Science.gov

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

  1. 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.

  2. Phases of non-extremal multi-centered bound states

    NASA Astrophysics Data System (ADS)

    Chowdhury, Borun D.; Mayerson, Daniel R.; Vercnocke, Bert

    2013-12-01

    We investigate the phase space of multi-centered near-extremal configurations previously studied in arXiv:1108.5821 [1] and arXiv:1110.5641 [2] in the probe limit. We confirm that in general the energetically favored ground state of the multi-center potential, which can be a single or multi-center configuration, has the most entropy and is thus thermodynamically stable. However, we find the surprising result that for a subset of configurations, even though a single center black hole seems to be energetically favored, it is entropically not allowed (the resulting black hole would violate cosmic censorship). This disproves classical intuition that everything would just fall into the black hole if energetically favored. Along the way we highlight a shortcoming in the literature regarding the computation of the angular momentum coming from electromagnetic interaction in the probe limit and rectify it. We also demonstrate that static supertubes can exist inside ergoregions where ordinary point particles would be frame dragged.

  3. 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.

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

    PubMed Central

    Likosky, Donald S.

    2009-01-01

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

  5. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 1 2011-07-01 2011-07-01 false Delegation of rulemaking authority. 1.05-1 Section 1.05-1 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY GENERAL GENERAL PROVISIONS Rulemaking § 1.05-1 Delegation of rulemaking authority. (a) The Secretary of Homeland Security is empowered by...

  6. Quantitative MR in multi-center clinical trials.

    PubMed

    Ashton, Edward

    2010-02-01

    MRI has a wide variety of applications in the clinical trials process. MR has shown particular utility in the early phases of clinical development, when trial sponsors are interested in demonstrating proof of concept and must make decisions about allocation of resources to a particular compound based on the results from a small number of experimental subjects. This utility is largely due to the many different imaging endpoints that can be measured using MR, ranging from structural (tumor burden, hippocampal volume) to functional (blood flow, vascular permeability) to molecular (hepatic fat fraction, glycosaminoglycan content). The unique flexibility of these systems has proven to be both a blessing and a curse to those attempting to deploy MR in multi-center clinical trials, however, as differences among scanner manufacturers and models in pulse sequence implementation, hardware capabilities, and even terminology make it increasingly difficult to ensure that results obtained at one center are comparable to those at another. These problems are compounded by the differences between the procedures used in clinical trials and those used in routine clinical practice, which make trial-specific training for site technologists and radiologists a necessity in many cases. This article will briefly review the benefits of including quantitative MR imaging in clinical trials, then explore in detail the challenges presented by the need to develop and deploy a detailed MR protocol that is both effective and implementable across many different MR systems and software versions.

  7. Ethics review of pediatric multi-center drug trials.

    PubMed

    Needham, Allison C; Kapadia, Mufiza Z; Offringa, Martin

    2015-02-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider local requirements while ensuring that the protection of human subjects is consistent across sites. In pediatrics, this requirement is complicated by pediatric-specific ethical concerns such as the acquisition of assent and consent and the need for pediatric expertise to assess the scholarly merit of the proposed research. Efforts to tackle these challenges have focused on the process of ethics review, which will improve efficiency. In addition to improving process, we suggest further research to fill gaps in the evidence base for recommendations and decisions made by REBs, specifically their effectiveness to protect human subjects. Evidence gathered will contribute to the successful development, adoption and implementation of harmonized guidance to apply ethics principles in order to protect children through research rather than from research.

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

    PubMed Central

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

    2014-01-01

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

  9. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and... 33 Navigation and Navigable Waters 1 2013-07-01 2013-07-01 false Delegation of rulemaking authority. 1.05-1 Section 1.05-1 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF...

  10. 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.

  11. 77 FR 9665 - Submission for OMB Emergency Review; Comment Request: A Multi-Center International Hospital-Based...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... Multi- Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI... currently valid OMB control number. Proposed Collection: Title: A Multi-Center International Hospital- Based... viral infections, ultraviolet radiation exposure, medical conditions, and other lifestyle factors...

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. Spectral-spatial hyperspectral classification based on multi-center SAM and MRF

    NASA Astrophysics Data System (ADS)

    Tang, Bo; Liu, Zhi; Xiao, Xiaoyan; Nie, Mingyu; Chang, Jun; Jiang, Wei; Li, Xiaomei; Zheng, Chengyun

    2015-12-01

    In this paper, a novel framework for an accurate spectral-spatial classification of hyperspectral images is proposed to address nonlinear classification problems. The algorithm is based on the spectral angle mapper (SAM), which is achieved by introducing the multi-center model and Markov random fields (MRF) into a probabilistic decision framework to obtain an accurate classification. Experimental comparisons between several traditional classification methods and the proposed MSAM-MRF algorithm have demonstrated that the performance of the proposed MSAM-MRF algorithm outperforms the traditional classification algorithms.

  18. 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.

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

    PubMed

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

    2015-01-01

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

  20. [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.

  1. 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…

  2. 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

  3. 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.

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

    PubMed

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

    2012-02-01

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

  5. On the Coulomb and Higgs branch formulae for multi-centered black holes and quiver invariants

    NASA Astrophysics Data System (ADS)

    Manschot, Jan; Pioline, Boris; Sen, Ashoke

    2013-05-01

    In previous work we have shown that the equivariant index of multi-centered {N}=2 black holes localizes on collinear configurations along a fixed axis. Here we provide a general algorithm for enumerating such collinear configurations and computing their contribution to the index. We apply this machinery to the case of black holes described by quiver quantum mechanics, and give a systematic prescription — the Coulomb branch formula — for computing the cohomology of the moduli space of quiver representations. For quivers without oriented loops, the Coulomb branch formula is shown to agree with the Higgs branch formula based on Reineke's result for stack invariants, even when the dimension vector is not primitive. For quivers with oriented loops, the Coulomb branch formula parametrizes the Poincaré polynomial of the quiver moduli space in terms of single-centered (or pure-Higgs) BPS invariants, which are conjecturally independent of the stability condition (i.e. the choice of Fayet-Iliopoulos parameters) and angular-momentum free. To facilitate further investigation we provide a M athematica package "CoulombHiggs.m" implementing the Coulomb and Higgs branch formulae.

  6. A multi-center quality control study of different CA15-3 immunoassays.

    PubMed

    Hubl, Walter; Demant, Thomas; Albrecht, Steffen; Bewarder, Nils; Grunow, Gabriele; Keller, Ruprecht; Klapdor, Rainer; Klos, Karl-Jürgen; Kruse, Klaus; Müller, Robert; Päge, Ilona; Schmidt, Reinhard; Stolle, Heidrun; Wiefelspütz, Johannes; vom Baur, Egon; Zinsmeyer, Jörg; Zwirner, Manfred

    2005-01-01

    A long-term multi-center quality control study of CA15-3 determinations based on measurements of liquid BIOREF CA15-3 control sera was conducted in 17 participating laboratories. Seven different CA15-3 assays were applied using the appropriate automatic immunoanalyzers. CA15-3 means were determined for BIOREF low, medium and high level control sera. Values were 19.3 +/- 2.7 kU/l, 75.2 +/- 11.4 kU/l and 162.9 +/- 37.1 kU/l, respectively. Inter-assay imprecisions were calculated for each of the controls for each laboratory and for each of the methods, with coefficients of variation (CV) ranging from 2.9-15.5%. As a means of evaluation of assay linearity concentration ratios (high/medium, medium/low, high/low) were calculated and found to be in good agreement with reference values throughout the study. Individual long-term time courses of CA15-3 control measurements provided evidence for variability of test results due to changes in assay calibration. Comparisons with CV data obtained with BIOREF controls 17 years ago demonstrate significant improvements of CA15-3 assay precision in recent years. In conclusion, test-independent reference material can be used for CA15-3 quality control and in particular enables applicants to check for long-term stability of CA15-3 assay performance.

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

    PubMed Central

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

    2010-01-01

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

  8. 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.

  9. 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

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

    PubMed

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

    2016-04-01

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

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

    PubMed

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

    2015-10-01

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

  12. 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.

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

    PubMed

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

    2015-03-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2014-03-01

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

  15. 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

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

    DOE PAGESBeta

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

    2015-05-26

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

  17. 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...

  18. 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...

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. 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

  2. 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

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

    PubMed

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

    2015-01-01

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

  4. 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

  5. Dielectron production in nucleus {plus} nucleus collisions at 1.05 GeV/nucleon

    SciTech Connect

    Porter, R.J.; Beedoe, S.; Bougteb, M.; Hallman, T.; Wang, Z.F.

    1996-06-28

    Measurements of dielectron production in heavy-ion collisions are valuable probes into the dynamics of the collision process. While the hadronic participants of the collision are subject to strong final state interactions, the coupling of the electron-positron pair to the collision medium is electromagnetic. Dielectrons, therefore suffer little rescattering leaving the interaction and can retain information about their production origins, probing even the early stages in the evolution of the collision. The DiLepton Spectrometer (DLS) collaboration`s original measurements of dielectron production established the existence of the signal at Bevalac energies. The 1992- 93 DLS measurements in nucleus+Nucleus collisions at a kinetic beam energy of 1.05 {ital GeV/nucleon} are the subject of this presentation.

  6. 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.

  7. A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion.

    PubMed

    Kanter, Adam S; Gandhoke, Gurpreet S; Welch, William C; Arnold, Paul M; Cheng, Joseph S; Okonkwo, David O

    2016-03-01

    This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

  8. 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

  9. 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

  10. 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

  11. 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

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

    PubMed

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

    2014-01-01

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

  13. Lifestyle factors and lumbar disc disease: results of a German multi-center case-control study (EPILIFT)

    PubMed Central

    2010-01-01

    Introduction In the large-scale case-control study EPILIFT, we investigated the dose-response relationship between lifestyle factors (weight, smoking amount, cumulative duration of different sports activities) and lumbar disc disease. Methods In four German study regions (Frankfurt am Main, Freiburg, Halle/Saale, Regensburg), 564 male and female patients with lumbar disc herniation and 351 patients with lumbar disc narrowing (chondrosis) aged 25 to 70 years were prospectively recruited. From the regional population registers, 901 population control subjects were randomly selected. In a structured personal interview, we enquired as to body weight at different ages, body height, cumulative smoking amount and cumulative duration of different sports activities. Confounders were selected according to biological plausibility and to the change-in-estimate criterion. Adjusted, gender-stratified odds ratios with 95% confidence intervals were calculated using unconditional logistic regression analysis. Results The results of this case-control study reveal a positive association between weight and lumbar disc herniation as well as lumbar disc narrowing among men and women. A medium amount of pack-years was associated with lumbar disc herniation and narrowing in men and women. A non-significantly lowered risk of lumbar disc disease was found in men with high levels of cumulative body building and strength training. Conclusions According to our multi-center case-control study, body weight might be related to lumbar disc herniation as well as to lumbar disc narrowing. Further research should clarify the potential protective role of body building or strength training on lumbar disc disease. PMID:20955546

  14. 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.

  15. Methods, Quality Control and Specimen Management in an International Multi-Center Investigation of Type 1 Diabetes: TEDDY

    PubMed Central

    Vehik, Kendra; Fiske, Steven W.; Logan, Chad A.; Agardh, Daniel; Cilio, Corrado M.; Hagopian, William; Simell, Olli; Roivainen, Merja; She, Jin-Xiong; Briese, Thomas; Oikarinen, Sami; Hyoty, Heikki; Ziegler, Anette-G.; Rewers, Marian; Lernmark, Ake; Akolkar, Beena; Krischer, Jeffrey P.; Burkhardt, Brant R.

    2014-01-01

    The Environmental Determinants of Diabetes in the Young (TEDDY) is a multi-center, international prospective study (n = 8,677) designed to identify environmental triggers of type 1 diabetes (T1D) in genetically at-risk children from age 3 months until 15 years. The study is conducted through six primary clinical centers located in four countries. As of May 2012, over three million biological samples and 250 million total data points have been collected which will be analyzed to assess autoimmunity status, presence of inflammatory biomarkers, genetic factors, exposure to infectious agents, dietary biomarkers, and other potentially important environmental exposures in relation to autoimmunity and progression to T1D. The vast array and quantity of longitudinal samples collected in the TEDDY study present a series of challenges in terms of quality control procedures and data validity. To address this, pilot studies have been conducted to standardize and enhance both biospecimen collection and sample obtainment in terms of autoantibody collection, stool sample preservation, RNA, biomarker stability, metabolic biomarkers, and T-cell viability. This paper details the procedures utilized to standardize both data harmonization and management when handling a large quantity of longitudinal samples obtained from multiple locations. In addition, we provide a description of the available specimens that serve as an invaluable repository for the elucidation of determinants in T1D focusing on autoantibody concordance and harmonization, transglutaminase autoantibody (tGA), inflammatory biomarkers (T-cells), genetic proficiency testing, RNA lab internal quality control testing, infectious agents (monitoring cross contamination, virus preservation, and nasal swab collection validity), and HbA1c testing. PMID:23674484

  16. 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

  17. 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

  18. Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

    PubMed Central

    Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

    2015-01-01

    BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

  19. [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

  20. 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

  1. Multi-center clinical study and review of fractional ablative CO2 laser resurfacing for the treatment of rhytides, photoaging, scars and striae.

    PubMed

    Alexiades-Armenakas, Macrene; Sarnoff, Deborah; Gotkin, Robert; Sadick, Neil

    2011-04-01

    Laser skin resurfacing has shifted over the past two decades from standard ablative resurfacing to non-ablative resurfacing and most recently, to fractional laser resurfacing. In this most recent category, fractional non-ablative lasers were first introduced followed by fractional ablative lasers, which offer an improved balance between safety and efficacy. In the current article, a review of fractional ablative resurfacing is presented alongside the results from a multi-center clinical study employing the fractional carbon dioxide (CO2) laser (SmartXide DOT, DEKA) for the treatment of rhytides, photoaging, scars and striae distensae.

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

    Atmospheric Science Data Center

    2016-10-24

    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:  ...

  3. CATS-ISS_L2O_D-M7.1-V1-05_05kmPro

    Atmospheric Science Data Center

    2016-10-25

    CATS-ISS_L2O_D-M7.1-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:  ...

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

    Atmospheric Science Data Center

    2016-10-24

    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:  ...

  5. Early Prophylactic versus Late Selective Use of Surfactant for Respiratory Distress Syndrome in Very Preterm Infants: A Collaborative Study of 53 Multi-Center Trials in Korea

    PubMed Central

    2014-01-01

    Pulmonary surfactant (PS) therapy was proven to be highly successful for the treatment of respiratory distress syndrome in premature infants. As a results, early prophylactic (EP) PS therapy has been introduced recently in Europe, the US and Korea. However, no multi-center study was compared EP and late selective (LS) PS therapies in Korea. We performed a retrospective multi-center study to compare the outcomes of EP and LS PS therapies in very preterm infants. We analyzed clinical morbidity and mortality for 1,291 infants in 2010 (LS group) and 1,249 infants in 2011 (EP group); the infants were born <30 weeks of gestation and had birth weight ≤1,250 g, and were chosen from 53 neonatal intensive care units in Korea. Compared to the LS group (22.5%), the overall mortality was better in the EP group (19.9%) and there was no increased need for retreatment.There were additional benefits in the EP group such as fewer associated complications. To the best of knowledge, our study is the first nationwide Korean study to compare the outcomes of EP and LS therapies, and it provides evidences that EP PS therapy is important in very preterm infants to improve for survival and reduce morbidities. Graphical Abstract PMID:25120324

  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. PMID:27491568

  7. 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.

  8. 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

  9. 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.

  10. 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.

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

    PubMed

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

    2016-05-01

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

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

    PubMed Central

    2014-01-01

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

  13. 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

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

    PubMed

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

    2016-05-01

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

  16. 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

  17. 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.

  18. Effect of Ni and Ti substitutions on Li1.05Mn2O4-δ electrical conductivities at high temperature

    NASA Astrophysics Data System (ADS)

    Abe, Satoko; Iwasaki, Shoko; Shimonishi, Yuta; Komine, Shigeki; Munakata, Fumio

    2016-10-01

    Samples of Li1.05Mn2O4-δ, Li1.05Mn1.5Ni0.5O4-δ, and Li1.05Mn1.0Ni0.5Ti0.5O4-δ were prepared by a solid-state reaction technique and ultimately refined to a space group Fd-3m of spinel structure by the Rietveld method using synchrotron powder X-ray diffraction data. Comparison of lattice constants suggested that Ni-substitution increased the covalency in the bonding of MO6 (M: metal ion at 16d site) octahedrals, but Ni/Ti co-substitution decreased the covalency of M-O bonds and introduced structural distortion. Electrical conductivity measurements by a four-probe method resulted in the determination that electrical conduction (within all samples) exhibits a nonadiabatic hopping process at high temperatures. The activation energies of Li1.05Mn2O4-δ and Li1.05Mn1.5Ni0.5O4-δ were found to be of similar values. The Ni/Ti co-substituted sample of Li1.05Mn1.0Ni0.5Ti0.5O4-δ, on the other hand, showed the highest activation energy among all the measured samples. Substitution reduced the electrical conductivity relative to Li1.05Mn2O4-δ; furthermore, both the substituted samples (Li1.05Mn1.5Ni0.5O4-δ and Li1.05Mn1.0Ni0.5Ti0.5O4-δ) were found to exhibit functional independence from oxygen partial pressure (PO2).

  19. 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

  20. Randomization is Not Associated with Socio-economic and Demographic Factors in a Multi-Center Clinical Trial of Children with Sickle Cell Anemia

    PubMed Central

    Rodeghier, Mark J.; Parmar, Nagina; DeBaun, Michael R.; Thompson, Alexis A.; Liem, Robert I.

    2014-01-01

    Background Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials. The Silent Cerebral Infarct Multi-Center Clinical (SIT) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children. Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease (SCD) and silent cerebral infarct (SCI) in the SIT Trial after initial consent. Procedure Differences in socio-economic and demographic variables, family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent. Head of household educational level and family income were examined separately for US versus non-US sites. Results Of 1,176 children enrolled in the SIT Trial, 1016 (86%) completed screening. Of 208 (20%) children with SCI on screening MRI, 196 (94%) were successfully randomized. There were no differences in socio-economic, demographic or disease-related variables between children who were or were not randomized. Participants from non-US sites were more likely to be randomized (22% vs. 12%, p = 0.011), although randomization by country was associated with neither head of household education nor family income. Conclusion In the SIT Trial, randomization after initial consent does not appear to be associated with socio-economic or demographic factors. Although these factors may represent barriers for some participants, they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation. PMID:24753128

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

    PubMed

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

    2016-08-01

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

  2. 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

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

    PubMed

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

    2015-12-01

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

  4. Improvement of left ventricular hypertrophy and arrhythmias after lanreotide-induced GH and IGF-I decrease in acromegaly. A prospective multi-center study.

    PubMed

    Lombardi, G; Colao, A; Marzullo, P; Biondi, B; Palmieri, E; Fazio, S

    2002-12-01

    We report the results of a prospective Italian multi-center study of the effects of lanreotide, a slow-release somatostatin analog, on left ventricular morphology and function and on the prevalence of ventricular arrhythmic events in 19 patients with active, newly diagnosed, uncomplicated acromegaly. Cardiac features were evaluated with Doppler-echocardiography and 24-h Holter ECG monitoring at baseline and after 6 months of lanreotide therapy. Fifteen patients (78.9%) had left ventricular hypertrophy. Lanreotide treatment significantly decreased the left ventricular mass (127.8+/-6.9 vs 140.7+/-7.1 g/m2, p<0.001) and left ventricular hypertrophy significantly disappeared in 6 of these patients. Treatment did not significantly affect systolic function, whereas it increased the Doppler-derived early-to-late mitral flow velocity, (E/A) ratio, of early-to-late trans-mitral flow velocity (1.34+/-0.1 vs 1.09+/-0.06, p=0.001). Stroke volume was slightly but not significantly increased after treatment, whereas systolic BP was significantly higher (134+/-14 vs 129+/-13 mmHg, p<0.05). The 24-h mean heart rate was significantly reduced after treatment (66.5+/-11 vs 71.5+/-20 beats/min, p<0.05). Supra-ventricular premature beats (>50/24 h) occurred in 16.6% of patients and were unaffected by treatment. Differently, ventricular premature beats (>50/24 h) occurred in 33.3% of patients before treatment vs 16.5%, after treatment. In conclusion, lanreotide reduced the left ventricular mass, and improved ventricular filling and ventricular arrhythmic profile.

  5. 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

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

    PubMed

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

    2015-12-01

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

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

    PubMed

    Tsukune, Yutaka; Komatsu, Norio

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2013-01-01

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

  10. 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

  11. 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

  12. Cumulative occupational lumbar load and lumbar disc disease – results of a German multi-center case-control study (EPILIFT)

    PubMed Central

    Seidler, Andreas; Bergmann, Annekatrin; Jäger, Matthias; Ellegast, Rolf; Ditchen, Dirk; Elsner, Gine; Grifka, Joachim; Haerting, Johannes; Hofmann, Friedrich; Linhardt, Oliver; Luttmann, Alwin; Michaelis, Martina; Petereit-Haack, Gabriela; Schumann, Barbara; Bolm-Audorff, Ulrich

    2009-01-01

    Background The to date evidence for a dose-response relationship between physical workload and the development of lumbar disc diseases is limited. We therefore investigated the possible etiologic relevance of cumulative occupational lumbar load to lumbar disc diseases in a multi-center case-control study. Methods In four study regions in Germany (Frankfurt/Main, Freiburg, Halle/Saale, Regensburg), patients seeking medical care for pain associated with clinically and radiologically verified lumbar disc herniation (286 males, 278 females) or symptomatic lumbar disc narrowing (145 males, 206 females) were prospectively recruited. Population control subjects (453 males and 448 females) were drawn from the regional population registers. Cases and control subjects were between 25 and 70 years of age. In a structured personal interview, a complete occupational history was elicited to identify subjects with certain minimum workloads. On the basis of job task-specific supplementary surveys performed by technical experts, the situational lumbar load represented by the compressive force at the lumbosacral disc was determined via biomechanical model calculations for any working situation with object handling and load-intensive postures during the total working life. For this analysis, all manual handling of objects of about 5 kilograms or more and postures with trunk inclination of 20 degrees or more are included in the calculation of cumulative lumbar load. Confounder selection was based on biologic plausibility and on the change-in-estimate criterion. Odds ratios (OR) and 95% confidence intervals (CI) were calculated separately for men and women using unconditional logistic regression analysis, adjusted for age, region, and unemployment as major life event (in males) or psychosocial strain at work (in females), respectively. To further elucidate the contribution of past physical workload to the development of lumbar disc diseases, we performed lag-time analyses. Results We

  13. 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

  14. 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.

  15. 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

  16. A Prospective Multi-Center Clinical Trial to Compare Efficiency, Accuracy and Safety Of the VisionScope Imaging System Compared to MRI and Diagnostic Arthroscopy

    PubMed Central

    Xerogeanes, John W.; Safran, Marc R.; Huber, Bryan; Mandelbaum, Bert R.; Robertson, William; Gambardella, Ralph A.

    2014-01-01

    Objectives: Until now, arthroscopic surgery has been the gold standard for the diagnosis of intra-articular pathology. When a patient presents with ongoing pain and/or disability despite non-operative care, MRI is commonly used as a diagnostic modality. To date, there is not a minimally-invasive option that can provide detailed information about the intra-articular pathology of a joint. VisionScope Imaging (VSI) is an office-based diagnostic modality that provides comprehensive real-time images and video of a joint with higher accuracy and reliability compared to static MR images. The purpose of this study was to compare the efficacy, accuracy and safety of VSI compared to MRI and surgical diagnostic arthroscopy. Methods: A prospective, blinded, multi-centered study was performed of all patients who had a routine surgical arthroscopy at one of the six participating clinical sites between July 2012 and May 2013. Patients were consented by the physician investigator at each site. Study inclusion criteria consisted of: suspected meniscal tears or articular cartilage damage. Patients were excluded from the study if they had (1) acute traumatic hemarthoses, (2) concomitant ligament injury, (3) active systemic infection, (4) allergy to silicone or any medication used during the procedure,. All patients had a MRI and a comprehensive physical exam prior to their surgical arthroscopy. Each patient underwent a MRI, VSI exam and surgical diagnostic arthroscopy. The attending physician completed standard forms comparing the VSI exam findings to the diagnostic arthroscopy findings on each patient. Two blinded experts unaffiliated with the study reviewed the VSI and MRI images. The arthroscopy served as the “control” comparison between the VSI and MRI findings. Results: There were 110 patients included in this study. The accuracy, sensitivity and specificity of VSI was equivalent to surgical diagnostic arthroscopy and more accurate than MRI (Table 1). When comparing VSI to

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

    PubMed

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

    2010-01-01

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

  18. 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.

  19. 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.

  20. 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.

  1. Multi-center randomized double-blind controlled clinical study of chemotherapy combined with or without traditional Chinese medicine on quality of life of postoperative non-small cell lung cancer patients

    PubMed Central

    2012-01-01

    Background Traditional Chinese medicine (TCM) is a widely applied complementary therapy for cancer patients. It can reduce the chemical drugs induced toxic effects to improve the quality of life (QOL). This study applies the highest quality of clinical trial methodology to examine the role of TCM in improving QOL of postoperative non-small-cell lung cancer patients. Methods and design This study is a multi-center, randomized, placebo-controlled, double-blind trial. Four hundred eighty patients will be recruited into seven different research centers in China. These patients that meet the inclusion criteria will be randomized into either a treatment group or a placebo group. Each group will receive treatments of 3-weekly chemotherapy with TCM or placebo for four cycles. The primary outcome will involve the evaluation of QOL and the secondary outcome assessments will include two-year disease-free survival rate and disease-free survival. Other efficacy assessments are changes of TCM symptoms and toxicity. Side effects and safety profile of the therapy would be evaluated at the same time. The investigators expect that TCM therapy combined with chemotherapy is superior to chemotherapy solely in terms of QOL improvement and disease-free survival extension. "Intention-to-treat" analysis will include all randomized participants. Discussion The results from the clinical trial will provide evidence for the effectiveness of chemotherapy combined with or without TCM in QOL of postoperative NSCLC patients. Trial registration Clinical Trials.gov (Identifier: NCT01441752). PMID:22853619

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

    PubMed

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

    2015-07-01

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

  3. 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.

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

    NASA Astrophysics Data System (ADS)

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

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

  5. 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

  6. 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

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

    PubMed

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

    2014-10-01

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

  8. 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

  9. [Ergoferon liquid dosage form--efficacious and safe treatment for childhood acute respiratory infections. Interim outcomes of a multi-center, randomized, double-blind, placebo-controlled clinical trial].

    PubMed

    Geppe, N A; Kondiurina, E G; Galustian, A N; Pak, T E; Bal'tserovich, N B; Zhiglinskaia, O V; Kamaev, A V; Lazareva, S G; Laléko, S L; Mel'nikova, I M; Perminova, O A; Sabitov, A U

    2014-01-01

    The pediatric dosage form of Egroferon--a drug indicated for the treatment of influenza and acute respiratory infections (ARIs)--is developed taking in account the broad range of pathogens (most of which are viruses), and age-dependent features of immune system reactions (absence of specific immunity and immunological memory, relative "immaturity" of immune reactions, reduced interferon production by immunocompetent cells, etc.). Ergoferon interferes with the non-specific mechanisms of antiviral defence that ensure eliciting of an immune response, regardless of the virus type (the interferon system and CD4+cells), and influences virus-induced histamine release and histamine-mediated inflammatory reactions. Used over four years in clinical practice, the drug has shown a high efficacy and safety profile for the treatment of influenza and ARIs in adult patients. The purpose of the multi-center, randomized, double-blind, placebo-controlled study was to evaluate the clinical efficacy and safety of a new ergoferon liquid dosage form in the treatment of ARIs in children. The publication contains the results of the fist study stage completed as per the study plan and data from the interim analysis. METHODS. The screening involved a total of 162 subjects, aged 3 to 17 years (average, 8.2 ± 3.9 years), that had presented to 13 research centers based in Russia with common signs and symptoms of ARI (body temperature ≥ 38.0 degrees C, as measured with a digital infrared temporal artery thermometer; symptom severity score ≥ 4) during seasonal morbidity. Ergoferon was administered in 82 subjects receiving the therapeutic regimen of the drug for 5 days; 80 children received placebo. The subjects were monitored for 6 days. Treatment efficacy was assessed on the basis of morning, evening and total daily ARI symptom scores, including scoring estimates of fever, general symptoms and symptoms affecting the nose, throat and chest. Along with this, calculations were performed to

  10. 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.

  11. A multi-center study in order to further define the molecular basis of beta-thalassemia in Thailand, Pakistan, Sri Lanka, Mauritius, Syria, and India, and to develop a simple molecular diagnostic strategy by amplification refractory mutation system-polymerase chain reaction.

    PubMed

    Old, J M; Khan, S N; Verma, I; Fucharoen, S; Kleanthous, M; Ioannou, P; Kotea, N; Fisher, C; Riazuddin, S; Saxena, R; Winichagoon, P; Kyriacou, K; Al-Quobaili, F; Khan, B

    2001-11-01

    The spectrum of the beta-thalassemia mutations of Thailand, Pakistan, India, Sri Lanka, Mauritius and Syria has been further characterized by a multi-center study of 1,235 transfusion-dependent patients, and the mutations discovered used to assess the fidelity of a simple diagnostic strategy. A total of 44 beta-thalassemia mutations were identified either by allele-specific oligonucleotide hybridization, amplification with allele-specific primers, or DNA sequencing of amplified product. The results confirm and extend earlier findings for Thailand, Pakistan, India, Mauritius and Syria. This is the first detailed report of the spectrum of mutations for Sri Lanka. Two novel mutations were identified, codon 55 (-A) and IVS-I-129 (A-->C), both found in Sri Lankan patients. Two beta-thalassemia mutations were found to coexist in one beta-globin gene: Sri Lankan patients homozygous for the beta0 codon 16 (-C) frameshift were also homozygous for the beta+ codon 10 (C-->A) mutation. Studies of Sri Lankan, Pakistani, and Indian carriers suggest the codon 10 (C-->A) mutation is just a rare polymorphism on an ancestral allele, on which the beta0 codon 16 (-C) mutation has arisen. Each country was found to have only a few common mutations accounting for 70% or more of the beta-thalassemia alleles. A panel of primers to diagnose the majority of the mutations by the amplification refractory mutation system was developed, enabling a simple molecular diagnostic strategy to be introduced for each country participating in the multi-center study.

  12. Anti-IFN-γ autoantibodies in adults with disseminated nontuberculous mycobacterial infections are associated with HLA-DRB1*16:02 and HLA-DQB1*05:02 and the reactivation of latent varicella-zoster virus infection.

    PubMed

    Chi, Chih-Yu; Chu, Chen-Chung; Liu, Jing-Pei; Lin, Chia-Hao; Ho, Mao-Wang; Lo, Wen-Jyi; Lin, Po-Chang; Chen, Hung-Jen; Chou, Chia-Huei; Feng, Jia-Yih; Fung, Chang-Phone; Sher, Yuh-Pyng; Li, Chi-Yuan; Wang, Jen-Hsien; Ku, Cheng-Lung

    2013-02-21

    Adult patients with disseminated nontuberculous mycobacterial (dNTM) infections usually have severe immune system defects. Recently, several studies have shown that anti-IFN-γ autoantibodies may play an important role in the pathogenicity of dNTM infections. A considerable proportion of reported cases of anti-IFN-γ autoantibodies show either clinical or laboratory evidence of autoimmune disease. In the present study, we identified 19 formerly healthy adults who later developed dNTM infections, of whom 17 were further investigated immunologically. High-titer anti-IFN-γ autoantibodies capable of inhibiting IL-12 production in vitro were found in the plasma of all of these patients. In addition to dNTM infection, 35% and 71% of our patients also suffered from salmonellosis and herpes zoster, respectively. This observation suggests that IFN-γ may be crucial in controlling salmonella infection and reactivating latent varicella-zoster virus infection in humans. 2 HLA alleles, DRB1*16:02 DQB1*05:02 (odds ratio 8.68; 95% confidence interval, 3.47-21.90; P = 1.1 × 10(-6); Pc = 3.08 × 10(-5) and odds ratio 7.16; 95% confidence interval, 3.02-17.05; P = 1 × 10(-7); Pc = 1.4 × 10(-6), respectively), were found in 82% (14 of 17) of our patients. In conclusion, our data suggest that anti-IFN-γ autoantibodies may play a critical role in the pathogenesis of dNTM infections and reactivation of latent varicella-zoster virus infection and are associated with HLA-DRB1*16:02 and HLA-DQB1*05:02.

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

    NASA Technical Reports Server (NTRS)

    Schmeer, James W.; Cassetti, Marlowe D.

    1960-01-01

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

  14. A calculation of all possible oligosaccharide isomers both branched and linear yields 1.05 x 10(12) structures for a reducing hexasaccharide: the Isomer Barrier to development of single-method saccharide sequencing or synthesis systems.

    PubMed

    Laine, R A

    1994-12-01

    The number of all possible linear and branched isomers of a hexasaccharide was calculated and found to be > 1.05 x 10(12). This large number defines the Isomer Barrier, a persistent technological barrier to the development of a single analytical method for the absolute characterization of carbohydrates, regardless of sample quantity. Because of this isomer barrier, no single method can be employed to determine complete oligosaccharide structure in 100 nmol amounts with the same assurance that can be achieved for 100 pmol amounts with single-procedure Edman peptide or Sanger DNA sequencing methods. Difficulties in the development of facile synthetic schemes for oligosaccharides are also explained by this large number. No current method of chemical or physical analysis has the resolution necessary to distinguish among 10(12) structures having the same mass. Therefore the 'characterization' of a middle-weight oligosaccharide solely by NMR or mass spectrometry necessarily contains a very large margin of error. Greater uncertainty accompanies results performed solely by sequential enzyme degradation followed by gel-permeation chromatography or electrophoresis, as touted by some commercial advertisements. Much of the literature which uses these single methods to 'characterize' complex carbohydrates is, therefore, in question, and journals should beware of publishing structural characterizations unless the authors reveal all alternate possible structures which could result from their analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

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

    PubMed

    Zheng, Ting; Jiang, Zhenggen; Wu, Jiagang

    2016-07-28

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

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

    PubMed

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

    2015-11-25

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

  17. Anal sphincter injuries during hemorrhoidectomy: a multi center study.

    PubMed

    Mirzaei, Rezvan; Mahjoubi, Bahar; Kadivar, Maryam; Azizi, Rasoul; Zahedi-Shoolami, Leila

    2012-01-01

    Hemorrhoidectomy is the treatment of choice for patients with third or fourth-degree hemorrhoids. Although the majority of surgeons believe that surgical hemorrhoidectomy is the most effective approach with excellent results in the management of hemorrhoid disease, but hemorrhoidectomy is not a simple procedure. One of the complications of this surgery is an injury to anal sphincters that can lead to incontinency in some patients. In this study, we aimed to reveal the percentage of external and internal anal sphincter injuries in surgical hemorrhoidectomy. We prospectively enrolled 128 patients from April 2006 to February 2007. They underwent hemorrhoidectomy in three general hospitals in Tehran. All patients were in grade III or IV and underwent open hemorrhoidectomy (Milligan-Morgan). After surgery, all resected material was histopathologically examined by two expert pathologists and the results confirmed by other one if there is any discrepancy. From all specimens which sent to the pathology department 15.8% (21 Pts.) had muscle fibers that Smooth muscle fibers were seen in 80.5% (17 Pts.) of them and striated muscle fibers were found in 19.5% (4 Pts.). Although hemorrhoidectomy is a safe and effective method for treatment of hemorrhoid, but the inadvertent removal of smooth and striated muscle during open hemorrhoidectomy had raised concerns about its effects on postoperative anorectal function.

  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. 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

  1. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....gov. To access a rulemaking, enter the docket number associated with rulemaking in the “Search” box... http://www.regulations.gov. Paragraph (a) of this section describes how to access and view these....gov. Paragraph (a) of this section describes how to access and view these documents....

  2. 33 CFR 1.05-25 - Public docket.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  3. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... meeting or request for comments in the Federal Register. Advance Notices of Proposed Rulemaking, Notices... provide 90 days, or more if possible, after publication for submission of comments. This time period...

  4. 33 CFR 1.05-15 - Public participation.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... meeting or request for comments in the Federal Register. Advance Notices of Proposed Rulemaking, Notices... provide 90 days, or more if possible, after publication for submission of comments. This time period...

  5. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., treaties and Executive Orders to the Assistant Commandant for Marine Safety, Security and Stewardship (CG-5... Commandant for Marine Safety, Security, and Stewardship may further reassign the delegated authority of this... Assistant Commandant for Marine Safety, Security and Stewardship, the authority to make the...

  6. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... designation of lightering zones. (iii) The operation of drawbridges. (iv) The establishment of Regulated..., Captains of the Port, the Deputy Commandant for Operations (CG-DCO), and the Assistant Commandant...

  7. 33 CFR 1.05-1 - Delegation of rulemaking authority.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...). The Commandant further redelegates this same authority to the Director, National Pollution Fund Center... designation of lightering zones. (iii) The operation of drawbridges. (iv) The establishment of Regulated..., Captains of the Port, the Deputy Commandant for Operations (CG-DCO), and the Assistant Commandant...

  8. 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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2016-04-01

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

  11. [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.

