Science.gov

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

  1. Euclidean supergravity and multi-centered solutions

    NASA Astrophysics Data System (ADS)

    Sabra, W. A.

    2017-04-01

    In ungauged supergravity theories, the no-force condition for BPS states implies the existence of stable static multi-centered solutions. The first solutions to Einstein-Maxwell theory with a positive cosmological constant describing an arbitrary number of charged black holes were found by Kastor and Traschen. Generalisations to five and higher dimensional theories were obtained by London. Multi-centered solutions in gauged supergravity, even with time-dependence allowed, have yet to be constructed. In this letter we construct supersymmetry-preserving multi-centered solutions for the case of D = 5, N = 2 Euclidean gauged supergravity coupled to an arbitrary number of vector multiplets. Higher dimensional Einstein-Maxwell multi-centered solutions are also presented.

  2. 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.

  3. 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.

  4. Research and operational applications in multi-center ensemble forecasting

    NASA Astrophysics Data System (ADS)

    Zhu, Y.; Toth, Z.

    2009-05-01

    The North American Ensemble Forecast System (NAEFS) was built up in 2004 by the Meteorological Service of Canada (MSC), the National Meteorological Service of Mexico (NMSM), and the US National Weather Service (NWS) as an operational multi-center ensemble forecast system. Currently it combines the 20-member MSC and NWS ensembles to form a joint ensemble of 40 members twice a day. The joint ensemble forecast, after bias correction and statistical downscaling, is used to generate a suite of products for CONUS, North America and for other regions of the globe. The THORPEX Interactive Grand Global Ensemble (TIGGE) project has been established a few years ago to collect operational global ensemble forecasts from world centers, and distribute to the scientific community, to encourage research leading to the acceleration of improvements in the skill and utility of high impact weather forecasts. TIGGE research is expected to advise the development of the operational NAEFS system and eventually the two projects are expected to converge into a single operational system, the Global Interactive Forecast System (GIFS). This presentation will review recent developments, the current status, and plans related to the TIGGE research and NAEFS operational multi-center ensemble projects.

  5. 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.

  6. Multi-center airborne coherent atmospheric wind sensor (MACAWS)

    SciTech Connect

    Rothermel, J.; Menzies, R.T.; Tratt, D.M.

    1996-11-01

    The Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) is an airborne scanning coherent Doppler lidar designed to acquire remote multi-dimensional measurements of winds and absolute aerosol backscatter in the troposphere and lower stratosphere. These measurements enable study of atmospheric dynamic processes and features at scales of motion that may be undersampled by, or may be beyond the capability of, existing or planned sensors. MACAWS capabilities enable more realistic assessments of concepts in global tropospheric wind measurement with satellite Doppler lidar, as well as a unique capability to validate the NASA Scatterometer currently scheduled for launch in late 1996. MACAWS consists of a Joule-class CO{sub 2} coherent Doppler lidar on a ruggedized optical table, a programmable scanner to direct the lidar beam in the desired direction, and a dedicated inertial navigation system to account for variable aircraft attitude and speed. MACAWS was flown for the first time in September 1995, over the eastern Pacific Ocean and western US. 33 refs., 2 figs.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. Reducing between scanner differences in multi-center PET studies.

    PubMed

    Joshi, Aniket; Koeppe, Robert A; Fessler, Jeffrey A

    2009-05-15

    This work is part of the multi-center Alzheimer's Disease Neuroimaging Initiative (ADNI), a large multi-site study of dementia, including patients having mild cognitive impairment (MCI), probable Alzheimer's disease (AD), as well as healthy elderly controls. A major portion of ADNI involves the use of [(18)F]-fluorodeoxyglucose (FDG) with positron emission tomography (PET). The objective of this paper is the reduction of inter-scanner differences in the FDG-PET scans obtained from the 50 participating PET centers having fifteen different scanner models. In spite of a standardized imaging protocol, systematic inter-scanner variability in PET images from various sites is observed primarily due to differences in scanner resolution, reconstruction techniques, and different implementations of scatter and attenuation corrections. Two correction steps were developed by comparison of 3-D Hoffman brain phantom scans with the 'gold standard' digital 3-D Hoffman brain phantom: i) high frequency correction; where a smoothing kernel for each scanner model was estimated to smooth all images to a common resolution and ii) low frequency correction; where smooth affine correction factors were obtained to reduce the attenuation and scatter correction errors. For the phantom data, the high frequency correction reduced the variability by 20%-50% and the low frequency correction further reduced the differences by another 20%-25%. Correction factors obtained from phantom studies were applied to 95 scans from normal control subjects obtained from the participating sites. The high frequency correction reduced differences similar to the phantom studies. However, the low frequency correction did not further reduce differences; hence further refinement of the procedure is necessary.

  12. 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... example, an interim rule may be issued in instances when normal procedures for notice and comment prior...

  13. 33 CFR 1.05-10 - Regulatory process overview.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Regulatory process overview. 1.05... GENERAL GENERAL PROVISIONS Rulemaking § 1.05-10 Regulatory process overview. (a) Most rules of local... (defined by Executive Order 12866, Regulatory Planning and Review) and non-significant rulemaking,...

  14. 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... 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...

  15. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 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...

  16. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 1 2012-07-01 2012-07-01 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...

  17. 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...

  18. 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...

  19. Research priorities for a multi-center child abuse pediatrics network - CAPNET.

    PubMed

    Lindberg, Daniel M; Wood, Joanne N; Campbell, Kristine A; Scribano, Philip V; Laskey, Antoinette; Leventhal, John M; Pierce, Mary Clyde; Runyan, Desmond K

    2017-03-01

    Although child maltreatment medical research has benefited from several multi-center studies, the new specialty of child abuse pediatrics has not had a sustainable network capable of pursuing multiple, prospective, clinically-oriented studies. The Child Abuse Pediatrics Network (CAPNET) is a new multi-center research network dedicated to child maltreatment medical research. In order to establish a relevant, practical research agenda, we conducted a modified Delphi process to determine the topic areas with highest priority for such a network. Research questions were solicited from members of the Ray E. Helfer Society and study authors and were sorted into topic areas. These topic areas were rated for priority using iterative rounds of ratings and in-person meetings. The topics rated with the highest priority were missed diagnosis and selected/indicated prevention. This agenda can be used to target future multi-center child maltreatment medical research.

  20. 33 CFR 1.05-10 - Regulatory process overview.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-10 Section 1.05-10 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY... begins when an office chief with program responsibilities identifies a possible need for a new regulation... significant regulatory approach is developed, a significant regulatory project proposal is submitted to...

  1. MULTI-CENTER PRECISION OF CORTICAL AND TRABECULAR BONE QUALITY MEASURES ASSESSED BY HR-PQCT

    PubMed Central

    Burghardt, Andrew J.; Pialat, Jean-Baptiste; Kazakia, Galateia J.; Boutroy, Stephanie; Engelke, Klaus; Patsch, Janina M.; Valentinitsch, Alexander; Liu, Danmei; Szabo, Eva; Bogado, Cesar E.; Zanchetta, Maria Belen; McKay, Heather A.; Shane, Elizabeth; Boyd, Steven K.; Bouxsein, Mary L.; Chapurlat, Roland; Khosla, Sundeep; Majumdar, Sharmila

    2012-01-01

    High-resolution peripheral quantitative computed tomography (HR-pQCT) has recently been introduced as a clinical research tool for in vivo assessment of bone quality. The utility of this technique to address important skeletal health questions requires translation to standardized multi-center data pools. Our goal was to evaluate the feasibility of pooling data in multi-center HR-pQCT imaging trials. Reproducibility imaging experiments were performed using structure and composition-realistic phantoms constructed from cadaveric radii. Single-center precision was determined by repeat scanning over short (<72hrs), intermediate (3–5mo), and long-term intervals (28mo). Multi-center precision was determined by imaging the phantoms at nine different HR-pQCT centers. Least significant change (LSC) and root mean squared coefficient of variation (RMSCV) for each interval and across centers was calculated for bone density, geometry, microstructure, and biomechanical parameters. Single-center short-term RMSCVs were <1% for all parameters except Ct.Th (1.1%), Ct.Th.SD (2.6%), Tb.Sp.SD (1.8%), and porosity measures (6–8%). Intermediate-term RMSCVs were generally not statistically different from short-term values. Long-term variability was significantly greater for all density measures (0.7–2.0%; p < 0.05 vs. short-term) and several structure measures: Ct.Th (3.4%; p < 0.01 vs. short-term), Ct.Po (15.4%; p < 0.01 vs. short-term), and Tb.Th (2.2%; p < 0.01 vs. short-term). Multi-center RMSCVs were also significantly higher than short-term values: 2–4% for density and µFE measures (p < 0.0001), 2.6–5.3% for morphometric measures (p < 0.001), while Ct.Po was 16.2% (p < 0.001). In the absence of subject motion, multi-center precision errors for HR-pQCT parameters were generally less than 5%. Phantom-based multi-center precision was comparable to previously reported in vivo single-center precision errors, although this was approximately 2–5 times worse than ex vivo short

  2. 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.

  3. Feasibility and variability of measuring the Lung Clearance Index in a multi-center setting.

    PubMed

    Fuchs, Susanne I; Ellemunter, Helmut; Eder, Johannes; Mellies, Uwe; Grosse-Onnebrink, Jörg; Tümmler, Burkhard; Staab, Doris; Jobst, Andrea; Griese, Matthias; Ripper, Jan; Rietschel, Ernst; Zeidler, Susanne; Ahrens, Frank; Gappa, Monika

    2012-07-01

    The Lung Clearance Index (LCI) is superior to spirometry in detecting early lung disease in cystic fibrosis (CF) and correlates with structural lung changes seen on CT scans. The LCI has the potential to become a novel outcome parameter for clinical and research purposes. However longitudinal studies are required to further prove its prognostic value. Multi-center design is likely to facilitate realization of such studies. Therefore the aim of the present study was to assess multi-center feasibility and inter-center variability of LCI measurements in healthy children and adolescents. Comparative measurements were performed in unselected patients with CF to confirm previous single-center results. LCI measurements were performed in eight centers using the EasyOne Pro, MBW Module (ndd Medical Technologies, Zurich, Switzerland). The overall success rate for LCI measurements was 75.5%, leaving 102/151 measurements in healthy volunteers and 139/183 measurements in patients with CF for final analysis. Age ranged between 4 and 24 years. Mean LCI (range of means among centers) was 6.3 (6.0-6.5) in healthy volunteers and thus normal. Inter-center variability of center means was 2.9%, ANOVA including Schffé procedure demonstrated no significant inter-center differences (P > 0.05). Mean LCI (range of means among centers) was 8.2 (7.4-8.9) in CF and thus abnormal. Our study demonstrates good multi-center feasibility and low inter-center variability of the LCI in healthy volunteers when measured with the EasyOne Pro MBW module. Our data confirm published LCI data in CF. However, central coordination, quality control, regular training, and supervision during the entire study appear essential for successfully performing multi-center trials.

  4. OnWARD: ontology-driven web-based framework for multi-center clinical studies.

    PubMed

    Tran, Van-Anh; Johnson, Nathan; Redline, Susan; Zhang, Guo-Qiang

    2011-12-01

    With a large percentage of clinical trials still using paper forms as the primary data collection tool, there is much potential for increasing efficiency through web-based data collection systems, especially for large-scale multi-center trials. This paper presents OnWARD, an ontology-driven, secure, rapidly-deployed, web-based framework supporting data capture for large-scale multi-center clinical research. Our approach is developed using the agile methodology to provide a flexible, user-centered dynamic form generator, which can be quickly deployed and customized for any clinical study without the need of deep technical expertise. Because of the flexible framework, the data management system can be extended to accommodate a large variety of data types, including genetic, genomic and proteomic data. In this paper, we demonstrate the initial deployment of OnWARD for a Phase II multi-center clinical trial after a development period of merely three months. The study utilizes 23 clinical report forms containing more than 1500 data points. Preliminary evaluation results show that OnWARD exceeded expectations of the clinical investigators in efficiency, flexibility and ease in setting up.

  5. 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

  6. 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.

  7. Suicide prevention by lithium SUPLI--challenges of a multi-center prospective study.

    PubMed

    Lauterbach, Erik; Ahrens, Bernd; Felber, Werner; Oerlinghausen, Bruno Muller; Kilb, Birgit; Bischof, Gerd; Heuser, Isabella; Werner, Petra; Hawellek, Barbara; Maier, Wolfgang; Lewitzka, Ute; Pogarell, Oliver; Hegerl, Ulrich; Bronisch, Thomas; Richter, Kneginja; Niklewski, Günther; Broocks, Andreas; Hohagen, Fritz

    2005-01-01

    Several studies have shown that there is a significantly increased risk of suicide related mortality in patients with a positive history of suicide attempts. The SUPLI-Study is the first prospective, randomized, double blind, placebo controlled multi-center trial focusing on the proposed suicide preventive effects of lithium in patients with suicidal behavior but not suffering from bipolar disorder or recurrent major depressive disorder. Patients with a recent history of a suicide attempt are treated with lithium versus placebo during a 12 month period. The hypothesis is that lithium treatment will lead to a 50% reduction of suicidal behavior. The protocol of the study and preliminary results are presented.

  8. 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

  9. 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.

  10. Remission of rheumatoid arthritis and potential determinants: a national multi-center cross-sectional survey.

    PubMed

    Wang, Guan-Ying; Zhang, Sa-Li; Wang, Xiu-Ru; Feng, Min; Li, Chun; An, Yuan; Li, Xiao-Feng; Wang, Li-Zhi; Wang, Cai-Hong; Wang, Yong-Fu; Yang, Rong; Yan, Hui-Ming; Wang, Guo-Chun; Lu, Xin; Liu, Xia; Zhu, Ping; Chen, Li-Na; Jin, Hong-Tao; Liu, Jin-Ting; Guo, Hui-Fang; Chen, Hai-Ying; Xie, Jian-Li; Wei, Ping; Wang, Jun-Xiang; Liu, Xiang-Yuan; Sun, Lin; Cui, Liu-Fu; Shu, Rong; Liu, Bai-Lu; Yu, Ping; Zhang, Zhuo-Li; Li, Guang-Tao; Li, Zhen-Bin; Yang, Jing; Li, Jun-Fang; Jia, Bin; Zhang, Feng-Xiao; Tao, Jie-Mei; Lin, Jin-Ying; Wei, Mei-Qiu; Liu, Xiao-Min; Ke, Dan; Hu, Shao-Xian; Ye, Cong; Han, Shu-Ling; Yang, Xiu-Yan; Li, Hao; Huang, Ci-Bo; Gao, Ming; Lai, Bei; Cheng, Yong-Jing; Li, Xing-Fu; Song, Li-Jun; Yu, Xiao-Xia; Wang, Ai-Xue; Wu, Li-Jun; Wang, Yan-Hua; He, Lan; Sun, Wen-Wen; Gong, Lu; Wang, Xiao-Yuan; Wang, Yi; Zhao, Yi; Li, Xiao-Xia; Wang, Yan; Zhang, Yan; Su, Yin; Zhang, Chun-Fang; Mu, Rong; Li, Zhan-Guo

    2015-02-01

    The aim of this study is to investigate the remission rate of rheumatoid arthritis (RA) in China and identify its potential determinants. A multi-center cross-sectional study was conducted from July 2009 to January 2012. Data were collected by face-to-face interviews of the rheumatology outpatients in 28 tertiary hospitals in China. The remission rates were calculated in 486 RA patients according to different definitions of remission: the Disease Activity Score in 28 joints (DAS28), the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI), and the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition. Potential determinants of RA remission were assessed by univariate and multivariate analyses. The remission rates of RA from this multi-center cohort were 8.6% (DAS28), 8.4% (SDAI), 8.2% (CDAI), and 6.8% (Boolean), respectively. Favorable factors associated with remission were: low Health Assessment Questionnaire (HAQ) score, absence of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP), and treatment of methotrexate (MTX) and hydroxychloroquine (HCQ). Younger age was also predictive for the DAS28 and the Boolean remission. Multivariate analyses revealed a low HAQ score, the absence of anti-CCP, and the treatment with HCQ as independent determinants of remission. The clinical remission rate of RA patients was low in China. A low HAQ score, the absence of anti-CCP, and HCQ were significant independent determinants for RA remission.

  11. [Significance of Multi-center Obstetrics Perioperative Team Training Including Various Medical Staffs].

    PubMed

    Komasawa, Nobuyasu; Fujita, Daisuke; Nakayama, Mai; Fujiwara, Shunsuke; Mihara, Ryosuke; Okada, Daisuke; Omoto, Haruka; Tanaka, Motoshige; Nishihara, Isao; Minami, Toshiaki

    2016-02-01

    We report the development of a multi-center/multispecialist obstetrics perioperative team training program. Participants were members of the team, including anesthesiologists, obstetricians, and operation nurses. A questionnaire survey was conducted prior to course participation to clarify any questions team members had. The courses included a lecture and simulation training with scenario-based discussions or the use of a simulator. Scenarios included massive bleeding during cesarean section, massive bleeding after vaginal delivery, and emergency cesarean section for premature placental abruption. After each course, participants discussed problems associated with obstetrics medical safety in the context of each theme. Simulation-based perioperative team training with anesthesiologists, obstetricians, and operation nurses may serve as a vehicle to promote perioperative obstetrics patient safety.

  12. 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…

  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

    ... Multi- Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI... Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of Information Collection Request... several centers in Asia thereby increasing the cancer burden in these populations, but the causes...

  14. Multi-Center Prediction of Hemorrhagic Transformation in Acute Ischemic Stroke using Permeability Imaging Features

    PubMed Central

    Scalzo, Fabien; Alger, Jeffry R.; Hu, Xiao; Saver, Jeffrey L.; Dani, Krishna A.; Muir, Keith W.; Demchuk, Andrew M.; Coutts, Shelagh B.; Luby, Marie; Warach, Steven; Liebeskind, David S.

    2013-01-01

    Permeability images derived from magnetic resonance (MR) perfusion images are sensitive to blood-brain barrier derangement of the brain tissue and have been shown to correlate with subsequent development of hemorrhagic transformation (HT) in acute ischemic stroke. This paper presents a multi-center retrospective study that evaluates the predictive power in terms of HT of six permeability MRI measures including contrast slope (CS), final contrast (FC), maximum peak bolus concentration (MPB), peak bolus area (PB), relative recirculation (rR), and percentage recovery (%R). Dynamic T2*-weighted perfusion MR images were collected from 263 acute ischemic stroke patients from four medical centers. An essential aspect of this study is to exploit a classifier-based framework to automatically identify predictive patterns in the overall intensity distribution of the permeability maps. The model is based on normalized intensity histograms that are used as input features to the predictive model. Linear and nonlinear predictive models are evaluated using a crossvalidation to measure generalization power on new patients and a comparative analysis is provided for the different types of parameters. Results demonstrate that perfusion imaging in acute ischemic stroke can predict HT with an average accuracy of more than 85% using a predictive model based on a nonlinear regression model. Results also indicate that the permeability feature based on the percentage of recovery performs significantly better than the other features. This novel model may be used to refine treatment decisions in acute stroke. PMID:23587928

  15. 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.

  16. A multi-center randomized trial of two different intravenous fluids during labor

    PubMed Central

    DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

    2017-01-01

    Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

  17. Multi-center harmonization of flow cytometers in the context of the European "PRECISESADS" project.

    PubMed

    Jamin, Christophe; Le Lann, Lucas; Alvarez-Errico, Damiana; Barbarroja, Nuria; Cantaert, Tineke; Ducreux, Julie; Dufour, Aleksandra Maria; Gerl, Velia; Kniesch, Katja; Neves, Esmeralda; Trombetta, Elena; Alarcón-Riquelme, Marta; Marañon, Concepción; Pers, Jacques-Olivier

    2016-11-01

    The innovative medicine initiative project called PRECISESADS will study 2.500 individuals affected by systemic autoimmune diseases (SADs) and controls. Among extensive OMICS approaches, multi-parameter flow cytometry analyses will be performed in eleven different centers. Therefore, the integration of all data in common bioinformatical and biostatistical investigations requires a fine mirroring of all instruments. We describe here the procedure elaborated to achieve this prerequisite. One flow cytometer chosen as reference instrument fixed the mean fluorescence intensities (MFIs) of 8 different fluorochrome-conjugated antibodies (Abs) using VersaComp Ab capture beads. The ten other centers adjusted their own PMT voltages to reach the same MFIs. Subsequently, all centers acquired Rainbow 8-peak beads data on a daily basis to follow the stability of their instrument overtime. One blood sample has been dispatched and concomitantly stained in all centers. Comparison of leukocytes frequencies and cell surface marker MFIs demonstrated the close sensitivity of all flow cytometers, allowing a multicenter analysis. The effective multi-center harmonization enables the constitution of a workable wide flow cytometry database for the identification of specific molecular signatures in individuals with SADs.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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

  3. 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.

  4. The costs in provision of haemodialysis in a developing country: A multi-centered study

    PubMed Central

    2011-01-01

    This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists. PMID:21896190

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

    DOE PAGES

    Ryu, H.; Lei, H.; Klobes, B.; ...

    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.

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. Evaluating the Discriminatory Power of a Computer-based System for Assessing Penetrating Trauma on Retrospective Multi-Center Data

    PubMed Central

    Matheny, Michael E.; Ogunyemi, Omolola I.; Rice, Phillip L.; Clarke, John R.

    2005-01-01

    Objective To evaluate the discriminatory power of TraumaSCAN-Web, a system for assessing penetrating trauma, using retrospective multi-center case data for gunshot and stab wounds to the thorax and abdomen. Methods 80 gunshot and 114 stab cases were evaluated using TraumaSCAN-Web. Areas under the Receiver Operator Characteristic Curves (AUC) were calculated for each condition modeled in TraumaSCAN-Web. Results Of the 23 conditions modeled by TraumaSCAN-Web, 19 were present in either the gunshot or stab case data. The gunshot AUCs ranged from 0.519 (pericardial tamponade) to 0.975 (right renal injury). The stab AUCs ranged from 0.701 (intestinal injury) to 1.000 (tracheal injury). PMID:16779090

  13. 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

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    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.

  14. 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

  15. 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

  16. Mid-rapidity pion cross sections: new data confront theories. [1. 05 GeV/A

    SciTech Connect

    Frankel, K.A.; Bistirlich, J.A.; Bossingham, R.

    1981-07-01

    Pion production by collisions of relativistic heavy ions has been studied recently by Wolf et al. For the reaction 1.05 GeV/A /sup 40/Ar + Ca ..-->.. ..pi../sup +/, they discovered a peak in the invariant cross section at mid-rapidity at P/sub perpendicular/ approx. 0.5 m/sub ..pi../c. This peak is not apparent in the 730 MeV p/sup +/p data of Cochran et al. and was attributed to possible hydrodynamic flow effects. Several authors have suggested that the ..pi../sup +/ peak is a Coulomb effect. These models predict the ..pi../sup -/ would be drawn in towards the fireball, leaving an essentially flat distribution in the mid-rapidity region. Mid-rapidity ..pi../sup +/ and ..pi../sup -/ cross sections were measured using a 1.05 GeV/A argon beam with a calcium target. The pions were measured with a magnetic spectrometer set at 15/sup 0/ to the beam and were stopped in a scintillator range telescope. Results are presented and discussed. (WHK)

  17. Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

    PubMed Central

    Choi, Chang Won

    2015-01-01

    The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated proof checks, electronic data validation, query creation, query resolution, and revalidation of the corrected data. SVM included SVM team organization, identification of unregistered cases, source document verification, and post-visit report production. By March 31, 2015, 4,063 VLBW infants were registered and 1,693 queries were produced. Of these, 1,629 queries were resolved and 64 queries remain unresolved. By November 28, 2014, 52 participating hospitals were visited, with 136 site-visits completed since April 2013. Each participating hospital was visited biannually. DM and SVM were performed to ensure the quality of the data collected for the KNN registry. Our experience with DM and SVM can be applied for similar multi-center registries with large numbers of participating centers. PMID:26566353

  18. Evaluation of a Teleform-based data collection system: A multi-center obesity research case study

    PubMed Central

    Jenkins, Todd M.; Boyce, Tawny Wilson; Akers, Rachel; Andringa, Jennifer; Liu, Yanhong; Miller, Rosemary; Powers, Carolyn; Buncher, C. Ralph

    2016-01-01

    Utilizing electronic data capture (EDC) systems in data collection and management allows automated validation programs to preemptively identify and correct data errors. For our multi-center, prospective study we chose to use TeleForm, a paper-based data capture software that uses recognition technology to create case report forms (CRFs) with similar functionality to EDC, including custom scripts to identify entry errors. We quantified the accuracy of the optimized system through a data audit of CRFs and the study database, examining selected critical variables for all subjects in the study, as well as an audit of all variables for 25 randomly selected subjects. Overall we found 6.7 errors per 10,000 fields, with similar estimates for critical (6.9/10,000) and non-critical (6.5/10,000) variables – values that fall below the acceptable quality threshold of 50 errors per 10,000 established by the Society for Clinical Data Management. However, error rates were found to widely vary by type of data field, with the highest rate observed with open text fields. PMID:24709056

  19. A new design of a polysomnography-based multi-center treatment study for the restless legs syndrome.

    PubMed

    Penzel, T; Brandenburg, U; Peter, J H; Otto, R; Hundemer, H P; Lledo, A; Wetter, T C; Trenkwalder, C

    2002-04-01

    Periodic limb movements (PLM) cause sleep disorders and daytime symptoms and are frequently associated with restless legs syndrome (RLS). Treatment of RLS with increased PLM during sleep (PLMS) has been evaluated in studies limited in size, methodology and study length. This long-term, placebo-controlled, multi-center, study with polysomnography (PSG) recordings has been designed in order to assess efficacy and safety parameters of pergolide treatment in RLS. This novel approach for a study was created to assure consistently high quality of sleep recording and analysis. Using defined criteria, 21 sleep centers were approved for the study after a pilot phase. Seventeen centers with 16 different PSG systems randomized 100 patients. Digital sleep recordings from 4 visits (baseline, 6 weeks, 6 months, 1 year) were submitted to one central evaluation center following previously defined standardized operating procedures. Visual scoring of all recordings was performed by one independent scorer. Reliability of scoring was evaluated for 20 randomly selected baseline recordings. The mean epoch by epoch agreement for sleep stages was 88% (range 81-96%), mean arousal re-scoring differed by 0.5 (range: -16 to 20), and mean PLM index re-scoring differed by 0.1 (range: -1.5 to 2.1). Using one scorer with a demonstrated high reliability in PSG scoring for all sleep recordings was very effective in terms of study cost, study duration, and data quality.

  20. Stability of R2* and quantitative susceptibility mapping of the brain tissue in a large scale multi-center study

    PubMed Central

    Wang, Rongpin; Xie, Guangyou; Zhai, Maoxiong; Zhang, Zhongping; Wu, Bing; Zheng, Dandan; Hong, Nan; Jiang, Tao; Wen, Baohong; Cheng, Jingliang

    2017-01-01

    Multi-center studies are advantageous for enrolling participants of varying pathological and demographical conditions, and especially in neurological studies. Hence stability of the obtained quantitative R2* and susceptibility in multicenter studies is a key issue for their widespread applications. In this work, the stabilities of simultaneously obtained R2* and susceptibility are investigated and compared across 10 sites that are equipped with the same scanner and receiver coil, the same post-processing process was used to achieve consistent experiment setup. Two healthy adult volunteers (one male and female) participated in this study. High intraclass correlation coefficient was obtained for both susceptibility (0.94) and R2* (0.96). The coefficients of variance for all measurements obtained were smaller than 0.1, the largest variations of measurements in all the chosen ROIs fall within ±20% from the median value. Higher level of stability was obtained in R2* as compared to susceptibility at 1 mm resolution (P < 0.05) and at 1.5 mm (P < 0.01). PMID:28349957

  1. Photoabsorption of ag (n = 6 - 6000) Clusters in he Droplets: a Transition from - to Multi-Centered Growth

    NASA Astrophysics Data System (ADS)

    Gomez, Luis F.; Loginov, Evgeny; Sliter, Russell; Vilesov, Andrey F.; Halder, Avik; Chiang, Naihao; Guggemos, Nicholas; Kresin, Vitaly V.

    2012-06-01

    Ag clusters with up to thousands of atoms were grown in large He droplets and studied by optical spectroscopy. For clusters smaller than about 103 the spectra are dominated by a surface plasmon resonance near 3.8 eV and a broad feature in the UV, consistent with the absorption of individual metallic particles. Larger Ag clusters reveal an unexpectedly strong, broad absorption extending to lower frequencies down to approximately 0.5 eV. This suggests a transition from single-center to multi-center formation, in agreement with estimates of the kinetics of Ag cluster growth in He droplets. Moreover, the spectra of large clusters develop a characteristic dispersion profile at 3.5-4.5 eV, indicative of the coexistence of localized and delocalized electronic excitations in composite clusters, as predicted theoretically. We also report on the characterization of He droplet beams, obtained in the supercritical expansion regime, comprised of large droplets of up to 1011 atoms.

  2. Stability of R2* and quantitative susceptibility mapping of the brain tissue in a large scale multi-center study.

    PubMed

    Wang, Rongpin; Xie, Guangyou; Zhai, Maoxiong; Zhang, Zhongping; Wu, Bing; Zheng, Dandan; Hong, Nan; Jiang, Tao; Wen, Baohong; Cheng, Jingliang

    2017-03-28

    Multi-center studies are advantageous for enrolling participants of varying pathological and demographical conditions, and especially in neurological studies. Hence stability of the obtained quantitative R2* and susceptibility in multicenter studies is a key issue for their widespread applications. In this work, the stabilities of simultaneously obtained R2* and susceptibility are investigated and compared across 10 sites that are equipped with the same scanner and receiver coil, the same post-processing process was used to achieve consistent experiment setup. Two healthy adult volunteers (one male and female) participated in this study. High intraclass correlation coefficient was obtained for both susceptibility (0.94) and R2* (0.96). The coefficients of variance for all measurements obtained were smaller than 0.1, the largest variations of measurements in all the chosen ROIs fall within ±20% from the median value. Higher level of stability was obtained in R2* as compared to susceptibility at 1 mm resolution (P < 0.05) and at 1.5 mm (P < 0.01).

  3. 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.

  4. 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.

  5. A multi-center survey of childhood asthma in Turke--I: the cost and its determinants.

    PubMed

    Beyhun, Nazim E; Soyer, Ozge U; Kuyucu, Semanur; Sapan, Nihat; Altintaş, Derya U; Yüksel, Hasan; Anlar, Fehmi Y; Orhan, Fazil; Cevit, Omer; Cokuğras, Haluk; Boz, Ayşen B; Yazicioğlu, Mehtap; Tanaç, Remziye; Sekerel, Bülent E

    2009-02-01

    Successful management of childhood asthma requires a thorough idea of the economic impact of asthma and its determinants, as policy makers and physicians inevitably influence the outcome. The aim of this study was to define the cost of childhood asthma in Turkey and its determinants. In April 2006, a multi-center, national study was performed where data regarding cost and control levels were collected. Asthmatic children (6-18 yr) with at least a 1-yr follow-up seen during a 1-month period with scheduled or unscheduled visits were included. The survey included a questionnaire-guided interview and retrospective evaluation of files. Cost and its determinants during the last year were analyzed. A total of 618 children from 12 asthma centers were surveyed. The total annual cost of childhood asthma was US$1597.4 +/- 236.2 and there was a significant variation in costs between study centers (p < 0.05). Frequent physician visits [odds ratio (95% confidence intervals)] [2.3 (1.6-3.4)], hospitalization [1.9 (1.1-3.3)], asthma severity [1.6 (1.1-2.8)], and school absenteeism due to asthma [1.5 (1.1-2.1)] were major predictors of total annual costs (p < 0.05 for each). The comparable cost of asthma among Turkish children with that reported in developed countries suggests that interventions to decrease the economic burden of pediatric asthma should focus on the cost-effectiveness of anti-allergic household measures and on improving the control levels of asthma.

  6. 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.

  7. 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.

  8. 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

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

    PubMed

    Moore, Sara E; Decker, Anna; 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

  10. 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

  11. [Evaluation of the Effectiveness and Safety in a Multi-center Clinical Trial of VIBRANT SOUNDBRIDGE in Japan].

    PubMed

    Doi, Katsumi; Kanzaki, Sho; Kumakawa, Kozo; Usami, Shin-ichi; Iwasaki, Satoshi; Yamanaka, Noboru; Naito, Yasushi; Gyo, Kiyofumi; Tono, Tetsuya; Takahashi, Haruo; Kanda, Yukihiko

    2015-12-01

    Middle ear implants (MEIs) such as the Vibrant Soundbridge (VSB) are attractive and alternative treatments for patients with conductive, sensorineural, and mixed hearing loss who do not benefit from, or who choose not to wear, conventional hearing aids (HAs). Recent studies suggest that MEIs can provide better improvements in functional gain, speech perception, and quality of life than HAs, although there are certain risks associated with the surgery which should be taken into consideration, including facial nerve or chorda tympanic nerve damage, dysfunctions of the middle and inner ears, and future device failure/explantation. In Japan, a multi-center clinical trial of VSB was conducted between 2011-2014. A round window vibroplasty via the transmastoid approach was adopted in the protocol. The bony lip overhanging the round window membrane (RWM) was extensively but very carefully drilled to introduce the Floating Mass Transducer (FMT). Perichondrium sheets were used to stabilize the FMT onto the RWM. According to the audiological criteria, the upper limit of bone conduction should be 45 dB, 50 dB, and 65 dB from 500 Hz to 4, 000 Hz. Twenty-five patients underwent the surgery so far at 13 different medical centers. The age at the surgery was between 26-79 years old, and there were 15 males and 10 females. The cause of conductive or mixed hearing loss was middle ear diseases in 23 cases and congenital aural atresia in two cases. The data concerning on the effectiveness and safety of VSB was collected before the surgery and 20 weeks after the surgery. Significant improvements of free-field Pure Tone Audiogram (PTA) from 250 Hz to 8, 000 Hz were confirmed (p < 0.001). Hearing gain up to 40 dB was achieved in the 1, 000 Hz to 4, 000 Hz range. No deterioration in either air conduction or bone conduction at PTA was noted at 20 weeks after the surgery. Monosyllable speech perception in both quiet and noisy conditions improved significantly (p < 0.001). The speech

  12. 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

  13. 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

  14. Anti-nuclear antibodies as predictor of outcome in a multi-center cohort of Italian children and adolescents with Raynaud's phenomenon.

    PubMed

    Falcini, Fernanda; Rigante, Donato; Candelli, Marcello; Martini, Giorgia; Corona, Fabrizia; Petaccia, Antonella; La Torre, Francesco; Raffaele, Carmela G L; Matucci Cerinic, Marco

    2015-01-01

    A retrospective multi-center data collection of clinical, laboratory, and treatment characteristics of 94 Caucasian children and adolescents with Raynaud's phenomenon (RP) started at a mean age of 12.8 ± 5 years, with variable involvement of hands, feet, and face, was performed for a period of 3 years. Collected data included nailfold videocapillaroscopy (NVC), lung function tests, and different laboratory tests finalized to characterize an eventual connective tissue disease (CTD), disclosed by RP itself. Twelve patients presented an early-scleroderma pattern at NVC, 1 a late-scleroderma pattern, and 58 a nonspecific pattern. Laboratory data results showed the positivity of anti-nuclear antibodies (ANA) in 29 % of patients. After this 3-year period of observation, 8 patients had developed a CTD. Our data examined by multivariate analysis, though limited to a multi-center cohort of pediatric patients with RP, strongly suggest that ANA positivity is a significant predictor of progression of RP towards a CTD.

  15. International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

    PubMed Central

    Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

    2015-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

  16. Overview of the first Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) experiment: Conversion of a ground-based lidar for airborne applications

    SciTech Connect

    Howell, J.N.; Hardesty, R.M.; Rothermel, J.; Menzies, R.T.

    1996-12-31

    The first Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) field experiment demonstrated an airborne high energy TEA CO{sub 2} 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 three-dimensional winds and backscatter fields, promises to be a valuable tool for climate and global change, severe weather, and air quality research. In this paper, the authors describe the airborne instrument, assess its performance, discuss future improvements, and show some preliminary results from September experiments.

  17. Anti-HMGCR antibodies as a biomarker for immune-mediated necrotizing myopathies: A history of statins and experience from a large international multi-center study.

    PubMed

    Musset, Lucile; Allenbach, Yves; Benveniste, Olivier; Boyer, Olivier; Bossuyt, Xavier; Bentow, Chelsea; Phillips, Joe; Mammen, Andrew; Van Damme, Philip; Westhovens, René; Ghirardello, Anna; Doria, Andrea; Choi, May Y; Fritzler, Marvin J; Schmeling, Heinrike; Muro, Yoshinao; García-De La Torre, Ignacio; Ortiz-Villalvazo, Miguel A; Bizzaro, Nicola; Infantino, Maria; Imbastaro, Tiziana; Peng, Qinglin; Wang, Guochun; Vencovský, Jiří; Klein, Martin; Krystufkova, Olga; Franceschini, Franco; Fredi, Micaela; Hue, Sophie; Belmondo, Thibaut; Danko, Katalin; Mahler, Michael

    2016-10-01

    In an effort to find naturally occurring substances that reduce cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), statins were first discovered by Endo in 1972. With the widespread prescription and use of statins to decrease morbidity from myocardial infarction and stroke, it was noted that approximately 5% of all statin users experienced muscle pain and weakness during treatment. In a smaller proportion of patients, the myopathy progressed to severe morbidity marked by proximal weakness and severe muscle wasting. Remarkably, Mammen and colleagues were the first to discover that the molecular target of statins, 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), is an autoantibody target in patients that develop an immune-mediated necrotizing myopathy (IMNM). These observations have been confirmed in a number of studies but, until today, a multi-center, international study of IMNM, related idiopathic inflammatory myopathies (IIM), other auto-inflammatory conditions and controls has not been published. Accordingly, an international, multi-center study investigated the utility of anti-HMGCR antibodies in the diagnosis of statin-associated IMNM in comparison to different forms of IIM and controls. This study included samples from patients with different forms of IIM (n=1250) and patients with other diseases (n=656) that were collected from twelve sites and tested for anti-HMGCR antibodies by ELISA. This study confirmed that anti-HMGCR autoantibodies, when found in conjunction with statin use, characterize a subset of IIM who are older and have necrosis on muscle biopsy. Taken together, the data to date indicates that testing for anti-HMGCR antibodies is important in the differential diagnosis of IIM and might be considered for future classification criteria.

  18. Apparent diffusion coefficient histogram analysis stratifies progression-free and overall survival in patients with recurrent GBM treated with bevacizumab: a multi-center study.

    PubMed

    Pope, Whitney B; Qiao, Xin Joe; Kim, Hyun J; Lai, Albert; Nghiemphu, Phioanh; Xue, Xi; Ellingson, Benjamin M; Schiff, David; Aregawi, Dawit; Cha, Soonmee; Puduvalli, Vinay K; Wu, Jing; Yung, Wai-Kwan A; Young, Geoffrey S; Vredenburgh, James; Barboriak, Dan; Abrey, Lauren E; Mikkelsen, Tom; Jain, Rajan; Paleologos, Nina A; Rn, Patricia Lada; Prados, Michael; Goldin, Jonathan; Wen, Patrick Y; Cloughesy, Timothy

    2012-07-01

    We have tested the predictive value of apparent diffusion coefficient (ADC) histogram analysis in stratifying progression-free survival (PFS) and overall survival (OS) in bevacizumab-treated patients with recurrent glioblastoma multiforme (GBM) from the multi-center BRAIN study. Available MRI's from patients enrolled in the BRAIN study (n = 97) were examined by generating ADC histograms from areas of enhancing tumor on T1 weighted post-contrast images fitted to a two normal distribution mixture curve. ADC classifiers including the mean ADC from the lower curve (ADC-L) and the mean lower curve proportion (LCP) were tested for their ability to stratify PFS and OS by using Cox proportional hazard ratios and the Kaplan-Meier method with log-rank test. Mean ADC-L was 1,209 × 10(-6)mm(2)/s ± 224 (SD), and mean LCP was 0.71 ± 0.23 (SD). Low ADC-L was associated with worse outcome. The hazard ratios for 6-month PFS, overall PFS, and OS in patients with less versus greater than mean ADC-L were 3.1 (95 % confidence interval: 1.6, 6.1; P = 0.001), 2.3 (95 % CI: 1.3, 4.0; P = 0.002), and 2.4 (95 % CI: 1.4, 4.2; P = 0.002), respectively. In patients with ADC-L <1,209 and LCP >0.71 versus ADC-L >1,209 and LCP <0.71, there was a 2.28-fold reduction in the median time to progression, and a 1.42-fold decrease in the median OS. The predictive value of ADC histogram analysis, in which low ADC-L was associated with poor outcome, was confirmed in bevacizumab-treated patients with recurrent GBM in a post hoc analysis from the multi-center (BRAIN) study.

  19. 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.

  20. 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.

  1. Not Only Sleepwalking But NREM Parasomnia Irrespective of the Type Is Associated with HLA DQB1*05:01

    PubMed Central

    Heidbreder, Anna; Frauscher, Birgit; Mitterling, Thomas; Boentert, Matthias; Schirmacher, Anja; Hörtnagl, Paul; Schennach, Harald; Massoth, Christina; Happe, Svenja; Mayer, Geert; Young, Peter; Högl, Birgit

    2016-01-01

    Study Objectives: Despite the high prevalence and clinical relevance of NREM parasomnias, data on supportive genetic markers are scarce, and mainly refer to sleepwalking only. Methods: We retrospectively analyzed clinical, polysomnographic, and HLA findings of 74 adults (37 men) with NREM parasomnia gathered from four neurological sleep centers. Parasomniac events were classified according to ICSD-2 criteria. HLA DQB1 genotyping was compared to regional-matched reference allele-frequencies. Results: Fifty-six patients had more than 2 different parasomnia type: 11 sleepwalking, 4 sleep terrors, 3 confusional arousals only. Parasomniac events were documented during video-polysomnography (V-PSG) in 70% (49/70) of subjects (71.4% confusional arousals, 8.2% sleep terrors, 4.1% sleepwalking, 16.3% ≥ 2 NREM parasomnia types). Violent behavior during V-PSG occurred in 8.5% (6/71). NREM parasomnia onset was reported after the age of 30 years in 6.8% (5/74). The HLA DQB1*05:01 allele was present in 41% (29/71) compared to 24.2% in the regional-matched reference allele group (p < 0.05). This haplotype prevalence did not differ within the NREM parasomnia type. Epworth Sleepiness Score was 10 or higher in 28.6%. Conclusions: This is a large polysomnography-based case series of patients with NREM parasomnia. In patients with suspected sleepwalking or sleep terrors, polysomnography is highly useful in detecting arousals from NREM sleep as a marker of NREM parasomnia. We confirmed previous findings by demonstrating a high prevalence of the HLA DQB1*05:01 genotype for different types of NREM parasomnias. Our findings therefore support a common genetic background, and corroborate the importance of video-polysomnography in the work-up of parasomnia. Citation: Heidbreder A, Frauscher B, Mitterling T, Boentert M, Schirmacher A, Hörtnagl P, Schennach H, Massoth C, Happe S, Mayer G, Young P. Not only sleepwalking but NREM parasomnia irrespective of the type is associated with HLA DQB1*05

  2. 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.

  3. 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.

  4. 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

  5. Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

    PubMed

    Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

    2017-01-01

    We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

  6. Dento-alveolar and maxillofacial injuries: a 5-year multi-center study. Part 1: general vs facial and dental trauma.

    PubMed

    Lin, Shaul; Levin, Liran; Goldman, Sharon; Peleg, Kobi

    2008-02-01

    Maxillofacial injuries are a significant cause of morbidity and demand meticulously planned treatment. The aim of this present multi-center study was to evaluate the occurrence of dento-alveolar and maxillofacial injuries over a 5-year period. A retrospective cohort study of data from the Israel Trauma Registry was conducted for the years 2000-2004. The registry includes all trauma patients admitted and hospitalized due to an injury. Of the 111,010 hospitalized trauma patients, 5886 (5.3%) were diagnosed with maxillofacial or dental injuries. The main causes of injuries for hospitalized trauma patients were falls (48.1%) and motor vehicle accidents (25.2%), while the major causes of facial and dental injuries were vehicle accidents (39.6%, 56.8%, respectively) and falls (32.1%, 26.7%, respectively). High-risk age groups for dental and facial trauma were 10-18 years and 19-28 years, respectively, while for other trauma, ages for the greatest risk ranged from 0 to 9 years and over 59 years. Males were injured two to three times more frequently than females. A better understanding of the etiology of maxillofacial and dental injuries and identifying the high-risk groups should lead to appropriate prevention programs and treatment methods.

  7. 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.

  8. 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

  9. Multi-Center Pilot Study to Evaluate the Safety Pro le of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis.

    PubMed

    Cohen, Joel L; Weiner, Steven F; Pozner, Jason N; Ibrahimi, Omar A; Vasily, David B; Ross, E Victor; Gabriel, Zena

    2016-11-01

    In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime. J Drugs Dermatol. 2016;15(11):1308-1312..

  10. 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.

  11. 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.

  12. Depressive Symptoms Correlate with Disability and Disease Course in Multiple Sclerosis Patients: An Italian Multi-Center Study Using the Beck Depression Inventory

    PubMed Central

    Solaro, C.; Trabucco, E.; Signori, A.; Martinelli, V.; Radaelli, M.; Centonze, D.; Rossi, S.; Grasso, M. G.; Clemenzi, A.; Bonavita, S.; D’Ambrosio, A.; Patti, F.; D’Amico, E.; Cruccu, G.; Truini, A.

