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Sample records for randomly selected subjects

  1. Selection bias and subject refusal in a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rochelle Yang

    2017-07-01

    Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

  2. Blocked Randomization with Randomly Selected Block Sizes

    Directory of Open Access Journals (Sweden)

    Jimmy Efird

    2010-12-01

    Full Text Available When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  3. Blocked randomization with randomly selected block sizes.

    Science.gov (United States)

    Efird, Jimmy

    2011-01-01

    When planning a randomized clinical trial, careful consideration must be given to how participants are selected for various arms of a study. Selection and accidental bias may occur when participants are not assigned to study groups with equal probability. A simple random allocation scheme is a process by which each participant has equal likelihood of being assigned to treatment versus referent groups. However, by chance an unequal number of individuals may be assigned to each arm of the study and thus decrease the power to detect statistically significant differences between groups. Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms, especially when the sample size is small. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block. Yet still, the allocation process may be predictable, for example, when the investigator is not blind and the block size is fixed. This paper provides an overview of blocked randomization and illustrates how to avoid selection bias by using random block sizes.

  4. Randomized selection on the GPU

    Energy Technology Data Exchange (ETDEWEB)

    Monroe, Laura Marie [Los Alamos National Laboratory; Wendelberger, Joanne R [Los Alamos National Laboratory; Michalak, Sarah E [Los Alamos National Laboratory

    2011-01-13

    We implement here a fast and memory-sparing probabilistic top N selection algorithm on the GPU. To our knowledge, this is the first direct selection in the literature for the GPU. The algorithm proceeds via a probabilistic-guess-and-chcck process searching for the Nth element. It always gives a correct result and always terminates. The use of randomization reduces the amount of data that needs heavy processing, and so reduces the average time required for the algorithm. Probabilistic Las Vegas algorithms of this kind are a form of stochastic optimization and can be well suited to more general parallel processors with limited amounts of fast memory.

  5. Transcranial cerebral oximetry in random normal subjects

    Science.gov (United States)

    Misra, Mukesh; Stark, Jennifer; Dujovny, Manuel; Alp, M. Serdar; Widman, Ronald; Ausman, James I.

    1997-08-01

    Near infrared optical spectroscopy is becoming a useful method for monitoring regional cerebral oxygenation status. The method is simple, reliable and noninvasive and the information which it provides is clinically significant in managing a growing number of neurological ailments. Use of this technique has been described previously by numerous authors. In the present study, regional cerebral oxygen saturation was measured at rest in 94 subjects randomly elected from a diverse population of individuals. This sample consisted of 38 males and 65 females, with the age ranging from 18 - 70. There were 68 light-skinned individuals and 35 with darker skin comprising various ethnic and cultural backgrounds. Mean regional cerebral hemoglobin oxygen saturation was recorded as 67.14 plus or minus 8.84%. The association of the mean regional cerebral hemoglobin oxygen saturation in various group of individuals in relationship of their age, race, sex and skin color is examined.

  6. Feature Multi-Selection among Subjective Features

    OpenAIRE

    Sabato, Sivan; Kalai, Adam

    2013-01-01

    When dealing with subjective, noisy, or otherwise nebulous features, the "wisdom of crowds" suggests that one may benefit from multiple judgments of the same feature on the same object. We give theoretically-motivated `feature multi-selection' algorithms that choose, among a large set of candidate features, not only which features to judge but how many times to judge each one. We demonstrate the effectiveness of this approach for linear regression on a crowdsourced learning task of predicting...

  7. Color Charts, Esthetics, and Subjective Randomness

    Science.gov (United States)

    Sanderson, Yasmine B.

    2012-01-01

    Color charts, or grids of evenly spaced multicolored dots or squares, appear in the work of modern artists and designers. Often the artist/designer distributes the many colors in a way that could be described as "random," that is, without an obvious pattern. We conduct a statistical analysis of 125 "random-looking" art and design color charts and…

  8. Random selection of Borel sets

    Directory of Open Access Journals (Sweden)

    Bernd Günther

    2010-10-01

    Full Text Available A theory of random Borel sets is presented, based on dyadic resolutions of compact metric spaces. The conditional expectation of the intersection of two independent random Borel sets is investigated. An example based on an embedding of Sierpinski’s universal curve into the space of Borel sets is given.

  9. The Use of Randomization Tests in Single-Subject Research

    Science.gov (United States)

    Haardorfer, Regine; Gagne, Phill

    2010-01-01

    Some researchers have argued for the use of or have attempted to make use of randomization tests in single-subject research. To address this tide of interest, the authors of this article describe randomization tests, discuss the theoretical rationale for applying them to single-subject research, and provide an overview of the methodological…

  10. Perturbation Solutions for Random Linear Structural Systems subject to Random Excitation using Stochastic Differential Equations

    DEFF Research Database (Denmark)

    Köyluoglu, H.U.; Nielsen, Søren R.K.; Cakmak, A.S.

    1994-01-01

    The paper deals with the first and second order statistical moments of the response of linear systems with random parameters subject to random excitation modelled as white-noise multiplied by an envelope function with random parameters. The method of analysis is basically a second order perturbat......The paper deals with the first and second order statistical moments of the response of linear systems with random parameters subject to random excitation modelled as white-noise multiplied by an envelope function with random parameters. The method of analysis is basically a second order...... for multi-degree-of-freedom (MDOF) systems and the method is illustrated for a single-degree-of-freedom (SDOF) oscillator. The results are compared to those of exact results for a random oscillator subject to white noise excitation with random intensity....

  11. Species selection and random drift in macroevolution.

    Science.gov (United States)

    Chevin, Luis-Miguel

    2016-03-01

    Species selection resulting from trait-dependent speciation and extinction is increasingly recognized as an important mechanism of phenotypic macroevolution. However, the recent bloom in statistical methods quantifying this process faces a scarcity of dynamical theory for their interpretation, notably regarding the relative contributions of deterministic versus stochastic evolutionary forces. I use simple diffusion approximations of birth-death processes to investigate how the expected and random components of macroevolutionary change depend on phenotype-dependent speciation and extinction rates, as can be estimated empirically. I show that the species selection coefficient for a binary trait, and selection differential for a quantitative trait, depend not only on differences in net diversification rates (speciation minus extinction), but also on differences in species turnover rates (speciation plus extinction), especially in small clades. The randomness in speciation and extinction events also produces a species-level equivalent to random genetic drift, which is stronger for higher turnover rates. I then show how microevolutionary processes including mutation, organismic selection, and random genetic drift cause state transitions at the species level, allowing comparison of evolutionary forces across levels. A key parameter that would be needed to apply this theory is the distribution and rate of origination of new optimum phenotypes along a phylogeny. © 2016 The Author(s). Evolution © 2016 The Society for the Study of Evolution.

  12. Demonstrating treatment efficacy using the single subject randomization design: A tutorial and demonstration.

    Science.gov (United States)

    Rvachew, Susan; Matthews, Tanya

    2017-05-01

    Single case research refers to the broader category of research designs in which each case serves as his or her own control. A single subject randomization design is a specific form in which sessions are randomly allocated to treatment conditions within subjects. Two tutorials on the application of these designs are provided. In the single subject randomized phase design, baseline probes are administered repeatedly during a no-treatment or usual care phase; subsequently probes are administered repeatedly during the treatment phase of the experiment; the starting point for the treatment phase is determined by random selection. In the single subject randomized alternation design, any session can be randomly allocated to any treatment condition. In either case, the test statistic can be the mean of probe performance during the treatment sessions after subtracting the baseline mean. The significance of the obtained test statistic is determined by resampling test. Specifically, the obtained test statistic is interpreted relative to a distribution of test statistics generated by all possible random allocations. This distribution yields a P value which represents the probability of obtaining a test statistic as large as that obtained by the selected allocation. In addition to the tutorials, two experiments using these designs with a single 8-year-old participant with Childhood Apraxia of Speech are presented to demonstrate the utility of these designs and the application of the associated statistical analysis procedures. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  14. Improving randomness characterization through Bayesian model selection.

    Science.gov (United States)

    Díaz Hernández Rojas, Rafael; Solís, Aldo; Angulo Martínez, Alí M; U'Ren, Alfred B; Hirsch, Jorge G; Marsili, Matteo; Pérez Castillo, Isaac

    2017-06-08

    Random number generation plays an essential role in technology with important applications in areas ranging from cryptography to Monte Carlo methods, and other probabilistic algorithms. All such applications require high-quality sources of random numbers, yet effective methods for assessing whether a source produce truly random sequences are still missing. Current methods either do not rely on a formal description of randomness (NIST test suite) on the one hand, or are inapplicable in principle (the characterization derived from the Algorithmic Theory of Information), on the other, for they require testing all the possible computer programs that could produce the sequence to be analysed. Here we present a rigorous method that overcomes these problems based on Bayesian model selection. We derive analytic expressions for a model's likelihood which is then used to compute its posterior distribution. Our method proves to be more rigorous than NIST's suite and Borel-Normality criterion and its implementation is straightforward. We applied our method to an experimental device based on the process of spontaneous parametric downconversion to confirm it behaves as a genuine quantum random number generator. As our approach relies on Bayesian inference our scheme transcends individual sequence analysis, leading to a characterization of the source itself.

  15. Solution Methods for Structures with Random Properties Subject to Random Excitation

    DEFF Research Database (Denmark)

    Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

    This paper deals with the lower order statistical moments of the response of structures with random stiffness and random damping properties subject to random excitation. The arising stochastic differential equations (SDE) with random coefficients are solved by two methods, a second order...... perturbation approach and a Markovian method. The second order perturbation approach is grounded on the total probability theorem and can be compactly written. Moreover, the problem to be solved is independent of the dimension of the random variables involved. The Markovian approach suggests transforming...... the SDE with random coefficients with deterministic initial conditions to an equivalent nonlinear SDE with deterministic coefficient and random initial conditions. In both methods, the statistical moment equations are used. Hierarchy of statistical moments in the markovian approach is closed...

  16. 32 CFR 1624.1 - Random selection procedures for induction.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Random selection procedures for induction. 1624... SYSTEM INDUCTIONS § 1624.1 Random selection procedures for induction. (a) The Director of Selective Service shall from time to time establish a random selection sequence for induction by a drawing to be...

  17. Detecting individual sites subject to episodic diversifying selection.

    Directory of Open Access Journals (Sweden)

    Ben Murrell

    Full Text Available The imprint of natural selection on protein coding genes is often difficult to identify because selection is frequently transient or episodic, i.e. it affects only a subset of lineages. Existing computational techniques, which are designed to identify sites subject to pervasive selection, may fail to recognize sites where selection is episodic: a large proportion of positively selected sites. We present a mixed effects model of evolution (MEME that is capable of identifying instances of both episodic and pervasive positive selection at the level of an individual site. Using empirical and simulated data, we demonstrate the superior performance of MEME over older models under a broad range of scenarios. We find that episodic selection is widespread and conclude that the number of sites experiencing positive selection may have been vastly underestimated.

  18. The genealogy of sequences containing multiple sites subject to strong selection in a subdivided population.

    Science.gov (United States)

    Nordborg, Magnus; Innan, Hideki

    2003-03-01

    A stochastic model for the genealogy of a sample of recombining sequences containing one or more sites subject to selection in a subdivided population is described. Selection is incorporated by dividing the population into allelic classes and then conditioning on the past sizes of these classes. The past allele frequencies at the selected sites are thus treated as parameters rather than as random variables. The purpose of the model is not to investigate the dynamics of selection, but to investigate effects of linkage to the selected sites on the genealogy of the surrounding chromosomal region. This approach is useful for modeling strong selection, when it is natural to parameterize the past allele frequencies at the selected sites. Several models of strong balancing selection are used as examples, and the effects on the pattern of neutral polymorphism in the chromosomal region are discussed. We focus in particular on the statistical power to detect balancing selection when it is present.

  19. Reproduction of Merino sheep subjected to divergent selection on ...

    African Journals Online (AJOL)

    Reproduction of Merino sheep subjected to divergent selection on maternal values for lambs weaned per ewe joined. SWP Cloete, A Durand. Abstract. No Abstract. Full Text: EMAIL FREE FULL TEXT EMAIL FREE FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · AJOL African Journals Online. HOW TO ...

  20. Stochastic analysis model for vehicle-track coupled systems subject to earthquakes and track random irregularities

    Science.gov (United States)

    Xu, Lei; Zhai, Wanming

    2017-10-01

    This paper devotes to develop a computational model for stochastic analysis and reliability assessment of vehicle-track systems subject to earthquakes and track random irregularities. In this model, the earthquake is expressed as non-stationary random process simulated by spectral representation and random function, and the track random irregularities with ergodic properties on amplitudes, wavelengths and probabilities are characterized by a track irregularity probabilistic model, and then the number theoretical method (NTM) is applied to effectively select representative samples of earthquakes and track random irregularities. Furthermore, a vehicle-track coupled model is presented to obtain the dynamic responses of vehicle-track systems due to the earthquakes and track random irregularities at time-domain, and the probability density evolution method (PDEM) is introduced to describe the evolutionary process of probability from excitation input to response output by assuming the vehicle-track system as a probabilistic conservative system, which lays the foundation on reliability assessment of vehicle-track systems. The effectiveness of the proposed model is validated by comparing to the results of Monte-Carlo method from statistical viewpoint. As an illustrative example, the random vibrations of a high-speed railway vehicle running on the track slabs excited by lateral seismic waves and track random irregularities are analyzed, from which some significant conclusions can be drawn, e.g., track irregularities will additionally promote the dynamic influence of earthquakes especially on maximum values and dispersion degree of responses; the characteristic frequencies or frequency ranges respectively governed by earthquakes and track random irregularities are greatly different, moreover, the lateral seismic waves will dominate or even change the characteristic frequencies of system responses of some lateral dynamic indices at low frequency.

  1. In-Place Randomized Slope Selection

    DEFF Research Database (Denmark)

    Blunck, Henrik; Vahrenhold, Jan

    2006-01-01

    Slope selection is a well-known algorithmic tool used in the context of computing robust estimators for fitting a line to a collection P of n points in the plane. We demonstrate that it is possible to perform slope selection in expected O(nlogn) time using only constant extra space in addition to...

  2. Random effect selection in generalised linear models

    DEFF Research Database (Denmark)

    Denwood, Matt; Houe, Hans; Forkman, Björn

    We analysed abattoir recordings of meat inspection codes with possible relevance to onfarm animal welfare in cattle. Random effects logistic regression models were used to describe individual-level data obtained from 461,406 cattle slaughtered in Denmark. Our results demonstrate that the largest ...

  3. Sequential selection of random vectors under a sum constraint

    OpenAIRE

    Stanke, Mario

    2004-01-01

    We observe a sequence X1,X2,...,Xn of independent and identically distributed coordinatewise nonnegative d-dimensional random vectors. When a vector is observed it can either be selected or rejected but once made this decision is final. In each coordinate the sum of the selected vectors must not exceed a given constant. The problem is to find a selection policy that maximizes the expected number of selected vectors. For a general absolutely continuous distribution of t...

  4. Mapping of medical acronyms and initialisms to Medical Subject Headings (MeSH) across selected systems.

    Science.gov (United States)

    Shultz, Mary

    2006-10-01

    Given the common use of acronyms and initialisms in the health sciences, searchers may be entering these abbreviated terms rather than full phrases when searching online systems. The purpose of this study is to evaluate how various MEDLINE Medical Subject Headings (MeSH) interfaces map acronyms and initialisms to the MeSH vocabulary. The interfaces used in this study were: the PubMed MeSH database, the PubMed Automatic Term Mapping feature, the NLM Gateway Term Finder, and Ovid MEDLINE. Acronyms and initialisms were randomly selected from 2 print sources. The test data set included 415 randomly selected acronyms and initialisms whose related meanings were found to be MeSH terms. Each acronym and initialism was entered into each MEDLINE MeSH interface to determine if it mapped to the corresponding MeSH term. Separately, 46 commonly used acronyms and initialisms were tested. While performance differed widely, the success rates were low across all interfaces for the randomly selected terms. The common acronyms and initialisms tested at higher success rates across the interfaces, but the differences between the interfaces remained. Online interfaces do not always map medical acronyms and initialisms to their corresponding MeSH phrases. This may lead to inaccurate results and missed information if acronyms and initialisms are used in search strategies.

  5. Selectivity and sparseness in randomly connected balanced networks.

    Directory of Open Access Journals (Sweden)

    Cengiz Pehlevan

    Full Text Available Neurons in sensory cortex show stimulus selectivity and sparse population response, even in cases where no strong functionally specific structure in connectivity can be detected. This raises the question whether selectivity and sparseness can be generated and maintained in randomly connected networks. We consider a recurrent network of excitatory and inhibitory spiking neurons with random connectivity, driven by random projections from an input layer of stimulus selective neurons. In this architecture, the stimulus-to-stimulus and neuron-to-neuron modulation of total synaptic input is weak compared to the mean input. Surprisingly, we show that in the balanced state the network can still support high stimulus selectivity and sparse population response. In the balanced state, strong synapses amplify the variation in synaptic input and recurrent inhibition cancels the mean. Functional specificity in connectivity emerges due to the inhomogeneity caused by the generative statistical rule used to build the network. We further elucidate the mechanism behind and evaluate the effects of model parameters on population sparseness and stimulus selectivity. Network response to mixtures of stimuli is investigated. It is shown that a balanced state with unselective inhibition can be achieved with densely connected input to inhibitory population. Balanced networks exhibit the "paradoxical" effect: an increase in excitatory drive to inhibition leads to decreased inhibitory population firing rate. We compare and contrast selectivity and sparseness generated by the balanced network to randomly connected unbalanced networks. Finally, we discuss our results in light of experiments.

  6. Decision Criteria and Their Subjectivity in Construction Procurement Selection

    Directory of Open Access Journals (Sweden)

    Thomas Ng

    2012-11-01

    Full Text Available Employing a suitable construction procurement system is crucial to project success. However,many clients select procurement systems in a cursory manner and some clientseven use a specific procurement system by default without deliberate choice. A systematicmethod for procurement selection would help clients to arrive at more informed decisions.The first step towards a systematic procurement selection method is to identify decisioncriteria pertinent to assessing the alternatives. This paper identifies the commonly consideredcriteria for procurement selection through a qualitative survey in Australia. The subjectivityof the identified criteria is considered and the effects on procurement selectionare examined. The results indicate that speed, complexity, flexibility, responsibility, qualitylevel, risk allocation, and price competition cannot be easily gauged by objective means,and a misperception of the degree of fulfilment of any of these criteria could affect theoutcome of procurement selection.

  7. Fast, Randomized Join-Order Selection - Why Use Transformations?

    NARCIS (Netherlands)

    C.A. Galindo-Legaria; A.J. Pellenkoft (Jan); M.L. Kersten (Martin)

    1994-01-01

    textabstractWe study the effectiveness of probabilistic selection of join-query evaluation plans, without reliance on tree transformation rules. Instead, each candidate plan is chosen uniformly at random from the space of valid evaluation orders. This leads to a transformation-free strategy where a

  8. The reliability of randomly selected final year pharmacy students in ...

    African Journals Online (AJOL)

    Employing ANOVA, factorial experimental analysis, and the theory of error, reliability studies were conducted on the assessment of the drug product chloroquine phosphate tablets. The G–Study employed equal numbers of the factors for uniform control, and involved three analysts (randomly selected final year Pharmacy ...

  9. Local randomization in neighbor selection improves PRM roadmap quality

    KAUST Repository

    McMahon, Troy

    2012-10-01

    Probabilistic Roadmap Methods (PRMs) are one of the most used classes of motion planning methods. These sampling-based methods generate robot configurations (nodes) and then connect them to form a graph (roadmap) containing representative feasible pathways. A key step in PRM roadmap construction involves identifying a set of candidate neighbors for each node. Traditionally, these candidates are chosen to be the k-closest nodes based on a given distance metric. In this paper, we propose a new neighbor selection policy called LocalRand(k,K\\'), that first computes the K\\' closest nodes to a specified node and then selects k of those nodes at random. Intuitively, LocalRand attempts to benefit from random sampling while maintaining the higher levels of local planner success inherent to selecting more local neighbors. We provide a methodology for selecting the parameters k and K\\'. We perform an experimental comparison which shows that for both rigid and articulated robots, LocalRand results in roadmaps that are better connected than the traditional k-closest policy or a purely random neighbor selection policy. The cost required to achieve these results is shown to be comparable to k-closest. © 2012 IEEE.

  10. Selecting a phoneme-to-grapheme mapping: Random or weighted selection?

    Directory of Open Access Journals (Sweden)

    Binna Lee

    2015-05-01

    Our findings demonstrate that random selection underestimates MOA’s PG correspondences whereas weighted selection predicts higher PG correspondences than he produces. To explain his intermediate spelling performance on PPEs, we will test additional approaches to weighing the relative probability of PG mappings, including using log frequencies, separating consonant and vowel status, and considering the number of grapheme options in each phoneme.

  11. Selection for altruism through random drift in variable size populations.

    Science.gov (United States)

    Houchmandzadeh, Bahram; Vallade, Marcel

    2012-05-10

    Altruistic behavior is defined as helping others at a cost to oneself and a lowered fitness. The lower fitness implies that altruists should be selected against, which is in contradiction with their widespread presence is nature. Present models of selection for altruism (kin or multilevel) show that altruistic behaviors can have 'hidden' advantages if the 'common good' produced by altruists is restricted to some related or unrelated groups. These models are mostly deterministic, or assume a frequency dependent fitness. Evolutionary dynamics is a competition between deterministic selection pressure and stochastic events due to random sampling from one generation to the next. We show here that an altruistic allele extending the carrying capacity of the habitat can win by increasing the random drift of "selfish" alleles. In other terms, the fixation probability of altruistic genes can be higher than those of a selfish ones, even though altruists have a smaller fitness. Moreover when populations are geographically structured, the altruists advantage can be highly amplified and the fixation probability of selfish genes can tend toward zero. The above results are obtained both by numerical and analytical calculations. Analytical results are obtained in the limit of large populations. The theory we present does not involve kin or multilevel selection, but is based on the existence of random drift in variable size populations. The model is a generalization of the original Fisher-Wright and Moran models where the carrying capacity depends on the number of altruists.

  12. Selection for altruism through random drift in variable size populations

    Directory of Open Access Journals (Sweden)

    Houchmandzadeh Bahram

    2012-05-01

    Full Text Available Abstract Background Altruistic behavior is defined as helping others at a cost to oneself and a lowered fitness. The lower fitness implies that altruists should be selected against, which is in contradiction with their widespread presence is nature. Present models of selection for altruism (kin or multilevel show that altruistic behaviors can have ‘hidden’ advantages if the ‘common good’ produced by altruists is restricted to some related or unrelated groups. These models are mostly deterministic, or assume a frequency dependent fitness. Results Evolutionary dynamics is a competition between deterministic selection pressure and stochastic events due to random sampling from one generation to the next. We show here that an altruistic allele extending the carrying capacity of the habitat can win by increasing the random drift of “selfish” alleles. In other terms, the fixation probability of altruistic genes can be higher than those of a selfish ones, even though altruists have a smaller fitness. Moreover when populations are geographically structured, the altruists advantage can be highly amplified and the fixation probability of selfish genes can tend toward zero. The above results are obtained both by numerical and analytical calculations. Analytical results are obtained in the limit of large populations. Conclusions The theory we present does not involve kin or multilevel selection, but is based on the existence of random drift in variable size populations. The model is a generalization of the original Fisher-Wright and Moran models where the carrying capacity depends on the number of altruists.

  13. Class switch recombination in selective IgA-deficient subjects

    DEFF Research Database (Denmark)

    Jensen, Lone Hummelshøj; Ryder, L P; Nielsen, L K

    2006-01-01

    control donors, all Caucasians. Stimulation of B cells from IgA-deficient donors with the cytokines transforming growth factor (TGF)-beta, interferon (IFN)-gamma or interleukin (IL)-10 in the presence of anti-CD40 antibodies showed reduced expression of both activation-induced cytidine deaminase (AID...... IL-4 to TGF-beta alone or in combination with IL-10, the immunoglobulin production in B cells from IgA-deficient donors was comparable with those of normal controls. These data show that in healthy subjects in vitro IgA production can be up-regulated by addition of IL-10 to CD40-stimulated B cells...

  14. Class switch recombination in selective IgA-deficient subjects

    DEFF Research Database (Denmark)

    Jensen, Lone Hummelshøj; Ryder, L P; Nielsen, L K

    2006-01-01

    control donors, all Caucasians. Stimulation of B cells from IgA-deficient donors with the cytokines transforming growth factor (TGF)-beta, interferon (IFN)-gamma or interleukin (IL)-10 in the presence of anti-CD40 antibodies showed reduced expression of both activation-induced cytidine deaminase (AID......) and alpha germline transcripts (GLT) compared to controls. It was possible, however, to induce AID and alpha GLT when stimulating the cells with anti-CD40 antibody and TGF-beta in the combination with IL-10. Moreover, in anti-CD40 antibody-stimulated cultures, addition of IL-10 or IL-10 + TGF......-beta in combination, induced IgA production, albeit lower than found in B cells from controls. The B cells from the IgA-deficient subjects were less effective in differentiating into CD138(+) X-box binding protein 1 (XBP-1)(+) plasma cells when stimulated with TGF-beta, IFN-gamma or IL-10. Interestingly, when adding...

  15. Interference-aware random beam selection for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed M.

    2012-09-01

    Spectrum sharing systems have been introduced to alleviate the problem of spectrum scarcity by allowing secondary unlicensed networks to share the spectrum with primary licensed networks under acceptable interference levels to the primary users. In this paper, we develop interference-aware random beam selection schemes that provide enhanced throughput for the secondary link under the condition that the interference observed at the primary link is within a predetermined acceptable value. For a secondary transmitter equipped with multiple antennas, our schemes select a random beam, among a set of power- optimized orthogonal random beams, that maximizes the capacity of the secondary link while satisfying the interference constraint at the primary receiver for different levels of feedback information describing the interference level at the primary receiver. For the proposed schemes, we develop a statistical analysis for the signal-to-noise and interference ratio (SINR) statistics as well as the capacity of the secondary link. Finally, we present numerical results that study the effect of system parameters including number of beams and the maximum transmission power on the capacity of the secondary link attained using the proposed schemes. © 2012 IEEE.

  16. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial

    NARCIS (Netherlands)

    van de Rest, O.; Geleijnse, J.M.; Kok, F. J.; van Staveren, W.A.; Dullemeijer, C.; Olde Rikkert, M.G.M.; Beekman, A.T.F.; de Groot, C.P.

    2008-01-01

    Background: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. Objective: To investigate the effect of

  17. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial.

    NARCIS (Netherlands)

    Rest, O van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Dullemeijer, C.; Olderikkert, M.G.; Beekman, A.T.; Groot, CP de

    2008-01-01

    BACKGROUND: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. OBJECTIVE: To investigate the effect of

  18. A data mining approach to selecting herbs with similar efficacy: Targeted selection methods based on medical subject headings (MeSH).

    Science.gov (United States)

    Yea, Sang-Jun; Seong, BoSeok; Jang, Yunji; Kim, Chul

    2016-04-22

    Natural products have long been the most important source of ingredients in the discovery of new drugs. Moreover, since the Nagoya Protocol, finding alternative herbs with similar efficacy in traditional medicine has become a very important issue. Although random selection is a common method of finding ethno-medicinal herbs of similar efficacy, it proved to be less effective; therefore, this paper proposes a novel targeted selection method using data mining approaches in the MEDLINE database in order to identify and select herbs with a similar degree of efficacy. From among sixteen categories of medical subject headings (MeSH) descriptors, three categories containing terms related to herbal compounds, efficacy, toxicity, and the metabolic process were selected. In order to select herbs of similar efficacy in a targeted way, we adopted the similarity measurement method based on MeSH. In order to evaluate the proposed algorithm, we built up three different validation datasets which contain lists of original herbs and corresponding medicinal herbs of similar efficacy. The average area under curve (AUC) of the proposed algorithm was found to be about 500% larger than the random selection method. We found that the proposed algorithm puts more hits at the front of the top-10 list than the random selection method, and precisely discerns the efficacy of the herbs. It was also found that the AUC of the experiments either remained the same or increased slightly in all three validation datasets as the search range was increased. This study reveals and proves that the proposed algorithm is significantly more accurate and efficient in finding alternative herbs of similar efficacy than the random selection method. As such, it is hoped that this approach will be used in diverse applications in the ethno-pharmacology field. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  19. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study.

