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Sample records for chip study protocol

  1. A chromatin immunoprecipitation (ChIP) protocol for use in whole human adipose tissue.

    PubMed

    Haim, Yulia; Tarnovscki, Tanya; Bashari, Dana; Rudich, Assaf

    2013-11-01

    Chromatin immunoprecipitation (ChIP) has become a central method when studying in vivo protein-DNA interactions, with the major challenge being the hope to capture "authentic" interactions. While ChIP protocols have been optimized for use with specific cell types and tissues including adipose tissue-derived cells, a working ChIP protocol addressing the challenges imposed by fresh whole human adipose tissue has not been described. Utilizing human paired omental and subcutaneous adipose tissue obtained during elective abdominal surgeries, we have carefully identified and optimized individual steps in the ChIP protocol employed directly on fresh tissue fragments. We describe a complete working protocol for using ChIP on whole adipose tissue fragments. Specific steps required adaptation of the ChIP protocol to human whole adipose tissue. In particular, a cross-linking step was performed directly on fresh small tissue fragments. Nuclei were isolated before releasing chromatin, allowing better management of fat content; a sonication protocol to obtain fragmented chromatin was optimized. We also demonstrate the high sensitivity of immunoprecipitated chromatin from adipose tissue to freezing. In conclusion, we describe the development of a ChIP protocol optimized for use in studying whole human adipose tissue, providing solutions for the unique challenges imposed by this tissue. Unraveling protein-DNA interaction in whole human adipose tissue will likely contribute to elucidating molecular pathways contributing to common human diseases such as obesity and type 2 diabetes.

  2. Protocol: methodology for chromatin immunoprecipitation (ChIP) in Chlamydomonas reinhardtii

    PubMed Central

    2011-01-01

    We report on a detailed chromatin immunoprecipitation (ChIP) protocol for the unicellular green alga Chlamydomonas reinhardtii. The protocol is suitable for the analysis of nucleosome occupancy, histone modifications and transcription factor binding sites at the level of mononucleosomes for targeted and genome-wide studies. We describe the optimization of conditions for crosslinking, chromatin fragmentation and antibody titer determination and provide recommendations and an example for the normalization of ChIP results as determined by real-time PCR. PMID:22050920

  3. An Optimized Protocol for Isolating Primary Epithelial Cell Chromatin for ChIP

    PubMed Central

    Browne, James A.; Harris, Ann; Leir, Shih-Hsing

    2014-01-01

    A critical part of generating robust chromatin immunoprecipitation (ChIP) data is the optimization of chromatin purification and size selection. This is particularly important when ChIP is combined with next-generation sequencing (ChIP-seq) to identify targets of DNA-binding proteins, genome-wide. Current protocols refined by the ENCODE consortium generally use a two-step cell lysis procedure that is applicable to a wide variety of cell types. However, the isolation and size selection of chromatin from primary human epithelial cells may often be particularly challenging. These cells tend to form sheets of formaldehyde cross-linked material in which cells are resistant to membrane lysis, nuclei are not released and subsequent sonication produces extensive high molecular weight contamination. Here we describe an optimized protocol to prepare high quality ChIP-grade chromatin from primary human bronchial epithelial cells. The ENCODE protocol was used as a starting point to which we added the following key steps to separate the sheets of formaldehyde-fixed cells prior to lysis. (1) Incubation of the formaldehyde-fixed adherent cells in Trypsin-EDTA (0.25% room temperature) for no longer than 5 min. (2) Equilibration of the fixed cells in detergent-free lysis buffers prior to each lysis step. (3) The addition of 0.5% Triton X-100 to the complete cell membrane lysis buffer. (4) Passing the cell suspension (in complete cell membrane lysis buffer) through a 25-gauge needle followed by continuous agitation on ice for 35 min. Each step of the modified protocol was documented by light microscopy using the Methyl Green-Pyronin dual dye, which stains cytoplasm red (Pyronin) and the nuclei grey-blue (Methyl green). This modified method is reproducibly effective at producing high quality sheared chromatin for ChIP and is equally applicable to other epithelial cell types. PMID:24971909

  4. Adaptive Code Division Multiple Access Protocol for Wireless Network-on-Chip Architectures

    NASA Astrophysics Data System (ADS)

    Vijayakumaran, Vineeth

    Massive levels of integration following Moore's Law ushered in a paradigm shift in the way on-chip interconnections were designed. With higher and higher number of cores on the same die traditional bus based interconnections are no longer a scalable communication infrastructure. On-chip networks were proposed enabled a scalable plug-and-play mechanism for interconnecting hundreds of cores on the same chip. Wired interconnects between the cores in a traditional Network-on-Chip (NoC) system, becomes a bottleneck with increase in the number of cores thereby increasing the latency and energy to transmit signals over them. Hence, there has been many alternative emerging interconnect technologies proposed, namely, 3D, photonic and multi-band RF interconnects. Although they provide better connectivity, higher speed and higher bandwidth compared to wired interconnects; they also face challenges with heat dissipation and manufacturing difficulties. On-chip wireless interconnects is one other alternative proposed which doesn't need physical interconnection layout as data travels over the wireless medium. They are integrated into a hybrid NOC architecture consisting of both wired and wireless links, which provides higher bandwidth, lower latency, lesser area overhead and reduced energy dissipation in communication. However, as the bandwidth of the wireless channels is limited, an efficient media access control (MAC) scheme is required to enhance the utilization of the available bandwidth. This thesis proposes using a multiple access mechanism such as Code Division Multiple Access (CDMA) to enable multiple transmitter-receiver pairs to send data over the wireless channel simultaneously. It will be shown that such a hybrid wireless NoC with an efficient CDMA based MAC protocol can significantly increase the performance of the system while lowering the energy dissipation in data transfer. In this work it is shown that the wireless NoC with the proposed CDMA based MAC protocol

  5. STATISTICAL PRINCIPLES FOR PROSPECTIVE STUDY PROTOCOLS:

    PubMed Central

    Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means, risk differences, and other quantities that convey information. One of the goals in biomedical research is to develop parsimonious models ‐ meaning as simple as possible. This approach is valid if the subsequent research report (the article) is written independent of whether the results are “statistically significant” or not. In the present paper we outline the considerations and suggestions on how to build a trial protocol, with an emphasis on having a rigorous protocol stage, always leading to a full article manuscript, independent of statistical findings. We conclude that authors, who find (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain the statistical principles for trial protocols in terms of design, analysis, and reporting of findings. PMID:23091782

  6. Evaluating Computer-Tutors: A Protocol Study.

    ERIC Educational Resources Information Center

    Strickland, James

    A protocol study investigated whether computer tutors (programs that interactively guide writers while they freewrite with a word processing program) promote or hinder a richer understanding of the composing process. The analysis focused on writers' attitudes toward computer tutors in the invention process. Data were collected by tape recording a…

  7. Using Microfluidics Chips for Live Imaging and Study of Injury Responses in Drosophila Larvae

    PubMed Central

    Mishra, Bibhudatta; Ghannad-Rezaie, Mostafa; Li, Jiaxing; Wang, Xin; Hao, Yan; Ye, Bing; Chronis, Nikos; Collins, Catherine A.

    2014-01-01

    Live imaging is an important technique for studying cell biological processes, however this can be challenging in live animals. The translucent cuticle of the Drosophila larva makes it an attractive model organism for live imaging studies. However, an important challenge for live imaging techniques is to noninvasively immobilize and position an animal on the microscope. This protocol presents a simple and easy to use method for immobilizing and imaging Drosophila larvae on a polydimethylsiloxane (PDMS) microfluidic device, which we call the 'larva chip'. The larva chip is comprised of a snug-fitting PDMS microchamber that is attached to a thin glass coverslip, which, upon application of a vacuum via a syringe, immobilizes the animal and brings ventral structures such as the nerve cord, segmental nerves, and body wall muscles, within close proximity to the coverslip. This allows for high-resolution imaging, and importantly, avoids the use of anesthetics and chemicals, which facilitates the study of a broad range of physiological processes. Since larvae recover easily from the immobilization, they can be readily subjected to multiple imaging sessions. This allows for longitudinal studies over time courses ranging from hours to days. This protocol describes step-by-step how to prepare the chip and how to utilize the chip for live imaging of neuronal events in 3rd instar larvae. These events include the rapid transport of organelles in axons, calcium responses to injury, and time-lapse studies of the trafficking of photo-convertible proteins over long distances and time scales. Another application of the chip is to study regenerative and degenerative responses to axonal injury, so the second part of this protocol describes a new and simple procedure for injuring axons within peripheral nerves by a segmental nerve crush. PMID:24562098

  8. Avian study protocols and wind energy development

    SciTech Connect

    Fisher, K.

    1995-12-01

    This paper identifies the need to develop and use standardized avian study protocols to determine avian impacts at new and existing wind energy facilities. This will allow data collected from various sites to be correlated for better understanding wind energy related avian impacts. Factors contributing to an increased interest in wind energy facilities by electric utilities include: (1) Increased demand for electricity;(2) increased constraints on traditional electrical generating facilities (i.e. hydroelectric and nuclear power plants);(3) improved wind turbine technology. During the 1980`s generous tax credits spawned the development of wind energy facilities, known as wind farms, in California. Commercial scale wind farm proposals are being actively considered in states across the country - Washington, Oregon, Wyoming, Wisconsin, Texas, and Vermont to name a few. From the wind farms in California the unexpected issue of avian impacts, especially to birds-of-prey, or raptor, surfaced and continues to plague the wind industry. However, most of the avian studies did not followed a standardized protocol or methodology and, therefore, data is unavailable to analyze and compare impacts at different sites or with differing technologies and configurations. Effective mitigation can not be designed and applied until these differences are understood. The Bonneville Power Administration is using comparable avian study protocols to collect data for two environmental impact statements being prepared for two separate wind farm proposals. Similar protocol will be required for any other avian impact analysis performed by the agency on proposed or existing wind farms. The knowledge gained from these studies should contribute to a better understanding of avian interactions with wind energy facilities and the identification of effective mitigation measures.

  9. Experiments on a videotape atom chip: fragmentation and transport studies

    NASA Astrophysics Data System (ADS)

    Llorente García, I.; Darquié, B.; Curtis, E. A.; Sinclair, C. D. J.; Hinds, E. A.

    2010-09-01

    This paper reports on experiments with ultracold rubidium atoms confined in microscopic magnetic traps created using a piece of periodically magnetized videotape mounted on an atom chip. The roughness of the confining potential is studied with atomic clouds at temperatures of a few μK and at distances between 30 and 80 μm from the videotape-chip surface. The inhomogeneities in the magnetic field created by the magnetized videotape close to the central region of the chip are characterized in this way. In addition, we demonstrate a novel transport mechanism whereby we convey cold atoms confined in arrays of videotape magnetic micro-traps over distances as large as ~1 cm parallel to the chip surface. This conveying mechanism enables us to survey the surface of the chip and observe potential-roughness effects across different regions.

  10. Study on the conversion and test of protocols

    NASA Astrophysics Data System (ADS)

    Choi, Y.

    1984-06-01

    The conversion of protocols nonadapted to the open systems interconnection (OSI) architecture into compatibility with the OSI system and the test of the equipment for converting protocols are studied. Specification and validation of protocols are reviewed. The test of the X-21 procedure and the test of the signal management equipment, parts of the Telecom project, are analyzed. A specification method based on extended finite state machines is developed. A test system for protocol conversion equipment is described.

  11. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software. PMID:27174763

  12. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

  13. [The research protocol IV: study variables].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The variables in a research study are all that is measured, the information collected, or the data that is collected in order to answer the research questions, which are specified in the objectives. Their selection is essential to the research protocol. This article aims to point out the elements to be considered in the section of the variables. To avoid ambiguity, it is necessary to select only those that will help achieve the study objectives. It should subsequently be defined how they will be measured to ensure that the findings can be replicated; it is therefore desirable to include conceptual and operational definitions. From the methodological point of view, the classification of variables helps us understand how the relationship between them is conceptualized. Depending on the study design, the independent, dependent, universal, and confounding variables should be noted. Another indispensable element for planning statistical analyses is the scale of variable measurement. Therefore, one must specify whether the variables correspond to one of the following four: qualitative nominal, qualitative ordinal, quantitative range, or quantitative ratio. Finally, we should detail the measurement units of each variable. PMID:27560918

  14. [The research protocol IV: study variables].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The variables in a research study are all that is measured, the information collected, or the data that is collected in order to answer the research questions, which are specified in the objectives. Their selection is essential to the research protocol. This article aims to point out the elements to be considered in the section of the variables. To avoid ambiguity, it is necessary to select only those that will help achieve the study objectives. It should subsequently be defined how they will be measured to ensure that the findings can be replicated; it is therefore desirable to include conceptual and operational definitions. From the methodological point of view, the classification of variables helps us understand how the relationship between them is conceptualized. Depending on the study design, the independent, dependent, universal, and confounding variables should be noted. Another indispensable element for planning statistical analyses is the scale of variable measurement. Therefore, one must specify whether the variables correspond to one of the following four: qualitative nominal, qualitative ordinal, quantitative range, or quantitative ratio. Finally, we should detail the measurement units of each variable.

  15. Improvement of Electrical Stimulation Protocol for Simultaneous Measurement of Extracellular Potential with On-Chip Multi-Electrode Array System

    NASA Astrophysics Data System (ADS)

    Kaneko, Tomoyuki; Nomura, Fumimasa; Hattori, Akihiro; Yasuda, Kenji

    2012-06-01

    Cardiotoxicity testing with a multi-electrode array (MEA) system requires the stable beating of cardiomyocytes for the measurement of the field potential duration (FPD), because different spontaneous beating rates cause different responses of FPD prolongation induced by drugs, and the beating rate change effected by drugs complicates the FPD prolongation assessment. We have developed an on-chip MEA system with electrical stimulation for the measurement of the FPD during the stable beating of human embryonic stem (ES) cell-derived cardiomyocyte clusters. Using a conventional bipolar stimulation protocol, we observed such large artifacts in electrical stimulation that we could not estimate the FPD quantitatively. Therefore, we improved the stimulation protocol by using sequential rectangular pulses in which the positive and negative stimulation voltages and number of pulses could be changed flexibly. The balanced voltages and number of pulses for sequential rectangular pulses enabled the recording of small negative artifacts only, which hardly affected the FPD measurement of human-ES-cell-derived cardiomyocyte clusters. These conditions of electrical stimulation are expected to find applications for the control of constant beating for cardiotoxicity testing.

  16. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality.

    PubMed

    Woiski, Mallory D; van Vugt, Helena C; Dijkman, Anneke; Grol, Richard P; Marcus, Abraham; Middeldorp, Johanna M; Mol, Ben W; Mols, Femke; Oudijk, Martijn A; Porath, Martina; Scheepers, Hubertina J; Hermens, Rosella P

    2016-10-01

    Objective Postpartum hemorrhage (PPH) has a continuously rising incidence worldwide, suggesting suboptimal care. An important step in optimizing care is the translation of evidence-based guidelines into comprehensive hospital protocols. However, knowledge about the quality of these protocols is lacking. The objective of this study was to evaluate the quality of PPH-protocols on structure and content in the Netherlands. Methods We performed an observational multicenter study. Eighteen PPH-protocols from 3 University Hospitals (UH), 8 Teaching Hospitals (TH) and 7 Non-Teaching hospitals (NTH) throughout the Netherlands were acquired. The structure of the PPH-protocols was assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) Instrument. The content was appraised using previously developed quality indicators, based on international guidelines and Advance-Trauma-Life-Support (ATLS)-based course instructions. Results The quality of the protocols for postpartum hemorrhage for both structure and content varied widely between different hospitals, but all of them showed room for improvement. The protocols scored mainly below average on the different items of the AGREE-II instrument (8 of the 10 items scored <4 on a 1-7 scale). Regarding the content, adoption of guideline recommendations in protocols was 46 %. In addition, a timely indication of 'when to perform' a recommendation was lacking in three-fourths of the items. Conclusion This study shows that the quality of the PPH-protocols for both structure and content in the Netherlands is suboptimal. This makes adherence to the guideline and ATLS-based course instructions difficult. PMID:27395381

  17. [Preliminary study on HLA-B genotyping by oligonucleotide chips].

    PubMed

    Lan, Ke; Hu, Shou-Wang; Zhang, Fan; Wang, Hui; Guan, Wei; Ding, Yu; Sun, Ou-Jun; Wang, Sheng-Qi

    2003-04-01

    HLA genes constitute a highly polymorphic multigene system. In the present study, HLA-B oligonucleotide chips were manufactured by using a set of sequence-specific oligonucleotide probes derived from polymorphic regions in exon 2 and exon 3 of HLA-B gene spotted by microarrayer onto the aldehyde modified glass slides. In addition, the sequenced HLA-B gene clones used as standard samples were amplified from exon 2 and exon 3 by PCR. Together with the correct hybridization and wash conditions, the PCR products were bound with the array probes on the chip, and the hybridization patterns were transformed to HLA-B genotypes. The results showed that the genotypes of standard samples by the HLA-B oligonucleotide chips were completely identical with the sequenced clones. In conclusion, the oligonucleotide chip method presented here for HLA-B genotyping is a rapid, accurate, sensitive and attractive high throughput biochemical way.

  18. A study of treadmill exercise protocols for Chinese males.

    PubMed

    Ho, B L

    1982-02-01

    Treadmill stress testing currently is used in screening for coronary artery disease. Maximal oxygen consumption is the best index of work capacity and maximal cardiovascular function. Clinically, there are many exercise protocols being utilized, including Bruce, Kattus, Balke, Naughton, and Chinese Air Force (CAF). The purpose of this study is to compare five of them and evaluate their reproducibility. Each of 24 volunteers performed one exercise test per week for 3 periods totalling 15 weeks. During each period, the five different protocols were performed in individually randomized order. Maximal and submaximal oxygen consumption and heart rate were determined. Statistical analysis revealed no difference in maximal oxygen consumption among the various protocols; however significant differences did exist in maximal treadmill time. Maximal exertional duration was not affected by the test periods. All of the five protocols were equally reproducible. The Chinese Air Force has adopted a treadmill protocol with a constant speed of 3.5 mph and a 5% increase in elevation every 3 min. The physiological parameters measured by this protocol include a maximal heart rate of 181 beats/min; maximal oxygen consumption of 48 ml/kg/min; and maximal exercise duration of 17 min. Bruce and Balke protocols were 13 and 24 min, respectively, in our study. The regression equation of oxygen consumption and duration was: Y (ml/kg/min) = 1.26X (min) + 26.3. The CAF protocol is a safe, reproducible, easily performed method with moderate exercise duration. We confirm its advantages and prefer to select this protocol to serve as a routine screening or clinical method for use in testing Chinese people.

  19. Experimental protocols and preparations to study respiratory long term facilitation

    PubMed Central

    Mateika, Jason H.; Sandhu, Kulraj S.

    2011-01-01

    Respiratory long-term facilitation is a form of neuronal plasticity that is induced following exposure to intermittent hypoxia. Long-term facilitation is characterized by a progressive increase in respiratory motor output during normoxic periods that separate hypoxic episodes and by a sustained elevation in respiratory activity for up to 90 min after exposure to intermittent hypoxia. This phenomenon is associated with increases in phrenic, hypoglossal or carotid sinus nerve inspiratory-modulated discharge. The examination of long-term facilitation has been steadily ongoing for approximately 3 decades. During this period of time a variety of animal models (e.g. cats, rats and humans), experimental preparations and intermittent hypoxia protocols have been used to study long-term facilitation. This review is designed to summarize the strengths and weaknesses of the models, preparations and protocols that have been used to study LTF over the past 30 years. The review is divided into two primary sections. Initially, the models and protocols used to study LTF in animals other than humans will be discussed, followed by a section specifically focused on human studies. Each section will begin with a discussion of various factors that must be considered when selecting an experimental preparation and intermittent hypoxia protocol to examine LTF. Model and protocol design recommendations will follow, with the goal of presenting a prevailing model and protocol that will ultimately ensure standardized comparisons across studies. PMID:21292044

  20. Study protocol: the Whitehall II imaging sub-study

    PubMed Central

    2014-01-01

    Background The Whitehall II (WHII) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing. This paper introduces the multi-modal magnetic resonance imaging (MRI) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study. Methods/design A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012–2013. A random sample of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and will be completed by 2016. The participants, for whom social and health records have been collected since 1985, were between 60–85 years of age at the time the MRI study started. Here, we describe the pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study. Discussion The integration of cutting-edge MRI techniques, clinical and cognitive tests in combination with retrospective data on social, behavioural and biological variables during the preceding 25 years from a well-established longitudinal epidemiological study (WHII cohort) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes. PMID:24885374

  1. Lab-on-a-chip technologies for single-molecule studies.

    PubMed

    Zhao, Yanhui; Chen, Danqi; Yue, Hongjun; French, Jarrod B; Rufo, Joseph; Benkovic, Stephen J; Huang, Tony Jun

    2013-06-21

    Recent developments on various lab-on-a-chip techniques allow miniaturized and integrated devices to perform on-chip single-molecule studies. Fluidic-based platforms that utilize unique microscale fluidic behavior are capable of conducting single-molecule experiments with high sensitivities and throughputs, while biomolecular systems can be studied on-chip using techniques such as DNA curtains, magnetic tweezers, and solid-state nanopores. The advances of these on-chip single-molecule techniques lead to next-generation lab-on-a-chip devices, such as DNA transistors, and single-molecule real-time (SMRT) technology for rapid and low-cost whole genome DNA sequencing. In this Focus article, we will discuss some recent successes in the development of lab-on-a-chip techniques for single-molecule studies and expound our thoughts on the near future of on-chip single-molecule studies.

  2. Lab-on-a-chip technologies for single-molecule studies

    PubMed Central

    Zhao, Yanhui; Chen, Danqi; Yue, Hongjun; French, Jarrod B.; Rufo, Joey; Benkovic, Stephen J.; Huang, Tony Jun

    2014-01-01

    Recent developments on various lab-on-a-chip techniques allow miniaturized and integrated devices to perform on-chip single-molecule studies. Fluidic-based platforms that utilize the unique microscale fluidic behavior are capable of conducting single-molecule experiments with high sensitivities and throughputs, while biomolecular systems can be studied on-chip using techniques such as DNA curtains, magnetic tweezers, and solid-state nanopores. The advances of these on-chip single-molecule techniques lead to next-generation lab-on-a-chip devices such as DNA transistors, and single-molecule real-time (SMRT) technology for rapid and low-cost whole genome DNA sequencing. In this Focus article, we will discuss some recent successes on developing lab-on-a-chip techniques for single-molecule studies and expound our thoughts on the near future of on-chip single-molecule studies. PMID:23670195

  3. Standardisation of Study Protocols - Pros and Cons.

    PubMed

    D'Haens, Geert

    2016-09-01

    Designing clinical trials in inflammatory bowel diseases is challenging. Composite scores that have been used for drug approval until recently such as the Crohn's disease activity index (CDAI) and the Mayo score for ulcerative colitis have been criticized by regulatory bodies for its lack of validation, poor correlation with objective mucosal disease and absence of 'patient reported outcomes'.Most drug development programs use the 'classic 'separation' between an induction and a maintenance phase. Challenging issues are the 'ideal timing' of the primary endpoint for induction and maintenance studies, strategies to reduce placebo response rates and rules for corticosteroids withdrawal. Discussion about which patients to re-randomize after induction into the maintenance phase of the study is critical.Presently, new instruments for disease assessment in IBD are being developed and validated. Central (independent) review of endoscopic recordings at screening and at the end of the intervention will probably become standard. Finally, the most optimal trial design for every individual intervention is likely to depend on the mechanism of action of the medication under study. PMID:27604980

  4. A microfluidic chip for studying the reproduction of Enteromorpha prolifera.

    PubMed

    Xu, Zhixuan; Liu, Qi; Zhang, Xinlian; Huang, Xuxiong; He, Peimin; Liu, Sixiu; Sui, Guodong

    2016-11-01

    In recent years, green tides caused by water eutrophication, has brought serious environmental problems. Enteromorpha prolifera (E. prolifera), an opportunistic macroalgae, is one of the main source contributing to the formation of green tides. It has been estimated that the excessive growth of E. prolifera is closely related to various reproductive ways of germ cells which are at the micrometer scale. Here we report a microfluidic device named Germ Cell Capture Chip (GCChip) to investigate the E. prolifera reproductive mechanism. GCChip integrates the functions of algal growing, and the release, capture and selective culture of germ cells. Automatic separation and capture of germ cells on the chip allows to study germ cells' response to different stimuli. The novel device greatly facilitates long-term live-cell imaging at cellular resolution and implements the rapid and accurate exchange of growth medium without manual intervention. Results showed that the starting time of germ cell releases were earlier on the chip than that of traditional experiments with more concentrated breakout. Moreover, GCChip can be widely applied on the study of other algae. The study of algae growth process, including the elongation of somatic cell, the generation, and the release of reproductive cells, can all be improved by using this microfluidic platform. PMID:27591653

  5. A microfluidic chip for studying the reproduction of Enteromorpha prolifera.

    PubMed

    Xu, Zhixuan; Liu, Qi; Zhang, Xinlian; Huang, Xuxiong; He, Peimin; Liu, Sixiu; Sui, Guodong

    2016-11-01

    In recent years, green tides caused by water eutrophication, has brought serious environmental problems. Enteromorpha prolifera (E. prolifera), an opportunistic macroalgae, is one of the main source contributing to the formation of green tides. It has been estimated that the excessive growth of E. prolifera is closely related to various reproductive ways of germ cells which are at the micrometer scale. Here we report a microfluidic device named Germ Cell Capture Chip (GCChip) to investigate the E. prolifera reproductive mechanism. GCChip integrates the functions of algal growing, and the release, capture and selective culture of germ cells. Automatic separation and capture of germ cells on the chip allows to study germ cells' response to different stimuli. The novel device greatly facilitates long-term live-cell imaging at cellular resolution and implements the rapid and accurate exchange of growth medium without manual intervention. Results showed that the starting time of germ cell releases were earlier on the chip than that of traditional experiments with more concentrated breakout. Moreover, GCChip can be widely applied on the study of other algae. The study of algae growth process, including the elongation of somatic cell, the generation, and the release of reproductive cells, can all be improved by using this microfluidic platform.

  6. Study on Cloud Security Based on Trust Spanning Tree Protocol

    NASA Astrophysics Data System (ADS)

    Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

    2015-09-01

    Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

  7. Computer-Tutors and a Freshman Writer: A Protocol Study.

    ERIC Educational Resources Information Center

    Strickland, James

    Although there are many retrospective accounts from teachers and professional writers concerning the effect of computers on their writing, there are few real-time accounts of students struggling to simultaneously develop as writers and cope with computers. To fill this void in "testimonial data," a study examining talking-aloud protocols from a…

  8. Radiation Tolerance Studies of BTeV Pixel Readout Chip Prototypes

    SciTech Connect

    Gabriele Chiodini et al.

    2001-09-11

    We report on several irradiation studies performed on BTeV preFPIX2 pixel readout chip prototypes exposed to a 200 MeV proton beam at the Indiana University Cyclotron Facility. The preFPIX2 pixel readout chip has been implemented in standard 0.25 micron CMOS technology following radiation tolerant design rules. The tests confirmed the radiation tolerance of the chip design to proton total dose of 26 MRad. In addition, non destructive radiation-induced single event upsets have been observed in on-chip static registers and the single bit upset cross section has been measured.

  9. Boosting bioluminescence neuroimaging: an optimized protocol for brain studies.

    PubMed

    Aswendt, Markus; Adamczak, Joanna; Couillard-Despres, Sebastien; Hoehn, Mathias

    2013-01-01

    Bioluminescence imaging is widely used for optical cell tracking approaches. However, reliable and quantitative bioluminescence of transplanted cells in the brain is highly challenging. In this study we established a new bioluminescence imaging protocol dedicated for neuroimaging, which increases sensitivity especially for noninvasive tracking of brain cell grafts. Different D-Luciferin concentrations (15, 150, 300 and 750 mg/kg), injection routes (i.v., i.p., s.c.), types of anesthesia (Isoflurane, Ketamine/Xylazine, Pentobarbital) and timing of injection were compared using DCX-Luc transgenic mice for brain specific bioluminescence. Luciferase kinetics was quantitatively evaluated for maximal photon emission, total photon emission and time-to-peak. Photon emission followed a D-Luciferin dose-dependent relation without saturation, but with delay in time-to-peak increasing for increasing concentrations. The comparison of intravenous, subcutaneous and intraperitoneal substrate injection reflects expected pharmacokinetics with fastest and highest photon emission for intravenous administration. Ketamine/Xylazine and Pentobarbital anesthesia showed no significant beneficial effect on maximal photon emission. However, a strong difference in outcome was observed by injecting the substrate pre Isoflurane anesthesia. This protocol optimization for brain specific bioluminescence imaging comprises injection of 300 mg/kg D-Luciferin pre Isoflurane anesthesia as an efficient and stable method with a signal gain of approx. 200% (compared to 150 mg/kg post Isoflurane). Gain in sensitivity by the novel imaging protocol was quantitatively assessed by signal-to-noise calculations of luciferase-expressing neural stem cells grafted into mouse brains (transplantation of 3,000-300,000 cells). The optimized imaging protocol lowered the detection limit from 6,000 to 3,000 cells by a gain in signal-to-noise ratio.

  10. A comparative study of protocols for secure quantum communication under noisy environment: single-qubit-based protocols versus entangled-state-based protocols

    NASA Astrophysics Data System (ADS)

    Sharma, Vishal; Thapliyal, Kishore; Pathak, Anirban; Banerjee, Subhashish

    2016-07-01

    The effect of noise on various protocols of secure quantum communication has been studied. Specifically, we have investigated the effect of amplitude damping, phase damping, squeezed generalized amplitude damping, Pauli type as well as various collective noise models on the protocols of quantum key distribution, quantum key agreement, quantum secure direct quantum communication and quantum dialogue. From each type of protocol of secure quantum communication, we have chosen two protocols for our comparative study: one based on single-qubit states and the other one on entangled states. The comparative study reported here has revealed that single-qubit-based schemes are generally found to perform better in the presence of amplitude damping, phase damping, squeezed generalized amplitude damping noises, while entanglement-based protocols turn out to be preferable in the presence of collective noises. It is also observed that the effect of noise depends upon the number of rounds of quantum communication involved in a scheme of quantum communication. Further, it is observed that squeezing, a completely quantum mechanical resource present in the squeezed generalized amplitude channel, can be used in a beneficial way as it may yield higher fidelity compared to the corresponding zero squeezing case.

  11. An improved pyrite pretreatment protocol for kinetic and isotopic studies

    NASA Astrophysics Data System (ADS)

    Mirzoyan, Natella; Kamyshny, Alexey; Halevy, Itay

    2014-05-01

    An improved pyrite pretreatment protocol for kinetic and isotopic studies Natella Mirzoyan1, Alexey Kamyshny Jr.2, Itay Halevy1 1Earth and Planetary Sciences, Weizmann Institute of Science, Rehovot 76100, Israel 2Geological and Environmental Sciences, Ben-Gurion University of the Negev, Beer Sheva 84105, Israel Pyrite is one of the most abundant and widespread of the sulfide minerals with a central role in biogeochemical cycles of iron and sulfur. Due to its diverse roles in the natural and anthropogenic sulfur cycle, pyrite has been extensively studied in various experimental investigations of the kinetics of its dissolution and oxidation, the isotopic fractionations associated with these reactions, and the microbiological processes involved. Pretreatment of pyrite for removal of oxidation impurities to prevent experimental artifacts and inaccuracies is often practiced. While numerous pyrite-cleaning methods have been used in experiments, a common pyrite pretreatment method, often used to investigate pyrite chemistry by the isotopic fractionations associated with it, includes several rinses by HCl, acetone and deionized water. Elemental sulfur (S0) is a common product of incomplete pyrite oxidation. Removal of S0 is desirable to avoid experimental biases associated with its participation in pyrite transformations, but is more complicated than the removal of sulfate. Although rinsing with an organic solvent is in part aimed at removing S0, to the best of our knowledge, the extraction efficiency of S0 in existing protocols has not been assessed. We have developed and tested a new protocol for elemental sulfur removal from the surface of pyrite by ultrasonication with warm acetone. Our data demonstrate the presence of large fractions of S0 on untreated pyrite particle surfaces, of which only approximately 60% was removed by the commonly used pretreatment method. The new protocol described here was found to be more efficient at S0 removal than the commonly used method

  12. Study of IC Compatible On-Chip Thermoelectric Coolers

    NASA Astrophysics Data System (ADS)

    Kong, Seong-Ho; Wijngaards, Davey D. L.; Wolffenbuttel, Reinoud F.

    2005-07-01

    A thin-film-based thermoelectric micro-cooler has been studied and realized using the standard integrated circuit (IC) fabrication technology and bulk micromachining technology in sequence. The whole fabrication process is kept IC compatible by postponing potassium hydroxide (KOH) etching step to the last part of the fabrication sequence. Considering the fabrication compatibility, polycrystalline silicon germanium (polySiGe) is chosen as thermoelectric material even though bismuth telluride (Bi2Te3) is one of the most effective thermoelectric materials. The influence of non-idealities on device performance, such as Joule heating due to contact resistance and parasitic heat loss through supporting membrane, is analyzed. The characterized thermoelectric, thermal and electric properties of the fabricated polySiGe thermoelectric material correspond well to those from literatures. Measured cooling performance demonstrates that an on-chip micro-cooler can be applied for thermal stabilization near ambient temperature.

  13. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    PubMed Central

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  14. CZE study on adsorption processes of aliphatic and aromatic amines on PMMA chip.

    PubMed

    Masár, Marián; Kruk, Pavol; Luc, Milan; Bodor, Róbert; Danč, Ladislav; Troška, Peter

    2013-02-01

    Adsorption processes on a PMMA chip linked with CZE separations of a group of 13 aliphatic and aromatic mono- and di-amines were studied. Due to the lack of chromophores within aliphatic amines, contact conductivity detection implemented directly onto the chip was used for monitoring of cationic CZE separations. To prevent an adsorption of studied amines to the chip channels, the surface of PMMA chip was modified by dynamic coating. Different surface modifiers, such as aliphatic oligoamines (diethylenetriamine and triethylenetetramine), were added to the BGE solutions filling the chip channels. The effect of various concentrations of surface modifiers on peak profiles and separation parameters of amines was monitored. Of these, mainly, aliphatic di-amines and aromatic mono-amines adversely affected the CZE resolution of a whole group of analytes by their strong adsorption to the chip channels. A propionate BGE with pH 3.2 containing 100 μM triethylenetetramine and 25 mM 18-crown-6-ether was found suitable for CZE resolution of 12 from a total of 13 amines studied. Simple dynamic modification of the surface of PMMA chip enabled fast (analysis time lasted 9 min), sensitive (sub-μM LODs reached) and reproducible (1-3% RSD of the peak areas) CZE analysis of the aliphatic and aromatic amines.

  15. Microfluidic chips for the study of cell migration under the effect of chemicals

    NASA Astrophysics Data System (ADS)

    Kukhtevich, I. V.; Belousov, K. I.; Bukatin, A. S.; Chubinskiy-Nadezhdin, V. I.; Vasileva, V. Yu.; Negulyaev, Yu. A.; Evstrapov, A. A.

    2016-05-01

    Numerical simulation of the formation of a chemoattractant gradient in reaction chambers of a chip having different geometries enabled the determination of a structure suitable for the study of cell migration, in accordance with which hybrid polymer-glass microfluidic devices were manufactured. Verification of the procedures of alignment of cells in the reaction chamber of the chip by centrifugal force and subsequent culturing of the cells showed that microfluidic chips can be used to study cell migration under the effect of the chemoattractant gradient in vitro.

  16. Study & Analysis of various Protocols in popular Web Browsers

    NASA Astrophysics Data System (ADS)

    Mishra, Bharat; Baghel, Harish Singh; Patil, Manoj; Singh, Pramod

    2012-08-01

    The web browsers are the application software that are used to access information from the World Wide Web. With the increasing popularity of the web browsers, the modern web browsers are designed to contain more features as compared to the existing web browsers. For the transferring of information through these browsers, various protocols have been implemented on these modern web browsers to make these browsers more efficient. Different protocols used in different layers have different functions and by increasing the efficiency of these protocols we can make the working of browsers more efficient.

  17. Chip, Chip, Hooray!

    ERIC Educational Resources Information Center

    Kelly, Susan

    2001-01-01

    Presents a science laboratory using different brands of potato chips in which students test their oiliness, size, thickness, saltiness, quality, and cost, then analyze the results to determine the best chip. Gives a brief history of potato chips. (YDS)

  18. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  19. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units

    PubMed Central

    Ali, Naeem A.; Gutteridge, David; Shahul, Sajid; Checkley, William; Sevransky, Jonathan; Martin, Greg S.

    2014-01-01

    Introduction Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee. Methods USCIITG-CIOS is a prospective, observational, ecological multi-centered “cohort” study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects. Conclusions USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover

  20. Individual empowerment in overweight and obese patients: a study protocol

    PubMed Central

    Struzzo, Pierluigi; Fumato, Raffaella; Tillati, Silvia; Cacitti, Anita; Gangi, Fabrizio; Stefani, Alessia; Torcutti, Alessia; Crapesi, Lucia; Tubaro, Gianni; Balestrieri, Matteo

    2013-01-01

    Introduction Obesity is a growing health problem in Europe and it causes many diseases. Many weight-reducing methods are reported in medical literature, but none of them proved to be effective in maintaining the results achieved over time. Self-empowerment can be an important innovative method, but an effectiveness study is necessary. In order to standardise the procedures for a randomised controlled study, a pilot study will be run to observe, measure and evaluate the effects of a period of self-empowerment group treatment on overweight/obese patients. Methods and analysis Non-controlled, experimental, pilot study. A selected group of patients with body mass index >25, with no severe psychiatric disorders, with no aesthetic or therapeutic motivation will be included in the study. A set of quantitative and qualitative measures will be utilised to evaluate the effects of a self-empowerment course in a 12 month time. Group therapy and medical examinations will also complete this observational phase. At the end of this pilot study, a set of appropriate measures and procedures to determine the effectiveness of individual empowerment will be identified and agreed among the different professional figures. Results will be recorded and analysed to start a randomised controlled trial to evaluate the effectiveness of the proposed methodology. Ethics and dissemination This protocol was approved by the local Ethics Committee of Udine in March 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Trial Registration http://www.clinicalstrials.gov identifier NCT01644708. PMID:23676799

  1. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance.

    PubMed

    Fronteira, Ines

    2013-01-01

    In this article, we propose a general structure for designing a research protocol of an observational epidemiological study. We start by highlighting the importance of the research protocol, namely in accounting for some bias and guaranteeing methodologic rigor and study reproductability. Next, we reflect on some of the essential elements of a research protocol no matter its objective. We further present some specific issues to be included according to the type of study: cross-sectional, case-control and cohort.

  2. A protocol for conducting rainfall simulation to study soil runoff.

    PubMed

    Kibet, Leonard C; Saporito, Louis S; Allen, Arthur L; May, Eric B; Kleinman, Peter J A; Hashem, Fawzy M; Bryant, Ray B

    2014-01-01

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff. PMID:24748061

  3. A protocol for conducting rainfall simulation to study soil runoff.

    PubMed

    Kibet, Leonard C; Saporito, Louis S; Allen, Arthur L; May, Eric B; Kleinman, Peter J A; Hashem, Fawzy M; Bryant, Ray B

    2014-04-03

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff.

  4. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

    PubMed Central

    Rajeswari, S. Raja; Seenivasagam, V.

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

  5. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks.

    PubMed

    Rajeswari, S Raja; Seenivasagam, V

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

  6. Protocol for fir tree sampling for provenance studies

    NASA Astrophysics Data System (ADS)

    Meisel, Thomas; Bandoniene, Donata; Zettl, Daniela

    2014-05-01

    Isotopic (stable and radiogenic) as well as trace element fingerprinting methods used for tracing the geographical origin, rely on databases, that need to contain data sets representative of the measurands of the individual samples for a specific geographic entity. Through this work, we want to assess different sampling strategies for obtaining representative sample of fir trees (Abies sp.). Motivation for this work is the protection of the local Austrian Christmas tree market from wrongly tagged trees of non-Austrian origin. In particular, we studied three typical Christmas trees the most common species sold as Christmas tree, namely Abies nordmanniana (Nordmann Fir), from the same locality in lower Austria. For the initial tests we applied the elemental fingerprinting method, to study the suitability of the different parts of the tree applying ICP-MS analysis after complete acid digestion in a high pressure asher system (HPA-S).Needle samples from each year of life of the tree and stem wood from three different heights were analyzed for their trace element content to prove the repeatability and to find the best sampling protocol. For the analysis of the needles, the natural wax coating had to be removed in order to get reproducible results. For the analysis of stem wood only the bark was removed. As expected the data of all three trees allowed the differentiation of the individual needle ages, but interestingly enough also between the three sampling heights of the needs. Both needles and wood proved to be suitable for successful fingerprinting, but importantly, provided that sample of the same type and ages are compared. The same samples for the three trees will also be used for isotopic analysis studies to better understand the influence of age and sampling height on the representativeness of fir tree samples. Based on elemental fingerprinting alone, a successful discrimination between local (Austrian) and foreign (Danish, Irish) Christmas trees was possible.

  7. Health Auctions: a Valuation Experiment (HAVE) study protocol

    PubMed Central

    Kularatna, Sanjeewa; Petrie, Dennis; Scuffham, Paul A; Byrnes, Joshua

    2016-01-01

    Introduction Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. Methods and analysis A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 ‘best’ health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. Ethics and dissemination Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences. PMID:27056589

  8. A Comparative experimental study of media access protocols for wireless radio networks

    SciTech Connect

    Barrett, C. L.; Drozda, M.; Marathe, M. V.

    2001-05-24

    We conduct a comparative experimental analysis of three well known media access protocols: 802.11, CSMA, and MACA for wireless radio networks. Both fixed and ad-hoc networks are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of experiments was to study how (i) the size of the network, (ii) number of open connections, (iii) the spatial location of individual connections, (iv) speed with which individual nodes move and (v) protocols higher up in the protocol stack (e,g. routing layer) affect the performance of the media access sublayer protocols. The performance of the protocols was measured w.r.t. three important parameters: (1) number of received packets, (2) average latency of each packet, and (3) throughput. The following general qualitative conclusions were obtained; some of the conclusions reinforce the earlier claims by other researchers. (1) Although 802.11 performs better than the other two protocols with respect to fairness of transmission, packets dropped, and latency, its performance is found to (i) show a lot of variance with changing input parameters and (ii) the overall performance still leaves a lot of room for improvement. (2) CSMA does not perform too well under the fairness criteria, however, was the best in terms of the latency criteria. (3) MACA also shows fairness problems and has poor performance at high packet injection rates. (4) Protocols in the higher level of the protocol stack affect the MAC layer performance. The main general implications of our work is two folds: (1) No single protocol dominated the other protocols across various measures of efficiency. This motivates the design of a new class of parameterized protocols that adapt to changes in the network connectivity and loads. We refer to these class of protocols as parameterized dynamically adaptive efficient protocols and as a first step suggest key design requirements for such a class of protocols. (2

  9. Improving outpatient safety through effective electronic communication: a study protocol

    PubMed Central

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-01-01

    Background Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Aim Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. Design This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis. PMID:19781075

  10. Electrotaxis Studies of Lung Cancer Cells using a Multichannel Dual-electric-field Microfluidic Chip.

    PubMed

    Hou, Hsien-San; Chang, Hui-Fang; Cheng, Ji-Yen

    2015-12-29

    The behavior of directional cell migration under a direct current electric-field (dcEF) is referred to as electrotaxis. The significant role of physiological dcEF in guiding cell movement during embryo development, cell differentiation, and wound healing has been demonstrated in many studies. By applying microfluidic chips to an electrotaxis assay, the investigation process is shortened and experimental errors are minimized. In recent years, microfluidic devices made of polymeric substances (e.g., polymethylmethacrylate, PMMA, or acrylic) or polydimethylsiloxane (PDMS) have been widely used in studying the responses of cells to electrical stimulation. However, unlike the numerous steps required to fabricate a PDMS device, the simple and rapid construction of the acrylic microfluidic chip makes it suitable for both device prototyping and production. Yet none of the reported devices facilitate the efficient study of the simultaneous chemical and dcEF effects on cells. In this report, we describe our design and fabrication of an acrylic-based multichannel dual-electric-field (MDF) chip to investigate the concurrent effect of chemical and electrical stimulation on lung cancer cells. The MDF chip provides eight combinations of electrical/chemical stimulations in a single test. The chip not only greatly shortens the required experimental time but also increases accuracy in electrotaxis studies.

  11. Electrotaxis Studies of Lung Cancer Cells using a Multichannel Dual-electric-field Microfluidic Chip.

    PubMed

    Hou, Hsien-San; Chang, Hui-Fang; Cheng, Ji-Yen

    2015-01-01

    The behavior of directional cell migration under a direct current electric-field (dcEF) is referred to as electrotaxis. The significant role of physiological dcEF in guiding cell movement during embryo development, cell differentiation, and wound healing has been demonstrated in many studies. By applying microfluidic chips to an electrotaxis assay, the investigation process is shortened and experimental errors are minimized. In recent years, microfluidic devices made of polymeric substances (e.g., polymethylmethacrylate, PMMA, or acrylic) or polydimethylsiloxane (PDMS) have been widely used in studying the responses of cells to electrical stimulation. However, unlike the numerous steps required to fabricate a PDMS device, the simple and rapid construction of the acrylic microfluidic chip makes it suitable for both device prototyping and production. Yet none of the reported devices facilitate the efficient study of the simultaneous chemical and dcEF effects on cells. In this report, we describe our design and fabrication of an acrylic-based multichannel dual-electric-field (MDF) chip to investigate the concurrent effect of chemical and electrical stimulation on lung cancer cells. The MDF chip provides eight combinations of electrical/chemical stimulations in a single test. The chip not only greatly shortens the required experimental time but also increases accuracy in electrotaxis studies. PMID:26780080

  12. Consumption study and identification of methyl salicylate in spicy cassava chips

    SciTech Connect

    Nirjana, Marlene Anggadiredja, Kusnandar; Damayanti, Sophi

    2015-09-30

    Spicy cassava chips is a popular snack. However, some news in electronic media reported addition of balsam which is a banned food additives in that product to give extra spicy flavor. This study aimed to determine ITB students’ pattern of consumption, health problems caused by spicy chips consumption, and knowledge about illicit use of food additives in that product, and identify the main content of balsam namely methyl salicylate in 10 samples of spicy cassava chips taken from inside and outside about ITB campus. A total of 300 questionnaires distributed to ITB students then data processing was performed. Spicy cassava chips sample macerated in 50 mL of methanol for 24 hours at room temperature, filtered and analyzed using gas chromatography capillary column with OV-1, nitrogen carrier gas and flame ionization detector. Based on questionnaires, 292 (97%) of 300 respondents had consumed spicy chips. A total of 247 (85%) from 292 respondents spicy chips consumed less than 3 times a week. A total of 195 respondents (67%) had experienced health problems after eating spicy chips. There were 137 (47%) of the 292 respondents who knew about the illicit addition of food additives into spicy chips; only 35 respondents (12%) who knew about balsam’s addition. There were 126 respondents (43%) who did not pay attention to their health because they will keep eating spicy chips despite the addition of banned food additives. Through the verification of the standard addition method in gas chromatography system with a hydrogen pressure of 1.5 bar, injector temperature 200 °C, detector temperature 230 °C, oven temperature 60 °C for 2 minutes and then increased to 230 °C with rate 6 °C/menit; linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity parameters met the acceptance limits. From 10 spicy cassava chips samples which were analyzed, they did not reveal any content of methyl salicylate. Methyl salicylate contained in the positive

  13. Consumption study and identification of methyl salicylate in spicy cassava chips

    NASA Astrophysics Data System (ADS)

    Nirjana, Marlene; Anggadiredja, Kusnandar; Damayanti, Sophi

    2015-09-01

    Spicy cassava chips is a popular snack. However, some news in electronic media reported addition of balsam which is a banned food additives in that product to give extra spicy flavor. This study aimed to determine ITB students' pattern of consumption, health problems caused by spicy chips consumption, and knowledge about illicit use of food additives in that product, and identify the main content of balsam namely methyl salicylate in 10 samples of spicy cassava chips taken from inside and outside about ITB campus. A total of 300 questionnaires distributed to ITB students then data processing was performed. Spicy cassava chips sample macerated in 50 mL of methanol for 24 hours at room temperature, filtered and analyzed using gas chromatography capillary column with OV-1, nitrogen carrier gas and flame ionization detector. Based on questionnaires, 292 (97%) of 300 respondents had consumed spicy chips. A total of 247 (85%) from 292 respondents spicy chips consumed less than 3 times a week. A total of 195 respondents (67%) had experienced health problems after eating spicy chips. There were 137 (47%) of the 292 respondents who knew about the illicit addition of food additives into spicy chips; only 35 respondents (12%) who knew about balsam's addition. There were 126 respondents (43%) who did not pay attention to their health because they will keep eating spicy chips despite the addition of banned food additives. Through the verification of the standard addition method in gas chromatography system with a hydrogen pressure of 1.5 bar, injector temperature 200 °C, detector temperature 230 °C, oven temperature 60 °C for 2 minutes and then increased to 230 °C with rate 6 °C/menit; linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity parameters met the acceptance limits. From 10 spicy cassava chips samples which were analyzed, they did not reveal any content of methyl salicylate. Methyl salicylate contained in the positive control

  14. Hybridization of Environmental Microbial Community Nucleic Acids by GeoChip.

    PubMed

    Van Nostrand, Joy D; Yin, Huaqin; Wu, Liyou; Yuan, Tong; Zhou, Jizhong

    2016-01-01

    Functional gene arrays, like the GeoChip, allow for the study of tens of thousands of genes in a single assay. The GeoChip array (5.0) contains probes for genes involved in geochemical cycling (N, C, S, and P), metal homeostasis, stress response, organic contaminant degradation, antibiotic resistance, secondary metabolism, and virulence factors as well as genes specific for fungi, protists, and viruses. Here, we briefly describe GeoChip design strategies (gene selection and probe design) and discuss minimum quantity and quality requirements for nucleic acids. We then provide detailed protocols for amplification, labeling, and hybridization of samples to the GeoChip.

  15. Implementing enhanced recovery after bariatric surgery protocol: a retrospective study.

    PubMed

    Proczko, Monika; Kaska, Lukasz; Twardowski, Pawel; Stepaniak, Pieter

    2016-02-01

    While the demand for bariatric surgery is increasing, hospital capacity remains limited. The ERABS (Enhanced Recovery After Bariatric Surgery) protocol has been implemented in a number of bariatric centers. We retrospectively compared the operating room logistics and postoperative complications between pre-ERABS and ERABS periods in an academic hospital. The primary endpoint was the length of stay in hospital. The secondary endpoints were turnover times-the time required for preparing the operating room for the next case, induction time (from induction of anesthesia until a patient is ready for surgery), surgical time (duration of surgery), procedure time (duration of stay in the operating room), and the incidence of re-admissions, re-operations and complications during admission and within 30 days after surgery. Of a total of 374 patients, 228 and 146 received surgery following the pre-ERABS and ERABS protocols, respectively. The length of hospital stay was significantly shortened from 3.7 (95 % confidence interval [CI] 3.1-4.7) days to 2.1 (95 % CI 1.6-2.6) days (P < 0.001). Procedure (surgical) times were shortened by 15 (7) min and 12 (5) min for gastric bypass and gastric sleeve surgery, respectively (P < 0.001 for both), by introducing the ERABS protocol. Induction times were reduced from 15.2 (95 % CI 14.3-16.1) min to 12.5 (95 % CI 11.7-13.3) min (P < 0.001).Turnover times were shortened significantly from 38 (95 % CI 44-32) min to 11 (95 % CI 8-14) min. The incidence of re-operations, re-admissions and complications did not change.

  16. Simulation and Reliability Study of Cu/Low-k Devices in Flip-chip Packages

    SciTech Connect

    Zhao, J.-H.; Wilkerson, Brett; Uehling, Trent

    2004-12-08

    The package impact to the mechanical integrity of the low dielectric constant (low-k) dielectrics back end of the line (BEOL) structure has been proven to be significant in recent publications. This work reports a simulation study of the package-induced delamination in low-k structures by interfacial fracture mechanics combined with multi-scale finite element method. The numerical simulation is validated by reliability test results of low-k devices in different flip-chip package configurations. The modeling result is compared to reliability test data of low-k devices in organic, ceramic flip-chip packages, and good correlation is found. Feasibility of flip-chip packaging for low-k devices is demonstrated. The risk of low-k delamination on different package configurations is rated based on both reliability data and numerical simulations.

  17. A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

    PubMed Central

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols. PMID:22163483

  18. Study protocol of the Center for Oral Health Research in Appalachia (COHRA) etiology study

    PubMed Central

    Polk, Deborah E; Weyant, Robert J; Crout, Richard J; McNeil, Daniel W; Tarter, Ralph E; Thomas, John G; Marazita, Mary L

    2008-01-01

    Background People in Appalachia experience some of the worst oral health in the United States. To develop effective intervention and prevention strategies in Appalachia, we must understand the complex relationships among the contributing factors and how they affect the etiology of oral diseases. To date, no such comprehensive analysis has been conducted. This report summarizes the characteristics of the sample and describes the protocol of a study determining contributions of individual, family, and community factors to oral diseases in Appalachian children and their relatives. Methods/Design Families participated in a comprehensive assessment protocol involving interviews, questionnaires, a clinical oral health assessment, a microbiological assessment, and collection of DNA. The design of the study is cross-sectional. Conclusion Due to its multilevel design and large, family-based sample, this study has the potential to greatly advance our understanding of factors that contribute to oral health in Appalachian children. PMID:18522740

  19. Studies on spectroscopy of glycerol in THz range using microfluidic chip-integrated micropump

    NASA Astrophysics Data System (ADS)

    Su, Bo; Han, Xue; Wu, Ying; Zhang, Cunlin

    2014-11-01

    Terahertz time-domain spectroscopy (THz-TDS) is a detection method of biological molecules with label-free, non-ionizing, non-intrusive, no pollution and real-time monitoring. But owing to the strong THz absorption by water, it is mainly used in the solid state detection of biological molecules. In this paper, we present a microfluidic chip technique for detecting biological liquid samples using the transmission type of THz-TDS system. The microfluidic channel of the microfluidic chip is fabricated in the quartz glass using Micro-Electro-Mechanical System (MEMS) technology and sealed with polydimethylsiloxane (PDMS) diaphragm. The length, width and depth of the microfluidic channel are 25mm, 100μm and 50μm, respectively. The diameter of THz detection zone in the microfluidic channel is 4mm. The thicknesses of quartz glass and PDMS diaphragm are 1mm and 250μm, individually. Another one of the same quartz glass is used to bond with the PDMS for the rigidity and air tightness of the microfluidic chip. In order to realize the automation of sampling and improve the control precise of fluid, a micropump, which comprises PDMS diaphragm, pump chamber, diffuser and nozzle and flat vibration motor, is integrated on the microfluidic chip. The diffuser and nozzle are fabricated on both sides of the pump chamber, which is covered with PDMS diaphragm. The flat vibration motor is stuck on the PDMS diaphragm as the actuator. We study the terahertz absorption spectroscopy characteristics of glycerol with the concentration of 98% in the microfluidic chip by the aid of the THz-TDS system, and the feasibility of the microfluidic chip for the detection of liquid samples is proved.