    2016-01-01

    Background Depression occurs in about 50% of patients with multiple sclerosis. The aims of this study was to investigate the prevalence of depressive symptoms in a multicenter MS population using the Beck Depression Inventory II (BDI II) and to identify possible correlations between the BDI II score and demographic and clinical variables. Methods Data were collected in a multi-center, cross-sectional study over a period of six months in six MS centers in Italy using BDI II. Results 1,011 MS patients participated in the study. 676 subjects were female, with a mean age of 34 years (SD 10.8), mean EDSS of 3.3 (0–8.5) and mean disease duration of 10.3 years (range 1–50 years). 668 (%) subjects scored lower than 14 on the BDI II and 343 (33.9%) scored greater than 14 (14 cut-off score). For patients with BDI>14 multivariate analysis showed a significant difference between EDSS and disease course. BDI II scores for subjects with secondary progressive (SP) MS were significantly different from primary progressive (PP) patients (p < 0.001) but similar to relapsing-remitting (RR) patients. Considering subjects with moderate to severe depressive symptoms (BDI II score from 20–63), in relation to disease course, 11.7% (83/710) had RR MS, 40.7% (96/236) SP and 13.6% (6/44) PP. Conclusions Using the BDI II, 30% of the current sample had depressive symptoms. BDI II score correlates with disability and disease course, particularly in subjects with SP MS. The BDI II scale can be a useful tool in clinical practice to screen depressive symptoms in people with MS. PMID:27632167

  13. Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy.

    PubMed

    Schicho, Andreas; Pereira, Philippe L; Pützler, Manfred; Michalik, Katharina; Albrecht, Thomas; Nolte-Ernsting, Claus; Stroszczynski, Christian; Wiggermann, Philipp

    2017-02-13

    BACKGROUND The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). MATERIAL AND METHODS This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. RESULTS Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). CONCLUSIONS The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime.

  14. Treatment of class II furcation involvements in humans with bioresorbable and nonresorbable guided tissue regeneration barriers. A randomized multi-center study.

    PubMed

    Hugoson, A; Ravald, N; Fornell, J; Johard, G; Teiwik, A; Gottlow, J

    1995-07-01

    In this multi-center study 38 patients with contralateral molar Class II furcation defects were treated with GTR therapy using a bioresorbable matrix barrier (test) and a nonresorbable expanded polytetrafluoroethylene (ePTFE) barrier (control). Following flap elevation, scaling, root planing, and removal of granulation tissue, each device was adjusted to cover the furcation defect. The flaps were repositioned and sutured to complete coverage of the barriers. A second surgical procedure was performed at control sites after 4 to 6 weeks to remove the nonresorbable barrier. Before treatment and 12 months postsurgery all patients were examined and probing depths, clinical attachment levels, and position of the gingival margin were recorded. The primary response variable was the change in clinical attachment level in a horizontal direction (CAL-H change). Both treatment procedures reduced the probing depths (P < or = 0.001). Statistically significant gain of clinical attachment level in both horizontal and vertical direction was found at the test sites. At control sites gain of attachment in horizontal direction was statistically significant. The gain of CAL-H was 2.2 mm at test sites compared to 1.4 mm at control sites (P < or = 0.05). At test sites, the gingival margin was maintained close to the pre-surgical level (0.3 mm), whereas at control sites gingival recession was evident (0.9 mm), the difference being statistically significant (P < or = 0.01). Postsurgical complications, such as swelling and pain were more frequent following the control treatment (P < or = 0.05).

  15. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    PubMed

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2016-07-22

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION(®)). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION(®) (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION(®). All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  16. 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

  17. Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy

    PubMed Central

    Schicho, Andreas; Pereira, Philippe L.; Pützler, Manfred; Michalik, Katharina; Albrecht, Thomas; Nolte-Ernsting, Claus; Stroszczynski, Christian; Wiggermann, Philipp

    2017-01-01

    Background The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). Material/Methods This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. Results Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). Conclusions The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime. PMID:28192388

  18. 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

  19. Tripartite Stratification of the Glasgow Coma Scale in Children with Severe Traumatic Brain Injury and Mortality: An Analysis from a Multi-Center Comparative Effectiveness Study.

    PubMed

    Murphy, Sarah; Thomas, Neal J; Gertz, Shira J; Beca, John; Luther, James F; Bell, Michael J; Wisniewski, Stephen R; Hartman, Adam L; Tasker, Robert C

    2017-02-27

    The Glasgow Coma Scale (GCS) score has not been validated in children younger than 5 years and the clinical circumstances at the time of assignment can limit its applicability. This study describes the distribution of GCS scores in the population, the relationship between injury characteristics with the GCS score, and the association between the tripartite stratification of the GCS on mortality in children with severe traumatic brain injury (TBI). The first 200 children from a multi-center comparative effectiveness study in severe TBI (inclusion criteria: age 0-18 years, GCS ≤8 at the time of intracranial pressure [ICP] monitoring) were analyzed. After tripartite stratification of GCS scores (Group A, GCS 3; Group B, GCS 4 - 5; and Group C, GCS 6 - 8), analyses of variance and chi-square testing were performed. Mean age was 7.61 years ±5.33 and mortality was 19.1%. There was no difference in etiology or type/mechanism of injury between groups. However, groups demonstrated differences in neuromuscular blockade, endotracheal intubation, pre-hospital events (cardiac arrest and apnea), coagulopathy, and pupil response. Mortality between groups was different (42.2% Group A, 22.6% Group B, and 3.8% Group C; p < 0.001), and adding pupil response improved mortality associations. In children younger than 5 years of age, a similar relationship between GCS and mortality was observed. Overall, GCS score at the time of ICP monitor placement is strongly associated with mortality across the pediatric age range. Development of models with GCS and other factors may allow identification of subtypes of children after severe TBI for future studies.

  20. Low Dose Parenteral Soybean Oil for the Prevention of Parenteral Nutrition Associated Liver Disease in Neonates with Gastrointestinal Disorders: a Multi-Center Randomized Controlled Pilot Study

    PubMed Central

    Calkins, Kara L.; Havranek, Thomas; Kelley-Quon, Lorraine I.; Cerny, Laura; Flores, Martiniano; Grogan, Tristan; Shew, Stephen B.

    2015-01-01

    Background Neonates with gastrointestinal disorders (GD) are at high risk for parenteral nutrition associated liver disease (PNALD). Soybean-based intravenous lipid emulsions (S-ILE) have been associated with PNALD. This study’s objective was to determine if a lower dose when compared to a higher dose of S-ILE prevents cholestasis without compromising growth. Material and Methods This multi-center randomized controlled pilot study enrolled subjects with GD who were ≤ 5 days of age to a low dose (approximately 1 g/kg/day) (LOW) or control dose of S-ILE (approximately 3 g/kg/day) (CON). The primary outcome was cholestasis (direct bilirubin (DB) > 2 mg/dL) after the first seven days of age. Secondary outcomes included growth, PN duration, and late onset sepsis. Results Baseline characteristics were similar between the LOW (n=20) and CON groups (n=16). When the LOW group was compared to the CON group, there was no difference in cholestasis (30% vs. 38%, p=0.7) or secondary outcomes. However, mean (±SE) DB rate of change over the first eight weeks (0.07±0.04 vs. 0.3±0.09 mg/dL/week, p=0.01) and entire study (0.008±0.03 vs. 0.2±0.07 mg/dL/week, p=0.02) was lower in the LOW group when compared to the CON group. Conclusion In neonates with GD who received a lower dose of S-ILE, DB increased at a slower rate in comparison to neonates who received a higher dose of S-ILE. Growth was comparable between the groups. This study demonstrates a need for a larger, randomized controlled trial comparing two different S-ILE doses for cholestasis prevention in neonates at risk for PNALD. PMID:26024828

  1. 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

  2. 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

  3. 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

  4. 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

  5. A Multi-center Clinical Study of Posterior Lumbar Interbody Fusion with the Expandable Stand-alone Cage (Tyche® Cage) for Degenerative Lumbar Spinal Disorders

    PubMed Central

    Kim, Jin Wook; Yoon, Seung Hwan; Oh, Seong Hoon; Roh, Sung Woo; Rim, Dae Cheol; Kim, Tae Sung

    2007-01-01

    Objective This multi-center clinical study was designed to determine the long-term results of patients who received a one-level posterior lumbar interbody fusion with expandable cage (Tyche® cage) for degenerative spinal diseases during the same period in each hospital. Methods Fifty-seven patients with low back pain who had a one-level posterior lumbar interbody fusion using a newly designed expandable cage were enrolled in this study at five centers from June 2003 to December 2004 and followed up for 24 months. Pain improvement was checked with a Visual Analogue Scale (VAS) and their disability was evaluated with the Oswestry Disability Index. Radiographs were obtained before and after surgery. At the final follow-up, dynamic stability, quality of bone fusion, interveretebral disc height, and lumbar lordosis were assessed. In some cases, a lumbar computed tomography scan was also obtained. Results The mean VAS score of back pain was improved from 6.44 points preoperatively to 0.44 at the final visit and the score of sciatica was reduced from 4.84 to 0.26. Also, the Oswestry Disability Index was improved from 32.62 points preoperatively to 18.25 at the final visit. The fusion rate was 92.5%. Intervertebral disc height, recorded as 9.94±2.69 mm before surgery was increased to 12.23±3.31 mm at postoperative 1 month and was stabilized at 11.43±2.23 mm on final visit. The segmental angle of lordosis was changed significantly from 3.54±3.70° before surgery to 6.37±3.97° by 24 months postoperative, and total lumbar lordosis was 20.37±11.30° preoperatively and 24.71±11.70° at 24 months postoperative. Conclusion There have been no special complications regarding the expandable cage during the follow-up period and the results of this study demonstrates a high fusion rate and clinical success. PMID:19096552

  6. 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.

  7. Measurement of the e+e-→K+K- cross section in the energy range √{s }=1.05 -2.0 GeV

    NASA Astrophysics Data System (ADS)

    Achasov, M. N.; Aulchenko, V. M.; Barnyakov, A. Yu.; Barnyakov, M. Yu.; Beloborodov, K. I.; Berdyugin, A. V.; Berkaev, D. E.; Bogdanchikov, A. G.; Botov, A. A.; Buzykaev, A. R.; Dimova, T. V.; Druzhinin, V. P.; Golubev, V. B.; Kardapoltsev, L. V.; Kharlamov, A. G.; Kononov, S. A.; Koop, I. A.; Korol, A. A.; Koshuba, S. V.; Kovrizhin, D. P.; Kravchenko, E. A.; Kupich, A. S.; Lysenko, A. P.; Martin, K. A.; Obrazovsky, A. E.; Onuchin, A. P.; Otboyev, A. V.; Pakhtusova, E. V.; Perevedentsev, E. A.; Rogovsky, Yu. A.; Serednyakov, S. I.; Shatunov, Yu. M.; Shatunov, P. Yu.; Shtol, D. A.; Silagadze, Z. K.; Skrinsky, A. N.; Surin, I. K.; Tikhonov, Yu. A.; Usov, Yu. V.; Vasiljev, A. V.; Zemlyansky, I. M.

    2016-12-01

    The e+e-→K+K- cross section is measured in the center-of-mass energy range 1.05-2.00 GeV at the SND detector. The measurement is based on data with an integrated luminosity of 35 pb-1 collected at the VEPP-2000 e+e--collider. The obtained results are consistent with the previous most accurate data obtained in the BABAR experiment and have a comparable accuracy.

  8. Heavy fragment production cross sections from 1.05 GeV/nucleon 56Fe in C, Al, Cu, Pb, and CH2 targets

    NASA Technical Reports Server (NTRS)

    Zeitlin, C.; Heilbronn, L.; Miller, J.; Rademacher, S. E.; Borak, T.; Carter, T. R.; Frankel, K. A.; Schimmerling, W.; Stronach, C. E.; Chatterjee, A. (Principal Investigator)

    1997-01-01

    We have obtained charge-changing cross sections and partial cross sections for fragmentation of 1.05 GeV/nucleon Fe projectiles incident on H, C, Al, Cu, and Pb nuclei. The energy region covered by this experiment is critical for an understanding of galactic cosmic ray propagation and space radiation biophysics. Surviving primary beam particles and fragments with charges from 12 to 25 produced within a forward cone of half-angle 61 mrad were detected using a silicon detector telescope to identify their charge and the cross sections were calculated after correction of the measured yields for finite target thickness effects. The cross sections are compared to model calculations and to previous measurements. Cross sections for the production of fragments with even-numbered nuclear charges are seen to be enhanced in almost all cases.

  9. 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.

  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. Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting.

    PubMed

    Irving, Julie; Jesson, Jenny; Virgo, Paul; Case, Marian; Minto, Lynne; Eyre, Lisa; Noel, Nigel; Johansson, Ulrika; Macey, Marion; Knotts, Linda; Helliwell, Margaret; Davies, Paul; Whitby, Liam; Barnett, David; Hancock, Jeremy; Goulden, Nick; Lawson, Sarah

    2009-06-01

    Minimal residual disease detection, used for clinical management of children with acute lymphoblastic leukemia, can be performed by molecular analysis of antigen-receptor gene rearrangements or by flow cytometric analysis of aberrant immunophenotypes. For flow minimal residual disease to be incorporated into larger national and international trials, a quality assured, standardized method is needed which can be performed in a multi-center setting. We report a four color, flow cytometric protocol established and validated by the UK acute lymphoblastic leukemia Flow minimal residual disease group. Quality assurance testing gave high inter-laboratory agreement with no values differing from a median consensus value by more than one point on a logarithmic scale. Prospective screening of B-ALL patients (n=206) showed the method was applicable to 88.3% of patients. The minimal residual disease in bone marrow aspirates was quantified and compared to molecular data. The combined risk category concordance (minimal residual disease levels above or below 0.01%) was 86% (n=134). Thus, this standardized protocol is highly reproducible between laboratories, sensitive, applicable, and shows good concordance with molecular-based analysis.

  12. Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting;

    PubMed Central

    Irving, Julie; Jesson, Jenny; Virgo, Paul; Case, Marian; Minto, Lynne; Eyre, Lisa; Noel, Nigel; Johansson, Ulrika; Macey, Marion; Knotts, Linda; Helliwell, Margaret; Davies, Paul; Whitby, Liam; Barnett, David; Hancock, Jeremy; Goulden, Nick; Lawson, Sarah

    2009-01-01

    Minimal residual disease detection, used for clinical management of children with acute lymphoblastic leukemia, can be performed by molecular analysis of antigen-receptor gene rearrangements or by flow cytometric analysis of aberrant immunophenotypes. For flow minimal residual disease to be incorporated into larger national and international trials, a quality assured, standardized method is needed which can be performed in a multi-center setting. We report a four color, flow cytometric protocol established and validated by the UK acute lymphoblastic leukemia Flow minimal residual disease group. Quality assurance testing gave high inter-laboratory agreement with no values differing from a median consensus value by more than one point on a logarithmic scale. Prospective screening of B-ALL patients (n=206) showed the method was applicable to 88.3% of patients. The minimal residual disease in bone marrow aspirates was quantified and compared to molecular data. The combined risk category concordance (minimal residual disease levels above or below 0.01%) was 86% (n=134). Thus, this standardized protocol is highly reproducible between laboratories, sensitive, applicable, and shows good concordance with molecular-based analysis. PMID:19377076

  13. 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

    2015-07-07

    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 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.

  14. 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.

  15. Structure of β-1,4-mannanase from the common sea hare Aplysia kurodai at 1.05 Å resolution

    PubMed Central

    Mizutani, Kimihiko; Tsuchiya, Sae; Toyoda, Mayuko; Nanbu, Yuko; Tominaga, Keiko; Yuasa, Keizo; Takahashi, Nobuyuki; Tsuji, Akihiko; Mikami, Bunzo

    2012-01-01

    β-1,4-Mannanase (EC 3.2.1.78) catalyzes the hydrolysis of β-1,4-glycosidic bonds within mannan, a major constituent group of the hemicelluloses. Bivalves and gastropods possess β-1,4-mannanase and may degrade mannan in seaweed and/or phytoplankton to obtain carbon and energy using the secreted enzymes in their digestive systems. In the present study, the crystal structure of AkMan, a gastropod β-1,4-mannanase prepared from the common sea hare Aplysia kurodai, was determined at 1.05 Å resolution. This is the first report of the three-dimensional structure of a gastropod β-1,4-mannanase. The structure was compared with bivalve β-1,4-mannanase and the roles of residues in the catalytic cleft were investigated. No obvious binding residue was found in subsite +1 and the substrate-binding site was exposed to the molecular surface, which may account for the enzymatic properties of mannanases that can digest complex substrates such as glucomannan and branched mannan. PMID:23027740

  16. Structure of β-1,4-mannanase from the common sea hare Aplysia kurodai at 1.05 Å resolution.

    PubMed

    Mizutani, Kimihiko; Tsuchiya, Sae; Toyoda, Mayuko; Nanbu, Yuko; Tominaga, Keiko; Yuasa, Keizo; Takahashi, Nobuyuki; Tsuji, Akihiko; Mikami, Bunzo

    2012-10-01

    β-1,4-Mannanase (EC 3.2.1.78) catalyzes the hydrolysis of β-1,4-glycosidic bonds within mannan, a major constituent group of the hemicelluloses. Bivalves and gastropods possess β-1,4-mannanase and may degrade mannan in seaweed and/or phytoplankton to obtain carbon and energy using the secreted enzymes in their digestive systems. In the present study, the crystal structure of AkMan, a gastropod β-1,4-mannanase prepared from the common sea hare Aplysia kurodai, was determined at 1.05 Å resolution. This is the first report of the three-dimensional structure of a gastropod β-1,4-mannanase. The structure was compared with bivalve β-1,4-mannanase and the roles of residues in the catalytic cleft were investigated. No obvious binding residue was found in subsite +1 and the substrate-binding site was exposed to the molecular surface, which may account for the enzymatic properties of mannanases that can digest complex substrates such as glucomannan and branched mannan.

  17. Haemophilus influenzae type b as an important cause of culture-positive acute otitis media in young children in Thailand: a tympanocentesis-based, multi-center, cross-sectional study

    PubMed Central

    2014-01-01

    Background Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. influenzae) are considered major causes of bacterial acute otitis media (AOM) worldwide, but data from Asia on primary causes of AOM are limited. This tympanocentesis-based, multi-center, cross-sectional study assessed bacterial etiology and antimicrobial susceptibility of AOM in Thailand. Methods Children 3 to 59 months presenting with AOM (< 72 hours of onset) who had not received prescribed antibiotics, or subjects who received prescribed antibiotics but remained symptomatic after 48–72 hours (treatment failures), were eligible. Study visits were conducted from April 2008 to August 2009. Bacteria were identified from middle ear fluid collected by tympanocentesis or spontaneous otorrhea swab sampling (< 20% of cases). S. pneumoniae and H. influenzae serotypes were determined and antimicrobial resistance was also assessed. Results Of the 123 enrolled children, 112 were included in analysis and 48% of the 118 samples were positive for S. pneumoniae (23% (27/118)), H. influenzae (18% (21/118)), Moraxella catarrhalis (6% (7/118)) or Streptococcus pyogenes (3% (4/118)). The most common pneumococcal serotypes were 19F (26%) and 14 (22%). The majority of H. influenzae isolates were encapsulated (18/21), with 13 type b (Hib) representing 62% of all H. influenzae isolate or 11% of all samples (13/118), and there were only 3 non-typeable isolates. Despite high antibiotic resistance, amoxicillin/clavulanate susceptibility was high. No pneumococcal vaccine use was reported. Conclusions S. pneumoniae and H. influenzae, both frequently antibiotic resistant, were leading causes of bacterial AOM and there was an unexpectedly high burden of Hib in this population unvaccinated by any Hib conjugate vaccine. Conjugate vaccines effective against pneumococcus and H. influenzae could potentially reduce the burden of AOM in this population. PMID:24947736

  18. 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

  19. 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

  20. Efficacy and Safety of Gemcitabine (G), Carboplatin (C), Dexamethasone (D), and Rituximab (R) in Patients with Relapsed/Refractory Lymphoma: A Prospective Multi-center Phase II Study of by the Puget Sound Oncology Consortium (PSOC)

    PubMed Central

    Gopal, Ajay K.; Press, Oliver W.; Shustov, Andrei R.; Petersdorf, Stephen H.; Gooley, Ted A.; Daniels, Jasmine T.; Garrison, Mitchell A.; Gjerset, George F.; Lonergan, Matthew; Murphy, Anne E.; Smith, Julie C.; Pagel, John M.

    2010-01-01

    We conducted a multi-center phase II trial of gemcitabine (G), carboplatin (C), dexamethasone (D), and rituximab (R) in order to examine its safety and efficacy as an outpatient salvage regimen for lymphoma. Fifty-one patients received 2–4 21-day cycles of G (1000mg/m2, days 1 and 8), C (AUC=5, day 1), D (40mg daily days 1–4), and R (375mg/m2, day 8 for CD20 positive disease) and were evaluable for response. Characteristics included: median age 58y (19–79y), stage III/IV 88%, elevated LDH 33%, median prior therapies 2, prior stem cell transplant 12%, chemoresistant 62%, median prior remission duration 2.5 months. The overall and complete response rates were 67% (95% confidence interval [CI], 54–80%) and 31% (95% CI 19–44%), respectively, with activity seen in a broad variety of histologies. Responses occurred in 16 of 17 (94%, 95% CI 83–100%) transplant eligible patients and 15 of 28 (54%, 95% CI 34–71%) with chemoresistant disease. The median CD34 yield in patients attempting peripheral blood stem cell (PBSC) collection following this regimen was 10.9 × 106 CD34+ cells/kg (range, 5.0 – 24.1 × 106). Hematologic toxicity was common but febrile neutropenia (2.5%) and grade 4 non-hematologic adverse events (n=2) were rare with no treatment-related deaths. GCD(R) is a safe and effective outpatient regimen for relapsed lymphoma and successfully mobilizes PBSC. PMID:20578815

  1. Can self-esteem, mastery and perceived stigma predict long-term adjustment in women carrying a BRCA1/2-mutation? Evidence from a multi-center study.

    PubMed

    Vodermaier, Andrea; Esplen, Mary Jane; Maheu, Christine

    2010-09-01

    Little is known about protective and vulnerability factors of long-term adjustment with BRCA1/2 carrier status. Specifically, the role of personal resources and perceptions of stigmatization have not been studied in the context of adjustment with hereditary breast cancer. The present study, therefore, explored associations of personal resources and stigma with cancer-specific anxiety in female BRCA1/2-carriers within a cross-sectional multi-center study. Participants (n = 237) had received carrier notification between 4 months and 8 years before data collection and experienced a low level of cancer-related anxiety on average. Younger age was associated with both higher perceptions of stigma (P = .002) and cancer-specific anxiety (P = .034). Time since receiving test results, affected status, having undergone prophylactic mastectomy or prophylactic oophorectomy was not associated with demographic or psychological variables. Global self-esteem (P = .002) and mastery (P < .001) were associated with fewer intrusive and avoidant thoughts, whereas stigma was associated with more (P < .001). Time since test result receipt did not moderate relations of self-esteem, mastery or stigma and cancer-specific anxiety. Cancer-specific anxiety did not vary as a function of time since carrier notification. Hence cancer-specific distress may be explained by past and ongoing experiences of cancer in the family rather than by the time point of carrier notification. Psychological interventions may benefit from specifically addressing feelings of stigmatization, and promoting self-worth and personal control in order to affect cancer-specific anxiety.

  2. Multi-center clinical evaluation of combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell binding peptide (P-15) as a bone replacement graft material in human periodontal osseous defects. 6-month results.

    PubMed

    Yukna, R A; Callan, D P; Krauser, J T; Evans, G H; Aichelmann-Reidy, M E; Moore, K; Cruz, R; Scott, J B

    1998-06-01

    A synthetic cell-binding peptide (P-15) combined with anorganic bovine-derived hydroxyapatite bone matrix (ABM) was compared to demineralized freeze-dried bone allograft (DFDBA) and open flap debridement (DEBR) in human periodontal osseous defects in a controlled, monitored, multi-center trial. Following appropriate initial preparation procedures, flap surgery with defect and root debridement was performed. Three osseous defects per patient were treated randomly with one of three procedures after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 to 7 months re-entry flap surgery was performed for documentation and finalization of treatment. Analysis of variation (ANOVA) and t test analyses of patient mean values from 31 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.8 +/- 1.2 mm (72.3%) versus a mean defect fill of 2.0 +/- 1.4 mm (51.4%) for defects treated with DFDBA (P <0.05) and a mean defect fill of 1.5 +/- 1.3 mm (40.3%) (P <0.05) for defects treated with DEBR. Other hard tissue findings showed similar clinically superior results with the use of ABM/P-15. Relative defect fill results showed 87% positive (50% to 100% defect fill) responses with ABM/P-15, 58% positive responses with DFDBA, and 41% positive responses with DEBR. There were 8 to 9 times more failures (minimal response) with DFDBA and DEBR (26% to 29% frequency) than with ABM/P-15. Soft tissue findings showed no significant differences among treatments except for greater clinical attachment level gain with ABM/P-15 compared to DEBR. These results suggest that the use of the P-15 synthetic cell-binding peptide combined with ABM yields better clinical results than either DFDBA or DEBR. Further studies are needed to determine the relative roles of the ABM and/or the P-15 in these improved results.

  3. 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.

  4. 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

  5. HLA-DPB1*05: 01-restricted WT1332-specific TCR-transduced CD4+ T lymphocytes display a helper activity for WT1-specific CTL induction and a cytotoxicity against leukemia cells.

    PubMed

    Lin, Yuhung; Fujiki, Fumihiro; Katsuhara, Akiko; Oka, Yoshihiro; Tsuboi, Akihiro; Aoyama, Nao; Tanii, Satoe; Nakajima, Hiroko; Tatsumi, Naoya; Morimoto, Soyoko; Tamanaka, Taichi; Tachino, Sho; Hosen, Naoki; Nishida, Sumiyuki; Oji, Yusuke; Kumanogoh, Atsushi; Sugiyama, Haruo

    2013-04-01

    Wilms tumor gene 1 (WT1) is overexpressed in various malignant neoplasms, and has been demonstrated as an attractive target for cancer immunotherapy. We previously reported the identification of a WT1 protein-derived, 16-mer helper peptide WT1332 that could elicit Th1-type CD4+ T-cell response and bind to multiple HLA class II molecules. In this study, we examined the feasibility of adoptive therapy using CD4+ T cells that were transduced an HLA-DPB1*05:01-restricted, WT1332-specific T-cell receptor (TCR). HLA-DPB1*05:01-restricted, WT1332-specific TCR-transduced CD4+ T cells were successfully generated using lentiviral vector and exhibited strong proliferative response and Th1-type cytokine production in response to WT1332 peptide, WT1 protein, or WT1-expressing tumor cell lysate. Furthermore, the WT1332-specific TCR-transduced CD4+ T cells lysed HLA-DPB1*05:01-positive, WT1-expressing human leukemia cells through granzyme B/perforin pathway. Furthermore, stimulation of peripheral blood mononuclear cells with both HLA-A*24:02-restricted cytotoxic T lymphocytes-epitope peptide (modified 9-mer WT1235 peptide, WT1235m) and WT1332 helper peptide in the presence of WT1332-specific TCR-transduced CD4+ T cells strikingly enhanced the induction of WT1235m-specific cytotoxic T lymphocytes. Thus, these results demonstrated the feasibility of immunotherapy based on adoptive transfer of WT1332-specific TCR-transduced CD4+ T cells for the treatment of leukemia.

  6. 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.

  7. Phase transitions and magnetocaloric effect in MnNiGe 1--xAlx, Ni50Mn35(In1--x Crx)15 and (Mn1--xCrx)NiGe 1.05

    NASA Astrophysics Data System (ADS)

    Quetz, Abdiel

    The magnetocaloric and thermomagnetic properties of the MnNiGe1-xAlx, Ni50Mn35(In 1-xCrx)15 and (Mn1-xCr x)NiGe1.05 systems have been studied by x-ray diffraction, differential scanning calorimetry (DSC), and magnetization measurements. Partial substitution of Al for Ge in MnNiGe1-xAl x results in a first-order magnetostructural transition (MST) from a hexagonal ferromagnetic to an orthorhombic antiferromagnetic phase at 186 K (for x = 0.09). A large magnetic entropy change of ∆SM = -17.6 J/kg K for ∆H = 5 T was observed in the vicinity of T M = 186 K for x = 0.09. This value is comparable to those of well-known giant magnetocaloric materials, such as Gd5Si2Ge 2, MnFeP0.45As0.55, and Ni50Mn 37Sn13 [1]. The values of the latent heat (L = 6.6 J/g) and corresponding total entropy changes (∆ST = 35 J/kg K) have been evaluated for the MST using DSC measurements. Large negative values of ∆S M of -5.8 and -4.8 J/kg K for ∆H = 5 T in the vicinity of T C were observed for x = 0.09 and 0.085, respectively. Partial substitution of Cr for Mn in(Mn1-xCrx)NiGe 1.05 results in a MST from a hexagonal paramagnetic to an orthorhombic paramagnetic phase near TM ~ 380 K (for x = 0.07). Partial substitution of Cr for In in Ni50Mn35(In1-xCr x)15 shifts the magnetostructural transition to a higher temperature (TM ~ 450 K) for x = 0.1. Large magnetic entropy changes of ∆SM = -12 (J/kgK) and ∆S = -11 (J/kgK), both for a magnetic field change of 5 T, were observed in the vicinity of TM for (Mn1-xCrx)NiGe1.05 and Ni 50Mn35(In1-xCrx)15, respectively. The concentration-dependent (T-x) phase diagram of transition temperatures (magnetic, structural, and magnetostructural) has been generated using magnetic, XRD, and DSC data. The role of magnetic and structural changes on transition temperatures are discussed.

  8. 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

  9. 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.

  10. Intravesical therapy in recurrent cystitis: a multi-center experience.

    PubMed

    Torella, Marco; Schettino, Maria Teresa; Salvatore, Stefano; Serati, Maurizio; De Franciscis, Pasquale; Colacurci, Nicola

    2013-10-01

    Approximately 20-30% of women suffer from recurrent cystitis. Recently, the problem of bacterial internalization, especially by Escherichia coli, has been significantly emerging as the main cause of recurrent episodes. It is believed that such a process is favored by damage to the urothelial mucous membrane. Concerning this, intravesical therapy with hyaluronic acid alone or in association with chondroitin sulfate was shown to improve urothelium thickness and reduction of bacterial load in the urine. The aim of our study was to assess whether intravesical therapy with hyaluronic acid (HA) and chondroitin sulfate (CS) is more effective than antibiotic therapy in reducing episodes and symptoms of recurrent urinary tract infections. We compared the number of recurring episodes in three groups of patients affected by recurrent urinary tract infections assigned to three different therapeutic regimens: the first group was treated only with HA and CS, the second group with HA and CS associated with fosfomycin, and the third group was treated only with fosfomycin (F). We assessed the number of recurrent episodes for each patient that occurred during a 6- to 12-month follow-up. The results showed 72.7% of patients in the HA-CS group, 75% in the fosfomycin + HA-CS group, and only 30.4% in the fosfomycin group were event free at follow-up. The results were analyzed using the Fisher's exact test. In conclusion, intravesical therapy with hyaluronic acid and chondroitin sulfate is an effective therapeutic approach to treat and prevent episodes of recurrent cystitis.

  11. 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

  12. Forecasting Emergency Department Crowding: An External, Multi-Center Evaluation

    PubMed Central

    Hoot, Nathan R.; Epstein, Stephen K.; Allen, Todd L.; Jones, Spencer S.; Baumlin, Kevin M.; Chawla, Neal; Lee, Anna T.; Pines, Jesse M.; Klair, Amandeep K.; Gordon, Bradley D.; Flottemesch, Thomas J.; LeBlanc, Larry J.; Jones, Ian; Levin, Scott R.; Zhou, Chuan; Gadd, Cynthia S.; Aronsky, Dominik

    2009-01-01

    Objective To apply a previously described tool to forecast ED crowding at multiple institutions, and to assess its generalizability for predicting the near-future waiting count, occupancy level, and boarding count. Methods The ForecastED tool was validated using historical data from five institutions external to the development site. A sliding-window design separated the data for parameter estimation and forecast validation. Observations were sampled at consecutive 10-minute intervals during 12 months (n = 52,560) at four sites and 10 months (n = 44,064) at the fifth. Three outcome measures – the waiting count, occupancy level, and boarding count – were forecast 2, 4, 6, and 8 hours beyond each observation, and forecasts were compared to observed data at corresponding times. The reliability and calibration were measured following previously described methods. After linear calibration, the forecasting accuracy was measured using the median absolute error (MAE). Results The tool was successfully used for five different sites. Its forecasts were more reliable, better calibrated, and more accurate at 2 hours than at 8 hours. The reliability and calibration of the tool were similar between the original development site and external sites; the boarding count was an exception, which was less reliable at four out of five sites. Some variability in accuracy existed among institutions; when forecasting 4 hours into the future, the MAE of the waiting count ranged between 0.6 and 3.1 patients, the MAE of the occupancy level ranged between 9.0 and 14.5% of beds, and the MAE of the boarding count ranged between 0.9 and 2.7 patients. Conclusion The ForecastED tool generated potentially useful forecasts of input and throughput measures of ED crowding at five external sites, without modifying the underlying assumptions. Noting the limitation that this was not a real-time validation, ongoing research will focus on integrating the tool with ED information systems. PMID:19716629

  13. 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

  14. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... designation of lightering zones. (iii) The operation of drawbridges. (iv) The establishment of Regulated Navigation Areas. (v) The establishment of safety and security zones. (vi) The establishment of special local... establish safety and security zones. (g) The Commandant has redelegated to Coast Guard District...

  15. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  16. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  17. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of...

  18. 33 CFR 1.05-60 - Negotiated rulemaking.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... will consider negotiated rulemaking when: (1) There is a need for a rule; (2) There are a limited number of representatives for identifiable parties affected by the rule; (3) There is a reasonable chance... committee members will negotiate in good faith; (4) There is a likelihood of a committee consensus in...

  19. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....gov. To access a rulemaking, enter the docket number associated with rulemaking in the “Search” box... Commanders are available for public inspection at the appropriate Coast Guard District office or online at... available for inspection at the appropriate Captains of the Port Office or online at...

  20. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Secretary of Homeland Security is empowered by various statutes to issue regulations regarding the functions... functions of the Coast Guard and the authority to redelegate and authorize successive redelegations of that... regulations determined to be significant under Executive Order 12866, Regulatory Planning and Review. (d)...

  1. GES User’s Guide Version 1.05

    DTIC Science & Technology

    2007-11-02

    energiesystemen aan elkaar gekoppeld worden. Daarvoor zijn een aantal afspraken gemaakt, hoe een specifiek systeem , in GES apparaat genoemd...zonder dat men direct rekening behoeft te houden met andere apparaten in het systeem . GES rekent stationaire Systemen door. Doordat er terugwerking...1997 2 Contents MANAGEMENTUITTREKSEL 1 1 INTRODUCTION 6 l.i PURPOSE OF GES 6 1.2 OVERVIEW OF GES 7 1.2.1 Energy apparatus 7 1.2.2 Signal

  2. 33 CFR 1.05-60 - Negotiated rulemaking.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Committee Act (FACA) (5 U.S.C. App. 2) when it is in the public interest. (b) Generally, the Coast Guard... that balanced representation can be reached in the negotiated rulemaking committee and that the... Coast Guard has resources to do negotiated rulemaking; and (7) The Coast Guard can use the consensus...

  3. 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.

  4. Economic Consequences Incurred by Living Kidney Donors: A Canadian Multi-Center Prospective Study

    PubMed Central

    Klarenbach, S; Gill, J S; Knoll, G; Caulfield, T; Boudville, N; Prasad, G V R; Karpinski, M; Storsley, L; Treleaven, D; Arnold, J; Cuerden, M; Jacobs, P; Garg, A X

    2014-01-01

    Some living kidney donors incur economic consequences as a result of donation; however, these costs are poorly quantified. We developed a framework to comprehensively assess economic consequences from the donor perspective including out-of-pocket cost, lost wages and home productivity loss. We prospectively enrolled 100 living kidney donors from seven Canadian centers between 2004 and 2008 and collected and valued economic consequences ($CAD 2008) at 3 months and 1 year after donation. Almost all (96%) donors experienced economic consequences, with 94% reporting travel costs and 47% reporting lost pay. The average and median costs of lost pay were $2144 (SD 4167) and $0 (25th–75th percentile 0, 2794), respectively. For other expenses (travel, accommodation, medication and medical), mean and median costs were $1780 (SD 2504) and $821 (25th–75th percentile 242, 2271), respectively. From the donor perspective, mean cost was $3268 (SD 4704); one-third of donors incurred cost >$3000, and 15% >$8000. The majority of donors (83%) reported inability to perform usual household activities for an average duration of 33 days; 8% reported out-of-pocket costs for assistance with these activities. The economic impact of living kidney donation for some individuals is large. We advocate for programs to reimburse living donors for their legitimate costs. In a prospective costing study, the authors find that economic consequences incurred by living kidney donors are frequent and nontrivial, and a notable proportion of donors experience significant costs. PMID:24597854

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. Efficacy and Safety of Frozen Blood for Transfusion in Trauma Patients - A Multi-Center Trial

    DTIC Science & Technology

    2015-04-01

    C, Maginnis M, et al. Does the storage time of transfused red blood cells influence regional or global indexes of tissue oxygenation in anemic...64. Berezina TL, Zaets SB, Morgan C, Spillert CR, Kamiyama M, et al. Influence of storage on red blood cell rheological properties. J Surg Res...transfusion viability to deformability of stored red cells . Br J Haematol. 1983; 53(2):237-240. 68. Parthasarathi K, Lipowsky HH. Capillary

  10. Surgery for spinal tuberculosis: a multi-center experience of 582 cases

    PubMed Central

    Phan, Kevin; Karim, Rezaul; Jonayed, Sharif Ahmed; Munir, Hasan Khalid Md.; Chakraborty, Shubhendu; Alam, Tashfique

    2015-01-01

    Background Tuberculosis (TB) of the spine is a common site of osseous TB, accounting for 50%-60% of cases. Spinal TB still occurs in both developed and developing countries. The diagnosis of spinal TB is difficult and it commonly presents at an advanced stage. Delays in establishing diagnosis and management result in complications such as spinal cord compression and spinal deformity. Methods A total of 582 patients with TB of the cervical, thoracic and lumbar spine with moderate to severe cord compression were studied. Variable degrees of neurological deficit with deformity were treated from January, 2003 to July, 2014. Thoracotomy along with anterolateral decompression and autogenous strut bone grafting with simultaneous fixation by screws and rods were performed in 113 cases. Posterior decompression, posterior interbody and posterolateral fusion by bone graft with stabilization by transpedicular screws and rods were done in the remaining 469 cases. Appropriate anti-TB drugs were given to all patients for 18-24 months. The follow-up period was 3 months to 10 years. Results The average age was 32.5 years. All patients survived surgery. There were 7 cases of superficial infections (1.2%) whilst there were 4 cases (0.7%) of deep infections. Revision surgery was performed in 6 patients (1.0%). Implant failure occurred in 4 cases (0.7%) whilst malposition of screws occurred in 12 cases (2.1%). Perioperative bleeding complications were reported for 4 patients (0.7%). Neurological improvement occurred in all patients except for 2 cases (0.3%). Preoperatively, the majority of patients (n=221, 38%) were classified with Class A on the American Spinal Injury Association (ASIS) neurological impairment scale. This was significantly reduced postoperatively to 0.4%. Conclusions For patients with spinal TB anterior debridement, auto graft bone fusion, anterior or posterior fixation appears to be effective in arresting disease, correcting kyphotic deformity and maintaining correction until solid spinal fusion. PMID:27683681

  11. 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

  12. 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..

  13. Early enteral nutrition in neonates with partial gastrectomy: a multi-center study.

    PubMed

    Jiang, Weiwei; Zhang, Jie; Geng, Qiming; Xu, Xiaoqun; Lv, Xiaofeng; Chen, Yongwei; Liu, Xiang; Tang, Weibing

    2016-01-01

    背景与目的:研究表明肠内营养比完全肠外营养更适合在术后运用。本文主要 目的是研究新生儿胃部分切除术后运用空肠营养管的安全性和可行性。方法与 研究设计:回顾性研究46 例胃穿孔行胃部分切除术的病人。这些病人被分为两 组,早期肠内营养组(24 例),空肠营养管在术中放置;完全肠外营养组即对 照组(22 例),未放置空肠营养管。比较两组的手术时间、术后首次排便时 间、术后首次经口喂养时间,术后住院时间,营养指标、术后并发症如脓毒症 导致的死亡率,胆汁淤积、肺炎、肠粘连、腹泻等。结果:手术时间和术后首 次经口喂养时间两组间差异无统计学意义。术后首次排便时间和术后住院时间 肠内营养组均明显短于完全肠外营养组。总蛋白、视黄醇结合蛋白及前白蛋白 肠内两组间术前和术后14 天差异均无统计学意义。胆汁淤积和肠梗阻的发生率 肠内营养组明显低于完全肠外营养组。结论:采用空肠营养管的早期肠内营养 方法在新生儿胃穿孔行胃部分切除术后使用是安全和可行的,且并发症较少。.

  14. 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.

  15. Insight: Semantic Provenance and Analysis Platform for Multi-center Neurology Healthcare Research

    PubMed Central

    Ramesh, Priya; Wei, Annan; Welter, Elisabeth; Bamps, Yvan; Stoll, Shelley; Bukach, Ashley; Sajatovic, Martha; Sahoo, Satya S.

    2016-01-01

    Insight is a Semantic Web technology-based platform to support large-scale secondary analysis of healthcare data for neurology clinical research. Insight features the novel use of: (1) provenance metadata, which describes the history or origin of patient data, in clinical research analysis, and (2) support for patient cohort queries across multiple institutions conducting research in epilepsy, which is the one of the most common neurological disorders affecting 50 million persons worldwide. Insight is being developed as a healthcare informatics infrastructure to support a national network of eight epilepsy research centers across the U.S. funded by the U.S. Centers for Disease Control and Prevention (CDC). This paper describes the use of the World Wide Web Consortium (W3C) PROV recommendation for provenance metadata that allows researchers to create patient cohorts based on the provenance of the research studies. In addition, the paper describes the use of descriptive logic-based OWL2 epilepsy ontology for cohort queries with “expansion of query expression” using ontology reasoning. Finally, the evaluation results for the data integration and query performance are described using data from three research studies with 180 epilepsy patients. The experiment results demonstrate that Insight is a scalable approach to use Semantic provenance metadata for context-based data analysis in healthcare informatics. PMID:27069752

  16. Economic consequences incurred by living kidney donors: a Canadian multi-center prospective study.

    PubMed

    Klarenbach, S; Gill, J S; Knoll, G; Caulfield, T; Boudville, N; Prasad, G V R; Karpinski, M; Storsley, L; Treleaven, D; Arnold, J; Cuerden, M; Jacobs, P; Garg, A X

    2014-04-01

    Some living kidney donors incur economic consequences as a result of donation; however, these costs are poorly quantified. We developed a framework to comprehensively assess economic consequences from the donor perspective including out-of-pocket cost, lost wages and home productivity loss. We prospectively enrolled 100 living kidney donors from seven Canadian centers between 2004 and 2008 and collected and valued economic consequences ($CAD 2008) at 3 months and 1 year after donation. Almost all (96%) donors experienced economic consequences, with 94% reporting travel costs and 47% reporting lost pay. The average and median costs of lost pay were $2144 (SD 4167) and $0 (25th-75th percentile 0, 2794), respectively. For other expenses (travel, accommodation, medication and medical), mean and median costs were $1780 (SD 2504) and $821 (25th-75th percentile 242, 2271), respectively. From the donor perspective, mean cost was $3268 (SD 4704); one-third of donors incurred cost >$3000, and 15% >$8000. The majority of donors (83%) reported inability to perform usual household activities for an average duration of 33 days; 8% reported out-of-pocket costs for assistance with these activities. The economic impact of living kidney donation for some individuals is large. We advocate for programs to reimburse living donors for their legitimate costs.

  17. 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.

  18. Forensic age diagnostics using projection radiography of the clavicle: a prospective multi-center validation study.

    PubMed

    Wittschieber, Daniel; Ottow, Christian; Schulz, Ronald; Püschel, Klaus; Bajanowski, Thomas; Ramsthaler, Frank; Pfeiffer, Heidi; Vieth, Volker; Schmidt, Sven; Schmeling, Andreas

    2016-01-01

    The radiological investigation of the ossification stage of the medial clavicular epiphysis represents the crucial tool for assessing whether a living individual has completed the age of 18 years. However, exposure to radiation cannot always be accepted due to legal reasons and radiation-free methods still lack reference data or are not available. Therefore, this study examines the role of pre-existing radiographic material of the clavicles, making it necessary to prospectively validate the established five-stage classification system for evaluating the clavicular ossification process as well as to enlarge the so far very limited pool of available reference data. Accordingly, standard posterior-anterior projection radiographs of 836 sternoclavicular joints prospectively obtained during 418 forensic autopsies (age range 15-30 years) were analyzed. Stage III was first found at ages 16 and 15 (males/females), stage IV at ages 22 and 21 (males/females), and stage V at age 26 in both sexes. The presented results principally corroborate the previous reference data from 2004, suggesting reliability of the five-stage classification system. In conclusion, chest radiographs may still be useful for forensic age diagnostics in living individuals but only in certain cases. In age estimations which can be planned in advance, projection radiography of the clavicle must still be considered obsolete.