    Science.gov (United States)

    Townsend, Robert; Desai, Amit; Rammelsberg, Diane; Kowalski, Donna; Simmons, Neal; Kitt, Therese M

    2017-02-01

    Regadenoson is a selective A 2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. However, the safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed. Healthy males and females were randomized to receive intravenous regadenoson [100 μg (3 doses), 200 μg (3 doses), or 400 μg (2 doses)], or placebo (2 or 3 doses; 0.9% sodium chloride); all doses 10 minutes apart. The primary endpoint was vital sign measurements (blood pressure and heart rate). Secondary endpoints included 12-lead electrocardiogram measurements, clinical laboratory evaluations (hematology, chemistry, and urinalysis), and adverse events. Thirty-six subjects were randomized and completed the study. Plasma concentrations of regadenoson increased in a dose-related manner and with successive doses. No consistent effect was observed for systolic blood pressure, although diastolic blood pressure was slightly lower than placebo for all regadenoson groups. Transient, dose-dependent increases in heart rate were observed in all regadenoson groups. There were no serious adverse events; 27 adverse events occurred in 14 regadenoson-treated subjects vs two events in two placebo-treated subjects. Repeated doses of regadenoson appeared to be safe and well tolerated in healthy subjects.

  20. Unbiased split variable selection for random survival forests using maximally selected rank statistics.

    Science.gov (United States)

    Wright, Marvin N; Dankowski, Theresa; Ziegler, Andreas

    2017-04-15

    The most popular approach for analyzing survival data is the Cox regression model. The Cox model may, however, be misspecified, and its proportionality assumption may not always be fulfilled. An alternative approach for survival prediction is random forests for survival outcomes. The standard split criterion for random survival forests is the log-rank test statistic, which favors splitting variables with many possible split points. Conditional inference forests avoid this split variable selection bias. However, linear rank statistics are utilized by default in conditional inference forests to select the optimal splitting variable, which cannot detect non-linear effects in the independent variables. An alternative is to use maximally selected rank statistics for the split point selection. As in conditional inference forests, splitting variables are compared on the p-value scale. However, instead of the conditional Monte-Carlo approach used in conditional inference forests, p-value approximations are employed. We describe several p-value approximations and the implementation of the proposed random forest approach. A simulation study demonstrates that unbiased split variable selection is possible. However, there is a trade-off between unbiased split variable selection and runtime. In benchmark studies of prediction performance on simulated and real datasets, the new method performs better than random survival forests if informative dichotomous variables are combined with uninformative variables with more categories and better than conditional inference forests if non-linear covariate effects are included. In a runtime comparison, the method proves to be computationally faster than both alternatives, if a simple p-value approximation is used. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  1. Subjectivity

    Directory of Open Access Journals (Sweden)

    Jesús Vega Encabo

    2015-11-01

    Full Text Available In this paper, I claim that subjectivity is a way of being that is constituted through a set of practices in which the self is subject to the dangers of fictionalizing and plotting her life and self-image. I examine some ways of becoming subject through narratives and through theatrical performance before others. Through these practices, a real and active subjectivity is revealed, capable of self-knowledge and self-transformation. 

  2. Who is the research subject in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2011-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

  3. The signature of positive selection at randomly chosen loci.

    Science.gov (United States)

    Przeworski, Molly

    2002-03-01

    In Drosophila and humans, there are accumulating examples of loci with a significant excess of high-frequency-derived alleles or high levels of linkage disequilibrium, relative to a neutral model of a random-mating population of constant size. These are features expected after a recent selective sweep. Their prevalence suggests that positive directional selection may be widespread in both species. However, as I show here, these features do not persist long after the sweep ends: The high-frequency alleles drift to fixation and no longer contribute to polymorphism, while linkage disequilibrium is broken down by recombination. As a result, loci chosen without independent evidence of recent selection are not expected to exhibit either of these features, even if they have been affected by numerous sweeps in their genealogical history. How then can we explain the patterns in the data? One possibility is population structure, with unequal sampling from different subpopulations. Alternatively, positive selection may not operate as is commonly modeled. In particular, the rate of fixation of advantageous mutations may have increased in the recent past.

  4. Blind Measurement Selection: A Random Matrix Theory Approach

    KAUST Repository

    Elkhalil, Khalil

    2016-12-14

    This paper considers the problem of selecting a set of $k$ measurements from $n$ available sensor observations. The selected measurements should minimize a certain error function assessing the error in estimating a certain $m$ dimensional parameter vector. The exhaustive search inspecting each of the $n\\\\choose k$ possible choices would require a very high computational complexity and as such is not practical for large $n$ and $k$. Alternative methods with low complexity have recently been investigated but their main drawbacks are that 1) they require perfect knowledge of the measurement matrix and 2) they need to be applied at the pace of change of the measurement matrix. To overcome these issues, we consider the asymptotic regime in which $k$, $n$ and $m$ grow large at the same pace. Tools from random matrix theory are then used to approximate in closed-form the most important error measures that are commonly used. The asymptotic approximations are then leveraged to select properly $k$ measurements exhibiting low values for the asymptotic error measures. Two heuristic algorithms are proposed: the first one merely consists in applying the convex optimization artifice to the asymptotic error measure. The second algorithm is a low-complexity greedy algorithm that attempts to look for a sufficiently good solution for the original minimization problem. The greedy algorithm can be applied to both the exact and the asymptotic error measures and can be thus implemented in blind and channel-aware fashions. We present two potential applications where the proposed algorithms can be used, namely antenna selection for uplink transmissions in large scale multi-user systems and sensor selection for wireless sensor networks. Numerical results are also presented and sustain the efficiency of the proposed blind methods in reaching the performances of channel-aware algorithms.

  5. Predictive value of testing random urine sample to detect microalbuminuria in diabetic subjects during outpatient visit.

    Science.gov (United States)

    Bouhanick, B; Berrut, G; Chameau, A M; Hallar, M; Bled, F; Chevet, B; Vergely, J; Rohmer, V; Fressinaud, P; Marre, M

    1992-01-01

    The predictive value of random urine sample during outpatient visit to predict persistent microalbuminuria was studied in 76 Type 1, insulin-dependent diabetic subjects, 61 Type 2, non-insulin-dependent diabetic subjects, and 72 Type 2, insulin-treated diabetic subjects. Seventy-six patients attended outpatient clinic during morning, and 133 during afternoon. Microalbuminuria was suspected if Urinary Albumin Excretion (UAE) exceeded 20 mg/l. All patients were hospitalized within 6 months following outpatient visit, and persistent microalbuminuria was assessed then if UAE was between 30 and 300 mg/24 h on 2-3 occasions in 3 urines samples. Of these 209 subjects eighty-three were also screened with Microbumintest (Ames-Bayer), a semi-quantitative method. Among the 209 subjects, 71 were positive both for microalbuminuria during outpatient visit and a persistent microalbuminuria during hospitalization: sensitivity 91.0%, specificity 83.2%, concordance 86.1%, and positive predictive value 76.3% (chi-squared test: 191; p less than 10(-4)). Data were not different for subjects examined on morning, or on afternoon. Among the 83 subjects also screened with Microbumintest, 22 displayed both a positive reaction and a persistent microalbuminuria: sensitivity 76%, specificity 81%, concordance 80%, and positive predictive value 69% (chi-squared test: 126; p less than 10(-4)). Both types of screening appeared equally effective during outpatient visit. Hence, a persistent microalbuminuria can be predicted during an outpatient visit in a diabetic clinic.

  6. A general symplectic method for the response analysis of infinitely periodic structures subjected to random excitations

    Directory of Open Access Journals (Sweden)

    You-Wei Zhang

    Full Text Available A general symplectic method for the random response analysis of infinitely periodic structures subjected to stationary/non-stationary random excitations is developed using symplectic mathematics in conjunction with variable separation and the pseudo-excitation method (PEM. Starting from the equation of motion for a single loaded substructure, symplectic analysis is firstly used to eliminate the dependent degrees of the freedom through condensation. A Fourier expansion of the condensed equation of motion is then applied to separate the variables of time and wave number, thus enabling the necessary recurrence scheme to be developed. The random response is finally determined by implementing PEM. The proposed method is justified by comparison with results available in the literature and is then applied to a more complicated time-dependent coupled system.

  7. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Ppsychomotricity a safe and efficacy therapy for pediatric selective mutism.

  8. Optimizing Event Selection with the Random Grid Search

    Energy Technology Data Exchange (ETDEWEB)

    Bhat, Pushpalatha C. [Fermilab; Prosper, Harrison B. [Florida State U.; Sekmen, Sezen [Kyungpook Natl. U.; Stewart, Chip [Broad Inst., Cambridge

    2017-06-29

    The random grid search (RGS) is a simple, but efficient, stochastic algorithm to find optimal cuts that was developed in the context of the search for the top quark at Fermilab in the mid-1990s. The algorithm, and associated code, have been enhanced recently with the introduction of two new cut types, one of which has been successfully used in searches for supersymmetry at the Large Hadron Collider. The RGS optimization algorithm is described along with the recent developments, which are illustrated with two examples from particle physics. One explores the optimization of the selection of vector boson fusion events in the four-lepton decay mode of the Higgs boson and the other optimizes SUSY searches using boosted objects and the razor variables.

  9. Safety and pharmacokinetics of oral delta-9-tetrahydrocannabinol in healthy older subjects: a randomized controlled trial.

    Science.gov (United States)

    Ahmed, Amir I A; van den Elsen, Geke A H; Colbers, Angela; van der Marck, Marjolein A; Burger, David M; Feuth, Ton B; Rikkert, Marcel G M Olde; Kramers, Cornelis

    2014-09-01

    There is a great concern about the safety of THC-based drugs in older people (≥65 years), as most of THC-trials did not include such group. In this phase 1, randomized, double-blind, double-dummy, placebo-controlled, cross-over trial, we evaluated the safety and pharmacokinetics of three oral doses of Namisol(®), a novel THC in tablet form, in older subjects. Twelve healthy older subjects (6 male; mean age 72±5 years) randomly received a single oral dose of 3mg, 5mg, or 6.5mg of THC or matching placebo, in a crossover manner, on each intervention day. The data for 11 subjects were included in the analysis. The data of 1 subject were excluded due to non-compliance to study medication. THC was safe and well tolerated. The most frequently reported adverse events (AEs) were drowsiness (27%) and dry mouth (11%). Subjects reported more AEs with THC 6.5mg than with 3mg (p=0.048), 5mg (p=0.034) and placebo (p=0.013). There was a wide inter-individual variability in plasma concentrations of THC. Subjects for whom the Cmax fell within the sampling period (over 2h), Cmax was 1.42-4.57ng/mL and Tmax was 67-92min. The AUC0-2h (n=11) was 1.67-3.51ng/mL. Overall, the pharmacodynamic effects of THC were smaller than effects previously reported in young adults. In conclusion, THC appeared to be safe and well tolerated by healthy older individuals. Data on safety and effectiveness of THC in frail older persons are urgently required, as this population could benefit from the therapeutic applications of THC. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

  10. Changes in depression status in low socioeconomic perinatal subjects in rural India after supervised physical exercise: A randomized controlled study

    Science.gov (United States)

    Bose, Gopal Nambi Subash Chandra

    2015-01-01

    Background: Perinatal depression is a major public health problem, affecting up to a quarter of all pregnant women in rural Asean countries and often leads to psychologic symptoms, lower quality of life, and higher health care costs. The purpose of this study was to assess the impact of supervised physical exercise on depression level of perinatal subjects. Subjects/Intervention: 60 subjects who fulfill the selection criteria were randomly assigned to exercise (Group-1, n=30) and control group (Group-2, n=30). Participants completed general screening form and Physical health questionnaire-9 (PHQ-9) before their intervention and again 4 weeks and 8 weeks later. Group-1 underwent aerobic training with 60-65% maximum heart rate and Group-2 was prescribed with handouts for 4 weeks. Statistics: Repeated-measures analysis of variance (ANOVA) was use to analyze group differences over time while controlling for baseline differences. Results: Demographic and the baseline values show homogenous population (P>0.05). Patients in both groups experienced significant reduction in depression level. Group A showed reduction of 91.70% (P=0.00) as compared to Group B 69.01% (P=0.00). Conclusion: These results suggest that supervised physical exercise provides better improvement in depression status in perinatal subjects than providing handouts alone. PMID:26816432

  11. EFFECTIVENESS OF MOTOR TASK INTERFERENCE DURING GAIT IN SUBJECTS WITH PARKINSON'S DISEASE: A RANDOMIZED CONTROLLED TRAIL

    Directory of Open Access Journals (Sweden)

    Jaya ShankerTedla

    2017-04-01

    Full Text Available Background: In this study, was to evaluated the effectiveness of motor task and cognitive task interference while walking to improve gait parameters of subjects with Parkinson’s disease. Methods: In this Randomized Controlled trial, 30 subjects with Parkinson’s disease of age group between 50and 70 years randomly divided into two groups. The first group had motor task interference, and the second group had calculation task interference while walking along with conventional physical therapy. Gait parameters recorded as outcome measures. Both the groups received 1-hour training for three weeks for one month. Results: As per the paired t-test values, there was significant (p<0.001 improvement in the gait parameters for both the group's pre and post training. Motor task interference showed better improvements than calculation-task interference group among subjects with Parkinson’s disease in all the gait parameters measured with a p-value less than 0.001. Conclusion: To improve the gait parameters for mild to moderately disabled patients with Parkinson’s disease, the dual task training by using motor task while gait training along with conventional Physical Therapy will be more useful than using cognitive task.

  12. Optimal positions and parameters of translational and rotational mass dampers in beams subjected to random excitation

    Science.gov (United States)

    Łatas, Waldemar

    2018-01-01

    The problem of vibrations of the beam with the attached system of translational and rotational dynamic mass dampers subjected to random excitations with peaked power spectral densities, is presented in the hereby paper. The Euler-Bernoulli beam model is applied, while for solving the equation of motion the Galerkin method and the Laplace time transform are used. The obtained transfer functions allow to determine power spectral densities of the beam deflection and other dependent variables. Numerical examples present simple optimization problems of mass dampers parameters for local and global objective functions.

  13. Effects of oral cetirizine, a selective H1 antagonist, on allergen- and exercise-induced bronchoconstriction in subjects with asthma.

    LENUS (Irish Health Repository)

    Gong, H

    1990-03-01

    The protective efficacy of oral cetirizine, a selective and potent H1-receptor antagonist, against the immediate bronchoconstrictive response to allergen inhalation and exercise challenge was evaluated in 16 subjects with stable, predominantly mild asthma. The subjects underwent double-blind, crossover pretreatments in randomized order in two separate protocols with (1) three daily oral doses of 20 mg of cetirizine and placebo, followed by allergen inhalation, and (2) single oral doses of cetirizine (5, 10, and 20 mg), albuterol (4 mg), and placebo, followed by exercise with cold-air inhalation. Cetirizine failed to decrease bronchial sensitivity to inhaled allergen in eight of 10 subjects. Neither cetirizine nor albuterol uniformly inhibited exercise-induced bronchoconstriction. Serum concentrations of cetirizine were consistent with systemic H1-blocking activity. Modest bronchodilation occurred after administration of cetirizine and albuterol before exercise but not after the third dose of cetirizine in the allergen protocol. One subject developed moderate drowsiness during multiple dosing with cetirizine. Thus, cetirizine, in the doses studied, is not uniformly effective in preventing allergen- or exercise-induced bronchoconstriction. Histamine is one of many mediators participating in immediate asthmatic responses, and selective H1 antagonists do not completely block these airway events. However, cetirizine may still clinically benefit some patients with asthma, such as patients with allergic rhinitis or urticaria.

  14. Hypoglycemic effect of triphala on selected non insulin dependent Diabetes mellitus subjects.

    Science.gov (United States)

    Rajan, Sowmya S; Antony, Seema

    2008-01-01

    Modern life style is characterized by high stress, increased automation, junk food consumption and sedentary life style which have lead to the incidence of Diabetes. The study involved selection of NIDDM subjects who were supplemented with Triphala powder called, The Three Myrobalans (Terminalia bellirica- Belliric myrobalan, Terminalia chebula-Inknut, Embilica officinalis - Indian gooseberry) for a period of 45 days. Statistical evaluation of the blood profile showed significant reduction in the blood glucose level of the subjects.

  15. Robust EEG Channel Selection across Subjects for Brain-Computer Interfaces

    Directory of Open Access Journals (Sweden)

    Lal Thomas Navin

    2005-01-01

    Full Text Available Most EEG-based brain-computer interface (BCI paradigms come along with specific electrode positions, for example, for a visual-based BCI, electrode positions close to the primary visual cortex are used. For new BCI paradigms it is usually not known where task relevant activity can be measured from the scalp. For individual subjects, Lal et al. in 2004 showed that recording positions can be found without the use of prior knowledge about the paradigm used. However it remains unclear to what extent their method of recursive channel elimination (RCE can be generalized across subjects. In this paper we transfer channel rankings from a group of subjects to a new subject. For motor imagery tasks the results are promising, although cross-subject channel selection does not quite achieve the performance of channel selection on data of single subjects. Although the RCE method was not provided with prior knowledge about the mental task, channels that are well known to be important (from a physiological point of view were consistently selected whereas task-irrelevant channels were reliably disregarded.

  16. Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

    Science.gov (United States)

    Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

    2017-10-01

    Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to

  17. Control group selection in critical care randomized controlled trials evaluating interventional strategies: An ethical assessment.

    Science.gov (United States)

    Silverman, Henry J; Miller, Franklin G

    2004-03-01

    Ethical concern has been raised with critical care randomized controlled trials in which the standard of care reflects a broad range of clinical practices. Commentators have argued that trials without an unrestricted control group, in which standard practices are implemented at the discretion of the attending physician, lack the ability to redefine the standard of care and might expose subjects to excessive harms due to an inability to stop early. To develop a framework for analyzing control group selection for critical care trials. Ethical analysis. A key ethical variable in trial design is the extent with which the control group adequately reflects standard care practices. Such a control group might incorporate either the "unrestricted" practices of physicians or a protocol that specifies and restricts the parameters of standard practices. Control group selection should be determined with respect to the following ethical objectives of trial design: 1) clinical value, 2) scientific validity, 3) efficiency and feasibility, and 4) protection of human subjects. Because these objectives may conflict, control group selection will involve trade-offs and compromises. Trials using a protocolized rather than an unrestricted standard care control group will likely have enhanced validity. However, if the protocolized control group lacks representativeness to standard care practices, then trials that use such groups will offer less clinical value and could provide less assurance of protecting subjects compared with trials that use unrestricted control groups. For trials evaluating contrasting strategies that do not adequately represent standard practices, use of a third group that is more representative of standard practices will enhance clinical value and increase the ability to stop early if needed to protect subjects. These advantages might come at the expense of efficiency and feasibility. Weighing and balancing the competing ethical objectives of trial design should be

  18. INFLUENCE OF CAFFEINE ON SELECTIVE ATTENTION IN WELL-RESTED AND FATIGUED SUBJECTS

    NARCIS (Netherlands)

    LORIST, MM; SNEL, J; KOK, A; MULDER, G

    1994-01-01

    Effects of caffeine were studied in a visual focused selective search task in well-rested and fatigued subjects. A dose of 200 + 50 mg caffeine or placebo, dissolved in decaffeinated coffee, was administered in a double-blind and deceptive fashion. The task was to detect a target letter on one

  19. Event selection with a Random Forest in IceCube

    Energy Technology Data Exchange (ETDEWEB)

    Ruhe, Tim [TU, Dortmund (Germany); Collaboration: IceCube-Collaboration

    2011-07-01

    The Random Forest method is a multivariate algorithm that can be used for classification and regression respectively. The Random Forest implemented in the RapidMiner learning environment has been used for training and validation on data and Monte Carlo simulations of the IceCube neutrino telescope. Latest results are presented.

  20. Multiple-mode large deflection random response of beams with nonlinear damping subjected to acoustic excitation

    Science.gov (United States)

    Prasad, C. B.; Mei, Chuh

    1987-01-01

    Multiple-mode nonlinear analysis is carried out for beams subjected to acoustic excitation. Effects of both nonlinear damping and large-deflection are included in the analysis in an attempt to explain the experimental phenomena of aircraft panels excited at high sound pressure levels; that is the broadening of the strain response peaks and the increase of modal frequency. An amplitude dependent nonlinear damping model is used in the anlaysis to study the effects and interactions of multiple modes, nonlinear stiffness and nonlinear damping on the random response of beams. Mean square maximum deflection, mean square maximum strain, and spectral density function of maximum strain for simple supported and clamped beams are obtained. It is shown analytically that nonlinear damping contributes significantly to the broadening of the response peak and to the mean square deflection and strain.

  1. Country Selection Model for Sustainable Construction Businesses Using Hybrid of Objective and Subjective Information

    Directory of Open Access Journals (Sweden)

    Kang-Wook Lee

    2017-05-01

    Full Text Available An important issue for international businesses and academia is selecting countries in which to expand in order to achieve entrepreneurial sustainability. This study develops a country selection model for sustainable construction businesses using both objective and subjective information. The objective information consists of 14 variables related to country risk and project performance in 32 countries over 25 years. This hybrid model applies subjective weighting from industrial experts to objective information using a fuzzy LinPreRa-based Analytic Hierarchy Process. The hybrid model yields a more accurate country selection compared to a purely objective information-based model in experienced countries. Interestingly, the hybrid model provides some different predictions with only subjective opinions in unexperienced countries, which implies that expert opinion is not always reliable. In addition, feedback from five experts in top international companies is used to validate the model’s completeness, effectiveness, generality, and applicability. The model is expected to aid decision makers in selecting better candidate countries that lead to sustainable business success.

  2. Efficacy of an orlistat-resveratrol combination for weight loss in subjects with obesity: A randomized controlled trial.

    Science.gov (United States)

    Arzola-Paniagua, María Angélica; García-Salgado López, Enrique Raúl; Calvo-Vargas, Cesar G; Guevara-Cruz, Martha

    2016-07-01

    To evaluate the efficacy of an orlistat-resveratrol (O-R) combination in subjects with obesity over a 6-month period. This study was a double-blind, parallel, randomized controlled clinical trial. Patients fulfilling the selection criteria (age from 20 to 60 years and body mass index (BMI) ≥30 and ≤39.9 kg/m(2) ) consumed an energy-reduced diet with 500 fewer calories than their usual diet for 2 weeks. Then the participants were randomly assigned to four groups, placebo, resveratrol, orlistat, or O-R, and they consumed the energy-reduced diet for 6 months. The study consisted of seven visits. During each visit, a 24-h recall was performed, along with measurements of anthropometric and serum biochemical parameters. A total of 161 participants were selected. Of these, 84 participants completed the study. A significant weight loss of -6.82 kg (95% CI -8.37 to -5.26) was observed in the O-R group compared with -3.50 kg (-5.05 to -1.95, P = 0.021) in the placebo group. In contrast, the -6.02 kg (-7.68 to -4.36) orlistat and -4.68 kg (-6.64 to -2.71) resveratrol monotherapy losses did not significantly differ from the placebo. Significant decreases in BMI, waist circumference, fat mass, triglycerides, leptin, and leptin/adiponectin ratio were observed with the O-R combination. The O-R combination was the most effective weight loss treatment. © 2016 The Obesity Society.

  3. Study on MAX-MIN Ant System with Random Selection in Quadratic Assignment Problem

    Science.gov (United States)

    Iimura, Ichiro; Yoshida, Kenji; Ishibashi, Ken; Nakayama, Shigeru

    Ant Colony Optimization (ACO), which is a type of swarm intelligence inspired by ants' foraging behavior, has been studied extensively and its effectiveness has been shown by many researchers. The previous studies have reported that MAX-MIN Ant System (MMAS) is one of effective ACO algorithms. The MMAS maintains the balance of intensification and diversification concerning pheromone by limiting the quantity of pheromone to the range of minimum and maximum values. In this paper, we propose MAX-MIN Ant System with Random Selection (MMASRS) for improving the search performance even further. The MMASRS is a new ACO algorithm that is MMAS into which random selection was newly introduced. The random selection is one of the edgechoosing methods by agents (ants). In our experimental evaluation using ten quadratic assignment problems, we have proved that the proposed MMASRS with the random selection is superior to the conventional MMAS without the random selection in the viewpoint of the search performance.

  4. Information Seeking Behavior & Information Resources Management:Mental Process Selecting Subjects & Identifying Information Needs Case study: Graduate Students in Women seminaries of Shiraz of Academic year 1393- 1394(

    Directory of Open Access Journals (Sweden)

    Zohre Eftekhar

    2016-08-01

    Full Text Available The aim of this research is Information Resources Management: Mental Process Selecting Subjects &  Identifying Information Needs. The research method used in this study is a Quantitative method. Sampling is purposeful. This means that it includes graduate Students in Women seminaries of Shiraz who have information-seeking experience and are able to express their views and information needs. The sample was selected according to the random sampling method with Cochran formula from 710 students. According to this sampling method there is 241 Graduate Students included in 1392-1393 seminaries year of  Women seminaries of Shiraz. This is a survey research Which has been carried out by employing a questionnaire and SPSS for windows to analyze data. The results showed that students for selecting subjects,  identifying information needs used methods and media such as Prying Mind, reviewing of information resources, Consulting with subject specialists.

  5. Specifics of Educational Texts Selection for Schoolchildren Doing the Humanities Subjects

    Directory of Open Access Journals (Sweden)

    T. V. Oblasova

    2015-02-01

    Full Text Available The paper proposes the new approach to educational text selection for the humanities teaching. Its specifics is based on the wide interpretation of educational texts, as the culture texts involved in cognitive learning activity and fulfilling the multiple tasks of the related subjects and personal development. The educational text is taken as a generalized model, its content and structure determining the scheme of a speech cognitive activity, as well as the meaning formation mechanism responsible for understanding and personal development. The texts and tasks selection is oriented on schoolchildren’s understanding with the reference to the psycholinguistic, psychological and hermeneutic approaches; information extraction and interpretation level related to the author’s and student’s context. The given approach could provide the basis for developing and structuring the textbooks content for the humanities subjects

  6. Specifics of Educational Texts Selection for Schoolchildren Doing the Humanities Subjects

    Directory of Open Access Journals (Sweden)

    T. V. Oblasova

    2012-01-01

    Full Text Available The paper proposes the new approach to educational text selection for the humanities teaching. Its specifics is based on the wide interpretation of educational texts, as the culture texts involved in cognitive learning activity and fulfilling the multiple tasks of the related subjects and personal development. The educational text is taken as a generalized model, its content and structure determining the scheme of a speech cognitive activity, as well as the meaning formation mechanism responsible for understanding and personal development. The texts and tasks selection is oriented on schoolchildren’s understanding with the reference to the psycholinguistic, psychological and hermeneutic approaches; information extraction and interpretation level related to the author’s and student’s context. The given approach could provide the basis for developing and structuring the textbooks content for the humanities subjects

  7. Hamming Distance Method with Subjective and Objective Weights for Personnel Selection

    Directory of Open Access Journals (Sweden)

    R. Md Saad

    2014-01-01

    Full Text Available Multicriteria decision making (MCDM is one of the methods that popularly has been used in solving personnel selection problem. Alternatives, criteria, and weights are some of the fundamental aspects in MCDM that need to be defined clearly in order to achieve a good result. Apart from these aspects, fuzzy data has to take into consideration that it may arise from unobtainable and incomplete information. In this paper, we propose a new approach for personnel selection problem. The proposed approach is based on Hamming distance method with subjective and objective weights (HDMSOW’s. In case of vagueness situation, fuzzy set theory is then incorporated onto the HDMSOW’s. To determine the objective weight for each attribute, the fuzzy Shannon’s entropy is considered. While for the subjective weight, it is aggregated into a comparable scale. A numerical example is presented to illustrate the HDMSOW’s.

  8. Hamming distance method with subjective and objective weights for personnel selection.

    Science.gov (United States)

    Saad, R; Ahmad, M Z; Abu, M S; Jusoh, M S

    2014-01-01

    Multicriteria decision making (MCDM) is one of the methods that popularly has been used in solving personnel selection problem. Alternatives, criteria, and weights are some of the fundamental aspects in MCDM that need to be defined clearly in order to achieve a good result. Apart from these aspects, fuzzy data has to take into consideration that it may arise from unobtainable and incomplete information. In this paper, we propose a new approach for personnel selection problem. The proposed approach is based on Hamming distance method with subjective and objective weights (HDMSOW's). In case of vagueness situation, fuzzy set theory is then incorporated onto the HDMSOW's. To determine the objective weight for each attribute, the fuzzy Shannon's entropy is considered. While for the subjective weight, it is aggregated into a comparable scale. A numerical example is presented to illustrate the HDMSOW's.