  20. Bulk transfer protocols on satellite link - Study within the OSI reference model

    NASA Astrophysics Data System (ADS)

    Valet, I.

    Since satellite systems, such as TELECOM1 in France, are available for data transmission, new protocols need to be designed to fit the requirements of satellite communication systems and to offer specific facilities to the users. The main features of these new transmission protocols, as they have been specified by NADIR studies, are described. Next, the reasons for choosing to study these protocols within the OSI Reference Model are explained. A detailed study about introducing the protocol mechanisms described above in the OSI Reference model layers is then presented. Different approaches are presented, and the solutions studied are appraised in terms of efficiency, and of conformity to the OSI Reference Model. Finally, the experiments planned by NADIR are mentionned.

  1. Predicting implementation from organizational readiness for change: a study protocol

    PubMed Central

    2011-01-01

    Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities), and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities). Convergent and discriminant validities will test associations between organizational readiness and different aspects of job

  2. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    USGS Publications Warehouse

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The <2-mm fraction of each sample was analyzed for Al, Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing the analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset

  3. Securing Contactless Chips with PACE

    NASA Astrophysics Data System (ADS)

    Kügler, Dennis

    PACE (Password Authenticated Connection Establishment) is a cryptographic protocol that was developed to provide a secure knowledge-based authentication mechanism for contactless chips. The problems that are inherent to (but not limited to) contactless chips are described and PACE as a solution based on cryptographic tools is sketched. Finally, it is shown how to use PACE together with traditional short PINs of 4-6 digits as access control mechanism for contactless chips withstanding denial-of-service attacks.

  4. Study of chip-breaking mechanisms in orthogonal cutting. Technical report, April 1, 1990--June 30, 1991

    SciTech Connect

    Strenkowski, J.S.

    1991-07-15

    This report summarizes the activities of the research project entitled {open_quotes}Study of Chip Breaking Mechanisms in Orthogonal Cutting{close_quotes}. The research effort took place from April 1990 to June 1991. The overall objective of the project was to develop a systematic procedure for gaining a more fundamental understanding of chip breaking mechanics. Central to this objective is a computer model that can simulate chip formation in orthogonal cutting. This model has been under development for the past seven years at NCSU. The model is based on an Eulerian formulation of the finite element technique. The model simulates the cutting process for various tool geometries over a wide range of cutting conditions. The model can be used to predict chip geometry, cutting forces, plastic strains, strain rates, and temperatures in the workpiece and chip, as well as temperatures in the tool itself. Of particular significance is that specific tool geometries can be simulated. Therefore, the model can be used to systematically evaluate the strains, strain rates, temperature, and geometry of the chip as a function of a specific chip-breaker tool design. These results can provide the crucial information necessary to formulate a fundamental understanding of the chip breaking mechanism over a wide range of operating conditions and workpiece materials.

  5. Conduct of a personal radiofrequency electromagnetic field measurement study: proposed study protocol

    PubMed Central

    2010-01-01

    Background The development of new wireless communication technologies that emit radio frequency electromagnetic fields (RF-EMF) is ongoing, but little is known about the RF-EMF exposure distribution in the general population. Previous attempts to measure personal exposure to RF-EMF have used different measurement protocols and analysis methods making comparisons between exposure situations across different study populations very difficult. As a result, observed differences in exposure levels between study populations may not reflect real exposure differences but may be in part, or wholly due to methodological differences. Methods The aim of this paper is to develop a study protocol for future personal RF-EMF exposure studies based on experience drawn from previous research. Using the current knowledge base, we propose procedures for the measurement of personal exposure to RF-EMF, data collection, data management and analysis, and methods for the selection and instruction of study participants. Results We have identified two basic types of personal RF-EMF measurement studies: population surveys and microenvironmental measurements. In the case of a population survey, the unit of observation is the individual and a randomly selected representative sample of the population is needed to obtain reliable results. For microenvironmental measurements, study participants are selected in order to represent typical behaviours in different microenvironments. These two study types require different methods and procedures. Conclusion Applying our proposed common core procedures in future personal measurement studies will allow direct comparisons of personal RF-EMF exposures in different populations and study areas. PMID:20487532

  6. Laboratory study on factors influencing nitrogen removal in marble chip biofilters incorporating nitritation and anammox.

    PubMed

    Tao, Wendong; Wen, Jianfeng; Norton, Christopher

    2011-01-01

    It remains challenging to integrate nitritation and anammox in ecologically engineered treatment systems such as passive biofilters that are packed with natural materials and have low energy inputs. This study explored the factors influencing nitritation-anammox through parallel operation of two laboratory-scale biofilters packed with large and small marble chips respectively. Clean marble chips (mainly CaCO3) had an alkalinity dissolution rate of 130 mg CaCO3/kg marble d when water pH approached 6.5. Marble chips effectively increased water pH and provided sufficient alkalinity to support nitritation-anammox in the biofilters. Ammonium and total nitrogen removal decreased by 47 and 26%, respectively, when nutrients were not amended to influent. An influent nitrite concentration above 8.9 mg N/L could inhibit anammox in thin biofilms of biofilters. Nitritation-anammox was enhanced with a hydraulic retention time of 2 d relative to 7 d, likely due to enhanced air entrainment. Size of marble chips rarely made a significant difference in nitrogen removal, possibly due to sufficient surface area available for bacterial attachment and alkalinity dissolution.

  7. Experimental Study of Novel Materials and Module for Cryogenic (4K) Superconducting Multi-Chip Modules

    NASA Astrophysics Data System (ADS)

    John, Ranjith Samuel E.

    Niobium based superconducting electronics (SCE) are the fastest known digital logic which operate at 100GHz and greater. Nevertheless, the performance of the SCE device depends on the temperature of the SCE integrated circuits being maintained between 4.2 -- 4.25 K. Additionally, as semiconductors are slowly approaching their performance limitations the SCE devices are viewed as a viable alternative for high end computing and commercial wireless applications. However, the successful commercialization of SCE's requires the demonstration of these devices in multichip module (MCM) architecture. Thus the stringent thermal constraint and the complex MCM architecture require an innovative method for thermal management. This research addressed the above challenges by using a nano-engineered polymer adhesive, namely, single walled carbon nanotube (SWCNT) integrated epoxy as underfill for the packaging of SCE in MCM architecture. The current research distinguished itself by (1) examining the thermal management issues across a single chip SCE-MCM and developing a thermal model based on literature and experimental analysis, (2) developing a new material, namely SWCNT-integrated epoxy whose thermal and electrical performance were analyzed as a function of SWCNT loading and (3) demonstrating the thermal and electrical performance of single chip SCE-MCM test structure and 2D SCE-MCM test structure with SWCNT-epoxy as underfill. The thermal analysis of the single chip SCE-MCM was studied by modeling, which illustrated that cryogenic underfill with thermal conductivity of 0.04 W/mK plays a vital role in thermal management of SCE-MCMs. A SWCNT-epoxy underfill material which was thermally conductive but electrically insulating was developed and the experimental verification of the thermal model was completed by studying the thermal performance of single chip SCE MCMs with and without SWCNT-epoxy as underfill. It was determined that the heat transport between the SCE chip and SCE

  8. Microfluidic heart on a chip for higher throughput pharmacological studies

    PubMed Central

    Agarwal, Ashutosh; Goss, Josue Adrian; Cho, Alexander; McCain, Megan Laura; Parker, Kevin Kit

    2013-01-01

    We present the design of a higher throughput “heart on a chip” which utilizes a semi-automated fabrication technique to process sub millimeter sized thin film cantilevers of soft elastomers. Anisotropic cardiac microtissues which recapitulate the laminar architecture of the heart ventricle are engineered on these cantilevers. Deflection of these cantilevers, termed Muscular Thin Films (MTFs), during muscle contraction allows calculation of diastolic and systolic stresses generated by the engineered tissues. We also present the design of a reusable one channel fluidic microdevice completely built out of autoclavable materials which incorporates various features required for an optical cardiac contractility assay: metallic base which fits on a heating element for temperature control, transparent top for recording cantilever deformation and embedded electrodes for electrical field stimulation of the tissue. We employ the microdevice to test the positive inotropic effect of isoproterenol on cardiac contractility at dosages ranging from 1 nM to 100 μM. The higher throughput fluidic heart on a chip has applications in testing of cardiac tissues built from rare or expensive cell sources and for integration with other organ mimics. These advances will help alleviate translational barriers for commercial adoption of these technologies by improving the throughput and reproducibility of readout, standardization of the platform and scalability of manufacture. PMID:23807141

  9. Chromatin immunoprecipitation (ChIP) coupled to detection by quantitative real-time PCR to study transcription factor binding to DNA in Caenorhabditis elegans

    PubMed Central

    Mukhopadhyay, Arnab; Deplancke, Bart; Walhout, Albertha J M; Tissenbaum, Heidi A

    2009-01-01

    In order to determine how signaling pathways differentially regulate gene expression, it is necessary to identify the interactions between transcription factors (TFs) and their cognate cis-regulatory DNA elements. Here, we have outlined a chromatin immunoprecipitation (ChIP) protocol for use in whole Caenorhabditis elegans extracts. We discuss optimization of the procedure, including growth and harvesting of the worms, formaldehyde fixation, TF immunoprecipitation and analysis of bound sequences through real-time PCR. It takes ∼10–12 d to obtain the worm culture for ChIP; the ChIP procedure is spaced out over a period of 2.5 d with two overnight incubations. PMID:18388953

  10. Characterizing Rat PNS Electrophysiological Response to Electrical Stimulation Using in vitro Chip-Based Human Investigational Platform (iCHIP)

    SciTech Connect

    Khani, Joshua; Prescod, Lindsay; Enright, Heather; Felix, Sarah; Osburn, Joanne; Wheeler, Elizabeth; Kulp, Kris

    2015-08-18

    Ex vivo systems and organ-on-a-chip technology offer an unprecedented approach to modeling the inner workings of the human body. The ultimate goal of LLNL’s in vitro Chip-based Human Investigational Platform (iCHIP) is to integrate multiple organ tissue cultures using microfluidic channels, multi-electrode arrays (MEA), and other biosensors in order to effectively simulate and study the responses and interactions of the major organs to chemical and physical stimulation. In this study, we focused on the peripheral nervous system (PNS) component of the iCHIP system. Specifically we sought to expound on prior research investigating the electrophysiological response of rat dorsal root ganglion cells (rDRGs) to chemical exposures, such as capsaicin. Our aim was to establish a protocol for electrical stimulation using the iCHIP device that would reliably elicit a characteristic response in rDRGs. By varying the parameters for both the stimulation properties – amplitude, phase width, phase shape, and stimulation/ return configuration – and the culture conditions – day in vitro and neural cell types - we were able to make several key observations and uncover a potential convention with a minimal number of devices tested. Future work will seek to establish a standard protocol for human DRGs in the iCHIP which will afford a portable, rapid method for determining the effects of toxins and novel therapeutics on the PNS.

  11. [The research protocol II: study designs in clinical research].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.

  12. Organ-on-a-Chip Platforms for Studying Drug Delivery Systems

    PubMed Central

    Bhise, Nupura S.; Ribas, João; Manoharan, Vijayan; Zhang, Yu Shrike; Polini, Alessandro; Massa, Solange; Dokmeci, Mehmet R.; Khademhosseini, Ali

    2014-01-01

    Novel microfluidic tools allow new ways to manufacture and test drug delivery systems. Organ-on-a-chip systems – microscale recapitulations of complex organ functions – promise to improve the drug development pipeline. This review highlights the importance of integrating microfluidic networks with 3D tissue engineered models to create organ-on-a-chip platforms, able to meet the demand of creating robust preclinical screening models. Specific examples are cited to demonstrate the use of these systems for studying the performance of drug delivery vectors and thereby reduce the discrepancies between their performance at preclinical and clinical trials. We also highlight the future directions that need to be pursued by the research community for these proof-of-concept studies to achieve the goal of accelerating clinical translation of drug delivery nanoparticles. PMID:24818770

  13. Cheaters and Cooperators: A Study of Bacterial Conflict on a Chip

    NASA Astrophysics Data System (ADS)

    Lambert, Guillaume; Galajda, Peter; Keymer, Juan; Austin, Robert

    2008-03-01

    We study the interaction of cheating and cooperating escherichia Coli metapopulations under selective pressure on chip designed to create a landscape of metabolic pressures. Using micro- and nano-fabrication techniques, we create microfluidic chips with an effective `fitness landscape' for the bacterial cells at the population level in which we can tune their access to spatial and energetic resources. Our custom-made micro habitats allow us to study the local density distribution and subpopulation dynamics of bacterial cells subjected to social pressure. We show that the microscopic collective behavior of the cheaters and cooperators differ greatly depending on the fitness landscape they evolved in. Locally, subpopulations emerge and compete in a `tug-of-war' fashion. Globally, metapopulations rise, fall, evolve and adapt to their hostile environment.

  14. LATEX sensitization in elderly: allergological study and diagnostic protocol

    PubMed Central

    2014-01-01

    Background The prevalence of latex allergy varies according to the population studied from 3% to 64%. No data exist in the present literature about elderly people because they were not considered among populations at risk. We report a retrospective observational study of 88 elderly patients of our centre of Dermatology and Allergology at Policlinico Umberto I, University of Rome, Sapienza. Results First and second level diagnostic tests showed latex positivity in 11,4% of patients studied for latex allergy in the elderly population. Conclusions Our study demonstrates a prevalence of elderly-latex sensitization of 11,4%, showing that allergy to latex is a growing disease that can occur at any age. So, we propose these patients as an additional risk category for latex allergy. PMID:24822075

  15. Case-control study on analgesics and nephropathy (SAN): protocol

    PubMed Central

    Heinemann, Lothar AJ; Garbe, Edeltraut; Lewis, Michael; van der Woude, Fokko; Graf, Helmut

    2005-01-01

    Background The association between intake of non-phenacetin-containing analgesics and the occurrence of chronic renal failure is still controversially discussed. A new epidemiologic study was planned and conducted in Germany and Austria. Methods/design The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations. A targeted sample of 1000 new (incident) dialysis patients, aged less than 50 years, was planned to recruit between January 1, 2001 and December 31, 2004. The age limit was chosen to avoid contamination of the study population with phenacetin-containing analgesics to the extent possible. Four control subjects per ESRD case, matched by age, sex, and region were selected from the population living in the region the case came from. Lifetime exposure to analgesics and potential renal risk factors were recorded in a single face-to-face interview. A set of aids was introduced to reinforce the memory of study participants. A standardized, pre-tested interview questionnaire (participants), a medical documentation sheet (physicians in dialysis centres), a logbook for all activities (dialysis centres) were used to collect the necessary data. Quality management consisted of the standardized procedures, (re-) training and supervision of interviewers, regular checks of all incoming data for completeness and plausibility. The study is scientifically independent and governed by a international Scientific Advisory Committee that bridged the gap between the sponsoring companies and the investigators. Also other advisory groups assisted the managing committee of the study. All relevant German and Austrian nephrological associations supported the study, and the study design was carefully reviewed and approved by the Kidney Foundation of Germany. Discussion The study is expected to answer the main

  16. Management of Chronic Periodontitis Using Chlorhexidine Chip and Diode Laser-A Clinical Study

    PubMed Central

    Ambooken, Majo; Mathew, Jayan Jacob; Issac, Annie Valayil; Kunju, Ajithkumar Parachalil; Parameshwaran, Renjith Athirkandathil

    2016-01-01

    Introduction The use of adjuncts like chlorhexidine local delivery and diode laser decontamination have been found to improve the clinical outcomes of scaling and root planing in non-surgical periodontal therapy in patients with chronic periodontitis. Aim To evaluate the effects of diode laser and chlorhexidine chip as adjuncts to scaling and root planing in the management of chronic periodontitis. The objective is to evaluate the outcome of chlorhexidine chip and diode laser as adjuncts to scaling and root planing on clinical parameters like Plaque Index, Gingival Index, probing pocket depth and clinical attachment level. Study and Design Department of Periodontics. Randomized clinical trial with split mouth design. Materials and Methods Fifteen chronic periodontitis patients having a probing pocket depth of 5mm-7mm on at least one interproximal site in each quadrant of the mouth were included in the study. After initial treatment, four sites in each patient were randomly subjected to scaling and root planing (control), chlorhexidine chip application (CHX chip group), diode laser (810 nm) decontamination (Diode laser group) or combination of both (Diode laser and chip group). Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD) and clinical attachment level (CAL) were assessed at baseline, one month and three months. Statistical analysis Results were statistically analysed using paired T test, one-way ANOVA, Tukey’s HSD test and repeated measure ANOVA. Results Post-treatment, the test and control sites showed a statistically significant reduction in PI, GI, PPD, and CAL. After three months, a mean PPD reduction of 1.47±0.52 mm in control group, 1.40±0.83 mm in diode laser group, 2.67±0.62 mm in CHX group, and 2.80± 0.77 mm in combination group was seen. The mean gain in CAL were 1.47±0.52 mm in the control group, 1.40±0.83 mm in diode laser group, 2.67± 0.49 mm in CHX group and 2.67± 0.82 mm in combination group respectively. The

  17. Atomic structure of machined semiconducting chips: An x-ray absorption spectroscopy study

    SciTech Connect

    Paesler, M.; Sayers, D.

    1988-12-01

    X-ray absorption spectroscopy (XAS) has been used to examine the atomic structure of chips of germanium that were produced by single point diamond machining. It is demonstrated that although the local (nearest neighbor) atomic structure is experimentally quite similar to that of single crystal specimens information from more distant atoms indicates the presence of considerable stress. An outline of the technique is given and the strength of XAS in studying the machining process is demonstrated.

  18. Thyroid and Pregnancy in Tehran, Iran: Objectives and Study Protocol

    PubMed Central

    Nazarpour, Sima; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Tohidi, Maryam; Azizi, Fereidoun

    2016-01-01

    Background Thyroid dysfunction is the second most common endocrine disease in females of reproductive age. There are controversial data on the adverse effect of subclinical thyroid dysfunctions on adverse feto-maternal outcomes. Objectives The current study aimed to identify the prevalence of thyroid dysfunction during pregnancy and to assess the effectiveness of treatment with levothyroxine on pregnancy outcomes of females with thyroid autoimmunity with or without subclinical thyroid dysfunction in Tehran, Iran. Patients and Methods The study encompassed two phases: 1) a population based cross sectional study using a cluster sampling method that screened first trimester pregnant females for thyroid disorders, 2) a double-blind randomized clinical trial to determine the effectiveness of levothyroxine on adverse pregnancy outcomes in females with thyroid autoimmunity with or without subclinical thyroid dysfunction. Pregnant females were assessed at their first prenatal visit for serum TSH, T4, T-uptake, TPOAb and urinary iodine following which they were classified as: 1) normal, 2) subclinical TPOAb negative and 3) subclinical/euthyroid TPOAb positive. Females in groups two and three were randomly divided into two groups: group A was treated with levothyroxine (LT4), and group B did not receive any treatment. There was a follow-up program for participants and rates of adverse pregnancy outcomes in the treated and untreated groups were measured. Results Results of the study provided reliable information regarding the prevalence of thyroid dysfunction among females in Tehran using universal thyroid screening, along with identification of the iodine status of their community. The study aimed to determine whether LT4 treatment exerts beneficial effects in females without overt thyroid dysfunction. PMID:27279833

  19. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    PubMed Central

    von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  20. Patient involvement in research priorities (PIRE): a study protocol

    PubMed Central

    Jarden, Mary

    2016-01-01

    Introduction Patient involvement in healthcare has expanded from the clinical practice setting to include collaboration during the research process. There has been a growing international interest in patient and public involvement in setting research priorities to reduce the risk of discrepancy between what patients with cancer and their relatives experience as important unanswered questions and those which are actually researched. This study aims to challenge the conventional research process by inviting patients with life-threatening cancer (primary malignant brain tumours or acute leukaemia), relatives and patient organisations to join forces with clinical specialists and researchers to identify, discuss and prioritise supportive care and rehabilitation issues in future research. Methods and analysis This is an exploratory qualitative study comprising two sets of three focus group interviews (FGIs): one set for primary malignant brain tumours and the other for acute leukaemia. Separate FGIs will be carried out with patients and relatives including representation from patient organisations and clinical specialists to identify important unanswered questions and research topics within each group. The FGIs will be video/audio recorded, transcribed and thematically analysed. This study will contribute to a patient-centred research agenda that captures issues that patients, their relatives, clinical specialists and researchers consider important. Ethics and dissemination The study is registered at the Danish Data Protection Agency (number: 2012-58-0004) and the Scientific Ethics Review Committee of the Capital Region of Denmark (number: H-15001485). Papers will be published describing the methods applied and the supportive care and rehabilitation issues that are identified as important for future research. Trial registration number ISRCTN57131943; Pre-results. PMID:27221126

  1. Protocol for studying cough frequency in people with pulmonary tuberculosis

    PubMed Central

    Bravard, Marjory A; Tracey, Brian H; López, José W; Comina, German; Zimic, Mirko; Coronel, Jorge; O'Neill Lee, Gwenyth; Caviedes, Luz; Luis Cabrera, Jose; Salas, Antonio; Ticona, Eduardo; Kirwan, Daniela E; Friedland, Jon S; Evans, Carlton A; Moore, David A; Gilman, Robert H

    2016-01-01

    Introduction Cough is a key symptom of tuberculosis (TB) as well as the main cause of transmission. However, a recent literature review found that cough frequency (number of coughs per hour) in patients with TB has only been studied once, in 1969. The main aim of this study is to describe cough frequency patterns before and after the start of TB treatment and to determine baseline factors that affect cough frequency in these patients. Secondarily, we will evaluate the correlation between cough frequency and TB microbiological resolution. Methods This study will select participants with culture confirmed TB from 2 tertiary hospitals in Lima, Peru. We estimated that a sample size of 107 patients was sufficient to detect clinically significant changes in cough frequency. Participants will initially be evaluated through questionnaires, radiology, microscopic observation drug susceptibility broth TB-culture, auramine smear microscopy and cough recordings. This cohort will be followed for the initial 60 days of anti-TB treatment, and throughout the study several microbiological samples as well as 24 h recordings will be collected. We will describe the variability of cough episodes and determine its association with baseline laboratory parameters of pulmonary TB. In addition, we will analyse the reduction of cough frequency in predicting TB cure, adjusted for potential confounders. Ethics and dissemination Ethical approval has been obtained from the ethics committees at each participating hospital in Lima, Peru, Asociación Benéfica PRISMA in Lima, Peru, the Universidad Peruana Cayetano Heredia in Lima, Peru and Johns Hopkins University in Baltimore, USA. We aim to publish and disseminate our findings in peer-reviewed journals. We also expect to create and maintain an online repository for TB cough sounds as well as the statistical analysis employed. PMID:27105713

  2. Radiation Doses of Various CT Protocols: a Multicenter Longitudinal Observation Study

    PubMed Central

    2016-01-01

    Emerging concerns regarding the hazard from medical radiation including CT examinations has been suggested. The purpose of this study was to observe the longitudinal changes of CT radiation doses of various CT protocols and to estimate the long-term efforts of supervising radiologists to reduce medical radiation. Radiation dose data from 11 representative CT protocols were collected from 12 hospitals. Attending radiologists had collected CT radiation dose data in two time points, 2007 and 2010. They collected the volume CT dose index (CTDIvol) of each phase, number of phases, dose length product (DLP) of each phase, and types of scanned CT machines. From the collected data, total DLP and effective dose (ED) were calculated. CTDIvol, total DLP, and ED of 2007 and 2010 were compared according to CT protocols, CT machine type, and hospital. During the three years, CTDIvol had significantly decreased, except for dynamic CT of the liver. Total DLP and ED were significantly decreased in all 11 protocols. The decrement was more evident in newer CT scanners. However, there was substantial variability of changes of ED during the three years according to hospitals. Although there was variability according to protocols, machines, and hospital, CT radiation doses were decreased during the 3 years. This study showed the effects of decreased CT radiation dose by efforts of radiologists and medical society. PMID:26908984

  3. IGG: A tool to integrate GeneChips for genetic studies.

    PubMed

    Li, M-X; Jiang, L; Ho, S-L; Song, Y-Q; Sham, P-C

    2007-11-15

    To facilitate genetic studies using high-throughput genotyping technologies, we have developed an open source tool to integrate genotype data across the Affymetrix and Illumina platforms. It can efficiently integrate a large amount of data from various GeneChips, add genotypes of the HapMap Project into a specific project, flexibly trim and export the integrated data with different formats of popular genetic analysis tools, and highly control the quality of genotype data. Furthermore, this tool has sufficiently simplified its usage through its user-friendly graphic interface and is independent of third-party databases. IGG has successfully been applied to a genome-wide linkage scan in a Charcot-Marie-Tooth disease pedigree by integrating three types of GeneChips and HapMap project genotypes. PMID:17872914

  4. IGG: A tool to integrate GeneChips for genetic studies.

    PubMed

    Li, M-X; Jiang, L; Ho, S-L; Song, Y-Q; Sham, P-C

    2007-11-15

    To facilitate genetic studies using high-throughput genotyping technologies, we have developed an open source tool to integrate genotype data across the Affymetrix and Illumina platforms. It can efficiently integrate a large amount of data from various GeneChips, add genotypes of the HapMap Project into a specific project, flexibly trim and export the integrated data with different formats of popular genetic analysis tools, and highly control the quality of genotype data. Furthermore, this tool has sufficiently simplified its usage through its user-friendly graphic interface and is independent of third-party databases. IGG has successfully been applied to a genome-wide linkage scan in a Charcot-Marie-Tooth disease pedigree by integrating three types of GeneChips and HapMap project genotypes.

  5. Protocols to study the physiology of oral biofilms.

    PubMed

    Lemos, José A; Abranches, Jacqueline; Koo, Hyun; Marquis, Robert E; Burne, Robert A

    2010-01-01

    The oral cavity harbors several hundred different bacterial species that colonize both hard (teeth) and soft tissues, forming complex populations known as microbial biofilms. It is widely accepted that the phenotypic characteristics of bacteria grown in biofilms are substantially different from those grown in suspensions. Because biofilms are the natural habitat for the great majority of oral bacteria, including those contributing to oral diseases, a better understanding of the physiology of adherent populations is clearly needed to control oral microbes in health and disease. In this chapter, we use oral streptococci as examples for studying the physiology of oral biofilms.

  6. The Japan Morning Surge-1 (JMS-1) study: protocol description.

    PubMed

    Ishikawa, Joji; Hoshide, Satoshi; Shibasaki, Seiichi; Matsui, Yoshio; Kabutoya, Tomoyuki; Eguchi, Kazuo; Ishikawa, Shizukiyo; Pickering, Thomas G; Shimada, Kazuyuki; Kario, Kazuomi

    2006-03-01

    Morning blood pressure is reported to be more closely related to hypertensive organ damages such as left ventricular mass index, microalbuminuria and silent cerebral infarcts, than blood pressure at other times of the day. Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage. The Japan Morning Surge-1 (JMS-1) study includes hypertensive outpatients with elevated morning systolic blood pressure (>or=135 mmHg) as assessed by self-measured blood pressure monitoring at home. All enrolled patients are under stable antihypertensive medication status. Exclusion criteria are arrhythmia, chronic inflammatory disease, and taking alpha-blockers or beta-blockers. The target number of patients to be enrolled in the JMS-1 study is 600, and the aim is to evaluate differences in the markers of hypertensive target organ damage, such as brain natriuretic peptide and the urinary albumin excretion/creatinine ratio. All of the patients are randomized to an experimental group or a control group, with randomization to be carried out by telephone interviews with the patients' physicians. In the experimental group, patients begin taking additional antihypertensive medication just before going to bed. This consists of doxazosin 1 mg/day, which then is increased to 2 mg/day and 4 mg/day, with a beta-blocker added after a 1-month interval until the morning systolic blood pressure is controlled to less than 135 mmHg. Patients in the control group continue the treatment they are receiving at the enrollment for 6 months. Blood pressure levels, adverse effects, and hypertensive target organ damage before and after the study are evaluated. In the JMS-1 study, we will evaluate whether strict

  7. Cytotoxicity of cadmium-containing quantum dots based on a study using a microfluidic chip

    NASA Astrophysics Data System (ADS)

    Zheng, Xiannuo; Tian, Jing; Weng, Lixing; Wu, Lei; Jin, Qinghui; Zhao, Jianlong; Wang, Lianhui

    2012-02-01

    There is a lack of reliable nanotoxicity assays available for monitoring and quantifying multiple cellular events in cultured cells. In this study, we used a microfluidic chip to systematically investigate the cytotoxicity of three kinds of well-characterized cadmium-containing quantum dots (QDs) with the same core but different shell structures, including CdTe core QDs, CdTe/CdS core-shell QDs, and CdTe/CdS/ZnS core-shell-shell QDs, in HEK293 cells. Using the microfluidic chip combined with fluorescence microscopy, multiple QD-induced cellular events including cell morphology, viability, proliferation, and QD uptake were simultaneously analysed. The three kinds of QDs showed significantly different cytotoxicities. The CdTe QDs, which are highly toxic to HEK293 cells, resulted in remarkable cellular and nuclear morphological changes, a dose-dependent decrease in cell viability, and strong inhibition of cell proliferation; the CdTe/CdS QDs were moderately toxic but did not significantly affect the proliferation of HEK293 cells; while the CdTe/CdS/ZnS QDs had no detectable influence on cytotoxicity with respect to cell morphology, viability, and proliferation. Our data indicated that QD cytotoxicity was closely related to their surface structures and specific physicochemical properties. This study also demonstrated that the microfluidic chip could serve as a powerful tool to systematically evaluate the cytotoxicity of nanoparticles in multiple cellular events.

  8. Iran's Multiple Indicator Demographic and Health Survey - 2010: Study Protocol

    PubMed Central

    Rashidian, Arash; Karimi-Shahanjarini, Akram; Khosravi, Ardeshir; Elahi, Elham; Beheshtian, Maryam; Shakibazadeh, Elham; Khabiri, Roghayeh; Arab, Mohammad; Zakeri, Mohammad-Reza

    2014-01-01

    Background: There is an international emphasis on providing timely and high quality data to monitor progress of countries toward Millennium Development Goals. Iran's Multiple Indicator Demographic and Health Survey (IrMIDHS) aimed to provide valid information on population and health outcomes to monitor progress in achieving national priorities and health programs and to assist policy makers to design effective strategies for improving health outcomes and equity in access to care. Methods: A cross-sectional multi-stage stratified cluster-random survey is conducted through face-to-face household interviews. The sampling frame is developed using Iran's 2006 population and housing census. Provincial samples ranging are from a minimum of 400 households per province to 6400 households in Tehran province. Cluster size is 10 households. The target sample includes 3096 clusters: 2187 clusters in urban and 909 clusters in rural areas. IrMIDHS instruments include three questionnaires: Household questionnaire, women aged 15-54 questionnaire, children under five questionnaire, supervision and quality assessment checklists and data collection sheets and standard weight and height measurement tools for under-five children. A cascading decentralized training method is used for training data collection and supervision teams. Quality assurance procedures are defined for the five steps of conducting the survey including: Sampling, training data collection and training teams, survey implementation, data entry and analysis. A multi-layer supervision and monitoring procedure is established. All the questionnaires are double entered. Conclusions: IrMIDHS will provide valuable data for policymakers in Iran. Designing and implementation of the study involve contributions from academics as well as program managers and policy makers. The collaborative nature of the study may facilitate better usage of its results. PMID:24932396

  9. Study Protocol for the Fukushima Health Management Survey

    PubMed Central

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    Background The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. Methods This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. Conclusions The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy

  10. The effect of a low radiation CT protocol on accuracy of CT guided implant migration measurement: A cadaver study.

    PubMed

    Boettner, Friedrich; Sculco, Peter K; Lipman, Joseph; Saboeiro, Gregory; Renner, Lisa; Faschingbauer, Martin

    2016-04-01

    The current study compared the impact of low radiation CT protocols on the accuracy, repeatability, and inter- and intra-observer variability of implant migration studies in total hip arthroplasty. Two total hip replacements were performed in two human cadavers and six tantalum beads were inserted into the femur similar to radiostereometric analysis. Six different 28 mm heads (-3 mm, 0 mm, 2.5 mm, 5.0 mm, 7.5 mm, and 10 mm) were added to simulate five reproducible translations (maximum total point migration) of the center of the head. Three CT scans with varying levels of radiation were performed for each head position. The effective dose (mSv) was 3.8 mSv for Protocol A (standard protocol), 0.7 mSv for Protocol B and 1.6 mSv for Protocol C. Implant migration was measured in a 3-D analysis software (Geomagic Studio 7). The accuracy was 0.16 mm for CT Protocol A, 0.13 mm for Protocol B and 0.14 mm for Protocol C; The repeatability was 0.22 mm for CT Protocol A, 0.18 mm for Protocol B and 0.20 mm for Protocol C; ICC for inter observer reliability was 0.89, intra observer reliability was 0.95. The difference in accuracy between standard protocol A and the two low radiation protocols (B, C) was less than 0.05 mm. The accuracy, inter- and intra-observer reliability of all three CT protocols is comparable to radiostereometric analysis. Reducing the CT radiation exposure to numbers similar to an AP Pelvis radiograph (0.7 mSv protocol B) does not affect the accuracy of implant migration measurements. PMID:26425921

  11. The effect of a low radiation CT protocol on accuracy of CT guided implant migration measurement: A cadaver study.

    PubMed

    Boettner, Friedrich; Sculco, Peter K; Lipman, Joseph; Saboeiro, Gregory; Renner, Lisa; Faschingbauer, Martin

    2016-04-01

    The current study compared the impact of low radiation CT protocols on the accuracy, repeatability, and inter- and intra-observer variability of implant migration studies in total hip arthroplasty. Two total hip replacements were performed in two human cadavers and six tantalum beads were inserted into the femur similar to radiostereometric analysis. Six different 28 mm heads (-3 mm, 0 mm, 2.5 mm, 5.0 mm, 7.5 mm, and 10 mm) were added to simulate five reproducible translations (maximum total point migration) of the center of the head. Three CT scans with varying levels of radiation were performed for each head position. The effective dose (mSv) was 3.8 mSv for Protocol A (standard protocol), 0.7 mSv for Protocol B and 1.6 mSv for Protocol C. Implant migration was measured in a 3-D analysis software (Geomagic Studio 7). The accuracy was 0.16 mm for CT Protocol A, 0.13 mm for Protocol B and 0.14 mm for Protocol C; The repeatability was 0.22 mm for CT Protocol A, 0.18 mm for Protocol B and 0.20 mm for Protocol C; ICC for inter observer reliability was 0.89, intra observer reliability was 0.95. The difference in accuracy between standard protocol A and the two low radiation protocols (B, C) was less than 0.05 mm. The accuracy, inter- and intra-observer reliability of all three CT protocols is comparable to radiostereometric analysis. Reducing the CT radiation exposure to numbers similar to an AP Pelvis radiograph (0.7 mSv protocol B) does not affect the accuracy of implant migration measurements.

  12. Journey to vaccination: a protocol for a multinational qualitative study

    PubMed Central

    Wheelock, Ana; Miraldo, Marisa; Parand, Anam; Vincent, Charles; Sevdalis, Nick

    2014-01-01

    Introduction In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2–3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants’ context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. Methods and analysis We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. Ethics and dissemination Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical

  13. Comparative study of preventive protocols in children at high cariogenic risk.

    PubMed

    Martínez, María C; Tolcachir, Betina; Lescano de Ferrer, Alfonsina; Bojanich, María A; Barembaum, Silvina R; Calamari, Silvia E; Azcurra, Ana I

    2012-01-01

    The aim of this study was to compare the efficacy of two preventive protocols -fluoride gel (F) alone or combined with chlorhexidine varnishes (CHX) - on sialochemical, clinical and microbiological parameters in a group of children at high cariogenic risk Two therapeutic-preventive protocols were applied in 73 children at high cariogenic risk (average age 6.2 +/- 1.4 years old) and clinical parameters (simplified oral hygiene index: OHI-S; decayed, missing and filled teeth: dmf index; sugar intake and exposure to fluoride), as well as sialochemical parameters (salivary pH and flow, buffer capacity) and microbiological parameters (CFU/mg of dental biofilm of Streptococcus mutans group) were recorded and correlated before and after the protocols. Association was found between parameters that cause deficient control of dental biofilm: high values of OHIS index, CFU/mg dental biofilm, sugar intake and the d component of dmft index, and lower values of salivary flow rate and buffer capacity. After the protocols, a significant decrease was found in OHI-S and CFU/mg dental biofilm. No significant difference was found with children's gender and age. The association observed between OHI-S and cariogenic bacteria emphasizes the importance of prevention, especially regarding the oral health of the most vulnerable children. The early inclusion of F associated with CHX in the initial step of preventive and therapeutic protocols would provide benefits regarding oral microbe control while children acquire new habits of oral hygiene.

  14. Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study

    PubMed Central

    Sargent, Randall; Brocklebank, Cynthia; Tam-Tham, Helen; Williamson, Tyler; Quail, Patrick; Turner, Diana; Drummond, Neil

    2016-01-01

    Background Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. Methods This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio (INR) tests in the range 2.0 to 3.0, time in range, number of tests, and frequency of bleeding at protocol and control sites. Our primary outcome, time in INR therapeutic range, is an indicator for assuring care quality. A cross-sectional survey at these sites compared health professionals’ perceptions of workload and effectiveness of warfarin management. Results Of the 197 residents’ charts reviewed in the study period, those on protocol had 45.0 INR tests while those on usual care had 52.7 tests (p = .034, 95% CI for the difference: 0.6 to 14.6 INR tests). No significant difference was found for time in therapeutic range, number of tests in range, or major bleeding events. Of 178 health professionals surveyed, those from protocol facilities were more satisfied with warfarin management (p = .013). Workload and safety were perceived similarly at all sites. Interpretation Our results suggest that a pharmacist-managed warfarin protocol is as effective as usual care and has advantages pertaining to work satisfaction, knowledge of drug interactions, consistent documentation, and fewer INR tests. Further research on teamwork and coagulation management in long-term care facilities is recommended. PMID:27403212

  15. A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

    ERIC Educational Resources Information Center

    Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

    2009-01-01

    The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

  16. Proposition for a protocol for anatomical studies on collection specimens by magnetic resonance imaging.

    PubMed

    Chanet, Bruno; Guintard, Claude

    2012-01-01

    Magnetic resonance imaging (MRI) examinations for anatomical studies on collection specimens are becoming more and more frequent. As the presence of metallic objects within the specimens can disturb the acquisition of images and damage both specimens and materials, a simple protocol using radiographs is here proposed to detect these objects in collection specimens before conducting an MRI examination.

  17. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    PubMed

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  18. Effectiveness of enteral feeding protocol on clinical outcomes in critically ill patients: a study protocol for before-and-after design

    PubMed Central

    Zhang, Zhongheng; Li, Qian; Jiang, Lingzhi; Xie, Bo; Ji, Xiaowei; Lu, Jiahong; Jiang, Ronglin; Lei, Shu; Mao, Shihao; Ying, Lijun; Lu, Di; Si, Xiaoshui; He, Jianxin; Ji, Mingxia; Zhu, Jianhua; Chen, Guodong; Shao, Yadi; Xu, Yinghe; Lin, Ronghai; Zhang, Chao; Zhang, Weiwen; Luo, Jian; Lou, Tianzheng; He, Xuwei; Chen, Kun

    2016-01-01

    Introduction Enteral feed is an important component of nutritional therapy in critically ill patients and underfeeding has been associated with adverse outcomes. The article developed an enteral feeding protocol and planed a before-and-after comparative trial to explore whether implementation of enteral feeding protocol was able to improve clinical outcomes. Methods and analysis The study will be conducted in intensive care units (ICUs) of ten tertiary care academic centers. Critically ill patients expected to stay in ICU for over 3 days and require enteral nutrition (EN) were potentially eligible. This is a before-and-after study comprising three phases: The first phase is the period without enteral feeding protocol; the second phase involves four-week training program, and the last phase is to perform the protocol in participating centers. We plan to enroll a total of 350 patients to provide an 80% power and 0.05 error rate to detect a 15% reduction of mortality. The primary outcome is 28-day mortality. Ethics and dissemination Ethical approval to conduct the research has been obtained from all participating centers. Additionally, the results will be published in peer-reviewed journal. Trial registration The study was registered at International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ISRCTN10583582). PMID:27668228

  19. Bridging the gap between comprehensive extraction protocols in plant metabolomics studies and method validation.

    PubMed

    Bijttebier, Sebastiaan; Van der Auwera, Anastasia; Foubert, Kenn; Voorspoels, Stefan; Pieters, Luc; Apers, Sandra

    2016-09-01

    It is vital to pay much attention to the design of extraction methods developed for plant metabolomics, as any non-extracted or converted metabolites will greatly affect the overall quality of the metabolomics study. Method validation is however often omitted in plant metabolome studies, as the well-established methodologies for classical targeted analyses such as recovery optimization cannot be strictly applied. The aim of the present study is to thoroughly evaluate state-of-the-art comprehensive extraction protocols for plant metabolomics with liquid chromatography-photodiode array-accurate mass mass spectrometry (LC-PDA-amMS) by bridging the gap with method validation. Validation of an extraction protocol in untargeted plant metabolomics should ideally be accomplished by validating the protocol for all possible outcomes, i.e. for all secondary metabolites potentially present in the plant. In an effort to approach this ideal validation scenario, two plant matrices were selected based on their wide versatility of phytochemicals: meadowsweet (Filipendula ulmaria) for its polyphenols content, and spicy paprika powder (from the genus Capsicum) for its apolar phytochemicals content (carotenoids, phytosterols, capsaicinoids). These matrices were extracted with comprehensive extraction protocols adapted from literature and analysed with a generic LC-PDA-amMS characterization platform that was previously validated for broad range phytochemical analysis. The performance of the comprehensive sample preparation protocols was assessed based on extraction efficiency, repeatability and intermediate precision and on ionization suppression/enhancement evaluation. The manuscript elaborates on the finding that none of the extraction methods allowed to exhaustively extract the metabolites. Furthermore, it is shown that depending on the extraction conditions enzymatic degradation mechanisms can occur. Investigation of the fractions obtained with the different extraction methods

  20. Comparison of Chip Inlet Geometry in Microfluidic Devices for Cell Studies.

    PubMed

    Sun, Yung-Shin

    2016-01-01

    Micro-fabricated devices integrated with fluidic components provide an in vitro platform for cell studies best mimicking the in vivo micro-environment. These devices are capable of creating precise and controllable surroundings of pH value, temperature, salt concentration, and other physical or chemical stimuli. Various cell studies such as chemotaxis and electrotaxis can be performed by using such devices. Moreover, microfluidic chips are designed and fabricated for applications in cell separations such as circulating tumor cell (CTC) chips. Usually, there are two most commonly used inlets in connecting the microfluidic chip to sample/reagent loading tubes: the vertical (top-loading) inlet and the parallel (in-line) inlet. Designing this macro-to-micro interface is believed to play an important role in device performance. In this study, by using the commercial COMSOL Multiphysics software, we compared the cell capture behavior in microfluidic devices with different inlet types and sample flow velocities. Three different inlets were constructed: the vertical inlet, the parallel inlet, and the vertically parallel inlet. We investigated the velocity field, the flow streamline, the cell capture rate, and the laminar shear stress in these inlets. It was concluded that the inlet should be designed depending on the experimental purpose, i.e., one wants to maximize or minimize cell capture. Also, although increasing the flow velocity could reduce cell sedimentation, too high shear stresses are thought harmful to cells. Our findings indicate that the inlet design and flow velocity are crucial and should be well considered in fabricating microfluidic devices for cell studies. PMID:27314318

  1. Comparison of Chip Inlet Geometry in Microfluidic Devices for Cell Studies.

    PubMed

    Sun, Yung-Shin

    2016-06-15

    Micro-fabricated devices integrated with fluidic components provide an in vitro platform for cell studies best mimicking the in vivo micro-environment. These devices are capable of creating precise and controllable surroundings of pH value, temperature, salt concentration, and other physical or chemical stimuli. Various cell studies such as chemotaxis and electrotaxis can be performed by using such devices. Moreover, microfluidic chips are designed and fabricated for applications in cell separations such as circulating tumor cell (CTC) chips. Usually, there are two most commonly used inlets in connecting the microfluidic chip to sample/reagent loading tubes: the vertical (top-loading) inlet and the parallel (in-line) inlet. Designing this macro-to-micro interface is believed to play an important role in device performance. In this study, by using the commercial COMSOL Multiphysics software, we compared the cell capture behavior in microfluidic devices with different inlet types and sample flow velocities. Three different inlets were constructed: the vertical inlet, the parallel inlet, and the vertically parallel inlet. We investigated the velocity field, the flow streamline, the cell capture rate, and the laminar shear stress in these inlets. It was concluded that the inlet should be designed depending on the experimental purpose, i.e., one wants to maximize or minimize cell capture. Also, although increasing the flow velocity could reduce cell sedimentation, too high shear stresses are thought harmful to cells. Our findings indicate that the inlet design and flow velocity are crucial and should be well considered in fabricating microfluidic devices for cell studies.

  2. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  3. Neurofeedback for insomnia: a pilot study of Z-score SMR and individualized protocols.

    PubMed

    Hammer, Barbara U; Colbert, Agatha P; Brown, Kimberly A; Ilioi, Elena C

    2011-12-01

    Insomnia is an epidemic in the US. Neurofeedback (NFB) is a little used, psychophysiological treatment with demonstrated usefulness for treating insomnia. Our objective was to assess whether two distinct Z-Score NFB protocols, a modified sensorimotor (SMR) protocol and a sequential, quantitative EEG (sQEEG)-guided, individually designed (IND) protocol, would alleviate sleep and associated daytime dysfunctions of participants with insomnia. Both protocols used instantaneous Z scores to determine reward condition administered when awake. Twelve adults with insomnia, free of other mental and uncontrolled physical illnesses, were randomly assigned to the SMR or IND group. Eight completed this randomized, parallel group, single-blind study. Both groups received fifteen 20-min sessions of Z-Score NFB. Pre-post assessments included sQEEG, mental health, quality of life, and insomnia status. ANOVA yielded significant post-treatment improvement for the combined group on all primary insomnia scores: Insomnia Severity Index (ISI p<.005), Pittsburgh Sleep Quality Inventory (PSQI p<.0001), PSQI Sleep Efficiency (p<.007), and Quality of Life Inventory (p<.02). Binomial tests of baseline EEGs indicated a significant proportion of excessively high levels of Delta and Beta power (p<.001) which were lowered post-treatment (paired z-tests p<.001). Baseline EEGs showed excessive sleepiness and hyperarousal, which improved post-treatment. Both Z-Score NFB groups improved in sleep and daytime functioning. Post-treatment, all participants were normal sleepers. Because there were no significant differences in the findings between the two groups, our future large scale studies will utilize the less burdensome to administer Z-Score SMR protocol.

  4. Study on surface properties of PDMS microfluidic chips treated with albumin.

    PubMed

    Schrott, Walter; Slouka, Zdenek; Cervenka, Petr; Ston, Jirí; Nebyla, Marek; Pribyl, Michal; Snita, Dalimil

    2009-10-12

    Electrokinetic properties and morphology of PDMS microfluidic chips intended for bioassays are studied. The chips are fabricated by a casting method followed by polymerization bonding. Microchannels are coated with 1% solution of bovine serum albumin (BSA) in Tris buffer. Albumin passively adsorbs on the PDMS surface. Electrokinetic characteristics (electro-osmotic velocity, electro-osmotic mobility, and zeta potential) of the coated PDMS channels are experimentally determined as functions of the electric field strength and the characteristic electrolyte concentration. Atomic force microscopy (AFM) analysis of the surface reveals a "peak and ridge" structure of the protein layer and an imperfect substrate coating. On the basis of the AFM observation, several topologies of the BSA-PDMS surface are proposed. A nonslip mathematical model of the electro-osmotic flow is then numerically analyzed. It is found that the electrokinetic characteristics computed for a channel with the homogeneous distribution of a fixed electric charge do not fit the experimental data. Heterogeneous distribution of the fixed electric charge and the surface roughness is thus taken into account. When a flat PDMS surface with electric charge heterogeneities is considered, the numerical results are in very good agreement with our experimental data. An optimization analysis finally allowed the determination of the surface concentration of the electric charge and the degree of the PDMS surface coating. The obtained findings can be important for correct prediction and possibly for robust control of behavior of electrically driven PDMS microfluidic chips. The proposed method of the electro-osmotic flow analysis at surfaces with a heterogeneous distribution of the surface electric charge can also be exploited in the interpretation of experimental studies dealing with protein-solid phase interactions or substrate coatings.

  5. Soil-on-a-Chip: microfluidic platforms for environmental organismal studies.

    PubMed

    Stanley, Claire E; Grossmann, Guido; i Solvas, Xavier Casadevall; deMello, Andrew J

    2016-01-21

    Soil is the habitat of countless organisms and encompasses an enormous variety of dynamic environmental conditions. While it is evident that a thorough understanding of how organisms interact with the soil environment may have substantial ecological and economical impact, current laboratory-based methods depend on reductionist approaches that are incapable of simulating natural diversity. The application of Lab-on-a-Chip or microfluidic technologies to organismal studies is an emerging field, where the unique benefits afforded by system miniaturisation offer new opportunities for the experimentalist. Indeed, precise spatiotemporal control over the microenvironments of soil organisms in combination with high-resolution imaging has the potential to provide an unprecedented view of biological events at the single-organism or single-cell level, which in turn opens up new avenues for environmental and organismal studies. Herein we review some of the most recent and interesting developments in microfluidic technologies for the study of soil organisms and their interactions with the environment. We discuss how so-called "Soil-on-a-Chip" technology has already contributed significantly to the study of bacteria, nematodes, fungi and plants, as well as inter-organismal interactions, by advancing experimental access and environmental control. Most crucially, we highlight where distinct advantages over traditional approaches exist and where novel biological insights will ensue.

  6. GCOD - GeneChip Oncology Database

    PubMed Central

    2011-01-01

    Background DNA microarrays have become a nearly ubiquitous tool for the study of human disease, and nowhere is this more true than in cancer. With hundreds of studies and thousands of expression profiles representing the majority of human cancers completed and in public databases, the challenge has been effectively accessing and using this wealth of data. Description To address this issue we have collected published human cancer gene expression datasets generated on the Affymetrix GeneChip platform, and carefully annotated those studies with a focus on providing accurate sample annotation. To facilitate comparison between datasets, we implemented a consistent data normalization and transformation protocol and then applied stringent quality control procedures to flag low-quality assays. Conclusion The resulting resource, the GeneChip Oncology Database, is available through a publicly accessible website that provides several query options and analytical tools through an intuitive interface. PMID:21291543

  7. Analysis of DNA-chip and antigen-chip data: studies of cancer, stem cells and autoimmune diseases

    NASA Astrophysics Data System (ADS)

    Domany, Eytan

    2005-07-01

    Biology has undergone a revolution during the past decade. Deciphering the human genome has opened new horizons, among which the advent of DNA microarrays has been perhaps the most significant. These miniature measuring devices report the levels at which tens of thousands of genes are expressed in a collection of cells of interest (such as tissue from a tumor). I describe here briefly this technology and present an example of how analysis of data obtained from such high throughput experiments provides insights of possible clinical and therapeutic relevance for Acute Lymphoblastic Leukemia. Next, I describe how gene expression data is used to deduce a new design principle, " Just In Case", used by stem cells. Finally I briefly review a different novel technology, of antigen chips, which provide a fingerprint of a subject's immune system and may become a predictive clinical tool. The work reviewed here was done in collaboration with numerous colleagues and students.

  8. Driving Position Field Study, Differences with the Whiplash Protocol and Biomechanics Experimental Responses

    PubMed Central

    Arregui-Dalmases, Carlos; Pozo, Eduardo Del; Lessley, David; Barrios, Jose Manuel; Nombela, Mario; Cisneros, Oscar; de Miguel, Juan Luis; Seguí-Gómez, María

    2011-01-01

    Rear-impact collisions at low speed are a leading cause of economic costs among motor vehicle accidents. Recently, EuroNCAP has incorporated in its protocol the whiplash test, to reproduce a low-speed rear impact. This paper presents a field driving study to assess the potential differences between the EuroNCAP dummy tests and actual drivers in the field, focusing on occupant position and biomechanics experimental results. A total of 182 drivers were randomly selected in two geographical areas in Spain. The driving position of each driver was recorded with a focus on the most relevant measurements for rear impact. Statistical analysis was performed to obtain means, standard deviations and density functions to compare observational seating position with that of the EuroNCAP testing protocol. The observational data showed a similar seatback angle to that used in the EuroNCAP protocol (24° in front of 25° for the protocol), a greater distance between the head vertex and the top of the head restraint (53mm compared to 39.5mm), and less distance between the occipital bone of the head and the headrest (67.9 compared to 89.3mm). Based on these data, 4 dummy tests were conducted using the dummy BioRID IIg. The baseline test was designed to reproduce the dummy position according to EuroNCAP 3.0 whiplash protocol. Three different additional tests were defined to reproduce the actual observed driving position as well as to assess a “worst case” scenario in terms of reduced seatback angle. These variations in initial driver position, comparing the EuroNCAP protocol to the observational study results, were not observed to cause significant differences in the biomechanical values measured in the BioRID IIg, The T1 acceleration was reduced less than 8%, the NIC was increased about 8%, and the NKm presented a reduction of 20%. Reducing the seat angle was observed to be more harmful in terms of NIC. PMID:22105385

  9. A follow-up study of heroin addicts (VEdeTTE2): study design and protocol

    PubMed Central

    Vigna-Taglianti, Federica D; Mathis, Federica; Diecidue, Roberto; Burroni, Paola; Iannaccone, Antonio; Lampis, Fabio; Zuccaro, Piergiorgio; Pacifici, Roberta; Versino, Elisabetta; Davoli, Marina; Faggiano, Fabrizio

    2007-01-01

    Background In Italy, a large cohort study (VEdeTTE1) was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2) was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%). Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78%) but lower for cocaine (42.3%), highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the pilot phase underline the

  10. Primary single event effect studies on Xilinx 28-nm System-on-Chip (SoC)

    NASA Astrophysics Data System (ADS)

    Zhang, Yao; Liu, Shuhuan; Du, Xuecheng; Yuan, Yuan; He, Chaohui; Ren, Xiaotang; Du, Xiaozhi; Li, Yonghong

    2016-09-01

    Single Event Effect (SEE) on Xilinx 28-nm System-on-Chip (SoC) was investigated by both simulation and experiments in this study. In the simulation process, typical structure of NAND gate and flip-flop in SoC were designed using Cadence tool. Various kinds of radiation were simulated as pulsed current source in consideration of multilayer wiring and energy loss before reaching the sensitive area. The circuit modules were simulated as SEE occurred and malfunctioned when pulsed current source existed. The changes of the circuit modules output were observed when pulsed current signals were placed at different sensitive nodes or the circuit operated under different conditions. The sensitive nodes in typical modules and the possible reasons of test program malfunction were primarily studied. In the experimental process, SoC chip was irradiated with α particles, protons and laser respectively. The irradiation test results showed that Single Event Upset (SEU) occurred in typical modules of SoC, in accordance with the simulation results.

