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. 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.

  6. 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.

  7. Chronic gastritis in China: a national multi-center survey.

    PubMed

    Du, Yiqi; Bai, Yu; Xie, Pei; Fang, Jingyuan; Wang, Xiaozhong; Hou, Xiaohua; Tian, Dean; Wang, Chengdang; Liu, Yandi; Sha, Weihong; Wang, Bangmao; Li, Yanqing; Zhang, Guoliang; Li, Yan; Shi, Ruihua; Xu, Jianming; Li, Youming; Huang, Minghe; Han, Shengxi; Liu, Jie; Ren, Xu; Xie, Pengyan; Wang, Zhangliu; Cui, Lihong; Sheng, Jianqiu; Luo, Hesheng; Wang, Zhaohui; Zhao, Xiaoyan; Dai, Ning; Nie, Yuqiang; Zou, Yiyou; Xia, Bing; Fan, Zhining; Chen, Zhitan; Lin, Sanren; Li, Zhao-Shen

    2014-02-07

    Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy.

  8. Chronic gastritis in China: a national multi-center survey

    PubMed Central

    2014-01-01

    Background Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. Methods A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data including sex, age, symptoms and endoscopic findings were prospectively recorded. Results Totally 8892 patients were included. At endoscopy, 4389, 3760 and 1573 patients were diagnosed to have superficial gastritis, erosive gastritis, and atrophic gastritis, respectively. After pathologic examination, it is found that atrophic gastritis, intestinal metaplasia and dysplasia were prevalent, which accounted for 25.8%, 23.6% and 7.3% of this patient population. Endoscopic features were useful for predicting pathologic atrophy (PLR = 4.78), but it was not useful for predicting erosive gastritis. Mucosal-protective agents and PPI were most commonly used medications for chronic gastritis. Conclusions The present study suggests non-atrophic gastritis is the most common endoscopic finding in Chinese patients with upper GI symptoms. Precancerous lesions, including atrophy, intestinal metaplasia and dysplasia are prevalent in Chinese patients with chronic gastritis, and endoscopic features are useful for predicting pathologic atrophy. PMID:24502423

  9. 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.

  10. 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...

  11. 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...

  12. 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,...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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

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

    NASA Technical Reports Server (NTRS)

    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

  3. Multi-center analytical evaluation of a novel automated tacrolimus immunoassay.

    PubMed

    Shipkova, Maria; Vogeser, Michael; Ramos, Pedro Alía; Verstraete, Alain G; Orth, Matthias; Schneider, Christian; Wallemacq, Pierre

    2014-08-01

    Tacrolimus (TAC) is a post-transplantation immunosuppressant drug used in patients for whom careful monitoring of TAC concentration is essential. A new semi-automated immunoassay for TAC measurement, the Elecsys Tacrolimus assay, is available and has been assessed in a multi-center evaluation. Residual whole blood samples from patients undergoing TAC therapy after organ transplant were used in assay evaluation at five clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), functional sensitivity, linearity according to CLSI EP6-A, and recovery from external quality assessment scheme (EQAS) samples. The assay was compared to LC-MS/MS used routinely at each investigational site, and to the Abbott Architect immunoassay. Linearity from 0.5 to 40 μg/L was observed and functional sensitivity of 0.3 μg/L (CV ≤ 20%) was determined. Within-run imprecision was ≤ 5.1% on cobas e 602 (5.1% at 1.5 μg/L) and ≤ 8.9% (8.9% at 0.8μg/L) on cobas e 411. The intermediate imprecision for TAC concentrations ≥ 6.8 μg/L was ≤ 6.5%. At lower therapeutic concentrations (to 1.5 μg/L) it was consistently ≤ 10%. Deming regression analysis of method comparison to LC-MS/MS yielded slopes of 1.07 (95%CI: 1.05/1.10) for heart transplant samples, 1.13 (95%CI: 1.09/1.16) for kidney, and 1.05 (95%CI: 1.02/1.08) for lung transplant samples. The Elecsys Tacrolimus assay has good linearity, functional sensitivity and intermediate imprecision and is comparable to LC-MS/MS methods. The over-all performance of ECLIA demonstrates a modern generation TAC assay that meets the demands of monitoring drug concentrations in current immunosuppressive regimens. Copyright © 2014. Published by Elsevier Inc.

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

    SciTech Connect

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

    2010-12-14

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

  5. 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...

  6. Multi-centered AdS3 solutions from Virasoro conformal blocks

    NASA Astrophysics Data System (ADS)

    Hulík, Ondřej; Procházka, Tomáš; Raeymaekers, Joris

    2017-03-01

    We revisit the construction of multi-centered solutions in three-dimensional anti-de Sitter gravity in the light of the recently discovered connection between particle worldlines and classical Virasoro conformal blocks. We focus on multi-centered solutions which represent the backreaction of point masses moving on helical geodesics in global AdS3, and argue that their construction reduces to a problem in Liouville theory on the disk with Zamolodchikov-Zamolodchikov boundary condition. In order to construct the solution one needs to solve a certain monodromy problem which we argue is solved by a vacuum classical conformal block on the sphere in a particular channel. In this way we construct multi-centered gravity solutions by using conformal blocks special functions. We show that our solutions represent left-right asymmetric configurations of operator insertions in the dual CFT. We also provide a check of our arguments in an example and comment on other types of solutions.

  7. 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.

  8. 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

  9. Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

    PubMed

    Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

    2011-01-01

    New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

  10. 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.

  11. 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.

  12. 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

  13. 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.

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

    PubMed

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

    2011-01-01

    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 project and is now supporting numerous international neurodevelopment and neurodegeneration research projects.

  15. 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.

  16. OnWARD: Ontology-driven Web-based Framework for Multi-center Clinical Studies

    PubMed Central

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

    2011-01-01

    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. PMID:21924379

  17. 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.

  18. Multi-center MRI prediction models: Predicting sex and illness course in first episode psychosis patients.

    PubMed

    Nieuwenhuis, Mireille; Schnack, Hugo G; van Haren, Neeltje E; Lappin, Julia; Morgan, Craig; Reinders, Antje A; Gutierrez-Tordesillas, Diana; Roiz-Santiañez, Roberto; Schaufelberger, Maristela S; Rosa, Pedro G; Zanetti, Marcus V; Busatto, Geraldo F; Crespo-Facorro, Benedicto; McGorry, Patrick D; Velakoulis, Dennis; Pantelis, Christos; Wood, Stephen J; Kahn, René S; Mourao-Miranda, Janaina; Dazzan, Paola

    2017-01-15

    Structural Magnetic Resonance Imaging (MRI) studies have attempted to use brain measures obtained at the first-episode of psychosis to predict subsequent outcome, with inconsistent results. Thus, there is a real need to validate the utility of brain measures in the prediction of outcome using large datasets, from independent samples, obtained with different protocols and from different MRI scanners. This study had three main aims: 1) to investigate whether structural MRI data from multiple centers can be combined to create a machine-learning model able to predict a strong biological variable like sex; 2) to replicate our previous finding that an MRI scan obtained at first episode significantly predicts subsequent illness course in other independent datasets; and finally, 3) to test whether these datasets can be combined to generate multicenter models with better accuracy in the prediction of illness course. The multi-center sample included brain structural MRI scans from 256 males and 133 females patients with first episode psychosis, acquired in five centers: University Medical Center Utrecht (The Netherlands) (n=67); Institute of Psychiatry, Psychology and Neuroscience, London (United Kingdom) (n=97); University of São Paulo (Brazil) (n=64); University of Cantabria, Santander (Spain) (n=107); and University of Melbourne (Australia) (n=54). All images were acquired on 1.5-Tesla scanners and all centers provided information on illness course during a follow-up period ranging 3 to 7years. We only included in the analyses of outcome prediction patients for whom illness course was categorized as either "continuous" (n=94) or "remitting" (n=118). Using structural brain scans from all centers, sex was predicted with significant accuracy (89%; p<0.001). In the single- or multi-center models, illness course could not be predicted with significant accuracy. However, when reducing heterogeneity by restricting the analyses to male patients only, classification accuracy

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. Identifying the impact of inflammatory breast cancer on survival: a retrospective multi-center cohort study.

    PubMed

    Diessner, J; Van Ewijk, R; Weiss, C R; Janni, W; Wischnewsky, M B; Kreienberg, R; Hancke, K; Blettner, M; Wöckel, A; Schwentner, L

    2015-09-01

    Inflammatory breast cancer (IBC) represents a rare and aggressive form of cancer with negative prognosis and high rate of recurrence. The purpose of this retrospective multi-center study was to evaluate the effect of IBC on overall and disease-free survival. Furthermore we analyzed the influence of hormone and Her2 receptor expression on inflammatory breast cancer cells on the clinical outcome of patients. This retrospective German multi-center study included 11,780 patients with primary breast cancer recruited from 1992 to 2008. In this sub-group analysis we focused on 70 patients with IBC. Despite the relatively small sample size, we could confirm the aggressiveness of inflammatory breast cancer and the different clinical behavior of IBC subtypes. It could be demonstrated that the lack of expression of hormone receptors on tumor cells is associated with a more aggressive clinical course and decreased overall and disease-free survival. Higher incidence of Her2 overexpression, that is typically associated with poor prognostic outcome among women with non-IBC tumors, seems however to have no prognostic significance. This BRENDA sub-group analysis, on a German cohort of breast cancer patients confirmed the negative outcome of IBC and the different clinical behavior of IBC subtypes. The best management of IBC requires intensive coordination and cooperation between various clinical disciplines involved in the treatment of IBC patients. Moreover there is a need to identify IBC-specific targeted therapies to improve the curing prospects of this subtype of cancer.

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

    PubMed Central

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

    2015-01-01

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

  5. [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.

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

    PubMed

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

    2010-02-01

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

  7. Predicting behavioral variant frontotemporal dementia with pattern classification in multi-center structural MRI data.

    PubMed

    Meyer, Sebastian; Mueller, Karsten; Stuke, Katharina; Bisenius, Sandrine; Diehl-Schmid, Janine; Jessen, Frank; Kassubek, Jan; Kornhuber, Johannes; Ludolph, Albert C; Prudlo, Johannes; Schneider, Anja; Schuemberg, Katharina; Yakushev, Igor; Otto, Markus; Schroeter, Matthias L

    2017-01-01

    Frontotemporal lobar degeneration (FTLD) is a common cause of early onset dementia. Behavioral variant frontotemporal dementia (bvFTD), its most common subtype, is characterized by deep alterations in behavior and personality. In 2011, new diagnostic criteria were suggested that incorporate imaging criteria into diagnostic algorithms. The study aimed at validating the potential of imaging criteria to individually predict diagnosis with machine learning algorithms. Brain atrophy was measured with structural magnetic resonance imaging (MRI) at 3 Tesla in a multi-centric cohort of 52 bvFTD patients and 52 healthy control subjects from the German FTLD Consortium's Study. Beside group comparisons, diagnosis bvFTD vs. controls was individually predicted in each subject with support vector machine classification in MRI data across the whole brain or in frontotemporal, insular regions, and basal ganglia known to be mainly affected based on recent meta-analyses. Multi-center effects were controlled for with a new method, "leave one center out" conjunction analyses, i.e. repeatedly excluding subjects from each center from the analysis. Group comparisons revealed atrophy in, most consistently, the frontal lobe in bvFTD beside alterations in the insula, basal ganglia and temporal lobe. Most remarkably, support vector machine classification enabled predicting diagnosis in single patients with a high accuracy of up to 84.6%, where accuracy was highest in a region-of-interest approach focusing on frontotemporal, insular regions, and basal ganglia in comparison with the whole brain approach. Our study demonstrates that MRI, a widespread imaging technology, can individually identify bvFTD with high accuracy in multi-center imaging data, paving the road to personalized diagnostic approaches in the future.

  8. 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…

  9. A Multi-Center, Cross-Sectional Study on the Burden of Infectious Keratitis in China

    PubMed Central

    Song, Xiusheng; Xie, Lixin; Tan, Xiaodong; Wang, Zhichong; Yang, Yanning; Yuan, Yuansheng; Deng, Yingping; Fu, Shaoying; Xu, Jianjiang; Sun, Xuguang; Sheng, Xunlun; Wang, Qing

    2014-01-01

    Objective To understand the prevalence and demographic characteristics of infectious keratitis and infectious corneal blindness. Methods A multi-center, population-based cross-sectional study was conducted from January 1 to August 31, 2010. A total of 191,242 individuals of all age groups from 10 geographically representative provinces were sampled using stratified, multi-stage, random and systematic sampling procedures. A majority, 168,673 (88.2%), of those sampled participated in the study. The examination protocol included a structured interview, visual acuity testing, an external eye examination, and an anterior segment examination using a slit lamp. The causes and sequelae of corneal disease were identified using uniform customized protocols. Blindness in one eye caused by infectious keratitis was defined as infectious corneal blindness. Results The prevalence of past and active infectious keratitis was 0.192% (95% confidence interval [CI], 0.171–0.213%), and the prevalence of viral, bacterial, and fungal keratitis was 0.11%, 0.075%, and 0.007%, respectively. There were 138 cases of infectious corneal blindness in at least one eye in the study population (prevalence of 0.082% [95%CI, 0.068%–0.095%]). Statistical analysis suggested that ocular trauma, alcoholic consumption, low socioeconomic levels, advanced age, and poor education were risk factors for infectious corneal blindness. Conclusions Infectious keratitis is the leading cause of corneal blindness in China. Eye care strategies should focus on the prevention and rehabilitation of infectious corneal blindness. PMID:25438169

  10. 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

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

    NASA Astrophysics Data System (ADS)

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

    2008-03-01

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

  12. 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.

  13. 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

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

    PubMed

    Dapuzzo-Argiriou, Lisa M; Smulian, John C; Rochon, Meredith L; Galdi, Luisa; Kissling, Jessika M; Schnatz, Peter F; Gonzalez Rios, Angel; Airoldi, James; Carrillo, Mary Anne; Maines, Jaimie; Kunselman, Allen R; Repke, John; Legro, Richard S

    2016-01-01

    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. This was a multi-center, prospective, single (patient) blind, randomized study design implemented at four obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6 cm 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. 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. The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor.

  15. 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.

  16. Multi-center prediction of hemorrhagic transformation in acute ischemic stroke using permeability imaging features.

    PubMed

    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

    2013-07-01

    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 cross-validation 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. Copyright © 2013 Elsevier Inc. All rights reserved.

  17. Function Biomedical Informatics Research Network Recommendations for Prospective Multi-Center Functional Magnetic Resonance Imaging Studies

    PubMed Central

    Glover, Gary H.; Mueller, Bryon A.; Turner, Jessica A.; van Erp, Theo G.M.; Liu, Thomas T.; Greve, Douglas N.; Voyvodic, James T.; Rasmussen, Jerod; Brown, Gregory G.; Keator, David B.; Calhoun, Vince D.; Lee, Hyo Jong; Ford, Judith M.; Mathalon, Daniel H.; Diaz, Michele; O’Leary, Daniel S.; Gadde, Syam; Preda, Adrian; Lim, Kelvin O.; Wible, Cynthia G.; Stern, Hal S.; Belger, Aysenil; McCarthy, Gregory; Ozyurt, Burak; Potkin, Steven G.

    2011-01-01

    This report provides practical recommendations for the design and execution of Multi-Center functional Magnetic Resonance Imaging (MC-fMRI) studies based on the collective experience of the Function Biomedical Informatics Research Network (FBIRN). The paper was inspired by many requests from the fMRI community to FBIRN group members for advice on how to conduct MC-fMRI studies. The introduction briefly discusses the advantages and complexities of MC-fMRI studies. Prerequisites for MC-fMRI studies are addressed before delving into the practical aspects of carefully and efficiently setting up a MC-fMRI study. Practical multi-site aspects include: (1) establishing and verifying scan parameters including scanner types and magnetic fields, (2) establishing and monitoring of a scanner quality program, (3) developing task paradigms and scan session documentation, (4) establishing clinical and scanner training to ensure consistency over time, (5) developing means for uploading, storing, and monitoring of imaging and other data, (6) the use of a traveling fMRI expert and (7) collectively analyzing imaging data and disseminating results. We conclude that when MC-fMRI studies are organized well with careful attention to unification of hardware, software and procedural aspects, the process can be a highly effective means for accessing a desired participant demographics while accelerating scientific discovery. PMID:22314879

  18. 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.

  19. Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study.

    PubMed

    Spiliopoulos, Stavros; Karnabatidis, Dimitrios; Katsanos, Konstantinos; Diamantopoulos, Athanasios; Ali, Tariq; Kitrou, Panagiotis; Cannavale, Alessandro; Krokidis, Miltiadis

    2016-12-01

    The purpose of the study was to investigate safety and feasibility of day-case endovascular procedures for the management of peripheral arterial disease. This was a multi-center, retrospective study including all patients treated over a 30-month period with endovascular angioplasty or stenting for intermittent claudication (IC) or critical limb ischemia (CLI) on a day-case basis, in Interventional Radiology (IR) departments of three European tertiary hospitals. Exclusion criteria were not related to the type of lesion and included unavailability of an adult able to take care of patient overnight; high bleeding risk and ASA score ≥4. Primary efficacy outcome was the rate of procedures performed on an outpatient basis requiring no further hospitalization and primary safety outcome was freedom from 30-day major complications' rate. The study included 652 patients (male 75 %; mean age 68 ± 10 years; range: 27-93), 24.6 % treated for CLI. In 53.3 % of the cases a 6Fr sheath was used. Technical success was 97.1 %. Haemostasis was obtained by manual compression in 52.4 % of the accesses. The primary efficacy outcome occurred in 95.4 % (622/652 patients) and primary safety outcome in 98.6 % (643/652 patients). Major complications included five (0.7 %) retroperitoneal hematomas requiring transfusion; one (0.1 %) common femoral artery pseudoaneurysm successfully treated with US-guided thrombin injection, two cases of intra-procedural distal embolization treated with catheter-directed local thrombolysis and one on-table cardiac arrest necessitating >24 h recovery. No major complication was noted after same-day discharge. Day-case endovascular procedures for the treatment of IC or CLI can be safely and efficiently performed in experienced IR departments of large tertiary hospitals.

  20. 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

  1. Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial.

    PubMed

    Guntinas-Lichius, Orlando; Volk, Gerd Fabian; Geissler, Katharina; Komann, Marcus; Meissner, Winfried

    2014-07-01

    The purpose of this study was to describe postoperative pain within the first day after pediatric otorhinolaryngologic surgery and to identify factors influencing postoperative pain. Using a prospective evaluation and a Web-based multi-center registry, children ≥4 years of age (n = 365) rated their pain using questionnaires of the project Quality Improvement in Postoperative Pain Treatment for Children including faces numeric rating scales (FNRS, 0-10) for the determination of patient's pain on ambulation and his/her maximal and minimal pain within 8 h after day case surgery or at the first postoperative day for inpatient cases. Additionally, functional interference and therapy-related side effects were assessed. Half of the children were 4 or 5 years of age. The predominant types of surgery were adenoidectomy and tonsillectomy ± ear ventilation tubes. Although analgesics were applied preoperatively, intraoperatively, in the recovery room and on ward, maximal pain within the first day after surgery reached 4.4 ± 3.3 (FNRS). Pain was highest after oral surgery, especially after tonsillectomy and nose surgery. 39% of the children reported pain interference with breathing (39%). The most frequent side effect was drowsiness (55%). Multivariate analysis revealed that maximal pain was independently associated with the non-standardized use of opioids in the recovery room, or use of non-opioid or opioids on ward. Analgesia and perioperative pain management in pediatric otorhinolaryngologic surgery seems to be highly variable. Tonsillectomy and nose surgery are very painful. After otorhinolaryngologic surgery many children seem to receive less analgesia than needed or ineffective analgesic drug regimes.

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

    PubMed

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

    2015-03-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson׳s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r=-0.133; p<0.001) and DD (r=-0.098; p=0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r=-0.492; P-value<0.001), T1 LL (r=-0.473; P-value<0.001) and nCSF (r=-0.367; P-value<0.001). Copyright © 2015 Elsevier B.V. All rights reserved.

  3. 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.

  4. Music therapy in Huntington's disease: a protocol for a multi-center randomized controlled trial.

    PubMed

    van Bruggen-Rufi, Monique; Vink, Annemieke; Achterberg, Wilco; Roos, Raymund

    2016-07-26

    Huntington's disease is a progressive, neurodegenerative disease with autosomal dominant inheritance, characterized by motor disturbances, cognitive decline and behavioral and psychological symptoms. Since there is no cure, all treatment is aimed at improving quality of life. Music therapy is a non-pharmacological intervention, aiming to improve the quality of life, but its use and efficacy in patients with Huntington's disease has hardly been studied. In this article, a protocol is described to study the effects of music therapy in comparison with a control intervention to improve quality of life through stimulating expressive and communicative skills. By targeting these skills we assume that the social-cognitive functioning will improve, leading to a reduction in behavioral problems, resulting in an overall improvement of the quality of life in patients with Huntington's disease. The study is designed as a multi-center single-blind randomised controlled intervention trial. Sixty patients will be randomised using centre-stratified block-permuted randomisation. Patients will be recruited from four long-term care facilities specialized in Huntington's disease-care in The Netherlands. The outcome measure to assess changes in expressive and communication skills is the Behaviour Observation Scale Huntington and changes in behavior will be assessed by the Problem Behaviour Assesment-short version and by the BOSH. Measurements take place at baseline, then 8, 16 (end of intervention) and 12 weeks after the last intervention (follow-up). This randomized controlled study will provide greater insight into the effectiveness of music therapy on activities of daily living, social-cognitive functioning and behavior problems by improving expressive and communication skills, thus leading to a better quality of life for patients with Huntington's disease. Netherlands Trial Register: NTR4904 , registration date Nov. 15, 2014.

  5. 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.

  6. Multi-Center Retrospective Evaluation of Screw and Polymethylmethacrylate Constructs for Atlantoaxial Fixation in Dogs.

    PubMed

    Stout Steele, Megan W; Hodshon, Amy W; Hopkins, Andrew L; Tracy, Gaemia M; Cohen, Noah D; Kerwin, Sharon C; Boudreau, C Elizabeth; Thomas, William B; Mankin, Joseph M; Levine, Jonathan M

    2016-10-01

    To evaluate outcome and adverse events following ventral stabilization of the atlantoaxial (AA) joint in dogs with clinical AA subluxation using screw/polymethymethacrylate (PMMA) constructs in a retrospective, multi-center cohort study. Historical cohort study. 35 client-owned dogs. Medical records from 3 institutions were reviewed to identify dogs with AA subluxation treated with ventral screw and PMMA constructs. Data on signalment, pre- and postoperative neurologic status, imaging performed, and adverse events were retrieved. Neurologic examination data were abstracted to generate a modified Frankel score at admission, discharge, and re-examination. Telephone interview of owners >180 days postoperative was conducted. Thirty-five dogs with AA subluxation treated with ventral screw/PMMA constructs were included. Most dogs were young (median age 1 year), small breed dogs with acute onset of neurologic signs (median duration 22.5 hours). Most dogs were non-ambulatory at the time of admission (median modified Frankel score 3). Adverse events were identified in 15/35 dogs including 9 dogs with major adverse events. Four dogs required a second surgery due to vertebral canal violation (n = 2) or implant failure (n = 2). Re-examination at 4-6 weeks postoperative reported 15/28 dogs with improved neurologic status and 19/28 dogs were ambulatory. Telephone follow-up was available for 23/35 dogs with 23/23 reported as ambulatory (median follow-up 390 days). Ventral application of screw and PMMA constructs for AA subluxation, as described here, is associated with clinical improvement in the majority of dog. Major adverse events are infrequent and the technique is considered relatively safe. © Copyright 2016 by The American College of Veterinary Surgeons.

  7. 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.

  8. Clinical manifestations of pediatric psoriasis: Results of a multi-center study in the United States

    PubMed Central

    Mercy, Katherine; Kwasny, Mary; Cordoro, Kelly M.; Menter, Alan; Tom, Wynnis L.; Korman, Neil; Belazarian, Leah; Armstrong, April W.; Levy, Moise L.; Paller, Amy S.

    2012-01-01

    Background/Objectives The clinical features of pediatric psoriasis warrant further attention. A national study was completed to determine the prevalence of scalp and nail involvement, and history of guttate psoriasis at onset, according to age, sex, and disease severity. Materials and Methods 181 children, ages 5 to 17 years, with plaque psoriasis were enrolled in a multi-center, cross-sectional study. Subjects/guardians were asked about a history of scalp and nail involvement and whether the initial presentation was guttate. Peak psoriasis severity was assessed and defined historically as mild psoriasis (MP) or severe psoriasis (SP) according to Physician Global Assessment and Body Surface Area measures. Results 79.0% (n=143) of subjects reported a history of scalp involvement and 39.2% (n=71) described a history of nail involvement. Boys were less likely than girls to report a history of scalp involvement (OR= 0.40 (0.19-0.84)), but were more likely to have had nail involvement (OR=3.01 (1.62-5.60)). Scalp and nail involvement was not related to psoriasis severity. In contrast, SP subjects (35.9%) more often reported a history of guttate lesions than did MP subjects (21.8%) (p=0.017). Antecedent streptococcal infection was more common in children with guttate vs. plaque psoriasis at onset (p=0.02), but did not correlate with severity. Conclusions Gender-related differences in scalp and nail involvement suggest koebnerization. Preceding streptococcal infection predicts guttate morphology but not severity, and initial guttate morphology is associated with eventual greater severity of disease More aggressive monitoring and management should be considered for guttate psoriasis, given its later association with more severe disease. PMID:23360462

  9. Impact of age on laryngopharyngeal reflux disease presentation: a multi-center prospective study.

    PubMed

    Lechien, Jérôme R; Finck, Camille; Huet, Kathy; Khalife, Mohamad; Fourneau, Anne-Françoise; Delvaux, Véronique; Piccaluga, Myriam; Harmegnies, Bernard; Saussez, Sven

    2017-07-17

    The objective is to assess the differences in the severity of symptoms, signs, voice quality, and quality of life before and after treatment according to age in suspected laryngopharyngeal reflux (LPR) patients. The design used in this paper is prospective multi-center study. Eighty clinically diagnosed LPR patients with a reflux finding score (RFS) >7 and a reflux symptom index (RSI) >13 were treated with pantoprazole and diet recommendations for 3 months. Patients were subdivided into three groups according their age: group 1 (18-39 years, N = 21), group 2 (40-59 years, N = 31), and group 3 (≥60 years, N = 28). RSI, RFS, Voice Handicap Index (VHI), Short Form 36 questionnaire (SF36), aerodynamic, and acoustic measurements were evaluated at baseline and after treatment. The response to the empiric treatment was also assessed. Significant improvements in RSI, RFS, and VHI were found in all patient groups. The elderly patients showed a significantly lower RSI score than younger subjects (p = 0.035) without RFS difference among groups. At baseline, the SF36 score was better in group 3 with respect to social functioning (p = 0.049). At the 3-month follow-up, we found significant improvement of acoustic parameters only in the younger age groups (group 1 and group 2). The rate of resistant patients to the empiric treatment was higher in the younger group than in the elderly patient group (42.9 versus 28.6%). Age appears to reduce the subjective LPR symptom perception, leading to a lower rate of uncured patients. The utilization of acoustic parameters as an indicator of treatment effectiveness seems less useful for elderly subjects, probably due to an overlap between an aging voice and LPR.

  10. Toward quality assurance for metaphase FISH: A multi-center experience

    SciTech Connect

    Dewald, G.; Higgins, R.; Hirsch, B.

    1996-09-06

    Although fluorescent in situ hybridization (FISH) is rapidly becoming a part of clinical cytogenetics, no organization sponsors multi-center determinations of the efficacy of probes. We report on 23 laboratories that volunteered to provide slides and to use a probe for SNRPN and a control locus. Experiences with FISH for these laboratories during 1994 ranged from 0 to 645 utilizations (median = 84) involving blood, amniotic fluid and bone marrow. In an initial study of hybridization efficiency, the median percentage of metaphases from normal individuals showing two SNRPN and 2 control signals for slides prepared at each site was 97.0 (range = 74-100); for slides prepared by a central laboratory, it was 97.8 (range = 81.6-100). In a subsequent blind study, each laboratory attempted to score 5 metaphases from each of 23 specimens [8 with del(15)(q11.2{r_arrow}q12) and 15 with normal 15 chromosomes]. Of 529 challenges, the correct SNRPN pattern was found in 5 of 5 metaphases in 457 (86%) and in 4 of 5 in 33 (6%). Ambiguous, incomplete or no results were reported for 32 (6%) challenges. Seven (1%) diagnostic errors were made including 6 false positives and 1 false negative: 1 laboratory made 3 errors, 1 made 2, and 2 made 1 each. Most errors and inconsistencies seemed due to inexperience with FISH. The working time to process and analyze slides singly averaged 49.5 minutes; slides processed in batches of 4 and analyzed singly required 36.9 minutes. We conclude that proficiency testing for FISH using an extensive array of challenges is possible and that multiple centers can collaborate to test probes and to evaluate costs. 10 refs., 1 fig., 4 tabs.

  11. [Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial].

    PubMed

    Yan, Xiao-ming; Sun, Xu-guang; Xie, Han-ping; Hong, Jing; Wang, Zhi-cong

    2013-01-01

    To realize the effectiveness and security of Tobramycin and Dexamethasone Eye Ointment for blepharitis treatment. Design Case control studies. Participants 148 patients be diagnosed as blepharitis including 81 cases as research group and 67 cases as control group. Multi-center randomized controlled clinical trial. The patients met the inclusion criteria from First Hospital Peking University, Beijing Tongren Hospital, Southwest Hospital, Ophthalmology Center Zhongshan University and Third Hospital Peking University were divided into two groups in Aug. to Dec. 2011. Tobramycin dexamethasone eye ointment was applied to eye lid in research group while patients in control group used tobramycin eye ointment. All patients were informed to apply warm compress to the lids, mechanically washing to the eyelids and artificial tears. At the beginning, the 7(th) day, the 14(th) day and the 28(th) day of treatment, observation of symptom, sign and side effect were recorded. Before treatment the difference of the symptom scores of burning sensation, tears, photophobia and itch of two groups has no statistically significant (t = 1.87, 0.43, -0.64, 0.93, P > 0.05), but the symptom scores have a statistically significant decrease (t = 1.99 - 6.90, P < 0.05) at the 7(th) day, 14(th) day, 28(th) day. Before treatment the difference of signs scores have no statistically significant except the term of new blood vessels (t = 2.32, P = 0.02) while all the signs scores have a statistically significant decrease at the 7(th) day, 14(th) day, 28(th) day. Side effect: the number of patients with elevated intraocular pressure of research and control group is 3 and 1 respectively and the ratio is 3.7% and 1.5%. The tobramycin dexamethasone eye ointment can improve signs and symptoms of blepharitis patients. Some patients have to face with the risk of elevated intraocular pressure and it's necessary to monitor the intraocular pressure.

  12. 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

  13. 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

  14. A Multi-center Comparison of the Safety of Oral versus Intravenous Acetylcysteine for Treatment of Acetaminophen Overdose

    PubMed Central

    2010-01-01

    Oral and intravenous (IV) acetylcysteine are used for treatment of acetaminophen poisoning. The objective of this multi-center study was to compare the safety of these two routes of administration. METHODS We conducted a multi-center chart review of all patients treated with acetylcysteine for acetaminophen poisoning. The primary safety outcome was the percentage of patients with of acetylcysteine-related adverse events. RESULTS A total of 503 subjects were included in the safety analysis (306 IV only, 145 oral only and 52 both routes).There were no serious adverse events related to acetylcysteine for either route. Nausea and vomiting were the most common related adverse events and were more common with oral treatment (23% vs 9%). Anaphylactoid reactions were more common with IV administration (6% vs 2%). Conclusions Intravenous and oral acetylcysteine are both associated with minimal side effects and are safe for treatment of acetaminophen toxicity. PMID:20524832

  15. 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.

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

    PubMed

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

    2011-01-01

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

  17. 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.

  18. Prediction of ineffective elective cardioversion of atrial fibrillation: a retrospective multi-center patient cohort study.

    PubMed

    Hellman, Tapio; Kiviniemi, Tuomas; Vasankari, Tuija; Nuotio, Ilpo; Biancari, Fausto; Bah, Aissa; Hartikainen, Juha; Mäkäräinen, Marianne; Airaksinen, K E Juhani

    2017-01-18

    Elective cardioversion (ECV) of atrial fibrillation (AF) is a standard procedure to restore sinus rhythm. However, predictors for ineffective ECV (failure of ECV or recurrence of AF within 30 days) are unknown. We investigated 1998 ECVs performed for AF lasting >48 h in 1,342 patients in a retrospective multi-center study. Follow-up data were collected from 30 days after ECV. Median number of cardioversions was one per patient with a range of 1-10. Altogether 303/1998 (15.2%) ECVs failed. Long (>5 years) AF history and over 30 days duration of the index AF episode were independent predictors for ECV failure and low (<60/min) ventricular rate of AF predicted success of ECV. In patients with successful ECVs an early recurrence of AF was detected in 549 (32.4%) cases. Female gender, high (>60/min) ventricular rate, renal failure and antiarrhythmic agents at discharge were the independent predictors for recurrence. In total ECV was ineffective in 852 (42.6%) cases. Female gender (OR 1.44, CI95% 1.15-1.80, p < 0.01), young (<65 years) age (OR 1.31, CI95% 1.07-1.62, p = 0.01), ventricular rate >60/min (OR 1.92, CI95% 1.08-3.41, p = 0.03), antiarrhythmic medication at discharge (OR 1.48, CI95% 1.14-1.93, p < 0.01) and low (<60/ml/min) estimated glomerular filtration rate (OR 1.59, CI95% 1.08-2.33, p = 0.02) were predictors of ineffective ECV. Female gender, use of antiarrhythmic drug therapy and renal failure predicted both recurrence of AF and the composite end point. For the first time in a large real-life study several clinical predictors for clinically ineffective ECV were identified.

  19. 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

  20. [Multi-center study on the treatment of sudden total deafness].

    PubMed

    Zheng, Hong; Dai, Qing-qing; Zhou, Lian; Feng, Ning-yu; Qiu, Jian-hua; Chen, Yang; Wen, Li-ting; Han, Yu; Chen, Jun; Lin, Ying

    2013-05-01

    To assess the results of drug therapy in patients with severe idiopathic sudden sensorineural hearing loss (ISSHL) with total frequency hearing loss. A prospective randomized, single blind, multi-center clinical trial was designed. The untreated patients with ISSHL were included, who had severe hearing loss (pure tone audiometry showed patients had total frequency hearing loss, and their mean auditory threshold of 500, 1000, 2000, 4000 Hz was beyond 81 dB HL), age between 18 to 65 years old, and within 14 days of the onset . The patients were divided into one of the four drug groups [batroxobin, batroxobin + ginkgo biloba leaves extract (EGb), batroxobin + EGb + glucocorticoids, EGb + glucocorticoids] according to the random table, and receive treatment. Totally 276 patients with unilateral severe ISSHL were included from 33 hospitals, from August 2007 to October 2011. Among them, male patients accounted for 135 (48.91%), female 141 (51.09%); the average age was (41.7 ± 13.3)years. Forty cases were recovered (14.49%), 78 cases had marked effective (28.26%), 76 cases were effective (27.54%), 82 cases were in-effective (29.71%), and the total effective rate was 70.29%. Among four drug groups, the separate effective rate were 73.33%, 61.43%, 78.31% and 67.95% respectively, no significant difference was found between groups (χ(2) = 9.97,P = 0.62). Among the four groups, the separate cure rate for hearing loss were 11.11%, 12.86%, 16.87% and 15.38%, the glucocorticoid groups were significantly better than those not used. Among severe sudden deafness patients, 92.39% cases accompanied with tinnitus, 44.93% with dizziness (or vertigo), 50.36% with ear stuffy. There had no significant difference between the four groups with accompanied symptoms (all P > 0.05). It is value to give active treatment to sever sudden deafness patients because of an effective rate of 70%. However, the doctors and patients should be mind of a cure rate of only 14%. Steroids are recommended

  1. [YANG's pricking-cupping therapy for knee osteoarthritis: a multi-center randomized controlled trial].

    PubMed

    Wang, Bo; Liu, Xiru; Hu, Zhihai; Sun, Aijun; Ma, Yanwen; Chen Yingying; Zhang, Xuzhi; Liu, Meiling; Wang, Yi; Wang, Shuoshuo; Zhang, Yunjia; Li, Yijing; Shen, Weidong

    2016-02-01

    To evaluate the clinical efficacy of YANG's pricking-cupping therapy for knee osteoar thritis (KOA). Methods This was a multi-center randomized parallel controlled trial. One hundred and seventy one patients with KOA were randomly allocated to a pricking-cupping group (89 cases) and a conventional acu puncture group (82 cases). Neixiyan (EX-LE 4), Dubi (ST 35) and ashi points were selected in the two groups. Patients in the pricking-cupping group were treated with YANG's pricking-cupping therapy; the seven-star needles were used to perform pricking at acupoints, then cupping was used until slight bleeding was observed. Patients in the conventional acupuncture group were treated with semi-standardized filiform needle therapy. The treatment was given for 4 weeks (from a minimum of 5 times to a maximum of 10 times). The follow-up visit was 4 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the visual analogue scale (VAS) were adopted for the efficacy assessments. The pain score, stiffness score, physical function score and total score of WOMAC were all reduced after 4-week treatment and during follow-up visit in the two groups (all P<0. 0001). Except that the difference of stiffness score between the two groups was not significant after 4-week treatment (P>0. 05), each score and total score of WOMAC in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P<0. 0001, P<0. 01). After 2-week treatment, 4-week treatment and during follow-up visit, the VAS was all reduced compared with that before treatment (all P<0. 0001) ; with the increase of the treatment, the reducing trend of VAS was more significant (P<0. 0001). The scores of VAS in the pricking-cupping group were lower than those in the conventional acupuncture group after 4-week treatment and during follow-up visit (P < 0. 01, P <0. 0001). CONCLUSION The YANG's pricking-cupping and conventional

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

    NASA Technical Reports Server (NTRS)

    Thipphavong, Jane; Landry, Steven J.

