Science.gov

Sample records for 2009-4437b 1-05 multi-center

  1. Elliptic genera from multi-centers

    NASA Astrophysics Data System (ADS)

    Gaddam, Nava

    2016-05-01

    I show how elliptic genera for various Calabi-Yau threefolds may be understood from supergravity localization using the quantization of the phase space of certain multi-center configurations. I present a simple procedure that allows for the enumeration of all multi-center configurations contributing to the polar sector of the elliptic genera — explicitly verifying this in the cases of the quintic in {P} 4, the sextic in {W}{P} (2,1,1,1,1), the octic in {W}{P} (4,1,1,1,1) and the dectic in {W}{P} (5,2,1,1,1). With an input of the corresponding `single-center' indices (Donaldson-Thomas invariants), the polar terms have been known to determine the elliptic genera completely. I argue that this multi-center approach to the low-lying spectrum of the elliptic genera is a stepping stone towards an understanding of the exact microscopic states that contribute to supersymmetric single center black hole entropy in {N} = 2 supergravity.

  2. Multi-Center Traffic Management Advisor Operational Field Test Results

    NASA Technical Reports Server (NTRS)

    Farley, Todd; Landry, Steven J.; Hoang, Ty; Nickelson, Monicarol; Levin, Kerry M.; Rowe, Dennis W.

    2005-01-01

    The Multi-Center Traffic Management Advisor (McTMA) is a research prototype system which seeks to bring time-based metering into the mainstream of air traffic control (ATC) operations. Time-based metering is an efficient alternative to traditional air traffic management techniques such as distance-based spacing (miles-in-trail spacing) and managed arrival reservoirs (airborne holding). While time-based metering has demonstrated significant benefit in terms of arrival throughput and arrival delay, its use to date has been limited to arrival operations at just nine airports nationally. Wide-scale adoption of time-based metering has been hampered, in part, by the limited scalability of metering automation. In order to realize the full spectrum of efficiency benefits possible with time-based metering, a much more modular, scalable time-based metering capability is required. With its distributed metering architecture, multi-center TMA offers such a capability.

  3. Forming a Research Question from a Multi-Center Database

    PubMed Central

    Likosky, Donald S.

    2009-01-01

    Abstract: It is not uncommon for individuals to ask biostatisiticians and epidemiologists to assist them with a research project. Often the request is in the shape of statistical analyses. However, most of these requests are nothing more than missed opportunities. This manuscript focuses on the reasons underlying such a statement. Most individuals might say that the most important aspect of a study is its conclusion. Many who would disagree with this sentiment and would feel that the most important aspect of a study rather is the question it intends to address. If this question is not articulated sufficiently, any additional information stemming from the study will most likely be irrelevant. Herein, some principles for formulating (successfully) a question from a multi-center database will be described. PMID:19361039

  4. 33 CFR 1.05-50 - Final rule.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Final rule. 1.05-50 Section 1.05... PROVISIONS Rulemaking § 1.05-50 Final rule. In some instances, a final rule may be issued without prior... have been considered, a final rule is issued. A final rule document contains a preamble that...

  5. 33 CFR 1.05-50 - Final rule.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Final rule. 1.05-50 Section 1.05... PROVISIONS Rulemaking § 1.05-50 Final rule. In some instances, a final rule may be issued without prior... have been considered, a final rule is issued. A final rule document contains a preamble that...

  6. 33 CFR 1.05-50 - Final rule.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Final rule. 1.05-50 Section 1.05... PROVISIONS Rulemaking § 1.05-50 Final rule. In some instances, a final rule may be issued without prior... have been considered, a final rule is issued. A final rule document contains a preamble that...

  7. 33 CFR 1.05-50 - Final rule.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Final rule. 1.05-50 Section 1.05... PROVISIONS Rulemaking § 1.05-50 Final rule. In some instances, a final rule may be issued without prior... have been considered, a final rule is issued. A final rule document contains a preamble that...

  8. 33 CFR 1.05-50 - Final rule.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Final rule. 1.05-50 Section 1.05... PROVISIONS Rulemaking § 1.05-50 Final rule. In some instances, a final rule may be issued without prior... have been considered, a final rule is issued. A final rule document contains a preamble that...

  9. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Public participation. 1.05-15 Section 1.05-15 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-15 Public participation. The Coast Guard considers public participation essential to effective rulemaking,...

  10. The Multi-Center Airborne Coherent Atmospheric Wind Sensor, MACAWS

    NASA Technical Reports Server (NTRS)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Menzies, Robert T.; Howell, James; Johnson, Steven C.; Tratt, David M.; Olivier, Lisa D.; Banta, Robert M.

    1997-01-01

    In 1992 the atmospheric lidar remote sensing groups of the NASA Marshall Space Flight Center, NOAA Environmental Technology Laboratory, and Jet Propulsion Laboratory began a joint collaboration to develop an airborne high-energy Doppler laser radar (lidar) system for atmospheric research and satellite validation and simulation studies. The result is the Multi-center Airborne Coherent Atmospheric Wind Sensor, MACAWS, which has the capability to remotely sense the distribution of wind and absolute aerosol backscatter in the troposphere and lower stratosphere. A factor critical to the programmatic feasibility and technical success of this collaboration has been the utilization of existing components and expertise which were developed for previous atmospheric research by the respective institutions. The motivation for the MACAWS program Is three-fold: to obtain fundamental measurements of sub-synoptic scale processes and features which may be used as a basis to improve sub-grid scale parameterizations in large-scale models; to obtain similar datasets in order to improve the understanding and predictive capabilities on the mesoscale; and to validate (simulate) the performance of existing (planned) satellite-borne sensors. Examples of the latter include participation in the validation of the NASA Scatterometer and the assessment of prospective satellite Doppler lidar for global tropospheric wind measurement. Initial flight tests were made in September 1995; subsequent flights were made in June 1996 following improvements. This paper describes the MACAWS instrument, principles of operation, examples of measurements over the eastern Pacific Ocean and western United States, and future applications.

  11. Computer Assisted Multi-Center Creation of Medical Knowledge Bases

    PubMed Central

    Giuse, Nunzia Bettinsoli; Giuse, Dario A.; Miller, Randolph A.

    1988-01-01

    Computer programs which support different aspects of medical care have been developed in recent years. Their capabilities range from diagnosis to medical imaging, and include hospital management systems and therapy prescription. In spite of their diversity these systems have one commonality: their reliance on a large body of medical knowledge in computer-readable form. This knowledge enables such programs to draw inferences, validate hypotheses, and in general to perform their intended task. As has been clear to developers of such systems, however, the creation and maintenance of medical knowledge bases are very expensive. Practical and economical difficulties encountered during this long-term process have discouraged most attempts. This paper discusses knowledge base creation and maintenance, with special emphasis on medical applications. We first describe the methods currently used and their limitations. We then present our recent work on developing tools and methodologies which will assist in the process of creating a medical knowledge base. We focus, in particular, on the possibility of multi-center creation of the knowledge base.

  12. The Multi-center Airborne Coherent Atmospheric Wind Sensor.

    NASA Astrophysics Data System (ADS)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Menzies, Robert T.; Howell, James N.; Johnson, Steven C.; Tratt, David M.; Olivier, Lisa D.; Banta, Robert M.

    1998-04-01

    In 1992 the atmospheric lidar remote sensing groups of the National Aeronautics and Space Administration Marshall Space Flight Center, the National Oceanic and Atmospheric Administration/Environmental Technology Laboratory (NOAA/ETL), and the Jet Propulsion Laboratory began a joint collaboration to develop an airborne high-energy Doppler laser radar (lidar) system for atmospheric research and satellite validation and simulation studies. The result is the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS), which has the capability to remotely sense the distribution of wind and absolute aerosol backscatter in three-dimensional volumes in the troposphere and lower stratosphere.A factor critical to the programmatic feasibility and technical success of this collaboration has been the utilization of existing components and expertise that were developed for previous atmospheric research by the respective institutions. For example, the laser transmitter is that of the mobile ground-based Doppler lidar system developed and used in atmospheric research for more than a decade at NOAA/ETL.The motivation for MACAWS is threefold: 1) to obtain fundamental measurements of subsynoptic-scale processes and features to improve subgrid-scale parameterizations in large-scale models, 2) to obtain datasets in order to improve the understanding of and predictive capabilities for meteorological systems on subsynoptic scales, and 3) to validate (simulate) the performance of existing (planned) satellite-borne sensors.Initial flight tests were made in September 1995; subsequent flights were made in June 1996 following system improvements. This paper describes the MACAWS instrument, principles of operation, examples of measurements over the eastern Pacific Ocean and western United States, and future applications.

  13. Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS)

    NASA Astrophysics Data System (ADS)

    Rhothermel, Jeffry; Jones, W. D.; Dunkin, J. A.; McCaul, E. W., Jr.

    1993-01-01

    This effort involves development of a calibrated, pulsed coherent CO2 Doppler lidar, followed by a carefully-planned and -executed program of multi-dimensional wind velocity and aerosol backscatter measurements from the NASA DC-8 research aircraft. The lidar, designated as the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS), will be applicable to two research areas. First, MACAWS will enable specialized measurements of atmospheric dynamical processes in the planetary boundary layer and free troposphere in geographic locations and over scales of motion not routinely or easily accessible to conventional sensors. The proposed observations will contribute fundamentally to a greater understanding of the role of the mesoscale, helping to improve predictive capabilities for mesoscale phenomena and to provide insights into improving model parameterizations of sub-grid scale processes within large-scale circulation models. As such, it has the potential to contribute uniquely to major, multi-institutional field programs planned for the mid 1990's. Second, MACAWS measurements can be used to reduce the degree of uncertainty in performance assessments and algorithm development for NASA's prospective Laser Atmospheric Wind Sounder (LAWS), which has no space-based instrument heritage. Ground-based lidar measurements alone are insufficient to address all of the key issues. To minimize costs, MACAWS is being developed cooperatively by the lidar remote sensing groups of the Jet Propulsion Laboratory, NOAA Wave Propagation Laboratory, and MSFC using existing lidar hardware and manpower resources. Several lidar components have already been exercised in previous airborne lidar programs (for example, MSFC Airborne Doppler Lidar System (ADLS) used in 1981,4 Severe Storms Wind Measurement Program; JPL Airborne Backscatter Lidar Experiment (ABLE) used in 1989,90 Global Backscatter Experiment Survey Missions). MSFC has been given responsibility for directing the overall

  14. Managing Multi-center Flow Cytometry Data for Immune Monitoring.

    PubMed

    White, Scott; Laske, Karoline; Welters, Marij Jp; Bidmon, Nicole; van der Burg, Sjoerd H; Britten, Cedrik M; Enzor, Jennifer; Staats, Janet; Weinhold, Kent J; Gouttefangeas, Cécile; Chan, Cliburn

    2014-01-01

    With the recent results of promising cancer vaccines and immunotherapy1-5, immune monitoring has become increasingly relevant for measuring treatment-induced effects on T cells, and an essential tool for shedding light on the mechanisms responsible for a successful treatment. Flow cytometry is the canonical multi-parameter assay for the fine characterization of single cells in solution, and is ubiquitously used in pre-clinical tumor immunology and in cancer immunotherapy trials. Current state-of-the-art polychromatic flow cytometry involves multi-step, multi-reagent assays followed by sample acquisition on sophisticated instruments capable of capturing up to 20 parameters per cell at a rate of tens of thousands of cells per second. Given the complexity of flow cytometry assays, reproducibility is a major concern, especially for multi-center studies. A promising approach for improving reproducibility is the use of automated analysis borrowing from statistics, machine learning and information visualization21-23, as these methods directly address the subjectivity, operator-dependence, labor-intensive and low fidelity of manual analysis. However, it is quite time-consuming to investigate and test new automated analysis techniques on large data sets without some centralized information management system. For large-scale automated analysis to be practical, the presence of consistent and high-quality data linked to the raw FCS files is indispensable. In particular, the use of machine-readable standard vocabularies to characterize channel metadata is essential when constructing analytic pipelines to avoid errors in processing, analysis and interpretation of results. For automation, this high-quality metadata needs to be programmatically accessible, implying the need for a consistent Application Programming Interface (API). In this manuscript, we propose that upfront time spent normalizing flow cytometry data to conform to carefully designed data models enables automated

  15. Managing Multi-center Flow Cytometry Data for Immune Monitoring

    PubMed Central

    White, Scott; Laske, Karoline; Welters, Marij JP; Bidmon, Nicole; van der Burg, Sjoerd H; Britten, Cedrik M; Enzor, Jennifer; Staats, Janet; Weinhold, Kent J; Gouttefangeas, Cécile; Chan, Cliburn

    2014-01-01

    With the recent results of promising cancer vaccines and immunotherapy1–5, immune monitoring has become increasingly relevant for measuring treatment-induced effects on T cells, and an essential tool for shedding light on the mechanisms responsible for a successful treatment. Flow cytometry is the canonical multi-parameter assay for the fine characterization of single cells in solution, and is ubiquitously used in pre-clinical tumor immunology and in cancer immunotherapy trials. Current state-of-the-art polychromatic flow cytometry involves multi-step, multi-reagent assays followed by sample acquisition on sophisticated instruments capable of capturing up to 20 parameters per cell at a rate of tens of thousands of cells per second. Given the complexity of flow cytometry assays, reproducibility is a major concern, especially for multi-center studies. A promising approach for improving reproducibility is the use of automated analysis borrowing from statistics, machine learning and information visualization21–23, as these methods directly address the subjectivity, operator-dependence, labor-intensive and low fidelity of manual analysis. However, it is quite time-consuming to investigate and test new automated analysis techniques on large data sets without some centralized information management system. For large-scale automated analysis to be practical, the presence of consistent and high-quality data linked to the raw FCS files is indispensable. In particular, the use of machine-readable standard vocabularies to characterize channel metadata is essential when constructing analytic pipelines to avoid errors in processing, analysis and interpretation of results. For automation, this high-quality metadata needs to be programmatically accessible, implying the need for a consistent Application Programming Interface (API). In this manuscript, we propose that upfront time spent normalizing flow cytometry data to conform to carefully designed data models enables

  16. 33 CFR 1.05-45 - Interim rule.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Interim rule. 1.05-45 Section 1... PROVISIONS Rulemaking § 1.05-45 Interim rule. (a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement....

  17. 33 CFR 1.05-45 - Interim rule.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Interim rule. 1.05-45 Section 1... PROVISIONS Rulemaking § 1.05-45 Interim rule. (a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement....

  18. 33 CFR 1.05-45 - Interim rule.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Interim rule. 1.05-45 Section 1... PROVISIONS Rulemaking § 1.05-45 Interim rule. (a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement....

  19. 33 CFR 1.05-45 - Interim rule.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Interim rule. 1.05-45 Section 1... PROVISIONS Rulemaking § 1.05-45 Interim rule. (a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement....

  20. 33 CFR 1.05-45 - Interim rule.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Interim rule. 1.05-45 Section 1... PROVISIONS Rulemaking § 1.05-45 Interim rule. (a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement....

  1. 33 CFR 1.05-10 - Regulatory process overview.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Regulatory process overview. 1.05... GENERAL GENERAL PROVISIONS Rulemaking § 1.05-10 Regulatory process overview. (a) Most rules of local... than those areas delegated to District Commanders and Captains of the Port, the regulatory...

  2. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Public docket. 1.05-25 Section 1... PROVISIONS Rulemaking § 1.05-25 Public docket. (a) A public docket is maintained electronically for each... Register. Each docket contains copies of every rulemaking document published for the project,...

  3. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Public participation. 1.05-15... GENERAL PROVISIONS Rulemaking § 1.05-15 Public participation. The Coast Guard considers public participation essential to effective rulemaking, and encourages the public to participate in its...

  4. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Public participation. 1.05-15... GENERAL PROVISIONS Rulemaking § 1.05-15 Public participation. The Coast Guard considers public participation essential to effective rulemaking, and encourages the public to participate in its...

  5. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Public docket. 1.05-25 Section 1... PROVISIONS Rulemaking § 1.05-25 Public docket. (a) A public docket is maintained electronically for each... Register. Each docket contains copies of every rulemaking document published for the project,...

  6. Multi-Center Electronic Structure Calculations for Plasma Equation of State

    SciTech Connect

    Wilson, B G; Johnson, D D; Alam, A

    2010-12-14

    We report on an approach for computing electronic structure utilizing solid-state multi-center scattering techniques, but generalized to finite temperatures to model plasmas. This approach has the advantage of handling mixtures at a fundamental level without the imposition of ad hoc continuum lowering models, and incorporates bonding and charge exchange, as well as multi-center effects in the calculation of the continuum density of states.

  7. Alcohol Consumption and Mortality in the Korean Multi-center Cancer Cohort Study

    PubMed Central

    Jung, En-Joo; Shin, Aesun; Park, Sue K.; Ma, Seung-Hyun; Cho, In-Seong; Park, Boyoung; Lee, Eun-Ha; Chang, Soung-Hoon; Shin, Hai-Rim; Kang, Daehee

    2012-01-01

    Objectives To examine the association between alcohol consumption habit, types of beverages, alcohol consumption quantity, and overall and cancer-specific mortality among Korean adults. Methods The alcohol consumption information of a total of 16 320 participants who were 20 years or older from the Korean Multi-center Cancer Cohort were analyzed to examine the association between alcohol consumption habit and mortality (median follow-up of 9.3 years). The Cox proportional hazard model was used to estimate the hazard ratio (HR) of alcohol consumption to mortality adjusting for age, sex, geographic areas, education, smoking status, and body mass index. Results Alcohol drinkers showed an increased risk for total mortality compared with never drinkers (HR, 1.72; 95% confidence interval [CI], 1.38 to 2.14 for past drinkers; HR, 1.21; 95% CI, 1.06 to 1.39 for current drinkers), while past drinkers only were associated with higher risk for cancer deaths (HR, 1.84; 95% CI, 1.34 to 2.53). The quantity of alcohol consumed per week showed a J-shaped association with risk of mortality. Relative to light drinkers (0.01 to 90 g/wk), never drinkers and heavy drinkers (>504 g/wk) had an increased risk for all-cause and cancer deaths: (HR, 1.18; 95% CI, 0.96 to 1.45) and (HR, 1.39; 95% CI, 1.05 to 1.83) for all-cause mortality; and (HR, 1.55; 95% CI, 1.15 to 2.11) and (HR, 2.07; 95% CI, 1.39 to 3.09) for all cancer mortality, respectively. Heavy drinkers (>504 g/wk) showed an elevated risk for death from stomach and liver cancers. Conclusions The present study supports the existence of a J-shaped association between alcohol consumption quantity and the risk of all-cause and cancer deaths. Heavy drinkers had an increased risk of death from cancer overall and liver and stomach cancer. PMID:23091655

  8. Solution of multi-center molecular integrals of Slater-type orbitals

    NASA Technical Reports Server (NTRS)

    Tai, H.

    1989-01-01

    The troublesome multi-center molecular integrals of Slater-type orbitals (STO) in molecular physics calculations can be evaluated by using the Fourier transform and proper coupling of the two center exchange integrals. A numerical integration procedure is then readily rendered to the final expression in which the integrand consists of well known special functions of arguments containing the geometrical arrangement of the nuclear centers and the exponents of the atomic orbitals. A practical procedure was devised for the calculation of a general multi-center molecular integrals coupling arbitrary Slater-type orbitals. Symmetry relations and asymptotic conditions are discussed. Explicit expressions of three-center one-electron nuclear-attraction integrals and four-center two-electron repulsion integrals for STO of principal quantum number n=2 are listed. A few numerical results are given for the purpose of comparison.

  9. LORIS: a web-based data management system for multi-center studies

    PubMed Central

    Das, Samir; Zijdenbos, Alex P.; Harlap, Jonathan; Vins, Dario; Evans, Alan C.

    2012-01-01

    Longitudinal Online Research and Imaging System (LORIS) is a modular and extensible web-based data management system that integrates all aspects of a multi-center study: from heterogeneous data acquisition (imaging, clinical, behavior, and genetics) to storage, processing, and ultimately dissemination. It provides a secure, user-friendly, and streamlined platform to automate the flow of clinical trials and complex multi-center studies. A subject-centric internal organization allows researchers to capture and subsequently extract all information, longitudinal or cross-sectional, from any subset of the study cohort. Extensive error-checking and quality control procedures, security, data management, data querying, and administrative functions provide LORIS with a triple capability (1) continuous project coordination and monitoring of data acquisition (2) data storage/cleaning/querying, (3) interface with arbitrary external data processing “pipelines.” LORIS is a complete solution that has been thoroughly tested through a full 10 year life cycle of a multi-center longitudinal project1 and is now supporting numerous international neurodevelopment and neurodegeneration research projects. PMID:22319489

  10. Expanding the Use of Time-Based Metering: Multi-Center Traffic Management Advisor

    NASA Technical Reports Server (NTRS)

    Landry, Steven J.; Farley, Todd; Hoang, Ty

    2005-01-01

    Time-based metering is an efficient air traffic management alternative to the more common practice of distance-based metering (or "miles-in-trail spacing"). Despite having demonstrated significant operational benefit to airspace users and service providers, time-based metering is used in the United States for arrivals to just nine airports and is not used at all for non-arrival traffic flows. The Multi-Center Traffic Management Advisor promises to bring time-based metering into the mainstream of air traffic management techniques. Not constrained to operate solely on arrival traffic, Multi-Center Traffic Management Advisor is flexible enough to work in highly congested or heavily partitioned airspace for any and all traffic flows in a region. This broader and more general application of time-based metering is expected to bring the operational benefits of time-based metering to a much wider pool of beneficiaries than is possible with existing technology. It also promises to facilitate more collaborative traffic management on a regional basis. This paper focuses on the operational concept of the Multi-Center Traffic Management Advisor, touching also on its system architecture, field test results, and prospects for near-term deployment to the United States National Airspace System.

  11. Design and methods in a multi-center case-control interview study.

    PubMed Central

    Hartge, P; Cahill, J I; West, D; Hauck, M; Austin, D; Silverman, D; Hoover, R

    1984-01-01

    We conducted a case-control study in ten areas of the United States in which a total of 2,982 bladder cancer patients and 5,782 population controls were interviewed. We employed a variety of existing and new techniques to reduce bias and to monitor the quality of data collected. We review here many of the design elements and field methods that can be generally applied in epidemiologic studies, particularly multi-center interview studies, and explain the reasons for our selection of the methods, instruments, and procedures used. PMID:6689843

  12. Construction of brain atlases based on a multi-center MRI dataset of 2020 Chinese adults.

    PubMed

    Liang, Peipeng; Shi, Lin; Chen, Nan; Luo, Yishan; Wang, Xing; Liu, Kai; Mok, Vincent C T; Chu, Winnie C W; Wang, Defeng; Li, Kuncheng

    2015-01-01

    Despite the known morphological differences (e.g., brain shape and size) in the brains of populations of different origins (e.g., age and race), the Chinese brain atlas is less studied. In the current study, we developed a statistical brain atlas based on a multi-center high quality magnetic resonance imaging (MRI) dataset of 2020 Chinese adults (18-76 years old). We constructed 12 Chinese brain atlas from the age 20 year to the age 75 at a 5 years interval. New Chinese brain standard space, coordinates, and brain area labels were further defined. The new Chinese brain atlas was validated in brain registration and segmentation. It was found that, as contrast to the MNI152 template, the proposed Chinese atlas showed higher accuracy in hippocampus segmentation and relatively smaller shape deformations during registration. These results indicate that a population-specific time varying brain atlas may be more appropriate for studies involving Chinese populations. PMID:26678304

  13. Insight into photofragment vector correlation by a multi-center impulsive model.

    PubMed

    Tsai, Po-Yu; Lin, King-Chuen

    2015-07-15

    A multi-center impulsive model has been recently developed to characterize the dynamic feature of product energy distribution in photodissociation of formaldehyde, H2CO → CO + H2. (J. Phys. Chem. A, 2015, 119, 29) The model is extended to predict the vector correlations among transition dipole moment μ of the parent molecule, recoil velocity v and rotational angular momentum j of the fragments produced via the transition state (TS) and roaming path. The correlation results of μ-j, j-j and μ-v vectors of the fragments are consistent with those reported using quasi-classical trajectory simulation on the global potential energy surface. In contrast to the TS route, the vector properties via the roaming path are loosely correlated. This work offers an alternative method to study stereodynamics of the photodissociation process, and is conducive to clarifying the origin of photofragment vector correlation especially for the roaming pathway. PMID:26150201

  14. Web-based multi-center data management system for clinical neuroscience research.

    PubMed

    Pozamantir, Alexander; Lee, Hedok; Chapman, Joab; Prohovnik, Isak

    2010-02-01

    Modern clinical research often involves multicenter studies, large and heterogeneous data flux, and intensive demands of collaboration, security and quality assurance. In the absence of commercial or academic management systems, we designed an open-source system to meet these requirements. Based on the Apache-PHP-MySQL platform on a Linux server, the system allows multiple users to access the database from any location on the internet using a web browser, and requires no specialized computer skills. Multi-level security system is implemented to safeguard the protected health information and allow partial or full access to the data by individual or class privilege. The system stores and manipulates various types of data including images, scanned documents, laboratory data and clinical ratings. Built-in functionality allows for various search, quality control, analytic data operations, visit scheduling and visit reminders. This approach offers a solution to a growing need for management of large multi-center clinical studies. PMID:20192052

  15. Authorship in a Multi-Center Clinical Trial: the HF-ACTION Experience

    PubMed Central

    Whellan, DJ; Kraus, WE; Kitzman, DW; Rooney, B; Keteyian, SJ; Piña, IL; Ellis, SJ; Ghali, JK; Lee, K; Cooper, L; O'Connor, CM

    2015-01-01

    Background Few guidelines exist regarding authorship on manuscripts resulting from large multicenter trials. The HF-ACTION investigators devised a system to address assignment of authorship on trial publications and tested the outcomes in the course of conducting the large, multi-center, NHLBI-funded trial (n=2,331; 82 clinical sites; 3 countries). The HF-ACTION Authorship and Publication (HAP) Scoring System was designed to enhance rate of dissemination, recognize investigator contributions to the successful conduct of the trial, and harness individual expertise in manuscript generation. Methods The HAP score was generated by assigning points based on investigators’ participation in trial enrollment, follow-up, and adherence, as well as participation in committees and other trial activity. Overall publication rates, publication rates by author, publication rates by site, and correlation between site publication and HAP score using a Poisson regression model were examined. Results Fifty peer-reviewed, original manuscripts were published within 6.5 years following conclusion of study enrollment. In total, 137 different authors were named in at least 1 publication. Forty-five of the 82 sites (55%) had an author named to at least one manuscript. A Poisson regression model examining incident rate ratios revealed that a higher HAP score resulted in a higher incidence of a manuscript, with a 100-point increase in site score corresponding to an approximately 32% increase in the incidence of a published manuscript. Conclusions Given the success in publishing a large number of papers and widely distributing authorship, regular use of a transparent, objective authorship assignment system for publishing results from multi-center trials may be recommended to optimize fairness and dissemination of trial results. PMID:25819851

  16. A Prospective Multi-Center Audit of Nutrition Support Parameters Following Burn Injury.

    PubMed

    Kurmis, Rochelle; Heath, Kathryn; Ooi, Selena; Munn, Zachary; Forbes, Sharon; Young, Vicki; Rigby, Paul; Wood, Kate; Phillips, Frances; Greenwood, John

    2015-01-01

    The importance of nutrition support delivery to the severe burn-injured patient is well recognized, however, nutrition provision to the patient may be sub optimal in practice. The aim of this study was to conduct a prospective multi-center audit across Australia and New Zealand using the Joanna Briggs Institute Burns Node Nutrition audit criteria. Thirty-four patients with severe burn injury (≥20% TBSA in adults and ≥10% TBSA in children) were identified on admission or on referral to the Dietitian at the eight participating Burn Units between February 1, 2012 and April 30, 2012 for inclusion in the study. De-identified patient data was analyzed using the Joanna Briggs Institute, Practical Application of Clinical Evidence System. Compliance with individual audit criterion ranged from 33 to 100%. Provision of prescribed enteral feed volumes and weekly weighing of patients were highlighted as key areas for clinical improvement. Clinical audit is a valuable tool for evaluating current practice against best evidence to ensure that quality patient care is delivered. The use of the Joanna Briggs Institute Burns Node audit criteria has allowed for a standardized multi-center audit to be conducted. Improving nutrition support delivery in burn patients was identified as a key area requiring ongoing clinical improvement across Australia and New Zealand. Clinician feedback on use of the audit criteria will allow for future refinement of individual criterion, and presentation of results of this audit has resulted in a review of the Bi-National Burns Registry nutrition quality indicators. PMID:25094004

  17. Factors Influencing Medical Student Attrition and Their Implications in a Large Multi-Center Randomized Education Trial

    ERIC Educational Resources Information Center

    Kalet, A.; Ellaway, R. H.; Song, H. S.; Nick, M.; Sarpel, U.; Hopkins, M. A.; Hill, J.; Plass, J. L.; Pusic, M. V.

    2013-01-01

    Participant attrition may be a significant threat to the generalizability of the results of educational research studies if participants who do not persist in a study differ from those who do in ways that can affect the experimental outcomes. A multi-center trial of the efficacy of different computer-based instructional strategies gave us the…

  18. 77 FR 12598 - Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ...-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) The Federal Register notice published on February 24, 2012 (77 FR 11136) announcing the submission to OMB of the project titled, ``A multi-center international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (NCI)'' was submitted with...

  19. Multi-Center Analysis of Novel and Established Variables Associated with Successful Human Islet Isolation Outcomes

    PubMed Central

    Kaddis, J.S; Danobeitia, J.S.; Niland, J.C.; Stiller, T.; Fernandez, L.A.

    2010-01-01

    Islet transplantation is a promising therapy used to achieve glycometabolic control in a select subgroup of individuals with type I diabetes. However, features that characterize human islet isolation success prior to transplantation are not standardized and lack validation. We conducted a retrospective analysis of 806 isolation records from 14 pancreas processing laboratories, considering variables from relevant studies in the last 15 years. The outcome was defined as post-purification islet equivalent count, dichotomized into yields ≥ 315,000 or ≤ 220,000. Univariate analysis showed that donor cause of death and use of hormonal medications negatively influenced outcome. Conversely, pancreata from heavier donors and those containing elevated levels of surface fat positively influence outcome, as did heavier pancreata and donors with normal amylase levels. Multivariable logistic regression analysis identified the positive impact on outcome of surgically intact pancreata and donors with normal liver function, and confirmed that younger donors, increased body mass index, shorter cold ischemia times, no administration of fluid/electrolyte medications, absence of organ edema, use of University of Wisconsin preservation solution, and a fatty pancreas improves outcome. In conclusion, this multi-center analysis highlights the importance of carefully reviewing of all donor, pancreas, and processing parameters prior to isolation and transplantation. PMID:20055802

  20. Calculations of fast ion collisions with multi-center molecular targets

    NASA Astrophysics Data System (ADS)

    Kirchner, Tom

    2011-05-01

    The theoretical treatment of ion-molecule collisions is challenging for several reasons: the systems have many degrees of freedom, a rather complex geometry, and the electron dynamics might be nonperturbative and involve electron-electron interaction effects. However, the interest in accurate calculations has been growing recently. An important reason for this development is the relevance of ion-molecule collisions for a number of fields, such as atmospheric science, and the understanding of radiation damage of biological tissue. We have developed a new approach to meet these challenges. It disregards rovibrational motion, but it does address the multi-center geometry of the system and the generally nonperturbative nature of the electron dynamics. The key ingredients are an expansion of the initially populated molecular orbitals in terms of a single-center basis and a spectral representation of the molecular Hamiltonian. This facilitates a separation of molecular geometry and collision dynamics and makes it possible to use well-established ion-atom methods with relatively minor modifications. We have extended our basis generator method to deal with the collision dynamics and report on results for ionization and fragmentation of water molecules by proton and He+ ion impact over wide ranges of collision energies. For the case of He+ impact this will include a discussion of effects due to the presence of the projectile electron. This work has been supported by the Natural Sciences and Engineering Research Council of Canada.

  1. Photorejuvenation with intense pulsed light: results of a multi-center study.

    PubMed

    Sadick, Neil S; Weiss, Robert; Kilmer, Suzanne; Bitter, Patrick

    2004-01-01

    This multi-center study evaluating the role of Intense Pulsed Light (IPL) in the non-ablative rejuvenation of Type I and Type II photoaged skin study was conducted in order to evaluate the clinical efficacy and safety of using IPL in treating clinical indications associated with photoaged skin. Ninety-three patients of Fitzpatrick skin phenotypes I-III, Fitzpatrick Wrinkle Classes I-II, and Elastosis Scores 1-6 were enrolled in the study. Up to five treatments were performed at 4-week intervals with follow-up visits at 4 and 6 months after the last treatment. Patients received full-face treatments using the recommended parameters of the Quantum SR/HR (Lumenis Ltd.) with the 560 or 640 nm cutoff filter. Parameters of elastometry, physicians' evaluation of the Elastosis Score ('W/ES'), and global improvement as well as patient satisfaction were analyzed. Results showed that the average Fitzpatrick W/ES improved significantly (p<0.001) by 1.39 and 1.32 units at the 4 and 6 months follow-ups, respectively; an improved W/ES evaluation was recorded for 82% and 75% of the patients at each of these time points. In conclusion, IPL treatment is an effective non-invasive, non-ablative method for rejuvenating photoaged skin with minimal adverse events, no downtime, excellent long-term results, and a very high measure of patient satisfaction. PMID:14964745

  2. ImTK: an open source multi-center information management toolkit

    NASA Astrophysics Data System (ADS)

    Alaoui, Adil; Ingeholm, Mary Lou; Padh, Shilpa; Dorobantu, Mihai; Desai, Mihir; Cleary, Kevin; Mun, Seong K.

    2008-03-01

    The Information Management Toolkit (ImTK) Consortium is an open source initiative to develop robust, freely available tools related to the information management needs of basic, clinical, and translational research. An open source framework and agile programming methodology can enable distributed software development while an open architecture will encourage interoperability across different environments. The ISIS Center has conceptualized a prototype data sharing network that simulates a multi-center environment based on a federated data access model. This model includes the development of software tools to enable efficient exchange, sharing, management, and analysis of multimedia medical information such as clinical information, images, and bioinformatics data from multiple data sources. The envisioned ImTK data environment will include an open architecture and data model implementation that complies with existing standards such as Digital Imaging and Communications (DICOM), Health Level 7 (HL7), and the technical framework and workflow defined by the Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure initiative, mainly the Cross Enterprise Document Sharing (XDS) specifications.

  3. Distributed Scheduling Architecture for Multi-Center Time-Based Metering

    NASA Technical Reports Server (NTRS)

    Landry, Steven; Farley, Todd; Foster, John; Green, Steve; Hoang, Ty; Wong, Gregory L.

    2003-01-01

    The Traffic Management Advisor (TMA) is an air traffic control automation system currently in use in seven Air Route Traffic Control Centers (ARTCCs) to enable time based metering to busy airports within their airspace. However, this system is limited to operation within a single ARTCC, within about a 200 nautical mile radius of the airport, and on relatively simple streams of traffic. The need for coordinated metering within a greater (300+ nautical mile) radius of an airport, on streams of traffic with significant branching, and across ARTCC boundaries, has been identified. Early tests revealed that TMA could not simply be scaled up to handle such a problem. Instead, a loosely coupled hierarchy of schedules, in which constraints from downstream schedules are passed upstream, is required. Such an architecture reduces the reliance on distant projections of arrival times, making schedules robust to changes in sequence and to additions of aircraft (such as aircraft departing inside the system s scheduling horizon). This architecture is also scaleable, easily reconfigurable, and can be networked together. As such, it can be adapted for use in any size or configuration of airspace and with any number of airports delivering restrictions. An implementation of this distributed scheduling architecture is currently undergoing testing in the TMA-Multi Center system. This paper describes the architecture and its motivation.

  4. Multi-center, multi-topic heart sound databases and their applications.

    PubMed

    Xie, Meilan; Xiao, Shouzhong; Liu, Tianhu; Yi, Qijian; You, Fengzhi; Guo, Xingming; Shao, Yong; Huo, Junmimg; Du, Deqi; Xu, Dongmei; Wu, Wenzhu; Xiao, Zifu; Yang, Yong; Guo, Weizhen

    2012-02-01

    This paper describes a large resource of multi-center and multi-topic heart sound databases, which were based on the measured data from more than 9,000 heart sound samples (saved in WAV file format). According to different research topics, these samples were respectively stored in different folders (corresponding to different research topics and distributed over various cooperative research centers), most of which as subfolds were stored in a pooled folder in the principal center. According to different research topics, the measured data from these samples were used to create different databases. Relevant data for a specific topic can be pooled in a large database for further analysis. This resource is shared by members of related centers for their own specific topic. The applications of this resource include evaluation of cardiac safety of pregnant women, evaluation of cardiac reserve for children, athletes, addicts, astronauts, and general populations, as well as studies on a bedside method for evaluating cardiac energy, reversal of S1-S2 ratio, etc. PMID:20703751

  5. Vitamin D Deficiency in Healthy Male Population: Results of the Iranian Multi- Center Osteoporosis Study

    PubMed Central

    Rahnavard, Z; Eybpoosh, S; Homami, M Rezaei; Meybodi, HR Aghaei; Azemati, B; Heshmat, R; Larijani, B

    2010-01-01

    Background: The prevalence of vitamin D deficiency and its causative factors has been estimated more frequently in elder population, women, and patients with osteoporosis in different countries, but this issue is less defined in male population within different age groups especially in Asian countries. Therefore, we studied the role of effective factors in vitamin D deficiency and its prevalence in Iranian healthy men. Methods: This study was a multi center and carried out in five metropolitans in Iran. Serum 25 Hydroxy vitamin D and other biochemical variables were determined in 2396 healthy men in late winter of 2001. Results: 68.8% of participants suffered from vitamin D deficiency. Vitamin D levels were the highest in Bushehr (n= 111, 40.3%) (P< 0.05) and between Shiraz and Tabriz, Shiraz had the better values (P< 0.05). Tehran had the highest prevalence of vitamin D deficiency (n= 380, n= 85.7%). Geographical zone independently predicted vitamin D status (P< 0.05). There was not any association among age (r= 0.035, P> 0.05), physical activity (r= 0.023, P> 0.05), and exposure of face & hands to sunlight (r= 0.022, P> 0.05) with vitamin D levels. Conclusion: Prevalence of vitamin D deficiency in Iranian male population is high, considering Iranian cultural and geographical zones, food fortification and life style modification is recommended. PMID:23113022

  6. The Multi-Center Airborne Coherent Atmospheric Wind Sensor: Recent Measurements and Future Applications

    NASA Technical Reports Server (NTRS)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Howell, James N.; Darby, Lisa S.; Tratt, David M.; Menzies, Robert T.

    1999-01-01

    The coherent Doppler lidar, when operated from an airborne platform, offers a unique measurement capability for study of atmospheric dynamical and physical properties. This is especially true for scientific objectives requiring measurements in optically-clear air, where other remote sensing technologies such as Doppler radar are at a disadvantage in terms of spatial resolution and coverage. Recent experience suggests airborne coherent Doppler lidar can yield unique wind measurements of--and during operation within--extreme weather phenomena. This paper presents the first airborne coherent Doppler lidar measurements of hurricane wind fields. The lidar atmospheric remote sensing groups of National Aeronautics and Space Administration (NASA) Marshall Space Flight Center, National Oceanic and Atmospheric Administration (NOAA) Environmental Technology Laboratory, and Jet Propulsion Laboratory jointly developed an airborne lidar system, the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS). The centerpiece of MACAWS is the lidar transmitter from the highly successful NOAA Windvan. Other field-tested lidar components have also been used, when feasible, to reduce costs and development time. The methodology for remotely sensing atmospheric wind fields with scanning coherent Doppler lidar was demonstrated in 1981; enhancements were made and the system was reflown in 1984. MACAWS has potentially greater scientific utility, compared to the original airborne scanning lidar system, owing to a factor of approx. 60 greater energy-per-pulse from the NOAA transmitter. MACAWS development was completed and the system was first flown in 1995. Following enhancements to improve performance, the system was re-flown in 1996 and 1998. The scientific motivation for MACAWS is three-fold: obtain fundamental measurements of subgrid scale (i.e., approx. 2-200 km) processes and features which may be used to improve parameterizations in hydrological, climate, and general

  7. Regional gray matter atrophy in relapsing remitting multiple sclerosis: baseline analysis of multi-center data.

    PubMed

    Datta, Sushmita; Staewen, Terrell D; Cofield, Stacy S; Cutter, Gary R; Lublin, Fred D; Wolinsky, Jerry S; Narayana, Ponnada A

    2015-03-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson׳s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r=-0.133; p<0.001) and DD (r=-0.098; p=0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r=-0.492; P-value<0.001), T1 LL (r=-0.473; P-value<0.001) and nCSF (r=-0.367; P-value<0.001). PMID:25787188

  8. DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials.

    PubMed

    Haak, Daniel; Page, Charles-E; Reinartz, Sebastian; Krüger, Thilo; Deserno, Thomas M

    2015-10-01

    Providing surrogate endpoints in clinical trials, medical imaging has become increasingly important in human-centered research. Nowadays, electronic data capture systems (EDCS) are used but binary image data is integrated insufficiently. There exists no structured way, neither to manage digital imaging and communications in medicine (DICOM) data in EDCS nor to interconnect EDCS with picture archiving and communication systems (PACS). Manual detours in the trial workflow yield errors, delays, and costs. In this paper, requirements for a DICOM-based system interconnection of EDCS and research PACS are analysed. Several workflow architectures are compared. Optimized for multi-center trials, we propose an entirely web-based solution integrating EDCS, PACS, and DICOM viewer, which has been implemented using the open source projects OpenClinica, DCM4CHEE, and Weasis, respectively. The EDCS forms the primary access point. EDCS to PACS interchange is integrated seamlessly on the data and the context levels. DICOM data is viewed directly from the electronic case report form (eCRF), while PACS-based management is hidden from the user. Data privacy is ensured by automatic de-identification and re-labelling with study identifiers. Our concept is evaluated on a variety of 13 DICOM modalities and transfer syntaxes. We have implemented the system in an ongoing investigator-initiated trial (IIT), where five centers have recruited 24 patients so far, performing decentralized computed tomography (CT) screening. Using our system, the chief radiologist is reading DICOM data directly from the eCRF. Errors and workflow processing time are reduced. Furthermore, an imaging database is built that may support future research. PMID:26001521

  9. Regional Gray Matter Atrophy in Relapsing Remitting Multiple Sclerosis: Baseline Analysis of Multi-Center Data

    PubMed Central

    Datta, Sushmita; Staewen, Terrell D.; Cofield, Stacy S.; Cutter, Gary R.; Lublin, Fred D.; Wolinsky, Jerry S.; Narayana, Ponnada A.

    2015-01-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson’s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r = −0.133; p < 0.001) and DD (r = −0.098; p = 0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r = −0.492; p-value < 0.001), T1 LL (r = −0.473; p-value < 0.001) and nCSF (r = −0.367; p-value < 0.001). PMID:25787188

  10. Multi-center reproducibility of neurochemical profiles in the human brain at 7 T.

    PubMed

    van de Bank, B L; Emir, U E; Boer, V O; van Asten, J J A; Maas, M C; Wijnen, J P; Kan, H E; Oz, G; Klomp, D W J; Scheenen, T W J

    2015-03-01

    The purpose of this work was to harmonize data acquisition and post-processing of single voxel proton MRS ((1) H-MRS) at 7 T, and to determine metabolite concentrations and the accuracy and reproducibility of metabolite levels in the adult human brain. This study was performed in compliance with local institutional human ethics committees. The same seven subjects were each examined twice using four different 7 T MR systems from two different vendors using an identical semi-localization by adiabatic selective refocusing spectroscopy sequence. Neurochemical profiles were obtained from the posterior cingulate cortex (gray matter, GM) and the corona radiata (white matter, WM). Spectra were analyzed with LCModel, and sources of variation in concentrations ('subject', 'institute' and 'random') were identified with a variance component analysis. Concentrations of 10-11 metabolites, which were corrected for T1 , T2 , magnetization transfer effects and partial volume effects, were obtained with mean Cramér-Rao lower bounds below 20%. Data variances and mean concentrations in GM and WM were comparable for all institutions. The primary source of variance for glutamate, myo-inositol, scyllo-inositol, total creatine and total choline was between subjects. Variance sources for all other metabolites were associated with within-subject and system noise, except for total N-acetylaspartate, glutamine and glutathione, which were related to differences in signal-to-noise ratio and in shimming performance between vendors. After multi-center harmonization of acquisition and post-processing protocols, metabolite concentrations and the sizes and sources of their variations were established for neurochemical profiles in the healthy brain at 7 T, which can be used as guidance in future studies quantifying metabolite and neurotransmitter concentrations with (1) H-MRS at ultra-high magnetic field. PMID:25581510

  11. A multi-center milestone study of clinical vertebral CT segmentation.

    PubMed

    Yao, Jianhua; Burns, Joseph E; Forsberg, Daniel; Seitel, Alexander; Rasoulian, Abtin; Abolmaesumi, Purang; Hammernik, Kerstin; Urschler, Martin; Ibragimov, Bulat; Korez, Robert; Vrtovec, Tomaž; Castro-Mateos, Isaac; Pozo, Jose M; Frangi, Alejandro F; Summers, Ronald M; Li, Shuo

    2016-04-01

    A multiple center milestone study of clinical vertebra segmentation is presented in this paper. Vertebra segmentation is a fundamental step for spinal image analysis and intervention. The first half of the study was conducted in the spine segmentation challenge in 2014 International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI) Workshop on Computational Spine Imaging (CSI 2014). The objective was to evaluate the performance of several state-of-the-art vertebra segmentation algorithms on computed tomography (CT) scans using ten training and five testing dataset, all healthy cases; the second half of the study was conducted after the challenge, where additional 5 abnormal cases are used for testing to evaluate the performance under abnormal cases. Dice coefficients and absolute surface distances were used as evaluation metrics. Segmentation of each vertebra as a single geometric unit, as well as separate segmentation of vertebra substructures, was evaluated. Five teams participated in the comparative study. The top performers in the study achieved Dice coefficient of 0.93 in the upper thoracic, 0.95 in the lower thoracic and 0.96 in the lumbar spine for healthy cases, and 0.88 in the upper thoracic, 0.89 in the lower thoracic and 0.92 in the lumbar spine for osteoporotic and fractured cases. The strengths and weaknesses of each method as well as future suggestion for improvement are discussed. This is the first multi-center comparative study for vertebra segmentation methods, which will provide an up-to-date performance milestone for the fast growing spinal image analysis and intervention. PMID:26878138

  12. Confirmed adult dengue deaths in Singapore: 5-year multi-center retrospective study

    PubMed Central

    2011-01-01

    Background Dengue re-emerges in Singapore despite decades of effective vector control; the infection predominantly afflicts adults. Severe dengue not fulfilling dengue hemorrhagic fever (DHF) criteria according to World Health Organization (WHO) 1997 guideline was increasingly reported. A new WHO 2009 guideline emphasized warning signs and a wider range of severe dengue manifestations. We aim to evaluate the utility of these two guidelines in confirmed adult dengue fatalities. Methods We conducted a multi-center retrospective chart review of all confirmed adult dengue deaths in Singapore from 1 January 2004 to 31 December 2008. Results Of 28 adult dengue deaths, median age was 59 years. Male gender comprised 67.9% and co-morbidities existed in 75%. From illness onset, patients presented for admission at a median of 4 days and death occurred at a median of 12 days. Intensive care admission was required in 71.4%. Probable dengue was diagnosed in 32.1% by WHO 1997 criteria and 78.6% by WHO 2009. The earliest warning sign was persistent vomiting at a median of 1.5 days. Hematocrit change ≥20% concurrent with platelet count <20 × 10^9/L was associated with the shortest interval to death at a median of 3 days. Only 35.7% of death cases fulfilled DHF criteria by WHO 1997 versus severe dengue in 100.0% by WHO 2009 criteria. Deaths were due to shock and organ failure. Acute renal impairment occurred in 71.4%, impaired consciousness 57.1% and severe hepatitis 53.6%. Conclusions In our adult fatal dengue cohort, WHO 2009 criteria had higher sensitivity in diagnosing probable dengue and severe dengue compared with WHO 1997. As warning signs, persistent vomiting occurred early and hematocrit change ≥20% concurrent with platelet count <20 × 10^9/L preceded death most closely. PMID:21569427

  13. Multi-Center Implementation of NPR 7123.1A: A Collaborative Effort

    NASA Technical Reports Server (NTRS)

    Hall, Phillip B.; McNelis, Nancy B.

    2011-01-01

    Collaboration efforts between MSFC and GRC Engineering Directorates to implement the NASA Systems Engineering (SE) Engine have expanded over the past year to include other NASA Centers. Sharing information on designing, developing, and deploying SE processes has sparked further interest based on the realization that there is relative consistency in implementing SE processes at the institutional level. This presentation will provide a status on the ongoing multi-center collaboration and provide insight into how these NPR 7123.1A SE-aligned directives are being implemented and managed to better support the needs of NASA programs and projects. NPR 7123.1A, NASA Systems Engineering Processes and Requirements, was released on March 26, 2007 to clearly articulate and establish the requirements on the implementing organization for performing, supporting, and evaluating SE activities. In early 2009, MSFC and GRC Engineering Directorates undertook a collaborative opportunity to share their research and work associated with developing, updating and revising their SE process policy to comply and align with NPR 7123.1A. The goal is to develop instructions, checklists, templates, and procedures for each of the 17 SE process requirements so that systems engineers will be a position to define work that is process-driven. Greater efficiency and more effective technical management will be achieved due to consistency and repeatability of SE process implementation across and throughout each of the NASA centers. An added benefit will be to encourage NASA centers to pursue and collaborate on joint projects as a result of using common or similar processes, methods, tools, and techniques.

  14. Distribution of guidance models for cardiac resynchronization therapy in the setting of multi-center clinical trials

    NASA Astrophysics Data System (ADS)

    Rajchl, Martin; Abhari, Kamyar; Stirrat, John; Ukwatta, Eranga; Cantor, Diego; Li, Feng P.; Peters, Terry M.; White, James A.

    2014-03-01

    Multi-center trials provide the unique ability to investigate novel techniques across a range of geographical sites with sufficient statistical power, the inclusion of multiple operators determining feasibility under a wider array of clinical environments and work-flows. For this purpose, we introduce a new means of distributing pre-procedural cardiac models for image-guided interventions across a large scale multi-center trial. In this method, a single core facility is responsible for image processing, employing a novel web-based interface for model visualization and distribution. The requirements for such an interface, being WebGL-based, are minimal and well within the realms of accessibility for participating centers. We then demonstrate the accuracy of our approach using a single-center pacemaker lead implantation trial with generic planning models.

  15. MiDas: automatic extraction of a common domain of discourse in sleep medicine for multi-center data integration.

    PubMed

    Sahoo, Satya S; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S; Zhang, Guo-Qiang

    2011-01-01

    Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI's Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry. PMID:22195180

  16. MiDas: Automatic Extraction of a Common Domain of Discourse in Sleep Medicine for Multi-center Data Integration

    PubMed Central

    Sahoo, Satya S.; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S.; Zhang, Guo-Qiang

    2011-01-01

    Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI’s Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry. PMID:22195180

  17. Spin glass in semiconducting KFe1.05Ag0.88Te2 single crystals

    DOE PAGESBeta

    Ryu, H.; Lei, H.; Klobes, B.; Warren, J. B.; Hermann, R. P.; Petrovic, C.

    2015-05-26

    We report discovery of KFe1.05Ag0.88Te2 single crystals with semiconducting spin glass ground state. Composition and structure analysis suggest nearly stoichiometric I4/mmm space group but allow for the existence of vacancies, absent in long range semiconducting antiferromagnet KFe1.05Ag0.88Te2. The subtle change in stoichometry in Fe/Ag sublattice changes magnetic ground state but not conductivity, giving further insight into the semiconducting gap mechanism.

  18. The Effects of the Uncertainty of Departures on Multi-Center Traffic Management Advisor (TMA) Scheduling

    NASA Technical Reports Server (NTRS)

    Thipphavong, Jane; Landry, Steven J.

    2005-01-01

    The Multi-center Traffic Management Advisor (McTMA) provides a platform for regional or national traffic flow management, by allowing long-range cooperative time-based metering to constrained resources, such as airports or air traffic control center boundaries. Part of the demand for resources is made up of proposed departures, whose actual departure time is difficult to predict. For this reason, McTMA does not schedule the departures in advance, but rather relies on traffic managers to input their requested departure time. Because this happens only a short while before the aircraft's actual departure, McTMA is unable to accurately predict the amount of delay airborne aircraft will need to take in order to accommodate the departures. The proportion of demand which is made up by such proposed departures increases as the horizon over which metering occurs gets larger. This study provides an initial analysis of the severity of this problem in a 400-500 nautical mile metering horizon and discusses potential solutions to accommodate these departures. The challenge is to smoothly incorporate departures with the airborne stream while not excessively delaying the departures.' In particular, three solutions are reviewed: (1) scheduling the departures at their proposed departure time; (2) not scheduling the departures in advance; and (3) scheduling the departures at some time in the future based on an estimated error in their proposed time. The first solution is to have McTMA to automatically schedule the departures at their proposed departure times. Since the proposed departure times are indicated in their flight times in advance, this method is the simplest, but studies have shown that these proposed times are often incorrect2 The second option is the current practice, which avoids these inaccuracies by only scheduling aircraft when a confirmed prediction of departure time is obtained from the tower of the departure airport. Lastly, McTMA can schedule the departures at a

  19. Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy.

    PubMed

    Antonini, G; Giancola, R; Berruti, D; Blanchietti, E; Pecchia, P; Francione, V; Greco, P; Russo, T C; Pietrogrande, L

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

  20. Data management in multi-center clinical trials and the role of a nation-wide computer network. A 5 year evaluation.

    PubMed Central

    Gerritsen, M. G.; Sartorius, O. E.; vd Veen, F. M.; Meester, G. T.

    1993-01-01

    Multidisciplinary collaboration in multi-center trials needs a formalized data management structure to ensure true progress monitoring and high quality research data. Cadans, a customized facility for data management, related to the Interuniversity Cardiology Institute of the Netherlands, designed a computer-based data management system for multidisciplinary multi-center collaborative research projects. In this paper we describe the system and the role of integrated access to research databases on a data network. Areas of concern are also discussed. PMID:8130557

  1. Contraceptive Use and the Risk of Ectopic Pregnancy: A Multi-Center Case-Control Study

    PubMed Central

    Meng, Chun-Xia; Ping, Hua; Qin, Guo-Juan; Cao, Shu-Jun; Xi, Xiaowei; Zhu, Qian; Li, Xiao-Cui; Zhang, Jian

    2014-01-01

    Objective To evaluate the association between the risk of ectopic pregnancy (EP) and the use of common contraceptives during the previous and current conception/menstrual cycle. Methods A multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411). Women with intrauterine pregnancy (IUP) (n = 2,416) and non-pregnant women (n = 2,419) were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs) and the corresponding 95% confidential intervals (CIs). Results Previous use of intrauterine devices (IUDs) was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48–2.37]; AOR2 = 1.84 [1.49–2.27]), and the risk increased with the duration of previous use (P1 for trend <10−4, P2 for trend <10−4). The current use of most contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03–0.05]; withdrawal method: AOR = 0.10 [0.07–0.13]; calendar rhythm method: AOR = 0.54 [0.40–0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02–0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16–0.30]; IUDs: AOR = 0.01 [0.005–0.012]; tubal sterilization: AOR = 0.01 [0.001–0.022]) and unwanted EP (condom: AOR1 = 0.05 [0.04–0.06]; withdrawal method: AOR1 = 0.13 [0.09–0.19]; calendar rhythm method: AOR1 = 0.66 [0.48–0.91]; OCPs: AOR1 = 0.14 [0.07–0.26]; IUDs: AOR1 = 0.17 [0.13–0.22]; tubal sterilization: AOR1 = 0.04 [0.02–0.08]). However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64–10.07]), LNG-EC (AOR2 = 4.87 [3.88–6.10]), IUDs (AOR2 = 21.08 [13.44–33.07]), and tubal sterilization (AOR2 = 7.68 [1.69–34.80]) increased the risk of EP compared

  2. 33 CFR 1.05-5 - Marine Safety and Security Council.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Marine Safety and Security... SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-5 Marine Safety and Security Council. The Marine... Commandant and is the focal point of the Coast Guard regulatory system. The Marine Safety and...

  3. 33 CFR 1.05-5 - Marine Safety and Security Council.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 false Marine Safety and Security... SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-5 Marine Safety and Security Council. The Marine... Commandant and is the focal point of the Coast Guard regulatory system. The Marine Safety and...

  4. 33 CFR 1.05-5 - Marine Safety and Security Council.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Marine Safety and Security... SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-5 Marine Safety and Security Council. The Marine... Commandant and is the focal point of the Coast Guard regulatory system. The Marine Safety and...

  5. 33 CFR 1.05-5 - Marine Safety and Security Council.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Marine Safety and Security... SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-5 Marine Safety and Security Council. The Marine... Commandant and is the focal point of the Coast Guard regulatory system. The Marine Safety and...

  6. 33 CFR 1.05-5 - Marine Safety and Security Council.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 1 2014-07-01 2014-07-01 false Marine Safety and Security... SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-5 Marine Safety and Security Council. The Marine... Commandant and is the focal point of the Coast Guard regulatory system. The Marine Safety and...

  7. All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)

    EPA Science Inventory

    The All-Ages Lead Model (AALM) Version 1.05, is an external review draft software and guidance manual. EPA released this software and associated documentation for public review and comment beginning September 27, 2005, until October 27, 2005. The public comments will be accepte...

  8. Prediction of accrual closure date in multi-center clinical trials with discrete-time Poisson process models

    PubMed Central

    Tang, Gong; Kong, Yuan; Chang, Chung-Chou Ho; Kong, Lan; Costantino, Joseph P.

    2016-01-01

    In a phase III multi-center cancer clinical trial or large public health studies, sample size is predetermined to achieve desired power and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date based on the observed accrual pattern and notify the participating sites several weeks in advance. In the past, projections were simply based on some crude assessment and conservative measures were incorporated in order to achieve the target accrual size. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of NSABP trial B-38. The results showed that application of proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi-center clinical trials. PMID:22411544

  9. Perinatal Exposure to Traffic-Related Air Pollution and Atopy at 1 Year of Age in a Multi-Center Canadian Birth Cohort Study

    PubMed Central

    Allen, Ryan W.; Becker, Allan; Brook, Jeffrey R.; Mandhane, Piush; Scott, James A.; Sears, Malcolm R.; Subbarao, Padmaja; Takaro, Tim K.; Turvey, Stuart E.; Brauer, Michael

    2015-01-01

    Background The role of traffic-related air pollution (TRAP) exposure in the development of allergic sensitization in children is unclear, and few birth cohort studies have incorporated spatiotemporal exposure assessment. Objectives We aimed to examine the association between TRAP and atopy in 1-year-old children from an ongoing national birth cohort study in four Canadian cities. Methods We identified 2,477 children of approximately 1 year of age with assessment of atopy for inhalant (Alternaria, Der p, Der f, cat, dog, cockroach) and food-related (milk, eggs, peanuts, soy) allergens. Exposure to nitrogen dioxide (NO2) was estimated from city-specific land use regression models accounting for residential mobility and temporal variability in ambient concentrations. We used mixed models to examine associations between atopy and exposure during pregnancy and the first year of life, including adjustment for covariates (maternal atopy, socioeconomic status, pets, mold, nutrition). We also conducted analyses stratified by time-location patterns, daycare attendance, and modeled home ventilation. Results Following spatiotemporal adjustment, TRAP exposure after birth increased the risk for development of atopy to any allergens [adjusted odds ratio (aOR) per 10 μg/m3 NO2 = 1.16; 95% CI: 1.00, 1.41], but not during pregnancy (aOR = 1.02; 95% CI: 0.86, 1.22). This association was stronger among children not attending daycare (aOR = 1.61; 95% CI: 1.28, 2.01) compared with daycare attendees (aOR = 1.05; 95% CI: 0.81, 1.28). Trends to increased risk were also found for food (aOR = 1.17; 95% CI: 0.95, 1.47) and inhalant allergens (aOR = 1.28; 95% CI: 0.93, 1.76). Conclusion Using refined exposure estimates that incorporated temporal variability and residential mobility, we found that traffic-related air pollution during the first year of life was associated with atopy. Citation Sbihi H, Allen RW, Becker A, Brook JR, Mandhane P, Scott JA, Sears MR, Subbarao P, Takaro TK, Turvey SE

  10. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    PubMed Central

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  11. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    PubMed Central

    Feis, Rogier A.; Smith, Stephen M.; Filippini, Nicola; Douaud, Gwenaëlle; Dopper, Elise G. P.; Heise, Verena; Trachtenberg, Aaron J.; van Swieten, John C.; van Buchem, Mark A.; Rombouts, Serge A. R. B.; Mackay, Clare E.

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software, and environmental differences. Here, we investigated whether a novel clean up tool for structured noise was capable of reducing center-related R-fMRI differences between healthy subjects. We analyzed three Tesla R-fMRI data from 72 subjects, half of whom were scanned with eyes closed in a Philips Achieva system in The Netherlands, and half of whom were scanned with eyes open in a Siemens Trio system in the UK. After pre-statistical processing and individual Independent Component Analysis (ICA), FMRIB's ICA-based X-noiseifier (FIX) was used to remove noise components from the data. GICA and dual regression were run and non-parametric statistics were used to compare spatial maps between groups before and after applying FIX. Large significant differences were found in all resting-state networks between study sites before using FIX, most of which were reduced to non-significant after applying FIX. The between-center difference in the medial/primary visual network, presumably reflecting a between-center difference in protocol, remained statistically significant. FIX helps facilitate multi-center R-fMRI research by diminishing structured noise from R-fMRI data. In doing so, it improves combination of existing data from different centers in new settings and comparison of rare diseases and risk genes for which adequate sample size remains a challenge. PMID:26578859

  12. Consulting Communities When Patients Cannot Consent: A Multi-Center Study of Community Consultation for Research in Emergency Settings

    PubMed Central

    Dickert, Neal W; Mah, Victoria A; Biros, Michelle H; Harney, Deneil M; Silbergleit, Robert; Sugarman, Jeremy; Veledar, Emir; Weinfurt, Kevin P; Wright, David W; Pentz, Rebecca D

    2013-01-01

    Objective To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. Design A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). Setting Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. Subjects Adult participants in community consultation events. Interventions Community consultation efforts at participating sites. Measurements and Main Results Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). Conclusions Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community

  13. Pre-Transplant Cardiovascular Risk Factors Affect Kidney Allograft Survival: A Multi-Center Study in Korea

    PubMed Central

    Lee, Jung Pyo; Bae, Eunjin; Kang, Eunjeong; Kim, Hack-Lyoung; Kim, Yong-Jin; Oh, Yun Kyu; Kim, Yon Su; Kim, Young Hoon; Lim, Chun Soo

    2016-01-01

    Background Pre-transplant cardiovascular (CV) risk factors affect the development of CV events even after successful kidney transplantation (KT). However, the impact of pre-transplant CV risk factors on allograft failure (GF) has not been reported. Methods and Findings We analyzed the graft outcomes of 2,902 KT recipients who were enrolled in a multi-center cohort from 1997 to 2012. We calculated the pre-transplant CV risk scores based on the Framingham risk model using age, gender, total cholesterol level, smoking status, and history of hypertension. Vascular disease (a composite of ischemic heart disease, peripheral vascular disease, and cerebrovascular disease) was noted in 6.5% of the patients. During the median follow-up of 6.4 years, 286 (9.9%) patients had developed GF. In the multivariable-adjusted Cox proportional hazard model, pre-transplant vascular disease was associated with an increased risk of GF (HR 2.51; 95% CI 1.66–3.80). The HR for GF (comparing the highest with the lowest tertile regarding the pre-transplant CV risk scores) was 1.65 (95% CI 1.22–2.23). In the competing risk model, both pre-transplant vascular disease and CV risk score were independent risk factors for GF. Moreover, the addition of the CV risk score, the pre-transplant vascular disease, or both had a better predictability for GF compared to the traditional GF risk factors. Conclusions In conclusion, both vascular disease and pre-transplant CV risk score were independently associated with GF in this multi-center study. Pre-transplant CV risk assessments could be useful in predicting GF in KT recipients. PMID:27501048

  14. Cognitive Dysfunction is Associated with Poor Socio-Economic Status in Patients with Cirrhosis: an International Multi-Center Study

    PubMed Central

    Bajaj, Jasmohan S; Riggio, Oliviero; Allampati, Sanath; Prakash, Ravi; Gioia, Stefania; Onori, Eugenia; Piazza, Nicole; Noble, Nicole A; White, Melanie B; Mullen, Kevin D

    2013-01-01

    Background & Aims In patients with cirrhosis, cognitive dysfunction most often results from covert hepatic encephalopathy (HE). These patients are not routinely tested for cognitive dysfunction, despite single-center evidence that it could be associated with poor socio-economic status (SES). We investigated the association between SES and cognition in a multi-center study of cirrhosis. Methods In a cross-sectional study, 236 cirrhotic patients from 3 centers (84 subjects from Virginia, 102 from Ohio, and 50 from Rome, Italy; age 57.7±8.6 y; 14% with prior overt HE) were given recommended cognitive tests and a validated SES questionnaire, which included questions about employment, personal and family income, and overall financial security. Comparisons were made among centers and between subjects who were employed or not. Regression analysis was performed using employment and personal income as outcomes. Results Only 37% of subjects had been employed in the last year. Subjects had substantial financial insecurity—their yearly personal income ranged from $16,000 to $24,999 and their family income ranged from $25,000 to $49,999. They were only able to maintain a residence for 3–6 months if their income stopped, and their current liquid assets were $500–$4999 (<$500 if debt was subtracted). Cognition and SES were worst in Ohio and best in Virginia. Cognition correlated with personal and family income, within and between centers. On regression analysis, cognitive performance (digit symbol, lures, and line tracing) was associated with personal yearly income, after controlling for demographics, country, employment, and overt HE. Unemployed subjects had a higher rate of overt HE, worse cognition, and lower personal income than employed subjects. On regression analysis, performance on digit symbol, line tracing, inhibitory control test lures, and serial dotting tests remained associated with income, similar to employment. Conclusions In an international, multi-center

  15. Open versus minimally invasive sacroiliac joint fusion: a multi-center comparison of perioperative measures and clinical outcomes

    PubMed Central

    2013-01-01

    Background Sacroiliac (SI) joint pain is an under diagnosed source of low back pain due in part to lack of visible pathology on radiographs and symptoms mimicking other back-related disorders. Open SI joint fusion has been performed since the 1920s. This technique has fallen out of favor with the introduction of minimally invasive options. To date there has been no direct comparison between open and MIS SI joint fusion. Methods We conducted a multi-center, retrospective comparative cohort study of patients who underwent SI joint fusion using either an open surgical (OS) technique using a combination of screws and cages or a minimally invasive surgical (MIS) technique with a series of titanium plasma spray (TPS) coated triangular implants. Operative measures including surgical operating time, length of hospitalization and estimated blood loss (EBL) were collected along with demographics and medical history, surgical complications, and 12- and 24-month pain scores. Improvements in pain were compared after matching for age and gender and controlling for a history of lumbar spine fusion using repeated measures analysis of variance. Results Data were available for 263 patients treated by 7 surgeons; 149 patients treated with OS and 114 treated with MIS SI joint fusion. Compared to OS patients, MIS patients were on average 10 years older (mean age 57 vs. 46) and 69% of all patients were female. MIS operative measures of EBL, operating time and length of hospitalization were significantly lower than open surgery (p < 0.001). Pain relief, measured as change from baseline to 12 months in VAS pain rating, was 3.5 points lower in the MIS vs. OS group (-6.2 vs. -2.7 points, p < 0.001). When matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain scores were on average 3.0 points (95% CI 2.1 – 4.0) lower in MIS vs. OS (rANOVA p < 0.001). Conclusions In this multi-center comparative study, patients who underwent either OS or MIS SI

  16. Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

    NASA Astrophysics Data System (ADS)

    Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

    2014-02-01

    Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

  17. Interaction of iron deficiency anemia and hemoglobinopathies among college students and pregnant women: a multi center evaluation in India.

    PubMed

    Mohanty, Dipika; Gorakshakar, Ajit C; Colah, Roshan B; Patel, Ramesh Z; Master, Dilip C; Mahanta, J; Sharma, Santanu K; Chaudhari, Utpal; Ghosh, Malay; Das, Sheila; Britt, Reitt P; Singh, Shawinder; Ross, Cecil; Jagannathan, Lata; Kaul, Rajni; Shukla, Deepak K; Muthuswamy, Vasantha

    2014-01-01

    Although iron deficiency anemia is very common in India, systematic large studies on the prevalence and hematological consequences of iron deficiency among carriers of β-thalassemia (β-thal) and other hemoglobinopathies are lacking. A multi center project was undertaken to screen college/university students and pregnant women for iron deficiency anemia and various hemoglobinopathies. Fifty-six thousand, seven hundred and seventy-two subjects from six states, Maharashtra, Gujarat, Karnataka, West Bengal, Assam and Punjab, were studied. Iron deficiency anemia was evaluated by measuring zinc protoporphyrin (ZPP) and hemoglobin (Hb) levels, while β-thal and other hemoglobinopathies were detected by measuring the red cell indices and by Hb analysis using high performance liquid chromatography (HPLC). College boys (2.2%), college girls (14.3%) and antenatal women (27.0%) without any hemoglobinopathies had iron deficiency anemia. Among the β-thal carriers, the prevalence of iron deficiency anemia was 17.3% in college boys, 38.1% in college girls and 55.9% in pregnant women, while in the Hb E [β26(B8)Glu→Lys; HBB: c.79G>A] carriers, it was 7.3% in college boys, 25.4% in college girls and 78.0% in antenatal women. In individuals with Hb E disease, the prevalence of iron deficiency anemia varied from 31.2-77.3% in the three groups. A significant reduction in Hb levels was seen when iron deficiency anemia was associated with hemoglobinopathies. However, the Hb A2 levels in β-thal carriers were not greatly reduced in the presence of iron deficiency anemia. PMID:25023086

  18. Protective Effect of Dual-Strain Probiotics in Preterm Infants: A Multi-Center Time Series Analysis

    PubMed Central

    Schwab, Frank; Garten, Lars; Geffers, Christine; Gastmeier, Petra; Piening, Brar

    2016-01-01

    Objective To determine the effect of dual-strain probiotics on the development of necrotizing enterocolitis (NEC), mortality and nosocomial bloodstream infections (BSI) in preterm infants in German neonatal intensive care units (NICUs). Design A multi-center interrupted time series analysis. Setting 44 German NICUs with routine use of dual-strain probiotics on neonatal ward level. Patients Preterm infants documented by NEO-KISS, the German surveillance system for nosocomial infections in preterm infants with birth weights below 1,500 g, between 2004 and 2014. Intervention Routine use of dual-strain probiotics containing Lactobacillus acidophilus and Bifidobacterium spp. (Infloran) on the neonatal ward level. Main outcome measures Incidences of NEC, overall mortality, mortality following NEC and nosocomial BSI. Results Data from 10,890 preterm infants in 44 neonatal wards was included in this study. Incidences of NEC and BSI were 2.5% (n = 274) and 15.0%, (n = 1631), respectively. Mortality rate was 6.1% (n = 665). The use of dual-strain probiotics significantly reduced the risk of NEC (HR = 0.48; 95% CI = 0.38–0.62), overall mortality (HR = 0.60, 95% CI = 0.44–0.83), mortality after NEC (HR = 0.51, 95% CI = 0.26–0.999) and nosocomial BSI (HR = 0.89, 95% CI = 0.81–0.98). These effects were even more pronounced in the subgroup analysis of preterm infants with birth weights below 1,000 g. Conclusion In order to reduce NEC and mortality in preterm infants, it is advisable to add routine prophylaxis with dual-strain probiotics to clinical practice in neonatal wards. PMID:27332554

  19. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study.

