces of GaAs(100), InAs(100), and GaP(100) substrates thermally treated in selenium vapor have been investigated by transmission electron microscopy and electron probe X-ray microanalysis. Some specific features and regularities of the formation of A{sub 3}{sup III}B{sub 4}{sup VI} (100)c(2 × 2) surface phases and thin layers of gallium or indium selenides A{sub 2}{sup III}B{sub 3}{sup VI} (100) on surfaces of different A{sup III}B{sup V}(100) semiconductors are discussed within the vacancy model of surface atomic structure.

  3. Water-quality data-collection activities in Colorado and Ohio; Phase II, Evaluation of 1984 field and laboratory quality-assurance practices

    USGS Publications Warehouse

    Childress, Carolyn J. Oblinger; Chaney, Thomas H.; Myers, Donna; Norris, J. Michael; Hren, Janet

    1987-01-01

    Serious questions have been raised by Congress about the usefulness of water-quality data for addressing issues of regional and national scope and, especially, for characterizing the current quality of the Nation's streams and ground water. In response, the U.S. Geological Survey has undertaken a pilot study in Colorado and Ohio to (1) determine the characteristics of current (1984) water-quality data-collection activities of Federal, regional, State, and local agencies, and academic institutions; and (2) determine how well the data from these activities, collected for various purposes and using different procedures, can be used to improve our ability to answer major broad-scope questions, such as:A. What are (or were) natural or near-natural water-quality conditions?B. What are existing water-quality conditions?C. How has water quality changed, and how do the changes relate to human activities?Colorado and Ohio were chosen for the pilot study largely because they represent regions with different types of waterquality concerns and programs. The study has been divided into three phases, the objectives of which are: Phase I--Inventory water-quality data-collection programs, including costs, and identify those programs that met a set of broad criteria for producing data that are potentially appropriate for water-quality assessments of regional and national scope. Phase II--Evaluate the quality assurance of field and laboratory procedures used in producing the data from programs that met the broad criteria of Phase I. Phase III--Compile the qualifying data and evaluate the adequacy of this data base for addressing selected water-quality questions of regional and national scope.Water-quality data are collected by a large number of organizations for diverse purposes ranging from meeting statutory requirements to research on water chemistry. Combining these individual data bases is an appealing and potentially cost-effective way to attempt to develop a data base adequate for regional or national water-quality assessments. However, to combine data from diverse sources, field and laboratory procedures used to produce the data need to be equivalent and need to meet specific qualityassurance standards. It is these factors that are the focus of Phase II, which is described in this report. In the first phase of this study, an inventory was made of all public organizations and academic institutions that undertook water-quality data-collection activities in Colorado and Ohio in 1984. Water-quality programs identified in Phase I were tested against a set of broad screening criteria. A total of 44 waterquality programs in Colorado and 29 programs in Ohio passed the Phase-I screen and were examined in Phase II. These programs accounted for an estimated 165,000 analyses in Colorado and 76,300 analyses in Ohio for 20 selected constituents and properties. Although qualifying programs included both surface- and ground-water sampling, they emphasized surface waters and produced few groundwater analyses (3,660 for Colorado and 470 for Ohio). For Phase II, information about field and laboratory qualityassurance practices was provided by each organization and its supporting laboratories through questionnaires. This information was evaluated against a set of specific criteria for field and laboratory practices. The criteria were developed from guidelines published by public agencies and professional organizations such as the American Public Health Association, the U.Sc, Environmental Protection Agency, and the U.S. Geological Survey. Each of the eight criteria that comprise the Phase-II screen fall into one of two major categories--field practices or laboratory practices.

  4. The history of couple therapy: a millennial review.

    PubMed

    Gurman, Alan S; Fraenkel, Peter

    2002-01-01

    In this article, we review the major conceptual and clinical influences and trends in the history of couple therapy to date, and also chronicle the history of research on couple therapy. The evolving patterns in theory and practice are reviewed as having progressed through four distinctive phases: Phase I--Atheoretical Marriage Counseling Formation (1930-1963); Phase II--Psychoanalytic Experimentation (1931-1966); Phase III--Family Therapy Incorporation (1963-1985); and Phase IV--Refinement, Extension, Diversification, and Integration (1986-present). The history of research in the field is described as having passed through three phases: Phase I--A Technique in Search of Some Data (1930-1974), Phase II--Irrational(?) Exuberance (1975-1992), and Phase III--Caution and Extension (1993-present). The article concludes with the identification of Four Great Historical Ironies in the History of Couple Therapy.

  5. Clinical evaluation of compounds targeting PD-1/PD-L1 pathway for cancer immunotherapy.

    PubMed

    Lu, Jing; Lee-Gabel, Linda; Nadeau, Michelle C; Ferencz, Thomas M; Soefje, Scott A

    2015-12-01

    Significant enthusiasm currently exists for new immunotherapeutic strategies: blocking the interaction between programmed death-1 receptor on T-cells and programmed death-ligand 1 on tumor cells to boost immune system stimulation to fight cancer. Immunomodulation with the antiprogrammed death-1/programmed death-ligand 1 monoclonal antibodies has shown to mediate tumor shrinkage and extend overall survival from several pivotal phase I/II studies in melanoma, renal cell carcinoma, and non-small cell lung cancer. This has prompted multiple large ongoing phase III trials with the expectation for fast-track FDA approvals to satisfy unmet medical needs. Compounds targeting the programmed death-1 pathway that are in clinical trials fall into two major categories, namely antiprogrammed death-1 antibodies: Nivolumab, MK-3475, and pidilizumab; and antiprogrammed death-ligand 1 antibodies: MPDL3280A, BMS-936559, MEDI4736, and MSB0010718C. We reviewed the clinical efficacy and safety of each compound based upon major registered clinical trials and published clinical data. Overall, response rate of more than 20% is consistently seen across all these trials, with maximal response of approximately 50% achieved by certain single antiprogrammed death-1 agents or when used in combination with cytotoxic T-lymphocyte antigen-4 blockade. The responses seen are early, durable, and have continued after treatment discontinuation. Immune-related adverse events are the most common side effects seen in these clinical trials. Overall, the skin and gastrointestinal tract are the most common organ systems affected by these compounds while hepatic, endocrine, and neurologic events are less frequent. These side effects are low grade, manageable, and typically resolve within a relatively short time frame with a predictable resolution pattern given proper management. We therefore propose detailed guidelines for management of major immune-related adverse events that are anticipated with antiprogrammed death-1/programmed death-ligand 1 therapies based on general experience with other monoclonal antibodies and the established management algorithms for immune-related adverse events for cytotoxic T-lymphocyte antigen-4 blockade with ipilimumab. We anticipate that the antiprogrammed death-1 strategy will become a viable and crucial clinical strategy for cancer therapy. © The Author(s) 2014.

  6. Prevalence of musculoskeletal diseases in Guatemala, Central America: the COPCORD study of 2 populations.

    PubMed

    Obregón-Ponce, Ariel; Iraheta, Isa; García-Ferrer, Helga; Mejia, Bayardo; García-Kutzbach, Abraham

    2012-06-01

    Guatemala is a multiethnic, multilingual, and multicultural country. We have evaluated 2 different ethnic groups from (1) San Juan Sacatepéquez County (SJSC), a rural population (30% illiterate), with 65% from Kaqchiquel ethnic group; and (2) Zone 5 of Guatemala City (Z5GC), an urban population (6.6% illiterate), with 95.5% mestizos. This study aimed to measure simultaneously the prevalence of rheumatic diseases in these 2 Guatemalan populations, both located in the State of Guatemala. A convenience sample of 4000 inhabitants 15 years and older was selected in each group. The Core Community Oriented Program for Control of Rheumatic Diseases Questionnaire was used in this survey. Phase 1 was for screening (identification of study subjects), phase 2 was for obtaining information from subjects with musculoskeletal complaints, and phase 3 was for rheumatologic diagnostic purposes. Phases 1 and 2 were performed by 6 interviewers. Phase 3 was completed by 4 rheumatologists. In phase I, 8000 subjects were identified in both groups. In phase II, 949 subjects reported musculoskeletal complaints: 371 (39%) in Z5GC and 578 (61%) in SJSC. In phase III, 419 patients were clinically evaluated: 141 (34%) in Z5GC and 278 (66%) in SJSC. The most prevalent musculoskeletal diseases were (1) osteoarthritis, (2) soft tissue rheumatism, (3) rheumatoid arthritis, (4) low back pain, and (5) arthralgias of unknown etiology. Osteoarthritis and soft tissue rheumatism were significantly more common in the rural population. The most prevalent musculoskeletal diseases in Guatemala seem to be similar to those in most previous Community Oriented Program for Control of Rheumatic Diseases studies. Most subjects were still working. Further studies examining medical care received and impact on function can now be of interest.

  7. 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.

  8. Anti-MRSA beta-lactams in development, with a focus on ceftobiprole: the first anti-MRSA beta-lactam to demonstrate clinical efficacy.

    PubMed

    Bush, Karen; Heep, Markus; Macielag, Mark J; Noel, Gary J

    2007-04-01

    Ceftobiprole is the first of the investigational beta-lactam antibiotics with in vitro activity against methicillin-resistant staphylococci to reach and complete Phase III therapeutic trials. Its antibacterial spectrum includes methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis, penicillin-resistant streptococci and many Gram-negative pathogens. It has demonstrated in vivo activity against many experimental infections caused by these pathogens. Ceftobiprole has completed Phase III clinical trials for complicated skin and skin structure infections, is being studied in Phase III pneumonia trials and has demonstrated non-inferiority compared with vancomycin in a Phase III complicated skin and skin structure infections trial, resulting in > 90% clinical cures of infections caused by MRSA. Other anti-MRSA beta-lactams in therapeutic clinical trials include the carbapenem CS-023/RO-4908463 and the cephalosporin ceftaroline (PPI-0903). The future of all of these agents will depend on their clinical efficacy, safety and their ability to be accepted as beta-lactams for the reliable treatment of a broad spectrum of infections, including those caused by MRSA.

  9. HST/COS Far-ultraviolet Spectroscopic Analysis of U Geminorum Following a Wide Outburst

    NASA Astrophysics Data System (ADS)

    Godon, Patrick; Shara, Michael M.; Sion, Edward M.; Zurek, David

    2017-12-01

    We used the Cosmic Origins Spectrograph (COS) on the Hubble Space Telescope (HST) to obtain a series of four far-ultraviolet (FUV; 915-2148 Å) spectroscopic observations of the prototypical dwarf nova U Geminorum during its cooling following a two-week outburst. Our FUV spectral analysis of the data indicates that the white dwarf (WD) cools from a temperature of ˜41,500 K, 15 days after the peak of the outburst, to ˜36,250 K, 56 days after the peak of the outburst, assuming a massive WD (log(g) = 8.8) and a distance of 100.4 ± 3.7 pc. These results are self-consistent with a ˜1.1 M ⊙ WD with a 5000 ± 200 km radius. The spectra show absorption lines of H I, He II, C II III IV, N III IV, O VI, S IV, Si II III IV, Al III, Ar III, and Fe II, but no emission features. We find suprasolar abundances of nitrogen, confirming the anomalous high N/C ratio. The FUV light curve reveals a ±5% modulation with the orbital phase, showing dips near phases 0.25 and ˜0.75, where the spectra exhibit an increase in the depth of some absorption lines and in particular strong absorption lines from Si II, Al III, and Ar III. The phase dependence we observe is consistent with material overflowing the disk rim at the hot spot, reaching a maximum elevation near phase 0.75, falling back at smaller radii near phase 0.5 where it bounces off the disk surface, and again rising above the disk near phase ˜0.25. There is a large scatter in the absorption lines’ velocities, especially for the silicon lines, while the carbon lines seem to match more closely the orbital velocity of the WD. This indicates that many absorption lines are affected by—or form in—the overflowing stream material veiling the WD, making the analysis of the WD spectra more difficult. Based on observations made with the NASA/ESA Hubble Space Telescope, obtained at the Space Telescope Science Institute, which is operated by AURA, Inc., under NASA contract NAS 5-26555.

  10. Microbial exudate promoted dissolution and transformation of chromium containing minerals

    NASA Astrophysics Data System (ADS)

    Saad, E. M.; Sun, J.; Tang, Y.

    2015-12-01

    Because of its utility in many industrial processes, chromium has become the second most common metal contaminant in the United States. The two most common oxidation states of chromium in nature are Cr(III), which is highly immobile, and Cr(VI), which is highly mobile and toxic. In both natural and engineered environments, the most common remediation of Cr(VI) is through reduction, which results in chromium sequestration in the low solubility mixed Cr(III)-Fe(III) (oxy)hydroxide phases. Consequently, the stability of these minerals must be examined to assess the fate of chromium in the subsurface. We examined the dissolution of mixed Cr(III)-Fe(III) (oxy)hydroxides in the presence of common microbial exudates, including the siderophore desferrioxamine B (DFOB; a common organic ligand secreted by most microbes with high affinity for ferric iron and other trivalent metal ions) and oxalate (a common organic acid produced by microbes). The solids exhibited incongruent dissolution with preferential leaching of Fe from the solid phase. Over time, this leads to a more Cr rich mineral, which is known to be more soluble than the corresponding mixed mineral phase. We are currently investigating the structure of the reacted mineral phases and soluble Cr(III) species, as well as the potential oxidation and remobilization of the soluble Cr species. Results from this study will provide insights regarding the long term transport and fate of chromium in the natural environment in the presence of microbial activities.

  11. The role of order-disorder transitions in the quest for molecular multiferroics: structural and magnetic neutron studies of a mixed valence iron(II)-iron(III) formate framework.

    PubMed

    Cañadillas-Delgado, Laura; Fabelo, Oscar; Rodríguez-Velamazán, J Alberto; Lemée-Cailleau, Marie-Hélène; Mason, Sax A; Pardo, Emilio; Lloret, Francesc; Zhao, Jiong-Peng; Bu, Xian-He; Simonet, Virginie; Colin, Claire V; Rodríguez-Carvajal, Juan

    2012-12-05

    Neutron diffraction studies have been carried out to shed light on the unprecedented order-disorder phase transition (ca. 155 K) observed in the mixed-valence iron(II)-iron(III) formate framework compound [NH(2)(CH(3))(2)](n)[Fe(III)Fe(II)(HCOO)(6)](n). The crystal structure at 220 K was first determined from Laue diffraction data, then a second refinement at 175 K and the crystal structure determination in the low temperature phase at 45 K were done with data from the monochromatic high resolution single crystal diffractometer D19. The 45 K nuclear structure reveals that the phase transition is associated with the order-disorder of the dimethylammonium counterion that is weakly anchored in the cavities of the [Fe(III)Fe(II)(HCOO)(6)](n) framework. In the low-temperature phase, a change in space group from P31c to R3c occurs, involving a tripling of the c-axis due to the ordering of the dimethylammonium counterion. The occurrence of this nuclear phase transition is associated with an electric transition, from paraelectric to antiferroelectric. A combination of powder and single crystal neutron diffraction measurements below the magnetic order transition (ca. 37 K) has been used to determine unequivocally the magnetic structure of this Néel N-Type ferrimagnet, proving that the ferrimagnetic behavior is due to a noncompensation of the different Fe(II) and Fe(III) magnetic moments.

  12. Relative Contributions of Regional and Sector Emissions to the Radiative Forcing of Aerosol-Radiation and Aerosol-Cloud Interactions Based on the AeroCOM Phase III/HTAP2 Experiment

    NASA Astrophysics Data System (ADS)

    Takemura, T.; Chin, M.

    2014-12-01

    It is important to understand relative contributions of each regional and sector emission of aerosols and their precursor gases to the regional and global mean radiative forcing of aerosol-radiation and aerosol-cloud interactions. This is because it is useful for international cooperation on controls of air pollution and anthropogenic climate change along most suitable reduction path of their emissions from each region and sector. The Task Force on Hemispheric Transport of Air Pollution (TF HTAP) under the United Nations researches the intercontinental transport of air pollutants including aerosols with strong support of the Aerosol Comparisons between Observations and Models (AeroCOM). The ongoing AeroCOM Phase III/HTAP2 experiment assesses relative contributions of regional and sector sources of aerosols and their precursor gases to the air quality using global aerosol transport models with latest emission inventories. In this study, the extended analyses on the relative contributions of each regional and sector emission to the radiative forcing of aerosol-radiation and aerosol-cloud interactions are done from the AeroCOM Phase III/HTAP2 experiment. Simulated results from MIROC-SPRINTARS and other some global aerosol models participating in the the AeroCOM Phase III/HTAP2 experiment are assessed. Acknowledgements: This study is based on the AeroCOM Phase III/HTAP2 experiment and partly supported by the Environment Research and Technology Development Fund (S-12-3) of the Ministry of the Environment, Japan.

  13. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

    PubMed Central

    2012-01-01

    Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

  14. Single-Crystal Sapphire Optical Fiber Sensor Instrumentation

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

    Pickrell, Gary; Scott, Brian; Wang, Anbo

    2013-12-31

    This report summarizes technical progress on the program “Single-Crystal Sapphire Optical Fiber Sensor Instrumentation,” funded by the National Energy Technology Laboratory of the U.S. Department of Energy, and performed by the Center for Photonics Technology of the Bradley Department of Electrical and Computer Engineering at Virginia Tech. This project was completed in three phases, each with a separate focus. Phase I of the program, from October 1999 to April 2002, was devoted to development of sensing schema for use in high temperature, harsh environments. Different sensing designs were proposed and tested in the laboratory. Phase II of the program, frommore » April 2002 to April 2009, focused on bringing the sensor technologies, which had already been successfully demonstrated in the laboratory, to a level where the sensors could be deployed in harsh industrial environments and eventually become commercially viable through a series of field tests. Also, a new sensing scheme was developed and tested with numerous advantages over all previous ones in Phase II. Phase III of the program, September 2009 to December 2013, focused on development of the new sensing scheme for field testing in conjunction with materials engineering of the improved sensor packaging lifetimes. In Phase I, three different sensing principles were studied: sapphire air-gap extrinsic Fabry-Perot sensors; intensity-based polarimetric sensors; and broadband polarimetric sensors. Black body radiation tests and corrosion tests were also performed in this phase. The outcome of the first phase of this program was the selection of broadband polarimetric differential interferometry (BPDI) for further prototype instrumentation development. This approach is based on the measurement of the optical path difference (OPD) between two orthogonally polarized light beams in a single-crystal sapphire disk. At the beginning of Phase II, in June 2004, the BPDI sensor was tested at the Wabash River coal gasifier facility in Terre Haute, Indiana. Due to business conditions at industrial partner and several logistical problems, this field test was not successful. An alternative high-temperature sensing system using sapphire wafer-based extrinsic Fabry-Perot interferometry was then developed as a significant improvement over the BPDI solution. From June 2006 to June 2008, three consecutive field tests were performed with the new sapphire wafer sensors at the TECO coal gasifier in Tampa, Florida. One of the sensors survived in the industrial coal gasifier for 7 months, over which time the existing thermocouples were replaced twice. The outcome of these TECO field tests suggests that the sapphire wafer sensor has very good potential to be commercialized. However packaging and sensor protection issues need additional development. During Phase III, several major improvements in the design and fabrication process of the sensor have been achieved through experiments and theoretical analysis. Studies on the property of the key components in the sensor head, including the sapphire fiber and sapphire wafer, were also conducted, for a better understanding of the sensor behavior. A final design based on all knowledge and experience has been developed, free of any issues encountered during the entire research. Sensors with this design performed well as expected in lab long-term tests, and were deployed in the sensing probe of the final coal-gasifier field test. Sensor packaging and protection was improved through materials engineering through testing of packaging designs in two blank probe packaging tests at Eastman Chemical in Kingsport, TN. Performance analysis of the blank probe packaging resulted in improve package designs culminating in a 3rd generation probe packaging utilized for the full field test of the sapphire optical sensor and materials designed sensor packaging.« less

  15. Characterization of the Solid-Phase Behavior of n-Nonylammonium Tetrachlorocuprate by Fourier Transform Infrared Spectroscopy

    NASA Astrophysics Data System (ADS)

    Ning, Guo

    1995-06-01

    The solid-phase behavior of [n-C9H19NH3]2CuCl4 was investigated by infrared spectroscopy. The nature of the three solid phases (phase I, phase II, and phase III) is discussed. A temperature-dependent study of infrared spectra provides evidence for the occurrence of structural phase transitions related to the dynamics of the alkyl chains and -NH3 polar heads. The phase transition at Tc1 (22°C) arises from variation in the interaction and packing structure of the chain. The phase transition at Tc2 (34°C) is related to variation in partial conformational order-disorder at the intramolecular level. The GTG or GTG‧ and small concentration of TG structures near the CH3 group are generated in phase III (above 38°C).

  16. NASA-Navy Telemedicine: Autogenic Feedback Training Exercises for Motion Sickness

    NASA Technical Reports Server (NTRS)

    Acromite, Michael T.; Cowings, Patricia; Toscano, William; Davis, Carl; Porter, Henry O.

    2010-01-01

    Airsickness is the most significant medical condition affecting naval aviation training. A 2001 study showed that airsickness was reported in 81% of naval aviation students and was associated with 82% of below average flight scores. The cost to a single training air-wing was over $150,000 annually for fuel and maintenance costs alone. Resistent cases are sent to the Naval Aerospace Medical Institute (NAMI) for evaluation and desensitization in the self-paced airsickness desensitization (SPAD) program. This approach is 75% successful, but can take up to 8 weeks at a significant travel cost. NASA Ames Research Center's Autogenic Feedback Training Exercises (AFTE) uses physiological and biofeedback training for motion sickness prevention. It has a remote capability that has been used from Moffett Field, CA to Atlanta, GA . AFTE is administered in twelve (30-minute) training sessions. The success rate for the NASA AFTE program has been over 85%. Methods: Implementation Phases: Phase I: Transfer NASA AFTE to NAMI; NASA will remotely train aviation students at NAMI. Phase II: NAMI-centered AFTE application with NASA oversight. Phase III: NAMI-centered AFTE to remotely train at various Navy sites. Phase IV: NAMI to offer Tri-service application and examine research opportunities. Results: 1. Use available telemedicine connectivity between NAMI and NASA. 2. Save over $2,000 per student trained. 3. Reduce aviation training attrition. 4. Provide standardization of multi-location motion sickness training. 5. Future tri-service initiatives. 6. Data to NASA and Navy for QA and research opportunities.

  17. A phase II clinical trial of a dental health education program delivered by aboriginal health workers to prevent early childhood caries

    PubMed Central

    2012-01-01

    Background Early Childhood Caries (ECC) is a widespread problem in Australian Aboriginal communities causing severe pain and sepsis. In addition dental services are difficult to access for many Aboriginal children and trying to obtain care can be stressful for the parents. The control of dental caries has been identified as a key indictor in the reduction of Indigenous disadvantage. Thus, there is a need for new approaches to prevent ECC, which reflect the cultural norms of Aboriginal communities. Methods/Design This is a Phase II single arm trial designed to gather information on the effectiveness of a dental health education program for Aboriginal children aged 6 months, followed over 2 years. The program will deliver advice from Aboriginal Health Workers on tooth brushing, diet and the use of fluoride toothpaste to Aboriginal families. Six waves of data collection will be conducted to enable estimates of change in parental knowledge and their views on the acceptability of the program. The Aboriginal Health Workers will also be interviewed to record their views on the acceptability and program feasibility. Clinical data on the child participants will be recorded when they are 30 months old and compared with a reference population of similar children when the study began. Latent variable modeling will be used to interpret the intervention effects on disease outcome. Discussion The research project will identify barriers to the implementation of a family centered Aboriginal oral health strategy, as well as the development of evidence to assist in the planning of a Phase III cluster randomized study. Trial registration ACTRN12612000712808 PMID:22909327

  18. Chemically-modified activated carbon with ethylenediamine for selective solid-phase extraction and preconcentration of metal ions.