  9. Basal DNA repair machinery is subject to positive selection in ionizing-radiation-resistant bacteria

    Directory of Open Access Journals (Sweden)

    Barkallah Insaf

    2008-06-01

    Full Text Available Abstract Background Ionizing-radiation-resistant bacteria (IRRB show a surprising capacity for adaptation to ionizing radiation and desiccation. Positive Darwinian selection is expected to play an important role in this trait, but no data are currently available regarding the role of positive adaptive selection in resistance to ionizing-radiation and tolerance of desiccation. We analyzed the four known genome sequences of IRRB (Deinococcus geothermalis, Deinococcus radiodurans, Kineococcus radiotolerans, and Rubrobacter xylanophilus to determine the role of positive Darwinian selection in the evolution of resistance to ionizing radiation and tolerance of desiccation. Results We used the programs MultiParanoid and DnaSP to deduce the sets of orthologs that potentially evolved due to positive Darwinian selection in IRRB. We find that positive selection targets 689 ortholog sets of IRRB. Among these, 58 ortholog sets are absent in ionizing-radiation-sensitive bacteria (IRSB: Escherichia coli and Thermus thermophilus. The most striking finding is that all basal DNA repair genes in IRRB, unlike many of their orthologs in IRSB, are subject to positive selection. Conclusion Our results provide the first in silico prediction of positively selected genes with potential roles in the molecular basis of resistance to γ-radiation and tolerance of desiccation in IRRB. Identification of these genes provides a basis for future experimental work aimed at understanding the metabolic networks in which they participate.

  10. Hypoglycemic effect of triphala on selected non insulin dependent Diabetes mellitus subjects

    OpenAIRE

    Rajan, Sowmya S.; Antony, Seema

    2008-01-01

    Modern life style is characterized by high stress, increased automation, junk food consumption and sedentary life style which have lead to the incidence of Diabetes. The study involved selection of NIDDM subjects who were supplemented with Triphala powder called, The Three Myrobalans ( Terminalia bellirica - Belliric myrobalan, Terminalia chebula -Inknut, Embilica officinalis - Indian gooseberry) for a period of 45 days. Statistical evaluation of the blood profile showed significant reduction...

  11. Cost-effectiveness of nutritional intervention in elderly subjects after hip fracture. A randomized controlled trial.

    Science.gov (United States)

    Wyers, C E; Reijven, P L M; Evers, S M A A; Willems, P C; Heyligers, I C; Verburg, A D; van Helden, S; Dagnelie, P C

    2013-01-01

    Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective. Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective. Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively. Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years. Intensive nutritional intervention in elderly hip fracture patients is likely to be cost

  12. Cross-Subject EEG Feature Selection for Emotion Recognition Using Transfer Recursive Feature Elimination.

    Science.gov (United States)

    Yin, Zhong; Wang, Yongxiong; Liu, Li; Zhang, Wei; Zhang, Jianhua

    2017-01-01

    Using machine-learning methodologies to analyze EEG signals becomes increasingly attractive for recognizing human emotions because of the objectivity of physiological data and the capability of the learning principles on modeling emotion classifiers from heterogeneous features. However, the conventional subject-specific classifiers may induce additional burdens to each subject for preparing multiple-session EEG data as training sets. To this end, we developed a new EEG feature selection approach, transfer recursive feature elimination (T-RFE), to determine a set of the most robust EEG indicators with stable geometrical distribution across a group of training subjects and a specific testing subject. A validating set is introduced to independently determine the optimal hyper-parameter and the feature ranking of the T-RFE model aiming at controlling the overfitting. The effectiveness of the T-RFE algorithm for such cross-subject emotion classification paradigm has been validated by DEAP database. With a linear least square support vector machine classifier implemented, the performance of the T-RFE is compared against several conventional feature selection schemes and the statistical significant improvement has been found. The classification rate and F-score achieve 0.7867, 0.7526, 0.7875, and 0.8077 for arousal and valence dimensions, respectively, and outperform several recent reported works on the same database. In the end, the T-RFE based classifier is compared against two subject-generic classifiers in the literature. The investigation of the computational time for all classifiers indicates the accuracy improvement of the T-RFE is at the cost of the longer training time.

  13. Negative mood increases selective attention to food cues and subjective appetite.

    Science.gov (United States)

    Hepworth, Rebecca; Mogg, Karin; Brignell, Catherine; Bradley, Brendan P

    2010-02-01

    Following negative reinforcement and affect-regulation models of dysfunctional appetitive motivation, this study examined the effect of negative mood on objective and subjective cognitive indices of motivation for food; i.e., attentional bias for food cues and self-reported hunger/urge to eat, respectively. The study extended previous research on the effect of mood on food motivation by using (i) an experimental mood manipulation, (ii) an established index of attentional bias from the visual-probe task and (iii) pictorial food cues, which have greater ecological validity than word stimuli. Young female adults (n=80) were randomly allocated to a neutral or negative mood induction procedure. Attentional biases were assessed at two cue exposure durations (500 and 2000ms). Results showed that negative mood increased both attentional bias for food cues and subjective appetite. Attentional bias and subjective appetite were positively inter-correlated, suggesting a common mechanism, i.e. activation of the food-reward system. Attentional bias was also associated with trait eating style, such as external and restrained eating. Thus, current mood and trait eating style each influenced motivation for food (as reflected by subjective appetite and attentional bias). Findings relate to models of cognitive mechanisms underlying normal and dysfunctional appetitive motivation and eating behaviour. 2009 Elsevier Ltd. All rights reserved.

  14. Oxytocin for male subjects with autism spectrum disorder and comorbid intellectual disabilities: A randomized pilot study

    Directory of Open Access Journals (Sweden)

    Toshio eMunesue

    2016-01-01

    Full Text Available Approximately half of autism spectrum disorder (ASD individual suffer from comorbid intellectual disabilities (ID. Oxytocin (OXT receptors are highly expressed in temporal lobe structures and are likely to play a modulatory role in excitatory/inhibitory balance, at least based on animal model findings. Thus, it is feasible that in the highly representative group of Kanner type ASD subjects OXT could have a beneficial effect on social communication and social interaction. The aim of this pilot study was to investigate the feasibility and adverse events, such as epilepsy, of the long-term administration of intranasal OXT for adolescent and adult ASD subjects with ID because such patients frequently have seizures. We also addressed the question on how to scale the OXT effects to the core symptoms of social deficits because of the relative difficulty in obtaining objective measurements. Twenty-nine males (aged 15-40 years old participated in a randomized, double-blind, placebo-controlled crossover study (each for 8 weeks with OXT (16 international units per day. Except for seizures experienced by one participant, other serious adverse events did not occur. The primary and secondary outcomes measured using the Childhood Autism Rating Scale and several standard scales, respectively, revealed no difference between the OXT and placebo groups. Instead, in an exploratory analysis, the social interactions observed in the play sessions or in daily-life were significantly more frequent in the initial half period in the OXT-first arm of the crossover trial. There were also significant correlations between the plasma OXT concentration and subscale scores for irritability on the Aberrant Behavior Checklist. In conclusion, this pilot study demonstrates that long-term administration of intranasal OXT is tolerable in a representative cohort of ASD individuals with ID and suggests that future multicenter trials of OXT are warranted and should include measurements

  15. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial.

    Science.gov (United States)

    Erickson, Jennifer; Korczak, Renee; Wang, Qi; Slavin, Joanne

    2017-05-25

    There has been increasing interest in utilizing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) for the treatment of irritable bowel syndrome (IBS), a functional gastrointestinal disease. While studies have indicated that this diet can be effective at symptom reduction, it is a restrictive diet and patients may find it challenging to find low FODMAP products to meet their nutrient needs. The primary objective of this study was to assess the gastrointestinal (GI) tolerance of three low FODMAP oral nutrition supplements (ONS) in healthy adults. A double-blind randomized controlled crossover study was conducted in 21 healthy adults (19-32 years). Fasted subjects consumed one of four treatments at each visit, with a one week wash out period between visits. Each participant received all treatments. Treatments included three low FODMAP ONS formulas (A, B, and C) as well as a positive control consisting of 5 g fructooligosaccharides (FOS) mixed in lactose-free milk. Breath hydrogen was measured at baseline, 1, 2, 3, and 4 h post treatment consumption. Subjective GI symptom questionnaires were completed at baseline, 0.5, 1, 1.5, 2, 3, 4, 12, 24 and 48 h following treatment consumption. Mean breath hydrogen concentrations and baseline corrected area under the curve for both breath hydrogen and GI symptoms were analyzed and compared between treatments. Significance was determined at P FODMAP ONS beverages at 3 and 4 h after consumption. There were no differences in GI symptom response between treatments. All treatments were well tolerated in healthy participants. The low FODMAP formulas resulted in a lower breath hydrogen response compared to the positive control, and may be better tolerated in individuals with IBS. More research should be conducted to better understand the GI tolerance of low FODMAP ONS in individuals with IBS. The protocol for this study was registered on ClinicalTrials.gov in January 2016 (Clinical

  16. Geography and genography: prediction of continental origin using randomly selected single nucleotide polymorphisms

    Directory of Open Access Journals (Sweden)

    Ramoni Marco F

    2007-03-01

    Full Text Available Abstract Background Recent studies have shown that when individuals are grouped on the basis of genetic similarity, group membership corresponds closely to continental origin. There has been considerable debate about the implications of these findings in the context of larger debates about race and the extent of genetic variation between groups. Some have argued that clustering according to continental origin demonstrates the existence of significant genetic differences between groups and that these differences may have important implications for differences in health and disease. Others argue that clustering according to continental origin requires the use of large amounts of genetic data or specifically chosen markers and is indicative only of very subtle genetic differences that are unlikely to have biomedical significance. Results We used small numbers of randomly selected single nucleotide polymorphisms (SNPs from the International HapMap Project to train naïve Bayes classifiers for prediction of ancestral continent of origin. Predictive accuracy was tested on two independent data sets. Genetically similar groups should be difficult to distinguish, especially if only a small number of genetic markers are used. The genetic differences between continentally defined groups are sufficiently large that one can accurately predict ancestral continent of origin using only a minute, randomly selected fraction of the genetic variation present in the human genome. Genotype data from only 50 random SNPs was sufficient to predict ancestral continent of origin in our primary test data set with an average accuracy of 95%. Genetic variations informative about ancestry were common and widely distributed throughout the genome. Conclusion Accurate characterization of ancestry is possible using small numbers of randomly selected SNPs. The results presented here show how investigators conducting genetic association studies can use small numbers of arbitrarily

  17. Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.

    Science.gov (United States)

    Darwish, Mona; Kirby, Mary; Hellriegel, Edward T; Yang, Ronghua; Robertson, Philmore

    2009-01-01

    Armodafinil (R-modafinil) is the R- and longer-lasting isomer of the racemic compound modafinil, a wakefulness-promoting medication. Armodafinil is eliminated approximately three times more slowly than the S-isomer of racemic modafinil. Published studies have demonstrated the efficacy of armodafinil for treating excessive sleepiness associated with obstructive sleep apnoea, shift work disorder and narcolepsy. The objectives of this study were to describe the pharmacokinetic profile, tolerability and safety of armodafinil in healthy subjects. Pooled pharmacokinetic data from three separate randomized studies in 119 healthy subjects who received single or multiple (once daily for up to 14 days) oral doses of armodafinil ranging between 50 and 400 mg were analysed. The impact of food on the single-dose pharmacokinetic profile of armodafinil was also assessed in subjects following an overnight fast and after the consumption of a standard fatty meal. Armodafinil was readily absorbed and exhibited linear pharmacokinetics over the 50-400 mg dose range. Peak plasma concentrations were reached around 2 hours after administration in the fasted state. Food had no effect on the overall bioavailability of armodafinil; however, the peak concentration was delayed by approximately 2-4 hours. In the multiple-dose study, dose proportionality was confirmed by linear regression analyses of the log-transformed area under the plasma concentration versus time curve (AUC) and maximum plasma concentration (Cmax) values as a function of dose. After reaching the peak, plasma concentrations of armodafinil declined in a monophasic manner, with a mean elimination half-life of approximately 15 hours. Steady state appeared to be reached within 7 days. At steady state, the systemic exposure to armodafinil was 1.8 times that observed after single-dose administration. Armodafinil was generally well tolerated, the most frequent adverse events being headache, dizziness and nausea. In the present

  18. Does green tea affect postprandial glucose, insulin and satiety in healthy subjects: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lindstedt Sandra

    2010-11-01

    Full Text Available Abstract Background Results of epidemiological studies have suggested that consumption of green tea could lower the risk of type 2 diabetes. Intervention studies show that green tea may decrease blood glucose levels, and also increase satiety. This study was conducted to examine the postprandial effects of green tea on glucose levels, glycemic index, insulin levels and satiety in healthy individuals after the consumption of a meal including green tea. Methods The study was conducted on 14 healthy volunteers, with a crossover design. Participants were randomized to either 300 ml of green tea or water. This was consumed together with a breakfast consisting of white bread and sliced turkey. Blood samples were drawn at 0, 15, 30, 45, 60, 90, and 120 minutes. Participants completed several different satiety score scales at the same times. Results Plasma glucose levels were higher 120 min after ingestion of the meal with green tea than after the ingestion of the meal with water. No significant differences were found in serum insulin levels, or the area under the curve for glucose or insulin. Subjects reported significantly higher satiety, having a less strong desire to eat their favorite food and finding it less pleasant to eat another mouthful of the same food after drinking green tea compared to water. Conclusions Green tea showed no glucose or insulin-lowering effect. However, increased satiety and fullness were reported by the participants after the consumption of green tea. Trial registration number NCT01086189

  19. A Comparison of Dietary Habits between Recreational Runners and a Randomly Selected Adult Population in Slovenia.

    Science.gov (United States)

    Škof, Branko; Rotovnik Kozjek, Nada

    2015-09-01

    The aim of the study was to compare the dietary habits of recreational runners with those of a random sample of the general population. We also wanted to determine the influence of gender, age and sports performance of recreational runners on their basic diet and compliance with recommendations in sports nutrition. The study population consisted of 1,212 adult Slovenian recreational runners and 774 randomly selected residents of Slovenia between the ages of 18 and 65 years. The data on the dietary habits of our subjects was gathered by means of two questionnaires. The following parameters were evaluated: the type of diet, a food pattern, and the frequency of consumption of individual food groups, the use of dietary supplements, fluid intake, and alcohol consumption. Recreational runners had better compliance with recommendations for healthy nutrition than the general population. This pattern increased with the runner's age and performance level. Compared to male runners, female runners ate more regularly and had a more frequent consumption of food groups associated with a healthy diet (fruit, vegetables, whole grain foods, and low-fat dairy products). The consumption of simple sugars and use of nutritional supplements by well-trained runners was inadequate with values recommended for physically active individuals. Recreational runners are an exemplary population group that actively seeks to adopt a healthier lifestyle.

  20. Subjective Social Status in select Ukrainians, Vietnamese, and Mongolians living in the Czech Republic.

    Science.gov (United States)

    Vacková, Jitka; Veleminsky, Milos; Brabcová, Iva; Záleská, Veronika

    2014-01-01

    This article discusses methods of examining subjective social status (SSS), which is based on the concept of social determinants of health described by Wilkinson and Marmot in 1998. SSS research was conducted with Cooperation from the Scientific and Technical Research (COST) program, with financial support from the Czech Ministry of Education, Youth and Sports. This study is part of a project entitled the "Health and Social Status of Immigrants and Asylum Seekers in the Czech Republic" (registration number OC 10031), which was started in 2010 and concluded in May 2011. The study included 246 respondents of which: 69 (28.1%) had emigrated from Vietnam; 93 (37.8%) from the Ukraine; and 84 (34.1%) from Mongolia. In terms of qualitative strategies, 13 individual immigrants and asylum seekers were personally interviewed. This research was thus conceived as being both quantitative-qualitative, which included the use of the appropriate technical tools (i.e., questionnaires and interviews with select immigrants and asylum seekers). SSS was determined using the Pearson's chi-square test, as well as through correspondence and cluster analyzes. Sign schemes were used to detect select significant relationships in contingency tables. The minimum significance level chosen was α ≤ 0.05. When examining the SSS of select nationalities, differences were observed in the perception of subjective social status. The correspondence analysis results clearly show that Ukrainians best perceived their social status (within the selected parameters). One measure of subjectively perceived social status related to Czech language proficiency (i.e., one criterion was the comprehension of spoken Czech; e.g., whether the respondent could read or speak Czech, or how they assessed their own Czech proficiency). The SSS study clearly revealed typical links among select nationalities living in the Czech Republic, and highlighted risks related to the degree of integration (and its relationship to

  1. A Solution Method for Linear and Geometrically Nonlinear MDOF Systems with Random Properties subject to Random Excitation

    DEFF Research Database (Denmark)

    Micaletti, R. C.; Cakmak, A. S.; Nielsen, Søren R. K.

    structural properties. The resulting state-space formulation is a system of ordinary stochastic differential equations with random coefficient and deterministic initial conditions which are subsequently transformed into ordinary stochastic differential equations with deterministic coefficients and random...... initial conditions. This transformation facilitates the derivation of differential equations which govern the evolution of the unconditional statistical moments of response. Primary consideration is given to linear systems and systems with odd polynomial nonlinearities, for in these cases...... there is a significant reduction in the number of equations to be solved. The method is illustrated for a five-story shear-frame structure with nonlinear interstory restoring forces and random damping and stiffness properties. The results of the proposed method are compared to those estimated by extensive Monte Carlo...

  2. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies.

    Science.gov (United States)

    Cahn, Anthony; Tal-Singer, Ruth; Pouliquen, Isabelle J; Mehta, Rashmi; Preece, Andrew; Hardes, Kelly; Crater, Glenn; Deans, Amanda

    2013-07-01

    Chronic obstructive pulmonary disease (COPD) has a significant negative impact on quality of life and increases the risk of premature death. Umeclidinium is a long-acting muscarinic receptor antagonist in development for the treatment of COPD with the aim to broaden treatment options for clinicians and patients by providing improved symptom control. To characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects. Two randomized, placebo-controlled, ascending-dose studies were conducted in healthy ipratropium bromide-responsive subjects. In the single-dose study, subjects (n = 20) received umeclidinium (10-350 μg), tiotropium bromide 18 μg and placebo in a crossover dosing schedule. In this study, lung function was assessed for 24 h by measuring specific airways conductance (sGaw) and forced expiratory volume in 1 s (FEV1). In the repeat-dose study, subjects (n = 36) received umeclidinium (250-1,000 μg) and placebo for 14 days in a parallel-group schedule. Adverse events (AEs) were reported in five subjects (single-dose study) and 23 subjects (repeat-dose study); none were serious. In both studies, no abnormalities in 12-lead electrocardiogram parameters, 24-h Holter monitoring or lead II monitoring were reported as AEs. Umeclidinium was rapidly absorbed following single-dose administration [time to reach the maximum plasma concentration (tmax) 5-15 min] and repeat-dose administration (tmax 5-7 min). Following repeat dosing, the geometric mean plasma elimination half-life was approximately 27 h and statistically significant accumulation was observed for the area under the plasma concentration-time curve, maximum plasma concentration and cumulative amount of unchanged drug excreted into the urine at 24 h (range 1.5- to 4.5-fold). Umeclidinium at doses of 100 μg and above, and tiotropium bromide demonstrated statistically significant bronchodilatory effects

  3. Reducing worry and subjective health complaints: A randomized trial of an internet-delivered worry postponement intervention.

    Science.gov (United States)

    Versluis, Anke; Verkuil, Bart; Brosschot, Jos F

    2016-05-01

    Several studies have shown that perseverative, worrisome thoughts are prospectively related to subjective health complaints (SHC) and that a short worry postponement intervention can decrease these complaints. As SHC and worry are prevalent and costly, we tested whether the intervention can be offered online to reduce these complaints in the general population. A randomized parallel-group trial was conducted with self-selected participants from the general population. Via the research website, 996 participants were instructed to register their worrying for 6 consecutive days. The intervention group was instructed to postpone worry to a special 30-min period in the early evening. The Subjective Health Complaints inventory, as administered before and after the intervention, and daily worry frequency and duration were considered the primary outcomes. Three hundred and sixty-one participants completed the study. Contrary to our expectation, the registration group (n = 188) did not differ from the intervention group (n = 163) in SHC (ηp² = .000, CI [0.000-0.003]), or in worry frequency or duration. Nevertheless, the different worry parameters were moderately related to SHC (r between .238 and .340, p ≤ .001). In contrast to previous studies using pen-and-pencil versions of the worry postponement intervention, this study suggests that a direct online implementation was not effective in reducing SHC and worry. Overall, participants had high trait worry levels and reported difficulty with postponing worrying. Reducing SHC and worries via the Internet might require more elaborate interventions that better incorporate the advantages of delivering interventions online. What is already known on this subject? The perseverative cognition hypothesis argues that perseverative cognition, such as worry and rumination, acts as a mediator by which psychosocial stress may produce negative health effects. Prior research has indeed shown that worry and subjective health complaints

  4. Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.

    Science.gov (United States)

    Meinzer, Caitlyn; Martin, Renee; Suarez, Jose I

    2017-09-08

    In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size. To balance these challenges, a novel placebo-controlled design is presented in which a restricted Bayesian response adaptive randomization (RAR) is used to allocate a majority of subjects to the optimal dose of active drug, defined as the dose with the lowest probability of poor outcome. However, the allocation between subjects who receive active drug or placebo is held constant to retain the maximum possible power for a hypothesis test of overall efficacy comparing the optimal dose to placebo. The design properties and optimization of the design are presented in the context of a phase II trial for subarachnoid hemorrhage. For a fixed total sample size, a trade-off exists between the ability to select the optimal dose and the probability of rejecting the null hypothesis. This relationship is modified by the allocation ratio between active and control subjects, the choice of RAR algorithm, and the number of subjects allocated to an initial fixed allocation period. While a responsive RAR algorithm improves the ability to select the correct dose, there is an increased risk of assigning more subjects to a worse arm as a function of ephemeral trends in the data. A subarachnoid treatment trial is used to illustrate how this design can be customized for specific objectives and available data. Bayesian adaptive designs are a flexible approach to addressing multiple questions surrounding the optimal dose for treatment efficacy

  5. In vivo selection of randomly mutated retroviral genomes

    NARCIS (Netherlands)

    Berkhout, B.; Klaver, B.

    1993-01-01

    Darwinian evolution, that is the outgrowth of the fittest variants in a population, usually applies to living organisms over long periods of time. Recently, in vitro selection/amplification techniques have been developed that allow for the rapid evolution of functionally active nucleic acids from a

  6. Noise-induced hearing loss in randomly selected New York dairy farmers.

    Science.gov (United States)

    May, J J; Marvel, M; Regan, M; Marvel, L H; Pratt, D S

    1990-01-01

    To understand better the effects of noise levels associated with dairy farming, we randomly selected 49 full-time dairy farmers from an established cohort. Medical and occupational histories were taken and standard audiometric testing was done. Forty-six males (94%) and three females (6%) with a mean age of 43.5 (+/- 13) years and an average of 29.4 (+/- 14) years in farming were tested. Pure Tone Average thresholds (PTA4) at 0.5, 1.0, 2.0, and 3.0 kHz plus High Frequency Average thresholds (HFA3) at 3.0, 4.0, and 6.0 kHz were calculated. Subjects with a loss of greater than or equal to 20 db in either ear were considered abnormal. Eighteen subjects (37%) had abnormal PTA4S and 32 (65%) abnormal HFA3S. The left ear was more severely affected in both groups (p less than or equal to .05, t-test). Significant associations were found between hearing loss and years worked (odds ratio 4.1, r = .53) and age (odds ratio 4.1, r = .59). No association could be found between hearing loss and measles; mumps; previous ear infections; or use of power tools, guns, motorcycles, snowmobiles, or stereo headphones. Our data suggest that among farmers, substantial hearing loss occurs especially in the high-frequency ranges. Presbycusis is an important confounding variable.

  7. Assessing the accuracy and stability of variable selection methods for random forest modeling in ecology

    Science.gov (United States)

    Random forest (RF) modeling has emerged as an important statistical learning method in ecology due to its exceptional predictive performance. However, for large and complex ecological datasets there is limited guidance on variable selection methods for RF modeling. Typically, e...

  8. The frequency of drugs in randomly selected drivers in Denmark

    DEFF Research Database (Denmark)

    Simonsen, Kirsten Wiese; Steentoft, Anni; Hels, Tove

    Introduction Driving under the influence of alcohol and drugs is a global problem. In Denmark as well as in other countries there is an increasing focus on impaired driving. Little is known about the occurrence of psychoactive drugs in the general traffic. Therefore the European commission...... initiated the DRUID project. This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Methods Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme...... stratified by time, season, and road type. The oral fluid samples were screened for 29 illegal and legal psychoactive substances and metabolites as well as ethanol. Results Fourteen (0.5%) drivers were positive for ethanol (alone or in combination with drugs) at concentrations above 0.53 g/l, which...

  9. Sample Selection in Randomized Experiments: A New Method Using Propensity Score Stratified Sampling

    Science.gov (United States)

    Tipton, Elizabeth; Hedges, Larry; Vaden-Kiernan, Michael; Borman, Geoffrey; Sullivan, Kate; Caverly, Sarah

    2014-01-01

    Randomized experiments are often seen as the "gold standard" for causal research. Despite the fact that experiments use random assignment to treatment conditions, units are seldom selected into the experiment using probability sampling. Very little research on experimental design has focused on how to make generalizations to well-defined…

  10. Pseudo cluster randomization dealt with selection bias and contamination in clinical trials

    NARCIS (Netherlands)

    Teerenstra, S.; Melis, R.J.F.; Peer, P.G.M.; Borm, G.F.

    2006-01-01

    BACKGROUND AND OBJECTIVES: When contamination is present, randomization on a patient level leads to dilution of the treatment effect. The usual solution is to randomize on a cluster level, but at the cost of efficiency and more importantly, this may introduce selection bias. Furthermore, it may slow

  11. Tolerability, pharmacokinetics and pharmacodynamics of TA-8995, a selective cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects

    NARCIS (Netherlands)

    Ford, John; Lawson, Matt; Fowler, David; Maruyama, Nobuko; Mito, Seiji; Tomiyasu, Koichi; Kinoshita, Shuji; Suzuki, Chisa; Kawaguchi, Atsuhiro; Round, Patrick; Boyce, Malcolm; Warrington, Steve; Weber, Werner; van Deventer, Sander; Kastelein, John J. P.

    2014-01-01

    Two double-blind, randomized studies were conducted to assess the tolerability, pharmacokinetics and pharmacodynamics of oral TA-8995, a new cholesteryl ester transfer protein (CETP) inhibitor, in healthy subjects. Study 1: Subjects received single doses of TA-8995 or placebo (fasted). Doses were 5,

  12. Different alternative splicing patterns are subject to opposite selection pressure for protein reading frame preservation

    Directory of Open Access Journals (Sweden)

    Chuang Trees-Juen

    2007-09-01

    Full Text Available Abstract Background Alternative splicing (AS has been regarded capable of altering selection pressure on protein subsequences. Particularly, the frequency of reading frame preservation (FRFP, as a measure of selection pressure, has been reported to be higher in alternatively spliced exons (ASEs than in constitutively spliced exons (CSEs. However, recently it has been reported that different ASE types – simple and complex ASEs – may be subject to opposite selection forces. Therefore, it is necessary to re-evaluate the evolutionary effects of such splicing patterns on frame preservation. Results Here we show that simple and complex ASEs, respectively, have higher and lower FRFPs than CSEs. Since complex ASEs may alter the ends of their flanking exons, the selection pressure on frame preservation is likely relaxed in this ASE type. Furthermore, conservation of the ASE/CSE splicing pattern increases the FRFPs of simple ASEs but decreases those of complex ASEs. Contrary to the well-recognized concept of strong selection pressure on conserved ASEs for protein reading frame preservation, our results show that conserved complex ASEs are relaxed from such pressure and the frame-disrupting effect caused by the insertion of complex ASEs can be offset by compensatory changes in their flanking exons. Conclusion In this study, we find that simple and complex ASEs undergo opposite selection pressure for protein reading frame preservation, with CSEs in-between. Simple ASEs have much higher FRFPs than complex ones. We further find that the FRFPs of complex ASEs coupled with flanking exons are close to those of simple ASEs, indicating that neighboring exons of an ASE may evolve in a coordinated way to avoid protein dysfunction. Therefore, we suggest that evolutionary analyses of AS should take into consideration the effects of different splicing patterns and the joint effects of multiple AS events.