    2005-01-01

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

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

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

    PubMed

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

    2012-01-01

    In a phase III multi-center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date on the basis of the observed accrual pattern and notify the participating sites several weeks in advance. In the past, projections were simply based on some crude assessment, and conservative measures were incorporated in order to achieve the target accrual size. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of the National Surgical Adjuvant Breast and Bowel Project trial B-38. The results showed that application of the proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi-center clinical trials. Copyright © 2012 John Wiley & Sons, Ltd.

  11. 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

  12. 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

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

    PubMed Central

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

    2013-01-01

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

  14. 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

  15. Center-defined unacceptable HLA antigens facilitate transplants for sensitized patients in a multi-center kidney exchange program.

    PubMed

    Baxter-Lowe, L A; Cecka, M; Kamoun, M; Sinacore, J; Melcher, M L

    2014-07-01

    Multi-center kidney paired donation (KPD) is an exciting new transplant option that has not yet approached its full potential. One barrier to progress is accurate virtual crossmatching for KPD waitlists with many highly sensitized patients. Virtual crossmatch results from a large multi-center consortium, the National Kidney Registry (NKR), were analyzed to determine the effectiveness of flexible center-specific criteria for virtual crossmatching. Approximately two-thirds of the patients on the NKR waitlist are highly sensitized (>80% CPRA). These patients have antibodies against HLA-A (63%), HLA-B (66%), HLA-C (41%), HLA-DRB1 (60%), HLA-DRB3/4/5 (18-22%), HLA-DQB1 (54%) and HLA-DPB1 (26%). With donors typed for these loci before activation, 91% of virtual crossmatches accurately predicted an acceptable cell-based donor crossmatch. Failed virtual crossmatches were attributed to equivocal virtual crossmatches (46%), changes in HLA antibodies (21%), antibodies against HLA-DQA (6%), transcription errors (6%), suspected non-HLA antibodies (5%), allele-specific antibodies (1%) and unknown causes (15%). Some failed crossmatches could be prevented by modifiable factors such as more frequent assessment of HLA antibodies, DQA1 typing of donors and auditing data entry. Importantly, when transplant centers have flexibility to define crossmatch criteria, it is currently feasible to use virtual crossmatching for highly sensitized patients to reliably predict acceptable cell-based crossmatches. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

  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. Development and multi-center evaluation of a novel immunoadsorption method for anti-DFS70 antibodies.

    PubMed

    Bentow, C; Rosenblum, R; Correia, P; Karayev, E; Karayev, D; Williams, D; Kulczycka, J; Fritzler, M J; Mahler, M

    2016-07-01

    Antinuclear antibodies (ANA) represent a hallmark in the diagnosis of ANA-associated rheumatic diseases (AARD). However, anti-DFS70 antibodies are present in a higher portion of the healthy individuals (HI) than in patients with AARD. Consequently, we developed a novel, highly specific indirect immunofluorescence (IIF) method that blocks anti-DFS70 antibodies from binding to HEp-2 cells and to evaluate the method in a multi-center study. A total of 18 samples from systemic lupus erythematosus patients (SLE, n = 7) and HI (n = 11) were used for the initial development of the immunoadsorption method. For the multi-center evaluation, samples with a dense fine speckled (DFS) pattern (n = 99) were collected at three different sites based on their established IIF screening procedure at the respective laboratories. Additionally, four characterized samples with established clinically relevant IIF patterns (centromere, nucleolar, speckled, homogeneous) were blended in five different ratios (10%, 25%, 50%, 75%, 90%) with a sample positive for anti-DFS70 antibodies, which by itself showed a dense fine speckled (DFS) IIF pattern. All samples were tested by IIF with NOVA Lite HEp-2 ANA and NOVA Lite HEp-2 Select on the NOVA View® instrument, and also tested by QUANTA Flash DFS70 chemiluminescent immunoassay (CIA) for confirmation of anti-DFS70 antibodies (Inova Diagnostics, San Diego, CA, USA). For the development of the immunoadsorption method, only 1/7 ANA-positive samples from SLE patients, but 8/10 ANA-positive samples from healthy individuals turned negative using the immunoadsorption. Subsequently, 73/99 (73.7%) of the DFS pattern samples were positive by CIA for anti-DFS70 antibodies showing a strong quantitative Spearman's correlation (rho = 0.57 (95% CI, 0.39-0.71, p < 0.0001)) between light intensity units (LIU) measured by NOVA View and CIA. Intensities measured with NOVA Lite HEp-2 and NOVA Lite HEp-2 Select demonstrated significantly lower

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

    PubMed Central

    2013-01-01

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

  19. 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.

  20. Physical fitness levels among independent non-institutionalized Spanish elderly: the elderly EXERNET multi-center study.

    PubMed

    Pedrero-Chamizo, R; Gómez-Cabello, A; Delgado, S; Rodríguez-Llarena, S; Rodríguez-Marroyo, J A; Cabanillas, E; Meléndez, A; Vicente-Rodríguez, G; Aznar, S; Villa, G; Espino, L; Gusi, N; Casajus, J A; Ara, I; González-Gross, M

    2012-01-01

    Physical fitness is gaining in importance in all population groups, including elderly, but data are still scarce. The aim of this study was to report gender and age specific physical fitness levels in non-institutionalized Spanish elderly. A representative sample of 3136 elderly (≥ 65 y), 724 men and 2412 women, from 6 Regions of Spain: Madrid, Aragón, Castilla y León, Castilla-La Mancha, Extremadura and Canarias were assessed in the elderly EXERNET multi-center study between 2008 and 2009. The authors assessed static balance, muscular strength, flexibility, agility, walking speed and cardiorespiratory fitness using eight different fitness tests: one leg balance, chair stand, arm curl, chair sit-and-reach, back scratch, 8-foot up-and-go, 30-m walk, and 6 min walk tests. The authors derived gender and age-specific normative values for physical fitness in the non-institutionalized Spanish elderly. The figures showed greater physical fitness in the elderly men than in women, except for the flexibility test, and a trend toward decreased physical fitness in both genders as their age increased. The normative values hereby provided will enable evaluation and correct interpretation of independent non-institutionalized Spanish elderly fitness status. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. A Multi-Center Study to Map Genes for Fuchs’ Endothelial Corneal Dystrophy: Baseline Characteristics and Heritability

    PubMed Central

    Louttit, Megan D; Kopplin, Laura J; Igo, Robert P; Fondran, Jeremy R; Tagliaferri, Angela; Bardenstein, David; Aldave, Anthony J; Croasdale, Christopher R; Price, Marianne; Rosenwasser, George O; Lass, Jonathan H; Iyengar, Sudha K

    2013-01-01

    Purpose To describe the methods for family and case-control recruitment for a multi-center genetic and associated heritability analysis of Fuchs’ Endothelial Corneal Dystrophy (FECD). Methods Twenty-nine enrolling sites with 62 trained investigators and coordinators gathered individual and family information, graded the phenotype, and collected blood and/or saliva for genetic analysis on all individuals with and without FECD. The degree of FECD was assessed in a 0–6 semi-quantitative scale using standardized clinical methods with pathologic verification of FECD on at least one member of each family. Central corneal thickness was measured by ultrasonic pachymetry. Results Three hundred twenty-two families with 330 affected sibling pairs with FECD were enrolled, and included a total of 650 sibling pairs of all disease grades. Using the entire 0–6 step FECD grading scale or a dichotomous definition of severe disease, heritability was assessed in families via sib-sib correlations. Both binary indicators of severe disease as well as semi-quantitative measures of disease severity were significantly heritable, with heritability estimates of 30% for severe disease, 37–39% for FECD score and 47% for central corneal thickness. Conclusion Genetic risk factors have a strong role in the severity of the FECD phenotype and corneal thickness. Genotyping this cohort with high-density genetic markers followed by appropriate statistical analyses should lead to novel loci for disease susceptibility. PMID:22045388

  2. 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

  3. 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.

  4. Alcohol Drinking, Cigarette Smoking and Risk of Colorectal Cancer in the Korean Multi-center Cancer Cohort.

    PubMed

    Cho, Sooyoung; Shin, Aesun; Park, Sue K; Shin, Hai-Rim; Chang, Soung-Hoon; Yoo, Keun-Young

    2015-06-01

    The present study aimed to examine the association between cigarette smoking, alcohol consumption and colorectal cancer risk among Korean adults. Data from the Korean Multi-center Cancer Cohort between 1993 and 2005 were analyzed. The study population comprised 18,707 subjects aged older than 20 years old. The subjects were followed until December 31, 2011 (median follow-up of 11.2 years). The Cox proportional hazard model was used to estimate the hazard ratio (HR) and 95% confidence intervals of cigarette smoking and alcohol consumption for colorectal cancer risk. In men, longer duration and higher average amount of alcohol consumption were associated with elevated risk of colorectal cancer (HR 1.93 [1.17-3.18] for ≥ 30 years of consumption compared to non-drinkers; HR 2.24 [1.31-3.84] for ≥ 30 g/d). Former smokers showed a non-significantly elevated risk of colorectal cancer in men. There was no apparent association between alcohol consumption or cigarette smoking and colorectal cancer risk among women. Alcohol consumption was associated with increased colorectal cancer risk among Korean men, and both a longer duration and a higher amount of consumption were associated with elevated risk.

  5. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study

    PubMed Central

    Thwin, Soe Soe; Clough-Gorr, Kerri M; McCarty, Maribet C; Lash, Timothy L; Alford, Sharon H; Buist, Diana SM; Enger, Shelley M; Field, Terry S; Frost, Floyd; Wei, Feifei; Silliman, Rebecca A

    2007-01-01

    Background The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study. Methods A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859), at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR) system was developed using a modified version of the EDC. Results Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites. Conclusion Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved. PMID:17577410

  6. 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

  7. 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

  8. Multi-center comparison of medial temporal atrophy in patients with Alzheimer's disease--data from the ICTUS study.

    PubMed

    Galluzzi, Samantha; Talassi, Erika; Belussi, Michela; Scheltens, Philip; van de Pol, Laura; Nobili, Flavio; Rodriguez, Guido; Froelich, Lutz; Damian, Marinella; Martinez-Lage, Pablo; Gomez-Isla, Teresa; Reynish, Emma; Ousset, Pierre Jean; Vellas, Bruno; Frisoni, Giovanni B

    2008-01-01

    To study multi-center variability of medial temporal lobe atrophy (MTA) in patients with Alzheimer's disease (AD) recruited in a European observational study of AD. 117 mild to moderate AD patients from 5 European centers (Amsterdam, The Netherlands; Brescia and Genova, Italy; Mannheim, Germany; Pamplona, Spain) had magnetic resonance imaging scans performed as part of the routine diagnostic examination. MTA was assessed with the visual Scheltens scale. AD patients from Brescia, Genova, Pamplona, and Mannheim had a mean 32% prevalence of no or borderline MTA vs. 62% of patients from Amsterdam (p = 0.002 for the difference between Amsterdam and all the other centers). The peculiar distribution of MTA in the Amsterdam patients may be attributable to younger age (70.7 +/- 8.4 vs. 75.3 +/- 6.8 years, p = 0.002), milder dementia severity (score 0.5 on the clinical dementia rating scale: 52 vs. 23%, p = 0.003), and less frequent depression (14 vs. 49%, p < 0.0005 in Amsterdam vs. all the other centers, respectively). Patients with probable AD recruited in different centers of Europe generally have similar MTA distribution, even if peculiar demographic and clinical findings might explain occasional differences. These results have implications for clinical trials in AD with biological markers as outcome measures. Copyright 2008 S. Karger AG, Basel.

  9. 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).

  10. 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.

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

    PubMed

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

    2014-06-01

    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. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    PubMed

    Choi, Chang Won; Park, Moon Sung

    2015-10-01

    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.

  13. 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

  14. 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

  15. Occupation and risk of lung cancer in Central and Eastern Europe: the IARC multi-center case-control study.

    PubMed

    Bardin-Mikolajczak, Alicja; Lissowska, Jolanta; Zaridze, David; Szeszenia-Dabrowska, Neonila; Rudnai, Peter; Fabianova, Eleonora; Mates, Dana; Navratilova, Marie; Bencko, Vladimir; Janout, Vladimir; Fevotte, Joelle; Fletcher, Tony; 't Mannetje, Andrea; Brennan, Paul; Boffetta, Paolo

    2007-08-01

    We sought to evaluate the role of occupation and industry in lung carcinogenesis in six countries in Central and Eastern Europe. This multi-center case-control study included 2,056 male and 576 female lung cancer incidence cases diagnosed from 1998 to 2001 and 2,144 male and 727 female controls frequency-matched for sex and age. Unconditional regression models were applied to calculate the odds ratios after controlling for potential confounders including age (5-year groups), study center (15 centers), and tobacco pack-years. Elevated odds ratios (ORs) were found for men employed as production workers (OR 1.45, 95% CI 1.22-1.72), bookkeepers and cashiers (1.81, 1.03-3.24), general farmers (1.67, 1.08-2.60), livestock workers (2.54, 1.09-5.88), miners (2.17, 1.47-3.23), toolmakers and metal patternmakers (2.56, 1.34-4.94), glass formers (2.55, 1.18-5.50), dockworkers, and freight handlers (1.49, 1.04-2.12). Industries with elevated risk among men included mining (1.75, 1.20-2.57), manufacture of cement, lime, or plaster (3.62, 1.11-12.00), casting of metals (2.00, 1.17-3.45), manufacture of electric motors (2.18, 1.24-3.86). For women, elevated ORs were found for medical, dental, veterinary doctors (2.54, 1.01-6.31), librarians and curators (7.03, 1.80-27.80), sewers 3.63 (1.12-10.23). This study identifies new areas for further, explanatory analyses, especially in production work, and indicates new possible sources of exposure to cancer risk for women.

  16. 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

  17. Benefit of a commercially available cochlear implant processor with dual-microphone beamforming: a multi-center study.

    PubMed

    Wolfe, Jace; Parkinson, Aaron; Schafer, Erin C; Gilden, Jan; Rehwinkel, Kathy; Mansanares, Jennifer; Coughlan, Elizabeth; Wright, Jennifer; Torres, Jennifer; Gannaway, Stephanie

    2012-06-01

    Previous research shows that cochlear implant users experience significant difficulty with speech perception in noisy listening situations. There is a paucity of research evaluating the potential improvement in speech recognition in noise provided by a dual-microphone directional system in a commercial implant sound processor. The primary objective of this study was to compare speech recognition in quiet and in noise for the Nucleus Freedom and Nucleus 5 CP810 sound processors set to the manufacturer's default user programs for quiet and noisy environments. Crossover with repeated-measures design. This multi-center study was conducted across four cochlear implant clinics in the United States. Thirty-five adults with unilateral Nucleus Freedom cochlear implants. All subjects had used their cochlear implant for at least 6 months and had substantial open-set word recognition as evidenced by a score of at least 40% correct on the Consonant-Nucleus-Consonant (CNC) monosyllabic word recognition test in quiet. All subjects (previous users of the Nucleus Freedom sound processor) were fitted with the Nucleus 5 sound processor. Performance was assessed while these subjects used each sound processor in the default user program the manufacturer recommends for quiet and noisy conditions. Speech recognition was assessed with CNC monosyllabic words in quiet and sentences in noise from the BKB-SIN (Bamford-Kowal-Bench Sentences in Noise) test. The data were analyzed with descriptive statistics and performance with each processor in each listening condition was compared using a repeated-measures analysis of variance. Word recognition in quiet was significantly better with the Nucleus 5 sound processor when compared to performance with the Nucleus Freedom processor. In noise, the Nucleus 5 sound processor also provided a significant improvement in speech recognition relative to the performance with the Nucleus Freedom. The results of the study suggest that the Nucleus 5 sound

  18. Persistent urinary retention after surgery for deep infiltrating endometriosis: a multi-center series of 16 cases.

    PubMed

    Azaïs, Henri; Rubod, Chrystèle; Ghoneim, Tarek; Vassilieff, Maud; Bailly, Emmanuel; Boileau, Laurent; Villet, Richard; Collinet, Pierre

    2015-06-01

    Persistent urinary retention (UR) is a complication of 3.5-14.3% of patients having undergone deep pelvic endometriosis (DPE) surgery of posterior compartment, and it is prone to persist. The purpose of this study is to identify surgical procedures and clinical circumstances associated with persistent UR, and consider its treatment. We undertook a multi-center retrospective study studying medical records of patients who had surgery for DPE between January 2005 and December 2012. Patients who suffered from UR defined as a post-void residual (PVR) volume >100 mL needing intermittent self-catheterizations more than 30 days after surgery were included. Preoperative data (functional complaints, clinical examination, imaging, medical treatment) were recorded. Types of surgery and detailed postoperative urinary symptoms were noted. 881 patients had surgery for DPE and 16 patients were included (1.8%). In 93.8% of cases, a lesion of posterior compartment was clinically significant. Mean lesion size was 28.8 ± 7.3 mm. Colorectal resection and colpectomy were necessary in 93.8 and 87.5% of cases, respectively. Loss of bladder sensation and straining during urination were the two most common post-operative symptoms. 11 patients still required self-catheterization up to 1 year after the intervention. Patients with increased risks of UR present with a symptomatic and clinically palpable deep pelvic endometriotic lesion of the posterior compartment. Treatment implies surgery with colorectal resection. Bilateral resection of utero-sacral ligaments and posterior colpectomy tend to increase that risk. Complications due to PVR volume and straining during urination may be prevented by self-catheterization.

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

    PubMed Central

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

    2009-01-01

    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±0.95mm and rotations of 1.56±0.66°. Mean gray matter CBF was 47.4±7.5 [ml/100g/min] with a between subject standard variation SDb = 5.5 [ml/100g/min] and a within subject standard deviation SDw = 4.7 [ml/100g/min]. The corresponding repeatability was 13.0 [ml/100g/min] and was found to be within the range of previous studies. PMID:19660557

  20. 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.

  1. 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.

  2. 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.

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

    PubMed Central

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

    2013-01-01

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

  4. A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.

    PubMed

    Yoritaka, Asako; Abe, Takashi; Ohtsuka, Chigumi; Maeda, Tetsuya; Hirayama, Masaaki; Watanabe, Hirohisa; Saiki, Hidemoto; Oyama, Genko; Fukae, Jiro; Shimo, Yasushi; Hatano, Taku; Kawajiri, Sumihiro; Okuma, Yasuyuki; Machida, Yutaka; Miwa, Hideto; Suzuki, Chikako; Kazama, Asuka; Tomiyama, Masahiko; Kihara, Takeshi; Hirasawa, Motoyuki; Shimura, Hideki; Hattori, Nobutaka

    2016-05-12

    Our previous randomized double-blind study showed that drinking hydrogen (H2) water for 48 weeks significantly improved the total Unified Parkinson's Disease Rating Scale (UPDRS) score of Parkinson's disease (PD) patients treated with levodopa. We aim to confirm this result using a randomized double-blind placebo-controlled multi-center trial. Changes in the total UPDRS scores from baseline to the 8(th), 24(th), 48(th), and 72(nd) weeks, and after the 8(th) week, will be evaluated. The primary endpoint of the efficacy of this treatment in PD is the change in the total UPDRS score from baseline to the 72(nd) week. The changes in UPDRS part II, UPDRS part III, each UPDRS score, PD Questionnaire-39 (PDQ-39), and the modified Hoehn and Yahr stage at these same time-points, as well as the duration until the protocol is finished because additional levodopa is required or until the disease progresses, will also be analyzed. Adverse events and screening laboratory studies will also be examined. Participants in the hydrogen water group will drink 1000 mL/day of H2 water, and those in the placebo water group will drink normal water. One-hundred-and-seventy-eight participants with PD (89 women, 89 men; mean age: 64.2 [SD 9.2] years, total UPDRS: 23.7 [11.8], with levodopa medication: 154 participants, without levodopa medication: 24 participants; daily levodopa dose: 344.1 [202.8] mg, total levodopa equivalent dose: 592.0 [317.6] mg) were enrolled in 14 hospitals and were randomized. This study will confirm whether H2 water can improve PD symptoms. UMIN000010014 (February, 13, 2013).

  5. Quantitative multi-parameter mapping of R1, PD(*), MT, and R2(*) at 3T: a multi-center validation.

    PubMed

    Weiskopf, Nikolaus; Suckling, John; Williams, Guy; Correia, Marta M; Inkster, Becky; Tait, Roger; Ooi, Cinly; Bullmore, Edward T; Lutti, Antoine

    2013-01-01

    Multi-center studies using magnetic resonance imaging facilitate studying small effect sizes, global population variance and rare diseases. The reliability and sensitivity of these multi-center studies crucially depend on the comparability of the data generated at different sites and time points. The level of inter-site comparability is still controversial for conventional anatomical T1-weighted MRI data. Quantitative multi-parameter mapping (MPM) was designed to provide MR parameter measures that are comparable across sites and time points, i.e., 1 mm high-resolution maps of the longitudinal relaxation rate (R1 = 1/T1), effective proton density (PD(*)), magnetization transfer saturation (MT) and effective transverse relaxation rate (R2(*) = 1/T2(*)). MPM was validated at 3T for use in multi-center studies by scanning five volunteers at three different sites. We determined the inter-site bias, inter-site and intra-site coefficient of variation (CoV) for typical morphometric measures [i.e., gray matter (GM) probability maps used in voxel-based morphometry] and the four quantitative parameters. The inter-site bias and CoV were smaller than 3.1 and 8%, respectively, except for the inter-site CoV of R2(*) (<20%). The GM probability maps based on the MT parameter maps had a 14% higher inter-site reproducibility than maps based on conventional T1-weighted images. The low inter-site bias and variance in the parameters and derived GM probability maps confirm the high comparability of the quantitative maps across sites and time points. The reliability, short acquisition time, high resolution and the detailed insights into the brain microstructure provided by MPM makes it an efficient tool for multi-center imaging studies.

  6. [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

  7. 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

  8. International multi-center evaluation of a novel chemiluminescence assay for the detection of anti-dsDNA antibodies.

    PubMed

    Bentow, C; Lakos, G; Martis, P; Wahl, E; Garcia, M; Viñas, O; Espinosa, G; Cervera, R; Sjöwall, C; Carmona-Fernandes, D; Santos, M J; Hanly, J G; Mahler, M

    2016-07-01

    Anti-double stranded desoxyribonucleic acid (anti-dsDNA) antibodies are considered fairly specific for systemic lupus erythematosus (SLE) and their quantification is useful for the clinical management of SLE patients. We assessed the diagnostic performance of the QUANTA Flash dsDNA chemiluminescent immunoassay (CIA) in comparison to an ELISA, using patients from five participating countries. The main focus was to evaluate the correlation between anti-dsDNA antibody results from the CIA and global SLE disease activity, as measured by the SLE Disease Activity Index 2000 (SLEDAI-2K). A total of 1431 samples (SLE, n = 843; disease controls, n = 588) from five countries (Canada, USA, Portugal, Sweden and Spain) were tested with QUANTA Flash dsDNA (Inova Diagnostics, San Diego, CA, USA). Data obtained with the QUANTA Lite dsDNA SC ELISA (Inova Diagnostics) were available for samples from three sites (Canada, USA and Sweden, n = 566). The SLEDAI-2K scores were available for 805 SLE patients and a cut-off of > 4 was used to define active disease. QUANTA Flash dsDNA had a sensitivity of 54.3% for the diagnosis of SLE, combined with 89.8% specificity. Anti-dsDNA antibody levels were significantly higher (p < 0.0001) in active SLE (SLEDAI-2K > 4; n = 232; median value 83.0 IU/mL) versus the inactive patients (n = 573; median value 22.3 IU/mL), and the SLEDAI-2K scoring correlated with their dsDNA antibody levels (Spearman's rho = 0.44, p < 0.0001). Similar but less pronounced findings were also found for the ELISA, in relation to disease activity. The QUANTA Flash dsDNA assay showed good clinical performance in a large international multi-center study. Additionally, the strong correlation between anti-dsDNA antibody results and SLEDAI-2K scores supported the potential utility of QUANTA Flash dsDNA for monitoring disease activity. © The Author(s) 2016.

  9. The prevalence of constipation at admission and after 1 week of palliative care: a multi-center study.

    PubMed

    Mercadante, Sebastiano; Masedu, Francesco; Maltoni, Marco; Giovanni, Daniela De; Montanari, Luigi; Pittureri, Cristina; Bertè, Raffaella; Ursini, Laura; Marinangeli, Franco; Aielli, Federica

    2017-08-16

    To assess the prevalence and intensity of constipation in advanced-cancer patients referred to palliative care, and to assess changes after 1 week of specialist palliative care. This was a prospective multi-center study in advanced patients for a period of 1 year. At admission (T0), age, gender, primary tumor, concomitant diseases, Karnofsky status, Palliative prognostic score (PaP), Edmonton Symptom Assessment scale (ESAS), Memorial Delirium Assessment Scale (MDAS), and bowel function index (BFI) were collected. In BFI, high values represent severe constipation. The use of medication was also recorded, as well as possible causes of constipation. The same parameters were recorded 1 week after admission for palliative care (T7). A total of 246 patients were screened for constipation. The mean BFI at T0 was 42.4 (SD = 26.92). One hundred and sixty-three patients (66.3%) had a BFI >28. The mean BFI at T7 was 35.7 (SD = 28.8), with a significant decrease from T0 to T7 (p = .000). A significant decrease of BFI in patients with a BFI >28 was reported (p = .000). In patients with a BFI ≤28 there was a significant worsening of constipation (p = .000). In patients with a BFI >28 at T0 there was a significant increase in the use of laxatives at T7 in comparison with patients having a BFI ≤28 (p = .002). In patients with a BFI ≤28 at T0, who had a significant worsening of BFI (Δ > 12), the use of laxatives was significantly lower in comparison to patients who had a BFI >28 (p = .000). In the multivariate analysis, dehydration and the use of benzodiazepines were independently associated with higher BFI scores. Constipation is present in approximately two-thirds of patients, and is principally associated with dehydration and the use of benzodiazepines. Patients with normal bowel function at initial assessment may see a worsening in their condition a week later due to lack of prevention or subsequent under-treatment.

  10. C-reactive protein, an early marker of community-acquired sepsis resolution: a multi-center prospective observational study.

    PubMed

    Póvoa, Pedro; Teixeira-Pinto, Armando M; Carneiro, António H

    2011-07-15

    C-reactive protein (CRP) has been shown to be a valuable marker in the diagnosis of infection and in monitoring its response to antibiotics. Our objective was to evaluate serial CRP measurements after prescription of antibiotics to describe the clinical course of Community-Acquired Sepsis admitted to intensive care units (ICU). During a 12-month period a multi-center, prospective, observational study was conducted, segregating adults with Community-Acquired Sepsis. Patients were followed-up during the first five ICU days, day of ICU discharge or death and hospital outcome. CRP-ratio was calculated in relation to Day 1 CRP concentration. Patients were classified according to the pattern of CRP-ratio response to antibiotics: fast response if Day 5 CRP-ratio was < 0.4, slow response if Day 5 CRP-ratio was between 0.4 and 0.8, and no response if Day 5 CRP-ratio was > 0.8. Comparison between survivors and non-survivors was performed. A total of 891 patients (age 60 ± 17 yrs, hospital mortality 38%) were studied. There were no significant differences between the CRP of survivors and non-survivors until Day 2 of antibiotic therapy. On the following three days, CRP of survivors was significantly lower (P < 0.001). After adjusting for the Simplified Acute Physiology Score II and severity of sepsis, the CRP course was significantly associated with mortality (ORCRP-ratio = 1.03, confidence interval 95%= (1.02, 1.04), P < 0.001). The hospital mortality of patients with fast response, slow response and no response patterns was 23%, 30% and 41%, respectively (P = 0.001). No responders had a significant increase on the odds of death (OR = 2.5, CI95% = (1.6, 4.0), P < 0.001) when compared with fast responders. Daily CRP measurements after antibiotic prescription were useful as early as Day 3 in identification of Community-Acquired Sepsis patients with poor outcome. The rate of CRP decline during the first five ICU days was markedly associated with prognosis. The identification of

  11. [Effect of clinical pathways based on integrative medicine for patients with chronic heart failure: a multi-center research].

    PubMed

    Zou, Xu; Pan, Guang-Ming; Sheng, Xiao-Gang; Yao, Geng-Zhen; Zhu, Ming-Jun; Wu, Yang; Chen, Xiao-Hu; Wang, Yong-Xia; Cui, Jie; Chen, Jian-Dong

    2013-06-01

    To assess a multi-center study effectiveness of clinical pathways based on integrative medicine (IM) for chronic heart failure (CHF) patients. A combined method of historical control study and clinical study on concurrent control was used. After the standard management for clinical pathways was carried out in four hospitals at home, the effects on hospitalization days, medical expenses, clinical efficacy, patient satisfaction, and quality of life were assessed. Results of non-concurrent historical control study showed that: the hospital stay was significantly shorter in the pathways group than in the retrospective group (12.59 days vs 18.44 days), and the total cost of hospitalization was significantly reduced in the pathways group (yen 9 051.90 vs yen 11 978.40), showing statistical difference (P < 0.01). Moreover, the effect on the heart function was better in the pathways group than in the retrospective group (the markedly effective rate: 45.60% vs 21.90%; the total effective rate: 96.80% vs 86.10%), showing statistical difference (P < 0.01). Results of clinical study on concurrent control showed that the hospital stay was significantly shorter in the pathways group than in the control group (11.19 days vs 13.21 days), showing statistical difference (P < 0.05). The average total cost of hospitalization was significantly lower in the pathways group than in the control group (yen 8 656.80 vs yen 11 609.70), showing statistical difference (P < 0.01). As for clinical efficacy of Chinese medical syndrome, the total effective rate was higher in the pathways group than in the control group (97.10% vs 93.62%), showing statistical difference (P < 0.05). The markedly effective rate of heart function was better in the pathways group than in the control group, showing statistical difference (49.30% vs 38.30%, P < 0.05). The overall satisfaction was higher in the pathways group than in the conventional group (P < 0.01). There was no statistical difference in the mortality

  12. Outcome of neurological early rehabilitation patients carrying multi-drug resistant bacteria: results from a German multi-center study.

    PubMed

    Rollnik, J D; Bertram, M; Bucka, C; Hartwich, M; Jöbges, M; Ketter, G; Leineweber, B; Mertl-Rötzer, M; Nowak, D A; Platz, T; Scheidtmann, K; Thomas, R; von Rosen, F; Wallesch, C W; Woldag, H; Peschel, P; Mehrholz, J; Pohl, M

    2017-03-20

    Colonization or infection with multi-drug resistant (MDR) bacteria is considered detrimental to the outcome of neurological and neurosurgical early rehabilitation patients. In a German multi-center study, 754 neurological early rehabilitation patients were enrolled and and reviewed in respect to MDR status, length of stay (LOS) and the following outcome variables: Barthel Index (BI), Early Rehabilitation Index (ERI), Glasgow Outcome Score Extended (GOSE), Coma Remission Scale (CRS), Functional Ambulation Categories (FAC). The mean age of the study population was 68.0 ± 14.8 years. Upon admission, the following prevalence for MDRs was observed: MRSA (methicillin resistant staphylococcus aureus) 7.0% (53/754), ESBL- (extended spectrum beta-lactamase) producing bacteria strains 12.6% (95/754), VRE (vancomycin resistant enterococci) 2.8% (21/754). Patients colonized or infected with MDR bacteria (MDR+) were significantly more frequently diagnosed with a critical illness polyneuropathy - CIP - than non-colonized (MDR-) patients: 29.0% vs. 14.8%. In addition, they were more frequently mechanically ventilated (MDR+: 55/138, 39.9%; MDR- 137/616, 22.2%). MDR+ patients were referred to rehabilitation earlier, had a longer LOS in early rehabilitation, lower BI on admission and at discharge, lower ERI on admission and lower CRS at discharge than MDR- patients. There was a highly significant correlation of the BI upon admission with the BI at discharge (rs = 0.492, p < 0.001). GOSE at discharge differed significantly between both groups (χ (2)-test, p < 0.01). Perhaps of greatest importance, mortality among MDR+ was higher in comparison to MDR- (18.1% vs. 7.6%). The outcome of neurological early rehabilitation patients colonized or infected with MDR bacteria including MRSA or ESBL producing strains is significantly poorer than by non-colonized patients. There is some evidence that the poor outcome could be related to the higher morbidity and lower functional

  13. 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

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

    PubMed Central

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

    2014-01-01

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

  15. CATS-ISS_L2O_D-M7.2-V1-05_05kmPro

    Atmospheric Science Data Center

    2017-08-01

    CATS-ISS_L2O_D-M7.2-V1-05_05kmPro Project Title:  CATS Discipline:  Clouds Aerosols Version:  ... and Order:  ASDC Order Tool Product Browse Tool:  CATS Order Tool OPeNDAP Access:  OPeNDAP Parameters:  ...

  16. CATS-ISS_L2O_N-M7.2-V1-05_05kmPro

    Atmospheric Science Data Center

    2017-08-01

    CATS-ISS_L2O_N-M7.2-V1-05_05kmPro Project Title:  CATS Discipline:  Clouds Aerosols Version:  ... and Order:  ASDC Order Tool Product Browse Tool:  CATS Order Tool OPeNDAP Access:  OPeNDAP Parameters:  ...

  17. CATS-ISS_L2O_N-M7.2-V1-05_05kmLay

    Atmospheric Science Data Center

    2017-08-01

    CATS-ISS_L2O_N-M7.2-V1-05_05kmLay Project Title:  CATS Discipline:  Clouds Aerosols Version:  ... and Order:  ASDC Order Tool Product Browse Tool:  CATS Order Tool OPeNDAP Access:  OPeNDAP Parameters:  ...

  18. [Design of ABC damage variable and positioning system for acetabular fractures and 1122 cases multi-center statistic analysis].

    PubMed

    Zhang, Chun-cai; Xu, Shuo-gui; Yu, Bao-qing; Ji, Fang; Fu, Qing-ge; Liu, Xin-wei; Zhang, Yun-tong; Niu, Yun-fei; Wang, Pan-feng; Su, Jia-can; Cao, Lie-hu; Xu, Yong-qing; Ruan, Mo; Chen, Zhuang-hong; Huang, Ji-feng; Cai, Xian-hua; Shen, Hui-liang; Liu, Li-min; Wang, Ji-fang; Wang, Yan; Tang, Pei-fu; Liang, Yu-tian; Wang, Jia-rang; Wang, Yu-ri; Wang, Zhen-hao; Liu, Wen-di; Li, Wen-rui; Li, Wen-hu; Wang, Xu-quan; Zhou, Dong-sheng; Zhang, Peng; Wang, Ren; Wang, Gang; Chen, Yu-yue; Cong, Yong-jian

    2011-02-01

    To design ABC damage variable and positioning system for acetabular fracture and explore the feasibility and clinical practical value of the system through the multi-center analysis of 1122 acetabular fractures. According to acetabular three-column conception, and pelvic ring lesions damage direction caused by acetabular fracture domino effect and injury degree of proximal femur joint, it defined class A as any column acetabular fracture; class B as any two-column acetabular fracture; class C as front, dome and posterior mixture acetabular fracture. Lower case English letters a, m, p represented front, dome, posterior fracture, respectively. Acetabular damage variables: 1 was simple displaced fractures; 2 was comminuted fractures; 3 was compression fractures. Pelvic ring lesions damage variables: alpha was sacroiliac joints or sacroiliac fracture horizontal separation deflection; beta was sacroiliac joints or sacroiliac fracture vertical separation deflection; gamma was pubic symphysis separation/superior and inferior ramus of pubis fracture deflection; alpha beta gamma delta was compound floating damage. Proximal humerus joint damage variables: I was femoral head fracture; II was femoral neck fracture; II was intertrochanteric fractures of femur; IV was I to III compound fracture. The ABC damage variable positioning system for acetabular fracture was made up by the above-mentioned variables. The statistics from March 1997 to February 2010 showed 1122 cases acetabular fractures with 18 cases of double side acetabular fracture and 1140 cases of acetabular fractures. The pelvics anterior-posterior view, ilium and obturator oblique view, and 2/3D-CT materials were analyzed and researched. Each damage variables distribution situation in 1140 cases of acetabular fracture involved A in 237 cases (20.8%), B in 605 cases (53.1%), C in 298 cases (26.1%);front column fracture in 808 cases(70.9%), dome fracture in 507 cases (44.5%), posterior fracture in 1026 cases (90

  19. 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

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

    PubMed

    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

    2016-07-01

    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. 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. 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. Through multi-center testing, any challenges or difficulties in the proposed audit methodology were identified, and the methodology improved. Using the experience of these studies, the participants could incorporate the auditing

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Total laparoscopic hysterectomy versus abdominal hysterectomy in the treatment of patients with early stage endometrial cancer: a randomized multi center study.