    PubMed

    Li, Zhenhua; Chang, Xijun; Zou, Xiaojun; Zhu, Xiangbing; Nie, Rong; Hu, Zheng; Li, Ruijun

    2009-01-26

    A new method that utilizes ethylenediamine-modified activated carbon (AC-EDA) as a solid-phase extractant has been developed for simultaneous preconcentration of trace Cr(III), Fe(III), Hg(II) and Pb(II) prior to the measurement by inductively coupled plasma optical emission spectrometry (ICP-OES). The new sorbent was prepared by oxidative surface modification. Experimental conditions for effective adsorption of trace levels of Cr(III), Fe(III), Hg(II) and Pb(II) were optimized with respect to different experimental parameters using batch and column procedures in detail. The optimum pH value for the separation of metal ions simultaneously on the new sorbent was 4.0. Complete elution of absorbed metal ions from the sorbent surface was carried out using 3.0 mL of 2% (%w/w) thiourea and 0.5 mol L(-1) HCl solution. Common coexisting ions did not interfere with the separation and determination of target metal ions. The maximum static adsorption capacity of the sorbent at optimum conditions was found to be 39.4, 28.9, 60.5 and 49.9 mg g(-1) for Cr(III), Fe(III), Hg(II) and Pb(II), respectively. The time for 94% adsorption of target metal ions was less than 2 min. The detection limits of the method was found to be 0.28, 0.22, 0.09 and 0.17 ng mL(-1) for Cr(III), Fe(III), Hg(II) and Pb(II), respectively. The precision (R.S.D.) of the method was lower 4.0% (n=8). The prepared sorbent as solid-phase extractant was successfully applied for the preconcentration of trace Cr(III), Fe(III), Hg(II) and Pb(II) in natural and certified samples with satisfactory results.

  19. 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

  20. 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

  1. Multipurpose Wetlands Phase II/III: final design and ongoing research investigations

    USGS Publications Warehouse

    Babbitt, Bruce; Beard, Daniel P.; Hancock, Lawrence F.

    1994-01-01

    The Eastern Municipal Water District (EMWD), the Bureau of Reclamation (USBR), and the National Biological Survey (NBS), in consultation with other governmental agencies, the academic community, and environmental groups, are involved in a cooperative wetlands research and demonstration effort. This report reflects progress through the first 3 years of a 5-year program. The goal of the Multipurpose Wetlands Research and Demonstration Project is to evaluate and expand the use of reclaimed water and contaminated ground water through the incorporation of multipurpose constructed wetlands into EMWD's total water resources management program. The focus of the wetlands is the development of design, construction, and operation criteria that will provide a cost-effective and innovative alternative for managing water resources and provide other public benefits in arid areas. The program also recognizes the fact that naturally-occurring wetlands, both coastal and inland, have been disappearing at an alarming rate.

  2. SiC MOSFET Switching Power Amplifier Project Summary

    NASA Astrophysics Data System (ADS)

    Miller, Kenneth E.; Ziemba, Timothy; Prager, James; Slobodov, Ilia; Henson, Alex

    2017-10-01

    Eagle Harbor Technologies has completed a Phase I/II program to develop SiC MOSFET based Switching Power Amplifiers (SPA) for precision magnet control in fusion science applications. During this program, EHT developed several units have been delivered to the Helicity Injected Torus (HIT) experiment at the University of Washington to drive both the voltage and flux circuits of the helicity injectors. These units are capable of switching 700 V at 100 kHz with an adjustable duty cycle from 10 - 90% and a combined total output current of 96 kA for 4 ms (at max current). The SPAs switching is controlled by the microcontroller at HIT, which adjusts the duty cycle to maintain a specific waveform in the injector. The SPAs include overcurrent and shoot-through protection circuity. EHT will present an overview of the program including final results for the SPA waveforms. With support of DOE SBIR.

  3. Action of Brazilian propolis on hematological and serum biochemical parameters of Blue-fronted Amazons (Amazona aestiva, Linnaeus, 1758) in captivity.

    PubMed

    Silva, Cínthia R B; Putarov, Thaila C; Fruhvald, Erika; Destro, Flavia C; Marques Filho, Wolff C; Thomazini, Camila M; Barbosa, Tatiana S; Orsi, Ricardo O; Siqueira, Edson R

    2014-07-01

    The present study aimed to evaluate the effect of propolis use on hematological and serum biochemical parameters in Blue-fronted Amazons (Amazona aestiva). For this, 12 adult birds were distributed randomly into individual cages, divided into treatments with different propolis levels (A = 0.0%; B = 0.5%; and C = 1.0%), in 3 distinct phases (I, II, and III), with 15-d duration for phases I and III and 30 d for phase II, totaling 60 d. In phases I and III, all birds received treatment A ration, and in phase II received A, B, or C (4 birds per treatment). At the end of each phase, blood was collected for biochemical and hematological evaluations. The variables were analyzed by ANOVA (P < 0.05). Results suggest that 0.5% propolis reduced lactate dehydrogenase levels, whereas treatment B augmented hemoglobin concentrations and eosinophil count. It is concluded that 0.5% propolis improves levels of lactate dehydrogenase, hemoglobin, and eosinophils. © 2014 Poultry Science Association Inc.

  4. Structural, magnetic and phonon properties of Cr(III)-doped perovskite metal formate framework [(CH{sub 3}){sub 2}NH{sub 2}][Mn(HCOO){sub 3}

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

    Mączka, Mirosław, E-mail: m.maczka@int.pan.wroc.pl; Gągor, Anna; Hermanowicz, Krzysztof

    2016-05-15

    We have incorporated Cr(III) into [(CH{sub 3}){sub 2}NH{sub 2}][Mn(HCOO){sub 3}] (DMMn) multiferroic metal organic framework (MOF). The highest concentration of Cr(III) in the synthesized samples reached 15.9 mol%. The obtained samples were characterized by powder and single-crystal X-ray diffraction, DSC, magnetic susceptibility, dielectric, EPR, Raman and IR methods. These methods and the performed chemical analysis revealed that electrical charge neutrality after substitution of Cr(III) for Mn(II) is maintained by partial replacement of dimethylammonium (DMA{sup +}) cations by neutral HCOOH molecules. These changes in the chemical composition are responsible for weakening of the hydrogen bonds and decreased flexibility of the framework.more » This in turn leads to lowering of the ferroelectric phase transition temperature, observed around 185 K for undoped DMMn and around 155 K for the sample containing 3.1 mol% of Cr(III), and lack of macroscopic phase transition for the samples with Cr(III) content of 8.2 and 15.9 mol %. Another interesting effect observed for the studied samples is pronounced strengthening of the weak ferromagnetism of in Cr(III)-doped samples, associated with slight decrease of the ferromagnetic ordering temperature from 8.5 K for DMMn to 7.0 K for the sample with 15.9 mol % Cr(III) content. - Graphical abstract: Incorporation of Cr(III) into [(CH3)2NH2[Mn(HCOO)3] framework increases the magnetization. - Highlights: • Chromium(III) substitutes for Mn(II) in the studied MOF. • Charge neutrality is maintained by replacing DMA{sup +} cations by neutral HCOOH molecules. • Compounds with 8.2 and 15.9% of Cr(III) show no phase transition above 100 K. • Doping with Cr(III) increases magnetization.« less

  5. 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.

  6. Clinical phase I/II research on ultrasound thermo-chemotherapy in oral and maxillofacial-head and neck carcinoma

    NASA Astrophysics Data System (ADS)

    Shen, Guofeng; Ren, Guoxin; Guo, Wei; Chen, Yazhu

    2012-11-01

    The principle of a ultrasound thermo-chemotherapy instrument and the clinical phase I/II research on short-term and long-term therapeutic effect and main side-effect of ultrasound hyperthermia combined with chemotherapy in oral and maxillofacial-head & neck carcinoma by the instrument will be presented in this paper.

  7. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals: Behavioral Interview Guidelines by Job Roles

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

    O'Neil, Lori Ross; Conway, T. J.; Tobey, D. H.

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Behavioral Interview Guidelines by Job Roles. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  8. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals. Individual and Team Performance Guidelines

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

    O'Neil, Lori Ross; Conway, T. J.; Tobey, D. H.

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Individual and Team Performance Guidelines. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  9. Gas-phase infrared spectrum of phosphorus (III) oxycyanide, OPCN: experimental and theoretical investigations

    NASA Astrophysics Data System (ADS)

    Allaf, Abdul. W.; Kassem, M.; Alibrahim, M.; Boustani, Ihsan

    1999-03-01

    An attempt was made to observe the gas-phase infrared spectrum of Phosphorus (III) oxycyanide, OPCN for the first time. This molecule was produced by an on-line process using phosphorus (III) oxychloride, OPCl as precursor passed over heated AgCN. The products were characterised by the infrared spectra of their vapours. The low resolution gas-phase Fourier transform infrared spectrum shows two bands centered at 2165 and 1385 cm -1. These bands are assigned to, ν1 (CN stretch) and ν2 (OP stretch), respectively. Ab initio self-consistent-field (SCF) molecular orbital (MO) and Møller-Plesset second order perturbation theory (MP2) calculations were performed to determine the geometry, total energy and vibrational frequencies of OPCN.

  10. Facilitating cultural border crossing in urban secondary science classrooms: A study of inservice teachers

    NASA Astrophysics Data System (ADS)

    Monteiro, Anna Karina

    Research acknowledges that if students are to be successful science, they must learn to navigate and cross cultural borders that exist between their own cultures and the subculture of science. This dissertation utilized a mixed methods approach to explore how inservice science teachers working in urban schools construct their ideas of and apply the concepts about the culture of science and cultural border crossing as relevant to the teaching and learning of science. The study used the lenses of cultural capital, social constructivism, and cultural congruency in the design and analysis of each of the three phases of data collection. Phase I identified the perspectives of six inservice science teachers on science culture, cultural border crossing, and which border crossing methods, if any, they used during science teaching. Phase II took a dialectical approach as the teachers read about science culture and cultural border crossing during three informal professional learning community meetings. This phase explored how teachers constructed their understanding of cultural border crossing and how the concept applied to the teaching and learning of science. Phase III evaluated how teachers' perspectives changed from Phase I. In addition, classroom observations were used to determine whether teachers' practices in their science classrooms changed from Phase I to Phase III. All three phases collected data through qualitative (i.e., interviews, classroom observations, and surveys) and quantitative (Likert items) means. The findings indicated that teachers found great value in learning about the culture of science and cultural border crossing as it pertained to their teaching methods. This was not only evidenced by their interviews and surveys, but also in the methods they used in their classrooms. Final conclusions included how the use of student capital resources (prior experiences, understandings and knowledge, ideas an interests, and personal beliefs), if supported by science practices and skills increases student cultural capital. With a greater cultural capital, the students experience cultural congruency between their cultures and the culture of science, enabling them to cross such borders in the science classroom. The implications such findings have on teacher training programs and professional development are discussed.

  11. Biogeochemical transformation of Fe minerals in a petroleum-contaminated aquifer

    USGS Publications Warehouse

    Zachara, John M.; Kukkadapu, Ravi K.; Glassman, Paul L.; Dohnalkova, Alice; Fredrickson, Jim K.; Anderson, Todd

    2004-01-01

    The Bemidji aquifer in Minnesota, USA is a well-studied site of subsurface petroleum contamination. The site contains an anoxic groundwater plume where soluble petroleum constituents serve as an energy source for a region of methanogenesis near the source and bacterial Fe(III) reduction further down gradient. Methanogenesis apparently begins when bioavailable Fe(III) is exhausted within the sediment. Past studies indicate that Geobacter species and Geothrix fermentens-like organisms are the primary dissimilatory Fe-reducing bacteria at this site. The Fe mineralogy of the pristine aquifer sediments and samples from the methanogenic (source) and Fe(III) reducing zones were characterized in this study to identify microbiologic changes to Fe valence and mineral distribution, and to identify whether new biogenic mineral phases had formed. Methods applied included X-ray diffraction; X-ray fluorescence (XRF); and chemical extraction; optical, transmission, and scanning electron microscopy; and Mössbauer spectroscopy.All of the sediments were low in total Fe content (≈ 1%) and exhibited complex Fe-mineralogy. The bulk pristine sediment and its sand, silt, and clay-sized fractions were studied in detail. The pristine sediments contained Fe(II) and Fe(III) mineral phases. Ferrous iron represented approximately 50% of FeTOT. The relative Fe(II) concentration increased in the sand fraction, and its primary mineralogic residence was clinochlore with minor concentrations found as a ferroan calcite grain cement in carbonate lithic fragments. Fe(III) existed in silicates (epidote, clinochlore, muscovite) and Fe(III) oxides of detrital and authigenic origin. The detrital Fe(III) oxides included hematite and goethite in the form of mm-sized nodular concretions and smaller-sized dispersed crystallites, and euhedral magnetite grains. Authigenic Fe(III) oxides increased in concentration with decreasing particle size through the silt and clay fraction. Chemical extraction and Mössbauer analysis indicated that this was a ferrihydrite like-phase. Quantitative mineralogic and Fe(II/III) ratio comparisons between the pristine and contaminated sediments were not possible because of textural differences. However, comparisons between the texturally-similar source (where bioavailable Fe(III) had been exhausted) and Fe(III) reducing zone sediments (where bioavailable Fe(III) remained) indicated that dispersed detrital, crystalline Fe(III) oxides and a portion of the authigenic, poorly crystalline Fe(III) oxide fraction had been depleted from the source zone sediment by microbiologic activity. Little or no effect of microbiologic activity was observed on silicate Fe(III). The presence of residual “ferrihydrite” in the most bioreduced, anoxic plume sediment (source) implied that a portion of the authigenic Fe(III) oxides were biologically inaccessible in weathered, lithic fragment interiors. Little evidence was found for the modern biogenesis of authigenic ferrous-containing mineral phases, perhaps with the exception of thin siderite or ferroan calcite surface precipitates on carbonate lithic fragments within source zone sediments.

  12. SUPERSTARS III: 6-8.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Education, Raleigh.

    SUPERSTARS III is a K-8 program designed as an enrichment opportunity for self-directed learners in mathematics. The basic purpose of SUPERSTARS III is to provide the extra challenge that self-motivated students need in mathematics and to do so in a structured, long-term program that does not impinge on the normal classroom routine or the…

  13. SUPERSTARS III: K-2.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Education, Raleigh.

    SUPERSTARS III is a K-8 program designed as an enrichment opportunity for self-directed learners in mathematics. The basic purpose of SUPERSTARS III is to provide the extra challenge that self-motivated students need in mathematics and to do so in a structured, long-term program that does not impinge on the normal classroom routine or the…

  14. SUPERSTARS III: 3-5.

    ERIC Educational Resources Information Center

    North Carolina State Dept. of Public Education, Raleigh.

    SUPERSTARS III is a K-8 program designed as an enrichment opportunity for self-directed learners in mathematics. The basic purpose of SUPERSTARS III is to provide the extra challenge that self-motivated students need in mathematics and to do so in a structured, long-term program that does not impinge on the normal classroom routine or the…

  15. Thermal neutron detector and gamma-ray spectrometer utilizing a single material

    DOEpatents

    Stowe, Ashley; Burger, Arnold; Lukosi, Eric

    2017-05-02

    A combined thermal neutron detector and gamma-ray spectrometer system, including: a detection medium including a lithium chalcopyrite crystal operable for detecting thermal neutrons in a semiconductor mode and gamma-rays in a scintillator mode; and a photodetector coupled to the detection medium also operable for detecting the gamma rays. Optionally, the detection medium includes a .sup.6LiInSe.sub.2 crystal. Optionally, the detection medium comprises a compound formed by the process of: melting a Group III element; adding a Group I element to the melted Group III element at a rate that allows the Group I and Group III elements to react thereby providing a single phase I-III compound; and adding a Group VI element to the single phase I-III compound and heating; wherein the Group I element includes lithium.

  16. International Space Programs. Aerospace Education III.

    ERIC Educational Resources Information Center

    Bulmer, S. B.

    This book, one in the series on Aerospace Education III, is a collection of the diverse information available regarding the international space programs. The five goals listed for the book are: to examine the Soviet space program, to understand the future of Soviet space activity, to examine other national and international space programs, to…

  17. A Regional Approach to Wildlife Monitoring Related to Energy Exploration and Development in Colorado

    USGS Publications Warehouse

    Kotliar, Natasha B.; Bowen, Zachary H.; Ouren, Douglas S.; Farmer, Adrian H.

    2008-01-01

    The U.S. Bureau of Land Management (BLM) is currently developing a National Monitoring Strategy that will guide efforts to create an efficient and effective process for monitoring land health by BLM. To inform the ongoing development of the national strategy, BLM selected two States (Colorado, Alaska) to serve as focal areas on which to base a flexible framework for developing monitoring programs that evaluate wildlife responses to energy development. We developed a three-phase monitoring plan to serve as a template and applied it to the design of a monitoring program for the Colorado focal area (White River and Glenwood Springs Field Offices of the BLM). Phase I is a synthesis and assessment of current conditions that capitalizes on existing but under used data sources. A key component is the use of existing habitat and landscape models to evaluate the cumulative effects of surface disturbance. Phase II is the data collection process that uses information provided in Phase I to refine management objectives and provide a linkage to management decisions. The linkage is established through targeted monitoring, adaptive management, and research. Phase III establishes priorities and strategies for regional and national monitoring, and facilitates coordination among other land management agencies and organizations. The three phases are designed to be flexible and complementary. The monitoring plan guides an iterative process that is performed incrementally, beginning with the highest-priority species and management issues, while building on lessons learned and coordination among administrative levels. The activities associated with each phase can be repeated or updated as new information, data, or tools become available. This allows the development of a monitoring program that expands gradually and allows for rapid implementation. A demonstration application of the three-phase monitoring plan was conducted for a study area encompassing five BLM field offices in Colorado: White River, Glenwood Springs, Kremmling, Grand Junction, and Little Snake. The overall study area was selected to encompass the primary distribution of sagebrush and greater sage-grouse (Centrocercus urophasianus) in Colorado and to provide a larger context for evaluating priority management issues of the White River and Glenwood Springs Field Offices. Within the study area, we selected an additional scale of analysis: the Roan Plateau, an area of increased energy development. We focused our demonstration project on the primary objectives identified by the BLM and other stakeholders: (1) How do we evaluate the cumulative effects of energy development and mitigation activities on species of management interest or concern? (2) How can cumulative effects, including direct and indirect effects, be quantified relative to natural variation? (3) How can we implement compliance and effectiveness monitoring to determine whether lease stipulations are met and restoration/mitigation goals are achieved? We targeted greater sage-grouse because this species was identified as a monitoring priority for the White River Field Office. We also evaluated landscape-level indices to address fragmentation resulting from surface disturbance. The primary purpose of this exercise was to highlight the types of analyses and approaches that could be used to evaluate energy development in an application of the three-phase framework. We provide examples of Phase I products that can be used to guide the refinement of management objectives, development of adaptive management and research frameworks, and planning activities in Phase II. Finally, we report on the BLM's National Sage-Grouse Habitat Conservation Strategy as an example of Phase III activities. The development of an effective monitoring program is a daunting task, and will be difficult to implement by the BLM independently due to the current work load of staff. However, the scientific expertise and experience for developing cr

  18. The Alzheimer's Prevention Initiative Generation Program: Evaluating CNP520 Efficacy in the Prevention of Alzheimer's Disease.

    PubMed

    Lopez Lopez, C; Caputo, A; Liu, F; Riviere, M E; Rouzade-Dominguez, M-L; Thomas, R G; Langbaum, J B; Lenz, R; Reiman, E M; Graf, A; Tariot, P N

    2017-01-01

    Alzheimer's disease pathology begins decades before the onset of clinical symptoms. This provides an opportunity for interventional clinical trials to potentially delay or prevent the onset of cognitive impairment or dementia. CNP520 (a beta-site-amyloid precursor protein-cleaving enzyme inhibitor) is in clinical development for the treatment of preclinical Alzheimer's disease under the Alzheimer's Prevention Initiative Generation Program. The Alzheimer's Prevention Initiative is a public-private partnership intended to accelerate the evaluation of Alzheimer's disease prevention therapies. The Generation Program comprises two pivotal phase II/III studies with similar designs to assess the efficacy and safety of investigational treatments in a cognitively unimpaired population at increased risk for developing Alzheimer's disease based on age and apolipoprotein E (APOE) genotype (i.e., presence of the APOE ε4 allele). The program has been designed to maximize benefit to Alzheimer's disease research. Generation Study 1 (NCT02565511) and Generation Study 2 (NCT03131453) are currently enrolling; their key features are presented here.

  19. Computer Program (HEVSIM) for Heavy Duty Vehicle Fuel Economy and Performance Simulation. Volume III.

    DOT National Transportation Integrated Search

    1981-09-01

    Volume III is the third and last volume of a three volume document describing the computer program HEVSIM. This volume includes appendices which list the HEVSIM program, sample part data, some typical outputs and updated nomenclature.

  20. Cd Mobility in Anoxic Fe-Mineral-Rich Environments - Potential Use of Fe(III)-Reducing Bacteria in Soil Remediation

    NASA Astrophysics Data System (ADS)

    Muehe, E. M.; Adaktylou, I. J.; Obst, M.; Schröder, C.; Behrens, S.; Hitchcock, A. P.; Tylsizczak, T.; Michel, F. M.; Krämer, U.; Kappler, A.

    2014-12-01

    Agricultural soils are increasingly burdened with heavy metals such as Cd from industrial sources and impure fertilizers. Metal contaminants enter the food chain via plant uptake from soil and negatively affect human and environmental health. New remediation approaches are needed to lower soil metal contents. To apply these remediation techniques successfully, it is necessary to understand how soil microbes and minerals interact with toxic metals. Here we show that microbial Fe(III) reduction initially mobilizes Cd before its immobilization under anoxic conditions. To study how microbial Fe(III) reduction influences Cd mobility, we isolated a new Cd-tolerant, Fe(III)-reducing Geobacter sp. from a heavily Cd-contaminated soil. In lab experiments, this Geobacter strain first mobilized Cd from Cd-loaded Fe(III) hydroxides followed by precipitation of Cd-bearing mineral phases. Using Mössbauer spectroscopy and scanning electron microscopy, the original and newly formed Cd-containing Fe(II) and Fe(III) mineral phases, including Cd-Fe-carbonates, Fe-phosphates and Fe-(oxyhydr)oxides, were identified and characterized. Using energy-dispersive X-ray spectroscopy and synchrotron-based scanning transmission X-ray microscopy, Cd was mapped in the Fe(II) mineral aggregates formed during microbial Fe(III) reduction. Microbial Fe(III) reduction mobilizes Cd prior to its precipitation in Cd-bearing mineral phases. The mobilized Cd could be taken up by phytoremediating plants, resulting in a net removal of Cd from contaminated sites. Alternatively, Cd precipitation could reduce Cd bioavailability in the environment, causing less toxic effects to crops and soil microbiota. However, the stability and thus bioavailability of these newly formed Fe-Cd mineral phases needs to be assessed thoroughly. Whether phytoremediation or immobilization of Cd in a mineral with reduced Cd bioavailability are feasible mechanisms to reduce toxic effects of Cd in the environment remains to be determined.

  1. 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.

  2. Solid phase extraction and spectrophotometric determination of Au(III) with 5-(2-hydroxy-5-nitrophenylazo)thiorhodanine.

    PubMed

    Hu, Qiufen; Chen, Xiubin; Yang, Xiangjun; Huang, Zhangjie; Chen, Jing; Yang, Guangyu

    2006-04-01

    A new chromogenic reagent, 5-(2-hydroxy-5-nitrophenylazo)thiorhodanine (HNATR) was synthesized. A highly sensitive, selective and rapid method for the determination microg l(-1) level of Au(III) based on the rapid reaction of Au(III) with HNATR and the solid phase extraction of the colored complex with a reversed phase polymer-based C(18) cartridge have been developed. The HNATR reacted with Au(III) to form a red complex of a molar ratio 1:2 (Au(III) to HNATR) in the presence of 0.05 - 0.5 mol l(-1) of phosphoric acid solution and emulsifier-OP medium. This complex was enriched by the solid phase extraction with a polymer-based C(18) cartridge. The enrichment factor of 100 was achieved. The molar absorptivity of the complex is 1.37 x 10(5) l mol(-1) cm(-1) at 520 nm in the measured solution. The system obeys Beer's law in the range of 0.01 - 3 microg ml(-1). The relative standard deviation for eleven replicates sample of 0.5 microg l(-1) level is 2.18%. The detection limit, based on the three times of standard deviation is 0.02 microg l(-1) in the original sample. This method was applied to the determination of gold in water and ore with good results.