  19. A multi-center study to define sarcopenia in patients with end-stage liver disease.

    PubMed

    Carey, Elizabeth J; Lai, Jennifer C; Wang, Connie W; Dasarathy, Srinivasan; Lobach, Iryna; Montano-Loza, Aldo J; Dunn, Michael A

    2017-02-27

    Sarcopenia is associated with increased waitlist mortality, but a standard definition is lacking. In this retrospective study, we sought to determine the optimal definition of sarcopenia in end-stage liver disease (ESLD) patients awaiting LT. Included were 396 patients newly listed for LT in 2012 at five North American transplant centers. All CT scans were read by two individuals with inter-observer correlation of 98%. Using image analysis software, the total cross-sectional area (cm(2) ) of abdominal skeletal muscle at L3 was measured. The skeletal muscle index (SMI), which normalizes muscle area to patient height, was then calculated. The primary outcome was waitlist mortality, defined as death on the waitlist or removal from the waitlist for reasons of clinical deterioration. Sex-specific potential cut-off values to define sarcopenia were determined with a grid search guided by log-rank test statistics. Optimal search method identified potential cutoffs to detect survival differences between groups. The overall median SMI was 47.6 cm(2) /m(2) : 50.0 in men and 42.0 in women. At a median of 8.8 months follow-up, mortality was 25% in men and 36% in women. Patients who died had lower SMI than those who survived (45.6 vs 48.5 cm(2) /m(2) , p<0.001) and SMI was associated with waitlist mortality (HR 0.95, p<0.001). Optimal search method yielded SMI cut-offs of 50 cm(2) /m(2) for men and 39 cm(2) /m(2) for women; these cutoff values best combined statistical significance with a sufficient number of events to detect survival differences between groups. In conclusion, we recommend that an SMI < 50 cm(2) /m(2) for men and < 39 cm(2) /m(2) for women be used to define sarcopenia in patients with ESLD awaiting LT. This article is protected by copyright. All rights reserved.

  20. Comparison of academic and nonacademic sites in multi-center clinical trials.

    PubMed

    Dording, Christina M; Dalton, Elizabeth D; Pencina, Michael J; Fava, Maurizio; Mischoulon, David

    2012-02-01

    The selection of appropriate subjects is a critical element of successful clinical trials. Failure to properly identify, select, and retain subjects in clinical trials of antidepressant medications may affect the ability to show separation from placebo. Little is known about which type of site, academic or nonacademic, is superior in selecting and retaining appropriate subjects. In the present investigation, the authors conducted a retrospective analysis comparing the performance of academic and nonacademic sites in selecting and retaining appropriate subjects in a recently completed multi-site clinical study of aripiprazole augmentation. The authors used a set of operationalized criteria called the SAFER to identify appropriate study subjects. No significant differences were found in rates of SAFER interview passing, study completion, and clinical outcomes between academic and nonacademic sites. Our findings suggest that academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.

  1. Prospective, Multi-Center Evaluation of the Beckman Coulter Prostate Health Index Using WHO Calibration

    PubMed Central

    Loeb, Stacy; Sokoll, Lori J.; Broyles, Dennis L.; Bangma, Chris H.; van Schaik, Ron H.N.; Klee, George G.; Wei, John T.; Sanda, Martin G.; Partin, Alan W.; Slawin, Kevin M.; Marks, Leonard S.; Mizrahi, Isaac A.; Shin, Sanghyuk S.; Cruz, Amabelle B.; Chan, Daniel W.; Roberts, William L.; Catalona, William J.

    2014-01-01

    Purpose Reported prostate-specific antigen (PSA) values may differ substantially between assays with the Hybritech and World Health Organization (WHO) standardization. [-2]proPSA (p2PSA) and the Beckman Coulter prostate health index (phi) are newly approved serum markers, which are associated with prostate cancer risk and aggressiveness. Our objective was to study the influence of assay standardization on these markers. Materials and Methods PSA, % free PSA (%fPSA), and p2PSA were measured using the Hybritech calibration in 892 men undergoing prostate biopsy from a prospective multicenter study. Phi was calculated as: [p2PSA/ fPSA) × (square root of PSA)]. Performance characteristics of phi for prostate cancer detection were then determined using re-calculated WHO calibration PSA values. Results The median phi was significantly higher in men with prostate cancer compared to those with negative biopsies using the WHO values (47.4 vs 39.8, p<0.001). Phi offered improved discrimination of prostate cancer detection on biopsy (AUC 0.704) compared to %fPSA or total PSA using the WHO calibration. Conclusions Phi can be calculated using Hybritech or WHO standardized assays, and significantly improved the prediction of biopsy outcome over %fPSA or PSA alone. PMID:23206426

  2. Nosocomial Rotavirus Gastroenteritis in pediatric patients: a multi-center prospective cohort study

    PubMed Central

    2010-01-01

    Background Few data are available on the incidence of nosocomial Rotavirus infections (NRVI) in pediatric hospitals and on their economic impact. The goals of this study were: to evaluate the incidence of NRVI in various Italian pediatric wards during the course of two peak RV seasons; to investigate possible risk factors for NRVI; to estimate the costs caused by NRVI. Methods prospective cohort study. Population: all the children under 30 months of age who were admitted without any symptom or diagnosis of gastroenteritis in the pediatric hospitals of Florence, Naples, Brescia and Ancona, Italy, during the winter-spring periods 2006-2007 and 2007-2008. Serial RV rapid tests and clinical monitoring were carried out on the cohort. Telephone interviews were performed from 3 to 5 days after discharge. Results 520 out of 608 children completed the study (85.6%). The overall incidence of NRVI was 5.3% (CI95% 3.6-7.5), (7.9 per 1,000 days of hospital stay, CI 95% 5.3-11.3). The average duration of hospital stay was significantly longer for children who had NRVI (8.1 days, SD 5.4) than for non-infected children (6.4 days, SD 5.8, difference 1.7 days, p = 0.004). The risk of contracting NRVI increased significantly if the child stayed in hospital more than 5 days, RR = 2.8 (CI95% 1.3-6), p = 0.006. In Italy the costs caused by NRVI can be estimated at 8,019,155.44 Euro per year. 2.7% of the children hospitalized with no gastroenteritis symptoms tested positive for RV. Conclusions Our study showed a relevant incidence of NRVI, which can increase the length of the children's stay in hospital. Limiting the number of nosocomial RV infections is important to improve patients' safety as well as to avoid additional health costs. PMID:20696065

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

    PubMed

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

    2016-09-01

    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.

  4. National down syndrome patient database: Insights from the development of a multi-center registry study.

    PubMed

    Lavigne, Jenifer; Sharr, Christianne; Ozonoff, Al; Prock, Lisa Albers; Baumer, Nicole; Brasington, Campbell; Cannon, Sheila; Crissman, Blythe; Davidson, Emily; Florez, Jose C; Kishnani, Priya; Lombardo, Angela; Lyerly, Jordan; McCannon, Jessica B; McDonough, Mary Ellen; Schwartz, Alison; Berrier, Kathryn L; Sparks, Susan; Stock-Guild, Kara; Toler, Tomi L; Vellody, Kishore; Voelz, Lauren; Skotko, Brian G

    2015-11-01

    The Down Syndrome Study Group (DSSG) was founded in 2012 as a voluntary, collaborative effort with the goal of supporting evidenced-based health care guidelines for individuals with Down syndrome (DS). Since then, 5 DS specialty clinics have collected prospective, longitudinal data on medical conditions that co-occur with DS. Data were entered by clinical staff or trained designees into the National Down Syndrome Patient Database, which we created using REDCap software. In our pilot year, we enrolled 663 participants across the U.S., ages 36 days to 70 years, from multiple racial and ethnic backgrounds. Here we report: (i) the demographic distribution of participants enrolled, (ii) a detailed account of our database infrastructure, and (iii) lessons learned during our pilot year to assist future researchers with similar goals for other patient populations.

  5. 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

  6. Chronic obstructive pulmonary disease assessment test can predict depression: a prospective multi-center study.

    PubMed

    Lee, Young Seok; Park, Sunghoon; Oh, Yeon-Mok; Lee, Sang-Do; Park, Sung-Woo; Kim, Young Sam; In, Kwang Ho; Jung, Bock Hyun; Lee, Kwan Ho; Ra, Seung Won; Hwang, Yong Il; Park, Yong-Bum; Jung, Ki-Suck

    2013-07-01

    This study was conducted to investigate the association between the chronic obstructive pulmonary disease (COPD) assessment test (CAT) and depression in COPD patients. The Korean versions of the CAT and patient health questionnaire-9 (PHQ-9) were used to assess COPD symptoms and depressive disorder, respectively. In total, 803 patients with COPD were enrolled from 32 hospitals and the prevalence of depression was 23.8%. The CAT score correlated well with the PHQ-9 score (r=0.631; P<0.001) and was significantly associated with the presence of depression (β±standard error, 0.452±0.020; P<0.001). There was a tendency toward increasing severity of depression in patients with higher CAT scores. By assessment groups based on the 2011 Global Initiative for Chronic Obstructive Lung Disease guidelines, the prevalence of depression was affected more by current symptoms than by airway limitation. The area under the receiver operating characteristic curve for the CAT was 0.849 for predicting depression, and CAT scores ≥21 had the highest accuracy rate (80.6%). Among the eight CAT items, energy score showed the best correlation and highest power of discrimination. CAT scores are significantly associated with the presence of depression and have good performance for predicting depression in COPD patients.

  7. 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

  8. 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.

  9. [Multi-center study of inter-scanner difference in brain positron emission tomography].

    PubMed

    Oda, Keiichi; Sakata, Muneyuki; Nishio, Tomoyuki; Tsushima, Hiroyuki; Tanizaki, Yasuo; Kato, Seiji; Ochi, Shinji

    2012-01-01

    We showed scanner dependence of brain (18)F-FDG and (11)C-PiB images by using phantom examination with nine kinds of positron emission tomography (PET) scanners. We used two types of phantoms, cylindrical phantom with 15 cm inside diameter and three-dimensional (3D) brain phantom, and we set the body phantom on the bed to examine the effect of scatter and random coefficients from outside of the axial field of view (AFOV). Radioactivity and distance of the two phantoms were determined by a pilot study to obtain a condition similar to the clinical study. Axial uniformity was evaluated by circular region of interest (ROI) of 12 cm diameter, set in the center of the reconstruction image of the cylindrical phantom. As a result, the standardized uptake value (SUV) was lower than the true value in some scanners, and there was a scanner in which the axial uniformity was deteriorated by high radioactivity outside the AFOV. In the cylindrical phantom, the axial uniformity of the scanner was improved using the new dead-time correction method; however, it was not improved in the 3D brain phantom. Quality-controlled PET scanners are important to maintain constant levels for multicenter studies.

  10. Iron Status and Helicobacter pylori Infection in Symptomatic Children: An International Multi-Centered Study

    PubMed Central

    Harris, Paul R.; Sanderson, Ian R.; Windle, Henry J.; Walker, Marjorie M.; Rocha, Andreia Maria Camargos; Rocha, Gifone Aguiar; Carvalho, Simone Diniz; Bittencourt, Paulo Fernando Souto; de Castro, Lucia Porto Fonseca; Villagrán, Andrea; Serrano, Carolina; Kelleher, Dermot

    2013-01-01

    Objective Iron deficiency (ID) and iron deficiency anaemia (IDA) are global major public health problems, particularly in developing countries. Whilst an association between H. pylori infection and ID/IDA has been proposed in the literature, currently there is no consensus. We studied the effects of H. pylori infection on ID/IDA in a cohort of children undergoing upper gastrointestinal endoscopy for upper abdominal pain in two developing and one developed country. Methods In total 311 children (mean age 10.7±3.2 years) from Latin America - Belo Horizonte/Brazil (n = 125), Santiago/Chile (n = 105) - and London/UK (n = 81), were studied. Gastric and duodenal biopsies were obtained for evaluation of histology and H. pylori status and blood samples for parameters of ID/IDA. Results The prevalence of H. pylori infection was 27.7% being significantly higher (p<0.001) in Latin America (35%) than in UK (7%). Multiple linear regression models revealed H. pylori infection as a significant predictor of low ferritin and haemoglobin concentrations in children from Latin-America. A negative correlation was observed between MCV (r = −0.26; p = 0.01) and MCH (r = −0.27; p = 0.01) values and the degree of antral chronic inflammation, and between MCH and the degree of corpus chronic (r = −0.29, p = 0.008) and active (r = −0.27, p = 0.002) inflammation. Conclusions This study demonstrates that H. pylori infection in children influences the serum ferritin and haemoglobin concentrations, markers of early depletion of iron stores and anaemia respectively. PMID:23861946

  11. 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

  12. [Sarcopenic obesity and physical fitness in octogenarians: the multi-center EXERNET Project].

    PubMed

    Muñoz-Arribas, Alberto; Mata, Esmeralda; Pedrero-Chamizo, Raquel; Espino, Luis; Gusi, Narcis; Villa, Gerardo; Gonzalez-Gross, Marcela; Casajús, José Antonio; Ara, Ignacio; Gómez-Cabello, Alba

    2013-11-01

    Objetivo: El objetivo de este estudio fue analizar la utilidad de diferentes test de condición física para detectar el riesgo de sufrir obesidad sarcopénica (OS) en octogenarios. Métodos: 306 sujetos (76 hombres, 230 mujeres) con una media de edad de 82,5±2,3 años, del total de la muestra del Proyecto Multi-céntrico EXERNET cumplieron con los criterios de inclusión. La composición corporal se evaluó en todos los sujetos mediante impedancia bioeléctrica. Se crearon 4 grupos basados en el porcentaje de masa grasa y masa muscular: 1) normal, 2) elevada masa grasa, 3) baja masa muscular y 4) OS. La condición física fue evaluada utilizando 8 test diferentes adaptados de las baterías “Senior Fitness Test” y “Eurofit” (batería EXERNET). La probabilidad de padecer OS en función del nivel de condición física se estudió mediante regresión logística. Resultados: Entre las pruebas de condición física estudiadas, los test que mejor predecían el riesgo de sufrir OS fueron la falta de fuerza de piernas, fuerza de brazos, agilidad, velocidad y equilibrio en hombres; 95% CI [(0,606-0,957); (0,496-0,882); (1,116-3,636); (1,060-1,825); (0,913-1,002); todos p.

  13. Challenges of Conducting Multi-Center, Multi-Disciplinary Urinary Incontinence Clinical Trials: Experience of the Urinary Incontinence Treatment Network

    PubMed Central

    Steers, William; Richter, Holly; Nyberg, Leroy; Kusek, John; Kraus, Stephen; Dandrea, Kimberly; Chai, Toby; Brubaker, Linda

    2009-01-01

    Aims The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. Methods Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. Results Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. Conclusions Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence. PMID:19030190

  14. Identification and Antifungal Susceptibility Profiles of Candida nivariensis and Candida bracarensis in a Multi-Center Chinese Collection of Yeasts

    PubMed Central

    Hou, Xin; Xiao, Meng; Chen, Sharon C.-A.; Wang, He; Yu, Shu-Ying; Fan, Xin; Kong, Fanrong; Xu, Ying-Chun

    2017-01-01

    Candida nivariensis and C. bracarensis are two emerging cryptic species within the C. glabrata complex. Thirteen of these isolates from 10 hospitals in China were studied for their species identification and antifungal susceptibilities. Phenotypic and molecular [rDNA ITS sequencing, D1/D2 sequencing and ITS sequencer-based capillary gel electrophoresis (SCGE)] and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS identification methods were compared for their performance in species identification. Twelve of 13 (92.3%) isolates were identified as C. nivariensis and one as C. bracarensis using ITS sequencing as the reference method. Results obtained by D1/D2 sequencing and ITS SCGE were concordant with ITS sequencing results for all (100%) isolates. SCGE was able to subtype 12 C. nivariensis into four ITS SCGE length types. All isolates failed to be identified by the Vitek MALDI-TOF MS system (bioMérieux), whilst the Bruker MS system (Bruker Daltoniks) correctly identified all C. nivariensis isolates but using a lowered (≥1.700) cut-off score for species assignment; the C. bracarensis isolate was identified but with score <1.700. The Vitek 2 Compact system could not identify 11 C. nivariensis and one C. bracarensis isolate and misidentified the remaining C. nivarensis strain as “C. glabrata.” All isolates were susceptible-dose dependent to fluconazole [minimum inhibitory concentration (MIC) range 0.5–4 μg/mL] and were classed as susceptible to echinocandins (MICs ≤ 0.06 μg/mL). All 13 isolates had low MICs for other azoles (MICs ≤ 0.5 μg/mL), amphotericin B (MICs ≤ 2 μg/mL) and 5-flucytosine (MICs ≤ 0.25 μg/mL). Our results reinforce the need for molecular differentiation of species of C. nivarensis and C. bracarensis. The performance of MALDI-TOF may be improved by adding mass spectral profiles (MSPs) into the current databases. The antifungal susceptibility profile of isolates should be monitored. PMID:28154553

  15. 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

    ... National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to... enrolled at treating hospitals. The annual reporting burden is estimated at 5,302 hours (see Table...

  16. Obesity/Overweight in Persons with Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention

    DTIC Science & Technology

    2012-10-01

    Use healthy alternatives when experiencing milk-related intolerance (stomach/ digestion problems): Lactose free low-fat or fat-free milk and cheese...Try to eat 3 meals each day. This will keep you from getting too hungry and losing control.  Eat slowly. You will digest your food better if you...3 teaspoons). Response of blood fats and body metabolism to food intake - To test how your body digests a meal, you will arrive at the testing center

  17. Safety of Daily Albuterol in Infants with a History of Bronchospasm: A Multi-Center Placebo Controlled Trial§

    PubMed Central

    Hedrick, James A; Baker, James W; Atlas, Arthur B; Naz, Aftab A; Lincourt, William R; Trivedi, Roopa; Ellworth, Anna; Davis, Angela M

    2009-01-01

    Introduction: Inhaled short-acting bronchodilators are recommended for the quick relief of bronchospasm symptoms in children including those less than five years of age. However, limited safety data is available in this young population. Methods: Safety data were analyzed from a randomized, double-blind, parallel group, placebo-controlled multicenter, study evaluating albuterol HFA 90µg or 180µg versus placebo three times a day for 4 weeks using a valved holding chamber, Aerochamber Plus and facemask in children birth ≤24 months old with a history of bronchospasm. Results: The overall incidence of adverse events (AE) during treatment was: albuterol 90µg (59%), albuterol 180µg (76%) and placebo (71%). The most frequently reported AEs were pyrexia in 7 (24%), 2 (7%), and 3 (11%) subjects in the albuterol 180µg, albuterol 90µg, and placebo groups, respectively. Upper respiratory tract infection (URTI) occurred in 5 (17%) and 3 (11%) subjects in the albuterol 180µg and placebo groups, respectively. Sinus tachycardia occurred in 5 (17%), 2 (7%) and 2 (7%) subjects receiving albuterol 180µg, albuterol 90µg and placebo, respectively. One subject in each of the albuterol treatment groups experienced drug related agitation and/or restlessness or mild sinus arrhythmia. No drug-related QT prolongation or abnormal serum potassium and glucose levels were reported in the albuterol treatment groups. Conclusion: This study provides additional albuterol HFA safety information for the treatment of children aged birth ≤24 months with a history of bronchospasm. PMID:19639035

  18. 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

  19. Outpatient management of intra-corporeal left ventricular assist device system in children: a multi-center experience.

    PubMed

    Schweiger, M; Vanderpluym, C; Jeewa, A; Canter, C E; Jansz, P; Parrino, P E; Miera, O; Schmitto, J; Mehegan, M; Adachi, I; Hübler, M; Zimpfer, D

    2015-02-01

    Little is known about the outcomes of children supported on intracorporeal left ventricular assist device (HVAD), and the feasibility of outpatient management. All centers with pediatric patients discharged from the hospital on the device were identified using company database. A total of 14 centers were contacted, with 9 centers, contributing data retrospectively. From 2011 to 2013, 12 pediatric patients (7 females), mean aged 11.9 ± 2.3 years (range 8-15), mean weight 43 ± 19 kg (range 18-81), mean body surface area 1.3 ± 0.3 m(2) (range 0.76-1.96) were identified. Diagnosis included: dilated cardiomyopathy (CMP) (n = 5), noncompaction CMP (n = 4), toxic CMP (n = 2) and viral CMP (n = 1). Indications for support were permanent support (n = 1), bridge to recovery (n = 1) and bridge to transplantation (n = 10). Prior to HVAD implantation, all patients received intravenous inotropes and two patients were on temporary mechanical support. Overall mortality was 0%. Mean duration of inpatient and outpatient support were 56 (range: 19-95 days) and 290 days (range: 42-790), respectively. Mean readmission rate was 0.02 per patient month (2.1 per patient). No adverse events involving emergency department occurred. Eight children resumed local schooling. Home discharge of children supported on HVAD is feasible and safe. School integration can be achieved. There is wide center variability to discharge practice for children.

  20. 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

    2016-01-01

    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.

  1. 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

  2. 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

  3. The Effect of Trimosan© Gel on Pessary-Associated Bacterial Vaginosis: A Multi-Center, Randomized, Controlled Trial

    PubMed Central

    Meriwether, Kate V.; Rogers, Rebecca G.; Craig, Ellen; Peterson, Sean D.; Gutman, Robert E.; Iglesia, Cheryl B.

    2015-01-01

    Objectives Pessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan© gel on BV prevalence among pessary users. Study Design Women presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy (HT) use and underwent a BV® BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan© placed vaginally twice weekly or to standard pessary care without TrimoSan© gel. Women returned 2 weeks and 3 months later for repeat slide collection for Gram stain, BV® BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary. Results There were 184 women randomized after successful fitting (92 to the TrimoSan© group), and 147 (79%) presented for 3 month follow up. Mean age was 56 ± 16 years; patients were mostly Caucasian (57%) or Hispanic (23%) and 36% were using HT. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan© vs 26% no gel, p=0.46) or 3 months (24% TrimoSan© vs 23% no gel, p=0.82), nor did they differ in BV by BV® BLUE testing at 2 weeks (0%TrimoSan©vs 4% no gel, p=0.12) or 3 months (3% TrimoSan© vs 0% no gel, p=0.15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan© vs 45% no gel, p=0.98) or 3 months (42% TrimoSan© vs 32% no gel, p=0.30). The TrimoSan© group was equally likely to want to continue their pessary use compared to the standard care group at 2 weeks (90% vs 86%, p=0.64) and 3 months (63% vs 60%, p=0.76). Conclusions TrimoSan© gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use. PMID:25935783

  4. 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

  5. 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

  6. 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

  7. Obesity/Overweight in Persons with Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention

    DTIC Science & Technology

    2013-10-01

    POINTS TO REMEMBER  Mediterranean-style diets emphasize the consumption of fish, seafood, and poultry over red meats and beef  All dairy products...sandwiches instead of luncheon/deli meats with more fat.. such as regular bologna or salami. o Trim away all of the visible fat from meats and poultry ...made from meat, poultry , meats, organ meats, pouh:ry, and eggs. seafood, beans and peas. eggs. processed beans and pea s : soy beans. split peas. tofu

  8. 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.

  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. Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multi-center survey

    PubMed Central

    Zeiser, Robert; Burchert, Andreas; Lengerke, Claudia; Verbeek, Mareike; Maas-Bauer, Kristina; Metzelder, Stephan K.; Spoerl, Silvia; Ditschkowski, Markus; Ecsedi, Matyas; Sockel, Katja; Ayuk, Francis; Ajib, Salem; de Fontbrune, Flore Sicre; Na, Il-Kang; Penter, Livius; Holtick, Udo; Wolf, Dominik; Schuler, Esther; Meyer, Everett; Apostolova, Petya; Bertz, Hartmut; Marks, Reinhard; Lübbert, Michael; Wäsch, Ralph; Scheid, Christof; Stölzel, Friedrich; Ordemann, Rainer; Bug, Gesine; Kobbe, Guido; Negrin, Robert; Brune, Mats; Spyridonidis, Alexandros; Schmitt-Gräff, Annette; van der Velden, Walter; Huls, Gerwin; Mielke, Stephan; Grigoleit, Götz Ulrich; Kuball, Jürgen; Flynn, Ryan; Ihorst, Gabriele; Du, Jing; Blazar, Bruce R; Arnold, Renate; Kröger, Nicolaus; Passweg, Jakob; Halter, Jörg; Socié, Gerard; Beelen, Dietrich; Peschel, Christian; Neubauer, Andreas; Finke, Jürgen; Duyster, Justus; von Bubnoff, Nikolas

    2016-01-01

    Despite major improvements in allogeneic hematopoietic cell transplantation over the last decades, corticosteroid-refractory (SR) acute (a) and chronic (c) graft-versus-host disease (GVHD) cause high mortality. Pre-clinical evidence indicates the potent anti-inflammatory properties of the JAK1/2 inhibitor ruxolitinib. In this retrospective survey, 19 stem cell transplant centers in Europe and the United States reported outcome data from 95 patients who had received ruxolitinib as salvage-therapy for SR-GVHD. Patients were classified as having SR-aGVHD (n=54, all grade III or IV) or SR-cGVHD (n=41, all moderate or severe). The median number of previous GVHD-therapies was 3 for both SR-aGVHD (1–7) and SR-cGVHD (1–10). The ORR was 81.5% (44/54) in SR-aGVHD including 25 CRs (46.3%), while for SR-cGVHD the ORR was 85.4% (35/41). Of those patients responding to ruxolitinib, the rate of GVHD-relapse was 6.8% (3/44) and 5.7% (2/35) for SR-aGVHD and SR-cGVHD, respectively. The 6-month-survival was 79% (67.3%–90.7%,95% CI) and 97.4% (92.3%–100%,95% CI) for SR-aGVHD and SR-cGVHD, respectively. Cytopenia and CMV-reactivation were observed during ruxolitinib-treatment in both SR-aGVHD (30/54, 55.6% and 18/54, 33.3%) and SR-cGVHD (7/41, 17.1% and 6/41, 14.6%) patients. Ruxolitinib may constitute a promising new treatment option for SR-aGVHD and SR-cGVHD that should be validated in a prospective trial. PMID:26228813

  11. 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

  12. Occurrence of Scopulariopsis and Scedosporium in nails and keratinous skin. A 5-year retrospective multi-center study.

    PubMed

    Issakainen, Jouni; Heikkilä, Hannele; Vainio, Eeva; Koukila-Kähkölä, Pirkko; Castren, Mirja; Liimatainen, Oili; Ojanen, Tarja; Koskela, Markku; Meurman, Olli

    2007-05-01

    A 5-year retrospective multicenter study was performed for microascaceous moulds (Microascaceae, Ascomycetes) in Finnish clinical specimens. The files from 1993-1997 of six clinical mycology laboratories in Finland were searched for reports of these fungi, mainly Scopulariopsis and Scedosporium anamorphs in keratinous specimens. From the 521 primary findings, 165 cases were selected for further study based on direct microscopy, colony numbers and accompanying fungi. The clinical records of 148 cases (141 Scopulariopsis, 7 Scedosporium) were studied. Of the nail infections from which Scopulariopsis was recovered, 39 cases were further separated which showed clinical or laboratory-based evidence of dermatophytosis. In the remaining 90 'non-dermatophyte' nail cases, Scopulariopsis spp. were the only documented fungal agents (c. 6 cases/million/year). The patients were mainly elderly, 66% of whom had problems involving their big toe nails. For 74% of them, the nail problem was mentioned as their reason for visiting the physician. However, only 18% had documented benefit from treatment. The Scopulariopsis nail infections seem to be treatment-resistant and the pathogenesis and etiological role of Scopulariopsis remain poorly understood.

  13. Eligibility for mechanical thrombectomy in acute ischemic stroke: A phase IV multi-center screening log registry.

    PubMed

    Tsivgoulis, Georgios; Goyal, Nitin; Mikulik, Robert; Sharma, Vijay K; Katsanos, Aristeidis H; Zand, Ramin; Paliwal, Prakash R; Roussopoulou, Andromachi; Volny, Ondrej; Pandhi, Abhi; Zompola, Christina; Elijovich, Lucas; Safouris, Apostolos; Chang, Jason; Alexandrov, Andrei V; Alexandrov, Anne W

    2016-12-15

    No eligibility screening logs were kept in recent mechanical thrombectomy (MT) RCTs establishing safety and efficacy of endovascular reperfusion therapies for acute ischemic stroke (AIS). We sought to evaluate the potential eligibility for MT among consecutive AIS patients in a prospective international multicenter study. We prospectively evaluated consecutive AIS patients admitted in four tertiary-care stroke centers during a twelve-month period. Potential eligibility for MT was evaluated using inclusion criteria from MR CLEAN & REVASCAT. Our study population consisted of 1464 AIS patients (mean age 67±14years, 56% men, median admission NIHSS-score: 5, IQR: 3-10). A total of 123 (8%, 95% CI: 7%-10%) and 82 (6%, 95% CI: 5%-7%) patients fulfilled the inclusion criteria for MR CLEAN&REVASCAT respectively. No evidence of heterogeneity (p>0.100) was found in the eligibility for MT across the participating centers. Absence of proximal intracranial occlusion (69%) and hospital arrival outside the eligible time window (38% for MR CLEAN & 35% for REVASCAT) were the two most common reasons for ineligibility for MT. Our everyday clinical practice experience suggests that approximately one out of thirteen to seventeen consecutive AIS may be eligible for MT if inclusion criteria for MR CLEAN and REVASCAT are strictly adhered to.

  14. 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

  15. Extra-hepatic anomalies in infants with biliary atresia: results of a large prospective North American multi-center study

    PubMed Central

    Schwarz, Kathleen B; Haber, Barbara H; Rosenthal, Philip; Mack, Cara L; Moore, Jeffrey; Bove, Kevin E; Bezerra, Jorge A; Karpen, Saul J; Kerkar, Nanda; Shneider, Benjamin L; Turmelle, Yumirle P; Whitington, Peter F; Molleston, Jean P; Murray, Karen F; Ng, Vicky L; Romero, René; Wang, Kasper S; Sokol, Ronald J; Magee, John C

    2013-01-01

    Background and aims The etiology of biliary atresia (BA) is unknown. Given that patterns of anomalies might provide etiopathogenetic clues, we utilized data from the North American Childhood Liver Disease Research and Education Network to analyze patterns of anomalies in infants with BA. Methods Two hundred eighty-nine infants who were enrolled into the prospective database prior to surgery at any of 15 centers participating were evaluated. Results Group 1 was non-syndromic, isolated BA (without major malformations) (n = 242, 84 %), Group 2 was BA and at least one malformation considered major as defined by the National Birth Defects Prevention Study but without laterality defects (n = 17, 6%). Group 3 was syndromic, with laterality defects (n = 30, 10%). In the population as a whole, anomalies (either major or minor) were most prevalent in the cardiovascular (16%) and gastrointestinal (14%) systems. Group 3 patients accounted for the majority of subjects with cardiac, gastrointestinal and splenic anomalies. Group 2 subjects also frequently displayed cardiovascular (71%) and gastrointestinal (24 %) anomalies; interestingly this group had genitourinary anomalies more frequently (47%) compared to Group 3 subjects (10%). Conclusions This study identified a group of BA (Group 2) that differed from the classical syndromic and non-syndromic groups and that was defined by multiple malformations without laterality defects. Careful phenotyping of the patterns of anomalies may be critical to the interpretation of both genetic and environmental risk factors associated with BA, allowing new insight into pathogenesis and/or outcome. PMID:23703680

  16. 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

  17. 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

  18. Constrained snake vs. conventional snake for carotid ultrasound automated IMT measurements on multi-center data sets.

    PubMed

    Molinari, Filippo; Meiburger, Kristen M; Saba, Luca; Acharya, U Rajendra; Ledda, Mario; Nicolaides, Andrew; Suri, Jasjit S

    2012-09-01

    Accurate intima-media thickness (IMT) measurement of the carotid artery from minimal plaque ultrasound images is a relevant clinical need, since IMT increase is related to the progression of atherosclerosis. In this paper, we describe a novel dual snake-based model for the high-performance carotid IMT measurement, called Carotid Measurement Using Dual Snakes (CMUDS). Snakes (which are deformable contours) adapt to the lumen-intima (LI) and media-adventitia (MA) interfaces, thus enabling the IMT computation as distance between the LI and MA snakes. However, traditional snakes might be unable to maintain a correct distance and in some spatial location along the artery, it might even collapse between them or diverge. The technical improvement of this work is the definition of a dual snake-based constrained system, which prevents the LI and MA snakes from collapsing or bleeding, thus optimizing the IMT estimation. The CMUDS system consists of two parametric models automatically initialized using the far adventitia border which we automatically traced by using a previously developed multi-resolution approach. The dual snakes evolve simultaneously and are constrained by the distances between them, ensuring the regularization of LI/MA topology. We benchmarked our automated CMUDS with the previous conventional semi-automated snake system called Carotid Measurement Using Single Snake (CMUSS). Two independent readers manually traced the LIMA boundaries of a multi-institutional, multi-ethnic, and multi-scanner database of 665 CCA longitudinal 2D images. We evaluated our system performance by comparing it with the gold standard as traced by clinical readers. CMUDS and CMUSS correctly processed 100% of the 665 images. Comparing the performance with respect to the two readers, our automatically measured IMT was on average very close to that of the two readers (IMT measurement biases for CMUSS was equal to -0.011±0.329mm and -0.045±0.317mm, respectively, while for CMUDS, it was 0.030±0.284mm and -0.004±0.273mm, respectively). The Figure-of-Merit of the system was 98.5% and 94.4% for CMUSS, while 96.0% and 99.6% for CMUDS, respectively. Results showed that the dual-snake system CMUDS reduced the IMT measurement error accuracy (Wilcoxon, p<0.02) and the IMT error variability (Fisher, p<3×10(-2)). We propose the CMUDS technique for use in large multi-centric studies, where the need for a standard, accurate, and automated IMT measurement technique is required.

  19. 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

  20. Brain morphometry reproducibility in multi-center 3T MRI studies: a comparison of cross-sectional and longitudinal segmentations.

    PubMed

    Jovicich, Jorge; Marizzoni, Moira; Sala-Llonch, Roser; Bosch, Beatriz; Bartrés-Faz, David; Arnold, Jennifer; Benninghoff, Jens; Wiltfang, Jens; Roccatagliata, Luca; Nobili, Flavio; Hensch, Tilman; Tränkner, Anja; Schönknecht, Peter; Leroy, Melanie; Lopes, Renaud; Bordet, Régis; Chanoine, Valérie; Ranjeva, Jean-Philippe; Didic, Mira; Gros-Dagnac, Hélène; Payoux, Pierre; Zoccatelli, Giada; Alessandrini, Franco; Beltramello, Alberto; Bargalló, Núria; Blin, Olivier; Frisoni, Giovanni B

    2013-12-01

    Large-scale longitudinal multi-site MRI brain morphometry studies are becoming increasingly crucial to characterize both normal and clinical population groups using fully automated segmentation tools. The test-retest reproducibility of morphometry data acquired across multiple scanning sessions, and for different MR vendors, is an important reliability indicator since it defines the sensitivity of a protocol to detect longitudinal effects in a consortium. There is very limited knowledge about how across-session reliability of morphometry estimates might be affected by different 3T MRI systems. Moreover, there is a need for optimal acquisition and analysis protocols in order to reduce sample sizes. A recent study has shown that the longitudinal FreeSurfer segmentation offers improved within session test-retest reproducibility relative to the cross-sectional segmentation at one 3T site using a nonstandard multi-echo MPRAGE sequence. In this study we implement a multi-site 3T MRI morphometry protocol based on vendor provided T1 structural sequences from different vendors (3D MPRAGE on Siemens and Philips, 3D IR-SPGR on GE) implemented in 8 sites located in 4 European countries. The protocols used mild acceleration factors (1.5-2) when possible. We acquired across-session test-retest structural data of a group of healthy elderly subjects (5 subjects per site) and compared the across-session reproducibility of two full-brain automated segmentation methods based on either longitudinal or cross-sectional FreeSurfer processing. The segmentations include cortical thickness, intracranial, ventricle and subcortical volumes. Reproducibility is evaluated as absolute changes relative to the mean (%), Dice coefficient for volume overlap and intraclass correlation coefficients across two sessions. We found that this acquisition and analysis protocol gives comparable reproducibility results to previous studies that used longer acquisitions without acceleration. We also show that the longitudinal processing is systematically more reliable across sites regardless of MRI system differences. The reproducibility errors of the longitudinal segmentations are on average approximately half of those obtained with the cross sectional analysis for all volume segmentations and for entorhinal cortical thickness. No significant differences in reliability are found between the segmentation methods for the other cortical thickness estimates. The average of two MPRAGE volumes acquired within each test-retest session did not systematically improve the across-session reproducibility of morphometry estimates. Our results extend those from previous studies that showed improved reliability of the longitudinal analysis at single sites and/or with non-standard acquisition methods. The multi-site acquisition and analysis protocol presented here is promising for clinical applications since it allows for smaller sample sizes per MRI site or shorter trials in studies evaluating the role of potential biomarkers to predict disease progression or treatment effects.

  1. Obesity/Overweight in Persons with Early and Chronic SCI: A Randomized Multi-Center Controlled Lifestyle Intervention

    DTIC Science & Technology

    2011-10-01

    1. Aioli Yields 16 servings Ingredients • 3 cloves garlic – peeled • 1 cup extra virgin olive oil • 1 pinch salt Preparation 1. Peel the...garlic cloves and cut them in half lengthwise to check if they have greenish shoots. If you see sprouts, cut them off, and discard them. o Garlic... cloves , and you can begin to mash them in the mortar without cutting them in half. 2. Drop the garlic cloves in your mortar, add a pinch of salt

  2. 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

    ... International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) SUMMARY: Under the... Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) (OMB No. 0925-0654). Type of Information... lymphoma overall and specifically for populations in Asia will be examined. Patients from 19...

  3. 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... international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (NCI)'' was submitted with...

  4. Treosulfan-Based Conditioning and Hematopoietic Cell Transplantation for Nonmalignant Diseases: A Prospective Multi-Center Trial

    PubMed Central

    Burroughs, Lauri M.; Nemecek, Eneida R.; Torgerson, Troy R.; Storer, Barry E.; Talano, Julie-An; Domm, Jennifer; Giller, Roger H.; Shimamura, Akiko; Delaney, Colleen; Skoda-Smith, Suzanne; Thakar, Monica S.; Baker, K. Scott; Rawlings, David J.; Englund, Janet A.; Flowers, Mary E. D.; Deeg, H. Joachim; Storb, Rainer; Woolfrey, Ann E.

    2015-01-01

    Hematopoietic cell transplantation (HCT) is effective in the treatment of patients with nonmalignant diseases and for many is the only known cure. Conventional myeloablative regimens have been associated with unacceptably high early transplant-related mortality (TRM) particularly in patients with co-morbid conditions. This prospective multicenter trial was designed to determine the safety and engraftment efficacy of treosulfan-based conditioning in patients with nonmalignant diseases. Thirty-one patients received HLA-matched related (n=4) or unrelated (n=27) grafts following conditioning with treosulfan (total dose: 42 g/m2), fludarabine (total dose: 150 mg/m2), ± thymoglobulin (6 mg/kg; n=22). Graft-versus-host disease (GVHD) prophylaxis consisted of tacrolimus and methotrexate. All patients engrafted. Day-100 TRM was 0%. With a median follow-up of 2 years, the 2-year survival was 90%. Three patients died of GVHD, recurrent hemophagocytic lymphohistiocytosis, and a surgical complication, respectively. The cumulative incidences of grades II–IV and III–IV acute GVHD at day 100 and chronic GVHD at 2 years were 62%, 10% and 21%, respectively. Patients who received thymoglobulin had a significantly lower incidence of grade III-IV acute GVHD (0% versus 33%; P = 0.005). These results indicate that the combination of treosulfan, fludarabine, and thymoglobulin is effective at establishing donor engraftment with low toxicity and improved survival in patients with nonmalignant diseases, and support the need for future disease-specific clinical trials. PMID:25196857

  5. 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.

  6. High intensity focused ultrasound (HIFU) treatment of BPH: results of a multi-center phase III study

    NASA Astrophysics Data System (ADS)

    Sanghvi, N.; Gardner, T.; Koch, M.; Bihrle, R.; Foster, R.; Resnick, M.; Seftel, A.; Grunberger, I.; Stiedle, C.; Corchan, J.

    2003-04-01

    The five centers phase III trial was to show that HIFU can treat prostate tissue thermally for symptomatic relief of BPH and improve flow rates. At five sites, 68 BPH patients were treated with the Sonablate device (Focus Surgery, Inc. Indianapolis, IN). A urethral Foley catheter was inserted into the urethra to aid in positioning and was kept in-situ during the treatment. A cooling device was used to cool the rectal wall. The patients returned home within a few hours after the procedure. The Foley catheter was kept electively to avoid any incidence of acute urinary retention following the therapy. The catheter was removed after 4-5 days. The average treatment time was 38 minutes. The patients were treated without pain, blood loss or complications. At 90 days post treatment, average Qmax and AUA Symptom Scores improved from 8.7 ml/s to 12.66 ml/s (48%) and 23.06 to 11.62 (52%), respectively. Significant prostate tissue changes took place before and after the treatment. 80% of the patients had cavity formation at the site of treatment at the bladder neck and prostate. Nonsurgical HIFU therapy is safe and effective for providing symptomatic relief of BPH symptoms and the treatment can be performed as an outpatient procedure.

  7. Influence of 8-bit versus 11-bit digital displays on observer performance and visual search: a multi-center evaluation

    NASA Astrophysics Data System (ADS)

    Krupinski, Elizabeth A.; Siddiqui, Khan; Siegel, Eliot; Shrestha, Rasu; Grant, Edward; Roehrig, Hans; Fan, Jiahua

    2007-03-01

    Monochrome monitors typically display 8 bits of data (256 shades of gray) at one time. This study determined if monitors that can display a wider range of grayscale information (11-bit) can improve observer performance and decrease the use of window/level in detecting pulmonary nodules. Three sites participated using 8 and 11-bit displays from three manufacturers. At each site, six radiologists reviewed 100 DR chest images on both displays. There was no significant difference in ROC Az (F = 0.0374, p = 0.8491) as a function of 8 vs 11 bit-depth. Average Az across all observers with 8-bits was 0.8284 and with 11-bits was 0.8253. There was a significant difference in overall viewing time (F = 10.209, p = 0.0014) favoring the 11-bit displays. Window/level use did not differ significantly for the two types of displays. Eye position recording on a subset of images at one site showed that cumulative dwell times for each decision category were lower with the 11-bit than with the 8-bit display. T-tests for paired observations showed that the TP (t = 1.452, p = 0.1507), FN (t = 0.050, p = 0.9609) and FP (t = 0.042, p = 0.9676) were not statistically significant. The difference for the TN decisions was statistically significant (t = 1.926, p = 0.05). 8-bit displays will not impact negatively diagnostic accuracy, but using 11-bit displays may improve workflow efficiency.

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

    PubMed Central

    2016-01-01

    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

  9. A multi-centered randomized trial of the treatment of pemphigus vulgaris patients with infliximab and prednisone compared to prednisone alone

    PubMed Central

    Hall, R.P.; Fairley, J.; Woodley, D.; Werth, V.P.; Hannah, D.; Streilein, R.D.; McKillip, J.; Okawa, J.; Rose, M.; Keyes-Elstein, L.L.; Pinckney, A.; Overington, A.; Wedgwood, J.; Ding, L.; Welch, B.

    2014-01-01

    Background Pemphigus vulgaris (PV) is a blistering disease in which TNF-α has a role in the pathogenesis. Objectives The objective was to evaluate the safety of infliximab (IFX) with prednisone compared to prednisone alone in the treatment of PV. In addition, treatment response was assessed and mechanistic studies were performed. Methods PV subjects who had ongoing disease activity while maintained on prednisone were randomized to receive either IFX or placebo in addition to prednisone. Response status and IgG anti-DSG1 and DSG3 antibodies were assessed at 18 and 26 weeks. . Results 10 subjects were randomized to each group. There were no safety signals during the course of the study. At week 18, 1 subject in each group had responded. At week 26, 3 IFX treated subjects vs. none in the placebo group had responded (p =0 .21). At weeks 18 and 26, the median IgG anti-DSG1 and anti-DSG3 levels were lower in the IFX treated-patients (IgG anti DSG-1: week 18 p =0.035, week 26 p = 0.022; IgG anti-DSG3; week 18 p=0.035, week 26 p = 0.05)). Limitations This study is limited by the relative small sample size. Conclusions There was no significant difference between study arms in the proportion of subjects with treatment-related Adverse Events > Grade 3. IFX therapy was not shown to be effective for the treatment of patients with PV in this randomized, placebo-controlled trial, although IFX treatment may be associated with a decrease in anti-DSG1 and DSG3 antibodies. PMID:25123295

  10. Comparisons of vaginal and abdominal radical trachelectomy for early-stage cervical cancer: preliminary results of a multi-center research in China

    PubMed Central

    Cao, D Y; Yang, J X; Wu, X H; Chen, Y L; Li, L; Liu, K J; Cui, M H; Xie, X; Wu, Y M; Kong, B H; Zhu, G H; Xiang, Y; Lang, J H; Shen, K

    2013-01-01

    Background: There are limited data comparing the prognosis and fertility outcomes of the patients with early cervical cancer treated by trans-vaginal radical trachelectomy (VRT) or abdominal radical trachelectomy (ART).The objective of this study was to compare the surgical and pathologic characteristics, the prognosis and fertility outcomes of the patients treated by VRT or ART. Methods: Matched-case study based on a prospectively maintained database of patients underwent radical trachelectomy in 10 centres of China was designed to compare the prognosis and fertility outcomes of the patients treated by VRT or ART. Results: Totally 150 cases, 77 in the VRT and 73 in the ART group, were included. VRT and ART provide similar surgical and pathological outcomes except larger specimens obtained by ART. In the ART group, no patient developed recurrent diseases, but, in the VRT group, 7 (9.8%) patients developed recurrent diseases and 2 (1.6%) patients died of the tumours (P=0.035). The rate of pregnancy in the VRT group was significantly higher than those of ART (39.5% vs 8.8% P=0.003). The patients with tumour size >2 cm showed significant higher recurrent rate (11.6% vs 2.4%, P<0.05) and lower pregnant rate (12.5% vs 32.1%, P=0.094) compared with the patients with tumour size <2 cm. Conclusion: Patients treated by ART obtained better oncology results, but their fertility outcomes were unfavourable compared with VRT. Tumour size <2 cm should be emphasised as an indication for radical trachelectomy for improving the outcome of fertility and prognosis. PMID:24169350

  11. Application of Thorpex-Tigge Multi-Center Weather Forecasts for River Discharge Forecasting: Application to Major Rivers in South Asia

    NASA Astrophysics Data System (ADS)

    Hopson, T. M.; Hamill, T.; Webster, P. J.