    PubMed

    Bijen, Claudia B M; Briët, Justine M; de Bock, Geertruida H; Arts, Henriëtte J G; Bergsma-Kadijk, Johanna A; Mourits, Marian J E

    2009-01-15

    Traditionally standard treatment for patients with early stage endometrial cancer (EC) is total abdominal hysterectomy and bilateral salpingo oophorectomy (TAH+BSO) with or without lymph node dissection through a vertical midline incision. While TAH is an accepted effective treatment, it is highly invasive, visibly scarring and associated with morbidity. An alternative treatment is the same operation by laparoscopy. Though in several studies total laparoscopic hysterectomy (TLH+ BSO) seems a safe and feasible alternative approach in early stage endometrial cancer patients, there are no randomized data available yet. Furthermore, a randomized controlled trial with surgeons trained in laparoscopy is warranted in order to implement this technique in a safe manner. The aim of this study is to compare the treatment related morbidity, cost-effectiveness and quality of life in early stage endometrial cancer patients treated by laparoscopy versus the standard open approach. A multi centre randomized clinical phase 3 trial, including 5 university hospitals and 15 regional hospitals in the Netherlands. Only gynecologists trained in performing a TLH are allowed to participate. Patients with a clinical stage I endometrioid adenocarcinoma or complex atypical hyperplasia are randomized in a 2:1 allocation to receive TLH or TAH. The main outcome measure is the rate of major complications, as assessed by an independent clinical review board. In total, 275 patients are required to have 80% power at alpha-0.05 to detect a significant difference of 15% complication rate. Secondary outcome measures are 1) costs and cost-effectiveness, 2) minor complications, and 3) quality of life. All data from this multi center study are reported using case record forms. Data regarding quality of life, pain, body Image, sexuality and additional homecare are assessed with self reported questionnaires. A randomized multi center study in early stage endometrial cancer patients with inclusion criteria

  8. 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.

  9. 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

  10. 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.

  11. Interaction of 1.05 μm and 0.53 μm lasers with gold disks

    NASA Astrophysics Data System (ADS)

    Shenye, Liu; Yaonan, Ding; Zhijian, Zheng; Daoyuan, Tang

    1996-05-01

    Gold disks were irradiated with 1.05 μm and 0.53 μm lasers at pulse duration of ˜0.8 ns, intensity ranging from 5×1013 W/cm2 to 4×1015 W/cm2 on the SHEN GUANG I laser facility in China. The experimental results of laser absorption, scattering light, x-ray emission and plasma blow-off are presented in this paper. When the laser irradiated the gold disk obliquely, the angular distribution of scattered lights produced by 0.53 μm lasers disagree with that predicted by the Brillouin scattering theory. The angular distribution is different from that reported previously by the others.

  12. 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.

  13. Verification and fine mapping of qGW1.05, a major QTL for grain weight in maize (Zea mays L.).

    PubMed

    Zhou, Qiang; Dong, Yongbin; Shi, Qingling; Zhang, Long; Chen, Huanqing; Hu, Chunhui; Li, Yuling

    2017-04-12

    Grain weight, one of the important factors to determine corn yield, is a typical quantitative inheritance trait. However, the molecular genetic basis of grain weight still remains limited. In our previous researches, a major QTL associated with grain weight, qGW1.05, has been identified between SSR markers umc1601 and umc1754 at bin locus 1.05-1.06 in maize. Here, its genetic and environmental stabiliteis were verified using a BC3F2 population to identify the effect of qGW1.05 on grain weight. Further, qGW1.05-NILs were obtained by MAS successfully. Via a large BC6F2 segregation population, together with polymorphic microsatellite markers developed between the parents to screen the genotype of the recombinant plants, qGW1.05 was positioned to a 1.11 Mb genome interval. Furthermore, the progenies of 15 recombinants were tested to confirm the effect of qGW1.05 on grain weight. Combining collinearity among cereal crops and genome annotation, the several candidate genes taking part in grain development were identified in the qGW1.05 region. In this study, qGW1.05 was limited to a 1.11 Mb region on chromosome 1, which established the foundation for understanding the molecular basis underlying kernel development and improving grain weight through MAS using the tightly flanking molecular markers in maize.

  14. 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.

  15. 1.05-GHz CMOS oscillator based on lateral- field-excited piezoelectric AlN contour- mode MEMS resonators.

    PubMed

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

    2010-01-01

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

  16. 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.

  17. [Sucrose gel for treatment of bacterial vaginosis: a randomized, double-blind, multi-center, parallel-group, phase III clinical trial].

    PubMed

    Xiao, Bing-bing; Zhang, Dai; Chen, Rui; Shi, Hui-rong; Xin, Xiao-ran; Wang, Hui-lan; Pang, Yi-cun; Zhu, Sai-nan; Yao, Chen; Liao, Qin-ping

    2015-12-18

    To evaluate the cure effectiveness and safety of sucrose gel in the treatment of bacterial vaginosis through a multi-center, randomized, double-blind, parallel controlled clinical study. A clinical research method of multi-center, randomly double-blind, and dose group parallel comparison was adopted. In the study, 533 patients with bacterial vaginosis were randomly divided into two groups, which included 214 cases in the control group (5.0 g metronidazole gel) and 319 cases in the trial group (5.0 g sucrose gel ). The patients were treated with different medication according to the group where they were. All the cases in these two groups were treated with drugs vaginally twice in a day, morning and evening separately, for 5 days. The curative effect and safety evaluation were assessed from 7 to 10 days and 21 to 30 days after treatment respectively. The efficacy of the comprehensive clinical treatment showed that the cure rate of metronidazole gel group and sucrose gel group were 70.53% and 80.83% respectively 7 to 10 days after treatment. The recovery rate of Nugent score for vaginal smear were 71.50% and 81.15% respectively. The differences in the efficacy between these two groups were significant statistically (P<0.05). However, the cure rates of metronidazole gel group and sucrose gel group were 63.29% and 61.98% respectively 21 to 30 days after treatment. No statistically significant difference (P>0.05) could be found in the cure rates of the two groups. The clinical comprehensive efficacy and recovery of vaginal bacteria of sucrose gel group in the treatment of bacterial vaginosis were obviously superior to those of metronidazole gel 7 to 10 days after treatment. The susucrose gel could improve the clinical efficacy index and laboratory index of bacterial vaginosis. Other effects included the release of clinical symptoms, and the recovery of the normal micro-environment in the vagina according to the Nugent score. The curative efficacy of sucrose gel was

  18. Total laparoscopic hysterectomy versus abdominal hysterectomy in the treatment of patients with early stage endometrial cancer: A randomized multi center study

    PubMed Central

    2009-01-01

    Background Traditionally standard treatment for patients with early stage endometrial cancer (EC) is total abdominal hysterectomy and bilateral salpingo oophorectomy (TAH+BSO) with or without lymph node dissection through a vertical midline incision. While TAH is an accepted effective treatment, it is highly invasive, visibly scarring and associated with morbidity. An alternative treatment is the same operation by laparoscopy. Though in several studies total laparoscopic hysterectomy (TLH+ BSO) seems a safe and feasible alternative approach in early stage endometrial cancer patients, there are no randomized data available yet. Furthermore, a randomized controlled trial with surgeons trained in laparoscopy is warranted in order to implement this technique in a safe manner. The aim of this study is to compare the treatment related morbidity, cost-effectiveness and quality of life in early stage endometrial cancer patients treated by laparoscopy versus the standard open approach. Methods A multi centre randomized clinical phase 3 trial, including 5 university hospitals and 15 regional hospitals in the Netherlands. Only gynecologists trained in performing a TLH are allowed to participate. Inclusion criteria: Patients with a clinical stage I endometrioid adenocarcinoma or complex atypical hyperplasia are randomized in a 2:1 allocation to receive TLH or TAH. The main outcome measure is the rate of major complications, as assessed by an independent clinical review board. In total, 275 patients are required to have 80% power at α-0.05 to detect a significant difference of 15% complication rate. Secondary outcome measures are 1) costs and cost-effectiveness, 2) minor complications, and 3) quality of life. All data from this multi center study are reported using case record forms. Data regarding quality of life, pain, body Image, sexuality and additional homecare are assessed with self reported questionnaires. Discussion A randomized multi center study in early stage

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

    PubMed Central

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

    2016-01-01

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

  20. Catheter-associated urinary tract infection (CAUTI) after term cesarean delivery: incidence and risk factors at a multi-center academic institution.

    PubMed

    Moulton, Laura; Lachiewicz, Mark; Liu, Xiaobo; Goje, Oluwatosin

    2017-02-14

    The purpose of this study is to identify the rate of catheter-associated urinary tract infection (CAUTI) after Cesarean delivery (CD) and to determine if any factors increase risk of infection. A retrospective cohort study was performed at a multi-center institution for patients who underwent CD in 2013. All patients had urinary catheters inserted before surgery. Diagnosis followed IDSA guidelines with culture growing greater than 10(3) CFU of bacteria per mL with symptoms or symptomatic urinary tract infections treated at provider discretion. Statistical analysis was assessed with Chi-square and Student's t-test followed by logistic regression. Of 2419 patients, 36 patients developed CAUTI (1.5%). In the 24 (66.7%) cases diagnosed by IDSA guidelines, Escherichia coli was the most common causative organism (54.1%); followed by Enterococcus faecalis (16.7%), Streptococccus agalactiae (8.3%), and Group A Streptococcus (8.3%). Longer operative time (OR 1.013; 95% 1.002-1.023; p = .02) and pregnancies complicated by STI (OR 4.15; 95% CI 1.11-15.0; p < .05) were associated with higher rates of CAUTI. The overall rate of CAUTI after CD was low at 1.5%. Escherichia coli was the most common causative pathogen. Identification of the patients at high risk for CAUTI allows for risk reduction measures.

  1. Mechanism of action in CBT (MAC): methods of a multi-center randomized controlled trial in 369 patients with panic disorder and agoraphobia.

    PubMed

    Gloster, A T; Wittchen, H U; Einsle, F; Höfler, M; Lang, T; Helbig-Lang, S; Fydrich, T; Fehm, L; Hamm, A O; Richter, J; Alpers, G W; Gerlach, A L; Ströhle, A; Kircher, T; Deckert, J; Zwanzger, P; Arolt, V

    2009-11-01

    Cognitive behavioral therapy (CBT) is efficacious for panic disorder with agoraphobia (PD/A). Nevertheless, the active ingredients of treatment and the mechanisms through which CBT achieves its effects remain largely unknown. The mechanisms of action in CBT (MAC) study was established to investigate these questions in 369 patients diagnosed with PD/A. The MAC study utilized a multi-center, randomized controlled design, with two active treatment conditions in which the administration of exposure was varied, and a wait-list control group. The special feature of MAC is the way in which imbedded experimental, psychophysiological, and neurobiological paradigms were included to elucidate therapeutic and psychopathological processes. This paper describes the aims and goals of the MAC study and the methods utilized to achieve them. All aspects of the research design (e.g., assessments, treatment, experimental procedures) were implemented so as to facilitate the detection of active therapeutic components, and the mediators and moderators of therapeutic change. To this end, clinical, behavioral, physiological, experimental, and genetic data were collected and will be integrated.

  2. Perceptions of Israeli women with breast cancer regarding the role of the Breast Care Nurse throughout all stages of treatment: a multi center study.

    PubMed

    Kadmon, Ilana; Halag, Hana; Dinur, Irit; Katz, Aliza; Zohar, Hana; Damari, Myra; Cohen, Malka; Levin, Elite; Kislev, Livia

    2015-02-01

    The role of the Breast Care Nurse (BCN) is well established in Israel. The purpose of this study is to examine the impact of the BCN on Israeli women with breast cancer at all stages of disease from diagnosis, through treatment and follow-up. This was a descriptive multi-center study on 321 women with non-metastatic breast cancer who completed their treatment <5 years before. Data collection took place in seven institutions in Israel, both in hospital and in the community. The women completed two questionnaires: a demographic questionnaire and the Ipswitch Patient Questionnaire looking at various aspects of care. Also included was one qualitative open question. Data analysis was performed checking for outliers and illogical observations. In most areas investigated the women perceived the overall contribution of the BCN as very high, with 87% reporting a general contribution of very high or high. It was found that 53% of the women received information about the position from the nurse herself. In 61.3% of the cases, initial contact with the BCN was made at the time of diagnosis. The qualitative findings concerning the open question are also reported. According to the perceptions of women with breast cancer in Israel, BCN support is an important part of the patient's ability to manage their diagnosis and related care. The multi-disciplinary breast cancer team should incorporate BCN specialists as part of their holistic care. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Performance of the COBAS® AmpliPrep/COBAS TaqMan® automated system for hepatitis C virus (HCV) quantification in a multi-center comparison.

    PubMed

    Bossler, Aaron; Gunsolly, Cynthia; Pyne, Michael T; Rendo, Angela; Rachel, Jane; Mills, Ray; Miller, Marjorie; Sipley, John; Hillyard, David; Jenkins, Stephen; Essmyer, Cynthia; Young, Steve; Lewinski, Michael; Rennert, Hanna

    2011-02-01

    Quantitative HCV RNA testing is considered standard of care for monitoring during treatment of patients infected with HCV. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test fully automates specimen processing and reaction assembly for HCV viral load testing using reverse transcription and real-time PCR amplification. The performance of the COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test was evaluated in a multi-center study. Typical plasma based specimens were tested for accuracy, analytic range of measurement, reproducibility and genotype specific quantitation. Linear regression analysis of the quantitative results demonstrated a linear range of detection from 50 to 5 million (1.7-6.7 log(10))IU/mL and a coefficient of determination (R(2)) of 0.9948. The precision of the assay was highly reproducible within and between runs and among laboratories with coefficients of variance (CV) ranging from 6.7% to 40.0% across the seven laboratories. A representative sample for each of the six major HCV genotypes demonstrated reproducible quantitation between the seven laboratories. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) HCV Test is a reliable and sensitive assay for HCV RNA quantitation. Copyright © 2010 Elsevier B.V. All rights reserved.

  4. 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.

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

    PubMed Central

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

    2008-01-01

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

  6. 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.

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

    PubMed

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

    2016-05-04

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

  8. 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.

  9. Multi-Center Randomized Controlled Trial on the Effect of Triclosan-Coated Sutures on Surgical Site Infection after Colorectal Surgery.

    PubMed

    Mattavelli, Ilaria; Rebora, Paola; Doglietto, Gianbattista; Dionigi, Paolo; Dominioni, Lorenzo; Luperto, Margherita; La Porta, Angela; Garancini, Mattia; Nespoli, Luca; Alfieri, Sergio; Menghi, Roberta; Dominioni, Tommaso; Cobianchi, Lorenzo; Rotolo, Nicola; Soldini, Gabriele; Valsecchi, Maria Grazia; Chiarelli, Marco; Nespoli, Angelo; Gianotti, Luca

    2015-06-01

    Surgical site infection (SSI) remains the most frequent complication after colorectal resection. The role of sutures coated with antimicrobial agents such as triclosan in reducing SSI is controversial. This was a multi-center randomized controlled trial with patients and outcome assessors blinded to treatment. The study was performed in four university referral hospitals. Patient candidates for elective colorectal resection were assigned randomly to abdominal incision closure with polyglactin 910 triclosan-coated sutures (triclosan group) or with polyglactin 910 without triclosan (control group). The primary outcome was the rate of SSI within 30 d after hospital discharge. The secondary outcomes were the overall rate of incision complications and length of hospital stay (LOS). Two hundred eighty-one patients (triclosan group: 140; control group: 141) were analyzed after randomization. The rate of SSI was 12.9% (18/140) in the triclosan group versus 10.6% (15/141) in the control group (odds ratio: 1.24; 95% confidence interval: 0.60-2.57; p=0.564). Secondary outcome analysis showed an overall incision complication rate of 38.3% in the control group versus 45.7% in the triclosan group (odds ratio: 1.36; 95% confidence interval: 0.84-2.18; p=0.208). Median LOS was 11 d in both groups (p=0.55). Surgical sutures coated with triclosan do not appear to be effective in reducing the rate of SSI.

  10. Between-Scanner and Between-Visit Variation in Normal White Matter Apparent Diffusion Coefficient Values in the Setting of a Multi-Center Clinical Trial.

    PubMed

    Huo, J; Alger, J; Kim, H; Brown, M; Okada, K; Pope, W; Goldin, J

    2016-12-01

    To study the between-scanner variation and the between-visit reproducibility of brain apparent diffusion coefficient (ADC) measurements in the setting of a multi-center chemotherapy clinical trial for glioblastoma multiforme. ADC maps of 52 patients at six sites were calculated in-house from diffusion-weighted images obtained by seven individual scanner models of two vendors. The median and coefficient of variation (CV) of normal brain white matter ADC values from a defined region of interest were used to evaluate the differences among scanner models, vendors, magnetic fields, as well as successive visits. All patients participating in this study signed institutional review board approved informed consent. Data acquisition was performed in compliance with all applicable Health Insurance Portability and Accountability Act regulations. The study spanned from August 1, 2006, to January 29, 2008. For baseline median ADC, no difference was observed between the different scanner models, different vendors, and different magnetic field strength. For baseline ADC CV, a significant difference was found between different scanner models (p = 0.0002). No between-scanner difference was observed in ADC changes between two visits. For between-visit reproducibility, significant difference was seen between the ADC values measured at two successive visits for the whole patient group. The CVs varied significantly between scanners, presumably due to image noise. Consistent scanner parameter setup can improve reproducibility of the ADC measurements between visits.

  11. 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

  12. 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..

  13. 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.

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

    PubMed

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

    2016-03-15

    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.

  15. 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

  16. 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.

  17. 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

  18. 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

    2017-07-01

    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.

  19. Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial.

    PubMed

    Fitzgerald, G K; Fritz, J M; Childs, J D; Brennan, G P; Talisa, V; Gil, A B; Neilson, B D; Abbott, J H

    2016-08-01

    (1) Do treatment effects differ between participants receiving manual therapy (MT) with exercise compared to subjects who don't, (2) are treatment effects sustained better when participants receive booster sessions compared to those who don't over a one year period in subjects with knee osteoarthritis (KOA)? Multi-center, 2 × 2 factorial randomized clinical trial. 300 participants with knee OA were randomized to four groups: exercise-no boosters (Ex), exercise-with boosters (Ex+B), manual therapy+exercise-no boosters (MT+Ex), manual therapy+exercise-with boosters (MT+Ex+B). The primary outcome was the Western Ontario and McMaster osteoarthritis index (WOMAC) at 1 year. Secondary outcomes included knee pain, physical performance tests, and proportions of participants meeting treatment responder criteria. There were no differences between groups on the WOMAC at 1 year or on any performance-based measures. Secondary analyses indicated a) better scores on the WOMAC and greater odds of being a treatment responder at 9 weeks for participants receiving MT, b) greater odds of being a treatment responder at 1 year for participants receiving boosters. Exploratory interaction analysis suggested knee pain decreases for participants receiving boosters and increases for participants not receiving boosters from 9 weeks to 1 year. MT or use of boosters with exercise did not result in additive improvement in the primary outcome at 1 year. Secondary outcomes suggest MT may have some short term benefit, and booster sessions may improve responder status and knee pain at 1 year. However, the role of booster sessions remains unclear in sustaining treatment effects and warrants further study. gov (NCT01314183). Copyright © 2016 Osteoarthritis Research Society International. All rights reserved.

  20. Long-Term Follow-up for Rheumatoid Arthritis Patients in a Multi-center Outcomes Study of Silicone Metacarpophalangeal Joint Arthroplasty

    PubMed Central

    Chung, Kevin C.; Burns, Patricia B.; Kim, H. Myra; Burke, Frank D.; Wilgis, E. F. Shaw; Fox, David A.

    2012-01-01

    Objective Rheumatoid arthritis often results in deformities at the metacarpophalangeal (MCP) joint. Patients with severe deformities can be treated by silicone metacarpophalangeal joint arthroplasty (SMPA). The objective of the study is to prospectively compare long-term outcomes for a SMPA surgical and a non-surgical cohort of rheumatoid arthritis patients. Methods A total of 67 surgical and 95 nonsurgical patients with severe subluxation and/or ulnar drift of the fingers at the MCP joints were recruited from 2004-2008 in this multi-center prospective cohort study. Patients could elect to undergo SMPA or not. Outcomes included the Michigan Hand Outcomes Questionnaire (MHQ), Arthritis Impact Measurement Scales (AIMS2), grip/pinch strength, Jebson-Taylor test and ulnar deviation, extensor lag and arc of motion measurements at the MCP joints. Results There was no significant difference in the mean age, race, education, and income at baseline between the two groups. Surgical subjects had worse MHQ function and functional measurements at baseline. At 3 years, the mean overall MHQ score and the MHQ function, activities of daily living, aesthetics and satisfaction scores showed significant improvement in the surgical group compared to the non-surgical group. Ulnar deviation, extensor lag and arc of motion in the MCP and PIP joints also improved significantly in the surgical group. No improvement was seen in the mean AIMS2 scores and grip/pinch strength. Complications were minimal with a fracture rate of 9.5%. Conclusion RA patients with poor baseline functioning showed long term improvement in hand function and appearance following treatment with SMPA compared to non-surgical controls. PMID:22511483

  1. 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.

  2. 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

  3. A prospective cohort study on the relationship of sleep duration with all-cause and disease-specific mortality in the Korean Multi-center Cancer Cohort study.

    PubMed

    Yeo, Yohwan; Ma, Seung Hyun; Park, Sue Kyung; Chang, Soung-Hoon; Shin, Hai-Rim; Kang, Daehee; Yoo, Keun-Young

    2013-09-01

    Emerging evidence indicates that sleep duration is associated with health outcomes. However, the relationship of sleep duration with long-term health is unclear. This study was designed to determine the relationship of sleep duration with mortality as a parameter for long-term health in a large prospective cohort study in Korea. The study population included 13 164 participants aged over 20 years from the Korean Multi-center Cancer Cohort study. Information on sleep duration was obtained through a structured questionnaire interview. The hazard ratios (HRs) and 95% confidence intervals (CIs) for mortality were estimated using a Cox regression model. The non-linear relationship between sleep duration and mortality was examined non-parametrically using restricted cubic splines. The HRs for all-cause mortality showed a U-shape, with the lowest point at sleep duration of 7 to 8 hours. There was an increased risk of death among persons with sleep duration of ≤5 hours (HR, 1.21; 95% CI, 1.03 to 1.41) and of ≥10 hours (HR, 1.36; 95% CI, 1.07 to 1.72). In stratified analysis, this relationship of HR was seen in women and in participants aged ≥60 years. Risk of cardiovascular disease-specific mortality was associated with a sleep duration of ≤5 hours (HR, 1.40; 95% CI, 1.02 to 1.93). Risk of death from respiratory disease was associated with sleep duration at both extremes (≤5 and ≥10 hours). Sleep durations of 7 to 8 hours may be recommended to the public for a general healthy lifestyle in Korea.

  4. 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

  5. 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).

  6. Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study.

    PubMed

    Xu, Ya-Wei; Wei, Yi-Dong; Tang, Kai; Chen, Yan-Qing; Li, Wei-Ming; Yu, Xue-Jing; Qin, Yong-Wen; Qi, Guo-Xian; Qu, Peng; Hou, Yu-Qing; Jain, Ashok; Grant, Parvez; Ramesh, Gudapati; Ramesh, Basavappa; Piamsomboon, Chumpol; Kuanprasert, Srun; Gwon, Hyeon-Cheol; Cho, Yoon Haeng; Kamar, Haizal Haroon; Huang, Cong-Xin

    2007-06-20

    Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents (BMS)-Multi-link (ML) Vision/ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease (CAD) after implanting the Multi-link Vision or MiniVision stent were investigated in this study. An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS-ML Vision/ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization (TLR) at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study. The average reference diameter of the lesions was (3.0 +/- 0.5) mm, and the mean length was (15.7 +/- 5.0) mm. The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization (TVR) were 6.8%, 3.5% and 1.4% respectively. The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.

  7. "I have to live like I'm old." Young adults' perspectives on managing hypertension: a multi-center qualitative study.

    PubMed

    Johnson, Heather M; Warner, Ryan C; LaMantia, Jamie N; Bowers, Barbara J

    2016-03-11

    In the U.S., young adults (18-39 year-olds) have the lowest hypertension control rates among hypertensive adults. Understanding young adults' unique perceptions about hypertension and perceived barriers to hypertension control is critical to develop effective interventions for this population. This multi-center study explored young adults': 1) emotions and reactions after a hypertension diagnosis, 2) attitudes about managing hypertension (lifestyle changes, follow-up visits, antihypertensive medication use), 3) opinions about their healthcare system's hypertension education materials, and 4) opinions about using social media to manage hypertension. Young adults (18-39 year-olds) with a diagnosis of hypertension and regular primary care access were recruited by the Wisconsin Research and Education Network (WREN). Two focus groups (one per age range: 18-29 years, 30-39 years) were conducted in three Midwestern Family Medicine Clinics (academic, rural, and urban). Conventional content analysis was performed. Thirty-eight young adults (mean: 26.7 [9.6] years old, 34% male, 45% Black, 42% with ≥1 year of college) identified barriers to managing hypertension. Emergent themes overlapped across age groups and geographic regions. Most respondents were surprised and angry about a hypertension diagnosis; they expected to develop hypertension, but at a much older age. A hypertension diagnosis negatively altered their "young" self-identity; suggested behavior changes and antihypertensive medications made them feel "older" than their peers. Young adults missed blood pressure follow-up visits due to co-payments, transportation barriers, and longer than desired wait times for brief visits. Contrary to our hypothesis, most young adults disliked social media or text messaging to support self-management; they were most concerned that their peers would see the hypertension communication. Current hypertension education materials were described as not addressing young adults' health

  8. The effect of class size in grades K-3 on adult earnings, employment, and disability status: evidence from a multi-center randomized controlled trial.

    PubMed

    Wilde, Elizabeth Ty; Finn, Jeremy; Johnson, Gretchen; Muennig, Peter

    2011-11-01

    Early education interventions have been forwarded as a means for reducing social disparities in income and health in adulthood. We explore whether a successful early education intervention, which occurred between 1985 and 1989, improved the employment rates, earnings and health of blacks relative to whites through 2008. We used data from Project STAR (Student Teacher Achievement Ratio), a four-year multi-center randomized controlled trial of reduced class sizes in Tennessee involving 11,601 students. Students were initially randomized within 79 schools to classes with 22-25 or 13-17 students. We linked subject records to Social Security Administration (SSA) earnings and disability data collected between 1997 and 2008-when the majority of subjects were between the ages of 18 and 28. We focused our analysis on annual, rather than cumulative, measures of earnings and employment because educational attainment after high school might reduce earnings through age 23. We considered three or more years of statistically significant positive (or negative) annual impacts to be a meaningful effect. Project STAR improved cognition and high school graduation rates. These benefits were primarily realized among low-income and minority students. These early education benefits did not translate into reduced disability claims in adulthood for treated subjects. However, exposure to small class size increased employment for blacks, and increased earnings for black males (p<0.05). Exposure to small classes also led to an increase in earnings for white males. However, white females exposed to small classes experienced a net decline in earnings and employment across the later years of follow up (p<0.05), offsetting any gains by white males. Exposure to small class size in grades K-3 appears to improve earnings and employment for black males and earnings for white males, while reducing employment and earnings among white females.

  9. Multi-center evaluation of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic hepatitis C.

    PubMed

    Vermehren, Johannes; Yu, Ming-Lung; Monto, Alexander; Yao, Joseph D; Anderson, Christopher; Bertuzis, Rasa; Schneider, George; Sarrazin, Christoph

    2011-10-01

    Hepatitis C virus (HCV) RNA monitoring during antiviral therapy is essential for early prediction of treatment success and failure to peginterferon alfa/ribavirin (PEG-IFN/RBV) therapy. In this multi-center study we assessed the clinical utility of the Abbott RealTime HCV assay for monitoring patients undergoing antiviral therapy for chronic infection with HCV genotypes (GT) 1-3. We analyzed serum from 361 patients with chronic hepatitis C who had been treated with PEG-IFN/RBV. The predictive value of rapid virologic response (RVR), partial (≥2log(10) decline) and complete (HCV-RNA undetectable) early virologic response (pEVR/cEVR) based on RealTime HCV for achieving sustained virologic response was evaluated. In addition, the utility of RealTime HCV to tailor treatment duration according to individual virologic responses was studied in a subset of 136 GT 1 patients and compared to the reference tests, Versant HCV Quantitative 3.0 (bDNA) and Qualitative (TMA) assay. At week 4 of therapy, patients with RVR had a 100% and 93.5% probability to achieve an SVR in GT 1 and GT 2/3 patients, respectively. At week 12, patients who did not achieve a pEVR had a 97.2% and 100% probability of not achieving an SVR. In addition, assignment of GT 1 patients to abbreviated or extended treatment durations based on low baseline HCV-RNA (<800,000IU/mL) and RVR or pEVR was highly concordant between RealTime HCV and bDNA/TMA assays (97.8% and 91.9%, respectively). The RealTime HCV assay is suitable for monitoring virologic response to PEG-INF/RBV therapy and tailoring treatment duration accordingly. Copyright © 2011 Elsevier B.V. All rights reserved.

  10. A multi-center phase II study of sequential paclitaxel and bryostatin-1 (NSC 339555) in patients with untreated, advanced gastric or gastroesophageal junction adenocarcinoma.

    PubMed

    Ajani, Jaffer A; Jiang, Yixing; Faust, Josephine; Chang, Baochong B; Ho, Linus; Yao, James C; Rousey, Steven; Dakhil, Shaker; Cherny, Richard C; Craig, Catherine; Bleyer, Archie

    2006-07-01

    Protein Kinase C (PKC), involved in transmembrane signaling of cell surface receptors, promotes carcinogenesis and tumor progression. Bryostatin-1 competes with PKC for phorbol esters (tumor promoters), thus inhibiting tumor progression. Bryostatin-1 also increases cytotoxicity of paclitaxel in a sequential fashion. We studied sequential paclitaxel and bryostatin-1 in patients with untreated, advanced gastric adenocarcinoma. Patients with histologic proof of gastric or gastroesophageal junction adenocarcinoma with advanced, measurable cancers were eligible. Patients were required to have near normal organ function and ECOG performance status of 0 or 1. All patients gave an informed consent. Patients received paclitaxel 80 mg/m2 in 2 h intravenously on day 1 and bryostatin-1 40 mcg/m2 in 1 h intravenously on day 2 each week for 3 consecutive weeks out of 4. Primary objective was to assess the objective response rate. In a multi-center setting, 37 patients were enrolled and 35 were assessable for response. A confirmed partial response rate was 29%. The median time-to-progression was 4.25 months and the median survival time was 8 months. Grade 3 cumulative myalgias occurred in 55% of patients. Twelve patients discontinued therapy due to myalgias, including 6 patients who had not progressed after achieving a partial response. Other toxic effects were uncommon. Sequential paclitaxel plus bryostatin-1 resulted in a superior response rate than would be expected of paclitaxel alone in patients with untreated, advanced gastric or gastroesophageal junction adenocarcinoma. Further development of this combination is warranted once an effective method to ameliorate or prevent myalgias can be established.

  11. Prevalence of non-syndromic orofacial clefts among Jews and Arabs, by type, site, gender and geography: a multi-center study in Israel.

    PubMed

    Shapira, Yehoshua; Haklai, Ziona; Blum, Itay; Shpack, Nir; Amitai, Yona

    2014-12-01

    Orofacial clefts are the most common craniofacial congenital malformations, with significant anatomic, ethnic, racial and gender differences. To investigate the prevalence, distribution and characteristic features of various types of non-syndromic clefts among Israeli Jews and Arabs. We conducted a retrospective multi-center survey in 13 major hospitals in Israel for the period 1993-2005. To obtain the true prevalence and detailed clinical characteristics, data on liveborn infants with non-syndromic clefts were obtained from the Ministry of Health's National Birth Defect Registry and completed by chart reviews in the 13 surveyed hospitals. Of 976,578 liveborn infants, 684 presented unilateral or bilateral clefts, with a prevalence of 7.00/10,000 live births; 479 were Jews and 205 were Arabs. The prevalence was higher among Arabs compared to Jews (11.12 and 6.22 per 10,000 live births in Arabs and Jews, respectively, P 0.00001). Males had higher cleft rates than females (7.69/10,000 and 6.17/10,000 live births, respectively, P = 0.05). Males had more cleft lips (P < 0.05) and cleft lips with cleft palate (P < 0.001). There was left-side predominance. Newborns of younger mothers (age < 20 years) and of older mothers (age ≥ 45 years) had higher cleft rates than those with mothers in the 20-44 year bracket (P < 0.009). Children born at or above the 5th birth order had a higher cleft rate (P < 0.001). The prevalence of non-syndromic clefts was 7.00/10,000 live births. The markedly higher rate in Arabs is related to the high rate of consanguinity. Both very young and old maternal age represents a higher risk of clefts in their offspring.

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

    PubMed

    Tsukune, Yutaka; Komatsu, Norio

    2016-01-01

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

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

    PubMed

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

    2016-08-01

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

  14. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial.

    PubMed

    Li, Huafang; Gu, Niufan; Zhang, Hongyan; Wang, Gang; Tan, Qingrong; Yang, Fude; Ning, Yuping; Zhang, Honggeng; Lu, Zheng; Xu, Xiufeng; Shi, Jianguo; Gao, Chengge; Li, Lingjiang; Zhang, Kerang; Tian, Hongjun; Wang, Xiaoping; Li, Keqing; Li, Huichun; Xu, Yi; Xie, Shiping; Yu, Xin

    2016-04-01

    Quetiapine extended release (XR) has been used to treat various psychiatric disorders, including depressive episodes associated with bipolar I and II disorders. Quetiapine XR is the first approved drug in China for the treatment of bipolar disorder. The study evaluated the efficacy and safety of short-term quetiapine XR monotherapy in the treatment of depressive episodes of bipolar I and II disorders. This was an 8-week multi-center, randomized, double-blind, placebo-controlled, fixed-dose phase 3 study. The primary endpoint was the mean change of the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Secondary endpoints included Clinical Global Impressions-Bipolar (CGI-BP) and remission rates. The study recruited 279 adult bipolar I or II patients currently experiencing depression from 11 Chinese provinces. Of these, 139 received quetiapine XR (300 mg/day) and 140 received placebo for 8 weeks. The mean change in the MADRS total score was significantly greater in the quetiapine XR group than in the placebo group (-19.00 ± 7.88 vs. -16.20 ± 9.32; p = 0.004). Adverse events occurred in 96 patients (65.3 %) in the quetiapine XR group and 72 (49.0 %) in the placebo group. The incidence of serious adverse events did not differ significantly between the groups (p = 0.247). This study, which is the first to evaluate 300 mg/day quetiapine XR monotherapy for depression in Chinese patients with bipolar disorders, found that this drug was superior to the placebo. Quetiapine XR was generally safe and well tolerated (ClinicalTrials.gov number, NCT01256177).

  15. Inter-vender and test-retest reliabilities of resting-state functional magnetic resonance imaging: Implications for multi-center imaging studies.

    PubMed

    An, Hyeong Su; Moon, Won-Jin; Ryu, Jae-Kyun; Park, Ju Yeon; Yun, Won Sung; Choi, Jin Woo; Jahng, Geon-Ho; Park, Jang-Yeon

    2017-09-06

    This prospective multi-center study aimed to evaluate the inter-vendor and test-retest reliabilities of resting-state functional magnetic resonance imaging (RS-fMRI) by assessing the temporal signal-to-noise ratio (tSNR) and functional connectivity. Study included 10 healthy subjects and each subject was scanned using three 3T MR scanners (GE Signa HDxt, Siemens Skyra, and Philips Achieva) in two sessions. The tSNR was calculated from the time course data. Inter-vendor and test-retest reliabilities were assessed with intra-class correlation coefficients (ICCs) derived from variant component analysis. Independent component analysis was performed to identify the connectivity of the default-mode network (DMN). In result, the tSNR for the DMN was not significantly different among the GE, Philips, and Siemens scanners (P=0.638). In terms of vendor differences, the inter-vendor reliability was good (ICC=0.774). Regarding the test-retest reliability, the GE scanner showed excellent correlation (ICC=0.961), while the Philips (ICC=0.671) and Siemens (ICC=0.726) scanners showed relatively good correlation. The DMN pattern of the subjects between the two sessions for each scanner and between three scanners showed the identical patterns of functional connectivity. The inter-vendor and test-retest reliabilities of RS-fMRI using different 3T MR scanners are good. Thus, we suggest that RS-fMRI could be used in multicenter imaging studies as a reliable imaging marker. Copyright © 2017. Published by Elsevier Inc.

  16. 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

  17. 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

  18. 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

  19. Prospective, randomized, multi-center feasibility trial of rhPDGF-BB versus autologous bone graft in a foot and ankle fusion model.

    PubMed

    Digiovanni, Christopher W; Baumhauer, Judith; Lin, Sheldon S; Berberian, Wayne S; Flemister, Adolph S; Enna, Matthew J; Evangelista, Peter; Newman, June

    2011-04-01

    The increased morbidity and surgical time associated with harvesting autologous bone graft (ABG) have encouraged surgeons to develop synthetic orthobiologic alternatives. The recombinant form of platelet-derived growth factor (rhPDGF-BB), an angiogenic, mitogenic, and chemotactic cytokine, has been shown to significantly enhance bone formation in human periodontal osseous defects when combined with a tricalcium phosphate carrier (β-TCP). The purpose of this prospective, controlled, randomized, multi-center feasibility clinical trial was to compare the safety and efficacy of this biosynthetic bone graft substitute (Augment™ Bone Graft) to ABG during ankle and hindfoot fusion. Twenty adult subjects requiring ankle or hindfoot fusion from three U.S. centers were enrolled and randomized in a 2:1 ratio to receive Augment™ or ABG, respectively. Surgical approach and fixation techniques were standardized, and minimum followup was 9 months. The primary endpoint was radiographic osseous union, evaluated by a blinded independent radiologist. Secondary endpoints included assessment of clinical success, union rate by serial computed tomography (CT) examination, time to full weightbearing, AOFAS Ankle-Hindfoot Score (AOFAS), Foot Function Index (FFI), Short Form-12 (SF-12), and Visual Analog pain assessment Scale (Pain VAS). At 36 weeks, 77% (10/13) of the Augment™ and 50% (3/6) of the ABG patients were fused based on radiographic criteria. There were two nonunions in the Augment™ group (9%, 2/14). Healing rates based on 12 week CT scanning (50% osseous bridging) were 69% (9/13) in the Augment™ and 60% (3/5) in the ABG groups, respectively. All functional outcome measures (FFI, AOFAS, SF-12), as well as the VAS pain scores, improved in both groups over time. Surgical procedure times lasted an average 26 minutes longer for the ABG as compared to the Augment™ populations. There were no device related serious adverse events in this study. Based on the available data

  20. 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

  1. Intra-individual head-to-head comparison of Sirolimus®- and Paclitaxel®-eluting stents for coronary revascularization. A randomized, multi-center trial.