    PubMed

    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing mean displacements of 1.87+/-0.95 mm and rotations of 1.56+/-0.66 degrees . Mean gray matter CBF was 47.4+/-7.5 [ml/100 g/min] with a between-subject standard variation SD(b)=5.5 [ml/100 g/min] and a within-subject standard deviation SD(w)=4.7 [ml/100 g/min]. The corresponding repeatability was 13.0 [ml/100 g/min] and was found to be within the range of previous studies. PMID:19660557

  20. A multi-center evaluation of a powered surgical stapler in video-assisted thoracoscopic lung resection procedures in China

    PubMed Central

    Qiu, Bin; Yan, Wanpu; Chen, Keneng; Fu, Xiangning; Hu, Jian; Knippenberg, Susan; Schwiers, Michael; Kassis, Edmund; Yang, Tengfei

    2016-01-01

    Background Lung cancer is one of the most prevalent malignancies worldwide. The number of anatomic lung cancer resections performed via video-assisted thoracoscopic surgery (VATS) is growing rapidly. Staplers are widely used in VATS procedures, but there is limited clinical data regarding how they might affect performance and postoperative outcomes, including air leak. This clinical trial assessed the use of a powered stapler in VATS lung resection, with a primary study endpoint being occurrence and duration of air leak and prolonged air leak (PAL). Methods Data was collected from a single arm, multi-center study in Chinese patients receiving VATS wedge resection or lobectomy. Intra-operative data included surgery duration; cartridge selection for ligation/transection of bronchus, major vessels, and lung parenchyma; staple line interventions; blood loss; and device usage. Post-operative data included air leak assessments, chest tube duration, length of hospital stay, and adverse events (AEs). Results A total of 94 procedures across four institutions in China were included in the final analysis: 15 wedge resections, 74 lobectomies, and five wedge resections followed by lobectomies. Post-operative air leak occurred in five (5.3%) patients who had lobectomy procedures, with PAL in one (1.1%) patient. Sites were generally consistent relative to cartridge use by tissue type. The incidence of stapler firings requiring surgical interventions was seven out of 550 (1.3%). Surgeons participating in the study were satisfied with the articulation and overall usability of the stapler. Conclusions The powered staplers make the VATS procedure easier for the surgeons and have achieved intra- and post-operative patient outcomes comparable to those previously reported. PMID:27162678

  1. Polymicrogyria-associated epilepsy: a multi-center phenotypic study from the Epilepsy Phenome/Genome Project

    PubMed Central

    Shain, Catherine; Ramgopal, Sriram; Fallil, Zianka; Parulkar, Isha; Alongi, Richard; Knowlton, Robert; Poduri, Annapurna

    2013-01-01

    Purpose Polymicrogyria (PMG) is an epileptogenic malformation of cortical development. We describe the clinical epilepsy and imaging features of a large cohort with PMG-related epilepsy. Methods Participants were recruited through the Epilepsy Phenome/Genome Project, a multi-center collaborative effort to collect detailed phenotypic data on individuals with epilepsy. We reviewed phenotypic data from participants with epilepsy and PMG. Key Findings We identified 87 participants, 43 female and 44 male, with PMG and epilepsy. Median age of seizure onset was 3 years (range <1 month-37 years). Most presented with focal epilepsy (87.4%), some in combination with seizures generalized from onset (23.0%). Focal seizures with dyscognitive features were most common (54.3%). Of those presenting with generalized seizure types, infantile spasms were most prevalent (45.2%). The most common topographic pattern was perisylvian PMG (77.0%), of which the majority was bilateral (56.7%). Generalized PMG presented with an earlier age of seizure onset (median age of 8 months) and an increased prevalence of developmental delay prior to seizure onset (57.1%). Of the focal, unilateral and asymmetric bilateral groups where PMG was more involved in one hemisphere, the majority (71.4%) of participants had seizures that lateralized to the same hemisphere as the PMG or the hemisphere with greater involvement. Significance Participants with PMG had both focal and generalized onset of seizures. Our data confirm the involvement of known topographic patterns of PMG and suggest that more extensive distributions of PMG present with an earlier age of seizure onset and increased prevalence of developmental delay prior to seizure onset. PMID:23750890

  2. Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT) Study

    PubMed Central

    Hubbard, Alan; Callcut, Rachael A.; Fox, Erin E.; del Junco, Deborah J.; Holcomb, John B.; Rahbar, Mohammad H.; Wade, Charles E.; Schreiber, Martin A.; Alarcon, Louis H.; Brasel, Karen J.; Bulger, Eileen M.; Cotton, Bryan A.; Muskat, Peter; Myers, John G.; Phelan, Herb A.; Cohen, Mitchell J.

    2015-01-01

    Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated). We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating on parameters that

  3. Blinded, multi-center validation of EEG and rating scales in identifying ADHD within a clinical sample.

    PubMed

    Snyder, Steven M; Quintana, Humberto; Sexson, Sandra B; Knott, Peter; Haque, A F M; Reynolds, Donald A

    2008-06-30

    Previous validation studies of attention deficit/hyperactivity disorder (ADHD) assessment by rating scales or EEG have provided Class-IV evidence per standards of the American Academy of Neurology. To investigate clinical applications, we collected Class-I evidence, namely from a blinded, prospective, multi-center study of a representative clinical sample categorized with a clinical standard. Participating males (101) and females (58) aged 6 to 18 had presented to one of four psychiatric and pediatric clinics because of the suspected presence of attention and behavior problems. DSM-IV diagnosis was performed by clinicians assisted with a semi-structured clinical interview. EEG (theta/beta ratio) and ratings scales (Conners Rating Scales-Revised and ADHD Rating Scales-IV) were collected separately in a blinded protocol. ADHD prevalence in the clinical sample was 61%, whereas the remainder had other childhood/adolescent disorders or no diagnosis. Comorbidities were observed in 66% of ADHD patients and included mood, anxiety, disruptive, and learning disorders at rates similar to previous findings. EEG identified ADHD with 87% sensitivity and 94% specificity. Rating scales provided sensitivity of 38-79% and specificity of 13-61%. While parent or teacher identification of ADHD by rating scales was reduced in accuracy when applied to a diverse clinical sample, theta/beta ratio changes remained consistent with the clinician's ADHD diagnosis. Because theta/beta ratio changes do not identify comorbidities or alternative diagnoses, the results do not support the use of EEG as a stand-alone diagnostic and should be limited to the interpretation that EEG may complement a clinical evaluation for ADHD. PMID:18423617

  4. Crystal structure of rat alpha-parvalbumin at 1.05 Angstrom resolution.

    PubMed

    Bottoms, Christopher A; Schuermann, Jonathan P; Agah, Sayeh; Henzl, Michael T; Tanner, John J

    2004-07-01

    The crystal structure of rat alpha-parvalbumin has been determined at 1.05 Angstrom resolution, using synchrotron data collected at Advanced Photon Source beamline 19-ID. After refinement with SHELX, employing anisotropic displacement parameters and riding hydrogen atoms, R = 0.132 and R(free) = 0.162. The average coordinate estimated standard deviations are 0.021 Angstrom and 0.038 Angstrom for backbone atoms and side-chain atoms, respectively. Besides providing a more precise view of the alpha-isoform than previously available, these data permit comparison with the 0.91 Angstrom structure determined for pike beta-parvalbumin. Visualization of the anisotropic displacement parameters as thermal ellipsoids yields insight into the atomic motion within the Ca(2+)-binding sites. The asymmetric unit includes three parvalbumin (PV) molecules. Interestingly, the EF site in one displays uncharacteristic flexibility. The ellipsoids for Asp-92 are particularly large and non-spherical, and the shape of the Ca(2+) ellipsoid implies significant vibrational motion perpendicular to the plane defined by the four y and z ligands. The relative dearth of crystal-packing interactions in this site suggests that the heightened flexibility may be the result of diminished intermolecular contacts. The implication is that, by impeding conformational mobility, crystal-packing forces may cause serious overestimation of EF-hand rigidity. The high quality of the data permitted 11 residues to be modeled in alternative side-chain conformations, including the two core residues, Ile-97 and Leu-105. The discrete disorder observed for Ile-97 may have functional ramifications, providing a mechanism for communicating binding status between the CD and EF binding loops and between the PV metal ion-binding domain and the N-terminal AB region. PMID:15169955

  5. Variation of Community Consultation and Public Disclosure for a Pediatric Multi-centered “Exception from Informed Consent” Trial

    PubMed Central

    Holsti, Maija; Zemek, Roger; Baren, Jill; Stanley, Rachel M.; Prashant, Mahajan; Vance, Cheryl; Brown, Kathleen M.; Gonzalez, Victor; King, Denise; Jacobsen, Kammy; Shreve, Kate; van de Bruinhorst, Katrina; Jones, Anne Marie; Chamberlain, James M.

    2014-01-01

    Background The U.S. federal regulation “Exception from Informed Consent (EFIC) for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards (IRBs) determine the adequacy of these activities at a local level. Thus there is potential for broad interpretation and practice variation. Aim To describe the variation of community consultation and public disclosure activities approved by IRBs, and the effectiveness of this process for a multi-center, EFIC, pediatric status epilepticus clinical research trial. Methods: Community consultation and public disclosure activities were analyzed for each of 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. Results Every IRB, among the 15 participating sites, had a varied interpretation of EFIC regulations for community consultation and public disclosure activities. IRBs required various combinations of focus groups, interviews, surveys, and meetings for community consultation; news releases, mailings, and public service announcements for public disclosure. At least 4,335 patients received information about the study from these efforts. 158 chose to be included in the “Opt Out” list. Of the 304 participants who were enrolled under EFIC, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for

  6. A Multi-Center Controlled Study of the Acute and Chronic Effects of Cooling Therapy for MS

    NASA Technical Reports Server (NTRS)

    Luna, Bernadette; Schwid, Steven W.; Cutter, Gary; Murray, Ronald; Bowen, James; Pellegrino, Richard; Guisado, Raul; Webbon, Bruce W.; DeVincenzi, Donald (Technical Monitor)

    2000-01-01

    To determine the acute and chronic effects of cooling therapy on patients with MS using objective functional performance measures and self-assessed measures of fatigue. Cooling demyelinated nerves can reduce conduction block, potentially improving symptoms of MS. Significant acute and chronic effects of cooling have not been demonstrated in a multi-center, controlled, blinded study using objective measures of neurologic function. Patients (N=84) with definite MS, mild to moderate disability (EDSS less than 6.0), and self-reported heat sensitivity were enrolled at 5 study sites. Acute effects of cooling were assessed by randomly assigning subjects to high-dose or low-dose cooling for one hour using an active cooling vest and cap (Life Enhancement Technologies, Santa Clara, CA). Settings were individualized to maintain the cooling garments at 55 F for the high-dose treatment and 70 F for the low-dose treatment. Both patients and examining investigators were blinded to treatment assignments. The MSFC and visual acuity/contrast sensitivity were assessed before and 30 minutes after treatment. The following week, subjects had an identical visit with the alternate cooling treatment. Chronic effects of cooling were assessed by randomly assigning the same subjects to unblinded daily home cooling or observation for 4 weeks. All subjects completed the Rochester Fatigue Diary (RFD) twice weekly and subjective measures of strength, cognition, and energy level daily. At the end of the period, subjects completed the Modified Fatigue Impact Scale (MFIS) and underwent another high-dose cooling session with assessment of the MSFC and vision. After a one-week washout period, subjects crossed over to the alternate 4-week treatment. Oral temperatures were reduced with both acute treatments (0.8 +/- .06 F, high and 0.5 +/- .06 F, low). While mean MSFC did not change significantly during individual cooling sessions, post hoc analysis pooling the 3 high-dose cooling sessions revealed an

  7. Testing the methodology for dosimetry audit of heterogeneity corrections and small MLC-shaped fields: Results of IAEA multi-center studies

    PubMed Central

    Izewska, Joanna; Wesolowska, Paulina; Azangwe, Godfrey; Followill, David S.; Thwaites, David I.; Arib, Mehenna; Stefanic, Amalia; Viegas, Claudio; Suming, Luo; Ekendahl, Daniela; Bulski, Wojciech; Georg, Dietmar

    2016-01-01

    Abstract The International Atomic Energy Agency (IAEA) has a long tradition of supporting development of methodologies for national networks providing quality audits in radiotherapy. A series of co-ordinated research projects (CRPs) has been conducted by the IAEA since 1995 assisting national external audit groups developing national audit programs. The CRP ‘Development of Quality Audits for Radiotherapy Dosimetry for Complex Treatment Techniques’ was conducted in 2009–2012 as an extension of previously developed audit programs. Material and methods. The CRP work described in this paper focused on developing and testing two steps of dosimetry audit: verification of heterogeneity corrections, and treatment planning system (TPS) modeling of small MLC fields, which are important for the initial stages of complex radiation treatments, such as IMRT. The project involved development of a new solid slab phantom with heterogeneities containing special measurement inserts for thermoluminescent dosimeters (TLD) and radiochromic films. The phantom and the audit methodology has been developed at the IAEA and tested in multi-center studies involving the CRP participants. Results. The results of multi-center testing of methodology for two steps of dosimetry audit show that the design of audit procedures is adequate and the methodology is feasible for meeting the audit objectives. A total of 97% TLD results in heterogeneity situations obtained in the study were within 3% and all results within 5% agreement with the TPS predicted doses. In contrast, only 64% small beam profiles were within 3 mm agreement between the TPS calculated and film measured doses. Film dosimetry results have highlighted some limitations in TPS modeling of small beam profiles in the direction of MLC leave movements. Discussion. Through multi-center testing, any challenges or difficulties in the proposed audit methodology were identified, and the methodology improved. Using the experience of these

  8. Spectrophotometry of J8, J9, and four Trojan asteroids from 0.32 to 1.05 microns

    NASA Technical Reports Server (NTRS)

    Smith, D. W.; Johnson, P. E.; Shorthill, R. W.

    1981-01-01

    New 30-channel narrowband photometry from 0.32 to 1.05 microns of the retrograde Jovian satellites J9 (to 0.7 micron) and J8 and the trailing Trojan asteroids 617, 884, 1172, and 1173 is presented. The data confirm previous measurements of J8, 617, 884, and 1172 at wavelengths less than 0.8 micron, but the extension into the infrared shows that the normalized spectral reflectance of these objects rises steadily from approximately 0.8 at 0.4 micron to approximately 1.4 at 1.05 microns, suggesting they are too bright in the near infrared to be C-type asteroids. The C classification of 1173 is confirmed. J9 is markedly redder than J8 at visible wavelengths. The results indicate a greater taxonomic contrast between these distant objects and main-belt asteroids than previously thought.

  9. Study of ablation by laser irradiation of plane targets at wavelengths 1. 05, 0. 53, and 0. 35. mu. m

    SciTech Connect

    Key, M.H.; Toner, W.T.; Goldsack, T.J.; Kilkenny, J.D.; Veats, S.A.; Cunningham, P.F.; Lewis, C.L.S.

    1983-07-01

    Ablation by laser irradiation at wavelengths lambda = 1.05, 0.53, and 0.35 ..mu..m has been studied from analysis of time-resolved x-ray spectra of layered targets and of ion emission. Irradiance was varied in the range 2 x 10/sup 13/ to 2 x 10/sup 15/ W cm/sup -2/ with constant laser power and variable focal spot size. Deductions include the effect of lateral energy transport from small focal spots and ablation rates and ablation pressures obtained both in the limit of negligible transport and when lateral transport is significant. Advantages of short wavelengths for ablatively driven implosions are quantified.

  10. Scan-rescan reproducibility of quantitative assessment of inflammatory carotid atherosclerotic plaque using dynamic contrast-enhanced 3T CMR in a multi-center study

    PubMed Central

    2014-01-01

    Background The aim of this study is to investigate the inter-scan reproducibility of kinetic parameters in atherosclerotic plaque using dynamic contrast-enhanced (DCE) cardiovascular magnetic resonance (CMR) in a multi-center setting at 3T. Methods Carotid arteries of 51 subjects from 15 sites were scanned twice within two weeks on 3T scanners using a previously described DCE-CMR protocol. Imaging data with protocol compliance and sufficient image quality were analyzed to generate kinetic parameters of vessel wall, expressed as transfer constant (Ktrans) and plasma volume (vp). The inter-scan reproducibility was evaluated using intra-class correlation coefficient (ICC) and coefficient of variation (CV). Power analysis was carried out to provide sample size estimations for future prospective study. Results Ten (19.6%) subjects were found to suffer from protocol violation, and another 6 (11.8%) had poor image quality (n = 6) in at least one scan. In the 35 (68.6%) subjects with complete data, the ICCs of Ktrans and vp were 0.65 and 0.28, respectively. The CVs were 25% and 62%, respectively. The ICC and CV for vp improved to 0.73 and 28% in larger lesions with analyzed area larger than 25 mm2. Power analysis based on the measured CV showed that 50 subjects per arm are sufficient to detect a 20% difference in change of Ktrans over time between treatment arms with 80% power without consideration of the dropout rate. Conclusion The result of this study indicates that quantitative measurement from DCE-CMR is feasible to detect changes with a relatively modest sample size in a prospective multi-center study despite the limitations. The relative high dropout rate suggested the critical needs for intensive operator training, optimized imaging protocol, and strict quality control in future studies. PMID:25084698

  11. Interplay between magnetic impurity and superconductivity in annealed Fe1.05Te0.75Se0.25

    NASA Astrophysics Data System (ADS)

    Lin, Wenzhi; Ganesh, Panchapakesan; Gianfrancesco, Anthony; Berlijn, Tom; Maier, Thomas; Kalilin, Sergei; Sales, Brian; Pan, Minghu

    2014-03-01

    By annealing Fe1.05Te0.75Se0.25 in Te vapor, we are able to recover the moment of the magnetic impurity in the bulk chalcogenide superconductor, and enhance the superconductivity in the material. Scanning tunneling microscopy/ spectroscopy studies across a local magnetic impurity reveal the modification of electronic structure around the impurity on the surface of Fe1.05Te0.75Se0.25 sample after being annealed in the Te-vapor. The superconducting gap feature, normally seen on a pristine area, is suppressed around the magnetic impurity. In addition, density-functional theory calculations are carried out to identify the atomic structure, chemical composition and magnetic moment of impurity. Research was supported (WL, BCS, SVK) by Materials Sciences and Engineering Division, Basic Energy Sciences, the U.S. Department of Energy. This research was conducted (WL, MP) at the Center for Nanophase Materials Sciences, which is sponsored at Oak Ridge National Laboratory by the Scientific User Facilities Division, Office of Basic Energy Sciences, U.S. Department of Energy. Fellowship support (AG) from the UT/ORNL Bredesen Center for Interdisciplinary Research and Graduate Education.

  12. Engineering Protein Allostery: 1.05 Å Resolution Structure and Enzymatic Properties of a Na[superscript +]-activated Trypsin

    SciTech Connect

    Page, Michael J.; Carrell, Christopher J.; Di Cera, Enrico

    2008-05-28

    Some trypsin-like proteases are endowed with Na{sup +}-dependent allosteric enhancement of catalytic activity, but this important mechanism has been difficult to engineer in other members of the family. Replacement of 19 amino acids in Streptomyces griseus trypsin targeting the active site and the Na{sup +}-binding site were found necessary to generate efficient Na{sup +} activation. Remarkably, this property was linked to the acquisition of a new substrate selectivity profile similar to that of factor Xa, a Na{sup -} activated protease involved in blood coagulation. The X-ray crystal structure of the mutant trypsin solved to 1.05 {angstrom} resolution defines the engineered Na{sup +} site and active site loops in unprecedented detail. The results demonstrate that trypsin can be engineered into an efficient allosteric protease, and that Na+ activation is interwoven with substrate selectivity in the trypsin scaffold.

  13. Faint meteor observation by large-format CMOS sensor with 1.05-m Kiso schmidt telescope

    NASA Astrophysics Data System (ADS)

    Watanabe, J.; Kasuga, T.; Terai, T.; Miyazaki, S.; Ohta, K.; Murooka, F.; Ohnishi, T.; Yamasaki, T.; Mito, H.; Aoki, T.; Soyano, T.; Tarusawa, K.; Matsunaga, N.; Sako, S.; Kobayashi, N.; Doi, M.; Enomoto, T.

    2014-07-01

    We tried to use a new high-sensitivity CMOS sensor of the world's largest size as a one-chip 20cmx 20cm square attached to the prime focus of the 1.05 m (F3.1) Schmidt telescope at the Kiso Observatory, University of Tokyo, for faint meteor observation. The resulting field of view was 3.3 by 3.3 degrees, with a limiting magnitude of about 12 in our preliminary analysis. Assuming the height of faint meteors at 100 km, the derived flux of sporadic meteors is about 5x10^{-4} km^{-2}s^{-1}. Although the analysis is still on going, it is clear that this CMOS sensor is useful and effective for observing faint meteors.

  14. The Development of the Multi-Center Traffic Management Advisor (MCTMA): Traffic Flow Management Research in a Multi-Facility Environment

    NASA Technical Reports Server (NTRS)

    Lee, Katharine K.; Davis, Thomas J.; Levin, Kerry M.; Rowe, Dennis W.

    2001-01-01

    The Traffic Management Advisor (TMA) is a decision-support tool for traffic managers and air traffic controllers that provides traffic flow visualization and other flow management tools. TMA creates an efficiently sequenced and safely spaced schedule for arrival traffic that meets but does not exceed specified airspace system constraints. TMA is being deployed at selected facilities throughout the National Airspace System in the US as part of the FAA's Free Flight Phase 1 program. TMA development and testing, and its current deployment, focuses on managing the arrival capacity for single major airports within single terminal areas and single en route centers. The next phase of development for this technology is the expansion of the TMA capability to complex facilities in which a terminal area or airport is fed by multiple en route centers, thus creating a multicenter TMA functionality. The focus of the multi-center TMA (McTMA) development is on the busy facilities in the Northeast comdor of the US. This paper describes the planning and development of McTMA and the challenges associated with adapting a successful traffic flow management tool for a very complex airspace.

  15. The Relationship Between Distance to Water Source and Moderate-to-Severe Diarrhea in the Global Enterics Multi-Center Study in Kenya, 2008-2011.

    PubMed

    Nygren, Benjamin L; O'Reilly, Ciara E; Rajasingham, Anangu; Omore, Richard; Ombok, Maurice; Awuor, Alex O; Jaron, Peter; Moke, Fenny; Vulule, John; Laserson, Kayla; Farag, Tamer H; Nasrin, Dilruba; Nataro, James P; Kotloff, Karen L; Levine, Myron M; Derado, Gordana; Ayers, Tracy L; Lash, R Ryan; Breiman, Robert F; Mintz, Eric D

    2016-05-01

    In the developing world, fetching water for drinking and other household uses is a substantial burden that affects water quantity and quality in the household. We used logistic regression to examine whether reported household water fetching times were a risk factor for moderate-to-severe diarrhea (MSD) using case-control data of 3,359 households from the Global Enterics Multi-Center Study in Kenya in 2009-2011. We collected additional global positioning system (GPS) data for a subset of 254 randomly selected households and compared GPS-based straight line and actual travel path distances to fetching times reported by respondents. GPS-based data were highly correlated with respondent-provided times (Spearman correlation coefficient = 0.81, P < 0.0001). The median estimated one-way distance to water source was 200 m for cases and 171 for controls (Wilcoxon rank sums/Mann-Whitney P = 0.21). A round-trip fetching time of > 30 minutes was reported by 25% of cases versus 15% of controls and was significantly associated with MSD where rainwater was not used in the last 2 weeks (odds ratio = 1.97, 95% confidence interval = 1.56-2.49). These data support the United Nations definition of access to an improved water source being within 30 minutes total round-trip travel time. PMID:26928833

  16. HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial

    PubMed Central

    2014-01-01

    Background Pulmonary coagulopathy is a hallmark of lung injury following inhalation trauma. Locally applied heparin attenuates lung injury in animal models of smoke inhalation. Whether local treatment with heparin benefits patients with inhalation trauma is uncertain. The present trial aims at comparing a strategy using frequent nebulizations of heparin with standard care in intubated and ventilated burn patients with bronchoscopically confirmed inhalation trauma. Methods The Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized HEParin versus Placebo in BURN Patients with Inhalation Trauma (HEPBURN) is an international multi-center, double-blind, placebo-controlled, two-arm study. One hundred and sixteen intubated and ventilated burn patients with confirmed inhalation trauma are randomized to nebulizations of heparin (the nebulized heparin strategy) or nebulizations of normal saline (the control strategy) every four hours for 14 days or until extubation, whichever comes first. The primary endpoint is the number of ventilator-free days, defined as days alive and breathing without assistance during the first 28 days, if the period of unassisted breathing lasts for at least 24 consecutive hours. Discussion As far as the authors know, HEPBURN is the first randomized, placebo-controlled trial, powered to investigate whether local treatment with heparin shortens duration of ventilation of intubated and ventilated burn patients with inhalation trauma. Trial registration NCT01773083 (http://www.clinicaltrials.gov), registered on 16 January 2013. Recruiting. Randomisation commenced on 1 January 2014. PMID:24661817

  17. Hepatitis B Virus Vaccination Coverage in Medical, Nursing, and Paramedical Students: A Cross-Sectional, Multi-Centered Study in Greece.

    PubMed

    Papagiannis, Dimitrios; Tsimtsiou, Zoi; Chatzichristodoulou, Ioanna; Adamopoulou, Maria; Kallistratos, Ilias; Pournaras, Spyros; Arvanitidou, Malamatenia; Rachiotis, George

    2016-03-01

    Students of health professions are at high risk of hepatitis B Virus (HBV) infection during their clinical training. The aim of this cross-sectional, multi-centered study was to investigate the HBV vaccination coverage in Greek medical, nursing, and paramedical students, to look into their attitudes towards the importance of vaccines and to reveal reasons associated with not being vaccinated. A self-completed, anonymous questionnaire was distributed to 2119 students of health professions in Greece, during the academic year 2013-2014. The HBV vaccination coverage of students was high (83%), being higher among medical students (88.1%, vs. 81.4% among nursing and 80.1% among paramedical students; p < 0.001). The vast majority of them (95%) have been vaccinated during childhood. In addition, 30% of the unvaccinated students declared fear over HBV safety. Our results indicate that the healthcare students achieved higher reported immunization rates compared to the currently serving healthcare workers, but also to the students of the last decade. The fact that nursing and paramedical students have lower coverage figures underlines the importance of targeted interventions for the different subgroups of healthcare students in terms of educational programs and screening for HBV markers in order to increase HBV vaccination uptake. PMID:26999171

  18. The Pregnancy in Polycystic Ovary Syndrome Study II: Baseline Characteristics and Effects of Obesity from a Multi-Center Randomized Clinical Trial

    PubMed Central

    Legro, Richard S.; Brzyski, Robert G.; Diamond, Michael P.; Coutifaris, Christos; Schlaff, William D.; Alvero, Ruben; Casson, Peter; Christman, Gregory M.; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J.; Barnhart, Kurt T.; Bates, G. Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J.C.; Krawetz, Stephen A.; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2014-01-01

    Objective To summarize baseline characteristics from a large multi-center infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of 2 treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the U.S. Interventions None Main Outcome Measure(s) Historical, biometric, biochemical and questionnaire parameters. Participants 750 women with PCOS and their male partners took part in the study. Results Females averaged ~30 years old and were obese (BMI 35) with ~20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). . Most of the females had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH:FSH ratio (~2), and AMH levels (8.0 ng/mL). Additionally, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH:FSH levels, AMH levels and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Males were obese (BMI 30) and had normal mean semen parameters. Conclusions The treatment groups were well-matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. PMID:24156957

  19. Hepatitis B Virus Vaccination Coverage in Medical, Nursing, and Paramedical Students: A Cross-Sectional, Multi-Centered Study in Greece

    PubMed Central

    Papagiannis, Dimitrios; Tsimtsiou, Zoi; Chatzichristodoulou, Ioanna; Adamopoulou, Maria; Kallistratos, Ilias; Pournaras, Spyros; Arvanitidou, Malamatenia; Rachiotis, George

    2016-01-01

    Students of health professions are at high risk of hepatitis B Virus (HBV) infection during their clinical training. The aim of this cross-sectional, multi-centered study was to investigate the HBV vaccination coverage in Greek medical, nursing, and paramedical students, to look into their attitudes towards the importance of vaccines and to reveal reasons associated with not being vaccinated. A self-completed, anonymous questionnaire was distributed to 2119 students of health professions in Greece, during the academic year 2013–2014. The HBV vaccination coverage of students was high (83%), being higher among medical students (88.1%, vs. 81.4% among nursing and 80.1% among paramedical students; p < 0.001). The vast majority of them (95%) have been vaccinated during childhood. In addition, 30% of the unvaccinated students declared fear over HBV safety. Our results indicate that the healthcare students achieved higher reported immunization rates compared to the currently serving healthcare workers, but also to the students of the last decade. The fact that nursing and paramedical students have lower coverage figures underlines the importance of targeted interventions for the different subgroups of healthcare students in terms of educational programs and screening for HBV markers in order to increase HBV vaccination uptake. PMID:26999171

  20. No association of TGFB1 L10P genotypes and breast cancer risk in BRCA1 and BRCA2 mutation carriers: a multi-center cohort study

    PubMed Central

    Antoniou, Antonis C.; Llopis, Trinidad Caldes; Nevanlinna, Heli; Aittomäki, Kristiina; Simard, Jacques; Spurdle, Amanda B.; Couch, Fergus J.; Pereira, Lutecia H. Mateus; Greene, Mark H.; Andrulis, Irene L.; Pasche, Boris; Kaklamani, Virginia; Hamann, Ute; Szabo, Csilla; Peock, Susan; Cook, Margaret; Harrington, Patricia A.; Donaldson, Alan; Male, Allison M.; Gardiner, Carol Anne; Gregory, Helen; Side, Lucy E.; Robinson, Anne C.; Emmerson, Louise; Ellis, Ian; Peyrat, Jean-Philippe; Fournier, Joëlle; Vennin, Philippe; Adenis, Claude; Muller, Danièle; Fricker, Jean-Pierre; Longy, Michel; Sinilnikova, Olga M.; Stoppa-Lyonnet, Dominique; Schmutzler, Rita K.; Versmold, Beatrix; Engel, Christoph; Meindl, Alfons; Kast, Karin; Schaefer, Dieter; Froster, Ursula G.; Chenevix-Trench, Georgia; Easton, Douglas F.

    2008-01-01

    Background The transforming growth factor β-1 gene (TGFB1) is a plausible candidate for breast cancer susceptibility. The L10P variant of TGFB1 is associated with higher circulating levels and secretion of TGF-β, and recent large-scale studies suggest strongly that this variant is associated with breast cancer risk in the general population. Methods To evaluate whether TGFB1 L10P also modifies the risk of breast cancer in BRCA1 or BRCA2 mutation carriers, we undertook a multi-center study of 3,442 BRCA1 and 2,095 BRCA2 mutation carriers. Results We found no evidence of association between TGFB1 L10P and breast cancer risk in either BRCA1 or BRCA2 mutation carriers. The per-allele HR for the L10P variant was 1.01 (95%CI: 0.92–1.11) in BRCA1 carriers and 0.92 (95%CI: 0.81–1.04) in BRCA2 mutation carriers. Conclusions These results do not support the hypothesis that TGFB1 L10P genotypes modify the risk of breast cancer in BRCA1 or BRCA2 mutation carriers. PMID:18523885

  1. A 1.05 M{sub ☉} companion to PSR J2222–0137: The coolest known white dwarf?

    SciTech Connect

    Kaplan, David L.; Boyles, Jason; McLaughlin, Maura A.; Lorimer, Duncan R.; Dunlap, Bart H.; Tendulkar, Shriharsh P.; Deller, Adam T.; Ransom, Scott M.; Stairs, Ingrid H.

    2014-07-10

    The recycled pulsar PSR J2222–0137 is one of the closest known neutron stars (NSs) with a parallax distance of 267{sub −0.9}{sup +1.2} pc and an edge-on orbit. We measure the Shapiro delay in the system through pulsar timing with the Green Bank Telescope, deriving a low pulsar mass (1.20 ± 0.14 M{sub ☉}) and a high companion mass (1.05 ± 0.06 M{sub ☉}) consistent with either a low-mass NS or a high-mass white dwarf. We can largely reject the NS hypothesis on the basis of the system's extremely low eccentricity (3 × 10{sup –4})—too low to have been the product of two supernovae under normal circumstances. However, despite deep optical and near-infrared searches with Southern Astrophysical Research and the Keck telescopes we have not discovered the optical counterpart of the system. This is consistent with the white dwarf hypothesis only if the effective temperature is <3000 K, a limit that is robust to distance, mass, and atmosphere uncertainties. This would make the companion to PSR J2222–0137 one of the coolest white dwarfs ever observed. For the implied age to be consistent with the age of the Milky Way requires the white dwarf to have already crystallized and entered the faster Debye-cooling regime.

  2. A 1.05 M ⊙ Companion to PSR J2222-0137: The Coolest Known White Dwarf?

    NASA Astrophysics Data System (ADS)

    Kaplan, David L.; Boyles, Jason; Dunlap, Bart H.; Tendulkar, Shriharsh P.; Deller, Adam T.; Ransom, Scott M.; McLaughlin, Maura A.; Lorimer, Duncan R.; Stairs, Ingrid H.

    2014-07-01

    The recycled pulsar PSR J2222-0137 is one of the closest known neutron stars (NSs) with a parallax distance of 267_{-0.9}^{+1.2} pc and an edge-on orbit. We measure the Shapiro delay in the system through pulsar timing with the Green Bank Telescope, deriving a low pulsar mass (1.20 ± 0.14 M ⊙) and a high companion mass (1.05 ± 0.06 M ⊙) consistent with either a low-mass NS or a high-mass white dwarf. We can largely reject the NS hypothesis on the basis of the system's extremely low eccentricity (3 × 10-4)—too low to have been the product of two supernovae under normal circumstances. However, despite deep optical and near-infrared searches with Southern Astrophysical Research and the Keck telescopes we have not discovered the optical counterpart of the system. This is consistent with the white dwarf hypothesis only if the effective temperature is <3000 K, a limit that is robust to distance, mass, and atmosphere uncertainties. This would make the companion to PSR J2222-0137 one of the coolest white dwarfs ever observed. For the implied age to be consistent with the age of the Milky Way requires the white dwarf to have already crystallized and entered the faster Debye-cooling regime.

  3. 1.05-GHz CMOS oscillator based on lateral- field-excited piezoelectric AlN contour- mode MEMS resonators.

    PubMed

    Zuo, Chengjie; Van der Spiegel, Jan; Piazza, Gianluca

    2010-01-01

    This paper reports on the first demonstration of a 1.05-GHz microelectromechanical (MEMS) oscillator based on lateral-field-excited (LFE) piezoelectric AlN contourmode resonators. The oscillator shows a phase noise level of -81 dBc/Hz at 1-kHz offset frequency and a phase noise floor of -146 dBc/Hz, which satisfies the global system for mobile communications (GSM) requirements for ultra-high frequency (UHF) local oscillators (LO). The circuit was fabricated in the AMI semiconductor (AMIS) 0.5-microm complementary metaloxide- semiconductor (CMOS) process, with the oscillator core consuming only 3.5 mW DC power. The device overall performance has the best figure-of-merit (FoM) when compared with other gigahertz oscillators that are based on film bulk acoustic resonator (FBAR), surface acoustic wave (SAW), and CMOS on-chip inductor and capacitor (CMOS LC) technologies. A simple 2-mask process was used to fabricate the LFE AlN resonators operating between 843 MHz and 1.64 GHz with simultaneously high Q (up to 2,200) and kt 2 (up to 1.2%). This process further relaxes manufacturing tolerances and improves yield. All these advantages make these devices suitable for post-CMOS integrated on-chip direct gigahertz frequency synthesis in reconfigurable multiband wireless communications. PMID:20040430

  4. Multi-Center Randomized Phase II Study Comparing Cediranib plus Gefitinib with Cediranib plus Placebo in Subjects with Recurrent/Progressive Glioblastoma

    PubMed Central

    Brown, Nicholas; McBain, Catherine; Nash, Stephen; Hopkins, Kirsten; Sanghera, Paul; Saran, Frank; Phillips, Mark; Dungey, Fiona; Clifton-Hadley, Laura; Wanek, Katharina; Krell, Daniel; Jeffries, Sarah; Khan, Iftekhar; Smith, Paul; Mulholland, Paul

    2016-01-01

    Background Cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, failed to show benefit over lomustine in relapsed glioblastoma. One resistance mechanism for cediranib is up-regulation of epidermal growth factor receptor (EGFR). This study aimed to determine if dual therapy with cediranib and the oral EGFR inhibitor gefitinib improved outcome in recurrent glioblastoma. Methods and Findings This was a multi-center randomized, two-armed, double-blinded phase II study comparing cediranib plus gefitinib versus cediranib plus placebo in subjects with first relapse/first progression of glioblastoma following surgery and chemoradiotherapy. The primary outcome measure was progression free survival (PFS). Secondary outcome measures included overall survival (OS) and radiologic response rate. Recruitment was terminated early following suspension of the cediranib program. 38 subjects (112 planned) were enrolled with 19 subjects in each treatment arm. Median PFS with cediranib plus gefitinib was 3.6 months compared to 2.8 months for cediranib plus placebo (HR; 0.72, 90% CI; 0.41 to 1.26). Median OS was 7.2 months with cediranib plus gefitinib and 5.5 months with cediranib plus placebo (HR; 0.68, 90% CI; 0.39 to 1.19). Eight subjects (42%) had a partial response in the cediranib plus gefitinib arm versus five patients (26%) in the cediranib plus placebo arm. Conclusions Cediranib and gefitinib in combination is tolerated in patients with glioblastoma. Incomplete recruitment led to the study being underpowered. However, a trend towards improved survival and response rates with the addition of gefitinib to cediranib was observed. Further studies of the combination incorporating EGFR and VEGF inhibition are warranted. Trial Registration ClinicalTrials.gov NCT01310855 PMID:27232884

  5. Fever Control Management Is Preferable to Mild Therapeutic Hypothermia in Traumatic Brain Injury Patients with Abbreviated Injury Scale 3-4: A Multi-Center, Randomized Controlled Trial.

    PubMed

    Hifumi, Toru; Kuroda, Yasuhiro; Kawakita, Kenya; Yamashita, Susumu; Oda, Yasutaka; Dohi, Kenji; Maekawa, Tsuyoshi

    2016-06-01

    In our prospective, multi-center, randomized controlled trial (RCT)-the Brain Hypothermia (B-HYPO) study-we could not show any difference on neurological outcomes in patients probably because of the heterogeneity in the severity of their traumatic condition. We therefore aimed to clarify and compare the effectiveness of the two therapeutic temperature management regimens in severe (Abbreviated Injury Scale [AIS] 3-4) or critical trauma patients (AIS 5). In the present post hoc B-HYPO study, we re-evaluated data based on the severity of trauma as AIS 3-4 or AIS 5 and compared Glasgow Outcome Scale score and mortality at 6 months by per-protocol analyses. Consequently, 135 patients were enrolled. Finally, 129 patients, that is, 47 and 31 patients with AIS 3-4 and 36 and 15 patients with AIS 5 were allocated to the mild therapeutic hypothermia (MTH) and fever control groups, respectively. No significant intergroup differences were observed with regard to age, gender, scores on head computed tomography (CT) scans, and surgical operation for traumatic brain injury (TBI), except for Injury Severity Score (ISS) in AIS 5. The fever control group demonstrated a significant reduction of TBI-related mortality compared with the MTH group (9.7% vs. 34.0%, p = 0.02) and an increase of favorable neurological outcomes (64.5% vs. 51.1%, p = 0.26) in patients with AIS 3-4, although the latter was not statistically significant. There was no difference in mortality or favorable outcome in patients with AIS 5. Fever control may be considered instead of MTH in patients with TBI (AIS 3-4). PMID:26413933

  6. Management of Adult Chronic Immune Thrombocytopenia in Japan: Patient and Hematologist Perspectives from a Multi-center Cross-sectional Questionnaire Survey.

    PubMed

    Tsukune, Yutaka; Komatsu, Norio

    2016-01-01

    Objective The objective of this study was to explore the perspective of hematologists and their patients regarding the management of adult chronic immune thrombocytopenia (ITP). Methods This was a multi-center, questionnaire-based, cross-sectional study conducted between 2012 and 2013 throughout Japan. Patients Hematologists, members of the Japanese Society of Hematology in 171 institutions, and their patients were invited to participate in this study. The hematologists were mainly asked about their treatment strategies, while patients were asked about their opinion of the applied treatments, treatment effect, impact on their quality of life (QOL), and treatment satisfaction. Results Questionnaires from 204 hematologists and 213 patients were collected. One hundred sixty hematologists (78.4%) started treatment based on the patient's platelet count. Corticosteroids were considered to be the most effective treatment (44.1%). Forty-six percent of hematologists responded that treatment would be started after the platelet count fell below 20×10(9)/L with bleeding symptoms, compared to 62.9% for patients with no bleeding symptoms. A platelet count of 50×10(9)/L or lower was acceptable for 94.0% of hematologists and 66.8% of patients. Fatigue was most frequently experienced by patients (44.6%). Patients also experienced psychological symptoms (feeling of anxiety or depressive mood: 29.1%, labyrinthitis: 23.5%). While 70.6% of hematologists assumed that the patient QOL was impaired to a moderate to substantial degree, the QOL was impaired in 34.3% of patients. Conclusion A substantial gap which exists between hematologists and their patients highlights a need for better understanding of potential conflicts for establishing effective strategies for ITP management. PMID:27580537

  7. Impaired visual fixation at age 2 years in children born before the 28th week of gestation. Antecedents and correlates in the multi-center ELGAN Study

    PubMed Central

    Phadke, Anuradha; Msall, Michael E; Droste, Patrick; Allred, Elizabeth N; O'Shea, T. Michael; Kuban, Karl; Dammann, Olaf; Leviton, Alan

    2014-01-01

    Background Very little is known about the prevalence, antecedents and correlates of impaired visual fixation in former very preterm newborns. Methods In the multi-center ELGAN Study sample of 1057 infants born before the 28th week of gestation who had a developmental assessment at 2 years corrected age, we identified 73 who were unable to follow an object across the midline. We compared them to the 984 infants who could follow an object across the midline. Results In this sample of very preterm newborns, those who had impaired visual fixation were much more likely than those without impaired visual fixation to have been born after the shortest of gestations (odds ratio = 3.2; 99% confidence interval =1.4, 7.5) and exposed to maternal aspirin (OR: 5.2; 99% CI: 2.2, 12). They were also more likely than their peers to have had prethreshold ROP (OR: 4.1; 99% CI: 1.8, 9.0). At age 2 years, the children with impaired fixation were more likely than others to be unable to walk (even with assistance) (OR: 7.5; 99% CI: 2.2, 26) and have a Mental Development Index more than 3 standard deviations below the mean of a normative sample (OR:3.6; 99% CI: 1.4, 8.2). Conclusion Risk factors for brain and retinal damage, such as very low gestational age, appear to be risk factors for impaired visual fixation. This inference is further supported by the co-occurrence at age 2 years of impaired visual fixation, inability to walk, and a very low Mental Development Index PMID:24938138

  8. Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment: a prospective web-based multi-center study in multiple sclerosis patients with a relapse.

    PubMed

    Jongen, Peter Joseph; Stavrakaki, Ioanna; Voet, Bernard; Hoogervorst, Erwin; van Munster, Erik; Linssen, Wim H; Sinnige, Ludovicus G; Verhagen, Wim I; Visser, Leo H; van der Kruijk, Ruud; Verheul, Freek; Boringa, Jan; Heerings, Marco; Gladdines, Werner; Lönnqvist, Fredrik; Gaillard, Pieter

    2016-08-01

    In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-report questionnaires stating IVMP's most common AEs were completed at baseline, the 2nd day of treatment, and 1 day and 1 week after treatment. Eighty-five patients were included, 66 completed the baseline questionnaire, and 59 completed at least one post-baseline questionnaire. Patients reported on average 4 (median) AEs; two (3.4 %) reported no AE. Most frequent was change in taste (61 %), facial flushing (61 %), sick/stomach pain (53 %), sleep disturbance (44 %), appetite change (37 %), agitation (36 %), and behavioral changes (36 %). Of all AEs, 34.3 % were severe and 37.9 % impacted on ADL. A 3-day course resulted in 4 (median) AEs and a 5-day course in 7. All patients with high disease impact had two or more AEs, compared with 79 % of those with low impact (p < 0.01). Of patients with high disability, 45 % had severe AEs, compared with 16 % of those with low disability. Severe central nervous system (CNS)-related AEs occurred two times more frequently in patients with high disease impact, and two-and-a-half times more frequently in patients with high disability. Therefore, in virtually all patients, high-dose IVMP leads to AEs, with about one of three AEs being severe with impact on ADL. Patients with high disease impact or high disability may experience more (severe) AEs, due to a higher occurrence of severe CNS-related AEs. PMID:27272956

  9. Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma.

    PubMed

    Melchior, Linea; Grauslund, Morten; Bellosillo, Beatriz; Montagut, Clara; Torres, Erica; Moragón, Ester; Micalessi, Isabel; Frans, Johan; Noten, Veerle; Bourgain, Claire; Vriesema, Renske; van der Geize, Robert; Cokelaere, Kristof; Vercooren, Nancy; Crul, Katrien; Rüdiger, Thomas; Buchmüller, Diana; Reijans, Martin; Jans, Caroline

    2015-12-01

    The advent of BRAF-targeted therapies led to increased survival in patients with metastatic melanomas harboring a BRAF V600 mutation (implicated in 46-48% of malignant melanomas). The Idylla(™) System (Idylla(™)), i.e., the real-time-PCR-based Idylla(™) BRAF Mutation Test performed on the fully-automated Idylla(™) platform, enables detection of the most frequent BRAF V600 mutations (V600E/E2/D, V600K/R/M) in tumor material within approximately 90 min and with 1% detection limit. Idylla(™) performance was determined in a multi-center study by analyzing BRAF mutational status of 148 archival formalin-fixed paraffin-embedded (FFPE) tumor samples from malignant melanoma patients, and comparing Idylla(™) results with assessments made by commercial or in-house routine diagnostic methods. Of the 148 samples analyzed, Idylla(™) initially recorded 7 insufficient DNA input calls and 15 results discordant with routine method results. Further analysis learned that the quality of 8 samples was insufficient for Idylla(™) testing, 1 sample had an invalid routine test result, and Idylla(™) results were confirmed in 10 samples. Hence, Idylla(™) identified all mutations present, including 7 not identified by routine methods. Idylla(™) enables fully automated BRAF V600 testing directly on FFPE tumor tissue with increased sensitivity, ease-of-use, and much shorter turnaround time compared to existing diagnostic tests, making it a tool for rapid, simple and highly reliable analysis of therapeutically relevant BRAF mutations, in particular for diagnostic units without molecular expertise and infrastructure. PMID:26407762

  10. Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study

    PubMed Central

    Le, Khang T.; Woo, Stacey M.; Rassoulian, Shahriar A.; McLachlan, Kimberly; Abbassi, Farah; Garland, Randy W.

    2016-01-01

    Background This prospective multi-center (PURE) clinical study evaluated healing rates for molars after root canal treatment employing the GentleWave® System (Sonendo, Inc., Laguna Hills, CA). Material and Methods Eighty-nine patients met the inclusion criteria and consented for this clinical study after referral for a root canal treatment. All enrolled patients were treated with the GentleWave System. Five endodontists performed the clinical procedures and follow-up evaluations. Pre-operative, intra-operative, and post-operative data were collected from the consented patients. Each patient was evaluated for clinical signs and symptoms. Two trained, blinded, and independent evaluators scored the subject tooth radiographs for apical periodontitis using the periapical index (PAI). The teeth classified as healing or healed were considered as a success and composed of a cumulative success rate of healing. Statistical analysis was performed by using the Fisher’s exact test, Pearson correlation, and multivariate logistic regression analyses of the pre-operative prognostic factors at 0.05 significance level. Results Seventy-seven patients were evaluated at six months with a follow-up rate of 86.5%. The cumulative success rate of healing was 97.4%. Eleven prognostic factors were identified using bivariate analyses. Using logistic analyses, the two prognostic significant variables that were directly correlated to healing were the pre-operative presence of periapical index (p value=0.016), and single treatment visits (p value=0.024). Conclusions In this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System. Key words:Healing rate, root canal treatment, molar, GentleWave™, Sonendo®, Multisonic Ultracleaning™ . PMID:27398180

  11. Impact of compliance with infection management guidelines on outcome in patients with severe sepsis: a prospective observational multi-center study

    PubMed Central

    2014-01-01

    Introduction Current sepsis guidelines recommend antimicrobial treatment (AT) within one hour after onset of sepsis-related organ dysfunction (OD) and surgical source control within 12 hours. The objective of this study was to explore the association between initial infection management according to sepsis treatment recommendations and patient outcome. Methods In a prospective observational multi-center cohort study in 44 German ICUs, we studied 1,011 patients with severe sepsis or septic shock regarding times to AT, source control, and adequacy of AT. Primary outcome was 28-day mortality. Results Median time to AT was 2.1 (IQR 0.8 – 6.0) hours and 3 hours (-0.1 – 13.7) to surgical source control. Only 370 (36.6%) patients received AT within one hour after OD in compliance with recommendation. Among 422 patients receiving surgical or interventional source control, those who received source control later than 6 hours after onset of OD had a significantly higher 28-day mortality than patients with earlier source control (42.9% versus 26.7%, P <0.001). Time to AT was significantly longer in ICU and hospital non-survivors; no linear relationship was found between time to AT and 28-day mortality. Regardless of timing, 28-day mortality rate was lower in patients with adequate than non-adequate AT (30.3% versus 40.9%, P < 0.001). Conclusions A delay in source control beyond 6 hours may have a major impact on patient mortality. Adequate AT is associated with improved patient outcome but compliance with guideline recommendation requires improvement. There was only indirect evidence about the impact of timing of AT on sepsis mortality. PMID:24589043

  12. THE ASSOCIATION BETWEEN PHYSIOLOGIC DEAD-SPACE FRACTION AND MORTALITY IN PATIENTS WITH THE ACUTE RESPIRATORY DISTRESS SYNDROME ENROLLED INTO A PROSPECTIVE MULTI-CENTERED CLINICAL TRIAL

    PubMed Central

    Kallet, Richard H; Zhuo, Hanjing; Liu, Kathleen D.; Calfee, Carolyn S.; Matthay, Michael A

    2014-01-01

    Objective To test the association between pulmonary dead-space fraction (VD/VT) and mortality in patients with ARDS (Berlin Definition, PaO2/FiO2 ≤ 300 mm Hg; PEEP ≥ 5 cm H2O) enrolled into a clinical trial incorporating lung-protective ventilation. Design Prospective, multi-center study. Setting Medical-surgical intensive care units in the United States. Subjects 126 ALI patients enrolled into a phase III randomized, placebo-controlled study of aerosolized albuterol. Interventions None Measurements and Main Results VD/VT and pulmonary mechanics were measured within 4 hours of enrollment and repeated daily on study days 1 and 2 in subjects requiring arterial blood gases for clinical management. At baseline, non-survivors had a trend towards higher VD/VT compared to survivors (0.62 ± 0.11 vs. 0.56 ± 0.11 respectively, p = 0.08). Differences in VD/VT between non-survivors and survivors became significant on study days 1 (0.64 ± 0.12 vs. 0.55 ± 0.11 respectively, p = 0.01) and 2 (0.67 ± 0.12 vs. 0.56 ± 0.11 respectively, p=0.004). Likewise, the association between VD/VT and mortality was significant on study day 1 (odds ratio per 0.10 change in VD/VT [95% confidence interval]: 6.84 [1.62–28.84] p = 0.01; and study day 2: 4.90 [1.28–18.73] p = 0.02) after adjusting for VD/VT, PaO2/FiO2, oxygenation index, vasopressor use and the primary risk for ARDS. Using a Cox proportional hazard model, VD/VT was associated with a trend towards higher mortality (HR = 4.37 [CI: 0.99 – 19.32]; p = 0.052) that became significant when the analysis was adjusted for daily oxygenation index (HR = 1.74 [95% CI: 1.12 – 3.35] p = 0.04). Conclusions Markedly elevated VD/VT (≥ 0.60) in early ARDS is associated with higher mortality. Measuring VD/VT may be useful in identifying ARDS patients at increased risk of death who are enrolled into a therapeutic trial. PMID:24381187

  13. Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial

    PubMed Central

    de Vos, Alexander M; Rutten, Annemarieke; van de Zaag-Loonen, Hester J; Bots, Michiel L; Dikkers, Riksta; Buiskool, Robert A; Mali, Willem P; Lubbers, Daniel D; Mosterd, Arend; Prokop, Mathias; Rensing, Benno J; Cramer, Maarten J; van Es, H Wouter; Moll, Frans L; van de Pavoordt, Eric D; Doevendans, Pieter A; Velthuis, Birgitta K; Mackaay, Albert J; Zijlstra, Felix; Oudkerk, Matthijs

    2008-01-01

    Background Peripheral arterial disease (PAD) is a common disease associated with a considerably increased risk of future cardiovascular events and most of these patients will die from coronary artery disease (CAD). Screening for silent CAD has become an option with recent non-invasive developments in CT (computed tomography)-angiography and MR (magnetic resonance) stress testing. Screening in combination with more aggressive treatment may improve prognosis. Therefore we propose to study whether a cardiac imaging algorithm, using non-invasive imaging techniques followed by treatment will reduce the risk of cardiovascular disease in PAD patients free from cardiac symptoms. Design The GROUND study is designed as a prospective, multi-center, randomized clinical trial. Patients with peripheral arterial disease, but without symptomatic cardiac disease will be asked to participate. All patients receive a proper risk factor management before randomization. Half of the recruited patients will enter the 'control group' and only undergo CT calcium scoring. The other half of the recruited patients (index group) will undergo the non invasive cardiac imaging algorithm followed by evidence-based treatment. First, patients are submitted to CT calcium scoring and CT angiography. Patients with a left main (or equivalent) coronary artery stenosis of > 50% on CT will be referred to a cardiologist without further imaging. All other patients in this group will undergo dobutamine stress magnetic resonance (DSMR) testing. Patients with a DSMR positive for ischemia will also be referred to a cardiologist. These patients are candidates for conventional coronary angiography and cardiac interventions (coronary artery bypass grafting (CABG) or percutaneous cardiac interventions (PCI)), if indicated. All participants of the trial will enter a 5 year follow up period for the occurrence of cardiovascular events. Sequential interim analysis will take place. Based on sample size calculations about

  14. A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage. Via the inhibition of inflammatory reactions and of apoptosis, stem cell recruitment, advancement of angiogenesis and growth factor release, EPO enhances healing and thus restitutio ad integrum after trauma. Human skin contains EPO receptors and is able to synthesize EPO. We therefore hypothesize that EPO is able to optimize wound healing in thermally injured patients. Methods/Design This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences. Discussion We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries. Trial registration EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT

  15. The design and rationale of a multi-center clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT)

    PubMed Central

    2014-01-01

    Background High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial. Purpose To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants. Methods SPRINT is a multi-center, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. SPRINT recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 ml/min/1.73m2), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first occurrence of a myocardial infarction, acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease

  16. Progress in Multi-Center Probabilistic Wave Forecasting and Ensemble-Based Data Assimilation using LETKF at the US National Weather Service

    NASA Astrophysics Data System (ADS)

    Alves, Jose-Henrique; Bernier, Natacha; Etala, Paula; Wittmann, Paul

    2015-04-01

    The combination of ensemble predictions of Hs made by the US National Weather Service (NEW) and the US Navy Fleet Numerical Meteorological and Oceanography Center (FNMOC) has established the NFCENS, a probabilistic wave forecast system in operations at NCEP since 2011. Computed from 41 combined wave ensemble members, the new product outperforms deterministic and probabilistic forecasts and nowcasts of Hs issued separately at each forecast center, at all forecast ranges. The successful implementation of the NFCENS has brought new opportunities for collaboration with Environment Canada (EC). EC is in the process of adding new global wave model ensemble products to its existing suite of operational regional products. The planned upgrade to the current NFCENS wave multi-center ensemble includes the addition of 20 members from the Canadian WES. With this upgrade, the NFCENS will be renamed North American Wave Ensemble System (NAWES). As part of the new system implementation, new higher-resolution grids and upgrades to model physics using recent advances in source-term parameterizations are being tested. We provide results of a first validation of NAWES relative to global altimeter data, and buoy measurements of waves, as well as its ability to forecast waves during the 2012 North Atlantic hurricane Sandy. A second line of research involving wave ensembles at the NWS is the implementation of a LETKF-based data assimilation system developed in collaboration with the Argentinian Navy Meteorological Service. The project involves an implementation of the 4D-LETKF in the NWS global wave ensemble forecast system GWES. The 4-D scheme initializes a full 81-member ensemble in a 6-hour cycle. The LETKF determines the analysis ensemble locally in the space spanned by the ensemble, as a linear combination of the background perturbations. Observations from three altimeters and one scatterometer were used. Preliminary results for a prototype system running at the NWS, including

  17. A randomized, blinded, controlled and multi-centered field study comparing the efficacy and safety of Bravecto™ (fluralaner) against Frontline™ (fipronil) in flea- and tick-infested dogs

    PubMed Central

    2014-01-01

    Background Fluralaner, a new molecular entity of the isoxazoline class, has potent insecticidal and acaricidal activity and can be safely administered orally to dogs. Methods A randomized, investigator-blinded, multi-centered field study compared the flea- and tick-control efficacy for dogs over a 12-week period with either a single oral dose of Bravecto™ (fluralaner) formulated as a chewable tablet or with three sequential topical Frontline™ (fipronil) treatments. Individual dogs were the experimental unit for ticks and households were the experimental unit for fleas. A total of 108 tick-infested dogs were treated with Bravecto™ (fluralaner) and 54 tick-infested dogs were treated with Frontline™ (fipronil). Dogs in 115 flea-infested households received Bravecto™ (fluralaner) and dogs in 61 flea-infested households received Frontline™ (fipronil). Flea and tick counts were conducted on all dogs at weeks 2, 4, 8, and 12 following initial treatment and efficacy was calculated as the mean percent reduction in tick or flea count at each time point compared with the mean pretreatment initiation count for each treatment group. Additionally, the percentages of tick-free and flea-free households were determined. Results At weeks 2, 4, 8, and 12, Bravecto™ (fluralaner) flea-control efficacy in treated households was 99.2%, 99.8%, 99.8%, and 99.9% respectively, while Frontline™ (fipronil) efficacy was 94.1%, 93.0%, 96.0%, and 97.3%, respectively. Bravecto™ (fluralaner) tick-control efficacy on treated dogs at weeks 2, 4, 8, and 12 was 99.9%, 99.9%, 99.7%, and 100%, respectively, and Frontline™ (fipronil) tick efficacy was 97.6%, 93.8%, 100%, and 100%, respectively. Of dogs showing clinical flea allergy dermatitis (FAD) signs at the study start, 85.7% in the Bravecto™ (fluralaner)-treated group and 55.6% in the Frontline™ (fipronil)-treated group were evaluated at each time point as showing no clinical signs of FAD until study completion. Conclusions

  18. Spin glass in semiconducting KFe1.05Ag0.88Te2 single crystals

    SciTech Connect

    Ryu, H.; Lei, H.; Klobes, B.; Warren, J. B.; Hermann, R. P.; Petrovic, C.

    2015-05-26

    We report discovery of KFe1.05Ag0.88Te2 single crystals with semiconducting spin glass ground state. Composition and structure analysis suggest nearly stoichiometric I4/mmm space group but allow for the existence of vacancies, absent in long range semiconducting antiferromagnet KFe1.05Ag0.88Te2. The subtle change in stoichometry in Fe/Ag sublattice changes magnetic ground state but not conductivity, giving further insight into the semiconducting gap mechanism.

  19. Natural-Cause Mortality and Long-Term Exposure to Particle Components: An Analysis of 19 European Cohorts within the Multi-Center ESCAPE Project

    PubMed Central

    Hoek, Gerard; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul H.; Nieuwenhuijsen, Mark J.; Xun, Wei W.; Katsouyanni, Klea; Dimakopoulou, Konstantina; Marcon, Alessandro; Vartiainen, Erkki; Lanki, Timo; Yli-Tuomi, Tarja; Oftedal, Bente; Schwarze, Per E.; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L.; Östenson, Claes-Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Sørensen, Mette; Eeftens, Marloes; Peeters, Petra H.; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, H. Bas; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Jaensch, Andrea; Ineichen, Alex; Tsai, Ming-Yi; Schaffner, Emmanuel; Probst-Hensch, Nicole M.; Schindler, Christian; Ragettli, Martina S.; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M.; Kukkonen, Jaakko; Sokhi, Ranjeet S.; Vineis, Paolo; Brunekreef, Bert

    2015-01-01

    , Pershagen G, Eriksen KT, Overvad K, Sørensen M, Eeftens M, Peeters PH, Meliefste K, Wang M, Bueno-de-Mesquita HB, Sugiri D, Krämer U, Heinrich J, de Hoogh K, Key T, Peters A, Hampel R, Concin H, Nagel G, Jaensch A, Ineichen A, Tsai MY, Schaffner E, Probst-Hensch NM, Schindler C, Ragettli MS, Vilier A, Clavel-Chapelon F, Declercq C, Ricceri F, Sacerdote C, Galassi C, Migliore E, Ranzi A, Cesaroni G, Badaloni C, Forastiere F, Katsoulis M, Trichopoulou A, Keuken M, Jedynska A, Kooter IM, Kukkonen J, Sokhi RS, Vineis P, Brunekreef B. 2015. Natural-cause mortality and long-term exposure to particle components: an analysis of 19 European cohorts within the Multi-Center ESCAPE Project. Environ Health Perspect 123:525–533; http://dx.doi.org/10.1289/ehp.1408095 PMID:25712504

  20. A multi-center randomized proof-of-concept clinical trial applying [¹⁸F]FDG-PET for evaluation of metabolic therapy with rosiglitazone XR in mild to moderate Alzheimer's disease.

    PubMed

    Tzimopoulou, Sofia; Cunningham, Vincent J; Nichols, Thomas E; Searle, Graham; Bird, Nick P; Mistry, Prafull; Dixon, Ian J; Hallett, William A; Whitcher, Brandon; Brown, Andrew P; Zvartau-Hind, Marina; Lotay, Narinder; Lai, Robert Y K; Castiglia, Mary; Jeter, Barbara; Matthews, Julian C; Chen, Kewei; Bandy, Dan; Reiman, Eric M; Gold, Michael; Rabiner, Eugenii A; Matthews, Paul M

    2010-01-01

    Here we report the first multi-center clinical trial in Alzheimer's disease (AD) using fluorodeoxyglucose positron emission tomography ([18F]FDG-PET) measures of brain glucose metabolism as the primary outcome. We contrasted effects of 12 months treatment with the PPARγ agonist Rosiglitazone XR versus placebo in 80 mild to moderate AD patients. Secondary objectives included testing for reduction in the progression of brain atrophy and improvement in cognition. Active treatment was associated with a sustained but not statistically significant trend from the first month for higher mean values in Kiindex and CMRgluindex, novel quantitative indices related to the combined forward rate constant for [18F]FDG uptake and to the rate of cerebral glucose utilization, respectively. However, neither these nor another analytical approach recently validated using data from the Alzheimer's Disease Neuroimaging Initiative indicated that active treatment decreased the progression of decline in brain glucose metabolism. Rates of brain atrophy were similar between active and placebo groups and measures of cognition also did not suggest clear group differences. Our study demonstrates the feasibility of using [18F]FDG-PET as part of a multi-center therapeutics trial. It suggests that Rosiglitazone is associated with an early increase in whole brain glucose metabolism, but not with any biological or clinical evidence for slowing progression over a 1 year follow up in the symptomatic stages of AD. PMID:20930300

  1. Association of Alcohol Consumption with Markers of Prostate Health and Reproductive Hormone Profiles: A Multi-Center Study of 4535 Men in China

    PubMed Central

    Fang, Fang; Martin, Kuete; Zheng, Yi; Zhang, Hui-Ping; Li, Hong-Gang; Zhu, Chang-Hong; Xiong, Cheng-Liang; Guan, Huang-Tao

    2015-01-01

    Background The effect of alcohol consumption on prostate health and reproductive hormone profiles has long been investigated and currently, no consensus has been reached. Additionally, large studies focusing on this topic are relatively rare in China. Purpose To investigate the association of alcohol consumption with prostate measurements and reproductive hormone profiles in Chinese population; and to examine the relationship between hormone levels and prostate measurements. Methods This cross-sectional study included 4535 men from four representative provinces of China. Demographic details, family history of prostate disease, tobacco and alcohol consumption, as well as International Prostate Symptom Score (I-PSS) were collected through a questionnaire. Total prostate specific antingen (total PSA), free PSA, free PSA/total PSA ratio (f/tPSA), and reproductive hormones were measured in serum. Multi-variable regression models were used to test for association of alcohol consumption with markers of prostate health, used to test for association of alcohol consumption with reproductive hormones, and reproductive hormones with markers of prostate health. Results Alcohol consumption had no obvious impact on total PSA concentration and I-PSS. Current drinkers had lower level of free PSA (β = -0.11, p = 0.02) and f/tPSA (β = -0.03, p = 0.005), former drinkers also had lower level of free PSA (β = -0.19, p = 0.02) when compared with never drinkers. Lower Luteinizing hormone (LH) (β = -1.05, p = 0.01), sex hormone-binding globulin (SHBG) (β = -4.71, p = 0.01) and higher estradiol (β = 7.81, p = 0.01) was found in current drinkers than never drinkers, whereas higher LH (β = 1.04, p = 0.04) and free testosterone (FT) (β = 0.03, p = 0.02) was detected in former drinkers than never drinkers. Furthermore, LH was positively associated with f/tPSA (β = 0.002, p = 0.006), SHBG was also positively related with free PSA (β = 0.003, p = 0.003) and f/tPSA (β = 0.0004, p = 0

  2. Phase diagram and magnetocaloric effects in Ni{sub 1-x}Cr{sub x}MnGe{sub 1.05}

    SciTech Connect

    Aryal, Anil Quetz, Abdiel; Pandey, Sudip; Eubank, Michael; Dubenko, Igor; Ali, Naushad; Samanta, Tapas; Stadler, Shane

    2015-05-07

    The structural and magnetic properties of the Ni{sub 1−x}Cr{sub x}MnGe{sub 1.05} system (for x = 0, 0.035, 0.070, 0.105) have been studied by x-ray diffraction (XRD), differential scanning calorimetry (DSC), and magnetization measurements. A change in crystal structure from orthorhombic to hexagonal was observed in the XRD data at chromium concentrations of x = 0.035, 0.070, and 0.105. The values of the cell parameters and volume of the unit cell for orthorhombic and hexagonal phase were determined. It was found that the partial substitution of Cr for Ni in Ni{sub 1−x}Cr{sub x}MnGe{sub 1.05} results in a first order magnetostructural transition from antiferromagnetic to ferromagnetic (FM) at T{sub M} = 132 K for x = 0.105. A FM to paramagnetic second order transition has been observed at T{sub C} = 204 K. A magnetic entropy change of |ΔS{sub M}| = 4.5 J/kg K for ΔH = 5 T was observed in the vicinity of T{sub C} and T{sub M} for x = 0.105. The values of the latent heat (L = 2.2 J/g) and corresponding total entropy changes (ΔS{sub T} = 16 J/kg K) have been determined from DSC measurements. A concentration-dependent phase diagram of transition temperatures has been constructed using the magnetic and DSC data.

  3. The PanAM study: a multi-center, double-blinded, randomized, non-inferiority study of paracetamol versus non-steroidal anti-inflammatory drugs in treating acute musculoskeletal trauma

    PubMed Central

    2013-01-01

    Background Acute musculoskeletal trauma, including strains, sprains or contusions, occur frequently. Pain management is a crucial component of treatment. However, there is no convincing evidence which drug is superior in managing pain in these patients. The aim of the PanAM Study is to compare analgesic efficacy of three strategies of pain management: paracetamol, diclofenac, or a combination of both in patients with acute musculoskeletal trauma. Methods/design The PanAM Study is a multi-center, double blind randomized controlled trial with non-inferiority design. Included are adult patients presenting to an academic, urban Emergency Department or to a General Practice with acute, blunt, traumatic limb injury. In total, 547 patients will be included using a predefined list of exclusion criteria, to be allocated by randomization to treatment with paracetamol + placebo diclofenac, diclofenac + placebo paracetamol or paracetamol + diclofenac. The hypothesis is that paracetamol will not be inferior to treatment with diclofenac, or the combination of both. Primary outcome will be between-group differences in decrease in pain, measured with Numerical Rating Scales at baseline and at 90 minutes after study drug administration. Secondary outcomes are Numerical Rating Scales at 30 and 60 minutes and measured frequently during three consecutive days after discharge; occurrence of adverse effects; patient satisfaction and an analysis of quality of life and cost-effectiveness. Recruitment started July 2013 and is expected to last a year. Discussion With this multi-center randomized clinical trial we will investigate whether treatment with paracetamol alone is not inferior to diclofenac alone or a combination of both drugs in adult patients with acute musculoskeletal trauma. The main relevance of the trial is to demonstrate the benefits and risks of three commonly used treatment regimens for musculoskeletal trauma. Data that lead to the prevention of severe Non

  4. Achieving lipid goals with rosuvastatin compared with simvastatin in high risk patients in real clinical practice: a randomized, open-label, parallel-group, multi-center study: the DISCOVERY-Beta study.