  12. 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

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

    PubMed

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

    2016-08-01

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

  14. Artificial dermis for major burns. A multi-center randomized clinical trial.

    PubMed Central

    Heimbach, D; Luterman, A; Burke, J; Cram, A; Herndon, D; Hunt, J; Jordan, M; McManus, W; Solem, L; Warden, G

    1988-01-01

    This communication presents an 11-center prospective randomized trial using the artificial dermis invented by Burke and Yannas. Patients with life-threatening burns who underwent primary excision and grafting within 7 days of injury had comparable sites randomized to receive either the artificial dermis (study site) or the investigator's usual skin grafting material (control site). Control materials were autograft, allograft, xenograft, or a synthetic dressing. Epidermal grafts were applied to the study site during a second operation, and surviving patients were followed for 1 year after grafting. One hundred thirty-nine sites on 106 patients were studied. Mean burn size was 46.5 +/- 15% mean total body surface (TBSA). Overall mortality was 13%, and mean hospital stay was 68 +/- 45 days. Median artificial dermis take was 80% compared with 95% for all comparative sites, but the take was equivalent to that of all nonautograft control materials. Results with the artificial dermis improved slightly as the investigators became more familiar with the material. Donor site thickness for the study site averaged .006'' +/- .002'' compared to .013'' +/- .018'' for control (p less than .0001) and the epidermal donor site healed an average of 4 days sooner (10 +/- 6 vs. 14 +/- 8 days) (p less than .0001). As the wounds matured during the first year, both patients and surgeons felt that both sites became more comparable in appearance and function. At the completion of the study, there was less hypertrophic scarring of the artificial dermis, and more patients preferred the artificial dermis to the control graft. Artificial dermis with an epidermal graft provides a permanent cover that is at least as satisfactory as currently available skin grafting techniques, and uses donor grafts that are thinner and donor sites that heal faster. Images Fig. 3. Fig. 4. Fig. 5. Fig. 6. Fig. 7. PMID:3048216

  15. 001. EGFR mutations in Greek patients with lung adenocarcinoma: a multi-center study (preliminary results)

    PubMed Central

    Zarogoulidis, Pavlos; Kallianos, Anastasios; Kerasiotis, Haralampos; Marosis, Konstantinos; Vlastos, Fotios; Veldekis, Ioannis; Aggelidou, Maria; Zarogoulidis, Konstantinos; Rapti, Aggeliki

    2015-01-01

    Background Integration of mutational epidermal growth factor receptor (EGFR) profiling to identify driver alterations in a clinical setting, is necessary to facilitate personalized lung cancer medicine. A tumor genotyping EGFR panel was developed and the Greek Mutation Study was initiated as a prospective tumor genotyping study. This study reports the frequency of driver genetic alterations in Greek lung adenocarcinoma patients, and epidemiology correlations with EGFR genotype. Methods Between November 2012 and June 2014, 211 lung adenocarcinoma patients were included in this study. EGFR mutations were tested in lung cancer tissues and histologic specimen. All patients completed informed consent. The method was high resolution melting analysis (HRMA) about mutations 18-21 and further analysis with method sequencing-ABI prism 3130 sequencer (DNA). Eighteen Surgically resected tissues (8.5%), 174 tumor biopsies (82%) and 19 (9%) body cavity fluids were collected and tested for EGFR mutations. We describe clinical and epidemiological profile of EGFR positive adenocarcinoma patients. Results Genetic EGFR positive mutations were detected in 10.8% (24 of 221) of all patients, fifteen women and nine men. All women were nonsmokers (100%) and seven of nine (78%) men were smokers. Mean age of this group was 64.3 years old. Eighteen patients were with stage IV and rest of them IIIa. None of them was operable. Conclusions This is one report of tumor EGFR positive Greek patients with adenocarcinoma. These data suggest that patients profiling data using a mutational testing platform would be valuable for observation for each group of patients helping clinical doctor for further molecular-targeted therapeutics in lung cancer.

  16. Managing Multi-Center Recruitment in the PLCO Cancer Screening Trial.

    PubMed

    Gohagan, John K; Broski, Karen; Gren, Lisa H; Fouad, Mona N; Higgins, Darlene; Lappe, Karen; Ogden, Sheryl; Shambaugh, Vicki; Pinsky, Paul F; O'Brien, Barbara; Yurgalevich, Susan; Riley, Tom; Wright, Patrick; Prorok, Philip C

    2015-01-01

    There were significant recruitment challenges specific to the PLCO Cancer Screening Trial. Large numbers of participants were to be randomized from ten catchment areas nationwide within time and budgetary constraints. The eligible population was elderly and had to meet health and behavioral thresholds. Informed consent was required to participate and be randomized to screening for three cancers at periodic clinic visits or to a usual care arm that included no clinical visits. Consenting required special efforts to fully explain the trial and its potential scientific benefit to future patients with potentially no benefits but possible harms to PLCO participants. Participation would include continued follow-up for at least 13 years after randomization. Strong collaborative investments were required by the NCI and screening centers (SCs) to assure timely recruitment and appropriate racial participation. A trial-wide pilot phase tested recruitment and protocol follow through at SCs and produced a vanguard population of 11,406 participants. NCI announced the trial nationally in advance of the pilot and followed with an even more intense collaborative role with SCs for the main phase to facilitate trial-wide efficient and timely recruitment. Special efforts to enhance recruitment in the main phase included centralized and local monitoring of progress, cross-linking SCs to share experiences in problem solving, centralized training, substantial additional funding dedicated to recruitment and retention, including specialized programs for minority recruitment, obtaining national endorsement by the American Cancer Society, launching satellite recruitment and screening centers, including minority focused satellites, and adding a new SC dedicated to minority recruitment.

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

    NASA Technical Reports Server (NTRS)

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

    1999-01-01

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

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

    PubMed

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

    2015-05-25

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

  19. 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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2016-01-01

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

  2. 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.

  3. 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

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

    PubMed Central

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

    2013-01-01

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

  5. 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..

  6. 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.

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

    PubMed

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

    2016-01-01

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

  8. 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.

  9. 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.

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

    PubMed

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

    2016-01-01

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

  11. Clinical management of acute liver failure: Results of an international multi-center survey

    PubMed Central

    Rabinowich, Liane; Wendon, Julia; Bernal, William; Shibolet, Oren

    2016-01-01

    AIM To assess the practice of caring for acute liver failure (ALF) patients in varying geographic locations and medical centers. METHODS Members of the European Acute Liver Failure Consortium completed an 88-item questionnaire detailing management of ALF. Responses from 22 transplantation centers in 11 countries were analyzed, treating between 300 and 500 ALF cases and performing over 100 liver transplants (LT) for ALF annually. The questions pertained to details of the institution and their clinical activity, standards of care, referral and admission, ward- based care versus intensive care unit (ICU) as well as questions regarding liver transplantation - including criteria, limitations, and perceived performance. Clinical data was also collected from 13 centres over a 3 mo period. RESULTS The interval between referral and admission of ALF patients to specialized units was usually less than 24 h and once admitted, treatment was provided by a multidisciplinary team. Principles of care of patients with ALF were similar among centers, particularly in relation to recognition of severity and care of the more critically ill. Centers exhibited similarities in thresholds for ICU admission and management of severe hepatic encephalopathy. Over 80% of centers administered n-acetyl-cysteine to ICU patients for non-paracetamol-related ALF. There was significant divergence in the use of prophylactic antibiotics and anti-fungals, lactulose, nutritional support and imaging investigations in admitted patients and in the monitoring and treatment of intra-cranial pressure (ICP). ICP monitoring was employed in 12 centers, with the most common indications being papilledema and renal failure. Most patients listed for transplantation underwent surgery within an average waiting time of 1-2 d. Over a period of 3 mo clinical data from 85 ALF patients was collected. Overall patient survival at 90-d was 76%. Thirty six percent of patients underwent emergency LT, with a 90% post transplant survival to hospital discharge, 42% survived with medical management alone. CONCLUSION Alongside similarities in principles of care of ALF patients, major areas of divergence were present in key areas of diagnosis, monitoring, treatment and decision to transplant. PMID:27672280

  12. Multi-center study of noise in patients from hospitals in Spain: a questionnaire survey.

    PubMed

    Marqués, Pilar; Calvo, Dolores; Mompart, Mari Paz; Arias, Natalia; Quiroga, Enedina

    2012-01-01

    To identify the most annoying noises in the hospital environment. One hundred and ninety-three patients took part in the study. A questionnaire collected the perceptions of patients from four hospitals in Spain, with three distinct units. The most annoying noises were the repetitive ones and the most unbearable source was the people who talk loudly. The daily hours were the noisiest and the most annoying, especially when patients wanted to rest and indicated that noise was annoying for them to get to sleep. Our results demonstrate how sensitive patients are toward noise in Spain. We also suggest some strategies to reduce the noise and the harmful physiological effects of increased sound levels in order to improve the quality of life in a healthcare environment.

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

    PubMed Central

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

    2015-01-01

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

  15. 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

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

    PubMed

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

    2016-08-01

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

  17. 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.

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

    PubMed

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

    2015-11-01

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

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

    PubMed

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

    2015-05-25

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

  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. [A multi-center prospective study for antibiotic prophylaxis to prevent perioperative infections in urologic surgery].

    PubMed

    Yamamoto, Shingo; Kunishima, Yasuharu; Kanamaru, Sojun; Ito, Noriyuki; Kinoshita, Hidefumi; Kamoto, Toshiyuki; Ogawa, Osamu; Arai, Yoichi; Okumura, Kazuhiro; Terachi, Toshiro; Moroi, Seiji; Okada, Yusaku; Nishio, Yasunori; Kanamaru, Hirofumi; Inui, Masashi; Asazuma, Akira; Kanatani, Isao; Sasaki, Miharu; Nishikawa, Nobuyuki; Hida, Shuichi; Nonomura, Mitsuo; Terai, Akito; Ogura, Keiji; Mitsumori, Kenji; Nishimura, Kazuo; Onishi, Hiroyuki; Horii, Yasuki; Yamasaki, Toshinari

    2004-10-01

    In order to assess the ability of our protocol for antibiotic prophylaxis to prevent perioperative infections in urologic surgery, 1,353 operations of open and laparoscopic urologic surgery conducted in 21 hospitals between September 2002 and August 2003 were subjected to analyses. We classified surgical procedures into four categories by invasiveness and contamination levels: Category A; clean less invasive surgery, Category B; clean invasive or clean-contaminated surgery, Category C; surgery with urinary tract diversion using the intestine. Prophylactic antibiotics were administrated intravenously according to our protocol, such as Category A; first or second generation cephems or penicillins on the operative day only, Category B; first and second generation cephems or penicillins for 3 days, and Category C; first, second or third generation cephems or penicillins for 4 days. The wound conditions and general conditions were evaluated in terms of the surgical site infection (SSI) as well as remote infection (RI) up to postoperative day (POD) 30. The SSI rate highest (23.3%) for surgery with intestinal urinary diversion, followed by 10.0% for surgery for lower urinary tract, 8.9% for nephroureterctomy, and 6.0% for radical prostatectomy. The SSI rates in clean surgery including open and laparoscopic nephrectomy/adrenalectomy were 0.7 and 1.4%, respectively. In SSIs, gram-positive cocci such as methicillin-resistant Staphylococcus aureus (58.8%) or Enterobacter faecalis (26.5%) were the most common pathogen. Similarly, the RI rate was the highest (35.2%) for surgery using intestinal urinary diversion, followed by 16.7% for surgery for lower urinary tract, 11.4% for nephroureterctomy, and 7.6% for radical prostatectomy, while RI rates for clean surgery were less than 5%. RIs most frequently reported were urinary tract infections (2.6%) where Pseudomonas aeruginosa (20.3%) and Enterobacter faecalis (15.3%) were the major causative microorganisms. Parameters such as age, obesity, nutritional status (low proteinemia), diabetes mellitus, lung disease, duration of operation, and blood loss volume were recognized as risk factors for SSI or RI in several operative procedures. Postoperative body temperatures, peripheral white blood counts, C reactive protein (CRP) levels in POD 3 were much higher than those in POD 2 in cases suffering from perioperative infections, especially suggesting that CRP could be a predictable marker for perioperative infections.

  2. 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

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

    PubMed Central

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

    2015-01-01

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

  4. Appreciating the broad clinical features of SMAD4 mutation carriers: a multi-center chart review

    PubMed Central

    Wain, K.E.; Ellingson, M.S.; McDonald, J.; Gammon, A.; Roberts, M.; Pichurin, P.; Winship, I.; Riegert-Johnson, D.; Weitzel, J. N.; Lindor, N.M.

    2014-01-01

    Heterozygous loss-of-function (LOF) SMAD4 mutations are associated with juvenile polyposis syndrome (JP) and hereditary hemorrhagic telangiectasia (HHT). Some carriers exhibit symptoms of both conditions, leading to the name JP-HHT syndrome. Three families have been reported with connective tissue abnormalities. In order to better understand the spectrum and extent of clinical findings in SMAD4 carriers, medical records of 34 patients (20 families) from five clinical practices were reviewed. Twenty-one percent (7/34) had features suggesting a connective tissue defect: enlarged aortic root (n=3), aortic and mitral insufficiency (n=2), aortic dissection (n=1), retinal detachment (n=1), brain aneurysms (n=1), lax skin and joints (n=1). JP-specific findings were almost uniformly present but variable. Ninety-seven percent had colon polyps that were generally pan-colonic and of variable histology and number. Forty-eight percent (15/31) had extensive gastric polyposis. HHT features were documented in 76% including epistaxis (19/31, 61%), mucocutaneous telangiectases (15/31, 48%), liver arteriovenous malformation (AVM) (6/16, 38%), brain AVM (1/26, 4%), pulmonary AVM (9/17, 53%), and intrapulmonary shunting (14/23, 61%). SMAD4 carriers should be managed for JP and HHT, since symptoms of both are likely yet unpredictable. Connective tissue abnormalities are an emerging component of JP-HHT syndrome, and larger studies are needed to understand these manifestations. PMID:24525918

  5. Intestinal fungal and parasitic infections in kidney transplant recipients: a multi-center study.

    PubMed

    Naeini, Afsoon Emami; Sharifi, Mehran; Shahidi, Shahrzad; Taheri, Shahram; Seirafian, Shiva; Taheri, Dyana; Tazhibi, Mahdi; Hejazi, Sayyed Hosein; Naini, Pardis Emami; Harandi, Asghar Amini

    2012-07-01

    Kidney transplant recipients are susceptible to various infections due to the use of immunosuppressive drugs. The present study was performed as studies on the prevalence of intestinal fungal and parasitic infections in kidney transplant recipients are limited. A total of 150 kidney transplant recipients and 225 matched immunocompetent outpatients, who were referred to the laboratory of Noor Hospital, Isfahan, were studied. After recording demographic characteristics, direct test and specific laboratory cultures were carried out on the stool specimens. Patients were instructed on sanitary rules and, during each medical visit, they were reminded of the same. The overall prevalence of intestinal parasitic and fungal infections was 33.3% and 58.7%, respectively, in transplant recipients and 20% and 51%, respectively, in the control group; the difference was not statistically significant. The most prevalent intestinal parasite was Entameba coli, which was seen in 9.3% of the study patients and 6.7% of the controls. The most prevalent fungus was Candida sp., which was seen in 22% of the study patients and 24.4% of the control group. Co-existing infection with two or more fungi was seen in 14.8% and 3.4% in the case and control groups, respectively; P <0.001. Interestingly, there was no significant difference in the prevalence of infection by a single organism between the two groups. However, co-existing infection with two or more species was more prevalent in transplant recipients. We conclude that further investigations are needed to evaluate the pathogenesis of infection with these microorganisms. PMID:22805377

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

    NASA Astrophysics Data System (ADS)

    Goldman, Nir

    2015-03-01

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

  7. 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.

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

    PubMed

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

    2014-09-22

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

  9. A multi-center retrospective analysis of treatment effects and quality of life in adult patients with cranial ependymomas.

    PubMed

    Dützmann, Stephan; Schatlo, Bawarjan; Lobrinus, Alexander; Murek, Michael; Wostrack, Maria; Weiss, Carolin; Schaller, Karl; Raabe, Andreas; Meyer, Bernhard; Goldbrunner, Roland; Franz, Kea; Seifert, Volker; Senft, Christian

    2013-09-01

    Long term quality of life data of adult patients harboring intracranial ependymomas have not been reported. The role of adjuvant radiation therapy in Grade II ependymomas is unclear and differs from study to study. We therefore sought to retrospectively analyze outcome and quality of life of adult patients that were operated on intracranial ependymomas at four different surgical centers in two countries. All patients were attempted to be contacted via telephone to assess quality of life (QoL) at the time of the telephone interview. The standard EORTC QoL Questionnaire C30 (EORTC QLQ-C30) and the EORTC QLQ-Brain Cancer Module (QLQ-BN20) were used. 64 adult patients with intracranial ependymomas were included in the study. The only factor that was associated with increased survival was age <55 years (p < 0.001). Supratentorial location was correlated with shorter progression free survival than infratentorial location (PFS; p = 0.048). In WHO Grade II tumors local irradiation did not lead to increased PFS (p = 0.888) or overall survival (p = 0.801). Even for incompletely resected Grade II tumors local irradiation did not lead to a benefit in PFS (p = 0.911). In a multivariate analysis of QoL, irradiated patients had significantly worse scores in the item "fatigue" (p = 0.037) than non-irradiated patients. Here we present QoL data of adult patients with intracranial ependymomas. Our data show that local radiation therapy may have long-term effects on patients' QoL. Since in the incompletely resected Grade II tumors local irradiation did not lead to a benefit in PFS in this retrospective study, prospective randomized studies are necessary. In addition to age, supratentorial tumor location is associated with a worse prognosis in adult ependymoma patients.

  10. 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

  11. Early non-invasive cardiac output monitoring in hemodynamically unstable intensive care patients: A multi-center randomized controlled trial

    PubMed Central

    2011-01-01

    Introduction Acute hemodynamic instability increases morbidity and mortality. We investigated whether early non-invasive cardiac output monitoring enhances hemodynamic stabilization and improves outcome. Methods A multicenter, randomized controlled trial was conducted in three European university hospital intensive care units in 2006 and 2007. A total of 388 hemodynamically unstable patients identified during their first six hours in the intensive care unit (ICU) were randomized to receive either non-invasive cardiac output monitoring for 24 hrs (minimally invasive cardiac output/MICO group; n = 201) or usual care (control group; n = 187). The main outcome measure was the proportion of patients achieving hemodynamic stability within six hours of starting the study. Results The number of hemodynamic instability criteria at baseline (MICO group mean 2.0 (SD 1.0), control group 1.8 (1.0); P = .06) and severity of illness (SAPS II score; MICO group 48 (18), control group 48 (15); P = .86)) were similar. At 6 hrs, 45 patients (22%) in the MICO group and 52 patients (28%) in the control group were hemodynamically stable (mean difference 5%; 95% confidence interval of the difference -3 to 14%; P = .24). Hemodynamic support with fluids and vasoactive drugs, and pulmonary artery catheter use (MICO group: 19%, control group: 26%; P = .11) were similar in the two groups. The median length of ICU stay was 2.0 (interquartile range 1.2 to 4.6) days in the MICO group and 2.5 (1.1 to 5.0) days in the control group (P = .38). The hospital mortality was 26% in the MICO group and 21% in the control group (P = .34). Conclusions Minimally-invasive cardiac output monitoring added to usual care does not facilitate early hemodynamic stabilization in the ICU, nor does it alter the hemodynamic support or outcome. Our results emphasize the need to evaluate technologies used to measure stroke volume and cardiac output--especially their impact on the process of care--before any large-scale outcome studies are attempted. Trial Registration The study was registered at ClinicalTrials.gov (Clinical Trials identifier NCT00354211) PMID:21676229

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

    PubMed

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

    2016-08-01

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

  13. Can the Risk of Lymph Node Metastases Be Gauged in Endoscopically Resected Submucosal Esophageal Adenocarcinomas? A Multi-Center Study.

    PubMed

    Boys, Joshua A; Worrell, Stephanie G; Chandrasoma, Parakrama; Vallone, John G; Maru, Dipen M; Zhang, Lizhi; Blackmon, Shanda H; Dickinson, Karen J; Dunst, Christy M; Hofstetter, Wayne L; Lada, Michael J; Louie, Brian E; Molena, Daniela; Watson, Thomas J; DeMeester, Steven R

    2016-01-01

    Endoscopic resection (ER) allows for local therapy of superficial esophageal cancers. Factors reported to be associated with an increased risk of lymph node metastases in patients with adenocarcinoma are poor differentiation, lymphovascular invasion (LVI), and submucosal invasion >500 μ. The aim of this study was to determine whether depth of invasion and tumor characteristics in an ER specimen can be used to gauge the risk of lymph node metastases in patients with superficial esophageal adenocarcinoma. Patients from seven US centers that had ER of an adenocarcinoma followed by an esophagectomy were identified. The ER pathology slides were rereviewed by three experienced GI pathologists for depth of invasion, presence of LVI, and tumor differentiation. The findings from the ER specimen were correlated with the presence and number of lymph node metastases in the final esophagectomy specimen. There were 19 T1a and 23 T1b tumors. A median of 24 nodes were resected per patient. None of the T1a tumors had involved lymph nodes despite the presence of LVI in 5% and poor differentiation in 21% of patients. In contrast, 26% of T1b tumors had involved nodes. None of the four patients with submucosal invasion ≤500 μ, no LVI, and no poor differentiation had involved nodes. However, with an increasing number of risk factors, the likelihood of involved lymph nodes increased, reaching 50% when all three factors were present. Endoscopic therapy appears appropriate for intramucosal tumors and may be an option for low-risk T1b tumors. Esophagectomy is preferred for patients with submucosal invasion and one or more risk factors.

  14. 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

  15. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    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

    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. We performed a prospective open-label, multicenter screening trial of 36 ALS patients treated with 2 mg 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. 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). In conclusion, engagement of exploratory biomarkers and questions about comparability of baseline characteristics lead us to recommend a further placebo-controlled trial. PMID:25832828

  18. 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

  19. 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...

  20. 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

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

    PubMed Central

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

    2009-01-01

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

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

    PubMed

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

    2016-09-01

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

  3. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2016-08-01

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

  6. 77 FR 56854 - Submission for OMB Review; Comment Request: A Multi-Center International Hospital-Based Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... information collection was previously published in the Federal Register on February 24, 2012 (77 FR 11136) and... patients undergoing surgery or other treatment for non-cancer related medical issues who live in Taiwan...

  7. 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

  8. 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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  11. Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.

    PubMed

    van Bakelen, N B; Buijs, G J; Jansma, J; de Visscher, J G A M; Hoppenreijs, Th J M; Bergsma, J E; Stegenga, B; Bos, R R M

    2013-12-01

    Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicenter randomized controlled trial (RCT) was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Plate removal was necessary in 16 of the 134 patients (11.9%) treated with titanium and in 21 of the 87 patients (24.1%) treated with the biodegradable system within the first 2 post-operative years [p = .016, HR biodegradable (95% CI) = 2.2 (1.1-4.2), HR titanium = 1]. Occlusion, VAS, and MFIQ scores showed that both groups had good mandibular function and were (almost) free of pain 1 and 2 years post-operatively (http://controlled-trials.com ISRCTN 44212338).

  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. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-05-01

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

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

    PubMed Central

    2015-01-01

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

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

    PubMed Central

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

    2006-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  1. Counseling to Reduce High-Risk Sexual Behavior in HIV Care: A Multi-Center, Direct Observation Study

    PubMed Central

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

    2013-01-01

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

  2. 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.

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

    PubMed Central

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2012-01-01

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

  14. Endoscopic ultrasound-guided fine needle aspiration cytology of metastatic renal cell carcinoma to the pancreas: A multi-center experience

    PubMed Central

    Pannala, Rahul; Hallberg-Wallace, Karyn M.; Smith, Amber L.; Nassar, Aziza; Zhang, Jun; Zarka, Matthew; Reynolds, Jordan P.; Chen, Longwen

    2016-01-01

    Introduction: The increasing use of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) cytology to examine pancreatic neoplasms has led to an increase in the diagnosis of metastases to the pancreas. Renal cell carcinoma (RCC) is the most common metastasis to the pancreas. Our study examines 33 cases of metastatic RCC to the pancreas sampled by EUS-FNA from four large tertiary care hospitals. Materials and Methods: We searched the cytopathology database for RCC metastatic to the pancreas diagnosed by EUS-FNA from January 2005 to January 2015. Patient age, history of RCC, nephrectomy history, follow-up postnephrectomy, radiological impression, and EUS-FNA cytologic diagnosis were reviewed. Results: Thirty-three patients were identified. The average age was 67.5 years (range, 49–84 years). Thirty-two patients had a previous documented history of RCC. One patient had the diagnosis of pancreatic metastasis at the same time of the kidney biopsy. Thirty-one patients had been treated with nephrectomy. Twenty-seven patients were being monitored annually by computed tomography or magnetic resonance imaging. Twenty-five patients had multiple masses by imaging, but 8 patients had a single mass in the pancreas at the time of EUS-FNA. EUS-FNA of 20 cases showed classic morphology of RCC. Thirteen cases had either “atypical” clinical-radiologic features or morphologic overlaps with primary pancreatic neoplasms or other neoplasms. Cell blocks were made on all 13 cases and immunochemical stains confirmed the diagnosis. Conclusions: EUS-FNA cytology is useful for the diagnosis of metastatic RCC to the pancreas. Cytomorphology can be aided with patient history, imaging analyses, cell blocks, and immunochemical stains. PMID:27761149

  15. Monitoring cartilage loss in the hands and wrists in rheumatoid arthritis with magnetic resonance imaging in a multi-center clinical trial: IMPRESS (NCT00425932)

    PubMed Central

    2013-01-01

    Introduction Magnetic resonance imaging (MRI) is increasingly being used in clinical trials of rheumatoid arthritis (RA) because of its superiority over x-ray radiography (XR) in detecting and monitoring change in bone erosion, osteitis and synovitis. However, in contrast to XR, the MRI scoring method that was used in most clinical trials did not include cartilage loss. This limitation has been an obstacle to accepting MRI as a potential alternative to XR in clinical trials. Cross-sectional studies have shown MRI to be sensitive for cartilage loss in the hands and wrist; although, longitudinal sensitivity to change has not yet been confirmed. In this study we examined the ability of MRI to monitor change in cartilage loss in patients with RA in a multi-site clinical trial setting. Methods Thirty-one active RA patients from a clinical trial (IMPRESS) who were randomized equally into treatment with either rituximab + methotrexate or placebo + methotrexate had MRI of the dominant hand/wrist at baseline, 12 weeks and 24 weeks at 3 clinical sites in the US. Twenty-seven of these patients also had XR of both hands/wrists and both feet at baseline and 24 weeks. One radiologist scored all XR images using the van der Heijde-modified Sharp method blinded to visit order. The same radiologist scored MR images for cartilage loss using a previously validated 9-point scale, and bone erosion using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA MRI Score (RAMRIS) blinded to visit order and XR scores. Data from the two treatment arms were pooled for this analysis. Results Mean MRI cartilage score increased at 12 and 24 weeks, and reached statistical significance at 24 weeks. XR total Sharp score, XR erosion score and XR joint-space narrowing (JSN) score all increased at 24 weeks, but only XR total Sharp score increased significantly. Conclusions To our knowledge, this is the first publication of a study demonstrating MRI's ability to monitor cartilage loss in a multi-site clinical trial. Combined with MRI's established performance in monitoring bone erosions in RA, these findings suggest that MRI may offer a superior alternative to XR in multi-site clinical trials of RA. PMID:23514433

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

    PubMed Central

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

    2016-01-01

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

  17. DNA image cytometry test for primary screening of esophageal cancer: a population-based multi-center study in high-risk areas in China

    PubMed Central

    Wang, Meng; Hao, Changqing; Ma, Qing; Song, Guohui; Ma, Shanrui; Zhao, Deli; Zhao, Lin; Li, Xinqing; Wei, Wenqiang

    2016-01-01

    Objective To evaluate the feasibility of DNA image cytometry (DNA-ICM) as a primary screening method for esophageal squamous cell cancer (ESCC). Methods A total of 5,382 local residents aged 40–69 years from three high-risk areas in China (Linzhou in Henan province, Feicheng in Shandong province and Cixian in Hebei province) from 2008 to 2011 were recruited in this population-based screening study. And 2,526 subjects declined to receive endoscopic biopsy examination with Lugol’s iodine staining, while 9 and 815 subjects were excluded from liquid-based cytology and DNA-ICM test respectively due to slide quality. Finally, 2,856, 5,373 and 4,567 subjects were enrolled in the analysis for endoscopic biopsy examination, liquid-based cytology and DNA-ICM test, respectively. Sensitivity (SE), specificity (SP), negative predictive values (NPV) and positive predictive values (PPV) as well as their 95% confidence intervals (95% CI) for DNA-ICM, liquid-based cytology and the combination of the two methods were calculated. Receiver operating characteristic (ROC) curves were applied to determine the cutoff point of DNA-ICM for esophageal cancer. Results DNA-ICM results were significantly correlative with esophageal cancer and precancer lesions (χ2=18.016, P<0.001). The cutoff points were 5,802, 5,803 and 8,002 based on dissimilar pathological types of low grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), and ESCC, respectively, and 5,803 was chosen in this study considering the SE and SP. The SE, SP, PPV, NPV of DNA-ICM test (cutoff point 5,803) combined with liquid-based cytology [threshold atypical squamous cells of undetermined significance (ASCUS)] were separately 72.1% (95% CI: 70.3%-73.9%), 43.3% (95% CI: 41.3%-45.3%), 22.8% (95% CI: 21.1%-24.5%) and 87.0% (95% CI: 85.7%-88.3%) for LGIN, 85.7% (95% CI: 84.3%-87.1%), 41.3% (95% CI: 39.3%-43.3%), 4.6% (95% CI: 3.8%-5.4%) and 98.9% (95% CI: 98.5%-99.3%) for HGIN, and 96.0% (95% CI: 95.2%-96.8%), 40.8% (95% CI: 38.8%-42.8%), 1.7% (95% CI: 1.2%-2.2%) and 99.9% (95% CI: 99.8%-100.0%) for ESCC. Conclusions It is possible to use DNA-ICM test as a primary screening method before endoscopic screening for esophageal cancer. PMID:27647968

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

    PubMed Central

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

    2015-01-01

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

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

    SciTech Connect

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

    2004-09-15

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

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

    PubMed

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

    2004-01-01

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

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

    PubMed

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

    2015-01-01

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

  2. Ensuring quality of services in HIV prevention research settings: findings from a multi-center quality improvement pilot in East Africa.

    PubMed

    Ngongo Bahati, Prince; Kidega, William; Ogutu, Hilda; Odada, Jane; Bender, Bonnie; Fast, Pat; Becker, Julie; Price, Matt

    2010-01-01

    Quality improvement (QI) has been widely implemented in health services but has not been widely applied in HIV prevention research. Most prevention research centers have commonly employed traditional approaches (e.g., checklists) to quality control that document what has been done but not the quality of what has been done. Unlike other health settings, prevention research settings have unique characteristics and ethical requirements that require the development or adaptation of specific quality indicators. A QI model for health services was adapted for use in prevention research settings and was piloted between August 2006 and July 2007 at three research centers in East Africa. Four hundred and twenty-six volunteers exit interviews were administered in two cycles. Quantitative and qualitative data were analyzed using Excel worksheets. QI meeting reports and QI plans were used to complement data from exit interviews. On average, 52% of total enrolled volunteers participated in the exit interview. The designed QI plans successfully helped reduce volunteers' reported waiting time to see counselors (p<0.001) and pharmacists (p<0.001). It also increased the percentage of interviewed volunteers who reported being counseled on family planning at clinical trials (from 66 to 93%; p=0.02) at follow-up visits, and who were refreshed on informed consent at follow-up visits (from 90 to 96%; p=0.009). The percentage of interviewed volunteers that expressed satisfaction with services received from counselors increased (from 87 to 94%; p=0.009) while the percentage of volunteer satisfied with services from trial physicians remained constant (93%). The majority of volunteers interviewed reported satisfaction with other major components of research such as confidentiality, understanding of trial objectives, benefits and risks of participation, and risk reduction counseling. However, satisfaction with services from community outreach workers and other staff at research centers dropped over the course of the study (from 88% in Cycle 1 to 74% in Cycle 3; p= < 0.001). Increased commitment to QI is crucial in ensuring quality of services and ethical conduct of HIV prevention research centers. PMID:20390489

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

    PubMed Central

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

    2015-01-01

    Objective Depression affects one in four adults with type 2 diabetes (T2DM) and is associated with worsened diabetes complications, increased health care costs and early mortality. Rural and low-income urban areas, including the Appalachian region, represent an epicenter of the T2DM epidemic. Program ACTIVE II is a comparative effectiveness treatment trial designed to test whether a combination of cognitive behavioral therapy (CBT) and community-based exercise (EXER) will offer greater improvements in diabetes and depression outcomes compared to individual treatment approaches and usual care (UC). The secondary aims are to assess changes in cardiovascular risk factors across groups and to conduct a cost-effectiveness analysis of predicted incidence of cardiovascular complications across groups. Methods The study is a 2-by-2 factorial randomized controlled trial consisting of 4 treatment groups: CBT alone, EXER alone, combination of CBT and EXER, and UC. Adults with T2DM for > 1 year and who meet DSM-IVTR criteria for Major Depressive Disorder (MDD) are eligible to participate at two rural Appalachian sites (southeastern Ohio and West Virginia) and one urban site (Indianapolis). This type II behavioral translation study uses a community-engaged research (CEnR) approach by incorporating community fitness centers and mental health practices as interventionists. Conclusions This is the first study to evaluate the comparative effectiveness of combined CBT and exercise in the treatment of depression using community-based intervention delivery. This approach may serve as a national model for expanding depression treatment for patients with T2DM. PMID:27500279

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2015-11-01

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

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

    PubMed Central

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

    2011-01-01

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

  7. A Unique Coplanar Multi-center Bonding Network in Doubly Acetylide-bridged Binuclear Zirconocene Complexes: A Density Functional Theory Study

    SciTech Connect

    Niu, Shuqiang; Derecskei-Kovacs, Agnes; Hall, Michael B.

    2007-10-01

    The research described in this product was performed in part in the Environmental Molecular Sciences Laboratory, a national scientific user facility sponsored by the Department of Energy's Office of Biological and Environmental Research and located at Pacific Northwest National Laboratory. A unique p-conjugative interaction pattern was experimentally revealed in the doubly acetylide-bridged binuclear group 4 metallocene complexes, which was involved in C–C coupling/cleavage reactions of acetylides and r-alkynyl migrations. To elucidate how this multicenter bonding network affects the structural and reaction properties of these complexes, density functional theory (DFT) calculations and molecular orbital (MO) analysis were carried out on the electronic structure and r-alkynyl migration mechanisms of the doubly acetylide-bridged binuclear Zr complexes, (L2Zr)2(l-C„CH)2 (L = Cp,Cl). The B3LYP calculations suggested that the doubly [r,p] acetylide-bridged complex C2h-(L2Zr)2(l-C„CH)2 was produced by the reaction of L2Zr(C„CH)2 with L2Zr through a C2v- (L2Zr)2(l-C„CH)2 intermediate followed by an isomerization process. In particular, the isomerization of C2h- or C2v-(L2Zr)2(l- C„CH)2 is almost thermoneutral through a low barrier of 15.3–17.0 kcal/mol. The MO Walsh diagram revealed that the two isomers have a very similar six-center-six-electron bonding network. The coplanar p-conjunctive interaction by the electron donating and backdonating interactions between the metal centers and acetylide ligands significantly stabilizes the doubly acetylide-bridged binuclear group 4 metallocene complexes and the isomerization transition state.