  3. Preparation of III-V semiconductor nanocrystals

    DOEpatents

    Alivisatos, A. Paul; Olshavsky, Michael A.

    1996-01-01

    Nanometer-scale crystals of III-V semiconductors are disclosed, They are prepared by reacting a group III metal source with a group V anion source in a liquid phase at elevated temperature in the presence of a crystallite growth terminator such as pyridine or quinoline.

  4. Immune checkpoint blockade: the role of PD-1-PD-L axis in lymphoid malignancies

    PubMed Central

    Ilcus, Cristina; Bagacean, Cristina; Tempescul, Adrian; Popescu, Cristian; Parvu, Andrada; Cenariu, Mihai; Bocsan, Corina; Zdrenghea, Mihnea

    2017-01-01

    The co-inhibitory receptor programmed cell death (PD)-1, expressed by immune effector cells, is credited with a protective role for normal tissue during immune responses, by limiting the extent of effector activation. Its presently known ligands, programmed death ligands (PD-Ls) 1 and 2, are expressed by a variety of cells including cancer cells, suggesting a role for these molecules as an immune evasion mechanism. Blocking of the PD-1-PD-L signaling axis has recently been shown to be effective and was clinically approved in relapsed/refractory tumors such as malignant melanoma and lung cancer, but also classical Hodgkin’s lymphoma. A plethora of trials exploring PD-1 blockade in cancer are ongoing. Here, we review the role of PD-1 signaling in lymphoid malignancies, and the latest results of trials investigating PD-1 or PD-L1 blocking agents in this group of diseases. Early phase studies proved very promising, leading to the clinical approval of a PD-1 blocking agent in Hodgkin’s lymphoma, and Phase III clinical studies are either planned or ongoing in most lymphoid malignancies. PMID:28496333

  5. Ankle Sprain Treatment

    MedlinePlus

    ... strengthening exercise"). Resume low-impact aerobic training; maintain general fitness. III Phase III treatment focuses on restoring ankle proprioception (balance and position awareness) as well as agility and ...

  6. Higher plasma motilin levels in obese patients decrease after Roux-en-Y gastric bypass surgery and regulate hunger.

    PubMed

    Deloose, E; Janssen, P; Lannoo, M; Van der Schueren, B; Depoortere, I; Tack, J

    2016-07-01

    Motilin-induced phase III contractions of the migrating motor complex (MMC) signal hunger in healthy volunteers. The current aim was to study the role of motilin as a hunger-inducing factor in obese patients and to evaluate the effect of Roux-en-Y gastric bypass (RYGB) surgery on plasma motilin levels and hunger scores. Motilin and ghrelin plasma levels were determined during a complete MMC cycle in controls and obese patients selected for RYGB before, 6 months and 1 year after surgery. 20 min after the end of the second phase III, obese patients received an intravenous infusion of 40 mg erythromycin. Hunger was scored every 5 min. Hedonic hunger was assessed in obese patients with the Power of Food Scale questionnaire. Obesity caused a switch in the origin of phase III from antrum to duodenum. Obese patients had significantly higher motilin levels compared with controls during the MMC but tended to lack the motilin peak prior to phase III necessary to trigger hunger. Hunger scores during phase III were significantly lower in obese patients, but could be restored to control levels through the administration of a low dose of the motilin agonist, erythromycin. After RYGB surgery motilin, but not ghrelin, levels decreased in parallel with hedonic hunger scores. Motilin may be an important regulator involved in the pathogenesis of obesity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Stakeholder perspectives on the use of positron emission tomography in phase III oncology trials in the UK.

    PubMed

    Rojas-Anaya, Hector; Skogen, Karoline; Miles, Kenneth Alan

    2012-06-01

    To identify factors that influence the use of PET in phase III oncology trials in the UK by evaluating stakeholder perspectives. A wide range of UK PET research stakeholders with a potential interest in the use of PET in phase III trials were identified and invited to participate. These UK PET research stakeholders were consulted using a semistructured questionnaire on their personal experience with and involvement in PET research, the role of PET in phase III oncology clinical trials and on the promotion of UK PET research and unmet clinical needs in oncology. Responses were analysed quantitatively and by qualitative content analysis of free-text responses. A total of 118 responses were received from a wide range of stakeholders representing several professional groups and working environments. Of these respondents, 49 (42%) were using PET in their research. There was the general perception that using PET in clinical research is beneficial in oncology. The two major barriers identified were poor availability of PET and perceived difficulties in funding of excess treatment costs (75% of respondents). Other factors included limited coverage of PET in training, uncertainty about developing imaging protocols or the status of tracers other than 18F-fluorodeoxyglucose, and low awareness of the role of PET in patient selection for therapeutic trials. Patient concerns about radiation were not perceived as a research barrier. Interventions that improve the availability and funding pathways for PET research scans and that increase researcher awareness could help promote the use of PET for phase III oncology trials in the UK.

  8. Objectives and methodology of BIOBADASER phase iii.

    PubMed

    Sanchez-Piedra, Carlos; Hernández Miguel, M Victoria; Manero, Javier; Roselló, Rosa; Sánchez-Costa, Jesús Tomás; Rodríguez-Lozano, Carlos; Campos, Cristina; Cuende, Eduardo; Fernández-Lopez, Jesús Carlos; Bustabad, Sagrario; Martín Domenech, Raquel; Pérez-Pampín, Eva; Del Pino-Montes, Javier; Millan-Arcineas, Ana Milena; Díaz-González, Federico; Gómez-Reino, Juan Jesús

    2017-09-18

    Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  9. National Dam Safety Program. Atwood Lake Dam (MO 31171), Upper Mississippi - Kaskaskia - ST. Louis Basin, Jefferson County, Missouri. Phase I Inspection Report.

    DTIC Science & Technology

    1980-12-01

    investigations are considered necessary. 2-3 SELCTI OdN 7, - VsI -I I N7SVLCF 3.1 FINDINGS a . Gene i’al A v i a , risoec 1, n 1 0f t oe IAt wr> -i k...ar sat is fact ory and conventi onna -; ety fmi-qioc I V’’ t . I iw-vv IfU is reccinmended thqt. the prescr! ied 5<mi i In Iii i nf r i hfe ippl 1w 1

  10. Charge Coupled Devices in Signal Processing Systems. Volume V. Final Report.

    DTIC Science & Technology

    1979-12-01

    the Phase III program. At that time, mutual customer /contractor interest arose in a unique application area, involving manipulation of lists of...using half adders and "or" circuits. 4-35 3 b 2 b3 01 b *3b, *2 b 1 b2b 1 0 1 b, + + + + + + ++ r T 7 7 r* 7FA +-0j FA 147 7 7 1 77 7 7 TL NO.6 NO. 5...which the cell could be step-and- repeated into an array in the CAD system. In practice we found that the attendent custom skewing delay layout

  11. Bacterial Formation of As(V) and As(III) Ferric Oxyhydroxides in Acid Mine Drainage.

    NASA Astrophysics Data System (ADS)

    Morin, G.; Juillot, F.; Lebrun, S.; Casiot, C.; Elbaz-Poulichet, F.; Bruneel, O.; Personne, J.; Leblanc, M.; Ildefonse, P.; Calas, G.

    2002-12-01

    The oxidation of dissolved Fe(II) which is often promoted by acidophilic bacteria in acid mine drainage (AMD) and some hot springs, leads to the precipitation of Fe(III) oxy-hydroxides which incorporate toxic elements within their structure or adsorb them at their surface, thus limiting their mobility. In such complex natural systems, synchrotron-based techniques as X-ray absorption spectroscopy offer the opportunity to monitor surface/solution interactions as well as redox changes affecting the mobility and toxicity of trace elements as arsenic. Spatial and seasonal variations of the (bio-) oxidation of Fe(II) and As(III), and the subsequent precipitation of As-Fe gels, were followed by XANES, XRD, and SEM along the CarnoulŠs AMD (Gard, France). Chemical and mineralogical data collected on sediments, stromatolite, and bioassay samples showed that some indigenous bacteria living in the As-rich CarnoulŠs water ([As] = up to 350 mg.l-1) play an important role in the nature and composition of the solid phases that sequester arsenic at the site. The formation of nano-crystalline and amorphous As(III) ferric oxy-hydroxides has been related to the presence of bacteria able to oxidize Fe(II) but not As(III), which are only present in winter in the upstream area. A rare ferric arsenite sulfate oxy-hydroxide mineral was discovered in this context. Other types of bacteria, occurring in the downstream area whatever the season, are able to catalyze As(III) to As(V) oxidation and, provided that enough Fe(II) oxidizes, promote the formation of amorphous As(V) rich ferric oxy-hydroxides. These bacterially mediated reactions significantly reduce the concentration of dissolved As(III), which is more toxic and mobile than As(V), and might thus be helpful for designing As-removal processes. This work was supported by the French PEVS and ACI Ecologie Quantitative Programs and the PIRAMID EC program. ?Deceased, 26 October 1999 Juillot F., Ildefonse Ph., Morin G., Calas G., De Kersabiec A.M. and Benedetti M. Applied Geochemistry 8, 1031-1048 (1999). Morin G., Lecocq D., Juillot F., Ildefonse Ph., Calas Bull. Soc. Géol. Fr. 173, 281-291 (2002). Morin G., Juillot F., Casiot C., Bruneel O., Personné J-C., Elbaz-Poulichet F., Leblanc M., Ildefonse P. and Calas G. Environ. Sci. Technol (in review.)

  12. Effects of PECS Phase III Application Training on Independent Mands in Young Children with Autism

    ERIC Educational Resources Information Center

    Love, Jessica June

    2013-01-01

    The purpose of this study was to examine the effects of PECS phase III application training on independent mands in young children with autism. Participants were five children with autism ranging from ages 2 to 4 years old. A multiple baseline across participants was used to evaluate acquisition of independent correct mands across baseline and…

  13. JumpStart III Final Report.

    ERIC Educational Resources Information Center

    Cohen, Arthur M.; Brawer, Florence B.; Kozeracki, Carol A.

    This final report for the JumpStart III program presents a summary of the entrepreneurship training programs developed by each of the four JumpStart III partners selected in March 1997. Grants for the colleges totaled $354,546 over 2 years. The Jumpstart funding has been only a starting point for these and the other 12 Jumpstart partners in…

  14. Pressure effect on the long-range order in CeB6

    NASA Astrophysics Data System (ADS)

    Sera, M.; Ikeda, S.; Iwakubo, H.; Uwatoko, Y.; Hane, S.; Kosaka, M.; Kunii, S.

    2006-08-01

    The pressure effect of CeB6 was investigated. The pressure dependence of the Néel temperature, TN and the critical field from the antiferro-magnetic phase III to antiferro-quadrupolar phase II, HcIII-II of CeB6 exhibits the unusual pressure dependence that the suppression rate of HcIII-II is much larger than that of TN. In order to explain this unusual result, we have performed the mean field calculation for the 4-sublattice model assuming that the pressure dependence of TN, the antiferro-octupolar and quadrupolar temperatures, Toct and TQ as follows; dTN/dP<0, dToct/dP>dTQ/dP>0 and could explain the unusual pressure dependence of TN and HcIII-II.

  15. 40 CFR 147.2650 - State-administered program-Class I, II, III, IV, and V wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CONTROL PROGRAMS Puerto Rico § 147.2650 State-administered program—Class I, II, III, IV, and V wells. The Underground Injection Control Program for all classes of wells in the Commonwealth of Puerto Rico, other than those on Indian lands, is the program administered by Puerto Rico's Environmental Quality Board (EQB...

  16. 40 CFR 147.2650 - State-administered program-Class I, II, III, IV, and V wells.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CONTROL PROGRAMS Puerto Rico § 147.2650 State-administered program—Class I, II, III, IV, and V wells. The Underground Injection Control Program for all classes of wells in the Commonwealth of Puerto Rico, other than those on Indian lands, is the program administered by Puerto Rico's Environmental Quality Board (EQB...

  17. 40 CFR 147.2650 - State-administered program-Class I, II, III, IV, and V wells.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CONTROL PROGRAMS Puerto Rico § 147.2650 State-administered program—Class I, II, III, IV, and V wells. The Underground Injection Control Program for all classes of wells in the Commonwealth of Puerto Rico, other than those on Indian lands, is the program administered by Puerto Rico's Environmental Quality Board (EQB...

  18. ESEA, Title III Dissemination Program Evaluation Report, 1972-73, 1973-74. Sections I and II.

    ERIC Educational Resources Information Center

    Soper, Dorothy B.

    This report evaluates the New Jersey ESEA Title III dissemination program during its first two years, 1972-74. Purposes of the program are to (a) determine if essential elements of successful education programs can be transferred from originating districts to adopter districts while yielding comparable student gains, and (b) provide educators with…

  19. Preparation of III-V semiconductor nanocrystals

    DOEpatents

    Alivisatos, A.P.; Olshavsky, M.A.

    1996-04-09

    Nanometer-scale crystals of III-V semiconductors are disclosed. They are prepared by reacting a group III metal source with a group V anion source in a liquid phase at elevated temperature in the presence of a crystallite growth terminator such as pyridine or quinoline. 4 figs.

  20. A Statewide Collaboration: Ohio Level III Trauma Centers' Approach to the Development of a Benchmarking System.

    PubMed

    Lang, Carrie L; Simon, Diane; Kilgore, Jane

    The American College of Surgeons Committee on Trauma revised the Resources for Optimal Care of the Injured Patient to include the criteria for trauma centers to participate in a risk-adjusted benchmarking system. Trauma Quality Improvement Program is currently the risk-adjusted benchmarking program sponsored by the American College of Surgeons, which will be required of all trauma centers to participate in early 2017. Prior to this, there were no risk-adjusted programs for Level III verified trauma centers. The Ohio Society of Trauma Nurse Leaders is a collaborative group made up of trauma program managers, coordinators, and other trauma leaders who meet 6 times a year. Within this group, a Level III Subcommittee was formed initially to provide a place for the Level III centers to discuss issues specific to the Level III centers. When the new requirement regarding risk-adjustment became official, the subcommittee agreed to begin reporting simple data points with the idea to risk adjust in the future.

  1. Quantitative Determining of Ultra-Trace Aluminum Ion in Environmental Samples by Liquid Phase Microextraction Assisted Anodic Stripping Voltammetry.

    PubMed

    Zhang, Liuyang; Luo, Jinju; Shen, Xinyu; Li, Chunya; Wang, Xian; Nie, Bei; Fang, Huaifang

    2018-05-10

    Direct detecting of trace amount Al(III) in aqueous solution by stripping voltammetry is often frustrated by its irreversible reduction, resided at −1.75 V (vs. Ag/AgCl reference), which is in a proximal potential of proton reduction. Here, we described an electroanalytical approach, combined with liquid phase microextraction (LPME) using ionic liquid (IL), to quantitatively assess trace amount aluminum in environmental samples. The Al(III) was caged by 8-hydroxyquinoline, forming a superb hydrophobic metal⁻chelate, which sequentially transfers and concentrates in the bottom layer of IL-phase during LPME. The preconcentrated Al(III) was further analyzed by a square-wave anodic stripping voltammetry (SW-ASV). The resulting Al-deposited electrodes were characterized by scanning electron microscopy and powder X-ray diffraction, showing the intriguing amorphous nanostructures. The method developed provides a linear calibration ranging from 0.1 to 1.2 ng L −1 with a correlation coefficient of 0.9978. The LOD attains as low as 1 pmol L −1 , which reaches the lowest report for Al(III) detection using electroanalytical techniques. The applicable methodology was implemented for monitoring Al(III) in commercial distilled water.

  2. Effect of Group-III precursors on unintentional gallium incorporation during epitaxial growth of InAlN layers by metalorganic chemical vapor deposition

    NASA Astrophysics Data System (ADS)

    Kim, Jeomoh; Ji, Mi-Hee; Detchprohm, Theeradetch; Dupuis, Russell D.; Fischer, Alec M.; Ponce, Fernando A.; Ryou, Jae-Hyun

    2015-09-01

    Unintentional incorporation of gallium (Ga) in InAlN layers grown with different molar flow rates of Group-III precursors by metalorganic chemical vapor deposition has been experimentally investigated. The Ga mole fraction in the InAl(Ga)N layer was increased significantly with the trimethylindium (TMIn) flow rate, while the trimethylaluminum flow rate controls the Al mole fraction. The evaporation of metallic Ga from the liquid phase eutectic system between the pyrolized In from injected TMIn and pre-deposited metallic Ga was responsible for the Ga auto-incorporation into the InAl(Ga)N layer. The theoretical calculation on the equilibrium vapor pressure of liquid phase Ga and the effective partial pressure of Group-III precursors based on growth parameters used in this study confirms the influence of Group-III precursors on Ga auto-incorporation. More Ga atoms can be evaporated from the liquid phase Ga on the surrounding surfaces in the growth chamber and then significant Ga auto-incorporation can occur due to the high equilibrium vapor pressure of Ga comparable to effective partial pressure of input Group-III precursors during the growth of InAl(Ga)N layer.

  3. Exploring the Photoreduction of Au(III) Complexes in the Gas-Phase

    NASA Astrophysics Data System (ADS)

    Marcum, Jesse C.; Kaufman, Sydney H.; Weber, J. Mathias

    2010-06-01

    We have used photodissociation spectroscopy to probe the electronic structure and photoreduction of Au(III) in gas-phase complexes containing Cl- and OH-. The gas-phase electronic spectrum of [AuCl_4]- closely resembles the aqueous solution spectrum, showing a lack of strong solvatochromic shifts. Substitution of Cl- ligands with OH- results in a strong blue shift, in agreement with ligand-field theory. Upon excitation, [AuCl_4]- can dissociate by loss of either one or two neutral Cl atoms, resulting in the reduction of gold from Au(III) to Au(II) and Au(I) respectively. The hydroxide substituted complex, [AuCl_2(OH)_2]-, demonstrates similar behavior but the only observable fragment channel is the loss of two neutral OH ligands, leading only to Au(I).

  4. Novel drugs in clinical development for hepatocellular carcinoma.

    PubMed

    Waidmann, Oliver; Trojan, Jörg

    2015-01-01

    Sorafenib is the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). Within recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development either due to toxicity or lack of benefit. This review covers recent clinical data on systemic agents and ongoing trials in patients with advanced HCC. In unselected patients with advanced HCC, disappointing results have been reported from several large trials. However, in two subgroups encouraging results have been achieved. Treatment with the MET inhibitor tivantinib resulted in a substantial survival benefit in the subgroup of MET overexpressing tumors in a randomized Phase II trial. Furthermore, the vascular endothelial growth factor receptor 2 antibody ramucirumab resulted in improved overall survival in patients with baseline α-fetoprotein (AFP) ≥ 400 ng/ml in a Phase III trial. These two agents, and several others, will be further developed in HCC. Moreover, immunotherapeutics such as checkpoint inhibitors, programmed death receptor-1 blocking antibodies and oncolytic viruses are under investigation in advanced HCC.

  5. The Center for Astronomy Education (CAE) Ushers in a New Community-Based Model for Astronomy Education Research with the NSF Funded CCLI Phase III Collaboration of Astronomy Teaching Scholars (CATS) Program

    NASA Astrophysics Data System (ADS)

    Brissenden, Gina; Impey, C.; Prather, E.; Lee, K.; Duncan, D.

    2009-01-01

    The Center for Astronomy Education (CAE) has been devoted to improving teaching & learning in Astro 101 by creating research-validated curriculum & assessment instruments for use in Astro 101 & by providing Astro 101 instructors professional development opportunities to increase their pedagogical content knowledge & instructional skills at implementing these curricula & assessment materials. To create sustainability and further expand this work, CAE, in collaboration with other national leaders in astronomy education & research, developed the Collaboration of Astronomy Teaching Scholars (CATS) Program. The primary goals of CATS are to: 1) increase the number of Astro 101 instructors conducting fundamental research in astronomy education 2) increase the amount of research-validated curriculum & assessment instruments available for use in Astro 101 3) increase the number of people prepared to develop & conduct their own CAE Teaching Excellence Workshops In our first year we have concluded a national study assessing the teaching & learning of Astro 101 & the effect of interactive instruction. We have begun the initial analysis of the demographics data of this study. We have begun a classroom research validation study on the use of the "ClassAction” electronic learning system. We have begun to analyze data from two different studies on students’ attitudes & understanding of science to inform the creation of an assessment instrument designed specifically for Astro 101 to evaluate the effectiveness of our instruction in improving students’ attitudes & beliefs about science. We have also begun the development of a Solar System Concept Inventory. Additionally the development of the Solar System Concept Inventory and research into students’ beliefs and reasoning difficulties on topics in Cosmology are well underway. We acknowledge the NSF for funding under Award No. 0715517, a CCLI Phase III Grant for the Collaboration of Astronomy Teaching Scholars (CATS) Program.

  6. Iron persistence in a distal hydrothermal plume supported by dissolved-particulate exchange

    NASA Astrophysics Data System (ADS)

    Fitzsimmons, Jessica N.; John, Seth G.; Marsay, Christopher M.; Hoffman, Colleen L.; Nicholas, Sarah L.; Toner, Brandy M.; German, Christopher R.; Sherrell, Robert M.

    2017-02-01

    Hydrothermally sourced dissolved metals have been recorded in all ocean basins. In the oceans' largest known hydrothermal plume, extending westwards across the Pacific from the Southern East Pacific Rise, dissolved iron and manganese were shown by the GEOTRACES program to be transported halfway across the Pacific. Here, we report that particulate iron and manganese in the same plume also exceed background concentrations, even 4,000 km from the vent source. Both dissolved and particulate iron deepen by more than 350 m relative to 3He--a non-reactive tracer of hydrothermal input--crossing isopycnals. Manganese shows no similar descent. Individual plume particle analyses indicate that particulate iron occurs within low-density organic matrices, consistent with its slow sinking rate of 5-10 m yr-1. Chemical speciation and isotopic composition analyses reveal that particulate iron consists of Fe(III) oxyhydroxides, whereas dissolved iron consists of nanoparticulate Fe(III) oxyhydroxides and an organically complexed iron phase. The descent of plume-dissolved iron is best explained by reversible exchange onto slowly sinking particles, probably mediated by organic compounds binding iron. We suggest that in ocean regimes with high particulate iron loadings, dissolved iron fluxes may depend on the balance between stabilization in the dissolved phase and the reversibility of exchange onto sinking particles.

  7. No meaningful association between suicidal behavior and the use of IL-17A-neutralizing or IL-17RA-blocking agents.

    PubMed

    Chiricozzi, Andrea; Romanelli, Marco; Saraceno, Rosita; Torres, Tiago

    2016-12-01

    An emerging class of agents blocking IL-17 signaling represents a very promising therapeutic approach. One of these agents, brodalumab, has been associated with an increased risk of suicide behavior. Areas covered: This review sought to provide an overview strictly focused on suicide behavior signals related to the use of IL-17 agents. Data collection regarding this peculiar safety aspect was primarily based on: (i) a revision of safety outcomes belonging to phase II and phase III trials; (ii) a systematic search using the Pubmed Medline database; and (iii) collecting recent data issued as posters or communications in eminent international meetings. Expert opinion: Whilst secukinumab and ixekizumab were not associated with increased signal of suicidal behavior, being recently approved for the treatment of psoriasis by EMA and FDA, brodalumab raised concern because of suicide behavior cases that led to pause momentarily its development program during pre-marketing stage before obtaining the positive recommendation by an FDA advisory panel for its approval. Indeed, a careful re-evaluation of brodalumab safety profile is being performed and no evidence clarified a significant association or a pathogenic mechanism linking brodalumab treatment to the risk of suicidal behavior, suggesting that cases of suicidal behavior accidentally occurred during brodalumab trials.