    PubMed

    Laks, Toivo; Keba, Ester; Leiner, Mariann; Merilind, Eero; Petersen, Mall; Reinmets, Sirje; Väli, Sille; Sööt, Terje; Otter, Karin

    2008-01-01

    The aim of this multi-center, open-label, randomized, parallel-group trial was to compare the efficacy of rosuvastatin with that of simvastatin in achieving the 1998 European Atherosclerosis Society (EAS) lipid treatment goals. 504 patients (> or =18 years) with primary hypercholesterolemia and a 10-year cardiovascular (CV) risk >20% or history of coronary heart disease (CHD) or other established atherosclerotic disease were randomized in a 2:1 ratio to receive rosuvastatin 10 mg or simvastatin 20 mg once daily for 12 weeks. A significantly higher proportion of patients achieved 1998 EAS low-density lipoprotein cholesterol (LDL-C) goal after 12 weeks of treatment with rosuvastatin 10 mg compared to simvastatin 20 mg (64 vs 51.5%, p < 0.01). Similarly, significantly more patients achieved the 1998 EAS total cholesterol (TC) goal and the 2003 EAS LDL-C and TC goals (p < 0.001) with rosuvastatin 10 mg compared with simvastatin 20 mg. The incidence of adverse events and the proportion of patients who discontinued study treatment were similar between treatment groups. In conclusion, in the DISCOVERY-Beta Study in patients with primary hypercholesterolemia greater proportion of patients in the rosuvastatin 10 mg group achieved the EAS LDL-C treatment goal compared with the simvastatin 20 mg group. Drug tolerability was similar across both treatment groups. PMID:19337553

  5. Achieving lipid goals with rosuvastatin compared with simvastatin in high risk patients in real clinical practice: a randomized, open-label, parallel-group, multi-center study: the DISCOVERY-Beta study

    PubMed Central

    Laks, Toivo; Keba, Ester; Leiner, Mariann; Merilind, Eero; Petersen, Mall; Reinmets, Sirje; Väli, Sille; Sööt, Terje; Otter, Karin

    2008-01-01

    The aim of this multi-center, open-label, randomized, parallel-group trial was to compare the efficacy of rosuvastatin with that of simvastatin in achieving the 1998 European Atherosclerosis Society (EAS) lipid treatment goals. 504 patients (≥18 years) with primary hypercholesterolemia and a 10-year cardiovascular (CV) risk >20% or history of coronary heart disease (CHD) or other established atherosclerotic disease were randomized in a 2:1 ratio to receive rosuvastatin 10 mg or simvastatin 20 mg once daily for 12 weeks. A significantly higher proportion of patients achieved 1998 EAS low-density lipoprotein cholesterol (LDL-C) goal after 12 weeks of treatment with rosuvastatin 10 mg compared to simvastatin 20 mg (64 vs 51.5%, p < 0.01). Similarly, significantly more patients achieved the 1998 EAS total cholesterol (TC) goal and the 2003 EAS LDL-C and TC goals (p < 0.001) with rosuvastatin 10 mg compared with simvastatin 20 mg. The incidence of adverse events and the proportion of patients who discontinued study treatment were similar between treatment groups. In conclusion, in the DISCOVERY-Beta Study in patients with primary hypercholesterolemia greater proportion of patients in the rosuvastatin 10 mg group achieved the EAS LDL-C treatment goal compared with the simvastatin 20 mg group. Drug tolerability was similar across both treatment groups. PMID:19337553

  6. Statistical analysis plan for the Stroke Oxygen Study (SO2S): a multi-center randomized controlled trial to assess whether routine oxygen supplementation in the first 72 hours after a stroke improves long-term outcome

    PubMed Central

    2014-01-01

    Background The Stroke Oxygen Study (SO2S) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke. The main hypothesis for the trial is that fixed-dose oxygen treatment during the first 3 days after an acute stroke improves outcome. The secondary hypothesis is that restricting oxygen supplementation to night time only is more effective than continuous supplementation. This paper describes the statistical analysis plan for the study. Methods and design Patients (n = 8000) are randomized to three groups: (1) continuous oxygen supplementation for 72 hours; (2) nocturnal oxygen supplementation for three nights; and (3) no routine oxygen supplementation. Outcomes are recorded at 7 days, 90 days, 6 months, and 12 months. The primary outcome measure is the modified Rankin scale at 90 days. Data will be analyzed according to the intention-to-treat principle. Methods of statistical analysis are described, including the handling of missing data, the covariates used in adjusted analyses, planned subgroups analyses, and planned sensitivity analyses. Trial registration This trial is registered with the ISRCTN register, number ISRCTN52416964 (30 September 2005). PMID:24939648

  7. Prospective multi-center study for quantification of chemotherapies and CTX-related direct medication costs avoided by use of biomarkers uPA and PAI-1 in primary breast cancer.

    PubMed

    Jacobs, Volker R; Augustin, Doris; Wischnik, Arthur; Kiechle, Marion; Höss, Cornelia; Steinkohl, Oliver; Rack, Brigitte; Kapitza, Thomas; Krase, Peter

    2013-08-01

    Biomarkers uPA/PAI-1 as recommended by ASCO and AGO are used in primary breast cancer to avoid unnecessary CTX in medium risk-recurrence patients. This study verified how many CTX cycles and CTX-related direct medication costs can be avoided by uPA/PAI-1 testing. A prospective, non-interventional, multi-center study was performed among six Certified Breast Centers to analyze application of uPA/PAI-1 and consecutive decision-making. CTX avoided were identified and direct costs for CTX, CTX-related concomitant medication and febrile neutropenia (FN) prophylaxis with G-CSF calculated. In n = 93 breast cancers n = 35 CTX (37.6%) with 210 CTX cycles were avoided according to uPA/PAI-1 test result. uPA/PAI-1 testing saved direct medication costs for CTX of 177,453 €, CTX-related concomitant medication of 27,482 € and FN prophylaxis of 20,599 €, overall 225,534 €. At test costs at 287.50 € uPA/PAI-1 testing resulted in additional costs of 26,737.50 €. uPA/PAI-1 has proven to be cost-effective at a return-on-investment ratio of 8.4:1. Indirect cost savings further increase this ROI. These results support decision-making for cost-effective diagnostics and therapy in breast cancer. PMID:23643802

  8. A hybrid framework of first principles molecular orbital calculations and a three-dimensional integral equation theory for molecular liquids: Multi-center molecular Ornstein–Zernike self-consistent field approach

    SciTech Connect

    Kido, Kentaro; Kasahara, Kento; Yokogawa, Daisuke; Sato, Hirofumi

    2015-07-07

    In this study, we reported the development of a new quantum mechanics/molecular mechanics (QM/MM)-type framework to describe chemical processes in solution by combining standard molecular-orbital calculations with a three-dimensional formalism of integral equation theory for molecular liquids (multi-center molecular Ornstein–Zernike (MC-MOZ) method). The theoretical procedure is very similar to the 3D-reference interaction site model self-consistent field (RISM-SCF) approach. Since the MC-MOZ method is highly parallelized for computation, the present approach has the potential to be one of the most efficient procedures to treat chemical processes in solution. Benchmark tests to check the validity of this approach were performed for two solute (solute water and formaldehyde) systems and a simple S{sub N}2 reaction (Cl{sup −} + CH{sub 3}Cl → ClCH{sub 3} + Cl{sup −}) in aqueous solution. The results for solute molecular properties and solvation structures obtained by the present approach were in reasonable agreement with those obtained by other hybrid frameworks and experiments. In particular, the results of the proposed approach are in excellent agreements with those of 3D-RISM-SCF.

  9. Evaluations of treatment efficacy of depression from perspective of both patients' symptoms and general sense of mental health and wellbeing: A large scale, multi-centered, longitudinal study in China.

    PubMed

    Zeng, Qingzhi; Wang, Wei Chun; Fang, Yiru; Mellor, David; Mccabe, Marita; Byrne, Linda; Zuo, Sai; Xu, Yifeng

    2016-07-30

    Relying on the absence, presence of level of symptomatology may not provide an adequate indication of the effects of treatment for depression, nor sufficient information for the development of treatment plans that meet patients' needs. Using a prospective, multi-centered, and observational design, the present study surveyed a large sample of outpatients with depression in China (n=9855). The 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Remission Evaluation and Mood Inventory Tool (REMIT) were administered at baseline, two weeks later and 4 weeks, to assess patients' self-reported symptoms and general sense of mental health and wellbeing. Of 9855 outpatients, 91.3% were diagnosed as experiencing moderate to severe depression. The patients reported significant improvement over time on both depressive symptoms and general sense after 4-week treatment. The effect sizes of change in general sense were lower than those in symptoms at both two week and four week follow-up. Treatment effects on both general sense and depressive symptomatology were associated with demographic and clinical factors. The findings indicate that a focus on both general sense of mental health and wellbeing in addition to depressive symptomatology will provide clinicians, researchers and patients themselves with a broader perspective of the status of patients. PMID:27156024

  10. A hybrid framework of first principles molecular orbital calculations and a three-dimensional integral equation theory for molecular liquids: Multi-center molecular Ornstein-Zernike self-consistent field approach

    NASA Astrophysics Data System (ADS)

    Kido, Kentaro; Kasahara, Kento; Yokogawa, Daisuke; Sato, Hirofumi

    2015-07-01

    In this study, we reported the development of a new quantum mechanics/molecular mechanics (QM/MM)-type framework to describe chemical processes in solution by combining standard molecular-orbital calculations with a three-dimensional formalism of integral equation theory for molecular liquids (multi-center molecular Ornstein-Zernike (MC-MOZ) method). The theoretical procedure is very similar to the 3D-reference interaction site model self-consistent field (RISM-SCF) approach. Since the MC-MOZ method is highly parallelized for computation, the present approach has the potential to be one of the most efficient procedures to treat chemical processes in solution. Benchmark tests to check the validity of this approach were performed for two solute (solute water and formaldehyde) systems and a simple SN2 reaction (Cl- + CH3Cl → ClCH3 + Cl-) in aqueous solution. The results for solute molecular properties and solvation structures obtained by the present approach were in reasonable agreement with those obtained by other hybrid frameworks and experiments. In particular, the results of the proposed approach are in excellent agreements with those of 3D-RISM-SCF.

  11. A hybrid framework of first principles molecular orbital calculations and a three-dimensional integral equation theory for molecular liquids: multi-center molecular Ornstein-Zernike self-consistent field approach.

    PubMed

    Kido, Kentaro; Kasahara, Kento; Yokogawa, Daisuke; Sato, Hirofumi

    2015-07-01

    In this study, we reported the development of a new quantum mechanics/molecular mechanics (QM/MM)-type framework to describe chemical processes in solution by combining standard molecular-orbital calculations with a three-dimensional formalism of integral equation theory for molecular liquids (multi-center molecular Ornstein-Zernike (MC-MOZ) method). The theoretical procedure is very similar to the 3D-reference interaction site model self-consistent field (RISM-SCF) approach. Since the MC-MOZ method is highly parallelized for computation, the present approach has the potential to be one of the most efficient procedures to treat chemical processes in solution. Benchmark tests to check the validity of this approach were performed for two solute (solute water and formaldehyde) systems and a simple SN2 reaction (Cl(-) + CH3Cl → ClCH3 + Cl(-)) in aqueous solution. The results for solute molecular properties and solvation structures obtained by the present approach were in reasonable agreement with those obtained by other hybrid frameworks and experiments. In particular, the results of the proposed approach are in excellent agreements with those of 3D-RISM-SCF. PMID:26156461

  12. A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds

    PubMed Central

    Pak, Changsik; Park, Jihoon; Hong, Jinmyung; Jeong, Jaehoon; Bang, Saik

    2015-01-01

    Background We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. Methods In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. Results Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. Conclusions In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings. PMID:26618119

  13. Shear elastic constants of thin films of the misfit layered compound [(SnSe)1.05]n[MoSe2]n

    NASA Astrophysics Data System (ADS)

    Li, Dongyao; Mitchson, Gavin; Johnson, David; Schleife, Andre; Cahill, David

    Crystalline materials with interlayer van der Waals bonding typically have low stiffness for shear deformation that reduces the through-plane thermal conductivity and facilitates the use of layered materials as solid-state lubricants. In graphite and MoS2, c44 = 5GPa and 18GPa respectively. The shear modulus of incommensurate layered materials is expected to be strongly reduced relative to ordered crystals but the magnitude of the suppression is currently unknown. We have recently developed an approach for measuring the shear modulus of thin layers using GHz surface acoustic waves (SAW). [(SnSe)1.05]n[MoSe2]n with n =1-4 were prepared as thin films (60 nm) on Si substrates using the modulated elemental reactants technique. The SAW velocity vSAWof Al/[(SnSe)(MoSe2) ]/Si structures was measured using a polydimethylsiloxane (PDMS) phase-shift optical mask in a pump-probe system. c44 was determined by fitting the measured vSAW to the calculated SAW velocity using multi-layer SAW model. c33was measured by picosecond acoustics. c11, c12 and c13 were calculated using density functional theory (DFT) with van der Waals correction. The measured c33 and c44 are compared with the DFT prediction. Experimentally we obtain c44 = 1.9GPa, 1.2GPa, and smaller than 0.05GPa for n =1, 2 and 4. The author acknowledge the support of International Institute for Carbon Neutral Energy Research.

  14. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

    PubMed Central

    Dayan, Steven

    2015-01-01

    Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm2 target area of the scalp after 90 and 180 days of treatment. Secondary endpoints were change in hair diameter and responses to Quality of Life and Self-Assessment questionnaires. Results: Subjects treated with the new oral supplement achieved a significant increase in the number of baseline terminal hairs at 90 and 180 days (for each, p<0.0001, respectively) and were significantly greater then placebo (p<0.0001). Treatment with the new oral supplement was also associated with a significant increase in baseline terminal hair diameter after 90 (p=0.006) and 180 days of treatment (p=0.001) which was significantly greater than placebo at the end of the study (p=0.003). Improvements in hair growth and hair diameter were associated with significant improvement in most responses to Self-Assessment and Quality of Life Questionnaire responses. There were no adverse events. Conclusion: The daily administration of a new oral supplement was associated with significant increases in the number of terminal and vellus hairs and hair diameter. Most study participants believed the use of the oral supplement resulted in significant improvement in skin and hair quality and quality of life. PMID:26705444

  15. Real-world Experience of Carotid Artery Stenting in Japan: Analysis of 7,134 Cases from JR-NET1 and 2 Nationwide Retrospective Multi-center Registries

    PubMed Central

    EGASHIRA, Yusuke; YOSHIMURA, Shinichi; SAKAI, Nobuyuki; ENOMOTO, Yukiko

    2014-01-01

    The present study aimed to demonstrate the “real-world” experiences of carotid artery stenting (CAS) in Japan using Japanese Registry of Neuroendovascular Therapy (JR-NET) 1 and 2, retrospective nationwide multi-center surveillances. JR-NET1 and 2 registries are retrospective surveillances conducted between January 2005 and December 2007 and January 2008 and December 2009, respectively, in Japan regarding neuroendovascular therapy. A total of 7,134 procedures (1,943 for JR-NET1 and 5,191 for JR-NET2) were included in this study and retrieved data were analyzed retrospectively. Treatment results of two surveillance periods were similar. In JR-NET2 registry, total of 5,191 lesions were treated by CAS and 5,008 of 5,191 procedures (96.5%) were performed by the board-certified surgeons of Japanese Society of Neuroendovascular Therapy. The rate of technical success was extremely high (99.99%), and the rate of clinically significant complication was low (3.2%). These results were comparable to a previous large study in Japan. Multivariate logistic analysis revealed that age [odds ratio (OR), 1.04 per year; 95% confidence interval (CI), 1.02–1.07; p = 0.0004), symptomatic lesion (OR, 1.87; 95% CI; p = 0.0004), and the use of closed-cell type stent (OR, 0.58; 95% CT, 0.32–1.00; p = 0.05) were independently associated with clinically significant complications. It was revealed that good clinical results were achieved in patients who underwent CAS in Japan. It is expected that the evolution of devices and increasing experiences of surgeons would lead to further improvement of the clinical results, and further investigation would be required to clarify the optimal treatment strategy and therapeutic efficacy of CAS, especially in symptomatic lesions. PMID:24305031

  16. A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

    PubMed Central

    Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

    2010-01-01

    Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

  17. Clinical utility of simultaneous measurement of alpha-fetoprotein and des-γ-carboxy prothrombin for diagnosis of patients with hepatocellular carcinoma in China: A multi-center case-controlled study of 1,153 subjects.

    PubMed

    Song, Peipei; Feng, Xiaobin; Inagaki, Yoshinori; Song, Tianqiang; Zhang, Keming; Wang, Zhigang; Zheng, Shuguo; Ma, Kuansheng; Li, Qiang; Kong, Dalu; Wu, Qiang; Zhang, Ti; Zhao, Xin; Hasegawa, Kiyoshi; Sugawara, Yasuhiko; Kokudo, Norihiro; Tang, Wei

    2014-10-01

    This study aimed to investigate the clinical utility of simultaneous measurement of alphafetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) for hepatocellular carcinoma (HCC) diagnosis in Chinese patients predominantly caused by hepatitis B virus infection by a multi-center case-controlled study. Subjects were 1,153 individuals from three major hospitals in China, including 550 cases in HCC group, 164 in Malignant disease group, 182 in Benign disease group, 85 in Chronic liver disease group, and 173 in Normal group. Serum levels of AFP and DCP were measured and clinicopathological features were determined for all subjects. Results showed that the levels of DCP and AFP were significantly higher in HCC group (550 patients, 74.18% with HBV infection) than that in other four groups (P < 0.001). Receiver operating curves (ROC) indicated the optimal cut-off value was 86 mAU/mL for DCP with a sensitivity of 71.50% and specificity of 86.30%, and 21 ng/mL for AFP with a sensitivity of 68.00% and specificity of 93.20%. The area under ROC curve was 0.846 for DCP, 0.832 for AFP, and 0.890 for the combination of DCP and AFP. The combination of DCP and AFP resulted in a higher Youden index and a sensitivity of approximately 90%, even for small tumors. The simultaneous measurement of AFP and DCP could achieve a better sensitivity in diagnosing Chinese HCC patients, even for small tumors. PMID:25382443

  18. The SNAP trial: a double blind multi-center randomized controlled trial of a silicon nitride versus a PEEK cage in transforaminal lumbar interbody fusion in patients with symptomatic degenerative lumbar disc disorders: study protocol

    PubMed Central

    2014-01-01

    Background Polyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion. Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages. Methods/Design This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18–75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists. Discussion In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled

  19. Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial

    PubMed Central

    2011-01-01

    Background Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF) with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation. Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. Methods/Design ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius) is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool. The primary objective is to determine differences in the Short Form 36 (SF-36) Physical Component Score (PCS) between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH) instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery), as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture involves a central

  20. Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial.

    PubMed

    Capobianco, Robyn; Cher, Daniel

    2015-01-01

    Postpartum posterior pelvic girdle pain (PPGP) affects nearly 20 % of women who experience back pain in the peripartum period. The sacroiliac joint is a source of this pain in 75 % of women with persistent PPGP. A subset of women will fail to obtain acceptable pain relief from the current array of non-surgical treatment options. The purpose of this study is to assess the safety and effectiveness of minimally invasive sacroiliac (SI) joint fusion in women with chronic SI joint dysfunction whose pain began in the peri-partum period whose symptoms were recalcitrant to non-surgical management. A sub-group analysis of subjects with sacroiliac joint disruption and/or degenerative sacroiliitis enrolled in a prospective, multi-center trial of SI joint fusion was performed. Subjects with PPGP were identified and compared with women without PPGP and with men. Of 172 enrolled subjects, 52 were male, 100 were females without PPGP and 20 females had PPGP. PPGP subjects were significantly younger (43.3 years, vs. 52.8 for females without PPGP and 50.5 for men, p = 0.002). There were no differences in any other demographic or baseline clinical measure. Women with PPGP experienced a significant improvement in pain (-51 mm on VAS), function (-20.6 pts on ODI) and quality of life (SF-36 PCS +10.4, MCS +7.2, EQ-5D +0.31) at 12 months after surgery. These improvements were characteristic of the overall study results; no difference was detected between sub-groups. The sacroiliac joint can be a source of pain in women with persistent PPGP and should be investigated as a pain generator. In this study, women with carefully diagnosed chronic SI joint pain from PPGP recalcitrant to conservative therapies experienced clinically beneficially improvements in pain, disability and quality of life after minimally invasive SI joint fusion using a series of triangular porous plasma spray coated implants. PMID:26543705

  1. Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial

    PubMed Central

    Zhang, Xian-Long; Yang, Jing; Yang, Liu; Liu, Jian-Guo; Cai, Xin-Yu; Fan, Wei-Ming; Yun, Xue-Qing; Ma, Jin-Zhong; Weng, Xi-Sheng

    2016-01-01

    Background: Knee osteoarthritis (KOA) is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling, stiffness, and movement disorders. The therapeutic goal is to alleviate or eliminate pain, correct deformities, improve or restore joint functions, and improve the quality of life. This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA. Methods: This multi-center, randomized, double-blind, double-dummy, parallel controlled trial, started from December 2011 to May 2014, was carried out in 6 cities, including Beijing, Shanghai, Chongqing, Changchun, Chengdu, and Nanjing. A total of 432 patients with KOA were divided into three groups (144 cases in each group). The groups were treated, respectively, with Zhuanggu joint capsules combined with celecoxib capsule simulants, Zhuanggu joint capsules combined with celecoxib capsules, and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively. The improvement of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment. Intergroup and intragroup comparisons of quantitative indices were performed. Statistically significant differences were evaluated with pairwise comparisons using Chi-square test (or Fisher's exact test) and an inspection level of α = 0.0167. Results: Four weeks after treatment, the total efficacies of Zhuanggu group, combination group, and celecoxib group were 65%, 80%, and 64%, respectively, with statistically significant differences among the three groups (P = 0.005). Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu (P = 0.005) and celecoxib (P = 0.003) groups. The difference between the latter two groups was not statistically

  2. Results from a 1-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral Deferasirox in patients diagnosed with low and int-1 risk myelodysplastic syndrome (MDS) and transfusion-dependent iron overload.

    PubMed

    Nolte, F; Höchsmann, B; Giagounidis, A; Lübbert, M; Platzbecker, U; Haase, D; Lück, A; Gattermann, N; Taupitz, M; Baier, M; Leismann, O; Junkes, A; Schumann, C; Hofmann, W K; Schrezenmeier, H

    2013-01-01

    The majority of patients with myelodysplastic syndrome (MDS) present with anemia and will become dependent on regular transfusions of packed red blood cells (PRBC) with the risk of iron overload (IOL). Liver iron content best reflects the total body iron content, and measurement of liver iron concentration (LIC) by MRI is a validated tool for detection, but data in MDS is rather limited. Here we present the results of a multi-center trial evaluating the efficacy and safety of deferasirox (DFX) in low and intermediate-1 risk MDS patients with transfusion-dependent IOL. Three patients with transfusion frequency of > 4 units PRBC per month were initially treated with 30 mg/kg/day while in 46 patients with a lower transfusion burden deferasirox was initiated at 20 mg/kg/day, due to patient related reasons one patient received DFX in a dose of 6 mg/kg/day only. LIC was measured by MRI at baseline and end of study using the method by St. Pierre et al. The intention to treat population consisted of 50 MDS patients (28 male; 22 female) with a median age of 69 years who were treated with DFX for a median duration of 354 days. Mean daily dose of DFX was 19 mg/kg/day. Median serum ferritin level (SF) at baseline was 2,447 ng/mL and decreased to 1,685 ng/mL (reduction by 31 %) at end of study (p = 0.01). In 7 (13 %) patients the initially chosen dose had to be increased due to unsatisfactory efficacy of chelation therapy. For 21 patients, LIC measurement by liver MRI was performed at baseline and for 19 of these patients at the end of study: mean LIC decreased significantly from 16,8 mg/g dry tissue weight (± 8.3 mg/g dry tissue weight) at study entry to 10,8 mg/g dry tissue weight (± 10.4 mg/g dry tissue weight) at end of study (p = 0.01). Of all patients exposed to the study drug (n = 54), 28 (52 %) did not complete the 12 month study period most commonly due to AEs in 28 % (n = 15) and abnormal laboratory values in 7 % (n = 4

  3. Study of the e{sup +}e{sup –} → π{sup +}π{sup –}π{sup 0} process in the energy range 1.05–2.00 GeV

    SciTech Connect

    Aul’chenko, V. M.; Achasov, M. N.; Barnyakov, A. Yu.; Beloborodov, K. I.; Berdyugin, A. V.; Bogdanchikov, A. G.; Botov, A. A.; Vasil’ev, A. V.; Golubev, V. B.; Dimova, T. V. Druzhinin, V. P.; Kardapol’tsev, L. V.; Kasaev, A. S.; Kirpotin, A. N.; Kirpotin, A. N.; Kovrizhin, D. P.; Koop, I. A.; Korol’, A. A.; Koshuba, S. V.; Kupich, A. S.; and others

    2015-07-15

    The cross section for the e{sup +}e{sup –} → π{sup +}π{sup –}π{sup 0} process in the energy range 1.05–2.00 GeV has been measured using the data collected in the experiment with the Spherical Neutral Detector (SND) at the VEPP-2000 e{sup +}e{sup –} collider. The obtained results on the cross section are in good agreement with previous measurements by the SND at the VEPP-2M collider and BABAR, but have a better accuracy.

  4. Performance, Stability, and Control Investigation at Mach Numbers from 0.60 to 1.05 of a Model of the "Swallow" with Outer Wing Panels Swept 75 degree with and without Power Simulations

    NASA Technical Reports Server (NTRS)

    Schmeer, James W.; Cassetti, Marlowe D.

    1960-01-01

    An investigation of the performance, stability, and control characteristics of a variable-sweep arrow-wing model with the outer wing panels swept 75 deg. has been conducted in the Langley 16-foot transonic tunnel. Four outboard engines located above and below the wing provided propulsive thrust, and, by deflecting in the pitch direction and rotating in the lateral plane, also produced control forces. The engine nacelles incorporated swept lateral and vertical fins for aerodynamic stability and control. Jet-off data were obtained with flow-through nacelles, simulating inlet flow; jet thrust and hot-jet interference effects were obtained with faired-nose nacelles housing hydrogen peroxide gas generators. Six-component force and moment data were obtained at Mach numbers from 0.60 to 1.05 through a range of angles of attack and angles of side-slip. Control characteristics were obtained by deflecting the nacelle-fin combinations as elevators, rudders, and ailerons at several fixed angles for each control. The results indicate that the basic wing-body configuration becomes neutrally stable or unstable at a lift coefficient of 0.15; addition of nacelles with fins delayed instability to a lift coefficient of 0.30. Addition of nacelles to the wing-body configuration increased minimum drag from 0.0058 to 0.0100 at a Mach number of 0.60 and from 0.0080 to 0.0190 at a Mach number of 1.05 with corresponding reductions in maximum lift-drag ratio of 12 percent and 33 percent, respectively. The nacelle-fin combinations were ineffective as longitudinal controls but were adequate as directional and lateral controls. The model with nacelles and fins was directionally and laterally stable; the stability generally increased with increasing lift. Jet interference effects on stability and control characteristics were small but the adverse effects on drag were greater than would be expected for isolated nacelles.

  5. Enhanced piezoelectricity in (1 -x)Bi1.05Fe1-yAyO3-xBaTiO3 lead-free ceramics: site engineering and wide phase boundary region.

    PubMed

    Zheng, Ting; Jiang, Zhenggen; Wu, Jiagang

    2016-07-28

    Site engineering has been employed to modulate the piezoelectric activity of high temperature (1 -x)Bi1.05Fe1-yScyO3-xBaTiO3 lead-free ceramics fabricated by a conventional solid-state method together with a quenching technique. The effects of x and y content on the phase structure, microstructure, and electrical properties have been investigated in detail. A wide rhombohedral (R) to pseudo-cubic (C) phase boundary was formed in the ceramics with x = 0.30 and 0 ≤y≤ 0.07, thus leading to enhanced piezoelectricity (d33 = 120-180 pC N(-1)), ferroelectricity (Pr = 19-22 μC cm(-2)) and a high Curie temperature (TC = 478-520 °C). In addition, the influence of different element substitutions for Fe(3+) on phase structure and electrical behavior was also investigated. Improved piezoelectricity (d33 = 160-180 pC N(-1)) and saturated P-E loops can be simultaneously achieved in the ceramics with A = Sc, Ga, and Al due to the R-C phase boundary. As a result, site engineering may be an efficient way to modulate the piezoelectricity of BiFeO3-BaTiO3 lead-free ceramics. PMID:27357104

  6. A Liquid Junction Photoelectrochemical Solar Cell Based on p-Type MeNH3PbI3 Perovskite with 1.05 V Open-Circuit Photovoltage.

    PubMed

    Hsu, Hsien-Yi; Ji, Li; Ahn, Hyun S; Zhao, Ji; Yu, Edward T; Bard, Allen J

    2015-11-25

    A liquid junction photoelectrochemical (PEC) solar cell based on p-type methylammonium lead iodide (p-MeNH3PbI3) perovskite with a large open-circuit voltage is developed. MeNH3PbI3 perovskite is readily soluble or decomposed in many common solvents. However, the solvent dichloromethane (CH2Cl2) can be employed to form stable liquid junctions. These were characterized with photoelectrochemical cells with several redox couples, including I3(-)/I(-), Fc/Fc(+), DMFc/DMFc(+), and BQ/BQ(•-) (where Fc is ferrocene, DMFc is decamethylferrocene, BQ is benzoquinone) in CH2Cl2. The solution-processed MeNH3PbI3 shows cathodic photocurrents and hence p-type behavior. The difference between the photocurrent onset potential and the standard potential for BQ/BQ(•-) is 1.25 V, which is especially large for a semiconductor with a band gap of 1.55 eV. A PEC photovoltaic cell, with a configuration of p-MeNH3PbI3/CH2Cl2, BQ (2 mM), BQ(•-) (2 mM)/carbon, shows an open-circuit photovoltage of 1.05 V and a short-circuit current density of 7.8 mA/cm(2) under 100 mW/cm(2) irradiation. The overall optical-to-electrical energy conversion efficiency is 6.1%. The PEC solar cell shows good stability for 5 h under irradiation. PMID:26523921

  7. MultiCenter Reliability of Diffusion Tensor Imaging

    PubMed Central

    Magnotta, Vincent A.; Matsui, Joy T.; Liu, Dawei; Johnson, Hans J.; Long, Jeffrey D.; Bolster, Bradley D.; Mueller, Bryon A.; Lim, Kelvin; Mori, Susumu; Helmer, Karl G.; Turner, Jessica A.; Reading, Sarah; Lowe, Mark J.; Aylward, Elizabeth; Flashman, Laura A.; Bonett, Greg

    2012-01-01

    Abstract A number of studies are now collecting diffusion tensor imaging (DTI) data across sites. While the reliability of anatomical images has been established by a number of groups, the reliability of DTI data has not been studied as extensively. In this study, five healthy controls were recruited and imaged at eight imaging centers. Repeated measures were obtained across two imaging protocols allowing intra-subject and inter-site variability to be assessed. Regional measures within white matter were obtained for standard rotationally invariant measures: fractional anisotropy, mean diffusivity, radial diffusivity, and axial diffusivity. Intra-subject coefficient of variation (CV) was typically <1% for all scalars and regions. Inter-site CV increased to ∼1%–3%. Inter-vendor variation was similar to inter-site variability. This variability includes differences in the actual implementation of the sequence. PMID:23075313

  8. Benefits Analysis of Multi-Center Dynamic Weather Routes

    NASA Technical Reports Server (NTRS)

    Sheth, Kapil; McNally, David; Morando, Alexander; Clymer, Alexis; Lock, Jennifer; Petersen, Julien

    2014-01-01

    Dynamic weather routes are flight plan corrections that can provide airborne flights more than user-specified minutes of flying-time savings, compared to their current flight plan. These routes are computed from the aircraft's current location to a flight plan fix downstream (within a predefined limit region), while avoiding forecasted convective weather regions. The Dynamic Weather Routes automation has been continuously running with live air traffic data for a field evaluation at the American Airlines Integrated Operations Center in Fort Worth, TX since July 31, 2012, where flights within the Fort Worth Air Route Traffic Control Center are evaluated for time savings. This paper extends the methodology to all Centers in United States and presents benefits analysis of Dynamic Weather Routes automation, if it was implemented in multiple airspace Centers individually and concurrently. The current computation of dynamic weather routes requires a limit rectangle so that a downstream capture fix can be selected, preventing very large route changes spanning several Centers. In this paper, first, a method of computing a limit polygon (as opposed to a rectangle used for Fort Worth Center) is described for each of the 20 Centers in the National Airspace System. The Future ATM Concepts Evaluation Tool, a nationwide simulation and analysis tool, is used for this purpose. After a comparison of results with the Center-based Dynamic Weather Routes automation in Fort Worth Center, results are presented for 11 Centers in the contiguous United States. These Centers are generally most impacted by convective weather. A breakdown of individual Center and airline savings is presented and the results indicate an overall average savings of about 10 minutes of flying time are obtained per flight.

  9. Multi-center analysis of glucocerebrosidase mutations in Parkinson disease

    PubMed Central

    Sidransky, Ellen; Nalls, Michael A.; Aasly, Jan O.; Aharon-Peretz, Judith; Annesi, Grazia; Barbosa, Egberto Reis; Bar-Shira, Anat; Berg, Daniela; Bras, Jose; Brice, Alexis; Chen, Chiung-Mei; Clark, Lorraine N.; Condroyer, Christel; De Marco, Elvira Valeria; Dürr, Alexandra; Eblan, Michael J.; Fahn, Stanley; Farrer, Matthew; Fung, Hon-Chung; Gan-Or, Ziv; Gasser, Thomas; Gershoni-Baruch, Ruth; Giladi, Nir; Griffith, Alida; Gurevich, Tanya; Januario, Cristina; Kropp, Peter; Lang, Anthony E.; Lee-Chen, Guey-Jen; Lesage, Suzanne; Marder, Karen; Mata, Ignacio F.; Mirelman, Anat; Mitsui, Jun; Mizuta, Ikuko; Nicoletti, Giuseppe; Oliveira, Catarina; Ottman, Ruth; Orr-Urtreger, Avi; Pereira, Lygia V.; Quattrone, Aldo; Rogaeva, Ekaterina; Rolfs, Arndt; Rosenbaum, Hanna; Rozenberg, Roberto; Samii, Ali; Samaddar, Ted; Schulte, Claudia; Sharma, Manu; Singleton, Andrew; Spitz, Mariana; Tan, Eng-King; Tayebi, Nahid; Toda, Tatsushi; Troiano, André; Tsuji, Shoji; Wittstock, Matthias; Wolfsberg, Tyra G.; Wu, Yih-Ru; Zabetian, Cyrus P.; Zhao, Yi; Ziegler, Shira G.

    2010-01-01

    Background Recent studies indicate an increased frequency of mutations in the gene for Gaucher disease, glucocerebrosidase (GBA), among patients with Parkinson disease. An international collaborative study was conducted to ascertain the frequency of GBA mutations in ethnically diverse patients with Parkinson disease. Methods Sixteen centers participated, including five from the Americas, six from Europe, two from Israel and three from Asia. Each received a standard DNA panel to compare genotyping results. Genotypes and phenotypic data from patients and controls were analyzed using multivariate logistic regression models and the Mantel Haenszel procedure to estimate odds ratios (ORs) across studies. The sample included 5691 patients (780 Ashkenazi Jews) and 4898 controls (387 Ashkenazi Jews). Results All 16 centers could detect GBA mutations, L444P and N370S, and the two were found in 15.3% of Ashkenazi patients with Parkinson disease (ORs = 4.95 for L444P and 5.62 for N370S), and in 3.2% of non-Ashkenazi patients (ORs = 9.68 for L444P and 3.30 for N370S). GBA was sequenced in 1642 non-Ashkenazi subjects, yielding a frequency of 6.9% for all mutations, demonstrate that limited mutation screens miss half the mutant alleles. The presence of any GBA mutation was associated with an OR of 5.43 across studies. Clinically, although phenotypes varied, subjects with a GBA mutation presented earlier, and were more likely to have affected relatives and atypical manifestations. Conclusion Data collected from sixteen centers demonstrate that there is a strong association between GBA mutations and Parkinson disease. PMID:19846850

  10. Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

    PubMed Central

    2013-01-01

    Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200 mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12 weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary

  11. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... docket. Public dockets for Coast Guard rulemakings are available electronically at http://www.regulations... http://www.regulations.gov. Paragraph (a) of this section describes how to access and view these... available for inspection at the appropriate Captains of the Port Office or online at...

  12. 33 CFR 1.05-20 - Petitions for rulemaking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... rulemaking, but the document should provide some supporting information as to why the petitioner believes the... reasons why. If the Coast Guard decides to initiate rulemaking, it will follow the procedure outlined...

  13. Phase diagram and magnetocaloric effects in Ni{sub 50}Mn{sub 35}(In{sub 1−x}Cr{sub x}){sub 15} and (Mn{sub 1−x}Cr{sub x})NiGe{sub 1.05} alloys

    SciTech Connect

    Quetz, Abdiel Muchharla, Baleeswaraiah; Dubenko, Igor; Talapatra, Saikat; Ali, Naushad; Samanta, Tapas; Stadler, Shane

    2014-05-07

    The magnetocaloric and thermomagnetic properties of Ni{sub 50}Mn{sub 35}(In{sub 1−x}Cr{sub x}){sub 15} and (Mn{sub 1−x}Cr{sub x}) NiGe{sub 1.05} systems for 0 ≤ x ≤ 0.105 and 0 ≤ x ≤ 0.1, respectively, have been studied by x-ray diffraction, differential scanning calorimetry, and magnetization measurements. Partial substitution of Cr for Mn in (Mn{sub 1−x}Cr{sub x})NiGe{sub 1.05} results in a first order magnetostructural transition from a hexagonal paramagnetic to an orthorhombic paramagnetic phase near T{sub M} ∼ 380 K (for x = 0.07). Partial substitution of Cr for In in Ni{sub 50}Mn{sub 35}(In{sub 1−x}Cr{sub x}){sub 15} shifts the magnetostructural transition to a higher temperature (T = T{sub M} ∼ 450 K) for x = 0.1. Large magnetic entropy changes of ΔS = −12 (J/(kgK)) and ΔS = −11 (J/(kgK)), both for a magnetic field change of 5 T, were observed in the vicinity of T{sub M} for (Mn{sub 1−x}Cr{sub x})NiGe{sub 1.05} and Ni{sub 50}Mn{sub 35}(In{sub 1−x}Cr{sub x}){sub 15}, respectively.

  14. Multi-Center Trial of Baclofen for Abstinence Initiation in Severe Cocaine Dependent Individuals

    PubMed Central

    Kahn, Roberta; Biswas, Kousick; Childress, Anna-Rose; Shoptaw, Steve; Fudala, Paul J.; Gorgon, Liza; Montoya, Ivan; Collins, Joseph; McSherry, Frances; Li, Shou-Hua; Chiang, Nora; Alathari, Husam; Watson, Donnie; Liberto, Joseph; Beresford, Thomas; Stock, Christopher; Wallace, Christopher; Gruber, Valerie; Elkashef, Ahmed

    2009-01-01

    Background Cocaine dependence is a major public health problem for which there is no FDA-approved pharmacological treatment. Baclofen is a GABAB receptor agonist that in preclinical and early pilot clinical trials has shown promise for the treatment of cocaine dependence. The purpose of this multi-site, double-blind study, was to compare the safety and efficacy of baclofen (60 mg/day) versus placebo in an 8-week treatment of individuals with severe cocaine dependence. The primary outcome measure was subjects' self-reported cocaine use substantiated by urine benzoylecgonine (BE). Analysis of the data did not show a significant difference between the groups treated with baclofen and placebo. The current results do not support a role for 60mg baclofen in treating cocaine dependence in the population studied. The contrast of this result to earlier, preclinical and human pilot data with baclofen may reflect the trial's focus on severe cocaine-dependent users, and/or the need for a higher baclofen dose. Baclofen's potential as a relapse prevention agent was not tested by the current design, but may be a useful target for future studies. PMID:19414226

  15. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial

    PubMed Central

    Elkashef, Ahmed; Kahn, Roberta; Yu, Elmer; Iturriaga, Erin; Li, Shou-Hua; Anderson, Ann; Chiang, Nora; Ait-Daoud, Nassima; Weiss, David; McSherry, Frances; Serpi, Tracey; Rawson, Richard; Hrymoc, Mark; Weis, Dennis; McCann, Michael; Pham, Tony; Stock, Christopher; Dickinson, Ruth; Campbell, Jan; Gorodetzky, Charles; Haning, William; Carlton, Barry; Mawhinney, Joseph; Li, Ming D.; Johnson, Bankole A.

    2012-01-01

    Aims Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled outpatient trial tested topiramate for treating methamphetamine addiction. Design Participants (N=140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 50 mg/day to the target maintenance of 200 mg/day in weeks 6–12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment. Setting The trial was conducted at eight medical centers in the United States. Participants One hundred forty methamphetamine-dependent adults took part in the trial. Measurements The primary outcome was abstinence from methamphetamine during weeks 6 – 12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables. Findings In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6–12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (N=26) had significantly greater abstinence on topiramate versus placebo during study weeks 6–12. Topiramate was safe and well tolerated. Conclusions Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent. PMID:22221594

  16. Thoracoscopic double sleeve lobectomy in 13 patients: a series report from multi-centers

    PubMed Central

    Huang, Jun; Li, Jingpei; Qiu, Yuan; Xu, Xin; Sekhniaidze, Dmitrii; Chen, Hanzhang; Gonzalez-Rivas, Diego

    2015-01-01

    Background This study aims to explore the feasibility and safety of video-assisted thoracic surgery (VATS) double sleeve lobectomy in patients with non-small lung cell cancer (NSCLC). Methods Between June 2012 and August 2014, 13 NSCLC patients underwent thoracoscopic double sleeve lobectomy and mediastinal lymphadenectomy at three institutions. A retrospective analysis of clinical characteristics, operative data, postoperative events and follow-up was performed. Results Thirteen NSCLC patients (median age, 60 years; range, 43-67 years) underwent thoracoscopic double sleeve lobectomy. There were no conversions to thoracotomy. Left upper lobectomy was most frequently performed (eleven patients). Median operative time was 263 minutes (range, 218-330 minutes), and median blood loss was 224 mL (range, 60-400 mL). The learning curve revealed reductions in both operative times and blood loss of ten cases from one center. Median data were duration of blocking pulmonary artery (PA) 72 minutes (range, 44-143 minutes), resected lymph nodes 24 (range, 10-46), stations of retrieved lymph nodes 6 (range, 5-9), thoracic drainage 1,042 mL (range, 500-1,700 mL), duration of thoracic drainage 5 days (range, 3-8 days), postoperative hospital stay 10 days (range, 7-20 days), and ICU stay 1 day (range, 1-2 days). One patient (1/13, 7.70%) suffered from pneumonia after surgery. There were no deaths at 30 days. Median duration of follow-up was 6 months (range, 1-26 months). And no local recurrences or distant metastasis were reported. Conclusions Thoracoscopic double sleeve lobectomy is a technically challenging, but feasible procedure for NSCLC patients and it should be restricted to skilled VATS surgeons. PMID:26101638

  17. The Multi-Center Airborne Coherent Atmospheric Wind Sensor: Recent Measurements and Future Applications

    NASA Technical Reports Server (NTRS)

    Rothermel, Jeffry; Cutten, Dean R.; Howell, Burgess F.; Hardesty, Robert M.; Tratt, David M.; Darby, Lisa S.

    1999-01-01

    The atmospheric lidar remote sensing groups of NOAA Environmental Technology Laboratory, Jet Propulsion Laboratory and NASA Marshall Space Flight Center jointly developed an airborne scanning coherent Doppler Lidar. We describe the system, present recent measurement (including the first wind fields measured within a hurricane using Doppler lidar), and describe prospective instrument improvements and research applications.

  18. A Multi-Center Assessment of Nutrient Levels and Foods Provided by Hospital Patient Menus

    PubMed Central

    Trang, Susan; Fraser, Jackie; Wilkinson, Lori; Steckham, Katherine; Oliphant, Heather; Fletcher, Heather; Tzianetas, Roula; Arcand, JoAnne

    2015-01-01

    Diets of high nutritional quality can aid in the prevention and management of malnutrition in hospitalized patients. This study evaluated the nutritional quality of hospital patient menus. At three large acute care hospitals in Ontario, Canada, 84 standard menus were evaluated, which included regular and carbohydrate-controlled diets and 3000 mg and 2000 mg sodium diets. Mean levels of calories, macronutrients and vitamins and minerals provided were calculated. Comparisons were made with the Dietary Reference Intakes (DRI) and Canada’s Food Guide (CFG) recommendations. Calorie levels ranged from 1281 to 3007 kcal, with 45% of menus below 1600 kcal. Protein ranged from 49 to 159 g (0.9–1.1 g/kg/day). Energy and protein levels were highest in carbohydrate-controlled menus. All regular and carbohydrate-controlled menus provided macronutrients within the Acceptable Macronutrient Distribution Ranges. The proportion of regular diet menus meeting the DRIs: 0% for fiber; 7% for calcium; 57% for vitamin C; and 100% for iron. Compared to CFG recommended servings, 35% met vegetables and fruit and milk and alternatives, 11% met grain products and 8% met meat and alternatives. These data support the need for frequent monitoring and evaluation of menus, food procurement and menu planning policies and for sufficient resources to ensure menu quality. PMID:26569294

  19. European multi-center evaluation of the Abbott Cell-Dyn sapphire hematology analyzer.

    PubMed

    Müller, Robert; Mellors, Ian; Johannessen, Berit; Aarsand, Aasne K; Kiefer, Paul; Hardy, John; Kendall, Richard; Scott, Colin Stephen

    2006-01-01

    This study presents the results of performance evaluations of the Cell-Dyn Sapphire (CD-Sapphire) undertaken by 3 study sites in Europe. These studies focused on the routine blood count analyses with specific consideration of precision and imprecision, linearity, inter-instrument correlations, and white blood cell differential and flagging efficiencies. The CD-Sapphire was compared to the Cell-Dyn CD4000, Bayer Advia 120, Beckman Coulter GenS, and reference microscopy. PMID:16513543

  20. Controlled Blood Pressure in Iranian Patients: A Multi-Center Report.

    PubMed

    Sadeghi, Ezzatollah; Behnood-Rod, Azin; Aerab-Sheibani, Hossein; Shobeiri, Elham; Pourzargar, Pirouz; Ormoz, Ehsan; Sadigh, Nader; Moharamzad, Yashar

    2016-04-01

    We decided to determine the percentage of hypertensive patients whose blood pressure (BP) measurements were within recommended controlled range and to identify predictive factors for controlled BP. In this study carried out in 2014, 280 patients were included consecutively through sampling from both university and private medical centers/pharmacies in four Iranian cities. Demographic data as well as information about duration of HTN and prescribed medications, admission to emergency department (ED) because of HTN crisis, comorbidities, and control of HTN during the last 6 months by a healthcare provider were gathered. Adherence to anti-hypertensives was also determined using the validated Persian version of the 8-item Morisky Medication Adherence Scale (MMAS-8). Controlled BP was defined as systolic BP< 140 and diastolic BP< 90 mmHg in non-diabetics and < 130/80 mmHg in diabetics. Of 280 patients, 122 subjects (43.6%) had controlled BP. Among 55 diabetics, only two patients (3.6%) had controlled BP. Multiple logistic regression revealed the following variables as significant predictors of controlled BP: higher MMAS-8 score (adjusted odds ratio (OR)= 1.19, P= 0.03), fewer number of comorbid conditions (adjusted OR= 0.71, P = 0.03), having occupation as clerk/military personnel (adjusted OR= 1.03, P= 0.04), and not having history of ED admission during the last 6 months because of HTN crisis (adjusted OR= 2.11, P= 0.01). Considerable number of the studied patients had uncontrolled BP. Regarding the dramatic consequences of uncontrolled high BP in long term, it is advisable that careful attention by health care providers to the aforementioned factors could raise the likelihood of achieving controlled BP. PMID:26573037

  1. Research Reproducibility in Longitudinal Multi-Center Studies Using Data from Electronic Health Records

    PubMed Central

    Zozus, Meredith N.; Richesson, Rachel L.; Walden, Anita; Tenenbaum, Jessie D.; Hammond, W.E.

    2016-01-01

    A fundamental premise of scientific research is that it should be reproducible. However, the specific requirements for reproducibility of research using electronic health record (EHR) data have not been sufficiently articulated. There is no guidance for researchers about how to assess a given project and identify provisions for reproducibility. We analyze three different clinical research initiatives that use EHR data in order to define a set of requirements to reproduce the research using the original or other datasets. We identify specific project features that drive these requirements. The resulting framework will support the much-needed discussion of strategies to ensure the reproducibility of research that uses data from EHRs. PMID:27570682

  2. Analysis of factors affecting failure of glass cermet tunnel restorations in a multi-center study.

    PubMed

    Pilebro, C E; van Dijken, J W

    2001-06-01

    The aim of this study was to analyze factors influencing the failures of tunnel restorations performed with a glass cermet cement (Ketac Silver). Caries activity, lesion size, tunnel cavity opening size, partial or total tunnel, composite lamination or operating time showed no significant correlation to failure rate. Twelve dentists in eight clinics clinically experienced and familiar with the tunnel technique placed 374 restorations. The occlusal sections of fifty percent of the restorations were laminated with hybrid resin composite. The results of the yearly clinical and radiographic evaluations over the course of 3 years were correlated to factors that could influence the failure rate using logistic regression analysis. At the 3-year recall a cumulative number of 305 restorations were available. The cumulative replacement rate was 20%. The main reasons for replacement were marginal ridge fracture (14%) and dentin caries (3%). Another 7% of the restorations which had not been replaced were classified as failures because of untreated dentin caries. The only significant variable observed was the individual failure rate of the participating dentists varying between 9 and 50% (p=0.013). PMID:11480816

  3. A Multi-Center Space Data System Prototype Based on CCSDS Standards

    NASA Technical Reports Server (NTRS)

    Rich, Thomas M.

    2016-01-01

    Deep space missions beyond earth orbit will require new methods of data communications in order to compensate for increasing RF propagation delay. The Consultative Committee for Space Data Systems (CCSDS) standard protocols Spacecraft Monitor & Control (SM&C), Asynchronous Message Service (AMS), and Delay/Disruption Tolerant Networking (DTN) provide such a method. The maturity level of this protocol set is, however, insufficient for mission inclusion at this time. This prototype is intended to provide experience which will raise the Technical Readiness Level (TRL) of these protocols..

  4. NFlex Dynamic Stabilization System : Two-Year Clinical Outcomes of Multi-Center Study

    PubMed Central

    Coe, Jeffrey D.; Kitchel, Scott H.; Meisel, Hans Jörg; Wingo, Charles H.; Lee, Soo Eon

    2012-01-01

    Objective Pedicle-based dynamic stabilization systems, in which semi-rigid rods or cords are used to restrict or control spinal segmental motion, aim to reduce or eliminate the drawbacks associated with rigid fusion. In this study, we analyzed the two-year clinical outcomes of patients treated with the NFlex (Synthes Spine, Inc.), a pedicle-based dynamic stabilization system. Methods Five sites participated in a retrospective study of 72 consecutive patients who underwent NFlex stabilization. Of these 72 patients, 65 were available for 2-year follow-up. Patients were included based on the presence of degenerative disc disease (29 patients), degenerative spondylolisthesis (16 patients), lumbar stenosis (9 patients), adjacent segment degeneration (6 patients), and degenerative lumbar scoliosis (5 patients). The clinical outcome measures at each assessment were Visual Analogue Scale (VAS) to measure back pain, and Oswestry Disability Index (ODI) to measure functional status. Radiographic assessments included evidence of instrumentation failure or screw loosening. Results Sixty-five patients (26 men and 39 women) with a mean age of 54.5 years were included. Mean follow-up was 25.6 months. The mean VAS score improved from 8.1 preoperatively to 3.8 postoperatively, representing a 53% improvement, and the ODI score from 44.5 to 21.8, representing a 51% improvement. Improvements in pain and disability scores were statistically significant. Three implant-related complications were observed. Conclusion Posterior pedicle-based dynamic stabilization using the NFlex system seems effective in improving pain and functional scores, with sustained clinical improvement after two years. With appropriate patient selection, it may be considered an effective alternative to rigid fusion. PMID:22949963

  5. A Multi-Center Assessment of Nutrient Levels and Foods Provided by Hospital Patient Menus.

    PubMed

    Trang, Susan; Fraser, Jackie; Wilkinson, Lori; Steckham, Katherine; Oliphant, Heather; Fletcher, Heather; Tzianetas, Roula; Arcand, JoAnne

    2015-11-01

    Diets of high nutritional quality can aid in the prevention and management of malnutrition in hospitalized patients. This study evaluated the nutritional quality of hospital patient menus. At three large acute care hospitals in Ontario, Canada, 84 standard menus were evaluated, which included regular and carbohydrate-controlled diets and 3000 mg and 2000 mg sodium diets. Mean levels of calories, macronutrients and vitamins and minerals provided were calculated. Comparisons were made with the Dietary Reference Intakes (DRI) and Canada's Food Guide (CFG) recommendations. Calorie levels ranged from 1281 to 3007 kcal, with 45% of menus below 1600 kcal. Protein ranged from 49 to 159 g (0.9-1.1 g/kg/day). Energy and protein levels were highest in carbohydrate-controlled menus. All regular and carbohydrate-controlled menus provided macronutrients within the Acceptable Macronutrient Distribution Ranges. The proportion of regular diet menus meeting the DRIs: 0% for fiber; 7% for calcium; 57% for vitamin C; and 100% for iron. Compared to CFG recommended servings, 35% met vegetables and fruit and milk and alternatives, 11% met grain products and 8% met meat and alternatives. These data support the need for frequent monitoring and evaluation of menus, food procurement and menu planning policies and for sufficient resources to ensure menu quality. PMID:26569294

  6. Safety and efficacy of dimethyl fumarate in multiple sclerosis: a multi-center observational study.

    PubMed

    Miclea, A; Leussink, V I; Hartung, H P; Gold, R; Hoepner, R

    2016-08-01

    Dimethyl fumarate (DMF) was recently approved for treating patients with relapsing-remitting multiple sclerosis (RRMS) based on two phase III clinical trials demonstrating its efficacy. This prompts the need for demonstrating the clinical efficacy and safety of DMF in the real world. By retrospective analysis of medical records at two German MS centers, 644 MS patients treated with DMF were identified. All were included in a safety analysis, and a subgroup of patients with available efficacy data during previous MS therapies (n = 352) was further analyzed for annualized relapse rate and disability progression assessed by the EDSS. In the overall DMF population studied, the annualized relapse rate decreased from 0.52 at baseline to 0.35, and the annualized disability progression from 0.15 to 0.10. Patients who were switched from interferons or glatiramer acetate to DMF revealed a greater benefit, whereas patients pretreated with more potent immunotherapies did not respond that well. Interestingly, patients with a lymphocyte count ≥2000/µl after 0.52 years (mean, SD 0.2) of DMF treatment did not benefit compared to those with lower lymphocyte counts. In total, 22.2 % of the patients withdrew from DMF due to side effects, with gastrointestinal discomfort (12.7 %) and lymphopenia (5.3 %) as most frequently reported reasons. Our study corroborates that DMF is an overall safe and effective drug that reduces relapse rate as well as disability progression in MS patients. Further prospective studies are warranted to establish the additional parameters predicting DMF response, especially in patients switching from other first-line immunotherapies. PMID:27260297

  7. Antibiotic resistance patterns of Staphylococcus aureus: A multi center study from India.

    PubMed

    Mendem, Suresh Kumar; Alasthimannahalli Gangadhara, Triveni; Shivannavar, Channappa T; Gaddad, Subhaschandra M

    2016-09-01

    Chemotherapy and emergence of drug resistance strains of Staphylococcus aureus is receiving serious threats, due to the origin and spread of hospital and community acquired MDR strains. The present study reports the prevalence of antibiotic resistance among Staphylococcus aureus isolated from clinical samples from different cities of India. Antibiotic sensitivity was performed by Kirby-Bauer disk diffusion method and minimum inhibitory concentrations were determined for vancomycin and methicillin according to CLSI (2014) guidelines. A total of 212 S. aureus were obtained from different samples such as pus, blood, urine. The antibiogram of these isolates indicated widespread resistance to various groups of antibiotics ranging from a minimum of 10.13% against Phenicols (Chloramphenicol) to a maximum of 97% against Penicillin and 44.8% isolates were MRSA and alarmingly 10.84% were VRSA. Most of the MRSA isolates showed inducible Clindamycin resistance. Widespread prevalence of MDR patterns, increasing incidence of MRSA and VRSA calls for exploration of alternative medicines and new approaches to combat Staphylococcal infections. PMID:27448836

  8. Research Reproducibility in Longitudinal Multi-Center Studies Using Data from Electronic Health Records.

    PubMed

    Zozus, Meredith N; Richesson, Rachel L; Walden, Anita; Tenenbaum, Jessie D; Hammond, W E

    2016-01-01

    A fundamental premise of scientific research is that it should be reproducible. However, the specific requirements for reproducibility of research using electronic health record (EHR) data have not been sufficiently articulated. There is no guidance for researchers about how to assess a given project and identify provisions for reproducibility. We analyze three different clinical research initiatives that use EHR data in order to define a set of requirements to reproduce the research using the original or other datasets. We identify specific project features that drive these requirements. The resulting framework will support the much-needed discussion of strategies to ensure the reproducibility of research that uses data from EHRs. PMID:27570682

  9. An Evaluation of Surgical Prophylaxis Procedures in Turkey: A Multi-Center Point Prevalence Study

    PubMed Central

    Kaya, Selcuk; Aktas, Seyhan; Senbayrak, Seniha; Tekin, Recep; Oztoprak, Nefise; Aksoy, Firdevs; Firat, Pinar; Yenice, Sevinc; Oncul, Ahsen; Gunduz, Alper; Solak, Semiha; Kadanali, Ayten; Cakar, Sule Eren; Caglayan, Derya; Yilmaz, Hava; Bozkurt, Ilkay; Elmaslar, Tulin; Tartar, Ayse Sagmak; Aynioglu, Aynur; Kocyigit, Nilgun Fidan; Koksal, Iftihar

    2016-01-01

    Objective: The purpose of this study was to evaluate compliance with guidelines in surgical prophylaxis (SP) procedures in Turkey. Materials and Methods: A point prevalence study involving 4 university, 5 education and research and 7 public hospitals was performed assessing compliance with guidelines for antibiotic use in SP. Compliance was based on the “Clinical Practice Guidelines for Antimicrobial Surgery (CPGAS) 2013” guideline. Results: Sixteen centers were included in the study, with 166 operations performed at these being evaluated. Parenteral antibiotic for SP was applied in 161 (96.9%) of these. Type of antibiotic was inappropriate in 66 (40.9%) cases and duration of use in 47 (29.1%). The main antibiotics used inappropriately in SP were ceftriaxone, glycopeptides and aminoglycosides. No significant difference was observed between secondary and tertiary hospitals in terms of inappropriate selection. Duration of prophylaxis was also incompatible with guideline recommendations in approximately half of surgical procedures performed in both secondary and tertiary hospitals, however statistical significance was observed between institutions in favor of tertiary hospitals. Conclusion: Antibiotics are to a considerable extent used in a manner incompatible with guidelines even in tertiary hospitals in Turkey. It must not be forgotten that several pre-, intra- and postoperative factors can be involved in the development of surgical site infections (SSI), and antibiotics are not the only option available for preventing these. A significant improvement can be achieved in prophylaxis with close observation, educational activities, collaboration with the surgical team and increasing compliance with guidelines. All health institutions must establish and apply their own SP consensus accompanied by the guidelines in order to achieve success in SP. PMID:27026760

  10. N = 2 SUGRA BPS multi-center solutions, quadratic prepotentials and Freudenthal transformations

    NASA Astrophysics Data System (ADS)

    Fernández-Melgarejo, J. J.; Torrente-Lujan, E.

    2014-05-01

    We present a detailed description of N = 2 stationary BPS multicenter black hole solutions for quadratic prepotentials with an arbitrary number of centers and scalar fields making a systematic use of the algebraic properties of the matrix of second derivatives of the prepotential, , which in this case is a scalar-independent matrix. In particular we obtain bounds on the physical parameters of the multicenter solution such as horizon areas and ADM mass. We discuss the possibility and convenience of setting up a basis of the symplectic vector space built from charge eigenvectors of the , the set of vectors (P± q a) with P± -eigenspace projectors. The anti-involution matrix can be understood as a Freudenthal duality . We show that this duality can be generalized to "Freudenthal transformations" under which the horizon area, ADM mass and intercenter distances scale up leaving constant the scalars at the fixed points. In the special case λ = 1, "-rotations", the transformations leave invariant the solution. The standard Freudenthal duality can be written as . We argue that these generalized transformations leave invariant not only the quadratic prepotential theories but also the general stringy extremal quartic form Δ4, Δ4( x) = Δ4(cos θx + sin θ ) and therefore its entropy at lowest order.

  11. N=2 SUGRA BPS multi-center black holes and freudenthal triple systems

    NASA Astrophysics Data System (ADS)

    Torrente-Lujan, E.; Fernandez-Melgarejo, J. J.

    2015-05-01

    We present a detailed description of N = 2 stationary BPS multicenter black hole solutions for quadratic prepotentials with an arbitrary number of centers and scalar fields making a systematic use of the algebraic properties of the matrix of second derivatives of the prepotential, S, which in this case is a scalar-independent matrix. The anti-involution matrix S can be understood as a Freudenthal duality x˜ = Sx. We show that this duality can be generalized to "Freudenthal transformations" x to λ exp ≤ft( {θ S} right)x = ax + btilde x under which the horizon area, ADM mass and intercenter distances scale up leaving constant the scalars at the fixed points. In the special case λ = 1, "S-rotations", the transformations leave invariant the solution. The standard Freudenthal duality can be written as tilde x = {{exp }}≤ft( {{π over 2}S} right){{ }}x. We argue that these generalized transformations leave invariant not only the quadratic preotential theories but also the general stringy extremal quartic form Δ4, Δ4(x) = Δ4(cos θx + sin θx˜) and therefore its entropy at lowest order.

  12. Electronic data capture and DICOM data management in multi-center clinical trials

    NASA Astrophysics Data System (ADS)

    Haak, Daniel; Page, Charles-E.; Deserno, Thomas M.

    2016-03-01

    Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging has become increasingly important in clinical trials. Here, subject's data is today captured in electronic case reports forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject's medical image data into eCRFs is insufficiently supported. Neither integration of subject's digital imaging and communications in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible. This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel, where subject's image data is stored and retrieved. Background communication with the PACS is completely hidden for the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are reduced, while, a research database is implicitly built up in the background.

  13. Coping Strategies and Locus of Control in Childhood Leukemia: A Multi-Center Research.

    PubMed

    Polizzi, Concetta; Fontana, Valentina; Perricone, Giovanna; D'Angelo, Paolo; Jankovic, Momcilo; Taormina, Calogero; Nichelli, Francesca; Burgio, Sofia

    2015-05-25

    Acute lymphoblastic leukemia (ALL) is a very distressing experience for children and requires a special effort of adjustment. Therefore, it seems to be crucial to explore coping resources for the experienced risk condition. In this sense, the study focuses on coping strategies and locus of control in children with ALL during the treatment phase, and on their possible relation. The correlation between children and maternal coping strategies is also investigated. The participants involved were an experimental group of 40 children with ALL and their mothers, and 30 healthy children as the control group. The tools used were: the Child Behavioral Style Scale and the Monitor-Blunter Style Scale to assess the coping strategies of children and mothers; the locus of Control Scale for Children to analyze the children's perception of controlling the events. Both children with ALL and their mothers resorted to monitoring coping strategies with a statistically significant rate of occurrence (children: M=17.8, SD=3.8; mothers: M=10.48, SD=3.4). The data concerning the locus of control show this tendency towards internal causes (M=53.1, SD=4.7). There were statistically significant correlations between monitoring coping strategies and external locus of control (r=0.400, P<0.05). The results gained from the control group are almost equivalent. The outcomes show several interesting resources of the psychological functioning of children as well as of their mothers. PMID:26266029

  14. Coping Strategies and Locus of Control in Childhood Leukemia: A Multi-Center Research

    PubMed Central

    Polizzi, Concetta; Fontana, Valentina; Perricone, Giovanna; D’Angelo, Paolo; Jankovic, Momcilo; Taormina, Calogero; Nichelli, Francesca; Burgio, Sofia

    2015-01-01

    Acute lymphoblastic leukemia (ALL) is a very distressing experience for children and requires a special effort of adjustment. Therefore, it seems to be crucial to explore coping resources for the experienced risk condition. In this sense, the study focuses on coping strategies and locus of control in children with ALL during the treatment phase, and on their possible relation. The correlation between children and maternal coping strategies is also investigated. The participants involved were an experimental group of 40 children with ALL and their mothers, and 30 healthy children as the control group. The tools used were: the Child Behavioral Style Scale and the Monitor-Blunter Style Scale to assess the coping strategies of children and mothers; the locus of Control Scale for Children to analyze the children’s perception of controlling the events. Both children with ALL and their mothers resorted to monitoring coping strategies with a statistically significant rate of occurrence (children: M=17.8, SD=3.8; mothers: M=10.48, SD=3.4). The data concerning the locus of control show this tendency towards internal causes (M=53.1, SD=4.7). There were statistically significant correlations between monitoring coping strategies and external locus of control (r=0.400, P<0.05). The results gained from the control group are almost equivalent. The outcomes show several interesting resources of the psychological functioning of children as well as of their mothers. PMID:26266029

  15. Characteristics and Outcomes of Second Malignant Neoplasms after Childhood Cancer Treatment: Multi-Center Retrospective Survey.

    PubMed

    Koh, Kyung-Nam; Yoo, Keon Hee; Im, Ho Joon; Sung, Ki Woong; Koo, Hong Hoe; Kim, Hyo Sun; Han, Jung Woo; Yoon, Jong Hyung; Park, Hyeon Jin; Park, Byung-Kiu; Baek, Hee Jo; Kook, Hoon; Lee, Jun Ah; Lee, Jae Min; Lee, Kwang Chul; Kim, Soon Ki; Park, Meerim; Lee, Young-Ho; Lyu, Chuhl Joo; Seo, Jong Jin

    2016-08-01

    This retrospective study investigated the clinical characteristics and outcomes of second malignant neoplasms (SMNs) in survivors of childhood cancer from multiple institutions in Korea. A total of 102 patients from 11 institutions who developed SMN after childhood cancer treatment between 1998 and 2011 were retrospectively enrolled. The most common primary malignant neoplasms (PMNs) were central nervous system (CNS) tumors (n = 17), followed by acute lymphoblastic leukemia (n = 16), non-Hodgkin lymphoma (n = 13), and osteosarcoma (n = 12). The most common SMNs were therapy-related myeloid neoplasms (t-MNs; acute myeloid leukemia [AML], 29 cases; myelodysplastic syndrome [MDS], 12 cases), followed by thyroid carcinomas (n = 15) and CNS tumors (n = 10). The median latency period was 4.9 years (range, 0.5-18.5 years). Among 45 patients with solid tumors defined as an SMN, 15 (33%) developed the lesion in a field previously subjected to radiation. The 5-year overall survival (OS) rate of patients with an SMN was 45% with a median follow-up time of 8.6 years. Patients with AML, MDS, and CNS tumors exhibited the poorest outcomes with 5-year OS rates of 18%, 33%, and 32%, respectively, whereas those with second osteosarcoma showed comparable outcomes (64%) to patients with primary counterpart and those with second thyroid carcinoma had a 100% OS rate. Further therapeutic efforts are recommended to improve the survival outcomes in patients with SMNs, especially in cases with t-MNs and CNS tumors. PMID:27478336

  16. A prospective, multi-center study: factors related to the management of diabetic foot infections.

    PubMed

    Ertugrul, B M; Oncul, O; Tulek, N; Willke, A; Sacar, S; Tunccan, O G; Yilmaz, E; Kaya, O; Ozturk, B; Turhan, O; Yapar, N; Ture, M; Akin, F

    2012-09-01

    The Turkish Association of Clinical Microbiology and Infectious Diseases, Diabetic Foot Infections Working Group conducted a prospective study to determine the factors affecting the outcomes of diabetic foot infections. A total of 96 patients were enrolled in the study. Microbiological assessment was performed in 86 patients. A total of 115 causative bacteria were isolated from 71 patients. The most frequently isolated bacterial species was Pseudomonas aeruginosa (n = 21, 18.3%). Among cases with bacterial growth, 37 patients (43%) were infected with 38 (33%) antibiotic-resistant bacteria. The mean (±SD) antibiotics cost was 2,220.42 (±994.59) USD in cases infected with resistant bacteria, while it was 1,206.60 (±1,160.6) USD in patients infected with susceptible bacteria (p < 0.001). According to the logistic regression analysis, the risk factors related to the growth of resistant bacteria were previous amputation (p = 0.018, OR = 7.229) and antibiotics administration within the last 30 days (p = 0.032, OR = 3.796); that related to the development of osteomyelitis was wound size >4.5 cm(2) (p = 0.041, OR = 2.8); and that related to the failure of the treatment was the growth of resistant bacteria (p = 0.016, OR = 5.333). Diabetic foot osteomyelitis is usually a chronic infection and requires surgical therapy. Amputation is the accepted form of treatment for osteomyelitis. Limited limb-saving surgery and prolonged antibiotic therapy directed toward the definitive causative bacteria are most appropriate. This may decrease limb loss through amputations. As a result the infections caused by resistant bacteria may lead to a high cost of antibiotherapy, prolonged hospitalization duration, and failure of the treatment. PMID:22354524

  17. Personality Traits Affect Teaching Performance of Attending Physicians: Results of a Multi-Center Observational Study

    PubMed Central

    Scheepers, Renée A.; Lombarts, Kiki M. J. M. H.; van Aken, Marcel A. G.; Heineman, Maas Jan; Arah, Onyebuchi A.