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

    PubMed

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

    2015-06-15

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

  9. 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

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

    PubMed Central

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

    2015-01-01

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

  11. Diverse spectrum of rare deafness genes underlies early-childhood hearing loss in Japanese patients: a cross-sectional, multi-center next-generation sequencing study

    PubMed Central

    2013-01-01

    Background Genetic tests for hereditary hearing loss inform clinical management of patients and can provide the first step in the development of therapeutics. However, comprehensive genetic tests for deafness genes by Sanger sequencing is extremely expensive and time-consuming. Next-generation sequencing (NGS) technology is advantageous for genetic diagnosis of heterogeneous diseases that involve numerous causative genes. Methods Genomic DNA samples from 58 subjects with hearing loss from 15 unrelated Japanese families were subjected to NGS to identify the genetic causes of hearing loss. Subjects did not have pathogenic GJB2 mutations (the gene most often associated with inherited hearing loss), mitochondrial m.1555A>G or 3243A>G mutations, enlarged vestibular aqueduct, or auditory neuropathy. Clinical features of subjects were obtained from medical records. Genomic DNA was subjected to a custom-designed SureSelect Target Enrichment System to capture coding exons and proximal flanking intronic sequences of 84 genes responsible for nonsyndromic or syndromic hearing loss, and DNA was sequenced by Illumina GAIIx (paired-end read). The sequences were mapped and quality-checked using the programs BWA, Novoalign, Picard, and GATK, and analyzed by Avadis NGS. Results Candidate genes were identified in 7 of the 15 families. These genes were ACTG1, DFNA5, POU4F3, SLC26A5, SIX1, MYO7A, CDH23, PCDH15, and USH2A, suggesting that a variety of genes underlie early-childhood hearing loss in Japanese patients. Mutations in Usher syndrome-related genes were detected in three families, including one double heterozygous mutation of CDH23 and PCDH15. Conclusion Targeted NGS analysis revealed a diverse spectrum of rare deafness genes in Japanese subjects and underscores implications for efficient genetic testing. PMID:24164807

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

    2012-01-01

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

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

    PubMed Central

    Ramezani, Gholamhossein; Valaie, Nasser; Rakhshan, Vahid

    2015-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2014-12-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Woelk, H; Schläfke, S

    2010-02-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-10-01

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

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

    PubMed Central

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

    2015-01-01

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

  5. Efficacy and safety of rituximab treatment in early primary Sjögren's syndrome: a prospective, multi-center, follow-up study

    PubMed Central

    2013-01-01

    Introduction Primary Sjögren’s syndrome (pSS) is an autoimmune disorder affecting exocrine glands; however, a subgroup of pSS patients experience systemic extra-glandular involvement leading to a worsening of disease prognosis. Current therapeutic options are mainly empiric and often translated by other autoimmune diseases. In the last few years growing evidence suggests that B-cell depletion by rituximab (RTX) is effective also in pSS. Patients with early active disease appear to be those who could benefit the most from RTX. The aim of this study was to investigate the efficacy and safety of RTX in comparison to disease modifying anti-rheumatic drugs (DMARDs) in early active pSS patients. Methods Forty-one patients with early pSS and active disease (EULAR Sjogren’s syndrome disease activity index, ESSDAI ≥ 6) were enrolled in the study. Patients were treated with either RTX or DMARDs in two different Rheumatology centers and followed up for 120 weeks. Clinical assessment was performed by ESSDAI every 12 weeks up to week 120 and by self-reported global disease activity pain, sicca symptoms and fatigue on visual analogic scales, unstimulated saliva flow and Schirmer’s I test at week 12, 24, 48, 72, 96, and 120. Laboratory assessment was performed every 12 weeks to week 120. Two labial minor salivary gland (MSG) biopsies were obtained from all patients at the time of inclusion in the study and at week 120. Results Our study demonstrated that RTX treatment results in a faster and more pronounced decrease of ESSDAI and other clinical parameters compared to DMARDs treatment. No adverse events were reported in the two groups. We also observed that RTX is able to reduce glandular infiltrate, interfere with B/T compartmentalization and consequently with the formation of ectopic lymphoid structures and germinal center-like structures in pSS-MSGs. Conclusions To our knowledge, this is the first study performed in a large cohort of early active pSS patients for a period of 120 weeks. We showed that RTX is a safe and effective agent to be employed in pSS patients with systemic, extra-glandular involvement. Furthermore, our data on pSS-MSGs provide additional biological basis to employ RTX in this disease. PMID:24286296

  6. Improving diabetes care: Multi-component CArdiovascular Disease Risk Reduction Strategies for People with Diabetes in South Asia - The CARRS Multi-center Translation Trial

    PubMed Central

    Shah, Seema; Singh, Kavita; Ali, Mohammed K.; Mohan, V.; Kadir, Muhammad Masood; Unnikrishnan, A.G.; Sahay, Rakesh Kumar; Varthakavi, Premlata; Dharmalingam, Mala; Viswanathan, Vijay; Masood, Qamar; Bantwal, Ganapathi; Khadgawat, Rajesh; Desai, Ankush; Sethi, Bipin Kumar; Shivashankar, Roopa; Ajay, Vamadevan S; Reddy, K. Srinath; Narayan, K.M. Venkat; Prabhakaran, Dorairaj; Tandon, Nikhil

    2012-01-01

    Aims Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in people with diabetes in South Asia. The CARRS translation trial tests the effectiveness, cost-effectiveness, and sustainability of a clinic-based multi-component CVD risk reduction intervention among people with diabetes in India and Pakistan. Methods We randomly assigned 1,146 adults with diabetes recruited from 10 urban clinic sites, to receive usual care by physicians or to receive an integrated multi-component CVD risk reduction intervention. The intervention involves electronic health record management, decision-support prompts to the healthcare team, and the support of a care coordinator to actively facilitate patient and provider adherence to evidence-based guidelines. The primary outcome is a composite of multiple CVD risk factor control (blood glucose and either blood pressure or cholesterol, or all three). Other outcomes include control of the individual CVD risk factors, process and patient-centered measures, cost-effectiveness, and acceptability/feasibility. Conclusion The CARRS translation trial tests a low-cost diabetes care delivery model in urban South Asia to achieve comprehensive cardio-metabolic disease case-management of high-risk patients (clinicaltrials.gov number: NCT01212328). PMID:23084280

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-08-01

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

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

    PubMed Central

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

    2005-01-01

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

  10. DNA image cytometry test for primary screening of esophageal cancer: a population-based multi-center study in high-risk areas in China

    PubMed Central

    Wang, Meng; Hao, Changqing; Ma, Qing; Song, Guohui; Ma, Shanrui; Zhao, Deli; Zhao, Lin; Li, Xinqing; Wei, Wenqiang

    2016-01-01

    Objective To evaluate the feasibility of DNA image cytometry (DNA-ICM) as a primary screening method for esophageal squamous cell cancer (ESCC). Methods A total of 5,382 local residents aged 40–69 years from three high-risk areas in China (Linzhou in Henan province, Feicheng in Shandong province and Cixian in Hebei province) from 2008 to 2011 were recruited in this population-based screening study. And 2,526 subjects declined to receive endoscopic biopsy examination with Lugol’s iodine staining, while 9 and 815 subjects were excluded from liquid-based cytology and DNA-ICM test respectively due to slide quality. Finally, 2,856, 5,373 and 4,567 subjects were enrolled in the analysis for endoscopic biopsy examination, liquid-based cytology and DNA-ICM test, respectively. Sensitivity (SE), specificity (SP), negative predictive values (NPV) and positive predictive values (PPV) as well as their 95% confidence intervals (95% CI) for DNA-ICM, liquid-based cytology and the combination of the two methods were calculated. Receiver operating characteristic (ROC) curves were applied to determine the cutoff point of DNA-ICM for esophageal cancer. Results DNA-ICM results were significantly correlative with esophageal cancer and precancer lesions (χ2=18.016, P<0.001). The cutoff points were 5,802, 5,803 and 8,002 based on dissimilar pathological types of low grade intraepithelial neoplasia (LGIN), high grade intraepithelial neoplasia (HGIN), and ESCC, respectively, and 5,803 was chosen in this study considering the SE and SP. The SE, SP, PPV, NPV of DNA-ICM test (cutoff point 5,803) combined with liquid-based cytology [threshold atypical squamous cells of undetermined significance (ASCUS)] were separately 72.1% (95% CI: 70.3%-73.9%), 43.3% (95% CI: 41.3%-45.3%), 22.8% (95% CI: 21.1%-24.5%) and 87.0% (95% CI: 85.7%-88.3%) for LGIN, 85.7% (95% CI: 84.3%-87.1%), 41.3% (95% CI: 39.3%-43.3%), 4.6% (95% CI: 3.8%-5.4%) and 98.9% (95% CI: 98.5%-99.3%) for HGIN, and 96.0% (95% CI: 95.2%-96.8%), 40.8% (95% CI: 38.8%-42.8%), 1.7% (95% CI: 1.2%-2.2%) and 99.9% (95% CI: 99.8%-100.0%) for ESCC. Conclusions It is possible to use DNA-ICM test as a primary screening method before endoscopic screening for esophageal cancer.

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

    PubMed

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

    1995-03-01

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

  12. Mechanism for limited 55 C storage performance of Li{sub 1.05}Mn{sub 1.95}O{sub 4} electrodes

    SciTech Connect

    Du Pasquier, A.; Blyr, A.; Courjal, P.; Larcher, D.; Gerand, B.; Amatucci, G.; Tarascon, J.M.

    1999-02-01

    A survey of the chemical stability of high-surface area LiMn{sub 2}O{sub 4} in various Li-based electrolytes was performed as a function of temperature. The evidence for an acidic-induced Mn dissolution was confirmed, but more importantly the authors identified, by means of combined infrared spectroscopy, thermogravimetric analysis, and X-ray diffraction measurements, the growth, upon storage of LiMn{sub 2}O{sub 4} in the electrolyte at 100 C, of a protonated {lambda}-MnO{sub 2} phase partially inactive with respect to lithium intercalation. This results sheds light on how the mechanism of high temperature irreversible capacity loss proceeds. Mn dissolution first occurs, leading to a deficient spinel having all the Mn in the +4 oxidation state. Once this composition is reached, Mn cannot be oxidized further, and a protonic ion-exchange reaction takes place at the expense of the delithiation reaction. The resulting protonated {lambda}-Mn{sub 2{minus}y}O{sub 4} phase has a reduced capacity with respect to lithium, thereby accounting for some of the irreversible capacity loss experienced at 55 C for such a material.

  13. All Globalization Is Local: Countervailing Forces and the Influence on Higher Education Markets. Research & Occasional Paper Series: CSHE.1.05

    ERIC Educational Resources Information Center

    Douglass, John Aubrey

    2005-01-01

    Globalization trends and innovations in the instructional technologies are widely believed to be creating new markets and forcing a revolution in higher education. Much of the rhetoric of globalists has presented a simplistic analysis of a paradigm shift in higher education markets and the way nations and institutions deliver educational services.…

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

    PubMed

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

    1995-03-01

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

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

    PubMed Central

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

    2014-01-01

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

  16. A phase 2 multi-center, open-label, switch-over trial to evaluate the safety and efficacy of Abcertin® in patients with type 1 Gaucher disease.

    PubMed

    Choi, Jin-Ho; Lee, Beom Hee; Ko, Jung Min; Sohn, Young Bae; Lee, Jin-Sung; Kim, Gu-Hwan; Heo, Sun Hee; Park, June-Young; Kim, Yoo-Mi; Kim, Ja-Hye; Yoo, Han-Wook

    2015-04-01

    Gaucher disease is a lysosomal storage disease for which enzyme replacement therapy has proven to be effective. A switch-over clinical trial was performed to evaluate the efficacy and safety of Abcertin® (ISU Abxis, Seoul, Korea) in subjects with type 1 Gaucher disease who were previously treated with imiglucerase. Five Korean patients with type 1 Gaucher disease were enrolled. Previous doses of imiglucerase ranged from 30 to 55 U/kg every other week. The same dose of Abcertin® was administered to all patients for 24 weeks. Primary efficacy endpoints were changes in hemoglobin levels and platelet counts, and the secondary efficacy endpoints included changes in liver and spleen volumes, serum biomarkers, skeletal status and bone mineral density (BMD). During the study period, no statistically significant changes were observed in all parameters including hemoglobin levels and platelet counts, liver and spleen volumes, skeletal status and BMD. Abcertin® administration was continued in three patients for another 24 weeks as an extension of the study. Hemoglobin levels and platelet counts were maintained in all three patients. In conclusion, the efficacy and safety of Abcertin® are similar to those of imiglucerase, and Abcertin® is an effective therapeutic agent for patients with type 1 Gaucher disease (Clinical Trial Registry No. NCT02053896 at www.clinicaltrials.gov). PMID:25829804

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

    PubMed Central

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

    2016-01-01

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

  18. Should I stay or should I go? Understanding families’ decisions regarding initiating, continuing, and terminating health services for managing pediatric obesity: the protocol for a multi-center, qualitative study

    PubMed Central

    2012-01-01

    Background At least two million Canadian children meet established criteria for weight management. Due to the adverse health consequences of obesity, most pediatric weight management research has examined the efficacy and effectiveness of interventions to improve lifestyle behaviors, reduce co-morbidities, and enable weight management. However, little information is available on families’ decisions to initiate, continue, and terminate weight management care. This is an important knowledge gap since a substantial number of families fail to initiate care after being referred for weight management while many families who initiate care discontinue it after a brief period of time. This research aims to understand the interplay between individual, family, environmental, and systemic factors that influence families’ decisions regarding the management of pediatric obesity. Methods/Design Individual interviews will be conducted with children and youth with obesity (n = 100) and their parents (n = 100) for a total number of 200 interviews with 100 families. Families will be recruited from four Canadian multi-disciplinary pediatric weight management centers in Vancouver, Edmonton, Hamilton, and Montreal. Participants will be purposefully-sampled into the following groups: (i) Non-Initiators (5 families/site): referred for weight management within the past 6 months and did not follow-up the referral; (ii) Initiators (10 families/site): referred for weight management within the past 6 months and did follow-up the referral with at least one clinic appointment; and (iii) Continuers (10 families/site): participated in a formal weight management intervention within the past 12 months and did continue with follow-up care for at least 6 months. Interviews will be digitally recorded and analyzed using an ecological framework, which will enable a multi-level evaluation of proximal and distal factors that underlie families’ decisions regarding initiation, continuation, and termination of care. Demographic and anthropometric/clinical data will also be collected. Discussion A better understanding of family involvement in pediatric weight management care will help to improve existing health services in this area. Study data will be used in future research to develop a validated survey that clinicians working in pediatric obesity management can use to understand and enhance their own health services delivery. PMID:23276163

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

    PubMed Central

    2013-01-01

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

  20. Low-dose Total Body Irradiation and Fludarabine Conditioning for HLA-Class I Mismatched Donor Stem Cell Transplantation and Immunological Recovery in Patients with Hematological Malignancies: A Multi-Center Trial

    PubMed Central

    Nakamae, Hirohisa; Storer, Barry E.; Storb, Rainer; Storek, Jan; Chauncey, Thomas R.; Pulsipher, Michael; Petersen, Finn B.; Wade, James C.; Maris, Michael B.; Bruno, Benedetto; Panse, Jens; Petersdorf, Effie; Woolfrey, Ann; Maloney, David G.; Sandmaier, Brenda M.

    2009-01-01

    HLA-mismatched grafts are a viable alternative source for patients without HLA-matched donors receiving ablative hematopoietic cell transplantation (HCT), though their use in reduced intensity or nonmyeloablative conditioning HCT has been not well established. Here we extended HCT to recipients of HLA-class I mismatched grafts to test whether nonmyeloablative conditioning can establish stable donor engraftment. Fifty-nine patients were conditioned with fludarabine 90 mg/m2 and 2 Gy total body irradiation (TBI) followed by immunosuppression with cyclosporine 5.0 mg/kg twice and mycophenolate mofetil 15 mg/kg three times daily for transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood cells from related (n=5) or unrelated donors (n=54) with one antigen ± one allele HLA-class I mismatch or two HLA-class I allele mismatches. Sustained donor engraftment was observed in 95% of evaluable patients. The incidences of grades II to IV acute and extensive chronic graft-versus-host disease were 69% and 41%, respectively. The cumulative probability of non-relapse mortality was 47% at 2 years. Two-year overall and progression-free survivals were 29% and 28%, respectively. Nonmyeloablative conditioning with fludarabine and low-dose TBI followed by HCT using HLA-class I mismatched donors leads to successful engraftment and long-term survival; however, the high incidence of acute GVHD and NRM needs to be addressed by alternate GVHD prophylaxis regimens. PMID:19900571

  1. The efficacy and safety of bupropion sustained-release formulation for the treatment of major depressive disorder: a multi-center, randomized, double-blind, placebo-controlled study in Asian patients.

    PubMed

    Koshino, Yoshifumi; Bahk, Won-Myong; Sakai, Hideaki; Kobayashi, Takayuki

    2013-01-01

    This study was conducted to compare the efficacy and safety of bupropion sustained-release (SR) formulation orally administered at daily doses of 150 mg/day (once daily) and 300 mg/day (150 mg twice daily) for 8 weeks versus placebo in Asian patients with major depressive disorder. The mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8 was compared between each of the bupropion SR dose groups and the placebo group using an analysis of covariance with the multiplicity adjustment by Dunnett's step-down procedure. A total of 569 subjects met all of the inclusion criteria and proceeded to the treatment phase. The subjects proceeding to the treatment phase included 454 Japanese patients and 115 Korean patients. There was no statistically significant difference between each of the bupropion SR dose groups and the placebo group in the primary efficacy endpoint of change from baseline in MADRS total score at week 8. Similar results were generally obtained for all of the secondary efficacy endpoints. The secondary analysis and the other subgroup analysis did not show a statistically significant difference in efficacy. There was no substantial difference in the type, severity, and incidence of adverse events (AEs) between the bupropion SR dose groups and the placebo group, which indicates a favorable safety profile for bupropion SR. There were no significant findings in subjects treated with bupropion SR in regard to sexual dysfunction, weight change, and withdrawal syndrome, which are frequently recognized as clinical concerns associated with selective serotonin reuptake inhibitors, widely used for the treatment of depression.

  2. Perception of barriers to postoperative pain management in elderly patients in Polish hospitals with and without a “Hospital Without Pain” Certificate – a multi-center study

    PubMed Central

    Dąbrowski, Sebastian; Basiński, Andrzej; Pilch, Dorota

    2015-01-01

    Introduction In 2005–2050, the global population of elderly people will increase by 12%. This will lead to increased demand for such healthcare services as hospital care or surgical interventions. Pain in elderly patients is a substantial problem. Insufficiently controlled postoperative pain continues to be a widespread phenomenon. Pain management in Poland is usually based on nursing care supervised by an anesthesiologist or surgeon. The aim of the study was to identify barriers to effective nurse-controlled analgesia in postoperative pain management in elderly patients in hospitals with and without a Hospital Without Pain certificate. Material and methods The study was conducted after the approval of the study protocol by the Independent Bioethics Committee for Scientific Research of the Medical University of Gdansk. The study project was multicenter and was conducted from July 2012 to December 2013. The research was questionnaire-based and used the Polish version of the Nurses’ Perceived Obstacles to Pain Assessment and Management Practices questionnaire. The project included 676 nurses from hospitals awarded the Hospital Without Pain Certificate and 926 respondents from hospitals without the certificate. Results After calculating the overall average result in particular groups, healthcare system-related problems were first among the barriers hindering pain management in elderly patients M = (C = 3.81, N/C = 3.87). Patient-related barriers were second (M = 3.77). Physician- and nurse-related barriers took the subsequent positions, with very similar scores M = (C = 3.47, N/C = 3.44) and M = (C = 3.46, N/C = 3.44), respectively. Conclusions The greatest barriers to pain management in elderly patients are related to the healthcare system. Nurses from Hospital Without Pain certified hospitals devoted significantly more time to relieving pain through non-pharmacological methods. PMID:27478463

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2013-01-01

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

  5. A Cancer and Leukemia Group B multi-center study of DA-EPOCH-rituximab in untreated diffuse large B-cell lymphoma with analysis of outcome by molecular subtype

    PubMed Central

    Wilson, Wyndham H.; Jung, Sin-Ho; Porcu, Pierluigi; Hurd, David; Johnson, Jeffrey; Martin, S. Eric; Czuczman, Myron; Lai, Raymond; Said, Jonathan; Chadburn, Amy; Jones, Dan; Dunleavy, Kieron; Canellos, George; Zelenetz, Andrew D.; Cheson, Bruce D.; Hsi, Eric D.

    2012-01-01

    Background A phase II trial of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (DA-EPOCH-R) from the National Cancer Institute showed promising activity in untreated diffuse large B-cell lymphoma. The Cancer and Leukemia Group B conducted a study to determine if these results could be reproduced in a multi-institutional setting. Design and Methods The study included 69 patients with untreated diffuse large B-cell lymphoma at least 18 years of age and at least stage II. Radiaton therapy was not permitted on study. Median age was 58 years (range 23–83) and 40% had high-intermediate or high International Prognostic Index risk. Immunohistochemical biomarkers for cell of origin and proliferation were performed. Results With a median follow up of 62 months, time to progression and overall survival were 81% and 84%, respectively, and time to progression was 87%, 92% and 54% for low/low-intermediate, high-intermediate and high International Prognostic Index risk groups, respectively, at 5-years and beyond. The time to progression and event-free survival of germinal center B-cell lymphoma were 100% and 94%, respectively, and non-germinal center B-cell GCB diffuse large B-cell lymphoma were 67% and 58%, respectively, at 62 months (germinal center vs. non-germinal center B cell P=0.008). DA-EPOCH-R was tolerated without significant grade 4 non-hematologic toxicities. Conclusions These results provide the first confirmation by a multi-institutional group that DA-EPOCH-R provides high durable remissions in diffuse large B-cell lymphoma and is effective in both germinal center and non-germinal center B-cell subtypes. The trial was registered at ClinicalTrials.Gov (NCT00032019). PMID:22133772

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

    PubMed Central

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

    2016-01-01

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

  7. Efficacy of a dopamine-somatostatin chimeric molecule, BIM-23A760, in the control of cell growth from primary cultures of human non-functioning pituitary adenomas: a multi-center study.

    PubMed

    Florio, Tullio; Barbieri, Federica; Spaziante, Renato; Zona, Gianluigi; Hofland, Leo J; van Koetsveld, Peter M; Feelders, Richard A; Stalla, Günter K; Theodoropoulou, Marily; Culler, Michael D; Dong, Jesse; Taylor, John E; Moreau, Jacques-Pierre; Saveanu, Alexandru; Gunz, Ginette; Dufour, Henry; Jaquet, Philippe

    2008-06-01

    Dopamine D2 and somatostatin receptors (sstrs) were reported to affect non-functioning pituitary adenoma (NFPA) proliferation in vitro. However, the reported results differ according to the experimental conditions used. We established an experimental protocol allowing reproducible evaluation of NFPA cell proliferation in vitro, to test and compare the antiproliferative effects of dopamine and somatostatin analogs (alone or in combination) with the activity of the dopamine-somatostatin chimeric molecule BIM-23A760. The protocol was utilized by four independent laboratories, studying 38 fibroblast-deprived NFPA cell cultures. Cells were characterized for GH, POMC, sstr1-sstr5, total dopamine D2 receptor (D2R) (in all cases), and D2 receptor long and short isoforms (in 15 out of 38 cases) mRNA expression and for alpha-subunit, LH, and FSH release. D2R, sstr3, and sstr2 mRNAs were consistently observed, with the dominant expression of D2R (2.9+/-2.6 copy/copy beta-glucuronidase; mean+/-s.e.m.), when compared with sstr3 and sstr2 (0.6+/-1.0 and 0.3+/-0.6 respectively). BIM-23A760, a molecule with high affinity for D2R and sstr2, significantly inhibited [3H]thymidine incorporation in 23 out of 38 (60%) NFPA cultures (EC50=1.2 pM and Emax=-33.6+/-3.7%). BIM-23A760 effects were similar to those induced by the selective D2R agonist cabergoline that showed a statistically significant inhibition in 18 out of 27 tumors (compared with a significant inhibition obtained in 17 out of 27 tumors using BIM-23A760, in the same subgroup of adenomas analyzed), while octreotide was effective in 13 out of 27 cases. In conclusion, superimposable data generated in four independent laboratories using a standardized protocol demonstrate that, in vitro, chimeric dopamine/sstr agonists are effective in inhibiting cell proliferation in two-thirds of NFPAs. PMID:18509006

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

    2011-01-01

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

  10. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial

    PubMed Central

    Mao, Ying; Yao, Yu; Zhang, Li-Wei; Lu, Yi-Cheng; Chen, Zhong-Ping; Zhang, Jian-Min; Qi, Song-Tao; You, Chao; Wang, Ren-Zhi; Yang, Shu-Yuan; Zhang, Xiang; Wang, Ji-Sheng; Chen, Ju-Xiang; Yang, Qun-Ying; Shen, Hong; Li, Zhi-Yong; Wang, Xiang; Ma, Wen-Bin; Yang, Xue-Jun; Zhen, Hai-Ning; Zhou, Liang-Fu

    2015-01-01

    Background: The radiochemotherapy regimen concomitantly employing temozolomide (TMZ) chemotherapy and radiotherapy (RT) 4 weeks after surgery, followed by 6 cycles of TMZ is a common treatment for glioblastoma (GBM). However, its median overall survival (OS) is only 14.6 months. This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Methods: A randomized, parallel group, open-label study of 99 newly diagnosed GBM patients was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide (early TMZ group) or standard concomitant radiochemotherapy regimen (control group). Overall response was assessed based on objective tumor assessments, administration of corticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event (AE), and neurological condition were measured for 24 months of follow-up. The primary efficacy endpoint of this study was overall survival (OS). The secondary endpoint was progression free survival (PFS). Results: The median OS time in the early TMZ group was 17.6 months, compared with 13.2 months in the control group (log-rank test P = 0.021). In addition, the OS rate in the early TMZ group was higher at 6, 12, and 18 months than in the control group, respectively (P < 0.05). The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group (log-rank test P = 0.695). AEs occurred in 29 (55.8%) and 31(73.8%) patients respectively in early and control groups, including nausea (15.4% vs. 33.3%), vomiting (7.7% vs. 28.6%), fever (7.7% vs. 11.9%), and headache (3.8% vs. 23.8%). Only 30.8% and 33.3% were drug-related, respectively. Conclusions: Addition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen was well tolerated and significantly improved the OS of the GBM patients, compared with standard concomitant radiochemotherapy regimen. However, a larger randomized trial is warranted to verify these results. PMID:26481741

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2016-07-01

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

  14. A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women

    ClinicalTrials.gov

    2015-03-18

    BACTERIAL VAGINOSIS; Signs and Symptoms to be Evaluated and Recorded Include:; Vaginal Discharge: Color, Odor, and Consistency;; Vulvovaginal Itching and Irritation (Subjective): Absent, Mild, Moderate, or Severe; Vulvovaginal Inflammation (Objective): Absent, Mild, Moderate, or Severe.

  15. Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. Methods/Design The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. Discussion It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. Trial registration Clinical trials gov. number: NCT01117662 PMID:23101480

  16. Knowledge of A1c Predicts Diabetes Self-Management and A1c Level among Chinese Patients with Type 2 Diabetes.

    PubMed

    Yang, Shengnan; Kong, Weimin; Hsue, Cunyi; Fish, Anne F; Chen, Yufeng; Guo, Xiaohui; Lou, Qingqing; Anderson, Robert

    2016-01-01

    This study was to identify current A1c understanding status among Chinese patients with type 2 diabetes, assess if knowledge of A1c affects their diabetes self-management and their glycemic control and recognize the factors influencing knowledge of A1c among patients with type 2 diabetes. A multi-center, cross-sectional survey was conducted between April and July 2010 in 50 medical centers in the Mainland China. Participants were recruited from inpatients and outpatients who were admitted to or visited those medical centers. The survey included core questions about their demographic characteristics, diabetes self-management behavior, and A1c knowledge. Overall, of 5957 patients, the percentage of patients with good understanding was 25.3%. In the multivariable logistic regression model, the variables related to the knowledge of A1c status are presented. We discovered that patients with longer diabetes duration (OR = 1.05; 95%CI = 1.04-1.06) and having received diabetes education (OR = 1.80; 95%CI = 1.49-2.17) were overrepresented in the good understanding of A1c group. In addition, compared to no education level, higher education level was statistically associated with good understanding of A1c (P<0.001). The percentage of patients with good understanding varied from region to region (P<0.001), with Eastern being highest (OR = 1.54; 95%CI = 1.32-1.80), followed by Central (OR = 1.25; 95%CI = 1.02-1.53), when referring to Western. Only a minority of patients with type 2 diabetes in China understood their A1c value. The patients who had a good understanding of their A1c demonstrated significantly better diabetes self-management behavior and had lower A1c levels than those who did not.

  17. Serum Estradiol Levels Are Not Associated with Urinary Incontinence in Mid-life Women Transitioning through Menopause

    PubMed Central

    Waetjen, L. Elaine; Johnson, Wesley O.; Xing, Guibo; Feng, Wen-Ying; Greendale, Gail A.; Gold, Ellen B.

    2012-01-01

    Objective We evaluated the relationship between annually measured serum endogenous estradiol and the development or worsening of stress and urge incontinence symptoms over 8 years in women transitioning through menopause. Methods This is a longitudinal analysis of women with incontinence in the Study of Women’s Health Across the Nation (SWAN), a multi-center, multi-racial/ethnic prospective cohort study of community-dwelling women transitioning through menopause. At baseline and each of 8 annual visits, SWAN elicited frequency and type of incontinence in a self-administered questionnaire and drew a blood sample on days 2-5 of the menstrual cycle. All endocrine assays were performed using a double-antibody chemiluminescent immunoassay. We analyzed data using discrete Cox survival models and generalized estimating equations with time dependent covariates. Results Estradiol levels drawn at either the annual visit concurrent with or previous to the first report of incontinence were not associated with the development of any (hazard ratio (HR) = 0.99, 95% CI 0.99, 1.01), stress, or urge incontinence in previously continent women. Similarly, estradiol levels were not associated with worsening of any (odds ratio (OR) = 1.00, 95% CI 0.99, 1.01), stress, or urge incontinence in incontinent women. Change in estradiol levels from one year to the next was also not associated with the development (HR = 0.98, 95% confidence interval 0.97, 1.00) or worsening (OR = 1.03, 95% CI 0.99, 1.05) of incontinence. Conclusions We found that annually measured values and year-to-year changes in endogenous estradiol levels had no effect on the development or worsening of incontinence in women transitioning through menopause. PMID:21785372

  18. Special Section: Colorectal Cancer Symptoms, Diagnosis and Treatment

    MedlinePlus

    ... ACRIN trial, sponsored by NCI, is the largest multi-center study to compare the accuracy of state-of-the-art CT colonography to the gold standard of conventional colonoscopy. Questions to Ask Your Doctor ...

  19. Hydrocephalus

    MedlinePlus

    ... or developmental disorders (such as those associated with neural tube defects including spina bifida and encephalocele). Other ... and abnormal brain development. The Hydrocephalus Clinical Research Network (HCRN, www.hcrn.org ) is a multi-center ...

  20. Radiosurgery

    MedlinePlus

    ... studies have been done, to date, not one randomized prospective study has been completed. Irrefutable evidence does ... Knife may be most suited. Until a definitive, randomized, multi-centered prospective study is completed, radiosurgery as ...

  1. ALHAT Integration and Testing

    NASA Video Gallery

    Autonomous Landing and Hazard Avoidance Technology (ALHAT) project integration and testing takes place at NASA Langley Research Center. The ALHAT project is a multi-center initiative to enable vari...

  2. Comprehensive Oncologic Emergencies Research Network (CONCERN)

    Cancer.gov

    The Comprehensive Oncologic Emergencies Research Network (CONCERN) was established in March 2015 with the goal to accelerate knowledge generation, synthesis and translation of oncologic emergency medicine research through multi-center collaborations.

  3. Brain Tumor Epidemiology Consortium (BTEC)

    Cancer.gov

    The Brain Tumor Epidemiology Consortium is an open scientific forum organized to foster the development of multi-center, international and inter-disciplinary collaborations that will lead to a better understanding of the etiology, outcomes, and prevention of brain tumors.

  4. Diagnostic challenge of gastrointestinal tuberculosis: a report of 34 cases and an overview of the literature.

    PubMed

    Radzi, Muhammad; Rihan, Nik; Vijayalakshmi, Natesan; Pani, Subhada Prasad

    2009-05-01

    We report 34 cases of gastrointestinal TB from Malaysia and present an overview of the diagnostic challenges. A concerted effort is necessary to improve the existing diagnostic methods, and develop and evaluate newer diagnostic tools through well designed multi-center studies. PMID:19842436

  5. NASA Ares I Crew Launch Vehicle Upper Stage Overview

    NASA Technical Reports Server (NTRS)

    Davusm Daniel J.; McArthur, J. Craig

    2008-01-01

    By incorporating rigorous engineering practices, innovative manufacturing processes and test techniques, a unique multi-center government/contractor partnership, and a clean-sheet design developed around the primary requirements for the International Space Station (ISS) and Lunar missions, the Upper Stage Element of NASA's Crew Launch Vehicle (CLV), the "Ares I," is a vital part of the Constellation Program's transportation system.

  6. OVERALL PROCEDURES PROTOCOL AND PATIENT ENROLLMENT PROTOCOL: TESTING FEASIBILITY OF 3D ULTRASOUND DATA ACQUISITION AND RELIABILITY OF DATA RETRIEVAL FROM STORED 3D IMAGES

    EPA Science Inventory

    The purpose of this study is to examine the feasibility of collecting, transmitting,

    and analyzing 3-D ultrasound data in the context of a multi-center study of pregnant

    women. The study will also examine the reliability of measurements obtained from 3-D

    imag...

  7. 76 FR 63933 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney... Kidney Diseases Special Emphasis Panel; NIDDK Multi-Center Clinical Study Cooperative Agreement (U01...; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)...

  8. Identifying Loci for the Overlap between Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder Using a Genome-Wide QTL Linkage Approach

    ERIC Educational Resources Information Center

    Nijmeijer, Judith S.; Arias-Vasquez, Alejandro; Rommelse, Nanda N. J.; Altink, Marieke E.; Anney, Richard J. L.; Asherson, Philip; Banaschewski, Tobias; Buschgens, Cathelijne J. M.; Fliers, Ellen A.; Gill, Michael; Minderaa, Ruud B.; Poustka, Luise; Sergeant, Joseph A.; Buitelaar, Jan K.; Franke, Barbara; Ebstein, Richard P.; Miranda, Ana; Mulas, Fernando; Oades, Robert D.; Roeyers, Herbert; Rothenberger, Aribert; Sonuga-Barke, Edmund J. S.; Steinhausen, Hans-Christoph; Faraone, Stephen V.; Hartman, Catharina A.; Hoekstra, Pieter J.

    2010-01-01

    Objective: The genetic basis for autism spectrum disorder (ASD) symptoms in children with attention-deficit/hyperactivity disorder (ADHD) was addressed using a genome-wide linkage approach. Method: Participants of the International Multi-Center ADHD Genetics study comprising 1,143 probands with ADHD and 1,453 siblings were analyzed. The total and…

  9. 77 FR 7167 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... Kidney Diseases Special Emphasis Panel Multi-Center Study of Tamsulosin for Ureteral Stones in the... of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Collaborative Interdisciplinary...@niddk.nih.gov . Name of Committee: National Institute of Diabetes and Digestive and Kidney...

  10. Occupation Attributes Relate to Location of Atrophy in Frontotemporal Lobar Degeneration

    ERIC Educational Resources Information Center

    Spreng, R. N.; Rosen, H. J.; Strother, S.; Chow, T. W.; Diehl-Schmid, J.; Freedman, M.; Graff-Radford, N. R.; Hodges, J. R.; Lipton, A. M.; Mendez, M. F.; Morelli, S. A.; Black, S. E.; Miller, B. L.; Levine, Brian

    2010-01-01

    Frontotemporal lobar degeneration (FTLD) often presents with asymmetric atrophy. We assessed whether premorbid occupations in FTLD patients were associated with these hemispheric asymmetries. In a multi-center chart review of 588 patients, occupation information was related to location of tissue loss or dysfunction. Patients with atrophy…

  11. FINAL INTERIM REPORT, CANDIDATE SITES, MACHINES IN USE, DATA STORAGE AND TRANSMISSION METHODS: TESTING FEASIBILITY OF 3D ULTRASOUND DATA ACQUISITION AND RELIABILITY OF DATA RETRIEVAL FROM STORED 3D IMAGES

    EPA Science Inventory

    The purpose of this Work Assignment, 02-03, is to examine the feasibility of collecting transmitting, and analyzing 3-D ultrasound data in the context of a multi-center study of pregnant women. The study will also examine the reliability of measurements obtained from 3-D images< ...

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  13. Process evaluation results from the HEALTHY nutrition intervention to modify the total school food environment

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The process evaluation of HEALTHY, a large multi-center trial to decrease type 2 diabetes mellitus in middle school children, monitored the implementation of the intervention to ascertain the extent that components were delivered and received as intended. The purpose of this article is to report the...

  14. Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial (OPUS [TIMI-16]).

    PubMed

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

    2007-01-01

    We sought to validate an automated outcomes surveillance system (DELTA) using OPUS (TIMI-16), a multi-center randomized, controlled trial that was stopped early due to elevated mortality in one of the two intervention arms. Methodologies that were incorporated into the application (Statistical Process Control [SPC] and Bayesian Updating Statistics [BUS]) were compared with standard Data Safety Monitoring Board (DSMB) protocols. PMID:18694141

  15. An Exploration of Radiation Physics in Electromagnetics

    NASA Technical Reports Server (NTRS)

    Lee, Katherine K.

    2005-01-01

    Contents include the following: NASA's Missions and Aeronautics Research. Today's Air Traffic Control System. Development of Decision-Support Tools. The Center-TRACON Automation System (CTAS). The Traffic Management Advisor (TMA). The Multi-Center Traffic Management Advisor (McTMA). The Surface Management System (SMS). Future Directions: The Joint Planning and Development Office.

  16. 77 FR 54582 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-05

    ... Crohn's Disease. Date: September 27, 2012. Time: 2 p.m. to 3 p.m. Agenda: To review and evaluate grant... Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as... Kidney Diseases Special Emphasis Panel, Multi-Center Clinical Trial Review. Date: September 14,...

  17. Plasma 25-hydroxyvitamin D and progression to diabetes in patients at risk for diabetes: an ancillary analysis in the diabetes prevention program

    Technology Transfer Automated Retrieval System (TEKTRAN)

    We investigated the association between vitamin D status, assessed by plasma 25-hydroxyvitamin D, and risk of incident diabetes. The research design and methods were a prospective observational study with a mean follow-up of 2.7 years in the Diabetes Prevention Program (DPP), a multi-center trial co...

  18. Non-BPS multi-bubble microstate geometries

    NASA Astrophysics Data System (ADS)

    Bena, Iosif; Bossard, Guillaume; Katmadas, Stefanos; Turton, David

    2016-02-01

    We construct the first smooth horizonless supergravity solutions that have two topologically-nontrivial three-cycles supported by flux, and that have the same mass and charges as a non-extremal D1-D5-P black hole. Our configurations are solutions to six-dimensional ungauged supergravity coupled to a tensor multiplet, and uplift to solutions of Type IIB supergravity. The solutions represent multi-center generalizations of the non-BPS solutions of Jejjala, Madden, Ross, and Titchener, which have over-rotating angular momenta. By adding an additional Gibbons-Hawking center, we succeed in lowering one of the two angular momenta below the cosmic censorship bound, and bringing the other very close to this bound. Our results demonstrate that it is possible to construct multi-center horizonless solutions corresponding to non-extremal black holes, and offer the prospect of ultimately establishing that finite-temperature black holes have nontrivial structure at the horizon.

  19. IND Regulatory & Manufacturing Resources - Cancer Imaging Program

    Cancer.gov

    The Cancer Imaging Program has been creating Investigational New Drug Applications (IND) for imaging agents in order to engage in multi-center clinical trials of these materials. A subset of the documents filed is being made available to the research community to implement routine synthesis of tracers at their own facilities and to assist investigators with the filing of their own INDs. The first of these document sets is for F-18 fluorothymidine (FLT).

  20. NASA Ares I Crew Launch Vehicle Upper State Overview

    NASA Technical Reports Server (NTRS)

    Davis, Daniel J.