  11. On-chip dynamic stress control for cancer cell evolution study

    NASA Astrophysics Data System (ADS)

    Liu, Liyu; Austin, Robert

    2010-03-01

    The growth and spreading of cancer in host organisms is an evolutionary process. Cells accumulate mutations that help them adapt to changing environments and to obtain survival fitness. However, all cancer--promoting mutations do not occur at once. Cancer cells face selective environmental pressures that drive their evolution in stages. In traditional cancer studies, environmental stress is usually homogenous in space and difficult to change in time. Here, we propose a microfluidic chip employing embedded dynamic traps to generate dynamic heterogeneous microenvironments for cancer cells in evolution studies. Based on polydimethylsiloxane (PDMS) flexible diaphragms, these traps are able to enclose and shield cancer cells or expose them to external environmental stress. Digital controls for each trap determine the nutrition, antibiotics, CO2/O2 conditions, and temperatures to which trapped cells are subjected. Thus, the stress applied to cells can be varied in intensity and duration in each trap independently. The chip can also output cells from specific traps for sequencing and other biological analysis. Hence our design simultaneously monitors and analyzes cell evolution behaviors under dynamic stresses.

  12. Study on reflow process of SWIR FPA during flip-chip bonding technology

    NASA Astrophysics Data System (ADS)

    Fan, Cui; Li, Xue; Shao, Xiumei; Zeng, Zhijiang; Tang, Hengjing; Li, Tao; Gong, Haimei

    2016-05-01

    Reflow soldering is the primary method for Flip-chip bonding without high bonding pressure. Reflow process during flip-chip technology in short wavelength infrared (SWIR) InGaAs/InP Focal Plane array (FPA) with indium solder was studied in this paper. In order to analyze the formation of Indium oxide and its effects on Indium bump reflow process. Indium bumps were investigated by X-ray Photoelectron Spectroscopy (XPS). The profiles of Indium bumps after reflow were observed by scanning electron microscopy (SEM). The interaction between Indium and the metal in under bump metallization (UBM) during reflow process was discussed. The current-voltage (I-V) curves of InGaAs/InP photodiodes were measured before and after the reflow process. The dark current density at 0.1 V reverse bias of InGaAs/InP photodiodes were studied. It was confirmed that the characteristics of InGaAs photodetectors haven't degenerated after reflow in this paper.

  13. The longitudinal urban cohort ageing study (LUCAS): study protocol and participation in the first decade

    PubMed Central

    2012-01-01

    Background We present concept, study protocol and selected baseline data of the Longitudinal Urban Cohort Ageing Study (LUCAS) in Germany. LUCAS is a long-running cohort study of community-dwelling seniors complemented by specific studies of geriatric patients or diseases. Aims were to (1) Describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability and need of care; (2) Find determinants of healthy ageing; (3) Assess long-term effects of specific health promotion interventions; (4) Produce results for health care planning for fit, pre-frail, frail and disabled elderly persons; (5) Set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly. Methods/Design In 2000, twenty-one general practitioners (GPs) were recruited in the Hamburg metropolitan area; they generated lists of all their patients 60 years and older. Persons not terminally ill, without daily need of assistance or professional care were eligible. Of these, n = 3,326 (48 %) agreed to participate and completed a small (baseline) and an extensive health questionnaire (wave 1). In 2007/2008, a re-recruitment took place including 2,012 participants: 743 men, 1,269 women (647 deaths, 197 losses, 470 declined further participation). In 2009/2010 n = 1,627 returned the questionnaire (90 deaths, 47 losses, 248 declined further participation) resulting in a good participation rate over ten years with limited and quantified dropouts. Presently, follow-up data from 2007/2008 (wave 2) and 2009/2010 (wave 3) are available. Data wave 4 is due in 2011/2012, and the project will be continued until 2013. Information on survival and need of nursing care was collected continuously and cross-checked against official records. We used Fisher’s exact test and t-tests. The study served repeatedly to evaluate health promotion interventions and concepts. Discussion LUCAS shows that a cohort

  14. On shaky ground - A study of security vulnerabilities in control protocols

    SciTech Connect

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-07-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

  15. Proposed computerized protocol for epidemiological study of patients undergoing microsurgery of the larynx

    PubMed Central

    Catani, Guilherme Simas do Amaral; Carvalho, Bettina; Filho, Jorge Massaaki Ido; Filho, Evaldo Dacheux de Macedo; Pinto, José Simão de Paula; Malafaia, Osvaldo; Stahlke, Henrique Jorge

    2012-01-01

    Summary Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patients undergoing laryngoscopic microsurgery of the larynx. Method: We created a database of ENT diseases through a literature review of textbooks and scientific articles. Next, we computerized the data and incorporated it into the SINPE©, creating a master protocol (ENT diseases) and a specific protocol (laryngeal diseases). Data were collected prospectively from patients undergoing laryngeal microsurgery in the ENT Hospital of Paraná. The collected data were analyzed with graphs through the SINPE© Analyzer module. Results: We evaluated 245 patients aged 9–79 years, and determined that 36.61% (93 patients) underwent surgery for the presence of polyps on the vocal folds, 12.6% (32) underwent surgery for papillomatosis, and 11.83% (29) underwent surgery for intracordal cysts. Conclusions: The creation of an electronic database of clinical ENT diseases was feasible. We were also able to implement and validate the protocol. The database may be released to physicians involved in clinical data collection and retrieval of information to conduct scientific research in an organized manner. The most common laryngeal disorders identified were polyps, papilloma, and intracordal cysts. PMID:25991956

  16. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    PubMed Central

    Sigilião, Lara Carvalho Freitas; Marquezan, Mariana; Elias, Carlos Nelson; Ruellas, Antônio Carlos; Sant'Anna, Eduardo Franzotti

    2015-01-01

    Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding. Methods: A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L), 12-blade bur at high speed (G12H), 30-blade bur at low speed (G30L), DU10CO ORTHO polisher (GDU), Renew System (GR) and Diagloss polisher (GD). Mean roughness (Ra) and mean roughness depth (Rz) of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz) were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM). Results: In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05) was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz); Ra and (∆Ra, ∆Rz); Rz (r = - 0.445, r = - 0.475, p < 0.01). Conclusion: All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness. PMID:26560825

  17. Use of clomiphene-based stimulation protocol in oocyte donors: A comparative study

    PubMed Central

    Singh, Aparna; Bhandari, Shilpa; Agrawal, Pallavi; Gupta, Nitika; Munaganuru, Niharika

    2016-01-01

    INTRODUCTION: This study was undertaken to compare between clomiphene citrate (CC) and gonadotropin-releasing hormone antagonist-based protocols in donor-recipient cycles in terms of parameters of ovarian stimulation and obstetric outcome. MATERIALS AND METHODS: Two hundred and three fertile oocyte donors were stimulated using two different protocols: Clomiphene based (n = 103) and antagonist based (n = 100). Donors in the one group were stimulated from day 1 or 2 of spontaneous or withdrawal bleeds with CC (50 mg/day) and recombinant follicle-stimulating hormone (FSH) till the day of trigger while donors in the other group were stimulated using recombinant FSH from day 1 or 2, and the antagonist was added as per flexible antagonist protocol. When >3 follicles were >17 mm in diameter, trigger was given with 2 mg leuprolide intramuscular. Transvaginal oocyte retrieval was done after 34 h of trigger. RESULTS: There was no significant difference in between the two groups in terms of age, antral follicle count, starting dose of gonadotropins, total dose required, duration of stimulation, number of follicles retrieved, mature follicles, and fertilization rate. The serum estradiol levels were significantly raised in the clomiphene group (P < 0.001). Pregnancy rate was similar in both the groups. The clinical pregnancy rate was 65.94% in the clomiphene group and 57.46% in the antagonist group. The live birth rate per cycle started was 47.8% in the clomiphene group and 39.55% in the antagonist group. There was one case of ectopic pregnancy in the antagonist group. CONCLUSION: Controlled ovarian stimulation using clomiphene and gonadotropin is a viable option for donor oocyte cycles. The cost and number of injections used per cycle can be reduced by using the clomiphene-based protocols. PMID:27803583

  18. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    NASA Astrophysics Data System (ADS)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain–computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  19. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    NASA Astrophysics Data System (ADS)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  20. Development of structural MR brain imaging protocols to study genetics and maturation

    PubMed Central

    Kochunov, Peter; Davis, M. Duff

    2009-01-01

    Structural imaging research offers excellent translational benefits when non-human primate (NHP) models are employed. In this paper, we will discuss the development of anatomical MR imaging protocols for two important applications of structural imaging in NHP: studies of genetic variability in brain morphology and longitudinal imaging of fetal brain maturation trends. In contrast with imaging studies of adult humans, structural imaging in the NHP is challenging due to a comparatively small brain size (2-200 fold smaller volume, depending on the species). This difference in size is further accentuated in NHP studies of brain development, in which fetal brain volumes are 10-50% of their adult size. The sizes of cortical gyri and sulci scale allometrically with brain size. Thus, achieving spatial sampling that is comparable to that of high-quality human studies (∼1.0 mm3) requires a brain-size-adjusted reduction in the sampling volumes of from 500-to-150 microns3. Imaging at this spatial resolution while maintaining sufficient contrast and signal to noise ratio necessitates the development of specialized MRI protocols. Here we discuss our strategy to optimize the protocol parameters for two commonly available structural imaging sequences: MPRAGE and TrueFisp. In addition, computational tools developed for the analysis of human structural images were applied to the NHP studies. These included removal of non-brain tissues, correction for RF inhomogeneity, spatial normalization, building of optimized target brain and analysis of cerebral gyrification and individual cortical variability. Finally, recent findings in the genetics of cerebral gyrification and tracking of maturation trends in the fetal, newborn and adult brain are described PMID:19665566

  1. A comparative study of routing protocols of heterogeneous wireless sensor networks.

    PubMed

    Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

    2014-01-01

    Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols. PMID:25050393

  2. Enabling rapid behavioral ecotoxicity studies using an integrated lab-on-a-chip systems

    NASA Astrophysics Data System (ADS)

    Huang, Yushi; Nugegoda, Dayanthi; Wlodkowic, Donald

    2015-12-01

    Behavioral ecotoxicity tests are gaining an increasing recognition in environmental toxicology. Behavior of sensitive bioindicator species can change rapidly in response to an acute exposure to contaminants and thus has a much higher sensitivity as compared to conventional LC50 mortality tests. Furthermore, behavioral endpoints seems to be very good candidates to develop early-warning biomonitoring systems needed for rapid chemical risk assessment. Behavioral tests are non-invasive, fast, do not harm indicator organisms (behavioural changes are very rapid) and are thus fully compatible with 3R (Replacement - Reduction - Refinement) principle encouraging alternatives to conventional animal testing. These characteristics are essential when designing improved ecotoxicity tests for chemical risk assessment. In this work, we present a pilot development of miniaturized Lab-on-a-Chip (LOC) devices for studying toxin avoidance behaviors of small aquatic crustaceans. As an investigative tool, LOCs represent a new direction that may miniaturize and revolutionize behavioral ecotoxicology. Specifically our innovative microfluidic prototype: (i) enables convening "caging" of specimens for real-time videomicroscopy; (ii) eliminates the evaporative water loss thus providing an opportunity for long-term behavioral studies; (iii) exploits laminar fluid flow under low Reynolds numbers to generate discrete domains and gradients enabling for the first time toxin avoidance studies on small aquatic crustaceans; (iv) integrates off-the-chip mechatronic interfaces and video analysis algorithms for single animal movement analysis. We provide evidence that by merging innovative bioelectronic and biomicrofluidic technologies we can deploy inexpensive and reliable systems for culture, electronic tracking and complex computational analysis of behavior of bioindicator organisms.

  3. Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

    PubMed Central

    2011-01-01

    Background In our original study of newborn weight loss, we determined there were positive correlations among newborn weight loss, neonatal output, and the IV fluids mothers received before their babies' birth. Basically, an increase in maternal IV fluids is correlated to an increase in neonatal output and newborn weight loss. When assessing newborn weight change, our recommendation is to change baseline from birth weight to a weight measured at 24 hours. The purpose of this paper is to provide a protocol for clinicians to collect and analyze data from their own maternity site to determine if the newborns experience such an iatrogenic weight loss and to make decisions about how to assess newborn weight changes. Methods We recommend a prospective observational study with data collected about maternal fluids, neonatal output, and newborn weight measurements. The methods we suggest include specifics about recruitment, data collection, and data analysis. Discussion Quality assurance and research ethics considerations are described. We also share practical information that we learned from our original study. Ultimately, to encourage knowledge translation and research uptake, we provide a protocol and sound advice to do a research study in your maternity setting. PMID:21843331

  4. Preliminary study of moisture effects on leadless chip carriers (LCCS) from aqueous cleaning

    SciTech Connect

    Adams, B.E.

    1992-02-01

    Deionized (DI) water cleaning of leadless chip carriers (LCCs) was tested to determine the effect on wire bonding, package sealing, and internal moisture content. The testing methods used to measure the effect of water included nondestructive wire pull testing (NDPT), fine leak testing, residual gas analysis on a mass spectrometer. Twenty LCCs were cleaned with deionized (DI) water and alcohol, and ten of those were vacuum baked. Ten other LCCs processed simultaneously with the first twenty had no cleaning. Results indicated that water cleaning had no effect on internal moisture of sealed LCCs. Also, sealing yields of each group were 100%. One wire bond failure in 80 occurred in the water and alcohol-cleaned non-vacuum-baked parts, which will require more study.

  5. An on-chip small intestine-liver model for pharmacokinetic studies.

    PubMed

    Kimura, Hiroshi; Ikeda, Takashi; Nakayama, Hidenari; Sakai, Yasuyuki; Fujii, Teruo

    2015-06-01

    Testing of drug effects and cytotoxicity by using cultured cells has been widely performed as an alternative to animal testing. However, the estimation of pharmacokinetics by conventional cell-based assay methods is difficult because of the inability to evaluate multiorgan effects. An important challenge in the field is to mimic the organ-to-organ network in the human body by using a microfluidic network connecting small-scale tissues based on recently emerging MicroTAS (Micro Total Analysis Systems) technology for prediction of pharmacokinetics. Here, we describe an on-chip small intestine-liver coupled model for pharmacokinetic studies. To construct an in vitro pharmacokinetic model that appropriately models in vivo conditions, physiological parameters such as the structure of internal circulation, volume ratios of each organ, and blood flow ratio of the portal vein to the hepatic artery were mimicked using microfluidic networks. To demonstrate interactions between organs in vitro in pharmacokinetic studies, Caco-2, HepG2, and A549 cell cultures were used as organ models of the small intestine, liver, and lung, respectively, and connected to each other through a microporous membrane and microchannels to prepare a simple model of a physiological organ-to-organ network. The on-chip organ model assay using three types of substrate-epirubicine (EPI), irinotecan (CPT-11), and cyclophosphamide (CPA)-were conducted to model the effects of orally administered or biologically active anticancer drugs. The result suggested that the device can replicate physiological phenomena such as activity of the anticancer drugs on the target cells. This microfluidic device can thus be used as an in vitro organ model to predict the pharmacokinetics of drugs in the human body and may thus provide not only an alternative to animal testing but also a method of obtaining parameters for in silico models of physiologically based pharmacokinetics. PMID:25385717

  6. Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function (ePDF) studies

    DOE PAGES

    Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun; Zhu, Yimei; Billinge, Simon J. L.

    2015-02-01

    We explore and describe different protocols for calibrating electron pair distribution function (ePDF) measurements for quantitative studies on nano-materials. We find the most accurate approach to determine the camera-length is to use a standard calibration sample of Au nanoparticles from National Institute of Standards and Technology. Different protocols for data collection are also explored, as are possible operational errors, to find the best approaches for accurate data collection for quantitative ePDF studies.

  7. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  8. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    PubMed

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  9. A study of admissions and inpatients over the Christmas period using the appropriateness evaluation protocol (AEP).

    PubMed

    Henshaw; Pollock; Rai; Gluck

    2000-08-01

    The aim of the study was to examine appropriateness of admissions and inpatients over Christmas especially in the elderly. The study was a prospective audit of admissions and inpatients to the Whittington Hospital. The main outcome measures were appropriateness of admission or day of hospital residence using the Appropriateness Evaluation Protocol. The protocol was applied to admissions and inpatients over Christmas and control periods. The results showed that there was a significant difference in the number of elderly admissions between the control period and Christmas period, 94 (34%) vs. 104 (43%) (P=0.02). However there was no corresponding change in appropriateness of elderly admissions, ten (10.6%) vs. six (5.8%), (P=0.2). The inappropriateness of day of hospital residence increased from 10% on the control day to 20% on the study day (P=0.02). In conclusion elderly patients are not admitted more inappropriately over Christmas but their discharge at this time appears to be delayed resulting in inappropriate bed use.

  10. Programmable parylene-C bonding layer fluorescence for storing information on microfluidic chips.

    PubMed

    Ciftlik, Ata Tuna; Dupouy, Diego Gabriel; Gijs, Martin A M

    2013-04-21

    We demonstrate data storage on glass/silicon microfluidic devices fabricated using parylene-C as a bonding layer. In particular, we report intermediate parylene-C bonding layer fluorescence (iPBLF) and its use as an on-chip medium for data storage by dynamic programming of iPBLF intensity, using alternating exposure of parylene-C to UV and Green light. This technique allows data on the microfluidic chip to be read, written and erased by a common fluorescent microscope. Until now, no studies have focused on storing data like expiry date, protocol or operational parameters on a chip. However, this can be useful to overcome certain automation challenges in industrial applications for which communication of information is required, like needed during operation of remote microfluidic platforms. Finally, we also demonstrate the application of iPBLF for detecting channel dimensions and positions, and for marking on-chip zones of particular interest.

  11. Income Eligibility Thresholds, Premium Contributions, and Children's Coverage Outcomes: A Study of CHIP Expansions

    PubMed Central

    Gresenz, Carole Roan; Edgington, Sarah E; Laugesen, Miriam J; Escarce, José J

    2013-01-01

    Objective To understand the effects of Children's Health Insurance Program (CHIP) income eligibility thresholds and premium contribution requirements on health insurance coverage outcomes among children. Data Sources 2002–2009 Annual Social and Economic Supplements of the Current Population Survey linked to data from multiple secondary data sources. Study Design We use a selection correction model to simultaneously estimate program eligibility and coverage outcomes conditional upon eligibility. We simulate the effects of three premium schedules representing a range of generosity levels and the effects of income eligibility thresholds ranging from 200 to 400 percent of the federal poverty line. Principal Findings Premium contribution requirements decrease enrollment in public coverage and increase enrollment in private coverage, with larger effects for greater contribution levels. Our simulation results suggest minimal changes in coverage outcomes from eligibility expansions to higher income families under premium schedules that require more than a modest contribution (medium or high schedules). Conclusions Our simulation results are useful counterpoints to previous research that has estimated the average effect of program expansions as they were implemented without disentangling the effects of premiums or other program features. The sensitivity to premiums observed suggests that although contribution requirements may be effective in reducing crowd-out, they also have the potential, depending on the level of contribution required, to nullify the effects of CHIP expansions entirely. The persistence of uninsurance among children under the range of simulated scenarios points to the importance of Affordable Care Act provisions designed to make the process of obtaining coverage transparent and navigable. PMID:23398477

  12. Testing a Theory-Based Mobility Monitoring Protocol Using In-Home Sensors: A Feasibility Study

    PubMed Central

    Reeder, Blaine; Chung, Jane; Lazar, Amanda; Joe, Jonathan; Demiris, George; Thompson, Hilaire J.

    2014-01-01

    Mobility is a key factor in the performance of many everyday tasks required for independent living as a person grows older. The purpose of this mixed methods study was to test a theory-based mobility monitoring protocol by comparing sensor-based measures to self-report measures of mobility and assessing the acceptability of in-home sensors with older adults. Standardized instruments to measure physical, psychosocial and cognitive parameters were administered to 8 community-dwelling older adults at baseline, 3 month and 6 month visits (examples: FES, GDS-SF, Mini-cog). Semi-structured interviews to characterize acceptability of the technology were conducted at 3 month and 6 month visits. Technical issues prevented comparison of sensor-based measures with self-report measures. In-home sensor technology for monitoring mobility is acceptable to older adults. Implementing our theory-based mobility monitoring protocol in a field study in the homes of older adults is a feasible undertaking but requires more robust technology for sensor-based measure validation. PMID:23938159

  13. Laboratory study of opposition surge of rock chips and particle layers

    NASA Astrophysics Data System (ADS)

    Honda, T.; Nakamura, A. M..; Mukai, T.

    Surfaces of small bodies such as asteroids are covered with regolith particles The intensity of the scattered light from such surface nonlinearly increases at small solar phase angles the angle between the light source and the detector as seen from the target The degree and the sharpness of the phenomena opposition surge are considered to depend on the physical state of the surface It was shown the opposition surge appears on scattered light from surface of rocks Shepard and Arvidson 1999 However it remains to be incompletely understood how the opposition surge varies with the structure and optical characteristics of the scattering target First we performed measurements of scattered light from rock chips and particle layers at low phase angles Measurements were performed using a multi phase angle near infrared spectrometer at Kobe University with the incident angle fixed at 2 degree and the phase angle varied within 0-25 degrees A clear differences were found between the phase curves of dunite chip and particles whereas there were no apparent difference between the chips and the powders for a meteorite and mortar We then performed new measurements to focus on clarifying whether or not 1 bulk chips consisting of uniform composition also show opposition surge 2 difference in size of the constituent grains of bulk chips affects the opposition surge and 3 difference in surface roughness of bulk chips has dominant effect We will show the results of several types of bulk chips and sintered powders and will discuss on the possible

  14. A custom 148 gene-based resequencing chip and the SNP explorer software: new tools to study antibody deficiency.

    PubMed

    Wang, Hong-Ying; Gopalan, Vivek; Aksentijevich, Ivona; Yeager, Meredith; Ma, Chi Adrian; Mohamoud, Yasmin Ali; Quinones, Mariam; Matthews, Casey; Boland, Joseph; Niemela, Julie E; Torgerson, Troy R; Giliani, Silvia; Uzel, Gulbu; Orange, Jordan S; Shapiro, Ralph; Notarangelo, Luigi; Ochs, Hans D; Fleisher, Thomas; Kastner, Daniel; Chanock, Stephen J; Jain, Ashish

    2010-09-01

    Hyper-IgM syndrome and Common Variable Immunodeficiency are heterogeneous disorders characterized by a predisposition to serious infection and impaired or absent neutralizing antibody responses. Although a number of single gene defects have been associated with these immune deficiency disorders, the genetic basis of many cases is not known. To facilitate mutation screening in patients with these syndromes, we have developed a custom 300-kb resequencing array, the Hyper-IgM/CVID chip, which interrogates 1,576 coding exons and intron-exon junction regions from 148 genes implicated in B-cell development and immunoglobulin isotype switching. Genomic DNAs extracted from patients were hybridized to the array using a high-throughput protocol for target sequence amplification, pooling, and hybridization. A Web-based application, SNP Explorer, was developed to directly analyze and visualize the single nucleotide polymorphism (SNP) annotation and for quality filtering. Several mutations in known disease-susceptibility genes such as CD40LG, TNFRSF13B, IKBKG, AICDA, as well as rare nucleotide changes in other genes such as TRAF3IP2, were identified in patient DNA samples and validated by direct sequencing. We conclude that the Hyper-IgM/CVID chip combined with SNP Explorer may provide a cost-effective tool for high-throughput discovery of novel mutations among hundreds of disease-relevant genes in patients with inherited antibody deficiency.

  15. Chip-on-Board Technology 1996 Year-end Report (Design, Manufacturing, and Reliability Study)

    NASA Technical Reports Server (NTRS)

    Le, Binh Q.; Nhan, Elbert; Maurer, Richard H.; Lew, Ark L.; Lander, Juan R.

    1996-01-01

    The major impetus for flight qualifying Chip-On-Board (COB) packaging technology is the shift in emphasis for space missions to smaller, better, and cheaper spacecraft and satellites resulting from the NASA New Millenium initiative and similar requirements in DoD-sponsored programs. The most important benefit that can potentially be derived from miniaturizing spacecraft and satellites is the significant cost saving realizable if a smaller launch vehicle may be employed. Besides the program cost saving, there are several other advantages to building COB-based space hardware. First, once a well-controlled process is established, COB can be low cost compared to standard Multi-Chip Module (MCM) technology. This cost competitiveness is regarded as a result of the generally greater availability and lower cost of Known Good Die (KGD). Coupled with the elimination of the first level of packaging (chip package), compact, high-density circuit boards can be realized with Printed Wiring Boards (PWB) that can now be made with ever-decreasing feature size in line width and via hole. Since the COB packaging technique in this study is based mainly on populating bare dice on a suitable multi-layer laminate substrate which is not hermetically sealed, die coating for protection from the environment is required. In recent years, significant improvements have been made in die coating materials which further enhance the appeal of COB. Hysol epoxies, silicone, parylene and silicon nitride are desirable because of their compatible Thermal Coefficient of Expansion (TCE) and good moisture resistant capability. These die coating materials have all been used in the space and other industries with varying degrees of success. COB technology, specifically siliconnitride coated hardware, has been flown by Lockheed on the Polar satellite. In addition, DARPA has invested a substantial amount of resources on MCM and COB-related activities recently. With COB on the verge of becoming a dominant player

  16. Rigorous anaesthesia management protocol for patients with intracranial arterial stenosis: a prospective controlled-cohort study

    PubMed Central

    Laiwalla, Azim N; Ooi, Yinn Cher; Van De Wiele, Barbara; Ziv, Keren; Brown, Adam; Liou, Raymond; Saver, Jeffrey L; Gonzalez, Nestor R

    2016-01-01

    Objectives Reducing variability is integral in quality management. As part of the ongoing Encephaloduroarteriosynangiosis Revascularisation for Symptomatic Intracranial Arterial Stenosis (ERSIAS) trial, we developed a strict anaesthesia protocol to minimise fluctuations in patient parameters affecting cerebral perfusion. We hypothesise that this protocol reduces the intraoperative variability of targeted monitored parameters compared to standard management. Design Prospective cohort study of patients undergoing encephaloduroarteriosynangiosis surgery versus standard neurovascular interventions. Patients with ERSIAS had strict perioperative management that included normocapnia and intentional hypertension. Control patients received regular anaesthetic standard of care. Minute-by-minute intraoperative vitals were electronically collected. Heterogeneity of variance tests were used to compare variance across groups. Mixed-model regression analysis was performed to establish the effects of treatment group on the monitored parameters. Setting Tertiary care centre. Participants 24 participants: 12 cases (53.8 years±16.7 years; 10 females) and 12 controls (51.3 years±15.2 years; 10 females). Adults aged 30–80 years, with transient ischaemic attack or non-disabling stroke (modified Rankin Scale <3) attributed to 70–99% intracranial stenosis of the carotid or middle cerebral artery, were considered for enrolment. Controls were matched according to age, gender and history of neurovascular intervention. Main outcome measures Variability of heart rate, mean arterial blood pressure (MAP), systolic blood pressure and end tidal CO2 (ETCO2) throughout surgical duration. Results There were significant reductions in the intraoperative MAP SD (4.26 vs 10.23 mm Hg; p=0.007) and ETCO2 SD (0.94 vs 1.26 mm Hg; p=0.05) between the ERSIAS and control groups. Median MAP and ETCO2 in the ERSIAS group were higher (98 mm Hg, IQR 23 vs 75 mm Hg, IQR 15; p<0

  17. Protocol for Studying Extinction of Conditioned Fear in Naturally Cycling Female Rats

    PubMed Central

    Maeng, Lisa Y.; Cover, Kara K.; Landau, Aaron J.; Milad, Mohammed R.; Lebron-Milad, Kelimer

    2015-01-01

    Extinction of conditioned fear has been extensively studied in male rodents. Recently, there have been an increasing number of studies indicating that neural mechanisms for certain behavioral tasks and response behaviors are different in females and males. Using females in research studies can represent a challenge because of the variation of gonadal hormones during their estrous cycle. This protocol describes well-established procedures that are useful in investigating the role of estrogen in fear extinction memory consolidation in female rats. Phase of the estrous cycle and exogenous estrogen administration prior to extinction training can influence extinction recall 24 hr later. The vaginal swabbing technique for estrous phase identification described here aids the examination and manipulation of naturally cycling gonadal hormones. The use of this basic rodent model may further delineate the mechanisms by which estrogen can modulate fear extinction memory in females. PMID:25741747

  18. Cohort vision study of Apache AH Mk1 pilots: protocol and methodology

    NASA Astrophysics Data System (ADS)

    Hiatt, Keith L.; Braithwaite, Malcolm G.; Crowley, John S.; Rash, Clarence E.; van de Pol, Corina; Ranchino, Daniel J.; Statz, William K.; Eke, Allison J.

    2002-08-01

    A collaborative occupational health study has been undertaken by Headquarters Director Army Aviation, Middle Wallop, UK, and the U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, to determine if the use of the monocular helmet-mounted display in the Apache AH Mk 1 attack helicopter has any long-term (10-year) effect on visual performance. This paper describes the protocol, methodology, development and initial execution phase of this study. The test methodology consists primarily of a battery of vision tests selected to capture changes in visual performance (with an emphasis on binocular visual functions) of Apache aviators over their flight career. It is anticipated that the number of Apache aviators will level out to approximately 70 by the end of the first three years of the study. Non-Apache aviators will serve as a control group.

  19. Effect of an analgo-sedation protocol for neurointensive patients: a two-phase interventional non-randomized pilot study

    PubMed Central

    2010-01-01

    Introduction Sedation protocols are needed for neurointensive patients. The aim of this pilot study was to describe sedation practice at a neurointensive care unit and to assess the feasibility and efficacy of a new sedation protocol. The primary outcomes were a shift from sedation-based to analgesia-based sedation and improved pain management. The secondary outcomes were a reduction in unplanned extubations and duration of sedation. Methods This was a two-phase (before-after), prospective controlled study at a university-affiliated, 14-bed neurointensive care unit in Denmark. The sample included patients requiring mechanical ventilation for at least 48 hours treated with continuous sedative and analgesic infusions or both. During the observation phase the participants (n = 106) were sedated as usual (non-protocolized), and during the intervention phase the participants (n = 109) were managed according to a new sedation protocol. Results Our study showed a shift toward analgo-sedation, suggesting feasibility of the protocol. We found a significant reduction in the use of propofol (P < .001) and midazolam (P = .001) and an increase in fentanyl (P < .001) and remifentanil (P = .003). Patients selected for daily sedation interruption woke up faster, and estimates of pain free patients increased from 56.8% to 82.7% (P < .001), suggesting efficacy of the protocol. The duration of sedation and unplanned extubations were unchanged. Conclusions Our pilot study showed feasibility and partial efficacy of our protocol. Some neurointensive patients might not benefit from protocolized practice. We recommend an interdisciplinary effort to target patients requiring less sedation, as issues of oversedation and inadequate pain management still need more attention. Trial registration ISRCTN80999859. PMID:20403186

  20. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

    PubMed

    Alanazi, Adwan; Elleithy, Khaled

    2015-09-02

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

  1. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis

    PubMed Central

    Alanazi, Adwan; Elleithy, Khaled

    2015-01-01

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol. PMID:26364639

  2. A multi-parametric protocol to study exercise intolerance in McArdle's disease.

    PubMed

    Ricci, Giulia; Bertolucci, Federica; Logerfo, Annalisa; Simoncini, Costanza; Papi, Riccardo; Franzoni, Ferdinando; Dell'Osso, Giacomo; Servadio, Adele; Masoni, Maria Chiara; Siciliano, Gabriele

    2015-12-01

    McArdle's disease is the most common metabolic myopathy of muscle carbohydrate metabolism, due to deficiency of myophosphorylase and alteration of glycogen breakdown in muscle. The clinical manifestations usually begin in young adulthood, with exercise intolerance, exercise-induced muscle cramps, pain and recurrent episodes of myoglobinuria. Many patients experience the second wind phenomenon, characterized by an improved tolerance for aerobic exercise approximately after eight minutes of motor activity, secondary to the increased availability of blood glucose and free fatty acids associated to an enhanced glucose uptake by muscle cells. In this study, we aimed to test a multi-parametric protocol in order to detect the impairment of muscular metabolism and motor performance in patients with McArdle's disease. We enrolled 5 patients and 5 age-matched healthy subjects, that were evaluated by: (01) monitoring of physical activity with an electronic armband; (02) testing of cardiopulmonary, metabolic and respiratory responses to exercise with a cardiopulmonary exercise test and analyzing muscle fatigue during exercise test by surface electromyography (04) evaluating blood lactate and oxidative stress biomarkers at rest and during exercise. The patients were tested at baseline and after three days of carbohydrate-rich diet integrated with tricarboxylic acid cycle intermediate and creatine. The multiparametric protocol proved to be useful to detect the oxidative capacity impairment and the second wind phenomenon of patients. We did not observe any significant differences of muscle metabolic response during the exercise test after three days of carbohydrate-rich diet. PMID:27199539

  3. Rationale, Timeline, Study Design, and Protocol Overview of the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trials

    PubMed Central

    Moler, Frank W.; Silverstein, Faye S.; Meert, Kathleen L.; Clark, Amy E.; Holubkov, Richard; Browning, Brittan; Slomine, Beth S.; Christensen, James R.; Dean, Michael

    2014-01-01

    Objective To describe the rationale, timeline, study design, and protocol overview of the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Design Multicenter randomized controlled trials. Setting Pediatric intensive care and cardiac ICUs in the United States and Canada. Patients Children from 48 hours to 18 years old, who have return of circulation after cardiac arrest, who meet trial eligibility criteria, and whose guardians provide written consent. Interventions Therapeutic hypothermia or therapeutic normothermia. Measurements and Main Results From concept inception in 2002 until trial initiation in 2009, 7 years were required to plan and operationalize the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Two National Institute of Child Health and Human Development clinical trial planning grants (R21 and R34) supported feasibility assessment and protocol development. Two clinical research networks, Pediatric Emergency Care Applied Research Network and Collaborative Pediatric Critical Care Research Network, provided infrastructure resources. Two National Heart Lung Blood Institute U01 awards provided funding to conduct separate trials of in-hospital and out-of-hospital cardiac arrest. A pilot vanguard phase that included half the clinical sites began on March 9, 2009, and this was followed by full trial funding through 2015. Conclusions Over a decade will have been required to plan, design, operationalize, and conduct the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials. Details described in this report, such as participation of clinical research networks and clinical trial planning grants utilization, may be of utility for individuals who are planning investigator-initiated, federally supported clinical trials. PMID:23842585

  4. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    PubMed Central

    2010-01-01

    Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1) To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2) To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1) To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1) in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2) To conduct patient focus group discussions at each of these (Phase 1) to determine care received. 3) To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2). 4) To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2). 5) To undertake document analysis to appraise

  5. The HALO submaximal treadmill protocol to measure cardiorespiratory fitness in obese children and youth: a proof of principle study.

    PubMed

    Breithaupt, Peter; Adamo, Kristi B; Colley, Rachel C

    2012-04-01

    Many limitations exist with completing cardiorespiratory fitness testing in obese children. The aim of this study was to determine if the new Healthy Active Living and Obesity Research Group's (HALO's) submaximal cardiorespiratory fitness testing protocol for obese children and youth provides a comparable estimate of peak oxygen uptake to that measured using validated maximal and submaximal, equation-based protocols in the obese pediatric population. A group of obese children (n = 21; all ≥95th body mass index percentile; aged 10-17 years) completed 3 exercise testing protocols. Testing was completed as part of an ongoing cohort study and 2 submaximal cardiorespiratory fitness tests were completed, in randomized order, during a second visit. Significant correlations were found between observed peak oxygen uptake (mL·min(-1)) and predicted peak oxygen uptake for both the HALO (r = 0.75, p = 0.001) and Nemeth (r = 0.66, p = 0.001) submaximal protocols. A similar correlation was found, after accounting for body mass, between measured and predicted HALO peak oxygen uptake (mL·kg(-1)·min(-1)) values (r = 0.54, p = 0.01). HALO predicted peak oxygen uptake values showed a significant correlation when plotted against the measured values (r = 0.99). A Bland-Altman analysis found agreement between the maximal and HALO submaximal protocols (mean bias = -201.75 mL·min(-1)). The significant relationships found between estimates of peak oxygen uptake from the HALO submaximal protocol and measures of peak oxygen uptake during maximal cardiorespiratory testing support the use of the HALO submaximal protocol as a valid measure to estimate maximal cardiorespiratory fitness within the obese pediatric population. Given the proof of principle goal of this study, future research in the obese, pediatric population is encouraged to confirm the generalizability of the protocol.

  6. Comprehensive Study of Microgel Electrode for On-Chip Electrophoretic Cell Sorting

    NASA Astrophysics Data System (ADS)

    Akihiro Hattori,; Kenji Yasuda,

    2010-06-01

    We have developed an on-chip cell sorting system and microgel electrode for applying electrostatic force in microfluidic pathways in the chip. The advantages of agarose electrodes are 1) current-driven electrostatic force generation, 2) stability against pH change and chemicals, and 3) no bubble formation caused by electrolysis. We examined the carrier ion type and concentration dependence of microgel electrode impedance, and found that CoCl2 has less than 1/10 of the impedance from NaCl, and the reduction of the impedance of NaCl gel electrode was plateaued at 0.5 M. The structure control of the microgel electrode exploiting the surface tension of sol-state agarose was also introduced. The addition of 1% (w/v) trehalose into the microgel electrode allowed the frozen storage of the microgel electrode chip. The experimental results demonstrate the potential of our system and microgel electrode for practical applications in microfluidic chips.

  7. Rapid manufacturing of low-noise membranes for nanopore sensors by trans-chip illumination lithography

    NASA Astrophysics Data System (ADS)

    Janssen, Xander J. A.; Jonsson, Magnus P.; Plesa, Calin; Soni, Gautam V.; Dekker, Cees; Dekker, Nynke H.

    2012-11-01

    In recent years, the concept of nanopore sensing has matured from a proof-of-principle method to a widespread, versatile technique for the study of biomolecular properties and interactions. While traditional nanopore devices based on a nanopore in a single layer membrane supported on a silicon chip can be rapidly fabricated using standard microfabrication methods, chips with additional insulating layers beyond the membrane region can provide significantly lower noise levels, but at the expense of requiring more costly and time-consuming fabrication steps. Here we present a novel fabrication protocol that overcomes this issue by enabling rapid and reproducible manufacturing of low-noise membranes for nanopore experiments. The fabrication protocol, termed trans-chip illumination lithography, is based on illuminating a membrane-containing wafer from its backside such that a photoresist (applied on the wafer’s top side) is exposed exclusively in the membrane regions. Trans-chip illumination lithography permits the local modification of membrane regions and hence the fabrication of nanopore chips containing locally patterned insulating layers. This is achieved while maintaining a well-defined area containing a single thin membrane for nanopore drilling. The trans-chip illumination lithography method achieves this without relying on separate masks, thereby eliminating time-consuming alignment steps as well as the need for a mask aligner. Using the presented approach, we demonstrate rapid and reproducible fabrication of nanopore chips that contain small (12 μm × 12 μm) free-standing silicon nitride membranes surrounded by insulating layers. The electrical noise characteristics of these nanopore chips are shown to be superior to those of simpler designs without insulating layers and comparable in quality to more complex designs that are more challenging to fabricate.

  8. A Pilot Study for Applying an Extravehicular Activity Exercise Prebreathe Protocol to the International Space Station

    NASA Technical Reports Server (NTRS)

    Woodruff, Kristin K.; Johnson, Anyika N.; Lee, Stuart M. C.; Gernhardt, Michael; Schneider, Suzanne M.; Foster, Philip P.

    2000-01-01

    Decompression sickness (DCS) is a serious risk to astronauts performing extravehicular activity (EVA). To reduce this risk, the addition of ten minutes of moderate exercise (75% VO2pk) during prebreathe has been shown to decrease the total prebreathe time from 4 to 2 hours and to decrease the incidence of DCS. The overall purpose of this pilot study was to develop an exercise protocol using flight hardware and an in-flight physical fitness cycle test to perform prebreathe exercise before an EVA. Eleven subjects volunteered to participate in this study. The first objective of this study was to compare the steady-state heart rate (HR) and oxygen consumption (VO2) from a submaximal arm and leg exercise (ALE) session with those predicted from a maximal ALE test. The second objective was to compare the steady-state HR and V02 from a submaximal elastic tube and leg exercise (TLE) session with those predicted from the maximal ALE test. The third objective involved a comparison of the maximal ALE test with a maximal leg-only (LE) test to conform to the in- flight fitness assessment test. The 75% VO2pk target HR from the LE test was significantly less than the target HR from the ALE test. Prescribing exercise using data from the maximal ALE test resulted in the measured submaximal values being higher than predicted VO2 and HR. The results of this pilot study suggest that elastic tubing is valid during EVA prebreathe as a method of arm exercise with the flight leg ergometer and it is recommended that prebreathe countermeasure exercise protocol incorporate this method.

  9. Prospective randomized study of D-Trp6-LHRH versus buserelin in long desensitization protocols for medically assisted conception cycles.

    PubMed

    Gianaroli, L; Ferraretti, A P; Feliciani, E; Tabanelli, C; Magli, C; Fortini, D

    1994-02-01

    In a prospective, controlled, randomized study where two different agonists were used, we compared three different long desensitization protocols for induction of multiple follicular growth in medically assisted conception cycles. In protocol A, 30 patients were injected with buserelin twice a day for 15 days prior to ovarian stimulation until human chorionic gonadotrophin (HCG) administration. In protocol B, 30 patients were injected with a single dose of long acting Triptorelin (3.75 mg) 15 days before the ovarian stimulation onset. In protocol C, 30 patients were injected with the long acting Triptorelin 4 weeks before ovarian stimulation followed by daily administration of 0.1 mg of the same agonist until HCG injection. There was no difference in the ovarian response to exogenous gonadotrophin stimulation, except for the presence of premature luteinization in two patients in group B. A significantly higher number of mature oocytes was collected from patients with protocol A; however, the fertilization and cleavage rate demonstrated no significant difference among the three groups of patients. The ongoing pregnancy rate and the implantation rate per treatment cycle were very similar in the three study groups. When the convenience, cost and side-effects for the patient are being considered, protocol B should be selected as the first choice when the agonist is utilized for the purpose of inducing pituitary desensitization before and during ovarian stimulation.

  10. A new technique for multiple re-use of planar patch clamp chips.

    PubMed

    Kao, Liyo; Abuladze, Natalia; Shao, Xuesi M; McKeegan, Kevin; Kurtz, Ira

    2012-07-15

    The patch clamp technique is widely used for recording the activity of ion channels in single cells and lipid bilayers. Most platforms utilize borosilicate glass configured as a pipette, however more recently planar patch clamp chips have been developed that require less technical expertise. Planar patch clamp chips in systems like the Nanion Port-a-Patch are useful in that they allow more rapid throughput in drug screening studies. This technique also has the ability to perform rapid solution changes from the intracellular side. A current drawback with the planar patch clamp chips is the need to utilize a separate chip for each experiment. This increases the cost of each experiment and is due to the fact that the ∼1μm aperture used for cell attachment is thought to retain cellular debris thereby preventing subsequent cell attachment and formation of GΩ seals. In the present study we have for the first time solved the technical problem of developing a simple protocol for re-use of Nanion planar patch clamp chips. The re-use methodology is demonstrated in whole cell patch clamp studies of HEK-293 cells expressing the electrogenic sodium bicarbonate cotransporter NBCe1-A in protocols involving external and internal solution changes, and CHO-K1 cells with incorporated gramicidin channels. PMID:22609774

  11. National validation study of a swab protocol for the recovery of Bacillus anthracis spores from surfaces.

    PubMed

    Hodges, Lisa R; Rose, Laura J; O'Connell, Heather; Arduino, Matthew J

    2010-05-01

    Twelve Laboratory Response Network (LRN) affiliated laboratories participated in a validation study of a macrofoam swab protocol for the recovery, detection, and quantification of viable B. anthracis (BA) Sterne spores from steel surfaces. CDC personnel inoculated steel coupons (26cm(2)) with 1-4 log(10) BA spores and recovered them by sampling with pre-moistened macrofoam swabs. Phase 1 (P1) of the study evaluated swabs containing BA only, while dust and background organisms were added to swabs in Phase 2 (P2) to mimic environmental conditions. Laboratories processed swabs and enumerated spores by culturing eluted swab suspensions and counting colonies with morphology consistent with BA. Processed swabs were placed in enrichment broth, incubated 24h, and cultured by streaking for isolation. Real-time PCR was performed on selected colonies from P2 samples to confirm the identity of BA. Mean percent recovery (%R) of spores from the surface ranged from 15.8 to 31.0% (P1) and from 27.9 to 55.0% (P2). The highest mean percent recovery was 31.0% (sd 10.9%) for P1 (4 log(10) inoculum) and 55.0% (sd 27.6%) for P2 (1 log(10) inoculum). The overall %R was higher for P2 (44.6%) than P1 (24.1%), but the overall reproducibility (between-lab variability) was lower in P2 than in P1 (25.0 vs 16.5%CV, respectively). The overall precision (within-lab variability) was close to identical for P1 and P2 (44.0 and 44.1, respectively), but varied greatly between inoculum levels. The protocol demonstrated linearity in %R over the three inoculum levels and is able to detect between 26 and 5x10(6)spores/26cm(2). Sensitivity as determined by culture was >98.3% for both phases and all inocula, suggesting that the culture method maintains sensitivity in the presence of contaminants. The enrichment broth method alone was less sensitive for sampled swabs (66.4%) during P2, suggesting that the presence of background organisms inhibited growth or isolation of BA from the broth. The addition of

  12. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

  13. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    PubMed Central

    Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

  14. Prediction of (19)F NMR Chemical Shifts in Labeled Proteins: Computational Protocol and Case Study.

    PubMed

    Isley, William C; Urick, Andrew K; Pomerantz, William C K; Cramer, Christopher J

    2016-07-01

    The structural analysis of ligand complexation in biomolecular systems is important in the design of new medicinal therapeutic agents; however, monitoring subtle structural changes in a protein's microenvironment is a challenging and complex problem. In this regard, the use of protein-based (19)F NMR for screening low-molecular-weight molecules (i.e., fragments) can be an especially powerful tool to aid in drug design. Resonance assignment of the protein's (19)F NMR spectrum is necessary for structural analysis. Here, a quantum chemical method has been developed as an initial approach to facilitate the assignment of a fluorinated protein's (19)F NMR spectrum. The epigenetic "reader" domain of protein Brd4 was taken as a case study to assess the strengths and limitations of the method. The overall modeling protocol predicts chemical shifts for residues in rigid proteins with good accuracy; proper accounting for explicit solvation of fluorinated residues by water is critical. PMID:27218275

  15. ChIP on chip and ChIP-Seq assays: genome-wide analysis of transcription factor binding and histone modifications.

    PubMed

    Pillai, Smitha; Chellappan, Srikumar P

    2015-01-01

    Deregulation of transcriptional activity of many genes has been causatively linked to human diseases including cancer. Altered patterns of gene expression in normal and cancer cells are the result of inappropriate expression of transcription factors and chromatin modifying proteins. Chromatin immunoprecipitation assay is a well-established tool for investigating the interactions between regulatory proteins and DNA at distinct stages of gene activation. ChIP coupled with DNA microarrays, known as ChIP on chip, or sequencing of DNA associated with the factors (ChIP-Seq) allow us to determine the entire spectrum of in vivo DNA binding sites for a given protein. This has been of immense value because ChIP on chip assays and ChIP-Seq experiments can provide a snapshot of the transcriptional regulatory mechanisms on a genome-wide scale. This chapter outlines the general strategies used to carry out ChIP-chip assays to study the differential recruitment of regulatory molecules based on the studies conducted in our lab as well as other published protocols; these can be easily modified to a ChIP-Seq analysis.

  16. Characterization of the Context of Drug Concepts in Research Protocols: An Empiric Study to Guide Ontology Development

    PubMed Central

    Cimino, James J.; Huser, Vojtech

    2015-01-01

    We examined a large body of research study documents (protocols) to identify mentions of drug concepts and established base concepts and roles needed to characterize the semantics of these instances. We found these concepts in three general situations: background knowledge about the drug, study procedures involving the drug, and other roles of the drug in the study. We identified 18 more specific contexts (e.g., adverse event information, administration and dosing of the drug, and interactions between the study drug and other drugs). The ontology was validated against a test set of protocol documents from NIH and ClinicalTrial.gov. The goal is to support the automated extraction of drug information from protocol documents to support functions such as study retrieval, determination of subject eligibility, generation of order sets, and creation of logic for decision support alerts and reminders. Further work is needed to formally extend existing ontologies of clinical research. PMID:26958176

  17. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  18. Work Smarter, Not Harder: Structured Reflection Protocol. Listening to Student Voices Self-Study Toolkit. [Videotape].

    ERIC Educational Resources Information Center

    Appalachia Educational Lab., Charleston, WV.

    This 19-minute VHS videotape introduces the structured reflection protocol, a tool designed to help teachers learn by working together and by using student work as a beginning point for their learning together. The videotape shows scenes of the structured reflection protocol being used in diverse school settings (elementary, secondary, rural,…

  19. How to design in situ studies: an evaluation of experimental protocols

    PubMed Central

    Sung, Young-Hye; Kim, Hae-Young; Son, Ho-Hyun

    2014-01-01

    Objectives Designing in situ models for caries research is a demanding procedure, as both clinical and laboratory parameters need to be incorporated in a single study. This study aimed to construct an informative guideline for planning in situ models relevant to preexisting caries studies. Materials and Methods An electronic literature search of the PubMed database was performed. A total 191 of full articles written in English were included and data were extracted from materials and methods. Multiple variables were analyzed in relation to the publication types, participant characteristics, specimen and appliance factors, and other conditions. Frequencies and percentages were displayed to summarize the data and the Pearson's chi-square test was used to assess a statistical significance (p < 0.05). Results There were many parameters commonly included in the majority of in situ models such as inclusion criteria, sample sizes, sample allocation methods, tooth types, intraoral appliance types, sterilization methods, study periods, outcome measures, experimental interventions, etc. Interrelationships existed between the main research topics and some parameters (outcome measures and sample allocation methods) among the evaluated articles. Conclusions It will be possible to establish standardized in situ protocols according to the research topics. Furthermore, data collaboration from comparable studies would be enhanced by homogeneous study designs. PMID:25110639

  20. Change to costs and lengths of stay in the emergency department and the Brisbane protocol: an observational study

    PubMed Central

    Cheng, Qinglu; Greenslade, Jaimi H; Parsonage, William A; Barnett, Adrian G; Merollini, Katharina; Graves, Nicholas; Peacock, W Frank; Cullen, Louise

    2016-01-01

    Objective To compare health service cost and length of stay between a traditional and an accelerated diagnostic approach to assess acute coronary syndromes (ACS) among patients who presented to the emergency department (ED) of a large tertiary hospital in Australia. Design, setting and participants This historically controlled study analysed data collected from two independent patient cohorts presenting to the ED with potential ACS. The first cohort of 938 patients was recruited in 2008–2010, and these patients were assessed using the traditional diagnostic approach detailed in the national guideline. The second cohort of 921 patients was recruited in 2011–2013 and was assessed with the accelerated diagnostic approach named the Brisbane protocol. The Brisbane protocol applied early serial troponin testing for patients at 0 and 2 h after presentation to ED, in comparison with 0 and 6 h testing in traditional assessment process. The Brisbane protocol also defined a low-risk group of patients in whom no objective testing was performed. A decision tree model was used to compare the expected cost and length of stay in hospital between two approaches. Probabilistic sensitivity analysis was used to account for model uncertainty. Results Compared with the traditional diagnostic approach, the Brisbane protocol was associated with reduced expected cost of $1229 (95% CI −$1266 to $5122) and reduced expected length of stay of 26 h (95% CI −14 to 136 h). The Brisbane protocol allowed physicians to discharge a higher proportion of low-risk and intermediate-risk patients from ED within 4 h (72% vs 51%). Results from sensitivity analysis suggested the Brisbane protocol had a high chance of being cost-saving and time-saving. Conclusions This study provides some evidence of cost savings from a decision to adopt the Brisbane protocol. Benefits would arise for the hospital and for patients and their families. PMID:26916691

  1. Study on a Real-Time BEAM System for Diagnosis Assistance Based on a System on Chips Design

    PubMed Central

    Sung, Wen-Tsai; Chen, Jui-Ho; Chang, Kung-Wei

    2013-01-01

    As an innovative as well as an interdisciplinary research project, this study performed an analysis of brain signals so as to establish BrainIC as an auxiliary tool for physician diagnosis. Cognition behavior sciences, embedded technology, system on chips (SOC) design and physiological signal processing are integrated in this work. Moreover, a chip is built for real-time electroencephalography (EEG) processing purposes and a Brain Electrical Activity Mapping (BEAM) system, and a knowledge database is constructed to diagnose psychosis and body challenges in learning various behaviors and signals antithesis by a fuzzy inference engine. This work is completed with a medical support system developed for the mentally disabled or the elderly abled. PMID:23681095

  2. Serum pattern profiling for analyzing different types of stress by protein chip technology: a preliminary study.

    PubMed

    Liu, Hui; Hou, Diandong; Wu, Da; Yin, Hong; Wu, Xiaoyi

    2010-01-01

    ProteinChip is a widely accepted tool for exploring serum pattern profile to evaluate the risk of somatic diseases from different stressors. In this study, by using surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-ToF), the serum proteome from mice under restraint and thermal stresses were profiled in detail and compared with the control group. Around 150 characteristic peaks were detected in all three groups, with m/z ranging from 1500 to 50,000, with most peaks being within the 2000 m/z to 20,000 m/z range. Compared with the control group, three significant protein peaks with m/z values of 2780, 3303 and 3450 appeared specifically in the restrained stress group and four other peaks with m/z values of 7500, 7811, 29,950 and 38,565 in the thermal stress group. Unexpectedly, no universal positive stress peaks were detected. These preliminary results clearly suggested that there might not be a common mechanism shared by various psychophysiological disorders under different stressors. By fast serum proteomics profiling, SELDI-ToF may be a convenient tool for evaluating the risk of stress-induced illness.