  8. Computer Program (HEVSIM) for Heavy Duty Vehicle Fuel Economy and Performance Simulation. Volume III: Appendices A through F

    DOT National Transportation Integrated Search

    1981-09-01

    Volume III is the third and last volume of a three volume document describing the computer program HEVSIM. This volume includes appendices which list the HEVSIM program, sample part data, some typical outputs and updated nomenclature.

  9. 48 CFR 234.004 - Acquisition strategy.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... acquisition strategy. The documentation— (A) Shall include an explanation of the level of program risk; and (B... the reasons for proceeding with Milestone B approval despite the high level of program risk; and (iii...'s written determination that— (A) The program is so complex and technically challenging that it...

  10. Developing an active implementation model for a chronic disease management program.

    PubMed

    Smidth, Margrethe; Christensen, Morten Bondo; Olesen, Frede; Vedsted, Peter

    2013-04-01

    Introduction and diffusion of new disease management programs in healthcare is usually slow, but active theory-driven implementation seems to outperform other implementation strategies. However, we have only scarce evidence on the feasibility and real effect of such strategies in complex primary care settings where municipalities, general practitioners and hospitals should work together. The Central Denmark Region recently implemented a disease management program for chronic obstructive pulmonary disease (COPD) which presented an opportunity to test an active implementation model against the usual implementation model. The aim of the present paper is to describe the development of an active implementation model using the Medical Research Council's model for complex interventions and the Chronic Care Model. We used the Medical Research Council's five-stage model for developing complex interventions to design an implementation model for a disease management program for COPD. First, literature on implementing change in general practice was scrutinised and empirical knowledge was assessed for suitability. In phase I, the intervention was developed; and in phases II and III, it was tested in a block- and cluster-randomised study. In phase IV, we evaluated the feasibility for others to use our active implementation model. The Chronic Care Model was identified as a model for designing efficient implementation elements. These elements were combined into a multifaceted intervention, and a timeline for the trial in a randomised study was decided upon in accordance with the five stages in the Medical Research Council's model; this was captured in a PaTPlot, which allowed us to focus on the structure and the timing of the intervention. The implementation strategies identified as efficient were use of the Breakthrough Series, academic detailing, provision of patient material and meetings between providers. The active implementation model was tested in a randomised trial (results reported elsewhere). The combination of the theoretical model for complex interventions and the Chronic Care Model and the chosen specific implementation strategies proved feasible for a practice-based active implementation model for a chronic-disease-management-program for COPD. Using the Medical Research Council's model added transparency to the design phase which further facilitated the process of implementing the program. http://www.clinicaltrials.gov/(NCT01228708).

  11. Polymerase III transcription factor B activity is reduced in extracts of growth-restricted cells.

    PubMed Central

    Tower, J; Sollner-Webb, B

    1988-01-01

    Extracts of cells that are down-regulated for transcription by RNA polymerase I and RNA polymerase III exhibit a reduced in vitro transcriptional capacity. We have recently demonstrated that the down-regulation of polymerase I transcription in extracts of cycloheximide-treated and stationary-phase cells results from a lack of an activated subform of RNA polymerase I which is essential for rDNA transcription. To examine whether polymerase III transcriptional down-regulation occurs by a similar mechanism, the polymerase III transcription factors were isolated and added singly and in pairs to control cell extracts and to extracts of cells that had reduced polymerase III transcriptional activity due to cycloheximide treatment or growth into stationary phase. These down-regulations result from a specific reduction in TFIIIB; TFIIIC and polymerase III activities remain relatively constant. Thus, although transcription by both polymerase III and polymerase I is substantially decreased in extracts of growth-arrested cells, this regulation is brought about by reduction of different kinds of activities: a component of the polymerase III stable transcription complex in the former case and the activated subform of RNA polymerase I in the latter. Images PMID:3352599

  12. Selective solid-phase extraction using oxidized activated carbon modified with triethylenetetramine for preconcentration of metal ions

    NASA Astrophysics Data System (ADS)

    Zhang, Li; Chang, Xijun; Li, Zhenhua; He, Qun

    2010-02-01

    A new selective solid-phase extractant using activated carbon as matrix which was purified, oxidized and modified by triethylenetetramine (AC-TETA) was prepared and characterized by FT-IR spectroscopy. At pH 4, quantitative extraction of trace Cr(III), Fe(III) and Pb(II) was obtained and determined by inductively coupled plasma optical emission spectrometry (ICP-OES). Complete elution of the adsorbed metal ions from the sorbent surface was carried out using 0.5 mol L -1 HCl. The maximum static adsorption capacity of sorbent for Cr(III), Fe(III) and Pb(II) was 34.6, 36.5 and 51.9 mg g -1, respectively. The time of quantitative adsorption was less than 2 min. The detection limits of the method was found to be 0.71, 0.35 and 0.45 ng mL -1 for Cr(III), Fe(III) and Pb(II), and the relative standard deviation (RSD) was 3.7%, 2.2% and 2.5%, respectively. Moreover, the method was free from interference with common coexiting ions. The method was also successfully applied to the preconcentration of trace Cr(III), Fe(III) and Pb(II) in synthetic samples and a real sample with satisfactory results.

  13. A study of solar preflare activity using two-dimensional radio and SMM-XRP observations

    NASA Technical Reports Server (NTRS)

    Kundu, M. R.; Gopalswamy, N.; Saba, J. L. R.; Schmelz, J. T. S.; Strong, K. T.

    1987-01-01

    A study of type III activity at meter-decameter wavelengths in the preflare phase of the February 3, 1986 flare is presented, using data obtained with the Clark Lake Multifrequency Radioheliograph. This activity is compared with similar type III burst activity during the impulsive phase, and it is found that there is a displacement of burst sources between the onset and end times of the activity. A comparison of this displacement at three frequencies suggests that the type III emitting electrons gain access progressively to diverging and different field lines relative to the initial field lines. The energetics of the type III emitting electrons are inferred from observations and compared with those of the associated hard X-ray emitting electrons. The soft X-ray data from SMM-XRP show enhanced emission measure, density, and temperature in the region associated with the preflare type III activity.

  14. A study of solar preflare activity using two-dimensional radio and SMM-XRP observations

    NASA Astrophysics Data System (ADS)

    Kundu, M. R.; Gopalswamy, N.; Saba, J. L. R.; Schmelz, J. T. S.; Strong, K. T.

    1987-09-01

    The authors present a study of type III activity at meter-decameter wavelengths in the preflare phase of the 1986 February 3 flare using data obtained with the Clark Lake Multifrequency Radioheliograph. They compare this activity with similar type III burst activity during the impulsive phase and find that there is a displacement of burst sources between the onset and end times of the activity. A comparison of this displacement at three frequencies suggests that the type III emitting electrons gain access progressively to diverging and different field lines relative to the initial field lines. The energetics of the type III emitting electrons are inferred from observations and compared with those of the associated hard X-ray emitting electrons. The soft X-ray data from SMM-XRP shows enhanced emission measure, density and temperature in the region associated with the preflare type III activity.

  15. Orbital phase dependent IUE spectra of the nova like binary II Arietis

    NASA Technical Reports Server (NTRS)

    Guinan, E. F.; Sion, E. M.

    1981-01-01

    Nine low dispersion IUE spectra of the nova like binary TT Ari over its 3h17m orbital period were obtained. Four short wave spectra and five long wave spectra exhibit marked changes in line strength and continuum shape with orbital phase. The short wave spectra show the presence in absorption of C III, Lyman alpha, SiIII, NV, SiIV, CIV, HeII, AlIII, and NIV. The CIV shows a P Cygni profile on two of the spectra. Implications of these spectra for the nature of nova like variables are discussed.

  16. Evolution of Government and Industrial Partnerships to Open the Space Frontier

    NASA Technical Reports Server (NTRS)

    Martin, Gary L.

    2008-01-01

    If the logical extension of the current exploration program is to develop self-sustaining settlements on the Moon and Mars over the next few centuries, then there is a path that takes civilization from its current one planet existence to a multi-world future. By considering the far term goal of space settlements as a desired endpoint and using the current state as a starting point, the policy drivers and potential pathways to the goal of sustainable space settlements can be explored. This paper describes a three-phased evolution of government and industrial partnerships from current day relationships to a time when there are sustainable settlements in space. Phase I details the current state government-led exploration while Phase III describes a desired endpoint of self-sufficient settlements in space. Phase II is an important transition phase, which acts as a bridge between now and the future. This paper discusses the critical evolution that must take place in two key areas to ensure a thriving future in space; space transportation and the right to use space property and resources. This paper focuses on the enabling role of government necessary to achieve United States (U.S.) goals for space exploration and open the frontier.

  17. Catalytic conversion of light alkanes. Final report, January 1, 1990--October 31, 1994

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

    NONE

    During the course of the first three years of the Cooperative Agreement (Phase I-III), we uncovered a family of metal perhaloporphyrin complexes which had unprecedented activity for the selective air-oxidation of fight alkanes to alcohols. The reactivity of fight hydrocarbon substrates with air or oxygen was in the order: isobutane>propane>ethane>methane, in accord with their homolytic bond dissociation energies. Isobutane was so reactive that the proof-of concept stage of a process for producing tert-butyl alcohol from isobutane was begun (Phase V). It was proposed that as more active catalytic systems were developed (Phases IV, VI), propane, then ethane and finally methanemore » oxidations will move into this stage (Phases VII through IX). As of this writing, however, the program has been terminated during the later stages of Phases V and VI so that further work is not anticipated. We made excellent progress during 1994 in generating a class of less costly new materials which have the potential for high catalytic activity. New routes were developed for replacing costly perfluorophenyl groups in the meso-position of metalloporphyrin catalysts with far less expensive and lower molecular weight perfluoromethyl groups.« less

  18. Evaluating the accuracy of technicians and pharmacists in checking unit dose medication cassettes.

    PubMed

    Ambrose, Peter J; Saya, Frank G; Lovett, Larry T; Tan, Sandy; Adams, Dale W; Shane, Rita

    2002-06-15

    The accuracy rates of board-registered pharmacy technicians and pharmacists in checking unit dose medication cassettes in the inpatient setting at two separate institutions were examined. Cedars-Sinai Medical Center and Long Beach Memorial Medical Center, both in Los Angeles county, petitioned the California State Board of Pharmacy to approve a waiver of the California Code of Regulations to conduct an experimental program to compare the accuracy of unit dose medication cassettes checked by pharmacists with that of cassettes checked by trained, certified pharmacy technicians. The study consisted of three parts: assessing pharmacist baseline checking accuracy (Phase I), developing a technician-training program and certifying technicians who completed the didactic and practical training (Phase II), and evaluating the accuracy of certified technicians checking unit dose medication cassettes as a daily function (Phase III). Twenty-nine pharmacists and 41 technicians (3 of whom were pharmacy interns) participated in the study. Of the technicians, all 41 successfully completed the didactic and practical training, 39 successfully completed the audits and became certified checkers, and 2 (including 1 of the interns) did not complete the certification audits because they were reassigned to another work area or had resigned. In Phase II, the observed accuracy rate and its lower confidence limit exceeded the predetermined minimum requirement of 99.8% for a certified checker. The mean accuracy rates for technicians were identical at the two institutions (p = 1.0). The difference in mean accuracy rates between pharmacists (99.52%; 95% confidence interval [CI] 99.44-99.58%) and technicians, (99.89%; 95% CI 99.87-99.90%) was significant (p < 0.0001). Inpatient technicians who had been trained and certified in a closely supervised program that incorporated quality assurance mechanisms could safely and accurately check unit dose medication cassettes filled by other technicians.

  19. Bilastine: in allergic rhinitis and urticaria.

    PubMed

    Carter, Natalie J

    2012-06-18

    Bilastine is an orally administered, second-generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhinoconjunctivitis and urticaria. In two well designed phase III trials, 14 days' treatment with bilastine was associated with a significantly lower area under the effect curve (AUEC) for the reflective total symptom score (TSS) than placebo in patients with symptomatic seasonal allergic rhinitis. Additionally, reflective nasal symptom scores were significantly lower in bilastine than placebo recipients in patients with a history of seasonal allergic rhinitis who were challenged with grass pollen allergen in a single-centre, phase II study. Neither bilastine nor cetirizine was effective in the treatment of perennial allergic rhinitis with regard to the mean AUEC for reflective TSS in another well designed phase III trial. However, results may have been altered by differences in some baseline characteristics and placebo responses between study countries. In another well designed phase III trial, compared with placebo, bilastine was associated with a significantly greater change from baseline to day 28 in the mean reflective daily urticaria symptom score in patients with chronic urticaria. There were no significant differences in primary endpoint results between bilastine and any of the active comparators used in these trials (i.e. cetirizine, levocetirizine and desloratadine). Bilastine was generally well tolerated, with a tolerability profile that was generally similar to that of the other second-generation antihistamines included in phase III clinical trials.

  20. Studies of phase transitions in the aripiprazole solid dosage form.

    PubMed

    Łaszcz, Marta; Witkowska, Anna

    2016-01-05

    Studies of the phase transitions in an active substance contained in a solid dosage form are very complicated but essential, especially if an active substance is classified as a BCS Class IV drug. The purpose of this work was the development of sensitive methods for the detection of the phase transitions in the aripiprazole tablets containing initially its form III. Aripiprazole exhibits polymorphism and pseudopolymorphism. Powder diffraction, Raman spectroscopy and differential scanning calorimetry methods were developed for the detection of the polymorphic transition between forms III and I as well as the phase transition of form III into aripiprazole monohydrate in tablets. The study involved the initial 10 mg and 30 mg tablets, as well as those stored in Al/Al blisters, a triplex blister pack and HDPE bottles (with and without desiccant) under accelerated and long term conditions. The polymorphic transition was not observed in the initial and stored tablets but it was visible on the DSC curve of the Abilify(®) 10 mg reference tablets. The formation of the monohydrate was observed in the diffractograms and Raman spectra in the tablets stored under accelerated conditions. The monohydrate phase was not detected in the tablets stored in the Al/Al blisters under long term conditions. The results showed that the Al/Al blisters can be recommended as the packaging of the aripiprazole tablets containing form III. Copyright © 2015 Elsevier B.V. All rights reserved.

  1. Lubiprostone: in constipation-predominant irritable bowel syndrome.

    PubMed

    Carter, Natalie J; Scott, Lesley J

    2009-06-18

    Lubiprostone is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of human gastrointestinal epithelial cells, thereby increasing chloride-rich fluid secretion. Although the mechanism is unclear, this may then decrease intestinal transit time, allowing the passage of stool and alleviating symptoms of constipation. Oral lubiprostone was effective in the treatment of patients with constipation-predominant irritable bowel syndrome (IBS-C) in large (n = 193-583) phase II (dose-finding) and phase III randomized, double-blind, placebo-controlled, multicentre trials. The number of patients with IBS-C demonstrating an overall response to treatment (primary endpoint) in the two phase III trials was significantly greater in patients receiving lubiprostone 8 microg twice daily for 3 months than in those receiving placebo. In addition, a randomized, 4-week withdrawal period at the end of one of the phase III trials demonstrated that discontinuation of lubiprostone was not associated with rebound of IBS symptoms. Lubiprostone was generally well tolerated in clinical trials, with the majority of adverse events being of mild to moderate severity. In patients with IBS-C who received lubiprostone 8 microg twice daily, nausea was the most frequently occurring adverse event that was considered possibly or probably treatment related. No serious treatment-related adverse events were reported in a 36-week open-label extension to the phase III trials.

  2. 76 FR 33589 - Standards Improvement Project-Phase III

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... rule: I. Background A. Introduction B. Regulatory History II. Legal Considerations III. Summary and... without diminishing worker protections. B. Regulatory History The Standards Improvement Project (SIP...

  3. Antisense oligonucleotide inhibition of apolipoprotein C-III reduces plasma triglycerides in rodents, nonhuman primates, and humans.

    PubMed

    Graham, Mark J; Lee, Richard G; Bell, Thomas A; Fu, Wuxia; Mullick, Adam E; Alexander, Veronica J; Singleton, Walter; Viney, Nick; Geary, Richard; Su, John; Baker, Brenda F; Burkey, Jennifer; Crooke, Stanley T; Crooke, Rosanne M

    2013-05-24

    Elevated plasma triglyceride levels have been recognized as a risk factor for the development of coronary heart disease. Apolipoprotein C-III (apoC-III) represents both an independent risk factor and a key regulatory factor of plasma triglyceride concentrations. Furthermore, elevated apoC-III levels have been associated with metabolic syndrome and type 2 diabetes mellitus. To date, no selective apoC-III therapeutic agent has been evaluated in the clinic. To test the hypothesis that selective inhibition of apoC-III with antisense drugs in preclinical models and in healthy volunteers would reduce plasma apoC-III and triglyceride levels. Rodent- and human-specific second-generation antisense oligonucleotides were identified and evaluated in preclinical models, including rats, mice, human apoC-III transgenic mice, and nonhuman primates. We demonstrated the selective reduction of both apoC-III and triglyceride in all preclinical pharmacological evaluations. We also showed that inhibition of apoC-III was well tolerated and not associated with increased liver triglyceride deposition or hepatotoxicity. A double-blind, placebo-controlled, phase I clinical study was performed in healthy subjects. Administration of the human apoC-III antisense drug resulted in dose-dependent reductions in plasma apoC-III, concomitant lowering of triglyceride levels, and produced no clinically meaningful signals in the safety evaluations. Antisense inhibition of apoC-III in preclinical models and in a phase I clinical trial with healthy subjects produced potent, selective reductions in plasma apoC-III and triglyceride, 2 known risk factors for cardiovascular disease. This compelling pharmacological profile supports further clinical investigations in hypertriglyceridemic subjects.

  4. 75 FR 63147 - Solicitation of Applications for the Public Works, Economic Adjustment Assistance, and Global...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ...] Solicitation of Applications for the Public Works, Economic Adjustment Assistance, and Global Climate Change... Program; and (iii) Global Climate Change Mitigation Incentive Fund (GCCMIF) Program. To enhance the...; and (iii) Global Climate Change Mitigation Incentive Fund (GCCMIF) Program. EDA will publish separate...

  5. Brush Day & Night Phase III to Phase IV: ensuring that good oral health habits are sustainable.

    PubMed

    Melo, Paulo; Fine, Charlotte; Malone, Sinead; Horn, Virginie

    2018-05-01

    Over the past 10 years, the FDI-Unilever Brush Day & Night partnership has significantly influenced the life of children worldwide through the implementation of school programmes for oral health education and prevention. This article reports the key facts and outcomes of Phase III of the partnership, and announces the launch of Phase IV. During Phase III, the expert advisors of the Brush Day & Night partnership conducted a longitudinal study to evaluate the impact of the '21 Day' programme in almost 8,000 children in 10 countries. Analysis revealed the effectiveness of the 21 Day programme in sustainably educating children to brush their teeth twice a day, with the greatest impact observed in children aged 7-9 years. With the launch of Phase IV, the Brush Day & Night partnership will continue to deliver its oral health school programme for 7-9 year-old children with a strengthened methodology, including randomized sampling and control groups. The scope of the evaluation will be broadened to include oral health-related quality of life indicators, and monitoring of the oral health knowledge of children's parents/carers. © 2018 FDI World Dental Federation.

  6. 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

  7. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies.

    PubMed

    Luo, Xiaoping; Hou, Ling; Liang, Li; Dong, Guanping; Shen, Shuixian; Zhao, Zhuhui; Gong, Chun Xiu; Li, Yuchuan; Du, Min-Lian; Su, Zhe; Du, Hongwei; Yan, Chaoying

    2017-08-01

    We assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD). Phase II and III, multicenter, open-label, randomized controlled trials. 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored. The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment ( P  < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment ( P  < 0.05). Adverse event rates and treatment compliance were comparable between the two groups. Jintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH. © 2017 The authors.

  8. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies

    PubMed Central

    Hou, Ling; Liang, Li; Dong, Guanping; Shen, Shuixian; Zhao, Zhuhui; Gong, Chun Xiu; Li, Yuchuan; Du, Min-lian; Su, Zhe; Du, Hongwei; Yan, Chaoying

    2017-01-01

    Objective We assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD). Design Phase II and III, multicenter, open-label, randomized controlled trials. Methods 108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored. Results The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment (P < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment (P < 0.05). Adverse event rates and treatment compliance were comparable between the two groups. Conclusion Jintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH. PMID:28566441

  9. Findings from an Evaluation of a Comprehensive Parent Education Program for School-Age Parents.

    ERIC Educational Resources Information Center

    Braun, Maureen H.; Fuscaldo, Diane P.

    This study evaluates the impact of the Parent Linking Project III (PLP III) on its participants. The PLP III is a comprehensive program for teenage mothers which offers workshops in parenting, mother-child interaction, and vocational awareness, and provides day care services that allow teen mothers to take the opportunity to complete their high…

  10. Prevention of Posttraumatic Contractures with Ketotifen (PERK)

    DTIC Science & Technology

    2017-10-01

    opportunity to design a Phase III RCT on the use of ketotifen in post -traumatic joint contractures. The goal is to design and develop the infrastructure to...Research (CIHR) for the Phase III RCT. 2. KEYWORDS Post -traumatic contractures, elbow fractures, randomized clinical trial, multicenter, ketotifen...application to use ketotifen in post -traumatic joint contracture prevention was submitted to the Division of Pulmonary, Allergy, and Rheumatology

  11. What Works in Oklahoma Schools: A Comprehensive Needs Assessment of Oklahoma Schools. Phase III Action Steps

    ERIC Educational Resources Information Center

    Marzano Research Laboratory, 2011

    2011-01-01

    This document contains the Phase III report from the "What Works in Oklahoma Schools" study. As opposed to describing the findings from the study that was conducted, it provides a tool-kit that can be used by Oklahoma principals and teachers to determine the best courses of action for their schools and classrooms. The tools provided in…

  12. Rimonabant Sanofi-Synthélabo.

    PubMed

    Fernandez, Jose R; Allison, David B

    2004-04-01

    Rimonabant, an antagonist of central cannabinoid type 1 (CB1) receptors, is being developed by Sanofi-Synthélabo for the potential treatment of obesity and as a potential smoking cessation agent. Phase III trials were initiated for obesity in August 2001 and were ongoing in September 2003. By September 2002, the compound had entered phase III trials for smoking cessation, and these trials were ongoing in September 2003.

  13. Ultracompact electro-optic phase modulator based on III-V-on-silicon microdisk resonator.

    PubMed

    Lloret, J; Kumar, R; Sales, S; Ramos, F; Morthier, G; Mechet, P; Spuesens, T; Van Thourhout, D; Olivier, N; Fédéli, J-M; Capmany, J

    2012-06-15

    A novel ultracompact electro-optic phase modulator based on a single 9 μm-diameter III-V microdisk resonator heterogeneously integrated on and coupled to a nanophotonic waveguide is presented. Modulation is enabled by effective index modification through carrier injection. Proof-of-concept implementation involving binary phase shift keying modulation format is assembled. A power imbalance of ∼0.6  dB between both symbols and a modulation rate up to 1.8 Gbps are demonstrated without using any special driving technique.

  14. US-UK Collaboration on Fossil Energy Advanced Materials: Task 1—Steam Oxidation

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

    Holcomb, Gordon R.; Tylczak, Joseph; Carney, Casey

    This presentation goes over the following from the US-UK collaboration on Fossil Energy Advanced Materials: Task 1, Steam Oxidation: US-led or co-led deliverables, Phase II products (US), 2011-present, Phase III products, Phase III Plan, an explanation of sCO 2 compared with sH 2O, an explanation of Ni-base Alloys, an explanation of 300 Series (18Cr-8Ni)/E-Brite, an explanation of the typical Microchannel HX Fabrication process, and an explanation of diffusion bonded Ni-base superalloys.