  13. A randomized, double-blind, placebo-controlled study assessing the safety and tolerability of regadenoson in subjects with asthma or chronic obstructive pulmonary disease.

    Science.gov (United States)

    Prenner, Bruce M; Bukofzer, Stan; Behm, Sarah; Feaheny, Kathleen; McNutt, Bruce E

    2012-08-01

    Adenosine receptor stress agents for myocardial perfusion imaging (MPI) may cause A(2B) and/or A(3) receptor-mediated bronchoconstriction, of particular concern to physicians testing patients with asthma or chronic obstructive pulmonary disease (COPD). A Phase 4, randomized, double-blind study (NCT00862641) assessed the safety of the selective A(2A) receptor agonist, regadenoson, compared with placebo in subjects with asthma or COPD who represented likely candidates for MPI. Overall, 356 and 176 subjects with asthma and 316 and 151 subjects with COPD received regadenoson and placebo, respectively. The percentage of subjects experiencing a >15% decrease in FEV(1) from baseline to any assessment up to 24 hours post-baseline was not statistically significantly different between the regadenoson and the placebo groups in the asthma or COPD stratum. Dyspnea, the most frequent respiratory adverse event, occurred with higher incidence (P regadenoson group than the placebo group in the asthma (10.7% vs 1.1%) and COPD (18.0% vs 2.6%) strata. No subjects experienced severe bronchoconstriction, although the occurrence of such reactions with adenosine receptor agonists cannot be ruled out, such that caution is advised. This information may be helpful to physicians selecting a pharmacologic stress agent for MPI in patients with asthma or COPD.

  14. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study

    Science.gov (United States)

    Byun, Tara McAllister

    2017-01-01

    Purpose: This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of…

  15. Acceptance sampling using judgmental and randomly selected samples

    Energy Technology Data Exchange (ETDEWEB)

    Sego, Landon H.; Shulman, Stanley A.; Anderson, Kevin K.; Wilson, John E.; Pulsipher, Brent A.; Sieber, W. Karl

    2010-09-01

    We present a Bayesian model for acceptance sampling where the population consists of two groups, each with different levels of risk of containing unacceptable items. Expert opinion, or judgment, may be required to distinguish between the high and low-risk groups. Hence, high-risk items are likely to be identifed (and sampled) using expert judgment, while the remaining low-risk items are sampled randomly. We focus on the situation where all observed samples must be acceptable. Consequently, the objective of the statistical inference is to quantify the probability that a large percentage of the unsampled items in the population are also acceptable. We demonstrate that traditional (frequentist) acceptance sampling and simpler Bayesian formulations of the problem are essentially special cases of the proposed model. We explore the properties of the model in detail, and discuss the conditions necessary to ensure that required samples sizes are non-decreasing function of the population size. The method is applicable to a variety of acceptance sampling problems, and, in particular, to environmental sampling where the objective is to demonstrate the safety of reoccupying a remediated facility that has been contaminated with a lethal agent.

  16. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  17. Noninvasive positive pressure ventilation in subjects with stable COPD: a randomized trial

    Directory of Open Access Journals (Sweden)

    Bhatt SP

    2013-11-01

    Full Text Available Surya P Bhatt,1 Michael W Peterson,2 Jeffrey S Wilson,1 Lakshmi Durairaj1 1Division of Pulmonary, Critical Care, and Occupational Medicine, Department of Internal Medicine, Roy J and Lucille A, Carver College of Medicine, University of Iowa Hospital, Iowa City, IA, USA; 2Department of Medicine, UCSF Fresno Medical Education Program, Fresno, CA, USA Background: The use of domiciliary noninvasive positive pressure ventilation (NPPV in stable chronic obstructive pulmonary disease (COPD with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life, and dyspnea. We hypothesized that use of NPPV in stable COPD and partial pressure of carbon dioxide (PaCO2 <52 mmHg might result in improvement in quality of life and dyspnea. Methods: Thirty patients with stable COPD (forced expiratory volume in the first second <50% predicted and PaCO2 <52 mmHg were prospectively randomized to receive domiciliary NPPV (bilevel positive airway pressure, 15/5 cm H2O or usual therapy for 6 months. Measurements were made at baseline, 6 weeks, 3 months, and 6 months. Primary outcomes were quality of life as assessed by the Chronic Respiratory Disease Questionnaire (CRQ, and dyspnea as measured by the Transitional Dyspnea Index (TDI. Results: Fifteen subjects in the NPPV arm and 12 controls completed all the study visits. At 6 weeks and 3 months, the NPPV arm showed significant improvement in TDI total score. However, this effect persisted only in the TDI-Task at 6 months (P=0.03. NPPV use was associated with a small improvement in the CRQ-Mastery domain (0.6 versus –0.1, P=0.04. The arterial partial pressure of oxygen (PaO2 in the control arm worsened over the period of the study, whereas it remained stable in the NPPV arm (change –7.2 mmHg versus +2.1 mmHg, respectively, P=0.02. Conclusion: NPPV resulted in a small improvement in quality of life indices in stable COPD patients with PaCO2 <52 mmHg. Future larger studies will

  18. RANDOM FORESTS-BASED FEATURE SELECTION FOR LAND-USE CLASSIFICATION USING LIDAR DATA AND ORTHOIMAGERY

    Directory of Open Access Journals (Sweden)

    H. Guan

    2012-07-01

    Full Text Available The development of lidar system, especially incorporated with high-resolution camera components, has shown great potential for urban classification. However, how to automatically select the best features for land-use classification is challenging. Random Forests, a newly developed machine learning algorithm, is receiving considerable attention in the field of image classification and pattern recognition. Especially, it can provide the measure of variable importance. Thus, in this study the performance of the Random Forests-based feature selection for urban areas was explored. First, we extract features from lidar data, including height-based, intensity-based GLCM measures; other spectral features can be obtained from imagery, such as Red, Blue and Green three bands, and GLCM-based measures. Finally, Random Forests is used to automatically select the optimal and uncorrelated features for landuse classification. 0.5-meter resolution lidar data and aerial imagery are used to assess the feature selection performance of Random Forests in the study area located in Mannheim, Germany. The results clearly demonstrate that the use of Random Forests-based feature selection can improve the classification performance by the selected features.

  19. Genome-Wide Analyses Reveal Genes Subject to Positive Selection in Pasteurella multocida

    Science.gov (United States)

    Cao, Peili; Guo, Dongchun; Liu, Jiasen; Jiang, Qian; Xu, Zhuofei; Qu, Liandong

    2017-01-01

    Pasteurella multocida, a Gram-negative opportunistic pathogen, has led to a broad range of diseases in mammals and birds, including fowl cholera in poultry, pneumonia and atrophic rhinitis in swine and rabbit, hemorrhagic septicemia in cattle, and bite infections in humans. In order to better interpret the genetic diversity and adaptation evolution of this pathogen, seven genomes of P. multocida strains isolated from fowls, rabbit and pigs were determined by using high-throughput sequencing approach. Together with publicly available P. multocida genomes, evolutionary features were systematically analyzed in this study. Clustering of 70,565 protein-coding genes showed that the pangenome of 33 P. multocida strains was composed of 1,602 core genes, 1,364 dispensable genes, and 1,070 strain-specific genes. Of these, we identified a full spectrum of genes related to virulence factors and revealed genetic diversity of these potential virulence markers across P. multocida strains, e.g., bcbAB, fcbC, lipA, bexDCA, ctrCD, lgtA, lgtC, lic2A involved in biogenesis of surface polysaccharides, hsf encoding autotransporter adhesin, and fhaB encoding filamentous haemagglutinin. Furthermore, based on genome-wide positive selection scanning, a total of 35 genes were subject to strong selection pressure. Extensive analyses of protein subcellular location indicated that membrane-associated genes were highly abundant among all positively selected genes. The detected amino acid sites undergoing adaptive selection were preferably located in extracellular space, perhaps associated with bacterial evasion of host immune responses. Our findings shed more light on conservation and distribution of virulence-associated genes across P. multocida strains. Meanwhile, this study provides a genetic context for future researches on the mechanism of adaptive evolution in P. multocida. PMID:28611758

  20. Genome-Wide Analyses Reveal Genes Subject to Positive Selection in Pasteurella multocida

    Directory of Open Access Journals (Sweden)

    Peili Cao

    2017-05-01

    Full Text Available Pasteurella multocida, a Gram-negative opportunistic pathogen, has led to a broad range of diseases in mammals and birds, including fowl cholera in poultry, pneumonia and atrophic rhinitis in swine and rabbit, hemorrhagic septicemia in cattle, and bite infections in humans. In order to better interpret the genetic diversity and adaptation evolution of this pathogen, seven genomes of P. multocida strains isolated from fowls, rabbit and pigs were determined by using high-throughput sequencing approach. Together with publicly available P. multocida genomes, evolutionary features were systematically analyzed in this study. Clustering of 70,565 protein-coding genes showed that the pangenome of 33 P. multocida strains was composed of 1,602 core genes, 1,364 dispensable genes, and 1,070 strain-specific genes. Of these, we identified a full spectrum of genes related to virulence factors and revealed genetic diversity of these potential virulence markers across P. multocida strains, e.g., bcbAB, fcbC, lipA, bexDCA, ctrCD, lgtA, lgtC, lic2A involved in biogenesis of surface polysaccharides, hsf encoding autotransporter adhesin, and fhaB encoding filamentous haemagglutinin. Furthermore, based on genome-wide positive selection scanning, a total of 35 genes were subject to strong selection pressure. Extensive analyses of protein subcellular location indicated that membrane-associated genes were highly abundant among all positively selected genes. The detected amino acid sites undergoing adaptive selection were preferably located in extracellular space, perhaps associated with bacterial evasion of host immune responses. Our findings shed more light on conservation and distribution of virulence-associated genes across P. multocida strains. Meanwhile, this study provides a genetic context for future researches on the mechanism of adaptive evolution in P. multocida.

  1. Genome-Wide Analyses Reveal Genes Subject to Positive Selection in Pasteurella multocida.

    Science.gov (United States)

    Cao, Peili; Guo, Dongchun; Liu, Jiasen; Jiang, Qian; Xu, Zhuofei; Qu, Liandong

    2017-01-01

    Pasteurella multocida, a Gram-negative opportunistic pathogen, has led to a broad range of diseases in mammals and birds, including fowl cholera in poultry, pneumonia and atrophic rhinitis in swine and rabbit, hemorrhagic septicemia in cattle, and bite infections in humans. In order to better interpret the genetic diversity and adaptation evolution of this pathogen, seven genomes of P. multocida strains isolated from fowls, rabbit and pigs were determined by using high-throughput sequencing approach. Together with publicly available P. multocida genomes, evolutionary features were systematically analyzed in this study. Clustering of 70,565 protein-coding genes showed that the pangenome of 33 P. multocida strains was composed of 1,602 core genes, 1,364 dispensable genes, and 1,070 strain-specific genes. Of these, we identified a full spectrum of genes related to virulence factors and revealed genetic diversity of these potential virulence markers across P. multocida strains, e.g., bcbAB, fcbC, lipA, bexDCA, ctrCD, lgtA, lgtC, lic2A involved in biogenesis of surface polysaccharides, hsf encoding autotransporter adhesin, and fhaB encoding filamentous haemagglutinin. Furthermore, based on genome-wide positive selection scanning, a total of 35 genes were subject to strong selection pressure. Extensive analyses of protein subcellular location indicated that membrane-associated genes were highly abundant among all positively selected genes. The detected amino acid sites undergoing adaptive selection were preferably located in extracellular space, perhaps associated with bacterial evasion of host immune responses. Our findings shed more light on conservation and distribution of virulence-associated genes across P. multocida strains. Meanwhile, this study provides a genetic context for future researches on the mechanism of adaptive evolution in P. multocida.

  2. Randomized placebo controlled trial of furosemide on subjective perception of dyspnoea in patients with pulmonary oedema because of hypertensive crisis.

    Science.gov (United States)

    Holzer-Richling, Nina; Holzer, Michael; Herkner, Harald; Riedmüller, Eva; Havel, Christof; Kaff, Alfred; Malzer, Reinhard; Schreiber, Wolfgang

    2011-06-01

    To compare the administration of furosemide with placebo on the subjective perception of dyspnoea in patients with acute pulmonary oedema because of hypertensive crisis. Design  Randomized, controlled and double-blinded clinical trial. Municipal emergency medical service system and university-based emergency department. Fifty-nine patients with pulmonary oedema because of hypertensive crisis. Additional to administration of oxygen, morphine-hydrochloride and urapidil until the systolic blood pressure was below 160mmHg, the patients were randomized to receive furosemide 80mg IV bolus (furosemide group) or saline placebo (placebo group). The primary outcome was the subjective perception of dyspnoea as measured with a modified BORG scale at one hour after randomization. Secondary outcome parameters were the subjective perception of dyspnoea of patients as measured with a modified BORG scale and a visual analogue scale at 2, 3 and 6h after randomization of the patient; course of the systolic arterial pressure and peripheral oxygen saturation and lactate at admission and at 6h after admission. In 25 patients in the furosemide group and in 28 patients in the placebo group, a BORG score could be obtained. There was no statistically significant difference in the severity of dyspnoea at one hour after randomization (P=0·40). The median BORG score at 1h after randomization in the furosemide group was 3 (IQR 2 to 4) compared to 3 (IQR 2 to 7) in the placebo group (P=0·40). Those patients who were randomized to the placebo group needed higher doses of urapidil at 20min after randomization. There were no significant differences in the rate of adverse events, nonfatal cardiac arrests or death between the two groups. The subjective perception of dyspnoea in patients with hypertensive pulmonary oedema was not influenced by the application of a loop-diuretic. Therefore, additional furosemide therapy needs to be scrutinized in the therapy of these patients. © 2010 The Authors

  3. EEG-based recognition of video-induced emotions: selecting subject-independent feature set.

    Science.gov (United States)

    Kortelainen, Jukka; Seppänen, Tapio

    2013-01-01

    Emotions are fundamental for everyday life affecting our communication, learning, perception, and decision making. Including emotions into the human-computer interaction (HCI) could be seen as a significant step forward offering a great potential for developing advanced future technologies. While the electrical activity of the brain is affected by emotions, offers electroencephalogram (EEG) an interesting channel to improve the HCI. In this paper, the selection of subject-independent feature set for EEG-based emotion recognition is studied. We investigate the effect of different feature sets in classifying person's arousal and valence while watching videos with emotional content. The classification performance is optimized by applying a sequential forward floating search algorithm for feature selection. The best classification rate (65.1% for arousal and 63.0% for valence) is obtained with a feature set containing power spectral features from the frequency band of 1-32 Hz. The proposed approach substantially improves the classification rate reported in the literature. In future, further analysis of the video-induced EEG changes including the topographical differences in the spectral features is needed.

  4. Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy adult male subjects

    Directory of Open Access Journals (Sweden)

    Shen Z

    2017-07-01

    Full Text Available Zancong Shen,1 Michael Gillen,2 Jeffrey N Miner,1 Gail Bucci,1 David M Wilson,1 Jesse W Hall1 1Ardea Biosciences, Inc., San Diego, CA, 2AstraZeneca, Gaithersburg, MD, USA Purpose: Verinurad (RDEA3170 is a selective uric acid reabsorption inhibitor in clinical development for the treatment of gout and asymptomatic hyperuricemia. The aim of this study was to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of verinurad in healthy adult males.Subjects and methods: This was a Phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study. Panels of eight male subjects received a single oral dose of verinurad or placebo in either a fasted or fed state; panels of 10–12 male subjects received ascending doses of once-daily verinurad or placebo in a fasted state for 10 days. Serial blood and urine samples were assayed for verinurad and uric acid. Safety was assessed by adverse event (AE reports, laboratory tests, vital signs, and electrocardiograms (ECGs.Results: A total of 81 adult males completed the study. Following single doses of verinurad, maximum observed plasma concentration (Cmax and area under the plasma concentration–time curve (AUC increased in a dose-proportional manner; Cmax occurred at 0.5–0.75 hours and 1.25 hours in the fasted and fed states, respectively. Food decreased AUC by 23% and Cmax by 37%-53%. There was a modest accumulation of verinurad following multiple daily doses. Verinurad reduced serum urate levels by up to 62% (40 mg, single dose and 61% (10 mg, multiple dose. The increase in urinary excretion of uric acid was greatest in the first 6 hours after dosing and was still evident ≥24 hours for verinurad doses ≥2 mg. Verinurad was well tolerated at all doses. No serious AEs, severe AEs, discontinuations due to AEs, or clinically significant laboratory or ECG abnormalities were reported.Conclusion: Single and multiple doses of verinurad were well tolerated

  5. SNP selection and classification of genome-wide SNP data using stratified sampling random forests.

    Science.gov (United States)

    Wu, Qingyao; Ye, Yunming; Liu, Yang; Ng, Michael K

    2012-09-01

    For high dimensional genome-wide association (GWA) case-control data of complex disease, there are usually a large portion of single-nucleotide polymorphisms (SNPs) that are irrelevant with the disease. A simple random sampling method in random forest using default mtry parameter to choose feature subspace, will select too many subspaces without informative SNPs. Exhaustive searching an optimal mtry is often required in order to include useful and relevant SNPs and get rid of vast of non-informative SNPs. However, it is too time-consuming and not favorable in GWA for high-dimensional data. The main aim of this paper is to propose a stratified sampling method for feature subspace selection to generate decision trees in a random forest for GWA high-dimensional data. Our idea is to design an equal-width discretization scheme for informativeness to divide SNPs into multiple groups. In feature subspace selection, we randomly select the same number of SNPs from each group and combine them to form a subspace to generate a decision tree. The advantage of this stratified sampling procedure can make sure each subspace contains enough useful SNPs, but can avoid a very high computational cost of exhaustive search of an optimal mtry, and maintain the randomness of a random forest. We employ two genome-wide SNP data sets (Parkinson case-control data comprised of 408 803 SNPs and Alzheimer case-control data comprised of 380 157 SNPs) to demonstrate that the proposed stratified sampling method is effective, and it can generate better random forest with higher accuracy and lower error bound than those by Breiman's random forest generation method. For Parkinson data, we also show some interesting genes identified by the method, which may be associated with neurological disorders for further biological investigations.

  6. An efficient method of wavelength interval selection based on random frog for multivariate spectral calibration

    Science.gov (United States)

    Yun, Yong-Huan; Li, Hong-Dong; Wood, Leslie R. E.; Fan, Wei; Wang, Jia-Jun; Cao, Dong-Sheng; Xu, Qing-Song; Liang, Yi-Zeng

    2013-07-01

    Wavelength selection is a critical step for producing better prediction performance when applied to spectral data. Considering the fact that the vibrational and rotational spectra have continuous features of spectral bands, we propose a novel method of wavelength interval selection based on random frog, called interval random frog (iRF). To obtain all the possible continuous intervals, spectra are first divided into intervals by moving window of a fix width over the whole spectra. These overlapping intervals are ranked applying random frog coupled with PLS and the optimal ones are chosen. This method has been applied to two near-infrared spectral datasets displaying higher efficiency in wavelength interval selection than others. The source code of iRF can be freely downloaded for academy research at the website: http://code.google.com/p/multivariate-calibration/downloads/list.

  7. A Preliminary Investigation of Individual Differences in Subjective Responses to D-Amphetamine, Alcohol, and Delta-9-Tetrahydrocannabinol Using a Within-Subjects Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Margaret C Wardle

    Full Text Available Polydrug use is common, and might occur because certain individuals experience positive effects from several different drugs during early stages of use. This study examined individual differences in subjective responses to single oral doses of d-amphetamine, alcohol, and delta-9-tetrahydrocannabinol (THC in healthy social drinkers. Each of these drugs produces feelings of well-being in at least some individuals, and we hypothesized that subjective responses to these drugs would be positively correlated. We also examined participants' drug responses in relation to personality traits associated with drug use. In this initial, exploratory study, 24 healthy, light drug users (12 male, 12 female, aged 21-31 years, participated in a fully within-subject, randomized, counterbalanced design with six 5.5-hour sessions in which they received d-amphetamine (20mg, alcohol (0.8 g/kg, or THC (7.5 mg, each paired with a placebo session. Participants rated the drugs' effects on both global measures (e.g. feeling a drug effect at all and drug-specific measures. In general, participants' responses to the three drugs were unrelated. Unexpectedly, "wanting more" alcohol was inversely correlated with "wanting more" THC. Additionally, in women, but not in men, "disliking" alcohol was negatively correlated with "disliking" THC. Positive alcohol and amphetamine responses were related, but only in individuals who experienced a stimulant effect of alcohol. Finally, high trait constraint (or lack of impulsivity was associated with lower reports of liking alcohol. No personality traits predicted responses across multiple drug types. Generally, these findings do not support the idea that certain individuals experience greater positive effects across multiple drug classes, but instead provide some evidence for a "drug of choice" model, in which individuals respond positively to certain classes of drugs that share similar subjective effects, and dislike other types

  8. Delay line length selection in generating fast random numbers with a chaotic laser.

    Science.gov (United States)

    Zhang, Jianzhong; Wang, Yuncai; Xue, Lugang; Hou, Jiayin; Zhang, Beibei; Wang, Anbang; Zhang, Mingjiang

    2012-04-10

    The chaotic light signals generated by an external cavity semiconductor laser have been experimentally demonstrated to extract fast random numbers. However, the photon round-trip time in the external cavity can cause the occurrence of the periodicity in random sequences. To overcome it, the exclusive-or operation on corresponding random bits in samples of the chaotic signal and its time-delay signal from a chaotic laser is required. In this scheme, the proper selection of delay length is a key issue. By doing a large number of experiments and theoretically analyzing the interplay between the Runs test and the threshold value of the autocorrelation function, we find when the corresponding delay time of autocorrelation trace with the correlation coefficient of less than 0.007 is considered as the delay time between the chaotic signal and its time-delay signal, streams of random numbers can be generated with verified randomness.

  9. Selected Cardiovascular Risk Markers in Vegetarians and Subjects of General Population.

    Science.gov (United States)

    Valachovičová, Martina; Príbojová, Jana; Urbánek, Vladimír; Bírošová, Lucia

    2017-12-01

    Besides genetic factors there are environmental effects including nutritional habits which can influence the risk of age-related diseases. The aim of the study was to assess the age dependence of selected cardiovascular risk markers in two groups of subjects with different nutritional pattern. In 470 long-term vegetarians and 478 subjects of general population the following indicators were measured: total cholesterol, HDL-cholesterol, triacylglycerol, glucose, insulin concentrations, LDL-cholesterol, atherogenic index and insulin resistance IR(HOMA) were also calculated in studied subjects. Obtained data were evaluated according to age decades. Vegetarian vs. non-vegetarian concentrations of total cholesterol, LDL-cholesterol, insulin, and values of atherogenic index and IR(HOMA) were significantly reduced in all age decades. Vegetarian vs. non-vegetarian triacalglycerol concentrations were significantly reduced from 4th–7th decade. Vegetarian average decade values of all lipid parameters were in reference range. In non-vegetarian group, the risk average values of total cholesterol (>5.2 mmol/l) were found from 5th–7th decade, LDL-cholesterol (>3.3 mmol/l) in 7th decade and atherogenic index (>4) in 6th–7th decade. In vegetarians vs. non-vegetarians were noted the average decade values for total cholesterol ranging from 4.01–4.59 vs. 4.48–5.67 mmol/l, for triacylglycerols 1.00–1.33 vs. 1.13–1.74 mmol/l, for LDL-cholesterol 2.03–2.58 vs. 2.43–3.49 mmol/l, for atherogenic index 2.72–3.31 vs. 3.05–4.21 and for IR(HOMA) 0.99–1.15 vs. 1.15–1.84. Our data show significantly reduced mean age decade values of lipid and non-lipid cardiovascular risk markers in all adult vegetarians. Smaller changes of markers between decades compared to non-vegetarians document a protective effect of vegetarian nutrition in prevention of cardiovascular disease.

  10. Safety and tolerability of intravenous regadenoson in healthy subjects: A randomized, repeat-dose, placebo-controlled study

    OpenAIRE

    Townsend, Robert; Desai, Amit; Rammelsberg, Diane; Kowalski, Donna; Simmons, Neal; Kitt, Therese M.

    2015-01-01

    Background Regadenoson is a selective A2A adenosine receptor agonist indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. However, the safety, tolerability, and plasma concentrations associated with repeated doses have not previously been assessed. Method and Results Healthy males and females were randomized to receive intravenous regadenoson [100??g (3 doses), 200??g (3 doses), or 400??g (2 doses)], or placebo (2 or 3 doses; 0.9% sod...

  11. Size-dependent piezoelectric energy-harvesting analysis of micro/nano bridges subjected to random ambient excitations

    Science.gov (United States)

    Radgolchin, Moeen; Moeenfard, Hamid

    2018-02-01

    The construction of self-powered micro-electro-mechanical units by converting the mechanical energy of the systems into electrical power has attracted much attention in recent years. While power harvesting from deterministic external excitations is state of the art, it has been much more difficult to derive mathematical models for scavenging electrical energy from ambient random vibrations, due to the stochastic nature of the excitations. The current research concerns analytical modeling of micro-bridge energy harvesters based on random vibration theory. Since classical elasticity fails to accurately predict the mechanical behavior of micro-structures, strain gradient theory is employed as a powerful tool to increase the accuracy of the random vibration modeling of the micro-harvester. Equations of motion of the system in the time domain are derived using the Lagrange approach. These are then utilized to determine the frequency and impulse responses of the structure. Assuming the energy harvester to be subjected to a combination of broadband and limited-band random support motion and transverse loading, closed-form expressions for mean, mean square, correlation and spectral density of the output power are derived. The suggested formulation is further exploited to investigate the effect of the different design parameters, including the geometric properties of the structure as well as the properties of the electrical circuit on the resulting power. Furthermore, the effect of length scale parameters on the harvested energy is investigated in detail. It is observed that the predictions of classical and even simple size-dependent theories (such as couple stress) appreciably differ from the findings of strain gradient theory on the basis of random vibration. This study presents a first-time modeling of micro-scale harvesters under stochastic excitations using a size-dependent approach and can be considered as a reliable foundation for future research in the field of

  12. Two-year Randomized Clinical Trial Of Self-etching Adhesives And Selective Enamel Etching

    OpenAIRE

    Pena, MR; Rodrigues CE; JA; Ely; Giannini, C.; Reis, M; AF

    2016-01-01

    Objective: The aim of this randomized, controlled prospective clinical trial was to evaluate the clinical effectiveness of restoring noncarious cervical lesions with two self-etching adhesive systems applied with or without selective enamel etching. Methods: A one-step self-etching adhesive (Xeno V+) and a two-step self-etching system (Clearfil SE Bond) were used. The effectiveness of phosphoric acid selective etching of enamel margins was also evaluated. Fifty-six cavities were restored with...

  13. Duplicated paralogous genes subject to positive selection in the genome of Trypanosoma brucei.

    Directory of Open Access Journals (Sweden)

    Richard D Emes

    2008-05-01

    Full Text Available Whole genome studies have highlighted duplicated genes as important substrates for adaptive evolution. We have investigated adaptive evolution in this class of genes in the human parasite Trypanosoma brucei, as indicated by the ratio of non-synonymous (amino-acid changing to synonymous (amino acid retaining nucleotide substitution rates.We have identified duplicated genes that are most rapidly evolving in this important human parasite. This is the first attempt to investigate adaptive evolution in this species at the codon level. We identify 109 genes within 23 clusters of paralogous gene expansions to be subject to positive selection.Genes identified include surface antigens in both the mammalian and insect host life cycle stage suggesting that competitive interaction is not solely with the adaptive immune system of the mammalian host. Also surface transporters related to drug resistance and genes related to developmental progression are detected. We discuss how adaptive evolution of these genes may highlight lineage specific processes essential for parasite survival. We also discuss the implications of adaptive evolution of these targets for parasite biology and control.