    2014-01-01

    Background Worldwide, attending physicians train residents to become competent providers of patient care. To assess adequate training, attending physicians are increasingly evaluated on their teaching performance. Research suggests that personality traits affect teaching performance, consistent with studied effects of personality traits on job performance and academic performance in medicine. However, up till date, research in clinical teaching practice did not use quantitative methods and did not account for specialty differences. We empirically studied the relationship of attending physicians' personality traits with their teaching performance across surgical and non-surgical specialties. Method We conducted a survey across surgical and non-surgical specialties in eighteen medical centers in the Netherlands. Residents evaluated attending physicians' overall teaching performance, as well as the specific domains learning climate, professional attitude, communication, evaluation, and feedback, using the validated 21-item System for Evaluation of Teaching Qualities (SETQ). Attending physicians self-evaluated their personality traits on a 5-point scale using the validated 10-item Big Five Inventory (BFI), yielding the Five Factor model: extraversion, conscientiousness, neuroticism, agreeableness and openness. Results Overall, 622 (77%) attending physicians and 549 (68%) residents participated. Extraversion positively related to overall teaching performance (regression coefficient, B: 0.05, 95% CI: 0.01 to 0.10, P = 0.02). Openness was negatively associated with scores on feedback for surgical specialties only (B: −0.10, 95% CI: −0.15 to −0.05, P<0.001) and conscientiousness was positively related to evaluation of residents for non-surgical specialties only (B: 0.13, 95% CI: 0.03 to 0.22, p = 0.01). Conclusions Extraverted attending physicians were consistently evaluated as better supervisors. Surgical attending physicians who display high levels of openness were evaluated as less adequate feedback-givers. Non-surgical attending physicians who were conscientious seem to be good at evaluating residents. These insights could contribute to future work on development paths of attending physicians in medical education. PMID:24844725

  18. Fully-automated quality assurance in multi-center studies using MRI phantom measurements.

    PubMed

    Davids, Mathias; Zöllner, Frank G; Ruttorf, Michaela; Nees, Frauke; Flor, Herta; Schumann, Gunter; Schad, Lothar R

    2014-07-01

    Phantom measurements allow for investigating the overall quality characteristics of an MRI scanner. Especially within multicenter studies, these characteristics ensure the comparability of the results across different sites, in addition to the performance stability of a single scanner over time. This comparability requires consistent phantoms, sequence protocols, and quality assurance criteria. Within the scope of this work, a software library was implemented for fully-automated determination of important quality characteristics (comprising signal-to-noise ratio, image uniformity, ghosting artifacts, chemical shift and spatial resolution and linearity) including methods for data preparation, automated pre- and postprocessing as well as visualization and interpretation. All methods were evaluated using both synthetic images with predefined distortions and a set of 44 real phantom measurements involving eight sites and three manufacturers. Using the synthetic phantom images, predefined levels of distortion that were incorporated artificially were correctly detected by the automated routines with no more than 2.6% of relative error. In addition, the methods were applied to real phantom measurements - all data sets could be evaluated automatically considering all quality parameters as long as the acquisition protocols are followed. Shortcomings of the processability only occurred in the ghosting artifacts (39/44 evaluable) and the spatial linearity (43/44 evaluable) analysis due to gross misalignments of the phantom during image acquisition. Based on evaluation results, the accuracy of the evaluation appears to be robust to misalignments, artifacts, and distortions affecting the images, allowing for objective fully-automated evaluation and interpretation of large data set numbers. PMID:24602825

  19. Controlled Blood Pressure in Iranian Patients: A Multi-Center Report

    PubMed Central

    Sadeghi, Ezzatollah; Behnood-Rod, Azin; Aerab-Sheibani, Hossein; Shobeiri, Elham; Pourzargar, Pirouz; Ormoz, Ehsan; Sadigh, Nader; Moharamzad, Yashar

    2016-01-01

    We decided to determine the percentage of hypertensive patients whose blood pressure (BP) measurements were within recommended controlled range and to identify predictive factors for controlled BP. In this study carried out in 2014, 280 patients were included consecutively through sampling from both university and private medical centers/pharmacies in four Iranian cities. Demographic data as well as information about duration of HTN and prescribed medications, admission to emergency department (ED) because of HTN crisis, comorbidities, and control of HTN during the last 6 months by a healthcare provider were gathered. Adherence to anti-hypertensives was also determined using the validated Persian version of the 8-item Morisky Medication Adherence Scale (MMAS-8). Controlled BP was defined as systolic BP< 140 and diastolic BP< 90 mmHg in non-diabetics and < 130/80 mmHg in diabetics. Of 280 patients, 122 subjects (43.6%) had controlled BP. Among 55 diabetics, only two patients (3.6%) had controlled BP. Multiple logistic regression revealed the following variables as significant predictors of controlled BP: higher MMAS-8 score (adjusted odds ratio (OR)= 1.19, P= 0.03), fewer number of comorbid conditions (adjusted OR= 0.71, P = 0.03), having occupation as clerk/military personnel (adjusted OR= 1.03, P= 0.04), and not having history of ED admission during the last 6 months because of HTN crisis (adjusted OR= 2.11, P= 0.01). Considerable number of the studied patients had uncontrolled BP. Regarding the dramatic consequences of uncontrolled high BP in long term, it is advisable that careful attention by health care providers to the aforementioned factors could raise the likelihood of achieving controlled BP. PMID:26573037

  20. Body Image in Young Gender Dysphoric Adults: A European Multi-Center Study.

    PubMed

    Becker, Inga; Nieder, Timo O; Cerwenka, Susanne; Briken, Peer; Kreukels, Baudewijntje P C; Cohen-Kettenis, Peggy T; Cuypere, GrietDe; Haraldsen, Ira R Hebold; Richter-Appelt, Hertha

    2016-04-01

    The alteration of sex-specific body features and the establishment of a satisfactory body image are known to be particularly relevant for individuals with Gender Dysphoria (GD). The aim of the study was to first develop new scales and examine the psychometric properties of the Hamburg Body Drawing Scale (Appelt & Strauß 1988). For the second part of this study, the satisfaction with different body features in young GD adults before cross-sex treatment were compared to female and male controls. Data collection took place within the context of the European Network for the Investigation of Gender Incongruence (ENIGI) including 135 female-to-male (FtMs) and 115 male-to-female (MtFs) young GD adults and 235 female and 379 male age-adjusted controls. The five female and six male body feature subscales revealed good internal consistency. The ENIGI sample reported less satisfaction with overall appearance (d = 0.30) and with all of their body features than controls, but no subgroup differences for sexual orientation (FtM and MtF) and Age of Onset (FtM) were found. Body dissatisfaction was higher with regard to sex-specific body features (largest effect sizes of d = 3.21 for Genitalia in FtMs and d = 2.85 for Androgen-responsive features and genitalia in MtFs) than with those that appeared less related to the natal sex (d = 0.64 for Facial features in FtMs and d = 0.59 for Body shape in MtFs). Not only medical body modifying interventions, but also psychosocial guidance with regard to body image might be helpful for GD individuals before transitioning. PMID:25836027

  1. Transplant Nurses' Work Environment: A Cross-Sectional Multi-Center Study.

    PubMed

    Kugler, Christiane; Akca, Selda; Einhorn, Ina; Rebafka, Anne; Russell, Cynthia L

    2016-01-01

    BACKGROUND Numerically, nurses represent the largest healthcare profession, thus setting norms for the quality and safety of direct patient care. Evidence of a global shortage of nurses in all clinical practice settings across different healthcare systems and countries has been documented. The aims of the present study were: (1) to assess work environments in a sample of German transplant nurses, and (2) to compare their statements with a US-based sample. MATERIAL AND METHODS In a cross-sectional study, 181 transplant nurses from 16 German transplant centers provided information on their work environments. The translated version of the Job Design (JD) and Job Satisfaction (JS) survey showed satisfactory internal consistency for the JD (0.78) and JS (0.93) subscales. German nurses' work environments were compared with 331 transplant nurses from the US. RESULTS The majority of transplant nurses were female (81.8%), 55.4% were age 21-40 years, and 78.1% were employed full-time. German (versus US) transplant nurses reported their job design to be best for 'skill varieties' (p≤0.0002), and worst for 'autonomy' (p≤0.01). Job satisfaction was best with 'opportunities for autonomy and growth' (p≤0.0001), and 'pay and benefits' (p≤0.0001) was lowest. A higher professional degree (OR 1.57; p≤0.03; 95% CI 1.19-2.86), and longer time in transplant (OR 1.24; p≤0.001; 95% CI 1.11-1.38) showed a positive impact on German transplant nurses' perceptions of 'job satisfaction'. Nurses with time-dependent working contracts perceived more stress negatively affecting job satisfaction (OR 1.13; p≤0.009; 95% CI 1.02-12.82). CONCLUSIONS German specialty nurses working in the field of solid organ transplantation rate their work environments with respect to job design and job satisfaction as satisfactory. Institutions' investment into satisfactory nurse work environments and specializing nurses might increase the quality of care, thus improving patient outcomes. PMID:27582230

  2. Data collection in multi-center clinical trials via Internet. A generic system in Java.

    PubMed

    Sippel, H; Eich, H P; Ohmann, C

    1998-01-01

    Data collection via Internet is usually performed with an HTML/CGI combination, which has a lot of disadvantages, most important the lack of security features. We therefore have developed a system written entirely in Java, which implements a true client/server application based on TCP/IP. The documents are created using a multi-lingual data dictionary, and the used GUI components are able to perform plausibility checks, which improves quality of the data. The system is designed to be easily extensible so that it can be used in almost any kind of clinical trials. It is based on a three-tier model where client requests are handled and monitored by an application server. We will describe this system and it's implementation and compare it to the HTML/CGI approach. Of special interest are security features, which are possible through the use of Java. PMID:10384427

  3. Battlefield tracheal intubation training using virtual simulation: a multi center operational assessment of video laryngoscope technology.

    PubMed

    Boedeker, Ben H; Boedeker, Kirsten A; Bernhagen, Mary A; Miller, David J; Lacy, Timothy

    2011-01-01

    Airway management is an essential skill in providing care in trauma situations. The video laryngoscope is a tool which offers improvement in teaching airway management skills and in managing airways of trauma patients on the far forward battlefield. An Operational Assessment (OA) of videolaryngoscope technology for medical training and airway management was conducted by the Center for Advanced Technology and Telemedicine (at the University of Nebraska Medical Center, Omaha, NE) for the US Air Force Modernization Command to validate this technology in the provision of Out of OR airway management and airway management training in military simulation centers. The value for both the training and performance of intubations was highly rated and the majority of respondents indicated interest in having a video laryngoscope in their facility. PMID:21335763

  4. Proton pump inhibitor step-down therapy for GERD: A multi-center study in Japan

    PubMed Central

    Tsuzuki, Takao; Okada, Hiroyuki; Kawahara, Yoshiro; Takenaka, Ryuta; Nasu, Junichiro; Ishioka, Hidehiko; Fujiwara, Akiko; Yoshinaga, Fumiya; Yamamoto, Kazuhide

    2011-01-01

    AIM: To investigate the predictors of success in step-down of proton pump inhibitor and to assess the quality of life (QOL). METHODS: Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy. RESULTS: In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for step-down. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy. CONCLUSION: OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before step-down require particular monitoring for relapse. PMID:21472108

  5. Methods for Identifying Neisseria meningitidis Carriers: A Multi-Center Study in the African Meningitis Belt

    PubMed Central

    Basta, Nicole E.; Stuart, James M.; Nascimento, Maria C.; Manigart, Olivier; Trotter, Caroline; Hassan-King, Musa; Chandramohan, Daniel; Sow, Samba O.; Berthe, Abdoulaye; Bedru, Ahmed; Tekletsion, Yenenesh K.; Collard, Jean-Marc; Jusot, Jean-François; Diallo, Aldiouma; Basséne, Hubert; Daugla, Doumagoum M.; Gamougam, Khadidja; Hodgson, Abraham; Forgor, Abudulai A.; Omotara, Babatunji A.; Gadzama, Galadima B.; Watkins, Eleanor R.; Rebbetts, Lisa S.; Diallo, Kanny; Weiss, Noel S.; Halloran, M. Elizabeth; Maiden, Martin C. J.; Greenwood, Brian

    2013-01-01

    Objective Detection of meningococcal carriers is key to understanding the epidemiology of Neisseria meningitidis, yet no gold standard has been established. Here, we directly compare two methods for collecting pharyngeal swabs to identify meningococcal carriers. Methods We conducted cross-sectional surveys of schoolchildren at multiple sites in Africa to compare swabbing the posterior pharynx behind the uvula (U) to swabbing the posterior pharynx behind the uvula plus one tonsil (T). Swabs were cultured immediately and analyzed using molecular methods. Results One thousand and six paired swab samples collected from schoolchildren in four countries were analyzed. Prevalence of meningococcal carriage was 6.9% (95% CI: 5.4-8.6%) based on the results from both swabs, but the observed prevalence was lower based on one swab type alone. Prevalence based on the T swab or the U swab alone was similar (5.2% (95% CI: 3.8-6.7%) versus 4.9% (95% CI: 3.6-6.4%) respectively (p=0.6)). The concordance between the two methods was 96.3% and the kappa was 0.61 (95% CI: 0.50-0.73), indicating good agreement. Conclusions These two commonly used methods for collecting pharyngeal swabs provide consistent estimates of the prevalence of carriage, but both methods misclassified carriers to some degree, leading to underestimates of the prevalence. PMID:24194921

  6. Multi-center semi-empirical quantum models for carbon under extreme thermodynamic conditions

    NASA Astrophysics Data System (ADS)

    Goldman, Nir

    2015-03-01

    We report on the development of many-body density functional tight binding (DFTB) models for carbon accurate over thousands of GPa and tens of thousands of Kelvin. DFTB holds promise as a fast quantum simulation approach that can yield several orders of magnitude increase in computational efficiency over Kohn-Sham Density Functional Theory (DFT) while retaining most of its accuracy. However, standard DFTB can yield large errors for materials under high pressures and temperatures, where electrons can become delocalized. Here, we overcome these limitations by computing the environmental dependence of the DFTB Hamiltonian matrix elements directly from DFT. We include these results in DFTB calculations by either explicitly calculating three-center terms in the Hamiltonian, or by implicitly incorporating them in the diagonal matrix elements. We then determine a three-body repulsive energy for the implicit approach, which yields accurate equation of state and structural properties for both solid and metallic liquid states of carbon. Our new models exhibit a straightforward method by which many-body effects can be included in DFTB, thus extending it to the time scales of current compression experiments, where physical and chemical properties can be difficult to interrogate directly. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344, and was funded by Laboratory Directed Research and Development Grant # 12-ERD-052.

  7. Depression and Wish to Die in a Multi-Center Cohort of ALS Patients

    PubMed Central

    Rabkin, Judith G.; Goetz, Raymond; Factor-Litvak, Pam; Hupf, Jonathan; McElhiney, Martin; Singleton, Jessica; Mitsumoto, Hiroshi

    2015-01-01

    Objective To determine prevalence of depressive disorders and wish to die at the baseline visit of a longitudinal multi-site study of patients with ALS. Methods Structured telephone interviews were conducted with patients diagnosed in past 18 months at 16 U.S. ALS centers. Demographic, medical, psychiatric and other psychological measures were administered. Results Of 329 patients assessed, mean ALSFRS-R score was 36.6; 88% (289/329) had no depressive disorder, 7% (24/329)had minor depression, and 5% (16/329)had current major depressive disorder (DSM-IV criteria). Demographic, financial and employment factors were unrelated to depression, as were duration of ALS symptoms and respiratory status, although depressed patients had lower scores on the total ALSFRS-R ( p = .004) and gross motor function (p<.001). Depressed patients reported less pleasure, greater suffering, weariness and anxiety, more stress, were less hopeful, felt less control over illness management, reported lower quality of life, more often had thoughts about ending their lives and hastening death (all p<.001). Of the 62 patients (19% of the sample) who expressed a wish to die, only 37% (23/62) were clinically depressed. Conclusions Depressive disorders are not only to be expected of ALS patients. Wish to die is not always expressed in the context of depression and does not necessarily represent psychopathology as such. PMID:25482273

  8. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: a Multi-Center, Randomized, Controlled Study

    PubMed Central

    Talley, Nicholas J.; Locke, G. Richard; Saito, Yuri A.; Almazar, Ann E.; Bouras, Ernest P.; Howden, Colin W.; Lacy, Brian E.; DiBaise, John K.; Prather, Charlene M.; Abraham, Bincy P.; El-Serag, Hashem B.; Moayyedi, Paul; Herrick, Linda M.; Szarka, Lawrence A.; Camilleri, Michael; Hamilton, Frank A.; Schleck, Cathy D.; Tilkes, Katherine E.; Zinsmeister, Alan R.

    2015-01-01

    Background & Aims Anti-depressants are frequently prescribed to treat functional dyspepsia (FD), a common disorder characterized by upper abdominal symptoms, including discomfort or post-prandial fullness. However, there is little evidence for the efficacy of these drugs in patients with FD. We performed a randomized, double-blind, placebo-controlled trial to evaluate the effects of anti-depressant therapy effects on symptoms, gastric emptying (GE), and mealinduced satiety in patients with FD. Methods We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use anti-depressants. Subjects (n=292; 44±15 y old, 75% female, 70% with dysmotility-like FD, and 30% with ulcer-like FD) were randomly assigned to groups given placebo, 50 mg amitriptyline, or 10 mg escitalopram for 10 weeks. The primary endpoint was adequate relief of FD symptoms for ≥5 weeks of the last 10 weeks (out of 12). Secondary endpoints included GE time, maximum tolerated volume in a nutrient drink test, and FD-related quality of life. Results An adequate relief response was reported by 39 subjects given placebo (40%), 51 given amitriptyline (53%), and 37 given escitalopram (38%) (P=.05, following treatment, adjusted for baseline balancing factors including all subjects). Subjects with ulcer-like FD given amitriptyline were more than 3-fold more likely to report adequate relief than those given placebo (odds ratio=3.1; 95% confidence interval, 1.1–9.0). Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10 week period in any group. Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE (odds ratio=0.4; 95% confidence interval, 0.2–0.8). Both anti-depressants improved overall quality-of-life. Conclusions Amitriptyline, but not escitalopram, appears to benefit some patients with FD— particularly those with ulcer-like (painful) FD. Patients with delayed GE do not respond to these drugs. PMID:25921377

  9. Therapeutic hypothermia in acute liver failure: a multi-center retrospective cohort analysis

    PubMed Central

    Karvellas, Constantine J.; Stravitz, R. Todd; Battenhouse, Holly; Lee, William M.; Schilsky, Michael L.

    2016-01-01

    Background The benefit of therapeutic hypothermia (TH) in Acute Liver Failure (ALF) has not been previously demonstrated in a controlled fashion. This study aimed to determine the impact of TH on 21-day survival and complications in ALF patients at high risk for cerebral edema. Methods Retrospective cohort study of ALF patients in the US ALFSG with Grade III or IV hepatic encephalopathy. TH (32°C – 35°C) was used in 97 (8%) patients; 1135 (92%) not cooled were controls. Results Intracranial pressure (ICP) was monitored in 38 (40%) TH ALF patients (vs. 22% controls, p=0.0001). Rates of bleeding (12% in both), bloodstream (17% vs. 18) and tracheal infections (21% vs. 23%, p> 0.5 for all) were similar. Unadjusted 21-day overall (62% vs. 60%) and transplant-free survival (45 vs. 39%, p>0.4 for both) were similar. Multivariable models were created for acetaminophen (APAP) (n= 582) and non-APAP (n=613) patients. For APAP patients, MELD (Odds ratio 0.91 per increment; 95% CI 0.89–0.94, p <0.001) and vasopressors (OR 0.16; 0.11–0.24, p < 0.0001) were associated with decreased 21-day spontaneous survival. Survival was improved with TH in APAP patients aged < 25y (Age 25: OR 2.735; 95% CI 1.001 – 7.467) but worsened in 64y or older APAP patients (Age = 64: OR 0.167; 95%CI 0.028 – 0.999). For non-APAP patients, MELD (OR 0.93 per increment; 0.91–0.95, p < 0.0001) and vasopressors (OR 0.60; 0.40–0.90, p=0.01) were associated with worse outcomes while TH had no impact (p= 0.93). Conclusions Therapeutic hypothermia in ALF was not associated with increased bleeding or infections. While young APAP-ALF patients may benefit, TH did not consistently impact 21-day survival. A prospective trial is required to clarify the utility of TH in ALF patients. PMID:25308108

  10. Characteristics and Outcomes of Second Malignant Neoplasms after Childhood Cancer Treatment: Multi-Center Retrospective Survey

    PubMed Central

    2016-01-01

    This retrospective study investigated the clinical characteristics and outcomes of second malignant neoplasms (SMNs) in survivors of childhood cancer from multiple institutions in Korea. A total of 102 patients from 11 institutions who developed SMN after childhood cancer treatment between 1998 and 2011 were retrospectively enrolled. The most common primary malignant neoplasms (PMNs) were central nervous system (CNS) tumors (n = 17), followed by acute lymphoblastic leukemia (n = 16), non-Hodgkin lymphoma (n = 13), and osteosarcoma (n = 12). The most common SMNs were therapy-related myeloid neoplasms (t-MNs; acute myeloid leukemia [AML], 29 cases; myelodysplastic syndrome [MDS], 12 cases), followed by thyroid carcinomas (n = 15) and CNS tumors (n = 10). The median latency period was 4.9 years (range, 0.5–18.5 years). Among 45 patients with solid tumors defined as an SMN, 15 (33%) developed the lesion in a field previously subjected to radiation. The 5-year overall survival (OS) rate of patients with an SMN was 45% with a median follow-up time of 8.6 years. Patients with AML, MDS, and CNS tumors exhibited the poorest outcomes with 5-year OS rates of 18%, 33%, and 32%, respectively, whereas those with second osteosarcoma showed comparable outcomes (64%) to patients with primary counterpart and those with second thyroid carcinoma had a 100% OS rate. Further therapeutic efforts are recommended to improve the survival outcomes in patients with SMNs, especially in cases with t-MNs and CNS tumors. PMID:27478336

  11. Intravenous ketamine for the treatment of refractory status epilepticus: a retrospective multi-center study

    PubMed Central

    Gaspard, Nicolas; Foreman, Brandon; Judd, Lilith M.; Brenton, James N.; Nathan, Barnett R.; McCoy, Blathnaid M.; Al-Otaibi, Ali; Kilbride, Ronan; Fernández, Ivan Sánchez; Mendoza, Lucy; Samuel, Sophie; Zakaria, Asma; Kalamangalam, Giridhar P.; Legros, Benjamin; Szaflarski, Jerzy P.; Loddenkemper, Tobias; Hahn, Cecil D.; Goodkin, Howard P.; Claassen, Jan; Hirsch, Lawrence J.; LaRoche, Suzette M.

    2013-01-01

    Summary Purpose To examine patterns of use, efficacy and safety of intravenous ketamine for the treatment of refractory status epilepticus (RSE). Methods Multicenter retrospective review of medical records and EEG reports in ten academic medical centers in North America and Europe, including 58 subjects, representing 60 episodes of RSE were identified between 1999 and 2012. Seven episodes occurred after anoxic brain injury. Key findings Permanent control of RSE was achieved in 57% (34/60) of episodes. Ketamine was felt to have contributed to permanent control (“possible” or “likely” responses) in 32% (19/60) including seven (12%) in which ketamine was the last drug added (likely responses). Four of the seven likely responses, but none of the 12 possible ones, occurred in patients with post-anoxic brain injury. No likely responses were observed when infusion rates were lower than 0.9mg/kg/h; when ketamine was introduced at least eight days after SE onset; or after failure of seven or more drugs. Ketamine was discontinued due to possible adverse events in five patients. Complications were mostly attributed to concurrent drugs, especially other anesthetics. Mortality rate was 43% (26/60), but was lower when SE was controlled within 24h of ketamine initiation (16% vs. 56%, p=0.0047). Significance Ketamine appears to be a relatively effective and safe drug for the treatment of RSE. This retrospective series provides preliminary data on effective dose and appropriate time of intervention to aid in the design of a prospective trial to further define the role of ketamine in the treatment of RSE. PMID:23758557

  12. 33 CFR 1.05-35 - Notice of proposed rulemaking (NPRM).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Administrative Procedure Act (APA), 5 U.S.C. 553, an NPRM is generally published in the Federal Register for... discussion of any comments received in response to prior notices, a citation of legal authority for the...

  13. 77 FR 9665 - Submission for OMB Emergency Review; Comment Request: A Multi-Center International Hospital-Based...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ...In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing this information collection by March 5, 2012. NCI is requesting emergency processing of this information collection, pursuant to 5 CFR......

  14. How vital are the vital signs? a multi-center observational study from emergency departments of Pakistan

    PubMed Central

    2015-01-01

    Background Vital signs play a critical role in prioritizing patients in emergency departments (EDs), and are the foundation of most triage methods and disposition decisions. This study was conducted to determine the frequency of vital signs documentation anytime during emergency department treatment and to explore if abnormal vital signs were associated with the likelihood of admission for a set of common presenting complaints. Methods Data were collected over a four-month period from the EDs of seven urban tertiary care hospitals in Pakistan. The variables included age, sex, hospital type (government run vs. private), presenting complaint, ED vital signs, and final disposition. Patients who were >12 years of age were included in the analysis. The data were analyzed to describe the proportion of patients with documented vitals signs, which was then crossed-tabulated with top the ten presenting complaints to identify high-acuity patients and correlation with their admission status. Results A total of 274,436 patients were captured in the Pakistan National Emergency Department Surveillance (Pak-NEDS), out of which 259,288 patients were included in our study. Vital signs information was available for 90,569 (34.9%) patients and the most commonly recorded vitals sign was pulse (25.7%). Important information such as level of consciousness was missing in the majority of patients with head injuries. Based on available information, only 13.3% with chest pain, 12.8% with fever and 12.8% patients with diarrhea could be classified as high-acuity. In addition, hospital admission rates were two- to four-times higher among patients with abnormal vital signs, compared with those with normal vital signs. Conclusion Most patients seen in the EDs in Pakistan did not have any documented vital signs during their visit. Where available, the presence of abnormal vital signs were associated with higher chances of admission to the hospital for the most common presenting symptoms. PMID:26690816

  15. Knowledge of HPV and Surgery among Women Who Underwent Cervical Conization: A Korean Multi-Center Study

    PubMed Central

    Jun, So Yeun; Kim, Se Ik; Lee, Jung-Yun; Lee, San Hui; Song, Yong Jung; Chun, Kyoung-Chul; Kim, Jae Weon; Park, Sang-Yoon

    2016-01-01

    Purpose Human papillomavirus (HPV) infection is a well-known cause of cervical cancer, which, along with its precursors, can be diagnosed and treated with cervical conization (CC). This study aimed to assess HPV- and procedure-related knowledge among women who had undergone CC. Materials and Methods Between February and May 2014, consecutive women who had undergone CC at five different educational hospitals were recruited. All patients had undergone a loop electrosurgical excision procedure as the method of CC. A survey was conducted with a self-developed, 29-item questionnaire, measuring knowledge related to HPV and CC. We analyzed the responses of 160 patients who completed the questionnaire. Results Mean total knowledge scores (±standard deviation) for HPV and CC were 5.2±3.0 of a possible 13.0 and 8.3±4.2 of a possible 16.0, respectively. While 73% of the patients knew that HPV is the main cause of cervical cancer, only 44% knew that HPV is sexually transmitted. The purpose of CC was correctly identified by 71% of the patients. However, 35% failed to indicate the anatomical area resected at the time of CC in the schematic diagram. Women who were younger (p<0.001), had higher education level (p<0.001), and higher family income (p=0.008) had higher knowledge scores. In contrast, neither interval from CC to survey nor disease severity were associated with total knowledge score. Conclusion The level of knowledge related to HPV and CC was unexpectedly low in women who had undergone CC. Intuitive educational resources may improve this knowledge, and further cohort studies are warranted. PMID:27401655

  16. 77 FR 56854 - Submission for OMB Review; Comment Request: A Multi-Center International Hospital-Based Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... information collection was previously published in the Federal Register on February 24, 2012 (77 FR 11136) and... cancer burden from lymphoid malignancies in the Asian population, the incidence of which has risen...

  17. Characteristics of MPO-ANCA-positive granulomatosis with polyangiitis: a retrospective multi-center study in Japan.

    PubMed

    Ono, Nobuyuki; Niiro, Hiroaki; Ueda, Akira; Sawabe, Takuya; Nishizaka, Hiroaki; Furugo, Isao; Yoshizawa, Seiji; Yoshizawa, Shigeru; Tsukamoto, Hiroshi; Kiyohara, Chikako; Tada, Yoshifumi; Horiuchi, Takahiko

    2015-03-01

    We studied the clinico-pathological differences among PR3-ANCA-positive granulomatosis with polyangiitis (PR3-GPA), MPO-ANCA-positive GPA (MPO-GPA) and microscopic polyangiitis (MPA). ANCA-associated vasculitis (AAV) was classified using the European Medicines Agency classification. We retrospectively analyzed 38 patients with GPA and 41 with MPA treated in eight hospitals in Japan. Of the patients with GPA, 17 were positive for MPO-ANCA, and 15 for PR3-ANCA. All patients with MPA were MPO-ANCA positive. The mean ages of those with MPO-GPA were 69.6 years old, 10 years older than those with PR3-GPA. The majority (82 %) of patients with MPO-GPA were woman, a significantly greater proportion than for PR3-GPA. We also found that ear, nose and throat (ENT), nervous system involvement were significantly more common in MPO-GPA, but renal function was less impaired than those with MPA. Both PR3-GPA and MPO-GPA relapsed more frequently than MPA, but overall survival was significantly better (P < 0.01 and P < 0.05, respectively). Univariate analysis identified the following factors as predictors of a poor prognosis: MPA (P < 0.01), pulmonary UIP pattern (P < 0.005) Cr ≥ 1.7 mg/dl (P < 0.01) and absence of ENT involvement (P < 0.05), which were characteristics of MPA. In our cohort, MPO-GPA was most likely to affect older women and was associated with otitis media, nervous system involvement, mild renal impairment and more favorable outcome. It is clinically useful to differentiate MPO-GPA from MPA and PR3-GPA in patients with AAV. PMID:25129031

  18. Percutaneous Radiofrequency Ablation of Painful Osseous Metastases: A Multi-center American College of Radiology Imaging Network Trial

    PubMed Central

    Dupuy, Damian E.; Liu, Dawei; Hartfeil, Donna; Hanna, Lucy; Blume, Jeffrey D.; Ahrar, Kamran; Lopez, Robert; Safran, Howard; DiPetrillo, Thomas

    2009-01-01

    Background To determine if radiofrequency ablation (RFA) can safely reduce pain from osseous metastatic disease. Methods A single arm prospective trial in patients with a single painful bone metastasis with unremitting pain of at least a score above 50 on a pain scale of 0–100. Percutaneous CT guided RFA of the bone metastasis to temperatures above 60 degrees Celsius was performed. Endpoints were the toxicity and pain effects of RFA before and at 2 weeks, one and three months after RFA. Results 55 patients completed RFA. Grade 3 toxicities occurred in 3 of 55 patients (5%). RFA reduced pain at 1- and 3-month for all pain assessment measures. The average increase in pain relief from pre-RFA to 1-month follow-up is 26.27 (95% CI, 17.65 to 34.89, P<0.0001) and the increase from pre-RFA to 3-month follow-up is 16.38 (95% CI, 3.37 to 29.39, P=0.02). The average decrease in pain intensity from pre-RFA to 1-month follow-up was 26.9 (P<0.0001) and 14.2 for 3-month follow-up (P=0.02). The odds of being in lower pain severity at 1-month follow-up is 14.03 (95% CI, 2.33 to 25.73, P<0.0001) times higher than that at pre-RFA, and the odds at 3-month follow-up is 8.00 (95% CI, 0.85 to 15.15, P<0.001) times higher than that at pre-RFA. The average increase in mood from pre-RFA to 1-month follow-up was 19.9 (P<0.0001) and 14.9 for 3-month follow-up (P=0.005). Conclusion This cooperative group trial strongly suggests that RFA can safely palliate pain from bone metastases. PMID:20041484

  19. Implementation and Outcomes of a Collaborative Multi-Center Network Aimed at Web-Based Cognitive Training – COGWEB Network

    PubMed Central

    Pais, Joana; Ruano, Luis; Mateus, Cátia; Colunas, Márcio; Alves, Ivânia; Barreto, Rui; Conde, Eduardo; Sousa, Andreia; Araújo, Isabel; Bento, Virgílio; Coutinho, Paula; Rocha, Nelson

    2014-01-01

    Background Cognitive care for the most prevalent neurologic and psychiatric conditions will only improve through the implementation of new sustainable approaches. Innovative cognitive training methodologies and collaborative professional networks are necessary evolutions in the mental health sector. Objective The objective of the study was to describe the implementation process and early outcomes of a nationwide multi-organizational network supported on a Web-based cognitive training system (COGWEB). Methods The setting for network implementation was the Portuguese mental health system and the hospital-, academic-, community-based institutions and professionals providing cognitive training. The network started in August 2012, with 16 centers, and was monitored until September 2013 (inclusions were open). After onsite training, all were allowed to use COGWEB in their clinical or research activities. For supervision and maintenance were implemented newsletters, questionnaires, visits and webinars. The following outcomes were prospectively measured: (1) number, (2) type, (3) time to start, and (4) activity state of centers; age, gender, level of education, and medical diagnosis of patients enrolled. Results The network included 68 professionals from 41 centers, (33/41) 80% clinical, (8/41) 19% nonclinical. A total of 298 patients received cognitive training; 45.3% (n=135) female, mean age 54.4 years (SD 18.7), mean educational level 9.8 years (SD 4.8). The number enrolled each month increased significantly (r=0.6; P=.031). At 12 months, 205 remained on treatment. The major causes of cognitive impairment were: (1) neurodegenerative (115/298, 38.6%), (2) structural brain lesions (63/298, 21.1%), (3) autoimmune (40/298, 13.4%), (4) schizophrenia (30/298, 10.1%), and (5) others (50/298, 16.8%). The comparison of the patient profiles, promoter versus all other clinical centers, showed significant increases in the diversity of causes and spectrums of ages and education. Conclusions Over its first year, there was a major increase in the number of new centers and professionals, as well as of the clinical diversity of patients treated. The consolidation of such a national collaborative network represents an innovative step in mental health care evolution. Furthermore, it may contribute to translational processes in the field of cognitive training and reduce disease burden. PMID:26543902

  20. Patterns of Clinical Response to PSA Elevation in American Indian/Alaska Native Men: A Multi-center Pilot Study

    PubMed Central

    Tilburt, Jon C.; Koller, Kathryn; Tiesinga, James J.; Wilson, Robin T.; Trinh, Anne C.; Hill, Kristin; Hall, Ingrid J.; Smith, Judith Lee; Ekwueme, Donatus U.; Petersen, Wesley O.

    2016-01-01

    Objective To assess clinical treatment patterns and response times among American Indian/Alaska Native men with a newly elevated PSA. Methods We retrospectively identified men ages 50–80 receiving care in one of three tribally-operated clinics in Northern Minnesota, one medical center in Alaska, and who had an incident PSA elevation (≥ 4 ng/ml) in a specified time period. A clinical response was considered timely if it was documented as occurring within 90 days of the incident PSA elevation. Results Among 82 AI/AN men identified from medical records with an incident PSA elevation, 49 (60%) received a timely clinical response, while 18 (22%) had no documented clinical response. Conclusions One in five AI/AN men in our study had no documented clinical action following an incident PSA elevation. Although a pilot study, these findings suggest the need to improve the documentation, notification, and care following an elevated PSA at clinics serving AI/AN men. PMID:24185163

  1. Quality of Life and its Determinants in a Multi-Center Cohort of Children with Alagille Syndrome

    PubMed Central

    Kamath, Binita M.; Chen, Zhen; Romero, Rene; Fredericks, Emily M.; Alonso, Estella M.; Arnon, Ronen; Heubi, James; Hertel, Paula M.; Karpen, Saul J.; Loomes, Kathleen M.; Murray, Karen F.; Rosenthal, Philip; Schwarz, Kathleen B.; Subbarao, Girish; Teckman, Jeffrey H.; Turmelle, Yumirle P.; Wang, Kasper S.; Sherker, Averell H.; Sokol, Ronald J.; Magee, John C.

    2015-01-01

    Objectives To assess health-related quality of life (HRQOL) in children with Alagille syndrome (ALGS) in comparison with healthy and other liver disease cohorts, and to identify determinants of HRQOL in patients with ALGS. Study design Within the Childhood Liver Disease Research Network prospective study of cholestasis, Pediatric Quality of Life Inventory™ (PedsQL) questionnaires were administered to 70 ALGS, 95 alpha-1-antitrypsin deficiency (A1ATD) and 49 children with other causes of chronic intrahepatic cholestasis (IHC) aged 5-18 years. Parent-proxy PedsQL scores were recorded for children aged 2-18 (98 ALGS, 123 A1ATD, 68 IHC). Results Mean ages and total bilirubin (mg/dL) were: ALGS 9.4y; 4.4, A1ATD 9.5y; 0.7, IHC 10.3y; 2.9. ALGS child PedsQL scores were lower than in healthy children and children with A1ATD (mean 73 vs. 83 p=0.001). Children with ALGS and IHC were similar, except in physical scores (73 vs. 79 p=0.05). ALGS parents perceived their children to have worse HRQOL than A1ATD (p<=0.001) and marginally lower compared with IHC. Univariate analysis revealed ALGS child-reported scores were positively associated with better growth and inversely with total bilirubin. Growth failure, elevated INR and an intra-cardiac defect were predictive of poor parental scores (p<=0.05). In multivariate analysis, only weight z-score remained significant for child and parent-reported scores. Conclusions HRQOL is impaired in ALGS compared with healthy and children with A1ATD, similar to IHC and is associated with growth failure, which is a potentially treatable cause of impaired HRQOL. PMID:26059338

  2. A Multi-centered Cross-sectional Study of Disease Burden of Pain of Inpatients in Southwest China

    PubMed Central

    Peng, Li-Hua; Jing, Ju-Yin; Qin, Pei-Pei; Su, Min

    2016-01-01

    Background: Pain is a common burden of disease globally; yet, it is not systematically investigated in China, especially in hospitalized patients. This study was aimed at clarifying the epidemiological characteristics of pain and related factors in hospitalized patients in Southwest China. Methods: A cross-sectional study was conducted to investigate the prevalence, severity, and influencing factors of pain and modes of postoperative analgesia in hospitalized patients from 17 hospitals in Southwest China. A prevalidated questionnaire was employed to calibrate all of these items within 3 days from March 18, 2015 to March 20, 2015. Results: A total of 2293 patients were surveyed, the incidence of pain was 57.4% in all hospitalized patients at rest, of which 62.1% were with acute pain and 37.9% had persistent to chronic pain. Among surgical patients, 90.8% of them complained of acute postoperative pain at rest and 97.1% in motion. The incidence of acute postoperative moderate-to-severe pain was 28.8% at rest and 45.1% in motion. Surgical patients reported higher incidences of pain, especially acute and persistent pain compared with nonsurgical patients (P < 0.05). Postoperative pain occurred predominately at surgical sites (95.2%) as compared with nonsurgical sites (4.8%). Agedness, lower education level, surgery, and history of smoking were factors associated with increased duration and severity of postoperative pain and nonsurgical pain (P < 0.05). Conclusions: Pain is a common burden of disease in China, of which surgical pain constituted an important component. Surgical patients complained more severe pain than those who did not undergo surgery. Postoperative analgesia still needs to be improved to control pain after surgery. Patients' perception might influence the efficacy of pain management, which should be implemented with a multidisciplinary approach. PMID:27064038

  3. Pipeline Embolization Device for Large/Giant or Fusiform Aneurysms: An Initial Multi-Center Experience in Korea

    PubMed Central

    Shin, Yong Sam; Baik, Min Woo; Lee, Deok Hee; Jeon, Pyoung; Baik, Seung Kug; Lee, Tae Hong; Kang, Dong-Hoon; Suh, Sang-il; Byun, Jun Soo; Jung, Jin-Young; Kwon, Kihun; Kim, Dong Joon; Park, Keun Young; Kim, Bum-soo; Park, Jung Cheol; Kim, Seong Rim; Kim, Young Woo; Kim, Hoon; Jo, Kyungil; Yoon, Chang Hyo; Kim, Young Soo

    2016-01-01

    Purpose The purpose of this study was to assess the safety and early outcomes of the Pipeline device for large/giant or fusiform aneurysms. Materials and Methods The Pipeline was implanted in a total of 45 patients (mean age, 58 years; M:F=10:35) with 47 large/giant or fusiform aneurysms. We retrospectively evaluated the characteristics of the treated aneurysms, the periprocedural events, morbidity and mortality, and the early outcomes after Pipeline implantation. Results The aneurysms were located in the internal carotid artery (ICA) cavernous segment (n=25), ICA intradural segment (n=11), vertebrobasilar trunk (n=8), and middle cerebral artery (n=3). Procedure-related events occurred in 18 cases, consisting of incomplete expansion (n=8), shortening-migration (n=5), transient occlusion of a jailed branch (n=3), and in-stent thrombosis (n=2). Treatment-related morbidity occurred in two patients, but without mortality. Both patients had modified Rankin scale (mRS) scores of 2, but had an improved mRS score of 0 at 1-month follow-up. Of the 19 patients presenting with mass effect, 16 improved but three showed no changes in their presenting symptoms. All patients had excellent outcomes (mRS, 0 or 1) during the follow-up period (median, 6 months; range, 2-30 months). Vascular imaging follow-up (n=31, 65.9%; median, 3 months, range, 1-25 months) showed complete or near occlusion of the aneurysm in 24 patients (77.4%) and decreased sac size in seven patients (22.6%). Conclusion In this initial multicenter study in Korea, the Pipeline seemed to be safe and effective for large/giant or fusiform aneurysms. However, a learning period may be required to alleviate device-related events. PMID:26958407

  4. Counseling to reduce high-risk sexual behavior in HIV care: a multi-center, direct observation study.

    PubMed

    Flickinger, Tabor E; Berry, Stephen; Korthuis, P Todd; Saha, Somnath; Laws, M Barton; Sharp, Victoria; Moore, Richard D; Beach, Mary Catherine

    2013-07-01

    A key opportunity to reduce HIV transmission lies with healthcare providers counseling HIV-infected patients about safer sex. We audio-recorded and transcribed clinical encounters between 45 healthcare providers and 417 of their HIV-infected patients at four outpatient sites in the United States. We used logistic regressions to evaluate associations between patient and provider characteristics, and the occurrence of discussion (any talk about sex) and counseling (advice about safer sex). Of the 417 encounters, discussion of sex occurred in 187 (45% of encounters, 95% CI: 40-50%). Counseling occurred for 49% (95% CI: 35-63%) of patients reporting unsafe sex. Discussion of sex was more likely with younger or less-educated patients and with less cultural difference between patient and provider, while counseling was associated with greater provider mindfulness and lower provider empathy. These findings suggest targets to improve communication regarding sexual risk reduction in HIV care. PMID:23802144

  5. Retrospective benzene exposure assessment for a multi-center case-cohort study of benzene-exposed workers in China.

    PubMed

    Portengen, Lützen; Linet, Martha S; Li, Gui-Lan; Lan, Qing; Dores, Graça M; Ji, Bu-Tian; Hayes, Richard B; Yin, Song-Nian; Rothman, Nathaniel; Vermeulen, Roel

    2016-05-01

    Quality of exposure assessment has been shown to be related to the ability to detect risk of lymphohematopoietic disorders in epidemiological investigations of benzene, especially at low levels of exposure. We set out to build a statistical model for reconstructing exposure levels for 2898 subjects from 501 factories that were part of a nested case-cohort study within the NCI-CAPM cohort of more than 110,000 workers. We used a hierarchical model to allow for clustering of measurements by factory, workshop, job, and date. To calibrate the model we used historical routine monitoring data. Measurements below the limit of detection were accommodated by constructing a censored data likelihood. Potential non-linear and industry-specific time-trends and predictor effects were incorporated using regression splines and random effects. A partial validation of predicted exposures in 2004/2005 was performed through comparison with full-shift measurements from an exposure survey in facilities that were still open. Median cumulative exposure to benzene at age 50 for subjects that ever held an exposed job (n=1175) was 509 mg/m(3) years. Direct comparison of model estimates with measured full-shift personal exposure in the 2004/2005 survey showed moderate correlation and a potential downward bias at low (<1 mg/m(3)) exposure estimates. The modeling framework enabled us to deal with the data complexities generally found in studies using historical exposure data in a comprehensive way and we therefore expect to be able to investigate effects at relatively low exposure levels. PMID:26264985

  6. A manual-based individual therapy to improve metacognition in schizophrenia: protocol of a multi-center RCT

    PubMed Central

    2014-01-01

    Background Metacognitive dysfunction has been widely recognized as a feature of schizophrenia. As it is linked with deficits in several aspects of daily life functioning, improvement of metacognition may lead to improvement in functioning. Individual psychotherapy might be a useful form of treatment to improve metacognition in patients with schizophrenia; multiple case reports and a pilot study show promising results. The present study aims to measure the effectiveness of an individual, manual-based therapy (Metacognitive Reflection and Insight Therapy, MERIT) in improving metacognition in patients with schizophrenia. We also want to examine if improvement in metacognitive abilities is correlated with improvements in aspects of daily life functioning namely social functioning, experience of symptoms, quality of life, depression, work readiness, insight and experience of stigma. Methods/Design MERIT is currently evaluated in a multicenter randomized controlled trial. Thirteen therapists in six mental health institutions in the Netherlands participate in this study. Patients are randomly assigned to either MERIT or the control condition: treatment as usual (TAU). Discussion If proven effective, MERIT can be a useful addition to the care for schizophrenia patients. The design brings along some methodological difficulties, these issues are addressed in the discussion of this paper. Trial registration Current Controlled Trials: ISRCTN16659871. PMID:24490942

  7. Attitudes Towards Patients with Sickle Cell Disease in a Multi-Center Sample of Emergency Department Providers

    PubMed Central

    Freiermuth, Caroline E; Haywood, Carlton; Silva, Susan; Cline, David M; Kayle, Mariam; Sullivan, Dori; Thornton, Victoria; Tanabe, Paula

    2015-01-01

    Objective Patients with sickle cell disease (SCD) often seek care in the emergency department (ED) for pain associated with vaso-occlusive crises (VOC). Research has shown that negative provider attitudes serve as a barrier to care in this patient population. Our aim was to validate a survey that measures attitudes towards patients with SCD among ED providers (nurses and physicians) and to compare differences in attitude scores between provider types. Methods We administered the General Perceptions about Sickle Cell Disease Patients Scale, previously validated amongst internal medicine providers, and the Medical Condition Regard Scale (MCRS) to ED nurses and physicians from two emergency departments. Results 215 surveys were returned (63% response rate, 200 with attitude items completed). Three subscales were identified: Negative attitudes, Uneasiness with care, and Positive attitudes. Cronbach alphas exceeded 0.81 for each subscale. Mean (SD) scores for the Negative, Uneasiness, and Positive subscales and MCRS were 61.5 (20.3), 66.1 (17.1), 41.2 (17.8), and 42.2 (8.9) respectively. Compared to physicians, nurses had significantly higher mean Negative attitude scores and lower Uneasiness scores. Conclusions A slightly modified version of the General Perceptions about Sickle Cell Disease Patients Scale appears to be a valid measure of ED provider attitudes towards patients with SCD. Amongst ED providers, this scale identified a dimension not observed in research with the original instrument amongst internal medicine providers. Practice Implications Provider attitudes influence patient-provider interactions and quality of care. The scale we present here has major clinical implications, particularly for advanced practice nurses, who can use the scale not only to assess providers’ attitudes towards patients with SCD, but also determine the effectiveness of tailored interventions to improve those attitudes. PMID:25356894

  8. New Tools for Systematic Evaluation of Teaching Qualities of Medical Faculty: Results of an Ongoing Multi-Center Survey

    PubMed Central

    Arah, Onyebuchi A.; Hoekstra, Joost B. L.; Bos, Albert P.; Lombarts, Kiki M. J. M. H.

    2011-01-01

    Background Tools for the evaluation, improvement and promotion of the teaching excellence of faculty remain elusive in residency settings. This study investigates (i) the reliability and validity of the data yielded by using two new instruments for evaluating the teaching qualities of medical faculty, (ii) the instruments' potential for differentiating between faculty, and (iii) the number of residents' evaluations needed per faculty to reliably use the instruments. Methods and Materials Multicenter cross-sectional survey among 546 residents and 629 medical faculty representing 29 medical (non-surgical) specialty training programs in the Netherlands. Two instruments—one completed by residents and one by faculty—for measuring teaching qualities of faculty were developed. Statistical analyses included factor analysis, reliability and validity exploration using standard psychometric methods, calculation of the numbers of residents' evaluations needed per faculty to achieve reliable assessments and variance components and threshold analyses. Results A total of 403 (73.8%) residents completed 3575 evaluations of 570 medical faculty while 494 (78.5%) faculty self-evaluated. In both instruments five composite-scales of faculty teaching qualities were detected with high internal consistency and reliability: learning climate (Cronbach's alpha of 0.85 for residents' instrument, 0.71 for self-evaluation instrument, professional attitude and behavior (0.84/0.75), communication of goals (0.90/0.84), evaluation of residents (0.91/0.81), and feedback (0.91/0.85). Faculty tended to evaluate themselves higher than did the residents. Up to a third of the total variance in various teaching qualities can be attributed to between-faculty differences. Some seven residents' evaluations per faculty are needed for assessments to attain a reliability level of 0.90. Conclusions The instruments for evaluating teaching qualities of medical faculty appear to yield reliable and valid data. They are feasible for use in medical residencies, can detect between-faculty differences and supply potentially useful information for improving graduate medical education. PMID:22022486

  9. Multi center cohort study on association of genotypes with prospective sports concussion: methods, lessons learned, and recommendations.

    PubMed

    Terrell, T; Abramson, R; Bostick, R; Barth, J; Sloane, R; Cantu, R; Bennett, E; Galloway, L; Erlanger, D; McKeag, D; Valentine, V; Nichols, G

    2014-09-22

    This was a multicenter prospective cohort study designed to investigate a potential association between genetic polymorphisms of apolipoprotein E gene, apolipoprotein E promoter G219T, and two Tau gene exon 6 polymorphisms (Ser53Pro and Hist47Tyr) with: (1) the risk of prospective concussion, (2) concussion severity, and (3) postconcussion neurocognitive recovery. Almost three thousand student athletes from 26 National Collegiate Athletic Association Division IA, II, III, and National Association of Intercollegiate Athletics academic institutions in the United States met inclusion criteria for this study. We assessed multiple variables including, gender, sport, family history of traumatic brain injury, history of mental illness, history of migraine headache, and baseline and postconcussion neuropsychological test results. Reported concussions were evaluated with multiple instruments including number of symptoms and symptom severity. Additionally, we gathered data via a questionnaire pertaining to medical history, demographics, and sportrelated information, and blood/saliva samples were collected for genetic analysis, and we conducted neuropsychological testing using Headminder and ImPACT software. The goal of this paper is to share our experiences conducting a large prospective cohort study. We recommend that future research include metaanalyses of various traumatic brain injury studies to increase power. Collaborative research is very likely needed given the nature of this study population. PMID:25242101

  10. Using IHE and HL7 conformance to specify consistent PACS interoperability for a large multi-center enterprise.

    PubMed

    Henderson, Michael L; Dayhoff, Ruth E; Titton, Csaba P; Casertano, Andrew

    2006-01-01

    As part of its patient care mission, the U.S. Veterans Health Administration performs diagnostic imaging procedures at 141 medical centers and 850 outpatient clinics. VHA's VistA Imaging Package provides a full archival, display, and communications infrastructure and interfaces to radiology and other HIS modules as well as modalities and a worklist provider In addition, various medical center entities within VHA have elected to install commercial picture archiving and communications systems to enable image organization and interpretation. To evaluate interfaces between commercial PACS, the VistA hospital information system, and imaging modalities, VHA has built a fully constrained specification that is based on the Radiology Technical Framework (Rad-TF) Integrating the Healthcare Enterprise. The Health Level Seven normative conformance mechanism was applied to the IHE Rad-TF and agency requirements to arrive at a baseline set of message specifications. VHA provides a thorough implementation and testing process to promote the adoption of standards-based interoperability by all PACS vendors that want to interface with VistA Imaging. PMID:16903661

  11. A multi-center, cross-sectional study on quality of life in cutaneous lupus erythematosus patients

    PubMed Central

    Vasquez, R.; Wang, D.; Tran, Q.P.; Adams-Huet, B.; Chren, M.-M.; Costner, M.I.; Cohen, J.B.; Werth, V.P.; Chong, B.F.

    2012-01-01

    Background A study at the University of Pennsylvania (UPenn) Medical Center demonstrated that quality of life in cutaneous lupus erythematosus (CLE) patients is negatively impacted. Whether CLE patients in other geographic locations have similar quality of life is unknown. Objective We sought to compare quality of life indicators between CLE patients at the University of Texas Southwestern (UTSW) Medical Center at Dallas and UPenn. Methods 248 CLE patients at UTSW (N=91) and UPenn (N=157) completed the Skindex-29+3 and Short Form-36 (SF-36) surveys related to quality of life. Additional information including demographics, presence of SLE, and disease severity were collected from UTSW CLE patients. Results Most Skindex-29+3 and SF-36 sub-domain scores between UTSW and UPenn CLE patients were similar. However, UTSW CLE patients were significantly more affected in the functioning and lupus-specific Skindex-29+3 domains, and physical functioning, role-physical, and general health SF-36 subscales than UPenn CLE patients (p<0.05). Factors related to poor quality of life in UTSW CLE patients include gender, income, education, presence of SLE, and skin disease activity. Conclusions Most quality of life indicators were similar between the two CLE populations. Differences in psychosocial behavior, and a larger proportion of SLE patients and females in the UTSW group likely attributed to differences in a minority of Skindex-29+3 and SF-36 sub-domains. Capturing data from CLE populations in different locations provides a more thorough picture of the quality of life that CLE patients experience on a daily basis with special attention to quality of life issues in select CLE patients. PMID:22708924

  12. Multi-center development and testing of a simulation-based cardiovascular assessment curriculum for advanced practice nurses.

    PubMed

    Jeffries, Pamela R; Beach, Michael; Decker, Sharon I; Dlugasch, Lucie; Groom, Jeffrey; Settles, Julie; O'Donnell, John M

    2011-01-01

    Cardiovascular assessment skills are deficient among advanced practice nursing students, and effective instructional methods to improve assessment skills are needed. The purpose of this study was to develop, implement, and evaluate outcomes of a cardiovascular assessment curriculum for advanced practice nurses at four institutions. Each institution used a one-group pre-to-post-intervention design. Educational interventions included faculty-led, simulation-based case presentations using the Harvey cardiopulmonary patient simulator (CPS), and independent learning sessions using the CPS and a multimedia, computer-based CD-ROM program. Outcome measures included a 31-item cognitive written exam, a 13-item skills checklist used in each of a three-station objective structured clinical exam, learner self-efficacy and satisfaction survey, instructor satisfaction and self-efficacy survey, and a participant logbook to record practice time using the self-learning materials. Thirty-six students who received the simulation-based training showed statistically significant pre-to-post-test improvement in cognitive knowledge and cardiovascular assessment skills. PMID:22029244

  13. Mortality and Morbidity of Extremely Low Birth Weight Infants in the Mainland of China: A Multi-center Study

    PubMed Central

    Lin, Hui-Jia; Du, Li-Zhong; Ma, Xiao-Lu; Shi, Li-Ping; Pan, Jia-Hua; Tong, Xiao-Mei; Li, Qiu-Ping; Zhou, Jian-Guo; Yi, Bing; Liu, Ling; Chen, Yun-Bing; Wei, Qiu-Fen; Wu, Hui-Qing; Li, Mei; Liu, Cui-Qing; Gao, Xi-Rong; Xia, Shi-Wen; Li, Wen-Bin; Yan, Chao-Ying; He, Ling; Liang, Kun; Zhou, Xiao-Yu; Han, Shu-Ping; Lyu, Qin; Qiu, Yin-Ping; Li, Wen; Chen, Dong-Mei; Lu, Hong-Ru; Liu, Xiao-Hong; Liu, Hong; Lin, Zhen-Lang; Liu, Li; Zhu, Jia-Jun; Xiong, Hong; Yue, Shao-Jie; Zhuang, Si-Qi

    2015-01-01

    Background: With the progress of perinatal medicine and neonatal technology, more and more extremely low birth weight (ELBW) survived all over the world. This study was designed to investigate the short-term outcomes of ELBW infants during their Neonatal Intensive Care Unit (NICU) stay in the mainland of China. Methods: All infants admitted to 26 NICUs with a birth weight (BW) < l000 g were included between January l, 2011 and December 31, 2011. All the data were collected retrospectively from clinical records by a prospectively designed questionnaire. The data collected from each NICU transmitted to the main institution where the results were aggregated and analyzed. Categorical variables were performed with Pearson Chi-square test. Binary Logistic regression analysis was used to detect risk factors. Results: A total of 258 ELBW infants were admitted to 26 NICUs, of whom the mean gestational age (GA) was 28.1 ± 2.2 weeks, and the mean BW was 868 ± 97 g. The overall survival rate at discharge was 50.0%. Despite aggressive treatment 60 infants (23.3%) died and another 69 infants (26.7%) died after medical care withdrawal. Furthermore, the survival rate was significantly higher in coastal areas than inland areas (53.6% vs. 35.3%, P = 0.019). BW < 750 g and GA < 28 weeks were the largest risk factors, and being small for gestational age was a protective factor related to mortality. Respiratory distress syndrome was the most common complication. The incidence of patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity was 26.2%, 33.7%, 6.7%, 48.1%, and 41.4%, respectively. Ventilator associated pneumonia was the most common hospital acquired infection during hospitalization. Conclusions: Our study was the first survey that revealed the present status of ELBW infants in the mainland of China. The mortality and morbidity of ELBW infants remained high as compared to other developed countries. PMID:26481740

  14. A Prospective Multi-center Trial of Escherichia coli Extract for the Prophylactic Treatment of Patients with Chronically Recurrent Cystitis

    PubMed Central

    Kim, Kun Suk; Kim, Ji-Yoon; Jeong, In Gab; Paick, Jae-Seung; Son, Hwancheol; Lim, Dae Jung; Shim, Hong Bang; Park, Won Hee; Jung, Hee Chang

    2010-01-01

    We have assessed the efficacy and safety of Escherichia coli extract (ECE; Uro-Vaxom®) which contains active immunostimulating fractions, in the prophylactic treatment of chronically recurrent cystitis. Forty-two patients with more than 2 episodes of cystitis in the proceeding 6 months were treated for 3 months with one capsule daily of ECE and observed for a further 6 months. The primary efficacy criterion was the number of episodes of recurrent cystitis during the 6 months after treatment compared to those during the 6 months before treatment. At the end of the 9-month trial, 34 patients (all women) were eligible for statistical analysis. Their mean age was 56.4 yr (range, 34-75 yr), and they had experienced recurrent urinary tract infections for 7.2±5.2 yr. The number of recurrences was significantly lower during the 6-month follow-up period than during the 6 months preceding the trial (0.35 vs. 4.26, P<0.001). During the follow-up, 28 (82.4%) patients had no recurrences and 4 (11.8%) had 1 each. In patients who relapsed, ECE alleviated cystitis symptoms, including painful voiding, frequency and urgency. There were no serious adverse events related to the study drug. Our study demonstrates the efficacy and safety of ECE in the prophylactic treatment of chronically recurrent cystitis. PMID:20191044

  15. A Multi-Center International Study Assessing the Impact of Differences in Baseline Characteristics and Perioperative Care Following Radical Cystectomy

    PubMed Central

    Osawa, Takahiro; Lee, Cheryl T.; Abe, Takashige; Takada, Norikata; Hafez, Khaled S.; Montgomery, Jeffrey S.; Weizer, Alon Z.; Hollenbeck, Brent K.; Skolarus, Ted A.; Murai, Sachiyo; Shinohara, Nobuo; Morgan, Todd M.

    2016-01-01

    Background: To identify potential avenues for quality improvement, we compared the variations in clinical practice and their association with perioperative morbidity and mortality following radical cystectomy (RC) for bladder cancer in the United States (US) and Japan. Methods: We reviewed our retrospectively collected database of 2240 patients who underwent RC for bladder cancer at the University of Michigan (n = 1427) and in 21 Japanese institutions (n = 813) between 1997 and 2014. We performed a systematic comparison of clinical and perioperative factors and assessed predictors of perioperative morbidity and mortality. Death within 90 days of surgery was the primary outcome. Results: There were apparent differences between the two study populations. Notably, US patients had a significantly greater BMI and higher ASA score. In Japanese institutions, median postoperative hospital stay was significantly higher (40 days vs. 7 days, p <  0.001) and 90-day readmission rates were significantly lower (0.6% vs. 26.8% , p <  0.001). There was a total of 1372/2240 (61.2%) patients with complications within 90 days and 66/2240 (2.9%) patient deaths. Significant predictors of 90-day mortality were older age (OR 1.04, CI 1.01–1.07), higher body mass index (OR 1.07, CI 1.02–1.12), node-positive disease (OR 3.14, CI 1.78–5.47), increased blood loss (OR 1.02, CI 1.01–1.03), and major (Clavien-grade 3 or greater) complication (OR 3.29, CI 1.88–5.71). Conclusion: Despite major differences in baseline characteristics and care of cystectomy patients between the two study populations, peri-operative mortality rates proved to be comparable. This data supports an exploration of non-traditional factors that may influence mortality after cystectomy. PMID:27376144

  16. An International Multi-center Study on Self-assessed and Family Quality of Life in Children with Atopic Dermatitis.

    PubMed

    Chernyshov, Pavel V; Ho, Roger C; Monti, Fiorella; Jirakova, Anna; Velitchko, Svitlana S; Hercogova, Jana; Neri, Erica

    2015-01-01

    Atopic dermatitis (AD) is a common childhood chronic inflammatory skin condition that greatly affects the quality of life (QoL) of affected children and their families. The aim of our study was to assess QoL and family QoL of children with AD from 4 different countries and then compare the data, evaluating the effects of AD severity and age of children. Data on the Children's Dermatology Life Quality Index (CDLQI) and the Dermatitis Family Impact (DFI) questionnaires and the SCORAD index of 167 AD children 5-16 years old from Ukraine, Czech Republic, Singapore, and Italy was used for the study. SCORAD correlated with the CDLQI in all 4 countries and with DFI in all countries except Singapore. Only in Czech children did the CDLQI correlate with their age. No significant correlations between age and DFI results were found. AD symptoms and expenditures related to AD were highly scored in all countries. Impact of AD on friendship and relations between family members were among the lower scored items, and family problems did not increase proportionately with duration of AD in any of the four countries. Self-assessed health-related QoL of children with AD in our study correlated better in most cases with disease severity than family QoL results. Parents of school children with AD were generally less stressed, tired, and exhausted than parents of preschool children. These data together with results showing that duration of AD in children does not affect relations between parents and other family members is optimistic news for families with children with AD who did not recover until adolescence. PMID:26724875

  17. Multi-center and multi-method evaluation of in vitro activities of ceftaroline against S. aureus.

    PubMed

    Koeth, Laura M; Apfalter, Petra; Becker, Karsten; Gesu, Giovanni; Martínez-Martínez, Luis; Lahiri, Sushmita D; Alm, Richard A; Ambler, Jane; Iaconis, Joseph

    2016-08-01

    This five-site study was performed to assess the reproducibility of ceftaroline MIC and disk results for Staphylococcus aureus. Three commercial broth microdilution, three gradient diffusion and ceftaroline 5μg disk diffusion methods were compared to a reference broth microdilution method against challenge isolates (n = 41) and isolates collected at four European sites (n = 30/site). For four MIC methods (Sensititre and three gradient diffusion methods), 99.0% of consolidated MIC results were within +/- 1 dilution of the reference MIC. Categorical agreement rates based on EUCAST breakpoints for the challenge isolates were 75.6-100% and for disk testing were 78.0-92.7%. There was no clear distinction between isolates with MIC results of 1 and 2mg/L with regard to variation in MIC or molecular genotyping results. The addition of an intermediate category for isolates with MIC results of 2mg/L would help to identify these isolates as borderline susceptible/non-susceptible isolates. PMID:27233426

  18. REFLEX, a social-cognitive group treatment to improve insight in schizophrenia: study protocol of a multi-center RCT

    PubMed Central

    2011-01-01

    Background Insight is impaired in a majority of people with schizophrenia. Impaired insight is associated with poorer outcomes of the disorder. Based on existing literature, we developed a model that explains which processes may possibly play a role in impaired insight. This model was the starting point of the development of REFLEX: a brief psychosocial intervention to improve insight in schizophrenia. REFLEX is a 12-sessions group training, consisting of three modules of four sessions each. Modules in this intervention are: "coping with stigma", "you and your personal narrative", and "you in the present". Methods/Design REFLEX is currently evaluated in a multicenter randomized controlled trial. Eight mental health institutions in the Netherlands participate in this evaluation. Patients are randomly assigned to either REFLEX or an active control condition, existing of cognitive remediation exercises in a group. In a subgroup of patients, fMRI scans are made before and after training in order to assess potential haemodynamic changes associated with the effects of the training. Discussion REFLEX is one of the few interventions aiming specifically to improving insight in schizophrenia and has potential value for improving insight. Targeting insight in schizophrenia is a complex task, that comes with several methodological issues. These issues are addressed in the discussion of this paper. Trial registration Current Controlled Trials: ISRCTN50247539 PMID:21975132

  19. Complications of Cardiac Perforation and Lead Dislodgement with an MRI-Conditional Pacing Lead: a Korean Multi-Center Experience.

    PubMed

    Kwon, Chang Hee; Choi, Jin Hee; Kim, Jun; Jo, Uk; Lee, Ji Hyun; Lee, Woo Seok; Kim, Yoo Ri; Lee, Soo Yong; Whang, Ki Won; Yang, Jihyun; Kim, Sung Hwan; Oh, Yong Seog; Park, Kyoung Min; Nam, Gi Byoung; Choi, Kee Joon; Kim, You Ho

    2016-09-01

    Medtronic CapSureFix MRI 5086 pacing lead (5086; Medtronic, Inc., Minneapolis, MN, USA) has been reported to be associated with increased cardiac perforation and lead dislodgement. This study aimed to compare the incidence of cardiac perforation and lead dislodgement within 30 days after pacemaker implantation between 5086 MRI lead and previous Medtronic CapSureFix Novus 5076 non-MRI pacing lead. This was a nationwide, multicenter retrospective study in which we compared the incidence of adverse events between 277 patients implanted with 5086 lead and 205 patients implanted with 5076 lead between March 2009 and September 2014. Cardiac perforation within 30 days of pacemaker implantation occurred in 4 patients (1.4%) with the 5086 lead and in no patient with the 5076 lead (P = 0.084). Lead dislodgement occurred in 8 patients (2.9%) with the 5086 lead and in 5 patients (2.4%) with the 5076 lead (P = 0.764). On multivariate logistic regression analysis, age was significantly associated with cardiac perforation. Congestive heart failure and implantation of right atrial (RA) lead at RA free wall or septum were significant factors for the incidence of lead dislodgement and lead revision. The incidence of cardiac perforation and lead dislodgement were not statistically different between the patients with 5086 lead and the patients with 5076 lead. However, careful attention for cardiac perforation may be needed when using the 5086 MRI lead, especially in elderly patients. PMID:27510382

  20. Standardized data collection for multi-center clinical studies of severe malaria in African children: establishing the SMAC network

    PubMed Central

    Taylor, Terrie; Olola, Christopher; Valim, Clarissa; Agbenyega, Tsiri; Kremsner, Peter; Krishna, Sanjeev; Kwiatkowski, Dominic; Newton, Charles; Missinou, Michel; Pinder, Margaret; Wypij, David

    2006-01-01

    The Severe Malaria in African Children (SMAC) network was established to conduct mortality-based trials. Although falciparum malaria kills more than one million children each year, single centers cannot enroll enough patients to detect reductions of 20–30% in mortality rates. Our aim was to quantify and describe severe malaria across a variety of epidemiological settings so that we could design intervention studies with more precise sample size estimates. We used a standardized surveillance mechanism to capture clinical, laboratory, and outcome data on all parasitemic children admitted to hospital. Between December 2000 and December 2003, 20,333 patients were enrolled in five sites. The frequency of severe malaria syndromes (cerebral malaria, severe malarial anemia and acidosis) differed between sites, as did the syndrome-specific mortality rates. Intervention studies targeted at reducing mortality in one or a combination of severe malaria syndromes would require 3–4 years to complete within the existing network. These data provide more accurate estimates of the disease burden of children hospitalized for malaria in sub-Saharan Africa. Networks are required to recruit enough patients for mortality-based studies and to encompass the epidemiological diversity of malaria in sub-Saharan Africa. SMAC represents the first effort to develop this capacity. PMID:16551469

  1. Bayesian methods to determine performance differences and to quantify variability among centers in multi-center trials: the IHAST trial

    PubMed Central

    2013-01-01

    Background To quantify the variability among centers and to identify centers whose performance are potentially outside of normal variability in the primary outcome and to propose a guideline that they are outliers. Methods Novel statistical methodology using a Bayesian hierarchical model is used. Bayesian methods for estimation and outlier detection are applied assuming an additive random center effect on the log odds of response: centers are similar but different (exchangeable). The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) is used as an example. Analyses were adjusted for treatment, age, gender, aneurysm location, World Federation of Neurological Surgeons scale, Fisher score and baseline NIH stroke scale scores. Adjustments for differences in center characteristics were also examined. Graphical and numerical summaries of the between-center standard deviation (sd) and variability, as well as the identification of potential outliers are implemented. Results In the IHAST, the center-to-center variation in the log odds of favorable outcome at each center is consistent with a normal distribution with posterior sd of 0.538 (95% credible interval: 0.397 to 0.726) after adjusting for the effects of important covariates. Outcome differences among centers show no outlying centers. Four potential outlying centers were identified but did not meet the proposed guideline for declaring them as outlying. Center characteristics (number of subjects enrolled from the center, geographical location, learning over time, nitrous oxide, and temporary clipping use) did not predict outcome, but subject and disease characteristics did. Conclusions Bayesian hierarchical methods allow for determination of whether outcomes from a specific center differ from others and whether specific clinical practices predict outcome, even when some centers/subgroups have relatively small sample sizes. In the IHAST no outlying centers were found. The estimated variability between centers was moderately large. PMID:23324207

  2. A prospective multi-center observational study of children hospitalized with diarrhea in Ho Chi Minh City, Vietnam.

    PubMed

    Thompson, Corinne N; Phan, My V T; Hoang, Nguyen Van Minh; Minh, Pham Van; Vinh, Nguyen Thanh; Thuy, Cao Thu; Nga, Tran Thi Thu; Rabaa, Maia A; Duy, Pham Thanh; Dung, Tran Thi Ngoc; Phat, Voong Vinh; Nga, Tran Vu Thieu; Tu, Le Thi Phuong; Tuyen, Ha Thanh; Yoshihara, Keisuke; Jenkins, Claire; Duong, Vu Thuy; Phuc, Hoang Le; Tuyet, Pham Thi Ngoc; Ngoc, Nguyen Minh; Vinh, Ha; Chinh, Nguyen Tran; Thuong, Tang Chi; Tuan, Ha Manh; Hien, Tran Tinh; Campbell, James I; Chau, Nguyen Van Vinh; Thwaites, Guy; Baker, Stephen

    2015-05-01

    We performed a prospective multicenter study to address the lack of data on the etiology, clinical and demographic features of hospitalized pediatric diarrhea in Ho Chi Minh City (HCMC), Vietnam. Over 2,000 (1,419 symptomatic and 609 non-diarrheal control) children were enrolled in three hospitals over a 1-year period in 2009-2010. Aiming to detect a panel of pathogens, we identified a known diarrheal pathogen in stool samples from 1,067/1,419 (75.2%) children with diarrhea and from 81/609 (13.3%) children without diarrhea. Rotavirus predominated in the symptomatic children (664/1,419; 46.8%), followed by norovirus (293/1,419; 20.6%). The bacterial pathogens Salmonella, Campylobacter, and Shigella were cumulatively isolated from 204/1,419 (14.4%) diarrheal children and exhibited extensive antimicrobial resistance, most notably to fluoroquinolones and third-generation cephalosporins. We suggest renewed efforts in generation and implementation of policies to control the sale and prescription of antimicrobials to curb bacterial resistance and advise consideration of a subsidized rotavirus vaccination policy to limit the morbidity due to diarrheal disease in Vietnam. PMID:25802437

  3. A Prospective Multi-Center Observational Study of Children Hospitalized with Diarrhea in Ho Chi Minh City, Vietnam

    PubMed Central

    Thompson, Corinne N.; Phan, My V. T.; Hoang, Nguyen Van Minh; Minh, Pham Van; Vinh, Nguyen Thanh; Thuy, Cao Thu; Nga, Tran Thi Thu; Rabaa, Maia A.; Duy, Pham Thanh; Dung, Tran Thi Ngoc; Phat, Voong Vinh; Nga, Tran Vu Thieu; Tu, Le Thi Phuong; Tuyen, Ha Thanh; Yoshihara, Keisuke; Jenkins, Claire; Duong, Vu Thuy; Phuc, Hoang Le; Tuyet, Pham Thi Ngoc; Ngoc, Nguyen Minh; Vinh, Ha; Chinh, Nguyen Tran; Thuong, Tang Chi; Tuan, Ha Manh; Hien, Tran Tinh; Campbell, James I.; Chau, Nguyen Van Vinh; Thwaites, Guy; Baker, Stephen

    2015-01-01

    We performed a prospective multicenter study to address the lack of data on the etiology, clinical and demographic features of hospitalized pediatric diarrhea in Ho Chi Minh City (HCMC), Vietnam. Over 2,000 (1,419 symptomatic and 609 non-diarrheal control) children were enrolled in three hospitals over a 1-year period in 2009–2010. Aiming to detect a panel of pathogens, we identified a known diarrheal pathogen in stool samples from 1,067/1,419 (75.2%) children with diarrhea and from 81/609 (13.3%) children without diarrhea. Rotavirus predominated in the symptomatic children (664/1,419; 46.8%), followed by norovirus (293/1,419; 20.6%). The bacterial pathogens Salmonella, Campylobacter, and Shigella were cumulatively isolated from 204/1,419 (14.4%) diarrheal children and exhibited extensive antimicrobial resistance, most notably to fluoroquinolones and third-generation cephalosporins. We suggest renewed efforts in generation and implementation of policies to control the sale and prescription of antimicrobials to curb bacterial resistance and advise consideration of a subsidized rotavirus vaccination policy to limit the morbidity due to diarrheal disease in Vietnam. PMID:25802437

  4. Adjudication of etiology of acute kidney injury: experience from the TRIBE-AKI multi-center study

    PubMed Central

    2014-01-01

    Background Adjudication of patient outcomes is a common practice in medical research and clinical trials. However minimal data exists on the adjudication process in the setting of Acute Kidney Injury (AKI) as well as the ability to judge different etiologies (e.g. Acute Tubular Necrosis (ATN), Pre-renal Azotemia (PRA)). Methods We enrolled 475 consecutive patients undergoing cardiac surgery at four sites of the Translational Research Investigating Biomarker Endpoints in AKI (TRIBE-AKI) study. Three expert nephrologists performed independent chart review, utilizing clinical variables and retrospective case report forms with pre intra and post-operative data, and then adjudicated all cases of AKI (n = 67). AKI was defined as a > 50% increase in serum creatinine for baseline (RIFLE Risk). We examined the patterns of AKI diagnoses made by the adjudication panel as well as association of these diagnoses with pre and postoperative kidney injury biomarkers. Results There was poor agreement across the panel of reviewers with their adjudicated diagnoses being independent of each other (Fleiss’ Kappa = 0.046). Based on the agreement of the two out of three reviewers, ATN was the adjudicated diagnosis in 41 cases (61%) while PRA occurred in 13 (19%). Neither serum creatinine or any other biomarker of AKI (urine or serum), was associated with an adjudicated diagnosis of ATN within the first 24 post-operative hours. Conclusion The etiology of AKI after cardiac surgery is probably multi-factorial and pure forms of AKI etiologies, such as ATN and PRA may not exist. Biomarkers did not appear to correlate with the adjudicated etiology of AKI; however the lack of agreement among the adjudicators impacted these results. Trial registration Clinicaltrials.gov: NCT00774137 PMID:24996668

  5. A Multi-Center, Qualitative Assessment of Pediatrician and Maternal Perspectives on Rotavirus Vaccines and the Detection of Porcine circovirus

    PubMed Central

    2011-01-01

    Background In 2010, researchers using novel laboratory techniques found that US-licensed rotavirus vaccines contain DNA or DNA fragments from Porcine circovirus (PCV), a virus common among pigs but not believed to cause illness in humans. We sought to understand pediatricians' and mothers' perspectives on this finding. Methods We conducted three iterations of focus groups for pediatricians and non-vaccine hesitant mothers in Seattle, WA, Cincinnati, OH, and Rochester, NY. Focus groups explored perceptions of rotavirus disease, rotavirus vaccination, and attitudes about the detection of PCV material in rotavirus vaccines. Results Pediatricians understood firsthand the success of rotavirus vaccines in preventing severe acute gastroenteritis among infants and young children. They measured this benefit against the theoretical risk of DNA material from PCV in rotavirus vaccines, determining overall that the PCV finding was of no clinical significance. Particularly influential was the realization that the large, randomized clinical trials that found both vaccines to be highly effective and safe were conducted with DNA material from PCV already in the vaccines. Most mothers supported the ideal of full disclosure regarding vaccination risks and benefits. However, with a scientific topic of this complexity, simplified information regarding PCV material in rotavirus vaccines seemed frightening and suspicious, and detailed information was frequently overwhelming. Mothers often remarked that if they did not understand a medical or technical topic regarding their child's health, they relied on their pediatrician's guidance. Many mothers and pediatricians were also concerned that persons who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears of the PCV finding. Conclusions Pediatricians considered the detection of DNA material from PCV in rotavirus vaccines a "non-issue" and reported little hesitation in continuing to recommend the vaccines. Mothers desired transparency, but ultimately trusted their pediatrician's recommendation. Both vaccines are currently approved for their intended use, and no risk of human PCV illness has been reported. Communicating this topic to pediatricians and mothers requires sensitivity to a broad range of technical understanding and personal concerns. PMID:21943237

  6. Multi-center evaluation of bioabsorbable collagen membrane for guided tissue regeneration in human Class II furcations.