    PubMed

    Kollum, M; Heitzer, T; Schmoor, C; Brunner, M; Witzenbichler, B; Wiemer, M; Hoffmann, R; Gutleben, K J; Schultheiss, H P; Horstkotte, D; Brachmann, J; Meinertz, T; Bode, Ch; Zehender, M

    2013-08-20

    Despite the known effects of drug-eluting stents (DES), other cofactors attributed to patient characteristics affect their success. Interest focused on designing a study minimizing these factors to answer continuing concerns on the heterogeneity of response to different DESs. The study's aim was to investigate the feasibility and impact of an intra-individual comparison design in patients (pts) with two coronary artery stenosis treated with a Sirolimus- (SES) and a Paclitaxel- (PES) eluting stent. The study was conducted as a prospective, randomized, multi-center trial in 112 pts who consented to treatment with a SES and a PES. Pts were eligible if they suffered from the presence of two single primary target lesions in two different native coronary arteries. Lesions were randomized to either SES or PES treatment. The primary endpoint was in-stent luminal late loss (LLL), as determined by quantitative angiography at 8 months; clinical follow up was obtained at 1, 8, and 12 months additionally. The LLL (0.13 ± 0.28 mm SES vs. 0.26 ± 0.35 mm PES, p=0.011) showed less neointima in SES. With a predefined cut-off criterion of 0.2mm difference in LLL, 53/87 pts SES and PES were similar effective. 34/87 pts had a divergent result, 26 pts had greater benefit from SES while 8 pts had greater benefit from PES. Overall, MACE (MI, TLR, and death) occurred in 19 (17%) pts. Based on lesion analysis of 108 lesions treated with SES and 110 lesions treated with PES, 5 (4.6%) lesions with SES and 3 (2.7%) lesions with PES required repeated TLR. An intra-individual comparison design to assess differences in efficacy of different DESs is feasible, safe and achieves similar results to inter-individual studies. This study is among the first to show that failure of one DES does not necessarily implicate failure of another DES and vice versa. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  2. Use of a structured functional evaluation process for independent medical evaluations of claimants presenting with disabling mental illness: rationale and design for a multi-center reliability study.

    PubMed

    Bachmann, Monica; de Boer, Wout; Schandelmaier, Stefan; Leibold, Andrea; Marelli, Renato; Jeger, Joerg; Hoffmann-Richter, Ulrike; Mager, Ralph; Schaad, Heinz; Zumbrunn, Thomas; Vogel, Nicole; Bänziger, Oskar; Busse, Jason W; Fischer, Katrin; Kunz, Regina

    2016-07-29

    Work capacity evaluations by independent medical experts are widely used to inform insurers whether injured or ill workers are capable of engaging in competitive employment. In many countries, evaluation processes lack a clearly structured approach, standardized instruments, and an explicit focus on claimants' functional abilities. Evaluation of subjective complaints, such as mental illness, present additional challenges in the determination of work capacity. We have therefore developed a process for functional evaluation of claimants with mental disorders which complements usual psychiatric evaluation. Here we report the design of a study to measure the reliability of our approach in determining work capacity among patients with mental illness applying for disability benefits. We will conduct a multi-center reliability study, in which 20 psychiatrists trained in our functional evaluation process will assess 30 claimants presenting with mental illness for eligibility to receive disability benefits [Reliability of Functional Evaluation in Psychiatry, RELY-study]. The functional evaluation process entails a five-step structured interview and a reporting instrument (Instrument of Functional Assessment in Psychiatry [IFAP]) to document the severity of work-related functional limitations. We will videotape all evaluations which will be viewed by three psychiatrists who will independently rate claimants' functional limitations. Our primary outcome measure is the evaluation of claimant's work capacity as a percentage (0 to 100 %), and our secondary outcomes are the 12 mental functions and 13 functional capacities assessed by the IFAP-instrument. Inter-rater reliability of four psychiatric experts will be explored using multilevel models to estimate the intraclass correlation coefficient (ICC). Additional analyses include subgroups according to mental disorder, the typicality of claimants, and claimant perceived fairness of the assessment process. We hypothesize that a

  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. Additional benefit of hemostatic sealant in preservation of ovarian reserve during laparoscopic ovarian cystectomy: a multi-center, randomized controlled trial.

    PubMed

    Song, Taejong; Lee, San-Hui; Kim, Woo Young

    2014-08-01

    Is hemostasis by hemostatic sealant superior to that achieved by bipolar coagulation in preserving ovarian reserve in patients undergoing laparoscopic ovarian cystectomy? Post-operative ovarian reserve, determined by serial serum anti-Müllerian hormone (AMH) levels, was significantly less diminished after ovarian hemostasis when hemostatic sealant was used rather than bipolar coagulation. Hemostasis achieved with bipolar coagulation at ovarian bleeding site results in damage to the ovarian reserve. A prospective, multi-center randomized trial was conducted on 100 participants with benign ovarian cysts, between December 2012 and October 2013. Participants were randomized to undergo hemostasis by use of either hemostatic sealant (FloSeal™) or bipolar coagulation during laparoendoscopic single-site (LESS) ovarian cystectomy. The primary end-point was the rate of decline of ovarian reserve calculated by measuring serum AMH levels preoperatively and 3 months post-operatively. Age, parity, socio-demographic variables, preoperative AMH levels, procedures performed and histologic findings were similar between the two groups of patients. There were also no differences in operative outcomes, such as conversion to other surgical approaches, operative time, estimated blood loss, or perioperative complications between the two groups. In both study groups, post-operative AMH levels were lower than preoperative AMH levels (all P < 0.001). The rate of decline of AMH levels was significantly greater in the bipolar coagulation group than the hemostatic sealant group (41.2% [IQR, 17.2-54.5%] and 16.1% [IQR, 8.3-44.7%], respectively, P = 0.004). Some caution is warranted because other ovarian reserve markers such as serum markers (basal FSH and inhibin-B) or sonographic markers were not assessed. The present study shows that the use of a hemostatic sealant during laparoscopic ovarian cystectomy should be considered, as hemostatic sealant provides the additional benefit of

  5. Design of a multi-center immunophenotyping analysis of peripheral blood, sputum and bronchoalveolar lavage fluid in the Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS).

    PubMed

    Freeman, Christine M; Crudgington, Sean; Stolberg, Valerie R; Brown, Jeanette P; Sonstein, Joanne; Alexis, Neil E; Doerschuk, Claire M; Basta, Patricia V; Carretta, Elizabeth E; Couper, David J; Hastie, Annette T; Kaner, Robert J; O'Neal, Wanda K; Paine, Robert; Rennard, Stephen I; Shimbo, Daichi; Woodruff, Prescott G; Zeidler, Michelle; Curtis, Jeffrey L

    2015-01-27

    Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) is a multi-center longitudinal, observational study to identify novel phenotypes and biomarkers of chronic obstructive pulmonary disease (COPD). In a subset of 300 subjects enrolled at six clinical centers, we are performing flow cytometric analyses of leukocytes from induced sputum, bronchoalveolar lavage (BAL) and peripheral blood. To minimize several sources of variability, we use a "just-in-time" design that permits immediate staining without pre-fixation of samples, followed by centralized analysis on a single instrument. The Immunophenotyping Core prepares 12-color antibody panels, which are shipped to the six Clinical Centers shortly before study visits. Sputum induction occurs at least two weeks before a bronchoscopy visit, at which time peripheral blood and bronchoalveolar lavage are collected. Immunostaining is performed at each clinical site on the day that the samples are collected. Samples are fixed and express shipped to the Immunophenotyping Core for data acquisition on a single modified LSR II flow cytometer. Results are analyzed using FACS Diva and FloJo software and cross-checked by Core scientists who are blinded to subject data. Thus far, a total of 152 sputum samples and 117 samples of blood and BAL have been returned to the Immunophenotyping Core. Initial quality checks indicate useable data from 126 sputum samples (83%), 106 blood samples (91%) and 91 BAL samples (78%). In all three sample types, we are able to identify and characterize the activation state or subset of multiple leukocyte cell populations (including CD4+ and CD8+ T cells, B cells, monocytes, macrophages, neutrophils and eosinophils), thereby demonstrating the validity of the antibody panel. Our study design, which relies on bi-directional communication between clinical centers and the Core according to a pre-specified protocol, appears to reduce several sources of variability often seen in flow cytometric

  6. Activating blood circulation to remove stasis treatment of hypertensive intracerebral hemorrhage: A multi-center prospective randomized open-label blinded-endpoint trial.

    PubMed

    Li, Jing-Ya; Yuan, Li-Xin; Zhang, Gen-Ming; Zhou, Li; Gao, Ying; Li, Qing-Bin; Chen, Che

    2016-05-01

    To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation (TRABC) in treatment of hypertensive intracerebral hemorrhage (HICH). This was a multi-center prospective randomized open-label blinded-endpoint (PROBE) trial with HICH admitted to 12 hospitals. Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months. Primary outcome was degree of disability as measured by modified Rankin Scale (mRS). Secondary outcomes were the absorption of hematoma and edema, National Institutes of Health Stroke Scale (NIHSS) scores and patient-reported outcome measures for stroke and Barthel activities of daily living index. Adverse events and mortality were also recorded. After 3 months of treatment, the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5% and 80.4%, respectively, and in the control group 48.1% and 63.9%, respectively, with a significant difference between groups (P<0.01). Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group (P=0.038). Average Barthel scores in the treatment group after treatment was 89.11±19.93, and in the control group 82.18±24.02 (P=0.003). NIHSS scores of the two groups after treatment decreased significantly compared with before treatment (P=0.001). Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment (P<0.05). There were 4 deaths, 2 in each group, and 11 adverse events, 6 in the treatment group and 5 in the control group. The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment, without increasing intracerebral hematoma expansion and re-bleeding.

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

    PubMed Central

    2014-01-01

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

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

    PubMed

    Rohdich, Nadja; Roepke, Rainer K A; Zschiesche, Eva

    2014-03-04

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

  9. 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

  10. 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.

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

    PubMed Central

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

    2015-01-01

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

  12. Study of the e + e - → π+π-π0 process in the energy range 1.05-2.00 GeV

    NASA Astrophysics Data System (ADS)

    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.; Lysenko, A. P.; Martin, K. A.; Obrazovskii, A. E.; Pakhtusova, E. V.; Perevedentsev, E. A.; Romanov, A. L.; Rogovskii, Yu. A.; Serednyakov, S. I.; Silagadze, Z. K.; Skrinskii, A. N.; Surin, I. K.; Tikhonov, Yu. A.; Kharlamov, A. G.; Shtol', D. A.

    2015-07-01

    The cross section for the e + e - → π+π-π0 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 + e - 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.

  13. 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.

  14. High frequency of DQB1*05 and absolute absence of DRB1*13 in muscle-specific tyrosine kinase positive myasthenia gravis.

    PubMed

    Nikolic, A V; Andric, Z P; Simonovic, R B; Rakocevic Stojanovic, V M; Basta, I Z; Bojic, S D; Lavrnic, D V

    2015-01-01

    Myasthenia gravis (MG) is an autoimmune disease but certain genetic factors predispose its development. Since susceptibility to different forms of MG is linked to a number of allelic variants, the aim of this study was to explore the human leukocyte antigen (HLA) profile of our patients with muscle-specific tyrosine kinase (MuSK) MG. Human leukocyte antigen (HLA) typing was performed in our cohort of 31 MuSK MG patients available for the study. The allele groups of DRB1* and DQB1* loci were typed with sequence-specific oligonucleotide probes and high resolution typing for DQB1* was performed using sequence-specific primers. HLA frequencies were compared with unrelated healthy bone marrow donors. Significant association of MuSK MG with alleles DRB1*14 [odds ratio (OR) 3.8], DRB1*16 (OR 3.3) (P < 0.01) and DQB1*05 (OR 2.2) (P < 0.05) was found. In our patients the most frequent DQB1* allele was DQB1*05:02. An absolute absence of DRB1*13 in our cohort of MuSK MG patients was also found, whilst this allele was present in 25% (495/1992) of control subjects (OR 0) (P < 0.01). The HLA DRB1*16-DQB1*05 (OR 2.9) haplotype was found to be associated with MuSK MG (P < 0.05). The strong association of MuSK MG with DQB1*05 alleles observed in patient series from other countries was confirmed. The novel finding in our cohort of MuSK MG patients was the absolute absence of DRB1*13 allele, which might have a protective role in the development of MuSK MG, at least in our population. © 2014 EAN.

  15. Location in the right hemi-colon is an independent risk factor for delayed post-polypectomy hemorrhage: a multi-center case-control study.

    PubMed

    Buddingh, K Tim; Herngreen, Thomas; Haringsma, Jelle; van der Zwet, Wil C; Vleggaar, Frank P; Breumelhof, Ronald; Ter Borg, Frank

    2011-06-01

    Delayed hemorrhage is an infrequent, but serious complication of colonoscopic polypectomy. Large size is the only polyp-related factor that has been unequivocally proven to increase the risk of delayed bleeding. It has been suggested that location in the right hemi-colon is also a risk factor. The objective of this study was to determine whether polyp location is an independent risk factor for delayed post-polypectomy hemorrhage. A retrospective case-control study was conducted in two university hospitals and two community hospitals. Thirty-nine cases and 117 controls were identified. In multivariate analysis, size and location were found to be independent polyp-related risk factors for delayed type hemorrhage. The risk increased by 13% for every 1 mm increase in polyp diameter (odds ratio (OR) 1.13, 95% confidence interval (CI) 1.05-1.20, P<0.001). Polyps located in the right hemi-colon had an OR of 4.67 (1.88-11.61, P=0.001) for delayed hemorrhage. Polyps in the cecum seemed to be especially at high risk in univariate analysis (OR 13.82, 95% CI 2.66-71.73), but this could not be assessed in multivariate analysis as the number of cases was too small. Polyp type (sessile or pedunculated) was not a risk factor. Polyp location in the right hemi-colon seems to be an independent and substantial risk factor for delayed post-polypectomy hemorrhage. A low threshold for preventive hemostatic measures is advised when removing polyps from this region.

  16. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data.

    PubMed

    Engblom, Henrik; Tufvesson, Jane; Jablonowski, Robert; Carlsson, Marcus; Aletras, Anthony H; Hoffmann, Pavel; Jacquier, Alexis; Kober, Frank; Metzler, Bernhard; Erlinge, David; Atar, Dan; Arheden, Håkan; Heiberg, Einar

    2016-05-04

    Late gadolinium enhancement (LGE) cardiovascular magnetic resonance (CMR) using magnitude inversion recovery (IR) or phase sensitive inversion recovery (PSIR) has become clinical standard for assessment of myocardial infarction (MI). However, there is no clinical standard for quantification of MI even though multiple methods have been proposed. Simple thresholds have yielded varying results and advanced algorithms have only been validated in single center studies. Therefore, the aim of this study was to develop an automatic algorithm for MI quantification in IR and PSIR LGE images and to validate the new algorithm experimentally and compare it to expert delineations in multi-center, multi-vendor patient data. The new automatic algorithm, EWA (Expectation Maximization, weighted intensity, a priori information), was implemented using an intensity threshold by Expectation Maximization (EM) and a weighted summation to account for partial volume effects. The EWA algorithm was validated in-vivo against triphenyltetrazolium-chloride (TTC) staining (n = 7 pigs with paired IR and PSIR images) and against ex-vivo high resolution T1-weighted images (n = 23 IR and n = 13 PSIR images). The EWA algorithm was also compared to expert delineation in 124 patients from multi-center, multi-vendor clinical trials 2-6 days following first time ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) (n = 124 IR and n = 49 PSIR images). Infarct size by the EWA algorithm in vivo in pigs showed a bias to ex-vivo TTC of -1 ± 4%LVM (R = 0.84) in IR and -2 ± 3%LVM (R = 0.92) in PSIR images and a bias to ex-vivo T1-weighted images of 0 ± 4%LVM (R = 0.94) in IR and 0 ± 5%LVM (R = 0.79) in PSIR images. In multi-center patient studies, infarct size by the EWA algorithm showed a bias to expert delineation of -2 ± 6 %LVM (R = 0.81) in IR images (n = 124) and 0 ± 5%LVM (R = 0.89) in

  17. Heavy fragment production cross sections from 1.05 GeV/nucleon{sup 56}Fe in C, Al, Cu, Pb and CH{sub 2} targets

    SciTech Connect

    Zeitlin, C.; Heilbronn, L.; Miller, J.; Rademacher, S.; Borak,T.; Carter, T.; Frankel, K.; Schimmerling, W.; Stronach, C.

    1997-04-14

    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 milliradians 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.

  18. 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.

  19. Production of recoil Nei+ ions accompanied by electron loss and capture of 1.05-MeV/amu Neq+ (q=2, 4, 6, 8, and 10) ions

    NASA Astrophysics Data System (ADS)

    Tawara, H.; Tonuma, T.; Kumagai, H.; Matsuo, T.

    1990-01-01

    The charge distributions and production cross sections of recoil ions accompanied by projectile electron loss and capture have been compared in 1.05-MeV/amu Neq+ (q=2, 4, 6, 8, and 10) +Ne collisions. While singly charged recoil ions are dominant in pure ionization processes, the production of highly charged recoil ions is strongly enhanced in collisions involving simultaneous charge change (by both electron loss and capture) of projectiles, and the charge distributions of recoil ions are found to be similar for both projectile loss and capture processes. These results have been analyzed with an independent-electron model and indicate that the dominant contribution to the production of higher-charge recoil ions comes from L-shell ionization, with some contribution from K-shell ionization of targets, accompanied by violent multiple ionization of projectiles.

  20. 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.

  1. Detection of a Bright H2O Maser Burst from G25.65+1.05 at the Simeiz Radio Telescope RT-22

    NASA Astrophysics Data System (ADS)

    Volvach, Alexandr E.; Volvach, Larisa N.; MacLeod, Gordon; Lekht, Evgueny E.; Rudnitskij, Georgij M.; Tolmachev, Alexandr M.

    2017-09-01

    The source of maser emission in 22.235-GHz H2O line in the star-forming region G25.65+1.05 has experienced a new rapid flare. The peak flux density of the main feature at VLSR = 42.5 km/s was: 2017 April 26 - 600 Jy (Simeiz RT-22 radio telescope); 2017 May 12 - 400 Jy (Simeiz); 2017 June 13 - 410 Jy (Simeiz); 2017 July 25 - 316 Jy (Pushchino RT-22 radio telescope); 2017 August 10 - 620 Jy (Simeiz); 2017 August 21 - 840 Jy (HartRAO); 2017 August 25 - 813 Jy (Pushchino); 2017 August 27 - from 1400 Jy to 2500 Jy (Simeiz); 2017 September 7 - 17000 Jy (Simeiz); 2017 September 8 - 20500 Jy (Simeiz); 2017 September 9 - 21000 Jy (HartRAO).

  2. Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.

    PubMed

    Gareen, Ilana F; Sicks, JoRean D; Jain, Amanda Adams; Moline, Denise; Coffman-Kadish, Nancy

    2013-01-01

    In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: The model used by the American College of Radiology arm of the National Lung Screening Trial

    PubMed Central

    Gareen, Ilana F.; Sicks, JoRean; Adams, Amanda; Moline, Denise; Coffman-Kadish, Nancy

    2012-01-01

    Background In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. Methods The framework used to select, request, and track medical records incorporated a participant questionnaire with unique identifiers for each medical provider. De-identified information from the questionnaires was sent to the coordinating center indexed by these identifiers. The central coordinating center selected specific medical providers for abstraction and notified sites using these identifiers. The site personnel then linked the identifiers with medical provider information. Staff at the sites collected medical records and provided them for central abstraction. Results Medical records were successfully obtained and abstracted to ascertain information on outcomes and health care utilization in a study with over 18,000 study participants. Collection of records required for outcomes related to positive screening examinations and lung cancer diagnosis exceeded 90%. Collection of records for all aims was 87.32%. Conclusions We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information. PMID:22982342

  4. 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.

  5. Higher frequencies of HLA DQB1*05:01 and anti-glycosphingolipid antibodies in a cluster of severe Guillain-Barré syndrome.

    PubMed

    Schirmer, L; Worthington, V; Solloch, U; Loleit, V; Grummel, V; Lakdawala, N; Grant, D; Wassmuth, R; Schmidt, A H; Gebhardt, F; Andlauer, T F M; Sauter, J; Berthele, A; Lunn, M P; Hemmer, Bernhard

    2016-10-01

    Few regional and seasonal Guillain-Barré syndrome (GBS) clusters have been reported so far. It is unknown whether patients suffering from sporadic GBS differ from GBS clusters with respect to clinical and paraclinical parameters, HLA association and antibody response to glycosphingolipids and Campylobacter jejuni (Cj). We examined 40 consecutive patients with GBS from the greater Munich area in Germany with 14 of those admitted within a period of 3 months in fall 2010 defining a cluster of GBS. Sequencing-based HLA typing of the HLA genes DRB1, DQB1, and DPB1 was performed, and ELISA for anti-glycosphingolipid antibodies was carried out. Clinical and paraclinical findings (Cj seroreactivity, cerebrospinal fluid parameters, and electrophysiology) were obtained and analyzed. GBS cluster patients were characterized by a more severe clinical phenotype with more patients requiring mechanical ventilation and higher frequencies of autoantibodies against sulfatide, GalC and certain ganglioside epitopes (54 %) as compared to sporadic GBS cases (13 %, p = 0.017). Cj seropositivity tended to be higher within GBS cluster patients (69 %) as compared to sporadic cases (46 %, p = 0.155). We noted higher frequencies of HLA class II allele DQB1*05:01 in the cluster cohort (23 %) as compared to sporadic GBS patients (3 %, p = 0.019). Cluster of severe GBS was defined by higher frequencies of autoantibodies against glycosphingolipids. HLA class II allele DQB1*05:01 might contribute to clinical worsening in the cluster patients.

  6. HLA-DRB1*14 and DQB1*05 are associated with Japanese anti-MuSK antibody-positive myasthenia gravis patients.

    PubMed

    Kanai, Tetsuya; Uzawa, Akiyuki; Kawaguchi, Naoki; Sakamaki, Tateo; Yoshiyama, Yasumasa; Himuro, Keiichi; Oda, Fumiko; Kuwabara, Satoshi

    2016-04-15

    Myasthenia gravis (MG) is an autoimmune disorder presumed to be associated with genetic susceptibility. This study aims to determine whether HLA is associated with MG in Japanese patients. We included 58 MG patients with anti-acetylcholine receptor antibody (AChR+MG) and 14 MG patients with muscle-specific receptor tyrosine kinase (MuSK+MG) and determined HLA-A, B, DRB1 and -DQB1 alleles using polymerase chain reaction with sequence-specific oligonucleotide and primers. AChR+MG was classified into the three subgroups: early-onset MG (EOMG; n=11), late-onset MG (LOMG; n=20), and thymoma-associated MG (n=27). Healthy volunteers (n=100) served as controls. A significant positive association was observed between MuSK+MG with the DRB1*14 [57.1%, MuSK+MG vs. 18.0%, healthy controls (HC); odds ratio (OR): 6.1] and DQB1*05 [78.6%, MuSK+MG vs. 30.0%, HC; odds ratio (OR): 8.5]. We found a negative association between LOMG and DQB1*04 [5.0%, LOMG vs. 37.0%, HC; OR: 0.09]. There was no association between other MG subgroups and HLA alleles. HLA-DRB1*14 and DQB1*05 were associated with MuSK+MG, therefore these alleles may play important roles in developing MuSK+MG across the races. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. 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.

  8. The persistence of the magnetocaloric effect in (La1-xAx)0.67Ba0.33Mn1.05O3-δ

    NASA Astrophysics Data System (ADS)

    Ancona-Torres, C.; Pryds, N.; Theil Kuhn, L.; Bahl, C. R. H.; Linderoth, S.

    2010-10-01

    Polycrystalline samples of (La1-xAx)0.67Ba0.33Mn1.05O3-δ, with A being a mixture of lanthanides containing 66% La, 22% Nd, 8% Pr, and 4% Ce, were prepared by the glycine-nitrate method, with target compositions of x =0, 0.33, 0.67, and 1. The effect of the mixture of lanthanides on the Curie temperature, TC, and the magnetocaloric properties was investigated. The prepared samples are single phase, with space group R3¯c. The lattice parameters and average A-site ionic radius, rA decrease linearly with x while the size disorder, as characterized by the variance, σ2, increases from 0.014 to 0.017 with x. As x is increased, the increase in σ2 drives a linear decrease in TC. The magnetic entropy change, ΔSM, for a field change of 1 T is obtained by magnetization measurements, giving a maximum value of 1.7 J/kg K, and a relative cooling power of 43 J/kg, independent of x. These results suggest that replacing lanthanum with a mixture of lanthanides is a realistic way to tune the working temperature of magnetocaloric manganites while maintaining a constant magnetocaloric effect.

  9. 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

  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. The PRAISE study: a prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749).

    PubMed

    Bärthel, Erik; Rauchfuss, Falk; Hoyer, Heike; Breternitz, Maria; Jandt, Karin; Settmacher, Utz

    2013-01-29

    Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level>2000 IU/ml within the first 7 postoperative days, bilirubine  ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

  16. The efficacy and safety of sodium hyaluronate injection (Adant®) in treating degenerative osteoarthritis: a multi-center, randomized, double-blind, positive-drug parallel-controlled and non-inferiority clinical study.

    PubMed

    Xin, Yang; Jianhao, Lin; Tiansheng, Sun; Yongqiang, Hao; Weimin, Fan; Ming, Chen; Tiezheng, Sun; Jianhua, Yao; Liang, Xuan; Xiaoyuan, Gu; Yongping, Cao

    2016-03-01

    To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. This randomized, multi-center, double-blind, positive-drug, parallel-controlled study included 229 patients aged ≥ 45 years who were clinically diagnosed with degenerative OA of the knee. The patients were randomly assigned to receive for 5 consecutive weeks a once-weekly intra-articular injection of the investigational drug Adant®, which is manufactured by fermentation, or the control drug Artz®, which is manufactured by extraction of cockscomb. The follow-up examinations were conducted 1, 2, 3, 4 and 6 weeks after the first injection. The primary efficacy parameter was the decrease in the visual analog scale (VAS) scores of pain on movement caused by load-bearing, and the secondary efficacy parameter was the decrease in the Lequesne index. The intra-articular injections of Adant® and Artz® produced a significant reduction in the VAS scores for pain on movement (50.4 and 50.3 mm, respectively) and in the Lequesne index. There were no significant differences in efficacy and safety between the two drugs and non-inferiority in VAS score decreases was confirmed. The results of this study show that both Adant® and Artz® are effective for the treatment of OA and that there were no statistical differences between them in the VAS scores of pain on movement, Lequesne index or safety during the observation period with short-time follow up. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

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

    PubMed Central

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

    2014-01-01

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

  18. A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

    PubMed Central

    Singla, Neil; Rock, Amy; Pavliv, Leo

    2010-01-01

    Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

  19. 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

  20. 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

  1. The impact of incidental durotomy on the outcome of decompression surgery in degenerative lumbar spinal canal stenosis: analysis of the Lumbar Spinal Outcome Study (LSOS) data--a Swiss prospective multi-center cohort study.

    PubMed

    Ulrich, Nils H; Burgstaller, Jakob M; Brunner, Florian; Porchet, François; Farshad, Mazda; Pichierri, Giuseppe; Steurer, Johann; Held, Ulrike

    2016-04-18

    Incidental durotomy is a well-known complication during surgery for degenerative lumbar spinal stenosis (DLSS). In this prospective multicenter cohort study including eight medical centers our aim was to assess whether incidental durotomy during first-time lumbar spinal stenosis decompression surgery without fusion has an impact on long-term outcome. Patients of the multi-center Lumbar Stenosis Outcome Study (LSOS) with confirmed DLSS undergoing first-time decompression without fusion were enrolled in this study. Baseline patient characteristics and outcomes were analyzed at 6, 12, and 24 months follow-up respectively with the Spinal Stenosis Measure (SSM), the Numeric Rating Scale (NRS), Feeling Thermometer (FT), the EQ-5D-EL, and the Roland and Morris Disability Questionnaire (RMDQ). A total of 167 patients met the inclusion criteria. Fifteen (9%) of those patients had an incidental durotomy. Baseline characteristics were similar between the durotomy and no-durotomy group. All patients improved over time. In the group of durotomy patients, the median improvement in SSM symptoms scale was 1.1 points at 6 months, 1.1 points at 12 months, and 1.6 points at 24 months after baseline. For the no-durotomy group, these improvements were 0.8, 0.9, and 0.9. For SSM function the improvements were 1.0, 0.8, and 0.9 in the durotomy group, and 0.6, 0.8, and 0.8 in the no-durotomy group. None of the between-group differences were statistically significant. Incidental durotomy in patients with DLSS undergoing first-time decompression surgery without fusion did not have negative effect on long-term outcome and quality of life. However, only 15 patients were included in the durotomy group but these findings remained even after adjusting for observed differences in baseline characteristics.

  2. The Optimal Cut-Off Level of The Fecal Immunochemical Test For Colorectal Cancer Screening in a Country with Limited Colonoscopy Resources: A Multi-Center Study from Thailand

    PubMed Central

    Aniwan, Satimai; Ek, Thawee Ratanachu; Pongprasobchai, Supot; Limsrivilai, Julajak; Praisontarangkul, Ong Ard; Pisespongsa, Pises; Mairiang, Pisaln; Sangchan, Apichat; Sottisuporn, Jaksin; Wisedopas, Naruemon; Kullavanijaya, Pinit; Rerknimitr, Rungsun

    2017-01-01

    Background: Selecting the cut-off point for the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening programs is of prime importance. The balance between the test performance for detecting advanced neoplasia and the available colonoscopy resources should be considered. We aimed to identify the optimal cut-off of FIT for advanced neoplasia in order to minimize colonoscopy burden. Methods: We conducted a multi-center study in 6 hospitals from diverse regions of Thailand. Asymptomatic participants, aged 50-75 years, were tested with one-time quantitative FIT (OC-SENSOR, Eiken Chemical Co.,Ltd., Tokyo, Japan) and all participants underwent colonoscopy. We assessed test performance in detecting advanced neoplasia (advanced adenoma and CRC) and measured the burden of colonoscopy with different cut-offs [25 (FIT25), 50 (FIT50), 100 (FIT100), 150 (FIT150), and 200 (FIT200)ng/ml]. Results: Among 1,479 participants, advanced neoplasia and CRC were found in 137 (9.3%) and 14 (0.9%), respectively. From FIT25 to FIT200, the positivity rate decreased from 18% to 4.9%. For advanced neoplasia, an increased cut-off decreased sensitivity from 42.3% to 16.8% but increased specificity from 84.2% to 96.3%. The increased cut-off increased the positive predictive value (PPV) from 21.5% to 31.5%. However, all cut-off points provided a high negative predictive value (NPV) (>90%). For CRC, the miss rate for FIT25 to FIT 150 was the same (n=3, 21%), whereas that with FIT200 increased to 35% (n=5). Conclusions: In a country with limited-colonoscopy resources, using FIT150 may be preferred because it offers both high PPV and NPV for advanced neoplasia detection. It could also decrease colonoscopy workload, while maintaining a CRC miss rate similar to those with lower cut-offs. PMID:28345822

  3. 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

  4. The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)

    PubMed Central

    2013-01-01

    Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749. PMID:23356494

  5. 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.

  6. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multi-center Trial Testing the Efficacy and Safety of a Novel 0.02% Mechlorethamine Gel in Mycosis Fungoides

    PubMed Central

    Lessin, Stuart R.; Duvic, Madeleine; Guitart, Joan; Pandya, Amit G.; Strober, Bruce E.; Olsen, Elise A.; Hull, Christopher M.; Knobler, Elizabeth H.; Rook, Alain H.; Kim, Ellen J.; Naylor, Mark F.; Adelson, David M.; Kimball, Alexa B.; Wood, Gary S.; Sundram, Uma; Wu, Hong; Kim, Youn H.

    2013-01-01

    Objective Evaluate the efficacy & safety of a novel 0.02% mechlorethamine (MCH) gel in mycosis fungoides (MF). Design Multi-center, randomized, observer-blinded, active controlled trial, comparing 0.02% MCH gel with 0.02% MCH compounded ointment. MCH was applied once daily for up to 12 months. Tumor response and adverse events (AEs) were assessed every month (months 1–6) and every 2 months (months 7–12). Serum drug levels were drawn on a subset of subjects. Setting Academic medical and/or cancer centers Patients 260 Stage IA-IIA MF patients who had not used topical MCH within 2 years and were naïve to prior use of topical carmustine therapy. Main Outcome Measures Response rates (RRs) of all subjects based on primary (composite assessment of index lesion severity - CAILS) and secondary (modified severity weighted assessment tool (mSWAT) and time to response analyses) clinical endpoints. Results RR for MCH gel and ointment were 59% vs. 48% by CAILS and 46.9% vs. 46.2% by mSWAT, respectively. The ratio of CAILS RR of MCH gel to ointment was 1.23 (CI: 0.97–1.55), which met the pre-specified criterion for non-inferiority. Time to response demonstrated superiority of MCH gel to ointment (p<0.012). No drug-related serious AEs were seen. Twenty percent (20%) of enrolled patients on gel and 17% on ointment withdrew due to drug-related skin irritation. No systemic absorption of the study medication was detected. Conclusions These results demonstrate the safety and efficacy of a novel 0.02% MCH gel in the treatment of MF patients. Clinical Trial Registration NCT00168064 PMID:23069814

  7. 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

  8. Quality of oral anticoagulation with phenprocoumon in regular medical care and its potential for improvement in a telemedicine-based coagulation service--results from the prospective, multi-center, observational cohort study thrombEVAL.

    PubMed

    Prochaska, Jürgen H; Göbel, Sebastian; Keller, Karsten; Coldewey, Meike; Ullmann, Alexander; Lamparter, Heidrun; Jünger, Claus; Al-Bayati, Zaid; Baer, Christina; Walter, Ulrich; Bickel, Christoph; ten Cate, Hugo; Münzel, Thomas; Wild, Philipp S

    2015-01-23

    The majority of studies on quality of oral anticoagulation (OAC) therapy with vitamin K-antagonists are performed with short-acting warfarin. Data on long-acting phenprocoumon, which is frequently used in Europe for OAC therapy and is considered to enable more stable therapy adjustment, are scarce. In this study, we aimed to assess quality of OAC therapy with phenprocoumon in regular medical care and to evaluate its potential for optimization in a telemedicine-based coagulation service. In the prospective observational cohort study program thrombEVAL we investigated 2,011 patients from regular medical care in a multi-center cohort study and 760 patients from a telemedicine-based coagulation service in a single-center cohort study. Data were obtained from self-reported data, computer-assisted personal interviews, and laboratory measurements according to standard operating procedures with detailed quality control. Time in therapeutic range (TTR) was calculated by linear interpolation method to assess quality of OAC therapy. Study monitoring was carried out by an independent institution. Overall, 15,377 treatment years and 48,955 international normalized ratio (INR) measurements were analyzed. Quality of anticoagulation, as measured by median TTR, was 66.3% (interquartile range (IQR) 47.8/81.9) in regular medical care and 75.5% (IQR 64.2/84.4) in the coagulation service (P <0.001). Stable anticoagulation control within therapeutic range was achieved in 63.8% of patients in regular medical care with TTR at 72.1% (IQR 58.3/84.7) as compared to 96.4% of patients in the coagulation service with TTR at 76.2% [(IQR 65.6/84.7); P = 0.001)]. Prospective follow-up of coagulation service patients with pretreatment in regular medical care showed an improvement of the TTR from 66.2% (IQR 49.0/83.6) to 74.5% (IQR 62.9/84.2; P <0.0001) in the coagulation service. Treatment in the coagulation service contributed to an optimization of the profile of time outside therapeutic range, a

  9. 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.

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

    PubMed Central

    2014-01-01

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

  11. Shared decision-making in end-stage renal disease: a protocol for a multi-center study of a communication intervention to improve end-of-life care for dialysis patients.