  14. Spencer-Brown vs. Probability and Statistics: Entropy’s Testimony on Subjective and Objective Randomness

    Directory of Open Access Journals (Sweden)

    Julio Michael Stern

    2011-04-01

    Full Text Available This article analyzes the role of entropy in Bayesian statistics, focusing on its use as a tool for detection, recognition and validation of eigen-solutions. “Objects as eigen-solutions” is a key metaphor of the cognitive constructivism epistemological framework developed by the philosopher Heinz von Foerster. Special attention is given to some objections to the concepts of probability, statistics and randomization posed by George Spencer-Brown, a figure of great influence in the field of radical constructivism.

  15. Hebbian Learning in a Random Network Captures Selectivity Properties of the Prefrontal Cortex.

    Science.gov (United States)

    Lindsay, Grace W; Rigotti, Mattia; Warden, Melissa R; Miller, Earl K; Fusi, Stefano

    2017-11-08

    Complex cognitive behaviors, such as context-switching and rule-following, are thought to be supported by the prefrontal cortex (PFC). Neural activity in the PFC must thus be specialized to specific tasks while retaining flexibility. Nonlinear "mixed" selectivity is an important neurophysiological trait for enabling complex and context-dependent behaviors. Here we investigate (1) the extent to which the PFC exhibits computationally relevant properties, such as mixed selectivity, and (2) how such properties could arise via circuit mechanisms. We show that PFC cells recorded from male and female rhesus macaques during a complex task show a moderate level of specialization and structure that is not replicated by a model wherein cells receive random feedforward inputs. While random connectivity can be effective at generating mixed selectivity, the data show significantly more mixed selectivity than predicted by a model with otherwise matched parameters. A simple Hebbian learning rule applied to the random connectivity, however, increases mixed selectivity and enables the model to match the data more accurately. To explain how learning achieves this, we provide analysis along with a clear geometric interpretation of the impact of learning on selectivity. After learning, the model also matches the data on measures of noise, response density, clustering, and the distribution of selectivities. Of two styles of Hebbian learning tested, the simpler and more biologically plausible option better matches the data. These modeling results provide clues about how neural properties important for cognition can arise in a circuit and make clear experimental predictions regarding how various measures of selectivity would evolve during animal training. SIGNIFICANCE STATEMENT The prefrontal cortex is a brain region believed to support the ability of animals to engage in complex behavior. How neurons in this area respond to stimuli-and in particular, to combinations of stimuli ("mixed

  16. [The request for consent in clinical research: a randomized study in healthy subjects].

    Science.gov (United States)

    Perrone, F; De Placido, S; Giusti, C; Gallo, C

    1995-09-01

    To compare two strategies of consent requirement (classical informed consent and randomised consent according to Zelen), the Clinical Data Elaboration Centre of South Italy, within the special project Clinical Application of Oncological Research of the National Research Council of Italy (CNR-ACRO) invited healthy people visiting the 7th edition of the scientific exhibition "Futuro Remoto" to simulate of being ill and receiving the offer of entering a clinical trial. Within informed consent strategy patients are asked to agree to the randomisation process, while, in the randomised consent, randomised treatment assignment is performed before consent requirement and patients should agree directly to the assigned therapy. Major aims of the study were (a) to compare the strategies in terms of refusal rate to a hypothetical clinical trial, and (b) to estimate whether severity of prognosis affected subjects' decision. 3,217 visiting people participated to the simulation; they were prevalently young, males and with a high level of school education. The study was performed in two different scenarios. In the first one, with one choice option, subject refusing consent could receive standard therapy only; refusal rate was 16% after informed consent and 13.4% after randomised consent (for experimental therapy). In the other scenario, with two choice options, subjects refusing consent could choose the preferred therapy; refusal rate was 20.6% after informed consent, 48.1% after randomised consent (for standard therapy) and 13.4% after randomised consent (for experimental therapy).(ABSTRACT TRUNCATED AT 250 WORDS)

  17. Selecting Optimal Parameters of Random Linear Network Coding for Wireless Sensor Networks

    DEFF Research Database (Denmark)

    Heide, Janus; Zhang, Qi; Fitzek, Frank

    2013-01-01

    This work studies how to select optimal code parameters of Random Linear Network Coding (RLNC) in Wireless Sensor Networks (WSNs). With Rateless Deluge [1] the authors proposed to apply Network Coding (NC) for Over-the-Air Programming (OAP) in WSNs, and demonstrated that with NC a significant...

  18. Consuming a mixed diet enriched with lupin protein beneficially affects plasma lipids in hypercholesterolemic subjects: a randomized controlled trial.

    Science.gov (United States)

    Bähr, Melanie; Fechner, Anita; Kiehntopf, Michael; Jahreis, Gerhard

    2015-02-01

    The objectives of this study were to assess whether 25 g/d lupin protein, integrated into a mixed diet, might affect cardiovascular risk factors and whether l-arginine was responsible for these effects. Seventy-two hypercholesterolemic subjects participated in the randomized, controlled, double-blind three-phase crossover study. They were assigned to three diets with 25 g/d lupin protein (LP), milk protein (MP) or milk protein plus 1.6 g/d arginine (MPA) each for 28 d in a random order interrupted by 6-week washout periods. Lupin protein and the comparator milk protein were incorporated into complex food products (bread, roll, sausage, and vegetarian spread). Arginine was administered via capsules. Sixty-eight subjects were included in final analyses. Compared with MP, LDL cholesterol was significantly lower after LP. Compared with MP and MPA, homocysteine was significantly lower after LP. Compared with baseline, concentrations of total, LDL, and HDL cholesterol significantly decreased after LP and MPA. Triacylglycerols and uric acid significantly decreased after LP. The relative changes in total and LDL cholesterol were significantly greater for subjects with severe hypercholesterolemia (>6.6 mmol/L) than those with moderate hypercholesterolemia (5.2-6.6 mmol/L). The present study showed for the first time that incorporation of 25 g/d of lupin protein into a variety of complex food products lowers total and LDL cholesterol, triacylglycerols, homocysteine, and uric acid in hypercholesterolemic subjects. The hypocholesterolemic effect is stronger in subjects with severe hypercholesterolemia. Arginine might be responsible for some, but not all of the beneficial effects of lupin protein. This trial was registered at http://clinicaltrials.gov (study ID number NCT01598649). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  19. Efficacy of Visual-Acoustic Biofeedback Intervention for Residual Rhotic Errors: A Single-Subject Randomization Study.

    Science.gov (United States)

    McAllister Byun, Tara

    2017-05-24

    This study documented the efficacy of visual-acoustic biofeedback intervention for residual rhotic errors, relative to a comparison condition involving traditional articulatory treatment. All participants received both treatments in a single-subject experimental design featuring alternating treatments with blocked randomization of sessions to treatment conditions. Seven child and adolescent participants received 20 half-hour sessions of individual treatment over 10 weeks. Within each week, sessions were randomly assigned to feature traditional or biofeedback intervention. Perceptual accuracy of rhotic production was assessed in a blinded, randomized fashion. Each participant's response to the combined treatment package was evaluated by using effect sizes and visual inspection. Differences in the magnitude of response to traditional versus biofeedback intervention were measured with individual randomization tests. Four of 7 participants demonstrated a clinically meaningful response to the combined treatment package. Three of 7 participants showed a statistically significant difference between treatment conditions. In all 3 cases, the magnitude of within-session gains associated with biofeedback exceeded the gains associated with traditional treatment. These results suggest that the inclusion of visual-acoustic biofeedback can enhance the efficacy of intervention for some individuals with residual rhotic errors. Further research is needed to understand which participants represent better or poorer candidates for biofeedback treatment.

  20. A whey-protein supplement increases fat loss and spares lean muscle in obese subjects: a randomized human clinical study

    Directory of Open Access Journals (Sweden)

    Ward Loren S

    2008-03-01

    Full Text Available Abstract Background This study evaluated a specialized whey fraction (Prolibra™, high in leucine, bioactive peptides and milk calcium for use as a dietary supplement to enhance weight loss. Methods This was a randomized, double-blind, parallel-arm, 12-week study. Caloric intake was reduced 500 calories per day. Subjects consumed Prolibra or an isocaloric ready-to-mix beverage 20 minutes before breakfast and 20 minutes before dinner. Body fat and lean muscle tissue were measured by dual-energy x-ray absorptiometry (DEXA. Body weight and anthropometric measurements were recorded every 4 weeks. Blood samples were taken at the beginning and end of the study. Statistical analyses were performed on all subjects that completed (completer analysis and all subjects that lost at least 2.25 kg of body weight (responder analysis. Within group significance was determined at P Results Both groups lost a significant amount of weight and the Prolibra group tended to lose more weight than the control group; however the amount of weight loss was not significantly different between groups after 12 weeks. Prolibra subjects lost significantly more body fat compared to control subjects for both the completer (2.81 vs. 1.62 kg P = 0.03 and responder (3.63 vs. 2.11 kg, P = 0.01 groups. Prolibra subjects lost significantly less lean muscle mass in the responder group (1.07 vs. 2.41 kg, P = 0.02. The ratio of fat to lean loss (kg fat lost/kg lean lost was much larger for Prolibra subjects for both completer (3.75 vs. 1.05 and responder (3.39 vs. 0.88 groups. Conclusion Subjects in both the control and treatment group lost a significant amount of weight with a 500 calorie reduced diet. Subjects taking Prolibra lost significantly more body fat and showed a greater preservation of lean muscle compared to subjects consuming the control beverage. Because subjects taking Prolibra lost 6.1% of their body fat mass, and because a 5% reduction of body fat mass has been shown to

  1. Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects.

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-10-01

    We assessed pharmacokinetic and safety profiles of ceftazidime-avibactam administered ± metronidazole, and whether drug-drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime-avibactam (2000-500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime-avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime-avibactam over 4 days to assess drug-drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime-avibactam and metronidazole in subjects receiving ceftazidime-avibactam (2000-500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime-avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80-125%) indicating no drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole.

  2. Randomized pharmacokinetic and drug–drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-01-01

    We assessed pharmacokinetic and safety profiles of ceftazidime–avibactam administered ± metronidazole, and whether drug–drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime–avibactam (2000–500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime–avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime–avibactam over 4 days to assess drug–drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime–avibactam and metronidazole in subjects receiving ceftazidime–avibactam (2000–500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime–avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80–125%) indicating no drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. PMID:26516584

  3. A finite element large deflection random response analysis of beams and plates subjected to acoustic loading

    Science.gov (United States)

    Mei, Chuh; Chiang, C. K.

    1987-01-01

    A finite element formulation is presented for the analysis of beams and rectangular plates undergoing large deflections subjected to Gaussian white noise excitations. Single-mode response is assumed in the present formulation. Root-mean-square (RMS) maximum deflections for simply supported and clamped beams and plates at various sound spectrum levels are obtained and compared with solutions using the Fokker-Planck-Kolmogorov equation and the equivalent linearization methods. RMS maximum stains and equivalent linear frequencies are compared with the equivalent linearization results for assessment of the accuracy of the finite element method.

  4. Random lock-in intervals for tubular structural elements subject to simulated natural wind

    DEFF Research Database (Denmark)

    Christensen, Claus F.; Ditlevsen, Ove Dalager

    1999-01-01

    The paper reports on wind tunnel experiments with an elastically suspended circular cylinder vibrating under the excitation of natural wind of high turbulence degree. The natural wind turbulence was simulated bysuperposing the low frequency part of the natural wind turbulence on the background high...... structural elements subject to thenatural wind. The engineering relevance of the investigation is supported by comparing with the unrealistic highlyconservative rules of wind induced fatique commonly given in codes of practice. The stochastic lock-in model aswell as the related fatigue calculation procedure...

  5. Energy harvesting in a quad-stable harvester subjected to random excitation

    Directory of Open Access Journals (Sweden)

    Zhi-yong Zhou

    2016-02-01

    Full Text Available In response to the defects of bi-stable energy harvester (BEH, we develop a novel quad-stable energy harvester (QEH to improve harvesting efficiency. The device is made up of a bimorph cantilever beam having a tip magnet and three external fixed magnets. By adjusting the positions of the fixed magnets and the distances between the tip magnet and the fixed ones, the quad-stable equilibrium positions can emerge. The potential energy shows that the barriers of the QEH are lower than those of the BEH for the same separation distance. Experiment results reveal that the QEH can realize snap-through easier and make a dense snap-through in response under random excitation. Moreover, its strain and voltage both become large for snap-through between the nonadjacent stable positions. There exists an optimal separation distance for different excitation intensities.

  6. Tehran Air Pollutants Prediction Based on Random Forest Feature Selection Method

    Science.gov (United States)

    Shamsoddini, A.; Aboodi, M. R.; Karami, J.

    2017-09-01

    Air pollution as one of the most serious forms of environmental pollutions poses huge threat to human life. Air pollution leads to environmental instability, and has harmful and undesirable effects on the environment. Modern prediction methods of the pollutant concentration are able to improve decision making and provide appropriate solutions. This study examines the performance of the Random Forest feature selection in combination with multiple-linear regression and Multilayer Perceptron Artificial Neural Networks methods, in order to achieve an efficient model to estimate carbon monoxide and nitrogen dioxide, sulfur dioxide and PM2.5 contents in the air. The results indicated that Artificial Neural Networks fed by the attributes selected by Random Forest feature selection method performed more accurate than other models for the modeling of all pollutants. The estimation accuracy of sulfur dioxide emissions was lower than the other air contaminants whereas the nitrogen dioxide was predicted more accurate than the other pollutants.

  7. TEHRAN AIR POLLUTANTS PREDICTION BASED ON RANDOM FOREST FEATURE SELECTION METHOD

    Directory of Open Access Journals (Sweden)

    A. Shamsoddini

    2017-09-01

    Full Text Available Air pollution as one of the most serious forms of environmental pollutions poses huge threat to human life. Air pollution leads to environmental instability, and has harmful and undesirable effects on the environment. Modern prediction methods of the pollutant concentration are able to improve decision making and provide appropriate solutions. This study examines the performance of the Random Forest feature selection in combination with multiple-linear regression and Multilayer Perceptron Artificial Neural Networks methods, in order to achieve an efficient model to estimate carbon monoxide and nitrogen dioxide, sulfur dioxide and PM2.5 contents in the air. The results indicated that Artificial Neural Networks fed by the attributes selected by Random Forest feature selection method performed more accurate than other models for the modeling of all pollutants. The estimation accuracy of sulfur dioxide emissions was lower than the other air contaminants whereas the nitrogen dioxide was predicted more accurate than the other pollutants.

  8. Classification of epileptic EEG signals based on simple random sampling and sequential feature selection.

    Science.gov (United States)

    Ghayab, Hadi Ratham Al; Li, Yan; Abdulla, Shahab; Diykh, Mohammed; Wan, Xiangkui

    2016-06-01

    Electroencephalogram (EEG) signals are used broadly in the medical fields. The main applications of EEG signals are the diagnosis and treatment of diseases such as epilepsy, Alzheimer, sleep problems and so on. This paper presents a new method which extracts and selects features from multi-channel EEG signals. This research focuses on three main points. Firstly, simple random sampling (SRS) technique is used to extract features from the time domain of EEG signals. Secondly, the sequential feature selection (SFS) algorithm is applied to select the key features and to reduce the dimensionality of the data. Finally, the selected features are forwarded to a least square support vector machine (LS_SVM) classifier to classify the EEG signals. The LS_SVM classifier classified the features which are extracted and selected from the SRS and the SFS. The experimental results show that the method achieves 99.90, 99.80 and 100 % for classification accuracy, sensitivity and specificity, respectively.

  9. Comparative effects of pulsed and continuous short wave diathermy on pain and selected physiological parameters among subjects with chronic knee osteoarthritis.

    Science.gov (United States)

    Teslim, Onigbinde Ayodele; Adebowale, Adenle Charles; Ojoawo, Adesola Ojo; Sunday, Odejide Akinwole; Bosede, Arilewola

    2013-01-01

    The purposes of this study were to compare the effects of pulsed and continuous short wave diathermy on pain, range of motion, pulse rate and skin temperature in subjects with chronic knee osteoarthritis. 24 Participants with grade 111 OA of the knee were randomly selected into CSWD and PSWD groups. Pre and post treatment parameters were recorded at onset and the end of 4th week. ANO VA, independent, paired t-test and chi-square were used to analyze the data. The pain experienced by participants in the CSWD group was significantly lower than that of the PSWD groups (P effective than PSWD in alleviating pain and in increasing knee flexion range of motion among subjects with chronic knee OA. Also, a mild elevation of skin temperature was able to elicit physiological effects that could exert therapeutic effects.

  10. A randomized double blind study of a green and black tea agent, AssuriTEA®, in healthy male subjects

    Directory of Open Access Journals (Sweden)

    Jillian Capodice

    2015-10-01

    Full Text Available Background: Green and black teas have known anti-oxidant and anti-inflammatory properties. The current study was a prospective randomized, double-blind, placebo controlled study of 3 doses of a water-extracted green and black tea agent (AssuriTEA® [AT]. Methods: Subjects who met inclusion criteria were randomized to one of four groups: 1000, 500, or 250 mg AT or placebo for 28 days. At baseline (BL and day 28, serum antioxidant capacity, quality of life and safety were assessed. Results: Of the 55 subjects screened, 43 were considered evaluable. Age was 56.77 ± 2.83 years (mean ± SEM. Evaluable subjects demonstrated improved antioxidant status, as measured by ferric iron reducing antioxidant power at all doses over the placebo (p < 0.05. There was significant improvement in cellular antioxidant protection in the 1000 mg AT group versus the placebo (p=0.032. Glucose levels were higher in the placebo group versus the 250 mg AT group (p=0.023 and there was a significant improvement in systolic blood pressure in the 250 mg AT group at day 28 versus BL (p=0.048. In the 1000 mg AT group, there was a significant decrease in systolic blood pressure at day 28 versus BL (p=0.017. There was a significant improvement in the vitality category in the 1000 mg AT group (p=0.029. Overall, AT was safe and well tolerated with no differences in adverse events or serum chemistries between groups. Conclusions: Results demonstrate that the administration of AT resulted in improvement of serum antioxidant status, vitality level, blood glucose, and systolic blood pressure in test subjects.

  11. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study.

    Science.gov (United States)

    Hsyu, Poe-Hirr; Pignataro, Daniela Soriano; Matschke, Kyle

    2017-10-23

    This study evaluated the absolute bioavailability of bosutinib and assessed its safety and tolerability after single-dose oral and intravenous administration. In this phase 1 open-label, 2-sequence, 2-period crossover study, healthy, fed subjects aged 18-55 years were randomized to 1 of 2 treatment sequences (n = 7/sequence): oral bosutinib (100 mg × 5) followed by intravenous bosutinib (120 mg in approximately 240 mL over 1 hour), with a ≥14-day washout, or intravenous bosutinib and then oral bosutinib. Results of plasma pharmacokinetics analyses demonstrated that exposure to intravenous bosutinib was 3-fold higher than for oral bosutinib (16.2 and 5.5 ng·h/mL/mg, respectively), and mean terminal half-life was similar (35.5 and 31.7 hours). The ratio of adjusted geometric means (90%CI) for the dose-normalized area under the plasma concentration-time profile (AUC0-∞ /D) was 33.85% (30.65%-37.38%). Most treatment-emergent adverse events (AEs) were mild in severity. Gastrointestinal (GI) AEs occurred in 9 of 13 subjects given oral bosutinib, whereas no subjects given intravenous bosutinib experienced GI AEs, suggesting bosutinib present in the GI tract had an effect. Bosutinib exhibited an absolute bioavailability of 33.85% based on the ratio of AUC0-∞ /D. Both oral and intravenous bosutinib were safe and well tolerated in healthy, fed adult subjects. © 2017, The American College of Clinical Pharmacology.

  12. Large Intra-subject Variability in Caffeine Pharmacokinetics: Randomized Cross-over Study of Single Caffeine Product.

    Science.gov (United States)

    Hammami, Muhammad M; Alvi, Syed N

    2017-09-01

    Background Average bioequivalence has been criticized for not adequately addressing individual variations. Importance of subjects' blinding in bioequivalence studies has not been well studied. We explored the extent of intra-subject pharmacokinetic variability and effect of drug-ingestion unawareness in subjects taking single caffeine product. Methods A single-dose randomized cross-over design was used to compare pharmacokinetics of 200 mg caffeine, described as caffeine (overt) or as placebo (covert). Maximum concentration (Cmax), Cmax first time (Tmax), area-under-the-concentration-time-curve, to last measured concentration (AUCT), extrapolated to infinity (AUCI), or to Tmax of overt caffeine (AUCOverttmax), and Cmax/AUCI were calculated blindly using standard non-compartmental method. Percentages of individual covert/overt ratios that are outside the ±25% range were determined. Covert-vs-overt effect on caffeine pharmacokinetics was evaluated by 90% confidence interval (CI) and 80.00-125.00% bioequivalence range. Results 32 healthy subjects (6% females, mean (SD) age 33.3 (7.2) year) participated in the study (28 analysed). Out of the 28 individual covert/overt ratios, 23% were outside the ±25% range for AUCT, 30% for AUCI, 20% for AUCOverttmax, 30% for Cmax, and 43% for Tmax. There was no significant covert-vs-overt difference in any of the pharmacokinetic parameters studied. Further, the 90% CIs for AUCT, AUCI, Cmax, AUCOverttmax, and Cmax/AUCI were all within the 80.00-125.00% bioequivalence range with mean absolute deviation of covert/overt ratios of 3.31%, 6.29%, 1.43%, 1.87%, and 5.19%, respectively. Conclusions Large intra-subject variability in main caffeine pharmacokinetic parameters was noted when comparing an oral caffeine product to itself. Subjects' blinding may not be important in average bioequivalence studies. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Subject Combination and Electrode Selection in Cooperative Brain-Computer Interface Based on Event Related Potentials

    Directory of Open Access Journals (Sweden)

    Hubert Cecotti

    2014-04-01

    Full Text Available New paradigms are required in Brain-Computer Interface (BCI systems for the needs and expectations of healthy people. To solve this issue, we explore the emerging field of cooperative BCIs, which involves several users in a single BCI system. Contrary to classical BCIs that are dependent on the unique subject’s will, cooperative BCIs are used for problem solving tasks where several people shall be engaged by sharing a common goal. Similarly as combining trials over time improves performance, combining trials across subjects can significantly improve performance compared with when only a single user is involved. Yet, cooperative BCIs may only be used in particular settings, and new paradigms must be proposed to efficiently use this approach. The possible benefits of using several subjects are addressed, and compared with current single-subject BCI paradigms. To show the advantages of a cooperative BCI, we evaluate the performance of combining decisions across subjects with data from an event-related potentials (ERP based experiment where each subject observed the same sequence of visual stimuli. Furthermore, we show that it is possible to achieve a mean AUC superior to 0.95 with 10 subjects and 3 electrodes on each subject, or with 4 subjects and 6 electrodes on each subject. Several emerging challenges and possible applications are proposed to highlight how cooperative BCIs could be efficiently used with current technologies and leverage BCI applications.

  14. Personal name in Igbo Culture: A dataset on randomly selected personal names and their statistical analysis.

    Science.gov (United States)

    Okagbue, Hilary I; Opanuga, Abiodun A; Adamu, Muminu O; Ugwoke, Paulinus O; Obasi, Emmanuela C M; Eze, Grace A

    2017-12-01

    This data article contains the statistical analysis of Igbo personal names and a sample of randomly selected of such names. This was presented as the following: 1). A simple random sampling of some Igbo personal names and their respective gender associated with each name. 2). The distribution of the vowels, consonants and letters of alphabets of the personal names. 3). The distribution of name length. 4). The distribution of initial and terminal letters of Igbo personal names. The significance of the data was discussed.

  15. Effects of High-Dose Capsaicin on TMD Subjects: A Randomized Clinical Study.

    Science.gov (United States)

    Campbell, B K; Fillingim, R B; Lee, S; Brao, R; Price, D D; Neubert, J K

    2017-01-01

    Temporomandibular joint disorder (TMD) is a complex musculoskeletal disorder that presents with pain, limited jaw opening, and abnormal noises in the temporomandibular joint. Despite the significant impact that TMD has in terms of suffering and financial burden, relatively few new treatments have emerged; therefore, development of novel treatments to treat TMD pain remains a high priority. The rationale of this study was to use a double-blind, vehicle-controlled clinical trial to evaluate the effects of a high-concentration (8%) capsaicin cream on TMD. This is based on the hypothesis that targeting TRP vanilloid subfamily member 1 (TRPV1) for pain control may provide a novel method for pain relief in TMD patients. TRPV1 is primarily expressed on a population of nociceptive-specific neurons and provides a candidate target for the development of pain treatments. Capsaicin is the primary agonist for TRPV1 and has been used previously in relatively low doses (0.025% to 0.075%) as a therapeutic for a variety of pain disorders, including postherpetic neuralgia and osteoarthritis; however, analgesic efficacy remains equivocal. TMD and healthy control subjects were assigned to either an active capsaicin or vehicle control group. The treatments were applied for 2 h and then removed. Quantitative sensory testing (QST) was completed prior to drug application (baseline), 2 h after drug application, and 1 wk later. Perceived pain intensity was measured using a visual analog scale (VAS) following capsaicin or vehicle cream application. Significantly lower pain was reported in the week after application in the capsaicin-treated TMD subjects. For QST measures, there was a decreased thermal pain threshold 2 h after capsaicin application for both the control and TMD groups, but this resolved within a week. Capsaicin had no effect on pressure pain threshold or mechanical sensitivity in both TMD and healthy individuals. This study demonstrates that 8% topical capsaicin therapy is a

  16. Evaluation of the effect of food and age on the pharmacokinetics of oral netupitant and palonosetron in healthy subjects: A randomized, open-label, crossover phase 1 study.

    Science.gov (United States)

    Calcagnile, Selma; Lanzarotti, Corinna; Gutacker, Michaela; Jakob-Rodamer, Verena; Peter Kammerer, Klaus; Timmer, Wolfgang

    2015-09-01

    Antiemetic treatment compliance is important to prevent chemotherapy-induced nausea and vomiting, a feared chemotherapy side effect. NEPA, a new oral fixed combination of netupitant, a highly selective NK1 receptor antagonist (RA), and palonosetron, a second-generation 5-HT3 RA, targets dual antiemetic pathways with a single dose. This study investigated the effect of food intake and age on NEPA pharmacokinetics (PK) and safety. In this open-label, single-center, randomized, phase 1 study, 24 adults (18-45 years) received NEPA in a fed or fasted state during the first treatment period and in the alternative state in the next treatment period. Twelve elderly subjects (≥65 years) received NEPA in a fasted state. Blood samples were taken for netupitant and palonosetron PK analysis. In the fed condition, netupitant plasma exposure increased, whereas palonosetron PK parameters were not affected. Furthermore, elderly subjects showed increased netupitant and palonosetron exposure compared with adults. All adverse events were mild/moderate, with constipation and headache the most common. Although food intake and age altered NEPA PK, dose adjustments were not needed, as netupitant and palonosetron exposure increases did not lead to safety concerns in healthy subjects. © 2015, The American College of Clinical Pharmacology.

  17. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Susan J van Dijk

    Full Text Available The ability of subjects to respond to nutritional challenges can reflect the flexibility of their biological system. Nutritional challenge tests could be used as an indicator of health status but more knowledge on metabolic and immune responses of different subjects to nutritional challenges is needed. The aim of this study was to compare the responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes.In a cross-over design 42 men (age 50-70 y consumed three high-fat shakes containing saturated fat (SFA, monounsaturated fat (MUFA or n-3 polyunsaturated (PUFA. Men were selected on BMI and health status (lean, obese or obese diabetic and phenotyped with MRI for adipose tissue distribution. Before and 2 and 4 h after shake consumption blood was drawn for measurement of expression of metabolic and inflammation-related genes in peripheral blood mononuclear cells (PBMCs, plasma triglycerides (TAG, glucose, insulin, cytokines and ex vivo PBMC immune response capacity. The MUFA and n-3 PUFA challenge, compared to the SFA challenge, induced higher changes in expression of inflammation genes MCP1 and IL1β in PBMCs. Obese and obese diabetic subjects had different PBMC gene expression and metabolic responses to high-fat challenges compared to lean subjects. The MUFA challenge induced the most pronounced TAG response, mainly in obese and obese diabetic subjects.The PBMC gene expression response and metabolic response to high-fat challenges were affected by fat type and metabolic risk phenotype. Based on our results we suggest using a MUFA challenge to reveal differences in response capacity of subjects.ClinicalTrials.gov NCT00977262.