    2013-12-01

    TIGGE, the THORPEX Interactive Grand Global Ensemble, is designed to accelerate the improvements in the accuracy of 1-day to 2 week high-impact weather forecasts for the benefit of humanity. In this presentation we examine the precipitation forecasting skill of the TIGGE ensemble to flood forecasting in South Asia. Natural flood disasters impact South Asia with profound societal impacts for the region and globally, with half the world's population depending on the region's great rivers: the Indus, Ganges, and Brahmaputra. The 2007 Brahmaputra floods affecting India and Bangladesh, and the 2010 flooding of the Indus River in Pakistan exemplify disasters on scales almost inconceivable elsewhere. In this presentation we examine the TIGGE precipitation forecasting skill over the basins of the Ganges, Brahmaputra, and Indus. Recent work (Hamill 2012) has shown the benefits of Tigge to precipitation forecasting over the conterminous US. In this work we also explore its utility in improving the skill of the Climate Forecasting Applications for Bangladesh (CFAB) forecast system, which has been providing operational probabilistic forecasts over the last decade of severe flooding of the Brahmaputra and Ganges Rivers as part of a humanitarian effort to mitigate the impacts of these events on the country of Bangladesh

  12. A randomized, double-blind, placebo controlled, multi-center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome.

    PubMed

    Grote, Ludger; Leissner, Lena; Hedner, Jan; Ulfberg, Jan

    2009-07-30

    Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S-ferritin < or =45 microg/L) recruited from a cohort of 231 patients were randomly assigned in a 12-months double-blind, multi-centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan-Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long-term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS.

  13. A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)

    ClinicalTrials.gov

    2016-12-03

    Refractory Diffuse Large B Cell Lymphoma; Refractory Primary Mediastinal B Cell Lymphoma; Refractory Transformed Follicular Lymphoma; Relapsed/Refractory Transplant Ineligible Diffuse Large B Cell Lymphoma; Relapsed/Refractory Transplant Ineligible Primary Mediastinal B Cell Lymphoma; Relapsed/Refractory Transplant Ineligible Transformed Follicular Lymphoma

  14. Evaluation of the Bio-Rad Geenius HIV 1/2 Confirmation Assay as an Alternative to Western Blot in the Korean Population: A Multi-Center Study.

    PubMed

    Moon, Hee-Won; Huh, Hee Jin; Oh, Gwi Young; Lee, Sang Gon; Lee, Anna; Yun, Yeo-Min; Hur, Mina

    2015-01-01

    Recently updated recommendations for diagnosis of HIV infection suggest a new diagnostic algorithm including HIV-1/HIV-2 antibody differentiation immunoassay instead of western blot (WB) as a confirmatory testing. We evaluated Bio-Rad Geenius HIV1/2 confirmation assay as a simple and reliable alternative to WB in the Korean population with low HIV prevalence. The Geenius HIV1/2 was performed in a total of 192 serum specimens (140 reactive and 52 nonreactive specimens by ARCHITECT HIV Ag/Ab Combo assay) that were prospectively collected from five institutions. HIV-1 nucleic acid amplification test (NAT) was performed in negative or indeterminate specimens by Geenius HIV1/2 or WB. Among 140 reactive specimens by HIV Ag/Ab assay, 82 (58.6%) were positive for HIV-1 Ab by Geenius HIV1/2. Among 58 negative or indeterminate specimens by Geenius HIV1/2, four specimens (6.9%) were positive by HIV-1 NAT. The sensitivity and specificity of Geenius HIV1/2 were 95.3% and 100.0%, respectively. When we considered only WB, the sensitivity and specificity of Geenius HIV1/2 were 100.0% and 99.1%, respectively. Agreement between Geenius HIV1/2 and WB was excellent (weighted Kappa = 0.89). The Geenius HIV1/2 is simple and time-saving compared with WB. It has an excellent performance and can be a reliable alternative to WB. HIV-1 NAT should be performed in negative or indeterminate specimens by Geenius HIV1/2 to detect acute HIV infection as recommended in new HIV testing algorithms.

  15. Early and very early hepatocellular carcinoma: when and how much do staging and choice of treatment really matter? A multi-center study

    PubMed Central

    2009-01-01

    Background A consensus on the most reliable staging system for hepatocellular carcinoma (HCC) is still lacking but the most used is a revised Barcelona Clinic Liver Cancer (BCLC) system, adopted by the American Association for the Study of Liver Diseases (AASLD). We investigated how many patients are diagnosed in "very early" and "early" stage, follow the AASLD guidelines for treatment and whether their survival depends on treatment. Methods Data were collected in 530 "very early" and "early" HCC patients recruited by a multicentric Italian collaborative group (ITA.LI.CA). The Kaplan-Meier method was used to estimate overall survival and the log rank to test the statistical significance of difference between groups. Cox's multivariate stepwise regression analysis was used to pinpoint independent prognostic factors and the adjusted relative risks (hazard ratios) were calculated as well. A statistical analysis based on the chi-square test was used to identify significant differences in clinical or pathological features between patients. A P-value < 0.05 was considered statistically significant. Results "Very early" HCC were 3%; Cox multivariate analysis did not identify variables independently associated with survival. The patients following AASLD recommendations (20%) did not show longer survival. In "early" HCC patients (25%), treatment significantly modulated survival (p = 0.0001); the 28% patients treated according to the AASLD criteria survived longer (p = 0,004). The Cox analysis however identified only age, gender, number of lesions and Child class as independent predictors of survival. Conclusion patients with very early" HCC were very few in this analysis. In most instances they were not treated with the treatment suggested as the most appropriate by the AASLD guidelines and the type of treatment had no impact on survival, even though the number of patients was relatively low and part of the patients were diagnosed before the introduction of the guidelines: this analysis, therefore, might not be considered as conclusive and should be validated. The "early" stage group involved more patients, rarely treated according to the guidelines, both overall and also in those diagnosed after their publication; the survival was in part predicted by the type of treatment, with better results in those treated according to AASLD indications. PMID:19171074

  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. 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

    2016-01-01

    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

  18. A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer

    PubMed Central

    Friess, Helmut; Langrehr, Jan M; Oettle, Helmut; Raedle, Jochen; Niedergethmann, Marco; Dittrich, Christian; Hossfeld, Dieter K; Stöger, Herbert; Neyns, Bart; Herzog, Peter; Piedbois, Pascal; Dobrowolski, Frank; Scheithauer, Werner; Hawkins, Robert; Katz, Frieder; Balcke, Peter; Vermorken, Jan; van Belle, Simon; Davidson, Neville; Esteve, Albert Abad; Castellano, Daniel; Kleeff, Jörg; Tempia-Caliera, Adrien A; Kovar, Andreas; Nippgen, Johannes

    2006-01-01

    Background Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer. Methods A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m2 twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m2 for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients. Results Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa. Conclusion There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent. PMID:17156477

  19. Improving intensive care unit-based palliative care delivery: a multi-center, multidisciplinary survey of critical care clinician attitudes and beliefs

    PubMed Central

    Wysham, Nicholas G.; Hua, May; Hough, Catherine L.; Gundel, Stephanie; Docherty, Sharron L.; Jones, Derek M.; Reagan, Owen; Goucher, Haley; Mcfarlin, Jessica; Galanos, Anthony; Knudsen, Nancy; Cox, Christopher E.

    2016-01-01

    Objective Addressing the quality gap in intensive care unit (ICU)-based palliative care is limited by uncertainty about acceptable models of collaborative specialist and generalist care. Therefore, we characterized the attitudes of physicians and nurses about palliative care delivery in an ICU environment. Design Mixed-methods study. Setting Medical and surgical ICUs at three large academic hospitals. Participants 303 nurses, intensivists, and advanced practice providers. Measurements and main results Clinicians completed written surveys that assessed attitudes about specialist palliative care presence and integration into the ICU setting, as well as acceptability of 23 published palliative care prompts (‘triggers’) for specialist consultation. Most (n=225, 75%) reported that palliative care consultation was underutilized. Prompting consideration of eligibility for specialist consultation by electronic health record searches for triggers was most preferred (n=123, 41%); only 17 (6%) felt current processes were adequate. The most acceptable specialist triggers were metastatic malignancy, unrealistic goals of care, end of life decision making, and persistent organ failure. Advanced age, length of stay, and duration of life support were the least acceptable. Screening led by either specialists or ICU teams was equally preferred. Central themes derived from qualitative analysis of 65 written responses to open-ended items included concerns about the roles of physicians and nurses, implementation, and impact on ICU team-family relationships. Conclusions Integration of palliative care specialists in the ICU is broadly acceptable and desired. However, the most commonly used current triggers for prompting specialist consultation were among the least well accepted, while more favorable triggers are difficult to abstract from electronic health record systems. There is also disagreement about the role of ICU nurses in palliative care delivery. These findings provide important guidance to the development of collaborative care models for the ICU setting. PMID:27618270

  20. Revisiting the male genetic landscape of China: a multi-center study of almost 38,000 Y-STR haplotypes.

    PubMed

    Nothnagel, Michael; Fan, Guangyao; Guo, Fei; He, Yongfeng; Hou, Yiping; Hu, Shengping; Huang, Jiang; Jiang, Xianhua; Kim, Wook; Kim, Kicheol; Li, Chengtao; Li, Hui; Li, Liming; Li, Shilin; Li, Zhao; Liang, Weibo; Liu, Chao; Lu, Di; Luo, Haibo; Nie, Shengjie; Shi, Meisen; Sun, Hongyu; Tang, Jianpin; Wang, Lei; Wang, Chuan-Chao; Wang, Dan; Wen, Shao-Qing; Wu, Hongyan; Wu, Weiwei; Xing, Jiaxin; Yan, Jiangwei; Yan, Shi; Yao, Hongbing; Ye, Yi; Yun, Libing; Zeng, Zhaoshu; Zha, Lagabaiyila; Zhang, Suhua; Zheng, Xiufen; Willuweit, Sascha; Roewer, Lutz

    2017-01-30

    China has repeatedly been the subject of genetic studies to elucidate its prehistoric and historic demography. While some studies reported a genetic distinction between Northern and Southern Han Chinese, others showed a more clinal picture of small differences within China. Here, we investigated the distribution of Y chromosome variation along administrative as well as ethnic divisions in the mainland territory of the People's Republic of China, including 28 administrative regions and 19 recognized Chinese nationalities, to assess the impact of recent demographic processes. To this end, we analyzed 37,994 Y chromosomal 17-marker haplotype profiles from the YRHD database with respect to forensic diversity measures and genetic distance between groups defined by administrative boundaries and ethnic origin. We observed high diversity throughout all Chinese provinces and ethnicities. Some ethnicities, including most prominently Kazakhs and Tibetans, showed significant genetic differentiation from the Han and other groups. However, differences between provinces were, except for those located on the Tibetan plateau, less pronounced. This discrepancy is explicable by the sizeable presence of Han speakers, who showed high genetic homogeneity all across China, in nearly all studied provinces. Furthermore, we observed a continuous genetic North-South gradient in the Han, confirming previous reports of a clinal distribution of Y chromosome variation and being in notable concordance with the previously observed spatial distribution of autosomal variation. Our findings shed light on the demographic changes in China accrued by a fast-growing and increasingly mobile population.

  1. Maté drinking and esophageal squamous cell carcinoma in South America: pooled results from two large multi-center case-control studies

    PubMed Central

    Lubin, Jay H.; De Stefani, Eduardo; Abnet, Christian C.; Acosta, Gisele; Boffetta, Paolo; Victora, Cesar; Graubard, Barry I.; Muñoz, Nubia; Deneo-Pellegrini, Hugo; Franceschi, Silvia; Castellsagué, Xavier; Ronco, Alvaro L; Dawsey, Sanford M.

    2013-01-01

    Background Maté tea is non-alcoholic infusion widely consumed in southern South America, and may increase risk of esophageal squamous cell carcinoma (ESCC) and other cancers due to polycyclic aromatic hydrocarbons and/or thermal injury. Methods We pooled two case-control studies: a 1988–2005 Uruguay study and a 1986–1992 multinational study in Argentina, Brazil, Paraguay and Uruguay, including 1,400 cases and 3,229 controls. We computed odds ratios (OR) and fitted a linear excess odds ratio (EOR) model for cumulative maté consumption in liters/day-year (LPDY). Results The adjusted OR for ESCC with 95% confidence interval (CI) by ever compared with never use of maté was 1.60 (1.2,2.2). ORs increased linearly with LPDY (test of non-linearity, P=0.69). The estimate of slope (EOR/LPDY) was 0.009 (0.005,0.014) and did not vary with daily intake, indicating maté intensity did not influence the strength of association. EOR/LPDY estimates for consumption at warm, hot and very hot beverage temperatures were 0.004 (−0.002,0.013), 0.007 (0.003,0.013) and 0.016 (0.009,0.027), respectively, and differed significantly (P<0.01). EOR/LPDY estimates were increased in younger (<65) individuals and never alcohol drinkers, but these evaluations were post hoc, and were homogeneous by sex. Conclusions ORs for ESCC increased linearly with cumulative maté consumption and were unrelated to intensity, so greater daily consumption for shorter duration or lesser daily consumption for longer duration resulted in comparable ORs. The strength of association increased with higher mate temperatures. Impact Increased understanding of cancer risks with maté consumption enhances the understanding of the public health consequences given its purported health benefits. PMID:24130226

  2. Establishing a reference interval for serum anti-dsDNA antibody: A large Chinese Han population-based multi-center study

    PubMed Central

    Deng, Chuiwen; Zhang, Shulan; Hu, Chaojun; Li, Ping; Wu, Ziyan; Chen, Si; Li, Jing; Li, Liubing; Zhang, Fengchun; Li, Yongzhe

    2017-01-01

    Background A reference interval (RI) for the circulating concentration of anti-dsDNA antibody is essential for clinicians to interpret laboratory results and make clinical decisions. Therefore, we aimed to establish the RI for anti-dsDNA antibody in the Chinese Han population. Methods This study was designed and carried out in accordance with guideline C28-A3, which is proposed by the International Federation of Clinical Chemistry and the Clinical and Laboratory Standards Institute. A total of 2,880 apparently healthy individuals were enrolled using a posteriori sampling. These individuals were recruited from four hospitals, representing the Han populations of north, south, east, and west China. Serum anti-dsDNA antibody levels were measured using the three analytical systems AESKU, EUROIMMUNE, and INOVA, which are the most commonly used systems in China. Individuals were stratified by gender, age, and region, and the RIs were obtained by nonparametric methods. Results Gender-specific RIs for serum anti-dsDNA antibody in the Chinese Han population were established. Conclusion This is the first exploration of the RI for anti-dsDNA antibody in the Chinese Han population. We have established gender-specific RIs for each assay method commonly used in China. PMID:28151970

  3. Gigantic Cavernous Hemangioma of the Liver Treated by Intra-Arterial Embolization with Pingyangmycin-Lipiodol Emulsion: A Multi-Center Study

    SciTech Connect

    Zeng Qingle; Li Yanhao; Chen Yong; Ouyang Yong; He Xiang; Zhang Heping

    2004-09-15

    Purpose: To evaluate the therapeutic effect and safety of pingyangmycin-lipiodol emulsion (PLE) intra-arterial embolization for treating gigantic cavernous hemangioma of the liver (CHL).Methods: Three hospitals (Nanfang Hospital, Inner Mongolia Autonomous Region's Hospital and Huai He Hospital) participated in the study during 1997-2001. A total of 98 patients with CHL were embolized with PLE via the hepatic artery. The therapeutic effects including changes in tumor diameter, symptomatic improvement and occurrence of complications were evaluated for a period of 12 months after the procedure.Results: The tumor diameters decreased significantly from 9.7 {+-} 2.3 cm to 5.6 {+-} 1.6 cm 6 months after the treatment (P < 0.01), and then to 3.0 {+-} 1.2 cm at 12 months (P < 0.01). Transient impairment of liver function was found in 77 cases after embolization, 69 cases of which returned to normal in 2 weeks, and the other eight cases of which recovered 1 month later. The clinical symptoms were significantly relieved in all 53 symptomatic patients. Persistent pain in the hepatic region was found in two cases, and these two patients resorted to surgery eventually.Conclusion: Intra-arterial PLE embolization proves to be effective and safe in treating patients with CHL.

  4. Effect of Helicobacter pylori Eradication on the Development of Reflux Esophagitis and Gastroesophageal Reflux Symptoms: A Nationwide Multi-Center Prospective Study

    PubMed Central

    Kim, Nayoung; Lee, Sang Woo; Kim, Jin Il; Baik, Gwang Ho; Kim, Sung Jung; Seo, Geom Seog; Oh, Hyo Jeong; Kim, Sang Wook; Jeong, Heyjin; Hong, Su Jin; Shim, Ki-Nam; Shin, Jeong Eun; Park, Seun Ja; Im, Eui Hyeog; Park, Jong-Jae; Cho, Sung-Il

    2011-01-01

    Background/Aims A two-year, prospective, nationwide multicenter study was undertaken to evaluate the effect of Helicobacter pylori eradication on the development of reflux esophagitis (RE) and gastroesophageal reflux disease (GERD) symptoms in the Korean population. Methods In total, 1,489 subjects without RE were enrolled at the outpatient clinics of 12 tertiary hospitals nationwide, and 452 subjects underwent follow-up (F/U) for 2 years to evaluate the development of RE and GERD symptoms. Results RE was found in 33 subjects (7.3% of 452 subjects) and 14 subjects (7.3% of 192 subjects) during the first and second year of F/U, respectively. H. pylori status was not associated with the development of RE. RE was found in six (9.0%) of 67 H. pylori-negative patients, in 26 (11.2%) of 233 eradicated subjects and in eight (7.0%) of 114 noneradicated subjects (p=0.532). Multivariate analysis showed that age ≥60 years (odds ratio [OR], 7.11; 95% confidence interval [CI], 1.92 to 26.41), alcohol consumption (OR, 4.43; 95% CI, 1.03 to 19.19) and F/U cholesterol levels ≥200 mg/dL (OR, 5.03; 95% CI, 1.32 to 19.17) were significant risk factors for the development of RE. There was no significant difference in the development of GERD symptoms or weight according to H. pylori status during the 2-year F/U. Conclusions Eradication of H. pylori did not affect the development of reflux esophagitis or GERD symptoms among patients in outpatient gastroenterology clinics in South Korea. PMID:22195241

  5. A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder.

    PubMed

    Woelk, H; Schläfke, S

    2010-02-01

    Generalized and persistent anxiety, accompanied by nervousness and other symptoms (Generalised Anxiety Disorder, GAD) is frequent in the general population and leads to benzodiazepine usage. Unfortunately, these substances induce sedation and have a high potential for drug abuse, and there is thus a need for alternatives. As the anxiolytic properties of lavender have already been demonstrated in pharmacological studies and small-scale clinical trials, it was postulated that lavender has a positive effect in GAD. A controlled clinical study was then performed to evaluate the efficacy of silexan, a new oral lavender oil capsule preparation, versus a benzodiazepine. In this study, the efficacy of a 6-week-intake of silexan compared to lorazepam was investigated in adults with GAD. The primary target variable was the change in the Hamilton Anxiety Rating Scale (HAM-A-total score) as an objective measurement of the severity of anxiety between baseline and week 6. The results suggest that silexan effectively ameliorates generalized anxiety comparable to a common benzodiazepine (lorazepam). The mean of the HAM-A-total score decreased clearly and to a similar extent in both groups (by 11.3+/-6.7 points (45%) in the silexan group and by 11.6+/-6.6 points (46%) in the lorazepam group, from 25+/-4 points at baseline in both groups). During the active treatment period, the two HAM-A subscores "somatic anxiety" (HAM-A subscore I) and "psychic anxiety" (HAM-A subscore II) also decreased clearly and to a similar extent in both groups. The changes in other subscores measured during the study, such as the SAS (Self-rating Anxiety Scale), PSWQ-PW (Penn State Worry Questionnaire), SF 36 Health survey Questionnaire and Clinical Global Impressions of severity of disorder (CGI item 1, CGI item 2, CGI item 3), and the results of the sleep diary demonstrated comparable positive effects of the two compounds. In conclusion, our results demonstrate that silexan is as effective as lorazepam in adults with GAD. The safety of silexan was also demonstrated. Since lavender oil showed no sedative effects in our study and has no potential for drug abuse, silexan appears to be an effective and well tolerated alternative to benzodiazepines for amelioration of generalised anxiety.

  6. 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

  7. A Korean Multi-Center Survey about Warfarin Management before Gastroenterological Endoscopy in Patients with a History of Mechanical Valve Replacement Surgery

    PubMed Central

    Son, Kuk Hui; Choi, Chang-Hyu; Lee, Jae-Ik; Kim, Kun Woo; Kim, Ji Sung; Lee, So Young; Park, Kook Yang; Park, Chul Hyun

    2016-01-01

    Background Guidelines for esophagogastroduodenoscopy (EGD) in the West allow the continued use of warfarin under therapeutic international normalized ratio (INR) level. In Korea, no guidelines have been issued regarding warfarin treatment before EGD. The authors surveyed Korean cardiac surgeons about how Korean cardiac surgeons handle warfarin therapy before EGD using a questionnaire. Participants were requested to make decisions regarding the continuation of warfarin therapy in two hypothetical cases. Methods The questionnaire was administered to cardiac surgeons and consisted of eight questions, including two case scenarios. Results Thirty-six cardiac surgeons at 28 hospitals participated in the survey, and 52.7% of the participants chose to stop warfarin before EGD in aortic valve replacement patients without risk factors for thromboembolism. When the patient’s INR level was 2, 31% of the participants indicated that they would choose to continue warfarin therapy. For EGD with biopsy, 72.2% of the participants chose warfarin withdrawal, and 25% of the participants chose heparin replacement. In mitral valve replacement patients, 47.2% of the participants chose to discontinue warfarin, and 22.2% of the participants chose heparin replacement. For EGD with biopsy in patients with a mitral valve replacement, 58.3% of the participants chose to stop warfarin, and 41.7% of the participants chose heparin replacement. Conclusion This study demonstrated that attitudes regarding warfarin treatment for EGD are very different among Korean surgeons. Guidelines specific to the Korean population are required. PMID:27733991

  8. Genetic variants, PM2.5 exposure level and global DNA methylation level: A multi-center population-based study in Chinese.

    PubMed

    Liu, Jia; Xie, Kaipeng; Chen, Weihong; Zhu, Meng; Shen, Wei; Yuan, Jing; Cheng, Yang; Geng, Liguo; Wang, Yuzhuo; Li, Zhihua; Zhang, Jiahui; Jin, Guangfu; Dai, Juncheng; Ma, Hongxia; Du, Jiangbo; Wang, Meilin; Zhang, Zhengdong; Hu, Zhibin; Wu, Tangchun; Shen, Hongbing

    2017-03-05

    Global DNA methylation levels can be determined by environmental and genetic factors. There are emerging evidences that methylation status can be modified as exposed to environmental factors such as PM2.5, but the genetic determinants are still largely unknown. To explore whether genetic variants contribute to global DNA methylation levels with consideration of environmental exposures, we systematically evaluated the association between genetic variants and global DNA methylation levels in 301 subjects from three cities in southern, central and northern China with different PM2.5 exposure levels (Zhuhai, Wuhan and Tianjin, respectively). Personal 24-h PM2.5 exposure levels and global DNA methylation levels for each subject were evaluated. Using Illumina Human Exome BeadChip, 241,305 SNVs was genotyped and assessed for their association with global DNA methylation levels. We found that after adjusting for age, gender, PM2.5 exposure level, pack-years of smoking and BMI, 14 SNVs were consistently associated with global DNA methylation levels with pooled P≤1.00×10(-4) after meta-analysis of three cohorts, in which 8 SNVs together with age were independent factors modifying global DNA methylation levels. Joint analysis of these identified SNVs showed a significant allele-dosage association between the number of variants and global DNA methylation levels (P=1.82×10(-23)). In particular, we detected a significant multiplicative interaction between rs4344916 on chromosome 2p22.3 and PM2.5 exposure on global DNA methylation level (P=0.0095). Our findings indicate that genetic variants alone or in combination with PM2.5 play an important role in modifying individual global DNA methylation levels.

  9. The effect of water fluoride concentration on dental caries and fluorosis in five Iran provinces: A multi-center two-phase study

    PubMed Central

    Ramezani, Gholamhossein; Valaie, Nasser; Rakhshan, Vahid

    2015-01-01

    Background: Water fluoride level is unknown in many regions of Iran. Besides, only few non-controlled studies world-wide have assessed the effect of water fluoride on dental fluorosis and caries. We aimed to measure the fluoride level of 76 water supplies in 54 cities and evaluate the effect of fluoride on dental caries and fluorosis in a large multi-project study. Materials and Methods: In the first phase (cross-sectional), fluoride levels of 76 water tanks in 54 cities/villages in five provinces of Iran were randomly evaluated in five subprojects. In the second phase (retrospective cohort), 1127 middle school children (563 cohort and 564 control subjects) in the high and low ends of fluoride concentration in each subproject were visited. Their decayed, missing and filled teeth (DMFT) and fluorosis states were assessed. The data were analyzed using Chi-square, Mann-Whitney U and independent-samples t-test (α = 0.05). Results: Mean fluoride level was 0.298 ± 0.340 mg/L in 54 cities/villages. Only eight water tanks had fluoride levels within the normal range and only one was higher than normal and the rest (67 tanks) were all at low levels. Overall, a significant association was observed between fluoride level and fluorosis. However, this was not the case in all areas, as in 2 of 5 provinces, the effect of fluoride on fluorosis was not confirmed. In 4 of the 5 areas studied, there was a significant link between fluoride level and DMFT. Conclusion: Extremely low fluoride levels in Iran cities are an alarming finding and need attention. Higher fluoride is likely to reduce dental caries while increasing fluorosis. This finding was not confirmed in all the areas studied. PMID:25709672

  10. 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

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

    PubMed

    Zhang, Yadong; Zheng, Tao; Tu, Xiang'an; 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.

  12. Evaluation following staggered implementation of the ‘Rethinking Critical Care’ ICU care bundle in a multi-center community setting

    PubMed Central

    Liu, Vincent; Herbert, David; Foss-Durant, Anne; Marelich, Gregory P.; Patel, Anandray; Whippy, Alan; Turk, Benjamin J; Ragins, Arona I; Kipnis, Patricia; Escobar, Gabriel J

    2016-01-01

    Objective To evaluate process metrics and outcomes following implementation of the ‘Rethinking Critical Care’ (RCC) ICU care bundle in a community setting. Design, Setting, and Patients Patients admitted to the intensive care unit (ICU) at three hospitals in the Kaiser Permanente Northern California integrated healthcare delivery system between January 1, 2009 and August 30, 2013. Interventions and Measurements The RCC ICU care bundle is designed to reduce potentially preventable complications by focusing on the management of delirium, sedation, mechanical ventilation, mobility, ambulation, and coordinated care. RCC implementation occurred in a staggered fashion between October 2011 and November 2012. We measured implementation metrics based on electronic medical record data and evaluated the impact of implementation on mortality with multivariable regression models. Main Results We evaluated 24,886 first ICU episodes in 19,872 patients. After implementation, some process metrics (e.g., ventilation start and stop times) were achieved at high rates while others (e.g., ambulation distance), available late in the study period, showed steep increases in compliance. Unadjusted mortality decreased from 12.3% to 10.9% (p-value<0.01) before and after implementation, respectively. The adjusted odds ratio for hospital mortality after implementation was 0.85 (95% confidence interval, 0.73–0.99) and for thirty-day mortality was 0.88 (95% CI, 0.80–0.97) compared with before implementation. However, the mortality rate trends were not significantly different before and after RCC implementation. The mean duration of mechanical ventilation and hospital stay also did not demonstrate incrementally greater declines after implementation. Conclusions RCC implementation was associated with changes in practice and a 12% to 15% reduction in the odds of short-term mortality. However, these findings may represent an evaluation of changes in practices and outcomes still in the mid-implementation phase and cannot be directly attributed to the elements of bundle implementation. PMID:26540402

  13. 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. PMID:27500279

  14. Comparison of industrial emissions and carpet dust concentrations of polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans in a multi-center U.S. study.

    PubMed

    Deziel, Nicole C; Nuckols, John R; Jones, Rena R; Graubard, Barry I; De Roos, Anneclaire J; Pronk, Anjoeka; Gourley, Chris; Colt, Joanne S; Ward, Mary H

    2017-02-15

    Proximity to facilities emitting polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/F) has been associated with increased risk of non-Hodgkin lymphoma (NHL). There is limited information about whether proximity to industrial sources leads to indoor PCDD/F contamination of homes. We measured carpet dust concentrations (pg/g) of 17 toxic PCDD/F congeners and calculated their toxic equivalence (TEQ) in 100 homes in a population-based case-control study of NHL in Detroit, Los Angeles, Seattle, and Iowa (1998-2000). We took global positioning system readings at residences and obtained coordinates and PCDD/F emissions (ng TEQ/yr) from an Environmental Protection Agency database for 6 facility types: coal-fired electricity generating plants, cement kilns burning non-hazardous waste, hazardous waste incinerators, medical waste incinerators, municipal solid waste incinerators, and sewage sludge incinerators. For each residence, we computed an inverse distance-squared weighted average emission index (AEI [pg TEQ/km(2)/yr]) for all facilities within 5km from 1983 to 2000. We also computed AEIs for each of the 6 facility types. We evaluated relationships between PCDD/F dust concentrations and the all-facility AEI or categories of facility-type AEIs using multivariable linear regression, adjusting for study center, demographics, and home characteristics. A doubling of the all-facility AEI was associated with a 4-8% increase in PCDD/F dust concentrations of 7 of 17 PCDD/F congeners and the TEQ (p-value<0.1). We also observed positive associations between PCDD/F dust concentrations and facility-type AEIs (highest vs. lowest exposure category) for municipal solid waste incinerators (9 PCDD/F, TEQ), and medical waste incinerators (7 PCDD/F, TEQ) (p<0.1). Our results from diverse geographical areas suggest that industrial PCDD/F emission sources contribute to residential PCDD/F dust concentrations. Our emissions index could be improved by incorporating local meteorological data and terrain characteristics. Future research is needed to better understand the links between nearby emission sources, human exposure pathways, and health risks.

  15. 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.

  16. Comparison of clinical outcomes of Chinese men and women after coronary stenting for coronary artery disease: a multi-center retrospective analysis of 4,334 patients

    PubMed Central

    Shrestha, Rajiv; Xu, Jing; Xie, Dujiang; Liu, Zhizhong; Xu, Tian; Ye, Fei; Din, Shiqing; Qian, Xuesong; Yang, Song; Liu, Yueqiang; Li, Feng; Zhang, Aiping; Chen, Shaoliang

    2014-01-01

    Abstract The outcome differences between Chinese male and female patients within one-year follow-up after percutaneous coronary intervention (PCI) with stent remain unclear. The present study was aimed to compare clinical outcomes in such two populations. From May 1999 to December 2009, 4,334 patients with acute myocardial infarction (MI), unstable angina, stable angina, or silent ischemia, who underwent PCI, were registered at our centers. Among these, 3,089 were men and 1,245 were women. We compared these groups with respect to the primary outcomes of MI and secondary outcomes including a composite of major adverse cardiac events (MACE) including cardiac death, MI, target lesion revascularization, target vessel revascularization (TVR), stent thrombosis (ST), definite ST and probable ST at one-year follow-up. Chinese male patients had a higher MACE rate (13% vs. 10.7%, P  =  0.039), mainly led by TVR (9.09% vs. 6.98%, P = 0.024) at one year, which was significantly different than female patients. Chinese male and female patients showed a significant difference on MACEs. However, there was no significant difference with respect to MI between these groups. PMID:25332708

  17. Clinical acceptability, use-patterns and use-effectiveness of the vaginal contraceptive sponge and Neo Sampoon tablets--an international multi-center randomized clinical trial.

    PubMed

    Chi, I C; Smith, S C; Borko, E; Sun, T H; Begum, S F; Hunt, W L; Wilkens, L R

    1987-11-01

    This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.

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

    PubMed Central

    2016-01-01

    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

  19. 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.

  20. 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

  1. 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

  2. Occurrence of infection following prostate biopsy procedures in Japan: Japanese Research Group for Urinary Tract Infection (JRGU) - a multi-center retrospective study.

    PubMed

    Togo, Yoshikazu; Kubo, Tatsuhiko; Taoka, Rikiya; Hiyama, Yoshiki; Uehara, Teruhisa; Hashimoto, Jiroh; Kurimura, Yuichiro; Takahashi, Satoshi; Tsukamoto, Taiji; Miyazaki, Jun; Nishiyama, Hiroyuki; Kira, Shinichiro; Kiyota, Hiroshi; Yazawa, Satoshi; Niwa, Naoya; Hongo, Hiroshi; Oya, Mototsugu; Kato, Taku; Yasuda, Mitsuru; Deguchi, Takashi; Ishikawa, Kiyohito; Hoshinaga, Kiyotaka; Matsumoto, Minori; Shigemura, Katsumi; Tanaka, Kazushi; Arakawa, Soichi; Fujisawa, Masato; Wada, Koichiro; Uehara, Shinya; Watanabe, Toyohiko; Kumon, Hiromi; Kobayashi, Kanao; Matsubara, Akio; Matsumoto, Masahiro; Sho, Takehiko; Hamasuna, Ryoichi; Matsumoto, Tetsuro; Hayami, Hiroshi; Nakagawa, Masayuki; Yamamoto, Shingo

    2014-04-01

    We retrospectively investigated the incidence of genitourinary tract infection in 5895 patients who underwent transrectal and/or transperineal prostate biopsy procedure between January and December 2011 at 46 institutions belonging to Japanese Research Group for Urinary Tract Infection (JRGU). The total rate of genitourinary tract infection after prostate biopsy was 0.76%, while that following transrectal procedure was 0.83% and following transperineal procedure was 0.57%, which were not significantly different. In contrast, febrile infection associated with a fever (≥38 °C) occurred significantly more frequently after transrectal (0.71%) than transperineal (0.16%) approach (P = 0.04). Notably, in infectious cases, Escherichia coli was most frequently isolated. Of the 9 E. coli strains isolated by urine culture, 6 (66.7%) produced extended spectrum β-lactamase (ESBL) and 7 (77.8%) showed levofloxacin resistance. Similarly, of 6 E. coli strains isolated by blood culture, 4 (66.7%) produced ESBL and 6 (100%) showed levofloxacin resistance. When the efficacy of antimicrobial prophylaxis (AMP) with levofloxacin for the patients undergoing transrectal or transperineal biopsy was compared between a single dose (500 mg) and that given for 2 or more days, no significant difference was observed for the rate of infection (transrectal: 0.82% vs. 1.04%, p = 0.94; transperineal: 0.30% vs. 0.46%, p = 0.68). Although a single dose of levofloxacin for AMP is sufficient to prevent genitourinary infection after transrectal or transperineal prostate biopsy, and recommended in this era of increased multi-drug resistant pathogens, the increase in fluoroquinolone-resistant E. coli and ESBL-producing E. coli has emerged as a profound problem for surveillance.

  3. 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

  4. Risk of bladder cancer among patients with diabetes treated with a 15 mg pioglitazone dose in Korea: a multi-center retrospective cohort study.

    PubMed

    Jin, Sang-Man; Song, Sun Ok; Jung, Chang Hee; Chang, Jin-Sun; Suh, Sunghwan; Kang, Seung Min; Jung, Inkyung; Park, Cheol-Young; Kim, Jae Hyeon; Cho, Jae Hyoung; Lee, Byung-Wan

    2014-02-01

    It has not yet been determined whether chronic exposure to relatively low doses of pioglitazone increases risk of bladder cancer. We aimed to assess the risk of bladder cancer associated with pioglitazone in Korean patients. This was a retrospective cohort study of diabetic patients who had ≥ 2 clinic visits between November 2005 and June 2011 at one of four tertiary referral hospitals in Korea. A prevalent case-control analysis nested within the cohort was conducted to further adjust confounders. A total of 101,953 control patients and 11,240 pioglitazone-treated patients were included, in which there were 237 and 30 cases of incidental bladder cancer (64.9 and 54.9 per 100,000 person-years; age, sex-adjusted HR 1.135, 95% confidence interval [CI] 0.769-1.677), respectively. In the prevalent case-control analysis nested within the cohort, use of pioglitazone for a duration of > 6 months, but not ever use of pioglitazone, was associated with an increased rate of bladder cancer as compared to never use of pioglitazone. In conclusion, we failed to exclude the possible association between use of pioglitazone for a duration of > 6 months and bladder cancer.

  5. 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.

  6. [Menstrual disturbances and alternations in hypophyseal gonadal axis in end-stage premenopausal women undergoing hemodialysis: a multi-center study].

    PubMed

    Matuszkiewicz-Rowińska, Joanna; Skórzewska, Katarzyna; Radowicki, Stanisław; Niemczyk, Stanisław; Przedlacki, Jerzy; Sokalski, Antoni; Wardyn, Kazimierz; Puka, Janusz; Switalski, Marek; Grochowski, Janusz; Ostrowski, Kazimierz

    2003-06-01

    The results of the studies of hypophyseal-gonadal axis in dialysis women are not uniform. Mostly the increased serum concentrations of prolactine and pituitary gonadotropins are observed; the data about ovarian secretion are much more scanty and contradictory. The aim of this crossectional study was to assess changes in sexual hormones secretion and their associations with menstrual disturbations in premenopausal women with end-stage renal failure undergoing hemodialysis. Sixty three women from six mazovian dialysis units, aged 18-45 years (mean 35 +/- 7 years) were enrolled into the study. They were divided into four groups according to their menstrual pattern: I--eumenorrhoea (n = 17), II--polymenorrhoea (n = 9), III--oligomenorrhoea (n = 16) i IV--amenorrhoea n = 21). There were no differences between both groups in respect to age, age of menarche, time on hemodialysis, and body mass index. In all subjects gynecological examination was performed and serum prolactin, FSH, LH, estradiol, progesterone and testosterone concentrations were assayed. In 49% women high serum prolactin concentrations were noted (the highest in group IV--1699 +/- 1022 vs 441 +/- 205 microIU/ml in group I; p < 0.05). Mean serum FSH and LH were increased in group IV only (33 +/- 59 and 22 +/- 31 mIU/ml); no significant differences among groups examined were seen. Serum estradiol was increased in groups I-III (95 +/- 46, 72 +/- 33, and 83 +/- 55 pg/ml, respectively) and decreased in group IV (27 +/- 22 pg/ml; p < 0.001 in respect to remaining groups). Mean serum progesterone and testosterone concentrations were normal in all four groups, but serum progesterone was significantly lower in groups II-IV than in group I (p < 0.05). No differences in hormonal status between patients receiving and not receiving rHuEpo were observed. Menstrual disturbances are common (73%) in premenopausal women with end-stage renal failure, with amenorrhea constituting a half of them. Hyperprolactinemia is the most frequently seen alteration in their hormonal profile with the highest concentrations in those with secondary amenorrhea. Increased serum gonadotropins and reduced serum estradiol concentrations are mostly seen in amenorrheic women, whereas in menstruating women serum estradiol is often slightly increased.

  7. [Implementation of the multi-center basis documentation CL-BaDo for conciliar and liaison services: generating data for internal quality management and cost calculation].

    PubMed

    Stein, Barbara; Fritzsche, Kurt; Schäfer, Christine; Pedrosa Gil, Francisco; Vitinius, Frank; von Wachter, Martin; Häfner, Steffen; Loew, Thomas; Herzog, Thomas; Söllner, Wolfgang

    2006-01-01

    In the German DRG system the funding of CL services is not ensured. The documentation of psychiatric comorbidity and CL care delivery is a pre-condition to the development of funding models for CL-services. A task force of several German psychosomatic associations (German College of Psychosomatic Medicine, German Society of Psychosomatic Medicine and Psychotherapy, General Medical Society for Psychotherapy) developed a new documentation form for CL-services (CL-BaDo). The pilot study explored the multicenter implementation of CL-BaDo and the use of the documentation form for quality management and cost calculation. Over a period of at least three months, participating CL-services documented all CL cases consecutively with the CL-BaDo. One site applied full electronic data processing. 2116 CL cases from eight psychosomatic CL-services were analysed. The CL-BaDo is a time-efficient, feasible and acceptable documentation form for CL-service delivery. The full electronic data processing enables networking with a hospital information system to produce higher data quality. The data of CL-BaDo can be used locally for quality management, development of management strategies and communication with consultants, as well as nationwide for health policy questions and research.

  8. 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

  9. Prognostic and Predictive Factors in Patients with Advanced Penile Cancer Receiving Salvage (2nd or Later Line) Systemic Treatment: A Retrospective, Multi-Center Study

    PubMed Central

    Buonerba, Carlo; Di Lorenzo, Giuseppe; Pond, Gregory; Cartenì, Giacomo; Scagliarini, Sarah; Rozzi, Antonio; Quevedo, Fernando J.; Dorff, Tanya; Nappi, Lucia; Lanzetta, Gaetano; Pagliaro, Lance; Eigl, Bernhard J.; Naik, Gurudatta; Ferro, Matteo; Galdiero, Mariano; De Placido, Sabino; Sonpavde, Guru

    2016-01-01

    Introduction and objectives: Metastatic penile squamous cell carcinoma (PSCC) is associated with dismal outcomes with median overall survival (OS) of 6–12 months in the first-line and <6 months in the salvage setting. Given the rarity of this disease, randomized trials are difficult. Prognostic risk models may assist in rational drug development by comparing observed outcomes in nonrandomized phase II studies and retrospective data vs. predicted outcomes based on baseline prognostic factors in the context of historically used agents. In this retrospective study, we constructed a prognostic model in the salvage setting of PSCC patients receiving second or later line systemic treatment, and also explored differences in outcomes based on type of treatment. Materials and methods: We performed a chart review to identify patients with locally advanced unresectable or metastatic PSCC who received second or later line systemic treatment in centers from North America and Europe. The primary outcome was OS from initiation of treatment, with secondary outcomes being progression-free survival (PFS) and response rate (RR). OS was estimated using the Kaplan-Meier method. Cox proportional hazards regression was used to identify prognostic factors for outcomes using univariable and multivariable models. Results: Sixty-five patients were eligible. Seventeen of 63 evaluable patients had a response (27.0%, 95% confidence interval [CI] = 16.6–39.7%) and median OS and PFS were 20 (95% CI = 20–21) and 12 (95% CI = 12, 16) weeks, respectively. Visceral metastasis (VM) and hemoglobin (Hb) ≤ 10 gm/dl were consistently significant poor prognostic factors for both OS and PFS, and Hb was also prognostic for response. The 28 patients with neither risk factor had a median OS (95% CI) of 24 (20–40) weeks and 1-year (95% CI) OS of 13.7% (4.4–42.7%), while the 37 patients with 1 or 2 risk factors had median OS (95% CI) of 20 (16–20) weeks and 1-year (95% CI) OS of 6.7% (1.8–24.9%). Cetuximab-including regimens were associated with a trend for improved RR compared to other agents (Odds ratio = 5.05, 95% CI = 0.84–30.37, p = 0.077). Taxanes vs. non-taxane, and combination vs. single agent therapy was not associated with improved outcomes. The study is limited by its modest sample size. Conclusion: This is the first prognostic classification proposed for patients receiving salvage systemic therapy for advanced PSCC. The presence of VM and Hb ≤ 10 gm/dl was associated with poor OS and PFS. Cetuximab appeared to be associated with better RR. This prognostic model may assist in salvage therapy drug development for this orphan disease by improving interpretation of outcomes seen in nonrandomized data. PMID:28066240

  10. Short-Term Outcomes and Safety of Computed Tomography-Guided Percutaneous Microwave Ablation of Solitary Adrenal Metastasis from Lung Cancer: A Multi-Center Retrospective Study

    PubMed Central

    Men, Min; Fan, Weijun; Zhang, Kaixian; Bi, Jingwang; Yang, Xia; Zheng, Aimin; Huang, Guanghui; Wei, Zhigang

    2016-01-01

    Objective To retrospectively evaluate the short-term outcomes and safety of computed tomography (CT)-guided percutaneous microwave ablation (MWA) of solitary adrenal metastasis from lung cancer. Materials and Methods From May 2010 to April 2014, 31 patients with unilateral adrenal metastasis from lung cancer who were treated with CT-guided percutaneous MWA were enrolled. This study was conducted with approval from local Institutional Review Board. Clinical outcomes and complications of MWA were assessed. Results Their tumors ranged from 1.5 to 5.4 cm in diameter. After a median follow-up period of 11.1 months, primary efficacy rate was 90.3% (28/31). Local tumor progression was detected in 7 (22.6%) of 31 cases. Their median overall survival time was 12 months. The 1-year overall survival rate was 44.3%. Median local tumor progression-free survival time was 9 months. Local tumor progression-free survival rate was 77.4%. Of 36 MWA sessions, two (5.6%) had major complications (hypertensive crisis). Conclusion CT-guided percutaneous MWA may be fairly safe and effective for treating solitary adrenal metastasis from lung cancer. PMID:27833402

  11. Is it possible to distinguish testicular torsion from other causes of acute scrotum in patients who underwent scrotal exploration? A multi-center clinical trial

    PubMed Central

    Umul, Mehmet; Altok, Muammer; Akyüz, Mehmet; İşoğlu, Cemal Selçuk; Uruç, Fatih; Aras, Bekir; Sertkaya, Zülfü; Ürkmez, Ahmet; Baş, Ercan; Keleş, Muzaffer Oğuz

    2015-01-01

    Introduction To assess the clinical presentation of patients who underwent surgical exploration for acute scrotum and to investigate the potentially related factors for differential dignosis. Material and methods We retrospectively analyzed the medical records of 97 patients who underwent surgical exploration for acute scrotum between May 2007 and July 2013. The patients were divided into two groups as follows: Group1 included patients with testicular torsion (TT) and Group 2 contained patients with acute scrotal pathologies other than TT, including torsion of the testicular appendage, epididymo-orchitis, trauma and Henoch-Schönlein purpura. The physical examination findings, colour Doppler ultrasound (CDUS) and laboratory findings for the groups were compared. Results In total, 97 scrotal explorations were carried out for acute scrotum. Group 1 included 72 patients (74.2%) and Group 2 included 25 patients (25.8%). Group 2 was comprised of patients with torsion of the testicular appendage (n = 13), epididymo-orchitis (n = 8), testicular trauma (n = 2) and Henoch-Schönlein purpura (n = 2). In Group 1, 32 cases (44.4%) presented to a hospital less than 6 hours after onset of pain. More than half (64%) of Group 2's cases presented more than 24 hours after pain onset. Fever and pyuria appeared more frequently in Group 2 than in Group 1 and the results reached statistical significance (p = 0.001 and p = 0.044, respectively). Group 1 had more testicular tenderness than Group 2 (p <0.001). Our testicular salvage rate was 59.7%, and 40.3% of patients underwent orchiectomy. Conclusions CDUS predicted the diagnosis of TT (sensitivity 98.6%). Furthermore, clinical findings may also play a substantial role in the differential diagnosis of acute scrotum. PMID:26251755

  12. 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

  13. Intracranial Pressure Monitoring in Severe Traumatic Brain Injury in Latin America: Process and Methods for a Multi-Center Randomized Controlled Trial

    PubMed Central

    Lujan, Silvia; Dikmen, Sureyya; Temkin, Nancy; Petroni, Gustavo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Cherner, Mariana; Chaddock, Kelley; Hendrix, Terence; Rondina, Carlos; Videtta, Walter; Celix, Juanita M.; Chesnut, Randall

    2012-01-01

    Abstract In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns. PMID:22435793

  14. Intracranial pressure monitoring in severe traumatic brain injury in latin america: process and methods for a multi-center randomized controlled trial.