    PubMed

    Eneanya, Nwamaka D; Goff, Sarah L; Martinez, Talaya; Gutierrez, Natalie; Klingensmith, Jamie; Griffith, John L; Garvey, Casey; Kitsen, Jenny; Germain, Michael J; Marr, Lisa; Berzoff, Joan; Unruh, Mark; Cohen, Lewis M

    2015-06-12

    End-stage renal disease carries a prognosis similar to cancer yet only 20 % of end-stage renal disease patients are referred to hospice. Furthermore, conversations between dialysis team members and patients about end-of-life planning are uncommon. Lack of provider training about how to communicate prognostic data may contribute to the limited number of end-of-life care discussions that take place with this chronically ill population. In this study, we will test the Shared Decision-Making Renal Supportive Care communication intervention to systematically elicit patient and caretaker preferences for end-of-life care so that care concordant with patients' goals can be provided. This multi-center study will deploy an intervention to improve end-of-life communication for hemodialysis patients who are at high risk of death in the ensuing six months. The intervention will be carried out as a prospective cohort with a retrospective cohort serving as the comparison group. Patients will be recruited from 16 dialysis units associated with two large academic centers in Springfield, Massachusetts and Albuquerque, New Mexico. Critical input from patient advisory boards, a stakeholder panel, and initial qualitative analysis of patient and caretaker experiences with advance care planning have informed the communication intervention. Rigorous communication training for hemodialysis social workers and providers will ensure that standardized study procedures are performed at each dialysis unit. Nephrologists and social workers will communicate prognosis and provide advance care planning in face-to-face encounters with patients and families using a social work-centered algorithm. Study outcomes including frequency and timing of hospice referrals, patient and caretaker satisfaction, quality of end-of-life discussions, and quality of death will be assessed over an 18 month period. The Shared Decision-Making Renal Supportive Care Communication intervention intends to improve discussions

  12. Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial.

    PubMed

    Burton, Nicola W; Ademi, Zanfina; Best, Stuart; Fiatarone Singh, Maria A; Jenkins, Jason S; Lawson, Kenny D; Leicht, Anthony S; Mavros, Yorgi; Noble, Yian; Norman, Paul; Norman, Richard; Parmenter, Belinda J; Pinchbeck, Jenna; Reid, Christopher M; Rowbotham, Sophie E; Yip, Lisan; Golledge, Jonathan

    2016-11-09

    Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... required by section 605(b) of the Regulatory Flexibility Act (Sec. 605(b), Pub. L. 96-354, 94 Stat. 1168 (5..., organizational, and conforming amendments and corrections to rules, regulations, and notices. (i) The Commandant...

  3. 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...

  4. 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

  5. 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)...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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.

  12. Current adoption of lung ultrasound in Intensive Care Units: an Italian multi-center survey.

    PubMed

    Calamai, Italo; Greco, Massimiliano; Bertolini, Guido; Spina, Rosario

    2017-07-01

    Lung ultrasound (LUS) is a useful tool for assessing lung status in critically ill patients, but is not widely applied in intensive care units (ICUs). The aim of this study was to investigate the use of LUS in Italian ICUs. A questionnaire was distributed to 116 ICU representatives belonging to the Italian GiViTI network, participating in a national project on continuous quality of care assessment. The answers to the questionnaire were analyzed with the data collected in the course of said project. 87 ICUs took part in the study. LUS was performed in 94.3% of them, generally by an internal intensivist. The mean number of tests per bed per week was 0.97 (SD, 1.0). A standardized reporting format was present in only 11% of ICUs. LUS was generally used to investigate known or suspected diseases and as a screening tool in only 10%. The number of testes per bed per week was inversely correlated to the number of beds per physician (P<0.001) and to the provider performing the LUS (P<0.001), but not to other structural, organizational or performance data. LUS is performed in the majority of ICUs and is generally used to investigate known or suspected diseases. Frequency of use appears to be low and related to selected organizational factors. There is generally no standardized format for reporting LUS findings.

  13. 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

  14. 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

  15. 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

  16. 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。.

  17. 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.

  18. Impact of disclosure of individual imaging results in a multi-center Parkinson clinical trial.

    PubMed

    Jennings, Danna; Eberly, Shirley; Oakes, David; Seibyl, John; Marek, Ken; Shoulson, Ira

    2014-01-01

    Little is known about the impact of providing individual research results to clinical trial participants or the impact of sharing such data. The objective of this follow-up study was to evaluate the desire of participants for learning their imaging results and the impact of this information on their perception of their PD diagnosis and care. The Parkinson Research Examination of CEP-1347 Trial (PRECEPT) evaluated the experimental treatment CEP-1347 obtaining dopamine transporter imaging at baseline and 22 months as a secondary outcome. Dopamine transporter imaging and results were categorized as 'dopamine transporter deficit', 'no dopamine transporter deficit' or 'indeterminate.' Self-administered surveys were provided on three occasions to subjects who chose to learn their dopamine transporter imaging results: prior to receiving imaging data, immediately following receipt of imaging information, and three months following image disclosure. 656/777 subjects (84.4%) consented to receive their individual imaging data, comprising overall result categories of 86.3% 'dopamine transporter deficit', 10.4% 'no dopamine transporter deficit', and 3.4% 'indeterminate.' 99.6% of subjects believed their decision to receive data was correct. Following disclosure of imaging results, 97% of the 'dopamine transporter deficit' and 'indeterminate' subjects believed they had Parkinson disease compared with 34% of 'no dopamine transporter deficit' subjects. About 45% of participants reported that learning individual imaging data resulted in improved understanding of their diagnosis. The majority of research participants chose to learn their individual dopamine transporter imaging results and were satisfied with their decision. Disclosure of imaging information resulted in improved understanding of parkinsonian symptoms in nearly half of subjects, and less belief among 'no dopamine transporter deficit' subjects that they had a diagnosis of Parkinson disease.

  19. 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.

  20. 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

  1. Neurosurgical management of adult diffuse low grade gliomas in Canada: a multi-center survey.

    PubMed

    Khan, Osaama H; Mason, Warren; Kongkham, Paul N; Bernstein, Mark; Zadeh, Gelareh

    2016-01-01

    Adult diffuse low-grade gliomas are slow growing, World Health Organization grade II lesions with insidious onset and ultimate anaplastic transformation. The timing of surgery remains controversial with polarized practices continuing to govern patient management. As a result, the management of these patients is variable. The goal of this questionnaire was to evaluate practice patterns in Canada. An online invitation for a questionnaire including diagnostic, preoperative, perioperative, and postoperative parameters and three cases with magnetic resonance imaging data with questions to various treatment options in these patients was sent to practicing neurosurgeons and trainees. Survey was sent to 356 email addresses with 87 (24.7%) responses collected. The range of years of practice was less than 10 years 36% (n = 23), 11-20 years 28% (n = 18), over 21 years 37% (n = 24). Twenty-two neurosurgery students of various years of training completed the survey. 94% (n = 47) of surgeons and trainees (n = 20) believe that we do not know the "right treatment". 90% of surgeons do not obtain formal preoperative neurocognitive assessments. 21% (n = 13) of surgeons and 23% of trainees (n = 5) perform a biopsy upon first presentation. A gross total resection was believed to increase progression free survival (surgeons: 75%, n = 46; trainees: 95%, n = 21) and to increase overall survival (surgeons: 64%, n = 39, trainees: 68%, n = 15). Intraoperative MRI was only used by 8% of surgeons. Awake craniotomy was the procedure of choice for eloquent tumors by 80% (n = 48) of surgeons and 100% of trainees. Of those surgeons who perform awake craniotomy 93% perform cortical stimulation and 38% performed subcortical stimulation. Using the aid of three hypothetical cases with progressive complexities in tumor eloquence there was a trend for younger surgeons to operate earlier, and use awake craniotomy to obtain greater extent of resection with the aid of cortical stimulation when compared to senior surgeons who still more often preferred a "wait-and-see" approach. Despite the limitations of an online survey study, it has offered insights into the variability in surgeon practice patterns in Canada and the need for a consensus on the workup and surgical management of this disease.

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

    DTIC Science & Technology

    2015-04-01

    increase (pɘ.05). CPRBCs contained significantly less α2-macrogobulin, haptoglobin, c- reactive protein, serum amyloid P, and free hemoglobin than the...Over Time ............12 6 Comparison of Circulating Free Hemoglobin Levels (ng/mL) in Trauma Patients ..........12 7 Comparison of...increase (pɘ.05). CPRBCs contained significantly less α2-macrogobulin, haptoglobin, C-reactive protein, serum amyloid P, and free hemoglobin than

  3. 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.

  4. [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.

  5. 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

  6. Clinical usefulness of double balloon enteroscopy in suspected Crohn's disease: the KASID multi-center trial.

    PubMed

    Jang, Hyun Joo; Choi, Min Ho; Eun, Chang Soo; Choi, Hwang; Choi, Kyu Yong; Park, Dong Il; Park, Jung Ho; Chang, Dong Kyung; Kim, Jin Oh; Ko, Bong Min; Huh, Kyu Chan; Byeon, Jeong Sik; Choi, Ki don; Choi, Jae Hyun; Shin, Sung Jae; Kae, Sea Hyub; Lee, Moon Sung

    2014-01-01

    The recently developed double balloon enteroscopy (DBE) may be useful to evaluate small bowel lesions in patients with suspected Crohn’s disease (CD). We investigated the findings of DBE, small bowel follow-through and abdominal CT in patients with suspected CD who could not be diagnosed with CD using conventional colonoscopy. Thirty patients (27 males, mean age 32.7±9.27 years) with suspected CD were consecutively enrolled in this study. The main symptoms were abdominal pain, chronic diarrhea, weight loss, obscure bleeding, or anemia. These patients were enrolled from May 2006 to January 2007 at 10 tertiary medical centers participating in the Korean Association for the Study of Intestinal Diseases. The DBE demonstrated definite CD in 24 patients (80.0%) and suspected findings of CD in six patients. The pathology results obtained by endoscopic biopsies revealed a granuloma in six patients (23.1%). The DBE identified additional findings not detected by radiology studies in 24 patients (80%) although the small bowel followthrough and the abdominal CT revealed the abnormal findings (73.1% and 64%). DBE may be a promising alternative and useful technique for patients with suspected CD. DBE provides biopsy sampling and more detailed information than radiology studies.

  7. [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.

  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. 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.

  10. 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..

  11. 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.

  12. 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.

  13. Illness perceptions in adult congenital heart disease: A multi-center international study.

    PubMed

    Rassart, Jessica; Apers, Silke; Kovacs, Adrienne H; Moons, Philip; Thomet, Corina; Budts, Werner; Enomoto, Junko; Sluman, Maayke A; Wang, Jou-Kou; Jackson, Jamie L; Khairy, Paul; Cook, Stephen C; Subramanyan, Raghavan; Alday, Luis; Eriksen, Katrine; Dellborg, Mikael; Berghammer, Malin; Johansson, Bengt; Rempel, Gwen R; Menahem, Samuel; Caruana, Maryanne; Veldtman, Gruschen; Soufi, Alexandra; Fernandes, Susan M; White, Kamila S; Callus, Edward; Kutty, Shelby; Luyckx, Koen

    2017-10-01

    Illness perceptions are cognitive frameworks that patients construct to make sense of their illness. Although the importance of these perceptions has been demonstrated in other chronic illness populations, few studies have focused on the illness perceptions of adults with congenital heart disease (CHD). This study examined (1) inter-country variation in illness perceptions, (2) associations between patient characteristics and illness perceptions, and (3) associations between illness perceptions and patient-reported outcomes. Our sample, taken from APPROACH-IS, consisted of 3258 adults with CHD from 15 different countries. Patients completed questionnaires on illness perceptions and patient-reported outcomes (i.e., quality of life, perceived health status, and symptoms of depression and anxiety). Patient characteristics included sex, age, marital status, educational level, employment status, CHD complexity, functional class, and ethnicity. Linear mixed models were applied. The inter-country variation in illness perceptions was generally small, yet patients from different countries differed in the extent to which they perceived their illness as chronic and worried about their illness. Patient characteristics that were linked to illness perceptions were sex, age, employment status, CHD complexity, functional class, and ethnicity. Higher scores on consequences, identity, and emotional representation, as well as lower scores on illness coherence and personal and treatment control, were associated with poorer patient-reported outcomes. This study emphasizes that, in order to gain a deeper understanding of patients' functioning, health-care providers should focus not only on objective indicators of illness severity such as the complexity of the heart defect, but also on subjective illness experiences. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    PubMed

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

    2016-04-01

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

  15. Mechanical ventilation in ICUs in Poland: a multi-center point-prevalence study.

    PubMed

    Kübler, Andrzej; Maciejewski, Dariusz; Adamik, Barbara; Kaczorowska, Małgorzata

    2013-06-03

    Mechanical ventilation is the primary method of supporting organ function in patients treated in intensive care units (ICUs). Lung damage from mechanical ventilation can be avoided by using the correct ventilation modes. This study was designed to assess the epidemiology and treatment strategies of patients receiving mechanical ventilation in ICUs in Poland. This study was done using a point-prevalence methodology. Questionnaires requesting demographic data, indications for ventilation, variables involved in ventilation, airway access, methods of sedation, and mode of weaning were sent to 148 ICUs. Eighty-three ICUs took part in the study. The rate of ventilated patients was 73.6%. The indications for mechanical ventilation were: acute respiratory failure (40%), coma (40%), chronic obstructive pulmonary disease (COPD) exacerbation (14%), and neuromuscular diseases (5%). Patients were ventilated by orotracheal tube (58%), tracheostomy tube (41%), and mask/helmet (1%). The mean tidal volume was 8 ml/kg and positive end-expiratory pressure was commonly used. The mean oxygen concentration was 40%. Synchronized intermittent mandatory ventilation with pressure support was the most frequently used ventilatory mode. Benzodiazepine and opioids were used for sedation in 91% of centers. A systematic testing of the depth of sedation was performed at 48% surveyed ICUs. Ventilation monitoring with biomechanical methods was used at 53% of centers. Mechanical ventilation is commonly used in ICUs in Poland. Almost half of the ventilated patients had extrapulmonary indications. Patients were ventilated with low concentrations of oxygen, and positive end-expiratory pressure (PEEP) was commonly employed.

  16. Mechanical ventilation in ICUs in Poland: A multi-center point-prevalence study

    PubMed Central

    Kübler, Andrzej; Maciejewski, Dariusz; Adamik, Barbara; Kaczorowska, Małgorzata

    2013-01-01

    Background Mechanical ventilation is the primary method of supporting organ function in patients treated in intensive care units (ICUs). Lung damage from mechanical ventilation can be avoided by using the correct ventilation modes. This study was designed to assess the epidemiology and treatment strategies of patients receiving mechanical ventilation in ICUs in Poland. Material/Methods This study was done using a point-prevalence methodology. Questionnaires requesting demographic data, indications for ventilation, variables involved in ventilation, airway access, methods of sedation, and mode of weaning were sent to 148 ICUs. Results Eighty-three ICUs took part in the study. The rate of ventilated patients was 73.6%. The indications for mechanical ventilation were: acute respiratory failure (40%), coma (40%), chronic obstructive pulmonary disease (COPD) exacerbation (14%), and neuromuscular diseases (5%). Patients were ventilated by orotracheal tube (58%), tracheostomy tube (41%), and mask/helmet (1%). The mean tidal volume was 8 ml/kg and positive end-expiratory pressure was commonly used. The mean oxygen concentration was 40%. Synchronized intermittent mandatory ventilation with pressure support was the most frequently used ventilatory mode. Benzodiazepine and opioids were used for sedation in 91% of centers. A systematic testing of the depth of sedation was performed at 48% surveyed ICUs. Ventilation monitoring with biomechanical methods was used at 53% of centers. Conclusions Mechanical ventilation is commonly used in ICUs in Poland. Almost half of the ventilated patients had extrapulmonary indications. Patients were ventilated with low concentrations of oxygen, and positive end-expiratory pressure (PEEP) was commonly employed. PMID:23727991

  17. 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

  18. 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.

  19. Urinary bladder cancer risk factors in Egypt: a multi-center case-control study

    PubMed Central

    Zheng, Yun-Ling; Amr, Sania; Saleh, Doa’a A.; Dash, Chiranjeev; Ezzat, Sameera; Mikhail, Nabiel N.; Gouda, Iman; Loay, Iman; Hifnawy, Tamer; Abdel-Hamid, Mohamed; Khaled, Hussein; Wolpert, Beverly; Abdel-Aziz, Mohamed A.; Loffredo, Christopher A.

    2011-01-01

    Background We investigated associations between tobacco exposure, history of schistosomiasis and bladder cancer risk in Egypt. Methods We analyzed data from a case-control study (1,886 newly diagnosed and histologically confirmed cases and 2,716 age-, gender-, and residence-matched, population-based controls). Using logistic regression we estimated the covariate-adjusted odds ratios (OR) and 95% confidence interval (CI) of the associations. Results Among men, cigarette smoking was associated with an increased risk of urothelial carcinoma (UC) (OR = 1.8, 95% CI = 1.4, 2.2), but not squamous cell carcinoma (SCC); smoking both waterpipes and cigarettes was associated with an even greater risk for UC (OR = 2.9, 95% CI = 2.1, 3.9) and a statistically significant risk for SCC (OR = 1.8, 95% CI = 1.2, 2.6). Among non-smoking men and women, to environmental tobacco smoke exposure was associated with an increased risk of UC. History of schistosomiasis was associated with increased risk of both UC (OR = 1.9, 95% CI = 1.2, 2.9) and SCC (OR = 1.9, 95% CI = 1.2, 3.0) in women and to a lesser extent (OR = 1.4, 95% CI = 1.2, 1.7 and OR = 1.4, 95% CI = 1.1, 1.7, for UC and SCC respectively) in men. Conclusions The results suggest that schistosomiasis and tobacco smoking increase the risk of both SCC and UC. Impact This study provides new evidence for associations between bladder cancer subtypes and schistosomiasis, and suggests that smoking both cigarettes and waterpipes increases the risk for SCC and UC in Egyptian men. PMID:22147365

  20. [Treatment of diabetic nephropathy by integrative medicine: a multi-center prospective cohort study].

    PubMed

    Li, Qing; Zhang, Hui-Min; Fei, Yu-Tong

    2012-03-01

    To assess the efficacy and safety of integrative medicine (IM) treatment for diabetic nephropathy (DN), and to explore the medication laws by Chinese medicine (CM) syndrome typing. One hundred and seventy outpatients or inpatients with DN at Dongfang Hospital of Beijing University of Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, and China-Japan Friendship Hospital of the Ministry of Health were recruited from March 2008 to July 2009. They were allocated into the IM group (116 cases) or the Western medicine group (54 cases) according to whether or not they were willing to receive CM syndrome typing. The incidence of endpoint events and secondary outcome measures [such as body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), urinary albumin excretion rate (UAER), 24 h urinary protein (24 hU), serum creatinine (SCr), fasting blood glucose (FBG), and glycosylated hemoglobin (HbA1c)] of two groups were observed at 3, 6, 12, 18, and 24 months respectively during the follow-ups. Patients in the IM group were syndrome typed. The CM recipes were collected to calculate the frequency of Chinese materia medica used. The liver function, blood routines, and ECG were observed and compared during the follow-ups. The follow-up period was 3 to 24 months with the mean of 14 months. Data suitable for analysis mainly covered the 3rd, 6th, 12th and 18th month of the follow-up. Both PPS and FAS analysis showed that there were no significant difference in the incidence of endpoint between two groups (11.2% vs 7.4%, P>0.05). The level of body mass index (BMI) [(25.0 +/- 3.1) kg/m2] and fasting blood glucose (FBG) [(7.9 +/- 1.5) mmol/L] in the IM group were lower than those of the Western medicine group [(28.6 +/- 4.4) kg/m2 and (8.8 +/- 2.9) mmol/L respectively] at the 6-month follow-up (P<0.05). The levels of FBG [(7.9 +/- 1.4) mmol/L] and HbA1c [(7.8 +/- 1.4)%] in the IM group were lower than those of the Western medicine group [(9.6 +/- 2.8) mmol/L and (8.5 +/- 1.6)% respectively] at the 12-month follow-up (P<0.05). There was no significant difference in other indices between the two groups at the 3- or 12-month follow-ups. The level of SCr in the IM group and the Western medicine group before follow-up were (96.8 +/- 35.2) micromol/L and (80.5 +/- 24.6) micromol/L respectively, showing statistical difference (P<0.01). There were no significance difference in SCr between the two groups at 3, 6, 12, 18-month follow-ups for center 2 (Xiyuan Hospital of China Academy of Chinese Medical Sciences) and center 3 (China-Japan Friendship Hospital of the Ministry of Health), while the level of SCr in the IM group [(82.4 +/- 25.7) micromol/L, (78.1 +/- 25.9) micromol/L, (80.3 +/- 24.0) micromol/L, respectively] were lower than that of the Western medicine group [(101.4 +/- 37.2) micromol/L, (96.5 +/- 34.1) micromol/L, (93.9 +/- 25.9) micromol/L, respectively] for center 1 (Dongfang Hospital of Beijing University of Chinese Medicine) at 3, 6, 12-month follow-ups (P<0.05). The top ten drugs used most frequently in the 237 prescriptions collected was astragali (68.4%), ophiopogonis tube (67.5%), rehmannia dried rhizome (67.1%), danshen root (49.4%), Codonopsis pilosula (41.8%), figwort root (35.4%), Chinese magnolia-vine fruit (29.5%), safflower (27.9%), peach seed (26.2%), and angelica root (25.3%). There was no abnormal liver function, blood abnormalities, and serious adverse events in two groups during the follow-ups. CM treatment based on syndrome typing in combination with routine Western medicine for DN could reduce the levels of BMI, FBG, HbA1c, and SCr at partial time points, showing favorable safety. Chinese medicinals applied in treatment based on syndrome typing for DN covered mainly supplementing qi, nourishing yin, and activating blood circulation to remove blood stasis.

  1. 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.

  2. Characteristics of Clinically Diagnosed Pediatric Myocarditis in a Contemporary Multi-Center Cohort.

    PubMed

    Butts, Ryan J; Boyle, Gerard J; Deshpande, Shriprasad R; Gambetta, Katheryn; Knecht, Kenneth R; Prada-Ruiz, Carolina A; Richmond, Marc E; West, Shawn C; Lal, Ashwin K

    2017-08-01

    The objective of this study was to describe a contemporary cohort of pediatric patients hospitalized for clinically suspected myocarditis. A retrospective chart review was performed at seven tertiary pediatric hospitals. Electronic medical records were searched between 2008 and 2012 for patients ≤18 years admitted with an ICD-9 code consistent with myocarditis. Patients were excluded if the admitting or consulting cardiologist did not suspect myocarditis during the admission or an alternative diagnosis was determined. One hundred seventy-one patients were discharged or died with a primary diagnosis of myocarditis. Median age was 13.1 years (IQR 2.1, 15.9), with a bimodal distribution; 24% <2 years and 46% between 13 and 18 years. Patients with moderate or severe systolic dysfunction were younger, had higher BNPs at admission, but had lower troponin. Mortality, heart transplantation, and readmission did not differ between patients who received only IVIG, only steroids, IVIG and steroids, and no immunotherapy. Ninety-four patients (55%) were discharged on heart failure medications, 16 were transplanted, and seven died. The presence at the time of admission of gastrointestinal (GI) symptoms (p = 0.01) and lower echo shortening fraction (SF) (p < 0.01) was associated with death/transplant. Within one year 16% had a readmission, one underwent heart transplant, and 39% received heart failure therapy. Pediatric myocarditis has a bimodal age distribution. The use of IVIG and steroids is not associated with mortality/heart transplantation. The presence of GI symptoms and lower echo SF may identify patients at risk for death and/or transplantation during the admission.

  3. 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

  4. Comparative cost-effectiveness of three intrauterine devices: a multi-center randomized trial.

    PubMed

    Wen, Jin; Li, Ying; Li, Youping; Wang, Li; Zhou, Jian; Ba, Lei; Shen, Suqi; Wu, Yulin

    2010-05-01

    To determine the relative cost-effectiveness of three intrauterine devices (IUDs), MLCu375, TCu380A, and YuangongCu365. Cost-effectiveness of three IUDs, namely MLCu375, TCu380A, and YuangongCu365, was analyzed from the provider's perspective by means of a randomized trial with one-year follow-up carried out in six centers in China. YuangongCu 365 had the lowest termination and pregnancy rates (4.17% and 0.54%, respectively), followed by TCu380A (8.59% and 1.11%, respectively) and MLCu375 (14.17% and 2.04%, respectively). YuangongCu365 was more effective yet more costly than the MLCu375. There was a favorably dominating trend of cost-effectiveness for TCu380A comparing with MLCu375 when taking continuation rate as the effectiveness indicator, but there was no difference in cost-effectiveness between the two IUDs when using the pregnancy avoidance rate as the effectiveness measure. TCu380A is slightly more cost-effective than the MLCu375. YuangongCu365 is the most effective of the three devices and be used provided it is economically affordable. The comparative long-term safety and cost-effectiveness of these devices need to be further investigated. © 2010 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

  5. 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. © 2014 The Authors. American Journal of Transplantation Published by Wiley Periodicals, Inc. on behalf of American Society of Transplant Surgeons.

  6. Lifestyles and health risks of collegiate athletes: a multi-center study.

    PubMed

    Nattiv, A; Puffer, J C; Green, G A

    1997-10-01

    To determine whether college athletes are at greater risk for maladaptive lifestyle and health-risk behaviors than their nonathletic peers and to identify high risk taking groups by gender, sport, and other identifiers. Multicenter, cross-sectional study. Seven major geographically represented collegiate institutions in the United States. A total of 2,298 college athletes and 683 randomized nonathlete controls completed a confidential survey questionnaire between the summer of 1993 and winter of 1994, assessing lifestyle and health-risk behaviors over the previous 12 months. Self-reports of lifestyle behaviors and health risks in the following areas: motor-vehicle safety, substance abuse, sexually transmitted diseases and contraception, mental health, cancer prevention, nutrition, exercise and general preventive health issues. Athletes demonstrated significantly higher risk-taking behaviors (p < 0.05) than their nonathlete peers in the following areas: less likely always to use seatbelts; less likely always to use helmets with motorcycles, mopeds, and bicycles; more often drive as a passenger with a driver under the influence of alcohol or drugs; greater quantity and frequency of alcoholic beverages; greater frequency of smokeless tobacco and anabolic steroid use; less-safe sex; greater number of sexual partners; less contraceptive use; and more involvement in physical fights. Female athletes reported a higher prevalence of irregular menses, amenorrhea, and stress fractures compared with female nonathletes. Male athletes had more risk-taking behaviors than did female athletes (p < 0.05), and athletes in contact sports demonstrated more risk-taking behaviors than did athletes in noncontact sports (p < 0.05). Athletes with one risk-taking behavior were likely to have multiple risk-taking behaviors (p < 0.05). College athletes appear to be at higher risk than their nonathletic peers for certain maladaptive lifestyle behaviors. Athlete subgroups at highest risk include male athletes and athletes participating in contact sports. Athletes at risk for one high-risk behavior demonstrated an increased risk for multiple risk-taking behaviors. Preventive health interventions deserve further study to determine strategies for risk reduction in high-risk groups.

  7. Progress in implantable gastric stimulation: summary of results of the European multi-center study.

    PubMed

    De Luca, Maurizio; Segato, Gianni; Busetto, Luca; Favretti, Franco; Aigner, Franz; Weiss, Helmut; de Gheldere, Charles; Gaggiotti, Giorgio; Himpens, Jacques; Limao, Jorge; Scheyer, Matthias; Toppino, Mauro; Zurmeyer, Ernst L; Bottani, Giorgio; Penthaler, Heinrich

    2004-09-01

    The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed. Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed. The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase. IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

  8. MultiCenter outcome of pediatric oncology patients requiring intensive care.

    PubMed

    Dalton, Heidi J; Slonim, Anthony D; Pollack, Murray M

    2003-12-01

    A retrospective cohort study was conducted to evaluate the intensive care outcome of pediatric cancer patients between 1996 and 1998. The study comprised 20 pediatric intensive care units (PICUs) and 802 patients with cancer requiring PICU care. Patients with a history of cancer were identified from PICUs participating in the Pediatric Intensive Care Unit Evaluations program. Their demographics, resource requirements, and outcomes were compared with those of noncancer patients. Cancer patients comprised 3.3% (802/24,431) of PICU admissions. Overall PICU survival was not different between cancer and noncancer patients (95% vs. 96%, p =.2). Cancer patients were older (99 +/- 3 vs. 72 +/- 1 months, p <.001), had similar gender distributions, and had similar lengths of stay (3.3 +/- 0.2 vs. 3.9 +/- 0.1 days, p =.98). The majority (72%) were admitted to the PICU for postoperative care; PICU survival in these patients was 100, 100, and 71% for those not receiving mechanical ventilation or vasoactive agent infusion, those receiving either mechanical ventilation or vasoactive agent infusion, and those receiving both, respectively. PICU survival in nonoperative patients was 87% overall; survival for those requiring ventilation, vasoactive infusions, or both was 93, 89 and 46%. Overall hospital survival was 99% in operative cancer patients and 81% in nonoperative patients (p =.004, operative vs. nonoperative patients). Pediatric cancer patients receiving intensive care do well overall. Outcomes have substantially improved and, in general, the diagnosis of cancer should not limit the provision of intensive care. Additionally, resource use in terms of lengths of stay in the PICU is not different between cancer and noncancer patients.

  9. 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

  10. A multi-center study benchmarks software tools for label-free proteome quantification

    PubMed Central

    Gillet, Ludovic C; Bernhardt, Oliver M.; MacLean, Brendan; Röst, Hannes L.; Tate, Stephen A.; Tsou, Chih-Chiang; Reiter, Lukas; Distler, Ute; Rosenberger, George; Perez-Riverol, Yasset; Nesvizhskii, Alexey I.; Aebersold, Ruedi; Tenzer, Stefan

    2016-01-01

    The consistent and accurate quantification of proteins by mass spectrometry (MS)-based proteomics depends on the performance of instruments, acquisition methods and data analysis software. In collaboration with the software developers, we evaluated OpenSWATH, SWATH2.0, Skyline, Spectronaut and DIA-Umpire, five of the most widely used software methods for processing data from SWATH-MS (sequential window acquisition of all theoretical fragment ion spectra), a method that uses data-independent acquisition (DIA) for label-free protein quantification. We analyzed high-complexity test datasets from hybrid proteome samples of defined quantitative composition acquired on two different MS instruments using different SWATH isolation windows setups. For consistent evaluation we developed LFQbench, an R-package to calculate metrics of precision and accuracy in label-free quantitative MS, and report the identification performance, robustness and specificity of each software tool. Our reference datasets enabled developers to improve their software tools. After optimization, all tools provided highly convergent identification and reliable quantification performance, underscoring their robustness for label-free quantitative proteomics. PMID:27701404

  11. Contrast-Enhanced Ultrasound in the Diagnosis of Gallbladder Diseases: A Multi-Center Experience

    PubMed Central

    Liu, Lin-Na; Xu, Hui-Xiong; Lu, Ming-De; Xie, Xiao-Yan; Wang, Wen-Ping; Hu, Bing; Yan, Kun; Ding, Hong; Tang, Shao-Shan; Qian, Lin-Xue; Luo, Bao-Ming; Wen, Yan-Ling

    2012-01-01

    Objective To assess the usefulness of contrast–enhanced ultrasound (CEUS) in differentiating malignant from benign gallbladder (GB) diseases. Methods This study had institutional review board approval. 192 patients with GB diseases from 9 university hospitals were studied. After intravenous bonus injection of a phospholipid-stabilized shell microbubble contrast agent, lesions were scanned with low acoustic power CEUS. A multiple logistic regression analysis was performed to identify diagnostic clues from 17 independent variables that enabled differentiation between malignant and benign GB diseases. Receiver operating characteristic (ROC) curve analysis was performed. Results Among the 17 independent variables, multiple logistic regression analysis showed that the following 4 independent variables were associated with the benign nature of the GB diseases, including the patient age, intralesional blood vessel depicted on CEUS, contrast washout time, and wall intactness depicted on CEUS (all P<0.05). ROC analysis showed that the patient age, intralesional vessels on CEUS, and the intactness of the GB wall depicted on CEUS yielded an area under the ROC curve (Az) greater than 0.8 in each and Az for the combination of the 4 significant independent variables was 0.915 [95% confidence interval (CI): 0.857–0.974]. The corresponding Az, sensitivity, and specificity for the age were 0.805 (95% CI: 0.746–0.863), 92.2%%, and 59.6%; for the intralesional vessels on CEUS were 0.813 (95% CI: 0.751–0.875), 59.8%, and 98.0%; and for the GB wall intactness were 0.857 (95% CI: 0.786–0.928), 78.4%, and 92.9%. The cut-off values for benign GB diseases were patient age <53.5 yrs, dotted intralesional vessels on CEUS and intact GB wall on CEUS. Conclusion CEUS is valuable in differentiating malignant from benign GB diseases. Branched or linear intralesional vessels and destruction of GB wall on CEUS are the CEUS features highly suggestive of GB malignancy and the patient age >53.5 yrs is also a clue for GB malignancy. PMID:23118996

  12. 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.

  13. 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

  14. [Multi-center study on the treatment of sudden deafness accompanied with tinnitus].

    PubMed

    Zhao, Hui; Dong, Hong; Cheng, Yan; Ma, Yuanxu; Lin, Peng; Zhong, Shixun; Kang, Houyong; Qian, Yi; Hu, Guohua

    2015-06-01

    To investigate the clinical characteristics and the effects of different drug therapies in patients of sudden deafness accompanied with tinnitus. The international standardized clinical research methods, the unified design and program were used in the study. The patients of sudden deafness accompanied with tinnitus, aged between 18 to 65 years old, were recruited, whose duration was less than two weeks with no medication. The patients were divided into four types according to the hearing curve: type A was acute sensorineural hearing loss in low tone frequencies, type B was acute sensorineural hearing loss in high tone frequencies, type C was acute sensorineural hearing loss in all frequencies and type D was total deafness. Each type had four different treatment programs, based on the unified designed randomized table. A total of 1024 cases with single side sudden deafness were recruited in the study by 33 hospitals in China from August 2007 to October 2011. Among the 1024 cases, 922 cases were accompanied with tinnitus (90.04%). By classification of audiogram, among the 922 cases, 169 cases were type A (82.44%), 127 cases were type B (90.07%), 370 cases were type C (92.04%), and 256 cases were type D (92.75%). The tinnitus mostly was persistent and low tone tinnitus. The degree of the tinnitus was mostly 2-3 grade. The curative effects of different types were analyzed, type A had the highest rate of 96.18%, type C was 87.75%, type B was 81.51%, and type D had the lowest rate of 75.32%. Significant difference of curative rate between different types was detected (χ² = 125.33, P = 0.000). There had no significant difference between the four different treatment groups (all P > 0.05). In the cases with single side sudden deafness accompanied with tinnitus, the type in low tone frequencies has the best curative effect, followed by the type in all frequencies. The type in high tone frequencies and the total deafness type have poor curative results. The steroid plays a good effect in the treatment.

  15. Family Access to a Dentist Study (FADS): A Multi-Center Randomized Controlled Trial

    PubMed Central

    Nelson, Suchitra; Riedy, Christine; Albert, Jeffrey M; Lee, Wonik; Slusar, Mary Beth; Curtan, Shelley; Ferretti, Gerald; Cunha-Cruz, Joana; Milgrom, Peter

    2015-01-01

    Introduction Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers’ illness perception of dental caries and increase utilization of care by children with restorative dental needs. Methods A multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016. Conclusion This study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings. PMID:26500170

  16. 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

  17. [Current status of surgical treatment of gastric gastrointestinal tumors: a national multi-center retrospective study].

    PubMed

    Feng, Xingyu; Li, Renjie; Zhang, Peng; Chen, Tao; Qiu, Haibo; Zhou, Yongjian; Du, Chunyan; Yin, Xiaonan; Pan, Fang; Zheng, Guoliang; Sun, Xiaowei; Yu, Jiang; Chen, Zhijing; Zhao, Yan; Liu, Xiufeng; Li, Jian; Zhang, Bo; Zhou, Ye; Huang, Changming; Zhou, Zhiwei; Li, Guoxin; Tao, Kaixiong; Li, Yong

    2016-11-25

    To retrospectively analyze the clinicopathology of patients with gastric gastrointestinal stromal tumor(gGIST) who underwent radical excision within 18 years in 10 domestic medical centers in order to understand the status of domestic surgical treatment of gGIST. Clinicopathological data of gGIST patients undergoing radical excision in 10 medical centers from January 1998 to January 2016 were collected, and their operational conditions, postoperative adjuvant therapy, gene detection and survival were analyzed retrospectively. A total of 1 846 cases were recruited in this study, including 246 cases from Guangdong General Hospital, 331 cases from Sun Yat-sen University Cancer Center, 374 cases from Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, 342 cases from Nanfang Hospital of Southern Medical University, 265 cases from Fujian Medical University Union Hospital, 148 cases from Fudan University Shanghai Cancer Center, 49 cases from West China Hospital of Sichuan University, 43 cases from Peking University Cancer Hospital and Institute, 28 cases from the 81st Hospital of Pepole's Liberation Army(PLA), 20 cases from Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute. There were 918 male (49.7%) and 928 female patients (50.3%) with median onset age of 59(18 to 95) years old. Fundus(735 cases, 39.8%) and body (781 cases, 42.3%) of stomach were the common sites of lesions. The average size of tumor was (5.3±4.6) cm. There were 1 421 cases with mitotic count ≤5(77.0%). According to the operation procedure, 924 cases (50.1%) underwent laparoscopic surgery, 759 cases (41.1%) laparotomy, 120 cases (6.5%) endoscopic surgery, and 20 cases (1.1%) laparoscopic combined with endoscopic surgery, 6 cases (0.3%) laparoscopic excision surgery through gastric wall and cavity, and 17 cases (0.9%) laparoscopy and then were transferred to laparotomy. Wedge excision were performed in 1 308 cases (70.9%), proximal gastric excision in 226 cases(12.2%), distal gastric excision in 92 cases (5.0%), total gastrectomy in 94 cases (5.1%), and local gastrectomy in 126 cases(6.8%). Multi-visceral excision was performed in 138 cases, and the splenectomy was performed in 83 cases(60.1%)with the highest ratio. According to modified NIH classification, 399 cases(21.6%) were extreme low risk, 580 cases(31.4%) were low risk, 424 cases(23.0%) were moderate risk, 443 cases (24.0%) were high risk. A total of 461 cases received postoperative imatinib adjuvant therapy, accounting for 53.2%(461/867) of patients with moderate and high risk. Among 1 846 cases, 1 402 cases (75.9%) had complete follow-up data and the median follow-up time was 33.6 (0.1 to 158) months. The 5-year survival rates of extreme low risk, low risk, moderate risk and high risk were 100%, 98.5%, 92.5%, and 79.2% with significant difference(P=0.000). Gastric GIST occurs mostly in fundus and body of stomach in China. Wedge excision is the main operational procedure and laparoscopic operation is over 50%. General prognosis of gastric GIST is quite good.