    2008-01-01

    By incorporating rigorous engineering practices, innovative manufacturing processes and test techniques, a unique multi-center government/contractor partnership, and a clean-sheet design developed around the primary requirements for the International Space Station (ISS) and Lunar missions, the Upper Stage Element of NASA s Crew Launch Vehicle (CLV), the "Ares I," is a vital part of the Constellation Program s transportation system.

  1. ALHAT: Autonomous Landing and Hazard Avoidance Technology

    NASA Technical Reports Server (NTRS)

    Robertson, Edward A.; Carson, John M., III

    2015-01-01

    The ALHAT project was chartered by NASA HQ in 2006 to develop and mature to TRL 6 an autonomous lunar landing GN&C and sensing system for crewed, cargo, and robotic planetary landing vehicles. The multi-center ALHAT team was tasked with providing a system capable of identifying and avoiding surface hazards in real time to enable safe precision landing to within tens of meters of a designated planetary landing site under any lighting conditions.

  2. Design of reflectance confocal microscopes for clinical applications

    NASA Astrophysics Data System (ADS)

    Zavislan, James M.

    2009-02-01

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

  3. A new frontier for an old drug? A word of caution for beta-blockers in sepsis!

    PubMed

    Maybauer, Marc O; Maybauer, Dirk M

    2015-01-01

    Recent promising findings indicate a possible benefit of β-blockade in septic patients. Ongoing trials on esmolol in septic shock are investigating its hemodynamic effects, focusing on heart rate control and echocardiographic changes, as well as potential anti-inflammatory effects. However, given the complex physiology of sepsis and pharmacological effects on β-blockade, large multi-center trials are essential before such a therapy may be applied safely. PMID:26296157

  4. Monitoring burst suppression in critically ill patients: Multi-centric evaluation of a novel method

    PubMed Central

    Fürbass, Franz; Herta, Johannes; Koren, Johannes; Westover, M. Brandon; Hartmann, Manfred M.; Gruber, Andreas; Baumgartner, Christoph; Kluge, Tilmann

    2016-01-01

    Objective To develop a computational method to detect and quantify burst suppression patterns (BSP) in the EEGs of critical care patients. A multi-center validation study was performed to assess the detection performance of the method. Methods The fully automatic method scans the EEG for discontinuous patterns and shows detected BSP and quantitative information on a trending display in real-time. The method is designed to work without setting any patient specific parameters and to be insensitive to EEG artifacts and periodic patterns. For validation a total of 3982 h of EEG from 88 patients were analyzed from three centers. Each EEG was annotated by two reviewers to assess the detection performance and the inter-rater agreement. Results Average inter-rater agreement between pairs of reviewers was κ = 0.69. On average 22% of the review segments included BSP. An average sensitivity of 90% and a specificity of 84% were measured on the consensus annotations of two reviewers. More than 95% of the periodic patterns in the EEGs were correctly suppressed. Conclusion A fully automatic method to detect burst suppression patterns was assessed in a multi-center study. The method showed high sensitivity and specificity. Significance Clinically applicable burst suppression detection method validated in a large multi-center study. PMID:26971487

  5. Habitat Demonstration Unit Project Leadership and Management Strategies

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project management team that put in place the key multi-center leadership skills and

  6. Habitat Demonstration Unit Project: Leadership and Management Strategies for a Rapid Prototyping Project

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Toup, Larry; Gill, Tracy; Tri, Terry; Howe, Scott; Smitherman, David

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies being used by the NASA HDU team for a rapid prototyping project. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team rapid prototyping approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project

  7. Swarm Intelligence for Urban Dynamics Modelling

    NASA Astrophysics Data System (ADS)

    Ghnemat, Rawan; Bertelle, Cyrille; Duchamp, Gérard H. E.

    2009-04-01

    In this paper, we propose swarm intelligence algorithms to deal with dynamical and spatial organization emergence. The goal is to model and simulate the developement of spatial centers using multi-criteria. We combine a decentralized approach based on emergent clustering mixed with spatial constraints or attractions. We propose an extension of the ant nest building algorithm with multi-center and adaptive process. Typically, this model is suitable to analyse and simulate urban dynamics like gentrification or the dynamics of the cultural equipment in urban area.

  8. NASA Workshop on Hybrid (Mixed-Actuator) Spacecraft Attitude Control

    NASA Technical Reports Server (NTRS)

    Dennehy, Cornelius J.; Kunz, Nans

    2014-01-01

    At the request of the Science Mission Directorate Chief Engineer, the NASA Technical Fellow for Guidance, Navigation & Control assembled and facilitated a workshop on Spacecraft Hybrid Attitude Control. This multi-Center, academic, and industry workshop, sponsored by the NASA Engineering and Safety Center (NESC), was held in April 2013 to unite nationwide experts to present and discuss the various innovative solutions, techniques, and lessons learned regarding the development and implementation of the various hybrid attitude control system solutions investigated or implemented. This report attempts to document these key lessons learned with the 16 findings and 9 NESC recommendations.

  9. Swarm Intelligence for Urban Dynamics Modelling

    SciTech Connect

    Ghnemat, Rawan; Bertelle, Cyrille; Duchamp, Gerard H. E.

    2009-04-16

    In this paper, we propose swarm intelligence algorithms to deal with dynamical and spatial organization emergence. The goal is to model and simulate the developement of spatial centers using multi-criteria. We combine a decentralized approach based on emergent clustering mixed with spatial constraints or attractions. We propose an extension of the ant nest building algorithm with multi-center and adaptive process. Typically, this model is suitable to analyse and simulate urban dynamics like gentrification or the dynamics of the cultural equipment in urban area.

  10. Solid organ transplants in HIV-infected patients.

    PubMed

    Harbell, Jack; Terrault, Norah A; Stock, Peter

    2013-09-01

    There is a growing need for kidney and liver transplants in persons living with HIV. Fortunately, with the significant advances in antiretroviral therapy and management of opportunistic infections, HIV infection is no longer an absolute contraindication for solid organ transplantation. Data from several large prospective multi-center cohort studies have shown that solid organ transplantation in carefully selected HIV-infected individuals is safe. However, significant challenges have been identified including prevention of acute rejection, management of drug-drug interactions and treatment of recurrent viral hepatitis. This article reviews the selection criteria, outcomes, and special management considerations for HIV-infected patients undergoing liver or kidney transplantation.

  11. Prevention of stricture recurrence following urethral internal urethrotomy: routine repeated dilations or active surveillance?

    PubMed

    Tian, Ye; Wazir, Romel; Wang, Jianzhong; Wang, Kunjie; Li, Hong

    2016-01-01

    Strictures of the urethra are the most common cause of obstructed micturition in younger men and there is frequent recurrence after initial treatment. Currently, routine repeated dilations, including intermittent self-catheterisation (ISC) are prescribed by urologists to prevent urethral stricture recurrence. There is, however, no high level evidence available supporting the effectiveness of practicing these painful techniques. Balancing efficacy, adverse effects and costs, we hypothesize that active surveillance is a better option for preventing stricture recurrence as compared with routine repeated dilations. However, well designed, adequately powered multi-center trials with comprehensive evaluation are urgently needed to confirm our hypothesis. .

  12. Tumors masquerading in patients with thyroid eye disease.

    PubMed

    Griepentrog, Gregory J; Burkat, Cat N; Kikkawa, Don O; Lucarelli, Mark J

    2013-08-01

    Thyroid eye disease (TED) is the most common cause of proptosis in adults. The external manifestations of TED are characteristic and the diagnosis is typically made without imaging. Although there are multiple descriptions of primary and secondary orbital tumors initially mistaken for TED in the literature, there are limited reports detailing the findings of patients with long-standing TED whom developed an orbital tumor at a later date. Herein, we present a 6-year retrospective multi-center report of three patients with long-standing TED who developed an initially unsuspected orbital or cavernous sinus tumor. PMID:23662589

  13. Heavy Lift Vehicle (HLV) Avionics Flight Computing Architecture Study

    NASA Technical Reports Server (NTRS)

    Hodson, Robert F.; Chen, Yuan; Morgan, Dwayne R.; Butler, A. Marc; Sdhuh, Joseph M.; Petelle, Jennifer K.; Gwaltney, David A.; Coe, Lisa D.; Koelbl, Terry G.; Nguyen, Hai D.

    2011-01-01

    A NASA multi-Center study team was assembled from LaRC, MSFC, KSC, JSC and WFF to examine potential flight computing architectures for a Heavy Lift Vehicle (HLV) to better understand avionics drivers. The study examined Design Reference Missions (DRMs) and vehicle requirements that could impact the vehicles avionics. The study considered multiple self-checking and voting architectural variants and examined reliability, fault-tolerance, mass, power, and redundancy management impacts. Furthermore, a goal of the study was to develop the skills and tools needed to rapidly assess additional architectures should requirements or assumptions change.

  14. Prevention of stricture recurrence following urethral internal urethrotomy: routine repeated dilations or active surveillance?

    PubMed

    Tian, Ye; Wazir, Romel; Wang, Jianzhong; Wang, Kunjie; Li, Hong

    2016-01-01

    Strictures of the urethra are the most common cause of obstructed micturition in younger men and there is frequent recurrence after initial treatment. Currently, routine repeated dilations, including intermittent self-catheterisation (ISC) are prescribed by urologists to prevent urethral stricture recurrence. There is, however, no high level evidence available supporting the effectiveness of practicing these painful techniques. Balancing efficacy, adverse effects and costs, we hypothesize that active surveillance is a better option for preventing stricture recurrence as compared with routine repeated dilations. However, well designed, adequately powered multi-center trials with comprehensive evaluation are urgently needed to confirm our hypothesis. . PMID:27576888

  15. High Power MPD Nuclear Electric Propulsion (NEP) for Artificial Gravity HOPE Missions to Callisto

    NASA Technical Reports Server (NTRS)

    McGuire, Melissa L.; Borowski, Stanley K.; Mason, Lee M.; Gilland, James

    2003-01-01

    This documents the results of a one-year multi-center NASA study on the prospect of sending humans to Jupiter's moon, Callisto, using an all Nuclear Electric Propulsion (NEP) space transportation system architecture with magnetoplasmadynamic (MPD) thrusters. The fission reactor system utilizes high temperature uranium dioxide (UO2) in tungsten (W) metal matrix cermet fuel and electricity is generated using advanced dynamic Brayton power conversion technology. The mission timeframe assumes on-going human Moon and Mars missions and existing space infrastructure to support launch of cargo and crewed spacecraft to Jupiter in 2041 and 2045, respectively.

  16. Flight Avionics Hardware Roadmap

    NASA Technical Reports Server (NTRS)

    Hodson, Robert; McCabe, Mary; Paulick, Paul; Ruffner, Tim; Some, Rafi; Chen, Yuan; Vitalpur, Sharada; Hughes, Mark; Ling, Kuok; Redifer, Matt; Wallace, Shawn

    2013-01-01

    As part of NASA's Avionics Steering Committee's stated goal to advance the avionics discipline ahead of program and project needs, the committee initiated a multi-Center technology roadmapping activity to create a comprehensive avionics roadmap. The roadmap is intended to strategically guide avionics technology development to effectively meet future NASA missions needs. The scope of the roadmap aligns with the twelve avionics elements defined in the ASC charter, but is subdivided into the following five areas: Foundational Technology (including devices and components), Command and Data Handling, Spaceflight Instrumentation, Communication and Tracking, and Human Interfaces.

  17. The antioxidant master glutathione and periodontal health

    PubMed Central

    Bains, Vivek Kumar; Bains, Rhythm

    2015-01-01

    Glutathione, considered to be the master antioxidant (AO), is the most-important redox regulator that controls inflammatory processes, and thus damage to the periodontium. Periodontitis patients have reduced total AO capacity in whole saliva, and lower concentrations of reduced glutathione (GSH) in serum and gingival crevicular fluid, and periodontal therapy restores the redox balance. Therapeutic considerations for the adjunctive use of glutathione in management of periodontitis, in limiting the tissue damage associated with oxidative stress, and enhancing wound healing cannot be underestimated, but need to be evaluated further through multi-centered randomized controlled trials. PMID:26604952

  18. Rigid diffusion phantom: acquisition and simulation.

    PubMed

    Sakai, Koji; Azuma, Takashi; Mori, Susumu

    2008-01-01

    Diffusion tensor imaging has already been a popular imaging modality for clinical researches. However, to setup an imaging protocol is not straightforward. This problem is critical issue for multi-center studies. We developed anisotropy phantoms and examined the feasibility of using water-filled arrays of channeled silicon plates. Various channel sizes were tested to optimize the diffusion and anisotropy properties. We succeeded in producing a phantom with high anisotropy (FA=0.8). However, a reason of high axial diffusivity needs further investigations.

  19. Integrated NASA Lidar System Strategy for Space-Based Remote Sensing

    NASA Technical Reports Server (NTRS)

    Singh, Upendra N.; Heaps, William S.; Krebs, Carolyn A. (Technical Monitor)

    2002-01-01

    Recent peer reviews of' NASA's space-based lidar missions and of the technology readiness of lasers appropriate for space-based lidars indicated a critical need for an integrated research and development strategy to move laser transmitter technology from low technical readiness levels to the higher levels required for space missions. This paper presents a multi-Center efforts leading to formulation of an integrated NASA strategy to provide the technology and maturity of systems necessary to make Lidar/Laser systems viable for space-based study and monitoring of the earth's atmosphere.

  20. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  1. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  2. 33 CFR 100.35 - Special local regulations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... MARINE PARADES SAFETY OF LIFE ON NAVIGABLE WATERS § 100.35 Special local regulations. (a) The Commander of a Coast Guard District or Captain of the Port (COTP) as authorized by 33 CFR 1.05-1(i), after.... (b) The Commander of a Coast Guard District or COTP as authorized by 33 CFR 1.05-1(i),...

  3. Synthesis and Thermal Properties of Solid-State Structural Isomers: Ordered Intergrowths of SnSe and MoSe2.

    PubMed

    Gunning, Noel S; Feser, Joseph; Beekman, Matt; Cahill, David G; Johnson, David C

    2015-07-15

    A family of structural isomers [(SnSe)1.05]m(MoSe2)n were prepared using the modulated elemental reactant method by varying the layer sequence and layer thicknesses in the precursor. By varying the sequence of Sn-Se and Mo-Se layer pairs deposited and annealing the precursors to self-assemble the targeted compound, all six possible isomers [(SnSe)1.05]4(MoSe2)4, [(SnSe)1.05]3(MoSe2)3[(SnSe)1.05]1(MoSe2)1, [(SnSe)1.05]3(MoSe2)2[(SnSe)1.05]1(MoSe2)2, [(SnSe)1.05]2(MoSe2)3[(SnSe)1.05]2(MoSe2)1, [(SnSe)1.05]2(MoSe2)1[(SnSe)1.05]1(MoSe2)2[(SnSe)1.05]1(MoSe2)1, and [(SnSe)1.05]2(MoSe2)2[(SnSe)1.05]1(MoSe2)1[(SnSe)1.05]1(MoSe2)1 were prepared. The structures were characterized by X-ray diffraction and electron microscopy which showed that all of the compounds have very similar c-axis lattice parameters and in-plane constituent lattice parameters yet distinct isomeric structures. These studies confirm that the structure, order, and thickness of the constituent layers match that of the precursors. The cross-plane thermal conductivity is found to be very low (∼0.08 Wm(-1) K(-1)) and independent of the number of SnSe-MoSe2 interfaces within uncertainty. The poor thermal transport in these layered isomers is attributed to a large cross-plane thermal resistance created by SnSe-MoSe2 and MoSe2-MoSe2 turbostratically disordered van der Waals interfaces, the density of which has less variation among the different compounds than the SnSe-MoSe2 interface density alone. PMID:26086400

  4. Epilepsy and seizure ontology: towards an epilepsy informatics infrastructure for clinical research and patient care

    PubMed Central

    Sahoo, Satya S; Lhatoo, Samden D; Gupta, Deepak K; Cui, Licong; Zhao, Meng; Jayapandian, Catherine; Bozorgi, Alireza; Zhang, Guo-Qiang

    2014-01-01

    Objective Epilepsy encompasses an extensive array of clinical and research subdomains, many of which emphasize multi-modal physiological measurements such as electroencephalography and neuroimaging. The integration of structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research requires an effective informatics infrastructure that is underpinned by a formal domain ontology. Methods We have developed an epilepsy and seizure ontology (EpSO) using a four-dimensional epilepsy classification system that integrates the latest International League Against Epilepsy terminology recommendations and National Institute of Neurological Disorders and Stroke (NINDS) common data elements. It imports concepts from existing ontologies, including the Neural ElectroMagnetic Ontologies, and uses formal concept analysis to create a taxonomy of epilepsy syndromes based on their seizure semiology and anatomical location. Results EpSO is used in a suite of informatics tools for (a) patient data entry, (b) epilepsy focused clinical free text processing, and (c) patient cohort identification as part of the multi-center NINDS-funded study on sudden unexpected death in epilepsy. EpSO is available for download at http://prism.case.edu/prism/index.php/EpilepsyOntology. Discussion An epilepsy ontology consortium is being created for community-driven extension, review, and adoption of EpSO. We are in the process of submitting EpSO to the BioPortal repository. Conclusions EpSO plays a critical role in informatics tools for epilepsy patient care and multi-center clinical research. PMID:23686934

  5. Quality control and assurance for validation of DOS/I measurements

    NASA Astrophysics Data System (ADS)

    Cerussi, Albert; Durkin, Amanda; Kwong, Richard; Quang, Timothy; Hill, Brian; Tromberg, Bruce J.; MacKinnon, Nick; Mantulin, William W.

    2010-02-01

    Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials, quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3. Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor, audit and communicate all research procedures (database, teleconferences, training sessions) between participants ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these strategies.

  6. The Habitat Demonstration Unit Project

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Gill, Tracy; Tri, Terry; Howe, Scott

    2009-01-01

    This paper will describe an overview of the NASA-led multi-center Habitat Demonstration Unit (HDU) Project. The HDU project is a technology-pull project that integrates technologies and innovations from numerous NASA centers. This project will be used to investigate and validate surface architectures, operations concepts, and requirements definition. The HDU project will be part of the 2010 Desert Research and Technologies Simulations (DRATS). The purpose of this project is to develop, integrate, test, and evaluate a HDU in the context of the mission architectures and surface operation concepts. This HDU is based on the Constellation Architecture Scenario 12.1 concept of a vertically oriented habitat module. A multi-center approach with be utilized to build, integrate, and test the HDU project through a shared collaborative effort of multiple NASA centers. This project is part of the strategic plan from the ESMD Directorate Integration Office (DIO) and the Lunar Surface Systems Project Office (LSSPO) to test surface elements in a surface analog environment which includes two Lunar Electric Rovers and the HDU during the 2010 analog field test. This paper will describe the overall objectives, its various configurations, strategic plan, and technology integration as it pertains to the 2010 and 2011 field analog tests.

  7. Advanced Air Transportation Technologies Project, Final Document Collection

    NASA Technical Reports Server (NTRS)

    Mogford, Richard H.; Wold, Sheryl (Editor)

    2008-01-01

    This CD ROM contains a compilation of the final documents of the Advanced Air Transportation Technologies (AAIT) project, which was an eight-year (1996 to 2004), $400M project managed by the Airspace Systems Program office, which was part of the Aeronautics Research Mission Directorate at NASA Headquarters. AAIT focused on developing advanced automation tools and air traffic management concepts that would help improve the efficiency of the National Airspace System, while maintaining or enhancing safety. The documents contained in the CD are final reports on AAIT tasks that serve to document the project's accomplishments over its eight-year term. Documents include information on: Advanced Air Transportation Technologies, Autonomous Operations Planner, Collaborative Arrival Planner, Distributed Air/Ground Traffic Management Concept Elements 5, 6, & 11, Direct-To, Direct-To Technology Transfer, Expedite Departure Path, En Route Data Exchange, Final Approach Spacing Tool - (Active and Passive), Multi-Center Traffic Management Advisor, Multi Center Traffic Management Advisor Technology Transfer, Surface Movement Advisor, Surface Management System, Surface Management System Technology Transfer and Traffic Flow Management Research & Development.

  8. A DICOM based radiotherapy plan database for research collaboration and reporting

    NASA Astrophysics Data System (ADS)

    Westberg, J.; Krogh, S.; Brink, C.; Vogelius, I. R.

    2014-03-01

    Purpose: To create a central radiotherapy (RT) plan database for dose analysis and reporting, capable of calculating and presenting statistics on user defined patient groups. The goal is to facilitate multi-center research studies with easy and secure access to RT plans and statistics on protocol compliance. Methods: RT institutions are able to send data to the central database using DICOM communications on a secure computer network. The central system is composed of a number of DICOM servers, an SQL database and in-house developed software services to process the incoming data. A web site within the secure network allows the user to manage their submitted data. Results: The RT plan database has been developed in Microsoft .NET and users are able to send DICOM data between RT centers in Denmark. Dose-volume histogram (DVH) calculations performed by the system are comparable to those of conventional RT software. A permission system was implemented to ensure access control and easy, yet secure, data sharing across centers. The reports contain DVH statistics for structures in user defined patient groups. The system currently contains over 2200 patients in 14 collaborations. Conclusions: A central RT plan repository for use in multi-center trials and quality assurance was created. The system provides an attractive alternative to dummy runs by enabling continuous monitoring of protocol conformity and plan metrics in a trial.

  9. [Development, Application Details, and Prospects of Uni-VATS on Lung Cancer Radical Operation under the Concept of "Precise Medical Treatment"].

    PubMed

    Deng, Yu; Hao, Zhipeng; Fu, Xiangning

    2016-06-20

    Uniportal video-assisted thoracic surgery (Uni-VATS) has become one of the most exciting new developments in minimally invasive thoracic surgery in recent 5 years. With the development of better thoracoscopic cameras and the availability of endoscopic linear mechanical staplers, experts in the technique are able to use uniportal VATS to encompass the most complex procedures such as bronchial sleeve/vascular reconstructions or carinal resections. A large number of multi-center reports have confirmed that Uni-VATS lobectomy is safe and feasible; dissected node group number and total number of mediastinal lymph nodes were not less than that of traditional muli VATS; Uni-VATS gained positive results in pain, trauma and recovery time. Although the large sample multi center clinical data, such as the five year survival rate has not yet been obtained, gradually carring out of uni-VATS will be an important direction for the future development of minimally invasive thoracic surgery. This article will focus on the principle of Uni-VATS and the specific operation details, combined with the basic operation concept, with a view to put forward the orderly and standard utilization of the Uni-VATS. PMID:27335300

  10. Cloudwave: distributed processing of "big data" from electrophysiological recordings for epilepsy clinical research using Hadoop.

    PubMed

    Jayapandian, Catherine P; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D; Zhang, Guo-Qiang; Sahoo, Satya S

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50-60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical "big data" consisting of more than 100 multi-channel signals with recordings from each patient generating 5-10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a "private cloud". Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with "montages" for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave). PMID:24551370

  11. ScolioMedIS: web-oriented information system for idiopathic scoliosis visualization and monitoring.

    PubMed

    Devedžić, Goran; Cuković, Saša; Luković, Vanja; Milošević, Danijela; Subburaj, K; Luković, Tanja

    2012-11-01

    Adolescent idiopathic scoliosis is the most common type of abnormal curvature observed in spine and it progresses rapidly during the puberty period. The most followed clinical way of assessing the spinal deformity is subjective by measuring the characteristic angles of spinal curve from a set of radiographic images. This paper presents a web-based information system (called ScolioMedIS) based on parameterized 3D anatomical models of the spine to quantitatively assess the deformity and to minimize the amount of radiation exposure by reducing the number of radiographs required. The main components of the system are 3D parametric solid model of spine, back surfaces, relevant clinical information and scoliosis ontology. The patient-specific spine model is regenerated from the parametric model and surface data using anatomical information extracted from radiographic images. The system is designed to take inherent advantage of Web for facilitating multi-center data collection and collaborative clinical decisions. The preliminary analysis of patient data showed promising results, which involve improved documentation standard, clinical decision knowledge base record, facilitated exchange and retrieval of medical data between institutions in multi-center clinical studies, 3D visualization of spinal deformity, and permanent monitoring of treatments.

  12. Probabilistic Quantitative Precipitation Forecasting over East China using Bayesian Model Averaging

    NASA Astrophysics Data System (ADS)

    Yang, Ai; Yuan, Huiling

    2014-05-01

    The Bayesian model averaging (BMA) is a post-processing method that weights the predictive probability density functions (PDFs) of individual ensemble members. This study investigates the BMA method for calibrating quantitative precipitation forecasts (QPFs) from The Observing System Research and Predictability Experiment (THORPEX) Interactive Grand Global Ensemble (TIGGE) database. The QPFs over East Asia during summer (June-August) 2008-2011 are generated from six operational ensemble prediction systems (EPSs), including ECMWF, UKMO, NCEP, CMC, JMA, CMA, and multi-center ensembles of their combinations. The satellite-based precipitation estimate product TRMM 3B42 V7 is used as the verification dataset. In the BMA post-processing for precipitation forecasts, the PDF matching method is first applied to bias-correct systematic errors in each forecast member, by adjusting PDFs of forecasts to match PDFs of observations. Next, a logistic regression and two-parameter gamma distribution are used to fit the probability of rainfall occurrence and precipitation distribution. Through these two steps, the BMA post-processing bias-corrects ensemble forecasts systematically. The 60-70% cumulative density function (CDF) predictions well estimate moderate precipitation compared to raw ensemble mean, while the 90% upper boundary of BMA CDF predictions can be set as a threshold of extreme precipitation alarm. In general, the BMA method is more capable of multi-center ensemble post-processing, which improves probabilistic QPFs (PQPFs) with better ensemble spread and reliability. KEYWORDS: Bayesian model averaging (BMA); post-processing; ensemble forecast; TIGGE

  13. Cloudwave: distributed processing of "big data" from electrophysiological recordings for epilepsy clinical research using Hadoop.

    PubMed

    Jayapandian, Catherine P; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D; Zhang, Guo-Qiang; Sahoo, Satya S

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50-60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical "big data" consisting of more than 100 multi-channel signals with recordings from each patient generating 5-10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a "private cloud". Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with "montages" for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave).

  14. Leveraging a clinical research information system to assist biospecimen data and workflow management: a hybrid approach

    PubMed Central

    2011-01-01

    Background Large multi-center clinical studies often involve the collection and analysis of biological samples. It is necessary to ensure timely, complete and accurate recording of analytical results and associated phenotypic and clinical information. The TRIBE-AKI Consortium http://www.yale.edu/tribeaki supports a network of multiple related studies and sample biorepository, thus allowing researchers to take advantage of a larger specimen collection than they might have at an individual institution. Description We describe a biospecimen data management system (BDMS) that supports TRIBE-AKI and is intended for multi-center collaborative clinical studies that involve shipment of biospecimens between sites. This system works in conjunction with a clinical research information system (CRIS) that stores the clinical data associated with the biospecimens, along with other patient-related parameters. Inter-operation between the two systems is mediated by an interactively invoked suite of Web Services, as well as by batch code. We discuss various challenges involved in integration. Conclusions Our experience indicates that an approach that emphasizes inter-operability is reasonably optimal in allowing each system to be utilized for the tasks for which it is best suited. PMID:21884570

  15. Detecting qualitative interaction: a Bayesian approach.

    PubMed

    Bayman, Emine Ozgür; Chaloner, Kathryn; Cowles, Mary Kathryn

    2010-02-20

    Differences in treatment effects between centers in a multi-center trial may be important. These differences represent treatment by subgroup interaction. Peto defines qualitative interaction (QI) to occur when the simple treatment effect in one subgroup has a different sign than in another subgroup: this interaction is important. Interaction where the treatment effects are of the same sign in all subgroups is called quantitative and is often not important because the treatment recommendation is identical in all cases. A hierarchical model is used here with exchangeable mean responses to each treatment between subgroups. The posterior probability of QI and the corresponding Bayes factor are proposed as a diagnostic and as a test statistic. The model is motivated by two multi-center trials with binary responses. The frequentist power and size of the test using the Bayes factor are examined and compared with two other commonly used tests. The impact of imbalance between the sample sizes in each subgroup on power is examined, and the test based on the Bayes factor typically has better power for unbalanced designs, especially for small sample sizes. An exact test based on the Bayes factor is also suggested assuming the hierarchical model. The Bayes factor provides a concise summary of the evidence for or against QI. It is shown by example that it is easily adapted to summarize the evidence for 'clinically meaningful QI,' defined as the simple effects being of opposite signs and larger in absolute value than a minimal clinically meaningful effect.

  16. Cloudwave: Distributed Processing of “Big Data” from Electrophysiological Recordings for Epilepsy Clinical Research Using Hadoop

    PubMed Central

    Jayapandian, Catherine P.; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D.; Zhang, Guo-Qiang; Sahoo, Satya S.

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50–60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical “big data” consisting of more than 100 multi-channel signals with recordings from each patient generating 5–10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a “private cloud”. Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with “montages” for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave) PMID:24551370

  17. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  18. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  19. 40 CFR 417.13 - Effluent limitations guidelines representing the degree of effluent reduction attainable by the...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... not exceed— Metric units (kilograms per 1,000 kg of anhydrous product) BOD5 0.80 0.40 COD 2.10 1.05... product) BOD5 0.80 0.40 COD 2.10 1.05 TSS 0.80 .40 Oil and grease 0.10 .05 pH (1) (1) 1 Within the range...

  20. Clinical Microfluidics for Neutrophil Genomics and Proteomics

    PubMed Central

    Kotz, Kenneth T.; Xiao, Wenzong; Miller-Graziano, Carol; Qian, Wei-Jun; Russom, Aman; Warner, Elizabeth A.; Moldawer, Lyle L.; De, Asit; Bankey, Paul E.; Petritis, Brianne O.; Camp, David G.; Rosenbach, Alan E.; Goverman, Jeremy; Fagan, Shawn P.; Brownstein, Bernard H.; Irimia, Daniel; Xu, Weihong; Wilhelmy, Julie; Mindrinos, Michael N.; Smith, Richard D.; Davis, Ronald W.; Tompkins, Ronald G.; Toner, Mehmet

    2010-01-01

    Neutrophils play critical roles in modulating the immune response. We present a robust methodology for rapidly isolating neutrophils directly from whole blood and develop ‘on-chip’ processing for mRNA and protein isolation for genomics and proteomics. We validate this device with an ex vivo stimulation experiment and by comparison with standard bulk isolation methodologies. Lastly, we implement this tool as part of a near patient blood processing system within a multi-center clinical study of the immune response to severe trauma and burn injury. The preliminary results from a small cohort of patients in our study and healthy controls show a unique time-dependent gene expression pattern clearly demonstrating the ability of this tool to discriminate temporal transcriptional events of neutrophils within a clinical setting. PMID:20802500

  1. Clinical microfluidics for neutrophil genomics and proteomics.

    PubMed

    Kotz, Kenneth T; Xiao, Wenzong; Miller-Graziano, Carol; Qian, Wei-Jun; Russom, Aman; Warner, Elizabeth A; Moldawer, Lyle L; De, Asit; Bankey, Paul E; Petritis, Brianne O; Camp, David G; Rosenbach, Alan E; Goverman, Jeremy; Fagan, Shawn P; Brownstein, Bernard H; Irimia, Daniel; Xu, Weihong; Wilhelmy, Julie; Mindrinos, Michael N; Smith, Richard D; Davis, Ronald W; Tompkins, Ronald G; Toner, Mehmet

    2010-09-01

    Neutrophils have key roles in modulating the immune response. We present a robust methodology for rapidly isolating neutrophils directly from whole blood with 'on-chip' processing for mRNA and protein isolation for genomics and proteomics. We validate this device with an ex vivo stimulation experiment and by comparison with standard bulk isolation methodologies. Last, we implement this tool as part of a near-patient blood processing system within a multi-center clinical study of the immune response to severe trauma and burn injury. The preliminary results from a small cohort of subjects in our study and healthy controls show a unique time-dependent gene expression pattern clearly demonstrating the ability of this tool to discriminate temporal transcriptional events of neutrophils within a clinical setting.

  2. Recommendations to improve the positive and negative syndrome scale (PANSS) based on item response theory.

    PubMed

    Levine, Stephen Z; Rabinowitz, Jonathan; Rizopoulos, Dimitris

    2011-08-15

    The adequacy of the Positive and Negative Syndrome Scale (PANSS) items in measuring symptom severity in schizophrenia was examined using Item Response Theory (IRT). Baseline PANSS assessments were analyzed from two multi-center clinical trials of antipsychotic medication in chronic schizophrenia (n=1872). Generally, the results showed that the PANSS (a) item ratings discriminated symptom severity best for the negative symptoms; (b) has an excess of "Severe" and "Extremely severe" rating options; and (c) assessments are more reliable at medium than very low or high levels of symptom severity. Analysis also showed that the detection of statistically and non-statistically significant differences in treatment were highly similar for the original and IRT-modified PANSS. In clinical trials of chronic schizophrenia, the PANSS appears to require the following modifications: fewer rating options, adjustment of 'Lack of judgment and insight', and improved severe symptom assessment.

  3. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used. PMID:25532410

  4. Acute leukemia in children: A review of the current Indian data

    PubMed Central

    Arora, Ramandeep Singh; Arora, Brijesh

    2016-01-01

    Acute leukemias are the most common diagnostic group of childhood cancer. This review summarizes the published literature on reported current outcomes of childhood acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) from India. Overall survival in ALL ranged from 45% to 81% (commonly >60%) and event-free survival ranged from 41% to 70% (commonly >50%). Outcome data for AML was patchy with varying duration of follow-up, but it can be inferred that 50–80% of treated patients had experienced an event (toxic death, refractory disease or relapse). It is imperative that going forward focus should be on collaborative efforts, which promote treatment of patients on risk-stratified adapted protocols based on local infrastructure, improvement in supportive care and encourage prospective multi-center clinical trials.

  5. [Application of extracorporeal shockwave therapy in andrology].

    PubMed

    Qin, Xin; Lu, Yi-Ping

    2012-12-01

    Extracorporeal shockwave therapy (ESWT) has been widely used in various fields ever since it was first introduced for the treatment of urinary stones in 1983. Recent years see a growing application of ESWT to andrology. Studies show that ESWT can relieve pain in 83% of the patients with Peyronie's disease, and has won favorable comments from 66% of the patients. ESWT can significantly improve the sexual life quality of the patients with organic erectile dysfunction, yields good effect in the treatment of chronic nonbacterial prostatitis, especially in pain relief. ESWT has offered new ideas and options for the treatment of andrological diseases. However, its mechanisms have yet to be clarified by more in-depth basic studies and multi-centered, large-sample randomized controlled trials.

  6. Numerical Modeling of Impact Initiation of High Explosives

    SciTech Connect

    Wu, C J; Piggott, T; Yoh, J; Reaugh, J

    2006-05-31

    We performed continuum mechanics simulations to examine the behavior of energetic materials in Ballistic Chamber Impact (BIC) experiments, using an Arbitrary Lagrangian-Eulerian code (ALE3D). Our simulations revealed that interface friction plays an important role in inducing the formation of shear bands, which result in 'hot spots' for ignition. The temperature localization during BIC impact was found to be significant in materials with high yield strength. In those materials, there are multiple locations inside shear bands can achieve temperatures exceeding the threshold temperature for reaction. In addition, we investigated the relevant parameters influencing the pressure profile of a BIC test by numerical analysis from a simple phenomenological model. To our surprise, we found that the peaks of BIC pressure profiles not only can be a result of multi-center chemical reactions, but can also arise from factors associated apparatus configuration.

  7. A new pure ω-3 eicosapentaenoic acid ethyl ester (AMR101) for the management of hypertriglyceridemia: the MARINE trial.

    PubMed

    Jacobson, Terry A

    2012-06-01

    ω-3 fatty acids reduce triglyceride (TG) levels, but corresponding increases in low-density lipoprotein cholesterol (LDL-C) levels may compromise achievement of lipid goals in patients with elevated cardiovascular risk. AMR101 is an investigational agent containing ≥96% of pure icosapent ethyl (the ethyl ester of eicosapentaenoic acid). The Phase III Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study with an Open-Label Extension (MARINE) investigated the efficacy and safety of AMR101 in 229 patients with very high TG levels (≥500 mg/dl). AMR101 4 g/day significantly reduced median placebo-adjusted TG levels from baseline by 33.1% (p < 0.0001), and AMR101 2 g/day reduced TG levels by 19.7% (p = 0.0051). Changes in LDL-C were minimal and nonsignificant. AMR101 may offer substantial TG lowering without increases in LDL-C levels. PMID:22894624

  8. Autonomous aircraft initiative study

    NASA Technical Reports Server (NTRS)

    Hewett, Marle D.

    1991-01-01

    The results of a consulting effort to aid NASA Ames-Dryden in defining a new initiative in aircraft automation are described. The initiative described is a multi-year, multi-center technology development and flight demonstration program. The initiative features the further development of technologies in aircraft automation already being pursued at multiple NASA centers and Department of Defense (DoD) research and Development (R and D) facilities. The proposed initiative involves the development of technologies in intelligent systems, guidance, control, software development, airborne computing, navigation, communications, sensors, unmanned vehicles, and air traffic control. It involves the integration and implementation of these technologies to the extent necessary to conduct selected and incremental flight demonstrations.

  9. The USA Multicenter Prehosptial Hemoglobin -based Oxygen Carrier Resuscitation Trial: Scientific Rationale, Study Design, and Results

    PubMed Central

    Moore, Ernest E.; Johnson, Jeffrey L.; Moore, Frederick A.; Moore, Hunter B.