  3. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study

    PubMed Central

    Berlin, Noémi; Goldzahl, Léontine; Jusot, Florence; Berlin, Ivan

    2016-01-01

    Introduction Maternal smoking during pregnancy is associated with adverse perinatal and postnatal health outcomes. The efficacy of nicotine replacement therapies in helping pregnant smokers to quit is not clearly demonstrated; therefore new interventions should be proposed and assessed. Financial incentives rewarding abstinence from tobacco smoking is one of the promising options. Objective To assess the efficacy of financial incentives on smoking abstinence among French pregnant smokers. Methods and analysis Participants: pregnant smokers aged ≥18 years, smoking at least five manufactured or three roll-your-own cigarettes per day, and pregnant for <18 weeks of amenorrhoea (WA). Setting: participants will be recruited, included and followed-up at monthly face-to-face visits in 16 maternity wards in France. Interventions: participants will be randomised to a control or an intervention group. After a predefined quit date, participants in the control group will receive €20 vouchers at the completion of each visit but no financial incentive for smoking abstinence. Participants in the intervention group will be rewarded for their abstinence by vouchers on top of the €20 show-up fee. The amount of reward for abstinence will increase as a function of duration of abstinence to stimulate longer periods of abstinence. Main outcome measure: complete abstinence from quit date to the last predelivery visit. Secondary outcome measures: point prevalence abstinence, time to relapse to smoking, birth weight, fetal growth restriction, preterm birth. Main data analysis: outcomes will be analysed on an intention-to-treat (ITT) basis. The ITT population is defined as all randomised smoking pregnant women. Ethics and dissemination The research protocol was approved by the ethics committee (Comité de Protection des Personnes, CPP) of the Pitié-Salpêtrière Hospital on 15 May 2015, and Amendment No 1 was approved on 13 July 2015. Results will be presented at scientific

  4. A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients

    PubMed Central

    Bittner, Ava K; Gould, Jeffrey M; Rosenfarb, Andy; Rozanski, Collin; Dagnelie, Gislin

    2014-01-01

    Background Patients with retinitis pigmentosa are motivated to try complementary or integrative therapies to slow disease progression. Basic science, clinical research and retinitis pigmentosa patients' self-reports support the hypothesis that acupuncture may improve visual function. Methods A prospective, case series, pilot study enrolled 12 adult patients with RP treated at an academic medical centre with a standardised protocol that combined electroacupuncture to the forehead and below the eyes and acupuncture to the body, at 10 half-hour sessions over two weeks. Pre- and post-treatment tests included Early Treatment Diabetic Retinopathy Study visual acuity (VA), Pelli-Robson contrast sensitivity (CS), Goldmann visual fields, and dark-adapted full-field stimulus threshold (FST)(n = 9). Scotopic Sensitivity Tester-1 (SST-1) dark-adaptometry was performed on the last two subjects. Results Six of 12 subjects had measurable, significant visual function improvements after treatment. Three of nine subjects tested with the FST had a significant 10.3 to 17.5 dB (that is, 13- to 53-fold) improvement in both eyes at one week after acupuncture, maintained for at least 10 to 12 months, which was well outside typical test-retest variability (95% CI: 3–3.5 dB) previously found in retinitis pigmentosa. SST-1 dark-adaptation was shortened in both subjects tested on average by 48.5 per cent at one week (range 36 to 62 per cent across 10 to 30 dB), which was outside typical coefficients of variation of less than 30 per cent previously determined in patients with retinitis pigmentosa and normals. Four of the five subjects with psychophysically measured scotopic sensitivity improvements reported subjective improvements in vision at night or in dark environments. One subject had 0.2 logMAR improvement in VA; another had 0.55 logCS improvement. Another subject developed more than 20 per cent improvement in the area of the Goldmann visual fields. The acupuncture protocol was

  5. The heart healthy lenoir project-an intervention to reduce disparities in hypertension control: study protocol

    PubMed Central

    2013-01-01

    Background Racial disparities in blood pressure control are well established; however the impact of low health literacy (LHL) on blood pressure has garnered less attention. Office based interventions that are created with iterative patient, practice and community stakeholder input and are rolled out incrementally, may help address these disparities in hypertension control. This paper describes our study protocol. Methods/design Using a community based participatory research (CBPR) approach, we designed and implemented a cohort study that includes both a practice level and patient level intervention to enhance the care and support of patients with hypertension in primary care practices in a rural region of eastern North Carolina. The study is divided into a formative phase and an ongoing 2.5 year implementation phase. Our main care enhancement activities include the integration of a community health coach, using home blood pressure monitoring in clinical decision making, standardizing care delivery processes, and working to improve medication adherence. Main outcomes include overall blood pressure change, the differential change in blood pressure by race (African American vs. White) and health literacy level (low vs. higher health literacy). Discussion Using a community based participatory approach in primary care practice settings has helped to engage patients and practice staff and providers in the research effort and in making practice changes to support hypertension care. Practices have engaged at varying levels, but progress has been made in implementing and iteratively improving upon the interventions to date. Trial registration ClinicalTrials.gov NCT01425515. PMID:24156629

  6. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol

    PubMed Central

    2015-01-01

    Background Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. Objective The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution’s workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. Methods An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population’s characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. Results The protocol has already received funding and the enrollment phase will begin in the coming months. Conclusions The results of this study will give the foundation for the design

  7. Validity and responsiveness of the Clubfoot Assessment Protocol (CAP). A methodological study

    PubMed Central

    Andriesse, Hanneke; Roos, Ewa M; Hägglund, Gunnar; Jarnlo, Gun-Britt

    2006-01-01

    Background The Clubfoot Assessment Protocol (CAP) is a multi dimensional instrument designed for longitudinal follow up of the clubfoot deformity during growth. Item reliability has shown to be sufficient. In this article the CAP's validity and responsiveness is studied using the Dimeglio classification scoring as a gold standard. Methods Thirty-two children with 45 congenital clubfeet were assessed prospectively and consecutively at ages of new-born, one, two, four months and two years of age. For convergent/divergent construct validity the Spearman's correlation coefficients were calculated. Discriminate validity was evaluated by studying the scores in bilateral clubfeet. The floor-ceiling effects at baseline (untreated clubfeet) and at two years of age (treated clubfeet) were evaluated. Responsiveness was evaluated by using effect sizes (ES) and by calculating if significant changes (Wilcoxons signed test) had occurred between the different measurement occasions. Results High to moderate significant correlation were found between CAP mobility I and morphology and the Dimeglio scores (rs = 0.77 and 0.44 respectively). Low correlation was found between CAP muscle function, mobility II and motion quality and the Dimeglio scoring system (rs = 0.20, 0.09 and 0.06 respectively). Of 13 children with bilateral clubfeet, 11 showed different CAP mobility I scores between right and left foot at baseline (untreated) compared with 5 with the Dimeglio score. At the other assessment occasions the CAP mobility I continued to show higher discrimination ability than the Dimeglio. No floor effects and low ceiling effects were found in the untreated clubfeet for both instruments. High ceiling effects were found in the CAP for the treated children and low for the Dimeglio. Responsiveness was good. ES from untreated to treated ranged from 0.80 to 4.35 for the CAP subgroups and was 4.68 for the Dimeglio. The first four treatment months, the CAP mobility I had generally higher ES

  8. The role of sand, marble chips and Typha latifolia in domestic wastewater treatment - a column study on constructed wetlands.

    PubMed

    Kadaverugu, Rakesh; Shingare, Rita P; Raghunathan, Karthik; Juwarkar, Asha A; Thawale, Prashant R; Singh, Sanjeev K

    2016-10-01

    The relative importance of sand, marble chips and wetland plant Typha latifolia is evaluated in constructed wetlands (CWs) for the treatment of domestic wastewater intended for reuse in agriculture. The prototype CWs for the experiments are realized in polyvinyl chloride columns, which are grouped into four treatments, viz. sand (<2 mm) + Typha latifolia (cattail), sand, marble chips (5-20 mm) + cattail and marble chips. The removal percentage of organic and nutritional pollutants from the wastewater is measured at varying hydraulic retention time in the columns. The statistical analysis suggests that the main effects of sand and cattail are found to be significant (p < .05) for the removal of biological oxygen demand and chemical oxygen demand from the wastewater. The presence of cattail significantly (p < .01) contributes to the conversion of total nitrogen in wastewater into [Formula: see text] by fostering the growth of favorable microbes for the nitrification. The removal of [Formula: see text] and turbidity from the wastewater is significantly (p < .01) influenced by sand than the presence of cattail. The maximum [Formula: see text] adsorption capacity of the sand is estimated to be 2.5 mg/g. Marble chips have significantly (p < .01) influenced the removal of [Formula: see text]and its maximum removal capacity is estimated to be 9.3 mg/g. The negative correlation between the filter media biofilm and column hydraulic conductivity is also reported for all the treatments. Thus, the findings of this study elucidate the role of low-cost and easily available filter media and it will guide the environmental practitioners in designing cost-effective CWs for wastewater treatment.

  9. The role of sand, marble chips and Typha latifolia in domestic wastewater treatment - a column study on constructed wetlands.

    PubMed

    Kadaverugu, Rakesh; Shingare, Rita P; Raghunathan, Karthik; Juwarkar, Asha A; Thawale, Prashant R; Singh, Sanjeev K

    2016-10-01

    The relative importance of sand, marble chips and wetland plant Typha latifolia is evaluated in constructed wetlands (CWs) for the treatment of domestic wastewater intended for reuse in agriculture. The prototype CWs for the experiments are realized in polyvinyl chloride columns, which are grouped into four treatments, viz. sand (<2 mm) + Typha latifolia (cattail), sand, marble chips (5-20 mm) + cattail and marble chips. The removal percentage of organic and nutritional pollutants from the wastewater is measured at varying hydraulic retention time in the columns. The statistical analysis suggests that the main effects of sand and cattail are found to be significant (p < .05) for the removal of biological oxygen demand and chemical oxygen demand from the wastewater. The presence of cattail significantly (p < .01) contributes to the conversion of total nitrogen in wastewater into [Formula: see text] by fostering the growth of favorable microbes for the nitrification. The removal of [Formula: see text] and turbidity from the wastewater is significantly (p < .01) influenced by sand than the presence of cattail. The maximum [Formula: see text] adsorption capacity of the sand is estimated to be 2.5 mg/g. Marble chips have significantly (p < .01) influenced the removal of [Formula: see text]and its maximum removal capacity is estimated to be 9.3 mg/g. The negative correlation between the filter media biofilm and column hydraulic conductivity is also reported for all the treatments. Thus, the findings of this study elucidate the role of low-cost and easily available filter media and it will guide the environmental practitioners in designing cost-effective CWs for wastewater treatment. PMID:26878342

  10. Chromosome Conformation Capture on Chip (4C): Data Processing.

    PubMed

    Leblanc, Benjamin; Comet, Itys; Bantignies, Frédéric; Cavalli, Giacomo

    2016-01-01

    4C methods are useful to investigate dependencies between regulatory mechanisms and chromatin structures by revealing the frequency of chromatin contacts between a locus of interest and remote sequences on the chromosome. In this chapter we describe a protocol for the data analysis of microarray-based 4C experiments, presenting updated versions of the methods we used in a previous study of the large-scale chromatin interaction profile of a Polycomb response element in Drosophila. The protocol covers data preparation, normalization, microarray probe selection, and the multi-resolution detection of regions with enriched chromatin contacts. A reanalysis of two independent mouse datasets illustrates the versatility of this protocol and the importance of data processing in 4C. Methods were implemented in the R package MRA.TA (Multi-Resolution Analyses on Tiling Array data), and they can be used to analyze ChIP-on-chip data on broadly distributed chromatin components such as histone marks. PMID:27659990

  11. Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study

    PubMed Central

    Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Şatıroğlu, Hakan

    2010-01-01

    Objective To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). Material and Methods The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. Results There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Conclusion Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI. PMID:24591934

  12. Experimental and modeling studies of ultrasound-assisted release of phenolics from oak chips into model wine.

    PubMed

    Tao, Yang; Zhang, Zhihang; Sun, Da-Wen

    2014-09-01

    The enhancement of release of oak-related compounds from oak chips during wine aging with oak chips may interest the winemaking industry. In this study, the 25-kHz ultrasound waves were used to intensify the mass transfer of phenolics from oak chips into a model wine. The influences of acoustic energy density (6.3-25.8 W/L) and temperature (15-25 °C) on the release kinetics of total phenolics were investigated systematically. The results exhibited that the total phenolic yield released was not affected by acoustic energy density significantly whereas it increased with the increase of temperature during sonication. Furthermore, to describe the mechanism of mass transfer of phenolics in model wine under ultrasonic field, the release kinetics of total phenolics was simulated by both a second-order kinetic model and a diffusion model. The modeling results revealed that the equilibrium concentration of total phenolics in model wine, the initial release rate and effective diffusivity of total phenolics generally increased with acoustic energy density and temperature. In addition, temperature had a negative effect on the second-order release rate constant whereas acoustic energy density had an opposite effect.

  13. Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed. Methods/Design This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect. Discussion This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been

  14. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

  15. Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

    PubMed

    Kim, Soo Ji; Jo, Uiri

    2013-01-01

    Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

  16. Protocol for the production of concentrated extracts of food folate for use in human bioavailability studies.

    PubMed

    McKillop, Derek J; Pentieva, Kristina D; Scott, John M; Strain, J J; McCreedy, Richard; Alexander, Joy; Patterson, Karen; Hughes, Joan; McNulty, Helene

    2003-07-16

    To provide a tool to study folate bioavailability under controlled conditions, a methodology was developed to produce extracts representative of natural food folates but removed from their matrix and sufficiently concentrated so as to elicit a response in biomarkers of folate status without distorting usual dietary intake patterns. Egg, spinach, and yeast were selected to represent the wide range in extent of folate conjugation found in foods (0, 60, and 100% polyglutamyl folate, respectively). The protocol, which was based on extracting food folates using only reagents safe for human consumption, was optimized in the laboratory (thermal extraction for 10 min in a 2% ascorbate solution at pH 5) and then adapted for industrial scale production in a food-processing facility. Results showed that the extracts were 2.3-12 times more concentrated in folate compared with their corresponding food sources. Neither the mono- to polyglutamate ratio nor the distribution of the main folate derivatives was altered during processing, making these extracts suitable for use in human bioavailability studies.

  17. μOrgano: A Lego®-Like Plug & Play System for Modular Multi-Organ-Chips

    PubMed Central

    Loskill, Peter; Marcus, Sivan G.; Mathur, Anurag; Reese, Willie Mae; Healy, Kevin E.

    2015-01-01

    Human organ-on-a-chip systems for drug screening have evolved as feasible alternatives to animal models, which are unreliable, expensive, and at times erroneous. While chips featuring single organs can be of great use for both pharmaceutical testing and basic organ-level studies, the huge potential of the organ-on-a-chip technology is revealed by connecting multiple organs on one chip to create a single integrated system for sophisticated fundamental biological studies and devising therapies for disease. Furthermore, since most organ-on-a-chip systems require special protocols with organ-specific media for the differentiation and maturation of the tissues, multi-organ systems will need to be temporally customizable and flexible in terms of the time point of connection of the individual organ units. We present a customizable Lego®-like plug & play system, μOrgano, which enables initial individual culture of single organ-on-a-chip systems and subsequent connection to create integrated multi-organ microphysiological systems. As a proof of concept, the μOrgano system was used to connect multiple heart chips in series with excellent cell viability and spontaneously physiological beat rates. PMID:26440672

  18. Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study

    PubMed Central

    Harrison, S; Petrovic, G; Chevassut, A; Brook, L; Higgins, N; Kenworthy, Y; Selwood, M; Snelgar, T; Arnold, L; Boardman, H; Heneghan, C; Leeson, P; Redman, C; Granne, I

    2015-01-01

    Introduction Some specific pregnancy disorders are known to be associated with increased incidence of long-term maternal ill health (eg, gestational diabetes with late onset type 2 diabetes; pre-eclampsia with arterial disease). To what degree these later health conditions are a consequence of the woman's constitution prior to pregnancy rather than pregnancy itself triggering changes in a woman's health is unknown. Additionally, there is little prospective evidence for the impact of pre-pregnancy risk factors on the outcome of pregnancy. To understand the importance of pre-pregnancy health requires the recruitment of women into a long-term cohort study before their first successful pregnancy. The aim of this feasibility study is to test recruitment procedures and acceptability of participation to inform the planning of a future large-scale cohort study. Methods The prospective cohort feasibility study will recruit nulliparous women aged 18–40 years. Women will be asked to complete a questionnaire to assess the acceptability of our recruitment and data collection procedures. Baseline biophysical, genetic, socioeconomic, behavioural and psychological assessments will be conducted and samples of blood, urine, saliva and DNA will be collected. Recruitment feasibility and retention rates will be assessed. Women who become pregnant will be recalled for pregnancy and postpregnancy assessments. Ethics and dissemination The study protocol was approved by South Central Portsmouth REC (Ref: 12/SC/0492). The findings from the study will be disseminated through peer reviewed journals, national and international conference presentations and public events. Trial registration number http://www.clinicaltrials.gov; NCT02419898. PMID:26553837

  19. A protocol for isolating insect mitochondrial genomes: a case study of NUMT in Melipona flavolineata (Hymenoptera: Apidae).

    PubMed

    Françoso, Elaine; Gomes, Fernando; Arias, Maria Cristina

    2016-07-01

    Nuclear mitochondrial DNA insertions (NUMTs) are mitochondrial DNA sequences that have been transferred into the nucleus and are recognized by the presence of indels and stop codons. Although NUMTs have been identified in a diverse range of species, their discovery was frequently accidental. Here, our initial goal was to develop and standardize a simple method for isolating NUMTs from the nuclear genome of a single bee. Subsequently, we tested our new protocol by determining whether the indels and stop codons of the cytochrome c oxidase subunit I (COI) sequence of Melipona flavolineata are of nuclear origin. The new protocol successfully demonstrated the presence of a COI NUMT. In addition to NUMT investigations, the protocol described here will also be very useful for studying mitochondrial mutations related to diseases and for sequencing complete mitochondrial genomes with high read coverage by Next-Generation technology.

  20. Efficacy of family mediation and the role of family violence: study protocol

    PubMed Central

    2014-01-01

    Background Family law reforms in Australia require separated parents in dispute to attempt mandatory family dispute resolution (FDR) in community-based family services before court attendance. However, there are concerns about such services when clients present with a history of high conflict and family violence. This study protocol describes a longitudinal study of couples presenting for family mediation services. The study aims to describe the profile of family mediation clients, including type of family violence, and determine the impact of violence profiles on FDR processes and outcomes, such as the type and durability of shared parenting arrangements and clients’ satisfaction with mediated agreements. Methods A mixed method, naturalistic longitudinal design is used. The sampling frame is clients presenting at nine family mediation centres across metropolitan, outer suburban, and regional/rural sites in Victoria, Australia. Data are collected at pre-test, completion of mediation, and six months later. Self-administered surveys are administered at the three time points, and a telephone interview at the final post-test. The key study variable is family violence. Key outcome measures are changes in the type and level of acrimony and violent behaviours, the relationship between violence and mediated agreements, the durability of agreements over six months, and client satisfaction with mediation. Discussion Family violence is a major risk to the physical and mental health of women and children. This study will inform debates about the role of family violence and how to manage it in the family mediation context. It will also inform decision-making about mediation practices by better understanding how mediation impacts on parenting agreements, and the implications for children, especially in the context of family violence. PMID:24443936

  1. Learning from positively deviant wards to improve patient safety: an observational study protocol

    PubMed Central

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-01-01

    Introduction Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Methods and analysis Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 ‘positively deviant’ and 5 matched ‘comparison’ wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. Ethics and dissemination The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer

  2. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

  3. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study

    PubMed Central

    2014-01-01

    Background Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. Methods/Design Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers’s diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods — pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance — with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation

  4. Evaluation of Heparin Anticoagulation Protocols in Post–Renal Transplant Recipients (EHAP-PoRT Study)

    PubMed Central

    Ng, Joan Chung Yan; Leung, Marianna; Landsberg, David

    2016-01-01

    Background: Disturbances in hemostasis are common among renal transplant recipients. Because of the risk of thromboembolism and graft loss after transplant, a prophylactic heparin protocol was implemented at St Paul’s Hospital in Vancouver, British Columbia, in 2011. Therapeutic heparin is sometimes prescribed perioperatively for patients with preexisting prothrombotic conditions. There is currently limited literature on the safety and efficacy of heparin use in the early postoperative period. Objectives: The primary objectives were to document, for patients who underwent renal transplant, the incidence of major bleeding and of thrombosis in those receiving therapeutic heparin, prophylactic heparin, and no heparin anticoagulation in the early postoperative period and to compare these rates for the latter 2 groups. The secondary objectives included a comparison of the risk factors associated with major bleeding and thrombosis. Methods: Adult patients who received a renal transplant at St Paul’s Hospital between January 2008 and July 2013 were included in this retrospective cohort study. Electronic health records and databases were used to divide patients into the 3 heparin-use cohorts, to identify cases of major bleeding and thrombosis, and to characterize patients and events. The Fisher exact test was used for the primary outcome analysis, and descriptive statistics were used for all other outcomes. Results: A total of 547 patients were included in the analysis. Major bleeding was observed in 6 (46%) of the 13 patients who received therapeutic heparin; no cases of thrombosis occurred in these patients. Major bleeding occurred in 8 (3.0%) of the 266 patients who received prophylactic heparin and 9 (3.4%) of the 268 who received no heparin (p > 0.99). Thrombosis occurred in 1 (0.4%) and 3 (1.1%) of these patients, respectively (p = 0.62). Major bleeding occurred more frequently among patients with a low-target heparin protocol, but 61% of values for partial

  5. Optimal Scanning Protocols for Dual-Energy CT Angiography in Peripheral Arterial Stents: An in Vitro Phantom Study

    PubMed Central

    Almutairi, Abdulrahman; Sun, Zhonghua; Al Safran, Zakariya; Poovathumkadavi, Abduljaleel; Albader, Suha; Ifdailat, Husam

    2015-01-01

    Objective: To identify the optimal dual-energy computed tomography (DECT) scanning protocol for peripheral arterial stents while achieving a low radiation dose, while still maintaining diagnostic image quality, as determined by an in vitro phantom study. Methods: Dual-energy scans in monochromatic spectral imaging mode were performed on a peripheral arterial phantom with use of three gemstone spectral imaging (GSI) protocols, three pitch values, and four kiloelectron volts (keV) ranges. A total of 15 stents of different sizes, materials, and designs were deployed in the phantom. Image noise, the signal-to-noise ratio (SNR), different levels of adaptive statistical iterative reconstruction (ASIR), and the four levels of monochromatic energy for DECT imaging of peripheral arterial stents were measured and compared to determine the optimal protocols. Results: A total of 36 scans with 180 datasets were reconstructed from a combination of different protocols. There was a significant reduction of image noise with a higher SNR from monochromatic energy images between 65 and 70 keV in all investigated preset GSI protocols (p < 0.05). In addition, significant effects were found from the main effect analysis for these factors: GSI, pitch, and keV (p = 0.001). In contrast, there was significant interaction on the unstented area between GSI and ASIR (p = 0.015) and a very high significant difference between keV and ASIR (p < 0.001). A radiation dose reduction of 50% was achieved. Conclusions: The optimal scanning protocol and energy level in the phantom study were GSI-48, pitch value 0.984, and 65 keV, which resulted in lower image noise and a lower radiation dose, but with acceptable diagnostic images. PMID:26006234

  6. Bio-Repository of DNA in stroke (BRAINS): A study protocol

    PubMed Central

    2011-01-01

    Background Stroke is one of the commonest causes of mortality in the world and anticipated to be an increasing burden to the developing world. Stroke has a genetic basis and identifying those genes may not only help us define the mechanisms that cause stroke but also identify novel therapeutic targets. However, large scale highly phenotyped DNA repositories are required in order for this to be achieved. Methods The proposed Bio-Repository of DNA in Stroke (BRAINS) will recruit all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the UK will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. South Asian cases will also have control subjects recruited. Discussion We describe a study protocol to establish a large and highly characterized stroke biobank in those of European and South Asian descent. With different ethnic populations being recruited, BRAINS has the ability to compare and contrast genetic risk factors between those of differing ancestral descent as well as those who migrate into different environments. PMID:21366918

  7. Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke. Methods/Design In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events. Discussion This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function. Trial registration Chinese Clinical Trial Registry ChiCTR-TRC-12001971. PMID:24908241

  8. Effectiveness of the Health Complex Model in Iranian primary health care reform: the study protocol

    PubMed Central

    Tabrizi, Jafar Sadegh; Farahbakhsh, Mostafa; Sadeghi-Bazargani, Homayoun; Hassanzadeh, Roya; Zakeri, Akram; Abedi, Leili

    2016-01-01

    Background Iranian traditional primary health care (PHC) system, although proven to be successful in some areas in rural populations, suffers major pitfalls in providing PHC services in urban areas especially the slum urban areas. The new government of Iran announced a health reform movement including the health reform in PHC system of Iran. The Health Complex Model (HCM) was chosen as the preferred health reform model for this purpose. Methods This paper aims to report a detailed research protocol for the assessment of the effectiveness of the HCM in Iran. An adaptive controlled design is being used in this research. The study is planned to measure multiple endpoints at the baseline and 2 years after the intervention. The assessments will be done both in a population covered by the HCM, as intervention area, and in control populations covered by the traditional health care system as the control area. Discussion Assessing the effectiveness of the HCM, as the Iranian PHC reform initiative, could help health system policy makers for future decisions on its continuation or modification. PMID:27784996

  9. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. Methods/Design The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to ‘ready for discharge’ from the post anaesthesia care unit (in minutes). The ‘ready for discharge’ end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). Discussion The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. Trial registration NCT01816386 (First received: 28 October 2012) PMID:25047046

  10. Qualitative approach to patient-reported outcomes in oncology: protocol of a French study

    PubMed Central

    Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

    2015-01-01

    Introduction The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients’ eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients’ perspectives about the care they receive, as well as families’ and doctors’ perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. Methods and analysis This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. Ethics and dissemination The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and

  11. The Malaysian Breast Cancer Survivorship Cohort (MyBCC): a study protocol

    PubMed Central

    Islam, Tania; Bhoo-Pathy, Nirmala; Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohd; Ng, Chong Guan; Dahlui, Maznah; Hussain, Samsinah; Cantwell, Marie; Murray, Liam; Taib, Nur Aishah

    2015-01-01

    Introduction Over recent decades, the burden of breast cancer has been increasing at an alarming rate in Asia. Prognostic research findings from Western countries may not readily be adapted to Asia, as the outcome of breast cancer depends on a multitude of factors ranging from genetic, clinical and histological predictors, to lifestyle and social predictors. The primary aim of this study is to determine the impact of lifestyle (eg, nutrition, physical activity), mental and sociocultural condition, on the overall survival and quality of life (QoL) among multiethnic Malaysian women following diagnosis of breast cancer. This study aims to advance the evidence on prognostic factors of breast cancer within the Asian setting. The findings may guide management of patients with breast cancer not only during active treatment but also during the survivorship period. Methods This hospital-based prospective cohort study will comprise patients with breast cancer (18 years and above), managed in the University Malaya Medical Centre (UMMC). We aim to recruit 1000 cancer survivors over a 6-year period. Data collection will occur at baseline (within 3 months of diagnosis), 6 months, and 1, 3 and 5 years following diagnosis. The primary outcomes are disease-free survival and overall survival, and secondary outcome is QoL. Factors measured are demographic and socioeconomic factors, lifestyle factors (eg, dietary intake, physical activity), anthropometry measurements (eg, height, weight, waist, hip circumference, body fat analysis), psychosocial aspects, and complementary and alternative medicine (CAM) usage. Ethics and dissemination This protocol was approved by the UMMC Ethical Committee in January 2012. All participants are required to provide written informed consent. The findings from our cohort study will be disseminated via scientific publication as well as presentation to stakeholders including the patients, clinicians, the public and policymakers, via appropriate

  12. How does capacity building of health managers work? A realist evaluation study protocol

    PubMed Central

    Marchal, Bruno; Hoeree, Tom; Devadasan, Narayanan; Macq, Jean; Kegels, Guy; Criel, Bart

    2012-01-01

    Introduction There has been a lot of attention on the role of human resource management interventions to improve delivery of health services in low- and middle-income countries. However, studies on this subject are few due to limited research on implementation of programmes and methodological difficulties in conducting experimental studies on human resource interventions. The authors present the protocol of an evaluation of a district-level capacity-building intervention to identify the determinants of performance of health workers in managerial positions and to understand how changes (if any) are brought about. Methods and analysis The aim of this study is to understand how capacity building works. The authors will use realist evaluation to evaluate an intervention in Karnataka, India. The intervention is a capacity-building programme that seeks to improve management capacities of health managers at district and subdistrict levels through periodic classroom-based teaching and mentoring support at the workplace. The authors conducted interviews and reviewed literature on capacity building in health to draw out the programme theory of the intervention. Based on this, the authors formulated hypothetical pathways connecting the expected outcomes of the intervention (planning and supervision) to the inputs (contact classes and mentoring). The authors prepared a questionnaire to assess elements of the programme theory—organisational culture, self-efficacy and supervision. The authors shall conduct a survey among health managers as well as collect qualitative data through interviews with participants and non-participants selected purposively based on their planning and supervision performance. The authors will construct explanations in the form of context–mechanism–outcome configurations from the results. This will be iterative and the authors will use a realist evaluation framework to refine the explanatory theories that are based on the findings to explain and

  13. Hand, hip and knee osteoarthritis in a Norwegian population-based study - The MUST protocol

    PubMed Central

    2013-01-01

    Background Knowledge about the prevalence and consequences of osteoarthritis (OA) in the Norwegian population is limited. This study has been designed to gain a greater understanding of musculoskeletal pain in the general population with a focus on clinically and radiologically confirmed OA, as well as risk factors, consequences, and management of OA. Methods/Design The Musculoskeletal pain in Ullensaker STudy (MUST) has been designed as an observational study comprising a population-based postal survey and a comprehensive clinical examination of a sub-sample with self-reported OA (MUST OA cohort). All inhabitants in Ullensaker municipality, Norway, aged 40 to 79 years receive the initial population-based postal survey questionnaire with questions about life style, general health, musculoskeletal pain, self-reported OA, comorbidities, health care utilisation, medication use, and functional ability. Participants who self-report OA in their hip, knee and/or hand joints are asked to attend a comprehensive clinical examination at Diakonhjemmet Hospital, Oslo, including a comprehensive medical examination, performance-based functional tests, different imaging modalities, cardiovascular assessment, blood and urine samples, and a number of patient-reported questionnaires including five OA disease specific instruments. Data will be merged with six national data registries. A subsample of those who receive the questionnaire has previously participated in postal surveys conducted in 1990, 1994, and 2004 with data on musculoskeletal pain and functional ability in addition to demographic characteristics and a number of health related factors. This subsample constitutes a population based cohort with 20 years follow-up. Discussion This protocol describes the design of an observational population-based study that will involve the collection of data from a postal survey on musculoskeletal pain, and a comprehensive clinical examination on those with self-reported hand, hip and

  14. Teacher's Perceptions of Sheltered Instruction Observation Protocol for Teaching Young English Language Learners: A Qualitative Case Study

    ERIC Educational Resources Information Center

    Rodriguez Moux, Shirley

    2010-01-01

    This qualitative case study explored the use of sheltered instruction observation protocol (SIOP) instructional practices to promote the language development and learning of elementary English language learners (ELLs) in an immersion setting in 1st and 2nd grades. The SIOP model was developed for middle school ELLs, and there is scant information…

  15. Exploring the Effect of Video Used to Enhance the Retrospective Verbal Protocol Analysis: A Multiple Case Study

    ERIC Educational Resources Information Center

    Monroe, Steven D.

    2012-01-01

    The purpose of this study was to explore how the use of video in the cognitive task analysis (CTA) retrospective verbal protocol analysis (RVPA) during a job analysis affects: (a) the quality of performing the CTA, (b) the time to complete the CTA, and (c) the cost to execute the CTA. Research has shown when using the simultaneous VPA during a CTA…

  16. Gene Assembly from Chip-Synthesized Oligonucleotides

    PubMed Central

    Eroshenko, Nikolai; Kosuri, Sriram; Marblestone, Adam H; Conway, Nicholas; Church, George M.

    2012-01-01

    De novo synthesis of long double-stranded DNA constructs has a myriad of applications in biology and biological engineering. However, its widespread adoption has been hindered by high costs. Cost can be significantly reduced by using oligonucleotides synthesized on high-density DNA chips. However, most methods for using off-chip DNA for gene synthesis have failed to scale due to the high error rates, low yields, and high chemical complexity of the chip-synthesized oligonucleotides. We have recently demonstrated that some commercial DNA chip manufacturers have improved error rates, and that the issues of chemical complexity and low yields can be solved by using barcoded primers to accurately and efficiently amplify subpools of oligonucleotides. This article includes protocols for computationally designing the DNA chip, amplifying the oligonucleotide subpools, and assembling 500-800 basepair (bp) constructs. PMID:25077042

  17. An ImmunoChip study of multiple sclerosis risk in African Americans.

    PubMed

    Isobe, Noriko; Madireddy, Lohith; Khankhanian, Pouya; Matsushita, Takuya; Caillier, Stacy J; Moré, Jayaji M; Gourraud, Pierre-Antoine; McCauley, Jacob L; Beecham, Ashley H; Piccio, Laura; Herbert, Joseph; Khan, Omar; Cohen, Jeffrey; Stone, Lael; Santaniello, Adam; Cree, Bruce A C; Onengut-Gumuscu, Suna; Rich, Stephen S; Hauser, Stephen L; Sawcer, Stephen; Oksenberg, Jorge R

    2015-06-01

    The aims of this study were: (i) to determine to what degree multiple sclerosis-associated loci discovered in European populations also influence susceptibility in African Americans; (ii) to assess the extent to which the unique linkage disequilibrium patterns in African Americans can contribute to localizing the functionally relevant regions or genes; and (iii) to search for novel African American multiple sclerosis-associated loci. Using the ImmunoChip custom array we genotyped 803 African American cases with multiple sclerosis and 1516 African American control subjects at 130 135 autosomal single nucleotide polymorphisms. We conducted association analysis with rigorous adjustments for population stratification and admixture. Of the 110 non-major histocompatibility complex multiple sclerosis-associated variants identified in Europeans, 96 passed stringent quality control in our African American data set and of these, >70% (69) showed over-representation of the same allele amongst cases, including 21 with nominally significant evidence for association (one-tailed test P < 0.05). At a further eight loci we found nominally significant association with an alternate correlated risk-tagging single nucleotide polymorphism from the same region. Outside the regions known to be associated in Europeans, we found seven potentially associated novel candidate multiple sclerosis variants (P < 10(-4)), one of which (rs2702180) also showed nominally significant evidence for association (one-tailed test P = 0.034) in an independent second cohort of 620 African American cases and 1565 control subjects. However, none of these novel associations reached genome-wide significance (combined P = 6.3 × 10(-5)). Our data demonstrate substantial overlap between African American and European multiple sclerosis variants, indicating common genetic contributions to multiple sclerosis risk.

  18. An ImmunoChip study of multiple sclerosis risk in African Americans

    PubMed Central

    Isobe, Noriko; Madireddy, Lohith; Khankhanian, Pouya; Matsushita, Takuya; Caillier, Stacy J.; Moré, Jayaji M.; Gourraud, Pierre-Antoine; McCauley, Jacob L.; Beecham, Ashley H.; Piccio, Laura; Herbert, Joseph; Khan, Omar; Cohen, Jeffrey; Stone, Lael; Santaniello, Adam; Cree, Bruce A. C.; Onengut-Gumuscu, Suna; Rich, Stephen S.; Hauser, Stephen L.; Sawcer, Stephen

    2015-01-01

    The aims of this study were: (i) to determine to what degree multiple sclerosis-associated loci discovered in European populations also influence susceptibility in African Americans; (ii) to assess the extent to which the unique linkage disequilibrium patterns in African Americans can contribute to localizing the functionally relevant regions or genes; and (iii) to search for novel African American multiple sclerosis-associated loci. Using the ImmunoChip custom array we genotyped 803 African American cases with multiple sclerosis and 1516 African American control subjects at 130 135 autosomal single nucleotide polymorphisms. We conducted association analysis with rigorous adjustments for population stratification and admixture. Of the 110 non-major histocompatibility complex multiple sclerosis-associated variants identified in Europeans, 96 passed stringent quality control in our African American data set and of these, >70% (69) showed over-representation of the same allele amongst cases, including 21 with nominally significant evidence for association (one-tailed test P < 0.05). At a further eight loci we found nominally significant association with an alternate correlated risk-tagging single nucleotide polymorphism from the same region. Outside the regions known to be associated in Europeans, we found seven potentially associated novel candidate multiple sclerosis variants (P < 10−4), one of which (rs2702180) also showed nominally significant evidence for association (one-tailed test P = 0.034) in an independent second cohort of 620 African American cases and 1565 control subjects. However, none of these novel associations reached genome-wide significance (combined P = 6.3 × 10−5). Our data demonstrate substantial overlap between African American and European multiple sclerosis variants, indicating common genetic contributions to multiple sclerosis risk. PMID:25818868

  19. Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol

    PubMed Central

    Keatley, David A; Daube, Mike; Hardcastle, Sarah J

    2015-01-01

    Background Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. Objective This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. Methods The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. Results The study is expected to take approximately 14 months to complete. Conclusions The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations. PMID:26582408

  20. False-positive diatom test: a real challenge? A post-mortem study using standardized protocols.

    PubMed

    Lunetta, Philippe; Miettinen, Arto; Spilling, Kristian; Sajantila, Antti

    2013-09-01

    The main criticism of the validity of the diatom test for the diagnosis of drowning is based on the potential ante- and post-mortem penetration of diatoms and the finding of diatoms in bodies of non-drowned human beings. However, qualitative and quantitative studies on diatoms in organs of the non-drowned have yielded both conflicting and contradictory results. In the present study, we have analysed under standardised methods the diatom content in several organs of 14 non-drowned human bodies. Overall, only 9 diatoms (6 entire, 3 fragmented) were disclosed in 6 of the 14 non-drowned bodies. Each of these 6 cadavers had only a single "positive" organ. Six diatoms were found in the bone marrow, 2 in the lung, and one in the pleural liquid. No diatoms were recovered from the brain, liver, kidney, or blood samples of any of these 14 bodies. Moreover, in five additional cadavers, whose lungs were injected, prior autopsy, with a 3.5L solution containing a bi-cellulate diatom culture (Thalassiosira baltica, Thalassiosira levanderi) via tracheostomy, a few diatoms appeared in the pleural cavity and in the blood from the left heart chamber, but none in any other internal organs investigated. The results of the presented study demonstrate that the issue of the false-positive diatom test should not be a logical impediment to the performance of the diatom method. However, strict and standardized protocols aimed at avoiding contamination during sample preparation must be used, appropriate separation values set and taxonomic analysis of all diatoms performed. PMID:23701706

  1. Communications protocol

    NASA Technical Reports Server (NTRS)

    Zhou, Xiaoming (Inventor); Baras, John S. (Inventor)

    2010-01-01

    The present invention relates to an improved communications protocol which increases the efficiency of transmission in return channels on a multi-channel slotted Alohas system by incorporating advanced error correction algorithms, selective retransmission protocols and the use of reserved channels to satisfy the retransmission requests.

  2. Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol

    PubMed Central

    De la Cruz-Cano, Eduardo; Tovilla-Zarate, Carlos Alfonso; Reyes-Ramos, Emilio; Gonzalez-Castro, Thelma Beatriz; Juarez-Castro, Isela; López-Narváez, Maria Lilia; Fresan, Ana

    2015-01-01

    Background: Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2. Methods: The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia). Conclusion: The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently

  3. Sydney epilepsy incidence study to measure illness consequences: the SESIMIC observational epilepsy study protocol

    PubMed Central

    2011-01-01

    Background Epilepsy affects an estimated 50 million people and accounts for approximately 1% of days lost to ill health globally, making it one of the most common, serious neurological disorders. While there are abundant global data on epilepsy incidence, prevalence and treatment, there is a paucity of Australian incidence data. There is also a general lack of information on the psychosocial impact and socioeconomic consequences of a new diagnosis of epilepsy on an individual, their family, household, and community which are often specific to the health and social system of each country. Methods/Design The Sydney Epilepsy Incidence Study to Measure Illness Consequences (SEISMIC) is an Australian population-based epilepsy incidence and outcome study that will recruit every newly diagnosed case of epilepsy in the Sydney South West Area Health Service to an epilepsy register. Multiple and overlapping sources of notification will be used to identify all new cases of epilepsy over a 24 month period in the Eastern Zone of the Sydney South West Area Health Service (SSWAHS) and follow up will occur over 12 months. SEISMIC will use the International League Against Epilepsy (ILAE) definitions and classifications for epidemiologic studies of epilepsy. The study will examine outcomes including mood, quality of life, employment, education performance, driving status, marital and social problems, medication use, health care usage, costs and stigma. Discussion This study is designed to examine how clinical, psychological factors, socioeconomic circumstances, and healthcare delivery influence the experience of epilepsy for individuals and families allowing better targeting of specific services and informing policy makers and practitioners. In addition, the study will provide the basis for a longitudinal population-based cohort study and potentially inform qualitative sub-studies and randomised controlled trials of intervention strategies. The study has been registered on the

  4. Development of patient decision support tools for motor neuron disease using stakeholder consultation: a study protocol

    PubMed Central

    Hogden, Anne; Greenfield, David; Caga, Jashelle; Cai, Xiongcai

    2016-01-01

    Introduction Motor neuron disease (MND) is a terminal, progressive, multisystem disorder. Well-timed decisions are key to effective symptom management. To date, there are few published decision support tools, also known as decision aids, to guide patients in making ongoing choices for symptom management and quality of life. This protocol is to develop and validate decision support tools for patients and families to use in conjunction with health professionals in MND multidisciplinary care. The tools will inform patients and families of the benefits and risks of each option, as well as the consequences of accepting or declining treatment. Methods and analysis The study is being conducted from June 2015 to May 2016, using a modified Delphi process. A 2-stage, 7-step process will be used to develop the tools, based on existing literature and stakeholder feedback. The first stage will be to develop the decision support tools, while the second stage will be to validate both the tools and the process used to develop them. Participants will form expert panels, to provide feedback on which the development and validation of the tools will be based. Participants will be drawn from patients with MND, family carers and health professionals, support association workers, peak body representatives, and MND and patient decision-making researchers. Ethics and dissemination Ethical approval for the study has been granted by Macquarie University Human Research Ethics Committee (HREC), approval number 5201500658. Knowledge translation will be conducted via publications, seminar and conference presentations to patients and families, health professionals and researchers. PMID:27053272

  5. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    PubMed Central

    2011-01-01

    Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic). Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT); referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide), will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration Australian and New Zealand

  6. Study and Analysis of the Internet Protocol Security and Its Impact on Interactive Communications

    NASA Astrophysics Data System (ADS)

    Khan, Arshi; Ansari, Seema

    Internet Protocol Security (IPSec) is the defacto standard, which offers secured Internet communications, providing traffic integrity, confidentiality and authentication. Besides this, it is assumed that IPSec is not suitable for the protection of realtime audio transmissions as the IPSec related enlargement of packets and the usage of the Cipher Block Chaining (CBC) mode contradict stringent requirements. IPSec overhead of at least 44 bytes for each Internet Protocol (IP)-packet cannot guarantee Quality of Service (QOS) due to a bad wireless link by which the Ethernet flow control intercepts and makes a real time transmission impossible.

  7. A verification system of RMAP protocol controller

    NASA Astrophysics Data System (ADS)

    Khanov, V. Kh; Shakhmatov, A. V.; Chekmarev, S. A.

    2015-01-01

    The functional verification problem of IP blocks of RMAP protocol controller is considered. The application of the verification method using fully- functional models of the processor and the internal bus of a system-on-chip is justified. Principles of construction of a verification system based on the given approach are proposed. The practical results of creating a system of verification of IP block of RMAP protocol controller is presented.

  8. Long Working Hours and Subsequent Use of Psychotropic Medicine: A Study Protocol

    PubMed Central

    Albertsen, Karen

    2014-01-01

    Background Mental ill health is the most frequent cause of long-term sickness absence and disability retirement in Denmark. Some instances of mental ill health might be due to long working hours. A recent large cross-sectional study of a general working population in Norway found that not only “very much overtime”, but also “moderate overtime” (41-48 work hours/week) was significantly associated with increased levels of both anxiety and depression. These findings have not been sufficiently confirmed in longitudinal studies. Objective The objective of the study is to give a detailed plan for a research project aimed at investigating the possibility of a prospective association between weekly working hours and use of psychotropic medicine in the general working population of Denmark. Methods People from the general working population of Denmark have been surveyed, at various occasions in the time period 1995-2010, and interviewed about their work environment. The present study will link interview data from these surveys to national registers covering all inhabitants of Denmark. The participants will be followed for the first occurrence of redeemed prescriptions for psychotropic medicine. Poisson regression will be used to analyze incidence rates as a function of weekly working hours (32-40; 41-48; > 48 hours/week). The analyses will be controlled for gender, age, sample, shift work, and socioeconomic status. According to our feasibility studies, the statistical power is sufficient and the exposure is stable enough to make the study worth the while. Results The publication of the present study protocol ends the design phase of the project. In the next phase, the questionnaire data will be forwarded to Statistics Denmark where they will be linked to data on deaths, migrations, socioeconomic status, and redeemed prescriptions for psychotropic medication. We expect the analysis to be completed by the end of 2014 and the results to be published mid 2015

  9. A comparative study of three cryopreservation protocols for effective storage of in vitro-grown mint (Mentha Spp.).

    PubMed

    Uchendu, Esther E; Reed, Barbara M

    2008-01-01

    This study was designed to determine the response of diverse mint genotypes to three commonly used cryopreservation techniques. Four mints [Mentha x piperita nothosubsp. citrata (Ehrh.) Briq.; M. canadensis L.; M. australis R. Br, and M. cunninghamii Benth] were cryopreserved using three protocols: controlled rate cooling (CC), encapsulation dehydration (ED) and PVS2 vitrification (VIT). Regrowth of mint species following controlled rate cooling (93 percent) was significantly (P < 0.0001) better than encapsulation dehydration (71 percent) and vitrification (73 percent). All four genotypes responded well to the controlled rate cooling protocol but there was some variability with the other two protocols. Genotype specific response to the individual protocols showed that there were significant differences in the recovery of Mentha x piperita nothosubsp. citrata and M. australis with CC > VIT > ED. There were also significant differences in the recovery of M. cunninghamii and M. canadensis, with CC and ED significantly better than VIT. Regrowth of the shoot tips of these mints ranged from 60 percent to 95 percent for all but one treatment. The overall results of this study compare favorably to other techniques. These improved results may be due to a combination of favorable growth conditions, cold acclimation and recovery medium. Controlled rate cooling was the most successful technique for the storage of these diverse mint genotypes; however recovery of shoot tips from VIT and ED was high and these techniques could also be used for cryogenic storage of mint germplasm.

  10. Study Protocol, Sample Characteristics, and Loss to Follow-Up: The OPPERA Prospective Cohort Study

    PubMed Central

    Bair, Eric; Brownstein, Naomi C.; Ohrbach, Richard; Greenspan, Joel D.; Dubner, Ron; Fillingim, Roger B.; Maixner, William; Smith, Shad; Diatchenko, Luda; Gonzalez, Yoly; Gordon, Sharon; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Dampier, Dawn; Knott, Charles; Slade, Gary D.

    2013-01-01

    When studying incidence of pain conditions such as temporomandibular disorders (TMDs), repeated monitoring is needed in prospective cohort studies. However, monitoring methods usually have limitations and, over a period of years, some loss to follow-up is inevitable. The OPPERA prospective cohort study of first-onset TMD screened for symptoms using quarterly questionnaires and examined symptomatic participants to definitively ascertain TMD incidence. During the median 2.8-year observation period, 16% of the 3,263 enrollees completed no follow-up questionnaires, others provided incomplete follow-up, and examinations were not conducted for one third of symptomatic episodes. Although screening methods and examinations were found to have excellent reliability and validity, they were not perfect. Loss to follow-up varied according to some putative TMD risk factors, although multiple imputation to correct the problem suggested that bias was minimal. A second method of multiple imputation that evaluated bias associated with omitted and dubious examinations revealed a slight underestimate of incidence and some small biases in hazard ratios used to quantify effects of risk factors. Although “bottom line” statistical conclusions were not affected, multiply-imputed estimates should be considered when evaluating the large number of risk factors under investigation in the OPPERA study. Perspective These findings support the validity of the OPPERA prospective cohort study for the purpose of investigating the etiology of first-onset TMD, providing the foundation for other papers investigating risk factors hypothesized in the OPPERA project. PMID:24275220

  11. Built Environment and Active Transport to School (BEATS) Study: protocol for a cross-sectional study

    PubMed Central

    Mandic, Sandra; Williams, John; Moore, Antoni; Hopkins, Debbie; Flaherty, Charlotte; Wilson, Gordon; García Bengoechea, Enrique; Spence, John C

    2016-01-01

    Introduction Active transport to school (ATS) is a convenient way to increase physical activity and undertake an environmentally sustainable travel practice. The Built Environment and Active Transport to School (BEATS) Study examines ATS in adolescents in Dunedin, New Zealand, using ecological models for active transport that account for individual, social, environmental and policy factors. The study objectives are to: (1) understand the reasons behind adolescents and their parents' choice of transport mode to school; (2) examine the interaction between the transport choices, built environment, physical activity and weight status in adolescents; and (3) identify policies that promote or hinder ATS in adolescents. Methods and analysis The study will use a mixed-method approach incorporating both quantitative (surveys, anthropometry, accelerometers, Geographic Information System (GIS) analysis, mapping) and qualitative methods (focus groups, interviews) to gather data from students, parents, teachers and school principals. The core data will include accelerometer-measured physical activity, anthropometry, GIS measures of the built environment and the use of maps indicating route to school (students)/work (parents) and perceived safe/unsafe areas along the route. To provide comprehensive data for understanding how to change the infrastructure to support ATS, the study will also examine complementary variables such as individual, family and social factors, including student and parental perceptions of walking and cycling to school, parental perceptions of different modes of transport to school, perceptions of the neighbourhood environment, route to school (students)/work (parents), perceptions of driving, use of information communication technology, reasons for choosing a particular school and student and parental physical activity habits, screen time and weight status. The study has achieved a 100% school recruitment rate (12 secondary schools). Ethics and

  12. Edge chipping and flexural resistance of monolithic ceramics☆

    PubMed Central

    Zhang, Yu; Lee, James J.-W.; Srikanth, Ramanathan; Lawn, Brian R.

    2014-01-01

    Objective Test the hypothesis that monolithic ceramics can be developed with combined esthetics and superior fracture resistance to circumvent processing and performance drawbacks of traditional all-ceramic crowns and fixed-dental-prostheses consisting of a hard and strong core with an esthetic porcelain veneer. Specifically, to demonstrate that monolithic prostheses can be produced with a much reduced susceptibility to fracture. Methods Protocols were applied for quantifying resistance to chipping as well as resistance to flexural failure in two classes of dental ceramic, microstructurally-modified zirconias and lithium disilicate glass–ceramics. A sharp indenter was used to induce chips near the edges of flat-layer specimens, and the results compared with predictions from a critical load equation. The critical loads required to produce cementation surface failure in monolithic specimens bonded to dentin were computed from established flexural strength relations and the predictions validated with experimental data. Results Monolithic zirconias have superior chipping and flexural fracture resistance relative to their veneered counterparts. While they have superior esthetics, glass–ceramics exhibit lower strength but higher chip fracture resistance relative to porcelain-veneered zirconias. Significance The study suggests a promising future for new and improved monolithic ceramic restorations, with combined durability and acceptable esthetics. PMID:24139756

  13. Cognitive Dysfunction Survey of the Japanese Patients with Moyamoya Disease (COSMO-JAPAN Study): study protocol.

    PubMed

    Takagi, Yasushi; Miyamoto, Susumu

    2015-01-01

    Moyamoya disease is a cerebrovascular occlusive disease characterized by progressive stenosis or by occlusion at the terminal portion of the bilateral internal carotid arteries. The unusual vascular network (moyamoya vessels) at the base of the brain with this disease as collateral channels is developed in this disease. Social independence because of cognitive impairment has recently been recognized as an important unsolved social issue with adult moyamoya disease. The patients with cognitive impairment have difficulty in proving their status because the standard neuroradiological and neuropsychological methods to define cognitive impairment with moyamoya disease are not determined. These patients with cognitive impairment should be supported by social welfare as psychologically handicapped persons. Thus Cognitive Dysfunction Survey of the Japanese Patients with Moyamoya Disease (COSMO-JAPAN study) is planned. In this study, we want to establish a standard finding of the cognitive impairment in patients with moyamoya disease.