  18. Distribution of genital wart human papillomavirus genotypes in China: a multi-center study.

    PubMed

    Chang, Lihong; Ci, Puwa; Shi, Jufang; Zhai, Kan; Feng, Xiaoli; Colombara, Danny; Wang, Wei; Qiao, Youlin; Chen, Wen; Wu, Yuping

    2013-10-01

    Although it is understood that low-risk human papillomavirus (HPV) genotypes are associated with genital warts, there have been very few published studies reporting the genotype-specific prevalence of HPV among Chinese population. The aim of the study was to assess the prevalence of HPV genotypes in genital warts across China, and thus to evaluate the potential benefit of a quadrivalent HPV vaccine in this population. The tissue samples of a total of 1,005 genital warts cases were collected from seven geographical regions of China. HPV genotypes were analyzed using the general primer PCR and sequence-based typing method. Prevalence differences between sexes, geographical regions and age groups were assessed. The overall prevalence of HPV DNA in genital warts patients was 88.7% (891/1,005). Low-risk genotypes predominated, with a prevalence of 78.1% (785/1,005). The most prevalent genotypes were HPV-6 (41.3%), HPV-11 (37.6%) and HPV-16 (10.4%). Among HPV positive patients, single infections were more frequent (866/891, 97.2%) than co-infections (25/891, 2.8%). Both the overall prevalence of HPV DNA and that of HPV-6/-11/-16 (positive for any of the three types) decreased with age (P-trend = 0.010 and P-trend = 0.025, respectively). The prevalence of HPV-6/-11 (positive for either HPV type) and HPV-16 varied by geographic region (P = 0.003 and P ≤ 0.001, respectively). The prevalence of HPV-16 in female patients between urban and rural areas showed a marginally significant difference (P = 0.05). In sum, the results provide strong evidence that, in China, the most prevalent HPV genotypes in genital warts are HPV-6, HPV-11 and HPV-16. This indicates that a quadrivalent HPV vaccine may decrease the incidence of genital warts in the future. Copyright © 2013 Wiley Periodicals, Inc.

  19. One year treatment of Barrett's oesophagus with proton pump inhibitors (a multi-center study).

    PubMed

    Babic, Z; Bogdanovic, Z; Dorosulic, Z; Petrovic, Z; Kujundzic, M; Banic, M; Marusic, M; Heinzl, R; Bilić, B; Andabak, M

    2015-12-01

    Aim of the study was to investigate the effects of 1-year therapy by different proton pump inhibitors (PPIs) on epithelial tissue and surrounding inflammatory changes in Barrett's oesophagus, in patients who have abandoned invasive therapy. A group of 120 patients (sampled in 60-month period, from 61201 upper gastrointestinal endoscopies) who were diagnosed both, endoscopically and pathohistologically with Barrett's oesophagus, and who have abandoned invasive therapeutic approach were enrolled in study. Treatment with different PPIs was initiated and continued for a year. At the end of treatment, patients were reassessed by endoscopy with tissue biopsy and pathohistological analysis. No difference in regenerating squamous epithelium or degree of dysplasia was seen between different treatment groups. Interestingly, most patients receiving pantoprazole (94%) ended up with thinner squamous epithel (P<0.0001). The squamous epithel was consider thinner only if its total thickness, measured on histological specimen, was smaller for more than 50% of the thickness before therapy. Significantly less of difference (P<0.0014) was seen with patients receiving lansoprazole (65%) and (P<0.003) omeprazole (50%). Regeneration of the squamous epithel was the same for all PPIs but not good enough to stop the progression of the disease.

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

    NASA Technical Reports Server (NTRS)

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

    1999-01-01

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

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

    PubMed Central

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

    2009-01-01

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

  2. [The method of joined multi-center studies in clinical psychopharmacology].

    PubMed

    Fleischhauer, J

    1975-01-01

    Joined multicentered studies are of interest more and more growing up in the field of clinical psychopharmacology. Only such studies should be carried out which have a high scientific value to avoid unnecessary waste. According to this fact the preconditions are greater than such required for a single-center study. Also long-term studies require more preconditions than short-term studies. Pilot studies with clinically more or less unknown drugs should be avoided in multicentered studies for the same reasons. Of great importance is the selection of subjects. The single centers should have well comparable groups of patients. Nevertheless the number of selection criterias should be as few as possible, because also with only some few simple criterias the total number of patients is greatly restricted. The most likely group would consist of patients with acut diseases either recently admitted to the hospital or outpatients who conform to some good defined criterias. Of great importance is the control group. Ethical problems are playing an important role in this field. In view of the fact that the precise action mechanism of drugs is unknown at present, the randomization method will appear to be the best available selection method at the moment. The cross-over-method in mentally ill patients seems hardly suitable out of diverse reasons. Considering the dosage it seems that a limited and fixed dosage is a practicable compromise. Of greatest importance naturally is the good documentation and quantification of the results. Rating-Scales therefore are more suitable than check-lists. Some well introduced and validated rating-scales are existing and mentioned. As important instruments as the rating-scales are the self-rating-scales. Furthermore of great interest in such studies can be the multicentered additional measuring of some psychophysiological variables, for example with the polygraph.

  3. Technical Considerations in Percutaneous Hepatic Perfusion—A Multi-Center Experience

    PubMed Central

    Antoine, Radcliffe A.

    2011-01-01

    Abstract: Patients diagnosed with primary or metastatic liver cancer face a daunting future that is complicated by limited treatment options. Percutaneous hepatic perfusion is a novel approach to chemotherapy delivery that offers significant benefits over contemporary modalities. Percutaneous hepatic perfusion is a procedure in which a chemotherapeutic agent is administered at high doses via the hepatic artery where it perfuses the liver, is extracted and filtered using a veno-veno bypass circuit, a fenestrated multi-lumen double-balloon catheter, and two biocompatible hemoperfusion filters. Venous access is gained at the groin through the femoral vein after which the catheter is advanced and positioned in the inferior vena cava just below the right atrium. The catheter’s proximal and distal balloons are inflated to occlude the inferior vena cava above and below the hepatic veins. The occlusion isolated the chemo-rich venous outflow of the liver from the systemic venous circulation. This maneuver also diverts venous blood returning to the heart from lower extremities of the azygos vein. Once the patient is on bypass, the agent is infused through the hepatic artery where it saturates the liver. The chemorich venous outflow is extracted through the double-balloon catheter by the bypass circuit. The blood is continuously filtered and cleared of the agent as it passes through the filters and returned to the patient through a catheter placed in the right internal jugular vein. A phase I study demonstrated efficacy with an overall radiographic response rate of 30% observed in treated patients. In 10 patients with ocular melanoma, a 50% overall response rate was observed, including two complete responses. The technique is minimally invasive and can be performed safely by a well-trained multi-disciplinary team. It offers significant benefits including multiple procedures without risks commonly associated with open abdominal surgery. PMID:21449232

  4. Technical considerations in percutaneous hepatic perfusion--a multi-center experience.

    PubMed

    Antoine, Radcliffe A

    2011-03-01

    Patients diagnosed with primary or metastatic liver cancer face a daunting future that is complicated by limited treatment options. Percutaneous hepatic perfusion is a novel approach to chemotherapy delivery that offers significant benefits over contemporary modalities. Percutaneous hepatic perfusion is a procedure in which a chemotherapeutic agent is administered at high doses via the hepatic artery where it perfuses the liver, is extracted and filtered using a veno-veno bypass circuit, a fenestrated multi-lumen double-balloon catheter, and two biocompatible hemoperfusion filters. Venous access is gained at the groin through the femoral vein after which the catheter is advanced and positioned in the inferior vena cava just below the right atrium.The catheter's proximal and distal balloons are inflated to occlude the inferior vena cava above and below the hepatic veins. The occlusion isolated the chemo-rich venous outflow of the liver from the systemic venous circulation. This maneuver also diverts venous blood returning to the heart from lower extremities of the azygos vein. Once the patient is on bypass, the agent is infused through the hepatic artery where it saturates the liver. The chemo-rich venous outflow is extracted through the double-balloon catheter by the bypass circuit. The blood is continuously filtered and cleared of the agent as it passes through the filters and returned to the patient through a catheter placed in the right internal jugular vein. A phase I study demonstrated efficacy with an overall radiographic response rate of 30% observed in treated patients. In 10 patients with ocular melanoma, a 50% overall response rate was observed, including two complete responses. The technique is minimally invasive and can be performed safely by a well-trained multi-disciplinary team. It offers significant benefits including multiple procedures without risks commonly associated with open abdominal surgery.

  5. Radiation-free quantitative assessment of scoliosis: a multi center prospective study

    PubMed Central

    Bar-On, Elhanan; Fragnière, Bruno; Rigo, Manuel; Dickman, Dalia; Leitner, Joseph; Wientroub, Shlomo; Dubousset, Jean

    2006-01-01

    Accurate quantitative measurements of the spine are essential for deformity diagnosis and assessment of curve progression. There is much concern related to the multiple exposures to ionizing radiation associated with the Cobb method of radiographic measurement, currently the standard procedure for diagnosis and follow-up of the progression of scoliosis. In addition, the Cobb method relies on 2-D analysis of a 3-D deformity. The aim of this prospective study was to investigate the clinical value of Ortelius800TM that provides a radiation-free method for scoliosis assessment in three planes (coronal, sagittal, apical), with simultaneous automatic calculation of the Cobb angle in both coronal and sagittal views. Analysis of the clinical value of the device for assessing spinal deformities was performed on patients with adolescent idiopathic scoliosis, deformity angles ranging from 10° to 48°. Correlation between Cobb angles measured manually on standard erect posteroanterior radiographs and those calculated by Ortelius800TM showed an absolute difference between the measurements to be significantly less than ± 5° for coronal measurements and significantly less than ± 6° for sagittal measurements indicating good correlation between the two methods. The measurements from four independent sites and six independent examiners were not significantly different. We found the novel clinical tool to be reliable for following mild and moderate idiopathic curves in both coronal and sagittal planes, without exposing the patient to ionizing radiation. Considering the need for further validation of this new method, any change in treatment protocol should still be based on radiographic control. PMID:16705434

  6. Multi-center machine learning in imaging psychiatry: A meta-model approach.

    PubMed

    Dluhoš, Petr; Schwarz, Daniel; Cahn, Wiepke; van Haren, Neeltje; Kahn, René; Španiel, Filip; Horáček, Jiří; Kašpárek, Tomáš; Schnack, Hugo

    2017-07-15

    One of the biggest problems in automated diagnosis of psychiatric disorders from medical images is the lack of sufficiently large samples for training. Sample size is especially important in the case of highly heterogeneous disorders such as schizophrenia, where machine learning models built on relatively low numbers of subjects may suffer from poor generalizability. Via multicenter studies and consortium initiatives researchers have tried to solve this problem by combining data sets from multiple sites. The necessary sharing of (raw) data is, however, often hindered by legal and ethical issues. Moreover, in the case of very large samples, the computational complexity might become too large. The solution to this problem could be distributed learning. In this paper we investigated the possibility to create a meta-model by combining support vector machines (SVM) classifiers trained on the local datasets, without the need for sharing medical images or any other personal data. Validation was done in a 4-center setup comprising of 480 first-episode schizophrenia patients and healthy controls in total. We built SVM models to separate patients from controls based on three different kinds of imaging features derived from structural MRI scans, and compared models built on the joint multicenter data to the meta-models. The results showed that the combined meta-model had high similarity to the model built on all data pooled together and comparable classification performance on all three imaging features. Both similarity and performance was superior to that of the local models. We conclude that combining models is thus a viable alternative that facilitates data sharing and creating bigger and more informative models. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    PubMed

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed. © The Author(s) 2015.

  8. Allergy march of Chinese children with infantile allergic symptoms: a prospective multi-center study.

    PubMed

    Gao, Qi; Ren, Yi-Xin; Liu, Yong-Ge; Ma, Lin; Gu, Xiao-Hong; Zhang, Wei-Xi; Liu, Li; Zhai, Xiao-Jia; Xiang, Li; Shen, Kun-Ling

    2017-08-01

    Allergy march refers to progression of allergic diseases from infantile food allergy to the development of asthma and allergic rhinitis (AR). Evidence come mostly from studies in European countries. This study aimed to investigate allergy march in Chinese children with infantile food protein allergy (FPA) with a special focus on the effect of different formula interventions. From 2008 to 2010, 153 infants diagnosed with FPA were recruited in five tertiary hospitals across China. They were randomly treated with amino-acid-based formula or soy-protein-based formula for a period of 3 months. Long-term follow-up was performed when they reached early school age, using questionnaires, physical examinations, and serum-specific immunoglobulin E. The overall follow-up rate was 73.20%. In patients who reached their early school years, the prevalence of physician-diagnosed AR and asthma were 43.75% and 23.21%, respectively. Only 40% of the subjects remained positive for food sensitizations upon follow-up. Twenty-six subjects receiving aeroallergen screening tests in infancy all proved negative, but upon follow-up, 65.57% were sensitized to aeroallergens (P=0.005). No significant difference between the effects of amino-acid-based formula and soy-protein-based formula on children's allergy march was observed. A high proportion (47.32%) of Chinese infants with early allergic symptoms developed respiratory allergies by their early school years. Most food-sensitized infants outgrew their condition several years later, but then aeroallergen sensitization often occurred. Amino-acid-based formula showed no advantages over soy protein-based formula with respect to arresting the allergy march.

  9. Mapping Anterior Temporal Lobe Language Areas with FMRI: A Multi-Center Normative Study

    PubMed Central

    Binder, Jeffrey R.; Gross, William L.; Allendorfer, Jane B.; Bonilha, Leonardo; Chapin, Jessica; Edwards, Jonathan C.; Grabowski, Thomas J.; Langfitt, John T.; Loring, David W.; Lowe, Mark J.; Koenig, Katherine; Morgan, Paul S.; Ojemann, Jeffrey G.; Rorden, Christopher; Szaflarski, Jerzy P.; Tivarus, Madalina E.; Weaver, Kurt E.

    2010-01-01

    Removal of the anterior temporal lobe (ATL) is an effective surgical treatment for intractable temporal lobe epilepsy but carries a risk of language and verbal memory deficits. Preoperative localization of functional zones in the ATL might help reduce these risks, yet fMRI protocols in current widespread use produce very little activation in this region. Based on recent evidence suggesting a role for the ATL in semantic integration, we designed an fMRI protocol comparing comprehension of brief narratives (Story task) with a semantically shallow control task involving serial arithmetic (Math task). The Story > Math contrast elicited strong activation throughout the ATL, lateral temporal lobe, and medial temporal lobe bilaterally in an initial cohort of 18 healthy participants. The task protocol was then implemented at 6 other imaging centers using identical methods. Data from a second cohort of participants scanned at these centers closely replicated the results from the initial cohort. The Story-Math protocol provides a reliable method for activation of surgical regions of interest in the ATL. The bilateral activation supports previous claims that conceptual processing involves both temporal lobes. Used in combination with language lateralization measures, reliable ATL activation maps may be useful for predicting cognitive outcome in ATL surgery, though the validity of this approach needs to be established in a prospective surgical series. PMID:20884358

  10. 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. © 2015 Wiley Periodicals, Inc.

  11. A MULTI-CENTER SHIELDING VERIFICATION STUDY FOR RADIOTHERAPY LINAC BUNKERS IN KARACHI, PAKISTAN.

    PubMed

    Raza, Muhammad; Jafri, Syed Mishkat Ali; Uddin, Zaheer; Memon, Sajjad; Ali, Shmshad

    2017-03-21

    The high energy radiotherapy linear accelerators (LINAC) offer considerable risk of radiation hazards to patient, worker and public if adequate safety measures are not taken into the account. Proper bunker designing with appropriate shielding is an important safety measure, which protects workers and member of general public. The present study describes the details of shielding of LINAC bunker in four radiotherapy centers of Karachi city. In order to conduct the study, shielding of five LINAC installed in four radiotherapy centers was assessed by considering real occupancy factor, dose limits for worker and public, etc. to verify that shielding of the bunkers conforms to the national and international standards like International Atomic Energy Agency and National Council on Radiation Protection and Measurement. After the assessment, it was concluded that all bunkers conform to the radiation protection requirements and present adequate shielded. This is an important step to achieve as low as reasonably achievable principle and protect workers and member of general public. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2012-07-01

      Topiramate has shown efficacy at facilitating abstinence from alcohol and cocaine abuse. This double-blind, placebo-controlled out-patient trial tested topiramate for treating methamphetamine addiction.   Participants (n = 140) were randomized to receive topiramate or placebo (13 weeks) in escalating doses from 25 mg/day [DOSAGE ERROR CORRECTED] to the target maintenance of 200 mg/day in weeks 6-12 (tapered in week 13). Medication was combined with weekly brief behavioral compliance enhancement treatment.   The trial was conducted at eight medical centers in the United States.   One hundred and forty methamphetamine-dependent adults took part in the trial.   The primary outcome was abstinence from methamphetamine during weeks 6-12. Secondary outcomes included use reduction versus baseline, as well as psychosocial variables.   In the intent-to-treat analysis, topiramate did not increase abstinence from methamphetamine during weeks 6-12. For secondary outcomes, topiramate reduced weekly median urine methamphetamine levels and observer-rated severity of dependence scores significantly. Subjects with negative urine before randomization (n = 26) had significantly greater abstinence on topiramate versus placebo during study weeks 6-12. Topiramate was safe and well tolerated.   Topiramate does not appear to promote abstinence in methamphetamine users but can reduce the amount taken and reduce relapse rates in those who are already abstinent. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  14. Predicting risk of substantial weight gain in German adults-a multi-center cohort approach.

    PubMed

    Bachlechner, Ursula; Boeing, Heiner; Haftenberger, Marjolein; Schienkiewitz, Anja; Scheidt-Nave, Christa; Vogt, Susanne; Thorand, Barbara; Peters, Annette; Schipf, Sabine; Ittermann, Till; Völzke, Henry; Nöthlings, Ute; Neamat-Allah, Jasmine; Greiser, Karin-Halina; Kaaks, Rudolf; Steffen, Annika

    2016-12-24

    A risk-targeted prevention strategy may efficiently utilize limited resources available for prevention of overweight and obesity. Likewise, more efficient intervention trials could be designed if selection of subjects was based on risk. The aim of the study was to develop a risk score predicting substantial weight gain among German adults. We developed the risk score using information on 15 socio-demographic, dietary and lifestyle factors from 32 204 participants of five population-based German cohort studies. Substantial weight gain was defined as gaining ≥10% of weight between baseline and follow-up (>6 years apart). The cases were censored according to the theoretical point in time when the threshold of 10% baseline-based weight gain was crossed assuming linearity of weight gain. Beta coefficients derived from proportional hazards regression were used as weights to compute the risk score as a linear combination of the predictors. Cross-validation was used to evaluate the score's discriminatory accuracy. The cross-validated c index (95% CI) was 0.71 (0.67-0.75). A cutoff value of ≥475 score points yielded a sensitivity of 71% and a specificity of 63%. The corresponding positive and negative predictive values were 10.4% and 97.6%, respectively. The proposed risk score may support healthcare providers in decision making and referral and facilitate an efficient selection of subjects into intervention trials. © The Author 2016. Published by Oxford University Press on behalf of the European Public Health Association.

  15. 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

  16. PS1-05: Feasibility of Extracting Oncology Treatment Data from on Electronic Health Record

    PubMed Central

    Carroll, Nikki; Luckett, Capp; Saylor, Gwyn; Ritzwoller, Debra

    2011-01-01

    Background/Aims New source data systems almost always cause angst among programmers. Source data systems usually are built for user ease of use and are not built for ease of getting data out. A new Electronic Health Record (EHR) module designed specifically for Oncology treatment was no different. Having access to data that was previously unavailable caused excitement among researchers, so we conducted a project to explore extracting Oncology protocols, treatment plans and medications from this new module in order to: determine the process needed to identify protocols, treatment plans and medications from the EHR, validate the process with medical record review, and build VDW tables that could logically hold this data and accommodate data from other HMOs. Methods The study team: identified EHR tables and fields that contained medication data, protocols and treatment plans specific to Oncology, completed multiple rounds of validation through chart review, and 3) identified the structure and key variables needed to construct VDW tables of Encounters, Treatment Plans, and Medications. These three steps were then used to identify patients currently receiving cancer treatment in the Oncology department and data is being pulled to populate these VDW tables. Results Multiple challenges were encountered and solutions identified. First, the EHR tables, fields and linkages required significant exploration to discern useful data elements and correct joins. For example, oral and infused medications are kept in separate tables and each table contains multiple and different date fields and status codes to determine if the drug was actually given to the patient. Other factors complicating identifying Oncology treatment included determining work flows and matching those work flows to data that was extractable from the EHR and poor documentation not specific to our HMO. An iterative process was used to validate each data pull. Conclusion Identifying Oncology treatment data in the EHR was a process fraught with multiple challenges. We believe, however, that we have developed code that identifies protocols, treatment plans and medications used to treat cancer patients. This is an important first step in compiling data needed for future research on the treatment of various cancers.

  17. The Degree of Disease Knowledge in Patients with Gastroesophageal Reflux Disease: A Multi-center Prospective Study in Korea

    PubMed Central

    Jeong, In Du; Park, Moo In; Kim, Sung Eun; Kim, Beom Jin; Kim, Sang Wook; Kim, Jie-Hyun; Sung, Hye Young; Oh, Tae-Hoon; Kim, Yeon Soo

    2017-01-01

    Background/Aims Patient education has been shown to be beneficial in several diseases. To properly educate patients with gastroesophageal reflux disease (GERD), it is necessary to understand how much they already know about their disease. However, no study has examined the degree of disease knowledge in Korean patients with GERD. Therefore, we conducted this study to assess the degree of knowledge in such patients. Methods This multicenter prospective study was conducted from January 2014 to January 2015. A total of 746 patients (mean age, 52 years; 57.6% female) were enrolled from 7 hospitals in Korea. Inclusion criteria were diagnosis of GERD and ability to properly complete a survey. Degree of disease knowledge was assessed using the translated, validated Korean Urnes questionnaire, which consists of 22 items related to GERD. Results Mean percentage of correct answers was 46.3% and mean GERD knowledge score was 9.6. Degree of knowledge (mean percentage of correct answers) regarding etiology, prognosis, and treatment of GERD were 49.5%, 36.7%, and 37.5%, respectively. Degree of disease knowledge differed significantly according to age (P < 0.001), education (P < 0.001), income (P = 0.028), and occupation (P < 0.001). In multivariate analysis, using multiple logistic regression, the higher knowledge score group tended to have higher education and professional occupation. Conclusions The surveyed Korean patients had relatively low disease knowledge, suggesting that a GERD educational program may be beneficial in Korea. Formulation of a program is underway. PMID:28478662

  18. 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.

  19. The epidemiology of developmental dysplasia of the hip in Japan: Findings from a nationwide multi-center survey.

    PubMed

    Hattori, Tadashi; Inaba, Yutaka; Ichinohe, Sadafumi; Kitano, Toshio; Kobayashi, Daisuke; Saisu, Takashi; Ozaki, Toshifumi

    2017-01-01

    It has been reported that the national incidence of developmental dysplasia of the hip (DDH) has decreased in Japan. This is because of prevention activities after birth since around 1970. However, cases of late-diagnosed DDH have still been noted in some children's hospitals. There has been no recent survey of DDH in Japan. The purpose of this study was to investigate the current epidemiology of DDH using a comprehensive nationwide survey. A questionnaire was sent to orthopedic surgeons in 1987 facilities nationwide, who were asked to complete and return a survey card on each DDH patient treated between April 2011 and March 2013. A total of 783 (39%) facilities completed and returned the card. Of these, 79% reported no cases of DDH-related dislocation over the 2-year period, while the remaining facilities reported 1295 cases. The characteristics of children diagnosed with DDH-related dislocation were as follows: girls (89%), left side involvement (69%), bilateral involvement (4%), positive family history (27%), first-born (56%), and pelvic position at birth (15%). Seasonal variation showed an increase in DDH incidence among those born in the winter. Overall, 199 cases (15%) were diagnosed at >1 year of age, and these included 36 cases diagnosed very late, at >3 years of age. The majority of the 199 cases of late diagnosis had received earlier routine screening at <1 year of age. The characteristics of the children diagnosed with DDH nationwide were similar to past data from local regions. However, many children were diagnosed late (>1 year of age), particularly in the more populous regions. The findings identify a need for improved early routine screening for DDH in Japan. Copyright © 2016 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

  20. A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.

    PubMed

    Na, Xi; Martin, Alan J; Sethi, Saurabh; Kyne, Lorraine; Garey, Kevin W; Flores, Sarah W; Hu, Mary; Shah, Dhara N; Shields, Kelsey; Leffler, Daniel A; Kelly, Ciarán P

    2015-01-01

    Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI. A cohort totaling 638 patients with CDI was prospectively studied at three tertiary care clinical sites (Boston, Dublin and Houston). The clinical prediction rule (CPR) was developed by multivariate logistic regression analysis using the Boston cohort and the performance of this model was then evaluated in the combined Houston and Dublin cohorts. The CPR included the following three binary variables: age ≥ 65 years, peak serum creatinine ≥ 2 mg/dL and peak peripheral blood leukocyte count of ≥ 20,000 cells/μL. The Clostridium difficile severity score (CDSS) correctly classified 76.5% (95% CI: 70.87-81.31) and 72.5% (95% CI: 67.52-76.91) of patients in the derivation and validation cohorts, respectively. In the validation cohort, CDSS scores of 0, 1, 2 or 3 were associated with severe clinical outcomes of CDI in 4.7%, 13.8%, 33.3% and 40.0% of cases respectively. We prospectively derived and validated a clinical prediction rule for severe CDI that is simple, reliable and accurate and can be used to identify high-risk patients most likely to benefit from measures to prevent complications of CDI.

  1. 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

    ... good. Public harm could result through the loss of critically needed information to understand and..., correlations between exposures, and variation in gene regions are of particular interest. Patients from 19...

  2. Psychiatric Symptoms in Acute Respiratory Distress Syndrome Survivors: A One-Year National Multi-Center Study

    PubMed Central

    Huang, Minxuan; Parker, Ann M.; Bienvenu, O. Joseph; Dinglas, Victor D.; Colantuoni, Elizabeth; Hopkins, Ramona O.; Needham, Dale M.

    2015-01-01

    Objective To evaluate prevalence, severity, and co-occurrence of, and risk factors for depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms over the first year after ARDS. Design Prospective longitudinal cohort study. Settings 41 ARDS Network hospitals across the U.S. Patients 698 ARDS survivors. Interventions None. Measurements and Main Results Psychiatric symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS) and Impact of Event Scale–Revised (IES-R) at 6 and 12 months. Adjusted prevalence ratios for substantial symptoms (binary outcome) and severity scores were calculated using Poisson and linear regression, respectively. During 12 months, a total of 416 of 629 patients (66%) with at least one psychiatric outcome measure had substantial symptoms in at least one domain. There was a high and almost identical prevalence of substantial symptoms (36%, 42%, and 24% for depression, anxiety and PTSD) at 6 and 12 months. The most common pattern of co-occurrence was having symptoms of all 3 psychiatric domains simultaneously. Younger age, female sex, unemployment, alcohol misuse, and greater opioids use in the ICU were significantly associated with psychiatric symptoms, while greater severity of illness and ICU length of stay were not associated. Conclusions Psychiatric symptoms occurred in two-thirds of ARDS survivors with frequent co-occurrence. Sociodemographic characteristics and in-ICU opioids administration, rather than traditional measures of critical illness severity, should be considered in identifying patients at highest risk for psychiatric symptoms during recovery. Given high co-occurrence, ARDS survivors should be simultaneously evaluated for a full spectrum of psychiatric sequelae to maximize recovery. PMID:26807686

  3. Neurodevelopmental disorders, maternal Rh-negativity, and Rho(D) immune globulins: a multi-center assessment.

    PubMed

    Geier, David A; Mumper, Elizabeth; Gladfelter, Bambi; Coleman, Lisa; Geier, Mark R

    2008-04-01

    Many formulations of Thimerosal (49.55% mercury by weight)-containing Rho(D) immune globulins (TCRs) were routinely administered to Rh-negative mothers in the US prior to 2002. It was hypothesized: (1) if prenatal Rho(D)-immune globulin preparation exposure was a risk factor for neurodevelopmental disorders (NDs) then more children with NDs would have Rh-negative mothers compared to controls; and (2) if Thimerosal in the Rho(D)-immune globulin preparations was the ingredient associated with NDs, following the removal of Thimerosal from all manufactured Rho(D)-immune globulin preparations from 2002 in the US the frequency of maternal Rh-negativity among children with NDs should be similar to control populations. Maternal Rh-negativity was assessed at two sites (Clinic A-Lynchburg, VA; Clinic B-Rockville and Baltimore, MD) among 298 Caucasian children with NDs and known Rh-status. As controls, maternal Rh-negativity frequency was determined from 124 Caucasian children (born 1987-2001) without NDs at Clinic A, and the Rh-negativity frequency was determined from 1,021 Caucasian pregnant mothers that presented for prenatal genetic care at Clinic B (1980-1989). Additionally, 22 Caucasian patients with NDs born from 2002 onwards (Clinics A and B) were assessed for maternal Rh-negativity. There were significant and comparable increases in maternal Rh-negativity among children with NDs (Clinic: A=24.2%), autism spectrum disorders (Clinic: A=28.3%, B=25.3%), and attention-deficit-disorder/attention-deficit-hyperactivity-disorder (Clinic: A=26.3%) observed at both clinics in comparison to both control groups (Clinic: A=12.1%, B=13.9%) employed. Children with NDs born post-2001 had a maternal Rh-negativity frequency (13.6%) similar to controls. This study associates TCR exposure with some NDs in children.

  4. 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

  5. The determinants of attitudinal change among medical students participating in home care training: a multi-center study.

    PubMed

    Flaherty, Joseph H; Fabacher, Diana A; Miller, Roberta; Fox, Andrea; Boal, Jeremy

    2002-04-01

    To report attitudinal changes of medical students from five medical schools rotating through a home care program, and to determine which of the program characteristics influenced attitudes the most. A survey instrument covering four home care domains (general attitudes, home-based therapies, home care training, and time and reimbursement) was designed and validated by the five schools involved. Using pre- and post-rotation scores, analyses were done to evaluate for attitudinal changes within and among schools. The programs had similar basic characteristics (home visits, attending physicians' involvement, didactics), but had differing degrees of these components. Significant improvements in attitude scores were found in three domains: general attitudes, homebased therapies, and home care training. For time and reimbursement, only three schools improved significantly between pre- and post-rotation scores. Among the five schools, there were significant differences in the homebased therapies and home care training domains (p <.05), and in the time and reimbursement domain the difference approached significance (p =.06). None of the students' characteristics but all of the programs' characteristics significantly correlated with changes in total scores. In the first multiple regression model, educational level (third year instead of fourth) was the only independent predictor of change in score, (adjusted r(2) =.14). In Model 2, the strongest predictor was "contact with physician-program director," followed by "number of visits" and "physician-precepted visits" (r(2) =.23). Educational home care programs of varying intensities can positively affect medical students' attitudes towards home care. At least three program characteristics, (the physician-program director, number of visits, and physician-precepted home visits), are important parts of a successful program.

  6. 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

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

    PubMed

    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

    2015-10-20

    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. 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. 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. 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.

  8. Molecular Epidemiology and Antifungal Susceptibility of Candida glabrata in China (August 2009 to July 2014): A Multi-Center Study

    PubMed Central

    Hou, Xin; Xiao, Meng; Chen, Sharon C.-A.; Kong, Fanrong; Wang, He; Chu, Yun-Zhuo; Kang, Mei; Sun, Zi-Yong; Hu, Zhi-Dong; Li, Ruo-Yu; Lu, Juan; Liao, Kang; Hu, Tie-Shi; Ni, Yu-Xing; Zou, Gui-Ling; Zhang, Ge; Fan, Xin; Zhao, Yu-Pei; Xu, Ying-Chun

    2017-01-01

    Candida glabrata is an increasingly important cause of invasive candidiasis. In China, relatively little is known of the molecular epidemiology of C. glabrata and of its antifungal susceptibility patterns. Here we studied 411 non-duplicate C. glabrata isolates from 411 patients at 11 hospitals participating in the National China Hospital Invasive Fungal Surveillance Net program (CHIF-NET; 2010-2014). Genotyping was performed using multilocus sequence typing (MLST) employing six genetic loci and by microsatellite analysis. Antifungal susceptibility testing was performed using Sensititre YeastOne™ YO10 methodology. Of 411 isolates, 35 sequence types (ST) were identified by MLST and 79 different genotypes by microsatellite typing; the latter had higher discriminatory power than MLST in the molecular typing of C. glabrata. Using MLST, ST7 and ST3 were the most common STs (66.4 and 9.5% of all isolates, respectively) with 24 novel STs identified; the most common microsatellite types were T25 (30.4% of all isolates) and T31 (12.4%). Resistance to fluconazole (MIC > 32 μg/mL) was seen in 16.5% (68/411) of isolates whilst MICs of >0.5 μg/mL for voriconazole, >2 μg/mL for itraconazole and >2 μg/mL for posaconazole were seen for 28.7, 6.8, and 7.3% of isolates, respectively; 14.8% of all isolates cross-resistant/non-wide-type to fluconazole and voriconazole. Fluconazole resistant rates increased 3-fold over the 5-year period whilst that of isolates with non-WT MICs to voriconazole, 7-fold. All echinocandins exhibited >99% susceptibility rates against all isolates but notably one isolate exhibited multi-drug resistance to the azoles and echinocandins. The study has provided a global picture of the molecular epidemiology and drug resistance rates of C. glabrata in China during the period of the study. PMID:28588560

  9. Molecular Epidemiology and Antifungal Susceptibility of Candida glabrata in China (August 2009 to July 2014): A Multi-Center Study.

    PubMed

    Hou, Xin; Xiao, Meng; Chen, Sharon C-A; Kong, Fanrong; Wang, He; Chu, Yun-Zhuo; Kang, Mei; Sun, Zi-Yong; Hu, Zhi-Dong; Li, Ruo-Yu; Lu, Juan; Liao, Kang; Hu, Tie-Shi; Ni, Yu-Xing; Zou, Gui-Ling; Zhang, Ge; Fan, Xin; Zhao, Yu-Pei; Xu, Ying-Chun

    2017-01-01

    Candida glabrata is an increasingly important cause of invasive candidiasis. In China, relatively little is known of the molecular epidemiology of C. glabrata and of its antifungal susceptibility patterns. Here we studied 411 non-duplicate C. glabrata isolates from 411 patients at 11 hospitals participating in the National China Hospital Invasive Fungal Surveillance Net program (CHIF-NET; 2010-2014). Genotyping was performed using multilocus sequence typing (MLST) employing six genetic loci and by microsatellite analysis. Antifungal susceptibility testing was performed using Sensititre YeastOne™ YO10 methodology. Of 411 isolates, 35 sequence types (ST) were identified by MLST and 79 different genotypes by microsatellite typing; the latter had higher discriminatory power than MLST in the molecular typing of C. glabrata. Using MLST, ST7 and ST3 were the most common STs (66.4 and 9.5% of all isolates, respectively) with 24 novel STs identified; the most common microsatellite types were T25 (30.4% of all isolates) and T31 (12.4%). Resistance to fluconazole (MIC > 32 μg/mL) was seen in 16.5% (68/411) of isolates whilst MICs of >0.5 μg/mL for voriconazole, >2 μg/mL for itraconazole and >2 μg/mL for posaconazole were seen for 28.7, 6.8, and 7.3% of isolates, respectively; 14.8% of all isolates cross-resistant/non-wide-type to fluconazole and voriconazole. Fluconazole resistant rates increased 3-fold over the 5-year period whilst that of isolates with non-WT MICs to voriconazole, 7-fold. All echinocandins exhibited >99% susceptibility rates against all isolates but notably one isolate exhibited multi-drug resistance to the azoles and echinocandins. The study has provided a global picture of the molecular epidemiology and drug resistance rates of C. glabrata in China during the period of the study.