    2013-01-01

    The current generation of blood substitutes tested in clinical trials are red blood cell (RBC) substitutes; that is, they are designed primarily to transport oxygen. The products now being used in advanced-phase clinical trials are derived from hemoglobin (Hb) and are thus often referred to as Hb-based oxygen carriers (HBOCs). The potential benefits of HBOCs are well known (Box 1). The objectives of this overview are to provide the scientific background and rationale for the study design of the USA Multi-center Prehospital HBOC Resuscitation Trial and to present the results and discuss clinical implications. Box 1Potential clinical benefits of hemoglobin-based oxygen carriers in trauma careAvailabilityAbundant supplyUniversally compatibleProlonged shelf-lifeStorage at room temperatureSafetyNo disease transmissionsNo antigenic reactionsNo immunologic effectsEfficacyEnhanced oxygen deliveryImproved rheologic properties PMID:19341912

  10. A combined pre-clinical meta-analysis and randomized confirmatory trial approach to improve data validity for therapeutic target validation

    PubMed Central

    Kleikers, Pamela WM.; Hooijmans, Carlijn; Göb, Eva; Langhauser, Friederike; Rewell, Sarah SJ.; Radermacher, Kim; Ritskes-Hoitinga, Merel; Howells, David W.; Kleinschnitz, Christoph; HHW Schmidt, Harald

    2015-01-01

    Biomedical research suffers from a dramatically poor translational success. For example, in ischemic stroke, a condition with a high medical need, over a thousand experimental drug targets were unsuccessful. Here, we adopt methods from clinical research for a late-stage pre-clinical meta-analysis (MA) and randomized confirmatory trial (pRCT) approach. A profound body of literature suggests NOX2 to be a major therapeutic target in stroke. Systematic review and MA of all available NOX2-/y studies revealed a positive publication bias and lack of statistical power to detect a relevant reduction in infarct size. A fully powered multi-center pRCT rejects NOX2 as a target to improve neurofunctional outcomes or achieve a translationally relevant infarct size reduction. Thus stringent statistical thresholds, reporting negative data and a MA-pRCT approach can ensure biomedical data validity and overcome risks of bias. PMID:26310318

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

    PubMed

    Anderegg, Tamara R; Jones, Ronald N

    2004-01-01

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

  12. Dimethindene maleate in the treatment of pruritus caused by varizella zoster virus infection in children.

    PubMed

    Englisch, W; Bauer, C P

    1997-11-01

    The efficacy and tolerability of dimethindene maleate (CAS 3614-69-5, DMM, Fenistil) as drops in the treatment of pruritus in children suffering from chicken-pox were investigated in a study with two different doses of dimethindene maleate and placebo. 128 children, 1 to 6 years of age, were included in a double blind, randomized, placebo controlled, multi-center clinical trial. Patients received either a dosage of DMM of 0.1 mg/kg x d, or 0.05 mg/kg x d, or placebo, respectively. All patients received a commercially available astringent lotion for topical treatment of skin lesions. The primary efficacy criterion which was the change in the itching severity score from baseline to the end of the treatment assessed as area under the baseline (AUB) showed for both treatments with DMM a statistically significant superiority versus placebo in reducing the severity of itching. There was no statistically proven difference between the two verum groups.

  13. Dissociative electron attachment studies on acetone

    SciTech Connect

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

    2014-10-28

    Dissociative electron attachment (DEA) to acetone is studied in terms of the absolute cross section for various fragment channels in the electron energy range of 0–20 eV. H{sup −} is found to be the most dominant fragment followed by O{sup −} and OH{sup −} with only one resonance peak between 8 and 9 eV. The DEA dynamics is studied by measuring the angular distribution and kinetic energy distribution of fragment anions using Velocity Slice Imaging technique. The kinetic energy and angular distribution of H{sup −} and O{sup −} fragments suggest a many body break-up for the lone resonance observed. The ab initio calculations show that electron is captured in the multi-centered anti-bonding molecular orbital which would lead to a many body break-up of the resonance.

  14. Confirmatory Factor Analysis of the ADNI Neuropsychological Battery

    PubMed Central

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

    2012-01-01

    The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a large multi-center study designed to develop optimized methods for acquiring longitudinal neuroimaging, cognitive, and biomarker measures of AD progression in a large cohort of patients with Alzheimer’s disease (AD), patients with mild cognitive impairment, and healthy controls. Detailed neuropsychological testing was conducted on all participants. We examined the factor structure of the ADNI Neuropsychological Battery across older adults with differing levels of clinical AD severity based on the Clinical Dementia Rating Scale (CDR). Confirmatory factor analysis (CFA) of 23 variables from 10 neuropsychological tests resulted in five factors (memory, language, visuospatial functioning, attention, and executive function/processing speed) that were invariant across levels of cognitive impairment. Thus, these five factors can be used as valid indicators of cognitive function in older adults who are participants in ADNI. PMID:22777078

  15. Improving cost efficiency in large programs

    NASA Technical Reports Server (NTRS)

    Hodge, John D.

    1994-01-01

    This paper examines the question of cost, from the birth of a program to its conclusion, particularly from the point of view of large multi-center programs, and suggests how to avoid some of the traps and pitfalls. Emphasis is given to cost in the systems engineering process, but there is an inevitable overlap with program management. (The terms systems engineering and program management have never been clearly defined.) In these days of vast Federal budget deficits and increasing overseas competition, it is imperative that we get more for each research and development dollar. This is the only way we will retain our leadership in high technology and, in the long run, our way of life.

  16. The Lunar Environment: Determining the Health Effects of Exposure to Moon Dusts

    NASA Technical Reports Server (NTRS)

    Khan-Mayberry, Noreen

    2007-01-01

    The moon's surface is covered with a thin layer of fine, charged, reactive dust capable of layer of fine, charged, reactive dust capable of capable of entering habitats and vehicle compartments, where it can result in crewmember health problems. NASA formed the Lunar Airborne Dust Toxicity Advisory Group (LADTAG) to study the effects of exposure to Lunar Dust on human health. To date, no scientifically defensible toxicological studies have been performed on lunar dusts, specifically the determination of exposure limits and their affect on human health. The multi-center LADTAG (Lunar Airborne Dust Toxicology center LADTAG (Lunar Airborne Dust Toxicology Advisory Group) was formed in response to the Office of the Chief Health and Medical Office s (OCHMO) request to develop recommendations for defining risk (OCHMO) request to develop recommendations for defining risk defining risk criteria for human lunar dust exposure.

  17. Information Infrastructure Technology and Applications (IITA) Program: Annual K-12 Workshop

    NASA Technical Reports Server (NTRS)

    Hunter, Paul; Likens, William; Leon, Mark

    1995-01-01

    The purpose of the K-12 workshop is to stimulate a cross pollination of inter-center activity and introduce the regional centers to curing edge K-1 activities. The format of the workshop consists of project presentations, working groups, and working group reports, all contained in a three day period. The agenda is aggressive and demanding. The K-12 Education Project is a multi-center activity managed by the Information Infrastructure Technology and Applications (IITA)/K-12 Project Office at the NASA Ames Research Center (ARC). this workshop is conducted in support of executing the K-12 Education element of the IITA Project The IITA/K-12 Project funds activities that use the National Information Infrastructure (NII) (e.g., the Internet) to foster reform and restructuring in mathematics, science, computing, engineering, and technical education.

  18. Earth Atmosphere Observatory Formation at L2

    NASA Technical Reports Server (NTRS)

    Mettler, Edward; Acikmese, A. Behcet; Breckenridge, William G.; Mecenka, Steven A.; Tubbs, Eldred F.

    2004-01-01

    This paper is a product of research supported by NASA under RASC (the Revolutionary Aerospace Systems Concepts) program. It presents an overall system architecture, and covers issues of deployment, navigation, and control related to a formation of two spacecraft in the neighborhood of the Sun-Earth L2 Lagrange point (on the Sun-Earth line), that serves as an observatory of Earth's atmosphere. The observatory concept definition study was a multi-center NASA effort conducted in 2003, and covered a much wider scope than is presented in this focused paper.The Earth observatory at L2 is a unique design concept that can improve the knowledge and understanding of dynamic, chemical and radiative mechanisms that cause changes in the atmosphere, and can lead to the development of models and techniques to predict short and long-term climate changes.

  19. Direct and Repeated Clinical Measurements of pO2 for Enhancing Cancer Therapy and Other Applications.

    PubMed

    Swartz, Harold M; Williams, Benjamin B; Hou, Huagang; Khan, Nadeem; Jarvis, Lesley A; Chen, Eunice Y; Schaner, Philip E; Ali, Arif; Gallez, Bernard; Kuppusamy, Periannan; Flood, Ann B

    2016-01-01

    The first systematic multi-center study of the clinical use of EPR oximetry has begun, with funding as a PPG from the NCI. Using particulate oxygen sensitive EPR, materials in three complementary forms (India Ink, "OxyChips", and implantable resonators) the clinical value of the technique will be evaluated. The aims include using repeated measurement of tumor pO2 to monitor the effects of treatments on tumor pO2, to use the measurements to select suitable subjects for the type of treatment including the use of hyperoxic techniques, and to provide data that will enable existing clinical techniques which provide data relevant to tumor pO2 but which cannot directly measure it to be enhanced by determining circumstances where they can give dependable information about tumor pO2. PMID:27526130

  20. Traumatic brain injury: family response and outcome.

    PubMed

    Kreutzer, J S; Marwitz, J H; Kepler, K

    1992-08-01

    Family outcome following traumatic brain injury has been the subject of investigation for nearly two decades. Researchers have reported on samples from Israel, Scotland, Denmark, England, and the United States. Cultural diversity as well as differences in design, assessment methods, injury characteristics, and definitions have contributed to difficulties establishing definitive conclusions. Findings indicate that patients' levels of emotional and personality disturbances are associated with levels of family disturbance, and are relatively more significant than physical disability. Undeniably, the long-term sequelae of injury have a long-term negative impact on families. Unfortunately, little has been done to establish the nature of family outcomes for patients younger than age 17, siblings, and less than severe injuries. Recent advances including development of valid measurement tools, definitions established through consensus, and multi-center collaborative research networks are promising and contribute to the likelihood of imminent progress.

  1. Cognitive Determinants of Academic Performance in Nigerian Pharmacy Schools.

    PubMed

    Ubaka, Chukwuemeka M; Sansgiry, Sujit S; Ukwe, Chinwe V

    2015-09-25

    Objective. To evaluate cognitive factors that might influence academic performance of students in Nigerian pharmacy schools. Methods. A cross-sectional, multi-center survey of Nigerian pharmacy students from 7 schools of pharmacy was conducted using 2 validated questionnaires measuring cognitive constructs such as test anxiety, academic competence, test competence, time management, and strategic study habits. Results. Female students and older students scored significantly better on time management skills and study habits, respectively. Test anxiety was negatively associated with academic performance while test competence, academic competence, and time management were positively associated with academic performance. These 4 constructs significantly discriminated between the lower and higher performing students, with the first 2 contributing to the most differences. Conclusion. Test and academic competence, test anxiety, and time management were significant factors associated with low and high academic performance among Nigerian pharmacy students. The study also demonstrated the significant effects of age, gender, and marital status on these constructs.

  2. Five-dimensional null and time-like supersymmetric geometries

    NASA Astrophysics Data System (ADS)

    Pasini, Giulio; Shahbazi, C. S.

    2016-09-01

    We show that there exist supersymmetric solutions of five-dimensional, pure, { N }=1 supergravity such that the norm of the supersymmetric Killing vector, built out of the Killing spinor, is a real not-everywhere analytic function such that all its derivatives vanish at a point where the Killing vector field becomes null. The norm of the Killing vector field then is not an analytic function on a neighborhood around this point. We explicitly construct such solutions by using a multi-center Gibbons–Hawking base. Although many of these solutions have infinite charges, we find explicit examples with finite charges that asymptote to {{AdS}}3× {S}2 and discuss their physical interpretation.

  3. Resource Prospector Lander: Architecture and Trade Studies

    NASA Technical Reports Server (NTRS)

    Moore, Josh; Calvert, Derek; Frady, Greg; Chavers, Greg; Wayne, Andrew; Hull, Patrick; Lowery, Eric; Farmer, Jeff; Trinh, Huu; Rojdev, Kristina; Piatek, Irene; Ess, Kim; Vitalpur, Sharada; Dunn, Kevin

    2014-01-01

    NASA's Resource Prospector (RP) is a multi-center and multi-institution collaborative project to investigate the polar regions of the Moon in search of volatiles. The mission is rated Class D and is approximately 10 days. The RP vehicle comprises three elements: the Lander, the Rover, and the Payload. The Payload is housed on the Rover and the Rover is on top of the Lander. The focus of this paper is on the Lander element for the RP vehicle. The design of the Lander was requirements driven and focused on a low-cost approach. To arrive at the final configuration, several trade studies were conducted. Of those trade studies, there were six primary trade studies that were instrumental in determining the final design. This paper will discuss each of these trades in further detail and show how these trades led to the final architecture of the RP Lander.

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

    PubMed Central

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

    2009-01-01

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

  5. Development of a Prototype Automation Simulation Scenario Generator for Air Traffic Management Software Simulations

    NASA Technical Reports Server (NTRS)

    Khambatta, Cyrus F.

    2007-01-01

    A technique for automated development of scenarios for use in the Multi-Center Traffic Management Advisor (McTMA) software simulations is described. The resulting software is designed and implemented to automate the generation of simulation scenarios with the intent of reducing the time it currently takes using an observational approach. The software program is effective in achieving this goal. The scenarios created for use in the McTMA simulations are based on data taken from data files from the McTMA system, and were manually edited before incorporation into the simulations to ensure accuracy. Despite the software s overall favorable performance, several key software issues are identified. Proposed solutions to these issues are discussed. Future enhancements to the scenario generator software may address the limitations identified in this paper.

  6. [Respiratory disease registries in Spain: fundamentals and organization].

    PubMed

    Lara, Beatriz; Morales, Pilar; Blanco, Ignacio; Vendrell, Montserrat; de Gracia Roldán, Javier; Monreal, Manel; Orriols, Ramón; Isidro, Isabel; Abú-Shams, Khalil; Escribano, Pilar; Villena, Victoria; Rodrigo, Teresa; Vidal Plà, Rafael; García-Yuste, Mariano; Miravitlles, Marc

    2011-08-01

    This present paper describes the general characteristics, objectives and organizational aspects of the respiratory disease registries in Spain with the aim to report their activities and increase their diffusion. The document compiles information on the following registries: the Spanish Registry of Patients with Alpha-1 Antitrypsin Deficiency, Spanish Registry of Bronchiectasis, International Registry of Thromboembolic Disease, Spanish Registry of Occupational Diseases, Spanish Registry of Pulmonary Artery Hypertension, Registry of Pleural Mesothelioma, Spanish Registry of Tuberculosis and Spanish Multi-center Study of Neuroendocrine Pulmonary Tumors. Our paper provides information on each of the registries cited. Each registry has compiled specific clinical information providing data in real situations, and completes the results obtained from clinical assays. Said information has been published both in national as well as international publications and has lead to the creation of various guidelines. Therefore, the activities of the professionals involved in the registries have spread the knowledge about the diseases studied, promoting the exchange of information among workgroups.

  7. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Morgan, Walter T; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects' experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26554277

  8. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects' disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525849

  9. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect.

    PubMed

    Ogden, Michael W; Marano, Kristin M; Jones, Bobbette A; Morgan, Walter T; Stiles, Mitchell F

    2015-01-01

    A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525962

  10. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 3. Biomarkers of biological effect

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, Walter T.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) for 24 weeks was conducted. Evaluation of biomarkers of biological effect (e.g. inflammation, lipids, hypercoaguable state) indicated that the majority of consistent and statistically significant improvements over time within each group were observed in markers of inflammation. Consistent and statistically significant differences in pairwise comparisons between product groups were not observed. These findings are relevant to the understanding of biomarkers of biological effect related to cigarette smoking as well as the risk continuum across various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525962

  11. Giant malignant phyllodes tumor of the breast: A rare case report and literature review

    PubMed Central

    LIU, MIN; YANG, SHUO; LIU, BIN; GUO, LIANG; BAO, XUEYING; LIU, BAILONG; DONG, LIHUA

    2016-01-01

    Malignant phyllodes tumor of the breast (MPTB) is rarely encountered in clinical practice. Preoperative diagnosis is challenging due to nonspecific radiological and histological features, and the prognostic factors and optimal treatment remain controversial. The current report describes the case of a middle-aged female with giant MPTB who underwent multidisciplinary intervention, including surgery, postoperative chemotherapy and radiotherapy. To date, the disease-free survival (DFS) of the patient has reached 18 months. Furthermore, a related literature review summarize the clinicopathological characteristics and treatment progress regarding MPTB is presented, along with an analysis of the indications for therapeutic strategy in the current case. In the future, multi-center clinical trials must be initiated to identify the criteria for diagnosis and optimal treatment consensus for MPTB. In conclusion, the present case highlights that multidisciplinary management may contribute to DFS following the treatment of giant MPTB. PMID:27347111

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

    PubMed Central

    Lee, Pamela P W; Lau, Yu-Lung

    2009-01-01

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

  13. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 1. Study design and methodology

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study was conducted to assess potential improvement in health status measures, as well as changes in biomarkers of tobacco exposure and biomarkers of biological effect, in current adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) evaluated over 24 weeks. Study design, conduct and methodology are presented here along with subjects’ disposition, characteristics, compliance and safety results. This design and methodology, evaluating generally healthy adult smokers over a relatively short duration, proved feasible. Findings from this randomized study provide generalized knowledge of the risk continuum among various tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26525849

  14. Psychosomatic problems and countermeasures in Japanese children and adolescents

    PubMed Central

    2012-01-01

    In Japan there are a number of children and adolescents with emotion-related disorders including psychosomatic diseases (orthostatic dysregulation, anorexia nervosa, recurrent pains), behavior problems and school absenteeism. According to our previous report, the Japanese children had significantly higher score of physical symptoms and psychiatric complaints than did the Swedish children, and these were more strongly influenced by school-related stress than by home-related stress. To enforce countermeasures for psychosomatic problems in children, the Japanese Society of Psychosomatic Pediatrics (established in 1982) have started several new projects including multi-center psychosomatic researches and society-based activities. In this article, we present an outline of our study on mental health in Japanese children in comparison with Swedish children. Countermeasures including clinical guidelines for child psychosomatic diseases are reviewed and discussed. PMID:22433184

  15. Genre Complexes in Popular Music.

    PubMed

    Silver, Daniel; Lee, Monica; Childress, C Clayton

    2016-01-01

    Recent work in the sociology of music suggests a declining importance of genre categories. Yet other work in this research stream and in the sociology of classification argues for the continued prevalence of genres as a meaningful tool through which creators, critics and consumers focus their attention in the topology of available works. Building from work in the study of categories and categorization we examine how boundary strength and internal differentiation structure the genre pairings of some 3 million musicians and groups. Using a range of network-based and statistical techniques, we uncover three musical "complexes," which are collectively constituted by 16 smaller genre communities. Our analysis shows that the musical universe is not monolithically organized but rather composed of multiple worlds that are differently structured-i.e., uncentered, single-centered, and multi-centered. PMID:27203852

  16. Medical therapy for pediatric inflammatory bowel disease.

    PubMed

    Sherlock, Mary E; Griffiths, Anne M

    2012-04-01

    Pediatric inflammatory bowel disease encompasses a spectrum of disease phenotype, severity, and responsiveness to treatment. Intestinal healing rather than merely symptom control is an especially important therapeutic goal in young patients, given the potential for growth impairment as a direct effect of persistent chronic inflammation and the long life ahead, during which other disease complications may occur. Corticosteroids achieve rapid symptom control, but alternate steroid-sparing strategies with greater potential to heal the intestine must be rapidly adopted. Exclusive enteral nutrition is an alternate short-term treatment in pediatric Crohn's disease. The results of multi-center pediatric clinical trials of both infliximab and adalimumab in Crohn's disease and of infliximab in ulcerative colitis (all in children with unsatisfactory responses to other therapies) have now been reported and guide treatment regimens in clinical practice. Optimal patient selection and timing of anti-TNF therapy requires clinical judgment. Attention must be paid to sustaining responsiveness safely.

  17. Acute leukemia in children: A review of the current Indian data.

    PubMed

    Arora, Ramandeep Singh; Arora, Brijesh

    2016-01-01

    Acute leukemias are the most common diagnostic group of childhood cancer. This review summarizes the published literature on reported current outcomes of childhood acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) from India. Overall survival in ALL ranged from 45% to 81% (commonly >60%) and event-free survival ranged from 41% to 70% (commonly >50%). Outcome data for AML was patchy with varying duration of follow-up, but it can be inferred that 50-80% of treated patients had experienced an event (toxic death, refractory disease or relapse). It is imperative that going forward focus should be on collaborative efforts, which promote treatment of patients on risk-stratified adapted protocols based on local infrastructure, improvement in supportive care and encourage prospective multi-center clinical trials. PMID:27606304

  18. Biomarkers for colitis-associated colorectal cancer.

    PubMed

    Chen, Ru; Lai, Lisa A; Brentnall, Teresa A; Pan, Sheng

    2016-09-21

    Patients with extensive ulcerative colitis (UC) of more than eight years duration have an increased risk of colorectal cancer. Molecular biomarkers for dysplasia and cancer could have a great clinical value in managing cancer risk in these UC patients. Using a wide range of molecular techniques - including cutting-edge OMICS technologies - recent studies have identified clinically relevant biomarker candidates from a variety of biosamples, including colonic biopsies, blood, stool, and urine. While the challenge remains to validate these candidate biomarkers in multi-center studies and with larger patient cohorts, it is certain that accurate biomarkers of colitis-associated neoplasia would improve clinical management of neoplastic risk in UC patients. This review highlights the ongoing avenues of research in biomarker development for colitis-associated colorectal cancer. PMID:27672285

  19. Perceived Benefits, Harms, and Views About How to Share Data Responsibly

    PubMed Central

    Tangseefa, Decha; Somsaman, Aimatcha; Chunsuttiwat, Tri; Nosten, François; Day, Nicholas P. J.; Bull, Susan; Parker, Michael

    2015-01-01

    The Thailand Major Overseas Programme coordinates large multi-center studies in tropical medicine and generates vast amounts of data. As the data sharing movement gains momentum, we wanted to understand attitudes and experiences of relevant stakeholders about what constitutes good data sharing practice. We conducted 15 interviews and three focus groups discussions involving 25 participants and found that they generally saw data sharing as something positive. Data sharing was viewed as a means to contribute to scientific progress and lead to better quality analysis, better use of resources, greater accountability, and more outputs. However, there were also important reservations including potential harms to research participants, their communities, and the researchers themselves. Given these concerns, several areas for discussion were identified: data standardization, appropriate consent models, and governance. PMID:26297749

  20. Most Probable Number Rapid Viability PCR Method to Detect Viable Spores of Bacillus anthracis in Swab Samples

    SciTech Connect

    Letant, S E; Kane, S R; Murphy, G A; Alfaro, T M; Hodges, L; Rose, L; Raber, E

    2008-05-30

    This note presents a comparison of Most-Probable-Number Rapid Viability (MPN-RV) PCR and traditional culture methods for the quantification of Bacillus anthracis Sterne spores in macrofoam swabs generated by the Centers for Disease Control and Prevention (CDC) for a multi-center validation study aimed at testing environmental swab processing methods for recovery, detection, and quantification of viable B. anthracis spores from surfaces. Results show that spore numbers provided by the MPN RV-PCR method were in statistical agreement with the CDC conventional culture method for all three levels of spores tested (10{sup 4}, 10{sup 2}, and 10 spores) even in the presence of dirt. In addition to detecting low levels of spores in environmental conditions, the MPN RV-PCR method is specific, and compatible with automated high-throughput sample processing and analysis protocols.

  1. Biomarkers for colitis-associated colorectal cancer

    PubMed Central

    Chen, Ru; Lai, Lisa A; Brentnall, Teresa A; Pan, Sheng

    2016-01-01

    Patients with extensive ulcerative colitis (UC) of more than eight years duration have an increased risk of colorectal cancer. Molecular biomarkers for dysplasia and cancer could have a great clinical value in managing cancer risk in these UC patients. Using a wide range of molecular techniques - including cutting-edge OMICS technologies - recent studies have identified clinically relevant biomarker candidates from a variety of biosamples, including colonic biopsies, blood, stool, and urine. While the challenge remains to validate these candidate biomarkers in multi-center studies and with larger patient cohorts, it is certain that accurate biomarkers of colitis-associated neoplasia would improve clinical management of neoplastic risk in UC patients. This review highlights the ongoing avenues of research in biomarker development for colitis-associated colorectal cancer. PMID:27672285

  2. Multivariate pattern recognition for diagnosis and prognosis in clinical neuroimaging: state of the art, current challenges and future trends.

    PubMed

    Haller, Sven; Lovblad, Karl-Olof; Giannakopoulos, Panteleimon; Van De Ville, Dimitri

    2014-05-01

    Many diseases are associated with systematic modifications in brain morphometry and function. These alterations may be subtle, in particular at early stages of the disease progress, and thus not evident by visual inspection alone. Group-level statistical comparisons have dominated neuroimaging studies for many years, proving fascinating insight into brain regions involved in various diseases. However, such group-level results do not warrant diagnostic value for individual patients. Recently, pattern recognition approaches have led to a fundamental shift in paradigm, bringing multivariate analysis and predictive results, notably for the early diagnosis of individual patients. We review the state-of-the-art fundamentals of pattern recognition including feature selection, cross-validation and classification techniques, as well as limitations including inter-individual variation in normal brain anatomy and neurocognitive reserve. We conclude with the discussion of future trends including multi-modal pattern recognition, multi-center approaches with data-sharing and cloud-computing.

  3. Risk of Spina Bifida and Maternal Cigarette, Alcohol, and Coffee Use during the First Month of Pregnancy

    PubMed Central

    Benedum, Corey M.; Yazdy, Mahsa M.; Mitchell, Allen A.; Werler, Martha M.

    2013-01-01

    This study was conducted to assess the association between the risks of spina bifida (SB) in relation to cigarette, alcohol, and caffeine consumption by women during the first month of pregnancy. Between 1988–2012, this multi-center case-control study interviewed mothers of 776 SB cases and 8,756 controls about pregnancy events and exposures. We evaluated cigarette smoking, frequency of alcohol drinking, and caffeine intake during the first lunar month of pregnancy in relation to SB risk. Logistic regression models were used to calculate adjusted odds ratios and 95% confidence intervals. Levels of cigarette smoking (1–9 and ≥10/day), alcohol intake (average ≥4 drinks/day) and caffeine intake (<1, 1, and ≥2 cups/day) were not likely to be associated with increased risk of SB. Further, results were similar among women who ingested less than the recommended amount of folic acid (400 μg/day). PMID:23917813

  4. [Promote the multi-disciplinary team, standardized diagnosis and treatment, translational research for ocular tumor in China].

    PubMed

    Fan, Xianqun

    2015-08-01

    Ocular tumor is one kind of life-threatening diseases which may causes vision loss as well as disability. Diagnostic evaluation should aim at not only primary lesion but also local or distant metastasis. Treatment on ocular tumor consists of surgery, radiotherapy, chemotherapy and immunotherapy. A multi-disciplinary team based treatment is required to deal with ocular tumor and it is the most effective shortcut for improving the diagnosis and treatment of the disease. Basic and translational researches and clinical application of new technology and equipment is the fundamental motivation of the development of diagnosis and treatment on ocular tumor. Bio-bank based translational research, multi-center clinical trial and standardized model setting up will contribute to the promotion of diagnosis and treatment on ocular tumor.

  5. Tranexamic acid in trauma: how should we use it?

    PubMed

    Roberts, I

    2015-06-01

    Tranexamic acid (TXA) reduces blood loss by inhibiting the enzymatic breakdown of fibrin. It is often used in surgery to decrease bleeding and the need for blood transfusion. In 2011, results from a multi-center, randomized, and placebo-controlled trial (CRASH-2 trial) showed that TXA (1 g loading dose over 10 min followed by an infusion of 1 g over 8 h) safely reduces mortality in bleeding trauma patients. Initiation of TXA treatment within 3 h of injury reduces the risk of hemorrhage death by about one-third, regardless of baseline risk. Because it does not have any serious adverse effects, TXA can be administered to a wide spectrum of bleeding trauma patients. Limiting its use to the most severely injured or those with a diagnosis of 'hyperfibrinolysis' would result in thousands of avoidable deaths. A clinical trial (CRASH-3 trial) of TXA in patients with traumatic brain injury is now in progress.

  6. Biomarkers for colitis-associated colorectal cancer

    PubMed Central

    Chen, Ru; Lai, Lisa A; Brentnall, Teresa A; Pan, Sheng

    2016-01-01

    Patients with extensive ulcerative colitis (UC) of more than eight years duration have an increased risk of colorectal cancer. Molecular biomarkers for dysplasia and cancer could have a great clinical value in managing cancer risk in these UC patients. Using a wide range of molecular techniques - including cutting-edge OMICS technologies - recent studies have identified clinically relevant biomarker candidates from a variety of biosamples, including colonic biopsies, blood, stool, and urine. While the challenge remains to validate these candidate biomarkers in multi-center studies and with larger patient cohorts, it is certain that accurate biomarkers of colitis-associated neoplasia would improve clinical management of neoplastic risk in UC patients. This review highlights the ongoing avenues of research in biomarker development for colitis-associated colorectal cancer.

  7. Vertical Aerosol Backscatter Variability from an Airborne Focused Continuous Wave CO2 Lidar

    NASA Technical Reports Server (NTRS)

    Jarzembski, Maurice A.; Srivastava, Vandana; Rothermel, Jeffry

    1998-01-01

    Atmospheric aerosol backscatter measurements using a continuous wave focused Doppler lidar at 9.1 micron wavelength were obtained over western North America and the Pacific Ocean during 13 - 26 September, 1995 as part of National Aeronautics and Space Administration's (NASA) Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) mission on board the NASA DC8 aircraft. Backscatter variability was measured for approximately 52 flight hours, covering equivalent horizontal distance of approximately 25,000 km in the troposphere. Quasi-vertical backscatter profiles were also obtained during various ascents and descents which ranged between approximately 0.1 to 12.0 km altitude. Aerosol haze layers were encountered at different altitudes. Similarities and differences for aerosol loading over land and over ocean were observed. A mid-tropospheric aerosol backscatter background mode was found with modal value approximately 1O(exp -10)/m/sr, consistent with previous airborne and ground-based datasets.

  8. A mini-review on factors and countermeasures associated with false-negative sentinel lymph node biopsies in breast cancer

    PubMed Central

    Han, Chao; Yang, Li

    2016-01-01

    Sentinel lymph node biopsy (SLNB) is a new surgical technique for local axillary lymph nodes (ALNs) of breast cancer. Large-scale clinical trials have confirmed that undergoing SLNB and ALN dissection (ALND) showed no significant difference for sentinel lymph node (SLN)-negative patients in terms of disease-free survival, overall survival and recurrence-free survival. However, false-negative results are still the main concern of physicians as well as patients who undergo SLNB instead of ALND. The American Society of Breast Surgeons established a task force to suggest acceptable standards for SLNB. In 2000, the task force recommended that the identification rate for SLNB be 85% or higher and the false-negative rate be 5% or lower. This review focuses on clinical factors (tumor volume, multifocal/multi-center cancers, neoadjuvant chemotherapy and skip metastasis), tracer techniques and pathological factors affecting SLNB and explores methods for reducing the false-negative rate PMID:27478323

  9. [Current status and future prospect of uveitis research in China].

    PubMed

    Yang, Peizeng

    2015-10-01

    Uveitis, as one of the major cause of blindness worldwide, seriously harms patients' vision and quality of life. The social and economic burden caused by uveitis cannot be ignored. Remarkable achievements in basic and clinical uveitis research were gained after decades of unremitting efforts by Chinese ophthalmologists. A number of original results and breakthroughs were achieved in researches on Behcet's disease, VKH syndrome and other important types of disease that lead to blindness. We are integrating the power of the Chinese Ocular Immunology Association, conducting multi-center collaborative research, and establishing the uveitis sample bank of Chinese. We need to train more uveitis specialists in the future, establish diagnostic and treatment practices of different types of uveitis, accelerate the research on main diseases which lead to blindness, further enhance the overall level of uveitis study, and enhance China's research position in international uveitis.

  10. Endovascular Treatment of Venous Occlusive Disease

    PubMed Central

    2008-01-01

    Endovascular treatment of acute and chronic iliac vein occlusions has proven to be safe and effective. Recanalization of chronic occlusions with balloon angioplasty and stenting can re-establish normal venous flow in the iliac veins and the IVC and relieve symptoms in the majority of treated patients. CDT with recanalization and stenting of underlying chronically obstructed iliofemoral segments is becoming the treatment of choice for patients with acute iliofemoral thrombosis, as anticoagulation and compression therapy alone are not satisfactory in preventing PTS. The new treatment modalities offer stimulating options for a patient group that is not adequately treated, neither by medical nor open surgical therapy. The substantial effort and additional costs of endovascular treatment appear to be justified by the encouraging mid-term results both for patients with acute and chronic occlusive iliofemoral disease. However, multi-center randomized prospective studies are required to further validate the role of these techniques. PMID:23555345

  11. Therapeutic directions for Parkinson's disease.

    PubMed

    Shoulson, Ira

    2010-01-01

    The focus on disease-modifying treatments and cures for Parkinson's disease (PD) has raised expectations for quantum leaps and overshadowed incremental gains that have been slowly achieved. Large multi-center clinical trials such as DATATOP and PRECEPT keep on generating new knowledge that is relevant to clinical care as well as experimental therapeutics. The largely unforeseen relationship between circulating uric acid and the occurrence and progression of PD was developed and confirmed in these clinical trials. Systematic follow-up of clinical trial cohorts after conclusion of the interventional phase provides added value that continues to inform about natural history, state and trait biomarkers, and genotype-phenotype relationships. These efforts are enhanced by data mining, public reporting, and timely sharing of data and biological samples. PMID:20187232

  12. Adrenocortical tumors and hyperplasias in childhood--etiology, genetics, clinical presentation and therapy.

    PubMed

    Sutter, Jennifer A; Grimberg, Adda

    2006-09-01

    Adrenocortical tumors are rare in children and are associated with a poor prognosis when malignant. The fund of knowledge regarding etiology, presentation and clinical outcomes remains limited. Evaluation of genetic disorders associated with the development of adrenocortical disorders has allowed researchers to identify a number of mutations that may be involved in tumorigenesis, including alterations in the GNAS1, PRKAR1A, TP53 and IGF2 genes. Clinical presentation in children is associated most commonly with young age, female gender and symptoms of virilization. Most children have localized disease at presentation which may be associated with a better prognosis when compared to adults. Surgical resection remains the only potentially curative treatment and mitotane, the most frequently used chemotherapeutic agent, has a poor response rate and is highly toxic. Broader participation in multi-center research, such as the International Pediatric Adrenocortical Tumor Registry, is needed to collect sufficient data to better guide our clinical management.

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

    PubMed

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

    2015-01-01

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

  14. CARs in Chronic Lymphocytic Leukemia – Ready to Drive

    PubMed Central

    Wierda, William; Jena, Bipulendu; Cooper, Laurence J. N.; Shpall, Elizabeth

    2013-01-01

    Adoptive transfer of antigen-specific T cells has been adapted by investigators for treatment of chronic lymphocytic leukemia (CLL). To overcome issues of immune tolerance which limits the endogenous adaptive immune response to tumor-associated antigens (TAAs), robust systems for the genetic modification and characterization of T cells expressing chimeric antigen receptors (CARs) to redirect specificity have been produced. Refinements with regards to persistence and trafficking of the genetically modified T cells are underway to help improve potency. Clinical trials utilizing this technology demonstrate feasibility, and increasingly, these early-phase trials are demonstrating impressive anti-tumor effects, particularly for CLL patients, paving the way for multi-center trials to establish the efficacy of CAR+ T cell therapy. PMID:23225251

  15. [Multidrug-resistant germs in neurological early rehabilitation (2004-2013)].

    PubMed

    Rollnik, J D; Samady, A-M; Grüter, L

    2014-10-01

    Multidrug-resistant germs are an increasing problem in neurological and neurosurgical early rehabilitation but reliable data is missing. The present study examined the prevalence of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and multidrug-resistant gram negative germs (MRGN) in a German neurological early rehabilitation facility (BDH Clinic Hessisch Oldendorf). Observation period was 2004-2013 (10 years). MRSA prevalence on admission was 11.4%, MRGN prevalence during rehabilitation 11.8%. A combination of different multidrug-resistant germs (MRSA plus MRGN) was observed in 3.8% of all cases. VRE were first detected in 2009, prevalence was as low as 0.1%. High prevalence of MRSA and MRGN raises major financial, medical, and ethical problems in early rehabilitation facilities. The authors encourage further multi-center studies and suggest a better recompense for this group of patients in the German DRG-system (Diagnosis Related Groups).