  15. Manufacturing Technology for Apparel Automation. Phase 1, 2 and 3 Activity.

    DTIC Science & Technology

    1987-10-15

    A189 129 MANUFACTURING TECHNOLOGY FOR APPAREL AUTOMATION PHASE I t/l 2 AND I ACTIVITY(U) NORTH CAROLINA STATE UNIV ATRALEIGH SCHOOL OF TEXTILES E M...34III 1.8 - iai T ON HART St 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 MTC FILE coax Report: NCSU/DLA-87/2 CDRL A004 MANUFACTURING TECHNOLOGY FOR APPAREL...I Report: NCSU/DLA-87/2 CDRL A004 MANUFACTURING TECHNOLOGY FOR APPAREL AUTOMATION Phase I, II and III Activity Edwin M. McPherson North Carolina

  16. Raman spectra of solid benzene under high pressure

    NASA Technical Reports Server (NTRS)

    Thiery, M.-M.; Kobashi, K.; Spain, I. L.

    1985-01-01

    Raman spectra of solid benzene have been measured at room temperature up to about 140 kbar, using the diamond anvil cell. Effort has been focused upon the lattice vibration spectra at pressures above that of phase II. It is found that a change in slopes occurs in the frequency-pressure curves at about 40 kbar. Furthermore, a new band appears above 90 kbar. These features probably correspond respectively to the II-III phase transition, which has been reported previously, and a III-IV phase transition, reported here for the first time.

  17. GLOBE Mission Earth: The evaluation of the first year's implementation.

    NASA Astrophysics Data System (ADS)

    Adaktylou, N. E.; Hedley, M. L.; Darche, S.; Harris-Stefanakis, E.; Silberglitt, M. D.; Struble, J.; Bingham, P.; Czajkowski, K.

    2017-12-01

    Here we present the evaluation findings for the first year of implementation of the `Mission Earth' Program.`Mission Earth' proposes the systematic embedding of GLOBE (Global Learning and Observations to Benefit the Environment) resources and NASA assets into the curricula of schools along the K-12 continuum, leveraging existing partnerships and networks. The main goal of the program is to create developmentally appropriate, vertically-integrated K-12 materials and activities,, supported by high quality professional development and ongoing support, engaging teachers from all grades. Its team consists of 5 geographically distributed universities and research institutions that have developed a curriculum progression following research-based best practices, have conducted the year's trainings for selected cohorts of teachers. The evaluation is a continuous process over the program's five year duration to examine implementation and opportunities for improvement. A broad set of data collection tools include a diagnostic component (needs assessment for teachers, capacity assessment for the school environment) and an assessment of implementation component (surveys for teachers and trainers, pre- and post tests for students, classroom observations, teacher interviews, portfolios). The tools used are validated instruments or ones modified to serve the program needs. The patterns emerging from the data provided information on: i) the quality of the intervention as to its design and content, ii) the alignment with the needs of the participants, iii) the implementation phase, iii) changes in the content knowledge of the students and their attitudes toward science, iv) changes in the facility of teachers to teach science in their classrooms after the professional development and materials provided, v) challenges and facilitators of implementation. Based on findings the program evaluation identifies additions/adjustments to be adopted in the following year.

  18. Phase III trial comparing 3-6 months of adjuvant FOLFOX4/XELOX in stage II-III colon cancer: safety and compliance in the TOSCA trial.

    PubMed

    Lonardi, S; Sobrero, A; Rosati, G; Di Bartolomeo, M; Ronzoni, M; Aprile, G; Massida, B; Scartozzi, M; Banzi, M; Zampino, M G; Pasini, F; Marchetti, P; Cantore, M; Zaniboni, A; Rimassa, L; Ciuffreda, L; Ferrari, D; Barni, S; Zagonel, V; Maiello, E; Rulli, E; Labianca, R

    2016-11-01

    Six months of oxaliplatin-based adjuvant chemotherapy is standard of care for radically resected stage III colon cancer and an accepted option for high-risk stage II. A shorter duration of therapy, if equally efficacious, would be advantageous for patients and Health-Care Systems. TOSCA ['Randomized trial investigating the role of FOLFOX-4 or XELOX (3 versus 6 months) regimen duration and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer] is an open-label, phase III, multicenter, noninferiority trial randomizing patients with high-risk stage II or stage III radically resected colon cancer to receive 3 months (arm 3 m) versus 6 months (arm 6 m) of FOLFOX4/XELOX. Primary end-point was relapse-free survival. We present here safety and compliance data. From June 2007 to March 2013, 3759 patients were accrued from 130 Italian sites, 64% receiving FOLFOX4 and 36% XELOX in either arm. Treatment completion rate without any modification was 35% versus 12% and with delays or dose reduction 52% versus 44% in arm 3 and 6 m. Treatment was permanently discontinued in 8% (arm 3 m) and 33% (arm 6 m). In arm 6 m, 50% of patients discontinuing treatment did so after completing 80% of planned program. Grade 3+ toxicities were higher in arm 6 m than that in 3 m. Grade 2+ neuropathy was 31.2% versus 8.8% (P < 0.0001) while grade 3+ was 8.4 versus 1.3 (P < 0.0001), in arm 3 and 6 m. Seven deaths within 30 days from last treatment administration in arm 6 m and three deaths in arm 3 m were observed (0.3% versus 0.1%, P = 0.34). TOSCA is the first trial comparing 3 versus 6 months of adjuvant chemotherapy completing accrual within the international initiative of treatment duration evaluation (International Duration Evaluation of Adjuvant, IDEA). High compliance to treatment in control arm will allow a correct assessment of potential differences between the two treatment durations. NCT00646607. © The Author 2016. 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.

  19. A comparison study of the Born effective charges and dielectric properties of the cubic, tetragonal, monoclinic, ortho-I, ortho-II and ortho-III phases of zirconia

    NASA Astrophysics Data System (ADS)

    Zhang, Yan; Chen, Hua-Xin; Duan, Li; Fan, Ji-Bin; Ni, Lei; Ji, Vincent

    2018-07-01

    Using density-functional perturbation theory, we systematically investigate the Born effective charges and dielectric properties of cubic, tetragonal, monoclinic, ortho-I (Pbca), ortho-II (Pnma) and ortho-III (Pca21) phases of ZrO2. The magnitudes of the Born effective charges of the Zr and oxygen atoms are greater than their nominal ionic valences (+4 for Zr and -2 for oxygen), indicating a strong dynamic charge transfer from Zr atoms to O atoms and a mixed covalent-ionic bonding in six phases of ZrO2. For all six phases of ZrO2, the electronic contributions εij∞ to the static dielectric constant are rather small (range from 5 to 6.5) and neither strongly anisotropic nor strongly dependent on the structural phase, while the ionic contributions εijion to the static dielectric constant are large and not only anisotropic but also dependent on the structural phase. The average dielectric constant εbar0 of the six ZrO2 phases decreases in the sequence of tetragonal, cubic, ortho-II (Pnma), ortho-I (Pbca), ortho-III (Pca21) and monoclinic. So among six phases of ZrO2, the tetragonal and cubic phases are two suitable phases to replace SiO2 as the gate dielectric material in modern integrated-circuit technology. Furthermore, for the tetragonal ZrO2 the best orientation is [100].

  20. Broadband microwave photonic fully tunable filter using a single heterogeneously integrated III-V/SOI-microdisk-based phase shifter.

    PubMed

    Lloret, Juan; Morthier, Geert; Ramos, Francisco; Sales, Salvador; Van Thourhout, Dries; Spuesens, Thijs; Olivier, Nicolas; Fédéli, Jean-Marc; Capmany, José

    2012-05-07

    A broadband microwave photonic phase shifter based on a single III-V microdisk resonator heterogeneously integrated on and coupled to a nanophotonic silicon-on-insulator waveguide is reported. The phase shift tunability is accomplished by modifying the effective index through carrier injection. A comprehensive semi-analytical model aiming at predicting its behavior is formulated and confirmed by measurements. Quasi-linear and continuously tunable 2π phase shifts at radiofrequencies greater than 18 GHz are experimentally demonstrated. The phase shifter performance is also evaluated when used as a key element in tunable filtering schemes. Distortion-free and wideband filtering responses with a tuning range of ~100% over the free spectral range are obtained.

  1. Motor associations of iron accumulation in deep grey matter nuclei in Parkinson's disease: a cross-sectional study of iron-related magnetic resonance imaging susceptibility.

    PubMed

    Martin-Bastida, A; Lao-Kaim, N P; Loane, C; Politis, M; Roussakis, A A; Valle-Guzman, N; Kefalopoulou, Z; Paul-Visse, G; Widner, H; Xing, Y; Schwarz, S T; Auer, D P; Foltynie, T; Barker, R A; Piccini, P

    2017-02-01

    To determine whether iron deposition in deep brain nuclei assessed using high-pass filtered phase imaging plays a role in motor disease severity in Parkinson's disease (PD). Seventy patients with mild to moderate PD and 20 age- and gender-matched healthy volunteers (HVs) underwent susceptibility-weighted imaging on a 3 T magnetic resonance imaging scanner. Phase shifts (radians) in deep brain nuclei were derived from high-pass filtered phase images and compared between groups. Analysis of clinical laterality and correlations with motor severity (Unified Parkinson's Disease Rating Scale, Part III, UPDRS-III) were performed. Phase shifts (in radians) were compared between HVs and three PD subgroups divided according to UPDRS-III scores using analysis of covariance, adjusting for age and regional area. Parkinson's disease patients had significantly (P < 0.001) higher radians than HVs bilaterally in the putamen, globus pallidus and substantia nigra (SN). The SN contralateral to the most affected side showed higher radians (P < 0.001) compared to the less affected side. SN radians positively correlated with UPDRS-III and bradykinesia-rigidity subscores, but not with tremor subscores. ancova followed by post hoc Bonferroni-adjusted pairwise comparisons revealed that SN radians were significantly greater in the PD subgroup with higher UPDRS-III scores compared to both lowest UPDRS-III PD and HV groups (P < 0.001). Increased nigral iron accumulation in PD appears to be stratified according to disease motor severity and correlates with symptoms related to dopaminergic neurodegeneration. This semi-quantitative in vivo iron assessment could prove useful for objectively monitoring PD progression, especially in clinical trials concerning iron chelation therapies. © 2016 EAN.

  2. Method for the determination of chromium in feed matrix by HPLC.

    PubMed

    Umesh, Balakrishnan; Rajendran, Rajendra Moorthy; Manoharan, Muthu Tamizh

    2015-11-01

    An improved method for the chromatographic separation and determination of chromium (III) and (VI) [ CRIII AND CRVI: ] in mineral mixtures and feed samples has been developed. The method uses precolumn derivatization using ammonium pyrrolidinedithiocarbamate ( APD: ) followed by reversed-phase liquid chromatography to separate the chromium ions. Both Cr(III) and Cr(VI) species are chelated with ammonium pyrrolidinedithiocarbamate prior to separation by mixing with acetonitrile and 0.5 mmol acetate buffer (pH 4.5). Optimum chromatographic separations were obtained with a polymer-based reversed-phase column (Kinetex, 5 μ, 250 × 4.5 mm, Phenomenex, Torrance, CA) and a mobile phase containing acetonitrile and water (7:3). Both Cr(III) and Cr(VI) ion concentrations were directly determined from the corresponding areas in the chromatogram. The effect of analytical parameters, including pH, concentration of ligand, incubation temperature, and mobile phase, was optimized for both chromium complexes. The range of the procedure was found to be linear for Cr(III) and Cr(VI) concentrations between 0.125 and 4 μg/mL (r² = 0.9926) and 0.1 and 3.0 μg/mL (r² = 0.9983), respectively. Precision was evaluated by replicate analysis in which the percentage relative standard deviation values for chromium complex were found to be below 4.0. The recoveries obtained (85-115%) for both Cr(III) and Cr(VI) complexes indicated the accuracy of the developed method. The degradation products, as well as the excipients, were well resolved from the chromium complex peak in the chromatogram. Finally, the new method proved to be suitable for routine analysis of Cr(III) and Cr(VI) species in raw materials, mineral mixtures, and feed samples. © 2015 Poultry Science Association Inc.

  3. The influence of different sets of surgical instrumentation in Oxford UKA on bearing size and component position.

    PubMed

    Walker, Tilman; Heinemann, Pascal; Bruckner, Thomas; Streit, Marcus R; Kinkel, Stefan; Gotterbarm, Tobias

    2017-07-01

    The Oxford unicompartmental knee arthroplasty (OUKA) has been proven to be an effective treatment for anteromedial osteoarthritis of the knee joint. New instrumentation has been introduced to improve the reproducibility of implant positioning and to minimize bone loss during tibial resection (Oxford Microplasty; Zimmer Biomet, Warsaw, Indiana, USA). To assess the effect of the new instrumentation, we retrospectively evaluated the postoperative radiographs and surgical records of 300 OUKAs in three consecutive cohorts of patients. The first cohort consists of the first 100 minimal invasive implantations of the OUKA using the conventional phase III instrumentation, the second cohort consists of the 100 most recent minimal invasive OUKA with the conventional phase III instrumentation and the third cohort consists of the first 100 minimal invasive OUKA using the new Oxford Microplasty instrumentation. Mean bearing thickness was statistically significant and lower in OUKA with use of the updated instrumentation than with the conventional instrumentation (p = 0.01 and p = 0.04). Additionally, statistically significant and more femoral components were aligned within the accepted range of tolerance in both the coronal and the sagittal plane with use of the updated instrumentation compared to the conventional phase III instrumentation in group A (p = 0.029 and p = 0.038) and in the sagittal plane with use of the updated instrumentation compared to the conventional phase III instrumentation in group B (p = 0.002). The new modified instrumentation seems to be an effective tool to reduce the risk of malalignment of the femoral component in the coronal and in the sagittal plane compared to the conventional phase III instrumentation. Furthermore, the instrumentation is also effective in determining an adequate level of tibial resection and thus avoiding unnecessary bone loss.

  4. The Combination Process for Preparative Separation and Purification of Paclitaxel and 10-Deacetylbaccatin III Using Diaion® Hp-20 Followed by Hydrophilic Interaction Based Solid Phase Extraction.

    PubMed

    Shirshekanb, Mahsa; Rezadoost, Hassan; Javanbakht, Mehran; Ghassempour, Ali Reza

    2017-01-01

    There is no other naturally occurring defense agent against cancer that has a stronger effect than paclitaxel, commonly known under the brand name of Taxol ® . The major drawback for the more widespread use of paclitaxel and its precious precursor, 10-deacetylbaccatin III (10-DAB III), is that they require large-scale extraction from different parts of yew trees ( Taxus species), cell cultures, taxane-producing endophytic fungi, and Corylus species. In our previous work, a novel online two-dimensional heart-cut liquid chromatography process using hydrophilic interaction/ reversed-phase chromatography was used to introduce a semi-preparative treatment for the separation of polar (10-deacetylbaccatin III) and non-polar (paclitaxel) taxanes from Taxus baccata L. In this work, a combination of the absorbent (Diaion ®  HP-20) and a silica based solid phase extraction is utilized as a new, efficient, and cost effective method for large-scale production of taxanes. This process avoids the technical problem of two-dimensional preparative liquid chromatography. The first stage of the process involves discarding co-extractive polar compounds including chlorophylls and pigments using a non-polar synthetic hydrophobic absorbent, Diaion ®  HP-20. Extract was then loaded on to a silica based hydrophilic interaction solid phase extraction (silica 40-60 micron). Taxanes was eluted using a mixture of water and methanol at the optimized ratio of 70:30. Finally, the fraction containing taxanes was applied to semi-preparative reversed phase HPLC. The results revealed that using this procedure, paclitaxel and 10-DAB III could be obtained at 8 and 3 times more, respectively than by the traditional method of extraction.

  5. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

    PubMed

    Zhang, Sheng; Liang, Fei; Li, Wenfeng

    2017-11-01

    The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Lorcaserin: an investigational serotonin 2C agonist for weight loss.

    PubMed

    Hurren, Kathryn M; Berlie, Helen D

    2011-11-01

    The pharmacology, pharmacokinetics, and adverse effects of the selective serotonin (5-HT) agonist lorcaserin are reviewed, with an emphasis on efficacy and safety data from Phase III clinical trials. Lorcaserin is highly selective for a subtype of 5-HT receptors important in appetite regulation, with low affinity for other 5-HT-receptor subtypes whose activation is thought to underlie serious cardiovascular adverse effects; such effects have been seen with nonselective serotonergic agents for weight loss (e.g., fenfluramine). In two Phase III trials of lorcaserin, the cumulative proportion of patients who achieved weight loss of ≥5% over 12 months was about 47% with lorcaserin use versus 20-25% among placebo users (p < 0.0001 for both trials). Lorcaserin was generally well tolerated in the clinical trials to date; nausea and vomiting, headache, and dizziness were the most commonly reported adverse effects. In two of the three Phase III trials to date, lorcaserin use was not found to increase the risk of cardiac valvulopathy; however, in the other Phase III trial, which focused on patients with diabetes, lorcaserin use was associated with an increased rate of new valvulopathy. In a carcinogenicity evaluation involving laboratory rats, lorcaserin was linked to the development of various malignancies, a finding with uncertain implications for its potential future use in humans. Lorcaserin, a 5-HT(2C) agonist, has demonstrated efficacy in patients who are obese or are overweight with associated comorbidities. Phase III trials have found that more than 35% of patients lost greater than 5% of their baseline weight. The maker of lorcaserin has indicated it will continue to seek U.S. marketing approval of the drug for the indications of long-term weight loss and weight-loss maintenance in specific patient populations.

  7. Sphingosine 1-phosphate receptor modulators in multiple sclerosis.

    PubMed

    Subei, Adnan M; Cohen, Jeffrey A

    2015-07-01

    Sphingosine 1-phosphate (S1P) receptor modulators possess a unique mechanism of action as disease-modifying therapy for multiple sclerosis (MS). Subtype 1 S1P receptors are expressed on the surfaces of lymphocytes and are important in regulating egression from lymph nodes. The S1P receptor modulators indirectly antagonize the receptor's function and sequester lymphocytes in lymph nodes. Fingolimod was the first S1P agent approved in the USA in 2010 for relapsing MS after two phase III trials (FREEDOMS and TRANSFORMS) demonstrated potent efficacy, and good safety and tolerability. Post-marketing experience, as well as a third phase III trial (FREEDOMS II), also showed favorable results. More selective S1P receptor agents-ponesimod (ACT128800), siponimod (BAF312), ozanimod (RPC1063), ceralifimod (ONO-4641), GSK2018682, and MT-1303-are still in relatively early stages of development, but phase I and II trials showed promising efficacy and safety. However, these observations have yet to be reproduced in phase III clinical trials.

  8. Mechanism of selenite removal by a mixed adsorbent based on Fe-Mn hydrous oxides studied using X-ray absorption spectroscopy.

    PubMed

    Chubar, Natalia; Gerda, Vasyl; Szlachta, Małgorzata

    2014-11-18

    Selenium cycling in the environment is greatly controlled by various minerals, including Mn and Fe hydrous oxides. At the same time, such hydrous oxides are the main inorganic ion exchangers suitable (on the basis of their chemical nature) to sorb (toxic) anions, separating them from water solutions. The mechanism of selenite adsorption by the new mixed adsorbent composed of a few (amorphous and crystalline) phases [maghemite, MnCO3, and X-ray amorphous Fe(III) and Mn(III) hydrous oxides] was studied by extended X-ray absorption fine structure (EXAFS) spectroscopy [supported by Fourier transform infrared (FTIR) and X-ray diffraction (XRD) data]. The complexity of the porous adsorbent, especially the presence of the amorphous phases of Fe(III) and Mn(III) hydrous oxides, is the main reason for its high selenite removal performance demonstrated by batch and column adsorption studies shown in the previous work. Selenite was bound to the material via inner-sphere complexation (via oxygen) to the adsorption sites of the amorphous Fe(III) and Mn(III) oxides. This anion was attracted via bidentate binuclear corner-sharing coordination between SeO3(2-) trigonal pyramids and both FeO6 and MnO6 octahedra; however, the adsorption sites of Fe(III) hydrous oxides played a leading role in selenite removal. The contribution of the adsorption sites of Mn(III) oxide increased as the pH decreased from 8 to 6. Because most minerals have a complex structure (they are seldom based on individual substances) of various crystallinity, this work is equally relevant to environmental science and environmental technology because it shows how various solid phases control cycling of chemical elements in the environment.

  9. Antisense inhibition of apoB synthesis with mipomersen reduces plasma apoC-III and apoC-III-containing lipoproteins.

    PubMed

    Furtado, Jeremy D; Wedel, Mark K; Sacks, Frank M

    2012-04-01

    Mipomersen, an antisense oligonucleotide that reduces hepatic production of apoB, has been shown in phase 2 studies to decrease plasma apoB, LDL cholesterol (LDL-C), and triglycerides. ApoC-III inhibits VLDL and LDL clearance, and it stimulates inflammatory responses in vascular cells. Concentrations of VLDL or LDL with apoC-III independently predict cardiovascular disease. We performed an exploratory posthoc analysis on a subset of hypercholesterolemic subjects obtained from a randomized controlled dose-ranging phase 2 study of mipomersen receiving 100, 200, or 300 mg/wk, or placebo for 13 wk (n = 8 each). ApoC-III-containing lipoproteins were isolated by immuno-affinity chromatography and ultracentrifugation. Mipomersen 200 and 300 mg/wk reduced total apoC-III from baseline by 6 mg/dl (38-42%) compared with placebo group (P < 0.01), and it reduced apoC-III in both apoB lipoproteins and HDL. Mipomersen 100, 200, and 300 mg doses reduced apoB concentration of LDL with apoC-III (27%, 38%, and 46%; P < 0.05). Mipomersen reduced apoC-III concentration in HDL. The drug had no effect on apoE concentration in total plasma and in apoB lipoproteins. In summary, antisense inhibition of apoB synthesis reduced plasma concentrations of apoC-III and apoC-III-containing lipoproteins. Lower concentrations of apoC-III and LDL with apoC-III are associated with reduced risk of coronary heart disease (CHD) in epidemiologic studies independent of traditional risk factors.