  18. IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial

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    Kloek Joris

    2010-11-01

    Full Text Available Abstract Background Milk derived peptides have been identified as potential antihypertensive agents. The primary objective was to investigate the effectiveness of IPP-rich milk protein hydrolysates (MPH on reducing blood pressure (BP as well as to investigate safety parameters and tolerability. The secondary objective was to confirm or falsify ACE inhibition as the mechanism underlying BP reductions by measuring plasma renin activity and angiotensin I and II. Methods We conducted a randomized, placebo-controlled, double blind, crossover study including 70 Caucasian subjects with prehypertension or stage 1 hypertension. Study treatments consisted of daily consumption of two capsules MPH1 (each containing 7.5 mg Isoleucine-Proline-Proline; IPP, MPH2 (each containing 6.6 mg Methionine-Alanine-Proline, 2.3 mg Leucine-Proline-Proline, 1.8 mg IPP, or placebo (containing cellulose for 4 weeks. Results In subjects with stage 1 hypertension, MPH1 lowered systolic BP by 3.8 mm Hg (P = 0.0080 and diastolic BP by 2.3 mm Hg (P = 0.0065 compared with placebo. In prehypertensive subjects, the differences in BP between MPH1 and placebo were not significant. MPH2 did not change BP significantly compared with placebo in stage I hypertensive or prehypertensive subjects. Intake of MPHs was well tolerated and safe. No treatment differences in hematology, clinical laboratory parameters or adverse effects were observed. No significant differences between MPHs and placebo were found in plasma renin activity, or angiotensin I and II. Conclusions MPH1, containing IPP and no minerals, exerts clinically relevant BP lowering effects in subjects with stage 1 hypertension. It may be included in lifestyle changes aiming to prevent or reduce high BP. Trial registration ClinicalTrials.gov NCT00471263

  19. Noradrenergic α₁ receptor antagonist treatment attenuates positive subjective effects of cocaine in humans: a randomized trial.

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    Thomas F Newton

    Full Text Available Preclinical research implicates dopaminergic and noradrenergic mechanisms in mediating the reinforcing effects of drugs of abuse, including cocaine. The objective of this study was to evaluate the impact of treatment with the noradrenergic α(1 receptor antagonist doxazosin on the positive subjective effects of cocaine.Thirteen non-treatment seeking, cocaine-dependent volunteers completed this single-site, randomized, placebo-controlled, within-subjects study. In one study phase volunteers received placebo and in the other they received doxazosin, with the order counterbalanced across participants. Study medication was masked by over-encapsulating doxazosin tablets and matched placebo lactose served as the control. Study medication treatment was initiated at 1 mg doxazosin or equivalent number of placebo capsules PO/day and increased every three days by 1 mg. After receiving 4 mg doxazosin or equivalent number of placebo capsules participants received masked doses of 20 and 40 mg cocaine IV in that order with placebo saline randomly interspersed to maintain the blind.Doxazosin treatment was well tolerated and doxazosin alone produced minimal changes in heart rate and blood pressure. During treatment with placebo, cocaine produced dose-dependent increases in subjective effect ratings of "high", "stimulated", "like cocaine", "desire cocaine", "any drug effect", and "likely to use cocaine if had access" (p<.001. Doxazosin treatment significantly attenuated the effects of 20 mg cocaine on ratings of "stimulated", "like cocaine", and "likely to use cocaine if had access" (p<.05. There were trends for doxazosin to reduce ratings of "stimulated", "desire cocaine", and "likely to use cocaine if had access" (p<.10.Medications that block noradrenergic α₁ receptors, such as doxazosin, may be useful as treatments for cocaine dependence, and should be evaluated further.Clinicaltrials.gov NCT01062945.

  20. Simulated Performance Evaluation of a Selective Tracker Through Random Scenario Generation

    DEFF Research Database (Denmark)

    Hussain, Dil Muhammad Akbar

    2006-01-01

      The paper presents a simulation study on the performance of a target tracker using selective track splitting filter algorithm through a random scenario implemented on a digital signal processor.  In a typical track splitting filter all the observation which fall inside a likelihood ellipse...... are used for update, however, in our proposed selective track splitting filter less number of observations are used for track update.  Much of the previous performance work [1] has been done on specific (deterministic) scenarios. One of the reasons for considering the specific scenarios, which were...

  1. Classification of epileptic EEG signals based on simple random sampling and sequential feature selection

    OpenAIRE

    Ghayab, Hadi Ratham Al; Li, Yan; Abdulla, Shahab; Diykh, Mohammed; Wan, Xiangkui

    2016-01-01

    Electroencephalogram (EEG) signals are used broadly in the medical fields. The main applications of EEG signals are the diagnosis and treatment of diseases such as epilepsy, Alzheimer, sleep problems and so on. This paper presents a new method which extracts and selects features from multi-channel EEG signals. This research focuses on three main points. Firstly, simple random sampling (SRS) technique is used to extract features from the time domain of EEG signals. Secondly, the sequential fea...

  2. The effects of three different exercise modalities on markers of male reproduction in healthy subjects: a randomized controlled trial.

    Science.gov (United States)

    Hajizadeh Maleki, Behzad; Tartibian, Bakhtyar; Chehrazi, Mohammad

    2017-02-01

    The aim of this study was to investigate the effects of moderate-intensity continuous training (MICT), high-intensity continuous training (HICT) and high-intensity interval training (HIIT) on markers of male reproduction including seminal markers of oxidative stress and inflammation as well as semen quality and sperm DNA integrity in healthy human subjects. A total of 397 healthy male volunteers were screened and 280 were randomly assigned to one of the MICT (n = 70), HICT (n = 70), HIIT (n = 70) and non-exercise (NON-EX, n = 70) groups. Subjects had inflammatory markers (IL-1β, IL-6, IL-8 and TNF-α), oxidants (ROS, MDA and 8-isoprostane), antioxidants (SOD, catalase and TAC), semen parameters and sperm DNA damage measured at baseline (T1), the end of week 12 (T2), the end of week 24 (T3), and 7 (T4) and 30 days (T5) after training. Chronic MICT, HICT and HIIT attenuated seminal markers of oxidative stress and inflammation with different kinetics for the three types of exercise (P reproductive function (P reproduction with different kinetics, suggesting intensity-, duration- and type-dependent adaptations to exercise training in healthy human subjects. © 2017 Society for Reproduction and Fertility.

  3. A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes.

    Science.gov (United States)

    Guess, Nicola D; Dornhorst, Anne; Oliver, Nick; Bell, Jimmy D; Thomas, E Louise; Frost, Gary S

    2015-01-01

    Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to investigate the effect of the fermentable carbohydrate inulin on weight maintenance, appetite and ectopic fat in subjects with prediabetes. Forty-four subjects with prediabetes were randomized to 18 weeks' inulin or cellulose supplementation. During weeks 1-9 (weight loss phase) all subjects had four visits with a dietitian to guide them towards a 5 % weight loss. During weeks 10-18 (weight maintenance phase) subjects continued taking their assigned supplementation and were asked to maintain the weight they had lost but were offered no further support. All subjects attended study sessions at baseline, 9 and 18 weeks for measurement of weight; assessment of adipose tissue and ectopic fat content by magnetic resonance imaging and magnetic resonance spectroscopy; glucose, insulin and GLP-1 levels following a meal tolerance test; and appetite by ad libitum meal test and visual analogue scales. Both groups lost approximately 5 % of their body weight by week nine (-5.3 ± 0.1 % vs -4.3 ± 0.4 %, p = 0.13, but the inulin group lost significantly more weight between 9 and 18 weeks (-2.3 ± 0.5 % vs -0.6 ± 0.4 %, p = 0.012). Subjects taking inulin had lower hepatic (p = 0.02) and soleus muscle (p fat content at 18 weeks compared to control even after controlling for weight loss and consumed less at the ad libitum meal test (p = 0.027). Fasting glucose significantly decreased at week nine only (p = 0.005), insulin concentrations did not change, and there

  4. Statistical inference of selection and divergence from a time-dependent Poisson random field model.

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    Amei Amei

    Full Text Available We apply a recently developed time-dependent Poisson random field model to aligned DNA sequences from two related biological species to estimate selection coefficients and divergence time. We use Markov chain Monte Carlo methods to estimate species divergence time and selection coefficients for each locus. The model assumes that the selective effects of non-synonymous mutations are normally distributed across genetic loci but constant within loci, and synonymous mutations are selectively neutral. In contrast with previous models, we do not assume that the individual species are at population equilibrium after divergence. Using a data set of 91 genes in two Drosophila species, D. melanogaster and D. simulans, we estimate the species divergence time t(div = 2.16 N(e (or 1.68 million years, assuming the haploid effective population size N(e = 6.45 x 10(5 years and a mean selection coefficient per generation μ(γ = 1.98/N(e. Although the average selection coefficient is positive, the magnitude of the selection is quite small. Results from numerical simulations are also presented as an accuracy check for the time-dependent model.

  5. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects.

    Science.gov (United States)

    Shin, Donghoon; Kim, Youngdoe; Kim, Yoo Seok; Körnicke, Thomas; Fuhr, Rainard

    2015-12-01

    SB2, a biosimilar to infliximab reference product (INF), has an identical amino acid sequence and similar physicochemical functional properties to its reference product. The primary objective of this study is to demonstrate pharmacokinetic (PK) bioequivalence between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF. This study was a randomized, single-blind, three-arm, parallel group study in 159 healthy subjects. All subjects received a single 5 mg/kg intravenous infusion of study drug and then were observed for 10 weeks to study PK, safety and immunogenicity. The primary PK parameters were area under the concentration-time curve (AUC) from time zero to infinity (AUCinf), AUC from time zero to the last quantifiable concentration (AUClast) and maximum concentration (C max). Bioequivalence for the primary PK parameters was to be concluded using an analysis of variance (ANOVA) if the 90 % confidence intervals (CIs) for the ratio of geometric least squares means (LSMeans) of the treatments compared were completely contained within the pre-defined equivalence margin, 0.8-1.25. All of the 90 % CIs for the geometric LSMean ratios of primary PK parameters for each comparison were within the pre-defined equivalence margin. The proportion of subjects who experienced treatment-emergent adverse events was comparable between treatments. The incidences of anti-drug antibodies between the three treatments were comparable. This study demonstrated biosimilarity of SB2 to its marketed reference products of infliximab in terms of PK equivalence in healthy subjects. SB2 was generally well tolerated and showed comparable safety and immunogenicity profiles to the reference products (ClinicalTrials.gov Identifier: NCT01922336).

  6. Effects of smartphone-based memory training for older adults with subjective memory complaints: a randomized controlled trial.

    Science.gov (United States)

    Oh, Seo Jin; Seo, Sungmin; Lee, Ji Hyun; Song, Myeong Ju; Shin, Min-Sup

    2017-01-10

    We explored whether newly developed application (Smartphone-based brain Anti-aging and memory Reinforcement Training, SMART) improved memory performance in older adults with subjective memory complaints (SMC). A total of 53 adults (range: 50-68 years; 52.8% female) were randomized into either one of two intervention groups [SMART (n = 18) vs. Fit Brains® (n = 19)] or a wait-list group (n = 16). Participants in the intervention groups underwent 15-20 minutes of training per day, five days per week for 8 weeks. We used objective cognitive measures to evaluate changes with respect to four domains: attention, memory, working memory (WM), and response inhibition. In addition, we included self-report questionnaires to assess levels of SMC, depression, and anxiety. Total WM quotient [t(17) = 6.27, p smartphone-based memory training program may improve WM function in older adults. However, objective improvement in performance does not necessarily lead to decreased SMC.

  7. Meditation and Music Improve Memory and Cognitive Function in Adults with Subjective Cognitive Decline: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2017-01-01

    While effective therapies for preventing or slowing cognitive decline in at-risk populations remain elusive, evidence suggests mind-body interventions may hold promise. In this study, we assessed the effects of Kirtan Kriya meditation (KK) and music listening (ML) on cognitive outcomes in adults experiencing subjective cognitive decline (SCD), a strong predictor of Alzheimer's disease. Sixty participants with SCD were randomized to a KK or ML program and asked to practice 12 minutes/day for 3 months, then at their discretion for the ensuing 3 months. At baseline, 3 months, and 6 months we measured memory and cognitive functioning [Memory Functioning Questionnaire (MFQ), Trail-making Test (TMT-A/B), and Digit-Symbol Substitution Test (DSST)]. The 6-month study was completed by 53 participants (88%). Participants performed an average of 93% (91% KK, 94% ML) of sessions in the first 3 months, and 71% (68% KK, 74% ML) during the 3-month, practice-optional, follow-up period. Both groups showed marked and significant improvements at 3 months in memory and cognitive performance (MFQ, DSST, TMT-A/B; p's≤0.04). At 6 months, overall gains were maintained or improved (p's≤0.006), with effect sizes ranging from medium (DSST, ML group) to large (DSST, KK group; TMT-A/B, MFQ). Changes were unrelated to treatment expectancies and did not differ by age, gender, baseline cognition scores, or other factors. Findings of this preliminary randomized controlled trial suggest practice of meditation or ML can significantly enhance both subjective memory function and objective cognitive performance in adults with SCD, and may offer promise for improving outcomes in this population.

  8. Model and Effectiveness of Endurance Exercise to Increase Physical Fitness in Intellectual Disability Subjects with Obesity: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tirza Z Tamin

    2015-04-01

    Full Text Available Aim: to design a model and assess the effectiveness of endurance exercise to increase physical fitness in intelectual disability (ID patients with obesity. Methods: a randomized-controlled clinical trial was performed in ID patients with obesity aged 10-30 years old from all Special School in DKI Jakarta, which were randomly allocated into 3 groups and then given 3 different type of exercises: lower extremity muscles endurance exercise for 20 RM followed by cardiorespiratory endurance exercise for 24-25 minutes (type I, lower extremity muscles endurance exercises for 10 RM followed by cardiorespiratory endurance exercises for 26-27 minutes (type II, and threw a tennis ball with 10 m distance for 10 minutes as control (type III. These program was performed 3 times a week for 4 months. Assesment of the exercise effectiveness was done by measuring maximum load that can be lifted and six-minutes walking test on rectangular track which was converted with the VO2 max prediction formula. Analysis was perfomed with Kruskal Wallis test. Results: two hundred and twelve (212 subjects were included in the study, randomly allocated into three types (I, II, and III of exercises groups. The type II of endurance exercise model was proved to be more effective in increasing lower extremity muscles endurance level compared to type I and III for ID patients with obesity (p<0.05. Meanwhile, type I of endurance exercise model was proved to be more effective in increasing cardiorespiratory endurance level compared to type II and III for ID patients with obesity (p<0.05. Conclusion: lower extremity muscles endurance exercise followed by a cardiorespiratory endurance exercise can be used to increase physical fitness in ID patients with obesity. Key words: intelectual disability patient, obesity, lower extremity muscles and cardiorespiratory endurance exercise, lower extremity muscles endurance level, cardiorespiratory endurance level.

  9. Factors influencing subject selection in upper secondary education (Key Stage 4 for males and females in England

    Directory of Open Access Journals (Sweden)

    Joanne Vaughan

    2015-08-01

    Full Text Available Background Research to date has investigated the potential factors that influence students’ decisions in opting to study certain subjects during their upper secondary education. Trends in subject selection at this level (Key Stage 4 have been maintained over time and have consistently displayed comparable differences for males and females. It is recognised that males typically opt for subjects such as physical education and science, while females are traditionally noted as favouring the arts and humanities. These educational decisions may impact on future occupational directions. In light of recent initiatives, such as the English Baccalaureate, it is of interest to explore whether such measures have had an influence on this noted gender gap. Participants and procedure The present study investigates the potential predictors of subject selection, while controlling for gender, offering a specific focus on the education system in England. Attention is given to students’ perceived academic ability and attitude toward school, and how such factors may guide subject choice. Participants (N = 276 were students currently in the process of selecting optional modules for Key Stage 4 study. Results The findings demonstrate that female students are less likely than their male counterparts to opt for physical education (PE and business studies/information and communication technology (ICT as preferred modules, in comparison to ‘creative and performance’ subjects (reference category. Higher levels of reported masculinity were also shown to relate to the up-take of PE at Key Stage 4. Conclusions The implications of these findings are discussed in relation to existing research and practical contributions to the educational arena.

  10. Effect of non-random mating on genomic and BLUP selection schemes

    Directory of Open Access Journals (Sweden)

    Nirea Kahsay G

    2012-04-01

    Full Text Available Abstract Background The risk of long-term unequal contribution of mating pairs to the gene pool is that deleterious recessive genes can be expressed. Such consequences could be alleviated by appropriately designing and optimizing breeding schemes i.e. by improving selection and mating procedures. Methods We studied the effect of mating designs, random, minimum coancestry and minimum covariance of ancestral contributions on rate of inbreeding and genetic gain for schemes with different information sources, i.e. sib test or own performance records, different genetic evaluation methods, i.e. BLUP or genomic selection, and different family structures, i.e. factorial or pair-wise. Results Results showed that substantial differences in rates of inbreeding due to mating design were present under schemes with a pair-wise family structure, for which minimum coancestry turned out to be more effective to generate lower rates of inbreeding. Specifically, substantial reductions in rates of inbreeding were observed in schemes using sib test records and BLUP evaluation. However, with a factorial family structure, differences in rates of inbreeding due mating designs were minor. Moreover, non-random mating had only a small effect in breeding schemes that used genomic evaluation, regardless of the information source. Conclusions It was concluded that minimum coancestry remains an efficient mating design when BLUP is used for genetic evaluation or when the size of the population is small, whereas the effect of non-random mating is smaller in schemes using genomic evaluation.

  11. Socio-emotional selectivity in elderly and old age as a factor of subjective well-being

    Directory of Open Access Journals (Sweden)

    Melehin A.I.

    2016-02-01

    Full Text Available The article shows that the presence of social support, сonfidant network is associated with positive subjective well-being in elderly (55 - 74 years and old age (75-90 years. However, certain types of social interaction can be considered as predictors of affective disorders and chronic somatic disorders in later ages as in normal aging and in neurodegenerative disorders. The purpose of this article is to familiarize professionals in the mental health of people of later ages with the theory of socio-emotional selectivity (Socioemotional Selectivity Theory L.L. Carstensen, who makes a significant contribution to the understanding of the specificity and mechanisms of selection in social interaction in elderly and old age. Central mechanisms of socio-emotional selection in the later ages are the awareness of time and limited future time perspective, which enhances the awareness of mortality.

  12. Proarrhythmic safety of repeat doses of mirabegron in healthy subjects: a randomized, double-blind, placebo-, and active-controlled thorough QT study.

    Science.gov (United States)

    Malik, M; van Gelderen, E M; Lee, J H; Kowalski, D L; Yen, M; Goldwater, R; Mujais, S K; Schaddelee, M P; de Koning, P; Kaibara, A; Moy, S S; Keirns, J J

    2012-12-01

    Potential effects of the selective β(3)-adrenoceptor agonist mirabegron on cardiac repolarization were studied in healthy subjects. The four-arm, parallel, two-way crossover study was double-blind and placebo- and active (moxifloxacin)-controlled. After 2 baseline ECG days, subjects were randomized to one of eight treatment sequences (22 females and 22 males per sequence) of placebo crossed over with once-daily (10 days) 50, 100, or 200 mg mirabegron or a single 400-mg moxifloxacin dose on day 10. In each period, continuous ECGs were recorded at two baselines and on the last drug administration day. The lower one-sided 95% confidence interval for moxifloxacin effect on QTcI was >5 ms, demonstrating assay sensitivity. According to ICH E14 criteria, mirabegron did not cause QTcI prolongation at the 50-mg therapeutic and 100-mg supratherapeutic doses in either sex. Mirabegron prolonged QTcI interval at the 200-mg supratherapeutic dose (upper one-sided 95% CI >10 ms) in females, but not in males.

  13. Effect of Kinesiology Tape on Measurements of Balance in Subjects With Chronic Ankle Instability: A Randomized Controlled Trial.

    Science.gov (United States)

    de-la-Torre-Domingo, Carlos; Alguacil-Diego, Isabel M; Molina-Rueda, Francisco; López-Román, Antonio; Fernández-Carnero, Josué

    2015-12-01

    To examine the immediate and prolonged effects (7d) of Kinesiology Tape (KT) on balance in subjects with chronic ankle instability using computerized dynamic posturography (CDP). A 7-day follow-up, single-blind randomized controlled trial. University community. Subjects (N=36) were screened for possible eligibility criteria, and 30 successfully completed the study protocol. Of these, 15 were randomly assigned to the experimental group (KT: 5 men, 10 women), and 15 were assigned to the control group (placebo tape: 10 men, 5 women). The experimental group was taped for a lateral ankle sprain with KT. In the control group, a placebo tape was used. Balance was assessed under the following 3 conditions: without taping, immediately after application, and after 7 days of use. The CDP device used in this study was the Smart Equitest version 8.2. CDP analysis was conducted using the Sensory Organization Test (SOT). As primaries outcome measures, the composite SOT score and composite SOT strategy were chosen. The partial score for SOT condition 2 and its strategy were considered as the secondary outcomes measures. Repeated-measures analysis of variance (ANOVA) demonstrated that there was not a significant interaction between group and time in the composite SOT score (F=.239; P=.73), SOT condition 2 (F=.333; P=.705), and SOT strategy 2 (F=.899; P=.43). Additionally, repeated-measures ANOVA showed a significant effect for time (composite SOT score: F=40.69; P≤.01; SOT condition 2: F=4.61; P=.014; SOT strategy 2: F=.899; P=.413; composite SOT strategy: F=15.14; P≤.01). Specifically, post hoc analysis showed that both groups obtained improvements in composite SOT scores immediately after tape application and 7 days of use. According to our results, the SOT scores of both the KT and control groups improved during follow-up. No differences between them were observed during the follow-up in most balance measurements. The observed changes may be related to a subjective increase

  14. Elastic Tape Improved Shoulder Joint Position Sense in Chronic Hemiparetic Subjects: A Randomized Sham-Controlled Crossover Study

    Science.gov (United States)

    Souza, Matheus Bragança; Desloovere, Kaat; Russo, Thiago Luiz

    2017-01-01

    Background Elastic tape has been widely used in clinical practice in order to improve upper limb (UL) sensibility. However, there is little evidence that supports this type of intervention in stroke patients. Objective To verify the effect of elastic tape, applied to the paretic shoulder, on joint position sense (JPS) during abduction and flexion in subjects with chronic hemiparesis compared to sham tape (non-elastic tape). Furthermore, to verify if this potential effect is correlated to shoulder subluxation measurements and sensorimotor impairment. Methods A crossover and sham-controlled study was conducted with post-stroke patients who were randomly allocated into two groups: 1) those who received Sham Tape (ST) first and after one month they received Elastic Tape (ET); 2) those who received Elastic Tape (ET) first and after one month they received Sham Tape (ST). The JPS was evaluated using a dynamometer. The absolute error for shoulder abduction and flexion at 30° and 60° was calculated. Sensorimotor impairment was determined by Fugl-Meyer, and shoulder subluxation was measured using a caliper. Results Thirteen hemiparetic subjects (average time since stroke 75.23 months) participated in the study. At baseline (before interventions), the groups were not different for abduction at 30° (p = 0.805; p = 0.951), and 60° (p = 0.509; p = 0.799), or flexion at 30° (p = 0.872; p = 0.897) and 60° (p = 0.853; p = 0.970). For the ET group, differences between pre and post-elastic tape for abduction at 30° (ptape for abduction at 30° (ptape improved shoulder JPS of subjects with chronic hemiparesis regardless of the level of UL sensorimotor impairment. However, this improvement was influenced by the subluxation degree at abduction. PMID:28099472

  15. Intranasal Oxytocin Selectively Modulates Social Perception, Craving, and Approach Behavior in Subjects With Alcohol Use Disorder.

    Science.gov (United States)

    Mitchell, Jennifer M; Arcuni, Peter A; Weinstein, Dawn; Woolley, Josh D

    2016-01-01

    A pharmacotherapy that both improves social abilities and promotes abstinence may be particularly helpful for the treatment of alcohol use disorder. Recent clinical and preclinical evidence suggests that oxytocin has prosocial and antiaddiction effects. We performed a pilot, laboratory-based, preclinical trial of oxytocin in subjects with alcohol abuse (as per Diagnostic and Statistical Manual of Mental Disorders, 4 Edition criteria) to evaluate therapeutic potential and assess tolerability. Social perceptual ability, cue-induced craving, and approach bias for alcohol and appetitive imagery were quantified after intranasal oxytocin and placebo administration to 32 nontreatment-seeking individuals with alcohol abuse in a double-blind, crossover study. Because attachment style can moderate the effects of oxytocin, we also explored whether attachment style moderated oxytocin's effects on our behavioral measures. Oxytocin significantly improved recognition of easier items on a social perception task, but had no significant group-level effect on cue-induced craving. However, oxytocin effects on craving were moderated by attachment anxiety, with oxytocin reducing craving in more anxiously attached individuals and increasing craving in less anxiously attached individuals. Subjects did not display an approach bias to alcohol images on the placebo day, preventing meaningful analysis of this measure. Subjects did display an approach bias to appetitive images on the placebo day, which was significantly reduced by oxytocin administration. No adverse reactions were observed. Intranasal oxytocin has potential to improve social perception, reduce cue-induced alcohol cravings, and reduce appetitive approach bias in subjects with alcohol abuse, and can be safely tolerated in this population. The effects of oxytocin are complex, however, and require further investigation.

  16. Emulsion PCR: a high efficient way of PCR amplification of random DNA libraries in aptamer selection.

    Directory of Open Access Journals (Sweden)

    Keke Shao

    Full Text Available Aptamers are short RNA or DNA oligonucleotides which can bind with different targets. Typically, they are selected from a large number of random DNA sequence libraries. The main strategy to obtain aptamers is systematic evolution of ligands by exponential enrichment (SELEX. Low efficiency is one of the limitations for conventional PCR amplification of random DNA sequence library in aptamer selection because of relative low products and high by-products formation efficiency. Here, we developed emulsion PCR for aptamer selection. With this method, the by-products formation decreased tremendously to an undetectable level, while the products formation increased significantly. Our results indicated that by-products in conventional PCR amplification were from primer-product and product-product hybridization. In emulsion PCR, we can completely avoid the product-product hybridization and avoid the most of primer-product hybridization if the conditions were optimized. In addition, it also showed that the molecule ratio of template to compartment was crucial to by-product formation efficiency in emulsion PCR amplification. Furthermore, the concentration of the Taq DNA polymerase in the emulsion PCR mixture had a significant impact on product formation efficiency. So, the results of our study indicated that emulsion PCR could improve the efficiency of SELEX.

  17. Randomized, Controlled, Thorough QT/QTc Study Shows Absence of QT Prolongation with Luseogliflozin in Healthy Japanese Subjects.

    Directory of Open Access Journals (Sweden)

    Yuji Kumagai

    Full Text Available Luseogliflozin is a selective sodium glucose co-transporter 2 (SGLT2 inhibitor. To evaluate the cardiac safety of luseogliflozin, a thorough QT/QTc study was conducted in healthy Japanese subjects. The effects of moxifloxacin on QT prolongation in Japanese subjects were also evaluated. In this double-blind, placebo- and open-label positive-controlled, 4-way crossover study, 28 male and 28 female subjects received a single dose of luseogliflozin 5 mg (therapeutic dose, luseogliflozin 20 mg (supratherapeutic dose, placebo, and moxifloxacin 400 mg. Serial triplicate digital 12-lead electrocardiograms (ECGs were recorded before and after dosing, and results were analyzed using the Fridericia correction (QTcF method. Serial blood sampling was performed for pharmacokinetic analyses of luseogliflozin and moxifloxacin to analyze the relationship between QTcF interval and plasma concentration. The upper limits of the two-sided 90% confidence intervals (CIs for baseline and placebo-adjusted QTcF intervals (ΔΔQTcF in the 5 mg and 20 mg luseogliflozin groups were less than 10 ms at all time points. No correlation between plasma luseogliflozin concentrations and ΔΔQTcF was observed. In the moxifloxacin group, the lower limits of the two-sided 90% CIs for ΔΔQTcF were greater than 5 ms at all time points. A positive relationship was observed between plasma moxifloxacin concentration and change in ΔΔQTcF. Luseogliflozin was well tolerated at both dose levels. The majority of adverse events were mild in severity, and no serious or life-threatening adverse events occurred. Neither therapeutic (5 mg nor supratherapeutic (20 mg doses of luseogliflozin affected QT prolongation in healthy Japanese subjects.