  16. Capnocytophaga ochracea-related Bacterium Bacteremia in a Hypertrophic Cardiomyopathy Patient without Neutropenia.

    PubMed

    Ito, Shimpei; Hagiya, Hideharu; Kimura, Keigo; Nishi, Isao; Yoshida, Hisao; Kioka, Hidetaka; Ohtani, Tomohito; Yamaguchi, Osamu; Tanabe, Kazuaki; Tomono, Kazunori; Sakata, Yasushi

    2016-01-01

    Gram-negative fusiform rods were detected in a blood culture obtained from a 63-year-old man who had been hospitalized for a long duration for severe heart failure. Although the organism could not be identified using a conventional method, it was finally identified as a bacterium of the Capnocytophaga ochracea group based on the results of biochemical testing, 16S rRNA sequencing and a matrix-assisted laser desorption ionization time-of-flight mass spectrometry analysis. Although neutropenic patients with poor oral hygiene are exclusively vulnerable to Capnocytophaga bacteremia, this case was unique because such predisposing conditions were not noted. A multi-centered investigation is warranted for a better understanding of this clinically rare, but potentially pathogenic organism. PMID:27629977

  17. Acute leukemia in children: A review of the current Indian data

    PubMed Central

    Arora, Ramandeep Singh; Arora, Brijesh

    2016-01-01

    Acute leukemias are the most common diagnostic group of childhood cancer. This review summarizes the published literature on reported current outcomes of childhood acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) from India. Overall survival in ALL ranged from 45% to 81% (commonly >60%) and event-free survival ranged from 41% to 70% (commonly >50%). Outcome data for AML was patchy with varying duration of follow-up, but it can be inferred that 50–80% of treated patients had experienced an event (toxic death, refractory disease or relapse). It is imperative that going forward focus should be on collaborative efforts, which promote treatment of patients on risk-stratified adapted protocols based on local infrastructure, improvement in supportive care and encourage prospective multi-center clinical trials. PMID:27606304

  18. The DFT study on C-H activation of ethene by YNH + and YC 2H 3N + in gas phase

    NASA Astrophysics Data System (ADS)

    Wang, Yong-Cheng; Li, Hui-Zhen; Geng, Zhi-Yuan; Zhang, Qing-Li; Si, Yu-Bing; Wang, Qing-Yun

    2009-09-01

    Calculations based on density functional theory (DFT) have been carried out to investigate the multi-centered transition state (MCTS) reaction mechanisms associated with the gas-phase ion/molecule reaction of YNH + with ethene. The potential energy surfaces (PESs), including both reaction pathways of hydrogen and ammonia elimination, have been explored and characterized. By contrast with ammonia elimination, dehydrogenation reaction channel is energetically favorable, which is in good agreement with the experimental observation. Moreover, the dominating product (YC 2H 3N +) can further react with ethene and the corresponding reaction mechanism which proceeds in a two-step manner and leads to the six-membered metallacyclic structure YC 4H 5N +, has also been investigated.

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

    PubMed Central

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

    2012-01-01

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

  20. Genre Complexes in Popular Music

    PubMed Central

    Childress, C. Clayton

    2016-01-01

    Recent work in the sociology of music suggests a declining importance of genre categories. Yet other work in this research stream and in the sociology of classification argues for the continued prevalence of genres as a meaningful tool through which creators, critics and consumers focus their attention in the topology of available works. Building from work in the study of categories and categorization we examine how boundary strength and internal differentiation structure the genre pairings of some 3 million musicians and groups. Using a range of network-based and statistical techniques, we uncover three musical “complexes,” which are collectively constituted by 16 smaller genre communities. Our analysis shows that the musical universe is not monolithically organized but rather composed of multiple worlds that are differently structured—i.e., uncentered, single-centered, and multi-centered. PMID:27203852

  1. The importance of cost considerations in the systems engineering process

    NASA Technical Reports Server (NTRS)

    Hodge, John D.

    1993-01-01

    This paper examines the question of cost, from the birth of a program to its conclusion, particularly from the point of view of large multi-center programs, and suggests how to avoid some of the traps and pitfalls. Emphasis is given to cost in the systems engineering process, but there is an inevitable overlap with program management. (These terms, systems engineering and program management, have never been clearly defined.) In these days of vast Federal budget deficits and increasing overseas competition, it is imperative that we get more for each research and development dollar. This is the only way we will retain our leadership in high technology and, in the long run, our way of life.

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

    PubMed Central

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

    2011-01-01

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

  3. Atomic Gaussian type orbitals and their Fourier transforms via the Rayleigh expansion

    NASA Astrophysics Data System (ADS)

    Yükçü, Niyazi

    2016-03-01

    Gaussian type orbitals (GTOs), which are one of the types of exponential type orbitals (ETOs), are used usually as basis functions in the multi-center atomic and molecular integrals to better understand physical and chemical properties of matter. In the Fourier transform method (FTM), basis functions have not simplicity to make mathematical operations, but their Fourier transforms are easier to use. In this work, with the help of FTM, Rayleigh expansion and some properties of unnormalized GTOs, we present new mathematical results for the Fourier transform of GTOs in terms of Laguerre polynomials, hypergeometric and Whittaker functions. Physical and analytical properties of GTOs are discussed and some numerical results have been given in a table. Finally, we compare our mathematical results with the other known literature results by using a computer program and details of evaluation are presented.

  4. Confidence-based ensemble for GBM brain tumor segmentation

    NASA Astrophysics Data System (ADS)

    Huo, Jing; van Rikxoort, Eva M.; Okada, Kazunori; Kim, Hyun J.; Pope, Whitney; Goldin, Jonathan; Brown, Matthew

    2011-03-01

    It is a challenging task to automatically segment glioblastoma multiforme (GBM) brain tumors on T1w post-contrast isotropic MR images. A semi-automated system using fuzzy connectedness has recently been developed for computing the tumor volume that reduces the cost of manual annotation. In this study, we propose a an ensemble method that combines multiple segmentation results into a final ensemble one. The method is evaluated on a dataset of 20 cases from a multi-center pharmaceutical drug trial and compared to the fuzzy connectedness method. Three individual methods were used in the framework: fuzzy connectedness, GrowCut, and voxel classification. The combination method is a confidence map averaging (CMA) method. The CMA method shows an improved ROC curve compared to the fuzzy connectedness method (p < 0.001). The CMA ensemble result is more robust compared to the three individual methods.

  5. Automated analysis of multi site MRI phantom data for the NIHPD project.

    PubMed

    Fu, Luke; Fonov, Vladimir; Pike, Bruce; Evans, Alan C; Collins, D Louis

    2006-01-01

    In large multi-center studies it is important to quantify data variations due to differences between sites and over time. Here we investigate inter-site variability in signal to noise ratio (SNR), percent integral uniformity (PIU), width and height using the American College of Radiology (ACR) phantom scans from the NIHPD project. Longitudinal variations are also analyzed. All measurements are fully automated. Our results show that the mean SNR, PIU and the 2 metric values were statistically different across sites. The maximum mean difference in diameter across sites was 2 mm (1.1%), and the maximum mean difference in height was 2.5 mm (1.7%). Over time, an average drift of 0.4 mm per year was observed for the diameter while a drift of 0.5 mm per year was observed for the height. Trends observed over time often depended not only on site, but also on modality and scanner manufacturer. PMID:17354766

  6. Detection of blood culture bacterial contamination using natural language processing.

    PubMed

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

    2009-11-14

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

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

    DOE PAGESBeta

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-22

    In this study, a coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomisticmore » simulations.« less

  8. Switching from usual brand cigarettes to a tobacco-heating cigarette or snus: Part 2. Biomarkers of exposure

    PubMed Central

    Ogden, Michael W.; Marano, Kristin M.; Jones, Bobbette A.; Morgan, Walter T.; Stiles, Mitchell F.

    2015-01-01

    Abstract A randomized, multi-center study of adult cigarette smokers switched to tobacco-heating cigarettes, snus or ultra-low machine yield tobacco-burning cigarettes (50/group) was conducted, and subjects’ experience with the products was followed for 24 weeks. Differences in biomarkers of tobacco exposure between smokers and never smokers at baseline and among groups relative to each other and over time were assessed. Results indicated reduced exposure to many potentially harmful constituents found in cigarette smoke following product switching. Findings support differences in exposure from the use of various tobacco products and are relevant to the understanding of a risk continuum among tobacco products (ClinicalTrials.gov Identifier: NCT02061917). PMID:26554277

  9. Barrett's Esophagus Methylation Profiles — EDRN Public Portal

    Cancer.gov

    We propose a nested case-control study of biomarkers in the setting of BE. By bringing together research institutions with large populations of patients with BE, we will perform a multi-center study of FISH and hypermethylation markers as possible prognostic factors in BE. The centers will select from their cohorts who have progressed to HGD or to adenocarcinoma of the esophagus ("progressors"), and who also donated samples prior to the development of cancer, when their histology was felt to be benign. These subjects will be compared to individuals who have been under endoscopic surveillance, but who have not progressed to HGD or EAC ("non-progressors"). Using this approach, we hope to identify promising markers for risk stratification in BE. We expect to be able to make successful application for a prospective study of markers identified in this case-control study.

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

    PubMed

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

    1993-01-01

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

  11. Therapeutic directions for Parkinson's disease.

    PubMed

    Shoulson, Ira

    2010-01-01

    The focus on disease-modifying treatments and cures for Parkinson's disease (PD) has raised expectations for quantum leaps and overshadowed incremental gains that have been slowly achieved. Large multi-center clinical trials such as DATATOP and PRECEPT keep on generating new knowledge that is relevant to clinical care as well as experimental therapeutics. The largely unforeseen relationship between circulating uric acid and the occurrence and progression of PD was developed and confirmed in these clinical trials. Systematic follow-up of clinical trial cohorts after conclusion of the interventional phase provides added value that continues to inform about natural history, state and trait biomarkers, and genotype-phenotype relationships. These efforts are enhanced by data mining, public reporting, and timely sharing of data and biological samples.

  12. Five-dimensional null and time-like supersymmetric geometries

    NASA Astrophysics Data System (ADS)

    Pasini, Giulio; Shahbazi, C. S.

    2016-09-01

    We show that there exist supersymmetric solutions of five-dimensional, pure, { N }=1 supergravity such that the norm of the supersymmetric Killing vector, built out of the Killing spinor, is a real not-everywhere analytic function such that all its derivatives vanish at a point where the Killing vector field becomes null. The norm of the Killing vector field then is not an analytic function on a neighborhood around this point. We explicitly construct such solutions by using a multi-center Gibbons-Hawking base. Although many of these solutions have infinite charges, we find explicit examples with finite charges that asymptote to {{AdS}}3× {S}2 and discuss their physical interpretation.

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

    PubMed

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

    2013-05-01

    Health disparities research among gay and bisexual men has focused primarily on risk and deficits. However, a focus on resiliencies within this population may greatly benefit health promotion. We describe a pattern of resilience (internalized homophobia (IHP) resolution) over the life-course and its associations with current health outcomes. 1,541 gay and bisexual men from the Multi-Center AIDS Cohort study, an ongoing prospective study of the natural and treated histories of HIV, completed a survey about life-course events thought to be related to health. The majority of men resolved IHP over time independent of demographics. Men who resolved IHP had significantly higher odds of positive health outcomes compared to those who did not. These results provide evidence of resilience among participants that is associated with positive health outcomes. Understanding resiliencies and incorporating them into interventions may help to promote health and well-being among gay and bisexual men.

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

    SciTech Connect

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-28

    A coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations.

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

    SciTech Connect

    Abbott, Lauren J.; Stevens, Mark J.

    2015-12-22

    In this study, a coarse-grained (CG) model is developed for the thermoresponsive polymer poly(N-isopropylacrylamide) (PNIPAM), using a hybrid top-down and bottom-up approach. Nonbonded parameters are fit to experimental thermodynamic data following the procedures of the SDK (Shinoda, DeVane, and Klein) CG force field, with minor adjustments to provide better agreement with radial distribution functions from atomistic simulations. Bonded parameters are fit to probability distributions from atomistic simulations using multi-centered Gaussian-based potentials. The temperature-dependent potentials derived for the PNIPAM CG model in this work properly capture the coil–globule transition of PNIPAM single chains and yield a chain-length dependence consistent with atomistic simulations.

  16. Computational Study of Supramolecular Self-Assembly Using CH/π Bonds

    NASA Astrophysics Data System (ADS)

    Han, C.; Li, Q.; Horton, S.; Fuentes-Cabrera, M.; Sumpter, B.; Lu, W.; Bernholc, J.; Maksymovych, P.; Pan, M.

    2012-02-01

    Self assembly is an important research area in supramolecular engineering. We show that CH/π bonds can be exploited as a vehicle to assemble clusters of well-defined sizes on metal surfaces. Specifically, we theoretically explain the observations of largely uniform distribution of phenylacetylene magic clusters, each consisting of six molecules, on Au(111) surfaces. Using density functional theory with a van der Waals functional, we discuss the reasons for the preference of the hexamer structure, the key effect of CH/π bonding on the self-assembly, and the critical role of the metal surface. Our calculated STM images and electronic properties are in good agreement with experiment. The cooperative, multi-center CH/π interactions offer an attractive tunability via chemical functionalization, and thus may provide a new avenue towards rationally designing a desired supramolecular shape and size.

  17. Cognitive Determinants of Academic Performance in Nigerian Pharmacy Schools.

    PubMed

    Ubaka, Chukwuemeka M; Sansgiry, Sujit S; Ukwe, Chinwe V

    2015-09-25

    Objective. To evaluate cognitive factors that might influence academic performance of students in Nigerian pharmacy schools. Methods. A cross-sectional, multi-center survey of Nigerian pharmacy students from 7 schools of pharmacy was conducted using 2 validated questionnaires measuring cognitive constructs such as test anxiety, academic competence, test competence, time management, and strategic study habits. Results. Female students and older students scored significantly better on time management skills and study habits, respectively. Test anxiety was negatively associated with academic performance while test competence, academic competence, and time management were positively associated with academic performance. These 4 constructs significantly discriminated between the lower and higher performing students, with the first 2 contributing to the most differences. Conclusion. Test and academic competence, test anxiety, and time management were significant factors associated with low and high academic performance among Nigerian pharmacy students. The study also demonstrated the significant effects of age, gender, and marital status on these constructs. PMID:27168614

  18. [Validation of simultaneously acquired blood pressure data by statistical coincidence determination of heart rate variability and blood pressure variability].

    PubMed

    Hopfe, J; Schütze, J; Voss, A

    2002-01-01

    We report on the comparison of simultaneous non-invasive measurements of finger blood pressure obtained at both hands with two Portapres systems. We investigated the impact of altering the measurement location on heart rate and blood pressure variability (HRV,BPV) parameters. Two 30 minutes recordings were done twice in 21 volunteers swapPing the systems. HRV and BPV parameters meanNN, sdNN, HF/P and Fw-Shannon were determined. Left and right side corresponding parameters were compared by U-test and correlations. Coincidence matrices were analysed by Mahalanobis distance. The minimal total divergence in HRV was 4.8%, in systolic BPV 6.7% and diastolic BPV 12.1%. These estimates recommend those parameters for multi-center studies that are insensitive to the measurement location. PMID:12465313

  19. HDU Deep Space Habitat (DSH) Overview

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.

    2011-01-01

    This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project Deep Space Habitat (DSH) analog that will be field-tested during the 2011 Desert Research and Technologies Studies (D-RATS) field tests. The HDU project is a technology pull project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU Pressurized Excursion Module (PEM) that was field tested in the 2010 D-RATS, adding habitation functionality to the prototype unit. The 2010 configuration of the HDU-PEM consisted of a lunar surface laboratory module that was used to bring over 20 habitation-related technologies together in a single platform that could be tested as an advanced habitation analog in the context of mission architectures and surface operations. The 2011 HDU-DSH configuration will build upon the PEM work, and emphasize validity of crew operations (habitation and living, etc), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The HDU project consists of a multi-center team brought together in a skunkworks approach to quickly build and validate hardware in analog environments. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 analog field test will include Multi Mission Space Exploration Vehicles (MMSEV) and the DSH among other demonstration elements to be brought together in a mission architecture context. This paper will describe overall objectives, various habitat configurations, strategic plan, and technology integration as it pertains to the 2011 field tests.

  20. Development, Implementation, and Compliance of Treatment Pathways in Radiation Medicine

    PubMed Central

    Potters, Louis; Raince, Jadeep; Chou, Henry; Kapur, Ajay; Bulanowski, Daniel; Stanzione, Regina; Lee, Lucille

    2013-01-01

    Introduction: While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. Methods: Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. Results: This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). Conclusion: This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians. PMID:23653892

  1. Evaluation of a virucidal quantitative carrier test for surface disinfectants.

    PubMed

    Rabenau, Holger F; Steinmann, Jochen; Rapp, Ingrid; Schwebke, Ingeborg; Eggers, Maren

    2014-01-01

    Surface disinfectants are part of broader preventive strategies preventing the transmission of bacteria, fungi and viruses in medical institutions. To evaluate their virucidal efficacy, these products must be tested with appropriate model viruses with different physico-chemical properties under conditions representing practical application in hospitals. The aim of this study was to evaluate a quantitative carrier assay. Furthermore, different putative model viruses like adenovirus type 5 (AdV-5) and different animal parvoviruses were evaluated with respect to their tenacity and practicability in laboratory handling. To evaluate the robustness of the method, some of the viruses were tested in parallel in different laboratories in a multi-center study. Different biocides, which are common active ingredients of surface disinfectants, were used in the test. After drying on stainless steel discs as the carrier, model viruses were exposed to different concentrations of three alcohols, peracetic acid (PAA) or glutaraldehyde (GDA), with a fixed exposure time of 5 minutes. Residual virus was determined after treatment by endpoint titration. All parvoviruses exhibited a similar stability with respect to GDA, while AdV-5 was more susceptible. For PAA, the porcine parvovirus was more sensitive than the other parvoviruses, and again, AdV-5 presented a higher susceptibility than the parvoviruses. All parvoviruses were resistant to alcohols, while AdV-5 was only stable when treated with 2-propanol. The analysis of the results of the multi-center study showed a high reproducibility of this test system. In conclusion, two viruses with different physico-chemical properties can be recommended as appropriate model viruses for the evaluation of the virucidal efficacy of surface disinfectants: AdV-5, which has a high clinical impact, and murine parvovirus (MVM) with the highest practicability among the parvoviruses tested.

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

    PubMed Central

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

    2013-01-01

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

  3. Randomized controlled trials and neuro-oncology: should alternative designs be considered?

    PubMed

    Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

    2015-09-01

    Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the

  4. Candida Infective Endocarditis

    PubMed Central

    Baddley, John W.; Benjamin, Daniel K.; Patel, Mukesh; Miró, José; Athan, Eugene; Barsic, Bruno; Bouza, Emilio; Clara, Liliana; Elliott, Tom; Kanafani, Zeina; Klein, John; Lerakis, Stamatios; Levine, Donald; Spelman, Denis; Rubinstein, Ethan; Tornos, Pilar; Morris, Arthur J.; Pappas, Paul; Fowler, Vance G.; Chu, Vivian H.; Cabell, Christopher

    2009-01-01

    Purpose Candida infective endocarditis (IE) is uncommon but often fatal. Most epidemiologic data are derived from small case series or case reports. This study was conducted to explore epidemiology, treatment patterns, and outcomes of patients with Candida IE. Methods We compared 33 Candida IE cases to 2716 patients with non-fungal IE in the International Collaboration on Endocarditis - Prospective Cohort Study. Patients were enrolled and data collected from June 2000 until August 2005. Results Patients with Candida IE were more likely to have prosthetic valves (p<0.001), short term indwelling catheters (p<0.0001), and have healthcare-associated infection (p<0.001). Reasons for surgery differed between the two groups: myocardial abscess (46.7% vs. 22.2% p=0.026) and persistent positive blood cultures (33.3% vs. 9.9%, p=0.003) were more common among those with Candida IE. Mortality at discharge was higher in patients with Candida IE (30.3%) when compared to non-fungal cases (17%, p=0.046). Among Candida patients, mortality was similar in patients who received combination surgical and antifungal therapy versus antifungal therapy alone (33.3% vs. 27.8%, p=0.26). New antifungal drugs, particularly echinocandins, were used frequently. Conclusions These multi-center data suggest distinct epidemiologic features of Candida IE when compared to non-fungal cases. Indications for surgical intervention are different and mortality is increased. Newer antifungal treatment options are increasingly used. Large, multi-center studies are needed to help better define Candida IE. PMID:18283504

  5. The growth and impact of Alzheimer's Disease Centers as measured by social network analysis

    PubMed Central

    Hughes, Michael E.; Peeler, John; Hogenesch, John B.; Trojanowski, John Q.

    2014-01-01

    Importance Alzheimer's disease (AD) is a devastating neurodegenerative disorder with no effective therapies. In 1984, the National Institute on Aging created the first five AD Centers (ADCs) in an effort to coordinate research efforts into the pathology and treatment of AD. Since that time, the ADC program has expanded to include 27 centers in major medical schools throughout the United States. A major aim of ADCs is to develop shared resources – such as tissue samples and patient populations – and thereby promote large-scale, high-impact studies that go beyond the capabilities of any single investigator or institution working in isolation. Objective and Design To quantitatively evaluate the performance of this program over the past quarter century, we systematically harvested every paper published by ADC investigators and used social network analysis to analyze co-publication networks. Results We found that the frequency of collaborations has increased dramatically during this time, even after the expansion of ADCs and the recruitment of new investigators plateaued. Moreover, the collaborations established within the context of the ADC program are increasingly inter-institutional, consistent with the overall goal of the program to catalyze multi-center research teams. Most importantly, we determined that collaborative, multi-center ADC research articles are consistently of higher-impact than AD papers as a whole. Conclusions We conclude that the ADC program has successfully fostered high-impact, multi-university collaborations, and suggest that its structural and administrative features could be replicated in other fields of patient oriented research. PMID:24514750

  6. A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury.

    PubMed

    Bragge, Peter; Synnot, Anneliese; Maas, Andrew I; Menon, David K; Cooper, D James; Rosenfeld, Jeffrey V; Gruen, Russell L

    2016-08-15

    Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative

  7. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation

    PubMed Central

    Alsheikh-Ali, Alawi A.; Hersi, Ahmad S.; Hamad, Adel K. S.; Al Fagih, Ahmed R.; Al-Samadi, Faisal M.; Almusaad, Abdulmohsen M.; Bokhari, Fayez A.; Al-Kandari, Fawzia; Al-Ghamdi, Bandar S.; Al Rawahi, Najib; Asaad, Nidal; Alkaabi, Salem; Daoulah, Amin; Zaky, Hosam A.; Elhag, Omer; Al Hebaishi, Yahya S.; Sweidan, Raed; Alanazi, Haitham; Chase, David; Sabbour, Hani; Al Meheiri, Mohammad; Al Abri, Ismail; Amin, Mohammad; Dagriri, Khaled; Ahmed, Adil O.; Shafquat, Azam; Khan, Shahul Hameed

    2015-01-01

    Background: The implantable cardioverter-defibrillator (ICD) is effective in the prevention of sudden cardiac death in high-risk patients. Little is known about ICD use in the Arabian Gulf. We designed a study to describe the characteristics and outcomes of patients receiving ICDs in the Arab Gulf region. Methods: Gulf ICD is a prospective, multi-center, multinational, and observational study. All adult patients 18 years or older, receiving a de novo ICD implant and willing to sign a consent form will be eligible. Data on baseline characteristics, ICD indication, procedure and programing, in-hospital, and 1-year outcomes will be collected. Target enrollment is 1500 patients, which will provide adequate precision across a wide range of expected event rates. Results: Fifteen centers in six countries are enrolling patients (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Bahrain, and Qatar). Two-thirds of the centers have dedicated electrophysiology laboratories, and in almost all centers ICDs are implanted exclusively by electrophysiologists. Nearly three-quarters of the centers reported annual ICD implant volumes of ≤150 devices, and pulse generator replacements constitute <30% of implants in the majority of centers. Enrollment started in December 2013, and accrual rate increased as more centers entered the study reaching an average of 98 patients per month. Conclusions: Gulf ICD is the first prospective, observational, multi-center, and multinational study of the characteristics and, the outcomes of patients receiving ICDs in the Arab Gulf region. The study will provide valuable insights into the utilization of and outcomes related to ICD therapy in the Gulf region. PMID:26900416

  8. Towards a National Pediatric Musculoskeletal Trauma Outcomes Registry: the Pediatric Orthopaedic Trauma Outcomes Research Group (POTORG) experience.

    PubMed

    Vitale, Michael G; Vitale, Mark A; Lehmann, Charles L; Hyman, Joshua E; Roye, David P; Skaggs, David L; Schmitz, Michael L; Sponseller, Paul D; Flynn, John M

    2006-01-01

    This study is a pilot effort towards the broader implementation of a national pediatric musculoskeletal trauma outcomes registry. The primary goal of this project is to explore the feasibility of a web-based data acquisition and management platform and to identify catalysts and obstacles to multi-center collaboration. A prospective cohort of children presenting to the Pediatric Emergency Departments with ankle, femur, supracondylar humerus, tibial spine, or open fractures at five clinical centers between October 2001 and March 2003 comprised the study population. Patients were enrolled via the treating orthopaedic resident, using a web-based data acquisition and management system. Orthopaedic attendees were sent an automated reminder to complete a follow-up form one week after treatment, and parents of enrolled children were sent child and parent health questionnaires by e-mail and mail in order to capture health-related quality of life and post-traumatic stress symptoms. A total of 299 patients were enrolled in the study with an average age of 7.3 years. Post-treatment follow-up questionnaires were completed by 39% of the attending orthopaedic surgeons, and by 43% of the enrolled patients or patient's parents. Children old enough to complete health questionnaires scored lower in 5 of 12 functional domains including Physical Function, Role/Social Emotional/Behavioral, Parental Impact-Emotional, Family Activities, and Family Cohesion. Within the subset of patients sustaining femur fractures whose parents completed health questionnaires, 9.5% reported significant post-traumatic stress symptoms. This study demonstrates the potential of a multi-center web-based registry to facilitate the collection of a rich array of pediatric trauma, treatment and patient-based outcomes data, although new regulatory issues regarding patient privacy pose challenges to such an approach.

  9. Wall crossing from Boltzmann black hole halos

    NASA Astrophysics Data System (ADS)

    Manschot, Jan; Pioline, Boris; Sen, Ashoke

    2011-07-01

    A key question in the study of mathcal{N} = 2 supersymmetric string or field theories is to understand the decay of BPS bound states across walls of marginal stability in the space of parameters or vacua. By representing the potentially unstable bound states as multi-centered black hole solutions in mathcal{N} = 2 supergravity, we provide two fully general and explicit formulæ for the change in the (refined) index across the wall. The first, "Higgs branch" formula relies on Reineke's results for invariants of quivers without oriented loops, specialized to the Abelian case. The second, "Coulomb branch" formula results from evaluating the symplectic volume of the classical phase space of multi-centered solutions by localization. We provide extensive evidence that these new formulæ agree with each other and with the mathematical results of Kontsevich and Soibelman (KS) and Joyce and Song (JS). The main physical insight behind our results is that the Bose-Fermi statistics of individual black holes participating in the bound state can be traded for Maxwell-Boltzmann statistics, provided the (integer) index Ω( γ) of the internal degrees of freedom carried by each black hole is replaced by an effective (rational) index bar{Ω }left( γ right) = sumnolimits_{left. m right|γ } {{{{Ω left( {{{γ } left/ {m} right.}} right)}} left/ {{{m^2}}} right.}} similar map also exists for the refined index. This observation provides a physical rationale for the appearance of the rational Donaldson-Thomas invariant bar{Ω }left( γ right) in the works of KS and JS.

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

    PubMed Central

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

    2014-01-01

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

  11. Evaluation of a virucidal quantitative carrier test for surface disinfectants.

    PubMed

    Rabenau, Holger F; Steinmann, Jochen; Rapp, Ingrid; Schwebke, Ingeborg; Eggers, Maren

    2014-01-01

    Surface disinfectants are part of broader preventive strategies preventing the transmission of bacteria, fungi and viruses in medical institutions. To evaluate their virucidal efficacy, these products must be tested with appropriate model viruses with different physico-chemical properties under conditions representing practical application in hospitals. The aim of this study was to evaluate a quantitative carrier assay. Furthermore, different putative model viruses like adenovirus type 5 (AdV-5) and different animal parvoviruses were evaluated with respect to their tenacity and practicability in laboratory handling. To evaluate the robustness of the method, some of the viruses were tested in parallel in different laboratories in a multi-center study. Different biocides, which are common active ingredients of surface disinfectants, were used in the test. After drying on stainless steel discs as the carrier, model viruses were exposed to different concentrations of three alcohols, peracetic acid (PAA) or glutaraldehyde (GDA), with a fixed exposure time of 5 minutes. Residual virus was determined after treatment by endpoint titration. All parvoviruses exhibited a similar stability with respect to GDA, while AdV-5 was more susceptible. For PAA, the porcine parvovirus was more sensitive than the other parvoviruses, and again, AdV-5 presented a higher susceptibility than the parvoviruses. All parvoviruses were resistant to alcohols, while AdV-5 was only stable when treated with 2-propanol. The analysis of the results of the multi-center study showed a high reproducibility of this test system. In conclusion, two viruses with different physico-chemical properties can be recommended as appropriate model viruses for the evaluation of the virucidal efficacy of surface disinfectants: AdV-5, which has a high clinical impact, and murine parvovirus (MVM) with the highest practicability among the parvoviruses tested. PMID:24475079

  12. Candida infective endocarditis.

    PubMed

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

    2008-07-01

    Candida infective endocarditis (IE) is uncommon but often fatal. Most epidemiologic data are derived from small case series or case reports. This study was conducted to explore the epidemiology, treatment patterns, and outcomes of patients with Candida IE. We compared 33 Candida IE cases to 2,716 patients with non-fungal IE in the International Collaboration on Endocarditis-Prospective Cohort Study (ICE-PCS). Patients were enrolled and the data collected from June 2000 until August 2005. We noted that patients with Candida IE were more likely to have prosthetic valves (p < 0.001), short-term indwelling catheters (p < 0.0001), and have healthcare-associated infections (p < 0.001). The reasons for surgery differed between the two groups: myocardial abscess (46.7% vs. 22.2%, p = 0.026) and persistent positive blood cultures (33.3% vs. 9.9%, p = 0.003) were more common among those with Candida IE. Mortality at discharge was higher in patients with Candida IE (30.3%) when compared to non-fungal cases (17%, p = 0.046). Among Candida patients, mortality was similar in patients who received combination surgical and antifungal therapy versus antifungal therapy alone (33.3% vs. 27.8%, p = 0.26). New antifungal drugs, particularly echinocandins, were used frequently. These multi-center data suggest distinct epidemiologic features of Candida IE when compared to non-fungal cases. Indications for surgical intervention are different and mortality is increased. Newer antifungal treatment options are increasingly used. Large, multi-center studies are needed to help better define Candida IE.

  13. Intra-/inter-laboratory validation study on reactive oxygen species assay for chemical photosafety evaluation using two different solar simulators.

    PubMed

    Onoue, Satomi; Hosoi, Kazuhiro; Toda, Tsuguto; Takagi, Hironori; Osaki, Naoto; Matsumoto, Yasuhiro; Kawakami, Satoru; Wakuri, Shinobu; Iwase, Yumiko; Yamamoto, Toshinobu; Nakamura, Kazuichi; Ohno, Yasuo; Kojima, Hajime

    2014-06-01

    A previous multi-center validation study demonstrated high transferability and reliability of reactive oxygen species (ROS) assay for photosafety evaluation. The present validation study was undertaken to verify further the applicability of different solar simulators and assay performance. In 7 participating laboratories, 2 standards and 42 coded chemicals, including 23 phototoxins and 19 non-phototoxic drugs/chemicals, were assessed by the ROS assay using two different solar simulators (Atlas Suntest CPS series, 3 labs; and Seric SXL-2500V2, 4 labs). Irradiation conditions could be optimized using quinine and sulisobenzone as positive and negative standards to offer consistent assay outcomes. In both solar simulators, the intra- and inter-day precisions (coefficient of variation; CV) for quinine were found to be below 10%. The inter-laboratory CV for quinine averaged 15.4% (Atlas Suntest CPS) and 13.2% (Seric SXL-2500V2) for singlet oxygen and 17.0% (Atlas Suntest CPS) and 7.1% (Seric SXL-2500V2) for superoxide, suggesting high inter-laboratory reproducibility even though different solar simulators were employed for the ROS assay. In the ROS assay on 42 coded chemicals, some chemicals (ca. 19-29%) were unevaluable because of limited solubility and spectral interference. Although several false positives appeared with positive predictivity of ca. 76-92% (Atlas Suntest CPS) and ca. 75-84% (Seric SXL-2500V2), there were no false negative predictions in both solar simulators. A multi-center validation study on the ROS assay demonstrated satisfactory transferability, accuracy, precision, and predictivity, as well as the availability of other solar simulators. PMID:24384453

  14. A Quantitative Analysis of Out-of-Hospital Pediatric and Adolescent Resuscitation Quality–A Report from the ROC Epistry–Cardiac Arrest

    PubMed Central

    Sutton, Robert M.; Case, Erin; Brown, Siobhan P.; Atkins, Dianne L.; Nadkarni, Vinay M.; Kaltman, Jonathan; Callaway, Clifton W.; Idris, Ahamed H.; Nichol, Graham; Hutchison, Jamie; Drennan, Ian R.; Austin, Michael A; Daya, Mohamud; Cheskes, Sheldon; Nuttall, Jack; Herren, Heather; Christenson, James; Andrusiek, Douglas L; Vaillancourt, Christian; Menegazzi, James J.; Rea, Thomas D.; Berg, Robert A.

    2015-01-01

    Aim High-quality cardiopulmonary resuscitation (CPR) may improve survival. The quality of CPR performed during pediatric out-of-hospital cardiac arrest (p-OHCA) is largely unknown. The main objective of this study was to describe the quality of CPR performed during p-OHCA resuscitation attempts. Methods Prospective observational multi-center cohort study of p-OHCA patients ≥1 and < 19 years of age registered in the Resuscitation Outcomes Consortium (ROC) Epistry database. The primary outcome was an a priori composite variable of compliance with American Heart Association (AHA) guidelines for both chest compression (CC) rate and CC fraction (CCF). Event compliance was defined as a case with 60% or more of its minute epochs compliant with AHA targets (rate 100–120 min−1; depth ≥38 mm; and CCF ≥0.80). In a secondary analysis, multivariable logistic regression was used to evaluate the association between guideline compliance and return of spontaneous circulation (ROSC). Results Between December 2005 and December 2012, 2,564 pediatric events were treated by EMS providers, 390 of which were included in the final cohort. Of these events, 22% achieved AHA compliance for both rate and CCF, 36% for rate alone, 53% for CCF alone, and 58% for depth alone. Over time, there was a significant increase in CCF (p< 0.001) and depth (p=0.03). After controlling for potential confounders, there was no significant association between AHA guideline compliance and ROSC. Conclusions In this multi-center study, we have established that there are opportunities for professional rescuers to improve prehospital CPR quality. Encouragingly, CCF and depth both increased significantly over time. PMID:25917262

  15. 12 CFR Appendix B to Subpart A of... - Appendix B to Subpart A of Part 327

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Converted value Standard & Poor's: AAA 1.00 AA+ 1.05 AA 1.15 AA− 1.30 A+ 1.50 A 1.80 A− 2.20 BBB+ 2.70 BBB or worse 3.00 Moody's: Aaa 1.00 Aa1 1.05 Aa2 1.15 Aa3 1.30 A1 1.50 A2 1.80 A3 2.20 Baa1 2.70 Baa2 or worse 3.00 Fitch's: AAA 1.00 AA+ 1.05 AA 1.15 AA− 1.30 A+ 1.50 A 1.80 A− 2.20 BBB+ 2.70 BBB or worse...

  16. Ceramic component for electrodes

    DOEpatents

    Marchant, David D.; Bates, J. Lambert

    1980-01-01

    A ceramic component suitable for preparing MHD generator electrodes having the compositional formula: Y.sub.x (Mg.sub.y Cr.sub.z).sub.w Al.sub.(1-w) O.sub.3 where x=0.9 to 1.05, y=0.02 to 0.2, z=0.8 to 1.05 and w=1.0 to 0.5. The component is resistant to the formation of hydration products in an MHD environment, has good electrical conductivity and exhibits a lower electrochemical corrosion rate than do comparable compositions of lanthanum chromite.

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

    NASA Astrophysics Data System (ADS)

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

    2016-09-01

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

  18. Artificial Gravity as a Multi-System Countermeasure to Bed Rest Deconditioning: Pilot Study Overview

    NASA Technical Reports Server (NTRS)

    Paloski, William H.; Young, L. R.

    2007-01-01

    Efficient, effective, multi-system countermeasures will likely be required to protect the health, safety, and performance of crews aboard planned exploration-class space flight missions to Mars and beyond. To that end, NASA, DLR, and IMBP initiated a multi-center international project to begin systematically exploring the utility of artificial gravity (AG) as a multi-system countermeasure in ground based venues using test subjects deconditioned by bed rest. The goal of this project is to explore the efficacy of short-radius, intermittent AG as a countermeasure to bone, muscle, cardiovascular, and sensory-motor adaptations to hypogravity. This session reports the results from a pilot study commissioned to validate a standardized protocol to be used by all centers involved in the project. Subject selection criteria, medical monitoring requirements, medical care procedures, experiment control procedures, and standardized dependent measures were established jointly. Testing was performed on 15 rigorously screened male volunteers subjected to 21 days of 6deg HDT bed rest. (All provided written consent to volunteer after the nature of the study and its hazards were clearly explained to them.) Eight were treated with daily 1hr AG exposures (2.5g at the feet decreasing to 1.0g at the heart) aboard a short radius (3m) centrifuge, while the other seven served as controls. Multiple tests of multiple dependent measures were made in each of the primary physiological systems of interest during a 10 day acclimatization period prior to HDT bed rest and again during an 8 day recovery period after the bed rest period was complete. Analyses of these data (presented in other papers in this session) suggest the AG prescription had salutary effects on aspects of the bone, muscle, and cardiovascular systems, with no untoward effects on the vestibular system, the immune system, or cognitive function. Furthermore, treatment subjects were able to tolerate 153/160 centrifuge sessions over

  19. The Habitat Demonstration Unit Project Overview

    NASA Technical Reports Server (NTRS)

    Kennedy, Kriss J.; Grill, Tracy R.; Tri, Terry O.; Howe, Alan S.