  14. Study protocol: first nationwide comparative audit of acute lower gastrointestinal bleeding in the UK

    PubMed Central

    Oakland, Kathryn; Guy, Richard; Uberoi, Raman; Seeney, Frances; Collins, Gary; Grant-Casey, John; Mortensen, Neil; Murphy, Mike; Jairath, Vipul

    2016-01-01

    Introduction Acute lower gastrointestinal bleeding (LGIB) is a common indication for emergency hospitalisation worldwide. In contrast to upper GIB, patient characteristics, modes of investigation, transfusion, treatment and outcomes are poorly described. There are minimal clinical guidelines to inform care pathways and the use of endoscopy, including (diagnostic and therapeutic yields), interventional radiology and surgery are poorly defined. As a result, there is potential for wide variation in practice and clinical outcomes. Methods and analysis The UK Lower Gastrointestinal Bleeding Audit is a large nationwide audit of adult patients acutely admitted with LGIB or those who develop LGIB while hospitalised for another reason. Consecutive, unselected presentations with LGIB will be enrolled prospectively over a 2-month period at the end of 2015 and detailed data will be collected on patient characteristics, comorbidities, use of anticoagulants, transfusion, timing and modalities of diagnostic and therapeutic procedures, clinical outcome, length of stay and mortality. These will be audited against predefined minimum standards of care for LGIB. It is anticipated that over 80% of all acute hospitals in England and some hospitals in Scotland, Wales and Northern Ireland will participate. Data will be collected on the availability and organisation of care, provision of diagnostic and therapeutic GI endoscopy, interventional radiology, surgery and transfusion protocols. Ethics and dissemination This audit will be conducted as part of the national comparative audit programme of blood transfusion through collaboration with specialists in gastroenterology, surgery and interventional radiology. Individual reports will be provided to each participant site as well as an overall report and disseminated through specialist societies. Results will also be published in peer-reviewed journals. The study has been funded by National Health Services (NHS) Blood and Transplant and the

  15. Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol

    PubMed Central

    Ilesanmi, Rose Ekama; Gillespie, Brigid M.; Adejumo, Prisca Olabisi; Chaboyer, Wendy

    2015-01-01

    Background: The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. Aim: To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Methods: Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. Results: A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Conclusion: Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources. PMID:27417784

  16. Age and gender leucocytes variances and references values generated using the standardized ONE-Study protocol.

    PubMed

    Kverneland, Anders H; Streitz, Mathias; Geissler, Edward; Hutchinson, James; Vogt, Katrin; Boës, David; Niemann, Nadja; Pedersen, Anders Elm; Schlickeiser, Stephan; Sawitzki, Birgit

    2016-06-01

    Flow cytometry is now accepted as an ideal technology to reveal changes in immune cell composition and function. However, it is also an error-prone and variable technology, which makes it difficult to reproduce findings across laboratories. We have recently developed a strategy to standardize whole blood flow cytometry. The performance of our protocols was challenged here by profiling samples from healthy volunteers to reveal age- and gender-dependent differences and to establish a standardized reference cohort for use in clinical trials. Whole blood samples from two different cohorts were analyzed (first cohort: n = 52, second cohort: n = 46, both 20-84 years with equal gender distribution). The second cohort was run as a validation cohort by a different operator. The "ONE Study" panels were applied to analyze expression of >30 different surface markers to enumerate proportional and absolute numbers of >50 leucocyte subsets. Indeed, analysis of the first cohort revealed significant age-dependent changes in subsets e.g. increased activated and differentiated CD4(+) and CD8(+) T cell subsets, acquisition of a memory phenotype for Tregs as well as decreased MDC2 and Marginal Zone B cells. Males and females showed different dynamics in age-dependent T cell activation and differentiation, indicating faster immunosenescence in males. Importantly, although both cohorts consisted of a small sample size, our standardized approach enabled validation of age-dependent changes with the second cohort. Thus, we have proven the utility of our strategy and generated reproducible reference ranges accounting for age- and gender-dependent differences, which are crucial for a better patient monitoring and individualized therapy. © 2016 International Society for Advancement of Cytometry. PMID:27144459

  17. Study protocol title: a prospective cohort study of low back pain

    PubMed Central

    2013-01-01

    Background Few prospective cohort studies of workplace low back pain (LBP) with quantified job physical exposure have been performed. There are few prospective epidemiological studies for LBP occupational risk factors and reported data generally have few adjustments for many personal and psychosocial factors. Methods/design A multi-center prospective cohort study has been incepted to quantify risk factors for LBP and potentially develop improved methods for designing and analyzing jobs. Due to the subjectivity of LBP, six measures of LBP are captured: 1) any LBP, 2) LBP ≥ 5/10 pain rating, 3) LBP with medication use, 4) LBP with healthcare provider visits, 5) LBP necessitating modified work duties and 6) LBP with lost work time. Workers have thus far been enrolled from 30 different employment settings in 4 diverse US states and performed widely varying work. At baseline, workers undergo laptop-administered questionnaires, structured interviews, and two standardized physical examinations to ascertain demographics, medical history, psychosocial factors, hobbies and physical activities, and current musculoskeletal disorders. All workers’ jobs are individually measured for physical factors and are videotaped. Workers are followed monthly for the development of low back pain. Changes in jobs necessitate re-measure and re-videotaping of job physical factors. The lifetime cumulative incidence of low back pain will also include those with a past history of low back pain. Incident cases will exclude prevalent cases at baseline. Statistical methods planned include survival analyses and logistic regression. Discussion Data analysis of a prospective cohort study of low back pain is underway and has successfully enrolled over 800 workers to date. PMID:23497211

  18. Study of streptomycin-induced ototoxicity: protocol for a longitudinal study.

    PubMed

    Adeyemo, Adebolajo A; Oluwatosin, Odunayo; Omotade, Olayemi O

    2016-01-01

    Hearing impairment is due to various causes including ototoxicity from aminoglycosides. The susceptibility to aminoglycosides increases in the presence of certain mitochondria gene mutations. There is unrestrained use of aminoglycosides in many developing nations which may worsen the burden of hearing impairment in these countries but there is lack of data to drive required policy changes. Streptomycin (an aminoglycoside) is part of the drug regimen in re-treatment of tuberculosis. Exploring the impact of streptomycin ototoxicity in tuberculosis patients provides a unique opportunity to study aminoglycoside ototoxicity within the population thus providing data that can inform policy. Also, since streptomycin ototoxicity could adversely affect treatment adherence in tuberculosis patients this study could enable better pre-treatment counseling with subsequent better treatment adherence. Patients on tuberculosis re-treatment will be recruited longitudinally from Direct Observation Therapy-Short course centers. A baseline full audiologic assessment will be done before commencement of treatment and after completion of treatment. Early detection of ototoxicity will be determined using the American Speech and Hearing Association criteria and genetic analysis to determine relevant mitochondria gene mutations will be done. The incidence of ototoxicity in the cohort will be analyzed. Both Kaplan-Meier survival curve and Cox proportional hazards tests will be utilized to determine factors associated with development of ototoxicity and to examine association between genotype status and ototoxicity. This study will provide data on the burden and associated predictors of developing aminoglycoside induced ototoxicity. This will inform public health strategies to regulate aminoglycoside usage and optimization of treatment adherence and the management of drug-induced ototoxicity among TB patients. Furthermore the study will describe mitochondrial gene mutations associated with

  19. Community paediatric respiratory infection surveillance study protocol: a feasibility, prospective inception cohort study

    PubMed Central

    Anderson, Emma C; Ingle, Suzanne Marie; Muir, Peter; Beck, Charles; Finn, Adam; Leeming, John Peter; Cabral, Christie; Kesten, Joanna May; Hay, Alastair D

    2016-01-01

    Introduction Paediatric respiratory tract infections (RTIs) are common reasons for primary care consultations and antibiotic prescribing. Locally relevant syndromic and microbiological surveillance information has the potential to improve the care of children with RTIs by normalising illness (parents) and reducing uncertainty (clinicians). Currently, most RTI studies are conducted at the point of healthcare service consultation, leaving the community burden, microbiology, symptom duration and proportion consulting largely unknown. This study seeks to establish the feasibility of (mainly online) participant recruitment and retention, and the acceptability/comparability of parent versus nurse-collected microbiological sampling, to inform the design of a future surveillance intervention study. Evidence regarding consultation rates and symptom duration is also sought. Methods and analysis A community-based, feasibility prospective inception cohort study, recruiting children aged ≥3 months and <16 years and their parents via general practitioner surgery invitation letter, aiming to collect data on 300 incident RTIs by July 2016. Following informed consent, parents provide baseline (demographic) data online, and respond to weekly emails to confirm the absence/presence of new RTI symptoms. Once symptomatic, parents provide daily data online (RTI symptoms, school/day-care attendance, time off work, health service use, medication), and a research nurse visits to collect clinical examination data and microbiological (nasal and saliva) swabs. Parents are invited to provide symptomatic (at nurse visit, but without nurse assistance) and asymptomatic (alone) swabs on recovery. A review of primary care medical notes will gather medical history, health service utilisation, referral and antibiotic prescribing rates. Feasibility will be assessed using recruitment and retention rates, data completeness; and acceptability by quantitative survey and qualitative interviews

  20. European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903

    PubMed Central

    Dinger, Juergen C; Heinemann, Lothar AJ

    2006-01-01

    Background The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor. Methods/design The primary objective of the study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes - in particular venous and arterial thromboembolism - and other serious adverse events (SAEs) in new HRT users over a period of several years. One product under surveillance is Angeliq®, which contains the novel progestagen drospirenone (DRSP) combined with estradiol. In addition, all other oral combined HRT products with a novel progestagen or estrogen that will be newly marketed during the study period will be studied. These new HRT products will be compared with established HRT products. The combined cohort will include at least 30,000 women recruited in several European countries. At least 90,000 years of observation are expected from the field work which started in early 2002 and will end around 2008. The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes occurring during the observational period will be evaluated. Discussion A complete lifetime medical history, individually validated SAEs over time, and a low loss to follow-up rate are essential for a robust safety assessment. Therefore, the lifetime history of

  1. Protocols for Online Teaching of Thucydides: The "Final Word" Case Study

    ERIC Educational Resources Information Center

    Aravani, ?vangelia

    2015-01-01

    This paper sets out to describe and analyze issues relating to the role of new literacies and technologies in the teaching process. More specifically, the article deals with how the educational design process of Ancient Greek changes through the implementation of technology by using online discussion protocols. These were utilized as a tool for…

  2. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study.

    PubMed

    Fairbairn, Peter; Leventis, Minas

    2015-01-01

    Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years). Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities. PMID:26858757

  3. A simulation study of TaMAC protocol using network simulator 2.

    PubMed

    Ullah, Sana; Kwak, Kyung Sup

    2012-10-01

    A Wireless Body Area Network (WBAN) is expected to play a significant role in future healthcare system. It interconnects low-cost and intelligent sensor nodes in, on, or around a human body to serve a variety of medical applications. It can be used to diagnose and treat patients with chronic diseases such as hypertensions, diabetes, and cardiovascular diseases. The lightweight sensor nodes integrated in WBAN require low-power operation, which can be achieved using different optimization techniques. We introduce a Traffic-adaptive MAC protocol (TaMAC) for WBAN that supports dual wakeup mechanisms for normal, emergency, and on-demand traffic. In this letter, the TaMAC protocol is simulated using a well-known Network Simulator 2 (NS-2). The problem of multiple emergency nodes is solved using both wakeup radio and CSMA/CA protocol. The power consumption, delay, and throughput performance are closely compared with beacon-enabled IEEE 802.15.4 MAC protocol using extensive simulations.

  4. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study.

    PubMed

    Fairbairn, Peter; Leventis, Minas

    2015-01-01

    Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years). Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  5. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

    PubMed Central

    2015-01-01

    Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years). Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities. PMID:26858757

  6. A preliminary study on the identification of vehicle paint chip based on optical coherence tomography

    NASA Astrophysics Data System (ADS)

    Zhang, Ning; Li, Zhihui; Xu, Xiaojing; Huang, Wei; Xu, Lei; Guo, Jingjing; Xie, Lanchi

    2015-12-01

    Vehicle paint chip is a common evidence that plays a significant role in many criminal cases. This paper introduced a novel imaging technology - optical coherence tomography (OCT), which can realize non-invasive, rapid, high-resolution and cross-sectional imaging for the identification of vehicle paint chips. In this paper, a 1310nm swept-source OCT system was adopted to implement the paint imaging. The results show that, compared with conventional spectroscopy and SEM methods, OCT technology can directly obtain the tomographic images of the paints without slicing. In addition, the optical attenuation properties were analyzed to provide a new feature for separating different paint samples. The OCT technology and traditional methods can be combined to further narrow the scope of investigation, providing a comprehensive means to determine or rule out the suspect vehicles.

  7. Ensembles of engineered cardiac tissues for physiological and pharmacological study: heart on a chip.

    PubMed

    Grosberg, Anna; Alford, Patrick W; McCain, Megan L; Parker, Kevin Kit

    2011-12-21

    Traditionally, muscle physiology experiments require multiple tissue samples to obtain morphometric, electrophysiological, and contractility data. Furthermore, these experiments are commonly completed one at a time on cover slips of single cells, isotropic monolayers, or in isolated muscle strips. In all of these cases, variability of the samples hinders quantitative comparisons among experimental groups. Here, we report the design of a "heart on a chip" that exploits muscular thin film technology--biohybrid constructs of an engineered, anisotropic ventricular myocardium on an elastomeric thin film--to measure contractility, combined with a quantification of action potential propagation, and cytoskeletal architecture in multiple tissues in the same experiment. We report techniques for real-time data collection and analysis during pharmacological intervention. The chip is an efficient means of measuring structure-function relationships in constructs that replicate the hierarchical tissue architectures of laminar cardiac muscle.

  8. Application of the Putting Women First protocol in a study on violence against immigrant women in Spain.

    PubMed

    Torrubiano-Domínguez, Jordi; Vives-Cases, Carmen

    2013-01-01

    In this paper, we describe our experience of using the Putting Women First protocol in the design and implementation of a cross-sectional study on violence against women (VAW) among 1607 immigrant women from Morocco, Ecuador and Romania living in Spain in 2011. The Putting Women First protocol is an ethical guideline for VAW research, which includes recommendations to ensure the safety of the women involved in studies on this subject. The response rate in this study was 59.3%. The prevalence of VAW cases last year was 11.7%, of which 15.6% corresponded to Ecuadorian women, 10.9% to Moroccan women and 8.6% to Romanian women. We consider that the most important goal for future research is the use of VAW scales validated in different languages, which would help to overcome the language barriers encountered in this study.

  9. Assessing function in patients undergoing joint replacement: a study protocol for a cohort study

    PubMed Central

    2012-01-01

    Background Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF), which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time. Methods/design Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over time. Discussion There are a

  10. Does bone debris in anterior cruciate ligament reconstruction really matter? A cohort study of a protocol for bone debris debridement

    PubMed Central

    Imam, Mohamed A.; Abdelkafy, Ashraf; Dinah, Feroz; Adhikari, Ajeya

    2015-01-01

    Background: The purpose of the current study was to determine whether a systematic five-step protocol for debridement and evacuation of bone debris during anterior cruciate ligament reconstruction (ACLR) reduces the presence of such debris on post-operative radiographs. Methods: A five-step protocol for removal of bone debris during arthroscopic assisted ACLR was designed. It was applied to 60 patients undergoing ACLR (Group 1), and high-quality digital radiographs were taken post-operatively in each case to assess for the presence of intra-articular bone debris. A control group of 60 consecutive patients in whom no specific bone debris protocol was applied (Group 2) and their post-operative radiographs were also checked for the presence of intra-articular bone debris. Results: In Group 1, only 15% of post-operative radiographs showed residual bone debris, compared to 69% in Group 2 (p < 0.001). Conclusion: A five-step systematic protocol for bone debris removal during arthroscopic assisted ACLR resulted in a significant decrease in residual bone debris seen on high-quality post-operative radiographs. PMID:27163060

  11. Development of an exercise testing protocol for patients with a lower limb amputation: results of a pilot study.

    PubMed

    Vestering, Myrthe M; Schoppen, Tanneke; Dekker, Rienk; Wempe, Johan; Geertzen, Jan H B

    2005-09-01

    Due to a decrease in physical activity, lower limb amputees experience a decline in physical fitness. This causes problems in walking with a prosthesis because energy expenditure in walking with a prosthesis is much higher than in walking with two sound legs. Exercise training may therefore increase the functional walking ability of these patients. To generate a safe and effective aerobic training program, exercise testing of amputees is recommended. The objectives of this study were to develop a maximal exercise testing protocol for lower limb amputees and to compare two different testing methods: combined arm-leg ergometry and arm ergometry. The protocols were tested in five amputee patients. Combined ergometry elicited a higher oxygen uptake and heart rate than arm ergometry. Electrocardiography during combined ergometry was easier to read. Combined ergometry was judged most comfortable by the amputees. The exercise testing protocol was useful in lower limb amputees to determine their maximal aerobic capacity and their main exercise limitation. Future exercise training programs may be based on this testing protocol. Combined arm-leg ergometry is appropriate for unilateral amputees without significant claudication of the remaining leg. Continuous arm ergometry is suitable for unilateral amputees with significant claudication of the remaining limb or bilateral amputees. PMID:16046917

  12. Study protocol: safety correction of high dose antipsychotic polypharmacy in Japan

    PubMed Central

    2014-01-01

    Background In Japan, combination therapy with high doses of antipsychotic drugs is common, but as a consequence, many patients with schizophrenia report extrapyramidal and autonomic nervous system side effects. To resolve this, we proposed a method of safety correction of high dose antipsychotic polypharmacy (the SCAP method), in which the initial total dose of all antipsychotic drugs is calculated and converted to a chlorpromazine equivalent (expressed as milligrams of chlorpromazine, mg CP). The doses of low-potency antipsychotic drugs are then reduced by ≤ 25 mg CP/week, and the doses of high-potency antipsychotics are decreased at a rate of ≤50 mg CP/week. Although a randomized, case-controlled comparative study has demonstrated the safety of this method, the number of participants was relatively small and its results required further validation. In this study of the SCAP method, we aimed to substantially increase the number of participants. Methods/design The participants were in- or outpatients treated with two or more antipsychotics at doses of 500–1,500 mg CP/day. Consenting participants were randomized into control and dose reduction groups. In the control group, patients continued with their normal regimen for 3 months without a dose change before undergoing the SCAP protocol. The dose reduction group followed the SCAP strategy over 3–6 months with a subsequent 3-month follow-up period. Outcome measures were measured at baseline and then at 3-month intervals, and included clinical symptoms measured on the Manchester scale, the extent of extrapyramidal and autonomic side effects, and quality of life using the Euro QOL scale. We also measured blood drug concentrations and drug efficacy-associated biochemical parameters. The Brief Assessment of Cognition in Schizophrenia, Japanese version, was also undertaken in centers where it was available. Discussion The safety and efficacy of the SCAP method required further validation in a large

  13. Shock in the first 24 h of intensive care unit stay: observational study of protocol-based fluid management.

    PubMed

    See, Kay Choong; Mukhopadhyay, Amartya; Lau, Samuel Chuan-Xian; Tan, Sandra Ming-Yien; Lim, Tow Keang; Phua, Jason

    2015-05-01

    Precision in fluid management for shock could lead to better clinical outcomes. We evaluated the association of protocol-based fluid management with intensive care unit (ICU) and hospital mortality. We performed an observational study of mechanically ventilated patients admitted directly from our emergency department to the ICU from August 2011 to December 2013, who had circulatory shock in the first 24 h of ICU stay (systolic blood pressure <90 mmHg at ICU admission or lactate >4 mmol/L). Patients with onset of shock beyond 24 h of ICU stay were excluded. Protocol-based fluid management required close physician-nurse cooperation and computerized documentation, checking for fluid response (≥10% arterial pulse pressure or stroke volume increase after two consecutive 250-mL crystalloid boluses), and fluid loading with repeated 500-mL boluses until fluid response became negative. Six hundred twelve mechanically ventilated patients with shock (mean [±SD] age, 63.0 years [16.5]; 252 or 41.2% females; mean Acute Physiology and Chronic Health Evaluation II score, 30.2 [8.8]) were studied. The fluid management protocol was used 455 times for 242 patients (39.5% of 612 patients) within the first 24 h of ICU stay, with 244 (53.6% of 455) positive responses. Adjusted for age, sex, Acute Physiology and Chronic Health Evaluation II score, comorbidity, and admission year, protocol use was associated with reduced ICU mortality (odds ratio, 0.60; 95% confidence interval, 0.39-0.94; P = 0.025) but not hospital mortality (odds ratio, 0.82; 95% confidence interval, 0.54-1.23; P = 0.369). Among mechanically ventilated patients with shock within the first 24 h of ICU stay, about half had positive fluid responses. Adherence to protocol-based fluid management was associated with improved ICU survival.

  14. Study protocol: Imaging brain development in the Childhood to Adolescence Transition Study (iCATS)

    PubMed Central

    2014-01-01

    Background Puberty is a critical developmental phase in physical, reproductive and socio-emotional maturation that is associated with the period of peak onset for psychopathology. Puberty also drives significant changes in brain development and function. Research to date has focused on gonadarche, driven by the hypothalamic-pituitary-gonadal axis, and yet increasing evidence suggests that the earlier pubertal stage of adrenarche, driven by the hypothalamic-pituitary-adrenal axis, may play a critical role in both brain development and increased risk for disorder. We have established a unique cohort of children who differ in their exposure to adrenarcheal hormones. This presents a unique opportunity to examine the influence of adrenarcheal timing on brain structural and functional development, and subsequent health outcomes. The primary objective of the study is to explore the hypothesis that patterns of structural and functional brain development will mediate the relationship between adrenarcheal timing and indices of affect, self-regulation, and mental health symptoms collected across time (and therefore years of development). Methods/Design Children were recruited based upon earlier or later timing of adrenarche, from a larger cohort, with 128 children (68 female; M age 9.51 years) and one of their parents taking part. Children completed brain MRI structural and functional sequences, provided saliva samples for adrenarcheal hormones and immune biomarkers, hair for long-term cortisol levels, and completed questionnaires, anthropometric measures and an IQ test. Parents completed questionnaires reporting on child behaviour, development, health, traumatic events, and parental report of family environment and parenting style. Discussion This study, by examining the neurobiological and behavioural consequences of relatively early and late exposure to adrenarche, has the potential to significantly impact our understanding of pubertal risk processes. PMID:24779869

  15. A cohort study of Chlamydia trachomatis treatment failure in women: a study protocol

    PubMed Central

    2013-01-01

    Background Chlamydia trachomatis is the most commonly diagnosed bacterial sexually transmitted infection in the developed world and diagnosis rates have increased dramatically over the last decade. Repeat infections of chlamydia are very common and may represent re-infection from an untreated partner or treatment failure. The aim of this cohort study is to estimate the proportion of women infected with chlamydia who experience treatment failure after treatment with 1 gram azithromycin. Methods/design This cohort study will follow women diagnosed with chlamydia for up to 56 days post treatment. Women will provide weekly genital specimens for further assay. The primary outcome is the proportion of women who are classified as having treatment failure 28, 42 or 56 days after recruitment. Comprehensive sexual behavior data collection and the detection of Y chromosome DNA and high discriminatory chlamydial genotyping will be used to differentiate between chlamydia re-infection and treatment failure. Azithromycin levels in high-vaginal specimens will be measured using a validated liquid chromatography – tandem mass spectrometry method to assess whether poor azithromycin absorption could be a cause of treatment failure. Chlamydia culture and minimal inhibitory concentrations will be performed to further characterize the chlamydia infections. Discussion Distinguishing between treatment failure and re-infection is important in order to refine treatment recommendations and focus infection control mechanisms. If a large proportion of repeat chlamydia infections are due to antibiotic treatment failure, then international recommendations on chlamydia treatment may need to be re-evaluated. If most are re-infections, then strategies to expedite partner treatment are necessary. PMID:23957327

  16. Individual and occupational risk factors for knee osteoarthritis – Study protocol of a case control study

    PubMed Central

    Klußmann, André; Gebhardt, Hansjuergen; Liebers, Falk; von Engelhardt, Lars Victor; Dávid, Andreas; Bouillon, Bertil; Rieger, Monika A

    2008-01-01

    Background Knee osteoarthritis (OA) is one of the frequent and functionally impairing disorders of the musculoskeletal system. In the literature, a number of occupational risk factors are discussed as being related to the development and progress of knee joint diseases, e.g. working in kneeling or squatting posture, lifting and carrying of heavy weights. The importance of the single risk factors and the possibility of prevention are currently under discussion. Besides the occupational factors, a number of individual risk factors are important, too. The distinction between work-related factors and individual factors is crucial in assessing the risk and in deriving preventive measures in occupational health. In existing studies, the occupational stress is determined mainly by surveys in employees and/or by making assumptions about individual occupations. Direct evaluation of occupational exposure has been performed only exceptionally. The aim of the research project ArGon is the assessment of different occupational factors in relation to individual factors (e.g. constitutional factors, leisure time activities, sports), which might influence the development and/or progression of knee (OA). The project is designed as a case control study. Methods/Design To raise valid data about the physical stress associated with occupational and leisure time activities, patients with and without knee OA are questioned by means of a standardised questionnaire and an interview. The required sample size was estimated to 800 cases and an equal number of controls. The degree and localisation of the knee cartilage or joint damages in the cases are documented on the basis of radiological, arthroscopic and/or operative findings in a patient record. Furthermore, occupational exposure is analysed at selected workplaces. To evaluate the answers provided in the questionnaire, work analysis is performed. Discussion In this research project, specific information on the correlation of occupational

  17. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol

    PubMed Central

    2013-01-01

    Background Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient ‘dose’. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. Methods/Design This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Discussion Addressing adherence in internet cessation programs is critical and timely to leverage

  18. Characterizing Diversity of Lactobacilli Associated with Severe Early Childhood Caries: A Study Protocol

    PubMed Central

    Argimón, Silvia; Schön, Catherine N.; Saraithong, Prakaimuk; Caufield, Page W.

    2015-01-01

    will be compared between children with or without S-ECC. One of the main objectives of this study is to establish a study protocol for the identification and characterization of lactobacilli in the oral cavity. Future caries risk assessments can include lactobacilli counts (quantitative) and the presence/absence of specific cariogenic genetic signatures of a Lactobacillus species (qualitative) associated with S-ECC. PMID:26413427

  19. Protocol design for large-scale cross-sectional studies of sexual abuse and associated factors in individual sports: feasibility study in Swedish athletics.

    PubMed

    Timpka, Toomas; Janson, Staffan; Jacobsson, Jenny; Ekberg, Joakim; Dahlström, Örjan; Kowalski, Jan; Bargoria, Victor; Mountjoy, Margo; Svedin, Carl G

    2015-03-01

    To ensure health and well-being for their athletes, sports organizations must offer preventive measures against sexual abuse. The aim of this study was to design and evaluate feasibility of a research protocol for cross-sectional epidemiological studies of sexual abuse in athletics. Examination of the requirements on the study of sexual abuse in athletics was followed by iterated drafting of protocol specifications and formative evaluations. The feasibility of the resulting protocol was evaluated in a national-level study among elite athletics athletes (n = 507) in Sweden. The definition of sexual abuse, the ethical soundness of the protocol, reference populations and study of co-morbidity, and the means for athlete-level data collection were identified as particularly complex issues in the requirements analyses. The web-based survey defined by the protocol facilitates anonymous athlete self-reporting of data on exposure to sexual abuse. 198 athletes (39%) fully completed the feasibility survey. 89% (n = 177) reported that they agreed with that the questions in the survey were important, and 95% (n = 189) reported that they answered truthfully to all questions. Similarly, 91% (n = 180) reported that they did not agree with that the questions were unpleasant for them. However, 16% (n = 32) reported that they did not find the survey to be of personal value, and 12% (n = 23) reported that the survey had caused them to think about issues that they did not want to think about. Responding that participation was not personally gratifying was associated with training more hours (p = 0.01). There is a scarcity of research on the prevention of sexual abuse in individual sports. The present protocol should be regarded as a means to overcome this shortcoming in athletics. When implementing the protocol, it is necessary to encourage athlete compliance and to adapt the web-based survey to the particular infrastructural conditions in the sports setting at hand. Key points

  20. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE)

    PubMed Central

    2011-01-01

    Background Maternal smoking is the most significant cause of preventable complications during pregnancy, with smoking cessation during pregnancy shown to increase birth weight and reduce preterm birth among pregnant women who quit smoking. Taking into account the fact that the number of women who smoke in Greece has increased steadily throughout the previous decade and that the prevalence of smoking among Greek females is one of the highest in the world, smoking cessation should be a top priority among Greek health care professionals. Methods/Design The Maternal Smoking Cessation during Pregnancy Study (M-SCOPE), is a Randomized Control Trial (RCT) that aims to test whether offering Greek pregnant smokers a high intensity intervention increases smoking cessation during the third trimester of pregnancy, when compared to a low intensity intervention. Prospective participants will be pregnant smokers of more than 5 cigarettes per week, recruited up to the second trimester of pregnancy. Urine samples for biomarker analysis of cotinine will be collected at three time points: at baseline, at around the 32nd week of gestation and at six months post partum. The control group/low intensity intervention will include: brief advice for 5 minutes and a short leaflet, while the experimental group/intensive intervention will include: 30 minutes of individualized cognitive-behavioural intervention provided by a trained health professional and a self-help manual especially tailored for smoking cessation during pregnancy, while counselling will be based on the ''5 As.'' After childbirth, the infants' birth weight, gestational age and any other health related complications during pregnancy will be recorded. A six months post-partum a follow up will be performed in order to re-assess the quitters smoking status. Discussion If offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation in comparison to a usual care low intensity

  1. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    PubMed Central

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and

  2. The randomized shortened dental arch study (RaSDA): design and protocol

    PubMed Central

    2010-01-01

    Background Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials. Methods/design This 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patients over 35 years of age with all molars missing in one jaw and with at least both canines and one premolar left on each side were eligible. One group received a treatment with removable dental prostheses for molar replacement (treatment A). The other group received a treatment limited to the replacement of all missing anterior and premolar teeth using fixed bridges (treatment B). A pilot trial with 32 patients was carried out. Two hundred and fifteen patients were enrolled in the main trial where 109 patients were randomized for treatment A and 106 for treatment B. The primary outcome measure is further tooth loss during the 5-year follow-up. The secondary outcome measures encompassed clinical, technical and subjective variables. The study is funded by the Deutsche Forschungsgemeinschaft (German Research Foundation, DFG WA 831/2-1, 2-2, 2-3, 2-4, 2-5). Discussion The particular value of this trial is the adaptation of common design components to the very specific features of complex dental prosthetic treatments. The pilot trial proved to be indispensable because it led to a number of adjustments in the study protocol that considerably improved the practicability. The expected results are of high clinical relevance and will show the efficacy of two common treatment approaches in terms of

  3. Computational Protocol for Modeling Thermochromic Molecular Crystals: Salicylidene Aniline As a Case Study.

    PubMed

    Presti, Davide; Labat, Fréderic; Pedone, Alfonso; Frisch, Michael J; Hratchian, Hrant P; Ciofini, Ilaria; Menziani, Maria Cristina; Adamo, Carlo

    2014-12-01

    A computational protocol that combines periodic and QM/QM' calculations has been applied to investigate the structural (geometrical and electronic) and photophysical absorption properties of the salicylidene aniline (SA) thermochromic molecular crystal. The protocol consists of three different steps, namely (i) the description of the molecular crystal using a periodic approach taking into account dispersion interactions, (ii) the identification of reliable finite models (clusters), and (iii) the calculation of vertical transition energies including environmental effects through the use of an electronic embedding model (QM/QM' ONIOM approach). The encouraging results obtained in this work for the β polymorph of SA, both in terms of accuracy and computational cost, open the way to the simulation and the prediction of the photophysical behavior of other molecular crystals, especially those much less well characterized experimentally. PMID:26583240

  4. Cactus and Visapult: A case study of ultra-high performance distributed visualization using connectionless protocols

    SciTech Connect

    Shalf, John; Bethel, E. Wes

    2002-05-07

    This past decade has seen rapid growth in the size, resolution, and complexity of Grand Challenge simulation codes. Many such problems still require interactive visualization tools to make sense of multi-terabyte data stores. Visapult is a parallel volume rendering tool that employs distributed components, latency tolerant algorithms, and high performance network I/O for effective remote visualization of massive datasets. In this paper we discuss using connectionless protocols to accelerate Visapult network I/O and interfacing Visapult to the Cactus General Relativity code to enable scalable remote monitoring and steering capabilities. With these modifications, network utilization has moved from 25 percent of line-rate using tuned multi-streamed TCP to sustaining 88 percent of line rate using the new UDP-based transport protocol.

  5. A Tribolium castaneum whole-embryo culture protocol for studying the molecular mechanisms and morphogenetic movements involved in insect development.

    PubMed

    Macaya, Constanza C; Saavedra, Patricio E; Cepeda, Rodrigo E; Nuñez, Viviana A; Sarrazin, Andres F

    2016-01-01

    The development of the red flour beetle Tribolium castaneum is more representative of arthropods than the evolutionarily derived fly, Drosophila melanogaster. Thus, Tribolium is becoming an emerging organism model for studying the evolution of the mechanisms that control embryonic development in arthropods. In this regard, diverse genetic and molecular tools are currently available for Tribolium, as well as imaging and embryonic techniques. Recently, we developed a method for culturing embryos in order to study specific stages during Tribolium development. In this report, we present a detailed and "easy-to-follow" protocol for embryo handling and dissection, extending the use of whole-embryo culture to functional analysis by performing in vivo pharmacological manipulations. This experimental accessibility allowed us to study the relevance of microtubules in axis elongation, using nocodazole and taxol drugs to interfere with microtubule networks, followed by length measurement analysis. Additionally, we demonstrated that embryo handling had no effect on the development of Tribolium embryos, and we checked viability after dissection and bisection and during incubation using propidium iodide. The embryo culture protocol we describe here can be applied to study diverse developmental processes in Tribolium. We expect that this protocol can be adapted and applied to other arthropods.

  6. Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study

    PubMed Central

    Kronzer, Vanessa L.; Jerry, Michelle R.; Avidan, Michael S.

    2016-01-01

    Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols. PMID:27635222

  7. Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study.

    PubMed

    Kronzer, Vanessa L; Jerry, Michelle R; Avidan, Michael S

    2016-01-01

    Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols. PMID:27635222

  8. Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based Acceptance and Commitment Therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. Methods/design We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (Acceptance and Commitment Therapy, Cognitive Behavior Therapy or waitlist control). Those in the Acceptance and Commitment Therapy and Cognitive Behavior Therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the Cognitive Behavior Therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. Discussion To the best of our knowledge, this study will be the largest trial of Acceptance and Commitment Therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of Acceptance and Commitment Therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of Cognitive Behavior Therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently

  9. A series of studies--a practical protocol for testing muscular endurance recovery.

    PubMed

    McLester, John R; Bishop, Phillip A; Smith, Joe; Wyers, Lana; Dale, Barry; Kozusko, Joseph; Richardson, Mark; Nevett, Michael E; Lomax, Richard

    2003-05-01

    The purpose of this series of studies was to use a practical measure to examine the course of muscular endurance recovery after 3 sets to failure in 10 men (ages 18 to 30 years) and then compare those results with 10 men (ages 18 to 30 years) who performed 7 sets and 10 older men (ages 50 to 65 years) who performed 3 sets. Recovery as indicated by number of repetitions performed was observed at 24, 48, 72, and 96 hours. Repeated-measures ANOVA was used to investigate differences in recovery over time. For group means, performance was significantly lower in all 3 groups after 24 hours (p < 0.05). At 48 hours, performance of the groups was not significantly different from baseline (p > 0.05). Number of repetitions performed at 72 hours was significantly higher than that in session 1 (10.2 +/- 1.4 reps in session 1 vs. 11.2 +/- 2.3 at 72 hours, p = 0.022) in the young 3-sets group, but not in the other groups. After 96 hours, only the young 7-sets group was found to be performing at a level approaching significance (10.3 +/- 1.2 reps in session 1 vs. 11.1 +/- 2.0 at 96 hours, p = 0.051). No significant difference was found between the young 3-sets and 7-sets groups at any time (p > 0.05). The young 3-sets group was found to be performing at a significantly higher level than the older group at 72 hours (11.2 +/- 2.3 reps in the younger vs. 9.9 +/- 1.7 in the older group, p = 0.008), a difference that also approached significance at 96 hours (p = 0.06). Large intersubject variability was observed at all time points. The results suggest that individual recovery testing before exercise prescription is practical, and this protocol may be sensitive to differences in training volume and subject age.

  10. The stages of implementation completion for evidence-based practice: protocol for a mixed methods study

    PubMed Central

    2014-01-01

    Background This protocol describes the ‘development of outcome measures and suitable methodologies for dissemination and implementation approaches,’ a priority for implementation research. Although many evidence-based practices (EBPs) have been developed, large knowledge gaps remain regarding how to routinely move EBPs into usual care. The lack of understanding of ‘what it takes’ to install EBPs has costly public health consequences, including a lack of availability of the most beneficial services, wasted efforts and resources on failed implementation attempts, and the potential for engendering reluctance to try implementing new EBPs after failed attempts. The Stages of Implementation Completion (SIC) is an eight-stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, sustainability). Items delineate the date that a site completes implementation activities, yielding an assessment of duration (time to complete a stage), proportion (of stage activities completed), and a general measure of how far a site moved in the implementation process. Methods/Design We propose to extend the SIC to EBPs operating in child service sectors (juvenile justice, schools, substance use, child welfare). Both successful and failed implementation attempts will be scrutinized using a mixed methods design. Stage costs will be measured and examined. Both retrospective data (from previous site implementation efforts) and prospective data (from newly adopting sites) will be analyzed. The influence of pre-implementation on implementation and sustainability outcomes will be examined (Aim 1). Mixed methods procedures will focus on increasing understanding of the process of implementation failure in an effort to determine if the SIC can provide early detection of sites that are unlikely to succeed (Aim 2). Study activities will include cost mapping of SIC stages and an examination of the relationship between

  11. Detection and Genotyping of Human Papillomavirus DNA in Formalin-Fixed Paraffin-Embedded Specimens with the HPV Direct Flow CHIP System

    PubMed Central

    Herraez-Hernandez, Elsa; Preda, Ovidiu; Alonso, Sonia; Pardo, Rosario Serrano; Olmo, Asuncion

    2013-01-01

    The novel HPV Direct Flow CHIP commercial system for Human Papillomavirus (HPV) genotyping is based on rapid PCR and automatic reverse dot blot hybridization to genotype-specific probes, allowing the detection of 36 HPV genotypes. This study examined the performance of HPV Direct Flow CHIP in formalin-fixed paraffin-embedded (FFPE) samples (n= 99). Each sample was analyzed both by Direct PCR, using crude cell extracts without DNA purification, and by conventional PCR, using purified DNA. Pair-wise analysis of the results demonstrated strong concordance between the results obtained with the two protocols, although a slightly higher rate of multiple infections was detected by conventional PCR. In summary, HPV Direct Flow CHIP achieves effective HPV detection from FFPE samples with both Direct PCR and Conventional PCR protocols. PMID:24222806

  12. Study of endothelial cell apoptosis using fluorescence resonance energy transfer (FRET) biosensor cell line with hemodynamic microfluidic chip system.

    PubMed

    Yu, J Q; Liu, X F; Chin, L K; Liu, A Q; Luo, K Q

    2013-07-21

    To better understand how hyperglycemia induces endothelial cell dysfunction under the diabetic conditions, a hemodynamic microfluidic chip system was developed. The system combines a caspase-3-based fluorescence resonance energy transfer (FRET) biosensor cell line which can detect endothelial cell apoptosis in real-time, post-treatment effect and with a limited cell sample, by using a microfluidic chip which can mimic the physiological pulsatile flow profile in the blood vessel. The caspase-3-based FRET biosensor endothelial cell line (HUVEC-C3) can produce a FRET-based sensor protein capable of probing caspase-3 activation. When the endothelial cells undergo apoptosis, the color of the sensor cells changes from green to blue, thus sensing apoptosis. A double-labeling fluorescent technique (yo pro-1 and propidium iodide) was used to validate the findings revealed by the FRET-based caspase sensor. The results show high rates of apoptosis and necrosis of endothelial cells when high glucose concentration was applied in our hemodynamic microfluidic chip combined with an exhaustive pulsatile flow profile. The two apoptosis detection techniques (fluorescent method and FRET biosensor) are comparable; but FRET biosensor offers more advantages such as real-time observation and a convenient operating process to generate more accurate and reliable data. Furthermore, the activation of the FRET biosensor also confirms the endothelial cell apoptosis induced by the abnormal pulsatile shear stress and high glucose concentration is through caspase-3 pathway. A 12% apoptotic rate (nearly a 4-fold increase compared to the static condition) was observed when the endothelial cells were exposed to a high glucose concentration of 20 mM under 2 h exhaustive pulsatile shear stress of 30 dyne cm(-2) and followed with another 10 h normal pulsatile shear stress of 15 dyne cm(-2). Therefore, the most important finding of this study is to develop a novel endothelial cell apoptosis detection

  13. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    PubMed Central

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  14. Monitoring activities of teenagers to comprehend their habits: study protocol for a mixed-methods cohort study

    PubMed Central

    2013-01-01

    Background Efforts to increase physical activity in youth need to consider which activities are most likely to be sustained over time in order to promote lifelong participation in physical activity. The Monitoring Activities of Teenagers to Comprehend their Habits (MATCH) study is a prospective cohort study that uses quantitative and qualitative methods to develop new knowledge on the sustainability of specific physical activities. Methods/design Eight hundred and forty-three grade 5 and 6 students recruited from 17 elementary schools in New Brunswick, Canada, are followed-up three times per year. At each survey cycle, participants complete self-report questionnaires in their classroom under the supervision of trained data collectors. A sub-sample of 24 physically active students is interviewed annually using a semi-structured interview protocol. Parents (or guardians) complete telephone administered questionnaires every two years, and a health and wellness school audit is completed for each school. Discussion MATCH will provide a description of the patterns of participation in specific physical activities in youth, and enable identification of the determinants of maintenance, decline, and uptake of participation in each activity. These data will inform the development of interventions that take into account which activities are the most likely to be maintained and why activities are maintained or dropped. PMID:23849265

  15. Influence of the short-axis cine acquisition protocol on the cardiac function evaluation: A reproducibility study

    PubMed Central

    Marchesseau, Stephanie; Ho, Jamie X.M.; Totman, John J.

    2016-01-01

    Purpose To define the optimal cardiac short-axis cine acquisition protocol for the assessment of the left and rightventricular functions. Materials and methods 20 volunteers were recruited and breath-hold CINE images were acquired on a Siemens Prisma 3T MRI. Four short-axis acquisition planes were defined from the 4-chamber view. AV Junctions: short-axis slices parallel to the plane that cuts through the external right and left atrioventricular junctions. Left AV Junctions: short-axis slices parallel to the plane that cuts through both left atrioventricular junctions. Septum: short-axis slices perpendicular to the septum with one cutting through the septum junction. LongAxis: short-axis slices perpendicular to the long axis with one cutting through the septum junction. Intra and inter reproducibility was assessed using Bland-Altman coefficient of variation (CV) and Lin’s concordance correlation coefficient (CCC). The influence of the protocol on the ejection fraction (EF) and stroke volume (SV) was quantified statistically using pair-wise CV and Pearson’s correlation coefficient R2. Results All protocols led to high reproducibility for the LV EF (mean intra CV = 3.83%, mean inter CV = 4.81%, lowest CV = 4.20% (AV junctions) and highest CV = 5.24% (Left AV Junctions)). Reproducibility of the RV measurements was lower (mean intra CV = 7.84%, mean inter CV = 9.17%). Septum protocol led to significantly lower variability compared to the other 3 protocols for RV EF (CV = 7.62% (Septum), CV = 8.42% (Long Axis), CV = 9.54% (Left AV Junctions) and CV = 11.08% (AV Junctions) with Lin’s CCC varying from 0.4 (AV Junctions) to 0.69 (Septum) for inter-observer reproducibility). No differences in group average for clinical parameters was found for both LV and RV clinical measurements. However, patient-specific RV EF evaluation is dependent on the chosen protocol (CV = 9.95%, R2 = 0.52). Conclusion Based on the results of the study cine mode short

  16. Immobilization of flavan-3-ols onto sensor chips to study their interactions with proteins and pectins by SPR

    NASA Astrophysics Data System (ADS)

    Watrelot, Aude A.; Tran, Dong Tien; Buffeteau, Thierry; Deffieux, Denis; Le Bourvellec, Carine; Quideau, Stéphane; Renard, Catherine M. G. C.

    2016-05-01

    Interactions between plant polyphenols and biomacromolecules such as proteins and pectins have been studied by several methods in solution (e.g. isothermal titration calorimetry, dynamic light scattering, nuclear magnetic resonance and spectrophotometry). Herein, these interactions were investigated in real time by Surface Plasmon Resonance (SPR) analysis after immobilization of flavan-3-ols onto a sensor chip surface. (-)-epicatechin, (+)-catechin and flavan-3-ol oligomers with an average degree of polymerization of 2 and 8 were chemically modified using N-(2-(tritylthio)ethyl)propiolamide in order to introduce a spacer unit onto the catecholic B ring. Modified flavan-3-ols were then immobilized onto a carboxymethylated dextran surface (CM5). Immobilization was validated and further verified by evaluating flavan-3-ol interaction with bovine serum albumin (BSA), poly-L-proline or commercial pectins. BSA was found to have a stronger association with monomeric flavan-3-ols than oligomers. SPR analysis of selected flavan-3-ols immobilized onto CM5 sensor chips showed a stronger association for citrus pectins than apple pectins, regardless of flavan-3-ol degree of polymerization.

  17. The Development of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: A Case Study

    PubMed Central

    Boisseau, Christina L.; Farchione, Todd J.; Fairholme, Christopher P.; Ellard, Kristen K.; Barlow, David H.

    2013-01-01

    A detailed description of treatment utilizing the Unified Protocol (UP), a transdiagnostic emotion-focused cognitive-behavioral treatment, is presented using a clinical case example treated during the most current phase of an ongoing randomized controlled trial of the UP. The implementation of the UP in its current, modular version is illustrated. A working case conceptualization is presented from the perspective of the UP drawing from theory and research that underlies current transdiagnostic approaches to treatment and consistent with recent dimensional classification proposals (Brown & Barlow, in press). Treatment is illustrated module-by-module describing how the principles of the UP were applied in the presented case. PMID:23997572

  18. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    PubMed Central

    Batchelor, Frances A; Hill, Keith D; Mackintosh, Shylie F; Said, Catherine M; Whitehead, Craig H

    2009-01-01

    Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home) project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404). PMID:19335909

  19. The Combating Obesity in Māori and Pasifika Adolescent School-Children Study: COMPASS Methodology and Study Protocol

    PubMed Central

    Stoner, Lee; Shultz, Sarah P.; Lambrick, Danielle M.; Krebs, Jeremy; Weatherall, Mark; Palmer, Barry R.; Lane, Andrew M.; Kira, Geoff; Witter, Trevor; Williams, Michelle A.

    2013-01-01

    Background: Lifestyle modifications including, physical activity can reduce obesity-related morbidity and subsequent cardiovascular disease in youth. This study will investigate the efficacy of a culturally-sensitive, non-contact, boxing-orientated training program on obesity and related cardio-metabolic conditions in Māori and Pasifika adolescents. Details of the methodological aspects of recruitment, inclusion criteria, randomization, cultural sensitivity, intervention program, assessments, process evaluation, and statistical analyses are described. Methods: This study will be a community based, New Zealand, randomized control trial (RCT). Male and female obese (body mass index >95th percentile) Māori and Pasifika adolescents aged 14-16 years will be recruited and the sample size will be confirmed through a feasibility study. Combating Obesity in Māori and Pasifika Adolescent School-children Study (COMPASS) is a 6-month, theory-based program, conducted 3-times/week in a culturally appropriate setting. Each session includes 40 min boxing-orientated training and 30 min resistance training. Assessments will be made at baseline, 3-months, 6-months, 12-months, and 24-months. Main outcomes include abdominal obesity, endothelial function, and insulin resistance. Other outcomes include arterial stiffness, lipid profile, inflammatory biomarkers, well-being, and aerobic fitness. Control measures include physical activity, sleep behavior, and dietary intake. Results: As a protocol paper there are no specific results to present, our purpose is to share our RCT design with the scientific community. Conclusions: COMPASS will be used to provide direction for exercise prescription policy in at-risk Māori and Pasifika adolescents. PMID:23930168

  20. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    PubMed Central

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. Methods and Findings We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were “bothersome,” a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc

  1. The water maze paradigm in experimental studies of chronic cognitive disorders: Theory, protocols, analysis, and inference.

    PubMed

    Kapadia, Minesh; Xu, Josie; Sakic, Boris

    2016-09-01

    An instrumental step in assessing the validity of animal models of chronic cognitive disorders is to document disease-related deficits in learning/memory capacity. The water maze (WM) is a popular paradigm because of its low cost, relatively simple protocol and short procedure time. Despite being broadly accepted as a spatial learning task, inference of generalized, bona fide "cognitive" dysfunction can be challenging because task accomplishment is also reliant on non-cognitive processes. We review theoretical background, testing procedures, confounding factors, as well as approaches to data analysis and interpretation. We also describe an extended protocol that has proven useful in detecting early performance deficits in murine models of neuropsychiatric lupus and Alzheimer's disease. Lastly, we highlight the need for standardization of inferential criteria on "cognitive" dysfunction in experimental rodents and exclusion of preparations of a limited scientific merit. A deeper appreciation for the multifactorial nature of performance in WM may also help to reveal other deficits that herald the onset of neurodegenerative brain disorders. PMID:27229758

  2. A study of the effectiveness of particulate cleaning protocols on intentionally contaminated niobium surfaces

    SciTech Connect

    Reece, Charles E.; Ciancio, Elizabeth J.; Keyes, Katharine A.; Yang, Dian

    2009-11-01

    Particulate contamination on the surface of SRF cavities limits their performance via the enhanced generation of field-emitted electrons. Considerable efforts are expended to actively clean and avoid such contamination on niobium surfaces. The protocols in active use have been developed via feedback from cavity testing. This approach has the risk of over-conservatively ratcheting an ever increasing complexity of methods tied to particular circumstances. A complementary and perhaps helpful approach is to quantitatively assess the effectiveness of candidate methods at removing intentional representative particulate contamination. Toward this end, we developed a standardized contamination protocol using water suspensions of Nb{sub 2}O{sub 5} and SS 316 powders applied to BCP’d surfaces of standardized niobium samples yielding particle densities of order 200 particles/mm{sup 2}. From these starting conditions, controlled application of high pressure water rinse, ultrasonic cleaning, or CO{sub 2} snow jet cleaning was applied and the resulting surfaces examined via SEM/scanning EDS with particle recognition software. Results of initial parametric variations of each will be reported.

  3. The Effect of Different Cleaning Protocols on Post Space: A SEM Study

    PubMed Central

    Lo Giudice, Giuseppe; Lizio, Angelo; Giudice, Roberto Lo; Centofanti, Antonio; Rizzo, Giuseppina; Runci, Michele; Alibrandi, Angela

    2016-01-01

    Aim. Purpose of the present paper is to analyze the efficiency of different post-space irrigation protocols. Methods. 28 single rooted teeth were endodontically treated. After post-space preparation every sample was assigned to one of three experimental groups and to one control group. In each group different irrigation protocols were performed as follows: EDTA (Group A), 37% orthophosphoric acid (Group B), and EDTA + 37% orthophosphoric acid with ultrasounds activation (Group C). In the control group (Group D) the irrigate association was not activated by ultrasounds. Three zones (coronal, middle, and apical) of each sample were analyzed by using Scan Electron Microscopy (SEM) without any metallization procedures. The presence of smear layer on the canal surface was qualitatively evaluated by applying Serafino's score with values included between 0 and 2. Results. The results of the research showed how Group C recorded the better results (0.81 ± 0.72). Group A and Group B showed lower mean scores (1.06 ± 0.69 and 1.08 ± 0.77); Group D showed the lowest mean score of 1.30 ± 0.69. The SEM observation analysis demonstrated how the smear layer presence decreased in the crown-apical direction. Conclusions. The different post-space treatments statistically determine significant differences on the dentinal surfaces cleansing. The absence of ultrasonic activation lowers the cleansing efficacy of endocanalar irrigants, showing sensible differences among each post-space zone. PMID:27766106

  4. A Field-Based Cleaning Protocol for Sampling Devices Used in Life-Detection Studies

    NASA Astrophysics Data System (ADS)

    Eigenbrode, Jennifer; Benning, Liane G.; Maule, Jake; Wainwright, Norm; Steele, Andrew; Amundsen, Hans E. F.

    2009-06-01

    Analytical approaches to extant and extinct life detection involve molecular detection often at trace levels. Thus, removal of biological materials and other organic molecules from the surfaces of devices used for sampling is essential for ascertaining meaningful results. Organic decontamination to levels consistent with null values on life-detection instruments is particularly challenging at remote field locations where Mars analog field investigations are carried out. Here, we present a seven-step, multi-reagent decontamination method that can be applied to sampling devices while in the field. In situ lipopolysaccharide detection via low-level endotoxin assays and molecular detection via gas chromatography-mass spectrometry were used to test the effectiveness of the decontamination protocol for sampling of glacial ice with a coring device and for sampling of sediments with a rover scoop during deployment at Arctic Mars-analog sites in Svalbard, Norway. Our results indicate that the protocols and detection technique sufficiently remove and detect low levels of molecular constituents necessary for life-detection tests.

  5. Evaluation of metatranscriptomic protocols and application to the study of freshwater microbial communities.

    PubMed

    Tsementzi, Despina; Poretsky, Rachel; Rodriguez-R, Luis M; Luo, Chengwei; Konstantinidis, Konstantinos T

    2014-12-01

    Metatranscriptomics of environmental samples enables the identification of community activities without a priori knowledge of taxonomic or functional composition. However, several technical challenges associated with the RNA preparation protocols can affect the relative representation of transcripts and data interpretation. Here, seven replicate metatranscriptomes from planktonic freshwater samples (Lake Lanier, USA) were sequenced to evaluate technical and biological reproducibility of different RNA extraction protocols. Organic versus bead-beating extraction showed significant enrichment for low versus high G + C% mRNA populations respectively. The sequencing data were best modelled by a negative binomial distribution to account for the large technical and biological variation observed. Despite the variation, the transcriptional activities of populations that persisted in year-round metagenomes from the same site consistently showed distinct expression patterns, reflecting different ecologic strategies and allowing us to test prevailing models on the contribution of both rare biosphere and abundant members to community activity. For instance, abundant members of the Verrucomicrobia phylum systematically showed low transcriptional activity compared with other abundant taxa. Our results provide a practical guide to the analysis of metatranscriptomes and advance understanding of the activity and ecology of abundant and rare members of temperate freshwater microbial communities.

  6. Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children’s Study

    PubMed Central

    Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

    2014-01-01

    Introduction Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. Methods and analysis This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children’s Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. Ethics and dissemination The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. Trial Registration number UMIN000010826. PMID:24958210

  7. An Australian Aboriginal birth cohort: a unique resource for a life course study of an Indigenous population. A study protocol

    PubMed Central

    Sayers, Susan M; Mackerras, Dorothy; Singh, Gurmeet; Bucens, Ingrid; Flynn, Kathryn; Reid, Alison

    2003-01-01

    Background The global rise of Type 2 diabetes and its complications has drawn attention to the burden of non-communicable diseases on populations undergoing epidemiological transition. The life course approach of a birth cohort has the potential to increase our understanding of the development of these chronic diseases. In 1987 we sought to establish an Australian Indigenous birth cohort to be used as a resource for descriptive and analytical studies with particular attention on non-communicable diseases. The focus of this report is the methodology of recruiting and following-up an Aboriginal birth cohort of mobile subjects belonging to diverse cultural and language groups living in a large sparsely populated area in the Top End of the Northern Territory of Australia. Methods A prospective longitudinal study of Aboriginal singletons born at the Royal Darwin Hospital 1987–1990, with second wave cross-sectional follow-up examination of subjects 1998–2001 in over 70 different locations. A multiphase protocol was used to locate and collect data on 686 subjects with different approaches for urban and rural children. Manual chart audits, faxes to remote communities, death registries and a full time subject locator with past experience of Aboriginal communities were all used. Discussion The successful recruitment of 686 Indigenous subjects followed up 14 years later with vital status determined for 95% of subjects and examination of 86% shows an Indigenous birth cohort can be established in an environment with geographic, cultural and climatic challenges. The high rates of recruitment and follow up indicate there were effective strategies of follow-up in a supportive population. PMID:12659639

  8. Discrete component bonding and thick film materials study. [of capacitor chips bonded with solders and conductive epoxies

    NASA Technical Reports Server (NTRS)

    Kinser, D. L.

    1976-01-01

    The bonding reliability of discrete capacitor chips bonded with solders and conductive epoxies was examined along with the thick film resistor materials consisting of iron oxide phosphate and vanadium oxide phosphates. It was concluded from the bonding reliability studies that none of the wide range of types of solders examined is capable of resisting failure during thermal cycling while the conductive epoxy gives substantially lower failure rates. The thick film resistor studies proved the feasibility of iron oxide phosphate resistor systems although some environmental sensitivity problems remain. One of these resistor compositions has inadvertently proven to be a candidate for thermistor applications because of the excellent control achieved upon the temperature coefficient of resistance. One new and potentially damaging phenomenon observed was the degradation of thick film conductors during the course of thermal cycling.

  9. CHIP-BASED DIRECT GENOTYPING OF CODING VARIANTS IN GENOME WIDE ASSOCIATION STUDIES: UTILITY, ISSUES AND PROSPECTS

    PubMed Central

    Nievergelt, Caroline M.; Wineinger, Nathan E.; Libiger, Ondrej; Pham, Phillip; Zhang, Guangfa; Baker, Dewleen G.; Schork, Nicholas J.

    2014-01-01

    There is considerable debate about the most efficient way to interrogate rare coding variants in association studies. The options include direct genotyping of specific known coding variants in genes or, alternatively, sequencing across the entire exome to capture known as well as novel variants. Each strategy has advantages and disadvantages, but the availability of cost-efficient exome arrays has made the former appealing. Here we consider the utility of a direct genotyping chip, the Illumina HumanExome array (HE), by evaluating its content based on: 1. functionality; and 2. amenability to imputation. We explored these issues by genotyping a large, ethnically diverse cohort on the HumanOmniExpressExome array (HOEE) which combines the HE with content from the GWAS array (HOE). We find that the use of the HE is likely to be a cost-effective way of expanding GWAS, but does have some drawbacks that deserve consideration when planning studies. PMID:24521671

  10. Toward on-chip functional neuronal networks: computational study on the effect of synaptic connectivity on neural activity.

    PubMed

    Foroushani, Armin Najarpour; Ghafar-Zadeh, Ebrahim

    2014-01-01

    This paper presents a new unified computational-experimental approach to study the role of the synaptic activity on the activity of neurons in the small neuronal networks (NNs). In a neuronal tissue/organ, this question is investigated with higher complexities by recording action potentials from population of neurons in order to find the relationship between connectivity and the recorded activities. In this approach, we study the dynamics of very small cortical neuronal networks, which can be experimentally synthesized on chip with constrained connectivity. Multi-compartmental Hodgkin-Huxley model is used in NEURON software to reproduce cells by extracting the experimental data from the synthesized NNs. We thereafter demonstrate how the type of synaptic activity affects the network response to specific spike train using the simulation results.