  10. Clinical characteristics of small bowel tumors diagnosed by double-balloon endoscopy: KASID multi-center study.

    PubMed

    Lee, Bo-In; Choi, Hwang; Choi, Kyu-Yong; Byeon, Jeong-Sik; Jang, Hyun-Joo; Eun, Chang-Soo; Cheon, Jae Hee; Shin, Sung Jae; Kim, Jin-Oh; Lee, Moon-Sung; Choi, Jai-Hyun

    2011-10-01

    Small bowel tumors are relatively rare, and their confirmative diagnosis before surgery is not easy. This study was performed to investigate the clinical characteristics of patients with small bowel tumors who received double-balloon enteroscopy (DBE). Secondary end points were to evaluate the usefulness and safety of DBE for the diagnosis of patients with suspected SB tumors derived from other previous procedures. We retrospectively analyzed consecutive DBE examinations to explore the small intestine in eight university hospitals over a 5-year period. A total of 877 DBE examinations (per oral 487, per anal 390) were performed in 645 patients (405 males, mean age 48.2 years). Small bowel tumors were diagnosed in 112 patients (17.4%), of which 38 patients had benign polyps, 29 had gastrointestinal stromal tumors/leiomyomata, 18 had lymphomas, 14 had adenocarcinomas, five had metastatic or invasive cancers, five had lipomas, and three patients had cystic tumors. The main reasons for DBE among patients with small bowel tumors were obscure gastrointestinal bleeding (OGIB, 40.2%) followed by abnormal imaging study (25.2%). The concordance rate of diagnoses based on DBE with diagnoses based on small bowel follow-through, CT, and capsule endoscopy among patients with small bowel tumors was 68.9% (42/61), 75.3% (70/93), and 78.3% (18/23), respectively. Therapeutic plans were changed due to the DBE results in 64.2% of patients with small bowel tumors. Approximately one-sixth of patients who received DBE had small bowel tumors, and the most common reason for DBE among patients with small bowel tumors was OGIB. DBE is a useful method for the confirmative diagnosis of small bowel tumors and has a good clinical impact on therapeutic plans and short-term clinical results.

  11. Detection of domestic violence by community mental health teams: a multi-center, cluster randomized controlled trial.

    PubMed

    Ruijne, Roos E; Howard, Louise M; Trevillion, Kylee; Jongejan, Femke E; Garofalo, Carlo; Bogaerts, Stefan; Mulder, Cornelis L; Kamperman, Astrid M

    2017-08-07

    Domestic Violence and Abuse (DVA) is associated with a range of psychosocial and mental health problems. Having a psychiatric illness increases likelihood of being a victim of DVA. Despite the evidence of a high risk for DVA and the serious effects of violent victimization in psychiatric patients, detection rates are low and responses are inadequate. The aim of the BRAVE (Better Reduction trough Assessment of Violence and Evaluation) study is to improve detection of and response to DVA in psychiatric patients. In this article, we present the protocol of the BRAVE study which follows the SPIRIT guidelines. The BRAVE study is a cluster randomized controlled trial. We will include 24 community mental health teams from Rotterdam and The Hague. Twelve teams will provide care as usual and 12 teams will receive the intervention. The intervention consists of 1) a knowledge and skills training for mental health professionals about DVA, 2) a knowledge and skills training of DVA professionals about mental illness, 3) provision and implementation of a referral pathway between community mental health and DVA services. The follow up period is 12 months. Our primary outcome is the rate of detected cases of recent or any history of DVA in patients per team in 12 months. Detection rates are obtained through a systematic search in electronic patient files. Our secondary aims are to obtain information about the gain and sustainability of knowledge on DVA in mental health professionals, and to obtain insight into the feasibility, sustainability and acceptability of the intervention. Data on our secondary aims will be obtained through structured in depth interviews and a questionnaire on knowledge and attitudes on DVA. This study is the first cluster randomized controlled trial to target both male and female psychiatric patients that experience DVA, using an intervention that involves training of professionals. We expect the rate of detected cases of DVA to increase in the intervention teams. With early detection of victimization of DVA in psychiatric patients we hope to improve the mental health of psychiatric patients in the short and long term. ISRCTN:14115257 . Date of registration: 15th January 2015.

  12. Nutritional status and dietary intake of institutionalized elderly in Turkey: a cross-sectional, multi-center, country representative study.

    PubMed

    Ongan, Dilek; Rakıcıoğlu, Neslişah

    2015-01-01

    To evaluate the nutritional status and dietary intake of institutionalized elderly in Turkey. Cross-sectional study. 25 institutions in 19 cities throughout Turkey. Elderly residents aged 65 years and older (n=554). Nutritional status using Mini Nutritional Assessment (MNA), food consumption with 24-h dietary recall and anthropometric measurements (body weight, height, body mass index (BMI), waist circumference (WC), hip circumference, waist/hip ratio, mid-upper arm circumference (MUAC)). The mean age of the elderly was 76.1±7.3 years. BMI of elderly men and women were found to be 26.59±4.58kg/m(2) and 30.07±6.32kg/m(2), respectively. WC of elderly men and women were found to be 98.90±1.33cm and 100.62±1.34cm, respectively. Most of the elderly were overweight based on BMI and at risk of metabolic diseases based on WC. According to MNA, 44.2% had normal nutritional status, 49.1% were at risk of malnutrition, 6.7% had malnutrition. All nutrients intake was favorable according to requirements, except for calcium and magnesium. Energy, protein, carbohydrate, fat, vitamins A, E, B1, B2, B6, C folat, iron, zinc intake of elderly who had normal nutritional status, who were at risk of malnutrition and malnourished were significantly different. Energy and nutrients intake of elderly who had normal nutritional status was found to be better than the others. Nutritional status should be periodically screened in the institutionalized elderly to prevent malnutrition. Also, it was noted that adequate energy and nutrients intake of the elderly played a crucial role in maintaining nutritional status and preventing malnutrition within residential homes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  13. Incidence and psychological-behavioral characteristics of refractory functional dyspepsia: a large, multi-center, prospective investigation from China.

    PubMed

    Jiang, Shu-Man; Jia, Lin; Lei, Xiao-Gai; Xu, Ming; Wang, Sheng-Bing; Liu, Jing; Song, Min; Li, Wei-Dong

    2015-02-14

    To explore the incidence and psychological and behavioral characteristics of refractory functional dyspepsia (RFD) in China. The subjects of this study were 1341 new outpatients with functional dyspepsia (FD) who were diagnosed according to the Rome III criteria at four hospitals in Guangdong Province between June and September 2012, and 100 healthy volunteers. All subjects completed questionnaires and scales administered. Three-hundred and twenty-seven of the 1341 patients with FD had RFD (24.4%). Patients with RFD had a longer disease duration and a more severe form of the disease than patients with non-refractory FD (NRFD). The prevalence of depression and anxiety symptoms was higher in patients with RFD than in patients with NRFD. The prevalence of unhealthy eating behaviors, lack of physical activity, and sleeping disorders was higher in patients with RFD than in patients with NRFD. Patients with RFD sought medical advice on more occasions and spent more money on treatment than patients with NRFD. Finally, patients with RFD had poorer quality of life than patients with NRFD. RFD is not rare in clinical practice and should get attention by patients and doctors because of its long duration, severe symptoms, and associations with abnormal psychology and poor quality of life.

  14. Multi-center surveillance for pneumonia & meningitis among children (<2 yr) for Hib vaccine probe trial preparation in India.

    PubMed

    Gupta, Madhu; Kumar, Rajesh; Deb, Alok Kumar; Bhattacharya, Sujit Kumar; Bose, Anuradha; John, Jacob; Balraj, Vinohar; Ganguly, N K; Kant, Lalit; Kapoor, Ambujam Nair; Watt, James; Shearer, Jessica; Santosham, Mathuram

    2010-05-01

    Severe clinical pneumonia and meningitis caused by Haemophilus influenzae type b in children less than 5 yr old is preventable by use of Hib vaccine. However, data on Hib burden in India are limited. To support an evidence-based decision for Hib vaccine introduction in India, a vaccine probe study was planned. This paper presents the results of the preparatory phase for such a study, which aimed to determine the feasibility of conducting a randomized vaccine probe study and to estimate the incidence of all causes of pneumonia and meningitis. The preparatory study included population- based, hospital-based and carriage surveillance. Children aged 18-24 months and were enrolled at PGIMER, Chandigarh, CMC, Vellore and NICED, Kolkata, from July 2005 to December 2006. At the time of enrollment, parents were informed about the signs and symptoms of pneumonia and meningitis, and were encouraged to take the child to study hospitals for treatment. Hospitalized children less than two years of age suspected of having pneumonia and/or meningitis were enrolled in study hospitals, whether or not they were from the cohort population. Patients were examined clinically and received chest radiograph for suspected cases of pneumonia or lumbar puncture for suspected cases of meningitis. Blood culture was done for both pneumonia and meningitis patients. Cerebrospinal fluid (CSF) was tested for biochemistry, culture, latex agglutination test and polymerase chain reaction. Nasopharyngeal swabs were collected from healthy children less than 2 yr of age at immunization clinics to estimate Hib carriage. A cohort of 17,951 children were recruited for the population-based arm. The incidence of severe clinical pneumonia ranged from 2717 to 7890 per 100,000 child-years of observation; suspected meningitis ranged from 1971 to 2433 per 100,000 child-years of observation. In the hospital-based study 7/90 (7.8%), 29/98 (29.6%) and 38/181 (21.0%) of CSF samples with cell count > or =100 WBCs/mm(3); were purulent at Chandigarh, Kolkata and Vellore respectively. Of these purulent CSF samples, Hib was detected in 2, 6 and 11 cases, respectively. The Hib nasopharyngeal carriage prevalence ranged from 6.0 - 7.6 per cent. Incidence of severe clinical pneumonia is comparable with other studies from India but that of suspected meningitis is higher. Although rates of Hib meningitis cannot be calculated from a hospital-based study, there is evidence of Hib meningitis in these study settings. Hib carriage prevalence indicates that Hib is present and circulating in these study areas. There is a significant burden of pneumonia and meningitis among children in India. Continued strengthening of laboratory capacity and bacterial surveillance systems are necessary.

  15. 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

  16. Implementation of baby boomer hepatitis C screening and linking to care in gastroenterology practices: a multi-center pilot study.

    PubMed

    Younossi, Zobair M; LaLuna, Louis L; Santoro, John J; Mendes, Flavia; Araya, Victor; Ravendhran, Natarajan; Pedicone, Lisa; Lio, Idania; Nader, Fatema; Hunt, Sharon; Racila, Andrei; Stepanova, Maria

    2016-04-04

    Estimates suggest that only 20 % of HCV-infected patients have been identified and <10 % treated. However, baby boomers (1945-1965) are identified as having a higher prevalence of HCV which has led the Centers for Disease Control and Prevention to make screening recommendations. The aim of this study was to implement the CDC's screening recommendations in the unique setting of gastroenterology practices in patients previously unscreened for HCV. After obtaining patient informed consent, demographics, clinical and health-related quality of life (HRQOL) data were collected. A blood sample was screened for HCV antibody (HCV AB) using the OraQuick HCV Rapid Antibody Test. HCV AB-positive patients were tested for presence of HCV RNA and, if HCV RNA positive, patients underwent treatment discussions. We screened 2,000 individuals in 5 gastroenterology centers located close to large metropolitan areas on the East Coast (3 Northeast, 1 Mid-Atlantic and 1 Southeast). Of the screened population, 10 individuals (0.5 %) were HCV AB-positive. HCV RNA testing was performed in 90 % (9/10) of HCV AB-positive individuals. Of those, 44.4 % (4/9) were HCV RNA-positive, and all 4 (100 %) were linked to caregiver. Compared to HCV AB negative subjects, HCV AB-positive individuals tended to be black (20.0 vs. 5.2 %, p = 0.09) and reported significantly higher rates of depression: 60.0 vs. 21.5 %, p = 0.009. These individuals also reported a significantly lower HRQOL citing having more fatigue, poorer concentration, and a decreased level of energy (p < 0.05). Although the prevalence of HCV AB-positive was low in previously unscreened subjects screened in the gastroenterology centers, the linkage to care was very high. The sample of patients used in this study may be biased, so further studies are needed to assess the effectiveness of the CDC screening recommendations. Implementation of the Baby Boomer Screening for HCV requires identifying screening environement with high prevalence of HCV+ individuals as well as an efficient process of linking them to care.

  17. 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

  18. 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

  19. 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..., methodology, or burden of the study. The program staff submitted a response to the public comment. The...

  20. 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...

  1. 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.

  2. 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

  3. 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 below...

  4. Security Policy and Infrastructure in the Context of a Multi-Centeric Information System Dedicated to Autism Spectrum Disorder.

    PubMed

    Ben Said, Mohamed; Robel, Laurence; Golse, Bernard; Jais, Jean Philippe

    2017-01-01

    Autism spectrum disorders (ASD) are complex neuro-developmental disorders affecting children in their early age. The diagnosis of ASD relies on multidisciplinary investigations, in psychiatry, neurology, genetics, electrophysiology, neuro-imagery, audiology and ophthalmology. In order to support clinicians, researchers and public health decision makers, we designed an information system dedicated to ASD, called TEDIS. TEDIS was designed to manage systematic, exhaustive and continuous multi-centric patient data collection via secured Internet connections. In this paper, we present the security policy and security infrastructure we developed to protect ASD' patients' clinical data and patients' privacy. We tested our system on 359 ASD patient records in a local secured intranet environment and showed that the security system is functional, with a consistent, transparent and safe encrypting-decrypting behavior. It is ready for deployment in the nine ASD expert assessment centers in the Ile de France district.

  5. A multi-center prospective cohort study of patient transfers from the intensive care unit to the hospital ward.

    PubMed

    Stelfox, Henry T; Leigh, Jeanna Parsons; Dodek, Peter M; Turgeon, Alexis F; Forster, Alan J; Lamontagne, Francois; Fowler, Rob A; Soo, Andrea; Bagshaw, Sean M

    2017-08-29

    To provide a 360-degree description of ICU-to-ward transfers. Prospective cohort study of 451 adults transferred from a medical-surgical ICU to a hospital ward in 10 Canadian hospitals July 2014-January 2016. Transfer processes documented in the medical record. Patient (or delegate) and provider (ICU/ward physician/nurse) perspectives solicited by survey 24-72 h after transfer. Medical records (100%) and survey responses (ICU physicians-80%, ICU nurses-80%, ward physicians-46%, ward nurses-64%, patients-74%) were available for most transfers. The median time from initiation to completion of transfer was 25 h (IQR 6-52). ICU physicians and nurses reported communicating with counterparts via telephone (78 and 75%) when transfer was requested (82 and 24%) or accepted (31 and 59%) and providing more elements of clinical information than ward physicians (mean 4.7 vs. 3.9, p < 0.001) and nurses (5.0 vs. 4.4, p < 0.001) reported receiving. Patients were more likely to report satisfaction with the transfer when they received more information (OR 1.32, 95% CI 1.18-1.48), had their questions addressed (OR 3.96, 95% CI 1.33-11.84), met the ward physician prior to transfer (OR 4.61, 95% CI 2.90-7.33), and were assessed by a nurse within 1 h of ward arrival (OR 4.70, 95% CI 2.29-9.66). Recommendations for improvement included having a documented care plan travel with the patient (all stakeholders), standardized face-to-face handover (physicians), avoiding transfers at shift change (nurses) and informing patients about pending transfers in advance (patients). ICU-to-ward transfers are characterized by failures of patient flow and communication; experienced differently by patients, ICU/ward physicians and nurses, with distinct suggestions for improvement.

  6. 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.

  7. 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

  8. Right ventricular afterload sensitivity dramatically increases after left ventricular assist device implantation: a multi-center hemodynamic analysis

    PubMed Central

    Houston, Brian A.; Kalathiya, Rohan J.; Hsu, Steven; Loungani, Rahul; Davis, Mary E.; Coffin, Samuel T.; Haglund, Nicholas; Maltais, Simon; Keebler, Mary E.; Leary, Peter J.; Judge, Daniel P.; Stevens, Gerin R.; Rickard, John; Sciortino, Chris M.; Whitman, Glenn J.; Shah, Ashish S.; Russell, Stuart D.; Tedford, Ryan J.

    2016-01-01

    Background Right ventricular (RV) failure is a source of morbidity and mortality after left ventricular assist device (LVAD) implantation. We sought to define hemodynamic changes in afterload and RV adaption to afterload both early after implantation and with prolonged LVAD support. Methods We reviewed right heart catheterization (RHC) data from participants who underwent continuous-flow LVAD implantation at our institutions (n=244), excluding those on inotropic or vasopressor agents, pulmonary vasodilators, or additional mechanical support at any RHC. Hemodynamic data was assessed at five time intervals: 1) pre-LVAD (within 6 months), 2) early post-LVAD (0–6 months), 3) 7–12 months, 4) 13–18 months and 3) very-late post-LVAD (18–36 months). Results Sixty participants met the inclusion criteria. All measures of right ventricular load (effective arterial elastance, pulmonary vascular compliance and pulmonary vascular resistance) improved between the pre- and early post-LVAD time periods. Despite decreasing load and pulmonary capillary artery pressure (PAWP), RAP remained unchanged and the RAP:PAWP ratio worsened early post-LVAD (0.44 [0.38, 0.63] versus 0.77 [0.59, 1.0], p<0.001), suggesting a worsening of RV adaptation to load. With continued LVAD support, both RV load and RAP:PAWP decreased in a steep, linear and dependent manner. Conclusion Despite reducing RV load, LVAD implantation leads to worsened RV adaptation. With continued LVAD support, both RV afterload and RV adaptation improve, and their relationship remains constant over time post-LVAD. These findings suggest the RV afterload sensitivity increases after LVAD implantation, which has important clinical implications for patients struggling with RV failure. PMID:27041496

  9. Post-Discharge Care of Pediatric Traumatic Brain Injury in Argentina: A Multi-Center Randomized Controlled Trial

    PubMed Central

    Carney, Nancy A.; Petroni, Gustavo J.; Luján, Silvia B.; Ballarini, Nicolás M.; Faguaga, Gabriela A.; du Coudray, Hugo E. M.; Huddleston, Amy E.; Baggio, Gloria M.; Becerra, Juan M.; Busso, Leonardo O.; Dikmen, Sureyya S.; Falcone, Roberto; García, Mirta E.; Carrillo, Osvaldo R. González; Medici, Paula L.; Quaglino, Marta B.; Randisi, Carina A.; Sáenz, Silvia S.; Temkin, Nancy R.; Vanella, Elida E.

    2016-01-01

    Objective To develop, in partnership with families of children with traumatic brain injury (TBI), a post-discharge intervention that is effective, simple and sustainable. Design Randomized Controlled Trial Setting Seven Level 1 Pediatric Trauma Centers in Argentina. Patients Persons less than 19 years of age admitted to one of the study hospitals with a diagnosis of severe, moderate, or complicated mild TBI, and were discharged alive. Interventions Patients were randomly assigned to either the Intervention or Standard Care group. A specially trained Community Resource Coordinator (CRC) was assigned to each family in the Intervention group. We hypothesized that children with severe, moderate, and complicated mild TBI who received the intervention would have significantly better functional outcomes at 6-months post-discharge than those who received standard care. We further hypothesized there would be a direct correlation between patient outcome and measures of family function. Measurements and Main Results The primary outcome measure was a composite measured at 6-months post-injury. There were 308 patients included in the study; 61% male. Forty-four percent sustained a complicated mild TBI, 18% moderate, and 38% severe. Sixty-five percent of the patients were 8 years old or younger, and over 70% were transported to the hospital without ambulance assistance. There was no significant difference between groups on the primary outcome measure. There was a statistically significant correlation between the primary outcome measure and scores on the Family Impact Module of the PedsQL (ρ= 0.57; p < 0.0001). Children with better outcomes lived with families reporting better function at 6-months post-injury. Conclusions While no significant effect of the intervention was demonstrated, this study represents the first conducted in Latin America that documents the complete course of treatment for pediatric patients with TBI spanning hospital transport through hospital care and into the post-discharge setting. PMID:27243414

  10. 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

  11. 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

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

    DTIC Science & Technology

    2012-10-01

    one year and a half) involving supervised and unsupervised treatment can lower your body weight, reduce your body fat, reduce your risk factors for...detailed exploration of these deficiencies and their association with CMS risks of dysglycemia and dyslipide- mia exceeds the scope of this monograph. In...array of CVD risk factors and predic- tions.6 In general, an intermediate CVD risk stratifica- tion may be used to define need for treatment, which

  13. 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

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

    PubMed Central

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

    2011-01-01

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

  15. Childhood trauma and dissociation in patients with alcohol dependence, drug dependence, or both-A multi-center study.

    PubMed

    Schäfer, Ingo; Langeland, Willemien; Hissbach, Johanna; Luedecke, Christel; Ohlmeier, Martin D; Chodzinski, Claudia; Kemper, Ulrich; Keiper, Peter; Wedekind, Dirk; Havemann-Reinecke, Ursula; Teunissen, Sybille; Weirich, Steffen; Driessen, Martin

    2010-06-01

    The aims of this study were to examine the level of dissociative symptoms in patients with different substance related disorders (alcohol dependence, drug dependence, and combined alcohol and drug dependence), and to investigate the influence of potentially traumatic events in childhood, age, gender, and posttraumatic stress disorder on the relationship between dissociative symptoms and type of substance abuse. Of the 459 participants (59.7% male) 182 (39.7%) were alcohol-dependent (A), 154 (33.6%) were drug-dependent (D), and 123 (26.8%) were dependent on both, alcohol and drugs (AD) based on the DSM-IV criteria for a current diagnosis. Participants completed the Childhood Trauma Questionnaire (CTQ) and the Dissociative Experiences Scale (DES). The International Diagnostics Checklist (IDCL) was administered to diagnose PTSD. Higher levels of dissociation were observed in patients with drug dependence as compared to patients with mere alcohol dependence (mean DES group A: 9.9+/-8.8; group D: 12.9+/-11.7; group AD: 15.1+/-11.3). However, when severity of potentially traumatic events in childhood, PTSD, age and gender were included in the analysis, the influence of the type of substance abuse did not prove to be statistically significant. The variable most strongly related to dissociative symptoms was severity of potentially traumatic events in childhood, in particular emotional abuse, even after controlling for PTSD and other potential confounders. It seems appropriate to screen SUD patients for dissociative symptoms, especially those with a more complex risk profile including (additional) drug abuse, female gender, younger age and most importantly a history of childhood trauma. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

  16. 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.

  17. Factors effecting influenza vaccination uptake among health care workers: a multi-center cross-sectional study.

    PubMed

    Asma, Süheyl; Akan, Hülya; Uysal, Yücel; Poçan, A Gürhan; Sucaklı, Mustafa Haki; Yengil, Erhan; Gereklioğlu, Çiğdem; Korur, Aslı; Başhan, İbrahim; Erdogan, A Ferit; Özşahin, A Kürşat; Kut, Altuğ

    2016-05-04

    The present study aimed to identify factors affecting vaccination against influenza among health professionals. We used a multi-centre cross-sectional design to conduct an online self-administered questionnaire with physicians and nurses at state and foundation university hospitals in the south-east of Turkey, between 1 January 2015 and 1 February 2015. The five participating hospitals provided staff email address lists filtered for physicians and nurses. The questionnaire comprised multiple choice questions covering demographic data, knowledge sources, and Likert-type items on factors affecting vaccination against influenza. The target response rate was 20 %. In total, 642 (22 %) of 2870 health professionals (1220 physicians and 1650 nurses) responded to the questionnaire. Participants' mean age was 29.6 ± 9.2 years (range 17-62 years); 177 (28.2 %) were physicians and 448 (71.3 %) were nurses. The rate of regular vaccination was 9.2 % (15.2 % for physicians and 8.2 % for nurses). Increasing age, longer work duration in health services, being male, being a physician, working in an internal medicine department, having a chronic disease, and living with a person over 65 years old significantly increased vaccination compliance (p < 0.05). We found differences between vaccine compliant and non-compliant groups for expected benefit from vaccination, social influences, and personal efficacy (p < 0.05). Univariate analysis showed differences between the groups in perceptions of personal risks, side effects, and efficacy of the vaccine (p < 0.05). Multivariate analysis found that important factors influencing vaccination behavior were work place, colleagues' opinions, having a chronic disease, belief that vaccination was effective, and belief that flu can be prevented by natural ways. Numerous factors influence health professionals' decisions about influenza vaccination. Strategies to increase the ratio of vaccination among physicians and nurses should consider all of these factors to increase the likelihood of success.

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

    PubMed Central

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

    2014-01-01

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

  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. 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

  1. VISIBILITY AS A SURROGATE FOR PARTICLE POLLUTION IN MULTI-CENTER POPULATION-BASED STUDIES. (R827994)

    EPA Science Inventory

    The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Concl...

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

    PubMed

    Van Donkersgoed, Rozanne J M; De Jong, Steven; Van der Gaag, Mark; Aleman, André; Lysaker, Paul H; Wunderink, Lex; Pijnenborg, G H M

    2014-02-03

    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. 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). 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. Current Controlled Trials: ISRCTN16659871.

  3. 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

  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. [Comparison of chest and abdominal x-ray radiation dose and its image quality-a multi-center study].

    PubMed

    Uto, Tomoyuki; Ishiyama, Akihiro; Kimura, Hiroya; Katuragi, Yuji; Masunari, Toyokazu; Shibutani, Takayuki; Ishiki, Koichi; Nakanishi, Ken; Anai, Tatuya; Sumida, Shigeru; Morimatu, Takashi; Miyano, Hideto

    2011-01-01

    While radiography provides us clinically valuable information, it increases the risk of radiation exposure. Previous studies have reported great variations in radiation doses among institutions. It is concerning that radiation doses will increase and vary greatly from institution to institution when digital radiographic modalities become more common. In the present study, we measured chest and abdominal radiation doses at 10 institutions that had X-ray digital imaging systems. Differences in radiation doses among the institutions were evaluated and compared with the previous reports. The image quality at the measured radiation doses were also evaluated. The doses were measured by the same dosimeter, and the image quality at a specific dose was evaluated using the standard deviation of the digital values and Wiener spectrum. Our results indicate that the difference in radiation among institutions was approximately five-fold at a maximum and smaller than the previous reports had indicated. The image quality was improved as the dose was increased. We considered the five-fold difference to be the result of variations in optimum image quality and associated radiation doses among institutions. In summary, evaluating the radiation dose along with the image quality is important to optimize the doses.

  6. Olanzapine for prevention of chemotherapy-induced nausea and vomiting in children and adolescents: a multi-center, feasibility study.

    PubMed

    Flank, J; Schechter, T; Gibson, P; Johnston, D L; Orsey, A D; Portwine, C; Sung, L; Dupuis, L L

    2017-08-30

    There are no prospective pediatric trials evaluating olanzapine for chemotherapy-induced nausea and vomiting (CINV) prevention. This study evaluated the feasibility of a trial of olanzapine to evaluate the contribution of olanzapine to CINV control in pediatric oncology patients. Patients < 18 years receiving CINV prophylaxis with ondansetron/granisetron/palonosetron ± dexamethasone ± aprepitant were eligible to participate in this prospective, single-arm, open-label study. All patients received olanzapine (0.14 mg/kg/dose; max 10 mg/dose) once daily orally starting before the first chemotherapy dose and continuing for up to four doses after the last chemotherapy administration. A future trial was considered feasible if mean time to enroll 15 patients was ≤ 12 months/site, ≥ 12/15 took at least half of the planned olanzapine doses, and ≤ 3/15 experienced significant sedation or dizziness despite dose reduction. The proportion of children who experienced complete CINV control (no nausea, vomiting, or retching) was described. Fifteen patients (range 4.1-17.4 years) participated; mean recruitment period was 9.3 months/site. All patients took at least half of the planned olanzapine doses. Six patients experienced sedation which resolved with olanzapine dose reduction (N = 5) or bedtime administration (N = 1). Olanzapine was stopped in one patient with blurry vision and in another with increased plasma GGT values. In both the acute and delayed phases, eight patients experienced complete control of vomiting but almost all (14/15) had nausea. A pediatric trial of olanzapine for CINV control is feasible. Our findings will inform the design of a future study.

  7. Mortality associated with late-onset pneumonia in the intensive care unit: results of a multi-center cohort study.

    PubMed

    Moine, Pierre; Timsit, Jean-François; De Lassence, Arnaud; Troché, Gilles; Fosse, Jean-Philippe; Alberti, Corrine; Cohen, Yves

    2002-02-01

    To evaluate the attributable mortality associated with late-onset nosocomial pneumonia (LOP) while taking into account the severity at admission, the evolution of the patients during the first 4 days after admission to the ICU and the appropriateness of initial empiric antibiotic treatment. Multicenter cohort study with prospective standardization of diagnostic interventions when nosocomial pneumonia develops. Medical and surgical ICUs of four university-affiliated teaching hospitals. Seven hundred sixty-four consecutive patients requiring ICU hospitalization for at least 4 days. The clinical and biological data as well as the therapeutic data and the outcome were prospectively recorded from the day of admission to ICU discharge. Simplified Acute Physiologic Score (SAPS II) and Logistic Organ Dysfunction (LOD) score were collected and computed within the first 4 calendar days of ICU admission. Variables associated with the outcome were selected using a stepwise Cox model. The time to acquisition of the first LOP was then introduced in the final model as a time-dependent covariate. The analysis was stratified by ICU center. Finally, as initial antibiotic therapy could have an impact on the increased risk of death induced by LOP, the Cox model was applied again introducing LOP immediately adequately treated and LOP not immediately adequately treated as two different time-dependent covariates. Late-onset pneumonia developed in 89 patients (12%). A McCabe score of more than 1, SAPS II score and increases in SAPS between days 1 and 2, days 2 and 3, and days 3 and 4 were significantly associated with an increased risk of death. When the time to acquisition of the first episode of LOP was introduced into the Cox model, the LOP occurrence was associated with increased mortality, even adjusted over the selected prognostic parameters and after stratification by center (hazard ratio (HR)=1.53, 95% CI 1.02-2.3, p=0.04). When LOP immediately adequately treated and LOP not immediately adequately treated were separately introduced into the Cox model, inappropriately treated LOP remained significantly associated with an increased risk of mortality (HR=1.69, 95% CI 1.08-2.65, p=0.022), whereas appropriately treated LOP did not (HR=1.44, 95% CI 0.75-2.76, p=0.27). These data suggest that, in addition to severity scores, the underlying medical conditions and the evolution of severity within the first 4 days in ICU, late-onset pneumonia independently contribute to ICU patient mortality when empirical antibiotic treatment is not immediately appropriate.

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

    DTIC Science & Technology

    2013-10-01

    and a ruler for measuring things like pizza , pieces of pie, and cookies. This scale is for weighing meats and cheese (briefly demonstrate how to...This scale is for weighing meats and cheese (briefly demonstrate how to use it). The ruler is for measuring things like pizza , pieces of pie, and...measuring cup, if you have one at home, for liquids and a ruler for measuring things like pizza , pieces of pie, and cookies. This scale is for

  10. 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

  11. [Effects of paroxetine with or without zolpidem on depression with insomnia: a multi-center randomized comparative study].

    PubMed

    Ji, Jian-Lin; Liu, Wen-Juan; Zhang, Ning; Chen, Zhi-Qing; Zheng, An-Lin; Mei, Qi-Yi; Pan, Ji-Yang; Zhao, Zhong-Xin; Tao, Ming; Wang, Yu-Ping; Wei, Jing

    2007-06-19

    To compare the effects of paroxetine with or without zolpidem on depression with insomnia. 229 consecutive outpatients with the diagnosis of major depression based on the CCMD-3 criteria who visited the departments of mental counseling, psychiatric, or neurology in 11 general hospitals the country over during a period of 4 weeks, were randomly allocated into 2 groups: paroxetine + zolpidem group (Group A, treated with paroxetine 10 - 20 mg/d and zolpidem 10 mg/d H. d. for 4 weeks) and paroxetine group (Group B, treated with paroxetine only), among which 221 underwent intention-to-treat analysis and 207 underwent completer analysis (CA). Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Pittsburg sleep quality index (PSQI), and 36-item Short Form Health Survey (SF-36) were used to evaluate the outcomes. One week after the beginning of treatment the reduction of PSQI score of Group A was 5.7, showing an improvement of sleep quality, significantly higher than that of Group B (1.6), and 4 weeks later the reduction of PSQI of Group A was 9.7 +/- 3.6, significantly higher than that of Group B (6.0 +/- 3.5, both P = 0.000). Four weeks after the beginning of treatment, the HAMD reduction rate of Group A was 68.5%, significantly higher than that of Group B (56.8%, P < 0.01), and the HAMA reduction rate of Group A was 66.2%, significantly higher than that of Group B (57.1%, P < 0.01), and the SF-36 score of Group A was 66 +/- 19 (last observation carry forward analysis) or 67 +/- 19 (CA), significantly higher than those of Group B (38 +/- 16 or 67 +/- 19 respectively, both P = 0.000). selective serotonin reuptake inhibitor antidepressant combined with hypnotic augments the effects of antidepressant on the depressive and anxiety symptoms.

  12. 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

  13. 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

  14. [Prospective clinical multi-center study on the treatment of sudden deafness with different typings in China].

    PubMed

    2013-05-01

    To investigate the necessity of subtyping for the treatment of sudden deafness. The international standardized clinical research methods, the unified design and program were used in the study. The sudden deafness patients between 18 to 65 years old were recruited, whose duration was less than two weeks with no medication. The patients were divided into four types according to the hearing curve: type A was acute sensorineural hearing loss in low tone frequencies, type B was acute sensorineural hearing loss in high tone frequencies, type C was acute sensorineural hearing loss in all frequencies and type D was total deafness. Each type had four different treatment programs, based on the unified designed randomized table. Total of 1024 cases with single side sudden deafness were recruited in the study by 33 hospitals in China from August 2007 to October 2011, including 492 male cases (48.05%), and 532 females (51.95%). The average age was (41.2 ± 12.8) years old. By classification of audiogram, among the 1024 cases, 205 cases were type A (20.20%), 141 cases were type B (13.77%), 402 cases were type C (39.26%), 276 cases were type D (26.95%). The curative effects of different types were analyzed, type A had the highest rate of 90.73%, type C was 82.59%, type D was 70.29% and type B had the lowest rate of 65.96%. Significant difference of curative rate between different types was detected (χ(2) = 231.58, P = 0.000). Regarding the curative results of the 1024 cases, 378 cases were recovery (36.91%), 229 cases were excellent better (22.36%), 198 cases were better (19.34%) and 219 cases were poor (21.39%). Glucocorticoid was effective for each type and the combined treatment was better than any single medication. Different types of the hearing curves of sudden deafness have different curing effect, it indicates that different types should use different treatments. It'is important that sudden deafness should be treated according to the types of the hearing curve. The type in low tone frequencies has the best curative effect, followed by the type in all frequencies. The type in high tone frequencies and the total deafness type has poor curative results.

  15. Olanzapine for treatment and prevention of acute chemotherapy-induced vomiting in children: a retrospective, multi-center review.

    PubMed

    Flank, Jacqueline; Thackray, Jennifer; Nielson, Danelle; August, Amanda; Schechter, Tal; Alexander, Sarah; Sung, Lillian; Dupuis, L Lee

    2015-03-01

    This retrospective review provides preliminary data regarding the safety and efficacy of olanzapine for chemotherapy-induced vomiting (CIV) control in children. Children <18 years old who received olanzapine for acute chemotherapy-induced nausea and vomiting (CINV) control from December 2010 to August 2013 at four institutions were identified. Patient characteristics, chemotherapy, antiemetic prophylaxis, olanzapine dosing, CIV control, liver function test results and adverse events were abstracted from the health record. Toxicity was graded using CTCAEv4.03. Sixty children (median age 13.2 years; range: 3.10-17.96) received olanzapine during 158 chemotherapy blocks. Olanzapine was most often (59%) initiated due to a history of poorly controlled CINV. The mean initial olanzapine dose was 0.1 mg/kg/dose (range: 0.026-0.256). Most children who received olanzapine beginning on the first day of the chemotherapy block experienced complete CIV control throughout the acute phase (83/128; 65%). There was no association between the olanzapine dose/kg and complete CIV control (OR 1.01; 95% CI: 0.999-1.020; P = 0.091). Sedation was reported in 7% of chemotherapy blocks and was significantly associated with increasing olanzapine dose (OR: 1.17; 95% CI: 1.08-1.27; P = 0.0001). Of the 25 chemotherapy blocks where ALT and/or AST were reported more than once, grade 1-3 elevations were observed in five. The mean weight change in 31 children who received olanzapine during more than one chemotherapy block was 0% (range: -22 to +18). Olanzapine may be an important option to improve CIV control in children. Prospective controlled evaluation of olanzapine for CINV prophylaxis in children is warranted. © 2014 Wiley Periodicals, Inc.

  16. Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

    PubMed

    Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

    2016-07-19

    The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

  17. Quality assurance of HIV prevention counseling in a multi-center randomized controlled trial. Project RESPECT Study Group.