    2010-01-01

    This paper will describe an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) Project. The HDU project is a "technology-pull" project that integrates technologies and innovations from numerous NASA centers. This project will be used to investigate and validate surface architectures, operations concepts, and requirements definition of various habitation concepts. The first habitation configuration this project will build and test is the Pressurized Excursion Module (PEM). This habitat configuration - the PEM - is based on the Constellation Architecture Scenario 12.1 concept of a vertically oriented habitat module. The HDU project will be tested as part of the 2010 Desert Research and Technologies Simulations (D-RATS) test objectives. The purpose of this project is to develop, integrate, test, and evaluate a habitat configuration in the context of the mission architectures and surface operation concepts. A multi-center approach will be leveraged to build, integrate, and test the PEM through a shared collaborative effort of multiple NASA centers. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Lunar Surface Systems Project Office (LSSPO) to test surface elements in a surface analog environment. The 2010 analog field test will include two Lunar Electric Rovers (LER) and the PEM among other surface demonstration elements. This paper will describe the overall objectives, its various habitat configurations, strategic plan, and technology integration as it pertains to the 2010 and 2011 field analog tests. To accomplish the development of the PEM from conception in June 2009 to rollout for operations in July 2010, the HDU project team is using a set of design standards to define the interfaces between the various systems of PEM and to the payloads, such as the Geology Lab, that those systems will support

  20. Design of a 2-Hour Prebreathe Protocol for Space Walks (EVAs) from the International Space Station (ISS)

    NASA Technical Reports Server (NTRS)

    Gernhardt, M. L.; Conkin, J.; Foster, P. P.; Pilmanis, A. A.; Butler, B. D.; Fife, C.; Vann, R. D.; Gerth, W. A.; Loftin, K. C.; Dervay, J.; Waligora, J. M.; Powell, M. R.; Homick, Jerry L. (Technical Monitor)

    2000-01-01

    The majority of extravehicular activities (EVAs) performed from the shuttle use a 10.2 psi staged decompression. The International Space Station (ISS) will operate at 14.7 psi, requiring crews to "campout" in the airlock at 10.2 psi. The constraints associated with campout (crew isolation, oxygen usage, and waste management), provided the rationale to develop a 2-hour prebreathe protocol from 14.7 psi. Previous studies on the affect of microgravity and exercise during prebreathe suggested the feasibility of this approach. Various combinations of adynamia (nonwalking subjects), prebreathe exercise doses, and space suit donning options (10.2 vs. 14.7 psi) were analyzed against timeline and consumable constraints. Prospective decompression sickness (DCS) and venous gas emboli (VGE) accept/reject criteria were defined from statistical analysis of historical DCS data, combined with risk management of DCS under ISS mission circumstances. Maximum operational DCS levels were defined based on protecting for EVA capability with two crew members at 95% confidence, throughout ISS lifetime (within the constraints of NASA DCS disposition policy JPG 1800.3). The accept / reject limits were adjusted for greater safety (including Grade IV VGE criteria) based on analysis of related medical factors. Monte-Carlo simulation was performed to design a closed sequential, multi-center laboratory trial, including the capability of rejecting the primary protocol and testing at least one alternate exercise dose, within the 2-hour prebreathe. The 2-hour protocol incorporates 0, breathing for 5 0 min at 14.7 psi, including 10 min dual cycle ergometry at 75%VO(2max). It requires an additional 30 minO2breathing during depress from 14.7 to 10.2 psi, followed by a 30-60 min suit donning break at 10.2 psi/26.5% O2. It concludes with a 40 min in-suit O2 prebreathe. The protocol would be accepted for operations, if the incidence of DCS was less than 15% and Grade IV VGE less than 20%, both at 95

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

    PubMed Central

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

    2012-01-01

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

  2. Independent but Coordinated Trials: Insights from the Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group

    PubMed Central

    Yeh, Hsin-Chieh; Clark, Jeanne M.; Emmons, Karen M.; Moore, Renee H.; Bennett, Gary G; Warner, Erica T.; Sarwer, Davis B.; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A.; Wells, Barbara; Wadden, Thomas A.; Colditz, Graham A.; Appel, Lawrence J.

    2011-01-01

    Background The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the “Practice Based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.” Purpose We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. Methods The Collaborative Research Group consists of three individual studies: “Be Fit, Be Well“(Washington University in St. Louis/Harvard University), “POWER Hopkins” (Johns Hopkins), and “POWER-UP” (University of Pennsylvania). There are a total of 15 participating clinics with ~1,100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. Results The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. Limitations The challenges of the organizational design include the complex decision making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols. Conclusions The POWER Trials Collaborative Research Group is a case study of an

  3. Measurement of the glial fibrillary acidic protein and its breakdown products GFAP-BDP biomarker for the detection of traumatic brain injury compared to computed tomography and magnetic resonance imaging.

    PubMed

    McMahon, Paul J; Panczykowski, David M; Yue, John K; Puccio, Ava M; Inoue, Tomoo; Sorani, Marco D; Lingsma, Hester F; Maas, Andrew I R; Valadka, Alex B; Yuh, Esther L; Mukherjee, Pratik; Manley, Geoffrey T; Okonkwo, David O

    2015-04-15

    Glial fibrillary acidic protein and its breakdown products (GFAP-BDP) are brain-specific proteins released into serum as part of the pathophysiological response after traumatic brain injury (TBI). We performed a multi-center trial to validate and characterize the use of GFAP-BDP levels in the diagnosis of intracranial injury in a broad population of patients with a positive clinical screen for head injury. This multi-center, prospective, cohort study included patients 16-93 years of age presenting to three level 1 trauma centers with suspected TBI (loss of consciousness, post-trauma amnesia, and so on). Serum GFAP-BDP levels were drawn within 24 h and analyzed, in a blinded fashion, using sandwich enzyme-linked immunosorbent assay. The ability of GFAP-BDP to predict intracranial injury on admission computed tomography (CT) as well as delayed magnetic resonance imaging was analyzed by multiple regression and assessed by the area under the receiver operating characteristic curve (AUC). Utility of GFAP-BDP to predict injury and reduce unnecessary CT scans was assessed utilizing decision curve analysis. A total of 215 patients were included, of which 83% suffered mild TBI, 4% moderate, and 12% severe; mean age was 42.1±18 years. Evidence of intracranial injury was present in 51% of the sample (median Rotterdam Score, 2; interquartile range, 2). GFAP-BDP demonstrated very good predictive ability (AUC=0.87) and demonstrated significant discrimination of injury severity (odds ratio, 1.45; 95% confidence interval, 1.29-1.64). Use of GFAP-BDP yielded a net benefit above clinical screening alone and a net reduction in unnecessary scans by 12-30%. Used in conjunction with other clinical information, rapid measurement of GFAP-BDP is useful in establishing or excluding the diagnosis of radiographically apparent intracranial injury throughout the spectrum of TBI. As an adjunct to current screening practices, GFAP-BDP may help avoid unnecessary CT scans without sacrificing

  4. Measurement of the Glial Fibrillary Acidic Protein and Its Breakdown Products GFAP-BDP Biomarker for the Detection of Traumatic Brain Injury Compared to Computed Tomography and Magnetic Resonance Imaging

    PubMed Central

    McMahon, Paul J.; Panczykowski, David M.; Yue, John K.; Puccio, Ava M.; Inoue, Tomoo; Sorani, Marco D.; Lingsma, Hester F.; Maas, Andrew I.R.; Valadka, Alex B.; Yuh, Esther L.; Mukherjee, Pratik; Manley, Geoffrey T.; Casey, Scott S.; Cheong, Maxwell; Cooper, Shelly R.; Dams-O'Connor, Kristen; Gordon, Wayne A.; Hricik, Allison J.; Lawless, Kerri; Menon, David; Schnyer, David M.; Vassar, Mary J.

    2015-01-01

    Abstract Glial fibrillary acidic protein and its breakdown products (GFAP-BDP) are brain-specific proteins released into serum as part of the pathophysiological response after traumatic brain injury (TBI). We performed a multi-center trial to validate and characterize the use of GFAP-BDP levels in the diagnosis of intracranial injury in a broad population of patients with a positive clinical screen for head injury. This multi-center, prospective, cohort study included patients 16–93 years of age presenting to three level 1 trauma centers with suspected TBI (loss of consciousness, post-trauma amnesia, and so on). Serum GFAP-BDP levels were drawn within 24 h and analyzed, in a blinded fashion, using sandwich enzyme-linked immunosorbent assay. The ability of GFAP-BDP to predict intracranial injury on admission computed tomography (CT) as well as delayed magnetic resonance imaging was analyzed by multiple regression and assessed by the area under the receiver operating characteristic curve (AUC). Utility of GFAP-BDP to predict injury and reduce unnecessary CT scans was assessed utilizing decision curve analysis. A total of 215 patients were included, of which 83% suffered mild TBI, 4% moderate, and 12% severe; mean age was 42.1±18 years. Evidence of intracranial injury was present in 51% of the sample (median Rotterdam Score, 2; interquartile range, 2). GFAP-BDP demonstrated very good predictive ability (AUC=0.87) and demonstrated significant discrimination of injury severity (odds ratio, 1.45; 95% confidence interval, 1.29–1.64). Use of GFAP-BDP yielded a net benefit above clinical screening alone and a net reduction in unnecessary scans by 12–30%. Used in conjunction with other clinical information, rapid measurement of GFAP-BDP is useful in establishing or excluding the diagnosis of radiographically apparent intracranial injury throughout the spectrum of TBI. As an adjunct to current screening practices, GFAP-BDP may help avoid unnecessary CT scans without

  5. Ethnic Incongruence and the Student-Teacher Relationship: The Perspective of Ethnic Majority Teachers

    ERIC Educational Resources Information Center

    Thijs, Jochem; Westhof, Saskia; Koomen, Helma

    2012-01-01

    Among 36 ethnic-Dutch school teachers in the Netherlands, the present study examined the role of ethnic incongruence in perceived student-teacher relationship quality. Teachers rated their relationships with 59 Turkish-Dutch, 62 Moroccan-Dutch, and 109 ethnic-Dutch students attending grades 4 through 6 (M[subscript age] = 10.81 years, SD = 1.05).…

  6. Determination of radiative current in LED's

    NASA Technical Reports Server (NTRS)

    Thomas, E. F.

    1976-01-01

    Directly measureable quantity of radiative output in LED's is total forward current. When applied forward voltage is below 1.05 V the forward current is primarily nonradiative and varies with forward voltage as exp(qV/2kT), when q is the charge, V is applied voltage, K is Boltzmann's constant, and T is operating temperature.

  7. The Jobs Can Be Found

    ERIC Educational Resources Information Center

    Conners, David; McCarthy, Laena

    2007-01-01

    In fall 2005, Rachel Holt and Adrienne L. Strock's article, "The Entry-Level Gap," ("Library Journal" 5/1/05, p.36-38) became the talk of the town. Holt and Strock argued that the new Master of Library Science (MLS) graduates have trouble finding work because of low salaries and the disappearance of entry-level positions owing to…

  8. Creation of a Cellooligosaccharide-Assimilating Escherichia coli Strain by Displaying Active Beta-Glucosidase on the Cell Surface via a Novel Anchor Protein ▿

    PubMed Central

    Tanaka, Tsutomu; Kawabata, Hitomi; Ogino, Chiaki; Kondo, Akihiko

    2011-01-01

    We demonstrated direct assimilation of cellooligosaccharide using Escherichia coli displaying beta-glucosidase (BGL). BGL from Thermobifida fusca YX (Tfu0937) was displayed on the E. coli cell surface using a novel anchor protein named Blc. This strain was grown successfully on 0.2% cellobiose, and the optical density at 600 nm (OD600) was 1.05 after 20 h. PMID:21742905

  9. 33 CFR 109.05 - Anchorage grounds.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Commander as provided in 33 CFR 1.05-1(e)(1)(i). (b) District Commanders will, whenever matters relating to...(j) of the Coast Guard and Maritime Transportation Act of 2006 (Pub. L. 109-241, 120 Stat. 516), and... CFR 1.46(c) and 1.45(b))...

  10. 21 CFR 73.2180 - Guaiazulene.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...). Saponification No., 60 to 70. Hydroxyl No., 63 to 78. Acid No., 2. Specific gravity, 1.05 to 1.07. (b... practice. Melting point, 30.5 °C to 31.5 °C. Lead (as Pb), not more than 20 parts per million. Arsenic...

  11. A comparison of the in vitro activity of metronidazole, tinidazole, and nimorazole against Gram-negative anaerobic bacilli.

    PubMed Central

    Reynolds, A V; Hamilton-Miller, J M; Brumfitt, W

    1975-01-01

    The in vitro activities of metronidazole, nimorazole, and tinidazole were compared against 69 strains of obligately anaerobic Gram-negative bacilli. Geometric mean MICs were 0-34, 1-05, and 0-28 mug/ml respectively. Thirty-six strains were also tested by the disk method. Correlation between MIC and diameter of the zones of inhibition was poor. PMID:1214009

  12. HLA-DRB1 and HLA-DQB1 Are Associated with Adult-Onset Immunodeficiency with Acquired Anti-Interferon-Gamma Autoantibodies

    PubMed Central

    Pithukpakorn, Manop; Roothumnong, Ekkapong; Angkasekwinai, Nasikarn; Suktitipat, Bhoom; Assawamakin, Anunchai; Luangwedchakarn, Voravich; Umrod, Pinklow; Thongnoppakhun, Wanna; Foongladda, Suporn; Suputtamongkol, Yupin

    2015-01-01

    Recently a newly identified clinical syndrome of disseminated non-tuberculous mycobacterial diseases (with or without other opportunistic infections in adult patients who were previously healthy, has been recognized in association with an acquired autoantibody to interferon-gamma. This syndrome is emerging as an important cause of morbidity and mortality, especially among people of Asian descent. Trigger for the production of this autoantibody remains unknown, but genetic factors are strongly suspected to be involved. We compared HLA genotyping between 32 patients with this clinical syndrome, and 38 controls. We found that this clinical syndrome was associated with very limited allele polymorphism, with HLA-DRB1 and DQB1 alleles, especially HLA-DRB1*15:01, DRB1*16:02, DQB1*05:01 and DQB1*05:02. Odds ratio of DRB1*15:01, DRB1*16:02, DQB1*05:01 and DQB1*05:02 were 7.03 (95% CI, 2.18–22.69, P<0.0001, 9.06 (95% CI, 2.79–29.46, P<0.0001), 6.68 (95% CI, 2.29–19.52, P = 0.0004), and 6.64 (95% CI, 2.30–19.20, P = 0.0004), respectively. Further investigation is warranted to provide better understanding on pathogenesis of this association. PMID:26011559

  13. NCI 1st International Workshop on the Biology, Prevention, and Treatment of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: Summary and Recommendations from the Organizing Committee

    PubMed Central

    Bishop, Michael R.; Alyea, Edwin P.; Cairo, Mitchell S.; Falkenburg, J.H. Frederik; June, Carl H.; Kröger, Nicolaus; Little, Richard F.; Miller, Jeffrey S.; Pavletic, Steven Z.; Porter, David L.; Riddell, Stanley R.; van Besien, Koen; Wayne, Alan S.; Weisdorf, Daniel J.; Wu, Roy S.; Giralt, Sergio

    2011-01-01

    The First International Workshop on The Biology, Prevention, and Treatment of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation was organized and convened to identify, prioritize, and coordinate future research activities related to relapse after allogeneic hematopoietic stem cell transplantation (alloHSCT). Each of the Workshop’s six working committees have published individual reports of ongoing basic, translational and clinical research and recommended areas for future research related to the areas of relapse biology, epidemiology, prevention and treatment. This document summarizes each of the committees’ recommendations and suggests three major initiatives for a coordinated research effort to address the problem of relapse after alloHSCT. The first is the need to establish multi-center correlative and clinical trials networks for basic/translational, epidemiological, and clinical research. Second, there is a need for a network of biorepositories for the collection of samples pre- and post-alloHSCT to aid in laboratory and clinical studies. Third, there should be further refinement, implementation, and study of the proposed Workshop disease-specific response and relapse definitions and the recommendations for monitoring of minimal residual disease. These recommendations, in coordination with ongoing research initiatives and transplant organizations, provide a research framework to rapidly and efficiently address the significant problem of relapse following alloHSCT. PMID:21224011

  14. Associated risk factors for silent cerebral infarcts in sickle cell anemia: low baseline hemoglobin, sex, and relative high systolic blood pressure

    PubMed Central

    Sarnaik, Sharada A.; Rodeghier, Mark J.; Minniti, Caterina P.; Howard, Thomas H.; Iyer, Rathi V.; Inusa, Baba; Telfer, Paul T.; Kirby-Allen, Melanie; Quinn, Charles T.; Bernaudin, Françoise; Airewele, Gladstone; Woods, Gerald M.; Panepinto, Julie Ann; Fuh, Beng; Kwiatkowski, Janet K.; King, Allison A.; Rhodes, Melissa M.; Thompson, Alexis A.; Heiny, Mark E.; Redding-Lallinger, Rupa C.; Kirkham, Fenella J.; Sabio, Hernan; Gonzalez, Corina E.; Saccente, Suzanne L.; Kalinyak, Karen A.; Strouse, John J.; Fixler, Jason M.; Gordon, Mae O.; Miller, J. Phillip; Noetzel, Michael J.; Ichord, Rebecca N.; Casella, James F.

    2012-01-01

    The most common form of neurologic injury in sickle cell anemia (SCA) is silent cerebral infarction (SCI). In the Silent Cerebral Infarct Multi-Center Clinical Trial, we sought to identify risk factors associated with SCI. In this cross-sectional study, we evaluated the clinical history and baseline laboratory values and performed magnetic resonance imaging of the brain in participants with SCA (HbSS or HbSβ° thalassemia) between the ages of 5 and 15 years with no history of overt stroke or seizures. Neuroradiology and neurology committees adjudicated the presence of SCI. SCIs were diagnosed in 30.8% (251 of 814) participants who completed all evaluations and had valid data on all prespecified demographic and clinical covariates. The mean age of the participants was 9.1 years, with 413 males (50.7%). In a multivariable logistic regression analysis, lower baseline hemoglobin concentration (P < .001), higher baseline systolic blood pressure (P = .018), and male sex (P = .030) were statistically significantly associated with an increased risk of an SCI. Hemoglobin concentration and systolic blood pressure are risk factors for SCI in children with SCA and may be therapeutic targets for decreasing the risk of SCI. This study is registered at www.clinicaltrials.gov as #NCT00072761. PMID:22096242

  15. The NASA-Sponsored Study of Cataract in Astronauts (NASCA). Relationship of Exposure to Radiation in Space and the Risk of Cataract Incidence and Progression. Report 1: Recruitment and Methodology

    NASA Technical Reports Server (NTRS)

    Chylack, Leo T.; Peterson, Leif E.; Feiveson, Alan H.; Wear, Mary; Manuel, F. Keith

    2007-01-01

    The NASA Study of Cataract in Astronauts (NASCA) is a five-year, multi-centered, investigation of lens opacification in populations of U.S. astronauts, military pilots, and ground-based (nonaviator) comparison participants. For astronauts, the explanatory variable of most interest is radiation exposure during space flight, however to properly evaluate its effect, the secondary effects of age, nutrition, general health, solar ocular exposure, and other confounding variables encountered in non-space flight must also be considered. NASCA contains an initial baseline, cross-sectional objective assessment of the severity of cortical (C), nuclear (N), and posterior subcapsular (PSC) lens opacification, and annual follow-on assessments of severity and progression of these opacities in the population of astronauts and in participants sampled from populations of military pilots and ground-based exposure controls. From these data, NASCA will estimate the degree to which space radiation affects lens opacification for astronauts and how the overall risks of each cataract type for astronauts compared with those of the other exposure control groups after adjusting for differences in age and other explanatory variables.

  16. How can carbon favor planar multi-coordination in boron-based clusters? Global structures of CB(x)E(y)(2-) (E = Al, Ga, x + y = 4).

    PubMed

    Cui, Zhong-hua; Sui, Jing-jing; Ding, Yi-hong

    2015-12-21

    With the high preference in forming multi-center bonding, boron has been a miracle ligand in constructing diverse planar multi-coordinate (pM) (tetra/hyper) species. Unfortunately, the boron ligand usually dislikes encompassing a pM carbon (pMC) due to the high competition with pM boron (pMB), which makes the realization of boron-based pMC very difficult and quite challenging. Herein, we propose a strategy that by means of cooperative doping and charge-compensation, we can successfully improve and tune the stability of pMC relative to pMB for CB4(2-). In the free CBxEy(2-) (E = Al/Ga) species, ptC is thermodynamically less stable than the global ptB in mono- and di-substituted systems, in agreement with the results of Boldyrev and Wang. However, the thermodynamic preference of pMC increases along with the Al/Ga-doping. The pMC species can be further stabilized by the introduction of the alkaline-earth counterion (Mg(2+)). CB2E2Mg (E = Al, Ga) designed in the present study represents the first successful design of a boron-based planar penta-coordinate carbon (ppC) structures as the global minima. The strategy proposed in this study should be useful in the manipulation of competition between exotic pMC and pMB in B-based systems. PMID:26574884

  17. Evaluating the Cost Effectiveness of Cancer Patient Navigation Programs: Conceptual and Practical Issues

    PubMed Central

    Ramsey, Scott; Whitley, Elizabeth; Mears, Victoria Warren; McKoy, June M.; Everhart, Rachel M.; Caswell, Robert J.; Fiscella, Kevin; Hurd, Thelma C.; Battalgia, Tracy; Mandelblatt, Jeanne

    2009-01-01

    Background Patient navigators--individuals who assist patients through the healthcare system to improve access to and understanding of their health and health care—are increasingly utilized for underserved individuals at risk for or with cancer. Navigation programs can improve access, but it is unclear whether they improve the efficiency and efficacy of cancer diagnostic and therapeutic services at a reasonable cost, such that they would be considered cost effective. Methods We outline a conceptual model for evaluating the cost effectiveness of cancer navigation programs. We describe how this model is being applied to the Patient Navigation Research Program (PNRP), a multi-center study supported by the National Cancer Institute’s Center to Reduce Cancer Health Disparities. Results The PNRP is testing navigation interventions which aim to reduce time to delivery of quality cancer care (non-cancer resolution or cancer diagnosis and treatment) after identification of a screening abnormality. Examples of challenges to evaluating cost effectiveness of navigation programs include the heterogeneity of navigation programs, the sometimes distant relationship between navigation programs and outcome of interest (e.g., improving access to prompt diagnostic resolution and life years gained) and accounting for factors in underserved populations that may influence both access to services and outcomes. In this article, we discuss several strategies for addressing these barriers. Conclusions Evaluating the costs and impact of navigation will require some novel methods, but will be critical in recommendations about dissemination of navigation programs. PMID:19685528

  18. Foundations for evidence-based intraoperative neurophysiological monitoring.

    PubMed

    Howick, Jeremy; Cohen, Bernard Allan; McCulloch, Peter; Thompson, Matthew; Skinner, Stanley A

    2016-01-01

    In this review, we recommend means to enhance the evidence-base for intraoperative neurophysiological monitoring (IONM). We address two preliminary issues: (1) whether IONM should be evaluated as a diagnostic test or an intervention, and (2) the state of the evidence for IONM (as presented in systematic reviews, for example). Three reasons may be suggested to evaluate at least some IONM applications as interventions (or as part of an "interventional cascade"). First, practical barriers limit our ability to measure IONM diagnostic accuracy. Second, IONM results are designed to be correlated with interventions during surgery. Third, IONM should improve patient outcomes when IONM-directed intervention alters the course of surgery. Observational evidence for IONM is growing yet more is required to understand the conditions under which IONM, in its variety of settings, can benefit patients. A multi-center observational cohort study would represent an important initial compromise between the pragmatic difficulties with conducting controlled trials in IONM and the Evidence-Based Medicine (EBM) view that large scale randomized trials are required. Such a cohort study would improve the evidence base and (if justified) provide the rationale for controlled trials.

  19. Tissue classification of large-scale multi-site MR data using fuzzy k-nearest neighbor method

    NASA Astrophysics Data System (ADS)

    Ghayoor, Ali; Paulsen, Jane S.; Kim, Regina E. Y.; Johnson, Hans J.

    2016-03-01

    This paper describes enhancements to automate classification of brain tissues for multi-site degenerative magnetic resonance imaging (MRI) data analysis. Processing of large collections of MR images is a key research technique to advance our understanding of the human brain. Previous studies have developed a robust multi-modal tool for automated tissue classification of large-scale data based on expectation maximization (EM) method initialized by group-wise prior probability distributions. This work aims to augment the EM-based classification using a non-parametric fuzzy k-Nearest Neighbor (k-NN) classifier that can model the unique anatomical states of each subject in the study of degenerative diseases. The presented method is applicable to multi-center heterogeneous data analysis and is quantitatively validated on a set of 18 synthetic multi-modal MR datasets having six different levels of noise and three degrees of bias-field provided with known ground truth. Dice index and average Hausdorff distance are used to compare the accuracy and robustness of the proposed method to a state-of-the-art classification method implemented based on EM algorithm. Both evaluation measurements show that presented enhancements produce superior results as compared to the EM only classification.

  20. [Research on tumor information grid framework].

    PubMed

    Zhang, Haowei; Qin, Zhu; Liu, Ying; Tan, Jianghao; Cao, Haitao; Chen, Youping; Zhang, Ke; Ding, Yuqing

    2013-10-01

    In order to realize tumor disease information sharing and unified management, we utilized grid technology to make the data and software resources which distributed in various medical institutions for effective integration so that we could make the heterogeneous resources consistent and interoperable in both semantics and syntax aspects. This article describes the tumor grid framework, the type of the service being packaged in Web Service Description Language (WSDL) and extensible markup language schemas definition (XSD), the client use the serialized document to operate the distributed resources. The service objects could be built by Unified Modeling Language (UML) as middle ware to create application programming interface. All of the grid resources are registered in the index and released in the form of Web Services based on Web Services Resource Framework (WSRF). Using the system we can build a multi-center, large sample and networking tumor disease resource sharing framework to improve the level of development in medical scientific research institutions and the patient's quality of life. PMID:24459945

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

    PubMed Central

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

    2014-01-01

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

  2. Endoscopic Submucosal Dissection for Early Gastric Cancers with Uncommon Histology

    PubMed Central

    Kim, Gwang Ha

    2016-01-01

    Endoscopic submucosal dissection (ESD) enables en bloc curative resection of early gastric cancers (EGCs) with a negligible risk of lymph node metastasis (LNM). Although ESD for EGCs with absolute and expanded indications is safe, the results differ between EGCs with specialized and common histologies. EGC with papillary adenocarcinoma is a differentiated-type adenocarcinoma. At present, it is treated with ESD according to the same criteria as other differentiated-type adenocarcinomas. The LNM rate under the current indication criteria is high, and over half of the patients who undergo ESD as a primary treatment for EGC with papillary adenocarcinoma achieve an out-of-ESD result. Gastric carcinoma with lymphoid stroma in EGC has a low LNM rate and a favorable outcome, despite deep submucosal invasion. Patients with this gastric cancer subtype may be good candidates for ESD, even with deep submucosal invasion. Large-scale prospective multi-center studies with longer follow-up periods are needed to set proper ESD criteria for these tumors. Clinicians should be aware of these disease entities and ESD should be more carefully considered for EGCs with papillary adenocarcinoma and gastric carcinoma with lymphoid stroma. PMID:27744663

  3. Cigarette smoking during pregnancy and preeclampsia risk: a systematic review and meta-analysis of prospective studies

    PubMed Central

    Wei, Jun; Liu, Cai-Xia; Gong, Ting-Ting; Wu, Qi-Jun; Wu, Lang

    2015-01-01

    Although evidence from epidemiological studies evaluating the association between cigarette smoking during pregnancy and preeclampsia risk has been systematically reviewed, the findings have been out of date. To further clarify the relationship, we conducted this comprehensive meta-analysis of prospective studies. We searched PubMed and Web of Science up to August 2015 to identify prospective studies that evaluated the association between cigarette smoking during pregnancy and preeclampsia risk. Random-effects models were used to estimate summarized relative risk (RR) and 95% confidence intervals (CIs). Seventeen prospective studies involving 62,089 preeclampsia patients from a total of approximately 1.8 million subjects were included. Overall, there was a significant negative association between smoking during pregnancy and incidence of preeclampsia (RR = 0.67, 95% CI: 0.60–0.75), with significant heterogeneity (I2 = 91.7%). Such an inverse association was also detected in strata of subgroup analyses according to study location, study sample size, parity of populations, singleton pregnancy, and adjustment for potential confounders including maternal age, diabetes mellitus, chronic hypertension, body mass index, and gender of infant. In summary, this meta-analysis suggests that smoking during pregnancy is inversely associated with incidence of preeclampsia. Further large scale multi-center prospective studies are warranted to validate our findings. PMID:26498356

  4. Antiresorptive treatment of postmenopausal osteoporosis: review of randomized clinical studies and rationale for the Evista alendronate comparison (EVA) trial.

    PubMed

    Lufkin, Edward G; Sarkar, Somnath; Kulkarni, Pandurang M; Ciaccia, Angelina V; Siddhanti, Suresh; Stock, John; Plouffe, Leo

    2004-03-01

    Standard pharmacological antiresorptive therapy for the prevention and/or treatment of postmenopausal osteoporosis now consists of four categories of drugs: estrogens, a selective estrogen receptor modulator (SERM), bisphosponates, and calcitonin. All of these drugs have been studied in randomized controlled trials, but meaningful comparisons of the efficacy of drugs have been difficult due to differences in baseline risks for fracture and differences in study design, including calcium and vitamin D supplementation, definition of fracture, and discontinuation rates. The current paper reviews results from pivotal studies of antiresorptive therapies with fracture as a primary endpoint, as well as head-to-head trials comparing these therapies using surrogate markers of fracture risk, and introduces the first head-to-head trial with fracture as a primary endpoint. The Evista Alendronate Comparison (EVA) trial, a multi-center, double-blind, double-dummy, randomized trial with two active treatment arms is currently underway to compare directly the osteoporotic fracture risk reduction efficacy of raloxifene and alendronate in postmenopausal women with osteoporosis as defined by bone mineral density. The results from this trial will permit more informed judgment by practitioners and provider groups concerning the relative clinical utility of these two drugs.

  5. Review of Neurosurgical Fluorescence Imaging Methodologies.

    PubMed

    Pogue, Brian W; Gibbs-Strauss, Summer; Valdés, Pablo A; Samkoe, Kimberley; Roberts, David W; Paulsen, Keith D

    2010-05-01

    Fluorescence imaging in neurosurgery has a long historical development, with several different biomarkers and biochemical agents being used, and several technological approaches. This review focuses on the different contrast agents, summarizing endogenous fluorescence, exogenously stimulated fluorescence and exogenous contrast agents, and then on tools used for imaging. It ends with a summary of key clinical trials that lead to consensus studies. The practical utility of protoporphyrin IX (PpIX) as stimulated by administration of δ-aminolevulinic acid (ALA) has had substantial pilot clinical studies and basic science research completed. Recently multi-center clinical trials using PpIx fluorescence to guide resection have shown efficacy for improved short term survival. Exogenous agents are being developed and tested pre-clinically, and hopefully hold the potential for long term survival benefit if they provide additional capabilities for resection of micro-invasive disease or certain tumor sub-types that do not produce PpIX or help delineate low grade tumors. The range of technologies used for measurement and imaging ranges widely, with most clinical trials being carried out with either point probes or modified surgical microscopes. At this point in time, optimized probe approaches are showing efficacy in clinical trials, and fully commercialized imaging systems are emerging, which will clearly help lead to adoption into neurosurgical practice.

  6. Review of Neurosurgical Fluorescence Imaging Methodologies

    PubMed Central

    Pogue, Brian W.; Gibbs-Strauss, Summer; Valdés, Pablo A.; Samkoe, Kimberley; Roberts, David W.; Paulsen, Keith D.

    2010-01-01

    Fluorescence imaging in neurosurgery has a long historical development, with several different biomarkers and biochemical agents being used, and several technological approaches. This review focuses on the different contrast agents, summarizing endogenous fluorescence, exogenously stimulated fluorescence and exogenous contrast agents, and then on tools used for imaging. It ends with a summary of key clinical trials that lead to consensus studies. The practical utility of protoporphyrin IX (PpIX) as stimulated by administration of δ-aminolevulinic acid (ALA) has had substantial pilot clinical studies and basic science research completed. Recently multi-center clinical trials using PpIx fluorescence to guide resection have shown efficacy for improved short term survival. Exogenous agents are being developed and tested pre-clinically, and hopefully hold the potential for long term survival benefit if they provide additional capabilities for resection of micro-invasive disease or certain tumor sub-types that do not produce PpIX or help delineate low grade tumors. The range of technologies used for measurement and imaging ranges widely, with most clinical trials being carried out with either point probes or modified surgical microscopes. At this point in time, optimized probe approaches are showing efficacy in clinical trials, and fully commercialized imaging systems are emerging, which will clearly help lead to adoption into neurosurgical practice. PMID:20671936

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

    PubMed

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

    2016-03-01

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

  8. Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study.

    PubMed

    Weisbord, Steven D; Shields, Anne Marie; Mor, Maria K; Sevick, Mary Ann; Homer, Marcia; Peternel, Janet; Porter, Patricia; Rollman, Bruce L; Palevsky, Paul M; Arnold, Robert M; Fine, Michael J

    2010-09-01

    Despite the high prevalence of pain, sexual dysfunction, and depression in patients on chronic hemodialysis, these symptoms are often unrecognized and under-treated by renal providers. This report describes the rationale and methodology of the SMILE study (Symptom Management Involving End-Stage Renal Disease), a multi-center, randomized clinical trial comparing the effectiveness of two strategies for implementing treatment for these symptoms in patients receiving chronic hemodialysis. Approximately 250 patients from nine outpatient dialysis units will participate. Over a 2-12 month observational phase, participants complete monthly surveys characterizing their pain, sexual dysfunction, and depression. Following this observational period, subjects are randomized to one of two study arms to receive a 12-month intervention. In one study arm (feedback intervention), patients continue to complete the same three symptom surveys, and the presence and severity of the symptoms reported on these surveys is mailed to the patient's renal provider along with evidence-based algorithms outlining treatment options for these symptoms. Decisions on treatment are left at the discretion of the provider. Patients randomized to the other study arm (management intervention) also continue to complete the same monthly symptom surveys and are evaluated by a symptom management nurse trained in the management of these symptoms. This nurse then discusses the patient's symptoms with the renal provider, provides specific recommendations for treatment, and facilitates the implementation of treatment. The primary endpoints are changes in scores on pain, erectile dysfunction, and depression surveys. This report describes the rationale and methodology of this clinical trial.

  9. Ofatumumab in combination with ICE or DHAP chemotherapy in relapsed or refractory intermediate grade B-cell lymphoma

    PubMed Central

    Czuczman, Myron S.; Rodriguez, Maria Alma; Fennessy, Michael; Shea, Thomas C.; Spitzer, Gary; Lossos, Izidore S.; Kharfan-Dabaja, Mohamed A.; Joyce, Robin; Fayad, Luis; Henkel, Kristen; Liao, Qiming; Edvardsen, Klaus; Jewell, Roxanne C.; Fecteau, Doug; Singh, Rajendra P.; Lisby, Steen; Moskowitz, Craig H.

    2013-01-01

    Standard treatment of transplant-eligible patients with relapsed diffuse large B-cell lymphoma (DLBCL) consists of rituximab and platinum-based chemotherapy, either ifosfamide, carboplatin, and etoposide (ICE) or dexamethasone, cytarabine, and cisplatin (DHAP), with autologous transplant consolidation for those with chemosensitive disease. Nonetheless, outcomes are suboptimal for patients failing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We performed a multi-center phase II trial investigating the safety and efficacy of ofatumumab, a monoclonal antibody against CD20, combined with ICE or DHAP second-line therapy in patients with relapsed or refractory DLBCL, grade 3b follicular lymphoma, or transformed follicular lymphoma. Sixty-one patients were treated with either ofatumumab-ICE (35) or ofatumumab-DHAP (26). The overall response rate (ORR) was 61%, and the complete response (CR) rate was 37%. In patients with 2 or 3 adverse risk factors according to the second-line, age-adjusted, international prognostic index, the ORR was 59% and CR 31%, and in patients with early-relapsing or primary refractory disease, the ORR was 55% and CR 30%. Toxicity was largely hematologic, and stem cell mobilization was successful in 43 of 45 patients. Substitution of ofatumumab for rituximab in standard second-line regimens following failure of R-CHOP is a promising approach. This trial was registered at www.clinicaltrials.gov as NCT00823719. PMID:23692856

  10. Evaluation of D-Dimer in Screening Deep Vein Thrombosis in Hospitalized Japanese Patients with Acute Medical Diseases/Episodes

    PubMed Central

    Nakajima, Yoshie; Ogawa, Tomohiro; Mo, Makoto; Tazaki, Junichi; Doi, Takahiro; Yamada, Norikazu; Suzuki, Takeo; Nakajima, Hiromu

    2016-01-01

    Objective: To investigate the usefulness of D-dimer as a screening method as well as to explore potent predictors of deep vein thrombosis (DVT) in hospitalized Japanese patients with acute medical diseases/episodes. Methods and Subjects: This study was a multi-center, prospective, observational study. The inclusion criteria were hospitalized patients at high risk of developing venous thromboembolism with; (1) congestive heart failure, acute exacerbation of chronic obstructive pulmonary disease, infectious diseases, or inflammatory diseases, (2) bed rest ≥4 days, and (3) ≥60 years old. D-dimer was measured on the same day as ultrasonography. Multivariate logistic regression analysis was performed to investigate predictors associated with the presence of DVT. Results: Sixty-nine patients were enrolled. The prevalence of DVT was 33.3% (23/69; 95% C.I., 19.4% to 47.3%). D-dimer was measured in 42 patients and the sensitivity and negative predictive value reached 100%, while the specificity (13.3%) and positive predictive value (31.6%) were low (cut-off value: 0.9 or 1.0 µg/mL). Statistically significant predictor was not assigned. Conclusion: As the sensitivity and negative predictive value of D-dimer reached 100%, D-dimer have a role in excluding patients who might otherwise undergo diagnostic imaging for DVT in hospitalized Japanese patients with acute medical diseases/episodes. PMID:27738461

  11. Jacobian integration method increases the statistical power to measure gray matter atrophy in multiple sclerosis☆

    PubMed Central

    Nakamura, Kunio; Guizard, Nicolas; Fonov, Vladimir S.; Narayanan, Sridar; Collins, D. Louis; Arnold, Douglas L.