  11. Study of individual erythrocyte deformability susceptibility to INFeD and ethanol using a microfluidic chip

    PubMed Central

    Liu, Lihong; Huang, Sha; Xu, Xiaoying; Han, Jongyoon

    2016-01-01

    Human red blood cells (RBCs) deformability in vitro was assessed during iron dextran (INFeD) loading and/or ethanol co-administration using microfluidic deformability screening. The results showed donor-specific variations in dose dependent deformability shift were revealed below 500 μg/mL iron dextran. Two out of nine blood samples exhibited significant cell stiffening at 500 μg/mL iron dextran loading concentration (p < 0.05, Tukey test). More interestingly, co-administration of moderate amount of ethanol was identified to have significant protective effects on RBC deformability. We also noted that ethanol can reverse the deformability of impaired RBCs. Meanwhile obvious donor dependent response to ethanol administration on RBC deformability was noted using our biomimetic microfluidic chip. PMID:26964754

  12. Thermomechanical Reliability Study of Benzocyclobutene Film in Wafer-Level Chip-Size Package

    NASA Astrophysics Data System (ADS)

    Lee, K.-O.

    2012-04-01

    A new wafer-level chip-scale package process for high-performance, low-cost packaging has been developed based on passivation with low dielectric constant. This process is simpler and shorter when using permanent photosensitive benzocyclobutene (BCB) compared with the conventional process. However, cracks nucleating on the BCB cause serious reliability problems. The major reasons for cracking of the BCB layer seem to be both thermal stress and a shortage of BCB cross-linking agent (cyclobutene). The stress was reduced by optimizing the thickness of the BCB layer and the underlying stress buffer layer. The BCB cracking resistance was improved by creating more cross-linking agent at the final curing process through modification of the photolithography processes.

  13. Design and measurement considerations for exercise protocols in human air-pollution inhalation studies

    SciTech Connect

    Horvath, S.M.

    1985-01-01

    The impact on pulmonary functions of exercising at different intensities during pollutant exposures was evaluated. It was apparent that there was considerable variation in exercise protocols. These variations occurred in the magnitude of the exercise load, the duration of the exercise period, and the timing of the exercise during exposure. It was also apparent that ventilation during rest and exercise was not always determined; in many instances ventilation was estimated based on other criteria, such as heart rate. The influence of ambient temperature conditions was frequently not considered. Determinations of pulmonary functions were also made at various time intervals following exercise or subsequent rest periods. All of these factors could result in some degree of misinterpretation of the consequences of pollutant exposure.

  14. HuMiChip: Development of a Functional Gene Array for the Study of Human Microbiomes

    SciTech Connect

    Tu, Q.; Deng, Ye; Lin, Lu; Hemme, Chris L.; He, Zhili; Zhou, Jizhong

    2010-05-17

    Microbiomes play very important roles in terms of nutrition, health and disease by interacting with their hosts. Based on sequence data currently available in public domains, we have developed a functional gene array to monitor both organismal and functional gene profiles of normal microbiota in human and mouse hosts, and such an array is called human and mouse microbiota array, HMM-Chip. First, seed sequences were identified from KEGG databases, and used to construct a seed database (seedDB) containing 136 gene families in 19 metabolic pathways closely related to human and mouse microbiomes. Second, a mother database (motherDB) was constructed with 81 genomes of bacterial strains with 54 from gut and 27 from oral environments, and 16 metagenomes, and used for selection of genes and probe design. Gene prediction was performed by Glimmer3 for bacterial genomes, and by the Metagene program for metagenomes. In total, 228,240 and 801,599 genes were identified for bacterial genomes and metagenomes, respectively. Then the motherDB was searched against the seedDB using the HMMer program, and gene sequences in the motherDB that were highly homologous with seed sequences in the seedDB were used for probe design by the CommOligo software. Different degrees of specific probes, including gene-specific, inclusive and exclusive group-specific probes were selected. All candidate probes were checked against the motherDB and NCBI databases for specificity. Finally, 7,763 probes covering 91.2percent (12,601 out of 13,814) HMMer confirmed sequences from 75 bacterial genomes and 16 metagenomes were selected. This developed HMM-Chip is able to detect the diversity and abundance of functional genes, the gene expression of microbial communities, and potentially, the interactions of microorganisms and their hosts.

  15. Validation study for using lab-on-chip technology for Coxiella burnetii multi-locus-VNTR-analysis (MLVA) typing: application for studying genotypic diversity of strains from domestic ruminants in France.

    PubMed

    Prigent, Myriam; Rousset, Elodie; Yang, Elise; Thiéry, Richard; Sidi-Boumedine, Karim

    2015-01-01

    Coxiella burnetii, the etiologic bacterium of Q fever zoonosis, is still difficult to control. Ruminants are often carriers and involved in human epidemics. MLVA is a promising genotyping method for molecular epidemiology. Different techniques are used to resolve the MLVA band profiles such as electrophoresis on agarose gels, capillary electrophoresis or using the microfluidic Lab-on-Chip system. In this study, system based on microfluidics electrophoresis with Lab-on-Chip technology was assessed and applied on DNA field samples to investigate the genotypic diversity of C. burnetii strains circulating in France. The Lab-on-Chip technology was first compared to agarose gel electrophoresis. Subsequently, the set-up Lab-on-Chip technology was applied on 97 samples collected from ruminants in France using the 17 markers previously described. A discordance rate of 27% was observed between Lab-on-Chip and agarose gel electrophoresis. These discrepancies were checked and resolved by sequencing. The cluster analysis revealed classification based on host species and/or geographic origin criteria. Moreover, the circulation of different genotypic strains within the same farm was also observed. In this study, MLVA with Lab-on-Chip technology was shown to be more accurate, reproducible, user friendly and safer than gel electrophoresis. It also provides an extended data set from French ruminant C. burnetii circulating strains useful for epidemiological investigations. Finally, it raises some questions regarding the standardization and harmonization of C. burnetii MLVA genotyping.

  16. Boron neutron capture therapy applied to advanced breast cancers: Engineering simulation and feasibility study of the radiation treatment protocol

    NASA Astrophysics Data System (ADS)

    Sztejnberg Goncalves-Carralves, Manuel Leonardo

    This dissertation describes a novel Boron Neutron Capture Therapy (BNCT) application for the treatment of human epidermal growth factor receptor type 2 positive (HER2+) breast cancers. The original contribution of the dissertation is the development of the engineering simulation and the feasibility study of the radiation treatment protocol for this novel combination of BNCT and HER2+ breast cancer treatment. This new concept of BNCT, representing a radiation binary targeted treatment, consists of the combination of two approaches never used in a synergism before. This combination may offer realistic hope for relapsed and/or metastasized breast cancers. This treatment assumes that the boronated anti-HER2 monoclonal antibodies (MABs) are administrated to the patient and accumulate preferentially in the tumor. Then the tumor is destroyed when is exposed to neutron irradiation. Since the use of anti-HER2 MABs yields good and promising results, the proposed concept is expected to amplify the known effect and be considered as a possible additional treatment approach to the most severe breast cancers for patients with metastasized cancer for which the current protocol is not successful and for patients refusing to have the standard treatment protocol. This dissertation makes an original contribution with an integral numerical approach and proves feasible the combination of the aforementioned therapy and disease. With these goals, the dissertation describes the theoretical analysis of the proposed concept providing an integral engineering simulation study of the treatment protocol. An extensive analysis of the potential limitations, capabilities and optimization factors are well studied using simplified models, models based on real CT patients' images, cellular models, and Monte Carlo (MCNP5/X) transport codes. One of the outcomes of the integral dosimetry assessment originally developed for the proposed treatment of advanced breast cancers is the implementation of BNCT

  17. Variable reproducibility in genome-scale public data: A case study using ENCODE ChIP sequencing resource

    PubMed Central

    Devailly, Guillaume; Mantsoki, Anna; Michoel, Tom; Joshi, Anagha

    2015-01-01

    Genome-wide data is accumulating in an unprecedented way in the public domain. Re-mining this data shows great potential to generate novel hypotheses. However this approach is dependent on the quality (technical and biological) of the underlying data. Here we performed a systematic analysis of chromatin immunoprecipitation (ChIP) sequencing data of transcription and epigenetic factors from the encyclopaedia of DNA elements (ENCODE) resource to demonstrate that about one third of conditions with replicates show low concordance between replicate peak lists. This serves as a case study to demonstrate a caveat concerning genome-wide analyses and highlights a need to validate the quality of each sample before performing further associative analyses. PMID:26619763

  18. Rational Protocols

    NASA Astrophysics Data System (ADS)

    Cachin, Christian

    Security research continues to provide a plethora of new protocols and mechanisms; these solutions patch either existing vulnerabilities found in practical systems or solve hypothetical security problems in the sense that the problem is often conceived at the same time when the first solution is proposed. Yet only a very small fraction of this research is relevant to ordinary users in the sense that they are willing to actually deploy the technology.

  19. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be

  20. Improving care for victims: a study protocol of the evaluation of a centre for sexual and family violence

    PubMed Central

    Zijlstra, E; LoFoWong, S; Hutschemaekers, G; Lagro-Janssen, A

    2016-01-01

    Introduction Worldwide, sexual and family violence are highly prevalent problems. Victims of sexual and family violence often do not seek formal help in the acute phase. When they do seek help, they encounter a system of scattered care. For this reason, a centre for sexual and family violence was launched in Nijmegen, the Netherlands. The centre provides multidisciplinary care for victims of acute sexual and/or family violence. With the study described in this study protocol, we want to evaluate the implementation process and the reach of the Center for Sexual and Family Violence Nijmegen (CSFVN). Methods and analysis We will conduct a mixed-methods study including quantitative and qualitative methods of data collection and analysis. Data about the implementation process will be obtained via semistructured interviews and focus group discussions. Content analysis will be done in software program Atlas.ti. Analysis of file data will be undertaken to assess the reach of the CSFVN (patient characteristics and characteristics of the care they received). The data will be analysed in SPSS. Ethics and dissemination The Medical Ethics Committee of the Radboud University Nijmegen Medical Center approved the study protocol under file number 2012–1218. Dissemination will be done by submitting scientific articles to academic peer-reviewed journals. We will present the results at relevant international, national and local conferences and meetings. We will send press releases to relevant media. We will share the results with the network of assault centres in the Netherlands. PMID:27619828

  1. Development of a Protocol for Epidemiologal Studies of Whole-Body Vibration and Musculoskeletal Disorders of the Lower Back

    NASA Astrophysics Data System (ADS)

    Magnusson, M. L.; Pope, M. H.; Hulshof, C. T. J.; Bovenzi, M.

    1998-08-01

    It seems evident from a large number of studies that there is a positive relationship between exposure to whole body vibration (WBV) and the occurrence of low back pain. There are existing standards for evaluating the human exposure to WBV, which are based on other factors than the effect of musculoskeletal disorders. Several national and international standards also exist for evaluating human exposure to WBV. The exposure limit values or health guidance caution zones included in some of these standards are not or only to a limited extent based on systematic epidemiological investigations. It has not yet been possible to establish a clear exposure-response relationship. There are many confounding or contributing factors which influence the hazards to workers caused by exposure to WBV. Reliable methods for the detection and prevention of injury due to vibration exposure at work, alone or in combination with other risk factors, need to be implemented. The aim of this paper was to design a protocol and a questionnaire for conducting collaborative studies of WBV and musculoskeletal back disorders. The protocol will be tested in a pilot study before it will be used in multi-center studies.

  2. A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol

    PubMed Central

    2013-01-01

    Background Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care. Methods Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions. Discussion As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have

  3. Design and experiment of silicon PCR chips

    NASA Astrophysics Data System (ADS)

    Cui, Zheng; Zhao, Zhan; Xia, Shanhong

    2002-04-01

    There are considerable interests in integrating Polymerase chain reaction (PCR) on a microchip can have much fast heating and cooling rate, the delicacy in its structure makes the PCR experiment difficult and cracks often occur particularly for the thin membrane type of PCR chips. Design study and experiment of silicon PCR chips are presented with the aim of identifying the problems encountered in experiment and finding an optimum chip structure. Heating characteristics of four different heater designs have been compared, so have the PCR chambers with fixed frame and with suspended frame. The thermal stress analysis has shown that the structure and heater design can make a significant difference in heating characteristics and in reducing the failure of PCR chips. Different solutions to reduce PCR chip failure have been proposed. One of the solutions was implemented in the experiment, confirming the design study results. Silicon PCR chips have been fabricated. Thermal cycling and initial DNA amplification results are presented.

  4. Using the intervention mapping protocol to reduce European preschoolers’ sedentary behavior, an application to the ToyBox-Study

    PubMed Central

    2014-01-01

    Background High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers’ sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Methods Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. Results The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers’ sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. Conclusions A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with

  5. A next-generation tissue microarray (ngTMA) protocol for biomarker studies.

    PubMed

    Zlobec, Inti; Suter, Guido; Perren, Aurel; Lugli, Alessandro

    2014-01-01

    Biomarker research relies on tissue microarrays (TMA). TMAs are produced by repeated transfer of small tissue cores from a 'donor' block into a 'recipient' block and then used for a variety of biomarker applications. The construction of conventional TMAs is labor intensive, imprecise, and time-consuming. Here, a protocol using next-generation Tissue Microarrays (ngTMA) is outlined. ngTMA is based on TMA planning and design, digital pathology, and automated tissue microarraying. The protocol is illustrated using an example of 134 metastatic colorectal cancer patients. Histological, statistical and logistical aspects are considered, such as the tissue type, specific histological regions, and cell types for inclusion in the TMA, the number of tissue spots, sample size, statistical analysis, and number of TMA copies. Histological slides for each patient are scanned and uploaded onto a web-based digital platform. There, they are viewed and annotated (marked) using a 0.6-2.0 mm diameter tool, multiple times using various colors to distinguish tissue areas. Donor blocks and 12 'recipient' blocks are loaded into the instrument. Digital slides are retrieved and matched to donor block images. Repeated arraying of annotated regions is automatically performed resulting in an ngTMA. In this example, six ngTMAs are planned containing six different tissue types/histological zones. Two copies of the ngTMAs are desired. Three to four slides for each patient are scanned; 3 scan runs are necessary and performed overnight. All slides are annotated; different colors are used to represent the different tissues/zones, namely tumor center, invasion front, tumor/stroma, lymph node metastases, liver metastases, and normal tissue. 17 annotations/case are made; time for annotation is 2-3 min/case. 12 ngTMAs are produced containing 4,556 spots. Arraying time is 15-20 hr. Due to its precision, flexibility and speed, ngTMA is a powerful tool to further improve the quality of TMAs used in

  6. A novel protocol to accelerate dynamic combinatorial chemistry via isolation of ligand-target adducts from dynamic combinatorial libraries: a case study identifying competitive inhibitors of lysozyme.

    PubMed

    Fang, Zheng; He, Wei; Li, Xin; Li, Zhengjiang; Chen, Beining; Ouyang, Pingkai; Guo, Kai

    2013-09-15

    A novel protocol based on size-exclusion chromatography (SEC) and MS was established to accelerate dynamic combinatorial chemistry (DCC) in this study. By isolating ligand-target adducts from the dynamic combinatorial library (DCL), ligands could be identified directly by MS after denaturation. Three new inhibitors for lysozyme were discovered by this SEC-MS protocol in a case study. Km Data for these new inhibitors was also determined.

  7. Health hazards caused by fungi in stored wood chips

    SciTech Connect

    Thoernquist, T.; Lundstroem, H.

    1982-11-01

    In connection with using wood chips for fuel in heating buildings, a number of people in Sweden were taken ill with a respiratory allergy similar to wood trimmer's disease and farmer's lung. The disease is presumably caused by airborne fungal particles (spores and hyphae) which are inhaled when working with infected wood chips. The occurrence of fungal particles in the air in wood chip storage rooms, halls, and kitchens was studied in 64 buildings heated by chips. Sampling was carried out by exposing 9-cm petri dishes containing malt agar. In the chip storage rooms of 10 of the 64 buildings examined, more than 500 fungal colonies were recorded before disturbing the chips. After disturbance the number of buildings with more than 500 colonies increased to 28. In the halls in three of the buildings and in the kitchens of two, more than 500 fungal colonies were recorded. The number of fungal particles in wood chip storage is mainly dependent on the condition of the raw material before chipping, tree species, and the final storage period. To reduce the risk of large numbers of fungal particles in stored chips, the trees should be limbed before chipping and the stems preferably dried. Hardwood chips are more easily infected by fungi than chips of coniferous wood. The storage of wood chips for periods longer than 3 months should be avoided and a Class 2B protective mask should always be worn when handling chips feared to be infected by fungi. (Refs. 5).

  8. A protocol for the development of Mediterranean climate services based on the experiences of the CLIM-RUN case studies

    NASA Astrophysics Data System (ADS)

    Goodess, Clare; Ruti, Paolo; Rousset, Nathalie

    2014-05-01

    During the closing stages of the CLIM-RUN EU FP7 project on Climate Local Information in the Mediterranean region Responding to User Needs, the real-world experiences encountered by the case-study teams are being assessed and synthesised to identify examples of good practice and, in particular, to produce the CLIM-RUN protocol for the development of Mediterranean climate services. The specific case studies have focused on renewable energy (Morocco, Spain, Croatia, Cyprus), tourism (Savoie, Tunisia, Croatia, Cyprus) and wild fires (Greece) as well as one cross-cutting case study (Veneto region). They have been implemented following a common programme of local workshops, questionnaires and interviews, with Climate Expert Team and Stakeholder Expert Team members collaborating to identify and translate user needs and subsequently develop climate products and information. Feedback from stakeholders has been essential in assessing and refining these products. The protocol covers the following issues: the overall process and methodological key stages; identification and selection of stakeholders; communication with stakeholders; identification of user needs; translation of needs; producing products; assessing and refining products; methodologies for evaluating the economic value of climate services; and beyond CLIM-RUN - the lessons learnt. Particular emphasis is given to stakeholder analysis in the context of the participatory, bottom-up approach promoted by CLIM-RUN and to the iterative approach taken in the development of climate products. Recommendations are also made for an envisioned three-tier business model for the development of climate services involving climate, intermediary and stakeholder tiers.

  9. Quantifying Habitual Levels of Physical Activity According to Impact in Older People: Accelerometry Protocol for the VIBE Study.

    PubMed

    Deere, Kevin C; Hannam, Kimberly; Coulson, Jessica; Ireland, Alex; McPhee, Jamie S; Moss, Charlotte; Edwards, Mark H; Dennison, Elaine; Cooper, Cyrus; Sayers, Adrian; Lipperts, Matthijs; Grimm, Bernd; Tobias, Jon H

    2016-04-01

    Physical activity (PA) may need to produce high impacts to be osteogenic. The aim of this study was to identify threshold(s) for defining high impact PA for future analyses in the VIBE (Vertical Impact and Bone in the Elderly) study, based on home recordings with triaxial accelerometers. Recordings were obtained from 19 Master Athlete Cohort (MAC; mean 67.6 years) and 15 Hertfordshire Cohort Study (HCS; mean 77.7 years) participants. Data cleaning protocols were developed to exclude artifacts. Accelerations expressed in g units were categorized into three bands selected from the distribution of positive Y-axis peak accelerations. Data were available for 6.6 and 4.4 days from MAC and HCS participants respectively, with approximately 14 hr recording daily. Three-fold more 0.5-1.0g impacts were observed in MAC versus HCS, 20-fold more 1.0-1.5g impacts, and 140-fold more impacts ≥ 1.5g. Our analysis protocol successfully distinguishes PA levels in active and sedentary older individuals. PMID:26372670

  10. Quantifying Habitual Levels of Physical Activity According to Impact in Older People: Accelerometry Protocol for the VIBE Study

    PubMed Central

    Deere, Kevin C.; Hannam, Kimberly; Coulson, Jessica; Ireland, Alex; McPhee, Jamie S.; Moss, Charlotte; Edwards, Mark H.; Dennison, Elaine; Cooper, Cyrus; Sayers, Adrian; Lipperts, Matthijs; Grimm, Bernd; Tobias, Jon H.

    2016-01-01

    Physical activity (PA) may need to produce high impacts to be osteogenic. The aim of this study was to identify threshold(s) for defining high impact PA for future analyses in the VIBE (Vertical Impact and Bone in the Elderly) study, based on home recordings with triaxial accelerometers. Recordings were obtained from 19 Master Athlete Cohort (MAC; mean 67.6 years) and 15 Hertfordshire Cohort Study (HCS; mean 77.7 years) participants. Data cleaning protocols were developed to exclude artifacts. Accelerations expressed in g units were categorized into three bands selected from the distribution of positive Y-axis peak accelerations. Data were available for 6.6 and 4.4 days from MAC and HCS participants respectively, with approximately 14 hr recording daily. Three-fold more 0.5–1.0g impacts were observed in MAC versus HCS, 20-fold more 1.0–1.5g impacts, and 140-fold more impacts ≥ 1.5g. Our analysis protocol successfully distinguishes PA levels in active and sedentary older individuals. PMID:26372670

  11. V-cryo-plate procedure as an effective protocol for cryobanks: case study of mint cryopreservation.

    PubMed

    Yamamoto, S; Rafique, T; Fukui, K; Sekizawa, K; Niino, T

    2012-01-01

    A vitrification procedure using aluminium cryo-plates (V-Cryo-plate procedure) was successfully developed and adjusted for in vitro-grown mint (Mentha spp.) shoot tips. Shoots were cultured at 25°C on MS medium containing 0.088 M sucrose for 7 to 14 days after the last subculture. Shoot tips with a basal part (1-1.5 mm × 1 mm) were dissected from the shoots and precultured at 25°C for 1 day on the same medium. Precultured shoot tips were placed on aluminium cryo-plates with 10 wells and embedded in alginate gel. Osmoprotection was performed by immersing the cryo-plates for 30 min at 25 degree C in 25 ml pipetting reservoirs filled with loading solution (2 M glycerol + 0.8 M sucrose). For dehydration, the cryo-plates were transferred and immersed in 25 ml pipetting reservoirs filled with PVS2 for 20 min at 25 degree C. Then the cryo-plates were transferred in uncapped 2 ml cryotubes and directly plunged into liquid nitrogen. For rewarming, shoot tips attached to the cryo-plates were immersed in cryotubes containing 2 ml 1 M sucrose solution at room temperature. Using this procedure, regrowth of cryopreserved shoot tips of line 'Fukuyamajisei' reached over 90 percent. This protocol was successfully applied to 16 additional Mentha lines, with regrowth ranging from 73 percent to 100 percent. This V-Cryo-plate method will facilitate the cryostorage of mint germplasm in our genebank.

  12. Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

    PubMed

    Ito, Masaya; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Fujisato, Hiroko; Nakajima, Shun; Kanie, Ayako; Miyamae, Mitsuhiro; Takebayashi, Yoshitake; Horita, Ryo; Usuki, Masato; Nakagawa, Atsuo; Ono, Yutaka

    2016-05-01

    Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial. PMID:27157034

  13. A study of topologies and protocols for fiber optic local area network

    NASA Technical Reports Server (NTRS)

    Yeh, C.; Gerla, M.; Rodrigues, P.

    1985-01-01

    The emergence of new applications requiring high data traffic necessitates the development of high speed local area networks. Optical fiber is selected as the transmission medium due to its inherent advantages over other possible media and the dual optical bus architecture is shown to be the most suitable topology. Asynchronous access protocols, including token, random, hybrid random/token, and virtual token schemes, are developed and analyzed. Exact expressions for insertion delay and utilization at light and heavy load are derived, and intermediate load behavior is investigated by simulation. A new tokenless adaptive scheme whose control depends only on the detection of activity on the channel is shown to outperform round-robin schemes under uneven loads and multipacket traffic and to perform optimally at light load. An approximate solution to the queueing delay for an oscillating polling scheme under chaining is obtained and results are compared with simulation. Solutions to the problem of building systems with a large number of stations are presented, including maximization of the number of optical couplers, and the use of passive star/bus topologies, bridges and gateways.

  14. COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis

    PubMed Central

    Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

    2015-01-01

    Introduction The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. Methods and analysis A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. Ethics and dissemination This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61–62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants

  15. Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies

    PubMed Central

    Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

    2014-01-01

    Introduction A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). Methods and analysis We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. Protocol registration in PROSPERO The protocol is registered with PROSPERO, registration number CRD42013006518. PMID:24833685

  16. From an MMIC chip to a working cryogenic low-noise amplifier: a detailed study on packaging

    NASA Astrophysics Data System (ADS)

    Valenziano, L.; Mariotti, S.; Armogida, A.; Baz, A.; Biggi, M.; Carbonaro, L.; Cremonini, A.; De Rosa, A.; Gervasi, M.; Passerini, A.; Schiavone, F.; Zannoni, M.; Zuccarelli, J.

    2012-09-01

    Cryogenic Low Noise Amplifiers, based on MMIC HEMT technology, require a careful packaging to reach optimal performance. Differences between modeled and measured performance can often be related to chip mounting details. In the framework of the development of new cryogenic LNAs, described in a companion paper, we have developed a specific packaging to host W-band cryogenic MMIC LNAs. We present here some of the main factors analyzed in the design and chip integration activities. In particular, mechanical and thermal modeling, LNA chip gluing and adhesive properties, sensitivity to components integration accuracy (i.e. deviation from the ideal orientation). Preliminary test results are also reported.

  17. Tetrameric assembly of CHIP28 water channels in liposomes and cell membranes: a freeze-fracture study.

    PubMed

    Verbavatz, J M; Brown, D; Sabolić, I; Valenti, G; Ausiello, D A; Van Hoek, A N; Ma, T; Verkman, A S

    1993-11-01

    Channel forming integral protein of 28 kD (CHIP28) functions as a water channel in erythrocytes, kidney proximal tubule and thin descending limb of Henle. CHIP28 morphology was examined by freeze-fracture EM in proteoliposomes reconstituted with purified CHIP28, CHO cells stably transfected with CHIP28k cDNA, and rat kidney tubules. Liposomes reconstituted with HPLC-purified CHIP28 from human erythrocytes had a high osmotic water permeability (Pf0.04 cm/s) that was inhibited by HgCl2. Freeze-fracture replicas showed a fairly uniform set of intramembrane particles (IMPs); no IMPs were observed in liposomes without incorporated protein. By rotary shadowing, the IMPs had a diameter of 8.5 +/- 1.3 nm (mean +/- SD); many IMPs consisted of a distinct arrangement of four smaller subunits surrounding a central depression. IMPs of similar size and appearance were seen on the P-face of plasma membranes from CHIP28k-transfected (but not mock-transfected) CHO cells, rat thin descending limb (TDL) of Henle, and S3 segment of proximal straight tubules. A distinctive network of complementary IMP imprints was observed on the E-face of CHIP28-containing plasma membranes. The densities of IMPs in the size range of CHIP28 IMPs, determined by non-linear regression, were (in IMPs/microns 2): 2,494 in CHO cells, 5,785 in TDL, and 1,928 in proximal straight tubules; predicted Pf, based on the CHIP28 single channel water permeability of 3.6 x 10(-14) cm3/S (10 degrees C), was in good agreement with measured Pf of 0.027 cm/S, 0.075 cm/S, and 0.031 cm/S, respectively, in these cell types. Assuming that each CHIP28 monomer is a right cylindrical pore of length 5 nm and density 1.3 g/cm3, the monomer diameter would be 3.2 nm; a symmetrical arrangement of four cylinders would have a greatest diameter of 7.2 nm, which after correction for the thickness of platinum deposit, is similar to the measured IMP diameter of approximately 8.5 nm. These results provide a morphological signature for CHIP28

  18. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol

    PubMed Central

    2014-01-01

    Background Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms. Methods/Design This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses. Discussion This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in

  19. Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390). PMID:22103965

  20. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

    PubMed Central

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-01-01

    dissemination The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137). Trial registration number ISRCTN31219579. PMID:25361841

  1. Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers (MeDS): Prospective Cohort Study Protocol

    PubMed Central

    2011-01-01

    Background Stroke is a major cause of death and leading cause of disability in the United States. To maximize a stroke patient's chances of receiving thrombolytic treatment for acute ischemic stroke, it is important to improve prehospital recognition of stroke. However, it is known from published reports that emergency medical dispatchers (EMDs) using Card 28 of the Medical Priority Dispatch System protocols recognize stroke poorly. Therefore, to improve EMD's recognition of stroke, the National Association of Emergency Medical Dispatchers recently designed a new diagnostic stroke tool (Cincinnati Stroke Scale -CSS) to be used with Card 28. The objective of this study is to determine whether the addition of CSS improves diagnostic accuracy of stroke triage. Methods/Design This prospective experimental study will be conducted during a one-year period in the 911 call center of Santa Clara County, CA. We will include callers aged ≥ 18 years with a chief complaint suggestive of stroke and second party callers (by-stander or family who are in close proximity to the patient and can administer the tool) ≥ 18 years of age. Life threatening calls will be excluded from the study. Card 28 questions will be administered to subjects who meet study criteria. After completion of Card 28, CSS tool will be administered to all calls. EMDs will record their initial assessment of a cerebro-vascular accident (stroke) after completion of Card 28 and their final assessment after completion of CSS. These assessments will be compared with the hospital discharge diagnosis (ICD-9 codes) recorded in the Office of Statewide Health Planning and Development (OSHPD) database after linking the EMD database and OSHPD database using probabilistic linkage. The primary analysis will compare the sensitivity of the two stroke protocols using logistic regression and generalizing estimating equations to account for clustering by EMDs. To detect a 15% difference in sensitivity between the two groups

  2. Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old. Methods/design SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine. Setting: Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear. Participants: Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings. Intervention: Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L). Randomization: Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit. Outcomes: Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors. SORTED B: Qualitative study using in-depth interviews to understand patients’ willingness to take part in a randomized controlled trial and participants’ experience of the intervention. SORTED C: Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over

  3. Development of an Optimized Protocol for NMR Metabolomics Studies of Human Colon Cancer Cell Lines and First Insight from Testing of the Protocol Using DNA G-Quadruplex Ligands as Novel Anti-Cancer Drugs

    PubMed Central

    Lauri, Ilaria; Savorani, Francesco; Iaccarino, Nunzia; Zizza, Pasquale; Pavone, Luigi Michele; Novellino, Ettore; Engelsen, Søren Balling; Randazzo, Antonio

    2016-01-01

    The study of cell lines by nuclear magnetic resonance (NMR) spectroscopy metabolomics represents a powerful tool to understand how the local metabolism and biochemical pathways are influenced by external or internal stimuli. In particular, the use of adherent mammalian cells is emerging in the metabolomics field in order to understand the molecular mechanism of disease progression or, for example, the cellular response to drug treatments. Hereto metabolomics investigations for this kind of cells have generally been limited to mass spectrometry studies. This study proposes an optimized protocol for the analysis of the endo-metabolome of human colon cancer cells (HCT116) by NMR. The protocol includes experimental conditions such as washing, quenching and extraction. In order to test the proposed protocol, it was applied to an exploratory study of cancer cells with and without treatment by anti-cancer drugs, such as DNA G-quadruplex binders and Adriamycin (a traditional anti-cancer drug). The exploratory NMR metabolomics analysis resulted in NMR assignment of all endo-metabolites that could be detected and provided preliminary insights about the biological behavior of the drugs tested. PMID:26784246

  4. IVF/ICSI outcomes between cycles with luteal estradiol (E2) pre-treatment before GnRH antagonist protocol and standard long GnRH agonist protocol: a prospective and randomized study

    PubMed Central

    Huang, Guo-ning; Zeng, Ping-hong; Pei, Li

    2009-01-01

    Objective To study if luteal E2 pre-treatment before GnRH antagonist protocol improves IVF/ICSI outcomes compared with standard long GnRH agonist protocol. Design A prospective, randomized and controlled study. Setting ART center of a state public hospital Patient(s) Two hundred twenty infertile women underwent IVF/ICSI treatments. Intervention(s) Participants received oral Estradiol Valerate 4 mg/day preceding the IVF cycle from day 21 until day 2 of next cycle before GnRH antagonist protocol (E2 pre-treatment group n = 109) or received standard long GnRH agonist protocol as control group (n = 111). Main outcome measure(s) Number of oocytes collected, MII oocytes, fertilization, implantation, live birth and early pregnancy rate, and hormone profiles. Result(s) E2 pre-treatment exerted a significant suppressive effect on FSH but not LH secretion compared with basal FSH and LH levels. In E2 pre-treatment group serum LH level was significantly higher during COH and serum P was also significantly higher on the day of HCG injection compared with control group. Five patients from E2 pre-treatment group had elevated LH at all time (≥10 IU/L) and also a concomitantly high P (>1 ng/mL). Two of the five women achieved pregnancy but had early pregnancy loss. Overall, IVF/ICSI outcomes such as implantation, clinical pregnancy and live birth rates were similar between E2 pre-treatment and control groups. Conclusion(s) Luteal E2 pre-treatment before GnRH antagonist protocol significantly increases serum LH level and incidence rate of premature LH but no significant effect is observed on implantation, clinical pregnancy, live birth and early pregnancy loss rates compared with long GnRH agonist protocol. However, more studies in large numbers of cycles are needed to confirm that increased serum LH level by E2 pre-treatment during COH has no negative effect on the IVF/ICSI outcomes. PMID:19225876

  5. Detection of Outliers Due to Participants’ Non-Adherence to Protocol in a Longitudinal Study of Cognitive Decline

    PubMed Central

    Shipley, Martin J.; Welch, Catherine; Kivimaki, Mika; Singh-Manoux, Archana

    2015-01-01

    Background Participants’ non adherence to protocol affects data quality. In longitudinal studies, this leads to outliers that can be present at the level of the population or the individual. The purpose of the present study is to elaborate a method for detection of outliers in a study of cognitive ageing. Methods In the Whitehall II study, data on a cognitive test battery have been collected in 1997-99, 2002-04, 2007-09 and 2012-13. Outliers at the 2012-13 wave were identified using a 4-step procedure: (1) identify cognitive tests with potential non-adherence to protocol, (2) choose a prediction model between a simple model with socio-demographic covariates and one that also includes health behaviours and health measures, (3) define an outlier using a studentized residual, and (4) study the impact of exclusion of outliers by estimating the effect of age and diabetes on cognitive decline. Results 5516 participants provided cognitive data in 2012-13. Comparisons of rates of annual decline over the first three and all four waves of data suggested outliers in three of the 5 tests. Mean residuals for the 2012-13 wave were larger for the basic compared to the more complex prediction model (all p<0.001), leading us to use the latter for the identification of outliers. Residuals greater than two standard deviation of residuals identified approximately 7% of observations as being outliers. Removal of these observations from the analyses showed that both age and diabetes had associations with cognitive decline similar to that observed with the first three waves of data; these associations were weaker or absent in non-cleaned data. Conclusions Identification of outliers is important as they obscure the effects of known risk factor and introduce bias in the estimates of cognitive decline. We showed that an informed approach, using the range of data collected in a longitudinal study, may be able to identify outliers. PMID:26161552

  6. Microbiological evaluation of different irrigation protocols on root canal disinfection in teeth with apical periodontitis: an in vivo study.

    PubMed

    Cohenca, Nestor; Silva, Lea Assed Bezerra; Silva, Raquel Assed Bezerra; Nelson-Filho, Paulo; Heilborn, Carlos; Watanabe, Evandro; Saraiva, Maria Conceição Pereira

    2013-01-01

    The present in vivo study was designed to evaluate the efficacy of apical negative pressure irrigation (ANP), passive ultrasonic irrigation (PUI) and positive pressure irrigation (PP) in the reduction of intracanal bacteria of dogs' teeth with pulp necrosis and apical periodontitis. Eighty root canals were randomly distributed into 3 experimental and 2 control groups according to the irrigation delivery system: group ANP (n=20), group PUI (n=20), group PP (n=20), group PC (positive control - sterile saline irrigation; n=10) and group NC (negative control - vital pulps not subjected to bacterial inoculation; n=10). The first sample (S1) was collected at baseline, and the second sample (S2) was collected after the disinfection protocols. All samples were seeded in culture media for anaerobic bacteria. CFU counts were analyzed statistically by the Kruskal-Wallis, Dwass-Steel-Critchlow-Fligner post-hoc and Chi-square followed by Tukey like multiple comparisons for proportions (α=0.05). All experimental groups were effective in reducing Gram-positive bacteria compared with PC (p<0.05). Regarding the reduction of Gram-negative bacteria, group ANP was significantly better than PP (p<0.05). No statistically significant difference could be found between PP and PUI (p>0.05). In dog's teeth with apical periodontitis, the use of ANP and PUI can be considered promising disinfection protocols as both delivery systems promoted a significant bacterial reduction.

  7. Optimization of the imaging quality of 64-slice CT acquisition protocol using Taguchi analysis: A phantom study.

    PubMed

    Pan, Lung Fa; Erdene, Erdenetsetseg; Chen, Chun Chi; Pan, Lung Kwang

    2015-01-01

    In this study, the phantom imaging quality of 64-slice CT acquisition protocol was quantitatively evaluated using Taguchi. The phantom acrylic line group was designed and assembled with multiple layers of solid water plate in order to imitate the adult abdomen, and scanned with Philips brilliance CT in order to simulate a clinical examination. According to the Taguchi L8(2(7)) orthogonal array, four major factors of the acquisition protocol were optimized, including (A) CT slice thickness, (B) the image reconstruction filter type, (C) the spiral CT pitch, and (D) the matrix size. The reconstructed line group phantom image was counted by four radiologists for three discrete rounds in order to obtain the averages and standard deviations of the line counts and the corresponding signal to noise ratios (S/N). The quantified S/N values were analyzed and the optimal combination of the four factor settings was determined to be comprised of (A) a 1-mm thickness, (B) a sharp filter type, (C) a 1.172 spiral CT pitch, and (D) a 1024×1024 matrix size. The dominant factors included the (A) filter type and the cross interaction between the filter type and CT slice thickness (A×B). The minor factors were determined to be (C) the spiral CT pitch and (D) the matrix size since neither was capable of yielding a 95% confidence level in the ANOVA test. PMID:26405931

  8. A protocol for the cryoconservation of breeds by low-cost emergency cell banks - a pilot study.

    PubMed

    Groeneveld, E; Tinh, Nguyen Huu; Kues, W; Vien, Nguyen Thi

    2008-01-01

    A protocol was developed for collection and storage of somatic cell samples under adverse conditions with little infrastructure, for somatic-cell banks as a backup for endangered livestock breeds. The procedure, which is uniform across species, includes sample collection with ear taggers with an integrated tag/vial system, and recording of global positioning system (GPS) coordinates, digital images and breed information. In a pilot study, the procedures were tested on six local Vietnamese populations of pigs, sheep and goats. Initial investment was around €3000, while the total variable cost for sampling one breed with 25 females and 25 males was less than €1000. With support from local organisations, the sampling of six breeds with 300 animals was carried out in 2 months. The protocol and the complete workflow for setting up a somatic-cell bank, together with data collection, are described. The procedure has proved practicable and exceedingly cheap relative to the cryopreservation of semen or embryos. PMID:22444957

  9. Wax-bonding 3D microfluidic chips.

    PubMed

    Gong, Xiuqing; Yi, Xin; Xiao, Kang; Li, Shunbo; Kodzius, Rimantas; Qin, Jianhua; Wen, Weijia

    2010-10-01

    We report a simple, low-cost and detachable microfluidic chip incorporating easily accessible paper, glass slides or other polymer films as the chip materials along with adhesive wax as the recycling bonding material. We use a laser to cut through the paper or film to form patterns and then sandwich the paper and film between glass sheets or polymer membranes. The hot-melt adhesive wax can realize bridge bonding between various materials, for example, paper, polymethylmethacrylate (PMMA) film, glass sheets, or metal plate. The bonding process is reversible and the wax is reusable through a melting and cooling process. With this process, a three-dimensional (3D) microfluidic chip is achievable by vacuating and venting the chip in a hot-water bath. To study the biocompatibility and applicability of the wax-based microfluidic chip, we tested the PCR compatibility with the chip materials first. Then we applied the wax-paper based microfluidic chip to HeLa cell electroporation (EP). Subsequently, a prototype of a 5-layer 3D chip was fabricated by multilayer wax bonding. To check the sealing ability and the durability of the chip, green fluorescence protein (GFP) recombinant Escherichia coli (E. coli) bacteria were cultured, with which the chemotaxis of E. coli was studied in order to determine the influence of antibiotic ciprofloxacin concentration on the E. coli migration.

  10. Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis. Methods The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument’s items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials. Discussion For clinicians, the CECOIA trial results may help with evidence-based recommendations

  11. The Agricultural Model Intercomparison and Improvement Project (AgMIP): Protocols and Pilot Studies

    NASA Technical Reports Server (NTRS)

    Rosenzweig, C.; Jones, J. W.; Hatfield, J. L.; Ruane, A. C.; Boote, K. J.; Thorburn, P.; Antle, J. M.; Nelson, G. C.; Porter, C.; Janssen, S.; Asseng, S.; Basso, B.; Ewert, F.; Wallach, D.; Baigorria, G.; Winter, J. M.

    2012-01-01

    The Agricultural Model Intercomparison and Improvement Project (AgMIP) is a major international effort linking the climate, crop, and economic modeling communities with cutting-edge information technology to produce improved crop and economic models and the next generation of climate impact projections for the agricultural sector. The goals of AgMIP are to improve substantially the characterization of world food security due to climate change and to enhance adaptation capacity in both developing and developed countries. Analyses of the agricultural impacts of climate variability and change require a transdisciplinary effort to consistently link state-of-the-art climate scenarios to crop and economic models. Crop model outputs are aggregated as inputs to regional and global economic models to determine regional vulnerabilities, changes in comparative advantage, price effects, and potential adaptation strategies in the agricultural sector. Climate, Crop Modeling, Economics, and Information Technology Team Protocols are presented to guide coordinated climate, crop modeling, economics, and information technology research activities around the world, along with AgMIP Cross-Cutting Themes that address uncertainty, aggregation and scaling, and the development of Representative Agricultural Pathways (RAPs) to enable testing of climate change adaptations in the context of other regional and global trends. The organization of research activities by geographic region and specific crops is described, along with project milestones. Pilot results demonstrate AgMIP's role in assessing climate impacts with explicit representation of uncertainties in climate scenarios and simulations using crop and economic models. An intercomparison of wheat model simulations near Obregón, Mexico reveals inter-model differences in yield sensitivity to [CO2] with model uncertainty holding approximately steady as concentrations rise, while uncertainty related to choice of crop model increases with

  12. The Acute Asthma Severity Assessment Protocol (AASAP) study: objectives and methods of a study to develop an acute asthma clinical prediction rule.

    PubMed

    Arnold, Donald H; Gebretsadik, Tebeb; Abramo, Thomas J; Sheller, James R; Resha, Donald J; Hartert, Tina V

    2012-06-01

    Acute asthma exacerbations are one of the most common reasons for paediatric emergency department visits and hospitalisations, and a relapse frequently necessitates repeat urgent care. While care plans exist, there are no acute asthma prediction rules (APRs) to assess severity and predict outcome. The primary objective of the Acute Asthma Severity Assessment Protocol study is to develop a multivariable APR for acute asthma exacerbations in paediatric patients. A prospective, convenience sample of paediatric patients aged 5-17 years with acute asthma exacerbations who present to an urban, academic, tertiary paediatric emergency department was enrolled. The study protocol and data analysis plan conform to accepted biostatistical and clinical standards for clinical prediction rule development. Modelling of the APR will be performed once the entire sample size of 1500 has accrued. It is anticipated that the APR will improve resource utilisation in the emergency department, aid in standardisation of disease assessment and allow physician and non-physician providers to participate in earlier objective decision making. The objective of this report is to describe the study objectives and detailed methodology of the Acute Asthma Severity Assessment Protocol study.

  13. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    PubMed Central

    Kasenda, Benjamin; von Elm, Erik; You, John J.; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J.; Stegert, Mihaela; Olu, Kelechi K.; Tikkinen, Kari A. O.; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M.; Mertz, Dominik; Akl, Elie A.; Bassler, Dirk; Busse, Jason W.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  14. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee. Methods/Design A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program + phototherapy, or exercise program + placebo phototherapy, all of which will last for eight weeks. Discussion The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed. Trial registration The protocol for this study has been submitted to Clinical Trials, registration number

  15. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    PubMed Central

    2012-01-01

    Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. Discussion The present study

  16. The Outcome of Patients With 2 Different Protocols of Do-Not-Resuscitate Orders: An Observational Cohort Study.

    PubMed

    Chen, Yen-Yuan; Gordon, Nahida H; Jr, Alfred F Connors; Garland, Allan; Chu, Tzong-Shinn; Youngner, Stuart J

    2015-10-01

    Lack of clarity about the exact clinical implications of do-not-resuscitate (DNR) has caused confusion that has been addressed repeatedly in the literature. To provide improved understanding about the portability of DNR and the medical care provided to DNR patients, the state of Ohio passed a Do-Not-Resuscitate Law in 1998, which clearly pointed out 2 different protocols of do-not-resuscitate: DNR comfort care (DNRCC) and DNR comfort care arrest (DNRCC-Arrest). The objective of this study was to examine the outcome of patients with the 2 different protocols of DNR orders.This is a retrospective observational study conducted in a medical intensive care unit (MICU) in a hospital located in Northeast Ohio. The medical records of the initial admissions to the MICU during data collection period were concurrently and retrospectively reviewed. The association between 2 variables was examined using Chi-squared test or Student's t-test. The outcome of DNRCC, DNRCC-Arrest, and No-DNR patients were compared using multivariate logistic regression analysis.The total of 188 DNRCC-Arrest, 88 DNRCC, and 2051 No-DNR patients were included in this study. Compared with the No-DNR patients, the DNRCC (odds ratio = 20.77, P < 0.01) and DNRCC-Arrest (odds ratio = 3.69, P < 0.01) patients were more likely to die in the MICU. Furthermore, the odds of dying during MICU stay for DNRCC patients were 7.85 times significantly higher than that for DNRCC-Arrest patients (odds ratio = 7.85, P < 0.01).Given Do-Not-Resuscitate Law in Ohio, we examined the outcome of the 2 different protocols of DNR orders, and to compare with the conventional DNR orders. Similar to conventional DNR, DNDCC and DNRCC-Arrest were both associated with the increased risk of death. Patients with DNRCC were more likely to be associated with increased risk of death than those with DNRCC-Arrest. PMID:26496311

  17. The Korean Gastric Cancer Cohort Study: Study Protocol and Brief Results of a Large-Scale Prospective Cohort Study

    PubMed Central

    Eom, Bang Wool; Kim, Young-Woo; Nam, Byung-Ho; Ryu, Keun Won; Jeong, Hyun-Yong; Park, Young-Kyu; Lee, Young-Joon; Yang, Han-Kwang; Yu, Wansik; Yook, Jeong-Hwan; Song, Geun Am; Youn, Sei-Jin; Kim, Heung Up; Noh, Sung-Hoon; Park, Sung Bae; Yang, Doo-Hyun; Kim, Sung

    2016-01-01

    Purpose This study aimed to establish a large-scale database of patients with gastric cancer to facilitate the development of a national-cancer management system and a comprehensive cancer control policy. Materials and Methods An observational prospective cohort study on gastric cancer was initiated in 2010. A total of 14 cancer centers throughout the country and 152 researchers were involved in this study. Patient enrollment began in January 2011, and data regarding clinicopathological characteristics, life style-related factors, quality of life, as well as diet diaries were collected. Results In total, 4,963 patients were enrolled until December 2014, and approximately 5% of all Korean patients with gastric cancer annually were included. The mean age was 58.2±11.5 years, and 68.2% were men. The number of patients in each stage was as follows: 3,394 patients (68.4%) were in stage IA/B; 514 patients (10.4%), in stage IIA/B; 469 patients (9.5%), in stage IIIA/B/C; and 127 patients (2.6%), in stage IV. Surgical treatment was performed in 3,958 patients (79.8%), endoscopic resection was performed in 700 patients (14.1%), and 167 patients (3.4%) received palliative chemotherapy. The response rate for the questionnaire on the quality of life was 95%; however, diet diaries were only collected for 27% of patients. Conclusions To provide comprehensive information on gastric cancer for patients, physicians, and government officials, a large-scale database of Korean patients with gastric cancer was established. Based on the findings of this cohort study, an effective cancer management system and national cancer control policy could be developed. PMID:27752396

  18. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK)

    PubMed Central

    2012-01-01

    Background An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the ‘normal’ schools of the region using the design of a “natural experiment”. Methods Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track) asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. Discussion This project is embedded in a local community, which set up the intervention (The Sport Schools) and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the ‘normal’ schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese) could be relatively small. Therefore, results specific to minority groups may be diluted. Nonetheless, the

  19. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  20. Complex social intervention for multidisciplinary teams to improve patient referrals in obstetrical care: protocol for a stepped wedge study design

    PubMed Central

    Romijn, Anita; de Bruijne, Martine C; Teunissen, Pim W; de Groot, Christianne J M; Wagner, Cordula

    2016-01-01

    Introduction In obstetrics, patients often experience referral situations between different care professionals. In these multidisciplinary teams, a focus on communication and interprofessional collaboration is needed to ensure care of high quality. Crew resource management team training is increasingly being applied in healthcare settings to improve team performance and coordination. Efforts to improve communication also include tools for standardisation such as SBAR (situation, background, assessment, recommendation). Despite the growing adoption of these interventions, evidence on their effectiveness is limited, especially on patient outcomes. This article describes a study protocol to examine the effectiveness of a crew resource management team training intervention aimed at implementing the SBAR tool for structured communication during patient referrals in obstetrical care. Methods and analysis The intervention is rolled out sequentially in five hospitals and surrounding primary care midwifery practices in the Netherlands, using a stepped wedge design. The intervention involves three phases over a period of 24 months: (1) preparation, (2) training and (3) follow-up with repeated measurements. The primary outcomes are perinatal and maternal outcomes calculated using the Adverse Outcome Index. The secondary outcomes are the reaction of participating professionals to the training programme, attitudes towards safety and teamwork (Safety Attitudes Questionnaire), cohesion (Interprofessional Collaboration Measurement Scale), use of the tool for structured communication (self-reported questionnaire) and patient experiences. These secondary outcomes from professional and patient level allow triangulation and an increased understanding of the effect of the intervention on patient outcomes. Ethics and dissemination The study was approved by the Medical Ethical Committee of the VU University Medical Centre in the Netherlands and the protocol is in accordance with Dutch

  1. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study)

    PubMed Central

    Bosmans, Joanna WAM; Kartal, Serdar; Lubbers, Tim; Sosef, Meindert; Slooter, Gerrit D; Stoot, Jan H; van Schooten, Frederik-Jan; Bouvy, Nicole D; Derikx, Joep PM

    2016-01-01

    Background Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor. Objective This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL. Methods This study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients’ inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter. Results This study has been open for inclusion since August 2015. Conclusions An estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an

  2. “Non-canonical protein-DNA interactions identified by ChIP are not artifacts”: response

    PubMed Central

    2013-01-01

    Background Studies of protein association with DNA on a genome wide scale are possible through methods like ChIP-Chip or ChIP-Seq. Massive problems with false positive signals in our own experiments motivated us to revise the standard ChIP-Chip protocol. Analysis of chromosome wide binding of the alternative sigma factor σ32 in Escherichia coli with this new protocol resulted in detection of only a subset of binding sites found in a previous study by Wade and colleagues. We suggested that the remainder of binding sites detected in the previous study are likely to be false positives. In a recent article the Wade group claimed that our conclusion is wrong and that the disputed sites are genuine σ32 binding sites. They further claimed that the non-detection of these sites in our study was due to low data quality. Results/discussion We respond to the criticism of Wade and colleagues and discuss some general questions of ChIP-based studies. We outline why the quality of our data is sufficient to derive meaningful results. Specific points are: (i) the modifications we introduced into the standard ChIP-Chip protocol do not necessarily result in a low dynamic range, (ii) correlation between ChIP-Chip replicates should not be calculated based on the whole data set as done in transcript analysis, (iii) control experiments are essential for identifying false positives. Suggestions are made how ChIP-based methods could be further optimized and which alternative approaches can be used to strengthen conclusions. Conclusion We appreciate the ongoing discussion about the ChIP-Chip method and hope that it helps other scientist to analyze and interpret their results. The modifications we introduced into the ChIP-Chip protocol are a first step towards reducing false positive signals but there is certainly potential for further optimization. The discussion about the σ32 binding sites in question highlights the need for alternative approaches and further investigation of appropriate

  3. Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study)

    PubMed Central

    Hilbert, Anja

    2016-01-01

    Introduction The long-term success of non-surgical weight loss treatment in adults with obesity is limited by substantial relapse, and only a few evidence-based weight loss maintenance treatments exist. This clinical trial investigates the feasibility and efficacy of a social facilitation maintenance programme for weight loss maintenance, tailored to meet the needs of obese adults who have undergone a lifestyle weight loss intervention. Methods and analysis In a single-centre, open feasibility trial, 72 adults currently or previously obese or overweight who have undergone a lifestyle weight loss intervention are centrally randomised to 4 months of social facilitation maintenance treatment or treatment as a usual control condition. In 16 outpatient group sessions, the social facilitation maintenance treatment, based on a socioecological model and on evidence supporting social facilitation as a key process in maintaining weight loss, focuses on promoting interpersonal relationships to build up a healthy lifestyle for long-term weight loss maintenance. Primary outcome is the amount of weight regain at 6-month follow-up, compared with pre-treatment weight, derived from measured body weight. Secondary outcomes address feasibility, including recruitment, attrition, assessment non-completion, compliance and patients' programme evaluation; and in comparison with pre-weight loss maintenance, social and interpersonal functioning, eating behaviour and physical activity, psychological and physical symptoms, body composition and risk of comorbidity, and quality of life at post-treatment and follow-up assessments. Ethics and dissemination The study was approved by the Ethical Committee at the University of Leipzig (165-13-15072013). The study results will be disseminated through peer-reviewed publications. Trial registration number DRKS00005182. PMID:27580827

  4. Use of a Modified Frazier Water Protocol in Critical Illness Survivors With Pulmonary Compromise and Dysphagia: A Pilot Study.

    PubMed

    Bernard, Shari; Loeslie, Vicki; Rabatin, Jeffrey

    2016-01-01

    Limited information is available regarding use of the Frazier free water protocol (FWP) with hospitalized patients who have dysphagia and have survived a critical illness with compromised pulmonary status. This pilot study used a two-group nonequivalent comparison group design to evaluate the FWP in 15 adults admitted to a respiratory care unit (RCU) with dysphagia concerns. Inclusion criteria included recommendation for a modified diet with thickened liquids by a dysphagia therapist and ability to follow the specific free water guidelines. The 15 control participants were chosen from a retrospective chart review of consecutive RCU admissions that met the same inclusion criteria. The intervention group for whom the free water guidelines were implemented did not differ significantly from the control group in rate of development of aspiration pneumonia, χ²(30) = .01, p = 1.00.