  10. Effect of Training on Physiological and Biochemical Variables of Soccer Players of Different Age Groups

    PubMed Central

    Manna, Indranil; Khanna, Gulshan Lal; Chandra Dhara, Prakash

    2010-01-01

    Purpose To find out the effect of training on selected physiological and biochemical variables of Indian soccer players of different age groups. Methods A total of 120 soccer players volunteered for the study, were divided (n = 30) into 4 groups: (i) under 16 years (U16), (ii) under 19 years (U19), (iii) under 23 years (U23), (iv) senior (SR). The training sessions were divided into 2 phases (a) Preparatory Phase (PP, 8 weeks) and (b) Competitive Phase (CP, 4 weeks). The training program consisted of aerobic, anaerobic and skill development, and were completed 4 hrs/day; 5 days/week. Selected physiological and biochemical variables were measured at zero level (baseline data, BD) and at the end of PP and CP. Results A significant increase (P < 0.05) in lean body mass (LBM), VO2max, anaerobic power, grip and back strength, urea, uric acid and high density lipoprotein cholesterol (HDL-C); and a significant decrease (P < 0.05) in body fat, hemoglobin (Hb), total cholesterol (TC), triglyceride (TG) and low density lipoprotein cholesterol (LDL-C) were detected in some groups in PP and CP phases of the training when compare to BD. However, no significant change was found in body mass and maximal heart rate of the players after the training program. Conclusion This study would provide useful information for training and selection of soccer players of different age groups. PMID:22375187

  11. Phase II trial of CoQ10 for ALS finds insufficient evidence to justify Phase III

    PubMed Central

    Kaufmann, Petra; Thompson, John L.P.; Levy, Gilberto; Buchsbaum, Richard; Shefner, Jeremy; Krivickas, Lisa S.; Katz, Jonathan; Rollins, Yvonne; Barohn, Richard J.; Jackson, Carlayne E.; Tiryaki, Ezgi; Lomen-Hoerth, Catherine; Armon, Carmel; Tandan, Rup; Rudnicki, Stacy A.; Rezania, Kourosh; Sufit, Robert; Pestronk, Alan; Novella, Steven P.; Heiman-Patterson, Terry; Kasarskis, Edward J.; Pioro, Erik P.; Montes, Jacqueline; Arbing, Rachel; Vecchio, Darleen; Barsdorf, Alexandra; Mitsumoto, Hiroshi; Levin, Bruce

    2010-01-01

    Objective Amyotrophic lateral sclerosis (ALS) is a devastating, and currently incurable, neuromuscular disease in which oxidative stress and mitochondrial impairment are contributing to neuronal loss. Coenzyme Q10 (CoQ10), an antioxidant and mitochondrial cofactor, has shown promise in ALS transgenic mice, and in clinical trials for neurodegenerative diseases other than ALS. Our aims were to choose between two high doses of CoQ10 for ALS, and to determine if it merits testing in a Phase III clinical trial. Methods We designed and implemented a multi-center trial with an adaptive, two-stage, bias-adjusted, randomized, placebo-controlled, double-blind, Phase II design (n=185). The primary outcome in both stages was decline in the ALS Functional Rating Scale-revised (ALSFRSr) score over 9 months. Stage 1 (dose selection, 35 participants per group) compared CoQ10 doses of 1,800 and 2,700 mg/day. Stage 2 (futility test, 75 patients per group) compared the dose selected in Stage 1 against placebo. Results Stage 1 selected the 2,700 mg dose. In Stage 2, the pre-specified primary null hypothesis that this dose is superior to placebo was not rejected. It was rejected, however, in an accompanying pre-specified sensitivity test, and further supplementary analyses. Pre-specified secondary analyses showed no significant differences between CoQ10 at 2,700 mg/day and placebo. There were no safety concerns. Interpretation CoQ10 at 2,700 mg daily for 9 months shows insufficient promise to warrant Phase III testing. Given this outcome, the adaptive Phase II design incorporating a dose selection and a futility test avoided the need for a much larger conventional Phase III trial. PMID:19743457

  12. 40 CFR 147.251 - EPA-administered program-Class I, III, IV and V wells and Indian lands.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., IV and V wells and Indian lands. 147.251 Section 147.251 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS California § 147.251 EPA-administered program—Class I, III, IV and V wells and...

  13. 40 CFR 147.301 - EPA-administered program-Class I, III, IV, V wells and Indian lands.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., IV, V wells and Indian lands. 147.301 Section 147.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Colorado § 147.301 EPA-administered program—Class I, III, IV, V wells and Indian...

  14. Youth Services Training Program 1972-1976: A Title III Project.

    ERIC Educational Resources Information Center

    Luskin, Bernice; And Others

    Described is a Title III work study model to provide a 4-year vocational training program for approximately 40 handicapped junior and senior high school students in Westport, Connecticut. Program activities (such as conferences with employers) and the needed professional personnel (such as a school psychologist) are outlined for each of the…

  15. 25 CFR 36.12 - Standard III-Program needs assessment.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 1 2013-04-01 2013-04-01 false Standard III-Program needs assessment. 36.12 Section 36... Management § 36.12 Standard III—Program needs assessment. The policy and procedures of each school and its curricula shall be developed and revised based on an assessment of educational needs. This needs assessment...

  16. 25 CFR 36.12 - Standard III-Program needs assessment.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Standard III-Program needs assessment. 36.12 Section 36.12... § 36.12 Standard III—Program needs assessment. The policy and procedures of each school and its curricula shall be developed and revised based on an assessment of educational needs. This needs assessment...

  17. 25 CFR 36.12 - Standard III-Program needs assessment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Standard III-Program needs assessment. 36.12 Section 36... Management § 36.12 Standard III—Program needs assessment. The policy and procedures of each school and its curricula shall be developed and revised based on an assessment of educational needs. This needs assessment...

  18. 25 CFR 36.12 - Standard III-Program needs assessment.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 1 2014-04-01 2014-04-01 false Standard III-Program needs assessment. 36.12 Section 36... Management § 36.12 Standard III—Program needs assessment. The policy and procedures of each school and its curricula shall be developed and revised based on an assessment of educational needs. This needs assessment...

  19. 40 CFR 147.251 - EPA-administered program-Class I, III, IV and V wells and Indian lands.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., IV and V wells and Indian lands. 147.251 Section 147.251 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS California § 147.251 EPA-administered program—Class I, III, IV and V wells and...

  20. 40 CFR 147.301 - EPA-administered program-Class I, III, IV, V wells and Indian lands.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., IV, V wells and Indian lands. 147.301 Section 147.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Colorado § 147.301 EPA-administered program—Class I, III, IV, V wells and Indian...

  1. Lack of effect of perampanel on QT interval duration: Results from a thorough QT analysis and pooled partial seizure Phase III clinical trials.

    PubMed

    Yang, Haichen; Laurenza, Antonio; Williams, Betsy; Patten, Anna; Hussein, Ziad; Ferry, Jim

    2015-08-01

    Perampanel is a selective, noncompetitive AMPA receptor antagonist approved as adjunctive treatment for partial seizures. To assess potential for delayed cardiac repolarization, a Phase I thorough QT study was performed, supplemented by plasma concentration-QT data modeled from 3 pooled Phase III studies. The Phase I thorough QT study (double-blind, combined fixed-sequence, parallel-group) quantified the effect of perampanel (6 mg once daily for 7 days, followed by dose escalation to a single 8-mg dose, a single 10-mg dose, then 12 mg once daily for 7 days), moxifloxacin positive control (single 400-mg dose on Day 16), and placebo on QT interval duration in healthy subjects (N = 261). Electrocardiograms were recorded at baseline, Day 7 (post 6 mg dose), and Day 16 (post 12 mg dose). Statistical comparisons were between the highest approved perampanel dose (12 mg) versus placebo, a "mid-therapeutic" dose (6 mg) versus placebo, and moxifloxacin versus placebo. Acknowledging that the Phase I thorough QT study could not incorporate a true "supratherapeutic" dose due to length of titration and tolerability concerns in healthy subjects, Phase III studies of perampanel included expanded electrocardiogram safety evaluations specifically intended to support concentration-QT response modeling. The lack of effect of perampanel on the QT interval is shown from pooled analysis of 3 double-blind, placebo-controlled, 19-week, Phase III studies with perampanel doses ≤ 12 mg (N = 1038, total perampanel; and N=442, placebo) in patients with partial seizures. QT measures were corrected for heart rate using Fridericia's (QTcF; the primary endpoint) and Bazett's (QTcB) formulas. In the Phase I thorough QT study, the positive control moxifloxacin caused peak time-matched, baseline-adjusted, placebo-corrected (ΔΔ) QTcF of 12.15 ms at 4h postdose, confirming a drug effect on QTc interval and study assessment sensitivity. Mean baseline-adjusted (Δ) QTcF versus nominal time curves were comparable between perampanel 12 mg and placebo, with most ΔQTcF values being slightly negative. Healthy subjects receiving perampanel 6 and 12 mg doses for 7 days showed no evidence of effects on cardiac repolarization. Peak ΔΔQTcF was 2.34 ms at 1.5h postdose for perampanel 6 mg and 3.92 ms at 0.5h postdose for perampanel 12 mg. At every time point, the upper 95% confidence limit of ΔΔQTcF for perampanel 6 and 12 mg was <10 ms. Phase III studies revealed no clinically significant difference between patients with partial seizures treated with perampanel or placebo in QTcF and QTcB values >450 ms, with no dose-dependent increases or large incremental changes from baseline of >60 ms. Regression analysis of individual plasma perampanel concentrations versus corresponding QTc interval values in Phase I thorough QT and Phase III studies demonstrated no relationship between perampanel concentrations and QT interval duration. Treatment with perampanel 6 mg and 12 mg for 7 days did not delay cardiac repolarization in healthy volunteers. In a population analysis of 1480 patients with partial seizures treated with perampanel doses ≤ 12 mg or placebo, no clinically significant trends in QT interval data were noted. Based on the thorough QT study and evaluations from pooled Phase III studies, there is no evidence of prolonged QT interval duration with perampanel treatment. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  2. 40 CFR 147.2200 - State-administered program-Class I, III, IV, and V wells.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the in situ combustion of coal are regulated by the Rail Road Commission of Texas under a separate UIC... program for Class I, III, IV, and V wells in the State of Texas, except for those wells on Indian lands... (SDWA). Notice of the original approval for Class I, III, IV, and V wells was published in the Federal...

  3. 40 CFR 147.2200 - State-administered program-Class I, III, IV, and V wells.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... the in situ combustion of coal are regulated by the Rail Road Commission of Texas under a separate UIC... program for Class I, III, IV, and V wells in the State of Texas, except for those wells on Indian lands... (SDWA). Notice of the original approval for Class I, III, IV, and V wells was published in the Federal...

  4. Annual Report of the National Science Foundation on Contract NSF-C414 Task III July 1966 through June 1967.

    ERIC Educational Resources Information Center

    American Chemical Society, Columbus, OH. Chemical Abstracts Service.

    This Annual Report describes in detail the work performed during the first year of Task III of Contract NSF-C414 and the present status of Task III work. The programs and achievements described constitute the first significant efforts to develop a user-oriented, cooperative program between major secondary scientific and technical information…

  5. 40 CFR Appendix III to Part 1068 - High-Altitude Counties

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 33 2011-07-01 2011-07-01 false High-Altitude Counties III Appendix III to Part 1068 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS GENERAL COMPLIANCE PROVISIONS FOR ENGINE PROGRAMS Pt. 1068, App. III Appendix III to Part 1068...

  6. 40 CFR Appendix III to Part 1068 - High-Altitude Counties

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false High-Altitude Counties III Appendix III to Part 1068 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS GENERAL COMPLIANCE PROVISIONS FOR ENGINE PROGRAMS Pt. 1068, App. III Appendix III to Part 1068...

  7. Can high pressure I-II transitions in semiconductors be affected by plastic flow and nanocrystal precipitation in phase I?

    NASA Astrophysics Data System (ADS)

    Weinstein, B. A.; Lindberg, G. P.

    Pressure-Raman spectroscopy in ZnSe and ZnTe single crystals reveals that Se and Te nano-crystals (NCs) precipitate in these II-VI hosts for pressures far below their I-II phase transitions. The inclusions are evident from the appearance and negative pressure-shift of the A1 Raman peaks of Se and Te (trigonal phase). The Se and Te NCs nucleate at dislocations and grain boundaries that arise from pressure-induced plastic flow. This produces chemical and structural inhomogeneities in the zincblende phase of the host. At substantially higher pressures, the I-II transition proceeds in the presence of these inhomogenities. This can affect the transition's onset pressure Pt and width ΔPt, and the occurrence of metastable phases along the transition path. Precipitation models in metals show that nucleation of inclusions depends on the Peierls stress τp and a parameter α related to the net free energy gained on nucleation. For favorable values of τp and α, NC precipitation at pressures below the I-II transition could occur in other compounds. We propose criteria to judge whether this is likely based on the observed ranges of τp in the hosts, and estimates of α derived from the cohesive energy densities of the NC materials. One finds trends that can serve as a useful guide, both to test the proposed criteria, and to decide when closer scrutiny of phase transition experiments is warranted, e.g., in powders where high dislocation densities are initially created

  8. The Effects of PECS Teaching to Phase III on the Communicative Interactions between Children with Autism and Their Teachers

    ERIC Educational Resources Information Center

    Carr, Deborah; Felce, Janet

    2007-01-01

    The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h…

  9. Phase 2 Site Investigations Report. Volume 3 of 3: Appendices

    DTIC Science & Technology

    1994-09-01

    Phase II Site Investigations Ee Report Cn Volume III of III Appendices Fort Devens Sudbury Training Annex, Massachusetts September 1994 Contract No...laboratory quality control (QC) samples collected during field investigations at the Sudbury Training Annex of Fort Devens , Massachusetts. The QC...returned to its original condition. E & E performed this procedure for each monitoring well tested during the 1993 slug testing activities at Fort Devens

  10. Whole Brain Radiotherapy and RRx-001: Two Partial Responses in Radioresistant Melanoma Brain Metastases from a Phase I/II Clinical Trial: A TITE-CRM Phase I/II Clinical Trial.

    PubMed

    Kim, Michelle M; Parmar, Hemant; Cao, Yue; Pramanik, Priyanka; Schipper, Matthew; Hayman, James; Junck, Larry; Mammoser, Aaron; Heth, Jason; Carter, Corey A; Oronsky, Arnold; Knox, Susan J; Caroen, Scott; Oronsky, Bryan; Scicinski, Jan; Lawrence, Theodore S; Lao, Christopher D

    2016-04-01

    Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with RRx-001 and whole brain radiotherapy (WBRT) without neurologic or systemic toxicity in the context of a phase I/II clinical trial. RRx-001 is an reactive oxygen and reactive nitrogen species (ROS/RNS)-dependent systemically nontoxic hypoxic cell radiosensitizer with vascular normalizing properties under investigation in patients with various solid tumors including those with brain metastases. Metastatic melanoma to the brain is historically associated with poor outcomes and a median survival of 4 to 5 months. WBRT is a mainstay of treatment for patients with multiple brain metastases, but no significant therapeutic advances for these patients have been described in the literature. To date, candidate radiosensitizing agents have failed to demonstrate a survival benefit in patients with brain metastases, and in particular, no agent has demonstrated improved outcome in patients with metastatic melanoma. Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with novel radiosensitizing agent RRx-001 and WBRT without neurologic or systemic toxicity in the context of a phase I/II clinical trial. Published by Elsevier Inc.

  11. A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09.

    PubMed

    Lee, Ki Hyeong; Kim, Ji-Yeon; Lee, Moon Hee; Han, Hye Sook; Lim, Joo Han; Park, Keon Uk; Park, In Hae; Cho, Eun Kyung; Yoon, So Young; Kim, Jee Hyun; Choi, In Sil; Park, Jae Hoo; Choi, Young Jin; Kim, Hee-Jun; Jung, Kyung Hae; Kim, Si-Young; Oh, Do-Youn; Im, Seock-Ah

    2016-04-01

    Pegylated granulocyte-colony-stimulating factor (G-CSF) is frequently used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy with a high risk of myelosuppression. This phase II/III study was conducted to determine the adequate dose of pegteograstim, a new formulation of pegylated G-CSF, and to evaluate the efficacy and safety of pegteograstim compared to pegfilgrastim. In the phase II part, 60 breast cancer patients who were undergoing DA (docetaxel and doxorubicin) or TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy were randomly selected to receive a single subcutaneous injection of 3.6 or 6.0 mg pegteograstim on day 2 of each chemotherapy cycle. The phase III part was seamlessly started to compare the dose of pegteograstim at selected in phase II with 6.0 mg pegfilgrastim in 117 breast cancer patients. The primary endpoint of both the phase II and III parts was the duration of grade 4 neutropenia in the chemotherapy cycle 1. The mean duration of grade 4 neutropenia for the 3.6 mg pegteograstim (n = 33) was similar to that for the 6.0 mg pegteograstim (n = 26) (1.97 ± 1.79 days vs. 1.54 ± 0.95 days, p = 0.33). The 6.0 mg pegteograstim was selected to be compared with the 6.0 mg pegfilgrastim in the phase III part. In the phase III part, the primary analysis revealed that the efficacy of pegteograstim (n = 56) was non-inferior to that of pegfilgrastim (n = 59) [duration of grade 4 neutropenia, 1.64 ± 1.18 days vs. 1.80 ± 1.05 days; difference, -0.15 ± 1.11 (p = 0.36, 97.5 % confidence intervals = 0.57 and 0.26)]. The time to the absolute neutrophil count (ANC) recovery of pegteograstim (≥2000/μL) was significantly shorter than that of pegfilgrastim (8.85 ± 1.45 days vs. 9.83 ± 1.20 days, p < 0.0001). Other secondary endpoints showed no significant difference between the two groups. The safety profiles of the two groups did not differ significantly. Pegteograstim was shown to be as effective as pegfilgrastim in the reduction of chemotherapy-induced neutropenia in the breast cancer patients who were undergoing chemotherapy with a high risk of myelosuppression.

  12. The Utilization of the Microflora Indigenous to and Present in Oil-Bearing Formations to Selectively Plug the More Porous Zones Thereby Increasing Oil Recovery During Waterflooding

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

    Brown, Lewis R.; Byrnes, Martin J.; Stephens, James O.

    This project was designed to demonstrate that a microbially enhanced oil recovery process (MEOR), developed in part under DOE Contract No. DE-AC22-90BC14665, will increase oil recovery from fluvial dominated deltaic oil reservoirs. The process involves stimulating the in-situ indigenous microbial population in the reservoir to grow in the more permeable zones, thus diverting flow to other areas of the reservoir, thereby increasing the effectiveness of the waterflood. This five and a half year project is divided into three phases, Phase I, Planning and Analysis (9 months), Phase II, Implementation (45 months), and Phase III, Technology Transfer (12 months). Phase Imore » was completed and reported in the first annual report. This fifth annual report covers the completion of Phase II and the first six months of Phase III.« less

  13. Effectiveness of a School- and Community-based Academic Asthma Health Education Program on Use of Effective Asthma Self-care Behaviors in Older School-age Students

    PubMed Central

    Kintner, Eileen K.; Cook, Gwendolyn; Marti, C. Nathan; Allen, April; Stoddard, Debbie; Harmon, Phyllis; Gomes, Melissa; Meeder, Linda; Van Egeren, Laurie A.

    2014-01-01

    Purpose The purpose was to evaluate the effectiveness of SHARP, an academic asthma health education and counseling program, on fostering use of effective asthma self-care behaviors. Design and Methods This was a phase III, two-group, cluster randomized, single-blinded, longitudinal design guided the study. Caregivers of 205 fourth- and fifth-grade students completed the asthma health behaviors survey at pre-intervention and 1, 12, and 24 months post-intervention. Analysis involved multilevel modeling. Results All students demonstrated improvement in episode management, risk-reduction/prevention, and health promotion behaviors; SHARP students demonstrated increased improvement in episode management and risk-reduction/prevention behaviors. Practice Implications Working with schoolteachers, nurses can improve use of effective asthma self-care behaviors. PMID:25443867

  14. Methods for forming particles

    DOEpatents

    Fox, Robert V.; Zhang, Fengyan; Rodriguez, Rene G.; Pak, Joshua J.; Sun, Chivin

    2016-06-21

    Single source precursors or pre-copolymers of single source precursors are subjected to microwave radiation to form particles of a I-III-VI.sub.2 material. Such particles may be formed in a wurtzite phase and may be converted to a chalcopyrite phase by, for example, exposure to heat. The particles in the wurtzite phase may have a substantially hexagonal shape that enables stacking into ordered layers. The particles in the wurtzite phase may be mixed with particles in the chalcopyrite phase (i.e., chalcopyrite nanoparticles) that may fill voids within the ordered layers of the particles in the wurtzite phase thus produce films with good coverage. In some embodiments, the methods are used to form layers of semiconductor materials comprising a I-III-VI.sub.2 material. Devices such as, for example, thin-film solar cells may be fabricated using such methods.

  15. Effect of Group-III precursors on unintentional gallium incorporation during epitaxial growth of InAlN layers by metalorganic chemical vapor deposition

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

    Kim, Jeomoh, E-mail: jkim610@gatech.edu; Ji, Mi-Hee; Detchprohm, Theeradetch

    2015-09-28

    Unintentional incorporation of gallium (Ga) in InAlN layers grown with different molar flow rates of Group-III precursors by metalorganic chemical vapor deposition has been experimentally investigated. The Ga mole fraction in the InAl(Ga)N layer was increased significantly with the trimethylindium (TMIn) flow rate, while the trimethylaluminum flow rate controls the Al mole fraction. The evaporation of metallic Ga from the liquid phase eutectic system between the pyrolized In from injected TMIn and pre-deposited metallic Ga was responsible for the Ga auto-incorporation into the InAl(Ga)N layer. The theoretical calculation on the equilibrium vapor pressure of liquid phase Ga and the effectivemore » partial pressure of Group-III precursors based on growth parameters used in this study confirms the influence of Group-III precursors on Ga auto-incorporation. More Ga atoms can be evaporated from the liquid phase Ga on the surrounding surfaces in the growth chamber and then significant Ga auto-incorporation can occur due to the high equilibrium vapor pressure of Ga comparable to effective partial pressure of input Group-III precursors during the growth of InAl(Ga)N layer.« less

  16. Progress report 3 of cooperative program for design, fabrication, and testing of high modulus composite helicopter shafting

    NASA Technical Reports Server (NTRS)

    Wright, C. C.; Baker, D. J.

    1980-01-01

    This report describes the third phase of work, the objective of which was to overcome the excessive brittleness of the previously developed UH-1 helicopter tail rotor drive shaft design which demonstrated a shaft train weight savings of 53.1% over the current 2024-T3 aluminum shaft train. A materials impact program demonstrated exceptionally noteworthy performance of two woven constructions containing E-glass and PRD 49-III (designation later changed to KEVLAR 49) fibers in an epoxy resin matrix. Thermoplastic matrices and PRD 49-III fiber provided impact resistance at low weight which was superior to composites having the same fiber in a thermoset resin matrix. A design, fabrication, and test program showed that shaft impact resistance could be improved over the previously developed graphite composite design at a cost in shaft train rate savings. The shaft train weight savings of the most impact tolerant construction was 4.0% over the current aluminum shaft train. Alternating plies of graphite and glass appear to provide substantially greater tube impact durability than that provided by hybridization of the two fibers into one tape wound to a ply design equivalent in strength and stiffness to that of the alternating ply design. Recommendations were made to continue research work to exploit the potential for more impact-durable structures through the use of KEVLAR 49 fiber, woven structures, thermoplastic matrices and THORNEL 50-S/KEVLAR 49 blends with thermoset matrices.

  17. Optical fluoride sensor based on monomer-dimer equilibrium of scandium(III)-octaethylporphyrin in a plasticized polymeric film.

    PubMed

    Kang, Youngjea; Kampf, Jeff W; Meyerhoff, Mark E

    2007-08-29

    A fluoride-selective optical sensor based on scandium(III)-octaethylporphyrin (Sc(III)OEP) as an ionophore within a plasticized PVC film is described. The presence of fluoride ion in the aqueous sample phase increases the formation of a difluoro-bridged Sc(III)OEP dimer species in the polymer film. The ability of the Sc(III) porphyrin to form the dimeric structure in the presence of fluoride is confirmed by UV-vis spectroscopy and X-ray crystallography. For more practical sensing applications, a pH chromoionophore (ETH 7075) is added to the plasticized PVC film along with Sc(III)OEP and the observed optical response is based on coextraction of protons with sample phase fluoride to create the dimeric porphyrin and a protonated chromoionophore species. The selectivity pattern observed is F- > ClO4(-), SCN-, NO3(-) > Br-, Cl-. Only organic salicylate is a significant interferent. Fast and reversible fluoride response is observed over the range of 10(-4) to 10(-2) M fluoride, allowing use of the sensing film in a waveguide configuration for flow-injection measurements.

  18. Optical Fluoride Sensor Based on Monomer-Dimer Equilibrium of Scandium(III)-Octaethylporphyrin in a Plasticized Polymeric Film

    PubMed Central

    Kang, Youngjea; Kampf, Jeff W.; Meyerhoff, Mark E.