    PubMed

    Carney, Nancy; Lujan, Silvia; Dikmen, Sureyya; Temkin, Nancy; Petroni, Gustavo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Cherner, Mariana; Chaddock, Kelley; Hendrix, Terence; Rondina, Carlos; Videtta, Walter; Celix, Juanita M; Chesnut, Randall

    2012-07-20

    In patients with severe traumatic brain injury (TBI), the influence on important outcomes of the use of information from intracranial pressure (ICP) monitoring to direct treatment has never been tested in a randomized controlled trial (RCT). We are conducting an RCT in six trauma centers in Latin America to test this question. We hypothesize that patients randomized to ICP monitoring will have lower mortality and better outcomes at 6-months post-trauma than patients treated without ICP monitoring. We selected three centers in Bolivia to participate in the trial, based on (1) the absence of ICP monitoring, (2) adequate patient accession and data collection during the pilot phase, (3) preliminary institutional review board approval, and (4) the presence of equipoise about the value of ICP monitoring. We conducted extensive training of site personnel, and initiated the trial on September 1, 2008. Subsequently, we included three additional centers. A total of 176 patients were entered into the trial as of August 31, 2010. Current enrollment is 81% of that expected. The trial is expected to reach its enrollment goal of 324 patients by September of 2011. We are conducting a high-quality RCT to answer a question that is important globally. In addition, we are establishing the capacity to conduct strong research in Latin America, where TBI is a serious epidemic. Finally, we are demonstrating the feasibility and utility of international collaborations that share resources and unique patient populations to conduct strong research about global public health concerns.

  15. The Prevalence of Erosive Esophagitis Is Not Significantly Increased in a Healthy Korean Population - Could It Be Explained?: A Multi-center Prospective Study

    PubMed Central

    Seo, Geom Seog; Jeon, Byung Jun; Chung, Jin Soo; Joo, Young-Eun; Kim, Dae Yong; Shin, Jeong Eun; Kim, Heung Up; Park, Hyun Kyung; Kim, Nayoung

    2013-01-01

    Background/Aims Researches on the potential risk factors for the development of erosive esophagitis have been conducted extensively, however, the results are conflicting. The aim of this multicenter study was to identify the prevalence rate and risk factors of erosive esophagitis and their interactions with residency status. Methods A total of 4,023 eligible subjects at 8 tertiary health care centers were evaluated using questionnaires, laboratory tests and endoscopy. Univariate and multivariate analyses were conducted to identify independent risk factors for erosive esophagitis. Results The prevalence rate of reflux esophagitis was 8.8%. Los Angeles grade A was common type of erosive esophagitis. Residence in a large urban areas was negatively associated with the development of erosive esophagitis (OR, 0.60; 95% CI, 0.40-0.90). The high body mass index (≥ 25 kg/m2) was more frequent in residents of small and medium-sized cities than those in big cities (38.8% and 26.9%, respectively; P < 0.001). Seronegativity of Helicobacter pylori was associated with increased erosive esophagitis (OR, 1.91; 95% CI, 1.48-2.46). Triglyceride ≥ 150 mg/dL (OR, 1.65; 95% CI, 1.08-2.07), fasting glucose level ≥ 126 mg/dL (OR, 1.73; 95% CI, 1.06-2.81), and hiatal hernia (OR, 3.11; 95% CI, 1.87-5.16) were also associated with erosive esophagitis. Conclusions The prevalence rate of erosive esophagitis and its risk factors in this study were similar to the result of 8.0% of nationwide study in 2006. Residency and obesity are more important independent risk factors than H. pylori infection status for development of erosive esophagitis in Korea. These results suggest that the prevalence rate of erosive esophagitis in Korea might not increase as in the Western countries. PMID:23350050

  16. Cognitive dysfunction in patients with multiple sclerosis treated with first-line disease-modifying therapy: a multi-center, controlled study using the BICAMS battery.

    PubMed

    Cinar, Bilge Piri; Kösehasanoğulları, Görkem; Yigit, Pinar; Ozakbas, Serkan

    2017-02-01

    Multiple sclerosis (MS) can impair cognitive functions even in the early stages. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery is very short and highly sensitive and can be used to evaluate cognitive status in the disease. Several clinical trials have shown beneficial effects of disease-modifying drugs (DMDs) on long-term cognitive measures which may even reduce cognitive deficits in MS patients. Relapsing remitting MS patients using DMDs were enrolled in the study and monitored for 12 months. BICAMS and the Expanded Disability Status Scale were applied to the study group. We evaluated and monitored 161 newly diagnosed cases of definite MS by the end of the trial. 110 patients (68.2%) were female. One hundred and two healthy subjects (female to male ratio 68:34) were enrolled into the study. MS patients were categorized into three DMT groups: IFNB1-a SC, IFNB1-b, and GA. Mean scores of all three cognitive tests (SDMT, BVMT-R, and CVLT-II) were significantly higher in the control group than in the MS patients. The number of cognitively impaired patients decreased from 31.7 to 21.7% on the basis of CVLT (p = 0.024), and 42 (26.1%) to 30 (18.6%) on the basis of BVMT-R at month 12. A significant difference was determined in terms of cognitive status between MS patients using both IFNB and GA and the healthy control group. Ours is the first study to compare IFNB and GA in terms of evaluating cognitive involvement and to use the BICAMS battery in monitoring treatment.

  17. 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.

  18. Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study

    PubMed Central

    2016-01-01

    Extended-release osmotic extended-release oral delivery system (OROS) hydromorphone is a strong synthetic opioid designed to maintain a constant blood concentration by once daily dosing. The objective of this observational study was to investigate the clinical usefulness of OROS hydromorphone in patients with cancer pain of moderate to severe intensity. Patients with cancer pain who required strong opioids were administered with OROS hydromorphone for 4 weeks. We assessed changes in pain intensity using a numerical rating scale (NRS) as well as levels of sleep disturbance, breakthrough pain, end-of-dose failure, patient satisfaction, and overall assessment of drug effectiveness based on investigator evaluation. Of the 648 enrolled patients, 553 patients were included in the full analysis set. The mean pain intensity was significantly decreased from the NRS value of 5.07 ± 1.99 to 2.75 ± 1.94 (mean % change of 42.13 ± 46.53, P < 0.001). The degree of sleep disturbance significantly improved (mean NRS change of 1.61 ± 2.57, P < 0.001), and the incidence of breakthrough pain was significantly decreased (mean NRS change of 1.22 ± 2.30, P < 0.001). The experience of end-of-dose failure also significantly decreased from 4.60 ± 1.75 to 3.93 ± 1.70, P = 0.007). The patient satisfaction rate was 72.7%, and 72.9% of investigators evaluated the study drug as effective. OROS hydromorphone was an effective and tolerable agent for cancer pain management. It effectively lowered pain intensity as well as improved sleep disturbance, breakthrough pain, and end-of-dose failure (Identifier: NCT 01273454). PMID:27822929

  19. 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

  20. Clinical features and surgical outcomes of cervical spondylotic myelopathy in patients aged 80 years or older: a multi-center retrospective study

    PubMed Central

    Dokai, Toshiyuki; Hashiguchi, Hirokazu; Ishii, Hiroyuki; Kameyama, Yasuhiro; Katae, Yuji; Morio, Yasuo; Morishita, Tsugutake; Murata, Masaaki; Nanjo, Yoshiro; Takahashi, Toshiaki; Tanida, Atsushi; Tanishima, Shinji; Yamane, Koji; Teshima, Ryota

    2011-01-01

    With the aging of the population in developed countries, spine surgeons have recently been more likely to encounter elderly patients in need of treatment. This study investigated whether decompression surgery for cervical spondylotic myelopathy (CSM) in elderly patients aged 80 years or older would likely be a reasonable treatment. We retrospectively reviewed 605 consecutive patients with cervical myelopathy who underwent decompression surgery between 2004 and 2008. Patients with other conditions that could affect functional status or compression factors other than spondylosis were excluded from this study. Of the remaining 189 patients, 161 with CSM whose condition could be evaluated 6 months after surgery were analyzed. The patients were divided into two age groups: 80 years or older (Group A, 37 patients) and younger than 80 years of age (Group B, 124 patients). We evaluated the differences in symptom duration, clinical data, involved levels, surgical outcome, comorbidities, and postoperative complications between the two groups. The symptom duration was significantly shorter in Group A. The average JOA scores preoperatively and 6 months postoperatively were significantly lower in Group A; however, there was no significant difference in the recovery ratio. There were no significant differences in the percentages of patients with comorbidities or those with postoperative complications. Elderly patients aged 80 years or older regained approximately 40% of their function postoperatively, and the incidence of postoperative complication was similar to that in younger patients. Since this age group shows a rapid deterioration after onset, prompt decompression surgery is required. PMID:21197553

  1. 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

  2. Results of a pilot multi-center genotype-based randomized placebo-controlled trial of propranolol to reduce pain after major thermal burn injury

    PubMed Central

    Orrey, Danielle C; Halawa, Omar I; Bortsov, Andrey V; Shupp, Jeffrey W; Jones, Samuel W; Haith, Linwood R; Hoskins, Janelle M; Jordan, Marion H; Bangdiwala, Shrikant I; Roane, Brandon; Platts-Mills, Timothy F; Holmes, James H; Hwang, James; Cairns, Bruce A; McLean, Samuel A

    2014-01-01

    Background Results of previous studies suggest that β-adrenoreceptor activation may augment pain, and that β-adrenoreceptor antagonists may be effective in reducing pain, particularly in individuals not homozygous for the catechol-O-methyltransferase (COMT) high activity haplotype. Methods Consenting patients admitted for thermal burn injury at participating burn centers were genotyped; those who were not high activity COMT homozygotes were randomized to propranolol 240mg/day or placebo. Primary outcomes were study feasibility (consent rate, protocol completion rate) and pain scores on study days 5-19. Secondary outcomes assessed pain and posttraumatic stress disorder (PTSD) symptoms 6 weeks post-injury. Results Seventy-seven (61/79) percent of eligible patients were consented and genotyped, and 77% (47/61) were genotype-eligible and randomized. Ninety-one percent (43/47) tolerated study drug and completed primary outcome assessments. In intention to treat and per protocol analyses, patients randomized to propranolol had worse pain scores on study days 5-19. Conclusions Genotype-specific pain medication interventions are feasible in hospitalized burn patients. Propranolol is unlikely to be a useful analgesic during the first few weeks after burn injury. PMID:25084070

  3. Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial.

    PubMed

    Trenkwalder, Claudia; Benes, Heike; Grote, Ludger; Happe, Svenja; Högl, Birgit; Mathis, Johannes; Saletu-Zyhlarz, Gerda M; Kohnen, Ralf

    2007-04-15

    We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 +/- 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 +/- 6.8. The baseline-adjusted mean change from baseline to week 6 in IRLS sum score was d = -16.1 in the CAB group and d = -9.5 in the levodopa group (d = -6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log-rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large-scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30-week long-term therapy. Tolerability was found more favorable with levodopa than with cabergoline.

  4. Prevalence, severity, and risk indicators of gingival inflammation in a multi-center study on South American adults: a cross sectional study

    PubMed Central

    Carvajal, Paola; Gómez, Mariel; Gomes, Sabrina; Costa, Ricardo; Toledo, Andres; Solanes, Fernando; Romanelli, Hugo; Oppermann, Rui; Rösing, Cassiano; Gamonal, Jorge

    2016-01-01

    ABSTRACT Objectives: The aim of this study is to investigate the prevalence and severity of gingival inflammation and associated risk indicators in South American adults. Material and Methods: Multi-stage samples totaling 1,650 adults from Porto Alegre (Brazil), Tucumán (Argentina), and Santiago (Chile) were assessed. The sampling procedure consisted of a 4-stage process. Examinations were performed in mobile dental units by calibrated examiners. A multivariable logistic regression model was utilized for associating variables as indicators of gingival inflammation (GI) (Gingival Index ≥0.5). Statistical significance was set at 0.05. Results: A total of 96.5% of the adults have GI. Regarding the severity of GI, 22.5% of participants examined have mild GI, 74.0% have moderate GI, and 3.6% have severe GI. The multivariate analyses identify the main risk indicators for GI as adults with higher mean of Calculus Index (OR=18.59); with a Visible Plaque Index ≥30% (OR=14.56); living in Santiago (OR=7.17); having ≤12 years of schooling (OR=2.18), and females (OR=1.93). Conclusions: This study shows a high prevalence and severity of gingival inflammation, being the first one performed in adult populations in three cities of South America. PMID:27812624

  5. 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.

  6. 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.

  7. 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

  8. A Comparison of the Clinical and Epidemiological Characteristics of Adult Patients with Laboratory-Confirmed Influenza A or B during the 2011–2012 Influenza Season in Korea: A Multi-Center Study

    PubMed Central

    Wie, Seong-Heon; So, Byung Hak; Song, Joon Young; Cheong, Hee Jin; Seo, Yu Bin; Choi, Sung Hyuk; Noh, Ji Yun; Baek, Ji Hyeon; Lee, Jin Soo; Kim, Hyo Youl; Kim, Young Keun; Choi, Won Suk; Lee, Jacob; Jeong, Hye Won; Kim, Woo Joo

    2013-01-01

    Background During the 2011/2012 winter influenza season in the Republic of Korea, influenza A (H3N2) was the predominant virus in the first peak period of influenza activity during the second half of January 2012. On the other hand, influenza B was the predominant virus in the second peak period of influenza activity during the second half of March 2012. The objectives of this study were to compare the clinical and epidemiological characteristics of patients with laboratory-confirmed influenza A or influenza B. Methodology/Principal Findings We analyzed data from 2,129 adult patients with influenza-like illnesses who visited the emergency rooms of seven university hospitals in Korea from October 2011 to May 2012. Of 850 patients with laboratory-confirmed influenza, 656 (77.2%) had influenza A (H3N2), and 194 (22.8%) influenza B. Age, and the frequencies of cardiovascular disorders, diabetes, hypertension were significantly higher in patients with influenza A (H3N2) (P<0.05). The frequencies of leukopenia or thrombocytopenia in patients with influenza B at initial presentation were statistically higher than those in patients with influenza A (H3N2) (P<0.05). The rate of hospitalization, and length of hospital stay were statistically higher in patients with influenza A (H3N2) (P<0.05), and of the 79 hospitalized patients, the frequency of diabetes, hypertension, cases having at least one of the comorbid conditions, and the proportion of elderly were significantly higher in patients with influenza A (H3N2) (P<0.05). Conclusions The proportion of males to females and elderly population were significantly higher for influenza A (H3N2) patients group compared with influenza B group. Hypertension, diabetes, chronic lung diseases, cardiovascular disorders, and neuromuscular diseases were independently associated with hospitalization due to influenza. Physicians should assess and treat the underlying comorbid conditions as well as influenza viral infections for the appropriate management of patients with influenza. PMID:23671624

  9. 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

  10. Comparing different revisions of the Childhood Health Assessment Questionnaire to reduce the ceiling effect and improve score distribution: Data from a multi-center European cohort study of children with JIA

    PubMed Central

    2010-01-01

    Background The original version of the Childhood Health Assessment Questionnaire (CHAQ30orig) suffers from a ceiling effect and hence has reduced clinical validity. The purpose of this study was to evaluate the effect of adding eight more demanding items (CHAQ38) and a new categorical response option (CATII) on discriminant validity and score distribution in a European patient sample. Methods Eighty-nine children with Juvenile Idiopathic arthritis (JIA) and 22 healthy controls, aged 7-16 years, were recruited from eight centres across Europe. Eight new CHAQ items and scoring option were translated back and forth for the countries in which they were not already present. Demographic, clinical, and CHAQ data were collected on-site. Subsequently, five different scoring methods were applied, i.e. the original method (CHAQ30orig) and four alternatives. These alternatives consisted of the mean item scores for the 30 and 38-question versions with either the original (CATI), or the new categorical response option (CATII). The five versions were tested for their ability to distinguish between patients and controls. Furthermore score distributions were evaluated and visualized by box and whisker plots. Results Two CHAQ revisions with the new response option showed poor discriminative ability, whereas one revised version (CHAQ38CATI) had comparable discriminative ability comparable to the original CHAQ. A profound ceiling effect was observed in the original scoring method of the CHAQ (27%). The addition of eight more demanding items and application of a plain mean item score reduced this significantly to 14% (χ2 = 4.21; p < 0.05). Conclusions Revising the CHAQ by adding eight more demanding items and applying a plain mean item scoring (CHAQ38CATI) maintained discriminant ability and reduced the ceiling effect in a European patient sample. The new categorical response option (CATII) seemed promising, but was less able to distinguish children with JIA from healthy controls and had less favourable distribution characteristics. The CHAQ38CATI is advocated for future use in mildly affected JIA patients. PMID:20478036

  11. Clinical features from the history and physical examination that predict the presence or absence of pulmonary embolism in symptomatic emergency department patients: results of a prospective, multi-center study

    PubMed Central

    Courtney, D. Mark; Kline, Jeffrey A.; Kabrhel, Christopher; Moore, Christopher L.; Smithline, Howard A; Nordenholz, Kristen E.; Richman, Peter B.; Plewa, Michael C.

    2009-01-01

    Study Objective Prediction rules for pulmonary embolism (PE) employ variables explicitly shown to estimate the probability of PE. However, clinicians often use variables that have not been similarly validated, yet are implicitly believed to modify probability of PE. The objective of this study was to measure the predictive value of 13 implicit variables. Methods Patients were enrolled in a prospective cohort study from 12 centers in the United States; all had an objective test for PE (D-dimer, CT angiography, or V/Q scan). Clinical features including 12 predefined previously validated (explicit) variables and 13 variables not part of existing prediction rules (implicit) were prospectively recorded at presentation. The primary outcome was VTE (venous thromboembolism: PE or deep venous thrombosis), diagnosed by imaging up to 45 days after enrollment. Variables with adjusted odds ratios from logistic regression with 95% confidence intervals not crossing unity were considered significant. Results 7,940 patients (7.2% VTE+) were enrolled. Mean age was 49±17 years and 67% were female. Eight of 13 implicit variables were significantly associated with VTE; those with an adjusted OR >1.5 included non-cancer related thrombophilia (1.99), pleuritic chest pain (1.53), and family history of VTE (1.51). Implicit variables that predicted no VTE outcome included: substernal chest pain, female gender, and smoking. Nine of 12 explicit variables predicted a positive outcome of VTE, including unilateral leg swelling, recent surgery, estrogen, hypoxemia and active malignancy. Conclusions In symptomatic outpatients being considered for possible PE, non-cancer related thrombophilia, pleuritic chest pain, and family history of VTE increase probability of PE or DVT. Other variables that are part of existing pretest probability systems were validated as important predictors in this diverse sample of US Emergency department patients. PMID:20045580

  12. Safety and Efficacy of Autologous CD34+ Hematopoietic Progenitor Cells Transduced with an Anti-Tat Ribozyme in a Multi-Center, Randomized, Placebo-Controlled, Phase II Gene Therapy Trial for the Human Immunodeficiency Virus

    PubMed Central

    Mitsuyasu, Ronald T; Merigan, Thomas C; Carr, Andrew; Zack, Jerome A; Winters, Mark A; Workman, Cassy; Bloch, Mark; Lalezari, Jacob; Becker, Stephen; Thornton, Lorna; Akil, Bisher; Khanlou, Homayoon; Finlayson, Robert; McFarlane, Robert; Smith, Don E; Garsia, Roger; Ma, David; Law, Matthew; Murray, John M.; von Kalle, Christof; Ely, Julie A; Patino, Sharon M; Knop, Alison E; Wong, Philip; Todd, Alison V; Haughton, Margaret; Fuery, Caroline; Macpherson, Janet L; Symonds, Geoff P; Evans, Louise A; Pond, Susan M; Cooper, David A

    2009-01-01

    SUMMARY Gene transfer has potential as a once-only treatment that reduces viral load, preserves the immune system, and avoids lifetime highly active antiretroviral therapy. This study, the first randomized, double-blind, placebo-controlled, phase II cell-delivered gene transfer clinical trial, was conducted in 74 HIV-1 infected adults who received a tat/vpr specific anti-HIV ribozyme (OZ1) or placebo delivered in autologous CD34+ hematopoietic progenitor cells. There were no OZ1-related adverse events. There was no statistical difference in viral load between the OZ1 and placebo group at the primary end-point (average at weeks 47 and 48) but time weighted areas under the curve from weeks 40-48 and 40-100 were significantly lower in the OZ1 group. Throughout the 100 weeks, CD4+ lymphocyte counts were higher in the OZ1 group. This study provides the first indication that cell-delivered gene transfer is safe and biologically active in HIV patients and can be developed as a conventional therapeutic product. PMID:19219022

  13. Quality of Piped and Stored Water in Households with Children Under Five Years of Age Enrolled in the Mali Site of the Global Enteric Multi-Center Study (GEMS)

    PubMed Central

    Baker, Kelly K.; Sow, Samba O.; Kotloff, Karen L.; Nataro, James P.; Farag, Tamer H.; Tamboura, Boubou; Doumbia, Mama; Sanogo, Doh; Diarra, Drissa; O'Reilly, Ciara E.; Mintz, Eric; Panchalingam, Sandra; Wu, Yukun; Blackwelder, William C.; Levine, Myron M.

    2013-01-01

    Water, sanitation, and hygiene information was collected during a matched case-control study of moderate and severe diarrhea (MSD) among 4,096 children < 5 years of age in Bamako, Mali. Primary use of piped water (conditional odds ratio [cOR] = 0.45; 0.34–0.62), continuous water access (cOR = 0.30; 0.20–0.43), fetching water daily (cOR = 0.77; 0.63–0.96), and breastfeeding (cOR = 0.65; 0.49–0.88) significantly reduced the likelihood of MSD. Fetching water in > 30 minutes (cOR = 2.56; 1.55–4.23) was associated with MSD. Piped tap water and courier-delivered water contained high (> 2 mg/L) concentrations of free residual chlorine and no detectable Escherichia coli. However, many households stored water overnight, resulting in inadequate free residual chlorine (< 0.2 mg/L) for preventing microbial contamination. Coliforms and E. coli were detected in 48% and 8% of stored household water samples, respectively. Although most of Bamako's population enjoys access to an improved water source, water quality is often compromised during household storage. PMID:23836570

  14. Preliminary Experimental Results from Multi-Center Clinical Trials for Detection of Cervical Precancerous Lesions Using the Cerviscan(TM) System: A Novel Full-Field Evoked Tissue Fluorescence Based Imaging Instrument

    DTIC Science & Technology

    2007-11-02

    Abstract- Cervical cancer is an important cause of death in women worldwide, accounting for 190,000 deaths annually. Women are currently screened for... cervical cancer using Pap smear – an imperfect technology with poor sensitivity and specificity. Furthermore, 5-10% of the Pap smear studies result...better patient management. I. INTRODUCTION Cervical cancer is an important cause of death in women worldwide, accounting for 190,000 deaths annually

  15. 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

  16. Ras-Association Domain Family 1 Isoform A (RASSF1A) Gene Polymorphism rs1989839 is Associated with Risk and Metastatic Potential of Osteosarcoma in Young Chinese Individuals: A Multi-Center, Case-Control Study

    PubMed Central

    Xu, Hongwei; Zhan, Wang; Chen, Zhiyuan

    2016-01-01

    Background The ras-association domain family 1 isoform A (RASSF1A) gene serves as a bona fide tumor suppressor gene. The polymorphisms in RASSF1A were previously reported to be associated with the risk of solid malignant tumors. We hypothesized herein that RASSF1A gene polymorphisms are involved in the risk and prognosis of osteosarcoma (OS). Material/Methods We recruited 279 young OS cases and 286 tumor-free controls from the east Chinese population. Five tagSNPs of RASSF1A gene (rs2236947A/C, rs2073497A/C, rs1989839C/T, rs72932987C/T, and rs4688728G/T) were genotyped. DNA was isolated from blood samples and then underwent PCR analysis for genotyping. Results rs1989839C/T is an important predictor of osteosarcoma risk and outcome. The CT genotype of rs1989839 is highly related to elevated risk of osteosarcoma. Furthermore, rs1989839C/T is also associated with the Enneking stage of osteosarcoma and risk of lung metastasis. One of the other 4 SNPs, rs2236947A/C, shows a borderline significance in predicting osteosarcoma risk. Conclusions Our study is the first to prove that RASSF1A gene polymorphisms may potentially be predictive for osteosarcoma risk and prognosis. PMID:27880743

  17. RESPECT-ED: Rates of Pulmonary Emboli (PE) and Sub-Segmental PE with Modern Computed Tomographic Pulmonary Angiograms in Emergency Departments: A Multi-Center Observational Study Finds Significant Yield Variation, Uncorrelated with Use or Small PE Rates

    PubMed Central

    Chu, Kevin; Joseph, Anthony; Read, Catherine; Blecher, Gabriel; Furyk, Jeremy; Bharat, Chrianna; Velusamy, Karthik; Munro, Andrew; Baker, Kylie; Kinnear, Frances; Mukherjee, Ahses; Watkins, Gina; Buntine, Paul; Livesay, Georgia

    2016-01-01

    Introduction Overuse of CT Pulmonary Angiograms (CTPA) for diagnosing pulmonary embolism (PE), particularly in Emergency Departments (ED), is considered problematic. Marked variations in positive CTPA rates are reported, with American 4–10% yields driving most concerns. Higher resolution CTPA may increase sub-segmental PE (SSPE) diagnoses, which may be up to 40% false positive. Excessive use and false positives could increase harm vs. benefit. These issues have not been systematically examined outside America. Aims To describe current yield variation and CTPA utilisation in Australasian ED, exploring potential factors correlated with variation. Methods A retrospective multi-centre review of consecutive ED-ordered CTPA using standard radiology reports. ED CTPA report data were inputted onto preformatted data-sheets. The primary outcome was site level yield, analysed both intra-site and against a nominated 15.3% yield. Factors potentially associated with yield were assessed for correlation. Results Fourteen radiology departments (15 ED) provided 7077 CTPA data (94% ≥64-slice CT); PE were reported in 1028 (yield 14.6% (95%CI 13.8–15.4%; range 9.3–25.3%; site variation p <0.0001) with four sites significantly below and one above the 15.3% target. Admissions, CTPA usage, PE diagnosis rates and size of PE were uncorrelated with yield. Large PE (≥lobar) were 55% (CI: 52.1–58.2%) and SSPE 8.8% (CI: 7.1–10.5%) of positive scans. CTPA usage (0.2–1.5% adult attendances) was correlated (p<0.006) with PE diagnosis but not SSPE: large PE proportions. Discussion/ Conclusions We found significant intra-site CTPA yield variation within Australasia. Yield was not clearly correlated with CTPA usage or increased small PE rates. Both SSPE and large PE rates were similar to higher yield historical cohorts. CTPA use was considerably below USA 2.5–3% rates. Higher CTPA utilisation was positively correlated with PE diagnoses, but without evidence of increased proportions of small PE. This suggests that increased diagnoses seem to be of clinically relevant sized PE. PMID:27918576

  18. Effects of recombinant human brain natriuretic peptide on the prognosis of patients with acute anterior myocardial infarction undergoing primary percutaneous coronary intervention: a prospective, multi-center, randomized clinical trial

    PubMed Central

    Hou, Ai-Jie; Zang, Hong-Yun; Huang, Ru-Gang; Zheng, Xiao-Qun; Lin, Hai-Long; Wang, Wei; Hou, Ping; Xia, Fei; Li, Zhan-Quan

    2017-01-01

    Background This study aims to investigate the effects of recombinant human brain natriuretic peptide (rhBNP) on serum enzyme data, cardiac function parameters and cardiovascular events in patients with acute anterior myocardial infarction (MI). Methods A total of 421 patients with acute anterior or extensive anterior MI were collected from 20 hospitals. These patients were randomly divided into two groups: rhBNP and control groups. Both groups of patients received primary percutaneous coronary intervention (PCI) within the effective time window. In the rhBNP group, rhBNP administration (0.01 µg/kg/min, 48–72 successive hours) was performed as early as possible after hospital admission. Prior to and one or seven days after PCI, serum concentrations of cardiac troponin (cTnT), creatine kinase-MB (CK-MB) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were measured. At seven days and 6 months after PCI, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd) and stroke volume (SV) were measured using 2D Doppler echocardiography. MACEs that occurred during hospitalization and within 6 months after PCI were recorded. Results At postoperative days one and seven, serum concentrations of cTnT were significantly lower in the rhBNP group than in the control group. At postoperative day one, serum concentrations of CK-MB were significantly lower in the rhBNP group than in the control group. At postoperative day seven, serum concentrations of NT-proBNP were significantly lower in the rhBNP group than in the control group, and LVEF was significantly greater in the rhBNP group than in the control group. At postoperative 6 months, LVEDd was significantly lower in the rhBNP group compared with the control group. In addition, SV and LVEF were significantly greater in the rhBNP group than in the control group. By postoperative month 6, the incidence of composite cardiovascular events (16.0% vs. 26.0%, P=0.012), cardiac death (7.0% vs.13.5%, P=0.030), and particularly cardiac death + re-hospitalization for congestive heart failure (13.1% vs. 25.5%, P=0.001) were significantly lower in the rhBNP group than in the control group. Conclusions Early intravenous rhBNP administration after PCI significantly lowered the serum concentrations of cTnT and NT-proBNP, increased LVEDd, SV and LVEF, and reduced MACEs, including cardiac death, in patients with acute anterior MI undergoing PCI. PMID:28203406

  19. The impact of nutritional status, nutritional risk, and nutritional treatment on clinical outcome of 2248 hospitalized cancer patients: a multi-center, prospective cohort study in Chinese teaching hospitals.

    PubMed

    Pan, Hongming; Cai, Sanjun; Ji, Jiafu; Jiang, Zhiwei; Liang, Houjie; Lin, Feng; Liu, Xiyong

    2013-01-01

    To better understand the impact of undernutrition, nutritional risk, and nutritional treatment on the clinical outcomes of hospitalized cancer patients in China, the authors conducted a multicenter, cross-sectional study with 2248 cancer patients from 20 hospitals from January to June 2010. The authors defined 19.7% and 26.8% patients as undernourished at baseline and reassessment, respectively. Patients with gastrointestinal malignancies had a higher rate of undernutrition than other patients. The nutritional risk rate was 24.6% and 40.2% at baseline and reassessment, respectively. For patients with nutritional risk, the relative risk (RR) of adverse events (AEs) significantly increased with and without nutritional treatment. In comparison with the nonnutritional treatment subgroup, patients who received enteral nutrition (EN) or total parenteral nutrition (TPN) significantly reduced the RR of AE development. The RR of AEs for EN and TPN were 0.08 (95% CI: 0.01-0.62) and 0.56 (95% CI: 0.33-0.96), respectively. Separated nutrient infusion increased the risk of AEs. The authors concluded that undernutrition and nutritional risk are general problems that impact the outcomes of hospitalized cancer patients in China. Higher NRS2002 scores are related to AE risk but not weight loss. In nutritional treatment, EN and TPN can significantly reduce the risk of AEs.

  20. A Snapshot on the On-Label and Off-Label Use of the Interleukin-1 Inhibitors in Italy among Rheumatologists and Pediatric Rheumatologists: A Nationwide Multi-Center Retrospective Observational Study

    PubMed Central

    Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; Gentileschi, Stefano; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria C.; Marcolongo, Renzo; La Torre, Francesco; Fabiani, Claudia; Colafrancesco, Serena; Ricci, Francesca; Galozzi, Paola; Viapiana, Ombretta; Verrecchia, Elena; Pardeo, Manuela; Cerrito, Lucia; Cavallaro, Elena; Olivieri, Alma N.; Paolazzi, Giuseppe; Vitiello, Gianfranco; Maier, Armin; Silvestri, Elena; Stagnaro, Chiara; Valesini, Guido; Mosca, Marta; de Vita, Salvatore; Tincani, Angela; Lapadula, Giovanni; Frediani, Bruno; De Benedetti, Fabrizio; Iannone, Florenzo; Punzi, Leonardo; Salvarani, Carlo; Galeazzi, Mauro; Rigante, Donato; Cantarini, Luca

    2016-01-01

    Background: Interleukin (IL)-1 inhibitors have been suggested as possible therapeutic options in a large number of old and new clinical entities characterized by an IL-1 driven pathogenesis. Objectives: To perform a nationwide snapshot of the on-label and off-label use of anakinra (ANA) and canakinumab (CAN) for different conditions both in children and adults. Methods: We retrospectively collected demographic, clinical, and therapeutic data from both adult and pediatric patients treated with IL-1 inhibitors from January 2008 to July 2016. Results: Five hundred and twenty-six treatment courses given to 475 patients (195 males, 280 females; 111 children and 364 adults) were evaluated. ANA was administered in 421 (80.04%) courses, CAN in 105 (19.96%). Sixty-two (32.1%) patients had been treated with both agents. IL-1 inhibitors were employed in 38 different indications (37 with ANA, 16 with CAN). Off-label use was more frequent for ANA than CAN (p < 0.0001). ANA was employed as first-line biologic approach in 323 (76.7%) cases, while CAN in 37 cases (35.2%). IL-1 inhibitors were associated with corticosteroids in 285 (54.18%) courses and disease modifying anti-rheumatic drugs (DMARDs) in 156 (29.65%). ANA dosage ranged from 30 to 200 mg/day (or 1.0–2.0 mg/kg/day) among adults and 2–4 mg/kg/day among children; regarding CAN, the most frequently used posologies were 150mg every 8 weeks, 150mg every 4 weeks and 150mg every 6 weeks. The frequency of failure was higher among patients treated with ANA at a dosage of 100 mg/day than those treated with 2 mg/kg/day (p = 0.03). Seventy-six patients (14.4%) reported an adverse event (AE) and 10 (1.9%) a severe AE. AEs occurred more frequently after the age of 65 compared to both children and patients aged between 16 and 65 (p = 0.003 and p = 0.03, respectively). Conclusions: IL-1 inhibitors are mostly used off-label, especially ANA, during adulthood. The high frequency of good clinical responses suggests that IL-1 inhibitors are used with awareness of pathogenetic mechanisms; adult healthcare physicians generally employ standard dosages, while pediatricians are more prone in using a weight-based posology. Dose adjustments and switching between different agents showed to be effective treatment strategies. Our data confirm the good safety profile of IL-1 inhibitors. PMID:27822185

  1. Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multi-center, three-armed randomized controlled trial conducted in primary care

    PubMed Central

    García-Ruiz, Antonio; Luciano, Juan V.; García Campayo, Javier; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; López-Del-Hoyo, Yolanda; Pérez Ara, Mª Ángeles; Modrego-Alarcón, Marta; Mayoral Cleríes, Fermín

    2017-01-01

    Depression is one of the most common mental disorders and will become one of the leading causes of disability in the world. Internet-based CBT programs for depression have been classified as “well established” following the American Psychological Association criteria for empirically supported treatments. The aim of this study is to analyze the cost effectiveness at 12-month follow-up of the Internet-based CBT program “Smiling is fun” with (LITG) and without psychotherapist support (TSG) compared to usual care. The perspective used in our analysis is societal. A sample of 296 depressed patients (mean age of 43.04 years; 76% female; BDI-II mean score = 22.37) from primary care services in four Spanish regions were randomized in the RCT. The complete case and intention-to-treat (ITT) perspectives were used for the analyses. The results demonstrated that both Internet-based CBT interventions exhibited cost utility and cost effectiveness compared with a control group. The complete case analyses revealed an incremental cost-effectiveness ratio (ICER) of €-169.50 and an incremental cost-utility ratio (ICUR) of €-11389.66 for the TSG group and an ICER of €-104.63 and an ICUR of €-6380.86 for the LITG group. The ITT analyses found an ICER of €-98.37 and an ICUR of €-5160.40 for the TSG group and an ICER of €-9.91 and an ICUR of €496.72 for the LITG group. In summary, the results of this study indicate that the two Internet-based CBT interventions are appropriate from both economic and clinical perspectives for depressed patients in the Spanish primary care system. These interventions not only help patients to improve clinically but also generate societal savings. Trial Registration: clinicaltrials.gov NCT01611818 PMID:28241025

  2. A multi-center open-labeled study of recombinant erythropoietin-beta in the treatment of anemic patients with multiple myeloma, low-grade non-Hodgkin's lymphoma, or chronic lymphocytic leukemia in Chinese population.

    PubMed

    Yang, Shen; Jun, Ma; Hong-Li, Zhu; Jian-Min, Wang; Chun, Wang; Lu-Gui, Qiu; Yong-Qiang, Zhao; Jun, Zhu; Jian, Hou; Zhi-Xiang, Shen

    2008-09-01

    The purpose of this study is to investigate the efficacy and safety of recombinant erythropoietin-beta in the treatment of anemic patients with multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), and chronic lymphocytic leukemia (CLL). From December 2005 to November 2006, the patients with MM, low-grade NHL, and CLL were enrolled in this study, male or female, aged > or = 18 years, transfusion-dependant, and receiving anti-neoplasia chemotherapy. Recombinant human erythropoietin-beta was used in this study with the dose initiated at 150 IU/kg, thrice a week, subcutaneously. The total treatment duration was 12 weeks. The primary endpoint of the study is response rate (RR), which is defined as hemoglobin increasing > or = 2 g/dL comparing to baseline level, or returning to normal range, without any transfusion within 6 weeks of evaluation. Fifty out of 82 (64.6%) patients enrolled in this study responded to the treatment and 29 patients had no response. Hypertension (12.2%) is the most common adverse effect; however, all the adverse events were mild, categorized in NCI grade I or II. We conclude that recombinant erythropoietin-beta was effective in the treatment of anemia of the patients with MM, NHL, and CLL, as well as it is well-tolerated.

  3. Multi-Center Evaluation of the Fully Automated PCR-Based Idylla™ KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer

    PubMed Central

    Solassol, Jérôme; Vendrell, Julie; Märkl, Bruno; Haas, Christian; Bellosillo, Beatriz; Montagut, Clara; Smith, Matthew; O’Sullivan, Brendan; D’Haene, Nicky; Le Mercier, Marie; Grauslund, Morten; Melchior, Linea Cecilie; Burt, Emma; Cotter, Finbarr; Stieber, Daniel; Schmitt, Fernando de Lander; Motta, Valentina; Lauricella, Calogero; Colling, Richard; Soilleux, Elizabeth; Fassan, Matteo; Mescoli, Claudia; Collin, Christine; Pagès, Jean-Christophe; Sillekens, Peter

    2016-01-01

    Since the advent of monoclonal antibodies against epidermal growth factor receptor (EGFR) in colorectal cancer therapy, the determination of RAS mutational status is needed for therapeutic decision-making. Most prevalent in colorectal cancer are KRAS exon 2 mutations (40% prevalence); lower prevalence is observed for KRAS exon 3 and 4 mutations (6%) and NRAS exon 2, 3, and 4 mutations (5%). The Idylla™ KRAS Mutation Test on the molecular diagnostics Idylla™ platform is a simple (<2 minutes hands-on time), highly reliable, and rapid (approximately 2 hours turnaround time) in vitro diagnostic sample-to-result solution. This test enables qualitative detection of 21 mutations in codons 12, 13, 59, 61, 117, and 146 of the KRAS oncogene being clinically relevant according to the latest clinical guidelines. Here, the performance of the Idylla™ KRAS Mutation Assay, for Research Use Only, was assessed on archived formalin-fixed paraffin-embedded (FFPE) tissue sections by comparing its results with the results previously obtained by routine reference approaches for KRAS genotyping. In case of discordance, samples were assessed further by additional methods. Among the 374 colorectal cancer FFPE samples tested, the overall concordance between the Idylla™ KRAS Mutation Assay and the confirmed reference routine test results was found to be 98.9%. The Idylla™ KRAS Mutation Assay enabled detection of 5 additional KRAS-mutated samples not detected previously with reference methods. As conclusion the Idylla™ KRAS Mutation Test can be applied as routine tool in any clinical setting, without needing molecular infrastructure or expertise, to guide the personalized treatment of colorectal cancer patients. PMID:27685259

  4. Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.

    PubMed Central

    Boyko, E J; Iravani, A; Silverman, M H; Schelling, D J; Wright, R A

    1990-01-01

    We conducted a randomized controlled trial of orally administered amifloxacin versus trimethoprimsulfamethoxazole (TMP-SMX) as treatments of acute uncomplicated urinary tract infection in women. Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX. PMID:2188590

  5. A Multi-Center Study of [−2]Pro-Prostate-Specific Antigen (PSA) in Combination with PSA and Free PSA for Prostate Cancer Detection in the 2.0 to 10.0 ng/mL PSA Range

    PubMed Central

    Catalona, William J.; Partin, Alan W.; Sanda, Martin G.; Wei, John T.; Klee, George G.; Bangma, Chris H.; Slawin, Kevin M.; Marks, Leonard S.; Loeb, Stacy; Broyles, Dennis L.; Shin, Sanghyuk S.; Cruz, Amabelle B.; Chan, Daniel W.; Sokoll, Lori J.; Roberts, William L.; van Schaik, Ron H.N.; Mizrahi, Isaac A.

    2011-01-01

    Purpose PSA and free PSA (fPSA) have limited specificity for detecting clinically significant, curable prostate cancer (PCa), leading to unnecessary biopsies and detection and treatment of some indolent tumors. [−2]proPSA (p2PSA) may improve specificity for detecting clinically significant PCa. Our objective was to evaluate p2PSA, fPSA, and PSA in a mathematical formula (prostate health index [phi] = [−2]proPSA / fPSA) × PSA1/2) to enhance specificity for detecting overall and high-grade PCa. Materials and Methods We enrolled 892 men in a prospective multi-institutional trial with no history of PCa, normal rectal examination, a PSA of 2–10 ng/mL, and ≥6- core prostate biopsy. We examined the relationship of serum PSA, %fPSA and phi with biopsy results. The primary endpoints were the specificity and AUC using phi to detect overall and Gleason ≥7 prostate cancer on biopsy compared with %fPSA. Results For the 2–10 ng/mL PSA range, at 80–95% sensitivity, the specificity and AUC (0.703) of phi exceeded those of PSA and %fPSA. Increasing phi was associated with a 4.7-fold increased risk of PCa and 1.61-fold increased risk of Gleason ≥7 disease on biopsy. The AUC for phi (0.724) exceeded that of %fPSA (0.670) in discriminating between PCa with Gleason ≥ 4+3 vs. lower grade disease or negative biopsies. Phi results were not associated with age and prostate volume. Conclusions Phi may be useful in PCa screening to reduce unnecessary biopsies in men age ≥50 years with PSA 2–10 ng/mL and negative DRE, with minimal loss in sensitivity. PMID:21419439

  6. 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

  7. A Simple Risk Stratification Model for ST-Elevation Myocardial Infarction (STEMI) from the Combination of Blood Examination Variables: Acute Myocardial Infarction-Kyoto Multi-Center Risk Study Group

    PubMed Central

    Nakamura, Takeshi; Yokota, Isao; Zen, Kan; Yamano, Tetsuhiro; Shiraishi, Hirokazu; Shiraishi, Jun; Sawada, Takahisa; Kohno, Yoshio; Kitamura, Makoto; Furukawa, Keizo; Matoba, Satoaki

    2016-01-01

    Background Many mortality risk scoring tools exist among patients with ST-elevation Myocardial Infarction (STEMI). A risk stratification model that evaluates STEMI prognosis more simply and rapidly is preferred in clinical practice. Methods and Findings We developed a simple stratification model for blood examination by using the STEMI data of AMI-Kyoto registry in the derivation set (n = 1,060) and assessed its utility for mortality prediction in the validation set (n = 521). We selected five variables that significantly worsen in-hospital mortality: white blood cell count, hemoglobin, C-reactive protein, creatinine, and blood sugar levels at >10,000/μL, <10 g/dL, >1.0 mg/dL, >1.0 mg/dL, and >200 mg/dL, respectively. In the derivation set, each of the five variables significantly worsened in-hospital mortality (p < 0.01). We developed the risk stratification model by combining laboratory variables that were scored based on each beta coefficient obtained using multivariate analysis and divided three laboratory groups. We also found a significant trend in the in-hospital mortality rate for three laboratory groups. Therefore, we assessed the utility of this model in the validation set. The prognostic discriminatory capacity of our laboratory stratification model was comparable to that of the full multivariable model (c-statistic: derivation set vs validation set, 0.81 vs 0.74). In addition, we divided all cases (n = 1,581) into three thrombolysis in myocardial infarction (TIMI) risk index groups based on an In TIME II substudy; the cases were further subdivided based on this laboratory model. The high laboratory group had significantly high in-hospital mortality rate in each TIMI risk index group (trend of in-hospital mortality; p < 0.01). Conclusions This laboratory stratification model can predict in-hospital mortality of STEMI simply and rapidly and might be useful for predicting in-hospital mortality of STEMI by further subdividing the TIMI risk index. PMID:27835698

  8. 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

  9. Outcomes of kidney transplants from non-heart-beating deceased donors as reported to the Japan Organ Transplant Network from April 1995-December 2003: a multi-center report.