  18. Selective REM-sleep deprivation does not diminish emotional memory consolidation in young healthy subjects.

    Science.gov (United States)

    Morgenthaler, Jarste; Wiesner, Christian D; Hinze, Karoline; Abels, Lena C; Prehn-Kristensen, Alexander; Göder, Robert

    2014-01-01

    Sleep enhances memory consolidation and it has been hypothesized that rapid eye movement (REM) sleep in particular facilitates the consolidation of emotional memory. The aim of this study was to investigate this hypothesis using selective REM-sleep deprivation. We used a recognition memory task in which participants were shown negative and neutral pictures. Participants (N=29 healthy medical students) were separated into two groups (undisturbed sleep and selective REM-sleep deprived). Both groups also worked on the memory task in a wake condition. Recognition accuracy was significantly better for negative than for neutral stimuli and better after the sleep than the wake condition. There was, however, no difference in the recognition accuracy (neutral and emotional) between the groups. In summary, our data suggest that REM-sleep deprivation was successful and that the resulting reduction of REM-sleep had no influence on memory consolidation whatsoever.

  19. Selective REM-sleep deprivation does not diminish emotional memory consolidation in young healthy subjects.

    Directory of Open Access Journals (Sweden)

    Jarste Morgenthaler

    Full Text Available Sleep enhances memory consolidation and it has been hypothesized that rapid eye movement (REM sleep in particular facilitates the consolidation of emotional memory. The aim of this study was to investigate this hypothesis using selective REM-sleep deprivation. We used a recognition memory task in which participants were shown negative and neutral pictures. Participants (N=29 healthy medical students were separated into two groups (undisturbed sleep and selective REM-sleep deprived. Both groups also worked on the memory task in a wake condition. Recognition accuracy was significantly better for negative than for neutral stimuli and better after the sleep than the wake condition. There was, however, no difference in the recognition accuracy (neutral and emotional between the groups. In summary, our data suggest that REM-sleep deprivation was successful and that the resulting reduction of REM-sleep had no influence on memory consolidation whatsoever.

  20. Novel Zn2+-chelating peptides selected from a fimbria-displayed random peptide library

    DEFF Research Database (Denmark)

    Kjærgaard, Kristian; Schembri, Mark; Klemm, Per

    2001-01-01

    H adhesin. FimH is a component of the fimbrial organelle that can accommodate and display a diverse range of peptide sequences on the E. coli cell surface. In this study we have constructed a random peptide library in FimH. The library, consisting of similar to 40 million individual clones, was screened...... for peptide sequences that conferred on recombinant cells the ability to bind Zn2+. By serial selection, sequences that exhibited various degrees of binding affinity and specificity toward Zn2+ were enriched. None of the isolated sequences showed similarity to known Zn2+-binding proteins, indicating...

  1. Increased orbitofrontal brain activation after administration of a selective adenosine A2A antagonist in cocaine dependent subjects

    Directory of Open Access Journals (Sweden)

    F. Gerard eMoeller

    2012-05-01

    Full Text Available Background: Positron Emission Tomography imaging studies provide evidence of reduced dopamine function in cocaine dependent subjects in the striatum, which is correlated with prefrontal cortical glucose metabolism, particularly in the orbitofrontal cortex. However, whether enhancement of dopamine in the striatum in cocaine dependent subjects would be associated with changes in prefrontal cortical brain activation is unknown. One novel class of medications that enhance dopamine function via heteromer formation with dopamine receptors in the striatum is the selective adenosine A2A receptor antagonists. This study sought to determine the effects administration of the selective adenosine A2A receptor antagonist SYN115 on brain function in cocaine dependent subjects. Methodology/Principle Findings: Twelve cocaine dependent subjects underwent two fMRI scans (one after a dose of placebo and one after a dose of 100 mg of SYN115 while performing a working memory task with 3 levels of difficulty (3, 5, and 7 digits. fMRI results showed that for 7-digit working memory activation there was significantly greater activation from SYN115 compared to placebo in portions of left (L lateral orbitofrontal cortex, L insula, and L superior and middle temporal pole. Conclusion/Significance: These findings are consistent with enhanced dopamine function in the striatum in cocaine dependent subjects via blockade of adenosine A2A receptors producing increased brain activation in the orbitofrontal cortex and other cortical regions. This suggests that at least some of the changes in brain activation in prefrontal cortical regions in cocaine dependent subjects may be related to altered striatal dopamine function, and that enhancement of dopamine function via adenosine A2A receptor blockade could be explored further for amelioration of neurobehavioral deficits associated with chronic cocaine use.

  2. Assessing the accuracy and stability of variable selection methods for random forest modeling in ecology.

    Science.gov (United States)

    Fox, Eric W; Hill, Ryan A; Leibowitz, Scott G; Olsen, Anthony R; Thornbrugh, Darren J; Weber, Marc H

    2017-07-01

    Random forest (RF) modeling has emerged as an important statistical learning method in ecology due to its exceptional predictive performance. However, for large and complex ecological data sets, there is limited guidance on variable selection methods for RF modeling. Typically, either a preselected set of predictor variables are used or stepwise procedures are employed which iteratively remove variables according to their importance measures. This paper investigates the application of variable selection methods to RF models for predicting probable biological stream condition. Our motivating data set consists of the good/poor condition of n = 1365 stream survey sites from the 2008/2009 National Rivers and Stream Assessment, and a large set (p = 212) of landscape features from the StreamCat data set as potential predictors. We compare two types of RF models: a full variable set model with all 212 predictors and a reduced variable set model selected using a backward elimination approach. We assess model accuracy using RF's internal out-of-bag estimate, and a cross-validation procedure with validation folds external to the variable selection process. We also assess the stability of the spatial predictions generated by the RF models to changes in the number of predictors and argue that model selection needs to consider both accuracy and stability. The results suggest that RF modeling is robust to the inclusion of many variables of moderate to low importance. We found no substantial improvement in cross-validated accuracy as a result of variable reduction. Moreover, the backward elimination procedure tended to select too few variables and exhibited numerous issues such as upwardly biased out-of-bag accuracy estimates and instabilities in the spatial predictions. We use simulations to further support and generalize results from the analysis of real data. A main purpose of this work is to elucidate issues of model selection bias and instability to ecologists interested in

  3. PReFerSim: fast simulation of demography and selection under the Poisson Random Field model.

    Science.gov (United States)

    Ortega-Del Vecchyo, Diego; Marsden, Clare D; Lohmueller, Kirk E

    2016-11-15

    The Poisson Random Field (PRF) model has become an important tool in population genetics to study weakly deleterious genetic variation under complicated demographic scenarios. Currently, there are no freely available software applications that allow simulation of genetic variation data under this model. Here we present PReFerSim, an ANSI C program that performs forward simulations under the PRF model. PReFerSim models changes in population size, arbitrary amounts of inbreeding, dominance and distributions of selective effects. Users can track summaries of genetic variation over time and output trajectories of selected alleles. PReFerSim is freely available at: https://github.com/LohmuellerLab/PReFerSim CONTACT: klohmueller@ucla.eduSupplementary information: Supplementary data are available at Bioinformatics online. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  4. Reduced plasma aldosterone concentrations in randomly selected patients with insulin-dependent diabetes mellitus.

    LENUS (Irish Health Repository)

    Cronin, C C

    2012-02-03

    Abnormalities of the renin-angiotensin system have been reported in patients with diabetes mellitus and with diabetic complications. In this study, plasma concentrations of prorenin, renin, and aldosterone were measured in a stratified random sample of 110 insulin-dependent (Type 1) diabetic patients attending our outpatient clinic. Fifty-four age- and sex-matched control subjects were also examined. Plasma prorenin concentration was higher in patients without complications than in control subjects when upright (geometric mean (95% confidence intervals (CI): 75.9 (55.0-105.6) vs 45.1 (31.6-64.3) mU I-1, p < 0.05). There was no difference in plasma prorenin concentration between patients without and with microalbuminuria and between patients without and with background retinopathy. Plasma renin concentration, both when supine and upright, was similar in control subjects, in patients without complications, and in patients with varying degrees of diabetic microangiopathy. Plasma aldosterone was suppressed in patients without complications in comparison to control subjects (74 (58-95) vs 167 (140-199) ng I-1, p < 0.001) and was also suppressed in patients with microvascular disease. Plasma potassium was significantly higher in patients than in control subjects (mean +\\/- standard deviation: 4.10 +\\/- 0.36 vs 3.89 +\\/- 0.26 mmol I-1; p < 0.001) and plasma sodium was significantly lower (138 +\\/- 4 vs 140 +\\/- 2 mmol I-1; p < 0.001). We conclude that plasma prorenin is not a useful early marker for diabetic microvascular disease. Despite apparently normal plasma renin concentrations, plasma aldosterone is suppressed in insulin-dependent diabetic patients.

  5. Resting Brain Perfusion and Selected Vascular Risk Factors in Healthy Elderly Subjects

    DEFF Research Database (Denmark)

    Henriksen, Otto M.; Jensen, Lars T; Krabbe, Katja

    2014-01-01

    with circulating homocysteine, but not with asymmetric dimethylarginine, dyslipidemia or the carotid intima-media thickness. The relative regional brain perfusion was associated with circulating homocysteine, with a relative parietal hypoperfusion and a frontal hyperperfusion. No effect on regional brain perfusion...... was observed for any of the other risk factors. A multiple regression model including homocysteine, caffeine, hematocrit and end-tidal PCO2, explained nearly half of the observed variability. CONCLUSION: Both intrinsic and extrinsic factors influenced global cerebral perfusion variation between subjects....... Further, the results suggest that the inverse relation between homocysteine and brain perfusion is owing to other mechanisms, than reflected by asymmetric dimethylarginine, and that homocysteine may be a marker of cerebral perfusion in aging brains....

  6. The prevalence of A. actinomycetemcomitans, P. gingivalis and P. intermedia in selected subjects with periodontitis.

    Science.gov (United States)

    Van der Weijden, G A; Timmerman, M F; Reijerse, E; Wolffe, G N; Van Winkelhoff, A J; Van der Velden, U

    1994-10-01

    The present study was carried out in a private periodontal practice. 8 clinical criteria were chosen to select patients for microbiological examination. These criteria characterize prominent features of disease which at the start, during, or in the maintenance phase of treatment suggest difficulties in the progress of the periodontal therapy. Based on these clinical characteristics, an inventory was made of the prevalence of the 3 putative periodontal pathogens: Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia. Out of 320 referred patients 91 patients did meet > or = 1 of the clinical criteria and consequently were selected for microbiological examination. Results showed that young patients (19-30 years) with periodontitis demonstrated the presence of A. actinomycetemcomitans more often (69%: p or = 5 mm. Retrospectively, these patients were further categorized, based on full mouth radiographs, in (1) patients with primarily horizontal bone loss and (2) patients with primarily angular bony defects. Results showed that A. actinomycetemcomitans occurred less frequently in patients showing horizontal bone loss (p < 0.05).

  7. What about Global History? Dilemmas in the Selection of Content in the School Subject History

    Directory of Open Access Journals (Sweden)

    Jens Aage Poulsen

    2013-11-01

    Full Text Available It is a cliché, but also a fundamental fact that we live in a world where globalization and international challenges, opportunities and relationships play an increasing role. However, how have these changing conditions affected the content of school history? To what degree have curricula and textbooks addressed these challenges? Is the main focus in school history still on the history of the nation state, or has it successfully integrated topics and themes from world history? These are questions I discuss in this paper. In the main, my starting point is the situation in Denmark, but with perspectives and comparisons from Norway, England and Germany. Among other things, I will put school history in a historical context, because the subject’s history and genesis—in my opinion—tends to maintain a traditional content and form of organization, thereby reducing the subject’s usefulness. At the end of the paper, I outline and discuss a few alternative options for selecting and organizing the content with the aim of being more inclusive with regard to global and international aspects. The paper must be understood as a step towards the clarification of a development project that aims to propose and experiment with practices for the selection and organization of the content of the history curriculum, with the aim of increasing the international and global dimensions in history teaching.

  8. Selective oropharyngeal decontamination versus selective digestive decontamination in critically ill patients: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhao D

    2015-07-01

    Full Text Available Di Zhao,1,* Jian Song,2,* Xuan Gao,3 Fei Gao,4 Yupeng Wu,2 Yingying Lu,5 Kai Hou1 1Department of Neurosurgery, The First Hospital of Hebei Medical University, 2Department of Neurosurgery, 3Department of Neurology, The Second Hospital of Hebei Medical University, 4Hebei Provincial Procurement Centers for Medical Drugs and Devices, 5Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang People’s Republic of China *These authors contributed equally to this work Background: Selective digestive decontamination (SDD and selective oropharyngeal decontamination (SOD are associated with reduced mortality and infection rates among patients in intensive care units (ICUs; however, whether SOD has a superior effect than SDD remains uncertain. Hence, we conducted a meta-analysis of randomized controlled trials (RCTs to compare SOD with SDD in terms of clinical outcomes and antimicrobial resistance rates in patients who were critically ill. Methods: RCTs published in PubMed, Embase, and Web of Science were systematically reviewed to compare the effects of SOD and SDD in patients who were critically ill. Outcomes included day-28 mortality, length of ICU stay, length of hospital stay, duration of mechanical ventilation, ICU-acquired bacteremia, and prevalence of antibiotic-resistant Gram-negative bacteria. Results were expressed as risk ratio (RR with 95% confidence intervals (CIs, and weighted mean differences (WMDs with 95% CIs. Pooled estimates were performed using a fixed-effects model or random-effects model, depending on the heterogeneity among studies. Results: A total of four RCTs involving 23,822 patients met the inclusion criteria and were included in this meta-analysis. Among patients whose admitting specialty was surgery, cardiothoracic surgery (57.3% and neurosurgery (29.7% were the two main types of surgery being performed. Pooled results showed that SOD had similar effects as SDD in day-28 mortality (RR =1

  9. A single consumption of curry improved postprandial endothelial function in healthy male subjects: a randomized, controlled crossover trial.

    Science.gov (United States)

    Nakayama, Hideki; Tsuge, Nobuaki; Sawada, Hiroshi; Masamura, Noriya; Yamada, Shohei; Satomi, Shigeki; Higashi, Yukihito

    2014-06-28

    Curry, one of the most popular foods in Japan, contains spices that are rich in potentially antioxidative compounds, such as curcumin and eugenol. Oxidative stress is thought to impair endothelial function associated with atherosclerosis, a leading cause of cardiovascular events. The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men. Fourteen healthy male subjects (BMI 23.7 ± 2.7 kg/m2; age 45 ± 9 years) were given a single serving of curry meal or spice-free control meal (180 g of curry or control and 200 g of cooked rice; approximately 500 kcal in total) in a randomized, controlled crossover design. Before and 1 hr after the consumption, fasting and postprandial flow-mediated vasodilation (FMD) responses and other parameters were measured. The consumption of the control meal decreased FMD from 5.8 ± 2.4% to 5.1 ± 2.3% (P = 0.039). On the other hand, the consumption of the curry meal increased FMD from 5.2 ± 2.5% to 6.6 ± 2.0% (P = 0.001), and the postprandial FMD after the curry meal was higher than that after the control meal (P = 0.002). Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics, or any biochemical parameters including oxidative stress markers measured. These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health. UMIN Clinical Trials Registry 000012012.

  10. Improvement of glucose and lipid profile status with Aloe vera in pre-diabetic subjects: a randomized controlled-trial.

    Science.gov (United States)

    Alinejad-Mofrad, Samaneh; Foadoddini, Mohsen; Saadatjoo, Seyed Alireza; Shayesteh, Majid

    2015-01-01

    Pre-diabetes is a disturbing trend in the population, who are at risk of developing type-two diabetes. The aim of this study was to determine the effects use of Aloe vera in different doses on glucose and lipid profile in pre-diabetic subjects. This study was a double blind randomized controlled trial (72 subjects) with pre-diabetes symptoms in 3 groups consumed capsules twice a day: Aloe vera 300 mg (AL300), 500 mg (AL500) and placebo (PL). Fasting blood glucose (FBS), HbA1C and lipid profile were evaluated in baseline, 4 or 8 weeks. On-way ANOVA, Friedman, Wilcoxon, Kruskal-Wallis , Mann-Whitney and Chi-square tests were used for within or between groups statistical analysis. FBS level in group AL300, showed significantly decreased in fourth week after the intervention, compared to PL in the same time (p = 0.001). Also, HbA1C level in this group at the eighth week after the intervention (p = 0.042), had a significant decrease. The levels of Total cholesterol and LDL-C, only in the group AL500 (p < 0.001 and p = 0.01), was significantly reduced, along with HDL-C level improvement just after eight weeks (p = 0.004). Triglyceride level showed a significant decrease (p < 0.045) just after four weeks use of AL500. The Use of Aloe vera extract in pre-diabetic patients, could revert impaired blood glucose within four weeks, but after eight weeks could alleviate their abnormal lipid profile.

  11. Ethnopharmacological versus random plant selection methods for the evaluation of the antimycobacterial activity

    Directory of Open Access Journals (Sweden)

    Danilo R. Oliveira

    2011-05-01

    Full Text Available The municipality of Oriximiná, Brazil, has 33 quilombola communities in remote areas, endowed with wide experience in the use of medicinal plants. An ethnobotanical survey was carried out in five of these communities. A free-listing method directed for the survey of species locally indicated against Tuberculosis and lung problems was also applied. Data were analyzed by quantitative techniques: saliency index and major use agreement. Thirty four informants related 254 ethnospecies. Among these, 43 were surveyed for possible antimycobacterial activity. As a result of those informations, ten species obtained from the ethnodirected approach (ETHNO and eighteen species obtained from the random approach (RANDOM were assayed against Mycobacterium tuberculosis by the microdilution method, using resazurin as an indicator of cell viability. The best results for antimycobacterial activity were obtained of some plants selected by the ethnopharmacological approach (50% ETHNO x 16,7% RANDOM. These results can be even more significant if we consider that the therapeutic success obtained among the quilombola practice is complex, being the use of some plants acting as fortifying agents, depurative, vomitory, purgative and bitter remedy, especially to infectious diseases, of great importance to the communities in the curing or recovering of health as a whole.

  12. Random forest variable selection in spatial malaria transmission modelling in Mpumalanga Province, South Africa.

    Science.gov (United States)

    Kapwata, Thandi; Gebreslasie, Michael T

    2016-11-16

    Malaria is an environmentally driven disease. In order to quantify the spatial variability of malaria transmission, it is imperative to understand the interactions between environmental variables and malaria epidemiology at a micro-geographic level using a novel statistical approach. The random forest (RF) statistical learning method, a relatively new variable-importance ranking method, measures the variable importance of potentially influential parameters through the percent increase of the mean squared error. As this value increases, so does the relative importance of the associated variable. The principal aim of this study was to create predictive malaria maps generated using the selected variables based on the RF algorithm in the Ehlanzeni District of Mpumalanga Province, South Africa. From the seven environmental variables used [temperature, lag temperature, rainfall, lag rainfall, humidity, altitude, and the normalized difference vegetation index (NDVI)], altitude was identified as the most influential predictor variable due its high selection frequency. It was selected as the top predictor for 4 out of 12 months of the year, followed by NDVI, temperature and lag rainfall, which were each selected twice. The combination of climatic variables that produced the highest prediction accuracy was altitude, NDVI, and temperature. This suggests that these three variables have high predictive capabilities in relation to malaria transmission. Furthermore, it is anticipated that the predictive maps generated from predictions made by the RF algorithm could be used to monitor the progression of malaria and assist in intervention and prevention efforts with respect to malaria.

  13. Random forest variable selection in spatial malaria transmission modelling in Mpumalanga Province, South Africa

    Directory of Open Access Journals (Sweden)

    Thandi Kapwata

    2016-11-01

    Full Text Available Malaria is an environmentally driven disease. In order to quantify the spatial variability of malaria transmission, it is imperative to understand the interactions between environmental variables and malaria epidemiology at a micro-geographic level using a novel statistical approach. The random forest (RF statistical learning method, a relatively new variable-importance ranking method, measures the variable importance of potentially influential parameters through the percent increase of the mean squared error. As this value increases, so does the relative importance of the associated variable. The principal aim of this study was to create predictive malaria maps generated using the selected variables based on the RF algorithm in the Ehlanzeni District of Mpumalanga Province, South Africa. From the seven environmental variables used [temperature, lag temperature, rainfall, lag rainfall, humidity, altitude, and the normalized difference vegetation index (NDVI], altitude was identified as the most influential predictor variable due its high selection frequency. It was selected as the top predictor for 4 out of 12 months of the year, followed by NDVI, temperature and lag rainfall, which were each selected twice. The combination of climatic variables that produced the highest prediction accuracy was altitude, NDVI, and temperature. This suggests that these three variables have high predictive capabilities in relation to malaria transmission. Furthermore, it is anticipated that the predictive maps generated from predictions made by the RF algorithm could be used to monitor the progression of malaria and assist in intervention and prevention efforts with respect to malaria.

  14. Selecting the appropriate pacing mode for patients with sick sinus syndrome: evidence from randomized clinical trials.

    Science.gov (United States)

    Albertsen, A E; Nielsen, J C

    2003-12-01

    Several observational studies have indicated that selection of pacing mode may be important for the clinical outcome in patients with symptomatic bradycardia, affecting the development of atrial fibrillation (AF), thromboembolism, congestive heart failure, mortality and quality of life. In this paper we present and discuss the most recent data from six randomized trials on mode selection in patients with sick sinus syndrome (SSS). In pacing mode selection, VVI(R) pacing is the least attractive solution, increasing the incidence of AF and-as compared with AAI(R) pacing, also the incidence of heart failure, thromboembolism and death. VVI(R) pacing should not be used as the primary pacing mode in patients with SSS, who haven't chronic AF. AAIR pacing is superior to DDDR pacing, reducing AF and preserving left ventricular function. Single site right ventricular pacing-VVI(R) or DDD(R) mode-causes an abnormal ventricular activation and contraction (called ventricular desynchronization), which results in a reduced left ventricular function. Despite the risk of AV block, we consider AAIR pacing to be the optimal pacing mode for isolated SSS today and an algorithm to select patients for AAIR pacing is suggested. Trials on new pacemaker algorithms minimizing right ventricular pacing as well as trials testing alternative pacing sites and multisite pacing to reduce ventricular desynchronization can be expected within the next years.

  15. A phase 2a randomized controlled study to evaluate the pharmacokinetic, safety, tolerability and clinical effect of topically applied Umeclidinium in subjects with primary axillary hyperhidrosis.

    Science.gov (United States)

    Nasir, A; Bissonnette, R; Maari, C; DuBois, J; Pene Dumitrescu, T; Haddad, J; Yamaguchi, Y; Dalessandro, M

    2018-01-01

    Hyperhidrosis is a common medical condition which can have a significant impact on quality of life. Umeclidinium (UMEC) is a long-acting muscarinic antagonist (LAMA) developed as a dermal formulation. This 2-week, double-blind, randomized, vehicle-controlled study evaluated systemic exposure, safety and tolerability of topically administered UMEC in subjects with primary axillary hyperhidrosis. Clinical effect was a secondary objective, measured by gravimetry and the hyperhidrosis disease severity scale (HDSS). Vehicle was included to evaluate safety. Twenty-three subjects were randomized to either 1.85% UMEC (N = 18) or vehicle (N = 5) once daily. Measurable plasma concentrations were observed in 78% of subjects after the treatment. Nine subjects (50%) on UMEC and two subjects (40%) on vehicle reported AEs, most commonly application site reactions. At Day 15, seven subjects (41%) in UMEC and two subjects (40%) in vehicle had at least a 50% reduction in sweat production. Eight subjects (47%) in UMEC and one subject (20%) in vehicle had at least a two-point reduction in HDSS. No comparisons of treatment arms were planned prospectively. The measurable exposure, acceptable safety and preliminary clinical activity observed in this proof-of-concept study suggest the potential clinical utility of topical UMEC in subjects with axillary hyperhidrosis. © 2017 European Academy of Dermatology and Venereology.

  16. Benefits of Selected Physical Exercise Programs in Detention: A Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Claudia Battaglia

    2013-10-01

    Full Text Available The aim of the study was to determine which kind of physical activity could be useful to inmate populations to improve their health status and fitness levels. A repeated measure design was used to evaluate the effects of two different training protocols on subjects in a state of detention, tested pre- and post-experimental protocol.Seventy-five male subjects were enrolled in the studyand randomly allocated to three groups: the cardiovascular plus resistance training protocol group (CRT (n = 25; mean age 30.9 ± 8.9 years,the high-intensity strength training protocol group (HIST (n = 25; mean age 33.9 ± 6.8 years, and a control group (C (n = 25; mean age 32.9 ± 8.9 years receiving no treatment. All subjects underwent a clinical assessmentandfitness tests. MANOVA revealed significant multivariate effects on group (p < 0.01 and group-training interaction (p < 0.05. CRT protocol resulted the most effective protocol to reach the best outcome in fitness tests. Both CRT and HIST protocols produced significant gains in the functional capacity (cardio-respiratory capacity and cardiovascular disease risk decrease of incarcerated males. The significant gains obtained in functional capacity reflect the great potential of supervised exercise interventions for improving the health status of incarcerated people.

  17. Joint random beam and spectrum selection for spectrum sharing systems with partial channel state information

    KAUST Repository

    Abdallah, Mohamed M.

    2013-11-01

    In this work, we develop joint interference-aware random beam and spectrum selection scheme that provide enhanced performance for the secondary network under the condition that the interference observed at the primary receiver is below a predetermined acceptable value. We consider a secondary link composed of a transmitter equipped with multiple antennas and a single-antenna receiver sharing the same spectrum with a set of primary links composed of a single-antenna transmitter and a single-antenna receiver. The proposed schemes jointly select a beam, among a set of power-optimized random beams, as well as the primary spectrum that maximizes the signal-to-interference-plus-noise ratio (SINR) of the secondary link while satisfying the primary interference constraint. In particular, we consider the case where the interference level is described by a q-bit description of its magnitude, whereby we propose a technique to find the optimal quantizer thresholds in a mean square error (MSE) sense. © 2013 IEEE.

  18. Interference-aware random beam selection schemes for spectrum sharing systems

    KAUST Repository

    Abdallah, Mohamed

    2012-10-19

    Spectrum sharing systems have been recently introduced to alleviate the problem of spectrum scarcity by allowing secondary unlicensed networks to share the spectrum with primary licensed networks under acceptable interference levels to the primary users. In this work, we develop interference-aware random beam selection schemes that provide enhanced performance for the secondary network under the condition that the interference observed by the receivers of the primary network is below a predetermined/acceptable value. We consider a secondary link composed of a transmitter equipped with multiple antennas and a single-antenna receiver sharing the same spectrum with a primary link composed of a single-antenna transmitter and a single-antenna receiver. The proposed schemes select a beam, among a set of power-optimized random beams, that maximizes the signal-to-interference-plus-noise ratio (SINR) of the secondary link while satisfying the primary interference constraint for different levels of feedback information describing the interference level at the primary receiver. For the proposed schemes, we develop a statistical analysis for the SINR statistics as well as the capacity and bit error rate (BER) of the secondary link.