    PubMed

    Yukna, C N; Yukna, R A

    1996-07-01

    Clinical data related to GTR therapy for Class II furcations were analyzed from 7 treatment centers that evaluated one of two possible treatment pairs, either bioabsorbable collagen membrane (Type I bovine tendon collagen) (COLL) versus control surgical debridement (DEBR) or COLL versus expanded polytetrafluoroethylene (ePTFE). After initial preparation and re-evaluation, full thickness flaps were reflected, the defects debrided, and the roots planed. Furcations and associated bony defects in each patient were randomly assigned to one of the 2 treatments in each pair, and the flaps closed. Patients received quarterly periodontal maintenance until surgical re-entry at 6 to 12 (mean 11.1) months. Data from 59 pairs of Class II furcations were analyzed via paired t, Wilcoxon signed rank, and RM ANOVA tests. COLL showed better results than DEBR for vertical defect fill, percent defect resolution, and horizontal furcation fill. When COLL was compared to ePTFE in furcations across patients, no differences were found. Both COLL and ePTFE resulted in an improvement in clinical furcation Class about 50% of the time (compared to 7% frequency with DEBR). COLL use yielded 8 and ePTFE yielded 1 clinically-complete furcation closures. COLL barriers resulted in generally favorable clinical results in furcation defects, appeared to be better than DEBR alone, and were at least similar to and often better than ePTFE. COLL of the type used in this study appears to be a useful and beneficial material for regenerative therapy in Class II furcation type periodontal defects. PMID:8832475

  7. Multi-center survey of House officers' choice of Medical specialties in Nigeria: preferences and determining factors.

    PubMed

    Okonta, Kelechi Emmanuel; Akpayak, Idorenyin Cletus; Amusan, Ezekiel Olatunde; Ekpe, Eyo Effiong; Adamu, Yahaya Baba; Ocheli, Emmanuel Ossai

    2015-01-01

    The objective of the study was to determine preferences and factors influencing the choice of medical specialties by House officers. Questionnaires were distributed to House-officers in 4 tertiary hospitals namely: the National hospital, Abuja, the University of Port-Harcourt, the Jos University, and the University of Uyo Teaching Hospitals. The data were simultaneously collected and analyzed using SPSS 20.0 version. Of the 150 questionnaires distributed, 129(86%) were duly filled. The mean age was 22.4 years (range 21-40 years), 79(61.2%) of the respondent were male. Fifty-nine(45.7%) chose training within the country while 32(24.8%) preferred outside as 107(86%) chose training in Teaching Hospitals. Teachers, Resident doctors and parents influenced choices in 34(26.3%), 17(13.1%) and 16(12.4%) respectively. Thirty-four(26.3%), 28 (21.7%), 13(10.1%) and 15(11.6%) preferred obstetrics, surgery, internal medicine and paediatrics respectively. Seventy (46.7%) chose specialties for personal likeness and 17(11.3%) for role models in that specialty. House officers preferred to pursue medical specialty in teaching hospitals within the country and they are motivated by personal fulfillment, independence of practice and role models while more prefer to specialize in more Obstetrics/ Gyaenocology and surgery. PMID:26175828

  8. Multi-center survey of House officers’ choice of Medical specialties in Nigeria: preferences and determining factors

    PubMed Central

    Okonta, Kelechi Emmanuel; Akpayak, Idorenyin Cletus; Amusan, Ezekiel Olatunde; Ekpe, Eyo Effiong; Adamu, Yahaya Baba; Ocheli, Emmanuel Ossai

    2015-01-01

    The objective of the study was to determine preferences and factors influencing the choice of medical specialties by House officers. Questionnaires were distributed to House-officers in 4 tertiary hospitals namely: the National hospital, Abuja, the University of Port-Harcourt, the Jos University, and the University of Uyo Teaching Hospitals. The data were simultaneously collected and analyzed using SPSS 20.0 version. Of the 150 questionnaires distributed, 129(86%) were duly filled. The mean age was 22.4 years (range 21-40 years), 79(61.2%) of the respondent were male. Fifty-nine(45.7%) chose training within the country while 32(24.8%) preferred outside as 107(86%) chose training in Teaching Hospitals. Teachers, Resident doctors and parents influenced choices in 34(26.3%), 17(13.1%) and 16(12.4%) respectively. Thirty-four(26.3%), 28 (21.7%), 13(10.1%) and 15(11.6%) preferred obstetrics, surgery, internal medicine and paediatrics respectively. Seventy (46.7%) chose specialties for personal likeness and 17(11.3%) for role models in that specialty. House officers preferred to pursue medical specialty in teaching hospitals within the country and they are motivated by personal fulfillment, independence of practice and role models while more prefer to specialize in more Obstetrics/ Gyaenocology and surgery. PMID:26175828

  9. Transdermal Wound Oxygen Therapy on Pressure Ulcer Healing: A Single-Blind Multi-Center Randomized Controlled Trial

    PubMed Central

    Azimian, Jalil; Dehghan Nayeri, Nahid; Pourkhaleghi, Enis; Ansari, Monireh

    2015-01-01

    Background: Although healthcare quality has considerably improved in many countries, pressure ulcer is still a major health challenge worldwide. Objectives: The current study aimed to evaluate the effects of TWOT on the healing of pressure ulcers. Patients and Methods: This study was a randomized controlled trial, and the convenient sample including 100 patients hospitalized in two university-affiliated medical-surgical intensive care units and one neurology unit located in Qazvin, Iran were studied. Patients with stage II-IV pressure ulcer on the sacral or ischial areas were randomly assigned to either the control or the experimental groups. The experimental group received a 12-day transdermal wound oxygen therapy. Wound status was assessed seven times before the intervention, as well as two, four, six, eight, ten, and twelve days after the intervention. Results: After 12 days of wound oxygen therapy, the number of patients with complete wound healing in the experimental group was significantly greater than that of the control group. Moreover, the total mean of wound area in the experimental group was significantly lower than that of the control group. Conclusions: Transdermal wound oxygen therapy can effectively promote wound healing in patients with pressure ulcers. PMID:26734476

  10. 77 FR 11136 - Proposed Collection; Comment Request; a Multi-Center International Hospital-Based Case-Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... identification of the key, functional alleles in gene regions associated with risk of NHL requires further..., prevalence of exposures, correlations between exposures, and variation in gene regions of particular...

  11. Risk factors for first cerebrospinal fluid shunt infection: findings from a multi-center prospective cohort study

    PubMed Central

    Simon, Tamara D.; Butler, Jerry; Whitlock, Kathryn B.; Browd, Samuel R.; Holubkov, Richard; Kestle, John R.W.; Kulkarni, Abhaya V.; Langley, Marcie; Limbrick, David D.; Mayer-Hamblett, Nicole; Tamber, Mandeep; Wellons, John C.; Whitehead, William E.; Riva-Cambrin, Jay

    2014-01-01

    Objective To quantify the extent to which revision(s) of cerebrospinal fluid (CSF) shunt are associated with increased risk of CSF shunt infection, after adjusting for patient factors that may contribute to infection risk. Study design We used the HCRN registry to assemble a large prospective six center cohort of 1,036 children undergoing initial CSF shunt placement between April 2008 and January 2012. The primary outcome of interest was first CSF shunt infection. Data for initial CSF shunt placement and all subsequent CSF shunt revisions prior to first CSF shunt infection, where applicable, were obtained. The risk of first infection was estimated using a multivariable Cox proportional hazard model accounting for patient characteristics and CSF shunt revisions, and is reported using hazard ratios (HR) with 95% confidence intervals (CI). Results Of the 102 children who developed first infection within 12 months of placement, 33 (32%) followed one or more CSF shunt revisions. Baseline factors independently associated with risk of first infection included: gastrostomy tube (HR 2.0, 95% CI: 1.1, 3.3), age 6–12 months (HR 0.3, 95% CI: 0.1, 0.8), and prior neurosurgery (HR 0.4, 95% CI: 0.2, 0.9). After controlling for baseline factors, infection risk was most significantly associated with the need for revision (1 revision vs. none, HR 3.9, 95% CI: 2.2, 6.5; ≥2 revisions, HR 13.0, 95% CI: 6.5, 24.9). Conclusions This study quantifies the elevated risk of infection associated with shunt revisions observed in clinical practice. To reduce risk of infection risk further work should optimize revision procedures. PMID:24661340

  12. A multi-center screening trial of rasagiline in patients with amyotrophic lateral sclerosis: Possible mitochondrial biomarker target engagement

    PubMed Central

    Macchi, Zachary; Wang, Yunxia; Moore, Dan; Katz, Jonathan; Saperstein, David; Walk, David; Simpson, Ericka; Genge, Angela; Bertorini, Tulio; Fernandes, J Americo; Swenson, Andrea; Elman, Lauren; Dimachkie, Mazen; Herbelin, Laura; Miller, Joann; Lu, Jianghua; Wilkins, Heather; Swerdlow, Russell H; Statland, Jeffrey; Barohn, Richard

    2015-01-01

    OBJECTIVE Rasagiline, a monoamine oxidase B inhibitor, slowed disease progression in the SOD1 mouse, and in a case series of patients with amyotrophic lateral sclerosis (ALS). Here we determine whether rasagiline is safe and effective in ALS compared to historical placebo controls, and whether it alters mitochondrial biomarkers. METHODS We performed a prospective open-label, multicenter screening trial of 36 ALS patients treated with 2mg oral rasagiline daily for 12 months. Outcomes included the slope of deterioration of the revised ALS Functional Rating Scale (ALSFRS-R), adverse event monitoring, time to treatment failure, and exploratory biomarkers. RESULTS Participants experienced no serious drug-related adverse events, and the most common adverse event was nausea (11.1%). Rasagiline did not improve the rate of decline in the ALSFRS-R; however, differences in symptom duration compared to historical placebo controls differentially affected ALSFRS-R slope estimates. Rasagiline changed biomarkers over 12 months, such that the mitochondrial membrane potential increased (JC-1 red/green fluorescent ratio 1.92, P=0.0001) and apoptosis markers decreased (Bcl-2/Bax ratio 0.24, P<0.0001). CONCLUSION Engagement of exploratory biomarkers and questions about comparability of baseline characteristics lead us to recommend a further placebo-controlled trial. PMID:25832828

  13. High fluence 1.05 {mu}m performance tests using 20 ns shaped pulses on the Beamlet prototype laser

    SciTech Connect

    Van Wonterghem, B.M.; Murray, J.E.; Burkhart, S.C.; Penko, F.; Henesian, M.A.; Auerbach, J.A.; Wegner, P.J.; Caird, J.A.

    1996-12-01

    Beamlet is a single beamline, nearly full scale physics prototype of the 192 beam Nd:Glass laser driver of the National Ignition Facility. It is used to demonstrate laser performance of the NIF multipass amplifier architecture. Initial system characterization tests have all been performed at pulse durations less than 10 ns. Pinhole closure and modulation at the end of long pulses are a significant concern for the operation of NIF. We recently demonstrated the generation, amplification and propagation of high energy pulses temporally shaped to mimic 20 ns long ignition pulse shapes at fluence levels exceeding the nominal NIF design requirements for Inertial Confinement Fusion by Indirect Drive. We also demonstrated the effectiveness of a new conical pinhole design used in the transport spatial filter to mitigate plasma closure effects and increase closure time to exceed the duration of the 20 ns long pulse.

  14. Management of high-output chylous ascites after D2-lymphadenectomy in patients with gastric cancer: a multi-center study

    PubMed Central

    Demir, Uygar; Alemdar, Ali; Ureyen, Orhan; Eryavuz, Yavuz; Mihmanli, Mehmet

    2016-01-01

    Background This study aimed to propose treatment strategies for high-output chylous ascites (CA) developed after gastric cancer surgery. Methods The data of patients with CA after gastric cancer surgery in three high volume Training and Research Hospitals between 2005 and 2015 were retrospectively evaluated. Results Nine patients out of 436 gastrectomies were detected with CA. The mean amount of daily fistula output was 939 mL. Treatment consisted of cessation of oral feeding, total parenteral nutrition (TPN), somatostatin analogs administration, clamping and/or removal of the drainage tube, diuretic administration and diet therapy with medium-chain triglycerides (MCTs) alone or in combination. The mean fistula closure time and length of hospital stay were 23 and 24 days respectively. Hemopneumothorax developed during right subclavian vein catheterisation for TPN implementation in one patient. There was no mortality. Conclusions Combined cessation of oral feeding and TPN are usually used for treatment of CA as first-line treatment. However, TPN is no harmless. Although our data are limited they do allow us to conclude that diet with MCT’s may use for medical treatment of CA as first-line. PMID:27284475

  15. A phase I, open-label, multi-center study of the JAK2 inhibitor AZD1480 in patients with myelofibrosis.

    PubMed

    Verstovsek, Srdan; Hoffman, Ronald; Mascarenhas, John; Soria, Jean-Charles; Bahleda, Ratislav; McCoon, Patricia; Tang, Weifeng; Cortes, Jorge; Kantarjian, Hagop; Ribrag, Vincent

    2015-02-01

    The anti-tumor activity of AZD1480, a potent, selective inhibitor of Janus-associated kinases 1 and 2, was demonstrated in preclinical models of myeloproliferative neoplasms. In a phase I clinical study, 35 patients with myelofibrosis received 2.5-70mg AZD1480 orally once daily (QD) or 10 or 15mg twice daily (BID) continuously during repeated 28-day cycles. Two patients experienced dose-limiting toxicities: one patient in the 2.5mg QD cohort had a grade 3 lung infiltration/acute pneumonia, and one patient receiving 50mg QD had grade 3 presyncope. Dosing was stopped at 70mg QD after the first patient experienced an adverse neurological event (AE) and evidence of low-grade neurological toxicity in patients on lower doses after the initial month of therapy became apparent. The most common AZD1480-related AEs were dizziness and anemia. AZD1480 was absorbed quickly and eliminated from the plasma rapidly, with a mean terminal half-life of 2.45-8.06h; accumulation was not observed after repeated daily dosing for 28 days. Four patients showed evidence of clinical improvement based on IWG-MRT 2006 criteria. AZD1480 was relatively well tolerated, however, low-grade, reversible neurological toxicity was therapy limiting and led to study termination. PMID:25530567

  16. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    PubMed

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome. PMID:25924999

  17. Quantitative High-Efficiency Cadmium-Zinc-Telluride SPECT with Dedicated Parallel-Hole Collimation System in Obese Patients: Results of a Multi-Center Study

    PubMed Central

    Nakazato, Ryo; Slomka, Piotr J.; Fish, Mathews; Schwartz, Ronald G.; Hayes, Sean W.; Thomson, Louise E.J.; Friedman, John D.; Lemley, Mark; Mackin, Maria L.; Peterson, Benjamin; Schwartz, Arielle M.; Doran, Jesse A.; Germano, Guido; Berman, Daniel S.

    2014-01-01

    Background Obesity is a common source of artifact on conventional SPECT myocardial perfusion imaging (MPI). We evaluated image quality and diagnostic performance of high-efficiency (HE) cadmium-zinc-telluride (CZT) parallel-hole SPECT-MPI for coronary artery disease (CAD) in obese patients. Methods and Results 118 consecutive obese patients at 3 centers (BMI 43.6±8.9 kg/m2, range 35–79.7 kg/m2) had upright/supine HE-SPECT and ICA >6 months (n=67) or low-likelihood of CAD (n=51). Stress quantitative total perfusion deficit (TPD) for upright (U-TPD), supine (S-TPD) and combined acquisitions (C-TPD) was assessed. Image quality (IQ; 5=excellent; <3 nondiagnostic) was compared among BMI 35–39.9 (n=58), 40–44.9 (n=24) and ≥45 (n=36) groups. ROC-curve area for CAD detection (≥50% stenosis) for U-TPD, S-TPD, and C-TPD were 0.80, 0.80, and 0.87, respectively. Sensitivity/specificity was 82%/57% for U-TPD, 74%/71% for S-TPD, and 80%/82% for C-TPD. C-TPD had highest specificity (P=.02). C-TPD normalcy rate was higher than U-TPD (88% vs. 75%, P=.02). Mean IQ was similar among BMI 35–39.9, 40–44.9 and ≥45 groups [4.6 vs. 4.4 vs. 4.5, respectively (P=.6)]. No patient had a non-diagnostic stress scan. Conclusions In obese patients, HE-SPECT MPI with dedicated parallel-hole collimation demonstrated high image quality, normalcy rate, and diagnostic accuracy for CAD by quantitative analysis of combined upright/supine acquisitions. PMID:25388380

  18. Neurocognitive impairments in non-deprived smokers--results from a population-based multi-center study on smoking-related behavior.

    PubMed

    Wagner, Michael; Schulze-Rauschenbach, Svenja; Petrovsky, Nadine; Brinkmeyer, Juergen; von der Goltz, Christoph; Gründer, Gerd; Spreckelmeyer, Katja N; Wienker, Thomas; Diaz-Lacava, Amalia; Mobascher, Arian; Dahmen, Norbert; Clepce, Marion; Thuerauf, Norbert; Kiefer, Falk; de Millas, J Walter; Gallinat, Jürgen; Winterer, Georg

    2013-07-01

    The aim of the present study was to examine neurocognitive function associated with chronic nicotine use. A total of 2163 healthy participants (1002 smokers, 1161 never-smoking controls) participated in a population-based case-control design. The main outcome measures were six cognitive domain factors derived from a neuropsychological test battery. In smokers, the battery was administered after controlled smoking of one cigarette. Analyses included age, sex and education as covariates. Results demonstrated small, but significant deficits in smokers for visual attention (P<0.001) and cognitive impulsivity (P<0.006), while verbal episodic memory, verbal fluency, verbal working memory, and Stroop-interference did not differ between groups. These attention/impulsivity deficits were also present in smokers with only a low amount of cigarette consumption. Lifetime nicotine use (pack-years) was not correlated with cognition in smokers. In conclusion, this study confirmed subtle and specific cognitive deficits in non-deprived smokers. The independence of these deficits from consumption intensity may argue for an a priori deficit of some cognitive abilities in smokers. These specific deficits may constitute intermediate phenotypes for genetic research on nicotine use. PMID:22339903

  19. Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial

    PubMed Central

    2014-01-01

    Background HS219 (40 mg chitosan-loaded chewing gum) is designed to bind salivary phosphorus as an add-on to available phosphorus binders. We performed a randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of HS219 in hemodialysis (HD) patients with hyperphosphatemia as an add-on to phosphorus binders. Methods Sixty-eight HD patients who were maintained on calcium carbonate (n = 33) or sevelamer hydrochloride (n = 35) were enrolled. The primary end point was a change in serum phosphorus levels. Secondary end points included changes in levels of salivary phosphorus, serum calcium, parathyroid hormone (PTH), and intact fibroblast growth factor (iFGF) 23. Results Sixty-three patients chewed either HS219 (n = 35) or placebo (n = 28) for 30 min, three times a day, for 3 weeks. HS219 was well tolerated and safe. However, HS219 was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period. There were no significant effects of HS219 on reduction of salivary phosphorus, serum calcium, iPTH, or iFGF23 levels. Conclusions The chitosan-loaded chewing gum HS219 does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia. Our findings do not support previous findings that 20 mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels. Trail registration ClinicalTrials.gov NCT01039428, 24 December, 2009. PMID:24968790

  20. PVP-coated, negatively charged silver nanoparticles: A multi-center study of their physicochemical characteristics, cell culture and in vivo experiments.

    PubMed

    Ahlberg, Sebastian; Antonopulos, Alexandra; Diendorf, Jörg; Dringen, Ralf; Epple, Matthias; Flöck, Rebekka; Goedecke, Wolfgang; Graf, Christina; Haberl, Nadine; Helmlinger, Jens; Herzog, Fabian; Heuer, Frederike; Hirn, Stephanie; Johannes, Christian; Kittler, Stefanie; Köller, Manfred; Korn, Katrin; Kreyling, Wolfgang G; Krombach, Fritz; Lademann, Jürgen; Loza, Kateryna; Luther, Eva M; Malissek, Marcelina; Meinke, Martina C; Nordmeyer, Daniel; Pailliart, Anne; Raabe, Jörg; Rancan, Fiorenza; Rothen-Rutishauser, Barbara; Rühl, Eckart; Schleh, Carsten; Seibel, Andreas; Sengstock, Christina; Treuel, Lennart; Vogt, Annika; Weber, Katrin; Zellner, Reinhard

    2014-01-01

    PVP-capped silver nanoparticles with a diameter of the metallic core of 70 nm, a hydrodynamic diameter of 120 nm and a zeta potential of -20 mV were prepared and investigated with regard to their biological activity. This review summarizes the physicochemical properties (dissolution, protein adsorption, dispersability) of these nanoparticles and the cellular consequences of the exposure of a broad range of biological test systems to this defined type of silver nanoparticles. Silver nanoparticles dissolve in water in the presence of oxygen. In addition, in biological media (i.e., in the presence of proteins) the surface of silver nanoparticles is rapidly coated by a protein corona that influences their physicochemical and biological properties including cellular uptake. Silver nanoparticles are taken up by cell-type specific endocytosis pathways as demonstrated for hMSC, primary T-cells, primary monocytes, and astrocytes. A visualization of particles inside cells is possible by X-ray microscopy, fluorescence microscopy, and combined FIB/SEM analysis. By staining organelles, their localization inside the cell can be additionally determined. While primary brain astrocytes are shown to be fairly tolerant toward silver nanoparticles, silver nanoparticles induce the formation of DNA double-strand-breaks (DSB) and lead to chromosomal aberrations and sister-chromatid exchanges in Chinese hamster fibroblast cell lines (CHO9, K1, V79B). An exposure of rats to silver nanoparticles in vivo induced a moderate pulmonary toxicity, however, only at rather high concentrations. The same was found in precision-cut lung slices of rats in which silver nanoparticles remained mainly at the tissue surface. In a human 3D triple-cell culture model consisting of three cell types (alveolar epithelial cells, macrophages, and dendritic cells), adverse effects were also only found at high silver concentrations. The silver ions that are released from silver nanoparticles may be harmful to skin with disrupted barrier (e.g., wounds) and induce oxidative stress in skin cells (HaCaT). In conclusion, the data obtained on the effects of this well-defined type of silver nanoparticles on various biological systems clearly demonstrate that cell-type specific properties as well as experimental conditions determine the biocompatibility of and the cellular responses to an exposure with silver nanoparticles. PMID:25383306

  1. Treatment of major depressive disorders with generic duloxetine and paroxetine: a multi-centered, double-blind, double-dummy, randomized controlled clinical trial

    PubMed Central

    WANG, Zhiyang; XU, Xiufeng; TAN, Qingrong; LI, Keqing; MA, Cui; XIE, Shiping; GAO, Chengge; WANG, Gang; LI, Huafang

    2015-01-01

    Background This study is a pre-registration trial of generic duloxetine that was approved by the China Food and Drug Administration (approval number: 2006L01603). Aims Compare the treatment efficacy and safety of generic duloxetine to that of paroxetine in patients with major depressive disorders (MDD). Methods This was a double-dummy, double-blind, multicenter, positive drug (paroxetine), parallel randomized controlled clinical trial. The 299 patients with MDD recruited for the study were randomly assigned to use duloxetine (n=149; 40–60 mg/d) or paroxetine (n=150; 20 mg/d) for 8 weeks. The Hamilton Depression rating scale (HAMD-17) was administered at baseline and 1, 2, 4, 6, and 8 weeks after starting treatment. Remission was defined as a HAMD-17 score below 8 at the end of the trial, and treatment effectiveness was defined as a decrease in baseline HAMD-17 score of at least 50% by the end of the trial. Safety was assessed based on the reported prevalence and severity of side effects and changes in laboratory and electrocardiographic findings. Three patients in the duloxetine group dropped out before starting medication, so results were analyzed using a modified intention-to-treat (ITT) method with 146 in the experimental group and 150 in the control group. Results Both groups experienced 29 dropouts during the 8-week trial. HAMD-17 scores decreased significantly from baseline throughout the trial in both groups. Based on the ITT analysis, at the end of the trial there was no significant difference between the duloxetine group and the paroxetine group in effectiveness (67.1% v. 71.3%, X2=0.62 p=0.433), remission rate (41.1% v. 51.3%, X2=3.12, p=0.077), or in the incidence of side effects (56.8% v. 54.7%, X2=0.14, p=0.705). Conclusions Generic duloxetine is as effective and safe as paroxetine in the acute treatment of patients with MDD who seek care at psychiatric outpatient departments in China. PMID:26549959

  2. PVP-coated, negatively charged silver nanoparticles: A multi-center study of their physicochemical characteristics, cell culture and in vivo experiments

    PubMed Central

    Ahlberg, Sebastian; Antonopulos, Alexandra; Diendorf, Jörg; Dringen, Ralf; Flöck, Rebekka; Goedecke, Wolfgang; Graf, Christina; Haberl, Nadine; Helmlinger, Jens; Herzog, Fabian; Heuer, Frederike; Hirn, Stephanie; Johannes, Christian; Kittler, Stefanie; Köller, Manfred; Korn, Katrin; Kreyling, Wolfgang G; Krombach, Fritz; Lademann, Jürgen; Loza, Kateryna; Luther, Eva M; Malissek, Marcelina; Meinke, Martina C; Nordmeyer, Daniel; Pailliart, Anne; Raabe, Jörg; Rancan, Fiorenza; Rothen-Rutishauser, Barbara; Rühl, Eckart; Schleh, Carsten; Seibel, Andreas; Sengstock, Christina; Treuel, Lennart; Vogt, Annika; Weber, Katrin; Zellner, Reinhard

    2014-01-01

    Summary PVP-capped silver nanoparticles with a diameter of the metallic core of 70 nm, a hydrodynamic diameter of 120 nm and a zeta potential of −20 mV were prepared and investigated with regard to their biological activity. This review summarizes the physicochemical properties (dissolution, protein adsorption, dispersability) of these nanoparticles and the cellular consequences of the exposure of a broad range of biological test systems to this defined type of silver nanoparticles. Silver nanoparticles dissolve in water in the presence of oxygen. In addition, in biological media (i.e., in the presence of proteins) the surface of silver nanoparticles is rapidly coated by a protein corona that influences their physicochemical and biological properties including cellular uptake. Silver nanoparticles are taken up by cell-type specific endocytosis pathways as demonstrated for hMSC, primary T-cells, primary monocytes, and astrocytes. A visualization of particles inside cells is possible by X-ray microscopy, fluorescence microscopy, and combined FIB/SEM analysis. By staining organelles, their localization inside the cell can be additionally determined. While primary brain astrocytes are shown to be fairly tolerant toward silver nanoparticles, silver nanoparticles induce the formation of DNA double-strand-breaks (DSB) and lead to chromosomal aberrations and sister-chromatid exchanges in Chinese hamster fibroblast cell lines (CHO9, K1, V79B). An exposure of rats to silver nanoparticles in vivo induced a moderate pulmonary toxicity, however, only at rather high concentrations. The same was found in precision-cut lung slices of rats in which silver nanoparticles remained mainly at the tissue surface. In a human 3D triple-cell culture model consisting of three cell types (alveolar epithelial cells, macrophages, and dendritic cells), adverse effects were also only found at high silver concentrations. The silver ions that are released from silver nanoparticles may be harmful to skin with disrupted barrier (e.g., wounds) and induce oxidative stress in skin cells (HaCaT). In conclusion, the data obtained on the effects of this well-defined type of silver nanoparticles on various biological systems clearly demonstrate that cell-type specific properties as well as experimental conditions determine the biocompatibility of and the cellular responses to an exposure with silver nanoparticles. PMID:25383306

  3. Program ACTIVE II: Design and Methods for a Multi-Center Community-Based Depression Treatment for Rural and Urban Adults with Type 2 Diabetes

    PubMed Central

    de Groot, Mary; Shubrook, Jay; Schwartz, Frank; Hornsby, W. Guyton; Pillay, Yegan; Saha, Chandan

    2015-01-01

    Objective Depression affects one in four adults with type 2 diabetes (T2DM) and is associated with worsened diabetes complications, increased health care costs and early mortality. Rural and low-income urban areas, including the Appalachian region, represent an epicenter of the T2DM epidemic. Program ACTIVE II is a comparative effectiveness treatment trial designed to test whether a combination of cognitive behavioral therapy (CBT) and community-based exercise (EXER) will offer greater improvements in diabetes and depression outcomes compared to individual treatment approaches and usual care (UC). The secondary aims are to assess changes in cardiovascular risk factors across groups and to conduct a cost-effectiveness analysis of predicted incidence of cardiovascular complications across groups. Methods The study is a 2-by-2 factorial randomized controlled trial consisting of 4 treatment groups: CBT alone, EXER alone, combination of CBT and EXER, and UC. Adults with T2DM for > 1 year and who meet DSM-IVTR criteria for Major Depressive Disorder (MDD) are eligible to participate at two rural Appalachian sites (southeastern Ohio and West Virginia) and one urban site (Indianapolis). This type II behavioral translation study uses a community-engaged research (CEnR) approach by incorporating community fitness centers and mental health practices as interventionists. Conclusions This is the first study to evaluate the comparative effectiveness of combined CBT and exercise in the treatment of depression using community-based intervention delivery. This approach may serve as a national model for expanding depression treatment for patients with T2DM.

  4. Effects of heat and moisture exchangers on tracheal mucociliary clearance in laryngectomized patients: a multi-center case-control study.

    PubMed

    van den Boer, C; Muller, S H; van der Noort, V; Olmos, R A Valdés; Minni, A; Parrilla, C; Hilgers, F J M; van den Brekel, M W M; van der Baan, S

    2015-11-01

    After total laryngectomy, inspired air is no longer optimally conditioned by the upper airways. Impaired mucociliary clearance and histological changes of respiratory epithelium, such as loss of ciliated cells, have been described in laryngectomized patients. Heat and moisture exchangers (HMEs) are passive humidifiers that re-condition the inspired air. Aim of this study was to assess the effect of HMEs on tracheal epithelium and tracheal mucus transport velocity (TMV). Tracheal brush biopsies were collected in three groups of TLE patients: 21 long-term HME users, 10 non-HME users, and 16 non-HME users before and after 4-9 months HME use. Tracheal epithelium biopsies were assessed using a digital high-speed camera mounted onto a light microscope. TMV was determined by scintigraphy in the first two patient groups. Significantly more ciliated cells were found in HME users compared to non-HME users (p = 0.05). TMV was higher in HME users (median 2 mm/min; 0-7.9) compared to non-HME users (median 0.8 mm/min; 0-12.3), but this difference was not significant (p = 0.37). One-hour breathing without HME in long-term HME users did not measurably decrease TMV (p = 0.13). The long-term use of an HME restores/prevents the loss of tracheal ciliated cells. A significant improvement in TMV was not found. Short-term (one hour) detachment of an HME has no measurable effect on TMV. PMID:25338182

  5. Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett's Esophagus: A Multi-Center Case–Control Study

    PubMed Central

    Ross-Innes, Caryn S.; Debiram-Beecham, Irene; O'Donovan, Maria; Walker, Elaine; Varghese, Sibu; Lao-Sirieix, Pierre; Lovat, Laurence; Griffin, Michael; Ragunath, Krish; Haidry, Rehan; Sami, Sarmed S.; Kaye, Philip; Novelli, Marco; Disep, Babett; Ostler, Richard; Aigret, Benoit; North, Bernard V.; Bhandari, Pradeep; Haycock, Adam; Morris, Danielle; Attwood, Stephen; Dhar, Anjan; Rees, Colin; Rutter, Matthew D. D.; Sasieni, Peter D.; Fitzgerald, Rebecca C.

    2015-01-01

    Background Barrett's esophagus (BE) is a commonly undiagnosed condition that predisposes to esophageal adenocarcinoma. Routine endoscopic screening for BE is not recommended because of the burden this would impose on the health care system. The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose BE. Methods and Findings A case–control study was performed across 11 UK hospitals between July 2011 and December 2013. In total, 1,110 individuals comprising 463 controls with dyspepsia and reflux symptoms and 647 BE cases swallowed a Cytosponge prior to endoscopy. The primary outcome measures were to evaluate the safety, acceptability, and accuracy of the Cytosponge-TFF3 test compared with endoscopy and biopsy. In all, 1,042 (93.9%) patients successfully swallowed the Cytosponge, and no serious adverse events were attributed to the device. The Cytosponge was rated favorably, using a visual analogue scale, compared with endoscopy (p < 0.001), and patients who were not sedated for endoscopy were more likely to rate the Cytosponge higher than endoscopy (Mann-Whitney test, p < 0.001). The overall sensitivity of the test was 79.9% (95% CI 76.4%–83.0%), increasing to 87.2% (95% CI 83.0%–90.6%) for patients with ≥3 cm of circumferential BE, known to confer a higher cancer risk. The sensitivity increased to 89.7% (95% CI 82.3%–94.8%) in 107 patients who swallowed the device twice during the study course. There was no loss of sensitivity in patients with dysplasia. The specificity for diagnosing BE was 92.4% (95% CI 89.5%–94.7%). The case–control design of the study means that the results are not generalizable to a primary care population. Another limitation is that the acceptability data were limited to a single measure. Conclusions The Cytosponge-TFF3 test is safe and acceptable, and has accuracy comparable to other screening tests. This test may be a simple and inexpensive approach to identify patients with reflux symptoms who warrant endoscopy to diagnose BE. PMID:25634542

  6. A Multi-Center Randomized Trial to Assess the Efficacy of Gatifloxacin versus Ciprofloxacin for the Treatment of Shigellosis in Vietnamese Children

    PubMed Central

    Vinh, Ha; Anh, Vo Thi Cuc; Anh, Nguyen Duc; Campbell, James I.; Hoang, Nguyen Van Minh; Nga, Tran Vu Thieu; Nhu, Nguyen Thi Khanh; Minh, Pham Van; Thuy, Cao Thu; Duy, Pham Thanh; Phuong, Le Thi; Loan, Ha Thi; Chinh, Mai Thu; Thao, Nguyen Thi Thu; Tham, Nguyen Thi Hong; Mong, Bui Li; Bay, Phan Van Be; Day, Jeremy N.; Dolecek, Christiane; Lan, Nguyen Phu Huong; Diep, To Song; Farrar, Jeremy J.; Chau, Nguyen Van Vinh; Wolbers, Marcel; Baker, Stephen

    2011-01-01

    Background The bacterial genus Shigella is the leading cause of dysentery. There have been significant increases in the proportion of Shigella isolated that demonstrate resistance to nalidixic acid. While nalidixic acid is no longer considered as a therapeutic agent for shigellosis, the fluoroquinolone ciprofloxacin is the current recommendation of the World Health Organization. Resistance to nalidixic acid is a marker of reduced susceptibility to older generation fluoroquinolones, such as ciprofloxacin. We aimed to assess the efficacy of gatifloxacin versus ciprofloxacin in the treatment of uncomplicated shigellosis in children. Methodology/Principal Findings We conducted a randomized, open-label, controlled trial with two parallel arms at two hospitals in southern Vietnam. The study was designed as a superiority trial and children with dysentery meeting the inclusion criteria were invited to participate. Participants received either gatifloxacin (10 mg/kg/day) in a single daily dose for 3 days or ciprofloxacin (30 mg/kg/day) in two divided doses for 3 days. The primary outcome measure was treatment failure; secondary outcome measures were time to the cessation of individual symptoms. Four hundred and ninety four patients were randomized to receive either gatifloxacin (n  =  249) or ciprofloxacin (n  =  245), of which 107 had a positive Shigella stool culture. We could not demonstrate superiority of gatifloxacin and observed similar clinical failure rate in both groups (gatifloxacin; 12.0% and ciprofloxacin; 11.0%, p  =  0.72). The median (inter-quartile range) time from illness onset to cessation of all symptoms was 95 (66–126) hours for gatifloxacin recipients and 93 (68–120) hours for the ciprofloxacin recipients (Hazard Ratio [95%CI]  =  0.98 [0.82–1.17], p  =  0.83). Conclusions We conclude that in Vietnam, where nalidixic acid resistant Shigellae are highly prevalent, ciprofloxacin and gatifloxacin are similarly effective for the treatment of acute shigellosis. Trial Registration Controlled trials number ISRCTN55945881 PMID:21829747

  7. Effect of Hydroxyurea Treatment on Renal Function Parameters: Results from the Multi-Center Placebo-Controlled BABY HUG Clinical Trial for Infants with Sickle Cell Anemia

    PubMed Central

    Alvarez, Ofelia; Miller, Scott T.; Wang, Winfred C.; Luo, Zhaoyu; McCarville, M. Beth; Schwartz, George J.; Thompson, Bruce; Howard, Thomas; Iyer, Rathi V.; Rana, Sohail R.; Rogers, Zora R.; Sarnaik, Sharada A.; Thornburg, Courtney D.; Ware, Russell E.

    2012-01-01

    Background Children with sickle cell anemia (SCA) often develop hyposthenuria and renal hyperfiltration at an early age, possibly contributing to the glomerular injury and renal insufficiency commonly seen later in life. The Phase III randomized double-blinded Clinical Trial of Hydroxyurea in Infants with SCA (BABY HUG) tested the hypothesis that hydroxyurea can prevent kidney dysfunction by reducing hyperfiltration. Procedure 193 infants with SCA (mean age 13.8 months) received hydroxyurea 20 mg/kg/day or placebo for 24 months. 99mTc diethylenetriaminepentaacetic acid (DTPA) clearance, serum creatinine, serum cystatin C, urinalysis, serum and urine osmolality after parent-supervised fluid deprivation, and renal ultrasonography were obtained at baseline and at exit to measure treatment effects on renal function. Results At exit children treated with hydroxyurea had significantly higher urine osmolality (mean 495 mOsm/kg H2O compared to 452 in the placebo group, p=0.007) and a larger percentage of subjects taking hydroxyurea achieved urine osmolality >500 mOsm/kg H2O. Moreover, children treated with hydroxyurea had smaller renal volumes (p=0.007). DTPA-derived glomerular filtration rate (GFR) was not significantly different between the two treatment groups, but was significantly higher than published norms. GFR estimated by the Chronic Kidney Disease in Children Schwartz formula was the best non-invasive method to estimate GFR in these children, as it was the closest to the DTPA-derived GFR. Conclusion Treatment with hydroxyurea for 24 months did not influence GFR in young children with SCA. However, hydroxyurea was associated with better urine concentrating ability and less renal enlargement, suggesting some benefit to renal function. PMID:22294512

  8. Design and Anticipated Outcomes of the eMERGE-PGx Project: A Multi-Center Pilot for Pre-Emptive Pharmacogenomics in Electronic Health Record Systems

    PubMed Central

    Rasmussen-Torvik, Laura J.; Stallings, Sarah C.; Gordon, Adam S.; Almoguera, Berta; Basford, Melissa A.; Bielinski, Suzette J.; Brautbar, Ariel; Brilliant, Murray; Carrell, David S.; Connolly, John; Crosslin, David R.; Doheny, Kimberly F.; Gallego, Carlos J.; Gottesman, Omri; Kim, Daniel Seung; Leppig, Kathleen A.; Li, Rongling; Lin, Simon; Manzi, Shannon; Mejia, Ana R.; Pacheco, Jennifer A.; Pan, Vivian; Pathak, Jyotishman; Perry, Cassandra L.; Peterson, Josh F.; Prows, Cynthia A.; Ralston, James; Rasmussen, Luke V.; Ritchie, Marylyn D.; Sadhasivam, Senthilkumar; Scott, Stuart A.; Smith, Maureen; Vega, Aida; Vinks, Alexander A.; Volpi, Simona; Wolf, Wendy A.; Bottinger, Erwin; Chisholm, Rex L.; Chute, Christopher G.; Haines, Jonathan L.; Harley, John B.; Keating, Brendan; Holm, Ingrid A.; Kullo, Iftikhar J.; Jarvik, Gail P.; Larson, Eric B.; Manolio, Teri; McCarty, Catherine A.; Nickerson, Deborah A.; Scherer, Steven E.; Williams, Marc S.; Roden, Dan M.; Denny, Joshua C.

    2014-01-01

    We describe here the design and initial implementation of the eMERGE-PGx project. eMERGE-PGx, a partnership of the eMERGE and PGRN consortia, has three objectives : 1) Deploy PGRNseq, a next-generation sequencing platform assessing sequence variation in 84 proposed pharmacogenes, in nearly 9,000 patients likely to be prescribed drugs of interest in a 1–3 year timeframe across several clinical sites; 2) Integrate well-established clinically-validated pharmacogenetic genotypes into the electronic health record with associated clinical decision support and assess process and clinical outcomes of implementation; and 3) Develop a repository of pharmacogenetic variants of unknown significance linked to a repository of EHR-based clinical phenotype data for ongoing pharmacogenomics discovery. We describe site-specific project implementation and anticipated products, including genetic variant and phenotype data repositories, novel variant association studies, clinical decision support modules, clinical and process outcomes, approaches to manage incidental findings, and patient and clinician education methods. PMID:24960519

  9. Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya

    PubMed Central

    Tuti, Timothy; Bitok, Michael; Paton, Chris; Makone, Boniface; Malla, Lucas; Muinga, Naomi; Gathara, David; English, Mike

    2015-01-01

    Objective To share approaches and innovations adopted to deliver a relatively inexpensive clinical data management (CDM) framework within a low-income setting that aims to deliver quality pediatric data useful for supporting research, strengthening the information culture and informing improvement efforts in local clinical practice. Materials and methods The authors implemented a CDM framework to support a Clinical Information Network (CIN) using Research Electronic Data Capture (REDCap), a noncommercial software solution designed for rapid development and deployment of electronic data capture tools. It was used for collection of standardized data from case records of multiple hospitals’ pediatric wards. R, an open-source statistical language, was used for data quality enhancement, analysis, and report generation for the hospitals. Results In the first year of CIN, the authors have developed innovative solutions to support the implementation of a secure, rapid pediatric data collection system spanning 14 hospital sites with stringent data quality checks. Data have been collated on over 37 000 admission episodes, with considerable improvement in clinical documentation of admissions observed. Using meta-programming techniques in R, coupled with branching logic, randomization, data lookup, and Application Programming Interface (API) features offered by REDCap, CDM tasks were configured and automated to ensure quality data was delivered for clinical improvement and research use. Conclusion A low-cost clinically focused but geographically dispersed quality CDM (Clinical Data Management) in a long-term, multi-site, and real world context can be achieved and sustained and challenges can be overcome through thoughtful design and implementation of open-source tools for handling data and supporting research. PMID:26063746

  10. Prospective, Multi-center Randomized Intermediate Biomarker Study of Oral Contraceptive vs. Depo-Provera for Prevention of Endometrial Cancer in Women with Lynch Syndrome

    PubMed Central

    Lu, Karen H.; Loose, David S.; Yates, Melinda S.; Nogueras-Gonzalez, Graciela M.; Munsell, Mark F.; Chen, Lee-may; Lynch, Henry; Cornelison, Terri; Boyd-Rogers, Stephanie; Rubin, Mary; Daniels, Molly S.; Conrad, Peggy; Milbourne, Andrea; Gershenson, David M.; Broaddus, Russell R.

    2013-01-01

    Women with Lynch syndrome have a 40–60% lifetime risk for developing endometrial cancer, a cancer associated with estrogen imbalance. The molecular basis for endometrial-specific tumorigenesis is unclear. Progestins inhibit estrogen-driven proliferation, and epidemiologic studies have demonstrated that progestin-containing oral contraceptives (OCP) reduce the risk of endometrial cancer by 50% in women at general population risk. It is unknown if they are effective in women with Lynch syndrome. Asymptomatic women age 25–50 with Lynch syndrome were randomized to receive the progestin compounds depo-Provera (depoMPA) or OCP for three months. An endometrial biopsy and transvaginal ultrasound were performed before and after treatment. Endometrial proliferation was evaluated as the primary endpoint. Histology and a panel of surrogate endpoint biomarkers were evaluated for each endometrial biopsy as secondary endpoints. A total of 51 women were enrolled, and 46 completed treatment. Two of the 51 women had complex hyperplasia with atypia at the baseline endometrial biopsy and were excluded from the study. Overall, both depoMPA and OCP induced a dramatic decrease in endometrial epithelial proliferation and microscopic changes in the endometrium characteristic of progestin action. Transvaginal ultrasound measurement of endometrial stripe was not a useful measure of endometrial response or baseline hyperplasia. These results demonstrate that women with Lynch syndrome do show an endometrial response to short term exogenous progestins, suggesting that OCP and depoMPA may be reasonable chemopreventive agents in this high-risk patient population. PMID:23639481

  11. A multi-center randomized trial of buprenorphine–naloxone versus clonidine for opioid detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    Ling, Walter; Amass, Leslie; Shoptaw, Steve; Annon, Jeffrey J.; Hillhouse, Maureen; Babcock, Dean; Brigham, Greg; Harrer, Judy; Reid, Malcolm; Muir, Joan; Buchan, Betty; Orr, Debbie; Woody, George; Krejci, Jonathan; Ziedonis, Douglas; Group, the Buprenorphine Study Protocol

    2005-01-01

    Aims The clinical effectiveness of buprenorphine–naloxone (bup-nx) and clonidine for opioid detoxification in in-patient and out-patient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network. Design Diagnostic and Statistical Manual version IV (DSM IV)-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2:1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine. Methods A total of 113 in-patients (77 bup-nx, 36 clonidine) and 231 out-patients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures guided by a self-help handbook. The criterion for treatment success was defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings. Findings A total of 59 of the 77 (77%) in-patients assigned to the bup-nx condition achieved the treatment success criterion compared to eight of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) out-patients assigned to the bup-nx condition achieved the treatment success criterion, compared to four of the 74 (5%) assigned to clonidine. Conclusion The benefits of bup-nx for opioid detoxification are supported and illustrate important ways in which clinical research can be conducted in community treatment programs. PMID:16042639

  12. Comparison between Total Parenteral Nutrition Vs. Partial Parenteral Nutrition on Serum Lipids Among Chronic Ventilator Dependent Patients; A Multi Center Study

    PubMed Central

    Radpay, Rojan; Radpay, Badiozaman

    2016-01-01

    Background: Malnutrition is very common among chronically hospitalized patients, especially those in the intensive care unit (ICU). Identifying the patients at risk and providing suitable nutritional support can prevent and/or overcome malnutrition in them. Total parenteral nutrition (TPN) and partial parenteral nutrition (PPN) are two common routes to deliver nutrition to hospitalized patients. We conducted a multicenter, prospective double blind randomized controlled trial to evaluate the benefits and compare their adverse effects of each method. Materials and Methods: 97 patients were enrolled and divided into two groups based on the inclusion criteria. Serum protein, serum albumin, serum transferrin, and total lymphocyte count were measured on days 7 and 14. Results: We did not find any statistically significant differences in clinical status or laboratory values between the two groups but there were significant improvements in measured lab values between days 7 and 14 (p<0.005) indicating improved nutritional status in each groups. Conclusion: This study shows that both TPN and PPN can be used safely in chronic ICU patients to provide nutritional support and prevent catabolic state among chronic critically ill patients. We need to develop precise selection criteria in order to choose the patients who would benefit the most from TPN and PPN. In addition, appropriate laboratory markers are needed to monitor the metabolic requirements of the patients and assess their progress. PMID:27403176

  13. Personal exposure to PM2.5, genetic variants and DNA damage: a multi-center population-based study in Chinese.

    PubMed

    Chu, Minjie; Sun, Chongqi; Chen, Weihong; Jin, Guangfu; Gong, Jianhang; Zhu, Meng; Yuan, Jing; Dai, Juncheng; Wang, Meilin; Pan, Yun; Song, Yuanchao; Ding, Xiaojie; Guo, Xuejiang; Du, Mulong; Xia, Yankai; Kan, Haidong; Zhang, Zhengdong; Hu, Zhibin; Wu, Tangchun; Shen, Hongbing

    2015-06-15

    Exposure to particulate matter (e.g., PM2.5) may result in DNA damage, a major culprit in mutagenesis and environmental toxicity. DNA damage levels may vary among individuals simultaneously exposed to PM2.5, however, the genetic determinants are still unclear. To explore whether PM2.5 exposure and genetic variants contribute to the alteration in DNA damage, we recruited 328 subjects from three independent cohorts (119 from Zhuhai, 123 from Wuhan and 86 from Tianjin) in southern, central and northern China with different PM2.5 exposure levels. Personal 24-h PM2.5 exposure levels and DNA damage levels of peripheral blood lymphocytes were evaluated. Genotyping were performed using Illumina Human Exome BeadChip with 241,305 single nucleotide variants (SNVs). The DNA damage levels are consistent with the PM2.5 exposure levels of each cohort. A total of 35 SNVs were consistently associated with DNA damage levels among the three cohorts with pooled P values less than 1.00×10(-3) after adjustment for age, gender, smoking status and PM2.5 exposure levels, of which, 18 SNVs together with gender and PM2.5 exposure levels were independent factors contributing to DNA damage. Gene-based test revealed 3 genes significantly associated with DNA damage levels (P=5.11×10(-3) for POLH, P=2.88×10(-3) for RIT2 and P=2.29×10(-2) for CNTN4). Gene ontology (GO) analyses indicated that the identified variants were significantly enriched in DNA damage response pathway. Our findings highlight the importance of genetic variation as well as personal PM2.5 exposure in modulating individual DNA damage levels. PMID:25889363

  14. A multi-center inter-manufacturer study of the temporal stability of phase-contrast velocity mapping background offset errors

    PubMed Central

    2012-01-01

    Background Phase-contrast velocity images often contain a background or baseline offset error, which adds an unknown offset to the measured velocities. For accurate flow measurements, this offset must be shown negligible or corrected. Some correction techniques depend on replicating the clinical flow acquisition using a uniform stationary phantom, in order to measure the baseline offset at the region of interest and subtract it from the clinical study. Such techniques assume that the background offset is stable over the time of a patient scan, or even longer if the phantom scans are acquired later, or derived from pre-stored background correction images. There is no published evidence regarding temporal stability of the background offset. Methods This study assessed the temporal stability of the background offset on 3 different manufacturers’ scanners over 8 weeks, using a retrospectively-gated phase-contrast cine acquisition with fixed parameters and at a fixed location, repeated 5 times in rapid succession each week. A significant offset was defined as 0.6 cm/s within 50 mm of isocenter, based upon an accuracy of 10% in a typical cardiac shunt measurement. Results Over the 5 repeated cine acquisitions, temporal drift in the baseline offset was insignificant on two machines (0.3 cm/s, 0.2 cm/s), and marginally insignificant on the third machine (0.5 cm/s) due to an apparent heating effect. Over a longer timescale of 8 weeks, insignificant drift (0.4 cm/s) occurred on one, with larger drifts (0.9 cm/s, 0.6 cm/s) on the other machines. Conclusions During a typical patient study, background drift was insignificant. Extended high gradient power scanning with work requires care to avoid drift on some machines. Over the longer term of 8 weeks, significant drift is likely, preventing accurate correction by delayed phantom corrections or derivation from pre-stored background offset data. PMID:23083397

  15. Deferiprone versus deferoxamine in sickle cell disease: results from a 5-year long-term Italian multi-center randomized clinical trial.

    PubMed

    Calvaruso, Giusi; Vitrano, Angela; Di Maggio, Rosario; Ballas, Samir; Steinberg, Martin H; Rigano, Paolo; Sacco, Massimiliano; Telfer, Paul; Renda, Disma; Barone, Rita; Maggio, Aurelio

    2014-12-01

    Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-years, without any effect on safety (p=0.005). Moreover, although the basal serum ferritin levels were higher in transfused compared with non-transfused group (p=0.031), the changes over time in serum ferritin levels were not statistically significantly different between transfused and non-transfused cohort of patients (p=0.389). Kaplan-Meier curve, during 5-years of study, suggests that Deferiprone does not alter survival in comparison with Deferoxamine (p=0.38). In conclusion, long-term iron chelation therapy with Deferiprone was associated with efficacy and safety similar to that of Deferoxamine. Therefore, in patients with Sickle-Cell-Disease, Deferiprone may represent an effective long-term treatment option. PMID:24814618

  16. Association of proinflammatory cytokines and chemotherapy-associated cognitive impairment in breast cancer patients: a multi-centered, prospective, cohort study†

    PubMed Central

    Cheung, Y. T.; Ng, T.; Shwe, M.; Ho, H. K.; Foo, K. M.; Cham, M. T.; Lee, J. A.; Fan, G.; Tan, Y. P.; Yong, W. S.; Madhukumar, P.; Loo, S. K.; Ang, S. F.; Wong, M.; Chay, W. Y.; Ooi, W. S.; Dent, R. A.; Yap, Y. S.; Ng, R.; Chan, A.

    2015-01-01

    Background Existing evidence suggests that proinflammatory cytokines play an intermediary role in postchemotherapy cognitive impairment. This is one of the largest multicentered, cohort studies conducted in Singapore to evaluate the prevalence and proinflammatory biomarkers associated with cognitive impairment in breast cancer patients. Patients and methods Chemotherapy-receiving breast cancer patients (stages I–III) were recruited. Proinflammatory plasma cytokines concentrations [interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, IL-10, granulocyte–macrophage colony-stimulating factor, interferon-γ and tumor necrosis factor-α] were evaluated at 3 time points (before chemotherapy, 6 and 12 weeks after chemotherapy initiation). The FACT-Cog (version 3) was utilized to evaluate patients' self-perceived cognitive disturbances and a computerized neuropsychological assessment (Headminder™) was administered to evaluate patients' memory, attention, response speed and processing speed. Changes of cognition throughout chemotherapy treatment were compared against the baseline. Linear mixed-effects models were applied to test the relationships of clinical variables and cytokine concentrations on self-perceived cognitive disturbances and each objective cognitive domain. Results Ninety-nine patients were included (age 50.5 ± 8.4 years; 81.8% Chinese; mean duration of education = 10.8 ± 3.3 years). Higher plasma IL-1β was associated with poorer response speed performance (estimate: −0.78; 95% confidence interval (CI) −1.34 to −0.03; P = 0.023), and a higher concentration of IL-4 was associated with better response speed performance (P = 0.022). Higher concentrations of IL-1β and IL-6 were associated with more severe self-perceived cognitive disturbances (P = 0.018 and 0.001, respectively). Patients with higher concentrations of IL-4 also reported less severe cognitive disturbances (P = 0.022). Conclusions While elevated concentrations of IL-6 and IL-1β were observed in patients with poorer response speed performance and perceived cognitive disturbances, IL-4 may be protective against chemotherapy-associated cognitive impairment. This study is important because cytokines would potentially be mechanistic mediators of chemotherapy-associated cognitive changes. PMID:25922060

  17. [Investigation of antibiotic resistance patterns and reduced vancomycin susceptibilities of methicillin-resistant Staphylococcus aureus isolates: a multi-center study].

    PubMed

    Çıkman, Aytekin; Aydın, Merve; Gülhan, Barış; Parlak, Mehmet; Gültepe, Bilge; Kalaycı, Yıldız; Bayındır Bilmen, Fulya; Solmaz, Sinem; Özekinci, Tuncer

    2015-04-01

    The aims of this study were to determine the minimum inhibitory concentration (MIC) values of vancomycin, teicoplanin, daptomycin, quinupristin/dalfopristin, linezolid, tigecycline, chloramphenicol, rifampicin, ofloxacin and tetracycline and to investigate the reduced vancomycin susceptibility among methicillin-resistant Staphylococcus aureus (MRSA) strains isolated in hospitals located in different geographical regions of Turkey. A total of 100 MRSA strains isolated from patients (of which 50% were from intensive care units) hospitalized in seven centers in Turkey [Istanbul (n= 15), Ankara (n= 15), Izmir (n= 15), Adana (n= 15), Diyarbakir (n=15), Erzincan (n= 15), Van (n= 10)], between August 2013 - August 2014, were included in the study. Fourty-three strains were isolated from blood, whereas 21 were from lower respiratory tract, 17 from wounds, eight from catheters, six from urine, four from nasal swab and one from cerebrospinal fluid samples. Methicillin resistance of the isolates was determined by using cefoxitin (30 µg) disk with standard disk diffusion method, while the MIC values of other antibiotics were determined with E-test in accordance with the recommendations of Clinical and Laboratory Standards Institute (CLSI). MIC results obtained for quinupristin-dalfopristin (Q/D) were evaluated according to the CLSI criteria used for methicillin-susceptible S.aureus and for tigecycline according to the criteria recommended by the Food and Drug Administration for MRSA. Primarily, agar screening method (ASM) was used for determination of vancomycin-intermediate S.aureus (VISA) and heterogeneous VISA (hVISA) strains. Brain heart infusion agar containing 6 µg/ml vancomycin was used in ASM, and the strains with suspicion of VISA/hVISA were screened by standard E-test and macro E-test methods. All MRSA strains were susceptible to vancomycin, teicoplanin, daptomycin, Q/D and linezolid by E-test method; and their rates of susceptibility for tigecycline, chloramphenicol, rifampicin, ofloxacin and tetracycline were detected as 89%, 97%, 40%, 39% and 32%, respectively. MIC50/MIC90 values were 1.5/2 µg/ml for vancomycin, 2/4 µg/ml for teicoplanin, 0.19/0.38 µg/ml for daptomycin, 0.19/0.38 µg/ml for Q/D, 0.75/1 µg/ml for linezolid, 0.19/0.75 µg/ml for tigecycline, 3/6 µg/ml for chloramphenicol, 32/32 µg/ml for rifampicin, 32/32 µg/ml for ofloxacin and 32/64 µg/ml for tetracycline, respectively. For the evaluation of reduced vancomycin susceptibility, 2% (2/100) of MRSA strains were defined as VISA and 5% (5/100) as hVISA with ASM. One of those seven isolates identified as VISA/hVISA with ASM was evaluated as suspected hVISA by using both standard E-test and macro E-test methods. In conclusion, no MRSA resistant strain to vancomycin, teicoplanin, daptomycin, Q/D and linezolid was determined in our study. However tigecycline resistance (11%) was found higher than expected. As the glycopeptide resistance is increasing in the world and because of the intense use of these drugs in Turkey, the rates of vancomycin resistance among MRSA strains should be investigated periodically. PMID:26167824

  18. Neuropathologic assessment of participants in two multi-center longitudinal observational studies: the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN).

    PubMed

    Cairns, Nigel J; Perrin, Richard J; Franklin, Erin E; Carter, Deborah; Vincent, Benjamin; Xie, Mingqiang; Bateman, Randall J; Benzinger, Tammie; Friedrichsen, Karl; Brooks, William S; Halliday, Glenda M; McLean, Catriona; Ghetti, Bernardino; Morris, John C

    2015-08-01

    It has been hypothesized that the relatively rare autosomal dominant Alzheimer disease (ADAD) may be a useful model of the more frequent, sporadic, late-onset AD (LOAD). Individuals with ADAD have a predictable age at onset and the biomarker profile of ADAD participants in the preclinical stage may be used to predict disease progression and clinical onset. However, the extent to which the pathogenesis and neuropathology of ADAD overlaps with that of LOAD is equivocal. To address this uncertainty, two multicenter longitudinal observational studies, the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN), leveraged the expertise and resources of the existing Knight Alzheimer Disease Research Center (ADRC) at Washington University School of Medicine, St. Louis, Missouri, USA, to establish a Neuropathology Core (NPC). The ADNI/DIAN-NPC is systematically examining the brains of all participants who come to autopsy at the 59 ADNI sites in the USA and Canada and the 14 DIAN sites in the USA (eight), Australia (three), UK (one) and Germany (two). By 2014, 41 ADNI and 24 DIAN autopsies (involving nine participants and 15 family members) had been performed. The autopsy rate in the ADNI cohort in the most recent year was 93% (total since NPC inception: 70%). In summary, the ADNI/DIAN NPC has implemented a standard protocol for all sites to solicit permission for brain autopsy and to send brain tissue to the NPC for a standardized, uniform and state-of-the-art neuropathologic assessment. The benefit to ADNI and DIAN of the implementation of the NPC is very clear. The NPC provides final "gold standard" neuropathological diagnoses and data against which the antecedent observations and measurements of ADNI and DIAN can be compared. PMID:25964057

  19. Association of Relapse with Renal Outcomes under the Current Therapy Regimen for IgA Nephropathy: A Multi-Center Study

    PubMed Central

    Ni, Zhaohui; Zhong, Yifei; Qi, Yinghui; Shao, Xinghua; Wang, Qin; Cao, Liou; Zhang, Minfang; Xie, Yuanyuan; Qi, Chaojun; Tian, Lei; Mou, Shan

    2015-01-01

    Background and Objectives Renal relapse is a very common manifestation of IgA nephropathy (IgAN). The clinical characteristics and long-term outcomes of this condition have not yet been carefully explored. Design and Patients Patients with biopsy-proven IgAN between January 2005 and December 2010 from three medical centers in China was a primary cohort of patients. From January 2010 to April 2012, data of an independent cohort of IgAN patients from Ren Ji Hospital, Shanghai, China was collected using the same inclusion and exclusion criteria. These patients formed the validation cohort of this study. Results Of the patients with biopsy-proven IgAN from three medical centers, 489 patients achieved remission within 6 months following the therapy. Additionally, 76 (15.5%) of these patients experienced a relapse after achieving remission. During the median follow-up period of 66 months, 6 patients (1.4%) in the non-relapse group experienced renal deterioration, compared with 22 patients (29.6%) in the relapse group. Our study indicated that each 1-mmHg increase in the baseline diastolic blood pressure (DBP) was associated with a 4.5% increase in the risk of renal relapse; additionally, the male patients had a 3.324-fold greater risk of relapse compared with the female patients according to the adjusted multivariate Cox analysis. The nomogram was based on 489 patients achieved remission. The predictive accuracy and discriminative ability of the nomogram were determined by concordance index (C-index) and calibration curve. The results were validated using bootstrap resampling on the validation cohort. Conclusions This study demonstrated that renal relapse is a potential predictor of prognostic outcomes in patients under the current therapeutic regimens for IgAN. And male patients with higher diastolic blood pressure had a greater risk of experiencing relapse. PMID:26371477

  20. Short-term effectiveness of an individual counseling program for impaired fasting glucose and mild type 2 diabetes in Japan: a multi-center randomized control trial.

    PubMed

    Watanabe, Makoto; Okayama, Akira; Shimamoto, Kazuaki; Ueshima, Hirotsugu

    2007-01-01

    The aim of this study is to evaluate the short-term effectiveness of our individual-based counseling program and tools among individuals in ordinary Japanese communities with impaired fasting glucose (IFG) and mild type 2 diabetes. A total of 233 eligible participants (age 30-69 years) in 14 local study centers were randomly assigned to an intervention group (INT, N=119) and a control group (CONT, N=114). During the 4-month intervention, the INT received 4 individual counseling sessions and one reminder on life style modification. The CONT received only an explanation of blood test results and general information on diabetes. Baseline characteristics did not differ significantly between groups. Percentages of participants with desirable changes in glycemic level and weight were significantly higher in INT than CONT: fasting plasma glucose reduction of more than 10 mg/dL (39% in INT vs. 26% in CONT, p=0.045), hemoglobinA1c reduction greater than 0.3% (14% vs. 4%, p=0.01), and weight reduction of more than 4 kg (13% vs. 4%, p=0.025). Decreases in total energy intake and percentage of heavy alcohol drinkers (more than 46 g/day) were significantly greater in INT than CONT. The increase in percentages of participants who engaged in leisure time physical activity more than 12 times per month was significantly greater in INT than CONT. Our program resulted in life style modification and glycemic level improvement in the short-term among individuals with IFG and mild type 2 diabetes. Results indicated that the program was sufficiently effective and feasible for implementation in ordinary communities. PMID:17704031

  1. Erectile Dysfunction in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Outcomes from a Multi-Center Study and Risk Factor Analysis in a Single Center

    PubMed Central

    Chen, Xin; Wang, Zhu; Chen, Shengfu; Yang, Qiyun; Wan, Zi; Han, Dayu; Xiao, Haipeng; Sun, Xiangzhou; Deng, Chunhua

    2016-01-01

    The aim of this study was to investigate the prevalence of erectile dysfunction (ED) in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and explore the influence of UPOINT domains, National Institutes of Health-CP symptom index (NIH-CPSI) and other factors on ED prevalence. This was a prospective study of consecutive patients with CP/CPPS seen at 11 tertiary hospitals during January–July 2014. ED was diagnosed as a score of<21 on the International Index of Erectile Function (IIEF-5). Patients from one center were evaluated by the UPOINT system and NIH-CPSI. Each patient was assessed using clinical examination, asocio-demographic questionnaire, the Patient Health Questionnaire (PHQ), the Pain Catastrophizing Scale (PCS), NIH-CPSI and IIEF-5.1406 patients from 11 centers (mean age, 32.18 years; range 18–60 years) were enrolled. ED was found in 638/1406 patients (45.4%), and was categorized as mild in 291(45.6%), moderate in 297(46.6%) and severe in50(7.7%). 192 patients from one center(mean age,31.3 years; range 18–57 years) were further studied.IIEF-5 score correlated negatively with NIH-CPSI(r = 0.251), PHQ (r = 0.355) and PCS (r = 0.322)scores (P<0.001).PHQ score correlated positively with NIH-CPSI (r = 0.586) and PCS(r = 0.662) scores (P<0.001).NIH-CPSI, PHQ, PCS and IIEF-5 scores did not differ significantly between class IIIA and IIIB CP/CPPS. Multivariate logistic regression showed that UPOINT psychological (P) domain and NIH-CPSI symptom severity were independent risk factors for ED in CP/CPPS. It is concluded that psychological factors and symptom severity are independent risk factors for ED in CP/CPPS. PMID:27120096

  2. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis – the membrane study

    PubMed Central

    2012-01-01

    Background Adequate anticoagulation is prerequisite for effective hemodialysis to prevent clotting in the extracorporeal circuit. We aimed providing first data on the efficacy and safety of the low-molecular-weight heparin certoparin in this setting. Methods Multicenter, open-label, 8-week trial. Patients received a single dose of 3,000 IU certoparin i.v. with additional titration steps of 600 IU and/or continuous infusion if necessary. Results 120 patients were screened, 109 enrolled (median age 71; range 26–90 years) and 106 available for efficacy analyses. The percentage of unsatisfactory dialysis results at 8 weeks due to clotting or bleeding, was 1.9% (n = 2/106; 95% confidence interval [CI] 0.23–6.65%); no major bleeding. 1.9% had moderate/severe clotting in the lines/bubble catcher and 2.8% in the dialyser at week 8. 15.7 ± 14.3% of the dialysis filters’ visual surface area was showing redness. In subgroups of patients receiving median doses of 3000 ± 0, 3000 (2400–6000) and 4200 (3000–6600) IU, plasma aXa levels at baseline, 4 and 8 weeks were 0.24 [95%CI 0.21–0.27], 0.33 [0.27–0.40] and 0.38 [0.33–0.45] aXa IU/ml at 2 h. C48h was 0.01 [0.01–0.02] aXa IU at all visits. At baseline and 4 weeks AUC0-48h was 2.66 [2.19–3.24] and 3.66 [3.00–4.45] aXa IU*h/ml. In 3.0% of dialyses (n = 83/2724) prolonged fistula compression times were documented. Eight patients (7.34%) had at least one episode of minor bleeding. 4) 85.3% of patients had any adverse event, 9.2% were serious without suspected drug relation; and in 32 patients a drug-relation was suspected. Conclusions Certoparin appears effective and safe for anticoagulation in patients undergoing maintenance hemodialysis. PMID:22742742

  3. Intense pulsed light, near infrared pulsed light, and fractional laser combination therapy for skin rejuvenation in Asian subjects: a prospective multi-center study in China.