    PubMed

    Teraoka, S; Nomoto, K; Kikuchi, K; Hirano, T; Satomi, S; Hasegawa, A; Uchida, K; Akiyama, T; Tanaka, S; Babazona, T; Shindo, K; Nakamura, N

    2004-01-01

    Between April 1995-December 2003, 1,324 deceased donor kidney transplantations were performed in 139 transplant institutes in Japan. Of these, 45 transplants were from heart-beating and 1,279 transplants were from non-heart-beating deceased donors (NHBDD). Clinical outcomes for the 1,279 recipients of NHBDD kidney transplants were investigated. The overall 5-year patient and graft survival rates were 90% and 72%, respectively. A total of 112 NHBDD kidney grafts never functioned after transplantation and the recipients had to remain on dialysis. The causes of nonfunction were rejection, primary nonfunction, death, thrombosis and others in the order of the incidence. The major causes of graft loss were nonfunction, death, chronic rejection and acute rejection in that order. Major causes of recipient deaths were pneumonia, sepsis and CVA within 12 months, and heart diseases, sepsis, malignancy and pneumonia more than 12 months after transplantation. Kidneys from female donors, donors aged 15 or less or over age 60, donors with extrinsic causes of death other than head trauma, recipients over age 60 and those with diabetic nephropathy as their original disease were found to be at risk for poor graft survival. The lowest and last donor serum creatinine level did not influence the incidence of nonfunction or graft survival. However, graft survival was significantly poorer among recipients of older "expanded" donor kidneys than for recipients of younger grafts. The warm and total ischemia times should be kept shorter than 30 minutes (better 15 minutes), and 12 hours, respectively to minimize the incidence of nonfunction and early graft loss. It is especially important in cases with WIT over 30 minutes that the total ischemia should be kept within 12 hours. Cannulation before cardiac standstill was important to reduce the incidence of nonfunction and achieve high graft survival rates with NHBDD kidneys. The discontinuance of ventilator support also reduced the incidence of graft nonfunction. The combination of CsA or Tacrolimus and MMF as both the induction and maintenance regimen significantly improved graft survival. The use of either anti-T cell antibodies or basiliximab was also associated with significantly better graft survival for NHBDD kidneys. The combination of basiliximab, CsA and MMF resulted in a graft survival rate of 98% at one and 2 years.

  10. 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

  11. Multi-Center Biologic Assignment Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Intermediate-2 and High Risk Myelodysplastic Syndrome Blood and Marrow Transplant Clinical Trials Network #1102 Study Rationale, Design and Methods

    PubMed Central

    Saber, Wael; Le Rademacher, Jennifer; Sekeres, Mikkael; Logan, Brent; Lewis, Moira; Mendizabal, Adam; Leifer, Eric; Appelbaum, Frederick R.; Horowitz, Mary M; Nakamura, Ryotaro; Cutler, Corey S.

    2014-01-01

    The introduction of reduced intensity conditioning regimens (RIC) made it possible to offer allogeneic hematopoietic cell transplantation (alloHCT) to older patients with myelodysplastic syndromes (MDS). However, the relative risks and benefits of alloHCT compared to novel non-transplant therapies continue to be the source of considerable uncertainty. We will perform a prospective biologic assignment trial to compare RIC alloHCT to non-transplant therapies based on donor availability. Primary outcome is 3-year overall survival. Secondary outcomes include leukemia-free survival, quality of life, and cost-effectiveness. Four hundred patients will be enrolled over roughly 3 years. Planned subgroup analyses will evaluate key biologic questions, such as the impact of age & response to hypomethylating agents on treatment effects. Findings from this study potentially may set a new standard of care for older MDS patients who are considered candidates for alloHCT. PMID:24972249

  12. 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.

  13. Dairy-Rich Diets Augment Fat Loss on an Energy-Restricted Diet: A Multicenter Trial

    PubMed Central

    Zemel, Michael B.; Teegarden, Dorothy; Loan, Marta Van; Schoeller, Dale A.; Matkovic, Velimir; Lyle, Roseann M.; Craig, Bruce A.

    2009-01-01

    A 12-week randomized controlled multi-center clinical trial was conducted in 106 overweight and obese adults. Diets were designed to produce a 2,093 kJ/day energy deficit with either low calcium (LC; ~600 mg/day), high calcium (HC; ~1,400 mg/day), or high dairy (HD; three dairy servings, diet totaling ~1,400 mg/day). Ninety-three subjects completed the trial, and 68 met all a priori weekly compliance criteria. Both HC and HD contained comparable levels of calcium, but HC was only ~30% as effective as HD in suppressing 1,25-(OH)2D and exerted no significant effects on weight loss or body composition compared to LC. In the group that met compliance criteria, HD resulted in ~two-fold augmentation of fat loss compared to LC and HC (HD: -4.43 ± 0.53 kg; LC: -2.69 ± 0.0.53 kg; HC: -2.23 ± 0.73kg, p < 0.025); assessment of all completers and an intent-to-treat analysis produced similar trends. HD augmentated central (trunk) fat loss (HD: -2.38 ± 0.30 kg; HC: -1.42 ± 0.30 kg; LC: -1.36 ± 0.42 kg, p < 0.05) and waist circumference (HD: -7.65 ± 0.75 cm; LC: -4.92 ± 0.74 cm; LC: -4.95 ± 1.05 cm, p < 0.025). Similar effects were noted among all subjects completing the study and in an intent-to-treat analysis. These data indicate that dairy-rich diets augment weight loss by targeting the fat compartment during energy restriction. PMID:22253969

  14. The correlates of unemployment and its association with quality of life in cervical cancer survivors

    PubMed Central

    Yoo, Shin-Hye; Park, Sangmin; Kim, Young Ae; Park, Sang-Yoon; Bae, Duk-Soo; Nam, Joo Hyun; Park, Chong Taik; Cho, Chi-Heum; Lee, Jong-Min

    2013-01-01

    Objective Little is known regarding cervical cancer survivors' employment status, which represents social integration of cancer survivors as a pivotal domain of long-term quality of life. The goal of this study was to assess the correlates of unemployment and evaluate the impact on the comprehensive quality of life in cervical cancer survivors. Methods We enrolled 858 cervical cancer survivors from the gynecologic oncology departments of multi-centers in Korea. Factors associated with unemployment were identified using multivariate logistic regression analyses. We assessed different health-related quality of life domains with multivariate-adjusted least-square means between cervical cancer survivors who currently work and do not. Results After diagnosis and treatment, the percentage of unemployed survivors increased from 50.6% to 72.8%. Lower income (adjusted odds ratio [aOR], 1.97; 95% confidence interval [CI], 1.38 to 2.81), medical aid (aOR, 1.58; 95% CI, 1.05 to 2.38), two or more comorbidities (aOR, 1.80; 95% CI, 1.12 to 2.90), current alcohol drinkers (aOR, 2.33; 95% CI, 1.54 to 3.52), and employed at the time of diagnosis (aOR, 10.72; 95% CI, 7.10 to 16.16) were significantly associated with unemployment. Non-working groups showed significant differences with respect to physical functioning, role functioning, depression, and existential well-being. Conclusion The proportion of unemployed cervical cancer survivors seems to increase, with low-income status and the presence of medical aid negatively being associated with employment, in addition to other comorbidities and previous working status. Effort should be made to secure the financial status of cervical cancer survivors. PMID:24167673

  15. 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...

  16. 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.

  17. 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.

  18. Does Patient Time Spent Viewing Computer-Tailored Colorectal Cancer Screening Materials Predict Patient-Reported Discussion of Screening with Providers?

    ERIC Educational Resources Information Center

    Sanders, Mechelle; Fiscella, Kevin; Veazie, Peter; Dolan, James G.; Jerant, Anthony

    2016-01-01

    The main aim is to examine whether patients' viewing time on information about colorectal cancer (CRC) screening before a primary care physician (PCP) visit is associated with discussion of screening options during the visit. We analyzed data from a multi-center randomized controlled trial of a tailored interactive multimedia computer program…

  19. 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

    2007-10-11

    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.

  20. 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.

  1. Personality Disorder Patients' Perspectives on the Introduction of Imagery within Schema Therapy: A Qualitative Study of Patients' Experiences

    ERIC Educational Resources Information Center

    ten Napel-Schutz, Marieke C.; Abma, Tineke A.; Bamelis, Lotte; Arntz, Arnoud

    2011-01-01

    A qualitative study was done on patients' perspectives on the first phases of imagery work in the context of schema therapy (ST) for personality disorders. Patients participated in a multi-center randomized controlled study of the effectiveness of ST. Patients' experiences and opinions were collected with semistructured in-depth interviews at the…

  2. 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...

  3. 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)...

  4. 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.

  5. Crozer-Chester Medical Center Burn Research Project

    DTIC Science & Technology

    2010-07-18

    computer system designed to collect data from this equipment at the bedside. Study 2: “Evaluation of Xxx Dressing for Autogenous Skin Donor...Quarter 1) Study 2, Protocol Title: “Evaluation of Xxx for Autogenous Skin Donor Sites” Task 1: Enroll up to 30 patients in this multi-center

  6. Crozer-Chester Medical Center Burn Research Project

    DTIC Science & Technology

    2011-07-01

    of Aquacel Ag Dressing for Autogenous Skin Donor Sites” This study will compare the performance of an agreed upon dressing to the normal standard of... Autogenous Skin Donor Sites” Task 1: Enroll up to 30 patients in this multi-center trial to evaluate the performance of the identified dressing versus

  7. 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< ...

  8. 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...

  9. 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...

  10. Development and Implementation of a Preschool Vision Screening Program in a Mobile Setting: Vision in Preschoolers (VIP) Study Group

    ERIC Educational Resources Information Center

    NHSA Dialog, 2005

    2005-01-01

    The Vision In Preschoolers (VIP) Study, is a multi-phased, multi-center study designed to identify screening tests that best detect vision problems in preschool children. The VIP Study uses mobile medical units that are specially equipped to conduct vision screenings and eye examinations. Known as Vision Vans, these mobile units are staffed by lay…

  11. 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...

  12. 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…

  13. 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…

  14. Analysis of Risk Factors for Severe Acute Respiratory Infection and Pneumonia and among Adult Patients with Acute Respiratory Illness during 2011-2014 Influenza Seasons in Korea

    PubMed Central

    Wie, Seong-Heon; Jeong, Hye Won; Kim, Young Keun; Park, Kyung Hwa; Kim, Shin Woo; Lee, Sun Hee

    2016-01-01

    Background The World Health Organization recommends the surveillance of influenza-like illness (ILI) and severe acute respiratory infection (SARI) to respond effectively to both seasonal influenza epidemics and pandemics. In Korea, the “Hospital-based Influenza Morbidity and Mortality (HIMM)” surveillance system has been operated to monitor ILI and SARI occurrences. Materials and Methods A multi-center prospective observational study was conducted. Adult patients with acute respiratory infection (ARI) were enrolled during the 2011-12, 2012-2013, and 2013-2014 influenza seasons at the 10 university hospitals using the HIMM surveillance system. With respect to SARI and pneumonia development, risk profiles were analyzed in patients with ARI in Korea. Results A total of 5,459 cases were eligible for this analysis. Among 5,459 cases with ARI, 2,887 cases (52.9%) were identified that they had influenza infection. Among enrolled cases, 750 cases belonged to the SARI group, while 4,709 cases belonged to the non-SARI group. With respect to pneumonia development, 317 cases were accompanied by pneumonia, and 5,142 cases were not. Multivariate analyses revealed that the following factors were associated with an increased risk of SARI: Old age (≥65 years) (odds ratio [OR] 2.69, 95% confidence interval [CI] 2.2-3.32), chronic heart disease (CHD) (OR 2.24, 95% CI 1.68-2.98), cerebrovascular disease (CVD) (OR 1.49, 95% CI 1.05-2.10), chronic obstructive pulmonary disease (COPD) (OR 2.34, 95% CI 1.48-3.69), asthma (OR 2.33, 95% CI 1.62-3.36), chronic kidney disease (CKD) (OR 2.62, 95% CI 1.73-3.99), chronic liver disease (OR 1.71, 95% CI 1.04-2.81), and autoimmune diseases (OR 2.53, 1.57-4.08). Multivariate analyses revealed that the following factors were independent risk factors for pneumonia development: Old age (≥65 years) (OR 5.71, 95% CI 4.10-7.94), CHD (OR 1.54, 95% CI 1.07-2.22), COPD (OR 2.34, 95% CI 1.48-3.69), asthma (OR 2.33, 95% CI 1.62-3.36), CKD (OR 2.62, 95

  15. Observing interference effect in binary (e, 2e) of molecules

    NASA Astrophysics Data System (ADS)

    Chen, Xiangjun; Yang, Jing; Shan, Xu; Zhang, Zhe; Tian, Qiguo; Wang, Enliang

    2015-04-01

    We present investigations on the two-center and multi-center interference effects of molecules in binary (e, 2e) experiments. The high energy resolution electron momentum spectroscopy (EMS) measurements on H2 are reported with final vibrational states resolved. The experimental momentum profiles for ionization transitions to the individual final vibrational states of the ion are obtained. The measured and calculated vibrational ratios of the cross sections deviate from Franck-Condon principle, which can be ascribed to the Young-type two-center interference. Furthermore, with the help of our latest version of EMS spectrometer which has considerably higher sensitivity and much wider momentum range from 0 to 8 a.u., we are able to extend our observations to multi-center interference effect in high symmetry molecules like NF3 and CF4 with several oscillation periods included.

  16. Angular distributions in the double ionization of DNA bases by electron impact

    NASA Astrophysics Data System (ADS)

    Khelladi, M. F.; Mansouri, A.; Dal Cappello, C.; Charpentier, I.; Hervieux, P. A.; Ruiz-Lopez, M. F.; Roy, A. C.

    2016-11-01

    Ab initio calculations of the five-fold differential cross sections for electron-impact double ionization of thymine, cytosine, adenine and guanine are performed in the first Born approximation for an incident energy close to 5500 eV. The wavefunctions of the DNA bases are constructed using the multi-center wave functions from the Gaussian 03 program. These multi-center wave functions are converted into single-center expansions of Slater-type functions. For the final state, the two ejected electrons are described by two Coulomb wave functions. The electron-electron repulsion between the two ejected electrons is also taken into account. Mechanisms of the double ionization are discussed for each case and the best choices of the kinematical parameters are determined for next experiments.

  17. Codimension-2 solutions in five-dimensional supergravity

    NASA Astrophysics Data System (ADS)

    Park, Minkyu; Shigemori, Masaki

    2015-10-01

    We study a new class of supersymmetric solutions in five-dimensional supergravity representing multi-center configurations of codimension-2 branes along arbitrary curves. Codimension-2 branes are produced in generic situations out of ordinary branes of higher codimension by the supertube effect and, when they are exotic branes, spacetime generally becomes non-geometric. The solutions are characterized by a set of harmonic functions on {{R}}^3 with non-trivial monodromies around codimension-2 branch-point singularities. The solutions can be regarded as generalizations of the Bates-Denef/Bena-Warner multi-center solutions with codimension-3 centers to include codimension-2 ones. We present some explicit examples of solutions with codimension-2 centers, and discuss their relevance for the black microstate (non-)geometry program.

  18. 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.

  19. [Attaching importance to study on acute health risk assessment and adaptation of air pollution and climate change].

    PubMed

    Shi, X M

    2017-03-10

    Air pollution and climate change have become key environmental and public health problems around the world, which poses serious threat to human health. How to assess and mitigate the health risks and increase the adaptation of the public have become an urgent topic of research in this area. The six papers in this issue will provide important and rich information on design, analysis method, indicator selection and setting about acute health risk assessment and adaptation study of air pollution and climate change in China, reflecting the advanced conceptions of multi-center and area-specific study and multi-pollutant causing acute effect study. However, the number and type of the cities included in these studies were still limited. In future, researchers should further expand detailed multi-center and multi-area study coverage, conduct area specific predicting and early warning study and strengthen adaptation study.

  20. 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.

  1. A Randomized Placebo-Controlled Trial of Citalopram for Anxiety Disorders Following Traumatic Brain Injury

    DTIC Science & Technology

    2005-04-01

    WRAMC and all other sites in the multi-center study have been trained to use our electronic data capture system. Recent literature on Escitalopram , the...Disorder (GAD). Based on the merits of three placebo- controlled studies, Forest Laboratories announced the FDA approval of Escitalopram for the treatment...therefore there are no conclusions that can be made at this time. References: Davidson JR, Bose A, Korotzer A, Hongije Z. Escitalopram in the

  2. 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.

  3. Design of reflectance confocal microscopes for clinical applications

    NASA Astrophysics Data System (ADS)

    Zavislan, James M.

    2009-02-01

    Reflectance confocal microscopy provides real time, cellular resolution images of in-vivo and ex-vivo tissues and has been cleared by the FDA and international regulatory agencies for medical applications. Clinical applications of reflectance confocal microscopy are being tested in single- and multi-center clinical trials. In this paper I will review the design challenges of sub-surface imaging with confocal microscopy and techniques to compare the instruments performance between different sites.

  4. Advances in Translational Medical Research

    DTIC Science & Technology

    2011-01-25

    the first nodes that receive lymph drainage allowed for a change in practice  Results of the clinical trial contributed to what is now the current...Raskind Seattle Institute for Biomedical and Clinical Research Got Nightmares? 2011 MHS Conference Quality of Life: Sentinel Lymph Node Biopsy 25...multi-center clinical trial testing the validity and accuracy of sentinel lymph node biopsy in predicting the spread of disease  Accurately identifying

  5. Clinical trials in pulmonary hypertension.

    PubMed

    Badesch, D B

    1997-01-01

    Progress in treatment of pulmonary hypertension has been impaired by the lack of formal clinical trials. This is now beginning to change, and the impact on our approach to treating patients with pulmonary hypertension in substantial. As with other relatively uncommon medical disorders, randomized, controlled, multi-center trials are needed to assess the safety and efficacy of potential therapeutic modalities. Treatments showing promise at the level of small pilot studies within a single center should be studied more rigorously.

  6. Strength Design of Reinforced Concrete Hydraulic Structures. Report 2. Design Aids for Use in the Design and Analysis of Reinforced Concrete Hydraulic Structural Members Subjected to Combined Flexure and Axial Loads.

    DTIC Science & Technology

    1981-12-01

    C1 0 1 1.06 1(.1! l-. 1 • 17 48. 0 01 1 . 05 1 I:𔃿 1 . 05 1 . 05 1 . 06 1. 0l6 1 . 0E. 1 . 6 1 " 17 50. I’lf 1. 05 1 . f15 1. 105 1. 05 1 . 05 1 . Oft...1_1506 1 1 . C1 . I 1 _5 I. i-15 1.1 It. I.0 72.01(, 1.0n5 1.05 1.05 1.115 1.0-5=. 1. 05 1. 05 1>. 1 . ia Table 4 Values of h/d for 3.5-in. Concrete...Cover h BFF I 12E ,- ~F’ 1.47 1 , 4 1 4𔃾 1 . C1 1 ,- 1 ’, ’’ 1 41 1 4c_ 1 4 1 44 . 4 . 4, 1. 4; 1 . n 1 C 14. ’’, 1 1 1 ’ 1 -4 , 1 41 4 1 4 1. 4’. 1 . 4

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. Organization and administration of the NIDCD/VA Hearing Aid Clinical Trial.

    PubMed

    Henderson, William G; Larson, Vernon D; Williams, David; Leuthke, Lynn

    2002-08-01

    This article describes the organization and administration of the NIDCD/VA Hearing Aid Clinical Trial. The trial involved a total of 360 patients with bilateral, sensorineural hearing loss from eight VA Medical Centers to study three different hearing aid circuits in a three-period, three-treatment crossover design. Strong central coordination of such a complex multi-center clinical trial is essential to its success. The trial took more than 5 years to design, implement, and complete. This timeline is also described.

  15. 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.

  16. It Offers the Appropriate Big-Picture

    NASA Astrophysics Data System (ADS)

    Schläpfer, Markus

    Every week, more than 1 million people are currently being added to cities across the globe. This unprecedented trend of urbanization, together with growing concerns over energy supply and climate change, rapidly outpaces existing approaches for the planning and design of cities. A prominent warning example is Beijing's recent failure to implement a multi-centered urban form that has led to counter-intuitive people flows, immense traffic congestion, and air pollution. Thus, a new quantitative understanding of cities is urgently needed to reduce the risks of such detrimental planning outcomes and to eventually build more sustainable and more livable urban spaces...

  17. Editorial: Advancing Adoption of Frailty to Improve the Care of Patients with Cirrhosis: Time for a Consensus on a Frailty Index.

    PubMed

    Lai, Jennifer C

    2016-12-01

    Frailty is a key determinant of outcomes in patients with cirrhosis. Two papers in this issue of the American Journal of Gastroenterology advance our understanding of the mechanism by which frailty impacts mortality-by increasing the risk of hospitalization for liver-related complications. We now have overwhelming justification to incorporate frailty into clinical practice, but this should be done in a systematic way to foster multi-center collaboration to accelerate research in this field. It is time for consensus on single frailty index to unify decision-making surrounding frailty and equalize outcomes for all cirrhotics across all centers.

  18. 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.

  19. Incidence and Outcomes of Cardiopulmonary Resuscitation in Pediatric Intensive Care Units

    PubMed Central

    Berg, Robert A.; Nadkarni, Vinay M.; Clark, Amy E.; Moler, Frank; Meert, Kathleen; Harrison, Rick E.; Newth, Christopher J. L.; Sutton, Robert M.; Wessel, David L.; Berger, John T.; Carcillo, Joseph; Dalton, Heidi; Heidemann, Sabrina; Shanley, Thomas P.; Zuppa, Athena F.; Doctor, Allan; Tamburro, Robert F.; Jenkins, Tammara L.; Dean, J. Michael; Holubkov, Richard; Pollack, Murray M.

    2015-01-01

    Objective To determine the incidence of cardiopulmonary resuscitation (CPR) in pediatric intensive care units (PICU) and subsequent outcomes. Design, Setting, and Patients Multi-center prospective observational study of children 30 minutes, p30 minutes of CPR. Conclusions These data establish that contemporary PICU CPR, including long durations of CPR, results in high rates of survival to hospital discharge (45%) and favorable neurologic outcomes among survivors (89%). Rates of survival with favorable neurologic outcomes were similar among cardiac and non-cardiac patients. The rigorous prospective, observational study design avoided the limitations of missing data and potential selection biases inherent in registry and administrative data. PMID:26646466

  20. 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

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Neuroimaging, Genetics, and Clinical Data Sharing in Python Using the CubicWeb Framework

    PubMed Central

    Grigis, Antoine; Goyard, David; Cherbonnier, Robin; Gareau, Thomas; Papadopoulos Orfanos, Dimitri; Chauvat, Nicolas; Di Mascio, Adrien; Schumann, Gunter; Spooren, Will; Murphy, Declan; Frouin, Vincent

    2017-01-01

    In neurosciences or psychiatry, the emergence of large multi-center population imaging studies raises numerous technological challenges. From distributed data collection, across different institutions and countries, to final data publication service, one must handle the massive, heterogeneous, and complex data from genetics, imaging, demographics, or clinical scores. These data must be both efficiently obtained and downloadable. We present a Python solution, based on the CubicWeb open-source semantic framework, aimed at building population imaging study repositories. In addition, we focus on the tools developed around this framework to overcome the challenges associated with data sharing and collaborative requirements. We describe a set of three highly adaptive web services that transform the CubicWeb framework into a (1) multi-center upload platform, (2) collaborative quality assessment platform, and (3) publication platform endowed with massive-download capabilities. Two major European projects, IMAGEN and EU-AIMS, are currently supported by the described framework. We also present a Python package that enables end users to remotely query neuroimaging, genetics, and clinical data from scripts. PMID:28360851

  8. 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

  9. Dynamic Sheaths, in the Nick of Time or Past Their Prime?

    PubMed

    Krajcer, Zvonimir; Parekh, Dhaval

    2016-12-01

    Risk factors for vascular complications include a sheath to femoral artery ratio (SFAR) > 1.05, use of sheaths >19 Fr, peripheral artery disease, female gender, and a learning curve. High rates of technical and procedural success were achieved with low rates of major vascular and bleeding complications. However, SFAR > 1.05, gender, diabetes, renal insufficiency, calcification, tortuosity, or aneurysm were not independent risk factors in this study. Despite an SFAR > 1.05 in 23 patients, increased rates of vascular complications were not seen using the SoloPath sheath. These findings may increase the pool of transfemoral TAVI patients.

  10. 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.

  11. A description of the social–ecological framework used in the trial of activity for adolescent girls (TAAG)

    PubMed Central

    Elder, John P.; Lytle, Leslie; Sallis, James F.; Young, Deborah Rohm; Steckler, Allan; Simons-Morton, Denise; Stone, Elaine; Jobe, Jared B.; Stevens, June; Lohman, Tim; Webber, Larry; Pate, Russell; Saksvig, Brit I.; Ribisl, Kurt

    2009-01-01

    Social–ecological (SE) models are becoming more widely used in health behavior research. Applying SE models to the design of interventions is challenging because models must be tailor-made for each behavior and population, other theories need to be integrated into multilevel frameworks, and empirical research to guide model development is limited. The purpose of the present paper is to describe a SE framework that guided the intervention and measurement plans for a specific study. The trial of activity for adolescent girls (TAAG) is a multi-center study of interventions to reduce the decline of physical activity in adolescent girls. The TAAG framework incorporates operant learning theory, social cognitive theory, organizational change theory and the diffusion of innovation model in a multi-level model. The explicit and practical model developed for TAAG has already benefited the study and may have elements that can generalize to other health promotion studies. PMID:16855014

  12. 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

  13. Registration and machine learning-based automated segmentation of subcortical and cerebellar brain structures.

    PubMed

    Powell, Stephanie; Magnotta, Vincent A; Johnson, Hans; Jammalamadaka, Vamsi K; Pierson, Ronald; Andreasen, Nancy C

    2008-01-01

    The large amount of imaging data collected in several ongoing multi-center studies requires automated methods to delineate brain structures of interest. We have previously reported on using artificial neural networks (ANN) to define subcortical brain structures. Here we present several automated segmentation methods using multidimensional registration. A direct comparison between template, probability, artificial neural network (ANN) and support vector machine (SVM)-based automated segmentation methods is presented. Three metrics for each segmentation method are reported in the delineation of subcortical and cerebellar brain regions. Results show that the machine learning methods outperform the template and probability-based methods. Utilization of these automated segmentation methods may be as reliable as manual raters and require no rater intervention.

  14. A Gaussian Copula Model for Multivariate Survival Data

    PubMed Central

    Othus, Megan; Li, Yi

    2011-01-01

    We consider a Gaussian copula model for multivariate survival times. Estimation of the copula association parameter is easily implemented with existing software using a two-stage estimation procedure. Using the Gaussian copula, we are able to test whether the association parameter is equal to zero. When the association term is positive, the model can be extended to incorporate cluster-level frailty terms. Asymptotic properties are derived under the two-stage estimation scheme. Simulation studies verify finite sample utility. We apply the method to a Children’s Oncology Group multi-center study of acute lymphoblastic leukemia. The analysis estimates marginal treatment effects and examines potential clustering within treatment institution. PMID:22162742

  15. Pressure Alopecia

    PubMed Central

    Davies, Kate E; Yesudian, PD

    2012-01-01

    Postoperative or pressure alopecia (PA) is an infrequently reported group of scarring and non-scarring alopecias. It has been reported after immobilization of the head during surgery and following prolonged stays on intensive care units, and may be analogous to a healed pressure ulcer. This review presents a summary of cases published in pediatrics and after cardiac, gynecological, abdominal and facial surgeries. PA may manifest as swelling, tenderness, and ulceration of the scalp in the first few postoperative days; in other cases, the alopecia may be the presenting feature with a history of scalp immobilization in the previous four weeks. The condition may cause considerable psychological distress in the long term. Regular head turning schedules and vigilance for the condition should be used as prophylaxis to prevent permanent alopecia. A multi-center study in high-risk patients would be beneficial to shed further light on the etiology of the condition. PMID:23180911

  16. 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.

  17. Disk diffusion quality control guidelines for NVP-PDF 713: a novel peptide deformylase inhibitor.

    PubMed

    Anderegg, Tamara R; Jones, Ronald N

    2004-01-01

    NVP-PDF713 is a peptide deformylase inhibitor that has emerged as a candidate for treating Gram-positive infections and selected Gram-negative species that commonly cause community-acquired respiratory tract infections. This report summarizes the results of a multi-center (seven participants) disk diffusion quality control (QC) investigation for NVP PDF-713 using guidelines of the National Committee for Clinical Laboratory Standards and the standardized disk diffusion method. A total of 420 NVP-PDF 713 zone diameter values were generated for each QC organism. The proposed zone diameter ranges contained 97.6-99.8% of the reported participant results and were: Staphylococcus aureus ATCC 25923 (25-35 mm), Streptococcus pneumoniae ATCC 49619 (30-37 mm), and Haemophilus influenzae ATCC 49247 (24-32 mm). These QC criteria for the disk diffusion method should be applied during the NVP-PDF 713 clinical trials to maximize test accuracy.

  18. Landscape of current and emerging cell therapy clinical trials in the UK: current status, comparison to global trends and future perspectives.

    PubMed

    Bisson, Isabelle; Green, Emma; Sharpe, Michaela; Herbert, Chris; Hyllner, Johan; Mount, Natalie

    2015-01-01

    Cell Therapy Clinical Trial and Preclinical Research databases have been established by the Cell Therapy Catapult to document current and future cell therapy clinical trials in the UK. We identified 41 ongoing trials in April 2014, an increase of seven trials from April 2013. In addition, we identified 45 late-stage preclinical research projects. The majority of the clinical trials are early phase, primarily led by academic groups. The leading therapeutic areas are cancer, cardiology and neurology. The trends in the UK are also seen globally. As the field matures, more later phase and commercial studies will emerge and the challenges will likely evolve into how to manufacture sufficient cell quantities, manage complex logistics for multi-center trials and control cost.

  19. 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.

  20. 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.

  1. 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.

  2. Sparsity based denoising of spectral domain optical coherence tomography images

    PubMed Central

    Fang, Leyuan; Li, Shutao; Nie, Qing; Izatt, Joseph A.; Toth, Cynthia A.; Farsiu, Sina

    2012-01-01

    In this paper, we make contact with the field of compressive sensing and present a development and generalization of tools and results for reconstructing irregularly sampled tomographic data. In particular, we focus on denoising Spectral-Domain Optical Coherence Tomography (SDOCT) volumetric data. We take advantage of customized scanning patterns, in which, a selected number of B-scans are imaged at higher signal-to-noise ratio (SNR). We learn a sparse representation dictionary for each of these high-SNR images, and utilize such dictionaries to denoise the low-SNR B-scans. We name this method multiscale sparsity based tomographic denoising (MSBTD). We show the qualitative and quantitative superiority of the MSBTD algorithm compared to popular denoising algorithms on images from normal and age-related macular degeneration eyes of a multi-center clinical trial. We have made the corresponding data set and software freely available online. PMID:22567586

  3. 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

  4. 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.

  5. 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.

  6. Confirmatory factor analysis of the ADNI Neuropsychological Battery.

    PubMed

    Park, Lovingly Quitania; Gross, Alden L; McLaren, Donald G; Pa, Judy; Johnson, Julene K; Mitchell, Meghan; Manly, Jennifer J

    2012-12-01

    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 indicators of cognitive function in older adults who are participants in ADNI.

  7. A Bayesian Hierarchical Non-Linear Regression Model in Receiver Operating Characteristic Analysis of Clustered Continuous Diagnostic Data

    PubMed Central

    Zou, Kelly H.; O’Malley, A. James

    2005-01-01

    Receiver operating characteristic (ROC) analysis is a useful evaluative method of diagnostic accuracy. A Bayesian hierarchical nonlinear regression model for ROC analysis was developed. A validation analysis of diagnostic accuracy was conducted using prospective multi-center clinical trial prostate cancer biopsy data collected from three participating centers. The gold standard was based on radical prostatectomy to determine local and advanced disease. To evaluate the diagnostic performance of PSA level at fixed levels of Gleason score, a normality transformation was applied to the outcome data. A hierarchical regression analysis incorporating the effects of cluster (clinical center) and cancer risk (low, intermediate, and high) was performed, and the area under the ROC curve (AUC) was estimated. PMID:16161801

  8. The Collaborative Pediatric Critical Care Research Network: Looking back and Moving Forward

    PubMed Central

    Willson, Douglas F.; Dean, J. Michael; Meert, Kathleen L.; Newth, Christopher J.L.; Anand, Kanwaljeet J.S.; Berger, John; Harrison, Rick; Zimmerman, Jerry; Carcillo, Joseph; Pollack, Murray; Holubkov, Richard; Jenkins, Tammara L.; Nicholson, Carol

    2012-01-01

    Objective To update the Pediatric Critical Care Community on the progress of the Collaborative Pediatric Critical Care Research Network (CPCCRN) and plans for the future. Setting The six sites, seven hospitals of the CPCCRN. Results Since its inception in August 2005 the Network has engaged in a number of observational and interventional trials, several of which are ongoing. Several additional studies are in the planning stages. To date these have resulted in the publication of 6 manuscripts and 5 abstracts, with 5 additional manuscripts accepted and in press. Conclusion The Network remains committed to its stated goal “to initiate a multi-centered program designed to investigate the safety and efficacy of treatment and management strategies to care for critically ill children, as well as the pathophysiologic basis of critical illness and injury in childhood”. PMID:19794321

  9. Developmental Profiles of Infant EEG: Overlap with Transient Cortical Circuits

    PubMed Central

    Myers, M.M.; Grieve, P.G.; Izraelit, A.; Fifer, W.P.; Isler, J.R.; Darnall, R.A.; Stark, R.I.

    2012-01-01

    Objective To quantify spectral power in frequency specific bands and commonly observed types of bursting activities in the EEG during early human development. Methods An extensive archive of EEG data from human infants from 35 to 52 weeks postmenstrual age obtained in a prior multi-center study was analyzed using power spectrum analyses and a high frequency burst detection algorithm. Results Low frequency power increased with age; however, high frequency power decreased from 35 to 45 weeks. This unexpected decrease was largely attributable to a rapid decline in the number of high frequency bursts. Conclusions The decline in high frequency bursting activity overlaps with a developmental shift in GABA's actions on neurons from depolarizing to hyperpolarizing and the dissolution of the gap junction circuitry of the cortical subplate. PMID:22341979

  10. 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.

  11. 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.

  12. 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.

  13. Detection of Blood Culture Bacterial Contamination using Natural Language Processing

    PubMed Central

    Matheny, Michael E.; FitzHenry, Fern; Speroff, Theodore; Hathaway, Jacob; Murff, Harvey J.; Brown, Steven H.; Fielstein, Elliot M.; Dittus, Robert S.; Elkin, Peter L.

    2009-01-01

    Microbiology results are reported in semi-structured formats and have a high content of useful patient information. We developed and validated a hybrid regular expression and natural language processing solution for processing blood culture microbiology reports. Multi-center Veterans Affairs training and testing data sets were randomly extracted and manually reviewed to determine the culture and sensitivity as well as contamination results. The tool was iteratively developed for both outcomes using a training dataset, and then evaluated on the test dataset to determine antibiotic susceptibility data extraction and contamination detection performance. Our algorithm had a sensitivity of 84.8% and a positive predictive value of 96.0% for mapping the antibiotics and bacteria with appropriate sensitivity findings in the test data. The bacterial contamination detection algorithm had a sensitivity of 83.3% and a positive predictive value of 81.8%. PMID:20351890

  14. [Ocular fundus disease in China: the current situation, progression, and issues to be resolved].

    PubMed

    Xu, Xun

    2014-11-01

    Ocular fundus disease is an important cause of blindness in China today. It has been a serious threat to people's health and quality of life. After unremitting efforts of generations, we have made remarkable achievements in the prevention, diagnosis, and treatment of ocular fundus disease. We have achieved many breakthroughs and progressions in the investigations of diabetic retinopathy, choroidal neovascularization, pediatric fundus disease, and other major diseases. And weare gradually standardizing imaging data management, new drug development procedures, and multi-center clinical trials. In the future, we need to further standardize the clinical diagnosis and treatment, to accelerate the basic research of serious and rare diseases, and to improve the overall level in the field of ocular fundus disease in China, so as to enhance our international influence in ophthalmology.

  15. [Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].

    PubMed

    Sone, Miyuki; Arai, Yasuaki; Kiuchi, Takahiro; Ishikawa, Hirono; Aoki, Noriaki; Inaba, Yoshitaka; Yoshioka, Tetsuya; Aramaki, Takeshi; Kobayashi, Takeshi; Matsuoka, Toshiyuki; Anai, Hiroshi; Tanigawa, Noboru; Osuga, Keigo; Takeuchi, Yoshito; Okusaka, Takushi; Kanazawa, Susumu; Matsui, Osamu; Endo, Keigo

    2012-04-01

    A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.

  16. 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).

  17. Role of environmental factors in autoantibody production - importance of a detailed analysis in a small cohort

    PubMed Central

    2012-01-01

    In the previous issue of Arthritis Research & Therapy, Muro and colleagues reported a detailed epidemiologic analysis in central Japan on one of the new myositis-specific autoantibodies to MDA-5 (melanoma differentiation-associated gene 5), which is associated with clinically amyopathic dermatomyositis accompanying interstitial lung disease. The increasing prevalence of anti-MDA-5, higher prevalence in small rural towns, and geographical clustering in two areas along the Kiso River suggest a role of environmental factors associated with rural communities or the river/water system or both. A detailed analysis of a small cohort may offer clues, which is ignored in multi-center studies, to the pathogenesis of systemic rheumatic diseases and autoantibody production. PMID:22380573

  18. 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.

  19. 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.

  20. Vane blood-bathed technique reveals the significance of adrenergic reaction in myocardial infarction.

    PubMed

    Herbaczyńska-Cedro, Krystyna; Ceremuzyński, Leszek

    2010-01-01

    Using the blood-bathed technique of Vane we induced acute coronary occlusion in the dog and subsequently detected adrenaline release into the circulatory system, determined the rate of release and documented its significance for induction of cardiac arrhythmias. In the intact anesthetized dog, adrenaline excess of the magnitude released after coronary occlusion was sufficient to injure the healthy myocardium and to induce unfavorable metabolic systemic alterations. Subsequently, clinical research has documented that a serious clinical course of acute myocardial infarction is associated not only with enhanced excretion of catecholamines but also with augmentation of plasma renin activity and aldosterone levels. The positive therapeutic effect of aldosterone antagonists in acute myocardial infarction has been documented. The clinical value of our results, which were obtained in experimental and clinical studies, was later confirmed in multi-center trials.

  1. Dissociative electron attachment studies on acetone

    NASA Astrophysics Data System (ADS)

    Prabhudesai, Vaibhav S.; Tadsare, Vishvesh; Ghosh, Sanat; Gope, Krishnendu; Davis, Daly; Krishnakumar, E.

    2014-10-01

    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- is found to be the most dominant fragment followed by O- and OH- 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- and O- 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.

  2. Text messaging versus email for emergency medicine residents’ knowledge retention: a pilot comparison in the United States

    PubMed Central

    2016-01-01

    We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required. PMID:27780350

  3. Primary Immunodeficiencies: “New” Disease in an Old Country

    PubMed Central

    Lee, Pamela P W; Lau, Yu-Lung

    2009-01-01

    Primary immunodeficiency disorders (PIDs) are rare inborn errors of the immune system. Patients with PIDs are unique models that exemplify the functional and phenotypic consequences of various immune defects underlying infections, autoimmunity, lymphoproliferation, allergy and cancer. Over 150 PID syndromes were characterized in the past 60 years, with an ever growing list of new entities being discovered. Because of their rarity, multi-center collaboration for pooled data analysis and molecular studies is important to gain meaningful insights into the phenotypic and genetic diversities of PIDs. In this article, we summarize our research findings on PIDs in Chinese population in the past 20 years. Close collaboration among various immunology centers, cross-referrals and systematic data analysis constitute the foundation for research on PIDs. Future directions include establishment of a national PID registry, raising awareness of PIDs and securing sufficient resources for patient care and scientific research. PMID:20003815

  4. A temperature-dependent coarse-grained model for the thermoresponsive polymer poly(N-isopropylacrylamide)

    DOE PAGES

    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

  5. 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

  6. 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.

  7. Metronomic chemotherapy

    PubMed Central

    Maiti, Rituparna

    2014-01-01

    Toxic effects and chemoresistance are major hurdles in chemotherapy and to avoid these problems caused by traditional chemotherapeutic regimens, a new modality of drug administration called “metronomic chemotherapy” has emerged. Such regimen involves the frequent administration of conventional chemotherapeutic agents at very low doses to target activated endothelial cells in tumors, the advantages of which include minimal adverse effects and a rare chance of developing acquired drug resistance. Previously it was thought that they act by targeting angiogenesis, but recently additional mechanisms have been discovered which has established metronomic chemotherapy as a type of multi-targeted therapy. The knowledge gained from the preclinical studies of metronomic chemotherapy, along with clinical experience, will help to design better therapeutic protocols against cancer. Detailed pharmacogenomic and pharmacoproteomic studies on tumor endothelial cells and large multi-centered clinical trials, integrating bio-marker analyzes, are needed to investigate and validate the best treatment combinations for each tumor type and patient population. PMID:25210398

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. Global trends in infective endocarditis epidemiology.

    PubMed

    Yew, Haur Sen; Murdoch, David R

    2012-08-01

    The global epidemiology of infective endocarditis is becoming better understood with the initiation of multi-center collaborative studies and with an increasing number of case series being reported from countries outside North America and Europe. However, there are still many knowledge gaps and a lack of population-based data. For endocarditis in developed countries, the role of rheumatic heart disease as a predisposing factor is diminishing; the population is increasingly elderly, staphylococci are becoming much more important pathogens, and proportionally more are healthcare-associated. In developing countries, the epidemiology of infective endocarditis remains similar to North America and Europe from the middle of the twentieth century, affecting a younger age group, is often associated with rheumatic heart disease, and is predominantly caused by streptococci.

  13. 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.

  14. 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).

  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. 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).

  17. 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

  18. Text messaging versus email for emergency medicine residents' knowledge retention: a pilot comparison in the United States.

    PubMed

    Hoonpongsimanont, Wirachin; Kulkarni, Miriam; Tomas-Domingo, Pedro; Anderson, Craig; McCormack, Denise; Tu, Khoa; Chakravarthy, Bharath; Lotfipour, Shahram

    2016-01-01

    We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required.

  19. 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.

  20. 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.

  1. 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.

  2. The Clinical Frailty Scale: Upgrade Your Eyeball Test.

    PubMed

    Afilalo, Jonathan

    2017-03-16

    With the emergence of transcatheter aortic valve replacement (TAVR) as a therapeutic option to treat high-risk older adults suffering from aortic stenosis, the geriatric concept of frailty has assumed mainstream relevance for cardiovascular practitioners. We have eagerly adopted tools to objectify the definition of frailty and accordingly discern good and bad candidates among a pool of complex octogenarians with multiple chronic conditions - a daunting yet mission-critical task. Initial studies published during the first half of this decade revealed that frailty status was one of the top predictors of mid-term mortality and incident disability after TAVR1, leading to its integration in clinical care pathways and predictive risk models. The encouraging findings from small single-center studies are now being validated in larger multi-center registries and trials, affirming the strengths and uncovering the limitations of various frailty assessment tools.

  3. Study and analysis of information technology in dentistry in Latin American countries.

    PubMed

    López Jordi, María Del C; Figueiredo, Marcia Ç; Barone, Dante; Pereira, Carolina

    2016-04-01

    Dentistry increasingly uses Information and Communication Technology (ICT), which has impact on teaching, research, the profession and dental care in general. However, there is a lack of valid information on ICT resources and use in Latin America. This was a descriptive, cross-sectional, multi-center, interdisciplinary study, the aim of which was to conduct a survey on how extensively ICT is used in Dentistry in Latin American countries by enquiring into two primary components: 1) use of ICT in student training and 2) use of ICT by professionals in consulting rooms and services. Two questionnaires on ICT were prepared: one for teachers/researchers and another for students/professionals. We received 94 answers from teachers/researchers at universities in the region providing information on ICT resources for teaching (type and implementation) and 221 answers from professionals (personal use and use in healthcare). Data are presented as absolute relative frequencies and analyzed quantitatively as percentages.

  4. 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.

  5. Methods and outcomes of engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma

    PubMed Central

    Erwin, Kim; Martin, Molly A.; Flippin, Tara; Norell, Sarah; Shadlyn, Ariana; Yang, Jie; Falco, Paula; Rivera, Jaime; Ignoffo, Stacy; Kumar, Rajesh; Margellos-Anast, Helen; McDermott, Michael; McMahon, Kate; Mosnaim, Giselle; Nyenhuis, Sharmilee M.; Press, Valerie G.; Ramsay, Jessica E.; Soyemi, Kenneth; Thompson, Trevonne M.; Krishnan, Jerry A.