    2007-01-01

    A fluoride-selective optical sensor based on scandium(III) octaethylporphyrin (Sc(III)OEP) as an ionophore within a plasticized PVC film is described. The presence of fluoride ion in the aqueous sample phase increases the formation of a difluoro-bridged Sc(III)OEP dimer species in the polymer film. The ability of the Sc(III) porphyrin to form the dimeric structure in the presence of fluoride is confirmed by UV-Vis spectroscopy and X-ray crystallography. For more practical sensing applications, a pH chromoionophore (ETH 7075) is added to the plasticized PVC film along with Sc(III)OEP and the observed optical response is based on co-extraction of protons with sample phase fluoride to create the dimeric porphyrin and a protonated chromoionophore species. The selectivity pattern observed is F-≫ClO4-, SCN-, NO3->Br-, Cl-. Only organic salicylate is a significant interferent. Fast and reversible fluoride response is observed over the range of 10-4 ~10-2 M fluoride, allowing use of the sensing film in a waveguide configuration for flow-injection measurements. PMID:17719905

  19. 34 CFR 299.2 - What general administrative regulations apply to ESEA programs?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... programs under title III of the Goals 2000: Educate America Act (title III of Goals 2000), unless a State...). Note: To meet the first of the three standards, alternative State provisions must, among other things...

  20. Vaccines for leishmaniasis in the fore coming 25 years.

    PubMed

    Palatnik-de-Sousa, Clarisa B

    2008-03-25

    Human vaccination against leishmaniasis using live Leishmania was used in Middle East and Russia (1941-1980). First-generation vaccines, composed by killed parasites induce low efficacies (54%) and were tested in humans and dogs Phase III trials in Asia and South America since 1940. Second-generation vaccines using live genetically modified parasites, or bacteria or viruses containing Leishmania genes, recombinant or native fractions are known since the 1990s. Due to the loss of PAMPs, the use of adjuvants increased vaccine efficacies of the purified antigens to 82%, in Phase III dog trials. Recombinant second-generation vaccines and third-generation DNA vaccines showed average values of parasite load reduction of 68% and 59% in laboratory animal models, respectively, but their success in field trials had not yet been reported. This review is focused on vaccine candidates that show any efficacy against leishmaniasis and that are already in different phase trials. A lot of interest though was generated in recent years, by the studies going on in experimental models. The promising candidates may find a place in the forth coming years. Among them most probably are the multiple-gene DNA vaccines that are stable and do not require cold-chain transportation. In the mean time, second-generation vaccines with native antigens and effective adjuvants are likely to be licensed and used in Public Health control programs in the fore coming 25 years. To date, only three vaccines have been licensed for use: one live vaccine for humans in Uzbekistan, one killed vaccine for human immunotherapy in Brazil and a second-generation vaccine for dog prophylaxis in Brazil.

  1. A Second Year Evaluation of the ESEA Title III Urban Leadership Program.

    ERIC Educational Resources Information Center

    Frerichs, Allen H.

    The Urban Leadership Program, funded under Title III of the Elementary and Secondary Education Act, was carried out among sixth graders at the Albert Einstein School in Chicago, Illinois. The primary purpose of the program was to develop skills and competence to prepare participants for survival and success in a large urban environment. A…

  2. Oregon Small Schools Program: A Title III Project. Independent Evaluation Report, 1972.

    ERIC Educational Resources Information Center

    Miller, Donald F.

    An Elementary and Secondary Education Act (ESEA) Title III project, the 1971-72 Oregon Small Schools Program (OSSP) objectives were (1) to increase member schools receptivity to new and better ideas in education; (2) to implement new programs and apply new techniques consistent with the Oregon Board of Education priority objectives and with the…

  3. A Study of the Education Professions Development Act Training Programs for Higher Education Personnel, Volume III: The EPDA V-E Training Programs. Final Report.

    ERIC Educational Resources Information Center

    Boyle, E.; Carlson, K.

    Volume III of a study of the Education Professions Development Act (EPDA) training programs for higher education personnel presents the second of a three-faceted approach to assess current needs. This document reviews the task of profiling EPDA V-E training programs to produce a small-scale information system. Section one reviews the profiling…

  4. A rapid monitoring method for inorganic arsenic in rice flour using reversed phase-high performance liquid chromatography-inductively coupled plasma mass spectrometry.

    PubMed

    Narukawa, Tomohiro; Chiba, Koichi; Sinaviwat, Savarin; Feldmann, Jörg

    2017-01-06

    A new rapid monitoring method by means of high performance liquid chromatography-inductively coupled plasma mass spectrometry (HPLC-ICP-MS) following the heat-assisted extraction was developed for measurement of total inorganic arsenic species in rice flour. As(III) and As(V) eluted at the same retention time and completely separated from organoarsenic species by an isocratic elution program on a reversed phase column. Therefore, neither ambiguous oxidation of arsenite to arsenate nor the integration of two peaks were necessary to determine directly the target analyte inorganic arsenic. Rapid injection allowed measuring 3 replicates within 6min and this combined with a quantitative extraction of all arsenic species from rice flour by a 15min HNO 3 -H 2 O 2 extraction makes this the fastest laboratory based method for inorganic arsenic in rice flour. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. Formation, Phase, and Elemental Composition of Micro- and Nano-Dimensional Particles of the Fe-Ti System

    NASA Astrophysics Data System (ADS)

    Dresvyannikov, A. F.; Kolpakov, M. E.

    2018-05-01

    X-ray fluorescence, X-ray phase analysis, and transmission Mössbauer and NGR spectrometry are used to study the formation, phase, and elemental composition of Fe-Ti particles. The interaction between Fe(III) ions and dispersed titanium in an aqueous solution containing chloride ions and HF is studied. It is shown that the resulting Fe-Ti samples are a set of core-shell microparticles with titanium cores coated with micro- and nanosized α-Fe nucleation centers with the thinness outer layer of iron(III) oxide characterized by a developed surface.

  6. 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.

  7. The emplacement of long lava flows in Mare Imbrium, the Moon

    NASA Astrophysics Data System (ADS)

    Garry, W. B.

    2012-12-01

    Lava flow margins are scarce on the lunar surface. The best developed lava flows on the Moon occur in Mare Imbrium where flow margins are traceable nearly their entire flow length. The flow field originates in the southwest part of the basin from a fissure or series of fissures and cones located in the vicinity of Euler crater and erupted in three phases (Phases I, II, III) over a period of 0.5 Billion years (3.0 - 2.5 Ga). The flow field was originally mapped with Apollo and Lunar Orbiter data by Schaber (1973) and shows the flow field extends 200 to 1200 km from the presumed source area and covers an area of 2.0 x 10^5 km^2 with an estimated eruptive volume of 4 x 10^4 km^3. Phase I flows extend 1200 km and have the largest flow volume, but interestingly do not exhibit visible topography and are instead defined by difference in color from the surrounding mare flows. Phases II and III flows have well-defined flow margins (10 - 65 m thick) and channels (0.4 - 2.0 km wide, 40 - 70 m deep), but shorter flow lengths, 600 km and 400 km respectively. Recent missions, including Lunar Reconnaissance Orbiter (LRO), Kaguya (Selene), and Clementine, provide high resolution data sets of these lava flows. Using a combination of data sets including images from LRO Wide-Angle-Camera (WAC)(50-100 m/pixel) and Narrow-Angle-Camera (NAC) (up to 0.5m/pixel), Kaguya Terrain Camera (TC) (10 m/pixel), and topography from LRO Lunar Orbiter Laser Altimeter (LOLA), the morphology has been remapped and topographic measurements of the flow features have been made in an effort to reevaluate the emplacement of the flow field. Morphologic mapping reveals a different flow path for Phase I compared to the original mapping completed by Schaber (1973). The boundaries of the Phase I flow field have been revised based on Moon Mineralogy Mapper color ratio images (Staid et al., 2011). This has implications for the area covered and volume erupted during this stage, as well as, the age of Phase I. Flow features and margins have been identified in the Phase I flow within the LROC WAC mosaic and in Narrow Angle Camera (NAC) images. These areas have a mottled appearance. LOLA profiles over the more prominent flow lobes in Phase I reveal these margins are less 10 m thick. Phase II and III morphology maps are similar to previous flow maps. Phase III lobes near Euler are 10-12 km wide and 20-30 m thick based on measurements of the LOLA 1024ppd Elevation Digital Terrain Model (DTM) in JMoon. One of the longer Phase III lobes varies between 15 to 50 km wide and 25 to 60 m thick, with the thickest section at the distal end of the lobe. The Phase II lobe is 15 to 25 m thick and up to 35 km wide. The eruptive volume of the Mare Imbrium lava flows has been compared to terrestrial flood basalts. The morphology of the lobes in Phase II and III, which includes levees, thick flow fronts, and lobate margins suggests these could be similar to terrestrial aa-style flows. The Phase I flows might be more representative of sheet flows, pahoehoe-style flows, or inflated flows. Morphologic comparisons will be made with terrestrial flows at Askja volcano in Iceland, a potential analog to compare different styles of emplacement for the flows in Mare Imbrium.

  8. Thermodynamic considerations of the vapor phase reactions in III-nitride metal organic vapor phase epitaxy

    NASA Astrophysics Data System (ADS)

    Sekiguchi, Kazuki; Shirakawa, Hiroki; Chokawa, Kenta; Araidai, Masaaki; Kangawa, Yoshihiro; Kakimoto, Koichi; Shiraishi, Kenji

    2017-04-01

    We analyzed the metal organic vapor phase epitaxial growth mechanism of the III-nitride semiconductors GaN, AlN, and InN by first-principles calculations and thermodynamic analyses. In these analyses, we investigated the decomposition processes of the group III source gases X(CH3)3 (X = Ga, Al, In) at finite temperatures and determined whether the (CH3)2GaNH2 adduct can be formed or not. The results of our calculations show that the (CH3)2GaNH2 adduct cannot be formed in the gas phase in GaN metal organic vapor phase epitaxy (MOVPE), whereas, in AlN MOVPE, the formation of the (CH3)2AlNH2 adduct in the gas phase is exclusive. In the case of GaN MOVPE, trimethylgallium (TMG, [Ga(CH3)3]) decomposition into Ga gas on the growth surface with the assistance of H2 carrier gas, instead of the formation of the (CH3)2GaNH2 adduct, occurs almost exclusively. Moreover, in the case of InN MOVPE, the formation of the (CH3)2InNH2 adduct does not occur and it is relatively easy to produce In gas even without H2 in the carrier gas.

  9. Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

    PubMed

    Takahashi, Fumihiro; Morita, Satoshi

    2018-02-08

    Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

  10. Southern Regional Center for Lightweight Innovative Design

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

    Horstemeyer, Mark F.; Wang, Paul

    The three major objectives of this Phase III project are: To develop experimentally validated cradle-to-grave modeling and simulation tools to optimize automotive and truck components for lightweighting materials (aluminum, steel, and Mg alloys and polymer-based composites) with consideration of uncertainty to decrease weight and cost, yet increase the performance and safety in impact scenarios; To develop multiscale computational models that quantify microstructure-property relations by evaluating various length scales, from the atomic through component levels, for each step of the manufacturing process for vehicles; and To develop an integrated K-12 educational program to educate students on lightweighting designs and impact scenarios.

  11. Metalloporphyrin Co(III)TMPyP ameliorates acute, sublethal cyanide toxicity in mice.

    PubMed

    Benz, Oscar S; Yuan, Quan; Amoscato, Andrew A; Pearce, Linda L; Peterson, Jim

    2012-12-17

    The formation of Co(III)TMPyP(CN)(2) at pH 7.4 has been shown to be completely cooperative (α(H) = 2) with an association constant of 2.1 (±0.2) × 10(11). The kinetics were investigated by stopped-flow spectrophotometry and revealed a complicated net reaction exhibiting 4 phases at pH 7.4 under conditions where cyanide was in excess. The data suggest molecular HCN (rather than CN(-)) to be the attacking nucleophile around neutrality. The two slower phases do not seem to be present when cyanide is not in excess, and the other two phases have rates comparable to that observed for cobalamin, a known effective cyanide scavenger. Addition of bovine serum albumin (BSA) did not affect the cooperativity of cyanide binding to Co(III)TMPyP, only lowered the equilibrium constant slightly to 1.2 (±0.2) × 10(11) and had an insignificant effect on the observed rate. A sublethal mouse model was used to assess the effectiveness of Co(III)TMPyP as a potential cyanide antidote. The administration of Co(III)TMPyP to sodium cyanide intoxicated mice resulted in the time required for the surviving mice to right themselves from a supine position being significantly decreased (9 ± 2 min) compared to that of the controls (33 ± 2 min). All observations were consistent with the demonstrated antidotal activity of Co(III)TMPyP operating through a cyanide-binding (i.e., scavenging) mechanism.

  12. The GKSS beamlines at PETRA III and DORIS III

    NASA Astrophysics Data System (ADS)

    Haibel, A.; Beckmann, F.; Dose, T.; Herzen, J.; Utcke, S.; Lippmann, T.; Schell, N.; Schreyer, A.

    2008-08-01

    Due to the high brilliance of the new storage ring PETRA III at DESY in Hamburg, the low emittance of 1 nmrad and the high fraction of coherent photons also in the hard X-ray range extremely intense and sharply focused X-ray light will be provided. These advantages of the beam fulfill excellently the qualifications for the planned Imaging BeamLine IBL and the High Energy Materials Science Beamline (HEMS) at PETRA III, i.e. for absorption tomography, phase enhanced and phase contrast experiments, for diffraction, for nano focusing, for nano tomography, and for high speed or in-situ experiments with highest spatial resolution. The existing HARWI II beamline at the DORIS III storage ring at DESY completes the GKSS beamline concept with setups for high energy tomography (16-150 keV) and diffraction (16-250 keV), characterized by a large field of view and an excellent absorption contrast with spatial resolutions down to 2 μm.

  13. OPTIM trial: a Phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma.

    PubMed

    Kaufman, Howard L; Bines, Steven D

    2010-06-01

    There are few effective treatment options available for patients with advanced melanoma. An oncolytic herpes simplex virus type 1 encoding granulocyte macrophage colony-stimulating factor (GM-CSF; Oncovex(GM-CSF)) for direct injection into accessible melanoma lesions resulted in a 28% objective response rate in a Phase II clinical trial. Responding patients demonstrated regression of both injected and noninjected lesions highlighting the dual mechanism of action of Oncovex(GM-CSF) that includes both a direct oncolytic effect in injected tumors and a secondary immune-mediated anti-tumor effect on noninjected tumors. Based on these preliminary results a prospective, randomized Phase III clinical trial in patients with unresectable Stage IIIb or c and Stage IV melanoma has been initiated. The rationale, study design, end points and future development of the Oncovex(GM-CSF) Pivotal Trial in Melanoma (OPTIM) trial are discussed in this article.

  14. SELENIUM TREATMENT/REMOVAL ALTERNATIVES DEMONSTRATION PROJECT - MINE WASTE TECHNOLOGY PROGRAM ACTIVITY III, PROJECT 20

    EPA Science Inventory

    This document is the final report for EPA's Mine WAste Technology Program (MWTP) Activity III, Project 20--Selenium Treatment/Removal Alternatives Demonstration project. Selenium contamination originates from many sources including mining operations, mineral processing, abandoned...

  15. Re-evaluating the kinetics of ATP hydrolysis during initiation of DNA sliding by Type III restriction enzymes

    PubMed Central

    Tóth, Júlia; Bollins, Jack; Szczelkun, Mark D.

    2015-01-01

    DNA cleavage by the Type III restriction enzymes requires long-range protein communication between recognition sites facilitated by thermally-driven 1D diffusion. This ‘DNA sliding’ is initiated by hydrolysis of multiple ATPs catalysed by a helicase-like domain. Two distinct ATPase phases were observed using short oligoduplex substrates; the rapid consumption of ∼10 ATPs coupled to a protein conformation switch followed by a slower phase, the duration of which was dictated by the rate of dissociation from the recognition site. Here, we show that the second ATPase phase is both variable and only observable when DNA ends are proximal to the recognition site. On DNA with sites more distant from the ends, a single ATPase phase coupled to the conformation switch was observed and subsequent site dissociation required little or no further ATP hydrolysis. The overall DNA dissociation kinetics (encompassing site release, DNA sliding and escape via a DNA end) were not influenced by the second phase. Although the data simplifies the ATP hydrolysis scheme for Type III restriction enzymes, questions remain as to why multiple ATPs are hydrolysed to prepare for DNA sliding. PMID:26538601

  16. 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.

  17. Effect of intravenous amino acids on interdigestive antroduodenal motility and small bowel transit time.

    PubMed

    Gielkens, H A; van den Biggelaar, A; Vecht, J; Onkenhout, W; Lamers, C B; Masclee, A A

    1999-02-01

    Patients on total parenteral nutrition have an increased risk of developing gallstones because of gall bladder hypomotility. High dose amino acids may prevent biliary stasis by stimulating gall bladder emptying. To investigate whether intravenous amino acids also influence antroduodenal motility. Eight healthy volunteers received, on three separate occasions, intravenous saline (control), low dose amino acids (LDA), or high dose amino acids (HDA). Antroduodenal motility was recorded by perfusion manometry and duodenocaecal transit time (DCTT) using the lactulose breath hydrogen test. DCTT was significantly prolonged during LDA and HDA treatment compared with control. The interdigestive motor pattern was maintained and migrating motor complex (MMC) cycle length was significantly reduced during HDA compared with control and LDA due to a significant reduction in phase II duration. Significantly fewer phase IIIs originated in the gastric antrum during LDA and HDA compared with control. Duodenal phase II motility index was significantly reduced during HDA, but not during LDA, compared with control. Separate intravenous infusion of high doses of amino acids in healthy volunteers: (1) modulates interdigestive antroduodenal motility; (2) shortens MMC cycle length due to a reduced duration of phase II with a lower contractile incidence both in the antrum and duodenum (phase I remains unchanged whereas the effect on phase III is diverse: in the antrum phase III is suppressed and in the duodenum the frequency is increased); and (3) prolongs interdigestive DCTT.

  18. Refinement of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians: detection of naturally occurring osteoarthritis in laboratory cats.

    PubMed

    Klinck, Mary P; Monteiro, Beatriz P; Lussier, Bertrand; Guillot, Martin; Moreau, Maxim; Otis, Colombe; Steagall, Paulo Vm; Frank, Diane; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Del Castillo, Jérôme Re; Troncy, Eric

    2017-09-01

    Objectives Feline osteoarthritis causes pain and disability. Detection and measurement is challenging, relying heavily on owner report. This study describes refinement of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians. Methods A video analysis of osteoarthritic (n = 6) and non-osteoarthritic (n = 4) cats facilitated expansion of scale items. Three successive therapeutic trials (using gabapentin, tramadol and oral transmucosal meloxicam spray) in laboratory cats with and without natural osteoarthritis (n = 12-20), permitted construct validation (assessments of disease status sensitivity and therapeutic responsiveness) and further scale refinements based on performance. Results Scale osteoarthritic sensitivity improved from phase I to phase III; phase III scale total score ( P = 0.0001) and 4/5 subcategories - body posture ( P = 0.0006), gait ( P = 0.0031), jumping (0.0824) and global distance examination ( P = 0.0001) - detected osteoarthritic cats. Total score inter-rater (intra-class correlation coefficients [ICC] = 0.64-0.75), intra-rater (ICC = 0.90-0.91) and overall internal consistency (Cronbach's alpha = 0.85) reliability were good to excellent. von Frey anesthesiometer-induced paw withdrawal threshold increased with gabapentin in phase I, in osteoarthritic cats ( P <0.001) but not in non-osteoarthritic cats ( P = 0.075). Night-time activity increased during gabapentin treatment. Objective measures also detected tramadol and/or meloxicam treatment effects in osteoarthritic cats in phases II and III. There was some treatment responsiveness: in phase I, 3/10 subcategory scores improved ( P <0.09) in treated osteoarthritic cats; in phase II, 3/8 subcategories; and in phase III, 1/5 subcategories improved ( P <0.096). Conclusions and relevance The revised scale detected naturally occurring osteoarthritis, but not treatment effects, in laboratory cats, suggesting future potential for screening of at-risk cats. Further study is needed to confirm reliability, validity (disease sensitivity and treatment responsiveness) and clinical feasibility, as well as cut-off scores for osteoarthritic vs non-osteoarthritic status, in client-owned cats.

  19. A crossover study of the combination therapy of metformin and exenatide or biphasic insulin aspart 30 in overweight or obese patients newly diagnosed with type 2 diabetes mellitus

    PubMed Central

    Quan, Huibiao; Zhang, Huachuan; Wei, Weiping; Fang, Tuanyu; Chen, Daoxiong; Chen, Kaining

    2017-01-01

    The aim of the present study was to explore the effects of various combinations of exenatide, metformin (MET) and biphasic insulin aspart 30 (BIA30) on type 2 diabetes mellitus (T2DM). Two hundred overweight or obese patients newly diagnosed with T2DM were evenly randomized into two groups: A (twice daily for all: Phase I, 5 µg exenatide + 0.5 g MET for 4 weeks, then 10 µg exenatide + 0.5 g MET for 8 weeks; Phase II, 0.5 g MET for 12 weeks; Phase III, 0.3–0.4 U/kg/day BIA30 + 0.5 g MET for 12 weeks) and B (Phases I, II, III matched the phases III, II and I in group A). In groups A and B a significant decrease and increase, respectively, in glycated hemoglobin (HbAlc) and body mass index (BMI) was noted during Phase I. A 3.2±0.4-kg decrease in body weight in group A and a 2.6±0.3-kg increase in group B was observed. In Phase II, HbAlc was significantly increased in both groups (P<0.05). In Phase III, the BMI was increased in group A and reduced in group B (P<0.05). There was a 3.8±0.4-kg weight decrease in group B and 4.2±0.5-kg increase in group A (P<0.05). The combination of exenatide and MET promoted weight loss, glycemic control, β-cell function index, C peptide and adiponectin levels. These results suggested that the combination of exenatide and MET is better than the combination of BIA and MET for the therapy of overweight or obese patients newly diagnosed with T2DM. PMID:28912879

  20. Guideline-based intervention to reduce telemetry rates in a large tertiary centre.

    PubMed

    Ramkumar, Satish; Tsoi, Edward H; Raghunath, Ajay; Dias, Floyd F; Li Wai Suen, Christopher; Tsoi, Andrew H; Mansfield, Darren R

    2017-07-01

    Inappropriate cardiac telemetry use is associated with reduced patient flow and increased healthcare costs. To evaluate the outcomes of guideline-based application of cardiac telemetry. Phase I involved a prospective audit (March to August 2011) of telemetry use at a tertiary hospital. Data were collected on indication for telemetry and clinical outcomes. Phase II prospectively included patients more than 18 years under general medicine requiring ward-based telemetry. As phase II occurred at a time remotely from phase I, an audit similar to phase I (phase II - baseline) was completed prior to a 3-month intervention (May to August 2015). The intervention consisted of a daily telemetry ward round and an admission form based on the American Heart Association guidelines (class I, telemetry indicated; class II, telemetry maybe indicated; class III, telemetry not indicated). Patient demographics, telemetry data, and clinical outcomes were studied. Primary endpoint was the percentage reduction of class III indications, while secondary endpoint included telemetry duration. In phase I (n = 200), 38% were admitted with a class III indication resulting in no change in clinical management. A total of 74 patients was included in phase II baseline (mean ± standard deviation (SD) age 73 years ± 14.9, 57% male), whilst 65 patients were included in the intervention (mean ± SD age 71 years ± 18.4, 35% male). Both groups had similar baseline characteristics. There was a reduction in class III admissions post-intervention from 38% to 11%, P < 0.001. Intervention was associated with a reduction in median telemetry duration (1.8 ± 1.8 vs 2.4 ± 2.5 days, P = 0.047); however, length of stay was similar in both groups (P > 0.05). Guideline-based telemetry admissions and a regular telemetry ward round are associated with a reduction in inappropriate telemetry use. © 2017 Royal Australasian College of Physicians.

  1. Separation and flame atomic absorption spectrometric determination of total chromium and chromium (III) in phosphate rock used for production of fertilizer.