    PubMed

    Tao, Li; Wu, Jiaqiang; Qian, Hui; Lu, Zhong; Li, Yuanhong; Wang, Weizhen; Zhao, Xiaozhong; Tu, Ping; Yin, Rui; Xiang, Leihong

    2015-09-01

    Ablative skin rejuvenation therapies have limitations for Asian people, including post-inflammatory hyperpigmentation and long down time. Non-ablative lasers are safer but have limited efficacy. This study is to investigate the safety and efficacy of a combination therapy consisting of intense pulsed light (IPL), near infrared (NIR) light, and fractional erbium YAG (Er:YAG) laser for skin rejuvenation in Asian people. This study recruited 113 subjects from six sites in China. Subjects were randomly assigned to a full-face group, who received combination therapy, and split-face groups, in which one half of the face received combination therapy and the other half received IPL monotherapy. Each subject received five treatment sessions during a period of 90 days. Subjects were followed up at 1 and 3 months post last treatment. Three months after last treatment, the full-face group (n = 57) had a global improvement rate of 29 % and 29 % for wrinkles, 32 % for skin texture, 33 % for pigment spots, 28 % for pore size, respectively. For patients in the split-face groups (n = 54), monotherapy side had a global improvement rate of 23 % and 20 % for wrinkles, 27 % for skin texture, 25 % for pigment spots, 25 % for pore size, respectively. Both combination therapy and monotherapy resulted in significant improvements at the follow-up visits compared to baseline (P < 0.001). Combination therapy showed significantly greater improvements compared to monotherapy at two follow-up visits (P < 0.05). Combination therapy is a safe and more effective strategy than IPL monotherapy for skin rejuvenation in Asian people. PMID:26266401

  4. Human Placental Extract as a Subcutaneous Injection Is Effective in Chronic Fatigue Syndrome: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study.

    PubMed

    Park, Sat Byul; Kim, Kyu-Nam; Sung, Eunju; Lee, Suk Young; Shin, Ho Cheol

    2016-05-01

    Chronic fatigue (CF) is a common reason for consulting a physician due to affecting quality of life, but only a few effective treatments are available. The aim of this study was to examine the effectiveness of subcutaneous injection of the human placental extract (HPE) on medically indescribable cases of CF and safety in a randomized, double-blind, placebo-controlled clinical trial. A total of 78 subjects with CF were randomly assigned to either a HPE group or a placebo group. Subjects in the HPE group were treated with HPE three times a week subcutaneously for 6 weeks, whereas those in the placebo group with normal saline. Then, the fatigue severity scale (FSS), visual analog scale (VAS) and multidimensional fatigue inventory (MFI) were measured in both CF group and chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) subgroup. The FSS, VAS and MFI score at baseline were not different between the HPE and placebo group in total subjects with CF. In CFS group, the FSS (p=0.0242), VAS (p=0.0009) and MFI (p=0.0159) scores measured at the end of the study period decreased more in the HPE group than in the placebo group when compared with those at the baseline. There were no significant differences between the HPE group and placebo group in the mean change from baseline in FSS, VAS, and MFI in subjects with ICF during the study period. The subcutaneous injection of HPE was effective in the improvement of CFS. PMID:26911970

  5. Randomized, Controlled, Multi-center Trial: Comparing the Safety and Efficacy of DA-9701 and Itopride Hydrochloride in Patients With Functional Dyspepsia

    PubMed Central

    Choi, Myung-Gyu; Rhee, Poong-Lyul; Park, Hyojin; Lee, Oh Young; Lee, Kwang Jae; Choi, Suck Chei; Seol, Sang Young; Chun, Hoon Jai; Rew, Jong-Sun; Lee, Dong Ho; Song, Geun Am; Jung, Hwoon Yong; Jeong, Hyung Yong; Sung, In Kyung; Lee, Joon Seong; Lee, Soo Teik; Kim, Sung Kook; Shin, Yong Woon

    2015-01-01

    Background/Aims Therapies of functional dyspepsia (FD) are limited. DA-9701 is a novel prokinetic agent formulated with Pharbitis semen and Corydalis Tuber. We aimed to assess the efficacy of DA-9701 compared with itopride in FD patients. Methods Patients with FD randomly received either itopride 50 mg or DA-9701 30 mg t.i.d after a 2-week baseline period. After 4 weeks of treatment, 2 primary efficacy endpoints were analyzed: the change from baseline in composite score of the 8 dyspeptic symptoms and the overall treatment effect. Impact on patients’ quality of life was assessed using the Nepean Dyspepsia Index (NDI) questionnaire. Results We randomly assigned 464 patients with 455 having outcome data. The difference of the composite score change of the 8 symptoms between the 2 groups was 0.62, indicating that DA-9701 was not inferior to itopride. The overall treatment effect response rate was not different between the groups. When responder was defined as ≥ 5 of the 7 Likert scale, responder rates were 37% of DA-9701 and 36% of itopride group. Patients receiving DA-9701 experienced similar mean percentage of days with adequate relief during the 4-week treatment period compared with those receiving itopride (56.8% vs 59.1%). Both drugs increased the NDI score of 5 domains without any difference in change of the NDI score between the groups. The safety profile of both drugs was comparable. Conclusions DA-9701 significantly improves symptoms in patients with FD. DA-9701 showed non-inferior efficacy to itopride with comparable safety. PMID:26130637

  6. Using a Validated Algorithm to Judge the Appropriateness of Total Knee Arthroplasty in the United States: A Multi-Center Longitudinal Cohort Study

    PubMed Central

    Riddle, Daniel L.; Jiranek, William A.; Hayes, Curtis W.

    2014-01-01

    Objective We used a modified version of validated appropriateness criteria to determine the prevalence rates of total knee arthroplasty (TKA) surgeries that were classified as appropriate, inconclusive or inappropriate. Based on prior evidence, we hypothesized that the prevalence of TKA surgeries classified as inappropriate would approximate 20%. Methods The appropriateness classification system was adapted for use on persons undergoing TKA in the Osteoarthritis Initiative dataset. A variety of pre-operative data were used including WOMAC Pain and Physical Function scores, radiographic and knee motion and laxity measures and age. Prevalence rates for classifications of appropriate, inconclusive and inappropriate were calculated. Results Data from 205 persons with TKA were examined. The prevalence rate was 44.0% (95%CI= 37, 51) for classifications of appropriate, 21.7% (95%CI = 16, 28) for inconclusive classifications and 34.3% (95%CI =27, 41) for inappropriate classifications. Conclusion Approximately a third of TKA surgeries were judged to be inappropriate. Variation in the characteristics of persons undergoing TKA was extensive. These data support the need for consensus development of criteria for patient selection among practitioners in the US treating potential TKA candidates. Among the important issues, consensus development needs to address variation in patient characteristics and the relative importance of pre-operative status and subsequent outcome. PMID:24974958

  7. Genetic Association for P2X7R rs3751142 and CARD8 rs2043211 Polymorphisms for Susceptibility of Gout in Korean Men: Multi-Center Study.

    PubMed

    Lee, Sung Won; Lee, Shin Seok; Oh, Dong Ho; Park, Dong Jin; Kim, Hyun Sook; Choi, Jung Ran; Chae, Soo Cheon; Yun, Ki Jung; Chung, Won Tae; Choe, Jung Yoon; Kim, Seong Kyu

    2016-10-01

    The aim of this study was to determine the association between P2X7R rs3751142 and CARD8 rs2043211 polymorphisms and gout susceptibility in male Korean subjects. This study enrolled a total of 242 male patients with gout and 280 healthy controls. The polymorphisms of two individual genes including rs3751142(C>A) in the P2X7R gene and rs2043211(A>T) in the CARD8 gene were assessed using Taq-Man analysis. Statistical analyses were performed using the Chi-square test, Kruskal-Wallis test, and logistic regression analyses. A difference in genotypic frequency of the P2X7R rs3751142 and CARD8 rs2043211 genes was not detected between gout and control patients. Clinical parameters including age, onset age, disease duration, body mass index, and serum uric acid levels were not different among the three genotypes for either P2X7R or CARD8 (P > 0.05 for all). A pair-wise comparison of P2X7R rs3751142 and CARD8 rs2043211 genotype combinations revealed that subjects with the CA P2X7R rs3751142 genotype and the TT CARD8 rs2043211 genotype had a trend toward a higher risk of gout compared to the CC/AA combination (P = 0.056, OR = 2.618, 95% CI 0.975 - 7.031). In conclusion, this study revealed that genetic variability of the P2X7R rs3751142 and CARD8 rs2043211 genes might, in part, be associated with susceptibility for gout. PMID:27550484

  8. Normal values and reproducibility of the real-time index of vagal tone in healthy humans: a multi-center study

    PubMed Central

    Farmer, Adam D.; Coen, Steven J.; Kano, Michiko; Weltens, Nathalie; Ly, Huynh Giao; Botha, Claude; Paine, Peter A.; Oudenhove, Lukas Van; Aziz, Qasim

    2014-01-01

    Background The parasympathetic nervous system has been implicated in the pathogenesis of a number of gastrointestinal disorders including irritable bowel syndrome. Within the field, cardiometric parameters of parasympathetic/vagal tone are most commonly derived from time, or frequency, domain analysis of heart rate variability (HRV), yet it has limited temporal resolution. Cardiac vagal tone (CVT) is a non-invasive beat-to-beat measure of brainstem efferent vagal activity that overcomes many of the temporal limitations of HRV parameters. However, its normal values and reproducibility in healthy subjects are not fully described. The aim of this study was to address these knowledge gaps. Methods 200 healthy subjects (106 males, median age 28 years, range 18-59 years) were evaluated across three study centers. After attachment of CVT recording equipment, 20 min of data (resting/no stimulation) was acquired. 30 subjects, selected at random, were restudied after 1 year. Results The mean CVT was 9.5±4.16 linear vagal scale (LVS). Thus, the normal range (mean±2 standard deviations) for CVT based on this data was 1.9-17.8 LVS. CVT correlated negatively with heart rate (r=-0.6, P=0.001). CVT reproducibility over 1 year, as indexed by an intra-class correlational coefficient of 0.81 (95% confidence interval 0.64-0.91), was good. Conclusions In healthy subjects, the normal range for CVT should be considered to be 1.9-17.8 LVS and is reproducible over 1 year. Future research utilizing CVT should refer to these values although further study is warranted in patient groups. PMID:25330916

  9. Neuropathologic assessment of participants in two multi-center longitudinal observational studies: the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN)

    PubMed Central

    Cairns, Nigel J.; Perrin, Richard J.; Franklin, Erin E.; Carter, Deborah; Vincent, Benjamin; Xie, Mingqiang; Bateman, Randall J.; Benzinger, Tammie; Friedrichsen, Karl; Brooks, William S; Halliday, Glenda M.; McLean, Catriona; Ghetti, Bernardino; Morris, John C.

    2015-01-01

    It has been hypothesized that the relatively rare autosomal dominant Alzheimer disease (ADAD) may be a useful model of the more frequent, sporadic, late-onset AD (LOAD). Individuals with ADAD have a predictable age at onset and the biomarker profile of ADAD participants in the preclinical stage may be used to predict disease progression and clinical onset. However, the extent to which the pathogenesis and neuropathology of ADAD overlaps with that of LOAD is equivocal. To address this uncertainty, two multicenter longitudinal observational studies, the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN), leveraged the expertise and resources of the existing Knight Alzheimer Disease Research Center (ADRC) at Washington University School of Medicine, St. Louis, Missouri, USA, to establish a Neuropathology Core (NPC). The ADNI/DIAN-NPC is systematically examining the brains of all participants who come to autopsy at the 59 ADNI sites in the USA and Canada and the 14 DIAN sites in the USA (8), Australia (3), UK (1), and Germany (2). By 2014, 41 ADNI and 24 DIAN autopsies (involving 9 participants and 15 family members) had been performed. The autopsy rate in the ADNI cohort in the most recent year was 93% (total since NPC inception: 70%). In summary, the ADNI/DIAN NPC has implemented a standard protocol for all sites to solicit permission for brain autopsy and to send brain tissue to the NPC for a standardized, uniform, and state-of-the-art neuropathologic assessment. The benefit to ADNI and DIAN of the implementation of the NPC is very clear. The NPC provides final ‘gold standard’ neuropathological diagnoses and data against which the antecedent observations and measurements of ADNI and DIAN can be compared. PMID:25964057

  10. Amelia: A Multi-Center Descriptive Epidemiologic Study in a Large Dataset from the International Clearinghouse for Birth Defects Surveillance and Research, and Overview of the Literature

    PubMed Central

    BERMEJO-SÁNCHEZ, EVA; CUEVAS, LOURDES; AMAR, EMMANUELLE; BAKKER, MARIAN K.; BIANCA, SEBASTIANO; BIANCHI, FABRIZIO; CANFIELD, MARK A.; CASTILLA, EDUARDO E.; CLEMENTI, MAURIZIO; COCCHI, GUIDO; FELDKAMP, MARCIA L.; LANDAU, DANIELLE; LEONCINI, EMANUELE; LI, ZHU; LOWRY, R. BRIAN; MASTROIACOVO, PIERPAOLO; MUTCHINICK, OSVALDO M.; RISSMANN, ANKE; RITVANEN, ANNUKKA; SCARANO, GIOACCHINO; SIFFEL, CSABA; SZABOVA, ELENA; MARTÍNEZ-FRÍAS, MARÍA-LUISA

    2015-01-01

    This study describes the epidemiology of congenital amelia (absence of limb/s), using the largest series of cases known to date. Data were gathered by 20 surveillance programs on congenital anomalies, all International Clearinghouse for Birth Defects Surveillance and Research members, from all continents but Africa, from 1968 to 2006, depending on the program. Reported clinical information on cases was thoroughly reviewed to identify those strictly meeting the definition of amelia. Those with amniotic bands or limb-body wall complex were excluded. The primary epidemiological analyses focused on isolated cases and those with multiple congenital anomalies (MCA). A total of 326 amelia cases were ascertained among 23,110,591 live births, stillbirths and (for some programs) elective terminations of pregnancy for fetal anomalies. The overall total prevalence was 1.41 per 100,000 (95% confidence interval: 1.26–1.57). Only China Beijing and Mexico RYVEMCE had total prevalences, which were significantly higher than this overall total prevalence. Some under-registration could influence the total prevalence in some programs. Liveborn cases represented 54.6% of total. Among monomelic cases (representing 65.2% of nonsyndromic amelia cases), both sides were equally involved, and the upper limbs (53.9%) were slightly more frequently affected. One of the most interesting findings was a higher prevalence of amelia among offspring of mothers younger than 20 years. Sixty-nine percent of the cases had MCA or syndromes. The most frequent defects associated with amelia were other types of musculoskeletal defects, intestinal, some renal and genital defects, oral clefts, defects of cardiac septa, and anencephaly. PMID:22002956

  11. A Phase 1, Multi-Center, Open-Label, Dose-Escalation Study of 131I-CLR1404 in Subjects with Relapsed or Refractory Advanced Solid Malignancies.

    PubMed

    Lubner, Sam Joseph; Mullvain, Jacqueline; Perlman, Scott; Pishvaian, Michael; Mortimer, Joanne; Oliver, Katherine; Heideman, Jennifer; Hall, Lance; Weichert, Jamey; Liu, Glenn

    2015-01-01

    This study explores the imaging and therapeutic properties of a novel radiopharmaceutical, (131)I-CLR1404. Phase 1a data demonstrated safety and tumor localization by SPECT-CT. This 1b study assessed safety, imaging characteristics, and possible antineoplastic properties and provided further proof-of-concept of phospholipid ether analogues' retention within tumors. A total of 10 patients received (131)I-CLR1404 in an adaptive dose-escalation design. Imaging characteristics were consistent with prior studies, showing tumor uptake in primary tumors and metastases. At doses of 31.25 mCi/m(2) and greater, DLTs were thrombocytopenia and neutropenia. Disease-specific studies are underway to identify cancers most likely to benefit from (131)I-CLR1404 monotherapy. PMID:26536061

  12. Web-based communications and management of a multi-center clinical trial: the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project.

    PubMed

    Wisniewski, Stephen R; Eng, Heather; Meloro, Leslie; Gatt, Robert; Ritz, Louise; Stegman, Diane; Trivedi, Madhukar; Biggs, Melanie M; Friedman, Edward; Shores-Wilson, Kathy; Warden, Diane; Bartolowits, Douglas; Martin, Jeffrey P; Rush, A John

    2004-01-01

    While efficient methods of communication are known to be essential in conducting large multicenter clinical trials, very little information is provided on actual methods that can be implemented to improve communication. An integrated technology-based communication system was developed for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project, which prospectively defines treatments that are most effective for participants with a diagnosis of a nonpsychotic major depressive disorder (MDD) who report an unsatisfactory clinical outcome to an initial and, if necessary, subsequent treatment(s). This web-based communication system is comprised of a multi-faceted study Web site, including a help desk, document sharing, a project directory and reports. In addition, automated reporting via e-mail and an online data correction mechanism are also available. The STAR*D communication system improves communication between study personnel and improves the quality of the study's data through the integration of system elements, the integration of those elements with traditional forms of communication,, by filling the gaps not addressed by those traditional methods and by reducing the staff workload burden. PMID:16279277

  13. A Multi-Center Study Comparing Shunt Type in the Norwood Procedure for Single-Ventricle Lesions: 3-Dimensional Echocardiographic Analysis

    PubMed Central

    Marx, Gerald R.; Shirali, Girish; Levine, Jami C.; Guey, Lin T.; Cnota, James F.; Baffa, Jeanne M.; Border, William L.; Colan, Steve; Ensing, Gregory; Friedberg, Mark K.; Goldberg, David J.; Idriss, Salim F.; John, J. Blaine; Lai, Wyman W.; Lu, Minmin; Menon, Shaji C.; Ohye, Richard G.; Saudek, David; Wong, Pierre C.; Pearson, Gail D.

    2013-01-01

    Background The Pediatric Heart Network’s (PHN) Single Ventricle Reconstruction Trial (SVR) randomized infants with single right ventricles (RV) undergoing a Norwood procedure to a modified Blalock-Taussig or RV-to-pulmonary artery shunt. This report compares RV parameters in the two groups using 3-dimensional echocardiography (3DE). Methods and Results 3DE studies were obtained at 10/15 SVR centers. Of the 549 subjects, 314 underwent 3DE studies at one to four time points (pre-Norwood, post-Norwood, pre-stage II, and 14 months) for a total of 757 3DEs. Of these, 565 (75%) were acceptable for analysis. RV volume, mass, mass:volume ratio, ejection fraction (EF), and severity of tricuspid regurgitation did not differ by shunt type. RV volumes and mass did not change after the Norwood, but increased from pre-Norwood to pre-stage II (end-diastolic volume [EDV, ml]/body surface area [BSA]1.3, end-systolic volume [ESV, ml]/BSA1.3 and mass[g]/BSA1.3 mean difference [95% confidence interval] = 25.0 [8.7, 41.3], 19.3 [8.3, 30.4], and 17.9 [7.3, 28.5], then decreased by 14 months (EDV/BSA1.3, ESV/BSA1.3 and mass/BSA1.3 mean difference [95% confidence interval] = −24.4 [−35.0, −13.7], −9.8 [−17.9, −1.7], and −15.3 [−22.0, −8.6]. EF decreased from pre-Norwood to pre-stage II (mean difference [95% confidence interval] = −3.7% [−6.9%, −0.5%]), but did not decrease further by 14 months. Conclusions We found no statistically significant differences between study groups in 3DE measures of RV size and function, or magnitude of tricuspid regurgitation. Volume unloading was seen after stage II, as expected, but EF did not improve. This study provides insights into the remodeling of the operated univentricular RV in infancy. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00115934. PMID:24097422

  14. High grade anal intraepithelial neoplasia among HIV-1-infected men screening for a multi-center clinical trial of a human papillomavirus vaccine

    PubMed Central

    Wilkin, Timothy; Lee, Jeannette Y.; Lensing, Shelly Y.; Stier, Elizabeth A.; Goldstone, Stephen E.; Berry, J. Michael; Jay, Naomi; Aboulafia, David M.; Einstein, Mark H.; Saah, Alfred; Mitsuyasu, Ronald T.; Palefsky, Joel M.

    2013-01-01

    Purpose High-grade anal intraepithelial neoplasia (HGAIN) is the precursor lesion to invasive anal cancer. HPV vaccination holds great promise for preventing anal cancer. Methods We examined 235 HIV-1-infected men screening for participation in a multi-site clinical trial of a quadrivalent HPV vaccine. All participants had anal swabs obtained for HPV testing and cytology, and high resolution anoscopy with biopsies of visible lesions to assess for HGAIN. Results HPV 16 and 18 were detected in 23% and 10%, respectively; abnormal anal cytology was found in 56% and HGAIN in 30%. HGAIN prevalence was significantly higher in those with HPV 16 detection compared to those without (38% vs. 17%, P=.01). Use of antiretroviral therapy, nadir and current CD4+ cell count were not associated with abnormal anal cytology or HGAIN. Conclusion HGAIN is highly prevalent in HIV-infected men. Further studies are needed on treatment and prevention of HGAIN. PMID:23611828

  15. The prevalence of abnormal celiac antibodies and celiac disease in patients with suspected irritable bowel syndrome: a prospective multi-center US study

    PubMed Central

    Cash, Brooks D.; Rubenstein, Joel H.; Young, Patrick E.; Gentry, Andrew; Nojkov, Borko; Lee, Dong; Andrews, A. Hirsohi; Dobhan, Richard; Chey, William D.

    2011-01-01

    Background & Aims Guidelines recommend that patients with symptoms of non-constipated inflammatory bowel syndrome (NC-IBS) undergo testing for celiac disease (CD). We evaluated the prevalence of CD antibodies and biopsy confirmed CD among patients with NC-IBS in a large US population. Methods In a study conducted at 4 sites, from 2003 to 2008, we compared data from 492 patients with symptoms of NC-IBS to 458 asymptomatic individuals who underwent colonoscopy examinations for cancer screening or polyp surveillance (controls). All participants provided blood samples for specific and non-specific CD-associated antibodies. Additionally, patients with IBS were analyzed for complete blood cell counts, metabolic factors, erythrocyte sedimentation rates, and levels of C-reactive protein and thyroid-stimulating hormone. Any subjects found to have CD-associated antibodies were offered esophagogastroduodenoscopy and duodenal biopsy analysis. Results Of patients with NC-IBS, 7.3% had abnormal results in tests for CD-associated antibodies, compared to 4.8% of controls (adjusted odds ratio=1.49; 95% confidence interval, 0.76–2.90. P=.25). Within the NC-IBS group, 6.51% had antibodies against gliadin, 1.22% against tissue transglutaminase, and 0.61% against endomysium (P>.05 vs controls for all antibodies tested). CD was confirmed in 0.41% of patients in the NC-IBS group and 0.44% of controls (P>0.99). Conclusions Although CD-associated antibodies are relatively common, the prevalence of CD among patients with NC-IBS is similar to that among controls in a large US population. These findings challenge recommendations to routinely screen patients with NC-IBS for CD. More than 7% of patients with NC-IBS had CD-associated antibodies, indicating that gluten sensitivity might mediate IBS symptoms; further studies are needed. PMID:21762658

  16. The Effect of Additional Training on Motor Outcomes at Discharge from Recovery Phase Rehabilitation Wards: A Survey from Multi-Center Stroke Data Bank in Japan

    PubMed Central

    Shiraishi, Nariaki; Suzuki, Yusuke; Matsumoto, Daisuke; Jeong, Seungwon; Sugiyama, Motoya; Kondo, Katsunori; Kuzuya, Masafumi

    2014-01-01

    Objectives The purpose of the present study was to examine the potential benefits of additional training in patients admitted to recovery phase rehabilitation ward using the data bank of post-stroke patient registry. Subjects and Methods Subjects were 2507 inpatients admitted to recovery phase rehabilitation wards between November 2004 and November 2010. Participants were retrospectively divided into four groups based upon chart review; patients who received no additional rehabilitation, patients who were added with self-initiated off hours training, patients who were added with off hours training by ward staff, patients who received both self-initiated training and training by ward staff. Parameters for assessing outcomes included length of stay, motor/cognitive subscales of functional independent measures (FIM) and motor benefit of FIM calculated by subtracting the score at admission from that at discharge. Results Participants were stratified into three groups depending on the motor FIM at admission (≦28, 29∼56, 57≦) for comparison. Regarding outcome variables, significant inter-group differences were observed in all items examined within the subgroup who scored 28 or less and between 29 and 56. Meanwhile no such trends were observed in the group who scored 57 or more compared with those who scored less. In a decision tree created based upon Exhaustive Chi-squared Automatic Interaction Detection method, variables chosen were the motor FIM at admission (the first node) additional training (the second node), the cognitive FIM at admission(the third node). Conclusions Overall the results suggest that additional training can compensate for the shortage of regular rehabilitation implemented in recovery phase rehabilitation ward, thus may contribute to improved outcomes assessed by motor FIM at discharge. PMID:24626224

  17. Methylprednisolone for the Treatment of Patients with Acute Spinal Cord Injuries: A Propensity Score-Matched Cohort Study from a Canadian Multi-Center Spinal Cord Injury Registry

    PubMed Central

    Evaniew, Nathan; Noonan, Vanessa K.; Fallah, Nader; Kwon, Brian K.; Rivers, Carly S.; Ahn, Henry; Bailey, Christopher S.; Christie, Sean D.; Fourney, Daryl R.; Hurlbert, R. John; Linassi, A.G.; Fehlings, Michael G.

    2015-01-01

    Abstract In prior analyses of the effectiveness of methylprednisolone for the treatment of patients with acute traumatic spinal cord injuries (TSCIs), the prognostic importance of patients' neurological levels of injury and their baseline severity of impairment has not been considered. Our objective was to determine whether methylprednisolone improved motor recovery among participants in the Rick Hansen Spinal Cord Injury Registry (RHSCIR). We identified RHSCIR participants who received methylprednisolone according to the Second National Spinal Cord Injury Study (NASCIS-II) protocol and used propensity score matching to account for age, sex, time of neurological exam, varying neurological level of injury, and baseline severity of neurological impairment. We compared changes in total, upper extremity, and lower extremity motor scores using the Wilcoxon signed-rank test and performed sensitivity analyses using negative binomial regression. Forty-six patients received methylprednisolone and 1555 received no steroid treatment. There were no significant differences between matched participants for each of total (13.7 vs. 14.1, respectively; p=0.43), upper extremity (7.3 vs. 6.4; p=0.38), and lower extremity (6.5 vs. 7.7; p=0.40) motor recovery. This result was confirmed using a multivariate model and, as predicted, only cervical (C1–T1) rather than thoracolumbar (T2–L3) injury levels (p<0.01) and reduced baseline injury severity (American Spinal Injury Association [ASIA] Impairment Scale grades; p<0.01) were associated with greater motor score recovery. There was no in-hospital mortality in either group; however, the NASCIS-II methylprednisolone group had a significantly higher rate of total complications (61% vs. 36%; p=0.02) NASCIS-II methylprednisolone did not improve motor score recovery in RHSCIR patients with acute TSCIs in either the cervical or thoracic spine when the influence of anatomical level and severity of injury were included in the analysis. There was a significantly higher rate of total complications in the NASCIS-II methylprednisolone group. These findings support guideline recommendations against routine administration of methylprednisolone in acute TSCI. PMID:26065706

  18. Deep, respiratory tract and ear infections caused by Pseudallescheria (Scedosporium) and Microascus (Scopulariopsis) in Finland. A 10-year retrospective multi-center study.

    PubMed

    Issakainen, J; Salonen, J H; Anttila, V-J; Koukila-Kähkölä, P; Castrén, M; Liimatainen, O; Vuento, R; Ojanen, T; Koivula, I; Koskela, M; Meurman, O

    2010-05-01

    Deep, respiratory tract and ear infections due to Microascaceae (Pseudallescheria, Scedosporium, Microascus or Scopulariopsis) were studied nationwide in Finland during 1993-2002. The data were based on 52,000 fungal cultures that represented about 50% of all such specimens in Finland and included all Finnish cases of profound immunosuppression. There were 39 cases that were re-evaluated as clinically significant, i.e., three pneumonias, two deep pedal infections and five wound infections, 11 sinusitis and 18 ear infections. The pedal infections and most pneumonias occurred in immunocompromised patients. Most cases, except the ear infections, were due to Pseudallescheria boydii. Two patients had lethal P. boydii pneumonia and a deep P. boydii infection of the foot contributed to a third lethal case. Two of the patients with lethal outcomes had received an allogeneic haematopoietic stem cell transplantation (AHSCT). Two patients with haematological malignancies were cured of deep site infections by a prolonged course of itraconazole. Wound, sinus and ear infections were cured or improved by local surgery or topical therapy. There were 0.8-1.7 cases of any type of infection per million inhabitants per year (MY) and 3.4 cases/1000 AHSCT. Mortality associated with Microascaceae in any type of patient was 0.06-0.12 MY. PMID:19672782

  19. Validation of Single Nucleotide Polymorphisms (SNPs) Associated with Acute Rejection in Kidney Transplant Recipients Using a Large Multi-Center Cohort

    PubMed Central

    Oetting, William S.; Schladt, David P.; Leduc, Robert E.; Jacobson, Pamala A.; Guan, Weihua; Matas, Arthur J.; Israni, Ajay

    2011-01-01

    There have been numerous reports proposing a statistically significant association between a genetic variant, usually in the form of a single nucleotide polymorphism (SNP), and acute rejection (AR). Unfortunately, there are additional publications reporting a lack of association with AR when a different cohort of recipients was analyzed for the same SNP. The objective of this report was to attempt replication of these published finding in our own kidney allograft recipient cohort. We analyzed 23 genetic variants, previously reported to have a significant association with AR, using a cohort of 969 clinically well defined kidney transplant recipients. Only one SNP, rs6025 (Leiden mutation), within the coagulation factor V gene, showed a significant association with a p-value of 0.011 in a race adjusted analysis and 0.0003 in multiple variable analysis. An additional SNP, rs11706052 in IMPDH2, gave a modest p-value of 0.044 using multiple variable analysis which is not significant when multiple testing is taken into consideration. Our results suggest that careful validation of previously reported associations with AR is necessary and different strategies other than candidate gene studies can help to identify causative genetic variants associated with AR. PMID:21955043

  20. Planetary environment protection ID no: F3.3-M.1.05 implications for the development of a network of surface stations on Mars.

    PubMed

    Scoon, G E; Chicarro, A; Schwehm, G H; Spiero, F

    1995-03-01

    The European Space Agency's studies of a Comet Nucleus Sample Return mission (ROSETTA) as its Planetary Cornerstone in its long-term programme 'Horizon 2000' and the Marsnet mission, a potential contribution of the Agency to an international network of surface stations on Mars, has revived the interest in the present state of Planetary Protection requirements. MARSNET was one of the four candidate missions selected in April 1991 for further Design Feasibility (Phase A) Studies. Furthermore, of all space agencies participating in planetary exploration activities only the United States National Aeronautics and Space Administration had a well established Planetary Protection Policy on Viking and other relevant planetary missions, whereas ESA is considering the feasibility and potential impact of a planetary protection policy on its Marsnet mission, within the framework of a tight budgetary envelope applicable to ESA's medium (M) class missions. This paper will discuss in general terms the impact of Planetary Protection measures, its implications for Marsnet and the issues arising from this for the implementation of the mission in ESA's scientific programme. PMID:11539236

  1. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study

    PubMed Central

    Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

    2015-01-01

    Background Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. Results From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9–6.6 m) and 5.4 months (95%CI 3.1–7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). Conclusions In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

  2. Implementation and Operational Research: Computer-Assisted Intervention for Safer Sex in HIV-Positive Men Having Sex With Men: Findings of a European Randomized Multi-Center Trial

    PubMed Central

    Platteau, Tom; Bogner, Johannes; Buyze, Jozefien; Dec-Pietrowska, Joanna; Dias, Sonia; Newbury-Helps, John; Kocsis, Agnes; Mueller, Matthias; Rojas, Daniela; Stanekova, Danica; van Lankveld, Jacques; Colebunders, Robert

    2016-01-01

    Objective: Men who have sex with men (MSM) are the key population most affected by HIV in Europe. We performed the first European multicenter, simple-randomized parallel-group study to test the effectiveness of a theory-guided computer-assisted intervention to improve safer sex among HIV-positive men who have sex with men. Methods: Between February, 2011 and February, 2013, 112 participants were enrolled in 8 different European HIV-care settings. Intervention participants received 3 individual counseling sessions facilitated by trained service providers using computer-assisted tools. The control-group received sexual health advice delivered as part of regular HIV care. Outcome behavior (self-reported condom use at last intercourse; combined HIV transmission risk score), its influencing factors, and mediating variables were assessed at baseline, and at 3 and 6 months follow-up. Mixed effects models were used to compare primary outcomes (condom use at last intercourse, HIV transmission risk score), and mediation analysis to explore intervention effects. Results: Condom use at last intercourse increased more among intervention than control participants at 3 months follow-up (odds ratio of 3.83; P = 0.03), but not significantly at 6 months follow-up. Intervention participants reported a lower transmission risk at 3 months follow-up than controls (odds ratio compared with baseline of 11.53 and 1.28, respectively; P = 0.008), but this effect became nonsignificant at 6 months. Intervention effects were mediated by the proximal variables, self-efficacy to negotiate condom use and condom attitudes. Conclusions: This intervention showed short-term effectiveness. The intervention should be replicated in other settings, eventually investigating if booster-counseling sessions would yield a longer lasting effect. PMID:26866955

  3. A Randomized, Multi-Center, Single Blind, Active-Controlled, Matched Pairs Clinical Study to Evaluate Prevention of Adhesion Formation and Safety of HyFence in Patients After Endoscopic Sinus Surgery

    PubMed Central

    Chang, Chul; Hong, Sung-Moon; Cho, Jin-Hee; Shim, Sang Yul; Cho, Jung-Sun

    2014-01-01

    Objectives Recurrent mucosal disease and anatomic obstruction are commonly cited causes of failed endoscopic sinus surgery (ESS). Hyaluronic acid (HA) has been reported to reduce scarring and to promote wound healing in sinonasal surgery. HyFence is HA stabilized by 1, 4-butandiol diglycidyl ether, which makes it less-water-soluble and highly viscoelastic. The purpose of this study is to examine the anti-adhesion effect of HyFence after ESS compared to that of HA-CMC (Guardix-Sol). Methods Seventy-four patients with chronic rhinosinusitis who underwent ESS were included in the study. After the ESS procedure, Merocel was placed in the ethmoidectomized areas of the both sides. Five milliliters of Guardix-Sol was then applied to the Merocel of one side and HyFence LV was applied to the other side. The effect of the agents was evaluated at one, two, and four weeks after surgery by endoscopic examination. The severity of adhesion, edema, infection and complications were evaluated. Results There was no significant difference in the incidence of postoperative adhesion between the HyFence group and the Guardix-Sol group (P>0.05). Mean postoperative grades of edema and infection showed no significant difference between groups (P>0.05). There was no significant postoperative complications associated with either anti-adhesion agent (P>0.05). Conclusion HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS. PMID:24587878

  4. A Multi-Center Pilot Evaluation of the National Institutes of Health Chronic Graft-versus-Host Disease (cGVHD) Therapeutic Response Measures: Feasibility, Inter-rater Reliability, and Minimum Detectable Change

    PubMed Central

    Mitchell, Sandra A.; Jacobsohn, David; Thormann Powers, Kimberly E.; Carpenter, Paul A.; Flowers, Mary E.D.; Cowen, Edward W.; Schubert, Mark; Turner, Maria; Lee, Stephanie J.; Martin, Paul; Bishop, Michael R.; Baird, Kristin; Bolaños-Meade, Javier; Boyd, Kevin; Fall-Dickson, Jane M.; Gerber, Lynn H.; Guadagnini, Jean-Pierre; Imanguli, Matin; Krumlauf, Michael C.; Lawley, Leslie; Li, Li; Reeve, Bryce B.; Clayton, Janine Austin; Vogelsang, Georgia B.; Pavletic, Steven Z.

    2011-01-01

    The lack of standardized criteria for measuring therapeutic response is a major obstacle to the development of new therapeutic agents for chronic graft-versus-host disease (cGVHD). National Institutes of Health (NIH) consensus criteria for evaluating therapeutic response were published in 2006. We report the results of four consecutive pilot trials evaluating the feasibility and estimating the inter-rater reliability and minimum detectable change of these response criteria. Hematology-oncology clinicians with limited experience in applying the NIH cGVHD response criteria (n=34), participated in a 2.5 hour training session on response evaluation in cGVHD. Feasibility and inter-rater reliability between subspecialty cGVHD experts and this panel of clinician raters were examined in a sample of 25 children and adults with cGVHD. The minimum detectable change was calculated using the standard error of measurement. Clinicians’ impressions of the brief training session, the photo atlas, and the response criteria documentation tools were generally favorable. Performing and documenting the full set of response evaluations required a median of 21 minutes (range 12 to 60 minutes) per rater. The Schirmer tear test required the greatest time of any single test (median 9 minutes). Overall, inter-rater agreement for skin and oral manifestations was modest, however, in the third and fourth trials, the agreement between clinicians and experts for all dimensions except movable sclerosis approached satisfactory values. In the final two trials, the threshold for defining change exceeding measurement error was 19–22% body surface area (BSA) for erythema, 18–26% BSA for movable sclerosis, 17–21% BSA for nonmovable sclerosis, and 2.1–2.6 points on the 15 point NIH Oral cGHVD scale. Agreement between clinician-expert pairs was moderate to substantial for the measures of functional capacity and for the gastrointestinal and global cGVHD rating scales. These results suggest that the NIH response criteria are feasible for use, and these reliability estimates are encouraging, because they were observed following a single 2.5 hour training session given at multiple transplant centers, with no opportunity for iterative training and calibration. Research is needed to evaluate inter- and intra-rater reliability in larger samples, and to evaluate these response criteria as predictors of outcomes in clinical trials. PMID:21536143

  5. A Multi-center Phase I Dose Escalation Trial to Evaluate Safety and Tolerability of Intra-arterial Temozolomide for Patients with Advanced Extremity Melanoma Using Normothermic Isolated Limb Infusion

    PubMed Central

    Beasley, Georgia M.; Speicher, Paul; Augustine, Christina K.; Dolber, Paul C.; Peterson, Bercedis L.; Sharma, Ketan; Mosca, Paul J.; Royal, Richard; Ross, Merrick; Zager, Jonathan S.; Tyler, Douglas S.

    2015-01-01

    Synopsis This phase I trial reports the first use of intra arterial temozolomide via isolated limb infusion for patients with advanced extremity melanoma. There was minimal toxicity and the maximum tolerated dose was determined. PMID:25145500

  6. The Stroke Oxygen Study (SO2S) - a multi-center, study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Mild hypoxia is common in stroke patients and may have significant adverse effects on the ischemic brain after stroke. The use of oxygen treatment is rapidly increasing in European stroke units but is not without side effects. It impedes early mobilization, could pose an infection risk, and may encourage the formation of toxic free radicals, leading to further damage to the ischemic brain. In the Stroke Oxygen Pilot Study (2 or 3 L/min for 72 hours) neurological recovery at one week was better in the oxygen group than in controls, and after correction for difference in baseline stroke severity and prognostic factors, there was a trend to better outcome with oxygen at six months. Oxygen was as effective in mild as in severe strokes. Oxygen saturation is lower at night than during the day, and episodes of oxygen desaturation are common during sleep. Nocturnal oxygen supplementation is likely to reduce the burden of hypoxia without interfering with daytime mobilization and rehabilitation. Before wider use of oxygen supplementation becomes established it is important to obtain better evidence on which patients benefit from such treatment. Methods Participants will be randomized to one of three groups: the first will receive continuous oxygen for 72 hours (at a rate of 2 or 3 L/min depending on baseline oxygen saturation), the second group will receive nocturnal oxygen only (at a rate of 2 or 3 L/min depending on baseline oxygen saturation) and the third group will not receive any oxygen (control). A baseline assessment is performed at randomization and a one-week follow-up completed. Outcome data at three, six and twelve months will be obtained via a questionnaire sent to the patient by the trial center. Discussion This study will provide evidence on the effectiveness of oxygen supplementation for the treatment of stroke and whether nocturnal oxygen is a potentially beneficial therapy regimen. Trial registration This trial is registered with the ISRCTN register ID number ISRCTN52416964 PMID:24684940

  7. AT-41MULTI-CENTER CLINICAL TRIAL OF INTRAVENOUS ADMINISTRATION OF BEVACIZUMAB FOR THE TREATMENT OF RADIATION NECROSIS IN THE BRAIN TO OBTAIN NDA APPLICATION FOR ON LABEL USE IN JAPAN

    PubMed Central

    Miyatake, Shin-Ichi; Arakawa, Yoshiki; Miwa, Kazuhiro; Tsuboi, Koji; Iuchi, Toshihiko; Terasaka, Shunsuke; Tabei, Yusuke; Nakamura, Hideo; Nagane, Motoo; Sugiyama, Kazuhiko; Terasaki, Mizuhiko; Abe, Tatsuya; Mukasa, Akitake; Beppu, Takaaki; Furuse, Motomasa

    2014-01-01

    Recent radiotherapeutic modalities including particle radiotherapy, IMRT, and SRS are able to irradiate tumor tissue with high absorbed doses. These radiation therapies are promising to provide a longer survival in patients with CNS malignant tumors, compared to conventional X-ray radiotherapy. Simultaneously radiation necrosis (RN) has been a serious problem in such patients. However, there is no effective treatment for progressive RN so far. VEGF has been reported to play an important role in the progression of RN. Some clinical reports including ours demonstrate good results of bevacizumab treatment for RN. However, so far, no country gives a permission to use bevacizumab for symptomatic radiation necrosisin the brain as on label use. We initiated a nation-wide multicenter clinical trial in Japan, with the correct diagnosis of RN by amino-acid PET, to obtain a new drug approval (NDA) applications from Japanese FDA, based on public knowledge. Primary endpoint was the improvement of cerebral edema in periodic MRI. Secondary endpoint were safety, reduction of steroids, improvement of KPS and recurrence rate of RN within a year. The back ground of the patients are as follows; primary brain tumors such as GBM, metastatic brain tumors and head and neck cancers are 28 cases (68.3%), 12 cases (29.3%) and 1 case (2.4%), respectively. Applied radiation modalities are as follows; external beam radio-therapy 17 cases, SES 29 cases, hypo-fractionated IMRT 4 cases, proton beam particle radiation 3 cases and boron neutron capture therapy 1 case. Totally 41 cases of patients' enrollment finished. Last patient, last visit was in April 2014. The results are now opening and hopefully we can present them in SNO meeting.

  8. The Multi-Center Randomized Controlled Trial (RCT) Published by the Journal of the American Medical Association (JAMA) on the Effect of Periodontal Therapy on Glycated Hemoglobin (HbA1c) Has Fundamental Problems

    PubMed Central

    Borgnakke, Wenche S.; Chapple, Iain L.C.; Genco, Robert J.; Armitage, Gary; Bartold, P. Mark; D’Aiuto, Francesco; Eke, Paul I.; Giannobile, William V.; Kocher, Thomas; Kornman, Kenneth S.; Lang, Niklaus P.; Madianos, Phoebus N.; Murakami, Shinya; Nishimura, Fusanori; Offenbacher, Steven; Preshaw, Philip M.; Rahman, Amin ur; Sanz, Mariano; Slots, Jørgen; Tonetti, Maurizio S.; Van Dyke, Thomas E.

    2015-01-01

    SUMMARY Subject Participants had type 2 diabetes, were on stable medication regimens, had HbA1c levels between 7% and <9%, retained at least 16 natural teeth, and had untreated chronic periodontitis. A total of 514 participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with five participating academic medical centers. They were randomized with half (n = 257) allocated to a treatment group and the other half (n = 257) to a control group. Key Exposure/Study Factor The exposure was non-surgical periodontal treatment comprising scaling and root planing, oral hygiene instruction, and oral rinsing with chlorhexidine provided to the treatment group at baseline. Supportive periodontal therapy was also provided at 3 and 6 months. The control group received no treatment for the 6-month duration of the study. Main Outcome Measure The primary outcome measure was “the difference in change in HbA1c level from baseline between the two groups at 6 months.” Secondary outcomes included changes in periodontal probing depth (PPD), clinical attachment loss, bleeding on probing (BOP), gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Main Results The authors report that enrollment into their Diabetes and Periodontal Therapy Trial (DPTT) was terminated early due to futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17 (±1.0)%, compared with 0.11 (±1.0)% in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, −0.05% [95% CI: −0.23% to 0.12%]; p = 0.55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI: 0.18–0.37) for PPD; 0.25 mm (95% CI: 0.14–0.36) for clinical attachment loss; 13.1% (95% CI: 8.1%–18.1%) for BOP; and 0.27 (95% CI: 0.17–0.37) for gingival index (p < 0.001 for all). Conclusions The authors conclude: “Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c.” PMID:25234213

  9. Multi-center, Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial Comparing Mobi-C Cervical Artificial Disc to Anterior Discectomy and Fusion in the Treatment of Symptomatic Degenerative Disc Disease in the Cervical Spine

    PubMed Central

    Bae, Hyun W.; Davis, Reginald; Gaede, Steven; Hoffman, Greg; Kim, Kee; Nunley, Pierce D.; Peterson, Daniel; Rashbaum, Ralph; Stokes, John

    2014-01-01

    Background Anterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration. Methods This was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications. Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. Results Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar. Conclusions Mobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I. Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration. PMID:25694918

  10. Peripheral artery disease assessed by ankle-brachial index in patients with established cardiovascular disease or at least one risk factor for atherothrombosis - CAREFUL Study: A national, multi-center, cross-sectional observational study

    PubMed Central

    2011-01-01

    Background To investigate the presence of peripheral artery disease (PAD) via the ankle brachial index (ABI) in patients with known cardiovascular and/or cerebrovascular diseases or with at least one risk factor for atherothrombosis. Methods Patients with a history of atherothrombotic events, or aged 50-69 years with at least one cardiovascular risk factor, or > = 70 years of age were included in this multicenter, cross-sectional, non-interventional study (DIREGL04074). Demographics, medical history, physical examination findings, and physician awareness of PAD were analyzed. The number of patients with low ABI (< = 0.90) was analyzed. Results A total of 530 patients (mean age, 63.4 ± 8.7 years; 50.2% female) were enrolled. Hypertension and dyslipidemia were present in 88.7% and 65.5% of patients, respectively. PAD-related symptoms were evident in about one-third of the patients, and at least one of the pedal pulses was negative in 6.5% of patients. The frequency of low ABI was 20.0% in the whole study population and 30% for patients older than 70 years. Older age, greater number of total risk factors, and presence of PAD-related physical findings were associated with increased likelihood of low ABI (p < 0.001). There was no gender difference in the prevalence of low ABI, PAD symptoms, or total number of risk factors. Exercise (33.6%) was the most common non-pharmacological option recommended by physicians, and acetylsalicylic acid (ASA) (45.4%) was the most frequently prescribed medication for PAD. Conclusion Our results indicate that advanced age, greater number of total risk factors and presence of PAD-related physical findings were associated with increased likelihood of low ABI. These findings are similar to those reported in similar studies of different populations, and document a fairly high prevalence of PAD in a Mediterranean country. PMID:21247449

  11. Treatment of hereditary angioedema with nanofiltered C1-esterase inhibitor concentrate (Cetor®): multi-center phase II and III studies to assess pharmacokinetics, clinical efficacy and safety.

    PubMed

    Hofstra, J J; Kleine Budde, I; van Twuyver, E; Choi, G; Levi, M; Leebeek, F W G; de Monchy, J G R; Ypma, P F; Keizer, R J; Huitema, A D R; Strengers, P F W

    2012-03-01

    From 1997, plasma-derived C1-inhibitor concentrate (Cetor®) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pharmacokinetics (PK) of nanofiltered (C1-INH-NF) with conventional C1-inhibitor (C1-INH). Efficacy and safety were investigated in an open-label, on-demand and a prophylactic study. No differences in pharmacokinetic parameters between C1-INH and C1-INH-NF were found (13 non-symptomatic HAE patients). Both C1-inhibitor products equally increased plasma C4 levels. In the on-demand study, 14 acute angioedema attacks in 8 patients were analyzed. In the prophylactic study, 1 AAE and 5 HAE patients experienced in total 31 attacks during 748 observation days. In total 180,000 units of C1-INH-NF were administered. No product-related adverse events occurred, and no anti-C1-antibodies were induced. Nanofiltration in the production process of C1-inhibitor did not affect the pharmacokinetics, efficacy, and safety. PMID:22197071

  12. A multi-center, randomized, clinical trial comparing adhesive polyurethane foam dressing and adhesive hydrocolloid dressing in patients with grade II pressure ulcers in primary care and nursing homes

    PubMed Central

    2013-01-01

    Background Pressure ulcers (PrUs) are ischemic wounds in the skin and underlying tissues caused by long-standing pressure force over an external bone or cartilaginous surface. PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life. Moreover, 95% of PrUs are avoidable, suggesting they are caused by poor quality care assistance. PrUs are also costly, increasing national costs. For example, they represent about 5% of overall annual health expenses in Spain. Stages I and II PrUs have a combined prevalence of 65%. According main clinical guidelines, stage II PrUs (PrU-IIs) are usually treated by applying special dressings (polyurethane or hydrocolloid). However, little scientific evidence regarding their efficacy has been identified in scientific literature. Our aim is to assess the comparative efficacy of adhesive polyurethane foam and hydrocolloid dressings in the treatment of PrU-IIs in terms of healed ulcer after 8 weeks of follow-up. Methods/design This paper describes the development and evaluation protocol of a randomized clinical trial of two parallel treatment arms. A total of 820 patients with at least 1 PrU-II will be recruited from primary health care and home care centers. All patients will receive standardized healing procedures and preventive measures (e.g. positional changes and pressure-relieving support surfaces), following standardized procedures. The main outcome will be the percentage of wounds healed after 8 weeks. Secondary outcomes will include cost-effectiveness, as evaluated by cost per healed ulcer and cost per treated patient and safety evaluated by adverse events. Discussion This trial will address the hypothesis that hydrocolloid dressings will heal at least 10% more stage II PrUs and be more cost-effective than polyurethane foam dressings after 8 weeks. Trial registration This trial has been registered with controlled-trials number ISCRCTN57842461 and EudraCT 2012-003945-14. PMID:24359122

  13. The Clinical and Laboratory Characteristics of Patients with Chronic Hepatitis B Using Current or Past Antiviral Therapy in Korea: A Multi-Center, Nation-Wide, Cross-Sectional Epidemiologic Study

    PubMed Central

    Choi, Moon Seok; Sinn, Dong Hyun; Kim, Su-A; Lee, Yil Seob; Choi, Won

    2012-01-01

    Background/Aims The proper assessment of the current disease status of patients with chronic hepatitis B would be valuable for establishing optimal management strategies. Methods The clinical and laboratory characteristics of 2,954 patients with current or previous antiviral treatment (46.2±10.8 years, 69.7% male) enrolled from 46 referral hospitals and 129 local hospitals or clinics throughout Korea were analyzed. Results The disease status included chronic hepatitis, cirrhosis, and hepatocellular carcinoma in 79.9%, 16.4%, and 3.7% of the patients, respectively. The major mode of hepatitis B virus (HBV) infection was vertical transmission. The hepatitis C virus (HCV) co-infection rate was 1.5%; however, only 50.8% of patients were evaluated for HCV. The use of herbal or complementary medicines was reported in 33.5% of the patients. The majority of patients (97.6%) were treated with oral nucleoside/nucleotide analogues. Several characteristics were different between the patients treated at referral hospitals and local hospitals/clinics, including the disease state, choice of antiviral drug, and methods of HBV DNA measurement. Conclusions This study provides a comprehensive picture of the clinical and laboratory characteristics of patients treated in Korea. Efforts to optimize management strategies are warranted. PMID:22570755

  14. Comparative Evaluation of Friction Resistance of Titanium, Stainless Steel, Ceramic and Ceramic with Metal Insert Brackets with Varying Dimensions of Stainless Steel Wire: An In vitro Multi-center Study

    PubMed Central

    Kumar, B Sunil; Miryala, Suresh; Kumar, K Kiran; Shameem, K; Regalla, Ravindra Reddy

    2014-01-01

    Background: The orthodontist seeks an archwire–bracket combination that has both good biocompatibility and low friction. Hence, the aim of this multicenter in vitro study was to evaluate and compare the frictional resistance generated between titanium (Ti), stainless steel (SS), ceramic and ceramic with metal insert (CMI) brackets with SS wires of varying dimensions in a specially designed apparatus. Materials and Methods: The material used in this study were Ti, SS, Ceramic and CMI with 0.018″ slot manufactured with zero degree tip and −7° torque premolar brackets (3M, Unitek) and SS wires of varying dimensions (0.016″ round, 0.016 × 0.016″ square, 0.016 × 0.022″ rectangular and 0.017 × 0.025″ rectangular) used. The frictional resistance was measured using Instron Universal testing machine (Model no. 4301). The specimen population in each center composed each of 160 brackets and wires. Differences among the all bracket/wire combinations were tested using (one-way) ANOVA, followed by the student Newman Keuls multiple comparisons of means ranking (at P < 0.05) for the determination of differences among the groups. Results: Ti bracket in combination with 0.017 × 0.025″ SS rectangular wire produced significant force levels for an optimum orthodontic movement with least frictional resistance. Conclusion: Ti brackets have least resistance and rectangular wires produced significant force. These can be used to avoid hazards of Nickel. SS brackets revealed higher static frictional force values as the wire dimension increased and showed lower static friction than Ti brackets for all wires except the thicker wire. Our study recommends the preclusion of brackets with rough surface texture (Ti brackets) with SS ligature wire for ligating bracket and archwire are better to reduce friction. PMID:25395796

  15. Clinical Effect of Antioxidant Glasses Containing Extracts of Medicinal Plants in Patients with Dry Eye Disease: A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

    PubMed Central

    Choi, Won; Kim, Jae Chan; Kim, Won Soo; Oh, Han Jin; Yang, Jee Myung; Lee, Jee Bum; Yoon, Kyung Chul

    2015-01-01

    Purpose To investigate the clinical efficacy and safety of wearable antioxidant glasses containing extracts of medicinal plants in patients with mild dry eye disease (DED). Methods Fifty patients with mild DED were randomly assigned to wear either extracts of antioxidant medicinal plants containing (N = 25) or placebo glasses (N = 25). Patients wore the glasses for 15 min three times daily. The ocular surface disease index (OSDI) score, tear film break up time (BUT), and Schirmer’s test were evaluated and compared within the group and between the groups at baseline, 4 weeks, and 8 weeks after treatment. Results OSDI score and tear film BUT were significantly improved in the treatment group at 4 and 8 weeks after wearing glasses (all P < 0.001). Compared to the placebo group, the OSDI scores were significantly lower in the treatment group at 8 weeks (P = 0.007). The results of the Schirmer’s test showed significant improvement in the treatment group at 4 weeks (P = 0.035), however there were no significant differences between the other groups or within the groups. No adverse events were reported during the study. Conclusions Antioxidant glasses containing extracts of medicinal plants were effective in improving in DED both subjectively and objectively. Wearing antioxidants glasses might be a safe and adjunctive therapeutic option for DED. Trial Registration ISRCTN registry 71217488 PMID:26457673

  16. Single- and dual-wavelength laser operation of a diode-pumped Nd:LaF3 single crystal around 1.05 μm and 1.32 μm

    NASA Astrophysics Data System (ADS)

    Xu, Bin; Huang, Xiaoxu; Lan, Jinglong; Lin, Zhi; Wang, Yi; Xu, Huiying; Cai, Zhiping; Moncorgé, Richard

    2016-07-01

    Calibrated room temperature polarized emission spectra recorded between 850 and 1400 nm and nearly free from any reabsorption effect are presented for the first time. A laser output power of 2.35 W is obtained at 1063.45 nm with a laser slope efficiency of about 56% by pumping an uncoated Nd:LaF3 single crystal with a fiber-coupled laser diode at 790 nm inside a standard two-mirror linear laser cavity. True dual-wavelength laser operation on two orthogonally polarized laser lines around 1040 and 1065 nm as well as continuous laser wavelength tuning around 1040 nm, 1048 nm and 1064 nm are also achieved for the first time by using either an intracavity etalon or a birefringent filter. Laser operation is finally obtained around 1330.73 nm with a maximum output power of 0.18 W and a laser slope efficiency of about 4% and simultaneous dual-wavelength laser operation at 1329.04 and 1359.67 nm is demonstrated by using a glass etalon.

  17. N-[2,4-Dioxo-3-aza­tricyclo­[7.3.1.05,13]trideca-1(13),5,7,9,11-pentaen-3-yl]thio­urea

    PubMed Central

    Al-Salahi, Rashad; Al-Omar, Mohamed; Marzouk, Mohamed; Ng, Seik Weng

    2012-01-01

    In the two independent mol­ecules in the asymmetric unit of the title compound, C13H9N3O2S, the aza­tricyclo­trideca­penta­ene ring system is approximately planar with r.m.s. deviations of 0.022 and 0.033 Å. The urea unit connected to the fused rings is approximately perpendicular [dihedral angles = 82.4 (1) and 82.7 (1)°]. In the crystal, the mol­ecules associate by N—H⋯O hydrogen bonds, forming a chain running along the a axis. The crystal studied was a non-merohedral twin with a fractional contribution of 49.6 (1)% for the minor domain. PMID:22719583

  18. The Procalcitonin And Survival Study (PASS) – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients

    PubMed Central

    Jensen, Jens-Ulrik; Lundgren, Bettina; Hein, Lars; Mohr, Thomas; Petersen, Pernille L; Andersen, Lasse H; Lauritsen, Anne Ø; Hougaard, Sine; Mantoni, Teit; Bømler, Bonnie; Thornberg, Klaus J; Thormar, Katrin; Løken, Jesper; Steensen, Morten; Carl, Peder; Petersen, J Asger; Tousi, Hamid; Søe-Jensen, Peter; Bestle, Morten; Hestad, Søren; Andersen, Mads H; Fjeldborg, Paul; Larsen, Kim M; Rossau, Charlotte; Thomsen, Carsten B; Østergaard, Christian; Kjær, Jesper; Grarup, Jesper; Lundgren, Jens D

    2008-01-01

    Background Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein) may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. Methods Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC)). Inclusion: 1) Age ≥ 18 years of age, 2) Admitted to the participating intensive care units, 3) Signed written informed consent. Exclusion: 1) Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2) Likely that safety is compromised by blood sampling, 3) Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1), n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. Discussion For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival of critically ill patients be improved by actively using biomarker procalcitonin in the treatment of infections? 700 critically ill patients are currently included of 1000 planned (June 2008). Two interim analyses have been passed without any safety or futility issues, and the third interim analysis is soon to take place. Trial registration number at clinicaltrials.gov: Id. nr.: NCT00271752). PMID:18620598

  19. A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women

    ClinicalTrials.gov

    2015-03-18

    BACTERIAL VAGINOSIS; Signs and Symptoms to be Evaluated and Recorded Include:; Vaginal Discharge: Color, Odor, and Consistency;; Vulvovaginal Itching and Irritation (Subjective): Absent, Mild, Moderate, or Severe; Vulvovaginal Inflammation (Objective): Absent, Mild, Moderate, or Severe.

  20. Outcomes of the largest multi-center trial stratified by the presence of diabetes mellitus comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease. The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT).

    PubMed

    Nakamura, Masato; Muramatsu, Toshiya; Yokoi, Hiroyoshi; Okada, Hisayuki; Ochiai, Masahiko; Suwa, Satoru; Hozawa, Hidenari; Kawai, Kazuya; Awata, Masaki; Mukawa, Hiroaki; Fujita, Hiroshi; Shiode, Nobuo; Asano, Ryuta; Tsukamoto, Yoshiaki; Yamada, Takahisa; Yasumura, Yoshio; Ohira, Hiroshi; Miyamoto, Akira; Takashima, Hiroaki; Ogawa, Takayuki; Matsuyama, Yutaka; Nanto, Shinsuke

    2015-04-01

    The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an "oculo-stenotic reflex" bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices. PMID:24969222

  1. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662 PMID:23101480

  2. 21 CFR 343.80 - Professional labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... Pectoris: In a randomized, multi-center, double-blind trial designed to assess the role of aspirin...

  3. 21 CFR 343.80 - Professional labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... Pectoris: In a randomized, multi-center, double-blind trial designed to assess the role of aspirin...

  4. 21 CFR 343.80 - Professional labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... Pectoris: In a randomized, multi-center, double-blind trial designed to assess the role of aspirin...

  5. 21 CFR 343.80 - Professional labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... Pectoris: In a randomized, multi-center, double-blind trial designed to assess the role of aspirin...

  6. 21 CFR 343.80 - Professional labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., randomized, multi-center, placebo-controlled trials of predominantly male post-MI subjects and one randomized... Pectoris: In a randomized, multi-center, double-blind trial designed to assess the role of aspirin...

  7. Physiological and toxicological transcriptome changes in HepG2 cells exposed to copper Address for reprint requests and other correspondence: J. H. Freedman, Laboratory of Molecular Toxicology, National Institute of Environmental Health Sciences, Mail Drop E1-05, PO Box 12233, 111 T.W. Alexander Dr., Research Triangle Park, NC 27709 (e-mail: freedma1@niehs.nih.gov).

    PubMed Central

    Song, Min Ok; Li, Jianying; Freedman, Jonathan H.

    2009-01-01

    Copper is an essential trace element; however, at supraphysiological levels, it can be extremely toxic. Microarray data from HepG2 cells exposed to 100, 200, 400, and 600 μM copper for 4, 8, 12 and 24 h were generated and analyzed. Principal components, K-means, and hierarchical clustering, interactome, and pathway mapping analyses indicated that these exposure conditions induce physiological and toxicological changes in the HepG2 transcriptome. As a general trend, when the level of toxicity increases, the number and diversity of affected genes, Gene Ontology categories, regulatory pathways, and complexity of interactomes increase. Physiological responses to copper include transition metal ion binding and responses to stress/stimulus, whereas toxicological responses include apoptosis, morphogenesis, and negative regulation of biomolecule metabolism. The global gene expression profile was overlaid onto biomolecular interaction networks and signal transduction cascades using pathway mapping and interactome identification. This analysis indicated that copper modulates signal transduction pathways associated with MAPK, NF-κB, death receptor, IGF-I, hypoxia, IL-10, IL-2, IL-6, EGF, Toll-like receptor, protein ubiquitination, xenobiotic metabolism, leukocyte extravasation, complement and coagulation, and sonic hedgehog signaling. These results provide insights into the global and molecular mechanisms regulating the physiological and toxicological responses to metal exposure. PMID:19549813

  8. Serum Estradiol Levels Are Not Associated with Urinary Incontinence in Mid-life Women Transitioning through Menopause

    PubMed Central

    Waetjen, L. Elaine; Johnson, Wesley O.; Xing, Guibo; Feng, Wen-Ying; Greendale, Gail A.; Gold, Ellen B.

    2012-01-01

    Objective We evaluated the relationship between annually measured serum endogenous estradiol and the development or worsening of stress and urge incontinence symptoms over 8 years in women transitioning through menopause. Methods This is a longitudinal analysis of women with incontinence in the Study of Women’s Health Across the Nation (SWAN), a multi-center, multi-racial/ethnic prospective cohort study of community-dwelling women transitioning through menopause. At baseline and each of 8 annual visits, SWAN elicited frequency and type of incontinence in a self-administered questionnaire and drew a blood sample on days 2-5 of the menstrual cycle. All endocrine assays were performed using a double-antibody chemiluminescent immunoassay. We analyzed data using discrete Cox survival models and generalized estimating equations with time dependent covariates. Results Estradiol levels drawn at either the annual visit concurrent with or previous to the first report of incontinence were not associated with the development of any (hazard ratio (HR) = 0.99, 95% CI 0.99, 1.01), stress, or urge incontinence in previously continent women. Similarly, estradiol levels were not associated with worsening of any (odds ratio (OR) = 1.00, 95% CI 0.99, 1.01), stress, or urge incontinence in incontinent women. Change in estradiol levels from one year to the next was also not associated with the development (HR = 0.98, 95% confidence interval 0.97, 1.00) or worsening (OR = 1.03, 95% CI 0.99, 1.05) of incontinence. Conclusions We found that annually measured values and year-to-year changes in endogenous estradiol levels had no effect on the development or worsening of incontinence in women transitioning through menopause. PMID:21785372

  9. Knowledge of A1c Predicts Diabetes Self-Management and A1c Level among Chinese Patients with Type 2 Diabetes.

    PubMed

    Yang, Shengnan; Kong, Weimin; Hsue, Cunyi; Fish, Anne F; Chen, Yufeng; Guo, Xiaohui; Lou, Qingqing; Anderson, Robert

    2016-01-01

    This study was to identify current A1c understanding status among Chinese patients with type 2 diabetes, assess if knowledge of A1c affects their diabetes self-management and their glycemic control and recognize the factors influencing knowledge of A1c among patients with type 2 diabetes. A multi-center, cross-sectional survey was conducted between April and July 2010 in 50 medical centers in the Mainland China. Participants were recruited from inpatients and outpatients who were admitted to or visited those medical centers. The survey included core questions about their demographic characteristics, diabetes self-management behavior, and A1c knowledge. Overall, of 5957 patients, the percentage of patients with good understanding was 25.3%. In the multivariable logistic regression model, the variables related to the knowledge of A1c status are presented. We discovered that patients with longer diabetes duration (OR = 1.05; 95%CI = 1.04-1.06) and having received diabetes education (OR = 1.80; 95%CI = 1.49-2.17) were overrepresented in the good understanding of A1c group. In addition, compared to no education level, higher education level was statistically associated with good understanding of A1c (P<0.001). The percentage of patients with good understanding varied from region to region (P<0.001), with Eastern being highest (OR = 1.54; 95%CI = 1.32-1.80), followed by Central (OR = 1.25; 95%CI = 1.02-1.53), when referring to Western. Only a minority of patients with type 2 diabetes in China understood their A1c value. The patients who had a good understanding of their A1c demonstrated significantly better diabetes self-management behavior and had lower A1c levels than those who did not. PMID:26959422

  10. Comprehensive Oncologic Emergencies Research Network (CONCERN)

    Cancer.gov

    The Comprehensive Oncologic Emergencies Research Network (CONCERN) was established in March 2015 with the goal to accelerate knowledge generation, synthesis and translation of oncologic emergency medicine research through multi-center collaborations.

  11. ALHAT Integration and Testing

    NASA Video Gallery

    Autonomous Landing and Hazard Avoidance Technology (ALHAT) project integration and testing takes place at NASA Langley Research Center. The ALHAT project is a multi-center initiative to enable vari...

  12. Brain Tumor Epidemiology Consortium Membership Information

    Cancer.gov

    BTEC welcomes new members interested in the development of multi-center, inter-disciplinary collaborations that will lead to a better understanding of the etiology, outcomes and prevention of all brain tumors.

  13. Hydrocephalus

    MedlinePlus

    ... or developmental disorders (such as those associated with neural tube defects including spina bifida and encephalocele). Other ... and abnormal brain development. The Hydrocephalus Clinical Research Network (HCRN, www.hcrn.org ) is a multi-center ...

  14. Radiosurgery

    MedlinePlus

    ... studies have been done, to date, not one randomized prospective study has been completed. Irrefutable evidence does ... Knife may be most suited. Until a definitive, randomized, multi-centered prospective study is completed, radiosurgery as ...

  15. 76 FR 63933 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney... Kidney Diseases Special Emphasis Panel; NIDDK Multi-Center Clinical Study Cooperative Agreement (U01...; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)...

  16. Identifying Loci for the Overlap between Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder Using a Genome-Wide QTL Linkage Approach

    ERIC Educational Resources Information Center

    Nijmeijer, Judith S.; Arias-Vasquez, Alejandro; Rommelse, Nanda N. J.; Altink, Marieke E.; Anney, Richard J. L.; Asherson, Philip; Banaschewski, Tobias; Buschgens, Cathelijne J. M.; Fliers, Ellen A.; Gill, Michael; Minderaa, Ruud B.; Poustka, Luise; Sergeant, Joseph A.; Buitelaar, Jan K.; Franke, Barbara; Ebstein, Richard P.; Miranda, Ana; Mulas, Fernando; Oades, Robert D.; Roeyers, Herbert; Rothenberger, Aribert; Sonuga-Barke, Edmund J. S.; Steinhausen, Hans-Christoph; Faraone, Stephen V.; Hartman, Catharina A.; Hoekstra, Pieter J.

    2010-01-01

    Objective: The genetic basis for autism spectrum disorder (ASD) symptoms in children with attention-deficit/hyperactivity disorder (ADHD) was addressed using a genome-wide linkage approach. Method: Participants of the International Multi-Center ADHD Genetics study comprising 1,143 probands with ADHD and 1,453 siblings were analyzed. The total and…

  17. Occupation Attributes Relate to Location of Atrophy in Frontotemporal Lobar Degeneration

    ERIC Educational Resources Information Center

    Spreng, R. N.; Rosen, H. J.; Strother, S.; Chow, T. W.; Diehl-Schmid, J.; Freedman, M.; Graff-Radford, N. R.; Hodges, J. R.; Lipton, A. M.; Mendez, M. F.; Morelli, S. A.; Black, S. E.; Miller, B. L.; Levine, Brian

    2010-01-01

    Frontotemporal lobar degeneration (FTLD) often presents with asymmetric atrophy. We assessed whether premorbid occupations in FTLD patients were associated with these hemispheric asymmetries. In a multi-center chart review of 588 patients, occupation information was related to location of tissue loss or dysfunction. Patients with atrophy…

  18. Diagnostic challenge of gastrointestinal tuberculosis: a report of 34 cases and an overview of the literature.

    PubMed

    Radzi, Muhammad; Rihan, Nik; Vijayalakshmi, Natesan; Pani, Subhada Prasad

    2009-05-01

    We report 34 cases of gastrointestinal TB from Malaysia and present an overview of the diagnostic challenges. A concerted effort is necessary to improve the existing diagnostic methods, and develop and evaluate newer diagnostic tools through well designed multi-center studies. PMID:19842436

  19. NASA Ares I Crew Launch Vehicle Upper Stage Overview

    NASA Technical Reports Server (NTRS)

    Davusm Daniel J.; McArthur, J. Craig

    2008-01-01

    By incorporating rigorous engineering practices, innovative manufacturing processes and test techniques, a unique multi-center government/contractor partnership, and a clean-sheet design developed around the primary requirements for the International Space Station (ISS) and Lunar missions, the Upper Stage Element of NASA's Crew Launch Vehicle (CLV), the "Ares I," is a vital part of the Constellation Program's transportation system.

  20. Plasma 25-hydroxyvitamin D and progression to diabetes in patients at risk for diabetes: an ancillary analysis in the diabetes prevention program

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We investigated the association between vitamin D status, assessed by plasma 25-hydroxyvitamin D, and risk of incident diabetes. The research design and methods were a prospective observational study with a mean follow-up of 2.7 years in the Diabetes Prevention Program (DPP), a multi-center trial co...

  1. OVERALL PROCEDURES PROTOCOL AND PATIENT ENROLLMENT PROTOCOL: TESTING FEASIBILITY OF 3D ULTRASOUND DATA ACQUISITION AND RELIABILITY OF DATA RETRIEVAL FROM STORED 3D IMAGES

    EPA Science Inventory

    The purpose of this study is to examine the feasibility of collecting, transmitting,

    and analyzing 3-D ultrasound data in the context of a multi-center study of pregnant

    women. The study will also examine the reliability of measurements obtained from 3-D

    imag...

  2. FINAL INTERIM REPORT, CANDIDATE SITES, MACHINES IN USE, DATA STORAGE AND TRANSMISSION METHODS: TESTING FEASIBILITY OF 3D ULTRASOUND DATA ACQUISITION AND RELIABILITY OF DATA RETRIEVAL FROM STORED 3D IMAGES

    EPA Science Inventory

    The purpose of this Work Assignment, 02-03, is to examine the feasibility of collecting transmitting, and analyzing 3-D ultrasound data in the context of a multi-center study of pregnant women. The study will also examine the reliability of measurements obtained from 3-D images< ...