    2016-01-01

    Aim To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. Methods We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: 1) Define design requirements; 2) Prototype and Refine; and 3) Evaluate. Results Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool (CHICAGO Action Plan after ED discharge, CAPE) over current tools. Conclusions Engaging end-users in contextual inquiry resulted in CAPE, a new stakeholder-balanced discharge tool, which is being tested in a multi-center comparative effectiveness trial. PMID:26690579

  6. PROGESTERONE AND VITAMIN D HORMONE FOR TREATMENT OF TRAUMATIC BRAIN INJURY IN THE AGED1

    PubMed Central

    Stein, Donald G.; Cekic, Milos M.

    2013-01-01

    There is growing recognition that traumatic brain injury (TBI) is a highly variable and complex systemic disorder that is refractory to therapies that target individual mechanisms. It is even more complex in the elderly, in whom frailty, prior comorbidities, altered metabolism, and a long history of medication use are likely to complicate the secondary effects of brain trauma. Progesterone, one of the few neuroprotective agents that has shown promise for the treatment of acute brain injury, is now in national and international Phase III multi-center trial. New findings show that vitamin D hormone (VDH) and vitamin D deficiency in aging (and across the developmental spectrum) may interact with progesterone and TBI treatment. This paper reviews the use of progesterone and VDH as biologics based therapies and recent studies showing that the combination of progesterone and VDH may promote better functional outcomes than either treatment independently. PMID:21703565

  7. [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.

  8. Risk perception, worry and satisfaction related to genetic counseling for hereditary cancer.

    PubMed

    Bjorvatn, Cathrine; Eide, Geir Egil; Hanestad, Berit Rokne; Øyen, Nina; Havik, Odd E; Carlsson, Anniken; Berglund, Gunilla

    2007-04-01

    In this multi center study, genetic counseling for hereditary cancer was evaluated by assessing patients' worry, perceived risk of developing cancer and satisfaction with genetic counseling. An overall aim was to identify characteristics of vulnerable patients in order to customize genetic counseling. In addition, agreement between patients' and counselors' scores was measured. A total of 275 Norwegian patients were consecutively recruited, and 213 completed questionnaires before and after genetic counseling. Patients' perceived risk decreased after the genetic counseling session. There was incongruence between risk perception expressed as a percentage and in words. Patients were significantly less worried after counseling. Higher levels of worry were predicted by low instrumental satisfaction with counseling, high degree of perceived risk of developing cancer and younger age. In conclusion, counselors met the patients' psychological needs to a satisfactory degree during counseling. However, patients did not fully understand their risk of developing cancer.

  9. PANSS rater training using Internet and videoconference: results from a pilot study.

    PubMed

    Kobak, Kenneth A; Opler, Mark G A; Engelhardt, Nina

    2007-05-01

    Problems associated with the clinician-administered rating scales have led to new approaches to improve rater training. These include interactive, on-line didactic tutorials and live, remote evaluation of raters' clinical skills through the use of videoconferencing. The purpose of this study was to evaluate this approach in training novice raters on the administration of the Positive and Negative Symptom Scale (PANSS). Twelve trainees with no prior PANSS experience completed didactic training via CD-ROM and two remote training sessions where they interviewed a standardized patient-actor while being remotely observed in real time and given feedback. Results found a significant improvement in trainees' conceptual knowledge and an improvement in trainees' clinical skills. The use of these technologies allows for training to be more effectively delivered to diverse sites in multi-center trials, and for evaluation of raters' applied clinical skills, an area that has previously been overlooked.

  10. 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).

  11. Multi-EMR Structured Data Entry Form: User-Acceptance Testing of a Prototype.

    PubMed

    Zavar, Abbas; Keshavjee, Karim

    2017-01-01

    Capturing standardized data from multiple EMRs at the point of care is highly desirable for a variety of uses, including quality improvement programs, multi-centered clinical trials and clinical decision support. In this paper, we describe the design, development and user acceptance testing of a prototype web-based form (the Form) that can integrate with multiple EMRs. We used the validated UTAUT questionnaire to assess the likelihood of uptake of the Form into clinical practice. The Form was found to be easy to use, elicits low anxiety, supports productivity and is perceived to have good support. Users would benefit from training and from better social signaling about the importance of using the Form in their practice. Making the Form more fun and interesting could help increase uptake.

  12. 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.

  13. 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.

  14. 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.

  15. Point charge representation of multicenter multipole moments in calculation of electrostatic properties

    NASA Technical Reports Server (NTRS)

    Sokalski, W. A.; Shibata, M.; Ornstein, R. L.; Rein, R.

    1993-01-01

    Distributed Point Charge Models (PCM) for CO, (H2O)2, and HS-SH molecules have been computed from analytical expressions using multi-center multipole moments. The point charges (set of charges including both atomic and non-atomic positions) exactly reproduce both molecular and segmental multipole moments, thus constituting an accurate representation of the local anisotropy of electrostatic properties. In contrast to other known point charge models, PCM can be used to calculate not only intermolecular, but also intramolecular interactions. Comparison of these results with more accurate calculations demonstrated that PCM can correctly represent both weak and strong (intramolecular) interactions, thus indicating the merit of extending PCM to obtain improved potentials for molecular mechanics and molecular dynamics computational methods.

  16. Design, Rationale, and Initiation of the Surgical Interventions for Moderate Ischemic Mitral Regurgitation Trial: A Report from the Cardiothoracic Surgical Trials Network

    PubMed Central

    Smith, Peter K.; Michler, Robert E.; Woo, Y. Joseph; Alexander, John H.; Puskas, John D.; D’Alessandro, David A.; Hahn, Rebecca T.; Williams, Judson B.; Dent, John M.; Ferguson, T. Bruce; Moquete, Ellen; Pagé, Pierre; Jeffries, Neal O.; O’Gara, Patrick T.; Ascheim, Deborah D.

    2011-01-01

    Background Patients with moderate ischemic mitral regurgitation have demonstrably poorer outcome compared to coronary artery disease patients without mitral regurgitation. The optimal treatment of this condition has become increasingly controversial and a randomized trial evaluating current practices is warranted. Methods and Results We describe the design and initial execution of the Cardiothoracic Surgical Trials Network moderate ischemic mitral regurgitation trial. This is an ongoing prospective, multi-center, randomized, controlled clinical trial designed to test the safety and efficacy of mitral repair in addition to coronary artery bypass grafting in the treatment of moderate ischemic mitral regurgitation. Conclusion The results of the Cardiothoracic Surgical Trials Network ischemic mitral regurgitation trials will provide long-awaited information on controversial therapies for a morbid disease process. PMID:21788032

  17. 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.

  18. Fragmentation of methane molecules by antiproton impact

    NASA Astrophysics Data System (ADS)

    Salehzadeh, Arash; Kirchner, Tom

    2016-09-01

    Extending previous work for proton impact, we have investigated the fragmentation of methane molecules due to collisions with antiprotons in the 25 keV to 5 MeV impact energy range. The multi-center nature of the problem is addressed by using a spectral representation of the molecular Hartree-Fock-level Hamiltonian and a single-center expansion of the initially populated molecular orbitals. The two-center basis generator method (TC-BGM) is used for orbital propagation. Electron-removal cross sections obtained from the TC-BGM solutions are complemented with a dynamical decay-route fragmentation model to calculate cross sections for the production of fragment ions. Good agreement with the available experimental data is observed for CH4+,CH3+,CH2+and CH+. Work supported by NSERC, Canada.

  19. It gets better: resolution of internalized homophobia over time and associations with positive health outcomes among MSM.

    PubMed

    Herrick, Amy L; Stall, Ron; Chmiel, Joan S; Guadamuz, Thomas E; Penniman, Typhanye; Shoptaw, Steven; Ostrow, David; Plankey, Michael W

    2013-05-01

    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.

  20. The genetics and epigenetics of autoimmune diseases

    PubMed Central

    Hewagama, Anura; Richardson, Bruce

    2010-01-01

    Self tolerance loss is fundamental to autoimmunity. While understanding of immune regulation is expanding rapidly, the mechanisms causing loss of tolerance in most autoimmune diseases remain elusive. Autoimmunity is believed to develop when genetically predisposed individuals encounter environmental agents that trigger the disease. Recent advances in the genetic and environmental contributions to autoimmunity suggest that interactions between genetic elements and epigenetic changes caused by environmental agents may be responsible for inducing autoimmune disease. Genetic loci predisposing to autoimmunity are being identified through multi-center consortiums, and the number of validated genes is growing rapidly. Recent reports also indicate that the environment can contribute to autoimmunity by modifying gene expression through epigenetic mechanisms. This article will review current understanding of the genetics and epigenetics of lupus, rheumatoid arthritis, multiple sclerosis and type 1 diabetes, using systemic lupus erythematosus as the primary example. Other autoimmune diseases may have a similar foundation. PMID:19349147

  1. The genetics and epigenetics of autoimmune diseases.

    PubMed

    Hewagama, Anura; Richardson, Bruce

    2009-08-01

    Self tolerance loss is fundamental to autoimmunity. While understanding of immune regulation is expanding rapidly, the mechanisms causing loss of tolerance in most autoimmune diseases remain elusive. Autoimmunity is believed to develop when genetically predisposed individuals encounter environmental agents that trigger the disease. Recent advances in the genetic and environmental contributions to autoimmunity suggest that interactions between genetic elements and epigenetic changes caused by environmental agents may be responsible for inducing autoimmune disease. Genetic loci predisposing to autoimmunity are being identified through multi-center consortiums, and the number of validated genes is growing rapidly. Recent reports also indicate that the environment can contribute to autoimmunity by modifying gene expression through epigenetic mechanisms. This article will review current understanding of the genetics and epigenetics of lupus, rheumatoid arthritis, multiple sclerosis and type 1 diabetes, using systemic lupus erythematosus as the primary example. Other autoimmune diseases may have a similar foundation.

  2. Are Sample Sizes Clear and Justified in RCTs Published in Dental Journals?

    PubMed Central

    Koletsi, Despina; Fleming, Padhraig S.; Seehra, Jadbinder; Bagos, Pantelis G.; Pandis, Nikolaos

    2014-01-01

    Sample size calculations are advocated by the CONSORT group to justify sample sizes in randomized controlled trials (RCTs). The aim of this study was primarily to evaluate the reporting of sample size calculations, to establish the accuracy of these calculations in dental RCTs and to explore potential predictors associated with adequate reporting. Electronic searching was undertaken in eight leading specific and general dental journals. Replication of sample size calculations was undertaken where possible. Assumed variances or odds for control and intervention groups were also compared against those observed. The relationship between parameters including journal type, number of authors, trial design, involvement of methodologist, single-/multi-center study and region and year of publication, and the accuracy of sample size reporting was assessed using univariable and multivariable logistic regression. Of 413 RCTs identified, sufficient information to allow replication of sample size calculations was provided in only 121 studies (29.3%). Recalculations demonstrated an overall median overestimation of sample size of 15.2% after provisions for losses to follow-up. There was evidence that journal, methodologist involvement (OR = 1.97, CI: 1.10, 3.53), multi-center settings (OR = 1.86, CI: 1.01, 3.43) and time since publication (OR = 1.24, CI: 1.12, 1.38) were significant predictors of adequate description of sample size assumptions. Among journals JCP had the highest odds of adequately reporting sufficient data to permit sample size recalculation, followed by AJODO and JDR, with 61% (OR = 0.39, CI: 0.19, 0.80) and 66% (OR = 0.34, CI: 0.15, 0.75) lower odds, respectively. Both assumed variances and odds were found to underestimate the observed values. Presentation of sample size calculations in the dental literature is suboptimal; incorrect assumptions may have a bearing on the power of RCTs. PMID:24465806

  3. Predicting primary progressive aphasias with support vector machine approaches in structural MRI data.

    PubMed

    Bisenius, Sandrine; Mueller, Karsten; Diehl-Schmid, Janine; Fassbender, Klaus; Grimmer, Timo; Jessen, Frank; Kassubek, Jan; Kornhuber, Johannes; Landwehrmeyer, Bernhard; Ludolph, Albert; Schneider, Anja; Anderl-Straub, Sarah; Stuke, Katharina; Danek, Adrian; Otto, Markus; Schroeter, Matthias L

    2017-01-01

    Primary progressive aphasia (PPA) encompasses the three subtypes nonfluent/agrammatic variant PPA, semantic variant PPA, and the logopenic variant PPA, which are characterized by distinct patterns of language difficulties and regional brain atrophy. To validate the potential of structural magnetic resonance imaging data for early individual diagnosis, we used support vector machine classification on grey matter density maps obtained by voxel-based morphometry analysis to discriminate PPA subtypes (44 patients: 16 nonfluent/agrammatic variant PPA, 17 semantic variant PPA, 11 logopenic variant PPA) from 20 healthy controls (matched for sample size, age, and gender) in the cohort of the multi-center study of the German consortium for frontotemporal lobar degeneration. Here, we compared a whole-brain with a meta-analysis-based disease-specific regions-of-interest approach for support vector machine classification. We also used support vector machine classification to discriminate the three PPA subtypes from each other. Whole brain support vector machine classification enabled a very high accuracy between 91 and 97% for identifying specific PPA subtypes vs. healthy controls, and 78/95% for the discrimination between semantic variant vs. nonfluent/agrammatic or logopenic PPA variants. Only for the discrimination between nonfluent/agrammatic and logopenic PPA variants accuracy was low with 55%. Interestingly, the regions that contributed the most to the support vector machine classification of patients corresponded largely to the regions that were atrophic in these patients as revealed by group comparisons. Although the whole brain approach took also into account regions that were not covered in the regions-of-interest approach, both approaches showed similar accuracies due to the disease-specificity of the selected networks. Conclusion, support vector machine classification of multi-center structural magnetic resonance imaging data enables prediction of PPA subtypes with

  4. 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

  5. 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

  6. Identifying inaccuracies on emergency medicine residency applications

    PubMed Central

    Katz, Eric D; Shockley, Lee; Kass, Lawrence; Howes, David; Tupesis, Janis P; Weaver, Christopher; Sayan, Osman R; Hogan, Victoria; Begue, Jason; Vrocher, Diamond; Frazer, Jackie; Evans, Timothy; Hern, Gene; Riviello, Ralph; Rivera, Antonio; Kinoshita, Keith; Ferguson, Edward

    2005-01-01

    Background Previous trials have showed a 10–30% rate of inaccuracies on applications to individual residency programs. No studies have attempted to corroborate this on a national level. Attempts by residency programs to diminish the frequency of inaccuracies on applications have not been reported. We seek to clarify the national incidence of inaccuracies on applications to emergency medicine residency programs. Methods This is a multi-center, single-blinded, randomized, cohort study of all applicants from LCME accredited schools to involved EM residency programs. Applications were randomly selected to investigate claims of AOA election, advanced degrees and publications. Errors were reported to applicants' deans and the NRMP. Results Nine residencies reviewed 493 applications (28.6% of all applicants who applied to any EM program). 56 applications (11.4%, 95%CI 8.6–14.2%) contained at least one error. Excluding "benign" errors, 9.8% (95% CI 7.2–12.4%), contained at least one error. 41% (95% CI 35.0–47.0%) of all publications contained an error. All AOA membership claims were verified, but 13.7% (95%CI 4.4–23.1%) of claimed advanced degrees were inaccurate. Inter-rater reliability of evaluations was good. Investigators were reluctant to notify applicants' dean's offices and the NRMP. Conclusion This is the largest study to date of accuracy on application for residency and the first such multi-centered trial. High rates of incorrect data were found on applications. This data will serve as a baseline for future years of the project, with emphasis on reporting inaccuracies and warning applicants of the project's goals. PMID:16105178

  7. 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

  8. MiRNA expression in squamous cell carcinoma and adenocarcinoma of the esophagus and associations with survival

    PubMed Central

    Mathé, Ewy A; Nguyen, Giang Huong; Bowman, Elise D; Zhao, Yiqiang; Budhu, Anuradha; Schetter, Aaron J; Braun, Rosemary; Reimers, Mark; Kumamoto, Kensuke; Hughes, Duncan; Altorki, Nasser K; Casson, Alan G; Liu, Chang-Gong; Wang, Xin Wei; Yanaihara, Nozomu; Hagiwara, Nobutoshi; Dannenberg, Andrew J; Miyashita, Masao; Croce, Carlo M; Harris, Curtis C

    2009-01-01

    Purpose The dismal outcome of esophageal cancer patients highlights the need for novel prognostic biomarkers, such as microRNAs (miRNAs). While recent studies have established the role of miRNAs in esophageal carcinoma, a comprehensive multi-center study investigating different histological types, including squamous cell carcinoma (SCC) and adenocarinoma (ADC) with or without Barrett's, is still lacking. Experimental Design MiRNA expression was measured in cancerous and adjacent non-cancerous tissue pairs collected from 100 ADC and 70 SCC patients enrolled at 4 clinical centers from the US, Canada, and Japan. Microarray-based expression was measured in a subset of samples in two cohorts and was validated in all available samples. Results In ADC patients, miR-21, miR-223, miR-192, and miR-194 expression was elevated, while miR-203 expression was reduced in cancerous compared to non-cancerous tissue. In SCC patients, we found elevated miR-21 and reduced mir-375 expression levels in cancerous compared to non-cancerous tissue. When comparing cancerous tissue expression between ADC and SCC patients, mir-194 and mir-375 were elevated in ADC patients. Significantly, elevated mir-21 expression in non-cancerous tissue of SCC patients and reduced levels of mir-375 in cancerous tissue of ADC patients with Barrett's were strongly associated with worse prognosis. Associations with prognosis were independent of tumor stage or nodal status, cohort type, and chemoradiation therapy. Conclusions Our multi-center-based results highlight miRNAs involved in major histological types of esophageal carcinoma and uncover significant associations with prognosis. Elucidating miRNAs relevant to esophageal carcinogenesis is potentially clinically useful for developing prognostic biomarkers and identifying novel drug targets and therapies. PMID:19789312

  9. The Prevalence and Epidemiology of Overweight and Obesity in Children with Inflammatory Bowel Disease

    PubMed Central

    Long, Millie D.; Crandall, Wallace V.; Leibowitz, Ian H.; Duffy, Lynn; del Rosario, Fernando; Kim, Sandra C.; Integlia, Mark J.; Berman, James; Grunow, John; Colletti, Richard B.; Schoen, Bess T.; Patel, Ashish S.; Baron, Howard; Israel, Esther; Russell, George; Ali, Sabina; Herfarth, Hans H.; Martin, Christopher; Kappelman, Michael D.

    2010-01-01

    Background Obesity is a significant public health threat to children in the United States. Aims 1) Determine the prevalence of obesity in a multi-center cohort of children with IBD; 2) Evaluate whether overweight and obese status is associated with patient demographics or disease characteristics. Methods We used data from the ImproveCareNow Collaborative for pediatric IBD, a multi-center registry of children with IBD, collected between April 2007 and December 2009. Children ages 2-18 years were classified into BMI percentiles. Bivariate analyses and multivariate logistic regression were used to compare demographic and disease characteristics by overweight (BMI>85%) and obese (BMI>95%) status. Results The population consisted of 1598 children with IBD. The prevalence of overweight/obese status in pediatric IBD is 23.6%, (20.0% for Crohn's disease (CD) and 30.1% for ulcerative colitis (UC) and indeterminate colitis (IC)). African American race (OR 1.64, 95% CI 1.10-2.48) and Medicaid insurance (OR 1.67, 95% CI 1.19-2.34) were positively associated with overweight/obese status. Prior IBD related surgery (OR 1.73, 95% CI 1.07-2.82) was also associated with overweight and obese status in children with CD. Other disease characteristics were not associated with overweight and obesity in children with IBD. Conclusions Approximately 1/5 of children with CD and 1/3 with UC are overweight or obese. Rates of obesity in UC are comparable to the general population. Obese IBD patients may have a more severe disease course, as indicated by increased need for surgery. Sociodemographic risk factors for obesity in the IBD population are similar to those in the general population. PMID:21910178

  10. Vaccination to improve the persistence of CD19CAR gene-modified T cells in relapsed pediatric acute lymphoblastic leukemia.

    PubMed

    Rossig, C; Pule, M; Altvater, B; Saiagh, S; Wright, G; Ghorashian, S; Clifton-Hadley, L; Champion, K; Sattar, Z; Popova, B; Hackshaw, A; Smith, P; Roberts, T; Biagi, E; Dreno, B; Rousseau, R; Kailayangiri, S; Ahlmann, M; Hough, R; Kremens, B; Sauer, M G; Veys, P; Goulden, N; Cummins, M; Amrolia, P J

    2017-03-10

    Trials with second generation CD19 chimeric antigen receptors (CAR) T-cells report unprecedented responses but are associated with risk of cytokine release syndrome (CRS). Instead, we studied the use of donor Epstein-Barr virus-specific T-cells (EBV CTL) transduced with a first generation CD19CAR, relying on the endogenous T-cell receptor for proliferation. We conducted a multi-center phase I/II study of donor CD19CAR transduced EBV CTL in pediatric acute lymphoblastic leukaemia (ALL). Patients were eligible pre-emptively if they developed molecular relapse (>5 × 10(-4)) post first stem cell transplant (SCT), or prophylactically post second SCT. An initial cohort showed poor expansion/persistence. We therefore investigated EBV-directed vaccination to enhance expansion/persistence. Eleven patients were treated. No CRS, neurotoxicity or graft versus host disease (GVHD) was observed. At 1 month, 5 patients were in CR (4 continuing, 1 de novo), 1 PR, 3 had stable disease and 3 no response. At a median follow-up of 12 months, 10 of 11 have relapsed, 2 are alive with disease and 1 alive in CR 3 years. Although CD19CAR CTL expansion was poor, persistence was enhanced by vaccination. Median persistence was 0 (range: 0-28) days without vaccination compared to 56 (range: 0-221) days with vaccination (P=0.06). This study demonstrates the feasibility of multi-center studies of CAR T cell therapy and the potential for enhancing persistence with vaccination.Leukemia advance online publication, 10 March 2017; doi:10.1038/leu.2017.39.

  11. 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.

  12. Multicenter Clinical Trial of the Nucleus® Hybrid™ S8 Cochlear Implant: Final Outcomes

    PubMed Central

    Gantz, Bruce J; Dunn, Camille; Oleson, Jacob; Hansen, Marlan; Parkinson, Aaron; Turner, Christopher

    2015-01-01

    Objective The concept expanding electrical speech processing to those with more residual acoustic hearing with a less invasive shorter cochlear implant has been ongoing since 1999. A multi-center study of the Nucleus Hybrid S8 CI took place between 2002–11. This report describes the final outcomes of this clinical trial. Study Design Multi-Center longitudinal single subject design Methods Eighty-seven subjects received a Nucleus® Hybrid™ S8 implant in their poorer ear. Speech perception in quiet (CNC words) and in noise (BKB-SIN) was collected pre- and post-operatively at 3, 6, and 12 months. Subjective questionnaire data using the APHAB was also collected. Results Some level of hearing preservation was accomplished in 98% subjects with 90% maintaining a functional low-frequency pure-tone average (LFPTA) at initial activation. By 12 months, 5 subjects had total hearing loss and 80% of subjects maintained functional hearing. CNC words demonstrated that 82.5% and 87.5% of subjects had significant improvements in the Hybrid and Combined conditions. The majority of had improvements with BKB-SIN. Results also indicated that as long as subjects maintained at least a severe LFPTA, there was significant improvement in speech understanding. Furthermore, all subjects reported positive improvements in hearing in three of the 4 subscales of the APHAB. Conclusion The concept of hybrid speech processing has significant advantages for subjects with residual low-frequency hearing. In this study, the Nucleus® Hybrid™ S8 provided improved word understanding in quiet and noise. Additionally, there appears to be stability of the residual hearing after initial activation of the device. Level of evidence 2c PMID:26756395

  13. The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) Study Protocol

    PubMed Central

    Woo, Daniel; Rosand, Jonathan; Kidwell, Chelsea; McCauley, Jacob L.; Osborne, Jennifer; Brown, Mark W.; West, Sandra E.; Rademacher, Eric W.; Waddy, Salina; Roberts, Jamie N.; Koch, Sebastian; Gonzales, Nicole R.; Sung, Gene; Kittner, Steven J.; Birnbaum, Lee; Frankel, Michael; Daniel Testai, Fernando; Hall, Christiana E.; Elkind, Mitchell S. V.; Flaherty, Matthew; Coull, Bruce; Chong, Ji Y.; Warwick, Tanya; Malkoff, Marc; James, Michael L.; Ali, Latisha K.; Worrall, Bradford B.; Jones, Floyd; Watson, Tiffany; Leonard, Anne; Martinez, Rebecca; Sacco, Ralph I; Langefeld, Carl D.

    2013-01-01

    Background and Purpose Epidemiologic studies of intracerebral hemorrhage (ICH) have consistently demonstrated variation in incidence, location, age at presentation, and outcomes among non-Hispanic white, black, and Hispanic populations. We report here the design and methods for this large, prospective, multi-center case-control study of ICH. Methods The ERICH study is a multi-center, prospective case-control study of ICH. Cases are identified by hot-pursuit and enrolled using standard phenotype and risk factor information and include neuroimaging and blood sample collection. Controls are centrally identified by random digit dialing to match cases by age (+/−5 years), race, ethnicity, gender and metropolitan region. Results As of March 22, 2013, 1,655 cases of ICH had been recruited into the study which is 101.5% of the target for that date and 851 controls had been recruited which is 67.2% of the target for that date (1,267 controls) for a total of 2,506 subjects which is 86.5% of the target for that date (2,897 subjects). Of the 1,655 cases enrolled, 1,640 cases had the case interview entered into the database of which 628 (38%) were non-Hispanic black, 458 (28%) were non-Hispanic white and 554 (34%) were Hispanic. Of the 1,197 cases with imaging submitted, 876 (73.2%) had a 24 hour follow-up CT available In addition to CT imaging, 607 cases have had MRI evaluation. Conclusion The ERICH study is a large, case-control study of ICH with particular emphasis on recruitment of minority populations for the identification of genetic and epidemiologic risk factors for ICH and outcomes after ICH. PMID:24021679

  14. Candida infective endocarditis.

    PubMed

    Baddley, J W; Benjamin, D K; Patel, M; Miró, J; Athan, E; Barsic, B; Bouza, E; Clara, L; Elliott, T; Kanafani, Z; Klein, J; Lerakis, S; Levine, D; Spelman, D; Rubinstein, E; Tornos, P; Morris, A J; Pappas, P; Fowler, V G; Chu, V H; Cabell, C

    2008-07-01

    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 the epidemiology, treatment patterns, and outcomes of patients with Candida IE. We compared 33 Candida IE cases to 2,716 patients with non-fungal IE in the International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS). Patients were enrolled and the data collected from June 2000 until August 2005. We noted that 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 infections (p < 0.001). The 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. 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.

  15. Challenges and Potential Solutions to Meeting Accrual Goals in a Phase II Chemoprevention Trial for Prostate Cancer

    PubMed Central

    Kumar, Nagi; Crocker, Theresa; Smith, Tiffany; Pow-Sang, Julio; Spiess, Philippe E.; Egan, Kathleen; Quinn, Gwen; Schell, Michael; Sebti, Said; Kazi, Aslam; Chuang, Tian; Salup, Raoul; Helal, Mohamed; Zagaja, Gregory; Trabulsi, Edouard; McLarty, Jerry; Fazili, Tajammul; Williams, Christopher R.; Schreiber, Fred; Slaton, Joel; Anderson, J Kyle

    2011-01-01

    Objective The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. Methods We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. Results Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. Conclusion A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. PMID:22101219

  16. 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

  17. 14 CFR Appendix A to Part 23 - Simplified Design Load Criteria

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. Stopping power for low-velocity heavy ions: (0-1.0)-MeV/nucleon Mg ions in 17 (Z=22-79) elemental solids

    NASA Astrophysics Data System (ADS)

    Arstila, K.; Keinonen, J.; Tikkanen, P.

    1990-04-01

    The stopping power for 24,26Mg ions in 17 (Z=22-79) elemental solids has been studied in the energy region 0-1.0 MeV/nucleon by application of the Doppler-shift attenuation method. At velocities 2v01.05 (Ge), 1.05 (Nb), 1.15 (Mo), 1.05 (Pd), 1.08 (Ag), 1.09 (Hf), 1.07 (Ta), 1.05 (W), 1.05 (Re), 1.05 (Pt), and 0.96 (Au) to the commonly used empirical electronic stopping power by Ziegler, Biersack, and Littmark were determined to an accuracy of +/-5%. At velocities v<2v0, much higher electronic stopping power and different velocity dependence than predicted by the empirical model were obtained. The electronic stopping power was determined to an accuracy of +/-5%. The reduction of the nuclear stopping power due to the polycrystalline structure of the slowing-down materials was taken into account in the deduction of the electronic stopping power.

  4. Aerobic bacterial microflora of Broad-snouted caiman (Caiman latirostris) oral cavity and cloaca, originating from parque Zoológico Arruda Câmara, Paraíba, Brazil

    PubMed Central

    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

  5. 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.

  6. 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

  7. Etiology and outcomes of acute kidney injury in Chinese children: a prospective multicentre investigation

    PubMed Central

    2013-01-01

    Background The incidence of AKI appears to have increasing trend. Up to now, prospective, multi-center, large-sample epidemiological study done on pediatric AKI on aspects of epidemiological characteristics, causes and outcomes have not reported. It is necessary to develop prospective, multi-center, large-sample epidemiological study in our country on pediatric AKI. The aim of this study was to determine the clinical features, etiology, and outcomes of acute kidney injury (AKI) in Chinese children. Method Paediatric patients (≤18 years old) admitted to 27 hospitals (14 children’s hospitals and 13 general hospitals) affiliated with the Medical University were investigated. AKI was defined using the 2005 Acute Kidney Injury Network criteria. Results During the study period, 388,736 paediatric patients were admitted. From this total, AKI was diagnosed in 1,257 patients, 43 of whom died. The incidence and mortality of AKI was 0.32% and 3.4% respectively. The mean (± SD) age of patients was 48.4 ± 50.4 months. Among the 1,257 AKI paediatric patients, 632 were less than one year old. Among the AKI paediatric patients, 615 (48.9%) were in stage 1, 277 (22.0%) in stage 2, and 365 (29.0%) in stage 3. The most common causes of AKI were renal causes (57.52%), whereas postrenal (25.69%) and prerenal (14.96%) causes were the least common. The three most common causes of AKI according to individual etiological disease were urolithiasis (22.35%), of which exposure to melamine-contaminated milk accounted for the highest incidence (63.7%); acute glomerulonephritis (10.10%); and severe dehydration (7.48%). A total of 43 AKI patients (3.4%) died during their hospital stay; 15 (34.9%) of the 43 died as a result of sepsis. Conclusion Primary renal diseases are a major risk factor for paediatric AKI in China. In terms of specific etiological disease, urolithiasis (postrenal disease) was the leading cause of paediatric AKI in 2008, when the disease was linked to exposure to

  8. 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

  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. 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

  11. The role of matched sibling donor allogeneic stem cell transplantation in pediatric high-risk acute myeloid leukemia: results from the AML-BFM 98 study

    PubMed Central

    Klusmann, Jan-Henning; Reinhardt, Dirk; Zimmermann, Martin; Kremens, Bernhard; Vormoor, Josef; Dworzak, Michael; Creutzig, Ursula; Klingebiel, Thomas

    2012-01-01

    Background The role of allogeneic stem cell transplantation in post-remission management of children with high-risk acute myeloid leukemia remains controversial. In the multi-center AML-BFM 98 study we prospectively evaluated the impact of allogeneic stem cell transplantation in children with high-risk acute myeloid leukemia in first complete remission. Design and Methods HLA-typed patients with high-risk acute myeloid leukemia, who achieved first complete remission (n=247), were included in this analysis. All patients received double induction and consolidation. Based on the availability of a matched-sibling donor, patients were allocated by genetic chance to allogeneic stem cell transplantation (n=61) or chemotherapy-only (i.e. intensification and maintenance therapy; n=186). The main analysis was done on an intention-to-treat basis according to this allocation. Results Intention-to-treat analysis did not show a significantly different 5-year disease-free survival (49±6% versus 45±4%, Plog rank=0.44) or overall survival (68±6% versus 57±4%, Plog rank=0.17) between the matched-sibling donor and no-matched-sibling donor groups, whereas late adverse effects occurred more frequently after allogeneic stem cell transplantation (72.5% versus 31.8%, PFischer<0.01). These results were confirmed by as-treated analysis corrected for the time until transplantation (5-year overall survival: 72±8% versus 60±4%, PMantel-Byar 0.21). Subgroup analysis demonstrated improved survival rates for patients with 11q23 aberrations allocated to allogeneic stem cell transplantation (5-year overall survival: 94±6% versus 52±7%, Plog-rank=0.01; n=18 versus 49) in contrast to patients without 11q23 aberrations (5-year overall survival: 58±8% versus 55±5%, Plog-rank=0.66). Conclusions Our analyses defined a genetic subgroup of children with high-risk acute myeloid leukemia who benefited from allogeneic stem cell transplantation in the prospective multi-center AML-BFM 98 study. For

  12. 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

  13. Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals

    PubMed Central

    Ivanov, Alexander; Kaczkowska, Beata A.; Khan, Saadat A.; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F.; Klem, Igor; Mehta, Parag; Briggs, William M.; Sacchi, Terrence J.; Heitner, John F.

    2017-01-01

    Context Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. Objective We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Data sources and Study Selection Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Data Extraction Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. Results 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas

  14. Instantons, black holes, and harmonic functions

    NASA Astrophysics Data System (ADS)

    Mohaupt, Thomas; Waite, Kirk

    2009-10-01

    We find a class of five-dimensional Einstein-Maxwell type Lagrangians which contains the bosonic Lagrangians of vector multiplets as a subclass, and preserves some features of supersymmetry, namely the existence of multi-centered black hole solutions and of attractor equations. Solutions can be expressed in terms of harmonic functions through a set of algebraic equations. The geometry underlying these Lagrangians is characterised by the existence of a Hesse potential and generalizes the very special real geometry of vector multiplets. Our construction proceeds by first obtaining instanton solutions for a class of four-dimensional Euclidean sigma models, which includes those occuring for four-dimensional Euclidean N = 2 vector multiplets as a subclass. For solutions taking values in a completely isotropic submanifold of the target space, we show that the solution can be expressed in terms of harmonic functions if an integrability condition is met. This condition can either be solved by imposing that the solution depends on a single coordinate, or by imposing that the target space is a para-Kähler manifold which can be obtained from a real Hessian manifold by a generalized r-map. In the latter case one obtains multi-centered solutions. Moreover, if the integrability condition is met, the second order equations of motion can always be reduced to first order equations, which become gradient flow equations if the solution is further required to depend on one coordinate only. The dualization of axions into tensor fields and the lifting of four-dimensional instantons to five-dimensional solitons are used to motivate the addition of a boundary term to the action, which accounts for the instanton action. If the sigma model is coupled to gravity, and if the Hesse potential is of a suitable form which we specify, then the four-dimensional Euclidean Lagrangian can be lifted consistently to a five-dimensional Einstein-Maxwell type Lagrangian. Instanton solutions lift to

  15. Leidenfrost Vapor Layers Reduce Drag without the Crisis in High Viscosity Liquids

    NASA Astrophysics Data System (ADS)

    Vakarelski, Ivan U.; Berry, Joseph D.; Chan, Derek Y. C.; Thoroddsen, Sigurdur T.

    2016-09-01

    The drag coefficient CD of a solid smooth sphere moving in a fluid is known to be only a function of the Reynolds number Re and diminishes rapidly at the drag crisis around Re ˜3 ×1 05 . A Leidenfrost vapor layer on a hot sphere surface can trigger the onset of the drag crisis at a lower Re. By using a range of high viscosity perfluorocarbon liquids, we show that the drag reduction effect can occur over a wide range of Re, from as low as ˜600 to 1 05. The Navier slip model with a viscosity dependent slip length can fit the observed drag reduction and wake shape.

  16. 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.

  17. Human Respiratory Responses during High Performance Flight

    DTIC Science & Technology

    1987-11-01

    of walking in chemical defence clothing. RAF Institute of Aviation Medicine Aircrew Equipment Group Report No 347 , 1975. 95 Gibson T M, Anton D...1.05 1.01 1.15 1.07 0.0391 0.6223 0.C243 2 Taxy (pre-flight) . 1.00 1.01 1.05 1.08 1.02 0.0296 0.4187 0.0124 1 Jako -oft . 1.09 - 1.13 1.15 1.55 1.14

  18. Breast cancer in systemic lupus.

    PubMed

    Bernatsky, S; Ramsey-Goldman, R; Petri, M; Urowitz, M B; Gladman, D D; Fortin, P F; Ginzler, E; Romero-Diaz, J; Peschken, C; Jacobsen, S; Hanly, J G; Gordon, C; Nived, O; Yelin, E H; Isenberg, D; Rahman, A; Bae, S-C; Joseph, L; Witte, T; Ruiz-Irastorza, G; Aranow, C; Kamen, D; Sturfeldt, G; Foulkes, W D; Hansen, J E; St Pierre, Y; Raymer, P Chrétien; Tessier-Cloutier, B; Clarke, A E

    2017-03-01

    Objective There is a decreased breast cancer risk in systemic lupus erythematosus (SLE) versus the general population. We assessed a large sample of SLE patients, evaluating demographic and clinical characteristics and breast cancer risk. Methods We performed case-cohort analyses within a multi-center international SLE sample. We calculated the breast cancer hazard ratio (HR) in female SLE patients, relative to demographics, reproductive history, family history of breast cancer, and time-dependent measures of anti-dsDNA positivity, cumulative disease activity, and drugs, adjusted for SLE duration. Results There were 86 SLE breast cancers and 4498 female SLE cancer-free controls. Patients were followed on average for 7.6 years. Versus controls, SLE breast cancer cases tended to be white and older. Breast cancer cases were similar to controls regarding anti-dsDNA positivity, disease activity, and most drug exposures over time. In univariate and multivariate models, the principal factor associated with breast cancers was older age at cohort entry. Conclusions There was little evidence that breast cancer risk in this SLE sample was strongly driven by any of the clinical factors that we studied. Further search for factors that determine the lower risk of breast cancer in SLE may be warranted.

  19. Tolerance in liver transplantation: Biomarkers and clinical relevance

    PubMed Central

    Baroja-Mazo, Alberto; Revilla-Nuin, Beatriz; Parrilla, Pascual; Martínez-Alarcón, Laura; Ramírez, Pablo; Pons, José Antonio

    2016-01-01

    Transplantation is the optimal treatment for end-stage organ failure, and modern immunosuppression has allowed important progress in short-term outcomes. However, immunosuppression poorly influences chronic rejection and elicits chronic toxicity in current clinical practice. Thus, a major goal in transplantation is to understand and induce tolerance. It is well established that human regulatory T cells expressing the transcription factor FoxP3 play important roles in the maintenance of immunological self-tolerance and immune homeostasis. The major regulatory T cell subsets and mechanisms of expansion that are critical for induction and long-term maintenance of graft tolerance and survival are being actively investigated. Likewise, other immune cells, such as dendritic cells, monocyte/macrophages or natural killer cells, have been described as part of the process known as “operational tolerance”. However, translation of these results towards clinical practice needs solid tools to identify accurately and reliably patients who are going to be tolerant. In this way, a plethora of genetic and cellular biomarkers is raising and being validated worldwide in large multi-center clinical trials. Few of the studies performed so far have provided a detailed analysis of the impact of immunosuppression withdrawal on pre-existing complications derived from the long-term administration of immunosuppressive drugs and the side effects associated with them. The future of liver transplantation is aimed to develop new therapies which increase the actual low tolerant vs non-tolerant recipients ratio. PMID:27678350

  20. Efficacy and safety of extract of Ginkgo biloba as an adjunct therapy in chronic schizophrenia: A systematic review of randomized, double-blind, placebo-controlled studies with meta-analysis.

    PubMed

    Chen, Xichuang; Hong, Yuan; Zheng, Panpan

    2015-07-30

    Our study was to review and evaluate the efficacy and safety of extract of Gb (EGb) as an adjuvant therapy to antipsychotics in chronic schizophrenia treatment. We searched Pubmed/Medline, Embase, PsycINFO, the Cochrane library, and especially the Chinese periodical databases. Finally, eight randomized, double-blind, placebo-controlled trials (RCTs) of 1033 patients were enrolled, with 571 cases in EGb group and 462 in placebo. The result showed that EGb had a significant difference in ameliorating total and negative symptoms of chronic schizophrenia as an adjuvant therapy to antipsychotics. Thus, the EGb therapy plus antipsychotics might be more efficacious. Although the studies describing adverse reactions showed no distinguishable difference between EGb and placebo group in mean total scores of Treatment Emergent Symptom Scale (TESS) or a Rating Scale for Extrapyramidal Side Effects (RSESE), the results of subscores varied in different studies. In addition, the severity of side effects of EGb might be related to its daily dosage. Therefore, the safety of EGb therapy in chronic schizophrenia treatment might need more evidence. And all of these eight trials were carried out in China; thus, the results might be restricted to the race and we need more high-quality studies of multi-center and randomized double-blind clinical trials to compare, analyze, and confirm the findings further.

  1. Testosterone therapy, thrombophilia, and hospitalization for deep venous thrombosis-pulmonary embolus, an exploratory, hypothesis-generating study.

    PubMed

    Glueck, Charles J; Friedman, Joel; Hafeez, Ahsan; Hassan, Atif; Wang, Ping

    2015-04-01

    Our hypothesis was that testosterone therapy (TT) interacts with previously undiagnosed thrombophilia-hypofibrinolysis, leading to hospitalization for deep venous thrombosis (DVT)-pulmonary emboli (PE). We determined the prevalence of DVT-PE associated with TT 147 men hospitalized in the last 12 months for DVT-PE. Of the 147 men, 2 (1.4%) had TT before and at the time of their DVT-PE. Neither had risk factors for thrombosis. Neither smoked. Case #1 (intramuscular T 50mg/week) had 2 PE, 6 and 24 months after starting TT. DVT-PE in case #2 (T gel 100mg/day) occurred 24 months after starting T. Both men were found to have previously undiagnosed familial thrombophilia (protein S deficiency, homocysteinemia, high Factor VIII). In case #2, on 100mg T gel/day, serum estradiol was high, 51 pg/ml (upper normal limit 42.6 pg/ml). At least 1.4% of men hospitalized for DVT-PE were on TT and had previously undiagnosed thrombophilia, suggesting a thrombotic interaction between exogenous T and thrombophilia-hypofibrinolysis. Given the increasing use of TT, our preliminary findings should facilitate design of a much-needed, multi-center, prospective study of pro-thrombotic interactions between T therapy and thrombophilia for subsequent thrombotic events including DVT-PE.

  2. Ophthalmologic Findings in Children with Leukemia: A Single-Center Study

    PubMed Central

    Orhan, Betül; Malbora, Barış; Akça Bayar, Sezin; Avcı, Zekai; Alioğlu, Bülent; Özbek, Namık

    2016-01-01

    Objectives: Ophthalmologic disease in patients with acute leukemia occurs due to primary leukemic infiltration (involvement), or secondary to the disease and its treatment. In recent years the life expectancy of acute leukemia patients has increased with the advent of modern therapies. The present study aimed to determine the incidence of ocular manifestations in children with acute leukemia. Materials and Methods: The study included 120 patients diagnosed with acute leukemia at Başkent University Hospital, Pediatric Hematology Department between 1995 and 2010. All the patients were examined by an ophthalmologist via direct and indirect ophthalmoscopy. Results: Among the patients, 83 (69.2%) were diagnosed with acute lymphoblastic leukemia, 35 (29.1%) with acute myeloblastic leukemia, and 2 (1.7%) with mixed-lineage leukemia. In all, 58 ophthalmic manifestations were noted in 41 patients (34.2%). In our patients, 12 ophthalmologic involvements were present at admission and 46 ocular findings occurred during follow-up. The incidence of these manifestations increased with age. Conclusion: Ophthalmologic manifestations were not correlated with gender, hematological parameters at disease onset, type of leukemia, or the frequency of relapse and survival. To more clearly determine the effect of ophthalmologic manifestations on the prognosis of leukemia, larger scale and multi-center studies are needed. PMID:27800262

  3. Comparison of the efficacy and safety of sildenafil citrate (Viagra) and oral phentolamine for the treatment of erectile dysfunction.

    PubMed

    Ugarte, F; Hurtado-Coll, A

    2002-08-01

    This open-label, multi-center study from Mexico compared the efficacy and safety of oral sildenafil and phentolamine in men with erectile dysfunction. Patients received sildenafil (25-100 mg; n=123) or phentolamine (40 mg; n=119) for 8 weeks, and efficacy was assessed using the International Index of Erectile Function (IIEF) as well as two global efficacy questions. Mean scores for the erectile function domain of the IIEF were significantly higher for sildenafil (27.23 +/- 0.62; P=0.0001) than for phentolamine (19.35 +/- 0.66). Approximately twice as many men receiving sildenafil had successful attempts at sexual intercourse (88% vs 42%), improved erections (95% vs 51.1%), and improved ability to have sexual intercourse (94.4% vs 46.4%) compared with phentolamine. The most common adverse events included rhinitis, headache, tachycardia, and nausea, with a higher frequency reported in patients receiving phentolamine than sildenafil (41% vs 33%), with the exception of headache, which was reported more frequently in sildenafil users. Overall, sildenafil was more effective and appeared to be better tolerated than phentolamine for the treatment of erectile dysfunction.