  5. Enhanced Evidence-Based Chinese Medicine Clinical Practice Guidelines in Hong Kong: A Study Protocol for Three Common Diseases

    PubMed Central

    Shi, Nannan; Zhong, Linda L. D.; Han, XueJie; Ng, Bacon; Bian, Zhaoxiang; Lu, Aiping

    2015-01-01

    We presented a study protocol of developing Chinese medicine clinical practice guidelines for three common diseases in Hong Kong, including insomnia, chronic gastritis, and cerebral infarction. This research project will be conducted in three phases. First phase is the preparation stage which consists of the establishment of steering committee and panel. Second phase involves 6 steps, which are searching and identifying evidence, text mining process, Delphi survey, synthesizing of data, consensus conference, and drafting guidelines. In this phase, text mining technique, evidence-based method, and formal consensus method are combined to get consolidated supporting data as the source of CM CPGs. The final phase comprised external reviews, dissemination, and updating. The outputs from this project will provide three CM CPGs for insomnia, chronic gastritis, and cerebral infarction for Hong Kong local use. PMID:25815035

  6. Microbial reduction by two chemical-mechanical protocols in primary teeth with pulp necrosis and periradicular lesion - an in vivo study.

    PubMed

    Triches, Thaisa Cezária; de Figueiredo, Luciene Cristina; Feres, Magda; de Freitas, Sérgio Fernando Torres; Zimmermann, Gláucia Santos; Cordeiro, Mabel Mariela Rodríguez

    2014-01-01

    The objective of this study was to determine the efficacy of chemical-mechanical procedures of two endodontic protocols for septic content reduction of root canals from primary teeth with pulp necrosis and periradicular lesion. Twenty-four primary root canals with pulp necrosis and periradicular lesion were divided into two treatment groups (n=12): multiple-visit and single-visit protocols. Samples were collected using sterile paper points before and after endodontic cleaning followed by microbiological identification through checkerboard DNA-DNA hybridization. Statistical analysis was performed using Proportion Test for score=0 comparing the findings before and after treatment for each group (Wilcoxon's test) as well as the differences in scores between protocols (Mann-Whitney's test) (p<0.05). Data were expressed as prevalence (presence or absence) and estimate of the average count (x10(5) cells) of each species. Differences in proportions of score=0 prior to treatment were non-significant (p=0.415), demonstrating equivalence between groups. A significant increase in score=0 was detected after treatment for both groups (p<0.0001). Single-visit protocol achieved a significantly greater reduction in mean scoring following endodontic treatment (p=0.024). Both protocols were capable of significantly reducing septic content in root canals of primary teeth with periradicular lesion. Moreover, single-visit protocol showed greater efficacy in reducing endodontic infection.

  7. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

    PubMed Central

    2012-01-01

    MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy

  8. The effect of two phototherapy protocols on pain control in orthodontic procedure--a preliminary clinical study.

    PubMed

    Esper, Maria Angela Lacerda Rangel; Nicolau, Renata Amadei; Arisawa, Emília Angela Lo Schiavo

    2011-09-01

    Phototherapy with low-level coherent light (laser) has been reported as an analgesic and anti-inflammatory as well as having a positive effect in tissue repair in orthodontics. However, there are few clinical studies using low-level LED therapy (non-coherent light). The aim of the present study was to analyze the pain symptoms after orthodontic tooth movement associated with and not associated with coherent and non-coherent phototherapy. Fifty-five volunteers (mean age = 24.1 ± 8.1 years) were randomly divided into four groups: G1 (control), G2 (placebo), G3 (protocol 1: laser, InGaAlP, 660 nm, 4 J/cm(2), 0.03 W, 25 s), G4 (protocol 2: LED, GaAlAs, 640 nm with 40 nm full-bandwidth at half-maximum, 4 J/cm(2), 0.10 W, 70 s). Separators were used to induce orthodontic pain and the volunteers pain levels were scored with the visual analog scale (VAS) after the separator placement, after the therapy (placebo, laser, or LED), and after 2, 24, 48, 72, 96, and 120 h. The laser group did not have statistically significant results in the reduction of pain level compared to the LED group. The LED group had a significant reduction in pain levels between 2 and 120 h compared to the control and the laser groups. The LED therapy showed a significant reduction in pain sensitivity (an average of 56%), after the orthodontic tooth movement when compared to the control group.

  9. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    PubMed Central

    2010-01-01

    Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs

  10. Comparison of Standard 1.5 T vs. 3 T Optimized Protocols in Patients Treated with Glatiramer Acetate. A Serial MRI Pilot Study

    PubMed Central

    Zivadinov, Robert; Hojnacki, David; Hussein, Sara; Bergsland, Niels; Carl, Ellen; Durfee, Jacqueline; Dwyer, Michael G.; Kennedy, Cheryl; Weinstock-Guttman, Bianca

    2012-01-01

    This study explored the effect of glatiramer acetate (GA, 20 mg) on lesion activity using the 1.5 T standard MRI protocol (single dose gadolinium [Gd] and 5-min delay) or optimized 3 T protocol (triple dose of Gd, 20-min delay and application of an off-resonance saturated magnetization transfer pulse). A 15-month, phase IV, open-label, single-blinded, prospective, observational study included 12 patients with relapsing-remitting multiple sclerosis who underwent serial MRI scans (Days −45, −20, 0; the minus ign indicates the number of days before GA treatment; and on Days 30, 60, 90, 120, 150, 180, 270 and 360 during GA treatment) on 1.5 T and 3 T protocols. Cumulative number and volume of Gd enhancing (Gd-E) and T2 lesions were calculated. At Days −45 and 0, there were higher number (p < 0.01) and volume (p < 0.05) of Gd-E lesions on 3 T optimized compared to 1.5 T standard protocol. However, at 180 and 360 days of the study, no significant differences in total and cumulative number of new Gd-E and T 2 lesions were found between the two protocols. Compared to pre-treatment period, at Days 180 and 360 a significantly greater decrease in the cumulative number of Gd-E lesions (p = 0.03 and 0.021, respectively) was found using the 3 T vs. the 1.5 T protocol (p = NS for both time points). This MRI mechanistic study suggests that GA may exert a greater effect on decreasing lesion activity as measured on 3 T optimized compared to 1.5 T standard protocol. PMID:22754322

  11. Comparison of standard 1.5 T vs. 3 T optimized protocols in patients treated with glatiramer acetate. A serial MRI pilot study.

    PubMed

    Zivadinov, Robert; Hojnacki, David; Hussein, Sara; Bergsland, Niels; Carl, Ellen; Durfee, Jacqueline; Dwyer, Michael G; Kennedy, Cheryl; Weinstock-Guttman, Bianca

    2012-01-01

    This study explored the effect of glatiramer acetate (GA, 20 mg) on lesion activity using the 1.5 T standard MRI protocol (single dose gadolinium [Gd] and 5-min delay) or optimized 3 T protocol (triple dose of Gd, 20-min delay and application of an off-resonance saturated magnetization transfer pulse). A 15-month, phase IV, open-label, single-blinded, prospective, observational study included 12 patients with relapsing-remitting multiple sclerosis who underwent serial MRI scans (Days -45, -20, 0; the minus ign indicates the number of days before GA treatment; and on Days 30, 60, 90, 120, 150, 180, 270 and 360 during GA treatment) on 1.5 T and 3 T protocols. Cumulative number and volume of Gd enhancing (Gd-E) and T2 lesions were calculated. At Days -45 and 0, there were higher number (p < 0.01) and volume (p < 0.05) of Gd-E lesions on 3 T optimized compared to 1.5 T standard protocol. However, at 180 and 360 days of the study, no significant differences in total and cumulative number of new Gd-E and T 2 lesions were found between the two protocols. Compared to pre-treatment period, at Days 180 and 360 a significantly greater decrease in the cumulative number of Gd-E lesions (p = 0.03 and 0.021, respectively) was found using the 3 T vs. the 1.5 T protocol (p = NS for both time points). This MRI mechanistic study suggests that GA may exert a greater effect on decreasing lesion activity as measured on 3 T optimized compared to 1.5 T standard protocol. PMID:22754322

  12. Identification of Optimal Protocols for Sequencing Difficult Templates: Results of the 2008 ABRF DNA Sequencing Research Group Difficult Template Study 2008

    PubMed Central

    Kieleczawa, Jan; Adam, Debbie; Bintzler, Doug; Detwiler, Michelle; Needleman, David; Schweitzer, Peter; Singh, Sushmita; Steen, Robert; Zianni, Michael

    2009-01-01

    The 2008 ABRF DNA Sequencing Research Group (DSRG) difficult template sequencing study was designed to identify a general set of guidelines that would constitute the best approaches for sequencing difficult templates. This was a continuation of previous DSRG difficult template studies performed in 1996, 1997, and 2003. The distinguishing factors in the present study were the number of DNA templates used, the number of different types of difficult regions tested, and the inclusion of a follow-up phase of the study to identify optimal protocols for each type of difficult template. DNA templates with associated sequencing primers were distributed to participating laboratories and each laboratory returned their sequencing results along with descriptions of the experimental conditions used. The data were analyzed and the best protocols were identified for each difficult template. This information was subsequently distributed to the participating laboratories for a second round of sequencing to evaluate the general applicability of the optimized protocols. The average improvements in sequencing results were 11% overall, with a range of −25% to +43% using the optimized protocols. The full results from this study are presented here and they demonstrate that general experimental protocols and common additives can be used to improve the sequencing success for many difficult templates. PMID:19503623

  13. Chip-off-the-old-rock: the study of reservoir-relevant geological processes with real-rock micromodels.

    PubMed

    Song, Wen; de Haas, Thomas W; Fadaei, Hossein; Sinton, David

    2014-11-21

    We present a real-rock micromodel approach whereby microfluidic channels are fabricated in a naturally occurring mineral substrate. The method is applied to quantify calcite dissolution which is relevant to oil/gas recovery, CO2 sequestration, and wastewater disposal in carbonate formations - ubiquitous worldwide. The key advantage of this method is the inclusion of both the relevant substrate chemistry (not possible with conventional microfluidics) and real-time pore-scale resolution (not possible with core samples). Here, microchannels are etched into a natural calcite crystal and sealed with a glass slide. The approach is applied to study acidified brine flow through a single channel and a two-dimensional micromodel. The single-channel case conforms roughly to a 1-D analytical description, with crystal orientation influencing the local dissolution rate an additional 25%. The two-dimensional experiments show highly flow-directed dissolution and associated positive feedback wherein acid preferentially invades high conductivity flow paths, resulting in higher dissolution rates ('wormholing'). These experiments demonstrate and validate the approach of microfabricating fluid structures within natural minerals for transport and geochemical studies. More broadly, real-rock microfluidics open the door to a vast array of lab-on-a-chip opportunities in geology, reservoir engineering, and earth sciences.

  14. Gene expression in the rat brain during sleep deprivation and recovery sleep: an Affymetrix GeneChip study.

    PubMed

    Terao, A; Wisor, J P; Peyron, C; Apte-Deshpande, A; Wurts, S W; Edgar, D M; Kilduff, T S

    2006-01-01

    Previous studies have demonstrated that macromolecular synthesis in the brain is modulated in association with the occurrence of sleep and wakefulness. Similarly, the spectral composition of electroencephalographic activity that occurs during sleep is dependent on the duration of prior wakefulness. Since this homeostatic relationship between wake and sleep is highly conserved across mammalian species, genes that are truly involved in the electroencephalographic response to sleep deprivation might be expected to be conserved across mammalian species. Therefore, in the rat cerebral cortex, we have studied the effects of sleep deprivation on the expression of immediate early gene and heat shock protein mRNAs previously shown to be upregulated in the mouse brain in sleep deprivation and in recovery sleep after sleep deprivation. We find that the molecular response to sleep deprivation and recovery sleep in the brain is highly conserved between these two mammalian species, at least in terms of expression of immediate early gene and heat shock protein family members. Using Affymetrix Neurobiology U34 GeneChips , we also screened the rat cerebral cortex, basal forebrain, and hypothalamus for other genes whose expression may be modulated by sleep deprivation or recovery sleep. We find that the response of the basal forebrain to sleep deprivation is more similar to that of the cerebral cortex than to the hypothalamus. Together, these results suggest that sleep-dependent changes in gene expression in the cerebral cortex are similar across rodent species and therefore may underlie sleep history-dependent changes in sleep electroencephalographic activity.

  15. Accuracy of a Computer-Aided Surgical Simulation (CASS) Protocol for Orthognathic Surgery: A Prospective Multicenter Study

    PubMed Central

    Hsu, Sam Sheng-Pin; Gateno, Jaime; Bell, R. Bryan; Hirsch, David L.; Markiewicz, Michael R.; Teichgraeber, John F.; Zhou, Xiaobo; Xia, James J.

    2012-01-01

    Purpose The purpose of this prospective multicenter study was to assess the accuracy of a computer-aided surgical simulation (CASS) protocol for orthognathic surgery. Materials and Methods The accuracy of the CASS protocol was assessed by comparing planned and postoperative outcomes of 65 consecutive patients enrolled from 3 centers. Computer-generated surgical splints were used for all patients. For the genioplasty, one center utilized computer-generated chin templates to reposition the chin segment only for patients with asymmetry. Standard intraoperative measurements were utilized without the chin templates for the remaining patients. The primary outcome measurements were linear and angular differences for the maxilla, mandible and chin when the planned and postoperative models were registered at the cranium. The secondary outcome measurements were: maxillary dental midline difference between the planned and postoperative positions; and linear and angular differences of the chin segment between the groups with and without the use of the template. The latter was measured when the planned and postoperative models were registered at mandibular body. Statistical analyses were performed, and the accuracy was reported using root mean square deviation (RMSD) and Bland and Altman's method for assessing measurement agreement. Results In the primary outcome measurements, there was no statistically significant difference among the 3 centers for the maxilla and mandible. The largest RMSD was 1.0mm and 1.5° for the maxilla, and 1.1mm and 1.8° for the mandible. For the chin, there was a statistically significant difference between the groups with and without the use of the chin template. The chin template group showed excellent accuracy with largest positional RMSD of 1.0mm and the largest orientational RSMD of 2.2°. However, larger variances were observed in the group not using the chin template. This was significant in anteroposterior and superoinferior directions, as in

  16. An Examination of the Design, Development, and Implementation of an Internet Protocol Version 6 Network: The ADTRAN Inc. Case Study

    ERIC Educational Resources Information Center

    Perigo, Levi

    2013-01-01

    In this dissertation, the author examined the capabilities of Internet Protocol version 6 (IPv6) in regard to replacing Internet Protocol version 4 (IPv4) as the internetworking technology for Medium-sized Businesses (MBs) in the Information Systems (IS) field. Transition to IPv6 is inevitable, and, thus, organizations are adopting this protocol…

  17. EVALUATION OF THE PROTOCOL FOR THE NATURAL ATTENUATION OF CHLORINATED SOLVENTS: CASE STUDY AT THE TWIN CITIES ARMY AMMUNITION PLANT

    EPA Science Inventory

    At the request of staff in the EPA Regions, EPA?s Office of Research and Development carried out an independent evaluation of the Technical Protocol for Evaluating Natural Attenuation of Chlorinated Solvents in Ground Water (EPA/600/R-98/128). The Protocol was developed around c...

  18. Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients’ associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Methods/design Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients’ associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. Discussion The first data gathered have allowed us to identify the

  19. Radiation Behavior of Analog Neural Network Chip

    NASA Technical Reports Server (NTRS)

    Langenbacher, H.; Zee, F.; Daud, T.; Thakoor, A.

    1996-01-01

    A neural network experiment conducted for the Space Technology Research Vehicle (STRV-1) 1-b launched in June 1994. Identical sets of analog feed-forward neural network chips was used to study and compare the effects of space and ground radiation on the chips. Three failure mechanisms are noted.

  20. Multimorbidity in primary care in Portugal (MM-PT): a cross-sectional three-phase observational study protocol

    PubMed Central

    Prazeres, Filipe; Santiago, Luiz

    2014-01-01

    Introduction Multimorbidity is defined as the co-occurrence of more than one chronic disease in one person without assigning an index disease. This rapidly increasing phenomenon markedly influences patients’ overall health, has major implications for effective provision of healthcare services and has a significant economic toll on individuals and society. Since Portugal is a country with a growing ageing population, a better understanding of the role of multimorbidity should be assessed. The aim of this study is to further the knowledge of the epidemiological factors associated with multimorbidity in Portugal, chiefly its prevalence and the health and social implications. Methods and analysis This study protocol describes a primary care nationwide three-phase study. The first phase is drawn to access the prevalence and patterns of multimorbidity. In the second phase, individual parameters are assessed, such as patients’ health-related quality of life, perceived family support and unmet health needs of patients with multimorbidity. The third and last phase of this study aims to characterise general practitioners’ knowledge, awareness and practices related to multimorbidity management. Ethics and dissemination The study will be conducted in accordance with the principles expressed in the Declaration of Helsinki. It has full approval from the Ethics Committee of the Faculty of Health Sciences, University of Beira Interior, and the Ethics Committee of the Central Health Region of Portugal. Study results will be published in peer-reviewed journals and presented at national and international conferences. PMID:24531449

  1. Integrative data analysis through coordination of measurement and analysis protocol across independent longitudinal studies.

    PubMed

    Hofer, Scott M; Piccinin, Andrea M

    2009-06-01

    Replication of research findings across independent longitudinal studies is essential for a cumulative and innovative developmental science. Meta-analysis of longitudinal studies is often limited by the amount of published information on particular research questions, the complexity of longitudinal designs and the sophistication of analyses, and practical limits on full reporting of results. In many cases, cross-study differences in sample composition and measurements impede or lessen the utility of pooled data analysis. A collaborative, coordinated analysis approach can provide a broad foundation for cumulating scientific knowledge by facilitating efficient analysis of multiple studies in ways that maximize comparability of results and permit evaluation of study differences. The goal of such an approach is to maximize opportunities for replication and extension of findings across longitudinal studies through open access to analysis scripts and output for published results, permitting modification, evaluation, and extension of alternative statistical models and application to additional data sets. Drawing on the cognitive aging literature as an example, the authors articulate some of the challenges of meta-analytic and pooled-data approaches and introduce a coordinated analysis approach as an important avenue for maximizing the comparability, replication, and extension of results from longitudinal studies. PMID:19485626

  2. Determining the role of sarcomeric proteins in facioscapulohumeral muscular dystrophy: a study protocol

    PubMed Central

    2013-01-01

    Background Although muscle weakness is a hallmark of facioscapulohumeral muscular dystrophy (FSHD), the molecular mechanisms that lead to weakness in FSHD remain largely unknown. Recent studies suggest aberrant expression of genes involved in skeletal muscle development and sarcomere contractility, and activation of pathways involved in sarcomeric protein degradation. This study will investigate the contribution of sarcomeric protein dysfunction to the pathogenesis of muscle weakness in FSHD. Methods/Design Evaluation of sarcomeric function using skinned single muscle fiber contractile studies and protein analysis in muscle biopsies (quadriceps femoris and tibialis anterior) from patients with FSHD and age- and gender-matched healthy controls. Patients with other forms of muscular dystrophy and inflammatory myopathy will be included as disease controls to assess whether results are due to changes specific for FSHD, or a consequence of muscle disease in general. A total of 56 participants will be included. Extensive clinical parameters will be measured using MRI, quantitative muscle studies and physical activity assessments. Discussion This study is the first to extensively investigate muscle fiber physiology in FSHD following an earlier pilot study suggesting sarcomeric dysfunction in FSHD. The results obtained in this study will increase the understanding of the pathophysiology of muscle weakness in FSHD, and possibly identify novel targets for therapeutic intervention. PMID:24119284

  3. Intra-Operatively Obtained Human Tissue: Protocols and Techniques for the Study of Neural Stem Cells

    PubMed Central

    Chaichana, Kaisorn; Guerrero-Cazares, Hugo; Capilla-Gonzalez, Vivian; Zamora-Berridi, Grettel; Achanta, Praganthi; Gonzalez-Perez, Oscar; Jallo, George I.; Garcia-Verdugo, Jose Manuel; Quiñones-Hinojosa, Alfredo

    2009-01-01

    The discoveries of neural (NSCs) and brain tumor stem cells (BTSCs) in the adult human brain and in brain tumors, respectively, have led to a new era in neuroscience research. These cells represent novel approaches to studying normal phenomena such as memory and learning, as well as pathological conditions such as Parkinson’s disease, stroke, and brain tumors. This new paradigm stresses the importance of understanding how these cells behave in vitro and in vivo. It also stresses the need to use human-derived tissue to study human disease because animal models may not necessarily accurately replicate the processes that occur in humans. An important, but often underused, source of human tissue and, consequently, both NSCs and BTSCs, is the operating room. This study describes in detail both current and newly developed laboratory techniques, which in our experience are used to process and study human NSCs and BTSCs from tissue obtained directly from the operating room. PMID:19427538

  4. Validation of the automatic image analyser to assess retinal vessel calibre (ALTAIR): a prospective study protocol

    PubMed Central

    Garcia-Ortiz, Luis; Gómez-Marcos, Manuel A; Recio-Rodríguez, Jose I; Maderuelo-Fernández, Jose A; Chamoso-Santos, Pablo; Rodríguez-González, Sara; de Paz-Santana, Juan F; Merchan-Cifuentes, Miguel A; Corchado-Rodríguez, Juan M

    2014-01-01

    Introduction The fundus examination is a non-invasive evaluation of the microcirculation of the retina. The aim of the present study is to develop and validate (reliability and validity) the ALTAIR software platform (Automatic image analyser to assess retinal vessel calibre) in order to analyse its utility in different clinical environments. Methods and analysis A cross-sectional study in the first phase and a prospective observational study in the second with 4 years of follow-up. The study will be performed in a primary care centre and will include 386 participants. The main measurements will include carotid intima-media thickness, pulse wave velocity by Sphygmocor, cardio-ankle vascular index through the VASERA VS-1500, cardiac evaluation by a digital ECG and renal injury by microalbuminuria and glomerular filtration. The retinal vascular evaluation will be performed using a TOPCON TRCNW200 non-mydriatic retinal camera to obtain digital images of the retina, and the developed software (ALTAIR) will be used to automatically calculate the calibre of the retinal vessels, the vascularised area and the branching pattern. For software validation, the intraobserver and interobserver reliability, the concurrent validity of the vascular structure and function, as well as the association between the estimated retinal parameters and the evolution or onset of new lesions in the target organs or cardiovascular diseases will be examined. Ethics and dissemination The study has been approved by the clinical research ethics committee of the healthcare area of Salamanca. All study participants will sign an informed consent to agree to participate in the study in compliance with the Declaration of Helsinki and the WHO standards for observational studies. Validation of this tool will provide greater reliability to the analysis of retinal vessels by decreasing the intervention of the observer and will result in increased validity through the use of additional information, especially

  5. Family-Centered Care in Juvenile Justice Institutions: A Mixed Methods Study Protocol

    PubMed Central

    Mulder, Eva; Rigter, Henk; Breuk, René; van der Vaart, Wander; Vermeiren, Robert

    2016-01-01

    Background Treatment and rehabilitation interventions in juvenile justice institutions aim to prevent criminal reoffending by adolescents and to enhance their prospects of successful social reintegration. There is evidence that these goals are best achieved when the institution adopts a family-centered approach, involving the parents of the adolescents. The Academic Workplace Forensic Care for Youth has developed two programs for family-centered care for youth detained in groups for short-term and long-term stay, respectively. Objective The overall aim of our study is to evaluate the family-centered care program in the first two years after the first steps of its implementation in short-term stay groups of two juvenile justice institutions in the Netherlands. The current paper discusses our study design. Methods Based on a quantitative pilot study, we opted for a study with an explanatory sequential mixed methods design. This pilot is considered the first stage of our study. The second stage of our study includes concurrent quantitative and qualitative approaches. The quantitative part of our study is a pre-post quasi-experimental comparison of family-centered care with usual care in short-term stay groups. The qualitative part of our study involves in-depth interviews with adolescents, parents, and group workers to elaborate on the preceding quantitative pilot study and to help interpret the outcomes of the quasi-experimental quantitative part of the study. Results We believe that our study will result in the following findings. In the quantitative comparison of usual care with family-centered care, we assume that in the latter group, parents will be more involved with their child and with the institution, and that parents and adolescents will be more motivated to take part in therapy. In addition, we expect family-centered care to improve family interactions, to decrease parenting stress, and to reduce problem behavior among the adolescents. Finally, we assume

  6. New insights into ROS dynamics: a multi-layered microfluidic chip for ecotoxicological studies on aquatic microorganisms.

    PubMed

    Koman, Volodymyr B; von Moos, Nadia R; Santschi, Christian; Slaveykova, Vera I; Martin, Olivier J F

    2016-10-01

    Reactive oxygen species (ROS) play an important role in the life of every cell, including cellular defense and signaling mechanisms. Continuous and quantitative ROS sensing can provide valuable information about the cell state, but it remains a challenge to measure. Here, we introduce a multi-layered microfluidic chip with an integrated optical sensor for the continuous sensitive detection of extracellular hydrogen peroxide (H2O2), one of the most stable ROS. This platform includes hydraulically controlled microvalves and microsieves, which enable the precise control of toxicants and complex exposure sequences. In particular, we use this platform to study the dynamics of toxicity-induced ROS generation in the green microalga Chlamydomonas reinhardtii during short-term exposures, recovery periods, and subsequent re-exposures. Two cadmium-based toxicants with distinct internalization mechanisms are used as stress inducers: CdSe/ZnS quantum dots (Qdots) and ionic cadmium (Cd(2+)). Our results show the quantitative dynamics of ROS generation by the model microalga, the recovery of cell homeostasis after stress events and the cumulative nature of two consecutive exposures. The dissolution of quantum dots and its possible influence on toxicity and H2O2 depletion is discussed. The obtained insights are relevant from ecotoxicological and physiological perspectives. PMID:26907664

  7. Large-Scale Wearable Sensor Deployment in Parkinson’s Patients: The Parkinson@Home Study Protocol

    PubMed Central

    Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

    2016-01-01

    Background Long-term management of Parkinson’s disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients’ own home environment) might fill this knowledge gap. Objective The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson’s patients during daily functioning. Methods The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson’s patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients’ self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Results Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. Conclusions The Parkinson@Home study is expected to generate new insights into the

  8. Elder mistreatment in a community dwelling population: the Malaysian Elder Mistreatment Project (MAESTRO) cohort study protocol

    PubMed Central

    Choo, Wan Yuen; Hairi, Noran Naqiah; Sooryanarayana, Rajini; Yunus, Raudah Mohd; Hairi, Farizah Mohd; Ismail, Norliana; Kandiben, Shathanapriya; Mohd Ali, Zainudin; Ahmad, Sharifah Nor; Abdul Razak, Inayah; Othman, Sajaratulnisah; Tan, Maw Pin; Mydin, Fadzilah Hanum Mohd; Peramalah, Devi; Brownell, Patricia; Bulgiba, Awang

    2016-01-01

    Introduction Despite being now recognised as a global health concern, there is still an inadequate amount of research into elder mistreatment, especially in low and middle-income regions. The purpose of this paper is to report on the design and methodology of a population-based cohort study on elder mistreatment among the older Malaysian population. The study aims at gathering data and evidence to estimate the prevalence and incidence of elder mistreatment, identify its individual, familial and social determinants, and quantify its health consequences. Methods and analysis This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments

  9. 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

  10. Micro-costing studies in the health and medical literature: protocol for a systematic review

    PubMed Central

    2014-01-01

    Background Micro-costing is a cost estimation method that allows for precise assessment of the economic costs of health interventions. It has been demonstrated to be particularly useful for estimating the costs of new interventions, for interventions with large variability across providers, and for estimating the true costs to the health system and to society. However, existing guidelines for economic evaluations do not provide sufficient detail of the methods and techniques to use when conducting micro-costing analyses. Therefore, the purpose of this study is to review the current literature on micro-costing studies of health and medical interventions, strategies, and programs to assess the variation in micro-costing methodology and the quality of existing studies. This will inform current practice in conducting and reporting micro-costing studies and lead to greater standardization in methodology in the future. Methods/Design We will perform a systematic review of the current literature on micro-costing studies of health and medical interventions, strategies, and programs. Using rigorously designed search strategies, we will search Ovid MEDLINE, EconLit, BIOSIS Previews, Embase, Scopus, and the National Health Service Economic Evaluation Database (NHS EED) to identify relevant English-language articles. These searches will be supplemented by a review of the references of relevant articles identified. Two members of the review team will independently extract detailed information on the design and characteristics of each included article using a standardized data collection form. A third reviewer will be consulted to resolve discrepancies. We will use checklists that have been developed for critical appraisal of health economics studies to evaluate the quality and potential risk of bias of included studies. Discussion This systematic review will provide useful information to help standardize the methods and techniques for conducting and reporting micro

  11. A Checklist for the Conduct, Reporting, and Appraisal of Microcosting Studies in Health Care: Protocol Development

    PubMed Central

    Reiff, Marian

    2016-01-01

    Background Microcosting is a cost estimation method that requires the collection of detailed data on resources utilized, and the unit costs of those resources in order to identify actual resource use and economic costs. Microcosting findings reflect the true costs to health care systems and to society, and are able to provide transparent and consistent estimates. Many economic evaluations in health and medicine use charges, prices, or payments as a proxy for cost. However, using charges, prices, or payments rather than the true costs of resources can result in inaccurate estimates. There is currently no existing checklist or guideline for the conduct, reporting, or appraisal of microcosting studies in health care interventions. Objective The aim of this study is to create a checklist and guideline for the conduct, reporting, and appraisal of microcosting studies in health care interventions. Methods Appropriate potential domains and items will be identified through (1) a systematic review of all published microcosting studies of health and medical interventions, strategies, and programs; (2) review of published checklists and guidelines for economic evaluations of health interventions, and selection of items relevant for microcosting studies; and (3) theoretical analysis of economic concepts relevant for microcosting. Item selection, formulation, and reduction will be conducted by the research team in order to develop an initial pool of items for evaluation by an expert panel comprising individuals with expertise in microcosting and economic evaluation of health interventions. A modified Delphi process will be conducted to achieve consensus on the checklist. A pilot test will be conducted on a selection of the articles selected for the previous systematic review of published microcosting studies. Results The project is currently in progress. Conclusions Standardization of the methods used to conduct, report or appraise microcosting studies will enhance the

  12. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations.

    PubMed

    Traub-Dargatz, Josie L; Weese, J Scott; Rousseau, Joyce D; Dunowska, Magdalena; Morley, Paul S; Dargatz, David A

    2006-07-01

    Reduction factors (RFs) for bacterial counts on examiners' hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations.

  13. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations

    PubMed Central

    Traub-Dargatz, Josie L.; Weese, J. Scott; Rousseau, Joyce D.; Dunowska, Magdalena; Morley, Paul S.; Dargatz, David A.

    2006-01-01

    Abstract Reduction factors (RFs) for bacterial counts on examiners’ hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations. PMID:16898109

  14. Melancholic versus non-melancholic depression: differences on cognitive function. A longitudinal study protocol

    PubMed Central

    2010-01-01

    Background Cognitive dysfunction is common among depressed patients. However, the pattern and magnitude of impairment during episodes of major depressive disorder (MDD) through to clinical remission remains unclear. Heterogeneity of depressive patients and the lack of longitudinal studies may account for contradictory results in previous research. Methods/Design This longitudinal study will analyze cognitive differences between CORE-defined melancholic depressed patients (n = 60) and non-melancholic depressed patients (n = 60). A comprehensive clinical and cognitive assessment will be performed at admission and after 6 months. Cognitive dysfunction in both groups will be longitudinally compared, and the persistence of cognitive impairment after clinical remission will be determined. Discussion The study of neuropsychological dysfunction and the cognitive changes through the different phases of depression arise a wide variety of difficulties. Several confounding variables must be controlled to determine if the presence of depression could be considered the only factor accounting for group differences. PMID:20565743

  15. ChIP bias as a function of cross-linking time.

    PubMed

    Baranello, Laura; Kouzine, Fedor; Sanford, Suzanne; Levens, David

    2016-05-01

    The chromatin immunoprecipitation (ChIP) assay is widely used to capture interactions between chromatin and regulatory proteins in vivo. Formaldehyde cross-linking of DNA and proteins is a critical step required to trap their interactions inside the cells before immunoprecipitation and analysis. Yet insufficient attention has been given to variables that might give rise to artifacts in this procedure, such as the duration of cross-linking. We analyzed the dependence of the ChIP signal on the duration of formaldehyde cross-linking time for two proteins: DNA topoisomerase 1 (Top1) that is functionally associated with the double helix in vivo, especially with active chromatin, and green fluorescent protein (GFP) that has no known bona fide interactions with DNA. With short time of formaldehyde fixation, only Top1 immunoprecipation efficiently recovered DNA from active promoters, whereas prolonged fixation augmented non-specific recovery of GFP dramatizing the need to optimize ChIP protocols to minimize the time of cross-linking, especially for abundant nuclear proteins. Thus, ChIP is a powerful approach to study the localization of protein on the genome when care is taken to manage potential artifacts. PMID:26685864

  16. Association between adiposity and systemic atherosclerosis: a protocol of a cross-sectional autopsy study

    PubMed Central

    Nishizawa, Aline; Suemoto, Claudia Kimie; Farias, Daniela Souza; Campos, Fernanda Marinho; da Silva, Karen Cristina Souza; Cuelho, Anderson; Leite, Renata Elaine Paraízo; Ferretti-Rebustini, Renata Eloah de Lucena; Grinberg, Lea Tenenholz; Farfel, José Marcelo; Jacob-Filho, Wilson; Pasqualucci, Carlos Augusto

    2016-01-01

    Introduction Adiposity has been associated with atherosclerosis in clinical studies. However, few autopsy studies have investigated this association, and they had only examined the coronary artery disease. Moreover, most studies had small sample sizes and were limited to middle-aged or young adults. Our aim is to investigate the association between adiposity and systemic atherosclerosis in an autopsy study. Methods and analysis A sample of 240 deceased with 30 years or more will be evaluated. The sample size was calculated using the lowest correlation coefficient found in previous studies (r=0.109), assuming a power of 90% and α=0.05. We will collect information about sociodemographics, frequency of previous contact of the deceased's next of kin and cardiovascular risk factors. We will measure neck, waist and hip circumferences, weight, height and abdominal subcutaneous tissue thickness, and then we will calculate the body mass index, waist-to-hip ratio, waist-to-height ratio and body shape index. We will also weigh the pericardial and abdominal visceral fat, the heart, and we will measure the left ventricular wall thickness. We will evaluate the presence of myocardial infarction, the degree of atherosclerosis in the aorta, carotid, coronary and cerebral arteries and plaque composition in carotid, coronary and cerebral arteries. For each individual, we will fix arterial and adipose tissue samples in 10% formalin and freeze another adipose tissue sample at −80°C for future studies. Ethics and dissemination Ethical approval was granted by the Ethics Committee of University of Sao Paulo Medical School, Brazil. Results will be submitted for publication in a peer-reviewed journal. PMID:27621828

  17. Longitudinal evaluation of dementia care in German nursing homes: the “DemenzMonitor” study protocol

    PubMed Central

    2013-01-01

    Background In Germany, the number of people with dementia living in nursing homes is rapidly increasing. Providing adequate care for their special needs is a challenge for institutions and their staff members. Because of the growing number of people with dementia, changes to the conceptual orientation of nursing homes have occurred. These changes include specialized living arrangements and psychosocial interventions recommended for people with dementia. Until now, the provision of dementia care and its association to the residents’ behavior and quality of life is not well investigated in Germany. The purpose of this study is to describe the provision of dementia care and to identify resident- as well as facility-related factors associated with residents behavior and quality of life. Methods/Design The DemenzMonitor study is designed as a longitudinal study that is repeated annually. Data will be derived from a convenience sample consisting of nursing homes across Germany. For the data collection, three questionnaires have been developed that measure information on the level of the nursing home, the living units, and the residents. Data collection will be performed by staff members from the nursing homes. The data collection procedure will be supervised by a study coordinator who is trained by the research team. Data analysis will be performed on each data level using appropriate techniques for descriptions and comparisons as well as longitudinal regression analysis. Discussion The DemenzMonitor is the first study in Germany that assesses how dementia care is provided in nursing homes with respect to living arrangements and recommended interventions. This study links the acquired data with residents’ outcome measurements, making it possible to evaluate different aspects and concepts of care. PMID:24237990

  18. Association between adiposity and systemic atherosclerosis: a protocol of a cross-sectional autopsy study

    PubMed Central

    Nishizawa, Aline; Suemoto, Claudia Kimie; Farias, Daniela Souza; Campos, Fernanda Marinho; da Silva, Karen Cristina Souza; Cuelho, Anderson; Leite, Renata Elaine Paraízo; Ferretti-Rebustini, Renata Eloah de Lucena; Grinberg, Lea Tenenholz; Farfel, José Marcelo; Jacob-Filho, Wilson; Pasqualucci, Carlos Augusto

    2016-01-01

    Introduction Adiposity has been associated with atherosclerosis in clinical studies. However, few autopsy studies have investigated this association, and they had only examined the coronary artery disease. Moreover, most studies had small sample sizes and were limited to middle-aged or young adults. Our aim is to investigate the association between adiposity and systemic atherosclerosis in an autopsy study. Methods and analysis A sample of 240 deceased with 30 years or more will be evaluated. The sample size was calculated using the lowest correlation coefficient found in previous studies (r=0.109), assuming a power of 90% and α=0.05. We will collect information about sociodemographics, frequency of previous contact of the deceased's next of kin and cardiovascular risk factors. We will measure neck, waist and hip circumferences, weight, height and abdominal subcutaneous tissue thickness, and then we will calculate the body mass index, waist-to-hip ratio, waist-to-height ratio and body shape index. We will also weigh the pericardial and abdominal visceral fat, the heart, and we will measure the left ventricular wall thickness. We will evaluate the presence of myocardial infarction, the degree of atherosclerosis in the aorta, carotid, coronary and cerebral arteries and plaque composition in carotid, coronary and cerebral arteries. For each individual, we will fix arterial and adipose tissue samples in 10% formalin and freeze another adipose tissue sample at −80°C for future studies. Ethics and dissemination Ethical approval was granted by the Ethics Committee of University of Sao Paulo Medical School, Brazil. Results will be submitted for publication in a peer-reviewed journal.

  19. PILOT STUDY PROTOCOL: APPLICATION OF MEASURES OF SPONTANEOUS MOTOR ACTIVITY FOR BEHAVORIAL ASSESSMENT IN HUMAN INFANTS

    EPA Science Inventory

    As a participant in planning the National Childrens Study (NCS), EPA is interested in the investigation of key developmental disorders that may be associated with environmental exposures. This is particularly important in light of research that has established that prenatal and e...

  20. Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol

    PubMed Central

    2014-01-01

    Background There is growing evidence that health and social outcomes following motor vehicle crash injury are related to cognitive and emotional responses of the injured individual, as well as relationships between the injured individual and the compensation systems with which they interact. As most of this evidence comes from other states in Australia or overseas, investigation is therefore warranted to identify the key determinants of health and social outcomes following injury in the context of the New South Wales motor accident insurance scheme. Methods/Design In this inception cohort study, 2400 participants, aged 17 years or more, injured in a motor vehicle crash in New South Wales will be identified though hospital emergency departments, general and physiotherapy practitioners, police records and a government insurance regulator database. Participants will be initially contacted through mail. Baseline interviews will be conducted by telephone within 28 days of the injury and participants will be followed up with interviews at 6, 12 and 24 months post-injury. Health insurance and pharmaceutical prescription data will also be collected. Discussion The study results will report short and long term health and social outcomes in the study sample. Identification of factors associated with health and social outcomes following injury, including related compensation factors will provide evidence for improved service delivery, post-injury management, and inform policy development and reforms. Trial registration Australia New Zealand Clinical trial registry identification number - ACTRN12613000889752. Available at: ANZCTR Registered FISH Study. PMID:24564821

  1. A randomized controlled trial on errorless learning in goal management training: study rationale and protocol

    PubMed Central

    2013-01-01

    Background Many brain-injured patients referred for outpatient rehabilitation have executive deficits, notably difficulties with planning, problem-solving and goal directed behaviour. Goal Management Training (GMT) has proven to be an efficacious cognitive treatment for these problems. GMT entails learning and applying an algorithm, in which daily tasks are subdivided into multiple steps. Main aim of the present study is to examine whether using an errorless learning approach (preventing the occurrence of errors during the acquisition phase of learning) contributes to the efficacy of Goal Management Training in the performance of complex daily tasks. Methods/Design The study is a double blind randomized controlled trial, in which the efficacy of Goal Management Training with an errorless learning approach will be compared with conventional Goal Management Training, based on trial and error learning. In both conditions 32 patients with acquired brain injury of mixed etiology will be examined. Main outcome measure will be the performance on two individually chosen everyday-tasks before and after treatment, using a standardized observation scale and goal attainment scaling. Discussion This is the first study that introduces errorless learning in Goal Management Training. It is expected that the GMT-errorless learning approach will improve the execution of complex daily tasks in brain-injured patients with executive deficits. The study can contribute to a better treatment of executive deficits in cognitive rehabilitation. Trial registration (Dutch Trial Register): http://NTR3567 PMID:23786651

  2. Computers and the Writing Process: A Comparative Protocol Study. CDC Technical Report No. 34.

    ERIC Educational Resources Information Center

    Haas, Christina

    A study examined the extent to which computers affect the writing process. In order to test several hypotheses about writing with a computer 15 experienced writers wrote persuasive letters under four conditions--using pen and paper once and a computer the other three times. All of the subjects were experienced with computers having worked daily or…

  3. Reading Error Protocol Study: A Data Base. Volume V. Grade Six.

    ERIC Educational Resources Information Center

    Simons, Herbert D.; Chambers, Richard

    This is the fifth of six volumes providing information drawn from a project designed to compile a substantial data base on reading errors for use by researchers and teachers. This volume contains transcriptions of oral reading error studies conducted with sixth grade students. The transcriptions are organized according to grade and…

  4. Reading Error Protocol Study: A Data Base. Volume II. Grades One and Two.

    ERIC Educational Resources Information Center

    Simons, Herbert D.; Chambers, Richard

    This is the second of six volumes providing information drawn from a project designed to compile a substantial data base on reading errors for use by researchers and teachers. This volume contains transcriptions of oral reading error studies conducted with first and second grade students. The transcriptions are organized according to grade and the…

  5. Reading Error Protocol Study: A Data Base. Volume IV. Grade Five.

    ERIC Educational Resources Information Center

    Simons, Herbert D.; Chambers, Richard

    This is the fourth of six volumes providing information drawn from a project designed to compile a substantial data base on reading errors for use by researchers and teachers. This volume contains transcriptions of oral reading error studies conducted with fifth grade students. The transcriptions are organized according to grade and…

  6. Reading Error Protocol Study: A Data Base. Volume III. Grades Three and Four.

    ERIC Educational Resources Information Center

    Simons, Herbert D.; Chambers, Richard

    This is the third of six volumes providing information drawn from a project designed to compile a substantial data base on reading errors for use by researchers and teachers. This volume contains transcriptions of oral reading error studies conducted with third and fourth grade students. The transcriptions are organized according to grade and…

  7. Reading Error Protocol Study: A Data Base. Volume VI. Grades Eight through Ten.

    ERIC Educational Resources Information Center

    Simons, Herbert D.; Chambers, Richard

    This is the last of six volumes providing information drawn from a project designed to compile a substantial data base on reading errors for use by researchers and teachers. This volume contains transcriptions of oral reading error studies conducted with eighth, ninth, and tenth grade students. The transcriptions are organized according to grade…

  8. WIC Infant and Toddler Feeding Practices Study: protocol design and implementation.

    PubMed

    Harrison, Gail G; Hirschman, Jay D; Owens, Tameka A; McNutt, Suzanne W; Sallack, Linnea E

    2014-03-01

    The federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which began in the 1970s, has undergone revisions in the past several years, including revision to contents of the supplemental food "packages" in 2009 based on recommendations provided by an Institute of Medicine (IOM) committee of The National Academies. In 2010, the IOM held a workshop to examine and recommend research priorities for the program. The overall purpose of the current (ie, second) WIC Infant and Toddler Feeding Practices Study (ITFPS-2) is to conduct a nationally representative, longitudinal study of contemporary WIC infant and toddler feeding practices. This study will update earlier studies and collect information on variations in WIC program components. The study will also assess ways in which WIC may address obesity in early childhood and examine changes in feeding practices that may stem from the 2009 food package revisions. The sample is drawn from the universe of WIC sites nationally, excluding only those with an insufficient volume of eligible participants. Eligibility for the study includes the ability to be interviewed in English or Spanish. Approximately 8000 women and infants are being sampled, and ∼ 4000 are expected to participate. Eligible women are invited to participate during their WIC enrollment visit, and informed consent is sought. The design includes a core sample to be followed until the infant reaches age 2 y and a supplemental sample to be used in some cross-sectional analyses to ensure adequate representation of groups that might be underrepresented in the core sample. Participants will complete up to 11 interviews (core sample) or 4 interviews (supplemental sample) each except for the prenatal interview, which includes a quantitative 24-h recall of food intake for the infant. Eighty sites have been sampled across 26 states and 1 territory. Instruments have been developed and pretested in both English and Spanish, and interviewers

  9. WIC Infant and Toddler Feeding Practices Study: protocol design and implementation.

    PubMed

    Harrison, Gail G; Hirschman, Jay D; Owens, Tameka A; McNutt, Suzanne W; Sallack, Linnea E

    2014-03-01

    The federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which began in the 1970s, has undergone revisions in the past several years, including revision to contents of the supplemental food "packages" in 2009 based on recommendations provided by an Institute of Medicine (IOM) committee of The National Academies. In 2010, the IOM held a workshop to examine and recommend research priorities for the program. The overall purpose of the current (ie, second) WIC Infant and Toddler Feeding Practices Study (ITFPS-2) is to conduct a nationally representative, longitudinal study of contemporary WIC infant and toddler feeding practices. This study will update earlier studies and collect information on variations in WIC program components. The study will also assess ways in which WIC may address obesity in early childhood and examine changes in feeding practices that may stem from the 2009 food package revisions. The sample is drawn from the universe of WIC sites nationally, excluding only those with an insufficient volume of eligible participants. Eligibility for the study includes the ability to be interviewed in English or Spanish. Approximately 8000 women and infants are being sampled, and ∼ 4000 are expected to participate. Eligible women are invited to participate during their WIC enrollment visit, and informed consent is sought. The design includes a core sample to be followed until the infant reaches age 2 y and a supplemental sample to be used in some cross-sectional analyses to ensure adequate representation of groups that might be underrepresented in the core sample. Participants will complete up to 11 interviews (core sample) or 4 interviews (supplemental sample) each except for the prenatal interview, which includes a quantitative 24-h recall of food intake for the infant. Eighty sites have been sampled across 26 states and 1 territory. Instruments have been developed and pretested in both English and Spanish, and interviewers

  10. Investigating silent strokes in hypertensives: a magnetic resonance imaging study (ISSYS): rationale and protocol design

    PubMed Central

    2013-01-01

    Background Silent brain infarcts are detected by neuroimaging in up to 20% of asymptomatic patients based on population studies. They are five times more frequent than stroke in general population, and increase significantly both with advancing age and hypertension. Moreover, they are independently associated with the risk of future stroke and cognitive decline. Despite these numbers and the clinical consequences of silent brain infarcts, their prevalence in Mediterranean populations is not well known and their role as predictors of future cerebrovascular and cardiovascular events in hypertensive remains to be determined. ISSYS (Investigating Silent Strokes in Hypertensives: a magnetic resonance imaging study) is an observational cross-sectional and longitudinal study aimed to: 1- determine the prevalence of silent cerebrovascular infarcts in a large cohort of 1000 hypertensives and to study their associated factors and 2-to study their relationship with the risk of future stroke and cognitive decline. Methods/Design Cohort study in a randomly selected sample of 1000 participants, hypertensive aged 50 to 70 years old, with no history of previous stroke or dementia. On baseline all participants will undergo a brain MRI to determine the presence of brain infarcts and other cerebrovascular lesions (brain microbleeds, white matter changes and enlarged perivascular spaces) and will be also tested to determine other than brain organ damage (heart-left ventricular hypertrophy, kidney-urine albumin to creatinine ratio, vessels-pulse wave velocity, ankle brachial index), in order to establish the contribution of other subclinical conditions to the risk of further vascular events. Several sub-studies assessing the role of 24 hour ambulatory BP monitoring and plasma or genetic biomarkers will be performed. Follow-up will last for at least 3 years, to assess the rate of further stroke/transient ischemic attack, other cardiovascular events and cognitive decline, and their

  11. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    PubMed Central

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  12. Study protocol of a Dutch smoking cessation e-health program

    PubMed Central

    2011-01-01

    Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES) and higher socio-economic status (HSES) smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages). The paper aims to describe the development and design of the two computer-tailored programs. Methods/design Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text) * 2(LSES/HSES) design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback) or to the control group (non-tailored generic advice). In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. Discussion The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. Trial registration Dutch Trial Register NTR3102 PMID:22059446

  13. Lab-on a-Chip

    NASA Technical Reports Server (NTRS)

    2003-01-01

    Helen Cole, the project manager for the Lab-on-a-Chip Applications Development program, and Lisa Monaco, the project scientist for the program, insert a lab on a chip into the Caliper 42 which is specialized equipment that controls processes on commercial chips to support development of lab-on-a-chip applications. The system has special microscopes and imaging systems, so scientists can process and study different types of fluid, chemical, and medical tests conducted on chips. For example, researchers have examined fluorescent bacteria as it flows through the chips' fluid channels or microfluidic capillaries. Researchers at NASA's Marshall Space Flight Center (MSFC) in Huntsville, Alabama, have been studying how the lab-on-a-chip technology can be used for microbial detection, water quality monitoring, and detecting biosignatures of past or present life on Mars. The Marshall Center team is also collaborating with scientists at other NASA centers and at universities to develop custom chip designs for not only space applications, but for many Earth applications, such as for detecting deadly microbes in heating and air systems. (NASA/MSFC/D.Stoffer)

  14. Clinical study protocol for the ARCH project - computational modeling for improvement of outcome after vascular access creation.

    PubMed

    Bode, Aron; Caroli, Anna; Huberts, Wouter; Planken, Nils; Antiga, Luca; Bosboom, Marielle; Remuzzi, Andrea; Tordoir, Jan

    2011-01-01

    Despite clinical guidelines and the possibility of diagnostic vascular imaging, creation and maintenance of a vascular access (VA) remains problematic: avoiding short- and long-term VA dysfunction is challenging. Although prognostic factors for VA dysfunction have been identified in previous studies, their potential interplay at a systemic level is disregarded. Consideration of multiple prognostic patient specific factors and their complex interaction using dedicated computational modeling tools might improve outcome after VA creation by enabling a better selection of VA configuration. These computational modeling tools are developed and validated in the ARCH project: a joint initiative of four medical centers and three industrial partners (FP7-ICT-224390). This paper reports the rationale behind computational modeling and presents the clinical study protocol designed for calibrating and validating these modeling tools. The clinical study is based on the pre-operative collection of structural and functional data at a vascular level, as well as a VA functional evaluation during the follow-up period. The strategy adopted to perform the study and for data collection is also described here. PMID:21667457

  15. Pilot Study: Colostomy and Urine Collection Protocol for Investigating Potential Inciting Causes of Hen Diuresis Syndrome.

    PubMed

    Jones, Kelli; Turner, Bradley; Brandão, João; Hubbard, Sue Ann; Magee, Danny; Baughman, Brittany; Wills, Robert; Tully, Thomas

    2015-06-01

    Hen diuresis syndrome has emerged over the past 5 yr as a significant cause of mortality in the U.S. broiler breeder industry. The condition affects hens in production and is characterized by transient muscle weakness in the vent region, transient diuresis, and often urate deposits on the skin below the vent. Affected hens are often seen straining to lay an egg, which suggests oviduct contraction is also impaired. Related hen mortality, often reaching 1% or more a week, is believed to be primarily the result of male aggression of the vent region (Turner et al., "Investigating Causes of Excessive Urate Production in Broiler Breeder Hens Associated with Peritonitis and Cannibalism Mortality," Oral Presentation at The American Association of Avian Pathologists Annual Meeting, p. 139, 2010). The exact association between the cause of mortality and this syndrome is unknown, but it may be the consequence of transient partial to full oviduct prolapse, which predisposes or stimulates cannibalism and aggression. Based on unpublished work done prior to this study (Turner et al., ibid.), the evidence suggests the underlying problem is metabolic. We feel that urine collection and analysis is an essential component to understanding this condition. This study serves as a pilot study for future investigations that attempt to identify the nature and cause of the metabolic disturbance through paired urine and serum collection and analysis. For the purpose of this study, a small sample of 10 affected and 10 unaffected birds was used for sample collection. In order to collect pure urine, the birds were surgically colostomized. Colostomy did prove to be a useful means of collecting urine free of feces, and for the purposes of our study it yielded adequate urine samples for analysis. There were statistically relevant urine values observed. Affected birds had a higher presence of blood in the urine, a lower uric acid excretion rate (mg/hr), higher concentration (mEq/L) of urine Na+, and

  16. The world health organization multicountry survey on maternal and newborn health: study protocol

    PubMed Central

    2011-01-01

    Background Effective interventions to reduce mortality and morbidity in maternal and newborn health already exist. Information about quality and performance of care and the use of critical interventions are useful for shaping improvements in health care and strengthening the contribution of health systems towards the Millennium Development Goals 4 and 5. The near-miss concept and the criterion-based clinical audit are proposed as useful approaches for obtaining such information in maternal and newborn health care. This paper presents the methods of the World Health Organization Multicountry Study in Maternal and Newborn Health. The main objectives of this study are to determine the prevalence of maternal near-miss cases in a worldwide network of health facilities, evaluate the quality of care using the maternal near-miss concept and the criterion-based clinical audit, and develop the near-miss concept in neonatal health. Methods/Design This is a large cross-sectional study being implemented in a worldwide network of health facilities. A total of 370 health facilities from 29 countries will take part in this study and produce nearly 275,000 observations. All women giving birth, all maternal near-miss cases regardless of the gestational age and delivery status and all maternal deaths during the study period comprise the study population. In each health facility, medical records of all eligible women will be reviewed during a data collection period that ranges from two to three months according to the annual number of deliveries. Discussion Implementing the systematic identification of near-miss cases, mapping the use of critical evidence-based interventions and analysing the corresponding indicators are just the initial steps for using the maternal near-miss concept as a tool to improve maternal and newborn health. The findings of projects using approaches similar to those described in this manuscript will be a good starter for a more comprehensive dialogue with

  17. Social and economic impact of diabetics in Bangladesh: protocol for a case–control study

    PubMed Central

    2013-01-01

    Background Diabetes affects both individuals and their families and has an impact on economic and social development of a country. Information on the availability, cost, and quality of medical care for diabetes is mostly not available for many low- and middle-income countries including Bangladesh. Complications from diabetes, which can be devastating, could largely be prevented by wider use of several inexpensive generic medicines, simple tests and monitoring and can be a cost saving intervention. This study will provide an in-depth and comprehensive picture of social and economic impacts of diabetes in Bangladesh and propose clear recommendations for improving prevention and management of diabetes. The objectives of the study are: 1) To study the association between diabetes and other health problems and its social impacts 2) To estimate the economic impact of diabetes including total direct and indirect costs 3) To measure the impact of diabetes on quality of life among diabetes patients in Bangladesh 4) To study the impact of diabetes on the health care system Methods This is a case–control study comparing cases with type 2 diabetes to controls without diabetes matched on age, sex and place of residence. 564 cases and 564 controls will be selected from the outpatient department of a tertiary hospital in Dhaka, Bangladesh. Data on socioeconomic status, health utility index, direct and indirect costs for diabetes, medication adherence, quality of life, treatment satisfaction, diet, physical activity, mental state examination, weight, height, hip and waist circumference, blood pressure, pulse, medication history, laboratory data and physical examination will be conducted. Outcome measures: The primary outcome measures will be association between diabetes and other health problems, cost of diabetes, impact of diabetes on quality of life and secondary outcome measures are impact of diabetes on healthcare systems in Bangladesh. Discussion This study will provide an

  18. Indoor air quality investigation protocols

    SciTech Connect

    Greene, R.E.; Williams, P.L.