  3. Molecular Subtypes of Non-muscle Invasive Bladder Cancer.

    PubMed

    Lerner, Seth P; Robertson, A Gordon

    2016-07-11

    In this issue of Cancer Cell, Hedegaard et al. report a comprehensive multi-center transcriptional analysis of non-muscle invasive urothelial bladder cancer. They describe three molecular subtypes similar to those seen in other cohorts, as well as a unique CIS signature associated with risk of progression to muscle invasive cancer. PMID:27411578

  4. Lipid metabolism predicts changes in body composition during energy restriction in overweight humans

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The objective of this analysis of a subset from a multi-center 12 wk weight-loss trial was to determine if calcium supplementation or dairy food consumption during energy restriction changed circulating lipids compared with an energy-restricted placebo group. Overweight adults (n = 63) were randomiz...

  5. Process evaluation results from the HEALTHY nutrition intervention to modify the total school food environment

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The process evaluation of HEALTHY, a large multi-center trial to decrease type 2 diabetes mellitus in middle school children, monitored the implementation of the intervention to ascertain the extent that components were delivered and received as intended. The purpose of this article is to report the...

  6. Brain Tumor Epidemiology Consortium (BTEC)

    Cancer.gov

    The Brain Tumor Epidemiology Consortium is an open scientific forum organized to foster the development of multi-center, international and inter-disciplinary collaborations that will lead to a better understanding of the etiology, outcomes, and prevention of brain tumors.

  7. Rationale, design and methods of the HEALTHY study behavior intervention component

    Technology Transfer Automated Retrieval System (TEKTRAN)

    HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physic...

  8. The CALERIE Study: design and methods of an innovative 25% caloric restriction intervention

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Animal studies have shown that life span is extended by caloric restriction (CR). This manuscript describes the design and methodology of an innovative CR intervention, which is the treatment arm of the CALERIE Study. This study is a multi-center, randomized, controlled trial examining the effects o...

  9. Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]).

    PubMed

    Matheny, Michael E; Morrow, David A; Ohno-Machado, Lucila; Cannon, Christopher P; Resnic, Frederic S

    2007-01-01

    We sought to validate an automated outcomes surveillance system (DELTA) using OPUS (TIMI-16), a multi-center randomized, controlled trial that was stopped early due to elevated mortality in one of the two intervention arms. Methodologies that were incorporated into the application (Statistical Process Control [SPC] and Bayesian Updating Statistics [BUS]) were compared with standard Data Safety Monitoring Board (DSMB) protocols. PMID:18694141

  10. An Exploration of Radiation Physics in Electromagnetics

    NASA Technical Reports Server (NTRS)

    Lee, Katherine K.

    2005-01-01

    Contents include the following: NASA's Missions and Aeronautics Research. Today's Air Traffic Control System. Development of Decision-Support Tools. The Center-TRACON Automation System (CTAS). The Traffic Management Advisor (TMA). The Multi-Center Traffic Management Advisor (McTMA). The Surface Management System (SMS). Future Directions: The Joint Planning and Development Office.

  11. Non-BPS multi-bubble microstate geometries

    NASA Astrophysics Data System (ADS)

    Bena, Iosif; Bossard, Guillaume; Katmadas, Stefanos; Turton, David

    2016-02-01

    We construct the first smooth horizonless supergravity solutions that have two topologically-nontrivial three-cycles supported by flux, and that have the same mass and charges as a non-extremal D1-D5-P black hole. Our configurations are solutions to six-dimensional ungauged supergravity coupled to a tensor multiplet, and uplift to solutions of Type IIB supergravity. The solutions represent multi-center generalizations of the non-BPS solutions of Jejjala, Madden, Ross, and Titchener, which have over-rotating angular momenta. By adding an additional Gibbons-Hawking center, we succeed in lowering one of the two angular momenta below the cosmic censorship bound, and bringing the other very close to this bound. Our results demonstrate that it is possible to construct multi-center horizonless solutions corresponding to non-extremal black holes, and offer the prospect of ultimately establishing that finite-temperature black holes have nontrivial structure at the horizon.

  12. ALHAT: Autonomous Landing and Hazard Avoidance Technology

    NASA Technical Reports Server (NTRS)

    Robertson, Edward A.; Carson, John M., III

    2015-01-01

    The ALHAT project was chartered by NASA HQ in 2006 to develop and mature to TRL 6 an autonomous lunar landing GN&C and sensing system for crewed, cargo, and robotic planetary landing vehicles. The multi-center ALHAT team was tasked with providing a system capable of identifying and avoiding surface hazards in real time to enable safe precision landing to within tens of meters of a designated planetary landing site under any lighting conditions.

  13. NASA Ares I Crew Launch Vehicle Upper State Overview

    NASA Technical Reports Server (NTRS)

    Davis, Daniel J.

    2008-01-01

    By incorporating rigorous engineering practices, innovative manufacturing processes and test techniques, a unique multi-center government/contractor partnership, and a clean-sheet design developed around the primary requirements for the International Space Station (ISS) and Lunar missions, the Upper Stage Element of NASA s Crew Launch Vehicle (CLV), the "Ares I," is a vital part of the Constellation Program s transportation system.

  14. A new frontier for an old drug? A word of caution for beta-blockers in sepsis!

    PubMed

    Maybauer, Marc O; Maybauer, Dirk M

    2015-01-01

    Recent promising findings indicate a possible benefit of β-blockade in septic patients. Ongoing trials on esmolol in septic shock are investigating its hemodynamic effects, focusing on heart rate control and echocardiographic changes, as well as potential anti-inflammatory effects. However, given the complex physiology of sepsis and pharmacological effects on β-blockade, large multi-center trials are essential before such a therapy may be applied safely. PMID:26296157

  15. IND Regulatory & Manufacturing Resources - Cancer Imaging Program

    Cancer.gov

    The Cancer Imaging Program has been creating Investigational New Drug Applications (IND) for imaging agents in order to engage in multi-center clinical trials of these materials. A subset of the documents filed is being made available to the research community to implement routine synthesis of tracers at their own facilities and to assist investigators with the filing of their own INDs. The first of these document sets is for F-18 fluorothymidine (FLT).

  16. Should High-Frequency Ventilation in the Adult Be Abandoned?

    PubMed

    Nguyen, Albert P; Schmidt, Ulrich H; MacIntyre, Neil R

    2016-06-01

    High-frequency oscillatory ventilation (HFOV) can improve ventilation-perfusion matching without excessive alveolar tidal stretching or collapse-reopening phenomenon. This is an attractive feature in the ventilation of patients with ARDS. However, two recent large multi-center trials of HFOV failed to show benefits in this patient population. The following review addresses whether, in view of these trails, HFOV should be abandoned in the adult population? PMID:27235314

  17. 29 CFR Appendix C to Part 4022 - Lump Sum Interest Rates for Private-Sector Payments

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 5-1-00 5.25 4.50 4.00 4.00 7 8 79 5-1-00 6-1-00 5.25 4.50 4.00 4.00 7 8 80 6-1-00 7-1-00 5.25 4.50 4...-1-04 2.75 4.00 4.00 4.00 7 8 134 12-1-04 1-1-05 2.75 4.00 4.00 4.00 7 8 135 1-1-05 2-1-05 3.00 4.00 4.00 4.00 7 8 136 2-1-05 3-1-05 3.00 4.00 4.00 4.00 7 8 137 3-1-05 4-1-05 2.75 4.00......

  18. Monitoring burst suppression in critically ill patients: Multi-centric evaluation of a novel method

    PubMed Central

    Fürbass, Franz; Herta, Johannes; Koren, Johannes; Westover, M. Brandon; Hartmann, Manfred M.; Gruber, Andreas; Baumgartner, Christoph; Kluge, Tilmann

    2016-01-01

    Objective To develop a computational method to detect and quantify burst suppression patterns (BSP) in the EEGs of critical care patients. A multi-center validation study was performed to assess the detection performance of the method. Methods The fully automatic method scans the EEG for discontinuous patterns and shows detected BSP and quantitative information on a trending display in real-time. The method is designed to work without setting any patient specific parameters and to be insensitive to EEG artifacts and periodic patterns. For validation a total of 3982 h of EEG from 88 patients were analyzed from three centers. Each EEG was annotated by two reviewers to assess the detection performance and the inter-rater agreement. Results Average inter-rater agreement between pairs of reviewers was κ = 0.69. On average 22% of the review segments included BSP. An average sensitivity of 90% and a specificity of 84% were measured on the consensus annotations of two reviewers. More than 95% of the periodic patterns in the EEGs were correctly suppressed. Conclusion A fully automatic method to detect burst suppression patterns was assessed in a multi-center study. The method showed high sensitivity and specificity. Significance Clinically applicable burst suppression detection method validated in a large multi-center study. PMID:26971487

  19. 29 CFR Appendix C to Part 4022 - Lump Sum Interest Rates for Private-Sector Payments

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and... 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6-1-05 2.75 4.00 4.00 4.00 7 8 140 6-1-05 7-1-05...-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75 4.00 4.00 4.00 7 8 182 12-1-08 01-1-09 4.75...

  20. 29 CFR Appendix C to Part 4022 - Lump Sum Interest Rates for Private-Sector Payments

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., appendix C, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed... 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6-1-05 2.75 4.00 4.00 4.00 7 8 140 6-1-05 7-1-05...-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75 4.00 4.00 4.00 7 8 182 12-1-08 01-1-09 4.75...

  1. 29 CFR Appendix C to Part 4022 - Lump Sum Interest Rates for Private-Sector Payments

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... C, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed... 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6-1-05 2.75 4.00 4.00 4.00 7 8 140 6-1-05 7-1-05...-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75 4.00 4.00 4.00 7 8 182 12-1-08 01-1-09 4.75...

  2. Launch Vehicle Ascent Stage Separation Wind Tunnel Test

    NASA Technical Reports Server (NTRS)

    Bordelon, Wayne; Frost, Alonzo; Pritchett, Victor

    2002-01-01

    The Aerodynamic Research Facility (ARF) LGBB (Liquid Glide-back Booster) Stage Separation Test is part of the Multi-Center Second Generation In-House Tool Development Task. The ARF LGBB Stage Separation Test has been completed at MSFC (Marshall Space Flight Center). It includes the following: PSP (Project Study Plan) Feasibility Test; Isolated Force/Moment Data; Bimese Configuration Force/Moment Data; Schlieren Video. The LGBB Bimese Reference Configuration Analyses and Test Results In-Work to Develop Tools and Database. Preliminary results showed qualitative agreement with CFD (computational fluid dynamics) aerodynamic predictions. The preliminary results exhibit the complex nature of the stage separation aerothermal problem.

  3. High Power MPD Nuclear Electric Propulsion (NEP) for Artificial Gravity HOPE Missions to Callisto

    NASA Technical Reports Server (NTRS)

    McGuire, Melissa L.; Borowski, Stanley K.; Mason, Lee M.; Gilland, James

    2003-01-01

    This documents the results of a one-year multi-center NASA study on the prospect of sending humans to Jupiter's moon, Callisto, using an all Nuclear Electric Propulsion (NEP) space transportation system architecture with magnetoplasmadynamic (MPD) thrusters. The fission reactor system utilizes high temperature uranium dioxide (UO2) in tungsten (W) metal matrix cermet fuel and electricity is generated using advanced dynamic Brayton power conversion technology. The mission timeframe assumes on-going human Moon and Mars missions and existing space infrastructure to support launch of cargo and crewed spacecraft to Jupiter in 2041 and 2045, respectively.

  4. NASA Workshop on Hybrid (Mixed-Actuator) Spacecraft Attitude Control

    NASA Technical Reports Server (NTRS)

    Dennehy, Cornelius J.; Kunz, Nans

    2014-01-01

    At the request of the Science Mission Directorate Chief Engineer, the NASA Technical Fellow for Guidance, Navigation & Control assembled and facilitated a workshop on Spacecraft Hybrid Attitude Control. This multi-Center, academic, and industry workshop, sponsored by the NASA Engineering and Safety Center (NESC), was held in April 2013 to unite nationwide experts to present and discuss the various innovative solutions, techniques, and lessons learned regarding the development and implementation of the various hybrid attitude control system solutions investigated or implemented. This report attempts to document these key lessons learned with the 16 findings and 9 NESC recommendations.

  5. Habitat Demonstration Unit Project Leadership and Management Strategies

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project management team that put in place the key multi-center leadership skills and

  6. Habitat Demonstration Unit Project: Leadership and Management Strategies for a Rapid Prototyping Project

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Toup, Larry; Gill, Tracy; Tri, Terry; Howe, Scott; Smitherman, David

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies being used by the NASA HDU team for a rapid prototyping project. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team rapid prototyping approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project

  7. Tumors masquerading in patients with thyroid eye disease.

    PubMed

    Griepentrog, Gregory J; Burkat, Cat N; Kikkawa, Don O; Lucarelli, Mark J

    2013-08-01

    Thyroid eye disease (TED) is the most common cause of proptosis in adults. The external manifestations of TED are characteristic and the diagnosis is typically made without imaging. Although there are multiple descriptions of primary and secondary orbital tumors initially mistaken for TED in the literature, there are limited reports detailing the findings of patients with long-standing TED whom developed an orbital tumor at a later date. Herein, we present a 6-year retrospective multi-center report of three patients with long-standing TED who developed an initially unsuspected orbital or cavernous sinus tumor. PMID:23662589

  8. Flight Avionics Hardware Roadmap

    NASA Technical Reports Server (NTRS)

    Hodson, Robert; McCabe, Mary; Paulick, Paul; Ruffner, Tim; Some, Rafi; Chen, Yuan; Vitalpur, Sharada; Hughes, Mark; Ling, Kuok; Redifer, Matt; Wallace, Shawn

    2013-01-01

    As part of NASA's Avionics Steering Committee's stated goal to advance the avionics discipline ahead of program and project needs, the committee initiated a multi-Center technology roadmapping activity to create a comprehensive avionics roadmap. The roadmap is intended to strategically guide avionics technology development to effectively meet future NASA missions needs. The scope of the roadmap aligns with the twelve avionics elements defined in the ASC charter, but is subdivided into the following five areas: Foundational Technology (including devices and components), Command and Data Handling, Spaceflight Instrumentation, Communication and Tracking, and Human Interfaces.

  9. Prevention of stricture recurrence following urethral internal urethrotomy: routine repeated dilations or active surveillance?

    PubMed

    Tian, Ye; Wazir, Romel; Wang, Jianzhong; Wang, Kunjie; Li, Hong

    2016-01-01

    Strictures of the urethra are the most common cause of obstructed micturition in younger men and there is frequent recurrence after initial treatment. Currently, routine repeated dilations, including intermittent self-catheterisation (ISC) are prescribed by urologists to prevent urethral stricture recurrence. There is, however, no high level evidence available supporting the effectiveness of practicing these painful techniques. Balancing efficacy, adverse effects and costs, we hypothesize that active surveillance is a better option for preventing stricture recurrence as compared with routine repeated dilations. However, well designed, adequately powered multi-center trials with comprehensive evaluation are urgently needed to confirm our hypothesis. . PMID:27576888

  10. The antioxidant master glutathione and periodontal health

    PubMed Central

    Bains, Vivek Kumar; Bains, Rhythm

    2015-01-01

    Glutathione, considered to be the master antioxidant (AO), is the most-important redox regulator that controls inflammatory processes, and thus damage to the periodontium. Periodontitis patients have reduced total AO capacity in whole saliva, and lower concentrations of reduced glutathione (GSH) in serum and gingival crevicular fluid, and periodontal therapy restores the redox balance. Therapeutic considerations for the adjunctive use of glutathione in management of periodontitis, in limiting the tissue damage associated with oxidative stress, and enhancing wound healing cannot be underestimated, but need to be evaluated further through multi-centered randomized controlled trials. PMID:26604952

  11. CARs: Driving T-cell specificity to enhance anti-tumor immunity

    PubMed Central

    Kebriaei, Partow; Kelly, Susan S.; Manuri, Pallavi; Jena, Bipulendu; Jackson, Rineka; Shpall, Elizabeth; Champlin, Richard; Cooper, Laurence J. N.

    2013-01-01

    Adoptive transfer of antigen-specific T cells is a compelling tool to treat cancer. To overcome issues of immune tolerance which limits the endogenous adaptive immune response to tumor-associated antigens, robust systems for the genetic modification and characterization of T cells expressing chimeric antigen receptors (CARs) to redirect specificity have been produced. Refinements with regards to persistence and trafficking of the genetically modified T cells are underway to help improve the potency of genetically modified T cells. Clinical trials utilizing this technology demonstrate feasibility, and increasingly, antitumor activity, paving the way for multi-center trials to establish the efficacy of this novel T-cell therapy. PMID:22202074

  12. Swarm Intelligence for Urban Dynamics Modelling

    NASA Astrophysics Data System (ADS)

    Ghnemat, Rawan; Bertelle, Cyrille; Duchamp, Gérard H. E.

    2009-04-01

    In this paper, we propose swarm intelligence algorithms to deal with dynamical and spatial organization emergence. The goal is to model and simulate the developement of spatial centers using multi-criteria. We combine a decentralized approach based on emergent clustering mixed with spatial constraints or attractions. We propose an extension of the ant nest building algorithm with multi-center and adaptive process. Typically, this model is suitable to analyse and simulate urban dynamics like gentrification or the dynamics of the cultural equipment in urban area.

  13. High Power MPD Nuclear Electric Propulsion (NEP) for Artificial Gravity HOPE Missions to Callisto

    NASA Astrophysics Data System (ADS)

    McGuire, Melissa L.; Borowski, Stanley K.; Mason, Lee M.; Gilland, James

    2003-01-01

    The following paper documents the results of a one-year multi-center NASA study on the prospect of sending humans to Jupiter's moon, Callisto, using an all Nuclear Electric Propulsion (NEP) space transportation system architecture with magnetoplasmadynamic (MPD) thrusters. The fission reactor system utilizes high temperature uranium dioxide (UO2) in tungsten (W) metal matrix ``cermet'' fuel and electricity is generated using advanced dynamic Brayton power conversion technology. The mission timeframe assumes on-going human Moon and Mars missions and existing space infrastructure to support launch of cargo and crewed spacecraft to Jupiter in 2041 and 2045, respectively.

  14. Risk stratification of thyroid nodules on ultrasonography with the French TI-RADS: description and reflections

    PubMed Central

    2016-01-01

    The widespread use of ultrasonography places it in a key position for use in the risk stratification of thyroid nodules. The French proposal is a five-tier system, our version of a thyroid imaging reporting and database system (TI-RADS), which includes a standardized vocabulary and report and a quantified risk assessment. It allows the selection of the nodules that should be referred for fine-needle aspiration biopsies. Effort should be directed towards merging the different risk stratification systems utilized around the world and testing this unified system with multi-center studies. PMID:26324117

  15. Heavy Lift Vehicle (HLV) Avionics Flight Computing Architecture Study

    NASA Technical Reports Server (NTRS)

    Hodson, Robert F.; Chen, Yuan; Morgan, Dwayne R.; Butler, A. Marc; Sdhuh, Joseph M.; Petelle, Jennifer K.; Gwaltney, David A.; Coe, Lisa D.; Koelbl, Terry G.; Nguyen, Hai D.

    2011-01-01

    A NASA multi-Center study team was assembled from LaRC, MSFC, KSC, JSC and WFF to examine potential flight computing architectures for a Heavy Lift Vehicle (HLV) to better understand avionics drivers. The study examined Design Reference Missions (DRMs) and vehicle requirements that could impact the vehicles avionics. The study considered multiple self-checking and voting architectural variants and examined reliability, fault-tolerance, mass, power, and redundancy management impacts. Furthermore, a goal of the study was to develop the skills and tools needed to rapidly assess additional architectures should requirements or assumptions change.

  16. Swarm Intelligence for Urban Dynamics Modelling

    SciTech Connect

    Ghnemat, Rawan; Bertelle, Cyrille; Duchamp, Gerard H. E.

    2009-04-16

    In this paper, we propose swarm intelligence algorithms to deal with dynamical and spatial organization emergence. The goal is to model and simulate the developement of spatial centers using multi-criteria. We combine a decentralized approach based on emergent clustering mixed with spatial constraints or attractions. We propose an extension of the ant nest building algorithm with multi-center and adaptive process. Typically, this model is suitable to analyse and simulate urban dynamics like gentrification or the dynamics of the cultural equipment in urban area.

  17. Integrated NASA Lidar System Strategy for Space-Based Remote Sensing

    NASA Technical Reports Server (NTRS)

    Singh, Upendra N.; Heaps, William S.; Krebs, Carolyn A. (Technical Monitor)

    2002-01-01

    Recent peer reviews of' NASA's space-based lidar missions and of the technology readiness of lasers appropriate for space-based lidars indicated a critical need for an integrated research and development strategy to move laser transmitter technology from low technical readiness levels to the higher levels required for space missions. This paper presents a multi-Center efforts leading to formulation of an integrated NASA strategy to provide the technology and maturity of systems necessary to make Lidar/Laser systems viable for space-based study and monitoring of the earth's atmosphere.

  18. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  19. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  20. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  1. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  2. Synthesis and Thermal Properties of Solid-State Structural Isomers: Ordered Intergrowths of SnSe and MoSe2.

    PubMed

    Gunning, Noel S; Feser, Joseph; Beekman, Matt; Cahill, David G; Johnson, David C

    2015-07-15

    A family of structural isomers [(SnSe)1.05]m(MoSe2)n were prepared using the modulated elemental reactant method by varying the layer sequence and layer thicknesses in the precursor. By varying the sequence of Sn-Se and Mo-Se layer pairs deposited and annealing the precursors to self-assemble the targeted compound, all six possible isomers [(SnSe)1.05]4(MoSe2)4, [(SnSe)1.05]3(MoSe2)3[(SnSe)1.05]1(MoSe2)1, [(SnSe)1.05]3(MoSe2)2[(SnSe)1.05]1(MoSe2)2, [(SnSe)1.05]2(MoSe2)3[(SnSe)1.05]2(MoSe2)1, [(SnSe)1.05]2(MoSe2)1[(SnSe)1.05]1(MoSe2)2[(SnSe)1.05]1(MoSe2)1, and [(SnSe)1.05]2(MoSe2)2[(SnSe)1.05]1(MoSe2)1[(SnSe)1.05]1(MoSe2)1 were prepared. The structures were characterized by X-ray diffraction and electron microscopy which showed that all of the compounds have very similar c-axis lattice parameters and in-plane constituent lattice parameters yet distinct isomeric structures. These studies confirm that the structure, order, and thickness of the constituent layers match that of the precursors. The cross-plane thermal conductivity is found to be very low (∼0.08 Wm(-1) K(-1)) and independent of the number of SnSe-MoSe2 interfaces within uncertainty. The poor thermal transport in these layered isomers is attributed to a large cross-plane thermal resistance created by SnSe-MoSe2 and MoSe2-MoSe2 turbostratically disordered van der Waals interfaces, the density of which has less variation among the different compounds than the SnSe-MoSe2 interface density alone. PMID:26086400

  3. 29 CFR Appendix B to Part 4022 - Lump Sum Interest Rates for PBGC Payments

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 5.25 4.50 4.00 4.00 7 8 80 6-1-00 7-1-00 5.25 4.50 4.00 4.00 7 8 81 7-1-00 8-1-00 5.50 4.75 4.00 4...-04 11-1-04 3.00 4.00 4.00 4.00 7 8 133 11-1-04 12-1-04 2.75 4.00 4.00 4.00 7 8 134 12-1-04 1-1-05 2.75 4.00 4.00 4.00 7 8 135 1-1-05 2-1-05 3.00 4.00 4.00 4.00 7 8 136 2-1-05 3-1-05 3.00 4.00......

  4. 29 CFR Appendix B to Part 4022 - Lump Sum Interest Rates for PBGC Payments

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Federal Register citations affecting part 4022, appendix B, see the List of CFR Sections Affected, which... 7 8 137 3-1-05 4-1-05 2.75 4.00 4.00 4.00 7 8 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6...-08 3.50 4.00 4.00 4.00 7 8 180 10-1-08 11-1-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75...

  5. 29 CFR Appendix B to Part 4022 - Lump Sum Interest Rates for PBGC Payments

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... citations affecting part 4022, appendix B, see the List of CFR Sections Affected, which appears in the... 7 8 137 3-1-05 4-1-05 2.75 4.00 4.00 4.00 7 8 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6...-08 3.50 4.00 4.00 4.00 7 8 180 10-1-08 11-1-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75...

  6. 29 CFR Appendix B to Part 4022 - Lump Sum Interest Rates for PBGC Payments

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Register citations affecting part 4022, appendix B, see the List of CFR Sections Affected, which appears in... 7 8 137 3-1-05 4-1-05 2.75 4.00 4.00 4.00 7 8 138 4-1-05 5-1-05 2.75 4.00 4.00 4.00 7 8 139 5-1-05 6...-08 3.50 4.00 4.00 4.00 7 8 180 10-1-08 11-1-08 3.25 4.00 4.00 4.00 7 8 181 11-1-08 12-1-08 3.75...

  7. Subcutaneous immunoglobulin in CIDP and MMN: a short-term nationwide study.

    PubMed

    Cocito, Dario; Merola, Aristide; Peci, Erdita; Mazzeo, Anna; Fazio, Raffaella; Francia, Ada; Valentino, Paola; Liguori, Rocco; Filosto, Massimiliano; Siciliano, Gabriele; Clerici, Angelo Maurizio; Lelli, Stefania; Marfia, Girolama Alessandra; Antonini, Giovanni; Cecconi, Ilaria; Nobile-Orazio, Eduardo; Lopiano, Leonardo

    2014-11-01

    This multi-center Italian prospective observational study reports the 4 months follow-up data of 87 patients affected by chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) shifted from intravenous to subcutaneous immunoglobulin treatment. A therapeutic shift from intravenous to subcutaneous immunoglobulin was performed in 87 patients (66 CIDP; 21 MMN) affected by immune-mediated peripheral neuropathies with evidence of a sustained clinical response to intravenous immunoglobulin. Patients were evaluated by means of the Overall Neuropathy Limitation Scale, Medical Research Council Scale and Life Quality Index questionnaire, both at the time of therapeutic shift and after 4 months of subcutaneous immunoglobulin treatment. A sustained clinical efficacy was observed after the switch to subcutaneous immunoglobulin: the Overall Neuropathy Limitation Scale score improved in the group of 66 CIDP patients (P = 0.018), with only one subject reporting a worsening of 1 point, and remained stable in the group of 21 MMN patients (P = 0.841), with one subject reporting a worsening of two points. An improvement in the patient's perception of therapeutic setting was reported in both groups. This large multi-center study confirms the short-term clinical equivalence of subcutaneous versus intravenous immunoglobulin and a possible improvement in the patient's perception of therapeutic setting with the subcutaneous administration. However, further studies are required to extend the results to a longer observational period. PMID:25149866

  8. Probabilistic Quantitative Precipitation Forecasting over East China using Bayesian Model Averaging

    NASA Astrophysics Data System (ADS)

    Yang, Ai; Yuan, Huiling

    2014-05-01

    The Bayesian model averaging (BMA) is a post-processing method that weights the predictive probability density functions (PDFs) of individual ensemble members. This study investigates the BMA method for calibrating quantitative precipitation forecasts (QPFs) from The Observing System Research and Predictability Experiment (THORPEX) Interactive Grand Global Ensemble (TIGGE) database. The QPFs over East Asia during summer (June-August) 2008-2011 are generated from six operational ensemble prediction systems (EPSs), including ECMWF, UKMO, NCEP, CMC, JMA, CMA, and multi-center ensembles of their combinations. The satellite-based precipitation estimate product TRMM 3B42 V7 is used as the verification dataset. In the BMA post-processing for precipitation forecasts, the PDF matching method is first applied to bias-correct systematic errors in each forecast member, by adjusting PDFs of forecasts to match PDFs of observations. Next, a logistic regression and two-parameter gamma distribution are used to fit the probability of rainfall occurrence and precipitation distribution. Through these two steps, the BMA post-processing bias-corrects ensemble forecasts systematically. The 60-70% cumulative density function (CDF) predictions well estimate moderate precipitation compared to raw ensemble mean, while the 90% upper boundary of BMA CDF predictions can be set as a threshold of extreme precipitation alarm. In general, the BMA method is more capable of multi-center ensemble post-processing, which improves probabilistic QPFs (PQPFs) with better ensemble spread and reliability. KEYWORDS: Bayesian model averaging (BMA); post-processing; ensemble forecast; TIGGE

  9. Advanced Air Transportation Technologies Project, Final Document Collection

    NASA Technical Reports Server (NTRS)

    Mogford, Richard H.; Wold, Sheryl (Editor)

    2008-01-01

    This CD ROM contains a compilation of the final documents of the Advanced Air Transportation Technologies (AAIT) project, which was an eight-year (1996 to 2004), $400M project managed by the Airspace Systems Program office, which was part of the Aeronautics Research Mission Directorate at NASA Headquarters. AAIT focused on developing advanced automation tools and air traffic management concepts that would help improve the efficiency of the National Airspace System, while maintaining or enhancing safety. The documents contained in the CD are final reports on AAIT tasks that serve to document the project's accomplishments over its eight-year term. Documents include information on: Advanced Air Transportation Technologies, Autonomous Operations Planner, Collaborative Arrival Planner, Distributed Air/Ground Traffic Management Concept Elements 5, 6, & 11, Direct-To, Direct-To Technology Transfer, Expedite Departure Path, En Route Data Exchange, Final Approach Spacing Tool - (Active and Passive), Multi-Center Traffic Management Advisor, Multi Center Traffic Management Advisor Technology Transfer, Surface Movement Advisor, Surface Management System, Surface Management System Technology Transfer and Traffic Flow Management Research & Development.

  10. Cloudwave: distributed processing of "big data" from electrophysiological recordings for epilepsy clinical research using Hadoop.

    PubMed

    Jayapandian, Catherine P; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D; Zhang, Guo-Qiang; Sahoo, Satya S

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50-60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical "big data" consisting of more than 100 multi-channel signals with recordings from each patient generating 5-10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a "private cloud". Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with "montages" for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave). PMID:24551370

  11. Bayesian inference for generalized linear mixed models with predictors subject to detection limits: an approach that leverages information from auxiliary variables.

    PubMed

    Yue, Yu Ryan; Wang, Xiao-Feng

    2016-05-10

    This paper is motivated from a retrospective study of the impact of vitamin D deficiency on the clinical outcomes for critically ill patients in multi-center critical care units. The primary predictors of interest, vitamin D2 and D3 levels, are censored at a known detection limit. Within the context of generalized linear mixed models, we investigate statistical methods to handle multiple censored predictors in the presence of auxiliary variables. A Bayesian joint modeling approach is proposed to fit the complex heterogeneous multi-center data, in which the data information is fully used to estimate parameters of interest. Efficient Monte Carlo Markov chain algorithms are specifically developed depending on the nature of the response. Simulation studies demonstrate the outperformance of the proposed Bayesian approach over other existing methods. An application to the data set from the vitamin D deficiency study is presented. Possible extensions of the method regarding the absence of auxiliary variables, semiparametric models, as well as the type of censoring are also discussed. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26643287

  12. A DICOM based radiotherapy plan database for research collaboration and reporting

    NASA Astrophysics Data System (ADS)

    Westberg, J.; Krogh, S.; Brink, C.; Vogelius, I. R.

    2014-03-01

    Purpose: To create a central radiotherapy (RT) plan database for dose analysis and reporting, capable of calculating and presenting statistics on user defined patient groups. The goal is to facilitate multi-center research studies with easy and secure access to RT plans and statistics on protocol compliance. Methods: RT institutions are able to send data to the central database using DICOM communications on a secure computer network. The central system is composed of a number of DICOM servers, an SQL database and in-house developed software services to process the incoming data. A web site within the secure network allows the user to manage their submitted data. Results: The RT plan database has been developed in Microsoft .NET and users are able to send DICOM data between RT centers in Denmark. Dose-volume histogram (DVH) calculations performed by the system are comparable to those of conventional RT software. A permission system was implemented to ensure access control and easy, yet secure, data sharing across centers. The reports contain DVH statistics for structures in user defined patient groups. The system currently contains over 2200 patients in 14 collaborations. Conclusions: A central RT plan repository for use in multi-center trials and quality assurance was created. The system provides an attractive alternative to dummy runs by enabling continuous monitoring of protocol conformity and plan metrics in a trial.

  13. Epilepsy and seizure ontology: towards an epilepsy informatics infrastructure for clinical research and patient care

    PubMed Central

    Sahoo, Satya S; Lhatoo, Samden D; Gupta, Deepak K; Cui, Licong; Zhao, Meng; Jayapandian, Catherine; Bozorgi, Alireza; Zhang, Guo-Qiang

    2014-01-01

    Objective Epilepsy encompasses an extensive array of clinical and research subdomains, many of which emphasize multi-modal physiological measurements such as electroencephalography and neuroimaging. The integration of structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research requires an effective informatics infrastructure that is underpinned by a formal domain ontology. Methods We have developed an epilepsy and seizure ontology (EpSO) using a four-dimensional epilepsy classification system that integrates the latest International League Against Epilepsy terminology recommendations and National Institute of Neurological Disorders and Stroke (NINDS) common data elements. It imports concepts from existing ontologies, including the Neural ElectroMagnetic Ontologies, and uses formal concept analysis to create a taxonomy of epilepsy syndromes based on their seizure semiology and anatomical location. Results EpSO is used in a suite of informatics tools for (a) patient data entry, (b) epilepsy focused clinical free text processing, and (c) patient cohort identification as part of the multi-center NINDS-funded study on sudden unexpected death in epilepsy. EpSO is available for download at http://prism.case.edu/prism/index.php/EpilepsyOntology. Discussion An epilepsy ontology consortium is being created for community-driven extension, review, and adoption of EpSO. We are in the process of submitting EpSO to the BioPortal repository. Conclusions EpSO plays a critical role in informatics tools for epilepsy patient care and multi-center clinical research. PMID:23686934

  14. Leveraging a clinical research information system to assist biospecimen data and workflow management: a hybrid approach

    PubMed Central

    2011-01-01

    Background Large multi-center clinical studies often involve the collection and analysis of biological samples. It is necessary to ensure timely, complete and accurate recording of analytical results and associated phenotypic and clinical information. The TRIBE-AKI Consortium http://www.yale.edu/tribeaki supports a network of multiple related studies and sample biorepository, thus allowing researchers to take advantage of a larger specimen collection than they might have at an individual institution. Description We describe a biospecimen data management system (BDMS) that supports TRIBE-AKI and is intended for multi-center collaborative clinical studies that involve shipment of biospecimens between sites. This system works in conjunction with a clinical research information system (CRIS) that stores the clinical data associated with the biospecimens, along with other patient-related parameters. Inter-operation between the two systems is mediated by an interactively invoked suite of Web Services, as well as by batch code. We discuss various challenges involved in integration. Conclusions Our experience indicates that an approach that emphasizes inter-operability is reasonably optimal in allowing each system to be utilized for the tasks for which it is best suited. PMID:21884570

  15. The Habitat Demonstration Unit Project

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Gill, Tracy; Tri, Terry; Howe, Scott

    2009-01-01

    This paper will describe an overview of the NASA-led multi-center Habitat Demonstration Unit (HDU) Project. The HDU project is a technology-pull project that integrates technologies and innovations from numerous NASA centers. This project will be used to investigate and validate surface architectures, operations concepts, and requirements definition. The HDU project will be part of the 2010 Desert Research and Technologies Simulations (DRATS). The purpose of this project is to develop, integrate, test, and evaluate a HDU in the context of the mission architectures and surface operation concepts. This HDU is based on the Constellation Architecture Scenario 12.1 concept of a vertically oriented habitat module. A multi-center approach with be utilized to build, integrate, and test the HDU project through a shared collaborative effort of multiple NASA centers. This project is part of the strategic plan from the ESMD Directorate Integration Office (DIO) and the Lunar Surface Systems Project Office (LSSPO) to test surface elements in a surface analog environment which includes two Lunar Electric Rovers and the HDU during the 2010 analog field test. This paper will describe the overall objectives, its various configurations, strategic plan, and technology integration as it pertains to the 2010 and 2011 field analog tests.

  16. Cloudwave: Distributed Processing of “Big Data” from Electrophysiological Recordings for Epilepsy Clinical Research Using Hadoop

    PubMed Central

    Jayapandian, Catherine P.; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D.; Zhang, Guo-Qiang; Sahoo, Satya S.

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50–60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical “big data” consisting of more than 100 multi-channel signals with recordings from each patient generating 5–10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a “private cloud”. Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with “montages” for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave) PMID:24551370

  17. Quality control and assurance for validation of DOS/I measurements

    NASA Astrophysics Data System (ADS)

    Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

    2010-02-01

    Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

  18. 14 CFR Appendix A to Part 23 - Simplified Design Load Criteria

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... single engine excluding turbine powerplants; (2) A main wing located closer to the airplane's center of... normal to the relative wind, and to have a magnitude of 1.05 times the airplane normal loads...

  19. 14 CFR Appendix A to Part 23 - Simplified Design Load Criteria

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... single engine excluding turbine powerplants; (2) A main wing located closer to the airplane's center of... normal to the relative wind, and to have a magnitude of 1.05 times the airplane normal loads...

  20. 14 CFR Appendix A to Part 23 - Simplified Design Load Criteria

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... single engine excluding turbine powerplants; (2) A main wing located closer to the airplane's center of... normal to the relative wind, and to have a magnitude of 1.05 times the airplane normal loads...

  1. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  2. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  3. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  4. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  5. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  6. Information Infrastructure Technology and Applications (IITA) Program: Annual K-12 Workshop

    NASA Technical Reports Server (NTRS)

    Hunter, Paul; Likens, William; Leon, Mark

    1995-01-01

    The purpose of the K-12 workshop is to stimulate a cross pollination of inter-center activity and introduce the regional centers to curing edge K-1 activities. The format of the workshop consists of project presentations, working groups, and working group reports, all contained in a three day period. The agenda is aggressive and demanding. The K-12 Education Project is a multi-center activity managed by the Information Infrastructure Technology and Applications (IITA)/K-12 Project Office at the NASA Ames Research Center (ARC). this workshop is conducted in support of executing the K-12 Education element of the IITA Project The IITA/K-12 Project funds activities that use the National Information Infrastructure (NII) (e.g., the Internet) to foster reform and restructuring in mathematics, science, computing, engineering, and technical education.

  7. Confidence-based ensemble for GBM brain tumor segmentation

    NASA Astrophysics Data System (ADS)

    Huo, Jing; van Rikxoort, Eva M.; Okada, Kazunori; Kim, Hyun J.; Pope, Whitney; Goldin, Jonathan; Brown, Matthew

    2011-03-01

    It is a challenging task to automatically segment glioblastoma multiforme (GBM) brain tumors on T1w post-contrast isotropic MR images. A semi-automated system using fuzzy connectedness has recently been developed for computing the tumor volume that reduces the cost of manual annotation. In this study, we propose a an ensemble method that combines multiple segmentation results into a final ensemble one. The method is evaluated on a dataset of 20 cases from a multi-center pharmaceutical drug trial and compared to the fuzzy connectedness method. Three individual methods were used in the framework: fuzzy connectedness, GrowCut, and voxel classification. The combination method is a confidence map averaging (CMA) method. The CMA method shows an improved ROC curve compared to the fuzzy connectedness method (p < 0.001). The CMA ensemble result is more robust compared to the three individual methods.

  8. Genre Complexes in Popular Music

    PubMed Central

    Childress, C. Clayton

    2016-01-01

    Recent work in the sociology of music suggests a declining importance of genre categories. Yet other work in this research stream and in the sociology of classification argues for the continued prevalence of genres as a meaningful tool through which creators, critics and consumers focus their attention in the topology of available works. Building from work in the study of categories and categorization we examine how boundary strength and internal differentiation structure the genre pairings of some 3 million musicians and groups. Using a range of network-based and statistical techniques, we uncover three musical “complexes,” which are collectively constituted by 16 smaller genre communities. Our analysis shows that the musical universe is not monolithically organized but rather composed of multiple worlds that are differently structured—i.e., uncentered, single-centered, and multi-centered. PMID:27203852

  9. Serelaxin for the treatment of heart failure.

    PubMed

    Moin, Danyaal S; Bloom, Michelle W; Papadimitriou, Lampros; Butler, Javed

    2016-06-01

    Outcomes for patients with acute heart failure remain suboptimal and treatments principally target improvement of symptoms. To date there has been no therapy approved for acute heart failure shown to improve mortality or readmission risk post-discharge. Serelaxin, a recombinant form of the naturally occurring polypeptide hormone relaxin, has demonstrated promise in preclinical and early clinical trials as a potentially novel therapy for acute heart failure. It is postulated through its anti-fibrotic and vasodilatory effects that this agent can improve outcomes in both the short and long term in these patients. Randomized clinical data has suggested that the medication is safe and well tolerated. However, definitive outcomes data is currently being assessed in a large multi-center trial. PMID:27045761

  10. Development of a system for transferring images via a network: supporting a regional liaison.

    PubMed

    Mihara, Naoki; Manabe, Shiro; Takeda, Toshihiro; Shinichirou, Kitamura; Junichi, Murakami; Kouji, Kiso; Matsumura, Yasushi

    2013-01-01

    We developed a system that transfers images via network and started using them in our hospital's PACS (Picture Archiving and Communication Systems) in 2006. We are pleased to report that the system has been re-developed and has been running so that there will be a regional liaison in the future. It has become possible to automatically transfer images simply by selecting the destination hospital that is registered in advance at the relay server. The gateway of this system can send images to a multi-center, relay management server, which receives the images and resends them. This system has the potential to be useful for image exchange, and to serve as a regional medical liaison. PMID:23920767

  11. Evaluation framework for carotid bifurcation lumen segmentation and stenosis grading.

    PubMed

    Hameeteman, K; Zuluaga, M A; Freiman, M; Joskowicz, L; Cuisenaire, O; Valencia, L Flórez; Gülsün, M A; Krissian, K; Mille, J; Wong, W C K; Orkisz, M; Tek, H; Hoyos, M Hernández; Benmansour, F; Chung, A C S; Rozie, S; van Gils, M; van den Borne, L; Sosna, J; Berman, P; Cohen, N; Douek, P C; Sánchez, I; Aissat, M; Schaap, M; Metz, C T; Krestin, G P; van der Lugt, A; Niessen, W J; van Walsum, T

    2011-08-01

    This paper describes an evaluation framework that allows a standardized and objective quantitative comparison of carotid artery lumen segmentation and stenosis grading algorithms. We describe the data repository comprising 56 multi-center, multi-vendor CTA datasets, their acquisition, the creation of the reference standard and the evaluation measures. This framework has been introduced at the MICCAI 2009 workshop 3D Segmentation in the Clinic: A Grand Challenge III, and we compare the results of eight teams that participated. These results show that automated segmentation of the vessel lumen is possible with a precision that is comparable to manual annotation. The framework is open for new submissions through the website http://cls2009.bigr.nl. PMID:21419689

  12. Review of the clinical research conducted by the Consortium for Improving Survival of Lymphoma of the Korean Society of Hematology Lymphoma Working Party

    PubMed Central

    Kim, Won Seog; Kim, Jin Seok; Park, Byeong-Bae

    2013-01-01

    The Consortium for Improving Survival of Lymphoma (CISL) in Korean Society of Hematology Lymphoma Working Party had first meeting in February, 2006 with 10 institutions and 12 members. Now CISL comprised of 64 centers. CISL has concentrated research activity on lymphomas which are relatively frequent in Korea and has tried to give favors for the Korean lymphoma patients. CISL has conducted more than 30 retrospective studies to evaluate Korean peculiar lymphoma subtypes. More than 30 prospective trials have been being performed for diffuse large B-cell lymphoma, marginal zone lymphoma, extra-nodal NK/T-cell lymphoma, and so on. The first prospective trial for advanced marginal zone lymphoma has led to use Rituximab containing chemotherapy with the re-imbursement of health insurance in Korea. The multi-center trials of the CISL with new therapeutic modalities will improve further the survival of lymphoma patients not only quantitatively but also qualitatively. PMID:24086936

  13. Automated analysis of multi site MRI phantom data for the NIHPD project.

    PubMed

    Fu, Luke; Fonov, Vladimir; Pike, Bruce; Evans, Alan C; Collins, D Louis

    2006-01-01

    In large multi-center studies it is important to quantify data variations due to differences between sites and over time. Here we investigate inter-site variability in signal to noise ratio (SNR), percent integral uniformity (PIU), width and height using the American College of Radiology (ACR) phantom scans from the NIHPD project. Longitudinal variations are also analyzed. All measurements are fully automated. Our results show that the mean SNR, PIU and the 2 metric values were statistically different across sites. The maximum mean difference in diameter across sites was 2 mm (1.1%), and the maximum mean difference in height was 2.5 mm (1.7%). Over time, an average drift of 0.4 mm per year was observed for the diameter while a drift of 0.5 mm per year was observed for the height. Trends observed over time often depended not only on site, but also on modality and scanner manufacturer. PMID:17354766

  14. Low-level laser therapy in chemo- and radiation-induced mucositis: results of multicenter phase III studies

    NASA Astrophysics Data System (ADS)

    Bensadoun, Rene-Jean

    2001-04-01

    Low of middle energy irradiation with helium-neon laser (LLLT) appears to be a simple atraumatic technique for the prevention and treatment of mucositis of various origins. Preliminary findings obtained by Ciais et al prompted randomized multi-center, double-blind trials to evaluate LLLT for the prevention of a acute chemo- and radiation- induced stomatitis. Irradiation by LLLT corresponds to local application of a high photon density monochromatic light source. Activation of epithelial healing on LLL-treated surfaces, the most commonly recognized effect, has been confirmed by numerous in vitro studies, and is a function of cell type, wavelength, and energy dose. The mechanism of action at a molecular and enzymatic level is currently being studied (detoxification of free-radicals).

  15. Clinical experience with the use of 5-ALA for the detection of superficial bladder cancer

    NASA Astrophysics Data System (ADS)

    Stepp, Herbert G.; Baumgartner, Reinhold; Knuechel, Ruth; Kriegmair, M.; Stepp, H. G.; Zaak, D.; Hofstetter, Alfons G.

    2000-06-01

    We report about the experience obtained in the fluorescence cystoscopic evaluation of 647 patients investigated since 1993. Of all histologically confirmed tumors, 32 percent would have been missed with conventional cystoscopy. Only 16 of 38 CIS were also detected under white light. In patients with entirely normal or unspecifically inflamed appearing mucosa, 44 otherwise invisible malignant lesions could be localized by fluorescence, 16 of them being present in patients with negative bladder washing cytology. The specificity of fluorescence cystoscopy is comparable to white light cystoscopy. A prospective multi-center study was conducted to show, whether a fluorescence controlled transurethral two weeks revealed residual tumor in 53 percent in the white light arm compared to 33 percent in the fluorescence arm. This difference was statistically significant. Of the 33 percent tumor in the fluorescence arm, most was gathered within the resection margins of the first resection, indicating an insufficiently deep resection rather than a failure in detecting the lesion.

  16. The effects of ADHD in adult substance abusers.

    PubMed

    Moura, Helena Ferreira; Faller, Sibele; Benzano, Daniela; Szobot, Cláudia; von Diemen, Lisia; Stolf, Anderson Ravy; Souza-Formigoni, Maria Lucia; Cruz, Marcelo Santos; Brasiliano, Sílvia; Pechansky, Flavio; Kessler, Felix Henrique Paim

    2013-01-01

    The aim of this study was to evaluate the psychiatric comorbidities and different areas of life functioning in substance abusers with attention deficit hyperactivity disorder symptoms. A cross-sectional, multi-center study involving 285 adult substance abusers from outpatient and inpatient clinics was performed. The Adult ADHD Self-Report Scale, the sixth version of the Addiction Severity Index, and the Mini International Neuropsychiatry Interview were used for data collection. Individuals with comorbid attention deficit hyperactivity disorder and substance use disorders showed increased addiction severity when compared with individuals without attention deficit hyperactivity disorder (53.3 ± 7.3 vs. 48.4 ± 8.4, respectively). Our results suggest that comorbid attention deficit hyperactivity disorder and substance use disorders is associated with a more severe course of substance use and with social and psychiatric impairment. PMID:24074191

  17. [Registration study on analysis of adaptation syndromes and medication characteristics of tanreqing injection].

    PubMed

    Xie, Peng-Yang; Xie, Yan-Ming; Wang, Lian-Xin; Chang, Yan-Peng; You, Li; Zhang, Xiao-Li

    2014-09-01

    Tanreqing injection is suitable for early pneumonia, acute bronchitis, acute exacerbations of chronic, and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine. To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection, the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method--prospective, multi-center, large sample, registration-type hospital centralized monitoring,and analyzes the general information, diagnostic information and medication characteristics of patients, in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use. PMID:25532398

  18. Indirect pulp therapy and stepwise excavation.

    PubMed

    Bjørndal, Lars

    2008-01-01

    Various treatment concepts have been suggested to solve the deep carious lesion dilemma. Recent systematic reviews are presented. Their conclusions are based on very few studies, and the main message is that optimal randomized clinical studies are lacking. Observational studies on indirect pulp treatment and stepwise excavation demonstrate that these treatments avoid pulp exposures, but it cannot be said which approach is best. A less invasive modified stepwise excavation approach is described, focusing on changing on active lesion into on arrested lesion even without performing an excavation close to the pulp. In Denmark and Sweden a randomized clinical multi-center trial is currently taking place, the Caries and Pulp (CAP) trial. This trial is investigating the effects of stepwise excavation over 2 visits versus 1 complete excavation of deep caries in permanent teeth. Guidelines for treatment are presented. PMID:18615988

  19. Indirect pulp therapy and stepwise excavation.

    PubMed

    Bjørndal, Lars

    2008-07-01

    Various treatment concepts have been suggested to solve the deep carious lesion dilemma. Recent systematic reviews are presented. Their conclusions are based on very few studies, and the main message is that optimal randomized clinical studies are lacking. Observational studies on indirect pulp treatment and stepwise excavation demonstrate that these treatments avoid pulp exposures, but it cannot be said which approach is best. A less invasive modified stepwise excavation approach is described, focusing on changing an active lesion into an arrested lesion even without performing an excavation close to the pulp. In Denmark and Sweden a randomized clinical multi-center trial is currently taking place, the Caries and Pulp (CAP) trial. This trial is investigating the effects of stepwise excavation over 2 visits versus 1 complete excavation of deep caries in permanent teeth. Guidelines for treatment are presented. PMID:18565369

  20. Risk of Spina Bifida and Maternal Cigarette, Alcohol, and Coffee Use during the First Month of Pregnancy

    PubMed Central

    Benedum, Corey M.; Yazdy, Mahsa M.; Mitchell, Allen A.; Werler, Martha M.

    2013-01-01

    This study was conducted to assess the association between the risks of spina bifida (SB) in relation to cigarette, alcohol, and caffeine consumption by women during the first month of pregnancy. Between 1988–2012, this multi-center case-control study interviewed mothers of 776 SB cases and 8,756 controls about pregnancy events and exposures. We evaluated cigarette smoking, frequency of alcohol drinking, and caffeine intake during the first lunar month of pregnancy in relation to SB risk. Logistic regression models were used to calculate adjusted odds ratios and 95% confidence intervals. Levels of cigarette smoking (1–9 and ≥10/day), alcohol intake (average ≥4 drinks/day) and caffeine intake (<1, 1, and ≥2 cups/day) were not likely to be associated with increased risk of SB. Further, results were similar among women who ingested less than the recommended amount of folic acid (400 μg/day). PMID:23917813

  1. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Morgan, Walter T; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects' experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26554277

  2. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Morgan, Walter T; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525962

  3. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects' disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525849

  4. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, Walter T.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects’ experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26554277

  5. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide)

    SciTech Connect

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-22

    In this study, a coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations.

  6. Perceived Benefits, Harms, and Views About How to Share Data Responsibly: A Qualitative Study of Experiences With and Attitudes Toward Data Sharing Among Research Staff and Community Representatives in Thailand.

    PubMed

    Cheah, Phaik Yeong; Tangseefa, Decha; Somsaman, Aimatcha; Chunsuttiwat, Tri; Nosten, François; Day, Nicholas P J; Bull, Susan; Parker, Michael

    2015-07-01

    The Thailand Major Overseas Programme coordinates large multi-center studies in tropical medicine and generates vast amounts of data. As the data sharing movement gains momentum, we wanted to understand attitudes and experiences of relevant stakeholders about what constitutes good data sharing practice. We conducted 15 interviews and three focus groups discussions involving 25 participants and found that they generally saw data sharing as something positive. Data sharing was viewed as a means to contribute to scientific progress and lead to better quality analysis, better use of resources, greater accountability, and more outputs. However, there were also important reservations including potential harms to research participants, their communities, and the researchers themselves. Given these concerns, several areas for discussion were identified: data standardization, appropriate consent models, and governance. PMID:26297749

  7. [Intramuscular etofenamate in the treatment of acute lumbago. Effectiveness and tolerance in comparison with intramuscular diclofenac-Na].

    PubMed

    Stratz, T

    1990-04-30

    In a controlled multi-center single-blind study, the relative efficacy and tolerance of i.m. injectable preparations of etofenamat(e) and diclofenac sodium were investigated in 96 patients with acute lumbago. Treatment resulted in obvious improvement in function and reduction in pain, no statistical difference being found between the two drugs. In 43% of the patients treated with etofenamat(e) and 27% of those receiving diclofenac, the final medical report indicated very good therapeutic results. Under etofenamat(e) i.m. therapy, no side effects occurred, and in no case did treatment have to be discontinued. Under diclofenac, two patients experienced adverse reactions, one allergic exanthema, and the other itching and a sensation of heat. A further patient experienced no improvement after the first injection and discontinued treatment. PMID:2142116

  8. Earth Atmosphere Observatory Formation at L2

    NASA Technical Reports Server (NTRS)

    Mettler, Edward; Acikmese, A. Behcet; Breckenridge, William G.; Mecenka, Steven A.; Tubbs, Eldred F.

    2004-01-01

    This paper is a product of research supported by NASA under RASC (the Revolutionary Aerospace Systems Concepts) program. It presents an overall system architecture, and covers issues of deployment, navigation, and control related to a formation of two spacecraft in the neighborhood of the Sun-Earth L2 Lagrange point (on the Sun-Earth line), that serves as an observatory of Earth's atmosphere. The observatory concept definition study was a multi-center NASA effort conducted in 2003, and covered a much wider scope than is presented in this focused paper.The Earth observatory at L2 is a unique design concept that can improve the knowledge and understanding of dynamic, chemical and radiative mechanisms that cause changes in the atmosphere, and can lead to the development of models and techniques to predict short and long-term climate changes.

  9. Therapeutic directions for Parkinson's disease.

    PubMed

    Shoulson, Ira

    2010-01-01

    The focus on disease-modifying treatments and cures for Parkinson's disease (PD) has raised expectations for quantum leaps and overshadowed incremental gains that have been slowly achieved. Large multi-center clinical trials such as DATATOP and PRECEPT keep on generating new knowledge that is relevant to clinical care as well as experimental therapeutics. The largely unforeseen relationship between circulating uric acid and the occurrence and progression of PD was developed and confirmed in these clinical trials. Systematic follow-up of clinical trial cohorts after conclusion of the interventional phase provides added value that continues to inform about natural history, state and trait biomarkers, and genotype-phenotype relationships. These efforts are enhanced by data mining, public reporting, and timely sharing of data and biological samples. PMID:20187232

  10. Overview of the first Multicenter Airborne Coherent Atmospheric Wind Sensor (MACAWS) experiment: conversion of a ground-based lidar for airborne applications

    NASA Astrophysics Data System (ADS)

    Howell, James N.; Hardesty, R. Michael; Rothermel, Jeffrey; Menzies, Robert T.

    1996-11-01

    The first Multi center Airborne Coherent Atmospheric Wind Sensor (MACAWS) field experiment demonstrated an airborne high energy TEA CO2 Doppler lidar system for measurement of atmospheric wind fields and aerosol structure. The system was deployed on the NASA DC-8 during September 1995 in a series of checkout flights to observe several important atmospheric phenomena, including upper level winds in a Pacific hurricane, marine boundary layer winds, cirrus cloud properties, and land-sea breeze structure. The instrument, with its capability to measure 3D winds and backscatter fields, promises to be a valuable tool for climate and global change, severe weather, and air quality research. In this paper, we describe the airborne instrument, assess its performance, discuss future improvements, and show some preliminary results from the September experiments.

  11. Autonomous aircraft initiative study

    NASA Technical Reports Server (NTRS)

    Hewett, Marle D.

    1991-01-01

    The results of a consulting effort to aid NASA Ames-Dryden in defining a new initiative in aircraft automation are described. The initiative described is a multi-year, multi-center technology development and flight demonstration program. The initiative features the further development of technologies in aircraft automation already being pursued at multiple NASA centers and Department of Defense (DoD) research and Development (R and D) facilities. The proposed initiative involves the development of technologies in intelligent systems, guidance, control, software development, airborne computing, navigation, communications, sensors, unmanned vehicles, and air traffic control. It involves the integration and implementation of these technologies to the extent necessary to conduct selected and incremental flight demonstrations.

  12. Acute leukemia in children: A review of the current Indian data

    PubMed Central

    Arora, Ramandeep Singh; Arora, Brijesh

    2016-01-01

    Acute leukemias are the most common diagnostic group of childhood cancer. This review summarizes the published literature on reported current outcomes of childhood acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) from India. Overall survival in ALL ranged from 45% to 81% (commonly >60%) and event-free survival ranged from 41% to 70% (commonly >50%). Outcome data for AML was patchy with varying duration of follow-up, but it can be inferred that 50–80% of treated patients had experienced an event (toxic death, refractory disease or relapse). It is imperative that going forward focus should be on collaborative efforts, which promote treatment of patients on risk-stratified adapted protocols based on local infrastructure, improvement in supportive care and encourage prospective multi-center clinical trials. PMID:27606304

  13. Total Joint Arthroplasty in Patients with Chronic Renal Disease: Is It Worth the Risk?

    PubMed

    Warth, Lucian C; Pugely, Andrew J; Martin, Christopher T; Gao, Yubo; Callaghan, John J

    2015-09-01

    26-27% of patients with end stage hip and knee arthritis requiring TJR have chronic renal disease. A multi-center, prospective clinical registry was queried for TJA's from 2006 to 2012, and 74,300 cases were analyzed. Renal impairment was quantified using estimated glomerular filtration rate (eGFR) to stratify each patient by stage of CRD (1-5). There was a significantly greater rate of overall complications in patients with moderate to severe CRD (6.1% vs. 7.6%, P<0.001). In those with CRD (Stage 3-5), mortality was twice as high (0.26% vs. 0.48%, P<0.001). Patients with Stage 4 and 5 CRD had a 213% increased risk of any complication (OR 2.13, 95% CI: 1.73-2.62). Surgeons may use these findings to discuss the risk-benefit ratio of elective TJR in patients with CRD. PMID:26122111

  14. Barrett's Esophagus Methylation Profiles — EDRN Public Portal

    Cancer.gov

    We propose a nested case-control study of biomarkers in the setting of BE. By bringing together research institutions with large populations of patients with BE, we will perform a multi-center study of FISH and hypermethylation markers as possible prognostic factors in BE. The centers will select from their cohorts who have progressed to HGD or to adenocarcinoma of the esophagus ("progressors"), and who also donated samples prior to the development of cancer, when their histology was felt to be benign. These subjects will be compared to individuals who have been under endoscopic surveillance, but who have not progressed to HGD or EAC ("non-progressors"). Using this approach, we hope to identify promising markers for risk stratification in BE. We expect to be able to make successful application for a prospective study of markers identified in this case-control study.

  15. Detecting data fabrication in clinical trials from cluster analysis perspective.

    PubMed

    Wu, Xiaoru; Carlsson, Martin

    2011-01-01

    Detecting data fabrication is of great importance in clinical trials. As the role of statisticians in detecting abnormal data patterns has grown, a large number of statistical procedures have been developed, most of which are based on descriptive statistics. Based upon the fact that substantial data fabrication cases have certain clustering structures, this paper discusses the potential for the use of statistical clustering method in fraud detection. Three clustering patterns, angular, neighborhood and repeated measurements clustering, are identified and explored. Correspondingly, simple and efficient test statistics are proposed and randomization tests are carried out. The proposed methods are applied to a 12-week multi-center study for illustration. Extensive simulations are conducted to validate the effectiveness of the procedures. PMID:20936626

  16. Improving cost efficiency in large programs

    NASA Technical Reports Server (NTRS)

    Hodge, John D.

    1994-01-01

    This paper examines the question of cost, from the birth of a program to its conclusion, particularly from the point of view of large multi-center programs, and suggests how to avoid some of the traps and pitfalls. Emphasis is given to cost in the systems engineering process, but there is an inevitable overlap with program management. (The terms systems engineering and program management have never been clearly defined.) In these days of vast Federal budget deficits and increasing overseas competition, it is imperative that we get more for each research and development dollar. This is the only way we will retain our leadership in high technology and, in the long run, our way of life.

  17. The importance of cost considerations in the systems engineering process

    NASA Technical Reports Server (NTRS)

    Hodge, John D.

    1993-01-01

    This paper examines the question of cost, from the birth of a program to its conclusion, particularly from the point of view of large multi-center programs, and suggests how to avoid some of the traps and pitfalls. Emphasis is given to cost in the systems engineering process, but there is an inevitable overlap with program management. (These terms, systems engineering and program management, have never been clearly defined.) In these days of vast Federal budget deficits and increasing overseas competition, it is imperative that we get more for each research and development dollar. This is the only way we will retain our leadership in high technology and, in the long run, our way of life.

  18. Effect of Breastfeeding Duration on Cognitive Development in Infants: 3-Year Follow-up Study

    PubMed Central

    2016-01-01

    We investigated the association between breastfeeding and cognitive development in infants during their first 3 years. The present study was a part of the Mothers’ and Children’s Environmental Health (MOCEH) study, which was a multi-center birth cohort project in Korea that began in 2006. A total of 697 infants were tested at age 12, 24, and 36 months using the Korean version of the Bayley Scales of Infant Development II (K-BSID-II). The use and duration of breastfeeding and formula feeding were measured. The relationship between breastfeeding and the mental development index (MDI) score was analyzed by multiple linear regression analysis. The results indicated a positive correlation between breastfeeding duration and MDI score. After adjusting for covariates, infants who were breastfed for ≥ 9 months had significantly better cognitive development than those who had not been breastfed. These results suggest that the longer duration of breastfeeding improves cognitive development in infants. PMID:27051242

  19. Application of arm support training in sub-acute stroke rehabilitation: first results on effectiveness and user experiences.

    PubMed

    Prange, G B Gerdienke; Kottink, Air Anke; Buurke, J H Jaap; Rietman, J S Hans

    2013-06-01

    A multi-center randomized clinical trial was performed in 7 Dutch rehabilitation centers, in the context of an implementation project (ROBAR), to compare the effect of an arm support (AS) training device to equally intensive conventional reach training (CON) on recovery of arm-hand function in sub-acute stroke. The Fugl-Meyer assessment (FM) and user experiences of therapists and patients were examined in both groups. An improvement of 10 and 8 points on the FM was found for respectively the CON and AS group. Both therapists and patients reported positive experiences on several aspects of user acceptance. These findings indicate that a low-tech system for arm support results in similar gains in arm function as conventional reach training in equal intensity, and is suitable for application in clinical practice. PMID:24187287

  20. Malignant Infiltration of the Liver Presenting as Acute Liver Failure

    PubMed Central

    Rich, Nicole E.; Sanders, Corron; Hughes, Randall S.; Fontana, Robert J.; Stravitz, R. Todd; Fix, Oren; Han, Steven H.; Naugler, Willscott E.; Zaman, Atif; Lee, William M.

    2014-01-01

    There have been few reports of acute liver failure (ALF, with encephalopathy and coagulopathy) due to infiltration of the liver by malignant cells. We describe a case series of 27 patients with ALF caused by malignancy. We examined a large, multi-center ALF registry (1910 patients; mean age, 47.1±13.9 years) and found only 27 cases (1.4%) of ALF attributed to malignancy. Twenty cases (74%) presented with abdominal pain and 11 with ascites. The malignancies included lymphoma or leukemia (33%), breast cancer, (30%), and colon cancer (7%); 90% of the patients with lymphoma or leukemia had no history of cancer, compared to 25% of patients with breast cancer. Overall, 44% of the patients had evidence of liver masses by imaging. Diagnosis was confirmed by biopsy in 15 (55%) and autopsy for 6 cases. Twenty-four patients (89%) died within 3 weeks of ALF. PMID:25277846

  1. Endovascular Treatment of Venous Occlusive Disease

    PubMed Central

    2008-01-01

    Endovascular treatment of acute and chronic iliac vein occlusions has proven to be safe and effective. Recanalization of chronic occlusions with balloon angioplasty and stenting can re-establish normal venous flow in the iliac veins and the IVC and relieve symptoms in the majority of treated patients. CDT with recanalization and stenting of underlying chronically obstructed iliofemoral segments is becoming the treatment of choice for patients with acute iliofemoral thrombosis, as anticoagulation and compression therapy alone are not satisfactory in preventing PTS. The new treatment modalities offer stimulating options for a patient group that is not adequately treated, neither by medical nor open surgical therapy. The substantial effort and additional costs of endovascular treatment appear to be justified by the encouraging mid-term results both for patients with acute and chronic occlusive iliofemoral disease. However, multi-center randomized prospective studies are required to further validate the role of these techniques. PMID:23555345

  2. Resource Prospector Lander: Architecture and Trade Studies

    NASA Technical Reports Server (NTRS)

    Moore, Josh; Calvert, Derek; Frady, Greg; Chavers, Greg; Wayne, Andrew; Hull, Patrick; Lowery, Eric; Farmer, Jeff; Trinh, Huu; Rojdev, Kristina; Piatek, Irene; Ess, Kim; Vitalpur, Sharada; Dunn, Kevin

    2014-01-01

    NASA's Resource Prospector (RP) is a multi-center and multi-institution collaborative project to investigate the polar regions of the Moon in search of volatiles. The mission is rated Class D and is approximately 10 days. The RP vehicle comprises three elements: the Lander, the Rover, and the Payload. The Payload is housed on the Rover and the Rover is on top of the Lander. The focus of this paper is on the Lander element for the RP vehicle. The design of the Lander was requirements driven and focused on a low-cost approach. To arrive at the final configuration, several trade studies were conducted. Of those trade studies, there were six primary trade studies that were instrumental in determining the final design. This paper will discuss each of these trades in further detail and show how these trades led to the final architecture of the RP Lander.

  3. Coordinating centers and multi-practice-based research network (PBRN) research.

    PubMed

    Mold, James W; Lipman, Paula Darby; Durako, Stephen J

    2012-01-01

    Practice-based research networks (PBRNs) have emerged as laboratories in which to address important primary care challenges. In 2011, the Agency for Healthcare Research and Quality's PBRN database included more than 130 networks, most regional and some national, with member practices in every state. Regional networks may have certain advantages over national networks with respect to practice recruitment and project quality control because of closer relationships and shorter distances. However, national networks often can achieve larger numbers of practices with greater diversity, resulting in broader generalizability of results. Increasingly, regional networks are collaborating on multinetwork projects, but this creates significant study coordination challenges. A potential solution is to incorporate PBRN coordinating centers similar to those used in many National Institutes of Health and industry-sponsored multi-center clinical trials. In this article, we discuss the potential functions of a coordinating center in multi-region PBRN studies based on our experience with 2 recent studies. PMID:22956693

  4. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide)

    NASA Astrophysics Data System (ADS)

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-01

    A coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil-globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations.

  5. A mini-review on factors and countermeasures associated with false-negative sentinel lymph node biopsies in breast cancer

    PubMed Central

    Han, Chao; Yang, Li

    2016-01-01

    Sentinel lymph node biopsy (SLNB) is a new surgical technique for local axillary lymph nodes (ALNs) of breast cancer. Large-scale clinical trials have confirmed that undergoing SLNB and ALN dissection (ALND) showed no significant difference for sentinel lymph node (SLN)-negative patients in terms of disease-free survival, overall survival and recurrence-free survival. However, false-negative results are still the main concern of physicians as well as patients who undergo SLNB instead of ALND. The American Society of Breast Surgeons established a task force to suggest acceptable standards for SLNB. In 2000, the task force recommended that the identification rate for SLNB be 85% or higher and the false-negative rate be 5% or lower. This review focuses on clinical factors (tumor volume, multifocal/multi-center cancers, neoadjuvant chemotherapy and skip metastasis), tracer techniques and pathological factors affecting SLNB and explores methods for reducing the false-negative rate PMID:27478323

  6. Five-dimensional null and time-like supersymmetric geometries

    NASA Astrophysics Data System (ADS)

    Pasini, Giulio; Shahbazi, C. S.

    2016-09-01

    We show that there exist supersymmetric solutions of five-dimensional, pure, { N }=1 supergravity such that the norm of the supersymmetric Killing vector, built out of the Killing spinor, is a real not-everywhere analytic function such that all its derivatives vanish at a point where the Killing vector field becomes null. The norm of the Killing vector field then is not an analytic function on a neighborhood around this point. We explicitly construct such solutions by using a multi-center Gibbons–Hawking base. Although many of these solutions have infinite charges, we find explicit examples with finite charges that asymptote to {{AdS}}3× {S}2 and discuss their physical interpretation.

  7. Cognitive Determinants of Academic Performance in Nigerian Pharmacy Schools.

    PubMed

    Ubaka, Chukwuemeka M; Sansgiry, Sujit S; Ukwe, Chinwe V

    2015-09-25

    Objective. To evaluate cognitive factors that might influence academic performance of students in Nigerian pharmacy schools. Methods. A cross-sectional, multi-center survey of Nigerian pharmacy students from 7 schools of pharmacy was conducted using 2 validated questionnaires measuring cognitive constructs such as test anxiety, academic competence, test competence, time management, and strategic study habits. Results. Female students and older students scored significantly better on time management skills and study habits, respectively. Test anxiety was negatively associated with academic performance while test competence, academic competence, and time management were positively associated with academic performance. These 4 constructs significantly discriminated between the lower and higher performing students, with the first 2 contributing to the most differences. Conclusion. Test and academic competence, test anxiety, and time management were significant factors associated with low and high academic performance among Nigerian pharmacy students. The study also demonstrated the significant effects of age, gender, and marital status on these constructs. PMID:27168614

  8. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide).