  4. Grey-Theory-Based Optimization Model of Emergency Logistics Considering Time Uncertainty

    PubMed Central

    Qiu, Bao-Jian; Zhang, Jiang-Hua; Qi, Yuan-Tao; Liu, Yang

    2015-01-01

    Natural disasters occur frequently in recent years, causing huge casualties and property losses. Nowadays, people pay more and more attention to the emergency logistics problems. This paper studies the emergency logistics problem with multi-center, multi-commodity, and single-affected-point. Considering that the path near the disaster point may be damaged, the information of the state of the paths is not complete, and the travel time is uncertainty, we establish the nonlinear programming model that objective function is the maximization of time-satisfaction degree. To overcome these drawbacks: the incomplete information and uncertain time, this paper firstly evaluates the multiple roads of transportation network based on grey theory and selects the reliable and optimal path. Then simplify the original model under the scenario that the vehicle only follows the optimal path from the emergency logistics center to the affected point, and use Lingo software to solve it. The numerical experiments are presented to show the feasibility and effectiveness of the proposed method. PMID:26417946

  5. Investigation of decision-making under uncertainty in healthy subjects: a multi-centric fMRI study.

    PubMed

    Krug, A; Cabanis, M; Pyka, M; Pauly, K; Walter, H; Landsberg, M; Shah, N Jon; Winterer, G; Wölwer, W; Musso, F; Müller, B W; Wiedemann, G; Herrlich, J; Schnell, K; Vogeley, K; Schilbach, L; Langohr, K; Rapp, A; Klingberg, S; Kircher, T

    2014-03-15

    Decision-making is an everyday routine that entails several subprocesses. Decisions under uncertainty occur when either prior information is incomplete or the outcomes of the decision are unclear. The aim of the present study was to disentangle the neural correlates of information gathering as well as reaching a decision and to explore effects of uncertainty acceptance or avoidance in a large sample of healthy subjects. Sixty-four healthy volunteers performed a decision-making under uncertainty task in a multi-center approach while BOLD signal was measured with fMRI. Subjects either had to indicate via button press from which of two bottles red or blue balls were drawn (decision-making under uncertainty condition), or they had to indicate whether 8 red balls had been presented (baseline condition). During the information gathering phase (contrasted against the counting phase) a widespread network was found encompassing (pre-)frontal, inferior temporal and inferior parietal cortices. Reaching a decision was correlated with activations in the medial frontal cortex as well as the posterior cingulate and the precuneus. Effects of uncertainty acceptance were found within a network comprising of the superior frontal cortex as well as the insula and precuneus while uncertainty avoidance was correlated with activations in the right middle frontal cortex. The results depict two distinct networks for information gathering and the indication of having made a decision. While information-gathering networks are modulated by uncertainty avoidance and - acceptance, underlying networks of the decision itself are independent of these factors.

  6. Sirolimus-eluting coronary stents: a review

    PubMed Central

    Abizaid, Alexandre

    2007-01-01

    The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and “high-risk” patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efficacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention. PMID:17580729

  7. [Estimation of the arterial blood radioactivity concentration using the whole body-to-arterial blood partition coefficients and the cross-calibration factor in 123I-iodoamphetamine SPECT--towards a noninvasive clinical protocol with the QSPECT-DTARG method].

    PubMed

    Iida, Hidehiro; Nakagawara, Jyoji; Hatazawa, Jun; Suzuki, Michiyasu; Takahashi, Masaaki; Shimosegawa, Eku; Shirao, Toshiyuki; Murakami, Shouta; Fukuda, Kenji

    2012-03-01

    The aim of this study is to develop a non-invasive procedure for quantitative assessment of regional cerebral blood flow using IMP and SPECT. A technique to utilize a population-based standardized arterial input function has been evaluated for the normal data base obtained from 3 institutions, which employed different SPECT device configurations. In total, data from 39 subjects were analyzed. Due to the unique feature of the QSPECT reconstruction software program, images are quantitative providing units of Bq/ml. Thus, the well counter values can be converted to absolute radioactivity concentration. The blood-to-whole-body average partition coefficient was 343.8 +/- 65.0 and did not show significant difference among the three institutions. The estimated blood counts agreed with those assessed by the well counter in all institutions, thus the arterial input function can be estimated with the unique conversion factor for all institutions. This feature may allow a large scale multi-center investigation, which may contribute to improve the non-invasive protocol.

  8. Future space transportation system architecture avionics requirements

    NASA Technical Reports Server (NTRS)

    Stone, Howard; Engelund, Walt

    1993-01-01

    NASA began a multi-center study in January 1993 to examine options for providing the most cost effective space transportation system in the future. The key advanced avionics requirements for these vehicle concepts are envisioned to provide significantly improved operational efficiency and effectiveness. It is very desirable to have adaptive guidance, navigation, and control approaches that will allow launch and return in almost any weather condition. The vehicles must be able to accommodate atmospheric density variations and winds without software changes. The flight operations must become much more autonomous in all flight regimes like an aircraft, and preflight checkout should make use of the onboard systems. When the vehicle returns to the launch site, subsystem health must be known and maintenance tasks scheduled accordingly. Ground testing of most subsystems must be eliminated. Also, the health monitoring system must be designed to enhance the ability to abort the mission significantly and save the crew and the vehicle. The displays and controls must be much less complex than current systems and must significantly reduce pilot work load. It is important to have low power, light weight displays and controls. Rendezvous and docking and all flight phases must have autopilot capability to reduce pilot work load for routine operations and in abort situations. The vehicles must have the demonstrated ability to return to the launch site. Abort from all mission phases can put additional demands on the communications system.

  9. Early prediction of major depression in chronic hepatitis C patients during peg-interferon α-2b treatment by assessment of vegetative-depressive symptoms after four weeks

    PubMed Central

    Robaeys, Geert; De Bie, Jozef; Wichers, Marieke C; Bruckers, Liesbeth; Nevens, Frederik; Michielsen, Peter; Van Ranst, Marc; Buntinx, Frank

    2007-01-01

    AIM: To study the predictive value of the vegetative-depressive symptoms of the Zung Depression Rating Scale for the occurrence of depression during treatment with peg-interferon α-2b of chronic hepatitis C (CHC) patients. METHODS: The predictive value of vegetative-depressive symptoms at 4 wk of treatment for the occurrence of a subsequent diagnosis of major depressive disorder (MDD) was studied in CHC patients infected after substance use in a prospective, multi-center treatment trial in Belgium. The presence of vegetative-depressive symptoms was assessed using the Zung Scale before and 4 wk after the start of antiviral treatment. RESULTS: Out of 49 eligible patients, 19 (39%) developed MDD. The area under the ROC curve of the vegetative Zung subscale was 0.73, P = 0.004. The sensitivity at a cut-point of > 15/35 was 95% (95% CI: 74-100). The positive predictive value equalled 44% (95% CI: 29-60). CONCLUSION: In this group of Belgian CHC patients infected after substance use, antiviral treatment caused a considerable risk of depression. Seven vegetative-depressive symptoms of the Zung scale at wk 4 of treatment predicted 95% of all emerging depressions, at a price of 56% false positive test results. PMID:17963300

  10. Proposal for a Prospective Registry for Moyamoya Disease in Japan

    PubMed Central

    KAZUMATA, Ken; ITO, Masaki; UCHINO, Haruto; NISHIHARA, Hiroshi; HOUKIN, Kiyohiro

    2017-01-01

    The number of clinical research papers published worldwide on moyamoya disease (MMD) has increased recently. However, the majority of the literature comprises retrospective single-center studies collecting data on small numbers of patients. Several multi-center studies are ongoing in Japan; however, the current data are insufficient for comprehensively outlining the various characteristics of MMD. To enhance our knowledge on epidemiologic, vascular, and genetic aspects of MMD, a prospective multicenter registry will be established in Japan that will help to streamline clinical research as well as improve clinical treatments and long-term outcomes. Patients with MMD or secondary moyamoya syndrome referred to the participating centers will be invited to the registry. Demographic and physiological parameters, along with neuroimaging data will be collected chronologically. Clinical events, including neurological, medical, and surgical interventions will be recorded. Whole blood samples will be collected. Extra- and intracranial vascular tissue, and/or cerebrospinal fluid will also be collected from patients who undergo surgical revascularization. These biospecimens will be stored at the repositories and utilized for genome-wide association studies for identifying genetic variants, as well as tissue-specific proteomic, and/or molecular analyses. Ethics approval will be obtained at all facilities collecting biospecimens. The registry will provide descriptive statistics on functional outcomes, surgical techniques used, medications, and neurological events stratified according to patients’ clinical characteristics. We expect this study to provide novel insights in the management of MMD patients and design better therapies. PMID:28070115

  11. Prevalence of chronic wounds and structural quality indicators of chronic wound care in Dutch nursing homes.

    PubMed

    Rondas, Armand A L M; Schols, Jos M G A; Stobberingh, Ellen E; Halfens, Ruud J G

    2015-12-01

    The aim of this study was to measure the prevalence of (infected) chronic wounds in Dutch nursing homes and to explore which signs and symptoms are used to diagnose infected chronic wounds. Moreover, it was to determine which structural quality indicators related to chronic wound care at ward and institutional levels were fulfilled. In April 2012, as part of the annual National Prevalence Measurement of Care Problems of Maastricht University [Landelijke Prevalentiemeting Zorgproblemen (LPZ)], a multi-center cross-sectional point-prevalence measurement was carried out together with an assessment of relevant care quality indicators. The prevalence was 4·2%; 16 of 72 (22%) chronic wounds were considered to be infected. Increase of exudate (81·3%; n = 13), erythema (68·8%; n = 11), pain (56·3%; n = 9) and wound recalcitrance (56·3%; n = 9) were considered to be diagnostic signs and symptoms of a chronic wound infection. Although at institutional level most quality indicators were fulfilled, at ward level this was not the case. Despite the relatively low number of residents, we consider our population as representative for the nursing home population. It may be an advantage to appoint specific ward nurses and to provide them specifically with knowledge and skills concerning chronic wounds.

  12. A Coarse-Grained Model for Thermoresponsive Poly(N-isopropylacrylamide)

    NASA Astrophysics Data System (ADS)

    Abbott, Lauren J.; Stevens, Mark J.

    Poly(N-isopropylacrylamide) (PNIPAM) is a thermoresponsive polymer that undergoes a phase transition at its lower critical solution temperature (LCST). Although atomistic simulations have been effective to study PNIPAM single chains in solution, they are limited in reaching longer length- and time-scales. In this work, a coarse-grained (CG) model is developed for PNIPAM that captures its thermoresponsive behavior. Nonbonded parameters are fit to experimental thermodynamic data, 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 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 and experiment. The self-assembly of PNIPAM surfactants is also explored. Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy's National Nuclear Security Administration under contract DE-AC04-94AL85000.

  13. Development of quantitative neuropsychological tests for diagnosis of subclinical hepatic encephalopathy in liver cirrhosis patients and establishment of diagnostic criteria-multicenter collaborative study in Japanese.

    PubMed

    Kato, Akinobu; Kato, Motoichiro; Ishii, Hiromasa; Ichimiya, Yosuke; Suzuki, Kazuyuki; Kawasaki, Hironaka; Yamamoto, Shin-Ichiro; Kumashiro, Ryukichi; Yamamoto, Kyosuke; Kawamura, Naohiro; Hayashi, Naoaki; Matsuzaki, Shohei; Terano, Akira; Okita, Kiwamu; Watanabe, Akiharu

    2004-10-01

    At present, there are no generally accepted diagnostic criteria or methods for subclinical hepatic encephalopathy (SHE) associated with liver cirrhosis. We therefore developed an easily conducted computer-aided quantitative neuropsychiatric function test system for use in routine medical practice. We established normal values in healthy Japanese subjects and determined differences between healthy persons and liver cirrhosis patients without clinical encephalopathy in a multi-center clinical trial. The test system consists of eight tests: number connection tests A and B, a figure position test, a digit symbol test, a block design test, and reaction time tests A, B and C. The test results were affected by age, but not by gender or facility. No learning effect was noted. The results were therefore reported by 5-year quartile ranges and differences were evaluated between 542 healthy subjects and 292 cirrhotic patients. When the cut-off value was set at the 10th/90th percentile of the results in healthy subjects, the results of each of the 8 tests were abnormal in about 25% of cirrhotic patients, and at least 1 of the 8 tests gave values greater than the 10th/90th percentile cut-off value in 58.2% of the 292 liver cirrhosis patients. SHE patients were thought to be included in these 58.2% of patients. The developed test makes it possible to quantitatively assess neuropsychiatric function, and the results obtained can be used as a basis for the diagnosis of SHE.

  14. Deeply learnt hashing forests for content based image retrieval in prostate MR images

    NASA Astrophysics Data System (ADS)

    Shah, Amit; Conjeti, Sailesh; Navab, Nassir; Katouzian, Amin

    2016-03-01

    Deluge in the size and heterogeneity of medical image databases necessitates the need for content based retrieval systems for their efficient organization. In this paper, we propose such a system to retrieve prostate MR images which share similarities in appearance and content with a query image. We introduce deeply learnt hashing forests (DL-HF) for this image retrieval task. DL-HF effectively leverages the semantic descriptiveness of deep learnt Convolutional Neural Networks. This is used in conjunction with hashing forests which are unsupervised random forests. DL-HF hierarchically parses the deep-learnt feature space to encode subspaces with compact binary code words. We propose a similarity preserving feature descriptor called Parts Histogram which is derived from DL-HF. Correlation defined on this descriptor is used as a similarity metric for retrieval from the database. Validations on publicly available multi-center prostate MR image database established the validity of the proposed approach. The proposed method is fully-automated without any user-interaction and is not dependent on any external image standardization like image normalization and registration. This image retrieval method is generalizable and is well-suited for retrieval in heterogeneous databases other imaging modalities and anatomies.

  15. Effects of intravenous ibandronate injection on renal function in women with postmenopausal osteoporosis at high risk for renal disease--the DIVINE study.

    PubMed

    Miller, Paul D; Ragi-Eis, Sergio; Mautalen, Carlos; Ramirez, Francisco; Jonkanski, Iris

    2011-12-01

    The Designed for intravenous (IV) Ibandronate reNal safety Evaluation (DIVINE) study was a 1-year prospective, randomized, open label, multi-center study that evaluated the renal safety of quarterly (every 3 months) ibandronate IV injection given over 15-30s compared with infusion given over 15 min, and weekly oral alendronate, in women with postmenopausal osteoporosis (PMO) at increased risk for renal disease. Both injection and infusion of IV ibandronate showed comparable safety to alendronate, with only small changes in serum creatinine (sCr) for each treatment group, and AEs were generally comparable between groups. All three treatments had similar effects on renal function, measured by change in baseline of the glomerular filtration rate; the ibandronate IV injection group was noninferior to the ibandronate IV infusion and weekly oral alendronate groups at 9 months, with similar results at 1 year. The results of this study demonstrate the profile of IV ibandronate, which allows it to be dosed as an IV injection in the primary care setting without the need for an infusion, even in patients with pre-existing hypertension or diabetes mellitus.

  16. Referral strategy for early recognition of axial spondyloarthritis: consensus recommendations from the Hong Kong Society of Rheumatology.

    PubMed

    Mok, C C; Tam, L S; Leung, M H; Ying, K Y; To, C H; Lee, K L; Ho, L Y; Yip, M L; Tsui, H S; Chan, T H; Lee, K W; Li, E K M

    2013-10-01

    Low back pain is one of commonest problems prompting a visit to the family physician. Up to 5% of patients with chronic low back pain in the primary care setting are diagnosed as having spondyloarthritis, which includes the prototype disease ankylosing spondylitis. Making a diagnosis of ankylosing spondylitis is often delayed for years, leading to significant pain, impairment of quality of life, disability and productivity loss. A recent breakthrough in the treatment of spondyloarthritis is the anti-tumor necrosis factor-alpha biologics, which lead to rapid relief of pain and inflammation, and improvement in all clinical parameters of the disease. Patients with early spondyloarthritis often respond better than those with late established disease. With proper recognition of inflammatory back pain, and the use of magnetic resonance imaging, spondyloarthritis can now be diagnosed much earlier before features are evident on plain radiographs. Referral to the rheumatologist based on onset of back pain (> 3 months) before the age of 45 years, and an inflammatory nature of the pain, or the presence of human leukocyte antigen-B27, or sacroiliitis by imaging, have been confirmed in multi-center international studies to be a pragmatic approach to enable early diagnosis of spondyloarthritis. This referral strategy has recently been adopted by the Hong Kong Society of Rheumatology for primary care physicians and non-rheumatology specialists.

  17. Traumeel S in preventing and treating mucositis in young patients undergoing SCT: a report of the Children’s Oncology Group

    PubMed Central

    Sencer, SF; Zhou, T; Freedman, LS; Ives, JA; Chen, Z; Wall, D; Nieder, ML; Grupp, SA; Yu, LC; Sahdev, I; Jonas, WB; Wallace, JD; Oberbaum, M

    2012-01-01

    Mucositis can be a serious complication of hematopoietic SCT (HSCT). A previous phase II trial in 32 children undergoing HSCT reported a beneficial effect of the homeopathic remedy Traumeel S. The Children’s Oncology Group sought to replicate the results in a multi-institutional trial. The study was an international multi-center, double-blind, randomized trial comparing Traumeel with placebo in patients aged 3–25 years undergoing myeloablative HSCT. Traumeel/placebo was started on Day −1 as a five-time daily mouth rinse. Efficacy of the treatment was assessed using the modified Walsh scale for mucositis, scored daily from Day −1 to 20 days after HCST. The main outcome was the sum of Walsh scale scores (area-under-the-curve (AUC)) over this period. Other outcomes included narcotic use, days of total parenteral feeding, days of nasogastric feeding and adverse events. In 181 evaluable patients, there was no statistical difference in mucositis (AUC) in the Traumeel group (76.7) compared with placebo (67.3) (P = 0.13). There was a trend towards less narcotic usage in the Traumeel patients. No statistically beneficial effect from Traumeel was demonstrated for mucositis. We could not confirm that Traumeel is an effective treatment for mucositis in children undergoing HSCT. PMID:22504933

  18. Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

    PubMed

    Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

    2016-03-01

    Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes.

  19. OC ToGo: bed site image integration into OpenClinica with mobile devices

    NASA Astrophysics Data System (ADS)

    Haak, Daniel; Gehlen, Johan; Jonas, Stephan; Deserno, Thomas M.

    2014-03-01

    Imaging and image-based measurements nowadays play an essential role in controlled clinical trials, but electronic data capture (EDC) systems insufficiently support integration of captured images by mobile devices (e.g. smartphones and tablets). The web application OpenClinica has established as one of the world's leading EDC systems and is used to collect, manage and store data of clinical trials in electronic case report forms (eCRFs). In this paper, we present a mobile application for instantaneous integration of images into OpenClinica directly during examination on patient's bed site. The communication between the Android application and OpenClinica is based on the simple object access protocol (SOAP) and representational state transfer (REST) web services for metadata, and secure file transfer protocol (SFTP) for image transfer, respectively. OpenClinica's web services are used to query context information (e.g. existing studies, events and subjects) and to import data into the eCRF, as well as export of eCRF metadata and structural information. A stable image transfer is ensured and progress information (e.g. remaining time) visualized to the user. The workflow is demonstrated for a European multi-center registry, where patients with calciphylaxis disease are included. Our approach improves the EDC workflow, saves time, and reduces costs. Furthermore, data privacy is enhanced, since storage of private health data on the imaging devices becomes obsolete.

  20. Radiation-Sensitive Severe Combined Immunodeficiency: The arguments for and against conditioning prior to hematopoietic cell transplantation – What to do?

    PubMed Central

    Cowan, MJ; Gennery, AR

    2015-01-01

    Defects in DCLRE1C, PRKDC, LIG4, NHEJ1, and NBS1, involving the non-homologous end joining (NHEJ) DNA repair pathway, result in radiation-sensitive severe combined immunodeficiency (RS-SCID). Results of hematopoietic cell transplantation for RS-SCID suggest that minimizing exposure to alkylating agents and ionizing radiation is important for optimizing survival and minimizing late effects. However, use of pre-conditioning with alkylating agents is associated with a greater likelihood of full T and B cell reconstitution compared to no conditioning or immunosuppression alone. A reduced intensity regimen using fludarabine and low dose cyclophosphamide may be effective for patients with LIG4, NHEJ1 and NBS1 defects although more data are needed to confirm these findings and characterize late effects. For patients with mutations in DCLRE1C (Artemis-deficient SCID), there is no optimal approach that uses standard dose alkylating agents without significant late effects. Until non-chemotherapy agents, e.g., anti-CD45 or anti-CD117 become available, options include minimizing exposure to alkylators, e.g., single agent low dose targeted Busulfan or achieving T cell reconstitution followed several years later with a conditioning regimen to restore B cell immunity. Gene therapy for these disorders will eventually remove the issues of rejection and GvHD. Prospective multi- center studies are needed to evaluate these approaches in this rare but highly vulnerable patient population. PMID:26055221

  1. Serum Levels of Substance P and Mortality in Patients with a Severe Acute Ischemic Stroke

    PubMed Central

    Lorente, Leonardo; Martín, María M.; Almeida, Teresa; Pérez-Cejas, Antonia; Ramos, Luis; Argueso, Mónica; Riaño-Ruiz, Marta; Solé-Violán, Jordi; Hernández, Mariano

    2016-01-01

    Substance P (SP), a member of tachykinin family, is involved in the inflammation of the central nervous system and in the appearance of cerebral edema. Higher serum levels of SP have been found in 18 patients with cerebral ischemia compared with healthy controls. The aim of our multi-center study was to analyze the possible association between serum levels of SP and mortality in ischemic stroke patients. We included patients with malignant middle cerebral artery infarction (MMCAI) and a Glasgow Coma Scale (GCS) lower than 9. Non-surviving patients at 30 days (n = 31) had higher serum concentrations of SP levels at diagnosis of severe MMCAI than survivors (n = 30) (p < 0.001). We found in multiple regression an association between serum concentrations of SP higher than 362 pg/mL and mortality at 30 days (Odds Ratio = 5.33; 95% confidence interval = 1.541–18.470; p = 0.008) after controlling for age and GCS. Thus, the major novel finding of our study was the association between serum levels of SP and mortality in patients suffering from severe acute ischemic stroke. PMID:27338372

  2. Premalignant SOX2 overexpression in the fallopian tubes of ovarian cancer patients: Discovery and validation studies.

    PubMed

    Hellner, Karin; Miranda, Fabrizio; Fotso Chedom, Donatien; Herrero-Gonzalez, Sandra; Hayden, Daniel M; Tearle, Rick; Artibani, Mara; KaramiNejadRanjbar, Mohammad; Williams, Ruth; Gaitskell, Kezia; Elorbany, Samar; Xu, Ruoyan; Laios, Alex; Buiga, Petronela; Ahmed, Karim; Dhar, Sunanda; Zhang, Rebecca Yu; Campo, Leticia; Myers, Kevin A; Lozano, María; Ruiz-Miró, María; Gatius, Sónia; Mota, Alba; Moreno-Bueno, Gema; Matias-Guiu, Xavier; Benítez, Javier; Witty, Lorna; McVean, Gil; Leedham, Simon; Tomlinson, Ian; Drmanac, Radoje; Cazier, Jean-Baptiste; Klein, Robert; Dunne, Kevin; Bast, Robert C; Kennedy, Stephen H; Hassan, Bassim; Lise, Stefano; Garcia, María José; Peters, Brock A; Yau, Christopher; Sauka-Spengler, Tatjana; Ahmed, Ahmed Ashour

    2016-08-01

    Current screening methods for ovarian cancer can only detect advanced disease. Earlier detection has proved difficult because the molecular precursors involved in the natural history of the disease are unknown. To identify early driver mutations in ovarian cancer cells, we used dense whole genome sequencing of micrometastases and microscopic residual disease collected at three time points over three years from a single patient during treatment for high-grade serous ovarian cancer (HGSOC). The functional and clinical significance of the identified mutations was examined using a combination of population-based whole genome sequencing, targeted deep sequencing, multi-center analysis of protein expression, loss of function experiments in an in-vivo reporter assay and mammalian models, and gain of function experiments in primary cultured fallopian tube epithelial (FTE) cells. We identified frequent mutations involving a 40kb distal repressor region for the key stem cell differentiation gene SOX2. In the apparently normal FTE, the region was also mutated. This was associated with a profound increase in SOX2 expression (p<2(-16)), which was not found in patients without cancer (n=108). Importantly, we show that SOX2 overexpression in FTE is nearly ubiquitous in patients with HGSOCs (n=100), and common in BRCA1-BRCA2 mutation carriers (n=71) who underwent prophylactic salpingo-oophorectomy. We propose that the finding of SOX2 overexpression in FTE could be exploited to develop biomarkers for detecting disease at a premalignant stage, which would reduce mortality from this devastating disease.

  3. Ethical Conduct in Research Involving Human Beings In Brazil

    PubMed Central

    Novaes, Maria Rita Garbi; Guilhem, Dirce; Lolas, Fernando

    2010-01-01

    Objective Diagnose ethical conduct in research involving human beings in Brazil and the last 10 years of activity by the Human Research Ethics Committee of the Health Department - Federal District - CEP/SES/DF. Methods This work was based on a documentary research, descriptive and retrospective. It examined the database containing records of cases brought before the CEP/SES/DF, corresponding the period of June 1997 to December 2007. Results were generated in Excel program, version 2007. Results CEP/SES/DF has presented increasing number of research projects submitted to appreciation (n = 1129), composing: 90.4% approved 1.7% disapproved, 7.4% removed/filed and 0.5% excluded. Of these projects, 83% belonged to Group III, 18% multi-centered projects and 10% protocols with foreign participation. Time for approval has decreased over the years (30 to 60 days). Frequent pendencies: End of Free and Informed Consent (30%), Cover Sheet (25%), Methodology (20%), Curriculum vitae (12%), Budget (9%), and Others (4%). Conclusion The assessment of the CEP/SES/DF activities, during a ten-year period has shown its commitment to the legitimacy of research ethics review and scientific production SES/DF. There were some weaknesses such as difficulty in monitoring the accompaniment of the research; interruption of works due to adverse drug reaction; gaps or errors in the protocol submitted by the researcher. These situations are the achieving targets for the elaboration of specific criteria. PMID:20981277

  4. Protective associations of HDL with blood-brain barrier injury in multiple sclerosis patients[S

    PubMed Central

    Fellows, Kelly; Uher, Tomas; Browne, Richard W.; Weinstock-Guttman, Bianca; Horakova, Dana; Posova, Helena; Vaneckova, Manuela; Seidl, Zdenek; Krasensky, Jan; Tyblova, Michaela; Havrdova, Eva; Zivadinov, Robert; Ramanathan, Murali

    2015-01-01

    The purpose of this work was to investigate the associations of serum cholesterol and apolipoproteins with measures of blood-brain barrier (BBB) permeability and CNS inflammation following the first clinical demyelinating event. This study included 154 patients [67% female; age, 29.5 ± 8.2 years (mean ± SD)] enrolled in a multi-center study of interferon β1-a treatment following the first demyelinating event. Blood and cerebrospinal fluid (CSF) were obtained at screening prior to treatment. A comprehensive serum lipid profile and multiple surrogate markers of BBB breakdown and CNS immune activity were obtained. Higher levels of serum HDL cholesterol (HDL-C) and ApoA-I were associated with lower CSF total protein level, CSF albumin level, albumin quotient, and CSF IgG level (all P ≤ 0.001 for HDL-C and all P < 0.01 for ApoA-I). HDL-C was also associated with CSF CD80+ (P < 0.001) and with CSF CD80+CD19+ (P = 0.007) cell frequencies. Higher serum HDL is associated with lower levels of BBB injury and decreased CD80+ and CD80+CD19+ cell extravasation into the CSF. HDL may potentially inhibit the initiation and/or maintenance of pathogenic BBB injury following the first demyelinating event. PMID:26243484

  5. Computer-Aided Diagnosis of Parkinson's Disease Using Enhanced Probabilistic Neural Network.

    PubMed

    Hirschauer, Thomas J; Adeli, Hojjat; Buford, John A

    2015-11-01

    Early and accurate diagnosis of Parkinson's disease (PD) remains challenging. Neuropathological studies using brain bank specimens have estimated that a large percentages of clinical diagnoses of PD may be incorrect especially in the early stages. In this paper, a comprehensive computer model is presented for the diagnosis of PD based on motor, non-motor, and neuroimaging features using the recently-developed enhanced probabilistic neural network (EPNN). The model is tested for differentiating PD patients from those with scans without evidence of dopaminergic deficit (SWEDDs) using the Parkinson's Progression Markers Initiative (PPMI) database, an observational, multi-center study designed to identify PD biomarkers for diagnosis and disease progression. The results are compared to four other commonly-used machine learning algorithms: the probabilistic neural network (PNN), support vector machine (SVM), k-nearest neighbors (k-NN) algorithm, and classification tree (CT). The EPNN had the highest classification accuracy at 92.5% followed by the PNN (91.6%), k-NN (90.8%) and CT (90.2%). The EPNN exhibited an accuracy of 98.6% when classifying healthy control (HC) versus PD, higher than any previous studies.

  6. The Efficacy of Triamcinolone Acetonide in Keloid Treatment: A Systematic Review and Meta-analysis

    PubMed Central

    Wong, Thian-Sze; Li, John Zeng-Hong; Chen, Siqi; Chan, Jimmy Yu-Wai; Gao, Wei

    2016-01-01

    Keloid is a cutaneous dermal outgrowth resulting from uncontrolled deposition of collagen and glycosaminoglycan around the wound. The uncontrolled and persistent growth of keloids scar will result in cosmetic disfigurement, functional impairment, and affect the quality of life. Triamcinolone acetonide (TAC) is traditionally employed in treating keloid scars. In this study, we aim to evaluate the effectiveness of TAC and compare it with other common therapy employed in keloid treatment. Only randomized controlled trial (RCT) and controlled trial were included. Inverse variance risk ratio, weighted mean difference, and corresponding 95% confidence intervals were calculated to evaluate the effect of intervention. Meta-analysis indicated that TAC treatment significantly reduced the size of keloid compared to untreated control. Reduction in size was statistically different in favor of TAC compared to silicone gel sheet. Significant difference in favor of TAC was observed compared with verapamil in term of vascularity and scar pliability. TAC treatment was more effective in reducing scar thickness in comparison with cryotherapy. However, the current meta-analysis has several limitations. Only a limited number of trials with the same comparison are available. Most trials recruited a small number of patients and used inconsistent outcome assessment. Most trials did not provide detail information on allocation concealment and blinding. Therefore, further evaluation in multi-center RCTs with consistent comparisons and outcome measurements are warrant to reach a consensus on the selection between TAC and different treatment modalities. PMID:28083534

  7. Standardization of Data for Clinical Use and Research in Spinal Cord Injury.

    PubMed

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-08-12

    Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities.

  8. Education attenuates the effect of medial temporal lobe atrophy on cognitive function in Alzheimer's disease: the MIRAGE study.

    PubMed

    Perneczky, Robert; Wagenpfeil, Stefan; Lunetta, Kathryn L; Cupples, L Adrienne; Green, Robert C; DeCarli, Charles; Farrer, Lindsay A; Kurz, Alexander

    2009-01-01

    Functional imaging and neuropathological studies suggest that individuals with higher education have better cognitive performance at the same level of brain pathology than less educated subjects. No in vivo studies are available that directly test how education modifies the effect of structural pathology on cognition in Alzheimer's disease (AD). The present study therefore aimed to measure this effect using data from a large multi-center study. 270 patients with AD underwent cognitive testing using the Mini Mental State Examination (MMSE), apolipoprotein E (APOE) genotyping, and cerebral magnetic resonance imaging. A linear regression analysis was used to examine the relation of medial temporal lobe atrophy (MTA), as a proxy of AD pathology, to MMSE score, adjusting for age, gender, APOE, cerebrovascular disease, ethnicity, education, and disease duration. An interaction term for MTA and education was introduced to test the hypothesis that education modifies the effect of MTA on cognition. There was a significant inverse association between MTA and cognition. Most interestingly, the interaction term between education and MTA was significant suggesting that education modifies the relation of MTA to cognition. At any level of pathology, cognition remained higher for better educated individuals.

  9. High-throughput morphometric analysis of pulmonary airways in MSCT via a mixed 3D/2D approach

    NASA Astrophysics Data System (ADS)

    Ortner, Margarete; Fetita, Catalin; Brillet, Pierre-Yves; Pr"teux, Françoise; Grenier, Philippe

    2011-03-01

    Asthma and COPD are complex airway diseases with an increased incidence estimated for the next decade. Today, the mechanisms and relationships between airway structure/physiology and the clinical phenotype and genotype are not completely understood. We thus lack the tools to predict disease progression or therapeutic responses. One of the main causes is our limited ability to assess the complexity of airway diseases in large populations of patients with appropriate controls. Multi-slice computed tomography (MSCT) imaging opened the way to the non-invasive assessment of airway physiology and structure, but the use of such technology in large cohorts requires a high degree of automation of the measurements. This paper develops an investigation framework and the associated image quantification tools for high-throughput analysis of airways in MSCT. A mixed approach is proposed, combining 3D and cross-section measurements of the airway tree where the user-interaction is limited to the choice of the desired analysis patterns. Such approach relies on the fully-automated segmentation of the 3D airway tree, caliber estimation and visualization based on morphologic granulometry, central axis computation and tree segment selection, cross-section morphometry of airway lumen and wall, and bronchus longitudinal shape analysis for stenosis/bronciectasis detection and measure validation. The developed methodology has been successfully applied to a cohort of 96 patients from a multi-center clinical study of asthma control in moderate and persistent asthma.

  10. Proposal for a Prospective Registry for Moyamoya Disease in Japan.

    PubMed

    Kazumata, Ken; Ito, Masaki; Uchino, Haruto; Nishihara, Hiroshi; Houkin, Kiyohiro

    2017-02-15

    The number of clinical research papers published worldwide on moyamoya disease (MMD) has increased recently. However, the majority of the literature comprises retrospective single-center studies collecting data on small numbers of patients. Several multi-center studies are ongoing in Japan; however, the current data are insufficient for comprehensively outlining the various characteristics of MMD. To enhance our knowledge on epidemiologic, vascular, and genetic aspects of MMD, a prospective multicenter registry will be established in Japan that will help to streamline clinical research as well as improve clinical treatments and long-term outcomes. Patients with MMD or secondary moyamoya syndrome referred to the participating centers will be invited to the registry. Demographic and physiological parameters, along with neuroimaging data will be collected chronologically. Clinical events, including neurological, medical, and surgical interventions will be recorded. Whole blood samples will be collected. Extra- and intra-cranial vascular tissue, and/or cerebrospinal fluid will also be collected from patients who undergo surgical revascularization. These biospecimens will be stored at the repositories and utilized for genome-wide association studies for identifying genetic variants, as well as tissue-specific proteomic, and/or molecular analyses. Ethics approval will be obtained at all facilities collecting biospecimens. The registry will provide descriptive statistics on functional outcomes, surgical techniques used, medications, and neurological events stratified according to patients' clinical characteristics. We expect this study to provide novel insights in the management of MMD patients and design better therapies.

  11. Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data

    PubMed Central

    Matheny, Michael E.; Morrow, David A.; Ohno-Machado, Lucila; Cannon, Christopher P.; Sabatine, Marc S.; Resnic, Frederic S.

    2009-01-01

    Objective We sought to validate three methods for automated safety monitoring by evaluating clinical trials with elevated adverse events. Methods An automated outcomes surveillance system was used to retrospectively analyze data from two randomized, TIMI multi-center trials. Trial A was stopped early due to elevated 30 day mortality rates in the intervention arm. Trial B was not stopped early, but there was transient concern regarding 30 day intracranial hemorrhage rates. We compared Statistical Process Control (SPC), Logistic Regression Risk Adjusted SPC (LR-SPC), and Bayesian Updating Statistic (BUS) methods with a standard prospective two-arm event rate analysis. Each method compares observed event rates to alerting boundaries established with previously collected data. In this evaluation, the control arms approximated prior data, and the intervention arms approximated the observed data. Results Trial A experienced elevated 30 day mortality rates beginning 7 months after the start of the trial and continuing until termination at month 14. Trial B did not experience elevated major bleeding rates. Combining the alerting performance of each method across both trials resulted in sensitivities and specificities of 100% and 85% for SPC, 0% and 100% for BUS, 100% and 93% for both LR-SPC models, respectively. Conclusion Both SPC and LR-SPC methods correctly identified the majority of months during which the cumulative event rates were elevated in Trial A, but were susceptible to false positive alerts in Trial B. The BUS method did not result in any alerts in either Trial and requires revision. PMID:19015285

  12. Anger Self-Management in Chronic Traumatic Brain Injury: Protocol for a Psycho-educational Treatment With a Structurally Equivalent Control and an Evaluation of Treatment Enactment

    PubMed Central

    Hart, Tessa; Brockway, Jo Ann; Fann, Jesse R.; Maiuro, Roland D.; Vaccaro, Monica J.

    2014-01-01

    Anger and irritability are important and persistent clinical problems following traumatic brain injury (TBI). Treatment options include medications, behavioral modification, and psychotherapies, but some are impractical and none have proven efficacy with this population. We describe a randomized multi-center clinical trial testing a novel, one-on-one, 8-session psychoeducational treatment program, Anger Self-Management Training (ASMT), designed specifically for people with TBI who have significant cognitive impairment. The trial is notable for its use of a structurally equivalent comparison treatment, called Personal Readjustment and Education (PRE), which was created for the study and is intended to maximize equipoise for both participants and treaters. Fidelity assessment is conducted in real time and used in therapist supervision sessions. The primary outcome is change in self-reported anger on validated measures from pre-treatment to 1 week after the final session. Secondary outcomes include participant anger as reported by a significant other; emotional distress in domains other than anger/ irritability; behavioral functioning; and quality of life. An interim assessment after the 4th session will allow examination of the trajectory of any observed treatment effects, and a follow-up assessment 2 months after the end of intervention will allow examination of persistence of effects. A treatment enactment phase, in which participants are interviewed several months after the last therapy session, is designed to provide qualitative data on whether and to what extent the principles and techniques learned in treatment are still carried out in daily life. PMID:25530306

  13. Application of lidar to current atmospheric topics

    SciTech Connect

    Sedlacek, A.J. III

    1996-12-31

    The goal of the conference was to address the various applications of lidar to topics of interest in the atmospheric community. Specifically, with the development of frequency-agile, all solid state laser systems, high-quantum-efficiency detectors, increased computational power along with new and more powerful algorithms, and novel detection schemes, the application of lidar to both old and new problems has expanded. This expansion is evidenced by the contributions to the proceedings, which demonstrate the progress made on a variety of atmospheric remote sensing problems, both theoretically and experimentally. The first session focused on aerosol, ozone, and temperature profile measurements from ground-based units. The second session, Chemical Detection, provided applications of lidar to the detection of atmospheric pollutants. Papers in the third session, Wind and Turbulence Measurements, described the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) experiments, Doppler techniques for ground-based wind profiling and mesopause radial wind and temperature measurements utilizing a frequency-agile lidar system. The papers in the last two sessions, Recent Advanced in Lidar Technology and Techniques and Advanced Operational Lidars, provided insights into novel approaches, materials, and techniques that would be of value to the lidar community. Papers have been processed separately for inclusion on the data base.

  14. Modification of primordial ices by cosmic rays as simulated by cyclotron irradiation

    NASA Technical Reports Server (NTRS)

    Kaiser, R. I.; Roessler, K.

    1992-01-01

    Frozen CH4 and CH4/Ar mixtures closed into metal cuvettes and open to the vacuum were irradiated at 15 and 77 K with 10 - 20 MeV p and He-3(2+) ions in order to simulate the effect of cosmic rays on solid organic matter in space. Ices exposed to vacuum represent surfaces of icy systems whereas closed systems stand for bulk ices. The products were analyzed by MS, SEM, RBS, ERDA, H-1-NMR, HPLC, GC-MS, NEXAFS, and FT-IR. Volatile products consisted of a mixture of low molecular species, e.g., C2H2, C2H4, C2H6, and long linear aliphatic and olefinic compounds. The formation of polycyclic aromatic hydrocarbons (PAH's) and related species in solid CH4 is due to a multi-center reaction within one collision cascade and is governed by energy density effects with critical linear energy transfer values L(sub T) between 2 and 10 keV/micron. Open ices exhibit preferential hydrogen release resulting in an increased carbonization as compared to more hydrogen rich molecules protected inside large icy bodies.

  15. Comparative Effectiveness of Less Commonly Used Systemic Monotherapies and Common Combination Therapies for Moderate-to-Severe Psoriasis in the Clinical Setting

    PubMed Central

    Takeshita, Junko; Wang, Shuwei; Shin, Daniel B.; Duffin, Kristina Callis; Krueger, Gerald G.; Kalb, Robert E.; Weisman, Jamie D.; Sperber, Brian R.; Stierstorfer, Michael B.; Brod, Bruce A.; Schleicher, Stephen M.; Robertson, Andrew D.; Linn, Kristin A.; Shinohara, Russell T.; Troxel, Andrea B.; Van Voorhees, Abby S.; Gelfand, Joel M.

    2014-01-01

    Background The effectiveness of psoriasis therapies in real-world settings remains relatively unknown. Objective To compare the effectiveness of less commonly used systemic monotherapies and commonly used combination therapies for psoriasis. Methods Multi-center cross-sectional study of 203 patients with plaque psoriasis receiving less common systemic monotherapy (acitretin, cyclosporine, or infliximab) or common combination therapies (adalimumab, etanercept, or infliximab and methotrexate) compared to 168 patients receiving methotrexate evaluated at one of ten US outpatient dermatology sites participating in the Dermatology Clinical Effectiveness Research Network. Results In adjusted analyses, patients on acitretin (relative response rate 2.01; 95% confidence interval, 1.18–3.41), infliximab (1.93; 1.26–2.98), adalimumab and methotrexate (3.04; 2.12–4.36), etanercept and methotrexate (2.22; 1.25–3.94), and infliximab and methotrexate (1.72; 1.10–2.70) were more likely to have clear or almost clear skin compared to patients on methotrexate. There were no differences among treatments when response rate was defined by health-related quality of life. Limitations Single time point assessment may result in overestimation of effectiveness. Conclusions The efficacy of therapies in clinical trials may overestimate their effectiveness as utilized in clinical practice. While physician-reported relative response rates were different among therapies, absolute differences were small and did not correspond to differences in patient-reported outcomes. PMID:25260564

  16. Can heartworm prevalence in dogs be used as provisional data for assessing the prevalence of the infection in cats?

    PubMed

    Venco, L; Genchi, M; Genchi, C; Gatti, D; Kramer, L

    2011-03-22

    Cats are considered a susceptible host for Dirofilaria immitis; however, increased host resistance is reflected by relatively low adult worm burdens in natural and experimental infections; the prolonged prepatent period (8 months); the low level and short duration of microfilaremia; and the short life span of adult worms (2-3 years). From April to September 2006, 212 cats and 608 dogs, all exposed for at least one transmission season, were screened for D. immitis infection in a multi-center study in the Po River Valley in northern Italy. Cats were initially evaluated by antibody testing; positive subjects were followed up by antigen testing and echocardiography (and necropsy if death occurred). The prevalence in dogs was 29% by a modified Knott test and antigen testing compared with a prevalence of 4.7% in cats by an antibody test; six of these infections (2.8%) were confirmed by the follow-up evaluations. This field study demonstrated that the prevalence of heartworm infection in cats in this area is within the expected limits of 9-18% of the prevalence in dogs. Antibody testing likely underestimates the real prevalence of D. immitis infection in cats. These results also emphasize the importance of preventive treatment in cats.

  17. Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

    PubMed Central

    2011-01-01

    Background Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. Methods/Design The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. Discussion This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. Trial registration Dutch Trial Register NTR2878 PMID:22185091

  18. Bacterial etiology and serotypes of acute otitis media in Mexican children.

    PubMed

    Parra, Mercedes Macias; Aguilar, Gerardo Martinez; Echaniz-Aviles, Gabriela; Rionda, Romulo Galo; Estrada, Maria de Los Angeles Meza; Cervantes, Yolanda; Pirçon, Jean-Yves; Van Dyke, Melissa K; Colindres, Romulo E; Hausdorff, William P

    2011-07-26

    Streptococcus pneumoniae and Haemophilus influenzae have been consistently reported to be the two major bacterial pathogens responsible for acute otitis media (AOM), mainly from studies in the US and Europe. However, data on bacterial pathogens causing AOM in Latin America are limited. Understanding the relative importance of these pathogens in a specific setting, the serotype distribution, and their antibiotic susceptibility levels is important to provide local vaccine and treatment recommendations. We therefore conducted a prospective, multi-center, tympanocentesis-based epidemiological study of Mexican children three months to less than five years of age. Fifty percent of episodes were in children who had received at least one dose of PCV7. Overall, 64% of samples were culture positive for bacterial pathogens. H. influenzae and S. pneumoniae were the leading causes of bacterial AOM, detected in 34% and 29% of AOM episodes, respectively. The most commonly isolated S. pneumoniae serotypes were 19A, 19F and 23F. All H. influenzae isolates were identified as non-typeable. Seventy-four percent of S. pneumoniae were susceptible to penicillin, while 97% were susceptible to amoxicillin/clavulanate. All H. influenzae samples were susceptible to amoxicillin/clavulanate and cefotaxime, 95% to cefuroxime and 75% to ampicillin. Both S. pneumoniae and non-typable H. influenzae represent important targets for vaccination strategies to reduce AOM in Mexican children.

  19. Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial.

    PubMed

    Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathi; Gorelick, David A; Wu, Li-Tzy; Gottheil, Edward

    2009-04-01

    Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and long-term treatment of opioid dependence.

  20. Origin of Transitions between Metallic and Insulating States in Simple Metals

    DOE PAGES

    Naumov, Ivan I.; Hemley, Russell J.

    2015-04-17

    Unifying principles that underlie recently discovered transitions between metallic and insulating states in elemental solids under pressure are developed. Using group theory arguments and first principles calculations, we show that the electronic properties of the phases involved in these transitions are controlled by symmetry principles not previously recognized. The valence bands in these systems are described by simple and composite band representations constructed from localized Wannier functions centered on points unoccupied by atoms, and which are not necessarily all symmetrical. The character of the Wannier functions is closely related to the degree of s-p(-d) hybridization and reflects multi-center chemical bondingmore » in these insulating states. The conditions under which an insulating state is allowed for structures having an integer number of atoms per primitive unit cell as well as re-entrant (i.e., metal-insulator-metal) transition sequences are detailed, resulting in predictions of novel behavior such as phases having three-dimensional Dirac-like points. The general principles developed are tested and applied to the alkali and alkaline earth metals, including elements where high-pressure insulating phases have been identified or reported (e.g., Li, Na, and Ca).« less