    PubMed

    El-Sheikh, Amjad H; Al-Degs, Yahya S; Sweileh, Jamal A; Said, Adi J

    2013-11-15

    Due to the commercial value of phosphate rock (PR) as a fertilizer precursor, it is necessary to investigate its heavy metals content. Chromium (Cr) may present as Cr(III) or Cr(VI) in PR; but quantitative differentiation between them is not an easy task. This is due to possible interconversion of Cr species during the digestion/leaching process. In this work, ultrasound digestion (USD) of PR was optimized (300 mg PR, 4.0 mL of 4.0 mol L(-1) nitric acid, 15 min sonication) for the sake of leaching Cr species prior to their determination by flame atomic absorption spectroscopy. Using multi-walled carbon nanotube (MWCNT) as adsorbent, solid phase extraction (SPE) was used to separate Cr(III) from the digestate at pH 9, while total Cr was estimated after reducing Cr(VI) into Cr(III). The optimum USD/SPE method gave LOQ and LOD of Cr(III) of 0.96 mg kg(-1) and 0.288 mg kg(-1), respectively. The method sensitivity was 1.44×10(-3) AU kg mg(-1) within the studied Cr concentration range (5-400 mg kg(-1)). The USD/SPE method was validated by analyzing lake sediments LKSD-4 certified reference material, and by comparison with classical digestion method (CD). Application of USD/SPE on Jordanian PR samples gave total Cr rang 29.1-122.0 mg kg(-1) (±1.4-6.3), while Cr(III) ranged between 23.8 and 101.7 mg kg(-1) (±1.3-5.5). AFPC Rock Check Program samples gave total Cr range 238.9-394.7 mg kg(-1) (±11.5-24.1), while Cr(III) ranged between 202.4 and 335.8 mg kg(-1) (±11.4-18.3). These results were very close to the results obtained by the CD method. Copyright © 2013 Elsevier B.V. All rights reserved.

  2. Topological transitions induced by antiferromagnetism in a thin-film topological insulator

    NASA Astrophysics Data System (ADS)

    Yin, Gen; He, Qinglin; Yu, Luyan; Pan, Lei; Wang, Kang

    Ferromagnetism introduced in topological insulators (TIs) opens a non-trivial exchange band gap, providing an exciting platform to control the topological order through an external magnetic field. The magnetization induces a topological transition that breaks time-reversal symmetry, resulting in anomalous Hall effects. Recently, it was experimentally shown that the surface of an antiferromagnetic (AFM) thin film can magnetize the surface Dirac fermions in a TI thin film similar to the case induced by ferromagnetism. Here, we show that when a TI thin film is sandwiched between two antiferromagnetic layers, an unsynchronized magnetic reversal introduces two intermediate spin configurations during the scan of the external field, resulting in a new topological phase with second Chern numbers. This topological phase introduces two counter-propagating chiral edge modes inside the exchange gap, changing the total number of transport channels drastically when the fermi level is close to the Dirac point. Induced by this change, the magnetoresistance of the channel presents an antisymmetric feature during the field scan. With the the help of the high ordering temperature of AFM layers, this transport signature of the phase transition persists up to 90K experimentally. This work is supported by (i) SHINES, an EFRC by US-DOE, Office of Science, BES, #SC0012670. (ii) US-NSF (DMR-1411085), (iii) ARO program W911NF-15-1-10561, and (iv) FAME Center in STARnet, an SRC program by MARCO and DARPA.

  3. Atezolizumab: A novel PD-L1 inhibitor in cancer therapy with a focus in bladder and non-small cell lung cancers.

    PubMed

    Krishnamurthy, A; Jimeno, A

    2017-04-01

    In recent years, immunotherapy has come to the forefront as a major development in cancer treatment. Evasion of the immune system by tumor cells has been identified as one of the hallmarks of cancer and multiple therapies have been developed to counter this process. Programmed cell death 1 ligand 1 (PD-L1), a ligand to programmed cell death protein 1 (PD-1), is expressed by many cancer cells and the binding of PD-L1 to PD-1 results in the suppression of T-cell-mediated immune response against cancer cells. Atezolizumab is a monoclonal antibody that binds to PD-L1 and blocks its interaction with PD-1, thereby enhancing T-cell activity against tumor cells. Atezolizumab has been shown to be well tolerated with no dose-limiting toxicities in phase I trials. Atezolizumab was approved by the U.S. Food and Drug Administration in 2016 for the treatment of platinum-resistant metastatic non-small cell lung cancer (NSCLC) and urothelial cancer based on phase II and preliminary phase III studies that have shown significant improvement in objective response rate and median overall survival. There are 117 ongoing clinical trials of atezolizumab currently. Given its efficacy in NSCLC and urothelial carcinoma, atezolizumab holds much potential in the future of cancer therapeutics. Copyright 2017 Clarivate Analytics.

  4. METALLURGY DIVISION QUARTERLY REPORT FOR JULY, AUGUST, AND SEPTEMBER 1957

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

    None

    1958-10-01

    Advanced Water Reactor Program. Three firings were made of initial closed-porosity fuel pellet bodies. Each firing coatained pellets of the composition 90 wt.% ThO/sub 2/-10 wt.%fl U0/sub 2/ with various additives and firing variables. Fast Power Breeder Reactor Program. To determine the potential usefulness of a Zr-5 wt. % Pu alloy, the fabricability of the alloy was tested. The manufacture of rod stock from which fuel and blanket elements for the Mark III loading of the EBR-1 were prcduced has been completed. The effect of irradiation on extruded and heat-treated U-2 wt.% Zr alloy for the EBR- 1 is reported.more » Fabrication procedures for making graphite-U/sub 3/O/sub 8/ test specimens for the TREAT Reactor were investigated. Advanced Engineering and Development. Ultrasonic bond tests were conducted on 590 EBR-1 Mark III blanket fuel elemeats. The blanket rods and part of the fuel rcds for the EBR-1 Mark III loading are being checked for cladding thickness by an eddy current system. Investigations of corrosionresistant Zr-Nb alloy were coatinued. Corrosion of MR alloys is being studied Ln support of the Mighty Mouse reactor program. Dynamic corrosion tests were performed on aluminum alloys, and results are included. Prcduction, Treatment, and Properties of Materials. The progress of the program of preparing highpurity Pu by fused salt electrolysis is summarized. Velocities of ultrasonic waves propagated in directions suitable for determining the room- temperature elastic moduli C/sub 12/, C/sub 13/, and C/sub 23/ of alpha U were determined. investigation of recrystallization in heavily coldrolled alpha- uranium sheet without a texture change was essentially concluded during this quarter. Selfdiffasion runs in polycrystalline uranium in the gamma phase, using the sputtering technique, have yielded a tentative value for the diffusion coefficient between 10/sup -8/ and 10/sup -7/ cm/sup 2/second. The preparation of high-purity U-Pan alloys is reponted. The data for the alpha-tobeta transformation temperatures in high-purity U and U-C alloys were confirmed by experiments on new specimens. Microstructure, density, and thermal arrest data were obtained for several injection cast, nominal U-5 wt.%fl fissium and U-8 wt.%fl fissium alloys. Phase diagrams are preseated for U-Mo and U-Ru alloys. Alloy Theory and The Nature of Solids. Four new isomorphs of Ti/sub 2/Ni have been discovered. Effects of Irradiation on Materials. The experimental and analytical work on the radial distribution of thermal neutrons within cylindrically shaped fuel specimens during irradiation was completed. (For preceding period see ANL-5790.) (W.L.H.)« less

  5. The local magnetic properties of [MnIII6 CrIII]3+ and [FeIII6 CrIII]3+ single-molecule magnets deposited on surfaces studied by spin-polarized photoemission and XMCD with circularly polarized synchrotron radiation

    NASA Astrophysics Data System (ADS)

    Heinzmann, U.; Helmstedt, A.; Dohmeier, N.; Müller, N.; Gryzia, A.; Brechling, A.; Hoeke, V.; Krickemeyer, E.; Glaser, T.; Fonin, M.; Bouvron, S.; Leicht, P.; Tietze, T.; Goering, E.; Kuepper, K.

    2014-04-01

    It is demonstrated that local magnetic moments of single molecule magnets (SMM) normally studied by XMCD at very low temperatures and high magnetic fields can be measured by means of spin-resolved electron emission in the paramagnetic phase at room temperature by use of circularly polarized radiation.

  6. High-pressure phase transitions, amorphization, and crystallization behaviors in Bi2Se3.

    PubMed

    Zhao, Jinggeng; Liu, Haozhe; Ehm, Lars; Dong, Dawei; Chen, Zhiqiang; Gu, Genda

    2013-03-27

    The phase transition, amorphization, and crystallization behaviors of the topological insulator bismuth selenide (Bi2Se3) were discovered by performing in situ high-pressure angle-dispersive x-ray diffraction experiments during an increasing, decreasing, and recycling pressure process. In the compression process, Bi2Se3 transforms from the original rhombohedral structure (phase I(A)) to a monoclinic structure (phase II) at about 10.4 GPa, and further to a body-centered tetragonal structure (phase III) at about 24.5 GPa. When releasing pressure to ambient conditions after the complete transformation from phase II to III, Bi2Se3 becomes an amorphous solid (AM). In the relaxation process from this amorphous state, Bi2Se3 starts crystallizing into an orthorhombic structure (phase I(B)) about five hours after releasing the pressure to ambient. A review of the pressure-induced phase transition behaviors of A2B3-type materials composed from the V and VI group elements is presented.

  7. Link to slower access to care: what is the stigma?: an Indian perspective.

    PubMed

    Kandwal, Rashmi; Bahl, Taru

    2011-12-01

    Stigma and discrimination have been "bed fellows" of HIV and AIDS in India. Perpetuated by lack of awareness, deep-rooted traditional beliefs, adherence to harmful practices, and a moralistic tag associated with a condition connected with sex (in India the method of HIV transmission being largely heterosexual in nature) and high-risk individuals such as sex workers, it made it difficult for the country to fight an epidemic that was hard to track, estimate, diagnose, and treat. Various interventions under India's National AIDS Control Program (NACP) have targeted stigma and discrimination among different groups. The program has been fairly successful in its outreach programs, bringing about a reduction in adult HIV prevalence and new infections. As the country transitions from NACP Phase III (2007-2012) to IV (2012-2017), making treatment and longevity its top priority, stigma is no longer such a terrifying word. This review discusses the social and cultural context of HIV/AIDS-related stigma in general and highlights various policies and intervention programs that have led India's campaign against HIV/AIDS-driven stigma into the testing, care, support, and treatment ambit.

  8. Systematic review of patient education practices in weight loss surgery.

    PubMed

    Groller, Karen D

    2017-06-01

    Education plays a key role in adherence to lifestyle modifications after weight loss surgery (WLS). Education given before and after surgery may decrease weight recidivism rates and improve outcomes. The purpose of this systematic review was to analyze educational practices in bariatric centers. The Cumulative Index to Nursing and Allied Health and PubMed databases were searched in May 2016 for English-language, peer-reviewed studies about WLS patient education practices from 1999 to 2016. Publications were: (1) rated with the Advancing Research and Clinical Practice through Close Collaboration levels of evidence hierarchy (see Melnyk's pryamid [http://guides.lib.umich.edu/c.php?g=282802&p=1888246]) and (2) analyzed according to surgical phase, curriculum, program delivery, and educator. Twenty-four publications met the study criteria. Evidence ratings for preoperative (n = 16) and postoperative studies (n = 8) were levels I to III (n = 5) and IV to VII (n = 17). Two publications were not ratable. Preoperative and postoperative education programs varied in curriculum, teaching methods, and educator. Topics varied in depth. Commonalities were surgical procedure, nutrition, activity, and psychosocial behaviors. Preoperative education was mostly provided in small groups, whereas individual sessions were used postoperatively. Lecture and discussion provided by myriad of healthcare experts from multiple disciplines were typical in both phases. Written or web-based aides supported learning needs in both phases. WLS patient education varied by curriculum and dose and commonly used passive learning methods (e.g., traditional lecture style instruction with minimal engagement from learners). Results shared can inform future bariatric education programs and accreditation standard development (e.g., Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program patient education standards). Additional study is needed, but existing evidence can guide improvements in high-quality, cost-effective, and patient-centered educational programs. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  9. Antisense inhibition of apoB synthesis with mipomersen reduces plasma apoC-III and apoC-III-containing lipoproteins

    PubMed Central

    Furtado, Jeremy D.; Wedel, Mark K.; Sacks, Frank M.

    2012-01-01

    Mipomersen, an antisense oligonucleotide that reduces hepatic production of apoB, has been shown in phase 2 studies to decrease plasma apoB, LDL cholesterol (LDL-C), and triglycerides. ApoC-III inhibits VLDL and LDL clearance, and it stimulates inflammatory responses in vascular cells. Concentrations of VLDL or LDL with apoC-III independently predict cardiovascular disease. We performed an exploratory posthoc analysis on a subset of hypercholesterolemic subjects obtained from a randomized controlled dose-ranging phase 2 study of mipomersen receiving 100, 200, or 300 mg/wk, or placebo for 13 wk (n = 8 each). ApoC-III–containing lipoproteins were isolated by immuno-affinity chromatography and ultracentrifugation. Mipomersen 200 and 300 mg/wk reduced total apoC-III from baseline by 6 mg/dl (38–42%) compared with placebo group (P < 0.01), and it reduced apoC-III in both apoB lipoproteins and HDL. Mipomersen 100, 200, and 300 mg doses reduced apoB concentration of LDL with apoC-III (27%, 38%, and 46%; P < 0.05). Mipomersen reduced apoC-III concentration in HDL. The drug had no effect on apoE concentration in total plasma and in apoB lipoproteins. In summary, antisense inhibition of apoB synthesis reduced plasma concentrations of apoC-III and apoC-III–containing lipoproteins. Lower concentrations of apoC-III and LDL with apoC-III are associated with reduced risk of coronary heart disease (CHD) in epidemiologic studies independent of traditional risk factors. PMID:22301884

  10. Method for Improving Mg Doping During Group-III Nitride MOCVD

    DOEpatents

    Creighton, J. Randall; Wang, George T.

    2008-11-11

    A method for improving Mg doping of Group III-N materials grown by MOCVD preventing condensation in the gas phase or on reactor surfaces of adducts of magnesocene and ammonia by suitably heating reactor surfaces between the location of mixing of the magnesocene and ammonia reactants and the Group III-nitride surface whereon growth is to occur.

  11. Impact of Availability of Companion Diagnostics on the Clinical Development of Anticancer Drugs.

    PubMed

    Tibau, Ariadna; Díez-González, Laura; Navarro, Beatriz; Galán-Moya, Eva M; Templeton, Arnoud J; Seruga, Bostjan; Pandiella, Atanasio; Amir, Eitan; Ocana, Alberto

    2017-06-01

    Companion diagnostics permit the selection of patients likely to respond to targeted anticancer drugs; however, it is unclear if the drug development process differs between drugs developed with or without companion diagnostics. Identification of differences in study design could help future clinical development. Anticancer drugs approved for use in solid tumors between 28 September 2000 and 4 January 2014 were identified using a search of the US FDA website. Phase III trials supporting registration were extracted from the drug label. Each published study was reviewed to obtain information about the phase I and II trials used for the development of the respective drug. We identified 35 drugs and 59 phase III randomized trials supporting regulatory approval. Fifty-three phase I trials and 47 phase II trials were cited in the studies and were used to support the design of these phase III trials. The approval of drugs using a companion diagnostic has increased over time (p for trend 0.01). Expansion cohorts were more frequently observed with drugs developed with a companion diagnostic (62 vs. 20%; p = 0.005). No differences between drugs developed with or without a companion diagnostic were observed for the design of phase I and II studies. The approval of drugs developed with a companion diagnostic has increased over time. The availability of a companion diagnostic was associated with more frequent use of phase I expansion cohorts comprising patients selected by the companion diagnostic.

  12. 40 CFR Appendix A to Subpart III... - States With Approved State Implementation Plan Revisions Concerning CAIR SO2 Opt-In Units

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Implementation Plan Revisions Concerning CAIR SO2 Opt-In Units A Appendix A to Subpart III of Part 97 Protection... BUDGET TRADING PROGRAM AND CAIR NOX AND SO2 TRADING PROGRAMS CAIR SO2 Opt-in Units Pt. 97, Subpt. III... Concerning CAIR SO2 Opt-In Units 1. The following States have State Implementation Plan revisions under § 51...

  13. International Space Programs. Aerospace Education III.

    ERIC Educational Resources Information Center

    Air Univ., Maxwell AFB, AL. Junior Reserve Office Training Corps.

    This curriculum guide is prepared for the Aerospace Education III series publication entitled "International Space Programs." The guide is organized according to specific chapters in the textbook. It provides guidelines for teachers in terms of objectives, behavioral objectives, suggested outlines, orientation, suggested key points,…

  14. Katimavik Participant's Manual, Book III, Work Skills = Katimavik manuel du participant, cahier III, les techniques de travail.

    ERIC Educational Resources Information Center

    Crelinsten, Michael, Ed.

    Part of the documentation for Katimavik, a nine-month volunteer community service and learning program for 17 to 21-year-old Canadians, the bilingual student manual focuses on the work skills portion of the learning program. The manual includes learning program objectives, trimester guidelines and a checklist for activity participation, optional…

  15. 78 FR 54200 - Virginia: Final Authorization of State Hazardous Waste Management Program Revisions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... take effect. We will then respond to public comments in a later final rule based on this proposal. You... Programs, U.S. EPA Region III, 1650 Arch Street, Philadelphia, PA 19103-2029. 4. Hand Delivery: At the... 3LC50, Office of State Programs, U.S. EPA Region III, 1650 Arch Street, Philadelphia, PA 19103-2029...

  16. The Biennial Report to Congress on the Implementation of the Title III State Formula Grant Program: School Years 2008-10

    ERIC Educational Resources Information Center

    Office of English Language Acquisition, US Department of Education, 2013

    2013-01-01

    This is the fourth biennial report to Congress on the implementation of the "Elementary and Secondary Education Act's" Title III State Formula Grant Program (also known as the English Language Acquisition State Grants Program). This report provides information reported by states to the U.S. Department of Education regarding services…

  17. The Biennial Report to Congress on the Implementation of the Title III State Formula Grant Program: School Years 2006-08

    ERIC Educational Resources Information Center

    Office of English Language Acquisition, US Department of Education, 2012

    2012-01-01

    This is the third biennial report to Congress on the implementation of the "Elementary and Secondary Education Act's" Title III State Formula Grant Program (also known as the English Language Acquisition State Grants Program). This report provides information regarding the U.S. Department of Education's efforts to hold states accountable…

  18. Sorption of Ferrioxime B to Synthetic and Biogenic layer type Mn Oxides

    NASA Astrophysics Data System (ADS)

    Duckworth, O. W.; Bargar, J. R.; Sposito, G.

    2005-12-01

    Siderophores are biogenic chelating agents produced in terrestrial and marine environments to increase the bioavailablity of ferric iron. Recent work has suggested that both aqueous and solid-phase Mn(III) may affect siderophore-mediated iron transport, but no information appears to be available about the effect of solid-phase Mn(IV). To probe the effect of solid-phase Mn(IV), we studied the sorption reaction of ferrioxamine B [principally the species, Fe(III)HDFOB+, an Fe(III) chelate of the trihydroxamate siderophore, desferrioxamine B (DFOB)] with two synthetic birnessites [layer type Mn(IV) oxides] and a biogenic birnessite produced by Pseudomonas putida MnB1. We found that all of these predominantly Mn(IV) oxides greatly reduced the aqueous concentration of Fe(III)HDFOB+ over the pH range between 5 and 9. After 72 h equilibration time at pH 8, the sorption behavior for the synthetic birnessites could be accurately described by a Langmuir isotherm; for the biogenic oxide, a Freundlich isotherm was best utilized to model the sorption data. To study the molecular nature of the interaction between the Fe(III)HDFOB+ complex and the oxide surface, Fe K-edge extended X-Ray absorption fine structure (EXAFS) spectroscopy was employed. Analysis of the X-ray absorption spectra indicated that Fe(III) associated with the Mn(IV) oxides is not complexed with DFOB, but instead is incorporated into the mineral structure, thus implying that the Mn(IV) oxides displaced Fe(III) from the siderophore complex. These results indicate that manganese oxides, including biominerals, may strongly sequester iron from soluble ferric complexes and thus may play a significant role in the biogeochemical cycling of iron.

  19. Public Health Nurses' Activities for Suicide Prevention in Japan.

    PubMed

    Marutani, Miki; Yamamoto-Mitani, Noriko; Kodama, Shimpei

    2016-07-01

    Suicide is a major health issue worldwide, including in Japan. Japanese public health nurses (PHNs) play a distinctive role in suicide prevention, although few studies have delineated this role. The purpose of this study was to develop a conceptual framework that elucidates PHNs' activities for suicide prevention. Semi-structured interviews were conducted in 2012-2013 with 15 PHNs who worked in Tokyo metropolitan regions. Data were analyzed qualitatively using grounded theory, and a conceptual framework with seven categories was developed. Three phases that depict the PHNs' suicide prevention activities emerged. Phase I, Pursuing to understand suicide cases, included two categories: tracing back individual suicide cases and raising consciousness among the general public. Phase II, Spreading a web of care, included three categories: knitting a caring network, weaving regular programs into the web, and continuing to be a member of the web. Phase III, Maintaining motivation and commitment, included two categories: legitimatizing suicide prevention and cultivating continued commitment in the community. The activities of suicide prevention by PHNs included a process of developing a caring network that lead to the enhancement of the caring capacity of the community as a whole. © 2016 Wiley Periodicals, Inc.

  20. The Importance of pH, Oxygen, and Bitumen on the Oxidation and Precipitation of Fe(III)-(oxy)hydroxides during Hydraulic Fracturing of Oil/Gas Shales

    NASA Astrophysics Data System (ADS)

    Jew, A. D.; Dustin, M. K.; Harrison, A. L.; Joe-Wong, C. M.; Thomas, D.; Maher, K.; Brown, G. E.; Bargar, J.

    2016-12-01

    Due to the rapid growth of hydraulic fracturing in the United States, understanding the cause for the rapid production drop off of new wells over the initial months of production is paramount. One possibility for the production decrease is pore occlusion caused by the oxidation of Fe(II)-bearing phases resulting in Fe(III) precipitates. To understand the release and fate of Fe in the shale systems, we reacted synthesized fracture fluid at 80oC with shale from four different geological localities (Marcellus Fm., Barnett Fm., Eagle Ford Fm., and Green River Fm.). A variety of wet chemical and synchrotron-based techniques (XRF mapping and x-ray absorption spectroscopy) were used to understand Fe release and solid phase Fe speciation. Solution pH was found to be the greatest factor for Fe release. Carbonate-poor Barnett and Marcellus shale showed rapid Fe release into solution followed by a plateau or significant drop in Fe concentrations indicating mineral precipitation. Conversely, in high carbonate shales, Eagle Ford and Green River, no Fe was detected in solution indicating fast Fe oxidation and precipitation. For all shale samples, bulk Fe EXAFS data show that a significant amount of Fe in the shales is bound directly to organic carbon. Throughout the course of the experiments inorganic Fe(II) phases (primarily pyrite) reacted while Fe(II) bound to C showed no indication of reaction. On the micron scale, XRF mapping coupled with μ-XANES spectroscopy showed that at pH < 4.0, Fe(III) bearing phases precipitated as diffuse surface precipitates of ferrihydrite, goethite, and magnetite away from Fe(II) point sources. In near circum-neutral pH systems, Fe(III)-bearing phases (goethite and hematite) form large particles 10's of μm's in diameter near Fe(II) point sources. Idealized systems containing synthesized fracturing fluid, dissolved ferrous chloride, and bitumen showed that bitumen released during reaction with fracturing fluids is capable of oxidizing Fe(II) to Fe(III) at pH's 2.0 and 7.0. This indicates that bitumen can play a large role in Fe oxidation and speciation in the subsurface. This work shows that shale mineralogy has a significant impact on the morphology and phases of Fe(III) precipitates in the subsurface which in turn can significantly impact subsurface solution flow.

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