    PubMed

    Abbott, Lauren J; Stevens, Mark J

    2015-12-28

    A coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil-globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations. PMID:26723705

  9. Is the copper T 380A device associated with an increased risk of removal due to bleeding and/or pain? An analysis.

    PubMed

    Chi, I C; Farr, G; Thompson, K; Acosta, M; Alvarado, G; Rivera, R; Bandaragoda, J; Delgado Betancourt, J

    1990-08-01

    Previous studies have consistently shown that the family of the Copper T 380 devices is more effective in preventing accidental pregnancies than the inert, as well as most other, if not all, copper devices. However, a number of these studies also reported a higher removal rate due to bleeding and/or pain for the TCu 380A than for other devices. The programmatical importance of these findings prompted us to analyze the international multi-center randomized clinical trial datasets to examine this question on the new TCu 380A (ParaGard) recently marketed in the U.S. Our results, while confirming the inherent superior efficacy of the TCu 380A, did not reveal a significantly higher removal rate because of bleeding and/or pain among TCu 380A users than among users of the comparative devices, which included the Lippes Loop D, the TCu 200, the TCu 220 and the Multiload Cu 250 devices. PMID:2085967

  10. Genre Complexes in Popular Music.

    PubMed

    Silver, Daniel; Lee, Monica; Childress, C Clayton

    2016-01-01

    Recent work in the sociology of music suggests a declining importance of genre categories. Yet other work in this research stream and in the sociology of classification argues for the continued prevalence of genres as a meaningful tool through which creators, critics and consumers focus their attention in the topology of available works. Building from work in the study of categories and categorization we examine how boundary strength and internal differentiation structure the genre pairings of some 3 million musicians and groups. Using a range of network-based and statistical techniques, we uncover three musical "complexes," which are collectively constituted by 16 smaller genre communities. Our analysis shows that the musical universe is not monolithically organized but rather composed of multiple worlds that are differently structured-i.e., uncentered, single-centered, and multi-centered. PMID:27203852

  11. Adrenocortical Tumors and Hyperplasias in Childhood - Etiology, Genetics, Clinical Presentation and Therapy

    PubMed Central

    Sutter, Jennifer A.; Grimberg, Adda

    2007-01-01

    Adrenocortical tumors are rare in children and are associated with a poor prognosis when malignant. The fund of knowledge regarding etiology, presentation and clinical outcomes remains limited. Evaluation of genetic disorders associated with the development of adrenocortical disorders has allowed researchers to identify a number of mutations that may be involved in tumorigenesis, including alterations in the GNAS1, PRKAR1A, TP53 and IGF2 genes. Clinical presentation in children is associated most commonly with young age, female gender and symptoms of virilization. Most children have localized disease at presentation which may be associated with a better prognosis when compared to adults. Surgical resection remains the only potentially curative treatment and mitotane, the most frequently used chemotherapeutic agent, has a poor response rate and is highly toxic. Broader participation in multi-center research, such as the International Pediatric Adrenocortical Tumor Registry, is needed to collect sufficient data to better guide our clinical management. PMID:17021581

  12. Human Trials of a 2-Hour Prebreathe Protocol

    NASA Technical Reports Server (NTRS)

    Butler, Bruce D.; Vann, R. D.; Nishi, Ronald Y.; Gerth, W. A.; Beltran, E.; Conkin, J.; Schneider, Suzanne; Loftin, K. C.; Sullivan, Pat A.; Homick, Jerry L. (Technical Monitor)

    2000-01-01

    We evaluate 2-hour prebreathe protocols combining simulated microgravity and exercise during prebreathe with the objective of validating a protocol for use on International Space Station (ISS). The protocol was tested with four different exercise doses during prebreathe in a multi-center trial involving three laboratories. Subject selection, Doppler monitoring techniques for venous gas emboli (VGE), test termination criteria, and definitions of decompression sickness (DCS) were standardized in all laboratories. The Phase II protocol met the accept criteria for a prebreathe procedure for use by astronauts during assembly and maintenance of the ISS Dual-cycle ergometry or light exercise individually was not sufficient to protect against DCS at acceptable levels. The combination of both was successful.

  13. CARs in Chronic Lymphocytic Leukemia – Ready to Drive

    PubMed Central

    Wierda, William; Jena, Bipulendu; Cooper, Laurence J. N.; Shpall, Elizabeth

    2013-01-01

    Adoptive transfer of antigen-specific T cells has been adapted by investigators for treatment of chronic lymphocytic leukemia (CLL). To overcome issues of immune tolerance which limits the endogenous adaptive immune response to tumor-associated antigens (TAAs), robust systems for the genetic modification and characterization of T cells expressing chimeric antigen receptors (CARs) to redirect specificity have been produced. Refinements with regards to persistence and trafficking of the genetically modified T cells are underway to help improve potency. Clinical trials utilizing this technology demonstrate feasibility, and increasingly, these early-phase trials are demonstrating impressive anti-tumor effects, particularly for CLL patients, paving the way for multi-center trials to establish the efficacy of CAR+ T cell therapy. PMID:23225251

  14. It Gets Better: Resolution of Internalized Homophobia over Time and Associations with Positive Health Outcomes among MSM

    PubMed Central

    Herrick, Amy L.; Stall, Ron; Chmiel, Joan S.; Guadamuz, Thomas E.; Penniman, Typhanye; Shoptaw, Steven; Ostrow, David; Plankey, Michael w.

    2013-01-01

    Health disparities research among gay and bisexual men has focused primarily on risk and deficits. However, a focus on resiliencies within this population may greatly benefit health promotion. We describe a pattern of resilience (internalized homophobia (IHP) resolution) over the life-course and its associations with current health outcomes. 1,541 gay and bisexual men from the Multi-Center AIDS Cohort study, an ongoing prospective study of the natural and treated histories of HIV, completed a survey about life-course events thought to be related to health. The majority of men resolved IHP over time independent of demographics. Men who resolved IHP had significantly higher odds of positive health outcomes compared to those who did not. These results provide evidence of resilience among participants that is associated with positive health outcomes. Understanding resiliencies and incorporating them into interventions may help to promote health and well-being among gay and bisexual men. PMID:23283578

  15. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, Walter T.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525962

  16. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used. PMID:25532410

  17. Numerical Modeling of Impact Initiation of High Explosives

    SciTech Connect

    Wu, C J; Piggott, T; Yoh, J; Reaugh, J

    2006-05-31

    We performed continuum mechanics simulations to examine the behavior of energetic materials in Ballistic Chamber Impact (BIC) experiments, using an Arbitrary Lagrangian-Eulerian code (ALE3D). Our simulations revealed that interface friction plays an important role in inducing the formation of shear bands, which result in 'hot spots' for ignition. The temperature localization during BIC impact was found to be significant in materials with high yield strength. In those materials, there are multiple locations inside shear bands can achieve temperatures exceeding the threshold temperature for reaction. In addition, we investigated the relevant parameters influencing the pressure profile of a BIC test by numerical analysis from a simple phenomenological model. To our surprise, we found that the peaks of BIC pressure profiles not only can be a result of multi-center chemical reactions, but can also arise from factors associated apparatus configuration.

  18. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects’ disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525849

  19. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide)

    SciTech Connect

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-28

    A coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations.

  20. Cognitive Determinants of Academic Performance in Nigerian Pharmacy Schools

    PubMed Central

    Sansgiry, Sujit S.; Ukwe, Chinwe V.

    2015-01-01

    Objective. To evaluate cognitive factors that might influence academic performance of students in Nigerian pharmacy schools. Methods. A cross-sectional, multi-center survey of Nigerian pharmacy students from 7 schools of pharmacy was conducted using 2 validated questionnaires measuring cognitive constructs such as test anxiety, academic competence, test competence, time management, and strategic study habits. Results. Female students and older students scored significantly better on time management skills and study habits, respectively. Test anxiety was negatively associated with academic performance while test competence, academic competence, and time management were positively associated with academic performance. These 4 constructs significantly discriminated between the lower and higher performing students, with the first 2 contributing to the most differences. Conclusion. Test and academic competence, test anxiety, and time management were significant factors associated with low and high academic performance among Nigerian pharmacy students. The study also demonstrated the significant effects of age, gender, and marital status on these constructs. PMID:27168614

  1. Development of a Prototype Automation Simulation Scenario Generator for Air Traffic Management Software Simulations

    NASA Technical Reports Server (NTRS)

    Khambatta, Cyrus F.

    2007-01-01

    A technique for automated development of scenarios for use in the Multi-Center Traffic Management Advisor (McTMA) software simulations is described. The resulting software is designed and implemented to automate the generation of simulation scenarios with the intent of reducing the time it currently takes using an observational approach. The software program is effective in achieving this goal. The scenarios created for use in the McTMA simulations are based on data taken from data files from the McTMA system, and were manually edited before incorporation into the simulations to ensure accuracy. Despite the software s overall favorable performance, several key software issues are identified. Proposed solutions to these issues are discussed. Future enhancements to the scenario generator software may address the limitations identified in this paper.

  2. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide)

    DOE PAGESBeta

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-22

    In this study, a coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomisticmore » simulations.« less

  3. Evaluation of oral care to prevent oral mucositis in estrogen receptor-positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): randomized controlled phase III trial.

    PubMed

    Niikura, Naoki; Ota, Yoshihide; Hayashi, Naoki; Naito, Mariko; Kashiwabara, Kosuke; Watanabe, Ken-Ichi; Yamashita, Toshinari; Mukai, Hirofumi; Umeda, Masahiro

    2016-09-01

    This is a randomized, multi-center, open-label, phase III study to evaluate the efficacy of professional oral care in preventing oral mucositis induced by everolimus in postmenopausal estrogen receptor-positive metastatic breast cancer. Patients will be randomized into professional oral care and control groups (1:1 ratio). All patients will receive everolimus with exemestane and will continue everolimus until disease progression. In the professional oral care group, patients will receive teeth surface cleaning, scaling and tongue cleaning before starting everolimus, and will continue to receive professional oral care weekly from oral surgeons throughout the 8 week treatment. In the control group, patients will brush their own teeth and gargle with 0.9% sodium chloride solution or water. The primary endpoint is the incidence of all grades of oral mucositis. Target accrual is 200 patients with a two-sided type I error rate of 5% and 80% power to detect 25% risk reduction. PMID:27365521

  4. An update on stem cell transplantation in autoimmune rheumatologic disorders.

    PubMed

    Mascarenhas, Sheryl; Avalos, Belinda; Ardoin, Stacy P

    2012-12-01

    Stem cell transplant (SCT) has long been the standard of care for several hematologic, immunodeficient, and oncologic disorders. Recently, SCT has become an increasingly utilized therapy for refractory autoimmune rheumatologic disorders (ARDs). The efficacy of SCT in ARDs has been attributed to resetting an aberrant immune system either through direct immune replacement with hematopoietic stem cells or through immunomodulation with mesenchymal stem cells. Among ARDs, refractory systemic sclerosis (SSc) and systemic lupus erythematosus (SLE) are the most common indications for SCT. SCT has also been used in refractory rheumatoid arthritis, inflammatory myopathies, antiphospholipid syndrome, granulomatosis with polyangiitis, and pediatric ARDs. Complete responses have been reported in approximately 30 % of patients in all disease categories. Transplant-related mortality, however, remains a concern. Future large multi-center prospective randomized clinical trials will help to better define the specific role of SCT in the treatment of patients with ARDs. PMID:22956390

  5. Atomic Gaussian type orbitals and their Fourier transforms via the Rayleigh expansion

    NASA Astrophysics Data System (ADS)

    Yükçü, Niyazi

    2016-03-01

    Gaussian type orbitals (GTOs), which are one of the types of exponential type orbitals (ETOs), are used usually as basis functions in the multi-center atomic and molecular integrals to better understand physical and chemical properties of matter. In the Fourier transform method (FTM), basis functions have not simplicity to make mathematical operations, but their Fourier transforms are easier to use. In this work, with the help of FTM, Rayleigh expansion and some properties of unnormalized GTOs, we present new mathematical results for the Fourier transform of GTOs in terms of Laguerre polynomials, hypergeometric and Whittaker functions. Physical and analytical properties of GTOs are discussed and some numerical results have been given in a table. Finally, we compare our mathematical results with the other known literature results by using a computer program and details of evaluation are presented.

  6. Perceived Benefits, Harms, and Views About How to Share Data Responsibly

    PubMed Central

    Tangseefa, Decha; Somsaman, Aimatcha; Chunsuttiwat, Tri; Nosten, François; Day, Nicholas P. J.; Bull, Susan; Parker, Michael

    2015-01-01

    The Thailand Major Overseas Programme coordinates large multi-center studies in tropical medicine and generates vast amounts of data. As the data sharing movement gains momentum, we wanted to understand attitudes and experiences of relevant stakeholders about what constitutes good data sharing practice. We conducted 15 interviews and three focus groups discussions involving 25 participants and found that they generally saw data sharing as something positive. Data sharing was viewed as a means to contribute to scientific progress and lead to better quality analysis, better use of resources, greater accountability, and more outputs. However, there were also important reservations including potential harms to research participants, their communities, and the researchers themselves. Given these concerns, several areas for discussion were identified: data standardization, appropriate consent models, and governance. PMID:26297749

  7. The Lunar Environment: Determining the Health Effects of Exposure to Moon Dusts

    NASA Technical Reports Server (NTRS)

    Khan-Mayberry, Noreen

    2007-01-01

    The moon's surface is covered with a thin layer of fine, charged, reactive dust capable of layer of fine, charged, reactive dust capable of capable of entering habitats and vehicle compartments, where it can result in crewmember health problems. NASA formed the Lunar Airborne Dust Toxicity Advisory Group (LADTAG) to study the effects of exposure to Lunar Dust on human health. To date, no scientifically defensible toxicological studies have been performed on lunar dusts, specifically the determination of exposure limits and their affect on human health. The multi-center LADTAG (Lunar Airborne Dust Toxicology center LADTAG (Lunar Airborne Dust Toxicology Advisory Group) was formed in response to the Office of the Chief Health and Medical Office s (OCHMO) request to develop recommendations for defining risk (OCHMO) request to develop recommendations for defining risk defining risk criteria for human lunar dust exposure.

  8. Giant malignant phyllodes tumor of the breast: A rare case report and literature review

    PubMed Central

    LIU, MIN; YANG, SHUO; LIU, BIN; GUO, LIANG; BAO, XUEYING; LIU, BAILONG; DONG, LIHUA

    2016-01-01

    Malignant phyllodes tumor of the breast (MPTB) is rarely encountered in clinical practice. Preoperative diagnosis is challenging due to nonspecific radiological and histological features, and the prognostic factors and optimal treatment remain controversial. The current report describes the case of a middle-aged female with giant MPTB who underwent multidisciplinary intervention, including surgery, postoperative chemotherapy and radiotherapy. To date, the disease-free survival (DFS) of the patient has reached 18 months. Furthermore, a related literature review summarize the clinicopathological characteristics and treatment progress regarding MPTB is presented, along with an analysis of the indications for therapeutic strategy in the current case. In the future, multi-center clinical trials must be initiated to identify the criteria for diagnosis and optimal treatment consensus for MPTB. In conclusion, the present case highlights that multidisciplinary management may contribute to DFS following the treatment of giant MPTB. PMID:27347111

  9. [Comparative multicenter study of carteolol eyedrops with other beta blockers in 768 patients under normal conditions].

    PubMed

    Schnarr, K D

    1988-02-01

    In an open multi-center study involving 768 patients the efficacy and tolerability of Carteolol eye drops as compared to other beta blockers were investigated. The patients started to use the new medication without a prior washout period. In patients who were well stabilized (57%), IOP either did not change when the medication was switched to Carteolol (73%) or it actually decreased. In 78% of the patients who had not responded altogether satisfactorily to the pretreatment, Carteolol eye drops lowered IOP to a tolerable level of 21 mm Hg or less without using any comedication. IOP remained hypertonic under Carteolol in only 19% of the cases. Fewer systemic and local side effects were observed under Carteolol therapy. Patients had fewer problems going upstairs. Burning after installation decreased by 25% to 2%. Even fluorescein-positive corneal findings almost completely disappeared under Carteolol. PMID:2896266

  10. A combined pre-clinical meta-analysis and randomized confirmatory trial approach to improve data validity for therapeutic target validation

    PubMed Central

    Kleikers, Pamela WM.; Hooijmans, Carlijn; Göb, Eva; Langhauser, Friederike; Rewell, Sarah SJ.; Radermacher, Kim; Ritskes-Hoitinga, Merel; Howells, David W.; Kleinschnitz, Christoph; HHW Schmidt, Harald

    2015-01-01

    Biomedical research suffers from a dramatically poor translational success. For example, in ischemic stroke, a condition with a high medical need, over a thousand experimental drug targets were unsuccessful. Here, we adopt methods from clinical research for a late-stage pre-clinical meta-analysis (MA) and randomized confirmatory trial (pRCT) approach. A profound body of literature suggests NOX2 to be a major therapeutic target in stroke. Systematic review and MA of all available NOX2-/y studies revealed a positive publication bias and lack of statistical power to detect a relevant reduction in infarct size. A fully powered multi-center pRCT rejects NOX2 as a target to improve neurofunctional outcomes or achieve a translationally relevant infarct size reduction. Thus stringent statistical thresholds, reporting negative data and a MA-pRCT approach can ensure biomedical data validity and overcome risks of bias. PMID:26310318

  11. Light-induced fluorescence endoscopy (LIFE) imaging system for early cancer detection

    NASA Astrophysics Data System (ADS)

    Zeng, Haishan; MacAulay, Calum E.; Lam, Stephen; Palcic, Branko

    1999-09-01

    This paper summarizes our experiences on the development of a Light Induced Fluorescence Endoscopy (LIFE) imaging system for early cancer detection in the respiratory and gastrointestinal tract. The system utilizes tissue autofluorescence to provide real time video imaging of the examined organ. No exogenous fluorescent tumor markers are needed. It is used by a physician in adjunct to conventional white-light endoscopy. Suspicious areas are identified in pseudo color to guide biopsy. A multi- center clinical trial has demonstrated that in the lung, the relative sensitivity of white-light imaging + LIFE imaging vs. white-light imaging alone was 6.3 for intraepithelial neoplastic lesion detection and 2.71 when invasive carcinomas were also included. The following issues will be discussed: (1) spectroscopy study design for imaging system development; (2) architecture of the imaging systems; (3) different imaging modalities (white-light imaging, dual channel fluorescence imaging, and combined fluorescence/reflectance imaging); and (4) clinical applications.

  12. Florbetapir (F18-AV-45) PET to assess amyloid burden in Alzheimer’s disease dementia, mild cognitive impairment, and normal aging

    PubMed Central

    Johnson, KA; Sperling, RA; Gidicsin, C; Carmasin, J; Maye, J; Coleman, RE; Reiman, EM; Sabbagh, MN; Sadowsky, CH; Fleisher, AS; Doraiswamy, PM; Carpenter, AP; Clark, CM; Joshi, AD; Lu, M; Grundman, M; Mintun, MA; Pontecorvo, MJ; Skovronsky, DM

    2013-01-01

    Objective To evaluate the performance characteristics of florbetapir F 18 PET in patients with Alzheimer’s disease dementia (AD), mild cognitive impairment (MCI) and healthy control subjects (HC). Methods Florbetapir PET was acquired in 184 subjects (45 AD, 60 MCI, and 79 HC) within a multi-center phase 2 study. Amyloid burden was assessed visually and quantitatively and classified as positive or negative. Results Florbetapir PET was visually rated amyloid positive in 76% of AD, 38% of MCI and 14% of HC. 84% of AD, 42% of MCI, and 23% of HC were classified as amyloid positive using a quantitative threshold. Amyloid positivity and mean cortical amyloid burden were associated with age and APOE ε4 carrier status. Interpretation The data are consistent with expected rates of amyloid positivity among individuals with clinical diagnoses of AD and MCI, and indicate potential value of florbetapir F 18 PET as an adjunct to clinical diagnosis. PMID:23375563

  13. The USA Multicenter Prehosptial Hemoglobin -based Oxygen Carrier Resuscitation Trial: Scientific Rationale, Study Design, and Results

    PubMed Central

    Moore, Ernest E.; Johnson, Jeffrey L.; Moore, Frederick A.; Moore, Hunter B.

    2013-01-01

    The current generation of blood substitutes tested in clinical trials are red blood cell (RBC) substitutes; that is, they are designed primarily to transport oxygen. The products now being used in advanced-phase clinical trials are derived from hemoglobin (Hb) and are thus often referred to as Hb-based oxygen carriers (HBOCs). The potential benefits of HBOCs are well known (Box 1). The objectives of this overview are to provide the scientific background and rationale for the study design of the USA Multi-center Prehospital HBOC Resuscitation Trial and to present the results and discuss clinical implications. Box 1Potential clinical benefits of hemoglobin-based oxygen carriers in trauma careAvailabilityAbundant supplyUniversally compatibleProlonged shelf-lifeStorage at room temperatureSafetyNo disease transmissionsNo antigenic reactionsNo immunologic effectsEfficacyEnhanced oxygen deliveryImproved rheologic properties PMID:19341912

  14. Progress in the understanding and utilization of biologic response modifiers in the treatment of uveitis.

    PubMed

    Maleki, Arash; Meese, Halea; Sahawneh, Haitham; Foster, C Stephen

    2016-07-01

    Uveitis is the third most common cause of blindness in developed countries. Considering the systemic and local complications of long-term corticosteroid therapy and the intolerance due to side effects and ineffectiveness of conventional chemotherapy, use of biologic response modifiers is a reasonable alternative in the treatment of non-infectious uveitis and persistent uveitic macular edema. The majority of the evidence presented here comes from open uncontrolled analyses. Based on these studies, tumor necrosis factor alpha inhibitors, especially infliximab and adalimumab, have been shown to be effective in the treatment of non-infectious uveitis in numerous studies. More research is necessary, particularly multi-center randomized clinical trials, to address the choice of biologic response modifier agent and the length of treatment as we employ biologic response modifiers in different types of uveitis and persistent uveitic macular edema. PMID:26972783

  15. Vertical Aerosol Backscatter Variability from an Airborne Focused Continuous Wave CO2 Lidar

    NASA Technical Reports Server (NTRS)

    Jarzembski, Maurice A.; Srivastava, Vandana; Rothermel, Jeffry

    1998-01-01

    Atmospheric aerosol backscatter measurements using a continuous wave focused Doppler lidar at 9.1 micron wavelength were obtained over western North America and the Pacific Ocean during 13 - 26 September, 1995 as part of National Aeronautics and Space Administration's (NASA) Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) mission on board the NASA DC8 aircraft. Backscatter variability was measured for approximately 52 flight hours, covering equivalent horizontal distance of approximately 25,000 km in the troposphere. Quasi-vertical backscatter profiles were also obtained during various ascents and descents which ranged between approximately 0.1 to 12.0 km altitude. Aerosol haze layers were encountered at different altitudes. Similarities and differences for aerosol loading over land and over ocean were observed. A mid-tropospheric aerosol backscatter background mode was found with modal value approximately 1O(exp -10)/m/sr, consistent with previous airborne and ground-based datasets.

  16. Clinical Microfluidics for Neutrophil Genomics and Proteomics

    PubMed Central

    Kotz, Kenneth T.; Xiao, Wenzong; Miller-Graziano, Carol; Qian, Wei-Jun; Russom, Aman; Warner, Elizabeth A.; Moldawer, Lyle L.; De, Asit; Bankey, Paul E.; Petritis, Brianne O.; Camp, David G.; Rosenbach, Alan E.; Goverman, Jeremy; Fagan, Shawn P.; Brownstein, Bernard H.; Irimia, Daniel; Xu, Weihong; Wilhelmy, Julie; Mindrinos, Michael N.; Smith, Richard D.; Davis, Ronald W.; Tompkins, Ronald G.; Toner, Mehmet

    2010-01-01

    Neutrophils play critical roles in modulating the immune response. We present a robust methodology for rapidly isolating neutrophils directly from whole blood and develop ‘on-chip’ processing for mRNA and protein isolation for genomics and proteomics. We validate this device with an ex vivo stimulation experiment and by comparison with standard bulk isolation methodologies. Lastly, we implement this tool as part of a near patient blood processing system within a multi-center clinical study of the immune response to severe trauma and burn injury. The preliminary results from a small cohort of patients in our study and healthy controls show a unique time-dependent gene expression pattern clearly demonstrating the ability of this tool to discriminate temporal transcriptional events of neutrophils within a clinical setting. PMID:20802500

  17. Theoretical study of the magnetic exchange interaction in catena-μ- Tris[oxalato(2-)-O 1,O 2;O 3,O 4]-dicopper complex with interlocked helical chains

    NASA Astrophysics Data System (ADS)

    Negodaev, Igor; Queralt, Núria; Caballol, Rosa; Graaf, Coen de

    2011-01-01

    The coupling of the spin moments has been studied in an oxalato-based 3D extended structure with Cu(II) ions as magnetic sites. The ab initio calculations reveal that two of the three different magnetic interaction paths are characterized by a strong coupling, while the third one presents weaker interaction. Based on these calculated values, the magnetic topology of the material is determined as an alternating chain with weak interchain coupling. A theoretical estimate of the temperature dependence of the magnetic susceptibility is derived from the diagonalization of the Heisenberg Hamiltonian for a multi-center magnetic model with boundary conditions. The theoretical procedure can serve as guide in an experimental determination of the magnetic coupling parameters in 3D extended structure with oxalato-bridges as found in the hexagonal layers of the bifunctional materials.

  18. Most Probable Number Rapid Viability PCR Method to Detect Viable Spores of Bacillus anthracis in Swab Samples

    SciTech Connect

    Letant, S E; Kane, S R; Murphy, G A; Alfaro, T M; Hodges, L; Rose, L; Raber, E

    2008-05-30

    This note presents a comparison of Most-Probable-Number Rapid Viability (MPN-RV) PCR and traditional culture methods for the quantification of Bacillus anthracis Sterne spores in macrofoam swabs generated by the Centers for Disease Control and Prevention (CDC) for a multi-center validation study aimed at testing environmental swab processing methods for recovery, detection, and quantification of viable B. anthracis spores from surfaces. Results show that spore numbers provided by the MPN RV-PCR method were in statistical agreement with the CDC conventional culture method for all three levels of spores tested (10{sup 4}, 10{sup 2}, and 10 spores) even in the presence of dirt. In addition to detecting low levels of spores in environmental conditions, the MPN RV-PCR method is specific, and compatible with automated high-throughput sample processing and analysis protocols.

  19. Acute leukemia in children: A review of the current Indian data.

    PubMed

    Arora, Ramandeep Singh; Arora, Brijesh

    2016-01-01

    Acute leukemias are the most common diagnostic group of childhood cancer. This review summarizes the published literature on reported current outcomes of childhood acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) from India. Overall survival in ALL ranged from 45% to 81% (commonly >60%) and event-free survival ranged from 41% to 70% (commonly >50%). Outcome data for AML was patchy with varying duration of follow-up, but it can be inferred that 50-80% of treated patients had experienced an event (toxic death, refractory disease or relapse). It is imperative that going forward focus should be on collaborative efforts, which promote treatment of patients on risk-stratified adapted protocols based on local infrastructure, improvement in supportive care and encourage prospective multi-center clinical trials. PMID:27606304

  20. Confirmatory Factor Analysis of the ADNI Neuropsychological Battery

    PubMed Central

    Park, Lovingly Quitania; Gross, Alden L.; McLaren, Donald; Pa, Judy; Johnson, Julene K.; Mitchell, Meghan; Manly, Jennifer J.

    2012-01-01

    The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a large multi-center study designed to develop optimized methods for acquiring longitudinal neuroimaging, cognitive, and biomarker measures of AD progression in a large cohort of patients with Alzheimer’s disease (AD), patients with mild cognitive impairment, and healthy controls. Detailed neuropsychological testing was conducted on all participants. We examined the factor structure of the ADNI Neuropsychological Battery across older adults with differing levels of clinical AD severity based on the Clinical Dementia Rating Scale (CDR). Confirmatory factor analysis (CFA) of 23 variables from 10 neuropsychological tests resulted in five factors (memory, language, visuospatial functioning, attention, and executive function/processing speed) that were invariant across levels of cognitive impairment. Thus, these five factors can be used as valid indicators of cognitive function in older adults who are participants in ADNI. PMID:22777078

  1. Framework design and development of an informatics architecture for a systems biology approach to traumatic brain injury

    NASA Astrophysics Data System (ADS)

    Alaoui, Adil; Kim, Dongkyu; Levine, Betty; Cleary, Kevin; Federoff, Howard J.; Mhyre, Timothy

    2010-03-01

    Traumatic Brain Injury (TBI) is a problem of major medical and socioeconomic significance, although the pathogenesis of its sequelae is not completely understood. As part of a large, multi-center project to study mild and moderate TBI, a database and informatics system to integrate a wide-range of clinical, biological, and imaging data is being developed. This database constitutes a systems-based approach to TBI with the goals of developing and validating biomarker panels that might be used to diagnose brain injury, predict clinical outcome, and eventually develop improved therapeutics. This paper presents the architecture for an informatics system that stores the disparate data types and permits easy access to the data for analysis.

  2. Eigen model with general fitness functions and degradation rates

    NASA Astrophysics Data System (ADS)

    Hu, Chin-Kun; Saakian, David B.

    2006-03-01

    We present an exact solution of Eigen's quasispecies model with a general degradation rate and fitness functions, including a square root decrease of fitness with increasing Hamming distance from the wild type. The found behavior of the model with a degradation rate is analogous to a viral quasi-species under attack by the immune system of the host. Our exact solutions also revise the known results of neutral networks in quasispecies theory. To explain the existence of mutants with large Hamming distances from the wild type, we propose three different modifications of the Eigen model: mutation landscape, multiple adjacent mutations, and frequency-dependent fitness in which the steady state solution shows a multi-center behavior.

  3. Effect of Breastfeeding Duration on Cognitive Development in Infants: 3-Year Follow-up Study.

    PubMed

    Lee, Hyungmin; Park, Hyewon; Ha, Eunhee; Hong, Yun-Chul; Ha, Mina; Park, Hyesook; Kim, Bung-Nyun; Lee, Boeun; Lee, Soo-Jeong; Lee, Kyung Yeon; Kim, Ja Hyeong; Jeong, Kyoung Sook; Kim, Yangho

    2016-04-01

    We investigated the association between breastfeeding and cognitive development in infants during their first 3 years. The present study was a part of the Mothers' and Children's Environmental Health (MOCEH) study, which was a multi-center birth cohort project in Korea that began in 2006. A total of 697 infants were tested at age 12, 24, and 36 months using the Korean version of the Bayley Scales of Infant Development II (K-BSID-II). The use and duration of breastfeeding and formula feeding were measured. The relationship between breastfeeding and the mental development index (MDI) score was analyzed by multiple linear regression analysis. The results indicated a positive correlation between breastfeeding duration and MDI score. After adjusting for covariates, infants who were breastfed for ≥ 9 months had significantly better cognitive development than those who had not been breastfed. These results suggest that the longer duration of breastfeeding improves cognitive development in infants. PMID:27051242

  4. The randomized shortened dental arch study: tooth loss.

    PubMed

    Walter, M H; Weber, A; Marré, B; Gitt, I; Gerss, J; Hannak, W; Hartmann, S; Heydecke, G; Huppertz, J; Jahn, F; Ludwig, A; Mundt, T; Kern, M; Klein, V; Pospiech, P; Stumbaum, M; Wolfart, S; Wöstmann, B; Busche, E; Böning, K; Luthardt, R G

    2010-08-01

    The evidence concerning the management of shortened dental arch (SDA) cases is sparse. This multi-center study was aimed at generating data on outcomes and survival rates for two common treatments, removable dental prostheses (RDP) for molar replacement or no replacement (SDA). The hypothesis was that the treatments lead to different incidences of tooth loss. We included 215 patients with complete molar loss in one jaw. Molars were either replaced by RDP or not replaced, according to the SDA concept. First tooth loss after treatment was the primary outcome measure. This event occurred in 13 patients in the RDP group and nine patients in the SDA group. The respective Kaplan-Meier survival rates at 38 months were 0.83 (95% CI: 0.74-0.91) in the RDP group and 0.86 (95% CI: 0.78-0.95) in the SDA group, the difference being non-significant. PMID:20400723

  5. Dissociative electron attachment studies on acetone

    SciTech Connect

    Prabhudesai, Vaibhav S. Tadsare, Vishvesh; Ghosh, Sanat; Gope, Krishnendu; Davis, Daly; Krishnakumar, E.

    2014-10-28

    Dissociative electron attachment (DEA) to acetone is studied in terms of the absolute cross section for various fragment channels in the electron energy range of 0–20 eV. H{sup −} is found to be the most dominant fragment followed by O{sup −} and OH{sup −} with only one resonance peak between 8 and 9 eV. The DEA dynamics is studied by measuring the angular distribution and kinetic energy distribution of fragment anions using Velocity Slice Imaging technique. The kinetic energy and angular distribution of H{sup −} and O{sup −} fragments suggest a many body break-up for the lone resonance observed. The ab initio calculations show that electron is captured in the multi-centered anti-bonding molecular orbital which would lead to a many body break-up of the resonance.

  6. Electroencephalographic Monitoring in Critically Ill Children: Current Practice and Implications for Future Study Design

    PubMed Central

    Sánchez, Sarah M; Arndt, Daniel H.; Carpenter, Jessica L.; Chapman, Kevin E; Cornett, Karen M.; Dlugos, Dennis J.; Gallentine, William B.; Giza, Christopher C; Goldstein, Joshua L; Hahn, Cecil D; Lerner, Jason T; Loddenkemper, Tobias; Matsumoto, Joyce H; McBain, Kristin; Nash, Kendall B; Payne, Eric; Sánchez Fernández, Iván; Shults, Justine; Williams, Korwyn; Yang, Amy; Abend, Nicholas S.

    2014-01-01

    Purpose Survey data indicate that continuous EEG (CEEG) monitoring is used with increasing frequency to identify electrographic seizures in critically ill children, but studies of current CEEG practice have not been conducted. We aimed to describe the clinical utilization of CEEG in critically ill children at tertiary care hospitals with a particular focus on variables essential for designing feasible prospective multi-center studies evaluating the impact of electrographic seizures on outcome. Methods Eleven North American centers retrospectively enrolled 550 consecutive critically ill children who underwent CEEG. We collected data regarding subject characteristics, CEEG indications, and CEEG findings. Key Findings CEEG indications were encephalopathy with possible seizures in 67% of subjects, event characterization in 38% of subjects, and management of refractory status epilepticus in 11% of subjects. CEEG was initiated outside routine work hours in 47% of subjects. CEEG duration was <12 hours in 16%, 12-24 hours in 34%, and >24 hours in 48%. Substantial variability existed among sites in CEEG indications and neurologic diagnoses, yet within each acute neurologic diagnosis category a similar proportion of subjects at each site had electrographic seizures. Electrographic seizure characteristics including distribution and duration varied across sites and neurologic diagnoses. Significance These data provide a systematic assessment of recent CEEG use in critically ill children and indicate variability in practice. The results suggest that multi-center studies are feasible if CEEG monitoring pathways can be standardized. However, the data also indicate that electrographic seizure variability must be considered when designing studies addressing the impact of electrographic seizures on outcome. PMID:23848569

  7. Development, Implementation, and Compliance of Treatment Pathways in Radiation Medicine

    PubMed Central

    Potters, Louis; Raince, Jadeep; Chou, Henry; Kapur, Ajay; Bulanowski, Daniel; Stanzione, Regina; Lee, Lucille

    2013-01-01

    Introduction: While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. Methods: Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. Results: This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). Conclusion: This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians. PMID:23653892

  8. Evaluation of a virucidal quantitative carrier test for surface disinfectants.

    PubMed

    Rabenau, Holger F; Steinmann, Jochen; Rapp, Ingrid; Schwebke, Ingeborg; Eggers, Maren

    2014-01-01

    Surface disinfectants are part of broader preventive strategies preventing the transmission of bacteria, fungi and viruses in medical institutions. To evaluate their virucidal efficacy, these products must be tested with appropriate model viruses with different physico-chemical properties under conditions representing practical application in hospitals. The aim of this study was to evaluate a quantitative carrier assay. Furthermore, different putative model viruses like adenovirus type 5 (AdV-5) and different animal parvoviruses were evaluated with respect to their tenacity and practicability in laboratory handling. To evaluate the robustness of the method, some of the viruses were tested in parallel in different laboratories in a multi-center study. Different biocides, which are common active ingredients of surface disinfectants, were used in the test. After drying on stainless steel discs as the carrier, model viruses were exposed to different concentrations of three alcohols, peracetic acid (PAA) or glutaraldehyde (GDA), with a fixed exposure time of 5 minutes. Residual virus was determined after treatment by endpoint titration. All parvoviruses exhibited a similar stability with respect to GDA, while AdV-5 was more susceptible. For PAA, the porcine parvovirus was more sensitive than the other parvoviruses, and again, AdV-5 presented a higher susceptibility than the parvoviruses. All parvoviruses were resistant to alcohols, while AdV-5 was only stable when treated with 2-propanol. The analysis of the results of the multi-center study showed a high reproducibility of this test system. In conclusion, two viruses with different physico-chemical properties can be recommended as appropriate model viruses for the evaluation of the virucidal efficacy of surface disinfectants: AdV-5, which has a high clinical impact, and murine parvovirus (MVM) with the highest practicability among the parvoviruses tested. PMID:24475079

  9. The growth and impact of Alzheimer's Disease Centers as measured by social network analysis

    PubMed Central

    Hughes, Michael E.; Peeler, John; Hogenesch, John B.; Trojanowski, John Q.

    2014-01-01

    Importance Alzheimer's disease (AD) is a devastating neurodegenerative disorder with no effective therapies. In 1984, the National Institute on Aging created the first five AD Centers (ADCs) in an effort to coordinate research efforts into the pathology and treatment of AD. Since that time, the ADC program has expanded to include 27 centers in major medical schools throughout the United States. A major aim of ADCs is to develop shared resources – such as tissue samples and patient populations – and thereby promote large-scale, high-impact studies that go beyond the capabilities of any single investigator or institution working in isolation. Objective and Design To quantitatively evaluate the performance of this program over the past quarter century, we systematically harvested every paper published by ADC investigators and used social network analysis to analyze co-publication networks. Results We found that the frequency of collaborations has increased dramatically during this time, even after the expansion of ADCs and the recruitment of new investigators plateaued. Moreover, the collaborations established within the context of the ADC program are increasingly inter-institutional, consistent with the overall goal of the program to catalyze multi-center research teams. Most importantly, we determined that collaborative, multi-center ADC research articles are consistently of higher-impact than AD papers as a whole. Conclusions We conclude that the ADC program has successfully fostered high-impact, multi-university collaborations, and suggest that its structural and administrative features could be replicated in other fields of patient oriented research. PMID:24514750

  10. HDU Deep Space Habitat (DSH) Overview

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project Deep Space Habitat (DSH) analog that will be field-tested during the 2011 Desert Research and Technologies Studies (D-RATS) field tests. The HDU project is a technology pull project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU Pressurized Excursion Module (PEM) that was field tested in the 2010 D-RATS, adding habitation functionality to the prototype unit. The 2010 configuration of the HDU-PEM consisted of a lunar surface laboratory module that was used to bring over 20 habitation-related technologies together in a single platform that could be tested as an advanced habitation analog in the context of mission architectures and surface operations. The 2011 HDU-DSH configuration will build upon the PEM work, and emphasize validity of crew operations (habitation and living, etc), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The HDU project consists of a multi-center team brought together in a skunkworks approach to quickly build and validate hardware in analog environments. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 analog field test will include Multi Mission Space Exploration Vehicles (MMSEV) and the DSH among other demonstration elements to be brought together in a mission architecture context. This paper will describe overall objectives, various habitat configurations, strategic plan, and technology integration as it pertains to the 2011 field tests.

  11. Association between N-acetyltransferase 2 polymorphisms and pancreatic cancer risk: a meta-analysis.

    PubMed

    Liang, J X; Gao, W; Liang, Y; Zhou, X M

    2015-01-01

    N-acetyltransferase 2 (NAT2) is an essential phase II enzyme in the metabolism of aromatic and heterocyclic amines and of hydrazines. NAT2 activity can be divided into three phenotypes: rapid, intermediate, and slow. Studies identifying an association between NAT2 polymorphism and the risk of pancreatic cancer have shown conflicting results. In order to assess this relationship comprehensively, we performed a meta-analysis that involved 1607 patients with pancreatic cancer and 1682 controls from six studies, which were selected from a group of ten, identified by a search of PubMed and Embase databases up to July 2014. Relative risks (RRs) with 95% confidence intervals (CIs) were used to evaluate the relationships. In the overall analysis, no significant associations between NAT2 rapid acetylation genotypes and pancreatic cancer risk (RR = 0.93, 95%CI = 0.73-1.19) were found; however, the results showed significant heterogeneity (I2 = 55.0%). The results from subgroup analysis suggested that the rapid genotypes might decrease the risk of pancreatic cancer (RR = 0.56, 95%CI = 0.38-0.84) in Turkey, although the association was not significant in the United States population (RR = 0.97, 95%CI = 0.71-1.34) or in the multi-center studies (RR = 1.10, 95%CI = 0.90-1.34). Analysis of the slow acetylation genotypes demonstrated the converse outcomes. In conclusion, the results of our study suggested that the NAT2 slow acetylation genotypes might increase the susceptibility to pancreatic cancer in Europe but that these have no significant effects in the United States and multi-center populations. PMID:26681215

  12. Towards a National Pediatric Musculoskeletal Trauma Outcomes Registry: the Pediatric Orthopaedic Trauma Outcomes Research Group (POTORG) experience.

    PubMed

    Vitale, Michael G; Vitale, Mark A; Lehmann, Charles L; Hyman, Joshua E; Roye, David P; Skaggs, David L; Schmitz, Michael L; Sponseller, Paul D; Flynn, John M

    2006-01-01

    This study is a pilot effort towards the broader implementation of a national pediatric musculoskeletal trauma outcomes registry. The primary goal of this project is to explore the feasibility of a web-based data acquisition and management platform and to identify catalysts and obstacles to multi-center collaboration. A prospective cohort of children presenting to the Pediatric Emergency Departments with ankle, femur, supracondylar humerus, tibial spine, or open fractures at five clinical centers between October 2001 and March 2003 comprised the study population. Patients were enrolled via the treating orthopaedic resident, using a web-based data acquisition and management system. Orthopaedic attendees were sent an automated reminder to complete a follow-up form one week after treatment, and parents of enrolled children were sent child and parent health questionnaires by e-mail and mail in order to capture health-related quality of life and post-traumatic stress symptoms. A total of 299 patients were enrolled in the study with an average age of 7.3 years. Post-treatment follow-up questionnaires were completed by 39% of the attending orthopaedic surgeons, and by 43% of the enrolled patients or patient's parents. Children old enough to complete health questionnaires scored lower in 5 of 12 functional domains including Physical Function, Role/Social Emotional/Behavioral, Parental Impact-Emotional, Family Activities, and Family Cohesion. Within the subset of patients sustaining femur fractures whose parents completed health questionnaires, 9.5% reported significant post-traumatic stress symptoms. This study demonstrates the potential of a multi-center web-based registry to facilitate the collection of a rich array of pediatric trauma, treatment and patient-based outcomes data, although new regulatory issues regarding patient privacy pose challenges to such an approach. PMID:16557126

  13. Surfactant replacement therapy for adult respiratory distress syndrome in children.

    PubMed

    Evans, D A; Wilmott, R W; Whitsett, J A

    1996-05-01

    Surfactant replacement therapy may have a role in the treatment of ARDS in children. The current studies suggest that rapid instillation of exogenous surfactant is more effective than slow tracheal instillation or aerosolized delivery. Studies suggest that exogenous surfactant given early in the development of ARDS is more effective than therapy provided late in the course of the disease. Natural surfactants appear to be more effective than artificial surfactants due to the presence of SP-B and SP-C, which prevent inhibition of the exogenous surfactant by the protein leakage into the alveolus that is characteristic of ARDS. Exogenous surfactant replacement therapy appears to be safe and well tolerated. A surfactant that can be delivered by aerosol would be useful since this is more easily tolerated by the patients, requires less surfactant, and would be more cost effective when compared with tracheal instillation. Aerosolized surfactant could be given to patients who have not yet required mechanical ventilation, thus potentially preventing the progression of the acute lung injury to respiratory failure. The recent failure of a large multi-center trial of aerosolized Exosurf for the treatment of sepsis-related ARDS72 may have been due to the failure of the delivery system as opposed to the surfactant used in the trial; therefore, further research into aerosol delivery systems is needed. There may be different responses to exogenous surfactant therapy by patients with ARDS of different etiologies, such as aspiration pneumonia, sepsis, or trauma. Well-planned placebo-controlled trials will be required to determine these differences. The data supporting the role of surfactant replacement for the treatment of ARDS in children is growing. However, before widespread use of surfactant is considered, a multi-center, placebo-controlled trial will be required to establish the safety and efficacy of surfactant replacement in such patients. PMID:8726159

  14. Transfusion of fresh frozen plasma in non-bleeding ICU patients -TOPIC TRIAL: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Fresh frozen plasma (FFP) is an effective therapy to correct for a deficiency of multiple coagulation factors during bleeding. In past years, use of FFP has increased, in particular in patients on the Intensive Care Unit (ICU), and has expanded to include prophylactic use in patients with a coagulopathy prior to undergoing an invasive procedure. Retrospective studies suggest that prophylactic use of FFP does not prevent bleeding, but carries the risk of transfusion-related morbidity. However, up to 50% of FFP is administered to non-bleeding ICU patients. With the aim to investigate whether prophylactic FFP transfusions to critically ill patients can be safely omitted, a multi-center randomized clinical trial is conducted in ICU patients with a coagulopathy undergoing an invasive procedure. Methods A non-inferiority, prospective, multicenter randomized open-label, blinded end point evaluation (PROBE) trial. In the intervention group, a prophylactic transfusion of FFP prior to an invasive procedure is omitted compared to transfusion of a fixed dose of 12 ml/kg in the control group. Primary outcome measure is relevant bleeding. Secondary outcome measures are minor bleeding, correction of International Normalized Ratio, onset of acute lung injury, length of ventilation days and length of Intensive Care Unit stay. Discussion The Transfusion of Fresh Frozen Plasma in non-bleeding ICU patients (TOPIC) trial is the first multi-center randomized controlled trial powered to investigate whether it is safe to withhold FFP transfusion to coagulopathic critically ill patients undergoing an invasive procedure. Trial Registration Trial registration: Dutch Trial Register NTR2262 and ClinicalTrials.gov: NCT01143909 PMID:22196464

  15. SURVIVAL IN INFECTION-RELATED ACUTE-ON-CHRONIC LIVER FAILURE IS DEFINED BY EXTRA-HEPATIC ORGAN FAILURES

    PubMed Central

    Bajaj, Jasmohan S; O’Leary, Jacqueline G; Reddy, K Rajender; Wong, Florence; Biggins, Scott W.; Patton, Heather; Fallon, Michael B; Garcia-Tsao, Guadalupe; Maliakkal, Benedict; Malik, Raza; Subramanian, Ram M; Thacker, Leroy R; Kamath, Patrick S

    2014-01-01

    Background Infections worsen survival in cirrhosis; however, simple predictors of survival in infection-related acute-on-chronic liver failure (I-ACLF) derived from multi-center studies are required in order to improve prognostication and resource allocation. Methods Using the NACSELD database, data from 18 centers were collected for survival analysis of prospectively enrolled cirrhotic patients hospitalized with an infection. We defined organ failures as (i) shock, (ii) grade III/IV hepatic encephalopathy(HE), (iii) need for dialysis (iv) mechanical ventilation. Determinants of survival with these organ failures were analyzed. Results 507 patients were included (55 yrs, 52% HCV, 15.8% nosocomial infection, 96% Child score≥7) and 30-day evaluations were available in 453 patients. Urinary tract infection (UTI) (28.5%), and spontaneous bacterial peritonitis (SBP) (22.5%) were most prevalent. During hospitalization, 55.7% developed HE, 17.6% shock, 15.1% required renal replacement, and 15.8% needed ventilation; 23% died within 30-days and 21.6% developed second infections. Admitted patients developed none (38.4%), one (37.3%), two (10.4%), three (10%) or four (4%) organ failures. 30-day survival worsened with higher number of extra-hepatic organ failures, none (92%), one (72.6%), two (51.3%), three (36%) and all four (23%). I-ACLF was defined as ≥2 organ failures given the significant change in survival probability associated at this cutoff. Baseline independent predictors for development of ACLF were nosocomial infections, MELD score, low mean arterial pressure (MAP), and non-SBP infections. Independent predictors of poor 30-day survival were I-ACLF, second infections, and admission values of high MELD, low MAP, high white blood count and low albumin. In conclusion, using multi-center study data in hospitalized decompensated infected cirrhotic patients, I-ACLF defined by the presence of two or more organ failures using simple definitions is predictive of poor

  16. Evaluation of a Virucidal Quantitative Carrier Test for Surface Disinfectants

    PubMed Central

    Rabenau, Holger F.; Steinmann, Jochen; Rapp, Ingrid; Schwebke, Ingeborg; Eggers, Maren

    2014-01-01

    Surface disinfectants are part of broader preventive strategies preventing the transmission of bacteria, fungi and viruses in medical institutions. To evaluate their virucidal efficacy, these products must be tested with appropriate model viruses with different physico-chemical properties under conditions representing practical application in hospitals. The aim of this study was to evaluate a quantitative carrier assay. Furthermore, different putative model viruses like adenovirus type 5 (AdV-5) and different animal parvoviruses were evaluated with respect to their tenacity and practicability in laboratory handling. To evaluate the robustness of the method, some of the viruses were tested in parallel in different laboratories in a multi-center study. Different biocides, which are common active ingredients of surface disinfectants, were used in the test. After drying on stainless steel discs as the carrier, model viruses were exposed to different concentrations of three alcohols, peracetic acid (PAA) or glutaraldehyde (GDA), with a fixed exposure time of 5 minutes. Residual virus was determined after treatment by endpoint titration. All parvoviruses exhibited a similar stability with respect to GDA, while AdV-5 was more susceptible. For PAA, the porcine parvovirus was more sensitive than the other parvoviruses, and again, AdV-5 presented a higher susceptibility than the parvoviruses. All parvoviruses were resistant to alcohols, while AdV-5 was only stable when treated with 2-propanol. The analysis of the results of the multi-center study showed a high reproducibility of this test system. In conclusion, two viruses with different physico-chemical properties can be recommended as appropriate model viruses for the evaluation of the virucidal efficacy of surface disinfectants: AdV-5, which has a high clinical impact, and murine parvovirus (MVM) with the highest practicability among the parvoviruses tested. PMID:24475079

  17. A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury.

    PubMed

    Bragge, Peter; Synnot, Anneliese; Maas, Andrew I; Menon, David K; Cooper, D James; Rosenfeld, Jeffrey V; Gruen, Russell L

    2016-08-15

    Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative

  18. A prospective, multi-centric, observational registry to evaluate performance of Excel™ DES in ‘Real World, All Comers’ patient population

    PubMed Central

    Hiremath, Shirish; Chandra, Praveen; Desai, Devang; Sivakumar, R.; Selvamani, S.; Srinivasan, Anand; Paulose, Madhu; Jose, Sajy; Kalmath, B.C.; Magarkar, Vilas.P.; Pathak, Abhijeet; Mhetre, Tushar

    2014-01-01

    Objectives This study aims to assess the safety and efficacy of a biodegradable polymer-coated Rapamycin-Eluting Stent (Excel) used in conjunction with six-month dual antiplatelet therapy in daily practice. Background The polymeric material of cardiac stents has been reported to adversely affect the safety profile of the drug-eluting stents and is also suspected to cause serious long-term complications. It has been proposed that the biodegradable polymer coatings may reduce such late-stage adverse effects. Methods This is a prospective, multi-center registry of 654 patients from across 9 cardiology centers in India, who were enrolled and exclusively treated with Excel stents between February 2008 and May 2010. The recommended antiplatelet regimen included clopidogrel and aspirin for 6 months period, followed by lifelong aspirin therapy. Results The study population included 46.94% diabetics, 24.31% smokers, 48.93% hypertensives and 14.98% hyperlipidemics. The cumulative rates of major adverse cardiac events were 0.153% at discharge and 1.38% at 12 months. The mean percentage of stenosis was 88.24 ± 9.17% No events occurred between 6 and 12 months. Conclusions This multi-center registry study on “real world, all comers” has, thus, showed that EXCEL™ stent which is PLA-coated biodegradable Rapamycin-Eluting Stent exhibited high efficacy and safety profile in treatment of patients undergoing PCI as evidenced by significantly lower rates of MACE and no case of stent thrombosis. There was no event even after DAPT was discontinued after 6 months. PMID:25634407

  19. Randomized controlled trials and neuro-oncology: should alternative designs be considered?

    PubMed

    Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

    2015-09-01

    Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

  20. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation

    PubMed Central

    Alsheikh-Ali, Alawi A.; Hersi, Ahmad S.; Hamad, Adel K. S.; Al Fagih, Ahmed R.; Al-Samadi, Faisal M.; Almusaad, Abdulmohsen M.; Bokhari, Fayez A.; Al-Kandari, Fawzia; Al-Ghamdi, Bandar S.; Al Rawahi, Najib; Asaad, Nidal; Alkaabi, Salem; Daoulah, Amin; Zaky, Hosam A.; Elhag, Omer; Al Hebaishi, Yahya S.; Sweidan, Raed; Alanazi, Haitham; Chase, David; Sabbour, Hani; Al Meheiri, Mohammad; Al Abri, Ismail; Amin, Mohammad; Dagriri, Khaled; Ahmed, Adil O.; Shafquat, Azam; Khan, Shahul Hameed

    2015-01-01

    Background: The implantable cardioverter-defibrillator (ICD) is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region. Methods: Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates. Results: Fifteen centers in six countries are enrolling patients (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar). Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of ≤150 devices, and pulse generator replacements constitute <30% of implants in the majority of centers. Enrollment started in December 2013, and accrual rate increased as more centers entered the study reaching an average of 98 patients per month. Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region. PMID:26900416

  1. Candida Infective Endocarditis

    PubMed Central

    Baddley, John W.; Benjamin, Daniel K.; Patel, Mukesh; Miró, José; Athan, Eugene; Barsic, Bruno; Bouza, Emilio; Clara, Liliana; Elliott, Tom; Kanafani, Zeina; Klein, John; Lerakis, Stamatios; Levine, Donald; Spelman, Denis; Rubinstein, Ethan; Tornos, Pilar; Morris, Arthur J.; Pappas, Paul; Fowler, Vance G.; Chu, Vivian H.; Cabell, Christopher

    2009-01-01

    Purpose Candida infective endocarditis (IE) is uncommon but often fatal. Most epidemiologic data are derived from small case series or case reports. This study was conducted to explore epidemiology, treatment patterns, and outcomes of patients with Candida IE. Methods We compared 33 Candida IE cases to 2716 patients with non-fungal IE in the International Collaboration on Endocarditis - Prospective Cohort Study. Patients were enrolled and data collected from June 2000 until August 2005. Results Patients with Candida IE were more likely to have prosthetic valves (p<0.001), short term indwelling catheters (p<0.0001), and have healthcare-associated infection (p<0.001). Reasons for surgery differed between the two groups: myocardial abscess (46.7% vs. 22.2% p=0.026) and persistent positive blood cultures (33.3% vs. 9.9%, p=0.003) were more common among those with Candida IE. Mortality at discharge was higher in patients with Candida IE (30.3%) when compared to non-fungal cases (17%, p=0.046). Among Candida patients, mortality was similar in patients who received combination surgical and antifungal therapy versus antifungal therapy alone (33.3% vs. 27.8%, p=0.26). New antifungal drugs, particularly echinocandins, were used frequently. Conclusions These multi-center data suggest distinct epidemiologic features of Candida IE when compared to non-fungal cases. Indications for surgical intervention are different and mortality is increased. Newer antifungal treatment options are increasingly used. Large, multi-center studies are needed to help better define Candida IE. PMID:18283504

  2. Intra-/inter-laboratory validation study on reactive oxygen species assay for chemical photosafety evaluation using two different solar simulators.

    PubMed

    Onoue, Satomi; Hosoi, Kazuhiro; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Nakamura, Kazuichi; Ohno, Yasuo; Kojima, Hajime

    2014-06-01

    A previous multi-center validation study demonstrated high transferability and reliability of reactive oxygen species (ROS) assay for photosafety evaluation. The present validation study was undertaken to verify further the applicability of different solar simulators and assay performance. In 7 participating laboratories, 2 standards and 42 coded chemicals, including 23 phototoxins and 19 non-phototoxic drugs/chemicals, were assessed by the ROS assay using two different solar simulators (Atlas Suntest CPS series, 3 labs; and Seric SXL-2500V2, 4 labs). Irradiation conditions could be optimized using quinine and sulisobenzone as positive and negative standards to offer consistent assay outcomes. In both solar simulators, the intra- and inter-day precisions (coefficient of variation; CV) for quinine were found to be below 10%. The inter-laboratory CV for quinine averaged 15.4% (Atlas Suntest CPS) and 13.2% (Seric SXL-2500V2) for singlet oxygen and 17.0% (Atlas Suntest CPS) and 7.1% (Seric SXL-2500V2) for superoxide, suggesting high inter-laboratory reproducibility even though different solar simulators were employed for the ROS assay. In the ROS assay on 42 coded chemicals, some chemicals (ca. 19-29%) were unevaluable because of limited solubility and spectral interference. Although several false positives appeared with positive predictivity of ca. 76-92% (Atlas Suntest CPS) and ca. 75-84% (Seric SXL-2500V2), there were no false negative predictions in both solar simulators. A multi-center validation study on the ROS assay demonstrated satisfactory transferability, accuracy, precision, and predictivity, as well as the availability of other solar simulators. PMID:24384453

  3. Aerobic bacterial microflora of Broad-snouted caiman (Caiman latirostris) oral cavity and cloaca, originating from parque Zoológico Arruda Câmara, Paraíba, Brazil.

    PubMed

    Silva, J S A; Mota, R A; Pinheiro Júnior, J W; Almeida, M C S; Silva, D R; Ferreira, D R A; Azevedo, J C N

    2009-01-01

    The objective of this study was to isolate and identify the aerobic bacterial microflora from the oral cavity mucosa and cloaca's samples, collected from Broad-snouted caiman (Caiman latirostris), born and bred in captivity at Parque Zoológico Arruda Câmara, João Pessoa, Paraíba, Brazil. The most common bacteria were Staphylococcus sp. (14.74%), Corynebacterium sp. (13.68%), Escherichia coli (13.68%) and Shigella sp.(11.58%), and the less common were Citrobacter sp. (1.05%), Klebsiella pneumoniae (1.05%) and Salmonella sp. (1.05%).This emphasizes the importance of these microorganisms' participation in infectious processes (sepsis) and injuries caused by crocodilians. PMID:24031343

  4. Ceramic component for electrodes

    DOEpatents

    Marchant, David D.; Bates, J. Lambert

    1980-01-01

    A ceramic component suitable for preparing MHD generator electrodes having the compositional formula: Y.sub.x (Mg.sub.y Cr.sub.z).sub.w Al.sub.(1-w) O.sub.3 where x=0.9 to 1.05, y=0.02 to 0.2, z=0.8 to 1.05 and w=1.0 to 0.5. The component is resistant to the formation of hydration products in an MHD environment, has good electrical conductivity and exhibits a lower electrochemical corrosion rate than do comparable compositions of lanthanum chromite.

  5. Artificial Gravity as a Multi-System Countermeasure to Bed Rest Deconditioning: Pilot Study Overview

    NASA Technical Reports Server (NTRS)

    Paloski, William H.; Young, L. R.

    2007-01-01

    Efficient, effective, multi-system countermeasures will likely be required to protect the health, safety, and performance of crews aboard planned exploration-class space flight missions to Mars and beyond. To that end, NASA, DLR, and IMBP initiated a multi-center international project to begin systematically exploring the utility of artificial gravity (AG) as a multi-system countermeasure in ground based venues using test subjects deconditioned by bed rest. The goal of this project is to explore the efficacy of short-radius, intermittent AG as a countermeasure to bone, muscle, cardiovascular, and sensory-motor adaptations to hypogravity. This session reports the results from a pilot study commissioned to validate a standardized protocol to be used by all centers involved in the project. Subject selection criteria, medical monitoring requirements, medical care procedures, experiment control procedures, and standardized dependent measures were established jointly. Testing was performed on 15 rigorously screened male volunteers subjected to 21 days of 6deg HDT bed rest. (All provided written consent to volunteer after the nature of the study and its hazards were clearly explained to them.) Eight were treated with daily 1hr AG exposures (2.5g at the feet decreasing to 1.0g at the heart) aboard a short radius (3m) centrifuge, while the other seven served as controls. Multiple tests of multiple dependent measures were made in each of the primary physiological systems of interest during a 10 day acclimatization period prior to HDT bed rest and again during an 8 day recovery period after the bed rest period was complete. Analyses of these data (presented in other papers in this session) suggest the AG prescription had salutary effects on aspects of the bone, muscle, and cardiovascular systems, with no untoward effects on the vestibular system, the immune system, or cognitive function. Furthermore, treatment subjects were able to tolerate 153/160 centrifuge sessions over

  6. Design of a 2-Hour Prebreathe Protocol for Space Walks (EVAs) from the International Space Station (ISS)

    NASA Technical Reports Server (NTRS)

    Gernhardt, M. L.; Conkin, J.; Foster, P. P.; Pilmanis, A. A.; Butler, B. D.; Fife, C.; Vann, R. D.; Gerth, W. A.; Loftin, K. C.; Dervay, J.; Waligora, J. M.; Powell, M. R.; Homick, Jerry L. (Technical Monitor)

    2000-01-01

    The majority of extravehicular activities (EVAs) performed from the shuttle use a 10.2 psi staged decompression. The International Space Station (ISS) will operate at 14.7 psi, requiring crews to "campout" in the airlock at 10.2 psi. The constraints associated with campout (crew isolation, oxygen usage, and waste management), provided the rationale to develop a 2-hour prebreathe protocol from 14.7 psi. Previous studies on the affect of microgravity and exercise during prebreathe suggested the feasibility of this approach. Various combinations of adynamia (nonwalking subjects), prebreathe exercise doses, and space suit donning options (10.2 vs. 14.7 psi) were analyzed against timeline and consumable constraints. Prospective decompression sickness (DCS) and venous gas emboli (VGE) accept/reject criteria were defined from statistical analysis of historical DCS data, combined with risk management of DCS under ISS mission circumstances. Maximum operational DCS levels were defined based on protecting for EVA capability with two crew members at 95% confidence, throughout ISS lifetime (within the constraints of NASA DCS disposition policy JPG 1800.3). The accept / reject limits were adjusted for greater safety (including Grade IV VGE criteria) based on analysis of related medical factors. Monte-Carlo simulation was performed to design a closed sequential, multi-center laboratory trial, including the capability of rejecting the primary protocol and testing at least one alternate exercise dose, within the 2-hour prebreathe. The 2-hour protocol incorporates 0, breathing for 5 0 min at 14.7 psi, including 10 min dual cycle ergometry at 75%VO(2max). It requires an additional 30 minO2breathing during depress from 14.7 to 10.2 psi, followed by a 30-60 min suit donning break at 10.2 psi/26.5% O2. It concludes with a 40 min in-suit O2 prebreathe. The protocol would be accepted for operations, if the incidence of DCS was less than 15% and Grade IV VGE less than 20%, both at 95

  7. The Habitat Demonstration Unit Project Overview

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Grill, Tracy R.; Tri, Terry O.; Howe, Alan S.

    2010-01-01

    This paper will describe an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) Project. The HDU project is a "technology-pull" project that integrates technologies and innovations from numerous NASA centers. This project will be used to investigate and validate surface architectures, operations concepts, and requirements definition of various habitation concepts. The first habitation configuration this project will build and test is the Pressurized Excursion Module (PEM). This habitat configuration - the PEM - is based on the Constellation Architecture Scenario 12.1 concept of a vertically oriented habitat module. The HDU project will be tested as part of the 2010 Desert Research and Technologies Simulations (D-RATS) test objectives. The purpose of this project is to develop, integrate, test, and evaluate a habitat configuration in the context of the mission architectures and surface operation concepts. A multi-center approach will be leveraged to build, integrate, and test the PEM through a shared collaborative effort of multiple NASA centers. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Lunar Surface Systems Project Office (LSSPO) to test surface elements in a surface analog environment. The 2010 analog field test will include two Lunar Electric Rovers (LER) and the PEM among other surface demonstration elements. This paper will describe the overall objectives, its various habitat configurations, strategic plan, and technology integration as it pertains to the 2010 and 2011 field analog tests. To accomplish the development of the PEM from conception in June 2009 to rollout for operations in July 2010, the HDU project team is using a set of design standards to define the interfaces between the various systems of PEM and to the payloads, such as the Geology Lab, that those systems will support

  8. Reducing Contrast-Induced Acute Kidney Injury Using a Regional Multicenter Quality Improvement Intervention

    PubMed Central

    Brown, Jeremiah R.; Solomon, Richard J.; Sarnak, Mark J.; McCullough, Peter A.; Splaine, Mark E.; Davies, Louise; Ross, Cathy S.; Dauerman, Harold L.; Stender, Janette L.; Conley, Sheila M.; Robb, John F.; Chaisson, Kristine; Boss, Richard; Lambert, Peggy; Goldberg, David J.; Lucier, Deborah; Fedele, Frank A.; Kellett, Mirle A.; Horton, Susan; Phillips, William J.; Downs, Cynthia; Wiseman, Alan; MacKenzie, Todd A.; Malenka, David J.

    2016-01-01

    Background Contrast-induced acute kidney injury (CI-AKI) is associated with increased morbidity and mortality following percutaneous coronary interventions (PCI) and is a patient safety objective of the National Quality Forum. However, no formal quality improvement program to prevent CI-AKI has been conducted. Therefore, we sought to determine if a six-year regional multi-center quality improvement intervention could reduce CI-AKI following PCI. Methods and Results We conducted a prospective multi-center quality improvement study to prevent CI-AKI (serum creatinine increase ≥0.3 mg/dL within 48 hours or ≥50% during hospitalization) among 21,067 non-emergent patients undergoing PCI at ten hospitals between 2007 and 2012. Six ‘intervention’ hospitals participated in the quality improvement intervention. Two hospitals with significantly lower baseline rates of CI-AKI, which served as “benchmark” sites and were used to develop the intervention and two hospitals not receiving the intervention were used as controls. Using time series analysis and multilevel poisson regression clustering to the hospital-level we calculated adjusted risk ratios (RR) for CI-AKI comparing the intervention period to baseline. Adjusted rates of CI-AKI were significantly reduced in hospitals receiving the intervention by 21% (RR 0.79; 95%CI: 0.67 to 0.93; p=0.005) for all patients and by 28% in patients with baseline eGFR<60 ml/min/1.73 m2 (RR 0.72; 95%CI: 0.56 to 0.91; p=0.007). Benchmark hospitals had no significant changes in CI-AKI. Key qualitative system factors associated with improvement included: multidisciplinary teams, limiting contrast volume, standardized fluid orders, intravenous fluid bolus, and patient education about oral hydration. Conclusions Simple cost-effective quality improvement interventions can prevent up to one in five CI-AKI events in patients with undergoing non-emergent PCI. PMID:25074372

  9. The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). Methods/Design 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. Discussion This multi-center study provides a large sample size, broad inclusion criteria and a follow

  10. Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group

    PubMed Central

    Yeh, Hsin-Chieh; Clark, Jeanne M.; Emmons, Karen M.; Moore, Renee H.; Bennett, Gary G; Warner, Erica T.; Sarwer, Davis B.; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A.; Wells, Barbara; Wadden, Thomas A.; Colditz, Graham A.; Appel, Lawrence J.

    2011-01-01

    Background The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.” Purpose We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. Methods The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. Results The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. Limitations The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols. Conclusions The POWER Trials Collaborative Research Group is a case study of an

  11. Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial

    PubMed Central

    2014-01-01

    Background Among the multiple conservative modalities, physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain. Despite the scientific progresses with regard to pain and motor control neuroscience, treatment of chronic spinal pain (CSP) often tends to stick to a peripheral biomechanical model, without targeting brain mechanisms. With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP, the development of clinical strategies targeted at ‘training the brain’ is to be pursued. Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care, but confirmation is required in a larger, multi-center trial with appropriate evidence-based control intervention and long-term follow-up. The aim of this study is to assess the effectiveness of a modern neuroscience approach, compared to usual care evidence-based physiotherapy, for reducing pain and improving functioning in patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP. Methods/Design The study is a multi-center, triple-blind, two-arm (1:1) randomized clinical trial with 1-year follow-up. 120 CSP patients will be randomly allocated to either the experimental (receiving pain neuroscience education followed by cognition-targeted motor control training) or the control group (receiving usual care physiotherapy), each comprising of 3 months treatment. The main outcome measures are pain (including symptoms and indices of central sensitization) and self-reported disability. Secondary outcome measures include brain gray matter structure, motor control, muscle properties, and psychosocial correlates. Clinical assessment and brain imaging will be performed at baseline, post-treatment and at 1-year follow-up. Web

  12. 33 CFR 117.1093 - Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... railroad bridge, mile 0.59, two prolonged blasts. (ii) The North Broadway Street bridge, mile 0.5, three prolonged blasts followed by one short blast. (iii) The North Water Street bridge, mile 0.6, three prolonged... Canadian Pacific railroad bridge across the Menomonee River, mile 1.05, is two prolonged blasts followed...

  13. Novette chain design and performance

    SciTech Connect

    Hunt, J.T.; Speck, D.R.

    1980-12-11

    The design and performance of the Novette laser system, which is a two-beam, two-wavelength (1.05 ..mu.. and 0.53 ..mu..) target irradiation facility using phosphate glass laser chains, are discussed with information on the glass properties, controlling factors in the design selection, and projected performance with varying operating conditions. (LCL)

  14. 33 CFR 117.1093 - Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... railroad bridge, mile 0.59, two prolonged blasts. (ii) The North Broadway Street bridge, mile 0.5, three prolonged blasts followed by one short blast. (iii) The North Water Street bridge, mile 0.6, three prolonged... Canadian Pacific railroad bridge across the Menomonee River, mile 1.05, is two prolonged blasts followed...

  15. 33 CFR 117.1093 - Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... railroad bridge, mile 0.59, two prolonged blasts. (ii) The North Broadway Street bridge, mile 0.5, three prolonged blasts followed by one short blast. (iii) The North Water Street bridge, mile 0.6, three prolonged... Canadian Pacific railroad bridge across the Menomonee River, mile 1.05, is two prolonged blasts followed...

  16. 33 CFR 117.1093 - Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... railroad bridge, mile 0.59, two prolonged blasts. (ii) The North Broadway Street bridge, mile 0.5, three prolonged blasts followed by one short blast. (iii) The North Water Street bridge, mile 0.6, three prolonged... Canadian Pacific railroad bridge across the Menomonee River, mile 1.05, is two prolonged blasts followed...

  17. 33 CFR 117.1093 - Milwaukee, Menomonee, and Kinnickinnic Rivers and South Menomonee and Burnham Canals.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... railroad bridge, mile 0.59, two prolonged blasts. (ii) The North Broadway Street bridge, mile 0.5, three prolonged blasts followed by one short blast. (iii) The North Water Street bridge, mile 0.6, three prolonged... Canadian Pacific railroad bridge across the Menomonee River, mile 1.05, is two prolonged blasts followed...

  18. Creation of a Cellooligosaccharide-Assimilating Escherichia coli Strain by Displaying Active Beta-Glucosidase on the Cell Surface via a Novel Anchor Protein ▿

    PubMed Central

    Tanaka, Tsutomu; Kawabata, Hitomi; Ogino, Chiaki; Kondo, Akihiko

    2011-01-01

    We demonstrated direct assimilation of cellooligosaccharide using Escherichia coli displaying beta-glucosidase (BGL). BGL from Thermobifida fusca YX (Tfu0937) was displayed on the E. coli cell surface using a novel anchor protein named Blc. This strain was grown successfully on 0.2% cellobiose, and the optical density at 600 nm (OD600) was 1.05 after 20 h. PMID:21742905

  19. Dietary L-arginine supplementation attenuates lipopolysaccharide-induced inflammatory response in broiler chickens

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Two experiments were conducted to investigate the effect of dietary L-arginine (Arg) supplementation on inflammatory response and innate immunity of broilers. Experiment 1 was designed as a 2 × 3 factorial arrangement (n = 8 cages/treatment; 6 birds/cage) with 3 dietary Arg concentrations (1.05, 1.4...

  20. Pre-discovery observations of MASTER OT J004514.13+420007.2

    NASA Astrophysics Data System (ADS)

    Maehara, Hiroyuki

    2016-01-01

    I report pre-discovery observations of the possible nova in M31 MASTER OT J004514.13+420007.2 (ATel # 8603). The observations were performed with the 1.05-m Schmidt telescope and KWFC (Sako et al. 2012, SPIE, 8446, 84466L) at Kiso Observatory.