    2013-01-01

    Gray matter atrophy provides important insights into neurodegeneration in multiple sclerosis (MS) and can be used as a marker of neuroprotection in clinical trials. Jacobian integration is a method for measuring volume change that uses integration of the local Jacobian determinants of the nonlinear deformation field registering two images, and is a promising tool for measuring gray matter atrophy. Our main objective was to compare the statistical power of the Jacobian integration method to commonly used methods in terms of the sample size required to detect a treatment effect on gray matter atrophy. We used multi-center longitudinal data from relapsing–remitting MS patients and evaluated combinations of cross-sectional and longitudinal pre-processing with SIENAX/FSL, SPM, and FreeSurfer, as well as the Jacobian integration method. The Jacobian integration method outperformed these other commonly used methods, reducing the required sample size by a factor of 4–5. The results demonstrate the advantage of using the Jacobian integration method to assess neuroprotection in MS clinical trials. PMID:24266007

  12. Intake of Soy Products and Other Foods and Gastric Cancer Risk: A Prospective Study

    PubMed Central

    Ko, Kwang-Pil; Park, Sue K.; Yang, Jae Jeong; Ma, Seung Hyun; Gwack, Jin; Shin, Aesun; Kim, YeonJu; Kang, Daehee; Chang, Soung-Hoon; Shin, Hai-Rim; Yoo, Keun-Young

    2013-01-01

    Background Gastric cancer, the most common cancer in the world, is affected by some foods or food groups. We examined the relationship between dietary intake and stomach cancer risk in the Korean Multi-Center Cancer Cohort (KMCC). Methods The KMCC included 19 688 Korean men and women who were enrolled from 1993 to 2004. Of those subjects, 9724 completed a brief 14-food frequency questionnaire at baseline. Through record linkage with the Korean Central Cancer Registry and National Death Certificate databases, we documented 166 gastric cancer cases as of December 31, 2008. Cox proportional hazard models were used to estimate relative risks (RRs) and 95% CIs. Results Frequent intake of soybean/tofu was significantly associated with reduced risk of gastric cancer, after adjustment for age, sex, cigarette smoking, body mass index, alcohol consumption, and area of residence (P for trend = 0.036). We found a significant inverse association between soybean/tofu intake and gastric cancer risk among women (RR = 0.41, 95% CI: 0.22–0.78). Men with a high soybean/tofu intake had a lower risk of gastric cancer, but the reduction was not statistically significant (RR = 0.77, 95% CI: 0.52–1.13). There was no interaction between soybean/tofu intake and cigarette smoking in relation to gastric cancer risk (P for interaction = 0.268). Conclusions Frequent soybean/tofu intake was associated with lower risk of gastric cancer. PMID:23812102

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

    PubMed

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

    2016-08-01

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

  14. Topical Nepafenec in Eyes with Non-Central Diabetic Macular Edema

    PubMed Central

    Friedman, Scott M.; Almukhtar, Talat H.; Baker, Carl W.; Glassman, Adam R.; Elman, Michael J.; Bressler, Neil M.; Maker, Manvi P.; Jampol, Lee M.; Melia, Michele

    2014-01-01

    Purpose To evaluate the effect of a topical non-steroidal anti-inflammatory drug, nepafenac 0.1%, in eyes with non-central diabetic macular edema (DME). Methods Multi-center double-masked randomized trial. Individuals with good visual acuity and non-center involved DME were randomly assigned to nepafenac 0.1% (N = 61) or placebo (nepafenac vehicle, N = 64) three times a day for 12 months. The primary outcome was mean change in OCT retinal volume at 12 months. Results Mean baseline retinal volume was 7.8 mm3. At 12 months, in the nepafenac and placebo groups respectively, mean change in retinal volume was -0.03 mm3 and -0.02 mm3 (treatment group difference: -0.02, 95% CI: -0.27 to 0.23, P = 0.89). Central involved DME was present in 7 eyes (11%) and 9 eyes (14%) at the 12-month visit (P = 0.79), respectively. No differences in visual acuity outcomes were identified. One study participant developed a corneal melt after using nepafenac in the non-study eye, which had a history of severe dry eye. No additional safety concerns were evident. Conclusion In eyes with non-central DME and good visual acuity, topical nepafenac 0.1% three times daily for 1 year likely does not have a meaningful effect on OCT-measured retinal thickness. PMID:25602634

  15. [Research on tumor information grid framework].

    PubMed

    Zhang, Haowei; Qin, Zhu; Liu, Ying; Tan, Jianghao; Cao, Haitao; Chen, Youping; Zhang, Ke; Ding, Yuqing

    2013-10-01

    In order to realize tumor disease information sharing and unified management, we utilized grid technology to make the data and software resources which distributed in various medical institutions for effective integration so that we could make the heterogeneous resources consistent and interoperable in both semantics and syntax aspects. This article describes the tumor grid framework, the type of the service being packaged in Web Service Description Language (WSDL) and extensible markup language schemas definition (XSD), the client use the serialized document to operate the distributed resources. The service objects could be built by Unified Modeling Language (UML) as middle ware to create application programming interface. All of the grid resources are registered in the index and released in the form of Web Services based on Web Services Resource Framework (WSRF). Using the system we can build a multi-center, large sample and networking tumor disease resource sharing framework to improve the level of development in medical scientific research institutions and the patient's quality of life.

  16. Diagnostic Performance of Indocyanine Green-Guided Sentinel Lymph Node Biopsy in Breast Cancer: A Meta-Analysis

    PubMed Central

    Zhou, Yidong; Mao, Feng; Lin, Yan; Guan, Jinghong; Sun, Qiang

    2016-01-01

    Background The diagnostic performance of indocyanine green (ICG) fluorescence-guided sentinel lymph node biopsy (SLNB) for the presence of metastases in breast cancer remains unclear. Objective We performed a meta-analysis to investigate the diagnostic performance of ICG-guided SLNB. Methods Eligible studies were identified from searches of the databases PubMed and EMBASE up to September 2015. Studies that reported the detection rate of ICG fluorescence-guided SLNB with full axillary lymph node dissection and histological or immunohistochemical examinations were included. A meta-analysis was performed to generate pooled detection rate, sensitivity, specificity, false negative rate, diagnostic odds ratio (DOR) and a summary receiver operator characteristic curve (SROC). Results Nineteen published studies were included to generate a pooled detection rate, comprising 2594 patients. The pooled detection rate was 0.98 (95% confidence interval [CI], 0.96–0.99). Six studies finally met the criteria for meta-analysis, which yielded a pooled sensitivity of 0.92 (95% CI, 0.85–0.96), specificity 1 (95% CI, 0.97–1), and DOR 311.47 (95% CI, 84.11–1153.39). The area under the SROC was 0.9758. No publication bias was found. Conclusion ICG fluorescence-guided SLNB is viable for detection of lymph node metastases in breast cancer. Large-scale randomized multi-center trials are necessary to confirm our results. PMID:27280407

  17. Developments in the Classification and Treatment of the Juvenile Idiopathic Inflammatory Myopathies

    PubMed Central

    Rider, Lisa G.; Katz, James D.; Jones, Olcay Y.

    2013-01-01

    The juvenile idiopathic inflammatory myopathies (JIIM) are rare, heterogeneous autoimmune diseases that share chronic muscle inflammation and weakness. JIIM broadly includes three major clinicopathologic groups: juvenile dermatomyositis, juvenile polymyositis, and overlap myositis. A growing spectrum of clinicopathologic groups and serologic phenotypes defined by the presence of myositis-specific or myositis-associated autoantibodies are now recognized, each with differing demographics, clinical manifestations, laboratory findings, and prognoses. With the first multi-center collaborative studies and controlled trials using standardized preliminarily validated outcome measures, the therapy of juvenile myositis has advanced. Although daily oral corticosteroids remain the backbone of treatment, disease-modifying anti-rheumatic drugs (DMARDs) are almost always used as adjunctive therapy. Methotrexate is the conventional DMARD for the initial therapy, either alone or combined with intravenous pulse methylprednisolone, and/or intravenous immunoglobulin for patients with moderate to severe disease. Cyclosporine may be added to these or serve as an alternative to methotrexate. Other drugs and biologic therapies, including mycophenolate mofetil, tacrolimus, cyclophosphamide, rituximab, and infliximab, might benefit selected patients with recalcitrant disease, unacceptable steroid toxicity, or patients with risk factors for poor prognosis. The treatment of cutaneous disease, calcinosis, and the role for rehabilitation are also discussed. PMID:24182859

  18. A randomized comparative trial in order to assess the reactogenicity and immunogenicity of a new measles mumps rubella (MMR) vaccine when given as a first dose at 12-24 months of age.

    PubMed

    Gatchalian, S; Cordero-Yap, L; Lu-Fong, M; Soriano, R; Ludan, A; Chitour, K; Bock, H L

    1999-09-01

    An open, randomized multi-center trial, involving 700 infants, was conducted in order to compare a new measles mumps rubella (MMR) vaccine, SB MMR (containing a Jeryl Lynn derived mumps strain RIT 4385) with a widely used vaccine, Merck MMR, when given to children between 12-24 months. Infants were divided between 2 groups; group 1 received SB MMR while group 2 received Merck MMR. Solicited local and general symptoms were recorded using diary cards and antibody levels were measured using ELISA assays. There was a significantly lower incidence of redness (p < 0.001) and swelling (p = 0.03) observed in group 1 compared with group 2. The incidence of all other solicited local and general symptoms were comparable between groups. In initially seronegative subjects equivalent seroconversion rates and post-vaccination GMTs were observed between groups. In conclusion, these results demonstrate that SB MMR is safe and well tolerated when given to children at this age range, and has an equivalent immunogenic profile compared to the widely used Merck MMR vaccine.

  19. Perspectives on a combined test of multi serum biomarkers in China: towards screening for and diagnosing hepatocellular carcinoma at an earlier stage.

    PubMed

    Zhang, Keming; Song, Peipei; Gao, Jianjun; Li, Gaohua; Zhao, Xin; Zhang, Shaogeng

    2014-06-01

    China has 50% of the worldwide hepatocellular carcinoma (HCC) cases, and the HBV-related cases accounts for approximately 85%. Over the past few decades, although a series of standardized management methods for HCC has been implemented in China, most HCC patient in China still suffered from advanced-stage disease, in consequence, reducing the opportunity of curable treatment that can be offered to achieve long-term disease-free survival for HCC patient. Accordingly, strategies including screening and diagnose HCC at an earlier stage are urgently needed in China. In this study, the current status, challenges, and prospects of early detection of HCC in China have been analyzed. The result indicated the need for using multi serum biomarkers for early HCC detection. During the past ten years, the research on the clinical usefulness of novel serum biomarkers of des-γ-carboxy-prothrombin (DCP), Dickkopf-1 (DKK1) and Midkine (MDK) in early HCC detection for Chinese patients found that the novel serum biomarker can complete the measurement of α-fetoprotein (AFP) in the diagnosis process of HCC, particularly for the patient with negative AFP with/or at an early stage. More large-scale, multi-center studies are expected to be performed in China to provide further evidence, and using novel and reliable serum biomarkers to complement AFP as a new trend is expected to be extensively used in clinical practice to facilitate early detection for those patients with HCC in China.

  20. Fixed combination of topical brimonidine 0.2% and timolol 0.5% for glaucoma and uncontrolled intraocular pressure

    PubMed Central

    Lee, Anne J; McCluskey, Peter

    2008-01-01

    Lowering IOP is the most readily modifiable risk factor to delay the development and progression of glaucoma (POAG). The fixed combination of brimonidine tartrate 0.2% and timolol maleate 0.5% (FCBT) combines a highly selective α2-adrenergic agonist (brimonidine) with a non-selective β-blocker (timolol). FCBT reduces aqueous production and enhances uveoscleral outflow. Concomitant brimonidine and timolol have additive effects on reducing intraocular pressure (IOP). Multi-center randomized control trials have documented superiority of FCBT twice daily on IOP control compared with monotherapy with the individual components, and equal efficacy compared with concomitant therapy. IOP reduction with FCBT versus fixed combination dorzolamide 2% and timolol 0.5% (FCDT) was similar in a small study. Other studies (n > 293) evaluating concomitant brimonidine and timolol have shown that it is not inferior to FCDT. However, concomitant brimonidine and timolol administered twice daily was significantly less efficacious in IOP reduction than fixed combination latanoprost 0.005% and timolol 0.5% (FCLT). There are no published studies comparing FCBT with FCLT. The side effect profile for FCBT reflects that of its individual components. FCBT was generally well tolerated, with less ocular side effects than brimondine alone, but more than timolol alone. Documented systemic effects were few, although this could be confounded by selection bias. FCBT is a safe and effective IOP lowering agent for POAG and ocular hypertension. PMID:19668752

  1. Systematic Review on the Efficacy and Safety of Herbal Medicines for Vascular Dementia

    PubMed Central

    Man, Sui Cheung; Chan, Kam Wa; Lu, Jia-Hong; Durairajan, Siva Sundara Kumar; Liu, Liang-Feng; Li, Min

    2012-01-01

    We present a systematic review of existing research that aims to assess the efficacy and safety of herbal medications (HM), as either monotherapy or adjunct to orthodox medications (OM), mainly comprised of cholinesterase inhibitors, for vascular dementia (VaD). We included 47 studies conducted in mainland China, each testing different HM. Of 43 HM monotherapy studies, 37 reported HM to be significantly better than OM or placebo; six reported similar efficacy between HM and OM. All four HM adjuvant studies reported significant efficacy. No major adverse events for HM were reported. Heterogeneity in diagnostic criteria, interventions and outcome measures hindered comprehensive data analysis. Studies suggested that HM can be a safe and effective treatment for VaD, either alone or in conjunction with OM. However, methodological flaws in the design of the studies limited the extent to which the results could be interpreted. Thirty most commonly used herbal constituents, including Rhizoma Chuanxiong (Chuanxiong in Chinese), Radix Polygoni Multiflori (Heshouwu in Chinese) and Radix Astragali (Huangqi in Chinese). were ranked. Further multi-center trials with large sample sizes, high methodological quality and standardized HM ingredients are necessary for clinical recommendations to be made. PMID:22235231

  2. Rapid Measurement and Correction of Phase Errors from B0 Eddy Currents: Impact on Image Quality for Non-Cartesian Imaging

    PubMed Central

    Brodsky, Ethan K.; Klaers, Jessica L.; Samsonov, Alexey A.; Kijowski, Richard; Block, Walter F.

    2014-01-01

    Non-Cartesian imaging sequences and navigational methods can be more sensitive to scanner imperfections that have little impact on conventional clinical sequences, an issue which has repeatedly complicated the commercialization of these techniques by frustrating transitions to multi-center evaluations. One such imperfection is phase errors caused by resonant frequency shifts from eddy currents induced in the cryostat by time-varying gradients, a phenomemon known as B0 eddy currents. These phase errors can have a substantial impact on sequences that use ramp sampling, bipolar gradients, and readouts at varying azimuthal angles. We present a method for measuring and correcting phase errors from B0 eddy currents and examine the results on two different scanner models. This technique yields significant improvements in image quality for high-resolution joint imaging on certain scanners. The results suggest that correction of short time B0 eddy currents in manufacturer provided service routines would simplify adoption of non-Cartesian sampling methods. PMID:22488532

  3. Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study

    PubMed Central

    Rodrigue, J. R.; Schold, J. D.; Morrissey, P.; Whiting, J.; Vella, J.; Kayler, L. K.; Katz, D.; Jones, J.; Kaplan, B.; Fleishman, A.; Pavlakis, M.; Mandelbrot, D. A.

    2016-01-01

    Limited information exists on the predonation costs incurred by eventual living kidney donors (LKDs). Expenses related to completion of the donation evaluation were collected from 194 LKDs participating in the multi-center, prospective Kidney Donor Outcomes Cohort (KDOC) Study. Most LKDs (n = 187, 96%) reported one or more direct costs, including ground transportation (80%), healthcare (24%), lodging (17%) and air transportation (14%), totaling $101 484 (USD; mean = $523 ± 942). Excluding paid vacation or sick leave, donor and companion lost wages totaled $35 918 (mean = $187 ± 556) and $14 378 (mean = $76 ± 311), respectively. One-third of LKDs used paid vacation or sick leave to avoid incurring lost wages. Few LKDs reported receiving financial support from the transplant candidate (6%), transplant candidate’s family (3%), a nonprofit organization (3%), the National Living Donor Assistance Center (7%), or transplant center (3%). Higher total costs were significantly associated with longer distance traveled to the transplant center (p < 0.001); however, total costs were not associated with age, sex, race/ethnicity, household income, marital status, insurance status, or transplant center. Moderate predonation direct and indirect costs are common for adults who complete the donation evaluation. Potential LKDs should be advised of these possible costs, and the transplant community should examine additional strategies to reimburse donors for them. PMID:25943721

  4. Multi-site study of diffusion metric variability: characterizing the effects of site, vendor, field strength, and echo time using the histogram distance

    NASA Astrophysics Data System (ADS)

    Helmer, K. G.; Chou, M.-C.; Preciado, R. I.; Gimi, B.; Rollins, N. K.; Song, A.; Turner, J.; Mori, S.

    2016-03-01

    MRI-based multi-site trials now routinely include some form of diffusion-weighted imaging (DWI) in their protocol. These studies can include data originating from scanners built by different vendors, each with their own set of unique protocol restrictions, including restrictions on the number of available gradient directions, whether an externally generated list of gradient directions can be used, and restrictions on the echo time (TE). One challenge of multi-site studies is to create a common imaging protocol that will result in a reliable and accurate set of diffusion metrics. The present study describes the effect of site, scanner vendor, field strength, and TE on two common metrics: the first moment of the diffusion tensor field (mean diffusivity, MD), and the fractional anisotropy (FA). We have shown in earlier work that ROI metrics and the mean of MD and FA histograms are not sufficiently sensitive for use in site characterization. Here we use the distance between whole brain histograms of FA and MD to investigate within- and between-site effects. We concluded that the variability of DTI metrics due to site, vendor, field strength, and echo time could influence the results in multi-center trials and that histogram distance is sensitive metrics for each of these variables.

  5. Multi-site study of diffusion metric variability: effects of site, vendor, field strength, and echo time on regions-of-interest and histogram-bin analyses

    NASA Astrophysics Data System (ADS)

    Helmer, K. G.; Chou, M.-C.; Preciado, R. I.; Gimi, B.; Rollins, N. K.; Song, A.; Turner, J.; Mori, S.

    2016-03-01

    It is now common for magnetic-resonance-imaging (MRI) based multi-site trials to include diffusion-weighted imaging (DWI) as part of the protocol. It is also common for these sites to possess MR scanners of different manufacturers, different software and hardware, and different software licenses. These differences mean that scanners may not be able to acquire data with the same number of gradient amplitude values and number of available gradient directions. Variability can also occur in achievable b-values and minimum echo times. The challenge of a multi-site study then, is to create a common protocol by understanding and then minimizing the effects of scanner variability and identifying reliable and accurate diffusion metrics. This study describes the effect of site, scanner vendor, field strength, and TE on two diffusion metrics: the first moment of the diffusion tensor field (mean diffusivity, MD), and the fractional anisotropy (FA) using two common analyses (region-of-interest and mean-bin value of whole brain histograms). The goal of the study was to identify sources of variability in diffusion-sensitized imaging and their influence on commonly reported metrics. The results demonstrate that the site, vendor, field strength, and echo time all contribute to variability in FA and MD, though to different extent. We conclude that characterization of the variability of DTI metrics due to site, vendor, field strength, and echo time is a worthwhile step in the construction of multi-center trials.

  6. Hypovalency--a kinetic-energy density description of a 4c-2e bond.

    PubMed

    Jacobsen, Heiko

    2009-06-01

    A bond descriptor based on the kinetic energy density, the localized-orbital locator (LOL), is used to characterize the nature of the chemical bond in electron deficient multi-center bonds. The boranes B(2)H(6), B(4)H(4), B(4)H(10), [B(6)H(6)](2-), and [B(6)H(7)](-) serve as prototypical examples of hypovalent 3c-2e and 4c-2e bonding. The kinetic energy density is derived from a set of Kohn-Sham orbitals obtained from pure density functional calculations (PBE/TZVP), and the topology of LOL is analyzed in terms of (3,-3) attractors (Gamma). The B-B-B and B-H-B 3c-2e, and the B-B-H-B 4c-2e bonding situations are defined by their own characteristic LOL profiles. The presence of one attractor in relation to the three or four atoms that are engaged in electron deficient bonding provides sufficient indication of the type of 3c-2e or 4c-2e bond present. For the 4c-2e bond in [B(6)H(7)](-) the LOL analysis is compared to results from an experimental QTAIM study. PMID:19452076

  7. Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non-obese humans.

    PubMed

    Meydani, Simin N; Das, Sai K; Pieper, Carl F; Lewis, Michael R; Klein, Sam; Dixit, Vishwa D; Gupta, Alok K; Villareal, Dennis T; Bhapkar, Manjushri; Huang, Megan; Fuss, Paul J; Roberts, Susan B; Holloszy, John O; Fontana, Luigi

    2016-07-01

    Calorie restriction (CR) inhibits inflammation and slows aging in many animal species, but in rodents housed in pathogen-free facilities, CR impairs immunity against certain pathogens. However, little is known about the effects of long-term moderate CR on immune function in humans. In this multi-center, randomized clinical trial to determine CR's effect on inflammation and cell-mediated immunity, 218 healthy non-obese adults (20-50 y), were assigned 25% CR (n=143) or an ad-libitum (AL) diet (n=75), and outcomes tested at baseline, 12, and 24 months of CR. CR induced a 10.4% weight loss over the 2-y period. Relative to AL group, CR reduced circulating inflammatory markers, including total WBC and lymphocyte counts, ICAM-1 and leptin. Serum CRP and TNF-α concentrations were about 40% and 50% lower in CR group, respectively. CR had no effect on the delayed-type hypersensitivity skin response or antibody response to vaccines, nor did it cause difference in clinically significant infections. In conclusion, long-term moderate CR without malnutrition induces a significant and persistent inhibition of inflammation without impairing key in vivo indicators of cell-mediated immunity. Given the established role of these pro-inflammatory molecules in the pathogenesis of multiple chronic diseases, these CR-induced adaptations suggest a shift toward a healthy phenotype. PMID:27410480

  8. Safety and lipid-altering efficacy of a new omega-3 fatty acid and antioxidant-containing medical food in men and women with elevated triacylglycerols.

    PubMed

    Maki, K C; Geohas, J G; Dicklin, M R; Huebner, M; Udani, J K

    2015-08-01

    This randomized, double-blind, placebo-controlled multi-center trial investigated the lipid-altering effects of a medical food (PDL-0101) providing 1.8 g/d eicosapentaenoic acid; 12 mg/d astaxanthin, a marine algae-derived carotenoid; and 100 mg/d tocopherol-free gamma/delta tocotrienols enriched with geranylgeraniol, extracted from annatto, on triacylglycerols (TAG), other lipoprotein lipids, and oxidized low-density lipoprotein (LDL) in 102 subjects with TAG 150-499 mg/dL (1.69-5.63 mmol/L) and LDL cholesterol (LDL-C) ≥70 mg/dL (1.81 mmol/L). Compared to placebo, after eight weeks of treatment, PDL-0101 significantly reduced median TAG (-9.5% vs. 10.6%, p<0.001), while not significantly altering mean LDL-C (-3.0% vs. -8.0% for PDL-0101 and placebo, respectively, p=0.071), mean high-density lipoprotein cholesterol (~3% decrease in both groups, p=0.732), or median oxidized LDL concentrations (5% vs. -5% for PDL-0101 and placebo, respectively, p=0.112). These results demonstrate that PDL-0101 is an effective medical food for the management of elevated TAG. PMID:26076828

  9. Concurrent Mission and Systems Design at NASA Glenn Research Center: The Origins of the COMPASS Team

    NASA Technical Reports Server (NTRS)

    McGuire, Melissa L.; Oleson, Steven R.; Sarver-Verhey, Timothy R.

    2012-01-01

    Established at the NASA Glenn Research Center (GRC) in 2006 to meet the need for rapid mission analysis and multi-disciplinary systems design for in-space and human missions, the Collaborative Modeling for Parametric Assessment of Space Systems (COMPASS) team is a multidisciplinary, concurrent engineering group whose primary purpose is to perform integrated systems analysis, but it is also capable of designing any system that involves one or more of the disciplines present in the team. The authors were involved in the development of the COMPASS team and its design process, and are continuously making refinements and enhancements. The team was unofficially started in the early 2000s as part of the distributed team known as Team JIMO (Jupiter Icy Moons Orbiter) in support of the multi-center collaborative JIMO spacecraft design during Project Prometheus. This paper documents the origins of a concurrent mission and systems design team at GRC and how it evolved into the COMPASS team, including defining the process, gathering the team and tools, building the facility, and performing studies.

  10. Exploring the role of paraoxonases in the pathogenesis of coronary artery disease: a systematic review.

    PubMed

    Abelló, David; Sancho, Elena; Camps, Jordi; Joven, Jorge

    2014-01-01

    Paraoxonases (PON) are three enzymes (PON1, PON2 and PON3) that play a role in the organism's antioxidant system; alterations in which are associated with diseases involving oxidative stress. In this review, we summarize the evidence of PON related to the pathogenesis of coronary artery disease (CAD) and atherosclerosis. We searched three electronic databases (PubMed, Scopus and Cochrane Database) with no date limit. All of the articles selected investigated PON enzymatic activity and/or PON gene polymorphisms. The selection focused on PON in relation to atherosclerosis, CAD and myocardial infarction. The exclusion criteria were a sample size <100 patients, non-human studies, editorials and systematic reviews without restrictions on the country of origin. With these criteria, we identified thirty-five prospective studies published between 1986 and 2014 with a total of 28,164 participants. The relationship between PON gene polymorphisms and CAD was not conclusive, but most studies support the concept that alterations in PON1 enzymatic activity levels do influence atheroma formation. Conversely, relationships between PON2 and PON3 vs. CAD have not been extensively investigated. Our review of the current data concludes that the bases of paraoxonases involvement in atherosclerosis are poorly understood and that this issue requires future comprehensive, multi-centered studies. PMID:25405733

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

    NASA Astrophysics Data System (ADS)

    Kaiser, R. I.; Roessler, K.

    1992-12-01

    Frozen CH4 and CH4/Ar mixtures closed into metal cuvettes and open to the vacuum were irradiated at 15 and 77 K with 10 - 20 MeV p and He-3(2+) ions in order to simulate the effect of cosmic rays on solid organic matter in space. Ices exposed to vacuum represent surfaces of icy systems whereas closed systems stand for bulk ices. The products were analyzed by MS, SEM, RBS, ERDA, H-1-NMR, HPLC, GC-MS, NEXAFS, and FT-IR. Volatile products consisted of a mixture of low molecular species, e.g., C2H2, C2H4, C2H6, and long linear aliphatic and olefinic compounds. The formation of polycyclic aromatic hydrocarbons (PAH's) and related species in solid CH4 is due to a multi-center reaction within one collision cascade and is governed by energy density effects with critical linear energy transfer values LT between 2 and 10 keV/micron. Open ices exhibit preferential hydrogen release resulting in an increased carbonization as compared to more hydrogen rich molecules protected inside large icy bodies.

  12. Engaging undergraduate summer research students and faculty in a regional neuroscience network.

    PubMed

    Yates, Jennifer R; Stavnezer, Amy Jo

    2014-01-01

    Students who engage in experiential research programs and who form communities of learning are more likely to persist in Science, Technology, Engineering, and Math (STEM) programs. Faculty who collaborate are more likely to publish and to stay engaged in their field. With funding from the Great Lakes Colleges Association (GLCA) Expanding Collaboration Initiative, we engaged in a series of summer seminars with neuroscience faculty and their research students at five regional institutions, the College of Wooster, Ohio Wesleyan University, Earlham College, Oberlin College and Kenyon College. Our goals were to provide an opportunity for faculty and students to learn about the methods used in the labs at these institutions, to increase collaborative relationships across these institutions, to develop a community of learning among participating students, and to provide students with professional development opportunities. Pre- and post-assessment data indicate knowledge gains in demonstrated methods and increased comfort performing the methods with supervision or collaboration. In addition, several collaborative relationships were formed and significant assistance with planning, materials, and/or apparatus was provided across institutions. In open-ended post-experience questions, students indicated valuing the relationships formed with other students in this community of learning. We will continue this program with continued funding through the GLCA Expanding Collaboration Initiative and submission of a multi-center National Science Foundation Research Experience for Undergraduates grant and encourage others to engage in similar practices at their own institutions.

  13. Sample Design and Cohort Selection in the Hispanic Community Health Study/Study of Latinos

    PubMed Central

    LaVange, Lisa M.; Kalsbeek, William; Sorlie, Paul D.; Avilés-Santa, Larissa M.; Kaplan, Robert C.; Barnhart, Janice; Liu, Kiang; Giachello, Aida; Lee, David J.; Ryan, John; Criqui, Michael H.; Elder, John P.

    2010-01-01

    PURPOSE The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) is a multi-center, community based cohort study of Hispanic/Latino adults in the United States. A diverse participant sample is required that is both representative of the target population and likely to remain engaged throughout follow-up. The choice of sample design, its rationale, and benefits and challenges of design decisions are described in this paper. METHODS The study design calls for recruitment and follow-up of a cohort of 16,000 Hispanics/Latinos aged 18-74 years, with 62.5% (10,000) over 44 years of age and adequate subgroup sample sizes to support inference by Hispanic/Latino background. Participants are recruited in community areas surrounding four field centers in the Bronx, Chicago, Miami, and San Diego. A two-stage area probability sample of households is selected with stratification and over-sampling incorporated at each stage to provide a broadly diverse sample, offer efficiencies in field operations, and ensure that the target age distribution is obtained. CONCLUSIONS Embedding probability sampling within this traditional, multi-site cohort study design enables competing research objectives to be met. However, the use of probability sampling requires developing solutions to some unique challenges in both sample selection and recruitment, as described here. PMID:20609344

  14. Emphysema: coiling up the lungs, trick or treat?

    PubMed

    Bezzi, M; Mondoni, M; Sorino, C; Solidoro, P

    2015-08-01

    Lung volume reduction coil (LVRC) treatment is a minimally-invasive technique planned to achieve an improvement of exercise capacity and pulmonary function in subjects with advanced emphysema and hyperinflation. It has been proposed together with other bronchoscopic lung volume reduction approaches to reduce lung hyperinflation in emphysema as less invasive alternatives to LVRS and are currently under clinical investigation. Following the successful early experiences in previous pilot trials, recent studies allow further investigation into the feasibility, safety and efficacy of LVR coil treatment in a multi-center setting in a larger group of patients. According to this studies we can state that LVR coil treatment results in significant clinical improvements in patients with severe emphysema, in multicenter analysis, with a good safety profile and sustained results for up to 1 year. The literature on endobronchial coils continues to look promising with an acceptable safety profile, and positive long-term follow-up data are certainly more and more available. However, further well-designed, blinded, placebo (or sham) controlled trials, and even randomized trials against LVRS (lung volume reduction surgery), are needed before routine clinical use can be recommended. This is true not only for endobronchial coils, but also for the whole field of bronchoscopic lung volume reduction. PMID:27427120

  15. Modeling urban expansion in Yangon, Myanmar using Landsat time-series and stereo GeoEye Images

    NASA Astrophysics Data System (ADS)

    Sritarapipat, Tanakorn; Takeuchi, Wataru

    2016-06-01

    This research proposed a methodology to model the urban expansion based dynamic statistical model using Landsat and GeoEye Images. Landsat Time-Series from 1978 to 2010 have been applied to extract land covers from the past to the present. Stereo GeoEye Images have been employed to obtain the height of the building. The class translation was obtained by observing land cover from the past to the present. The height of the building can be used to detect the center of the urban area (mainly commercial area). It was assumed that the class translation and the distance of multi-centers of the urban area also the distance of the roads affect the urban growth. The urban expansion model based on the dynamic statistical model was defined to refer to three factors; (1) the class translation, (2) the distance of the multicenters of the urban areas, and (3) the distance from the roads. Estimation and prediction of urban expansion by using our model were formulated and expressed in this research. The experimental area was set up in Yangon, Myanmar. Since it is the major of country's economic with more than five million population and the urban areas have rapidly increased. The experimental results indicated that our model of urban expansion estimated urban growth in both estimation and prediction steps in efficiency.

  16. Nature of Pressure-induced Insulating States in Simple Metals

    NASA Astrophysics Data System (ADS)

    Naumov, Ivan; Hemley, Russell

    As experimentally established, all the alkali metals and heavy alkaline earth metals (Ca, Sr and Ba) become progressively less conductive on compression, at least up to some critical limit over a broad pressure range. Of these metals, Li and Na clearly undergo pressure-induced metal-insulator transitions, which may also be called reverse Mott transitions. Here, using group theory arguments and first-principles calculations, we show that such transitions can be understood in terms of band representations introduced by Zak. The valence bands in the insulating states are described by simple and composite band representations constructed from localized Wannier functions centered on points unoccupied by atoms. The character of the Wannier functions is closely related to the degree of s-p(-d) hybridization and reflects multi-center chemical bonding in these insulating states. The conditions under which an insulating state is allowed for structures having an integer number of atoms per primitive unit cell as well as re-entrant (i.e., metal-insulator-metal) transition sequences are detailed, resulting in predictions of semimetallic phases with flat surface states. The general principles developed are tested and applied to the alkali and alkaline earth metals, including elements where high-pressure insulating phases have been identified or reported (e.g., Li, Na, and Ca). This research was supported by EFree, an Energy Frontier Research Center funded by the U.S. Department of Energy, Office of Science, Basic Energy Sciences under Award DESC0001057.

  17. Dominant Mutations in KAT6A Cause Intellectual Disability with Recognizable Syndromic Features

    PubMed Central

    Tham, Emma; Lindstrand, Anna; Santani, Avni; Malmgren, Helena; Nesbitt, Addie; Dubbs, Holly A.; Zackai, Elaine H.; Parker, Michael J.; Millan, Francisca; Rosenbaum, Kenneth; Wilson, Golder N.; Nordgren, Ann

    2015-01-01

    Through a multi-center collaboration study, we here report six individuals from five unrelated families, with mutations in KAT6A/MOZ detected by whole-exome sequencing. All five different de novo heterozygous truncating mutations were located in the C-terminal transactivation domain of KAT6A: NM_001099412.1: c.3116_3117 delCT, p.(Ser1039∗); c.3830_3831insTT, p.(Arg1278Serfs∗17); c.3879 dupA, p.(Glu1294Argfs∗19); c.4108G>T p.(Glu1370∗) and c.4292 dupT, p.(Leu1431Phefs∗8). An additional subject with a 0.23 MB microdeletion including the entire KAT6A reading frame was identified with genome-wide array comparative genomic hybridization. Finally, by detailed clinical characterization we provide evidence that heterozygous mutations in KAT6A cause a distinct intellectual disability syndrome. The common phenotype includes hypotonia, intellectual disability, early feeding and oromotor difficulties, microcephaly and/or craniosynostosis, and cardiac defects in combination with subtle facial features such as bitemporal narrowing, broad nasal tip, thin upper lip, posteriorly rotated or low-set ears, and microretrognathia. The identification of human subjects complements previous work from mice and zebrafish where knockouts of Kat6a/kat6a lead to developmental defects. PMID:25728777

  18. Trade Space Assessment for Human Exploration Mission Design

    NASA Technical Reports Server (NTRS)

    Joosten, B. Kent

    2006-01-01

    Many human space exploration mission architecture assessments have been performed over the years by diverse organizations and individuals. Direct comparison of metrics among these studies is extremely difficult due to widely varying assumptions involving projected technology readiness, mission goals, acceptable risk criteria, and socio-political environments. However, constant over the years have been the physical laws of celestial dynamics and rocket propulsion systems. A finite diverse yet finite architecture trade space should exist which captures methods of human exploration - particularly of the Moon and Mars - by delineating technical trades and cataloging the physically realizable options of each. A particular architectural approach should then have a traceable path through this "trade tree". It should be pointed out that not every permutation of paths will result in a physically realizable mission approach, but cataloging options that have been examined by past studies should help guide future analysis. This effort was undertaken in two phases by multi-center NASA working groups in the spring and summer of 2004 using more than thirty years of past studies to "flesh out" the Moon-Mars human exploration trade space. The results are presented, not as a "trade tree", which would be unwieldy, but as a "menu" of potential technical options as a function of mission phases. This is envisioned as a tool to aid future mission designers by offering guidance to relevant past analyses.

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

    NASA Technical Reports Server (NTRS)

    Kaiser, R. I.; Roessler, K.

    1992-01-01

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

  20. Ionization and fragmentation of complex molecules studied with a density functional theory based approach

    NASA Astrophysics Data System (ADS)

    Kirchner, Tom

    2013-05-01

    Ion-impact induced ionization and fragmentation of complex molecules have important applications in many branches of science. If the molecule is H2O an obvious topic to address is the radiobiological relevance of these processes, e.g. in the context of hadron therapy, to name just one example. From a more fundamental physics viewpoint ion-molecule collision systems constitute interesting many-body systems, whose analysis poses challenges to both experimentalists and theorists. This talk will describe a theoretical approach to ion-molecule collisions, which is based on density functional theory to describe the nonperturbative electron dynamics. The basis generator method applied in the past successfully to ion-atom collisions is adapted to deal with the multi-center problem one faces when one considers molecular targets. Cross sections for single- and multiple-electron processes (capture and transfer to the continuum) are obtained directly from solving time-dependent Kohn-Sham-type orbital equations and using a Slater determinant based analysis. Fragmentation yields are predicted on the basis of a semi-phenomenological model which uses the calculated cross sections as input. Results will be presented for various ions impacting on water molecules in the energy range of 10-5000 keV/amu and compared with experimental data and previous theoretical calculations where available. First applications of the model to collisions involving CH4 molecules will also be discussed. This work has been supported by SHARCNET and NSERC Canada.