    1996-10-01

    Over the past 10 to 15 years, an increasing number of complaints about discomfort and health effects related to indoor air quality (IAQ) have been reported. The increase in complaints has been accompanied by an increase in requests for IAQ investigations. This study presents an overview of the many IAQ investigation protocols published since 1984. For analysis, the protocols are divided into four categories: solution-oriented, building diagnostics, industrial hygiene, and epidemiology. In general, the protocols begin with general observations, proceed to collect more specific data as indicated, and end with conclusions and recommendations. A generic IAQ protocol is presented that incorporates the common aspects of the various protocols. All of the current protocols place heavy emphasis on the ventilation system during the investigation. A major problem affecting all of the current protocols is the lack of generally accepted IAQ standards. IN addition, the use of questionnaires, occupant interviews, and personal diaries (as well as the point in the investigation at which they are administered) differs among the protocols. Medical evaluations and verification procedures also differ among the protocols.

  19. Evaluating holistic needs assessment in outpatient cancer care—a randomised controlled trial: the study protocol

    PubMed Central

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-01-01

    Introduction People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients’ needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. Methods and analysis The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care—routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. Ethics and dissemination This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Trail registration number

  20. Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

    PubMed Central

    2012-01-01

    Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study

  1. Cognitive Impairment in Diabetes: Rationale and Design Protocol of the Cog-ID Study

    PubMed Central

    Janssen, Jolien; Kooistra, Minke; van den Berg, Esther; Kappelle, L Jaap; Biessels, Geert Jan; Rutten, Guy EHM

    2015-01-01

    Background Cognitive impairment frequently co-occurs with type 2 diabetes but is often undiagnosed. Cognitive impairment affects self-management leading to treatment-related complications. Objective The aim of this study is to develop a stepped diagnostic procedure, consisting of a screening test complemented by an evaluation by a general practitioner (GP), to detect undiagnosed cognitive impairment in older people with type 2 diabetes. Methods The accuracy of two self-administered cognitive tests, the “Test Your Memory” (TYM) and “Self-Administered Gerocognitive Examination” (SAGE) alone, and in combination with an evaluation by a GP will be assessed. A diagnosis of mild cognitive impairment (MCI) or dementia at a memory clinic will serve as reference standard. This cognitive impairment in diabetes (Cog-ID) study will include 513 people from primary care facilities aged ≥70 with type 2 diabetes. The participants will first fill out the TYM and SAGE tests, followed by a standardized GP evaluation for cognitive impairment, including a mini mental state examination (MMSE). Subsequently, participants suspected of cognitive impairment (on either test or the GP assessment) and a random sample of 15% (65/435) of participants without suspected cognitive impairment will be referred to the memory clinic. At the memory clinic, a medical examination, neuropsychological examination, and magnetic resonance imaging (MRI) of the brain will be performed. Participants will also fill out questionnaires assessing health status and depressive symptoms at baseline and after 6 and 24 months. Results This research obtained funding and ethical approval. Enrolment started in August, 2012, and all study-related activities will be completed in September, 2016. Conclusions With the results from this study, physicians will be able to detect cognitive impairment affecting type 2 diabetes patients through case-finding, and can use tailored care to reduce associated complications

  2. Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax

    PubMed Central

    Brown, Simon G A; Ball, Emma L; Perrin, Kyle; Read, Catherine A; Asha, Stephen E; Beasley, Richard; Egerton-Warburton, Diana; Jones, Peter G; Keijzers, Gerben; Kinnear, Frances B; Kwan, Ben C H; Lee, Y C Gary; Smith, Julian A; Summers, Quentin A; Simpson, Graham

    2016-01-01

    Introduction Current management of primary spontaneous pneumothorax (PSP) is variable, with little evidence from randomised controlled trials to guide treatment. Guidelines emphasise intervention in many patients, which involves chest drain insertion, hospital admission and occasionally surgery. However, there is evidence that conservative management may be effective and safe, and it may also reduce the risk of recurrence. Significant questions remain regarding the optimal initial approach to the management of PSP. Methods and analysis This multicentre, prospective, randomised, open label, parallel group, non-inferiority study will randomise 342 participants with a first large PSP to conservative or interventional management. To maintain allocation concealment, randomisation will be performed in real time by computer and stratified by study site. Conservative management will involve a period of observation prior to discharge, with intervention for worsening symptoms or physiological instability. Interventional treatment will involve insertion of a small bore drain. If drainage continues after 1 hour, the patient will be admitted. If drainage stops, the drain will be clamped for 4 hours. The patient will be discharged if the lung remains inflated. Otherwise, the patient will be admitted. The primary end point is the proportion of participants with complete lung re-expansion by 8 weeks. Secondary end points are as follows: days in hospital, persistent air leak, predefined complications and adverse events, time to resolution of symptoms, and pneumothorax recurrence during a follow-up period of at least 1 year. The study has 95% power to detect an absolute non-inferiority margin of 9%, assuming 99% successful expansion at 8 weeks in the invasive treatment arm. The primary analysis will be by intention to treat. Ethics and dissemination Local ethics approval has been obtained for all sites. Study findings will be disseminated by publication in a high

  3. Assessment of equity in healthcare financing in Fiji and Timor-Leste: a study protocol

    PubMed Central

    Asante, Augustine D; Price, Jennifer; Hayen, Andrew; Irava, Wayne; Martins, Joao; Guinness, Lorna; Ataguba, John E; Limwattananon, Supon; Mills, Anne; Jan, Stephen; Wiseman, Virginia

    2014-01-01

    Introduction Equitable health financing remains a key health policy objective worldwide. In low and middle-income countries (LMICs), there is evidence that many people are unable to access the health services they need due to financial and other barriers. There are growing calls for fairer health financing systems that will protect people from catastrophic and impoverishing health payments in times of illness. This study aims to assess equity in healthcare financing in Fiji and Timor-Leste in order to support government efforts to improve access to healthcare and move towards universal health coverage in the two countries. Methods and analysis The study employs two standard measures of equity in health financing increasingly being applied in LMICs—benefit incidence analysis (BIA) and financing incidence analysis (FIA). In Fiji, we will use a combination of secondary and primary data including a Household Income and Expenditure Survey, National Health Accounts, and data from a cross-sectional household survey on healthcare utilisation. In Timor-Leste, the World Bank recently completed a health equity and financial protection analysis that incorporates BIA and FIA, and found that the distribution of benefits from healthcare financing is pro-rich. Building on this work, we will explore the factors that influence the pro-rich distribution. Ethics and dissemination The study is approved by the Human Research Ethics Committee of University of New South Wales, Australia (Approval number: HC13269); the Fiji National Health Research Committee (Approval # 201371); and the Timor-Leste Ministry of Health (Ref MS/UNSW/VI/218). Results Study outcomes will be disseminated through stakeholder meetings, targeted multidisciplinary seminars, peer-reviewed journal publications, policy briefs and the use of other web-based technologies including social media. A user-friendly toolkit on how to analyse healthcare financing equity will be developed for use by policymakers and

  4. A protocol and pilot study for managing fibromyalgia with yoga and meditation.

    PubMed

    Hennard, Janet

    2011-01-01

    Fibromyalgia is a chronic syndrome characterized by widespread pain, sleep disturbance, stiffness, fatigue, headache, and mood disorders. Recent research has resulted in an improved understanding of fibromyalgia and its possible causes. This article highlights some of the current research, discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers, and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms. The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness, anxiety, and depression. Significant improvements were also seen in the reported number of days "felt good" and number of days "missed work" because of fibromyalgia. Nonsignificant improvements were seen in measures of pain, fatigue, and how one felt in the morning. Effect sizes were medium to large for most tested areas. This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as standard therapies for fibromyalgia.

  5. The effect of a cadence retraining protocol on running biomechanics and efficiency: a pilot study.

    PubMed

    Hafer, Jocelyn F; Brown, Allison M; deMille, Polly; Hillstrom, Howard J; Garber, Carol Ewing

    2015-01-01

    Many studies have documented the association between mechanical deviations from normal and the presence or risk of injury. Some runners attempt to change mechanics by increasing running cadence. Previous work documented that increasing running cadence reduces deviations in mechanics tied to injury. The long-term effect of a cadence retraining intervention on running mechanics and energy expenditure is unknown. This study aimed to determine if increasing running cadence by 10% decreases running efficiency and changes kinematics and kinetics to make them less similar to those associated with injury. Additionally, this study aimed to determine if, after 6 weeks of cadence retraining, there would be carryover in kinematic and kinetic changes from an increased cadence state to a runner's preferred running cadence without decreased running efficiency. We measured oxygen uptake, kinematic and kinetic data on six uninjured participants before and after a 6-week intervention. Increasing cadence did not result in decreased running efficiency but did result in decreases in stride length, hip adduction angle and hip abductor moment. Carryover was observed in runners' post-intervention preferred running form as decreased hip adduction angle and vertical loading rate.

  6. The ANIBES Study on Energy Balance in Spain: Design, Protocol and Methodology

    PubMed Central

    Ruiz, Emma; Ávila, José Manuel; Castillo, Adrián; Valero, Teresa; del Pozo, Susana; Rodriguez, Paula; Bartrina, Javier Aranceta; Gil, Ángel; González-Gross, Marcela; Ortega, Rosa M.; Serra-Majem, Lluis; Varela-Moreiras, Gregorio

    2015-01-01

    Energy Balance (EB) is an important topic to understand how an imbalance in its main determinants (energy intake and consumption) may lead to inappropriate weight gain, considered to be “dynamic” and not “static”. There are no studies to evaluate EB in Spain, and new technologies reveal themselves as key tools to solve common problems to precisely quantify energy consumption and expenditure at population level. The overall purpose of the ANIBES (“Anthropometry, Intake and Energy Balance”) Study was to carry out an accurate updating of food and beverage intake, dietary habits/behaviour and anthropometric data of the Spanish population (9–75 years, n = 2009), as well as the energy expenditure and physical activity patterns. Anthropometry measurements (weight, height, body mass index, waist circumference, % body fat, % body water) were obtained; diet was evaluated throughout a three-day dietary record (tablet device) accompanied by a 24 h-dietary recall; physical activity was quantified by questionnaire and accelerometers were also employed. Finally, information about perception and understanding of several issues related to EB was also obtained. The ANIBES study will contribute to provide valuable useful data to inform food policy planning, food based dietary guidelines development and other health oriented actions in Spain. PMID:25658237

  7. Prescribing for Australians living with dementia: study protocol using the Delphi technique

    PubMed Central

    Page, Amy; Potter, Kathleen; Clifford, Rhonda; McLachlan, Andrew; Etherton-Beer, Christopher

    2015-01-01

    Introduction Prescribing is complicated for people living with dementia, and careful consideration should be given to continuing and initiating all medicines. This study aims to elicit opinion and gain consensus on appropriate medicine use for people living with dementia in Australia to create a consensus-based list of explicit prescribing criteria. Methods and analysis A Delphi technique will be used to develop explicit criteria of medication use in adults aged 65 years and above. An interdisciplinary panel of Australian experts in geriatric therapeutics will be convened that will consist of a minimum of 10 participants. To develop the consensus-based criteria, this study will use an iterative, anonymous, multistaged approach with controlled feedback. Round 1 questionnaire will be administered, and subsequently qualitatively analysed. The round 1 results will be fed back to the panel members, and a round 2 questionnaire developed using questions on a five-point Likert scale. This process will repeat until consensus is developed, or diminishing returns are noted. Ethics and dissemination All participants will be provided with a participant information sheet, and sign a written consent form. Ethical approval has been granted from the University of Western Australia's Human Research Ethics Committee (HREC) (reference: RA/4/1/7172). We expect that data from this study will result in a paper published in a peer-reviewed clinical journal and will also present the results at conferences. PMID:26264272

  8. The effect of a cadence retraining protocol on running biomechanics and efficiency: a pilot study.

    PubMed

    Hafer, Jocelyn F; Brown, Allison M; deMille, Polly; Hillstrom, Howard J; Garber, Carol Ewing

    2015-01-01

    Many studies have documented the association between mechanical deviations from normal and the presence or risk of injury. Some runners attempt to change mechanics by increasing running cadence. Previous work documented that increasing running cadence reduces deviations in mechanics tied to injury. The long-term effect of a cadence retraining intervention on running mechanics and energy expenditure is unknown. This study aimed to determine if increasing running cadence by 10% decreases running efficiency and changes kinematics and kinetics to make them less similar to those associated with injury. Additionally, this study aimed to determine if, after 6 weeks of cadence retraining, there would be carryover in kinematic and kinetic changes from an increased cadence state to a runner's preferred running cadence without decreased running efficiency. We measured oxygen uptake, kinematic and kinetic data on six uninjured participants before and after a 6-week intervention. Increasing cadence did not result in decreased running efficiency but did result in decreases in stride length, hip adduction angle and hip abductor moment. Carryover was observed in runners' post-intervention preferred running form as decreased hip adduction angle and vertical loading rate. PMID:25369525

  9. The EMBARC European Bronchiectasis Registry: protocol for an international observational study

    PubMed Central

    Aliberti, Stefano; Polverino, Eva; Vendrell, Montserrat; Crichton, Megan; Loebinger, Michael; Dimakou, Katerina; Clifton, Ian; van der Eerden, Menno; Rohde, Gernot; Murris-Espin, Marlene; Masefield, Sarah; Gerada, Eleanor; Shteinberg, Michal; Ringshausen, Felix; Haworth, Charles; Boersma, Wim; Rademacher, Jessica; Hill, Adam T.; Aksamit, Timothy; O'Donnell, Anne; Morgan, Lucy; Milenkovic, Branislava; Tramma, Leandro; Neves, Joao; Menendez, Rosario; Paggiaro, Perluigi; Botnaru, Victor; Skrgat, Sabina; Wilson, Robert; Goeminne, Pieter; De Soyza, Anthony; Welte, Tobias; Torres, Antoni; Elborn, J. Stuart; Blasi, Francesco

    2016-01-01

    Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials. PMID:27730179

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

    PubMed Central

    2011-01-01

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

  11. Financial incentives for smoking cessation in pregnancy: protocol for a single arm intervention study

    PubMed Central

    2013-01-01

    Background Smoking during pregnancy and in the postnatal period is a major cause of low birth weight and a range of adverse infant health outcomes. Stop smoking services can double quit rates, but only 17% of pregnant women smoking at the time they book for antenatal care use these services. In a recent Cochrane review on the effectiveness of smoking cessation interventions in pregnancy, financial incentives were found to be the single most effective intervention. We describe a single arm intervention study offering participation in a financial incentive scheme for smoking cessation to all pregnant smokers receiving antenatal care in one area in England. The aim of the study is to assess the potential effectiveness of using financial incentives to achieve smoking cessation in pregnant women who smoke, to inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies. Method/design 500 consecutive pregnant smokers are offered participation in the scheme, which involves attending for up to 32 assessments until six months post-partum, to verify smoking cessation by self report and a negative exhaled carbon monoxide measurement. At each visit when cessation is verified, participants receive a shopping voucher starting at a value of £8 and increasing by £1 at each consecutive successful visit. Assessments decline in frequency, occurring most frequently during the first two weeks after quitting and the first two weeks after delivery. The maximum cumulative total that can be earned through the scheme is £752. Discussion The results of this study will inform the use of financial incentive schemes in routine clinical practice as well as the interpretation of existing trials and the design of future studies. The main results are (a) an estimate of the proportion of pregnant smokers who enrol in the scheme; (b) estimates of the proportion of pregnant smokers who participate in the

  12. Recognising the differences in the nurse consultant role across context: a study protocol

    PubMed Central

    2014-01-01

    Background The advanced practice role of the Nurse Consultant is unique in its capacity to provide clinical leadership across a range of contexts. However, the Nurse Consultant role has been plagued with confusion due to lack of clarity over function and appropriateness for purpose within health organisations across contexts. Changing health service delivery models are driving the emergence of new nursing roles, further clouding the waters related to role positioning and purpose. There is an urgent need for evidence of impact and demonstration of how Nurse Consultants contribute to health care outcomes. This study aims to gain a clearer understanding of the Nurse Consultant role and its impact in metropolitan and rural New South Wales (NSW) Australia. Design The proposed study employs a sequential mixed method design, underpinned by Realistic Evaluation, to explore how Nurse Consultants contribute to organisational outcomes. The ‘context – mechanism – outcome’ approach of realistic evaluation provides a sound framework to examine the complex, diverse and multifaceted nature of the Nurse Consultant’s role. Method Participants will be stakeholders, recruited across a large Local Health District in NSW, comprising rural and metropolitan services. A modified and previously validated survey will be used providing information related to role characteristics, patterns and differences across health context. Focus groups with Nurse Consultant’s explore issues highlighted in the survey data. Focus groups with other clinicians, policy makers and managers will help to achieve understanding of how the role is viewed and enacted across a range of groups and contexts. Discussion Lack of role clarity is highlighted extensively in international and Australian studies examining the role of the Nurse Consultant. Previous studies failed to adequately examine the role in the context of integrated and complex health services or to examine the role in detail. Such examination

  13. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse

  14. Neuropsychiatric symptoms in patients with dementia in primary care: a study protocol

    PubMed Central

    2014-01-01

    Background Neuropsychiatric symptoms (NPS) frequently occur in patients with dementia. To date, prospective studies on the course of NPS have been conducted in patients with dementia in clinical centers or psychiatric services. The primary goal of this study is to investigate the course of NPS in patients with dementia and caregiver distress in primary care. We also aim to detect determinants of both the course of NPS in patients with dementia and informal caregiver distress in primary care. Methods/design This is a prospective observational study on the course of NPS in patients with dementia in primary care. Thirty-seven general practitioners (GPs) in 18 general practices were selected based on their interest in participating in this study. We will retrieve electronic medical files of patients with dementia from these general practices. Patients and caregivers will be followed for 18 months during the period January 2012 to December 2013. Patient characteristics will be collected at baseline. Time to death or institutionalization will be measured. Co-morbidity will be assessed using the Charlson index. Psychotropic drug use and primary and secondary outcome measures will be measured at 3 assessments, baseline, 9 and 18 months. The primary outcome measures are the Neuropsychiatric Inventory score for patients with dementia and the Sense of Competence score for informal caregivers. In addition to descriptive analyses frequency parameters will be computed. Univariate analysis will be performed to identify determinants of the course of NPS and informal caregiver distress. All determinants will then be tested in a multivariate regression analysis to determine their unique contribution to the course of NPS and caregiver distress. Discussion The results of this study will provide data on the course of NPS, which is clinically important for prognosis. The data will help GPs and other professionals in planning follow-up visits and in the timing for offering psycho

  15. Improving practice in community-based settings: a randomized trial of supervision – study protocol

    PubMed Central

    2013-01-01

    Background Evidence-based treatments for child mental health problems are not consistently available in public mental health settings. Expanding availability requires workforce training. However, research has demonstrated that training alone is not sufficient for changing provider behavior, suggesting that ongoing intervention-specific supervision or consultation is required. Supervision is notably under-investigated, particularly as provided in public mental health. The degree to which supervision in this setting includes ‘gold standard’ supervision elements from efficacy trials (e.g., session review, model fidelity, outcome monitoring, skill-building) is unknown. The current federally-funded investigation leverages the Washington State Trauma-focused Cognitive Behavioral Therapy Initiative to describe usual supervision practices and test the impact of systematic implementation of gold standard supervision strategies on treatment fidelity and clinical outcomes. Methods/Design The study has two phases. We will conduct an initial descriptive study (Phase I) of supervision practices within public mental health in Washington State followed by a randomized controlled trial of gold standard supervision strategies (Phase II), with randomization at the clinician level (i.e., supervisors provide both conditions). Study participants will be 35 supervisors and 130 clinicians in community mental health centers. We will enroll one child per clinician in Phase I (N = 130) and three children per clinician in Phase II (N = 390). We use a multi-level mixed within- and between-subjects longitudinal design. Audio recordings of supervision and therapy sessions will be collected and coded throughout both phases. Child outcome data will be collected at the beginning of treatment and at three and six months into treatment. Discussion This study will provide insight into how supervisors can optimally support clinicians delivering evidence-based treatments. Phase I will

  16. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    PubMed Central

    2011-01-01

    Background Dissemination is a critical facet of implementing quality improvement in organizations. As a field, addiction treatment has produced effective interventions but disseminated them slowly and reached only a fraction of people needing treatment. This study investigates four methods of disseminating quality improvement (QI) to addiction treatment programs in the U.S. It is, to our knowledge, the largest study of organizational change ever conducted in healthcare. The trial seeks to determine the most cost-effective method of disseminating quality improvement in addiction treatment. Methods The study is evaluating the costs and effectiveness of different QI approaches by randomizing 201 addiction-treatment programs to four interventions. Each intervention used a web-based learning kit plus monthly phone calls, coaching, face-to-face meetings, or the combination of all three. Effectiveness is defined as reducing waiting time (days between first contact and treatment), increasing program admissions, and increasing continuation in treatment. Opportunity costs will be estimated for the resources associated with providing the services. Outcomes The study has three primary outcomes: waiting time, annual program admissions, and continuation in treatment. Secondary outcomes include: voluntary employee turnover, treatment completion, and operating margin. We are also seeking to understand the role of mediators, moderators, and other factors related to an organization's success in making changes. Analysis We are fitting a mixed-effect regression model to each program's average monthly waiting time and continuation rates (based on aggregated client records), including terms to isolate state and intervention effects. Admissions to treatment are aggregated to a yearly level to compensate for seasonality. We will order the interventions by cost to compare them pair-wise to the lowest cost intervention (monthly phone calls). All randomized sites with outcome data will be

  17. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Ravn, Henrik; Batista, Celso Soares Pereira; Rodrigues, Amabelia

    2016-01-01

    Background Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have

  18. International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol

    PubMed Central

    2011-01-01

    Background Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls). Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D) ClinicalTrials.gov Identifier: NCT00693849 URL: http

  19. Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Rozental, Alexander

    2013-01-01

    Background Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment

  20. Comparison of the BPLab® sphygmomanometer for ambulatory blood pressure monitoring with mercury sphygmomanometry in pregnant women: validation study according to the British Hypertension Society protocol

    PubMed Central

    Dorogova, Inna V; Panina, Elena S

    2015-01-01

    The purpose of this study was to validate the automated BPLab® sphygmomanometer for ambulatory blood pressure monitoring (ABPM) in pregnant women according to Part II of the 1993 British Hypertension Society protocol. Pregnant women attending the antenatal clinic were randomly asked to participate (n=30). The BPLab sphygmomanometer was tested on pregnant women in this study and achieved A/A ratings according to the BHS protocol when compared with the “gold” standard of mercury sphygmomanometry. The device can therefore be recommended for use in pregnancy. PMID:25926739

  1. Measuring the relationship between interruptions, multitasking and prescribing errors in an emergency department: a study protocol

    PubMed Central

    Raban, Magdalena Z; Walter, Scott R; Douglas, Heather E; Strumpman, Dana; Mackenzie, John; Westbrook, Johanna I

    2015-01-01

    Introduction Interruptions and multitasking are frequent in clinical settings, and have been shown in the cognitive psychology literature to affect performance, increasing the risk of error. However, comparatively less is known about their impact on errors in clinical work. This study will assess the relationship between prescribing errors, interruptions and multitasking in an emergency department (ED) using direct observations and chart review. Methods and analysis The study will be conducted in an ED of a 440-bed teaching hospital in Sydney, Australia. Doctors will be shadowed at proximity by observers for 2 h time intervals while they are working on day shift (between 0800 and 1800). Time stamped data on tasks, interruptions and multitasking will be recorded on a handheld computer using the validated Work Observation Method by Activity Timing (WOMBAT) tool. The prompts leading to interruptions and multitasking will also be recorded. When doctors prescribe medication, type of chart and chart sections written on, along with the patient's medical record number (MRN) will be recorded. A clinical pharmacist will access patient records and assess the medication orders for prescribing errors. The prescribing error rate will be calculated per prescribing task and is defined as the number of errors divided by the number of medication orders written during the prescribing task. The association between prescribing error rates, and rates of prompts, interruptions and multitasking will be assessed using statistical modelling. Ethics and dissemination Ethics approval has been obtained from the hospital research ethics committee. Eligible doctors will be provided with written information sheets and written consent will be obtained if they agree to participate. Doctor details and MRNs will be kept separate from the data on prescribing errors, and will not appear in the final data set for analysis. Study results will be disseminated in publications and feedback to the ED. PMID

  2. Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol

    PubMed Central

    2013-01-01

    Background Trypanosoma cruzi has been divided into Discrete Typing Units I and non-I (II-VI). T. cruzi I is predominant in Mexico and Central America, while non-I is predominant in most of South America, including Argentina. Little is known about congenital transmission of T. cruzi I. The specific aim of this study is to determine the rate of congenital transmission of T. cruzi I compared to non-I. Methods/design We are conducting a prospective study to enroll at delivery, 10,000 women in Argentina, 7,500 women in Honduras, and 13,000 women in Mexico. We are measuring transmitted maternal T. cruzi antibodies by performing two rapid tests in cord blood (Stat-Pak, Chembio, Medford, New York, and Trypanosoma Detect, InBios, Seattle, Washington). If at least one of the results is positive, we are identifying infants who are congenitally infected by performing parasitological examinations on cord blood and at 4–8 weeks, and serological follow-up at 10 months. Serological confirmation by ELISA (Wiener, Rosario, Argentina) is performed in cord and maternal blood, and at 10 months. We also are performing T. cruzi standard PCR, real-time quantitative PCR and genotyping on maternal venous blood and on cord blood, and serological examinations on siblings. Data are managed by a Data Center in Montevideo, Uruguay. Data are entered online at the sites in an OpenClinica data management system, and digital pictures of data forms are sent to the Data Center for quality control. Weekly reports allow for rapid feedback to the sites. Trial registration Observational study with ClinicalTrials.gov Identifier NCT01787968 PMID:24119247

  3. Default options in advance directives: study protocol for a randomised clinical trial

    PubMed Central

    Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea B; Arnold, Robert M; White, Douglas B; Angus, Derek C; Loewenstein, George; Volpp, Kevin G; Bryce, Cindy L; Halpern, Scott D

    2016-01-01

    Introduction Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will promote better patient-centred outcomes. Methods and analysis This multicentre trial randomises seriously ill adults to receive 1 of 3 different ADs: (1) a traditional AD that requires patients to actively choose their goals of care or preferences for specific interventions (eg, feeding tube insertion) or otherwise have their care guided by their surrogates and the prevailing societal default toward aggressive care; (2) an AD that defaults to life-extending care and receipt of life-sustaining interventions, enabling patients to opt out from such care; or (3) an AD that defaults to comfort care, enabling patients to opt into life-extending care. We seek to enrol 270 patients who return complete, legally valid ADs so as to generate sufficient power to detect differences in the primary outcome of hospital-free days (days alive and not in an acute care facility). Secondary outcomes include hospital and intensive care unit admissions, costs of care, hospice usage, decision conflict and satisfaction, quality of life, concordance of preferences with care received and bereavement outcomes for surrogates of patients who die. Ethics and dissemination This study has been approved by the Institutional Review Boards at all trial centres, and is guided by a data safety and monitoring board and an ethics advisory board. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. Trial registration number NCT02017548

  4. How safe are our paediatric emergency departments? Protocol for a national prospective cohort study

    PubMed Central

    Plint, Amy C; Newton, Amanda; Stang, Antonia; Bhatt, Maala; Barrowman, Nick; Calder, Lisa

    2014-01-01

    Introduction Adverse events (AEs), defined as unintended patient harm related to healthcare provided rather than an underlying medical condition, represent a significant threat to patient safety and public health. The emergency department (ED) is a high-risk patient safety setting for many reasons including presentation ‘outside of regular hours’, high patient volumes, and a chaotic work environment. Children have also been identified as particularly vulnerable to AEs. Despite the identification of the ED as a high-risk setting and the vulnerability of the paediatric population, little research has been conducted regarding paediatric patient safety in the ED. The study objective is to generate an estimate of the risk and type of AEs, as well as their preventability and severity, for children seen in Canadian paediatric EDs. Methods and analysis This multicentre, prospective cohort study will enrol patients under 18 years of age from nine paediatric EDs across Canada. A stratified cluster random sampling scheme will be used to ensure patients recruited are representative of the overall ED population. A rigorous, standardised two-stage process will be used for AE identification. The primary outcome will be the proportion of children with AEs associated with ED care in the 3 weeks following the ED visit. Secondary outcomes will include the proportion of children with preventable AEs and the types and severity of AEs. We will aim to recruit 5632 patients over 1 year and this will allow us to detect a proportion of patients with an AE of 5% (to within an absolute margin of error of 0.6%). Ethics and dissemination Ethics approval has been obtained from participating sites. Results will be disseminated through presentations, peer review publications, linkages with emergency research network and a webinars for key knowledge user groups. Trial registration number This study is registered at Clinicaltrials.gov (NCT02162147; https://clinicaltrials.gov/ct2/show

  5. Multi-level analysis of electronic health record adoption by health care professionals: A study protocol

    PubMed Central

    2010-01-01

    Background The electronic health record (EHR) is an important application of information and communication technologies to the healthcare sector. EHR implementation is expected to produce benefits for patients, professionals, organisations, and the population as a whole. These benefits cannot be achieved without the adoption of EHR by healthcare professionals. Nevertheless, the influence of individual and organisational factors in determining EHR adoption is still unclear. This study aims to assess the unique contribution of individual and organisational factors on EHR adoption in healthcare settings, as well as possible interrelations between these factors. Methods A prospective study will be conducted. A stratified random sampling method will be used to select 50 healthcare organisations in the Quebec City Health Region (Canada). At the individual level, a sample of 15 to 30 health professionals will be chosen within each organisation depending on its size. A semi-structured questionnaire will be administered to two key informants in each organisation to collect organisational data. A composite adoption score of EHR adoption will be developed based on a Delphi process and will be used as the outcome variable. Twelve to eighteen months after the first contact, depending on the pace of EHR implementation, key informants and clinicians will be contacted once again to monitor the evolution of EHR adoption. A multilevel regression model will be applied to identify the organisational and individual determinants of EHR adoption in clinical settings. Alternative analytical models would be applied if necessary. Results The study will assess the contribution of organisational and individual factors, as well as their interactions, to the implementation of EHR in clinical settings. Conclusions These results will be very relevant for decision makers and managers who are facing the challenge of implementing EHR in the healthcare system. In addition, this research constitutes a

  6. Safety in home care: A research protocol for studying medication management

    PubMed Central

    2010-01-01

    Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB), Ontario (ON), Quebec (QC) and Nova Scotia (NS), we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange throughout the study with the use

  7. [Comparative study of two protocols of antibiotic prophylaxis in endoscopic urologic surgery].

    PubMed

    Lepage, J Y; Malinowsky, J M; Cozian, A; Viers, M F; Rolland, M T; Péron, M; Souron, R; Baron, D

    1990-06-01

    We report an open, prospective, randomized and double-blind study which compared two groups of patients without preoperative bacteriuria, undergoing transurethral urologic surgery. A first group received cefazoline 3 g perioperatively and a second group a single preoperative dose of cefotiam 1 g. A hundred patients were included in each group which were well matched on all essential characteristics, risk factors, surgery, anesthesia and postoperative temperature. The incidence of postoperative infection (bacteriemia and bacteriuria) was the same in both groups (16%). It is concluded that in transurethral urologic surgery performed in patients without preoperative bacteriuria, 1 preoperative dose cefotiam is as efficacious as 3 perioperative doses cefazoline.

  8. A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    PubMed Central

    Smits, Christel CF; Jaddoe, Vincent WV; Hofman, Albert; Toelsie, Jerry R

    2015-01-01

    Background Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results The data as collected allow for national inference and

  9. Cohort protocol paper: The Pain and Opioids In Treatment (POINT) study

    PubMed Central

    2014-01-01

    Background Internationally, there is concern about the increased prescribing of pharmaceutical opioids for chronic non-cancer pain (CNCP). In part, this is related to limited knowledge about the long-term benefits and outcomes of opioid use for CNCP. There has also been increased injection of some pharmaceutical opioids by people who inject drugs, and for some patients, the development of problematic and/or dependent use. To date, much of the research on the use of pharmaceutical opioids among people with CNCP, have been clinical trials that have excluded patients with complex needs, and have been of limited duration (i.e. fewer than 12 weeks). The Pain and Opioids In Treatment (POINT) study is unique study that aims to: 1) examine patterns of opioid use in a cohort of patients prescribed opioids for CNCP; 2) examine demographic and clinical predictors of adverse events, including opioid abuse or dependence, medication diversion, other drug use, and overdose; and 3) identify factors predicting poor pain relief and other outcomes. Methods/Design The POINT cohort comprises around 1,500 people across Australia prescribed pharmaceutical opioids for CNCP. Participants will be followed-up at four time points over a two year period. POINT will collect information on demographics, physical and medication use history, pain, mental health, drug and alcohol use, non-adherence, medication diversion, sleep, and quality of life. Data linkage will provide information on medications and services from Medicare (Australia’s national health care scheme). Data on those who receive opioid substitution therapy, and on mortality, will be linked. Discussion This study will rigorously examine prescription opioid use among CNCP patients, and examine its relationship to important health outcomes. The extent to which opioids for chronic pain is associated with pain reduction, quality of life, mental and physical health, aberrant medication behavior and substance use disorders will be

  10. Factors influencing delay in the diagnosis of colorectal cancer: a study protocol

    PubMed Central

    Esteva, Magdalena; Ramos, Maria; Cabeza, Elena; Llobera, Joan; Ruiz, Amador; Pita, Salvador; Segura, Josep M; Cortés, Jose M; González-Lujan, Luis

    2007-01-01

    Background Colorectal cancer (CRC) is the second most frequent tumor in developed countries. Since survival from CRC depends mostly on disease stage at the time of diagnosis, individuals with symptoms or signs suspicious of CRC should be examined without delay. Many factors, however, intervene between symptom onset and diagnosis. This study was designed to: 1) Describe the diagnostic process of CRC from the onset of first symptoms to diagnosis and treatment. 2) Establish the time interval from initial symptoms to diagnosis and treatment, globally and considering patient's and doctors' delay, with the latter due to family physician and/or hospital services. 3) Identify the factors related to defined types of delay. 4) Assess the concordance between information included in primary health care and hospital clinical records regarding onset of first symptoms. Methods/Design Descriptive study, coordinated, with 5 participant groups of 5 different Spanish regions (Balearic Islands, Galicia, Catalunya, Aragón and Valencia Health Districts), with a total of 8 acute public hospitals and 140 primary care centers. Incident cases of CRC during the study period, as identified from pathology services at the involved hospitals. A sample size of 896 subjects has been estimated, 150 subjects for each participant group. Information will be collected through patient interviews and primary health care and hospital clinical records. Patient variables will include sociodemographic variables, family history of cancer, symptom perception, and confidence in the family physician; tumor variables will include tumor site, histological type, grade and stage; symptom variables will include date of onset, type and number of symptoms; health system variables will include number of patient contacts with family physician, type and content of the referral, hospital services attending the patient, diagnostic modalities and results; and delay intervals, including global delays and delays attributed to

  11. Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    PubMed Central

    Álvarez-del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; del Amo, Julia; Burns, Fiona M

    2016-01-01

    Background Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires

  12. Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

    PubMed Central

    2012-01-01

    Background The prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis unrelated to cystic fibrosis (CF) among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. Methods/design We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis) with no underlying disease identified (such as CF or primary immunodeficiency), and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week) or placebo (once a week) for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years), and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical assessments every 3 to 4

  13. Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

    PubMed

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs. PMID:27332433

  14. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other

  15. Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol

    PubMed Central

    Artinian, Nancy T; Schwiebert, Loren; Yarandi, Hossein; Levy, Phillip D

    2015-01-01

    Background Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population. Objective The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN. Methods In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention. Results Although data collection is now complete, data analysis from the

  16. Study Protocol: The influence of Running Therapy on executive functions and sleep of prisoners

    PubMed Central

    Meijers, Jesse; Harte, Joke; Meynen, Gerben; Cuijpers, Pim

    2015-01-01

    Background: Executive dysfunction appears to be related to increased recidivism. Of note is that sleep disturbances, which are highly prevalent in prisons, may attenuate executive functions. Thus, improving executive functions, either directly or indirectly through the improvement of sleep, may reduce recidivism. It is hypothesised that physical exercise, in the form of Running Therapy, has a direct positive effect on executive functions as well as an indirect effect through the improvement of sleep. Methods/Design: Seventy two (N = 72) detainees in various penitentiary institutions in the Netherlands will be recruited in this study. A baseline measurement, including six neuropsychological tests of the Cambridge Neuropsychological Test Automated Battery (CANTAB), an assessment of sleep quality and duration using the Actiwatch (Actiwatch 2, Philips Respironics, Murrysville, PA, USA) and various other measurements will be administered before the start of the treatment. After 3 months of Running Therapy, participants will be assessed again with the same tests for neuropsychological and physical functioning. Primary outcomes are executive functioning and various sleep variables. Discussion: This study will be the first to investigate the possible influence of Running Therapy on the cognitive functioning, sleep and aggression in prisoners. PMID:26664703

  17. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability.

    PubMed

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and

  18. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability

    PubMed Central

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A.; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and (c) suggestions for further research. PMID:27445902

  19. A comparative study of Sterofundin and Ringer lactate based infusion protocol in scoliosis correction surgery

    PubMed Central

    Sharma, Ashima; Yadav, Monu; Kumar, B. Rajesh; Lakshman, P. Sai; Iyenger, Raju; Ramchandran, Gopinath

    2016-01-01

    Background: A major change in anesthesia practice as regards to intraoperative infusion therapy is the present requirement. Switching over to balanced fluids can substantially decrease the incidence of lactic acidosis and hyperchloremic acidosis. The deleterious effects of unbalanced fluids are more recognizable during major surgeries. We prospectively studied the influence of Sterofundin (SF) and Ringer lactate (RL) on acid–base changes, hemodynamics, and readiness for extubation during scoliosis surgery. Subjects and Methods: Thirty consecutive children posted for scoliosis surgery were randomized to receive either RL (n = 15) or SF (n = 15) as intraoperative fluid at 10 mg/kg/h. Fluid boluses were added according to the study fluid algorithm. Arterial blood was sampled and analyzed at hourly intervals during surgery. Red blood cell transfusion was guided by hematocrit below 27. Patients were followed for 24 h postoperatively in the Intensive Care Unit. Results: There was no statistically significant difference in the volume of infused fluid (2400 ± 512 ml in Group RL and 2200 ± 640 ml in Group SF. There were no significant changes in pH of patients infused with SF. Statistically, significant higher lactate levels were seen in RL-infused group. The strong ion difference was decreased in both groups, but it normalized earlier with SF. Conclusions: SF-infused patients had nonremarkable changes in acid–base physiology in scoliosis surgery. PMID:27746547

  20. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability.

    PubMed

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and PMID:27445902

  1. Low-Frequency Repetitive Transcranial Magnetic Stimulation and Intensive Occupational Therapy for Poststroke Patients with Upper Limb Hemiparesis: Preliminary Study of a 15-Day Protocol

    ERIC Educational Resources Information Center

    Kakuda, Wataru; Abo, Masahiro; Kobayashi, Kazushige; Momosaki, Ryo; Yokoi, Aki; Fukuda, Akiko; Ishikawa, Atsushi; Ito, Hiroshi; Tominaga, Ayumi

    2010-01-01

    The purpose of the study was to determine the safety and feasibility of a 15-day protocol of low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with intensive occupational therapy (OT) on motor function and spasticity in hemiparetic upper limbs in poststroke patients. Fifteen poststroke patients (age at study entry 55 [plus…

  2. Reference gene selection and RNA preservation protocol in the cat flea, Ctenocephalides felis, for gene expression studies.

    PubMed

    McIntosh, Catriona H; Baird, John; Zinser, Erich; Woods, Debra J; Campbell, Ewan M; Bowman, Alan S

    2016-10-01

    The cat flea, Ctenocephalides felis, is a major pest species on companion animals thus of significant importance to the animal health industry. The aim of this study was to develop sampling and storage protocols and identify stable reference genes for gene expression studies to fully utilize the growing body of molecular knowledge of C. felis. RNA integrity was assessed in adult and larvae samples, which were either pierced or not pierced and stored in RNAlater at ambient temperature. RNA quality was maintained best in pierced samples, with negligible degradation evident after 10 days. RNA quality from non-pierced samples was poor within 3 days. Ten candidate reference genes were evaluated for their stability across four group comparisons (developmental stages, genders, feeding statuses and insecticide-treatment statuses). Glyceraldehyde 3 phosphate dehydrogenase (GAPDH), 60S ribosomal protein L19 (RPL19) and elongation factor-1α (Ef) were ranked highly in all stability comparisons, thus are recommended as reference genes under similar conditions. Employing just two of these three stable reference genes was sufficient for accurate normalization. Our results make a significant contribution to the future of gene expression studies in C. felis, describing validated sample preparation procedures and reference genes for use in this common pest.

  3. Formative research to develop theory-based messages for a Western Australian child drowning prevention television campaign: study protocol

    PubMed Central

    Denehy, Mel; Crawford, Gemma; Leavy, Justine; Nimmo, Lauren; Jancey, Jonine

    2016-01-01

    Introduction Worldwide, children under the age of 5 years are at particular risk of drowning. Responding to this need requires the development of evidence-informed drowning prevention strategies. Historically, drowning prevention strategies have included denying access, learning survival skills and providing supervision, as well as education and information which includes the use of mass media. Interventions underpinned by behavioural theory and formative evaluation tend to be more effective, yet few practical examples exist in the drowning and/or injury prevention literature. The Health Belief Model and Social Cognitive Theory will be used to explore participants' perspectives regarding proposed mass media messaging. This paper describes a qualitative protocol to undertake formative research to develop theory-based messages for a child drowning prevention campaign. Methods and analysis The primary data source will be focus group interviews with parents and caregivers of children under 5 years of age in metropolitan and regional Western Australia. Qualitative content analysis will be used to analyse the data. Ethics and dissemination This study will contribute to the drowning prevention literature to inform the development of future child drowning prevention mass media campaigns. Findings from the study will be disseminated to practitioners, policymakers and researchers via international conferences, peer and non-peer-reviewed journals and evidence summaries. The study was submitted and approved by the Curtin University Human Research Ethics Committee. PMID:27207621

  4. The Cessation in Pregnancy Incentives Trial (CPIT): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010) highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600) will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an efficient trial design without

  5. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

    PubMed Central

    2014-01-01

    Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and

  6. The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Axillary lymph node dissection (ALND) in patients with breast cancer has the potential to induce side-effects, including upper-limb lymphedema. Axillary reverse mapping (ARM) is a technique that enables discrimination of the lymphatic drainage of the breast from that of the upper limb in the axillary lymph node (LN) basin. If lymphedema is caused by removing these lymphatics and nodes in the upper limb, the possibility of identifying these lymphatics would enable surgeons to preserve them. The aim of this study is to determine the clinical relevance of selective axillary LN and lymphatic preservation by means of ARM. To minimize the risk of overlooking tumor-positive ARM nodes and the associated risk of undertreatment, we will only include patients with a tumor-positive sentinel lymph node (SLN). Patients who are candidates for ALND because of a proven positive axillary LN at clinical examination can be included in a registration study. Methods/design The study will enroll 280 patients diagnosed with SLN biopsy-proven metastasis of invasive breast cancer with an indication for a completion ALND. Patients will be randomized to undergo standard ALND or an ALND in which the ARM nodes and their corresponding lymphatics will be left in situ. Primary outcome is the presence of axillary surgery-related lymphedema at 6, 12, and 24 months post-operatively, measured by the water-displacement method. Secondary outcome measures include pain, paresthesia, numbness, and loss of shoulder mobility, quality of life, and axillary recurrence risk. Discussion The benefit of ALND in patients with a positive SLN is a subject of debate. For many patients, an ALND will remain the treatment of choice. This multicenter randomized trial will provide evidence of whether or not axillary LN preservation by means of ARM decreases the side-effects of an ALND. Enrolment of patients will start in April 2013 in five breast-cancer centers in the Netherlands, and is expected to conclude by

  7. Piccolipiù, a multicenter birth cohort in Italy: protocol of the study

    PubMed Central

    2014-01-01

    Background The fetal and infant life are periods of rapid development, characterized by high susceptibility to exposures. Birth cohorts provide unique opportunities to study early-life exposures in association with child development and health, as well as, with longer follow-up, the early life origin of adult diseases. Piccolipiù is an Italian birth cohort recently set up to investigate the effects of environmental exposures, parental conditions and social factors acting during pre-natal and early post-natal life on infant and child health and development. We describe here its main characteristics. Methods/design Piccolipiù is a prospective cohort of expected 3000 newborns, who will be recruiting in six maternity units of five Italian cities (Florence, Rome, Trieste, Turin and Viareggio) since October 2011. Mothers are contacted during pregnancy or at delivery and are offered to participate in the study. Upon acceptance, their newborns are recruited at birth and followed up until at least 18 years of age. At recruitment, the mothers donate a blood sample and complete a baseline questionnaire. Umbilical cord blood, pieces of umbilical cord and heel blood spots are also collected. Postnatal follow-up currently occurs at 6, 12, and 24 months of age using on-line or postal self administered questionnaire; further questionnaires and medical examinations are envisaged. Questionnaires collect information on several factors, including mother’s and/or child’s environmental exposures, anthropometric measures, reproductive factors, diet, supplements, medical history, cognitive development, mental health and socioeconomic factors. Health promotion materials are also offered to parents. Discussion Piccolipiù will broaden our understanding of the contribution of early-life factors to infant and child health and development. Several hypotheses on the developmental origins of health can be tested or piloted using the data collected from the Piccolipiù cohort. By pooling

  8. Subgroups of musculoskeletal pain patients and their psychobiological patterns – The LOGIN study protocol

    PubMed Central

    2012-01-01

    Background Pain conditions of the musculoskeletal system are very common and have tremendous socioeconomic impact. Despite its high prevalence, musculoskeletal pain remains poorly understood and predominantly non-specifically and insufficiently treated. The group of chronic musculoskeletal pain patients is supposed to be heterogeneous, due to a multitude of mechanisms involved in chronic pain. Psychological variables, psychophysiological processes, and neuroendocrine alterations are expected to be involved. Thus far, studies on musculoskeletal pain have predominantly focused on the general aspects of pain processing, thus neglecting the heterogeneity of patients with musculoskeletal pain. Consequently, there is a need for studies that comprise a multitude of mechanisms that are potentially involved in the chronicity and spread of pain. This need might foster research and facilitate a better pathophysiological understanding of the condition, thereby promoting the development of specific mechanism-based treatments for chronic pain. Therefore, the objectives of this study are as follows: 1) identify and describe subgroups of patients with musculoskeletal pain with regard to clinical manifestations (including mental co-morbidity) and 2) investigate whether distinct sensory profiles or 3) distinct plasma levels of pain-related parameters due to different underlying mechanisms can be distinguished in various subgroups of pain patients. Methods/Design We will examine a population-based chronic pain sample (n = 100), a clinical tertiary care sample (n = 100) and pain-free patients with depression or post-traumatic stress disorder and pain-free healthy controls (each n = 30, respectively). The samples will be pain localisation matched by sex and age to the population-based sample. Patients will undergo physical examination and thorough assessments of mental co-morbidity (including psychological trauma), perceptual and central sensitisation (quantitative sensory

  9. Food choices and practices during pregnancy of immigrant and Aboriginal women in Canada: a study protocol

    PubMed Central

    2011-01-01

    Background Facilitating the provision of appropriate health care for immigrant and Aboriginal populations in Canada is critical for maximizing health potential and well-being. Numerous reports describe heightened risks of poor maternal and birth outcomes for immigrant and Aboriginal women. Many of these outcomes may relate to food consumption/practices and thus may be obviated through provision of resources which suit the women's ethnocultural preferences. This project aims to understand ethnocultural food and health practices of Aboriginal and immigrant women, and how these intersect with respect to the legacy of Aboriginal colonialism and to the social contexts of cultural adaptation and adjustment of immigrants. The findings will inform the development of visual tools for health promotion by practitioners. Methods/Design This four-phase study employs a case study design allowing for multiple means of data collection and different units of analysis. Phase 1 consists of a scoping review of the literature. Phases 2 and 3 incorporate pictorial representations of food choices (photovoice in Phase 2) with semi-structured photo-elicited interviews (in Phase 3). The findings from Phases 1-3 and consultations with key stakeholders will generate key understandings for Phase 4, the production of culturally appropriate visual tools. For the scoping review, an emerging methodological framework will be utilized in addition to systematic review guidelines. A research librarian will assist with the search strategy and retrieval of literature. For Phases 2 and 3, recruitment of 20-24 women will be facilitated by team member affiliations at perinatal clinics in one of the city's most diverse neighbourhoods. The interviews will reveal culturally normative practices surrounding maternal food choices and consumption, including how women negotiate these practices within their own worldview and experiences. A structured and comprehensive integrated knowledge translation plan has been

  10. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

    PubMed Central

    2013-01-01

    Background Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. Methods/Design The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month’s duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. Discussion

  11. Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study. Methods/design This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about

  12. Effects of space environment on structural materials - A preliminary study and development of materials characterization protocols

    NASA Technical Reports Server (NTRS)

    Miglionico, C.; Stein, C.; Murr, L. E.

    1991-01-01

    A preliminary study of materials exposed in space in LEO for nearly six years in the NASA Long-Duration Exposure Facility is presented. It is demonstrated that it will be necessary to isolate surface debris and reaction products from materials exposed in space. Replication techniques originally designed for electron microscopy examination of surfaces can be applied to lift off and isolate such surface features. Debris and reaction products were examined through a variety of analytical techniques, including the surface morphology by SEM, and internal microstructures by STEM and TEM, EDS, and SAD. The results illustrate the role that atomic oxygen and micrometeorites play in surface alteration and reaction in LEO space environments, as well as the role of debris created from other proximate materials.

  13. Nutritional Strategies Facing an Older Demographic: The Nutrition UP 65 Study Protocol

    PubMed Central

    2016-01-01

    Background The population of Portugal is aging. The lack of data on older adults’ nutritional status and the lack of nutrition knowledge amongst health professionals, caregivers, and older adults themselves, remains a challenge. Objective The Nutrition UP 65 study aims to reduce nutritional inequalities in the older Portuguese adult population and improve knowledge regarding older Portuguese adults’ nutritional status, specifically relating to undernutrition, obesity, sarcopenia, frailty, hydration, sodium, and vitamin D statuses. Methods A representative sample of older Portuguese adults was selected. Sociodemographic, lifestyle, anthropometric, functional, and clinical data were collected. Sodium excretion, hydration, and vitamin D statuses were assessed. Results Data collection (n=1500) took place between December, 2015 and June, 2016. Results will be disseminated in national and international scientific journals, and via Portuguese media. Conclusions Nutrition UP 65 results will provide evidence for the design and implementation of effective preventive public health strategies regarding the elderly. These insights may represent relevant health gains and costs savings. PMID:27628097

  14. Physical Activity through Sustainable Transport Approaches (PASTA): a study protocol for a multicentre project

    PubMed Central

    de Nazelle, Audrey; Nieuwenhuijsen, Mark; Panis, Luc Int; Anaya, Esther; Avila-Palencia, Ione; Boschetti, Florinda; Brand, Christian; Cole-Hunter, Tom; Dons, Evi; Eriksson, Ulf; Gaupp-Berghausen, Mailin; Kahlmeier, Sonja; Laeremans, Michelle; Mueller, Natalie; Orjuela, Juan Pablo; Racioppi, Francesca; Raser, Elisabeth; Rojas-Rueda, David; Schweizer, Christian; Standaert, Arnout; Uhlmann, Tina; Wegener, Sandra; Götschi, Thomas

    2016-01-01

    Introduction Only one-third of the European population meets the minimum recommended levels of physical activity (PA). Physical inactivity is a major risk factor for non-communicable diseases. Walking and cycling for transport (active mobility, AM) are well suited to provide regular PA. The European research project Physical Activity through Sustainable Transport Approaches (PASTA) pursues the following aims: (1) to investigate correlates and interrelations of AM, PA, air pollution and crash risk; (2) to evaluate the effectiveness of selected interventions to promote AM; (3) to improve health impact assessment (HIA) of AM; (4) to foster the exchange between the disciplines of public health and transport planning, and between research and practice. Methods and analysis PASTA pursues a mixed-method and multilevel approach that is consistently applied in seven case study cities. Determinants of AM and the evaluation of measures to increase AM are investigated through a large scale longitudinal survey, with overall 14 000 respondents participating in Antwerp, Barcelona, London, Örebro, Rome, Vienna and Zurich. Contextual factors are systematically gathered in each city. PASTA generates empirical findings to improve HIA for AM, for example, with estimates of crash risks, factors on AM-PA substitution and carbon emissions savings from mode shifts. Findings from PASTA will inform WHO's online Health Economic Assessment Tool on the health benefits from cycling and/or walking. The study's wide scope, the combination of qualitative and quantitative methods and health and transport methods, the innovative survey design, the general and city-specific analyses, and the transdisciplinary composition of the consortium and the wider network of partners promise highly relevant insights for research and practice. Ethics and dissemination Ethics approval has been obtained by the local ethics committees in the countries where the work is being conducted, and sent to the European

  15. Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study

    PubMed Central

    Marcano-Belisario, José S; Gupta, Ajay K; O'Donoghue, John; Morrison, Cecily; Car, Josip

    2016-01-01

    Introduction Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices. Methods and analysis We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages. Ethics and dissemination This study has been approved by the National Research Ethics Service Committee South East Coast—Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers. PMID:26801468

  16. A prospective cohort study to evaluate peridomestic infection as a determinant of dengue transmission: Protocol

    PubMed Central

    2012-01-01

    Background Vector control programs, which have focused mainly on the patient house and peridomestic areas around dengue cases, have not produced the expected impact on transmission. This project will evaluate the assumption that the endemic/epidemic transmission of dengue begins around peridomestic vicinities of the primary cases. Its objective is to assess the relationship between symptomatic dengue case exposure and peridomestic infection incidence. Methods/Design A prospective cohort study will be conducted (in Tepalcingo and Axochiapan, in the state of Morelos, Mexico), using the state surveillance system for the detection of incident cases. Paired blood specimens will be collected from both the individuals who live with the incident cases and a sample of subjects residing within a 25-meter radius of such cases (exposed cohort), in order to measure dengue-specific antibodies. Other subjects will be selected from areas which have not presented any incident cases within 200 meters, during the two months preceding the sampling (non-exposed cohort). Symptomatic/asymptomatic incident infection will be considered as the dependent variable, exposure to confirmed dengue cases, as the principal variable, and the socio-demographic, environmental and socio-cultural conditions of the subjects, as additional explanatory variables. Discussion Results indicating a high infection rate among the exposed subjects would justify the application of peridomestic control measures and call for an evaluation of alternate causes for insufficient program impact. On the other hand, a low incidence of peridomestic-infected subjects would support the hypothesis that infection occurs outside the domicile, and would thus explain why the vector control measures applied in the pas