    PubMed Central

    Kamb, M L; Dillon, B A; Fishbein, M; Willis, K L

    1996-01-01

    Current HIV prevention counseling strategies rely largely on interventions aimed at changing behaviors. Among these is HIV prevention counseling and testing, which has been a prominent component in the federally supported strategies for HIV/AIDS prevention in the United States. To assess the efficacy of HIV counseling in reducing risk behaviors and preventing HIV infection and other sexually transmitted diseases, a multicenter, randomized controlled trial is being conducted among sexually transmitted disease clinic patients (Project RESPECT). The trial compares three separate HIV prevention strategies on increasing condom use and decreasing new cases of sexually transmitted diseases. The strategies are (a) Enhanced HIV Prevention Counseling, a 4-session individual counseling intervention based on behavioral and social science theory; (b) HIV Prevention Counseling, a 2-session individual pre- and post test counseling strategy that attempts to increase perception of risk and reduce risk behaviors using small, achievable steps; and (c) HIV Education, a brief 2-session pre- and post-test strategy that is purely informational. One difficulty in conducting randomized trials of behavioral interventions is assuring that the interventions are being conducted both as conceptualized and in a consistent manner by different counselors and, for multicenter studies, at different study sites. This article describes the quality assurance measures that have been used for Project RESPECT. These have included development of standard tools, standard training, frequent observation and feedback to study personnel, and process evaluation. PMID:8862164

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

    PubMed Central

    2014-01-01

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

  19. Quality of life and related factors among chronic hepatitis B-infected patients: a multi-center study, Turkey.

    PubMed

    Karacaer, Zehra; Cakir, Banu; Erdem, Hakan; Ugurlu, Kenan; Durmus, Gul; Ince, Nevin Koc; Ozturk, Cinar; Hasbun, Rodrigo; Batirel, Ayse; Yilmaz, Esmeray Mutlu; Bozkurt, Ilkay; Sunbul, Mustafa; Aynioglu, Aynur; Atilla, Aynur; Erbay, Ayse; Inci, Ayse; Kader, Cigdem; Tigen, Elif Tukenmez; Karaahmetoglu, Gokhan; Coskuner, Seher Ayten; Dik, Ebru; Tarakci, Huseyin; Tosun, Selma; Korkmaz, Fatime; Kolgelier, Servet; Karadag, Fatma Yilmaz; Erol, Serpil; Turker, Kamuran; Necan, Ceyda; Sahin, Ahmet Melih; Ergen, Pinar; Iskender, Gulsen; Korkmaz, Pinar; Eroglu, Esma Gulesen; Durdu, Yasemin; Ulug, Mehmet; Deniz, Suna Secil; Koc, Filiz; Alpat, Saygın Nayman; Oztoprak, Nefise; Evirgen, Omer; Sozen, Hamdi; Dogan, Mustafa; Kaya, Selcuk; Kaya, Safak; Altindis, Mustafa; Aslan, Emel; Tekin, Recep; Sezer, Busra Ergut; Ozdemir, Kevser; Ersoz, Gulden; Sahin, Ahmet; Celik, Ilhami; Aydin, Emsal; Bastug, Aliye; Harman, Rezan; Ozkaya, Hacer Deniz; Parlak, Emine; Yavuz, Ilknur; Sacar, Suzan; Comoglu, Senol; Yenilmez, Ercan; Sirmatel, Fatma; Balkan, Ilker Inanc; Alpay, Yesim; Hatipoglu, Mustafa; Denk, Affan; Senol, Gunes; Bitirgen, Mehmet; Geyik, Mehmet Faruk; Guner, Rahmet; Kadanali, Ayten; Karakas, Ahmet; Namiduru, Mustafa; Udurgucu, Hatice; Boluktas, Rukiye Pinar; Karagoz, Ergenekon; Ormeci, Necati

    2016-11-03

    The aim of this study was to assess health-related quality of life (HRQOL) among chronic hepatitis B (CHB) patients in Turkey and to study related factors. This multicenter study was carried out between January 01 and April 15, 2015 in Turkey in 57 centers. Adults were enrolled and studied in three groups. Group 1: Inactive HBsAg carriers, Group 2: CHB patients receiving antiviral therapy, Group 3: CHB patients who were neither receiving antiviral therapy nor were inactive HBsAg carriers. Study data was collected by face-to-face interviews using a standardized questionnaire, Short Form-36 (SF-36) and Hepatitis B Quality of Life (HBQOL). Values equivalent to p < 0.05 in analyses were accepted as statistically significant. Four thousand two hundred fifty-seven patients with CHB were included in the study. Two thousand five hundred fifty-nine (60.1 %) of the patients were males. Groups 1, 2 and 3, consisted of 1529 (35.9 %), 1721 (40.4 %) and 1007 (23.7 %) patients, respectively. The highest value of HRQOL was found in inactive HBsAg carriers. We found that total HBQOL score increased when antiviral treatment was used. However, HRQOL of CHB patients varied according to their socio-demographic properties. Regarding total HBQOL score, a higher significant level of HRQOL was determined in inactive HBV patients when matched controls with the associated factors were provided. The HRQOL score of CHB patients was higher than expected and it can be worsen when the disease becomes active. Use of an antiviral therapy can contribute to increasing HRQOL of patients.

  20. Content and timing of feedback and reflection: a multi-center qualitative study of experienced bedside teachers.

    PubMed

    Gonzalo, Jed D; Heist, Brian S; Duffy, Briar L; Dyrbye, Liselotte; Fagan, Mark J; Ferenchick, Gary; Harrell, Heather; Hemmer, Paul A; Kernan, Walter N; Kogan, Jennifer R; Rafferty, Colleen; Wong, Raymond; Elnicki, Michael D

    2014-10-10

    Competency-based medical education increasingly recognizes the importance of observation, feedback, and reflection for trainee development. Although bedside rounds provide opportunities for authentic workplace-based implementation of feedback and team-based reflection strategies, this relationship has not been well described. The authors sought to understand the content and timing of feedback and team-based reflection provided by bedside teachers in the context of patient-centered bedside rounds. The authors conducted a thematic analysis qualitative study using transcripts from audio-recorded, semi-structured telephone interviews with internal medicine attending physicians (n= 34) identified as respected bedside teachers from 10 academic US institutions (2010-2011). Half of the respondents (50%) were associate/full professors, with an average of 14 years of academic experience. In the context of bedside encounters, bedside teachers reported providing feedback on history-taking, physical-examination, and case-presentation skills, patient-centered communication, clinical decision-making, leadership, teaching skills, and professionalism. Positive feedback about physical-exam skills or clinical decision-making occurred during encounters, positive or constructive team-based feedback occurred immediately following encounters, and individualized constructive feedback occurred in one-on-one settings following rounding sessions. Compared to less frequent, emotionally-charged events, bedside teachers initiated team-based reflection on commonplace "teachable moments" related to patient characteristics or emotions, trainee actions and emotions, and attending physician role modeling. Bedside teachers use bedside rounds as a workplace-based method to provide assessment, feedback, and reflection, which are aligned with the goals of competency-based medical education. Embedded in patient-centered activities, clinical teachers should be encouraged to incorporate these content- and timing-related feedback and reflection strategies into their bedside teaching.

  1. Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo-controlled multi-center trial

    PubMed Central

    Lu, Lun-Gen; Zeng, Min-De; Mao, Yi-Min; Li, Ji-Qiang; Wan, Mo-Bin; Li, Cheng-Zhong; Chen, Cheng-Wei; Fu, Qing-Chun; Wang, Ji-Yao; She, Wei-Min; Cai, Xiong; Ye, Jun; Zhou, Xia-Qiu; Wang, Hui; Wu, Shan-Ming; Tang, Mei-Fang; Zhu, Jin-Shui; Chen, Wei-Xiong; Zhang, Hui-Quan

    2003-01-01

    AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B. METHODS: A randomised double-blind and placebo-controlled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 wk, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo. After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed. RESULTS: Among the 216 patients, six were dropped off, and 11 inconsistent with the standard were excluded. Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47% became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33% became normal in ALT level, 43.33% and 39.29% became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00% became normal in ALT level, 7.46% and 6.45% became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84% in the capsule treated patients, and 33.33% and 50.00% in the injection treated patients, and 2.99% and 41.79% in the placebo treated patients, respectively. There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule, injection and placebo were 7.77%, 6.67% and 8.82%, respectively. There was no statistically significant difference among them. CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B. PMID:14606080

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

    PubMed

    Bayman, Emine O; Chaloner, Kathryn M; Hindman, Bradley J; Todd, Michael M

    2013-01-16

    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. 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. 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. 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.

  3. 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

  4. Chinese multi-center study of lung scintigraphy and CT pulmonary angiography for the diagnosis of pulmonary embolism.

    PubMed

    He, Jia; Wang, Feng; Dai, Hao-jie; Li, Mei; Wang, Qian; Yao, Zhiming; Lv, Bin; Xiong, Chang-ming; He, Jian-guo; Liu, Zhi-hong; He, Zuo-Xiang; Fang, Wei

    2012-10-01

    To evaluate diagnostic value of the PISA-PED and PIOPED II criteria for lung scintigraphy and compare it with CT pulmonary angiography (CTPA) for the detection of pulmonary embolism (PE). Five hundred and forty-four consecutive patients with suspected PE were enrolled. All patients underwent lung ventilation/perfusion (V/P) scan, chest radiography, and CTPA. Two readers used the PIOPED II criteria, and 2 used the PISA-PED criteria for the interpretation of lung scintigraphy. CTPA scans were interpreted by two experienced radiologists. Lung scintigraphy and CTPA were categorized as PE present, absent or non-diagnostic. PE was present in 321 of 544 patients. Using PIOPED II criteria, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 85.1, 82.5, 88.1, and 78.4% respectively for V/P scan. Using PISA-PED criteria, sensitivity, specificity, PPV, and NPV were 86.0, 81.2, 86.8, and 80.1% respectively, and none was non-diagnostic. Sensitivity, specificity, PPV, and NPV were 81.7, 93.4, 94.9, and 77.3%, respectively for CTPA. PISA-PED interpretation has similar diagnostic accuracy to PIOPED II interpretation, does not have non-diagnostic scan, with lower cost and radiation, thus should be considered as a choice for patients with suspected PE.

  5. A multi-center field study of two point-of-care tests for circulating Wuchereria bancrofti antigenemia in Africa.

    PubMed

    Chesnais, Cédric B; Awaca-Uvon, Naomi-Pitchouna; Bolay, Fatoma K; Boussinesq, Michel; Fischer, Peter U; Gankpala, Lincoln; Meite, Aboulaye; Missamou, François; Pion, Sébastien D; Weil, Gary J

    2017-09-01

    The Global Programme to Eliminate Lymphatic Filariasis uses point-of-care tests for circulating filarial antigenemia (CFA) to map endemic areas and for monitoring and evaluating the success of mass drug administration (MDA) programs. We compared the performance of the reference BinaxNOW Filariasis card test (ICT, introduced in 1997) with the Alere Filariasis Test Strip (FTS, introduced in 2013) in 5 endemic study sites in Africa. The tests were compared prior to MDA in two study sites (Congo and Côte d'Ivoire) and in three sites that had received MDA (DRC and 2 sites in Liberia). Data were analyzed with regard to % positivity, % agreement, and heterogeneity. Models evaluated potential effects of age, gender, and blood microfilaria (Mf) counts in individuals and effects of endemicity and history of MDA at the village level as potential factors linked to higher sensitivity of the FTS. Lastly, we assessed relationships between CFA scores and Mf in pre- and post-MDA settings. Paired test results were available for 3,682 individuals. Antigenemia rates were 8% and 22% higher by FTS than by ICT in pre-MDA and in post-MDA sites, respectively. FTS/ICT ratios were higher in areas with low infection rates. The probability of having microfilaremia was much higher in persons with CFA scores >1 in untreated areas. However, this was not true in post-MDA settings. This study has provided extensive new information on the performance of the FTS compared to ICT in Africa and it has confirmed the increased sensitivity of FTS reported in prior studies. Variability in FTS/ICT was related in part to endemicity level, history of MDA, and perhaps to the medications used for MDA. These results suggest that FTS should be superior to ICT for mapping, for transmission assessment surveys, and for post-MDA surveillance.

  6. Axial Globe Position Measurement: A Prospective Multi-center Study by the International Thyroid Eye Disease Society

    PubMed Central

    Bingham, Chad M.; Sivak-Callcott, Jennifer A.; Gurka, Matthew J.; Nguyen, John; Hogg, Jeffery P.; Feldon, Steve E.; Fay, Aaron; Seah, Lay-Leng; Strianese, Diego; Durairaj, Vikram D.; Uddin, Jimmy; Devoto, Martin H.; Harris, Matheson; Saunders, Justin; Osaki, Tammy H.; Looi, Audrey; Teo, Livia; Davies, Brett W.; Elefante, Andrea; Shen, Sunny; Realini, Tony; Fischer, William; Kazim, Michael

    2015-01-01

    Purpose Identify a reproducible measure of axial globe position (AGP) for multicenter studies of patients with thyroid eye disease (TED). Methods This is a prospective, international, multicenter, observational study in which 3 types of AGP evaluation were examined: radiologic, clinical, and photographic. In this study, computed tomography (CT) was the modality to which all other methods were compared. CT AGP was measured from an orthogonal line between the anterior lateral orbital rims to the cornea. All CT measurements were made at a single institution by 3 individual clinicians. Clinical evaluation was performed with exophthalmometry. Three clinicians from each clinical site assessed AGP with 3 different exophthalmometers and horizontal palpebral width using a ruler. Each physician made 3 separate measurements with each type of exophthalmometer, not in succession. All photographic measurements were made at a single institution. AGP was measured from lateral photographs in which a standard marker was placed at the anterior lateral orbital rim. Horizontal and vertical palpebral fissure were measured from frontal photographs. Three trained readers measured 3 separate times, not in succession. Exophthalmometry and photography method validity was assessed by agreement with CT (mean differences calculation, ICC’s, Bland-Altman figures). Correlation between palpebral fissure and CT AGP was assessed with Pearson correlation. Intraclinician and interclinician reliability was evaluated using intraclass correlation coefficients (ICC). Results Sixty-eight patients from 7 centers participated. CT mean AGP was 21.37mm (15.96 – 28.90mm) right, 21.22mm (15.87 – 28.70mm) left (ICC 0.996 and 0.995). Exophthalmometry AGP fell between 18mm and 25mm. Intraclinician agreement across exophthalmometers was ideal (ICC 0.948 – 0.983). Agreement between clinicians was greater than 0.85 for all upright exophthalmometry measurements. Photographic mean AGP was 20.47mm (10.92 – 30.88mm) right, 20.30mm (8.61 – 28.72mm) left. Intrareader and interreader agreement was ideal (ICC 0.991 – 0.989). All exophthalmometers’ mean differences from CT ranged between −0.06mm (+/− 1.36mm) and 0.54mm (+/− 1.61mm); 95% CI fell within 1mm. Magnitude of AGP did not affect exophthalmometry validity. Oculus best estimated CT AGP but differences form other exophthalmometers were not clinically meaningful in upright measurements. Photographic AGP (right ICC=0.575, left ICC=0.355) and palpebral fissure do not agree with CT. Conclusions Upright clinical exophthalmometry accurately estimates CT AGP in TED. AGP measurement was reliably reproduced by the same clinician and between clinicians at multiple institutions using the protocol in this study. These findings allow reliable measurement of AGP that will be of considerable value in future outcome studies. PMID:25719380

  7. [Multi-center study on the treatment for intermediate and high-frequency sudden sensorineural hearing loss].

    PubMed

    Wang, Ming-ming; Fan, Zhao-min; Luo, Jian-fen; Hou, Zhi-qiang; Ai, Yu; Wang, Hai-bo; Xu, Min; Zhu, Kang; Hou, Jin; Li, Wen-yan

    2013-05-01

    To analyze the therapeutic effect of treatment for intermediate and high-frequency sudden sensorineural hearing loss (SSNHL). A prospective clinical multicentre research was conducted using international standardized approach of clinical research. SSNHL Cases with intermediate and high-frequency hearing loss, that accepted no medication from onset of hearing loss within two weeks duration and ages ranged between 18 and 65, were collected. All patients were treated by one of four treatments plans chosen by unified random table. 141 patients with intermediate and high-frequency SSNHL were recruited in the research. Twenty subjects were treated with lidocaine, 21 cases with lidocaine and hormone, 40 cases with Ginaton, and 60 cases with Ginaton and hormone. 42 out of 141 (29.79%) patients were total recovery, 24 (17.02%)achieved excellent recovery, 27 (19.15%)achieved partial recovery, and 48 (34.04%) were ineffective. The total effective rate was 65.96%. In lidocaine group, the total effective rate was 55.00%, 66.67% in lidocaine and hormone group, 67.50% in Ginaton group, and 68.33% in Ginaton and hormone group. Considering the total effective rate, there was no statistical difference between four groups (P > 0.05). However, the recovery rate in Ginaton group was significant difference comparing with that in lidocaine group (P = 0.0496). 119 had concomitant symptom of tinnitus, and the tinnitus was improved in patients of 81.51%. With regard to total effective rate of tinnitus in four treatment groups, it was 57.89% (11/19) in lidocaine group, 100.00% (18/18) in lidocaine and hormone group, 88.57% (31/35) in Ginaton group, 78.72% (37/47) in Ginaton and hormone group. There was significant ascendancy in lidocaine and hormone group versus that in lidocaine group (P = 0.002) and Ginaton and hormone group (P = 0.029). And the difference between lidocaine and Ginaton groups was statistical significance (χ(2) = 6.705, P < 0.05). In 43 patients with muffled symptom in aural region, 90.70% was partial recovery. There was no statistical difference between each groups (χ(2) = 5.97,P = 0.74). There were 17 with dizziness or vertigo improved in all cases. Another 10 patients accompanied other complaints all improved. for the treat of intermediate and high-frequency SSNHL, the therapeutic effect in hearing has no significantly different between single and combined drug therapies. Considering the recovery rate, there is an obvious advantage in Ginaton group compared with lidocaine group. Tinnitus is the major concomitant symptom in intermediate and high-frequency SSNHL, and lidocaine and hormone therapy should be used.

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

    PubMed

    Tedim Cruz, Vítor; 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

    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. 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). 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. 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. 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.

  9. Clinical symptoms of FSSG in gastroesophageal reflux disease are critical for PPI treatment: Japanese multi-centers with 185 patients.

    PubMed

    Komatsu-Tanaka, Mio; Iwakiri, Ryuichi; Fujimoto, Kazuma; Fujiwara, Yasuhiro; Inamori, Masahiko; Tanaka, Junji; Shimatani, Tomohiko; Akiyama, Junichi; Ando, Takashi; Manabe, Noriaki; Kinjo, Fukunori; Deguchi, Ryuzo; Kusano, Motoyasu

    2012-11-01

    The main aim of this study was to determine whether questionnaire evaluations of clinical symptoms in gastroesophageal reflux disease were useful to assess proton pump inhibitor therapy. A total of 185 Japanese patients (men, 88; women, 97; age: 55.7 ± 16.1 years) with gastroesophageal reflux disease were enrolled. The patients were divided based on the frequency scale for symptoms of gastroesophageal reflux disease: severe symptoms with scores ≥8 and mild symptoms with scores ≤7. Quality of life was evaluated with the Medical Outcomes Study 8-Item Short-Form Health Survey. All patients were treated with a proton pump inhibitor, rabeprazole (10 mg/day), for 8 weeks. Patients were classified into four groups: reflux esophagitis with severe symptoms (n = 92, 49.7%); reflux esophagitis with mild symptoms (n = 17, 9.2%); non-erosive reflux disease with severe symptoms (n = 66, 35.7%); and non-erosive reflux disease with mild symptoms (n = 10, 5.4%). The dysmotility score was high in non-erosive reflux disease with severe symptoms compared with reflux esophagitis with severe symptoms (9.1 ± 0.5 vs 6.8 ± 0.5, P < 0.05). The symptom score and quality of life in the severe symptoms groups for both reflux esophagitis and non-erosive reflux disease were significantly improved by rabeprazole treatment. Only the reflux score was improved by rabeprazole in the reflux esophagitis with mild symptoms group; no therapeutic effect was observed for the non-erosive reflux disease with mild symptoms group. Low scores on the frequency scale for the symptoms of gastroesophageal reflux disease indicate poor responsiveness to proton pump inhibitor treatment, and high scores indicate good responsiveness. © 2012 The Authors. Digestive Endoscopy © 2012 Japan Gastroenterological Endoscopy Society.

  10. 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.

  11. 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

  12. 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.

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

    DTIC Science & Technology

    2011-10-01

    measurements will be made in the anterior-posterior position using a Lunar DPX-L scanner generating X-rays at 2 energy levels (40 and 70 kVp). A series of...certificate of participation. There are several versions; choose the version that is appropriate for the participant’s level of progress. You may want to print ...Table – Time Process tab/window Click ‘6’ – Print Output on the left-hand side of the screen Designing Reports:  Select the GENERATION tab

  14. 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

  15. 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.

  16. 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

  17. 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.

  18. Challenges in harmonizing integrated healthcare network laboratories: Multi-center evaluation of the AccuTnI+3 troponin assay.

    PubMed

    Greene, Dina N; Holmes, Daniel T; Liang, Joy; Kwong, Shiu-Land; Lorey, Thomas S; Petrie, Matthew S

    2015-03-01

    Beckman Coulter has recently introduced a new troponin assay manufactured for the Access2 and DxI platforms, releasing it under the name AccuTnI+3. Clinical laboratories are required to validate method performance before testing and reporting patient results. Beckman Coulter Access 2 instruments (n=42) across Kaiser Permanente Northern California were evaluated for their performance characteristics using the AccuTnI+3 reagent. Precision, linearity, and patient sample comparisons were performed on each instrument. Limit of the blank (LOB), limit of detection (LOD), limit of quantitation (LOQ), serum plasma comparisons, and specimen stability were evaluated using a single instrument. The assay was linear from 0-100,000ng/L. The LOB, LOD and LOQ were determined to be 5, 8 and 20ng/L, respectively. Interday precision on the low QC (mean concentration 41ng/L) ranged from 3.0% to 14.2%. The bias observed between the former assay (AccuTnI) and the AccuTnI+3 was comparable to the inter-instrument bias for either assay. Non-uniform distribution was observed in the precision and inter-instrument/inter-assay comparisons among the instruments evaluated. The AccuTnI and AccuTnI+3 troponin assays are equivalent across the analytical measuring range. There was no significant difference at the medical decision point. No changes in patient results are anticipated. However, the assay-independent inter-instrument bias observed is an important consideration for harmonization efforts. Copyright © 2014. Published by Elsevier Inc.

  19. A multi-center, qualitative assessment of pediatrician and maternal perspectives on rotavirus vaccines and the detection of Porcine circovirus.

    PubMed

    Payne, Daniel C; Humiston, Sharon; Opel, Douglas; Kennedy, Allison; Wikswo, Mary; Downing, Kimberly; Klein, Eileen J; Kobayashi, Ana; Locke, David; Albertin, Christina; Chesley, Claudia; Staat, Mary A

    2011-09-26

    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. 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. 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. 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.

  20. PS1-05: Hyperglycemia Stimulates Intracellular Renin Expression in Both Cardiac Myocytes and Fibroblasts: Implications for Diabetic Cardiomyopathy

    PubMed Central

    Singh, Vivek; Naik, Sunil; Baker, Kenneth; Kumar, Rajesh

    2010-01-01

    Background / Aim: The upregulation of the renin-angiotensin system (RAS) represents a major pathological mechanism in diabetes. We have previously reported that hyperglycemia preferentially increases intracellular generation of angiotensin (Ang) II. However, circulating RAS is down regulated in diabetes implying the accelerated intracellular RAS mechanism as a major contributor to diabetic cardiomyopathy. In this study, we determined expression of RAS components and their effect on cardiac cells to give us a venue to intervene. Methods: Diabetes was induced in Sprague-Dawley rats and C57/BL6J mice with injection of streptozotocin for 5 days and verified by sustained blood glucose levels >15 mmol/L. Control mice received buffered saline alone. One week after diabetes induction the mice hearts were removed and perfused by the Langendorff method. Myocytes were isolated with enzymatic dispersion and centrifugation. RAS proteins were determined by real-time PCR and Western analysis. These included angiotensinogen, renin, angiotensin converting enzyme, AT1, AT2, and ACE 2. Angiotensin II was purified by reverse-phase chromatography and quantified by competitive ELISA. Results: Among cells obtained from diabetic hearts, expression of AGT (3.5+/− 0.8 fold), renin (2.4 +/− 0.4), and AT1 (2.6+/− 0.3) was significantly increased compared to cells from control hearts (p<0.05, ANOVA). No significant change in the gene expression of ACE (1.2+/− 0.4), ACE2 (0.97+/− 0.2), and AT2 (1.2+/− 0.2), was observed. Increased expression at the protein level for AGT (2.2 +/− 0.1), renin (1.9 +/− 0.08), and AT1 (2.3+/− 0.2) was also observed by Western analysis. No significant changes in the protein levels of AT2, ACE, and ACE2 were observed. AngII levels in cardiac myocytes were determined by quantitative ELISA, which demonstrated significantly enhanced levels of AngII (140+/− 10 fmol/mg protein) synthesis in diabetic mice compared to controls (20 +/− 10 fmol/mg protein). Conclusions: This study suggests that local activation of the RAS in diabetes has a significant role in the development of cardiac dysfunction. Demonstration of renin expression in cardiac myocytes and enhanced expression in diabetic conditions represent a particularly significant finding. The latter suggests that locally produced, not circulating renin has a major role in cardiac Ang II generation and subsequent cardiomyopathy.

  1. PS1-05: Predicting the Risk of Hyperkalemia in Patients with Kidney Disease Starting Angiotensin-Converting Enzyme Inhibitors

    PubMed Central

    Johnson, Eric S; Weinstein, Jessica R; Thorp, Micah L; Platt, Robert W; Petrik, Amanda F; Yang, Xiuhai; Anderson, Sharon; Smith, David H

    2010-01-01

    Background and Aims: Angiotensin converting enzyme (ACE) inhibitors are widely used in patients with chronic kidney disease (CKD) because the drugs slow disease progression. But some physicians are reluctant to prescribe ACE inhibitors “or use higher doses” because of concerns about the risk of hyperkalemia (high potassium), a potentially fatal adverse effect. Physicians need a tool to help them predict the risk of hyperkalemia; for example, high risk patients could be targeted for intensive laboratory monitoring. We synthesized known predictors of hyperkalemia into a prognostic risk score to predict the risk of hyperkalemia. Methods: We assembled a retrospective cohort of adult patients with possible CKD (at least one recently estimated glomerular filtration rate (eGFR) value less than 60 mL/min/1.73m2) who started an ACE inhibitor between 1998 and 2006 at Kaiser Permanente Northwest, a health maintenance organization (HMO). We followed patients for the earliest evidence of hyperkalemia: potassium value > 5.5 mmol/L; diagnosis code for hyperkalemia (ICD-9-CM 276.7). Cox regression synthesized known predictors of hyperkalemia that were recorded in the electronic medical record or KPNW databases into a risk score to predict the absolute risk of hyperkalemia 90 days after starting therapy. Results: We followed 5,097 patients who experienced 145 hyperkalemic events, a 90-day risk of 2.1% (95% CI 1.9% to 2.4%). The following baseline characteristics predicted hyperkalemia and contributed to the risk score: age, eGFR, diabetes, heart failure, current use of potassium supplements, current use of potassium sparing diuretics (e.g., spironolactone), and a high starting dose for the ACEinhibitor. The risk score discriminated high-risk patients (top quintile, observed risk of 7%) from low risk patients (bottom quintile, observed risk of 0.7%). Predicted and observed risks agreed closely (within 1%) for each quintile. Conclusions: The risk score separated high-risk patients (who may need more intensive laboratory monitoring) from low risk patients (whose physicians could use ACE-inhibitors more confidently). If validated in other clinical settings, the risk score could improve the efficiency of laboratory monitoring for hyperkalemia by focusing attention on higher risk patients.

  2. CATS-ISS_L2O_D-M7.2-V1-05_05kmLay

    Atmospheric Science Data Center

    2017-08-01

    ... Ratio Aerosol Feature Type Aerosol Optical Depth Aerosol Backscatter Aerosol Layer Thickness Aerosol Layer Height Cloud Phase Cloud Depolarization Cloud Ice Water Content Cloud Layer Height Cloud Layer Thickness Cloud ...

  3. Wall effects observed in tissue-equivalent proportional counters from 1.05 GeV/nucleon iron-56 particles

    NASA Technical Reports Server (NTRS)

    Rademacher, S. E.; Borak, T. B.; Zeitlin, C.; Heilbronn, L.; Miller, J.; Chatterjee, A. (Principal Investigator)

    1998-01-01

    Tissue-equivalent proportional counters (TEPCs) have been used to measure energy deposition in simulated volumes of tissue ranging in diameter from 0.1 to 10 microm. There has been some concern that the wall used to define the volume of interest could influence energy deposition within the sensitive volume because it has a density significantly greater than that of the cavity gas. These effects become important for high-velocity heavy ions. Measurements of energy deposition were made for 1 GeV/nucleon iron particles in a TEPC simulating a 1-microm-diameter sphere of tissue. The TEPC was nested within a particle spectrometer that provided identification and flight path of individual particles. Energy deposition was studied as a function of pathlength through the TEPC. Approximately 30% of the energy transfer along trajectories through the center of the detector escapes the sensitive volume. The response of the TEPC, for trajectories through the detector, is always larger than calculations for energy loss in a homogeneous medium. This enhancement is greatest for trajectories near the cavity/wall interface. An integration of the response indicates that charged-particle equilibrium is essentially achieved for a wall thickness of 2.54 mm. However, estimates of the linear energy transfer for the incident particles are influenced by these wall effects.

  4. 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. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. 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

  6. Gaps and opportunities in refractory status epilepticus research in children: a multi-center approach by the Pediatric Status Epilepticus Research Group (pSERG).

    PubMed

    Sánchez Fernández, Iván; Abend, Nicholas S; Agadi, Satish; An, Sookee; Arya, Ravindra; Carpenter, Jessica L; Chapman, Kevin E; Gaillard, William D; Glauser, Tracy A; Goldstein, David B; Goldstein, Joshua L; Goodkin, Howard P; Hahn, Cecil D; Heinzen, Erin L; Mikati, Mohamad A; Peariso, Katrina; Pestian, John P; Ream, Margie; Riviello, James J; Tasker, Robert C; Williams, Korwyn; Loddenkemper, Tobias

    2014-02-01

    Status epilepticus (SE) is a life-threatening condition that can be refractory to initial treatment. Randomized controlled studies to guide treatment choices, especially beyond first-line drugs, are not available. This report summarizes the evidence that guides the management of refractory convulsive SE (RCSE) in children, defines gaps in our clinical knowledge and describes the development and works of the 'pediatric Status Epilepticus Research Group' (pSERG). A literature review was performed to evaluate current gaps in the pediatric SE and RCSE literature. In person and online meetings helped to develop and expand the pSERG network. The care of pediatric RCSE is largely based on extrapolations of limited evidence derived from adult literature and supplemented with case reports and case series in children. No comparative effectiveness trials have been performed in the pediatric population. Gaps in knowledge include risk factors for SE, biomarkers of SE and RCSE, second- and third-line treatment options, and long-term outcome. The care of children with RCSE is based on limited evidence. In order to address these knowledge gaps, the multicenter pSERG was established to facilitate prospective collection, analysis, and sharing of de-identified data and biological specimens from children with RCSE. These data will allow identification of treatment strategies associated with better outcomes and delineate evidence-based interventions to improve the care of children with SE. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. 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

  8. Does cannabis use moderate smoking cessation outcomes in treatment-seeking tobacco smokers? Analysis from a large multi-center trial.

    PubMed

    Rabin, Rachel A; Ashare, Rebecca L; Schnoll, Robert A; Cinciripini, Paul M; Hawk, Larry W; Lerman, Caryn; Tyndale, Rachel F; George, Tony P

    2016-06-01

    Tobacco and cannabis are frequently used in combination and cannabis co-use may lead to poor tobacco cessation outcomes. Therefore, it is important to explore if cannabis co-use is associated with a reduced likelihood of achieving successful tobacco abstinence among treatment-seeking tobacco smokers. The present study examined whether current cannabis use moderated tobacco cessation outcomes after 12 weeks of pharmacological treatment (varenicline vs. nicotine patch vs. placebo) with adjunctive behavioral counseling. Treatment-seeking tobacco smokers (N = 1,246) were enrolled in an intent-to-treat study, of which 220 were current cannabis users. Individuals were randomly assigned to 12 weeks of placebo (placebo pill plus placebo patch), nicotine patch (active patch plus placebo pill), or varenicline (active pill plus placebo patch), plus behavioral counseling. The primary endpoint was biochemically verified 7-day point prevalence abstinence at the end of treatment. Controlling for rate of nicotine metabolism, treatment arm, age, sex, alcohol, and level of nicotine dependence, cannabis users were as successful at achieving biochemically verified 7-day point prevalence abstinence compared to tobacco-only smokers. Findings suggest that cannabis use does not hinder the ability to quit tobacco smoking. Future tobacco cessation studies should employ prospective, longitudinal designs investigating cannabis co-use over time and at different severity levels. (Am J Addict 2016;25:291-296). © 2016 American Academy of Addiction Psychiatry.

  9. A multi-center survey of age of sexual debut and sexual behavior in Chinese women:Suggestions for optimal age of human papillomavirus vaccination in China

    PubMed Central

    Zhao, Fang-Hui; Tiggelaar, Sarah M.; Hu, Shang-Ying; Xu, Li-Na; Hong, Ying; Niyazi, Mayinuer; Gao, Xiao-Hong; Ju, Li-Rong; Zhang, Li-Qin; Feng, Xiang-Xian; Duan, Xian-Zhi; Song, Xiu-Ling; Wang, Jing; Yang, Yun; Li, Chang-Qing; Liu, Jia-Hua; Liu, Ji-Hong; Lu, Yu-Bo; Li, Li; Zhou, Qi; Liu, Jin-feng; Zhao, Na; Schmidt, Johannes E.; Qiao, You-Lin

    2017-01-01

    Objective Cervical cancer is the second most common cancer among women worldwide, and over 85% of cervical cancers occur in developing countries such as China. Lack of resources for nationwide cervical cancer screening in China makes vaccination against oncogenic strains of HPV particularly important. Knowledge of age at sexual debut and sexual behavior is essential prior to implementation of a national vaccination program. Methods and materials A cross-sectional epidemiologic survey was conducted across 21 urban and rural sites in China to assess age at sexual debut and sexual behavior. 98.6% of the 11,852 recruited women aged 15–59 years were included in the analysis. Data were collected using a short, nurse-administered questionnaire and analyzed using standard descriptive statistics and survival analysis. Results In urban areas, more than ten percent of the 15–19 year old age group were already sexually active at the time of interview; this number increased to nearly 44% in the 20–24 year old age group. Chinese young women with an occupation were more likely to be sexually active compared to female students of the same age, irrespective of area of residence. The crude median sexual debut age for the youngest age group was 17 years, earlier than the sexual debut age reported by older cohorts. Younger age cohorts had an earlier menarche age than older cohorts and were more likely to have more sexual partners than older women, and more likely to have partners with more than one female partner. Conclusion There is a trend towards earlier sexual debut and riskier sexual behaviors in younger age groups of Chinese women. These findings suggest that HPV vaccination of women between the ages of 13 and 15 years, before the completion of national compulsory education, is likely to contribute to the prevention of HPV infection and cervical cancer in China. PMID:22377277

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

    PubMed Central

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

    2011-01-01

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

  11. First Definition of Reference Intervals of Liver Function Tests in China: A Large-Population-Based Multi-Center Study about Healthy Adults

    PubMed Central

    Zhang, Chuanbao; Guo, Wei; Huang, Hengjian; Ma, Yueyun; Zhuang, Junhua; Zhang, Jie

    2013-01-01

    Background Reference intervals of Liver function tests are very important for the screening, diagnosis, treatment, and monitoring of liver diseases. We aim to establish common reference intervals of liver function tests specifically for the Chinese adult population. Methods A total of 3210 individuals (20–79 years) were enrolled in six representative geographical regions in China. Analytes of ALT, AST, GGT, ALP, total protein, albumin and total bilirubin were measured using three analytical systems mainly used in China. The newly established reference intervals were based on the results of traceability or multiple systems, and then validated in 21 large hospitals located nationwide qualified by the National External Quality Assessment (EQA) of China. Results We had been established reference intervals of the seven liver function tests for the Chinese adult population and found there were apparent variances of reference values for the variables for partitioning analysis such as gender(ALT, GGT, total bilirubin), age(ALP, albumin) and region(total protein). More than 86% of the 21 laboratories passed the validation in all subgroup of reference intervals and overall about 95.3% to 98.8% of the 1220 validation results fell within the range of the new reference interval for all liver function tests. In comparison with the currently recommended reference intervals in China, the single side observed proportions of out of range of reference values from our study for most of the tests deviated significantly from the nominal 2.5% such as total bilirubin (15.2%), ALP (0.2%), albumin (0.0%). Most of reference intervals in our study were obviously different from that of other races. Conclusion These used reference intervals are no longer applicable for the current Chinese population. We have established common reference intervals of liver function tests that are defined specifically for Chinese population and can be universally used among EQA-approved laboratories located all over China. PMID:24058449

  12. Efficacy and safety of pramipexole in chinese patients with restless legs syndrome: results from a multi-center, randomized, double-blind, placebo-controlled trial.

    PubMed

    Ma, Jian-Fang; Wan, Qi; Hu, Xin-Yue; Sun, Sheng-Gang; Wang, Wei-Zhi; Zhao, Zhong-Xin; Wang, Yong-Jun; Liu, Chun-Feng; Li, Ji-Mei; Jiang, Yu-Ping; Chen, Sheng-Di

    2012-01-01

    We performed a six-week study of pramipexole vs. a placebo in Chinese restless legs syndrome patients. Overall, 305 enrolled patients were assigned randomly in a 2:1 ratio to the pramipexole group (N=202) and the placebo group (N=103). Of 287 patients in the full analysis set, the pramipexole group showed significant improvement compared with the placebo group in the change of their International Restless Legs Syndrome Study Group Rating Scale of Severity (IRLS) total score from baseline to week 6 after adjustment of centers and baseline characters (-15.87±0.66 vs. -11.35±0.92, p<0.0001) and in the proportion of patients who were "much improved" and "very much improved" when measured by Clinical Global Impressions-Improvement (81.9% vs. 54.3%, p<0.0001). At week 6, the IRLS responder rate was 73.8% (pramipexole) and 48.9% (placebo) (p<0.0001) and the patient global impression responder rate was 68.6% (pramipexole) and 43.5% (placebo) (p<0.0001). The proportion of adverse events was 62.9% in the pramipexole group and 43.7% in the placebo group, respectively. No deaths occurred. Pramipexole was effective and well-tolerated in Chinese patients with restless legs syndrome. Copyright © 2011 Elsevier B.V. All rights reserved.

  13. 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 fe