  19. Feature selection for outcome prediction in oesophageal cancer using genetic algorithm and random forest classifier.

    Science.gov (United States)

    Paul, Desbordes; Su, Ruan; Romain, Modzelewski; Sébastien, Vauclin; Pierre, Vera; Isabelle, Gardin

    2017-09-01

    The outcome prediction of patients can greatly help to personalize cancer treatment. A large amount of quantitative features (clinical exams, imaging, …) are potentially useful to assess the patient outcome. The challenge is to choose the most predictive subset of features. In this paper, we propose a new feature selection strategy called GARF (genetic algorithm based on random forest) extracted from positron emission tomography (PET) images and clinical data. The most relevant features, predictive of the therapeutic response or which are prognoses of the patient survival 3 years after the end of treatment, were selected using GARF on a cohort of 65 patients with a local advanced oesophageal cancer eligible for chemo-radiation therapy. The most relevant predictive results were obtained with a subset of 9 features leading to a random forest misclassification rate of 18±4% and an areas under the of receiver operating characteristic (ROC) curves (AUC) of 0.823±0.032. The most relevant prognostic results were obtained with 8 features leading to an error rate of 20±7% and an AUC of 0.750±0.108. Both predictive and prognostic results show better performances using GARF than using 4 other studied methods. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Male and female brain evolution is subject to contrasting selection pressures in primates

    Science.gov (United States)

    Dunbar, Robin IM

    2007-01-01

    The claim that differences in brain size across primate species has mainly been driven by the demands of sociality (the "social brain" hypothesis) is now widely accepted. Some of the evidence to support this comes from the fact that species that live in large social groups have larger brains, and in particular larger neocortices. Lindenfors and colleagues (BMC Biology 5:20) add significantly to our appreciation of this process by showing that there are striking differences between the two sexes in the social mechanisms and brain units involved. Female sociality (which is more affiliative) is related most closely to neocortex volume, but male sociality (which is more competitive and combative) is more closely related to subcortical units (notably those associated with emotional responses). Thus different brain units have responded to different selection pressures. PMID:17493267

  1. The effect of selective serotonin reuptake inhibitors in healthy subjects. A systematic review

    DEFF Research Database (Denmark)

    Knorr, Ulla; Kessing, Lars Vedel; Knorr, Ulla

    2010-01-01

    BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) show antidepressant properties in many patients with a diagnosis of depression. An understanding of the underlying mechanisms of the effect of SSRIs in healthy patients may lead to an understanding of the yet unclear pathophysiology...... of depression. Recent reviews of studies investigating the effect of SSRIs in healthy persons conclude that the results are inconsistent and that--in relation to a wide range of outcomes--the effect of SSRIs is limited; however, reasons for the inconsistencies are poorly studied. AIMS AND METHODS...... of SSRIs in healthy persons may lead to an understanding of the pathophysiology of depression, since the present evidence is divergent and may be severely influenced by a number of methodological drawbacks....

  2. What about Global History? Dilemmas in the Selection of Content in the School Subject History

    DEFF Research Database (Denmark)

    Poulsen, Jens Aage

    2013-01-01

    Abstract: It is a cliché, but also a fundamental fact that we live in a world where globalization and international challenges, opportunities and relationships play an increasing role. However, how have these changing conditions affected the content of school history? To what degree have curricula...... and textbooks addressed these challenges? Is the main focus in school history still on the history of the nation state, or has it successfully integrated topics and themes from world history? These are questions I discuss in this paper. In the main, my starting point is the situation in Denmark...... of the paper, I outline and discuss a few alternative options for selecting and organizing the content with the aim of being more inclusive with regard to global and international aspects. The paper must be understood as a step towards the clarification of a development project that aims to propose...

  3. Male and female brain evolution is subject to contrasting selection pressures in primates

    Directory of Open Access Journals (Sweden)

    Dunbar Robin IM

    2007-05-01

    Full Text Available Abstract The claim that differences in brain size across primate species has mainly been driven by the demands of sociality (the "social brain" hypothesis is now widely accepted. Some of the evidence to support this comes from the fact that species that live in large social groups have larger brains, and in particular larger neocortices. Lindenfors and colleagues (BMC Biology 5:20 add significantly to our appreciation of this process by showing that there are striking differences between the two sexes in the social mechanisms and brain units involved. Female sociality (which is more affiliative is related most closely to neocortex volume, but male sociality (which is more competitive and combative is more closely related to subcortical units (notably those associated with emotional responses. Thus different brain units have responded to different selection pressures.

  4. Impacts of Supervised Exercise Training in Addition to Interdisciplinary Lifestyle Management in Subjects Awaiting Bariatric Surgery: a Randomized Controlled Study.

    Science.gov (United States)

    Baillot, Aurélie; Mampuya, Warner M; Dionne, Isabelle J; Comeau, Emilie; Méziat-Burdin, Anne; Langlois, Marie-France

    2016-11-01

    Experts recommend physical activity (PA) to optimize bariatric surgery (BS) results. However, evidence on the effect of PA before BS is missing. The aim of this study was to assess the impact of adding a Pre-Surgical Exercise Training (PreSET) to an interdisciplinary lifestyle intervention on physical fitness, quality of life, PA barriers, and anthropometric parameters of subjects awaiting BS. Thirty candidates for BS (43.2 ± 9.2 years, 47.5 ± 8.1 kg/m2) have been randomized in two groups: one group following the PreSET (endurance and strength training) and another receiving usual care. Before and after 12 weeks, we assessed physical fitness with a battery of tests (symptom-limited exercise test, 6-min walk test (6MWT), sit-to-stand test, half-squat test, and arm curl test), quality of life with the laval questionnaire, and PA barriers with the physical exercise belief questionnaire. One control group subject abandoned the study. Subjects in the PreSET group participated in 60.0 % of the supervised exercise sessions proposed. Results showed significant improvements in the 6MWT (17.4 ± 27.2 vs. -16.4 ± 42.4 m; p = 0.03), half-squat test (17.1 ± 17.9 vs. -0.9 ± 14.5 s; p = 0.05), arm curl repetitions (4.8 ± 2.3 vs. 1.0 ± 4.1; p = 0.01), social interaction score (10.7 ± 12.5 vs. -2.1 ± 11.0 %; p = 0.02), and embarrassment (-15.6 ± 10.2 vs. -3.1 ± 17.8 %; p = 0.02) in completers (n = 8) compared to the non-completers (n = 21). No significant difference between groups in BMI and other outcomes studied was observed after the intervention. Adding a PreSET to an individual lifestyle counselling intervention improved physical fitness, social interactions, and embarrassment. Post-surgery data would be interesting to confirm these benefits on the long term.

  5. Fast Random Permutation Tests Enable Objective Evaluation of Methods for Single-Subject fMRI Analysis

    Directory of Open Access Journals (Sweden)

    Anders Eklund

    2011-01-01

    Full Text Available Parametric statistical methods, such as Z-, t-, and F-values, are traditionally employed in functional magnetic resonance imaging (fMRI for identifying areas in the brain that are active with a certain degree of statistical significance. These parametric methods, however, have two major drawbacks. First, it is assumed that the observed data are Gaussian distributed and independent; assumptions that generally are not valid for fMRI data. Second, the statistical test distribution can be derived theoretically only for very simple linear detection statistics. With nonparametric statistical methods, the two limitations described above can be overcome. The major drawback of non-parametric methods is the computational burden with processing times ranging from hours to days, which so far have made them impractical for routine use in single-subject fMRI analysis. In this work, it is shown how the computational power of cost-efficient graphics processing units (GPUs can be used to speed up random permutation tests. A test with 10000 permutations takes less than a minute, making statistical analysis of advanced detection methods in fMRI practically feasible. To exemplify the permutation-based approach, brain activity maps generated by the general linear model (GLM and canonical correlation analysis (CCA are compared at the same significance level.

  6. Fast Random Permutation Tests Enable Objective Evaluation of Methods for Single-Subject fMRI Analysis

    Science.gov (United States)

    Eklund, Anders; Andersson, Mats; Knutsson, Hans

    2011-01-01

    Parametric statistical methods, such as Z-, t-, and F-values, are traditionally employed in functional magnetic resonance imaging (fMRI) for identifying areas in the brain that are active with a certain degree of statistical significance. These parametric methods, however, have two major drawbacks. First, it is assumed that the observed data are Gaussian distributed and independent; assumptions that generally are not valid for fMRI data. Second, the statistical test distribution can be derived theoretically only for very simple linear detection statistics. With nonparametric statistical methods, the two limitations described above can be overcome. The major drawback of non-parametric methods is the computational burden with processing times ranging from hours to days, which so far have made them impractical for routine use in single-subject fMRI analysis. In this work, it is shown how the computational power of cost-efficient graphics processing units (GPUs) can be used to speed up random permutation tests. A test with 10000 permutations takes less than a minute, making statistical analysis of advanced detection methods in fMRI practically feasible. To exemplify the permutation-based approach, brain activity maps generated by the general linear model (GLM) and canonical correlation analysis (CCA) are compared at the same significance level. PMID:22046176

  7. Probiotics, Symptoms, and Gut Microbiota: What Are the Relations? A Randomized Controlled Trial in Subjects with Irritable Bowel Syndrome

    Directory of Open Access Journals (Sweden)

    Per G. Farup

    2012-01-01

    Full Text Available Introduction. Knowledge of the mechanism of action of probiotics in subjects with irritable bowel syndrome (IBS is imperfect. Objective. This trial aimed at discriminating between a direct effect on the gut wall and an indirect effect caused by modulation of the fecal microbiota. Design. Randomized, double-blind, crossover trial. Material and Methods. Patients with IBS were given one capsule of 1010 CFU L. plantarum MF 1298 or placebo once daily. Symptoms were registered (score 0–15 and feces collected at the end of each period. The gut microbiota was analyzed with 16S rRNA gene analyses and results reported as proportions of Bacteroides, Faecalibacterium, and Lachnospiraceae and Simpson’s D diversity score. Results. Sixteen participants (11 women with a mean age of 50 years (SD 11 were available for the analyses. Intake of L. plantarum MF 1298 was associated with a significant aggravation of symptoms, but neither intake of L. plantarum MF 1298 nor symptoms were associated with the composition of the fecal microbiota (P values >0.10. Conclusions. The trial indicates that the symptomatic aggravation related to intake of L. plantarum MF 1298 was a direct effect of the microbe on the gut wall and not caused by changes in the fecal microbiota.

  8. Behavioral Effects in Forming the Preferences of the Economic Selection of the Economic Subject

    Directory of Open Access Journals (Sweden)

    Svetlana, V. Belikova

    2017-03-01

    Full Text Available An attempt has been made to substantiate the behavioral features of the economic choice of an economic entity in the context of the decision-making environment transformation, and also to study their influence on the forming subjective preferences. At the same time, the behavioral paradigm is identified as a basic theoretical construct, which makes it possible to identify the main irrationalizing factors. Based on the study of the conceptual provisions of the behavioral paradigm, it was concluded that the preferences of the economic entity in the process of implementing the economic choice are formed under the influence of motivational and cognitive predictors, which limit the rationality of the economic entity. Deviating from rational criteria towards irrational, the economic entity shapes its preferences on the basis of economic and non-economic criteria, systematically making mistakes in the context of the influence of cognitive distortions manifested in decision-making under modern conditions. Based on the findings, the author constructs a model of economic choice, taking into account behavioral predictors. Among the most important cognitive distortions are herd instinct, professional deformation, "curse of knowledge", bias toward information retrieval, error of substantiation of assessment, bias of confirmation, neglect of formalized methods of cognition, conservatism, preferences of personified trust and heuristics of asymmetric perception.

  9. Total Dietary Fiber, and Selected Vegetable, Fruit, Legume and Cereal Fiber Intake and Risk of Heart Attack in Periodontitis Subjects

    Directory of Open Access Journals (Sweden)

    Nelson Wood

    2011-10-01

    Full Text Available Background: Epidemiological studies have found an association between periodontal disease and coronary artery disease(Arbes, Slade et al. 1999; Beck, Elter et al. 2001; Genco, Offenbacher et al. 2002, and have even implicated periodontal disease as a risk factor(Arbes, Slade et al. 1999; Beck, Elter et al. 2001, however have not proven causality(Hujoel, Drangholt et al. 2000. Although dietary amounts, sources, and types (soluble versus insoluble of fiber have been shown to reduce the risk of heart attack (Liu, Buring et al. 2002; Negri, Vecchia et al. 2003, this author is unaware of studies that have examined the association between food sources of dietary fiber and heart attack risk in subjects with periodontitis.This study was designed to determine whether total dietary fiber and fiber from different plant sources (vegetables, fruits, legumes, or cereals modified self-reported HA risk, as well as acute-phase inflammatory responses in subjects with periodontitis using NHANES III data.Objectives: The objective of this study was to investigate the association between total dietary fiber intake levels, and selected vegetables, fruits, legumes, and cereal fiber intake and the risk of self-reported history of heart attack (HA in periodontitis subjects using data available in the Third National Health and Nutrition Examination Survey (NHANES III.Materials and Methods: Adult participants in NHANES III were used in this study. Zero to thirty three (0-33 percent of sites with periodontal attachment loss > 3 mm was considered a healthy periodontium, while greater than thirty three percent (>33 of sites with periodontal attachment loss of > 3 mm as periodontitis. The outcome variable was the self-reported history of HA. Total dietary fiber, and monthly selected vegetable, fruit, legume and cereal consumption were divided into low and adequate levels. Data was analyzed by Kruskal-Wallis, ANOVA and multivariate analyses using SPSS ®. P<0.05 was used to

  10. Comparative gut microbiota and resistome profiling of intensive care patients receiving selective digestive tract decontamination and healthy subjects.

    Science.gov (United States)

    Buelow, Elena; Bello González, Teresita D J; Fuentes, Susana; de Steenhuijsen Piters, Wouter A A; Lahti, Leo; Bayjanov, Jumamurat R; Majoor, Eline A M; Braat, Johanna C; van Mourik, Maaike S M; Oostdijk, Evelien A N; Willems, Rob J L; Bonten, Marc J M; van Passel, Mark W J; Smidt, Hauke; van Schaik, Willem

    2017-08-14

    The gut microbiota is a reservoir of opportunistic pathogens that can cause life-threatening infections in critically ill patients during their stay in an intensive care unit (ICU). To suppress gut colonization with opportunistic pathogens, a prophylactic antibiotic regimen, termed "selective decontamination of the digestive tract" (SDD), is used in some countries where it improves clinical outcome in ICU patients. Yet, the impact of ICU hospitalization and SDD on the gut microbiota remains largely unknown. Here, we characterize the composition of the gut microbiota and its antimicrobial resistance genes ("the resistome") of ICU patients during SDD and of healthy subjects. From ten patients that were acutely admitted to the ICU, 30 fecal samples were collected during ICU stay. Additionally, feces were collected from five of these patients after transfer to a medium-care ward and cessation of SDD. Feces from ten healthy subjects were collected twice, with a 1-year interval. Gut microbiota and resistome composition were determined using 16S rRNA gene phylogenetic profiling and nanolitre-scale quantitative PCRs. The microbiota of the ICU patients differed from the microbiota of healthy subjects and was characterized by lower microbial diversity, decreased levels of Escherichia coli and of anaerobic Gram-positive, butyrate-producing bacteria of the Clostridium clusters IV and XIVa, and an increased abundance of Bacteroidetes and enterococci. Four resistance genes (aac(6')-Ii, ermC, qacA, tetQ), providing resistance to aminoglycosides, macrolides, disinfectants, and tetracyclines, respectively, were significantly more abundant among ICU patients than in healthy subjects, while a chloramphenicol resistance gene (catA) and a tetracycline resistance gene (tetW) were more abundant in healthy subjects. The gut microbiota of SDD-treated ICU patients deviated strongly from the gut microbiota of healthy subjects. The negative effects on the resistome were limited to selection

  11. Neural signals of selective attention are modulated by subjective preferences and buying decisions in a virtual shopping task.

    Science.gov (United States)

    Goto, Nobuhiko; Mushtaq, Faisal; Shee, Dexter; Lim, Xue Li; Mortazavi, Matin; Watabe, Motoki; Schaefer, Alexandre

    2017-09-01

    We investigated whether well-known neural markers of selective attention to motivationally-relevant stimuli were modulated by variations in subjective preference towards consumer goods in a virtual shopping task. Specifically, participants viewed and rated pictures of various goods on the extent to which they wanted each item, which they could potentially purchase afterwards. Using the event-related potentials (ERP) method, we found that variations in subjective preferences for consumer goods strongly modulated positive slow waves (PSW) from 800 to 3000 milliseconds after stimulus onset. We also found that subjective preferences modulated the N200 and the late positive potential (LPP). In addition, we found that both PSW and LPP were modulated by subsequent buying decisions. Overall, these findings show that well-known brain event-related potentials reflecting selective attention processes can reliably index preferences to consumer goods in a shopping environment. Based on a large body of previous research, we suggest that early ERPs (e.g. the N200) to consumer goods could be indicative of preferences driven by unconditional and automatic processes, whereas later ERPs such as the LPP and the PSW could reflect preferences built upon more elaborative and conscious cognitive processes. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Protective Effects of Quercetin on Selected Oxidative Biomarkers in Bovine Spermatozoa Subjected to Ferrous Ascorbate.

    Science.gov (United States)

    Tvrdá, E; Tušimová, E; Kováčik, A; Paál, D; Libová, Ľ; Lukáč, N

    2016-08-01

    Quercetin (QUE) is a natural flavonol-type flavonoid with antibacterial, anti-inflammatory and anti-aggregatory properties. It is also a powerful reactive oxygen species (ROS) scavenger and chelating agent. The aim of this study was to assess the effectiveness of QUE to reverse ROS-mediated alterations to the motility, viability and intracellular antioxidant profile of bovine spermatozoa. Spermatozoa were washed out of fresh bovine semen, suspended in 2.9% sodium citrate and subjected to QUE treatment (7.5, 25, 50 and 100 μmol/l) in the presence or absence of a pro-oxidant, that is ferrous ascorbate (FeAA; 150 μmol/l FeSO4 and 750 μmol/l ascorbic acid) during a 6-h in vitro culture. Spermatozoa motion characteristics were assessed using the SpermVision computer-aided sperm analysis (CASA) system. Cell viability was examined with the metabolic activity (MTT) assay, ROS generation was quantified via luminometry, and the nitroblue tetrazolium (NBT) test was applied to quantify the intracellular superoxide formation. Cell lysates were prepared at the end of the in vitro culture to investigate the intracellular activity of superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPx) as well as the concentrations of glutathione (GSH) and malondialdehyde (MDA). FeAA treatment led to a reduced sperm motility (p vitality and antioxidant characteristics (p < 0.01 with respect to the enzymatic antioxidants, p < 0.001 in relation to GSH) with a concentration range of 50-100 μmol/l QUE revealing to be the most effective. Our results suggest that QUE exhibits significant ROS-scavenging and metal-chelating properties which may prevent spermatozoa alterations caused by ROS, and preserve the functionality of male reproductive cells. © 2016 Blackwell Verlag GmbH.

  13. How Much Will the Sea Level Rise? Outcome Selection and Subjective Probability in Climate Change Predictions.

    Science.gov (United States)

    Juanchich, Marie; Sirota, Miroslav

    2017-08-17

    We tested whether people focus on extreme outcomes to predict climate change and assessed the gap between the frequency of the predicted outcome and its perceived probability while controlling for climate change beliefs. We also tested 2 cost-effective interventions to reduce the preference for extreme outcomes and the frequency-probability gap by manipulating the probabilistic format: numerical or dual-verbal-numerical. In 4 experiments, participants read a scenario featuring a distribution of sea level rises, selected a sea rise to complete a prediction (e.g., "It is 'unlikely' that the sea level will rise . . . inches") and judged the likelihood of this sea rise occurring. Results showed that people have a preference for predicting extreme climate change outcomes in verbal predictions (59% in Experiments 1-4) and that this preference was not predicted by climate change beliefs. Results also showed an important gap between the predicted outcome frequency and participants' perception of the probability that it would occur. The dual-format reduced the preference for extreme outcomes for low and medium probability predictions but not for high ones, and none of the formats consistently reduced the frequency-probability gap. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  14. Phenotypic heterogeneity is a selected trait in natural yeast populations subject to environmental stress

    Science.gov (United States)

    Holland, Sara L; Reader, Tom; Dyer, Paul S; Avery, Simon V

    2014-01-01

    Populations of genetically uniform microorganisms exhibit phenotypic heterogeneity, where individual cells have varying phenotypes. Such phenotypes include fitness-determining traits. Phenotypic heterogeneity has been linked to increased population-level fitness in laboratory studies, but its adaptive significance for wild microorganisms in the natural environment is unknown. Here, we addressed this by testing heterogeneity in yeast isolates from diverse environmental sites, each polluted with a different principal contaminant, as well as from corresponding control locations. We found that cell-to-cell heterogeneity (in resistance to the appropriate principal pollutant) was prevalent in the wild yeast isolates. Moreover, isolates with the highest heterogeneity were consistently observed in the polluted environments, indicating that heterogeneity is positively related to survival in adverse conditions in the wild. This relationship with survival was stronger than for the property of mean resistance (IC50) of an isolate. Therefore, heterogeneity could be the major determinant of microbial survival in adverse conditions. Indeed, growth assays indicated that isolates with high heterogeneities had a significant competitive advantage during stress. Analysis of yeasts after cultivation for ≥ 500 generations additionally showed that high heterogeneity evolved as a heritable trait during stress. The results showed that environmental stress selects for wild microorganisms with high levels of phenotypic heterogeneity. PMID:24000788

  15. Comparison of statistical and operational properties of subject randomization procedures for large multicenter clinical trial treating medical emergencies

    Science.gov (United States)

    Zhao, Wenle; Mu, Yunming; Tayama, Darren; Yeatts, Sharon D.

    2015-01-01

    Large multicenter acute stroke trials demand a randomization procedure with a high level of treatment allocation randomness, an effective control on overall and within-site imbalances, and a minimized time delay of study treatment caused by the randomization procedure. Driven by the randomization algorithm design of A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS) (NCT02072226), this paper compares operational and statistical properties of different randomization algorithms in local, central, and step-forward randomization settings. Results show that the step-forward randomization with block urn design provides better performances over others. If the concern on the potential time delay is not serious and a central randomization system is available, the minimization method with an imbalance control threshold and a biased coin probability could be a better choice. PMID:25638754

  16. Carotenoid profiling of the leaves of selected African eggplant accessions subjected to drought stress.

    Science.gov (United States)

    Mibei, Elias K; Ambuko, Jane; Giovannoni, James J; Onyango, Arnold N; Owino, Willis O

    2017-01-01

    African eggplants (Solanum aethiopicum and S. macrocarpon) are among the most economically important and valuable vegetable and fruit crops. They are a major source of biologically active nutritional substances and metabolites which are essential for plant growth, development, stress adaptation and defense. Among these metabolites are the carotenoids which act as accessory pigments for photosynthesis and precursor to plant hormones. Though African eggplants are known to be resistant to various abiotic stresses, the effect of these stresses on secondary metabolites has not been well defined. The objective of this study was to establish the effect of drought stress on carotenoid profiles of nineteen African eggplant accessions selected based on leaf and fruit morphological traits. Stress was achieved by limiting irrigation and maintaining the wilting state of the crops. Fresh leaves were sampled at different maturity stages; before stress, 2 weeks and 4 weeks after stress for carotenoid analysis. The fresh harvested leaf tissues were immediately frozen in liquid nitrogen and ground. Analysis was carried out using a Dionex HPLC machine coupled to Photo Array Detector and Chromeleon software package (Thermo Fisher Scientific Inc, Waltham, Massachusetts, USA). Major carotenoids viz;. Xanthophylls (neoxanthin, violaxanthin, zeaxanthin and lutein) and carotenes (β-carotene and α-carotene), phytofluene, lycopene, phytoene as well as chlorophylls (chlorophyll-b and Chlorophyll-a) were targeted. The carotenoids increased with maturity stage of the crop. Although the stressed crops reported significantly decreased amount of carotenes, chlorophylls, neoxanthin and violaxanthin, the concentration of zeaxanthin increased with stress whereas lutein had no significant change. Chlorophyll-a was significantly high in all the control accessions. Two accessions reported significantly higher contents of carotenoids as compared to the other accessions. The results of this study

  17. Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects.

    Science.gov (United States)

    Patel, C G; Kornhauser, D; Vachharajani, N; Komoroski, B; Brenner, E; Handschuh del Corral, M; Li, L; Boulton, D W

    2011-07-01

    To evaluate the pharmacokinetic interactions of the potent, selective, dipeptidyl peptidase-4 inhibitor, saxagliptin, in combination with metformin, glyburide or pioglitazone. To assess the effect of co-administration of saxagliptin with oral antidiabetic drugs (OADs) on the pharmacokinetics and tolerability of saxagliptin, 5-hydroxy saxagliptin, metformin, glyburide, pioglitazone and hydroxy-pioglitazone, analyses of variance were performed on maximum (peak) plasma drug concentration (C(max)), area under the plasma concentration-time curve from time zero to infinity (AUC(∞)) [saxagliptin + metformin (study 1) and saxagliptin + glyburide (study 2)] and area under the concentration-time curve from time 0 to time t (AUC) [saxagliptin + pioglitazone (study 3)] for each analyte in the respective studies. Studies 1 and 2 were open-label, randomized, three-period, three-treatment, crossover studies, and study 3 was an open-label, non-randomized, sequential study in healthy subjects. Co-administration of saxagliptin with metformin, glyburide or pioglitazone did not result in clinically meaningful alterations in the pharmacokinetics of saxagliptin or its metabolite, 5-hydroxy saxagliptin. Following co-administration of saxagliptin, there were no clinically meaningful alterations in the pharmacokinetics of metformin, glyburide, pioglitazone or hydroxy-pioglitazone. Saxagliptin was generally safe and well tolerated when administered alone or in combination with metformin, glyburide or pioglitazone. Saxagliptin can be co-administered with metformin, glyburide or pioglitazone without a need for dose adjustment of either saxagliptin or these OADs. © 2011 Blackwell Publishing Ltd.

  18. Reinforcement of intestinal epithelial barrier by arabinoxylans in overweight and obese subjects: A randomized controlled trial: Arabinoxylans in gut barrier.

    Science.gov (United States)

    Salden, Bouke N; Troost, Freddy J; Wilms, Ellen; Truchado, Pilar; Vilchez-Vargas, Ramiro; Pieper, Dietmar H; Jáuregui, Ruy; Marzorati, Massimo; van de Wiele, Tom; Possemiers, Sam; Masclee, Ad A

    2017-02-03

    Obesity and metabolic diseases are associated with alterations in microbial composition and impaired gut barrier. Previous in vitro and animal studies have shown that arabinoxylans (AX) have the potential to modulate gut microbiota and gut barrier and therefore could have a protective role. Primary aim of the study was to investigate the effect of AX on intestinal permeability. Secondary aims included the effect of AX on gene transcription and protein expression of tight junctions (TJ), intestinal microbiota composition and activity, immune response and metabolic markers in overweight and obese individuals. In this randomized, double-blind, placebo-controlled trial, 47 overweight subjects were randomly assigned to groups receiving 7.5 g/d AX (n = 16), 15 g/d AX (n = 17) or 15 g/d placebo (n = 14) for 6 wks. Intestinal permeability was investigated using a multi-sugar test. Sigmoid colon tissue was obtained from a subgroup (n = 26) for analyzing gene transcription and mucosal expression of TJ proteins. Fecal samples were collected to assess microbial composition and activity. Furthermore, the production of cytokines by stimulated peripheral blood mononuclear cells (PBMCs) was examined. Blood was also sampled for measuring metabolic markers. No significant changes in gastrointestinal permeability and TJ protein expression were observed after 6 wks AX supplementation compared to placebo. However, gene transcription of occludin was upregulated in the 7.5 g AX group, and transcription of claudin-3 and claudin-4 were upregulated in the 15 g AX group compared to placebo. Furthermore, fecal microbiota diversity was decreased after 6 wks 15 g AX treatment, but no change in relative abundance of dominant phyla was observed. AX intake significantly decreased fecal pH and increased fecal concentrations of total SCFAs, acetate, propionate and butyrate, compared to placebo. Additionally, a decreased TNFα production by stimulated PBMCs was observed after 15

  19. Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial

    NARCIS (Netherlands)

    Korteland, Nelleke M.; Ahmed, Yunus; Koolbergen, David R.; Brouwer, Marjan; de Heer, Frederiek; Kluin, Jolanda; Bruggemans, Eline F.; Klautz, Robert J. M.; Stiggelbout, Anne M.; Bucx, Jeroen J. J.; Roos-Hesselink, Jolien W.; Polak, Peter; Markou, Thanasie; van den Broek, Inge; Ligthart, Rene; Bogers, Ad J. J. C.; Takkenberg, Johanna J. M.

    2017-01-01

    A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed. A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. In

  20. Whole Grain Intake and Glycaemic Control in Healthy Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Stefano Marventano

    2017-07-01

    Full Text Available Backgrounds: There is growing evidence from both observational and intervention studies that Whole Grain (WG cereals exert beneficial effects on human health, especially on the metabolic profile. The aim of this study was to perform a meta-analysis of randomised controlled trials (RCT to assess the acute and medium/long-term effect of WG foods on glycaemic control and insulin sensitivity in healthy individuals. Methods: A search for all the published RCT on the effect of WG food intake on glycaemic and insulin response was performed up to December 2016. Effect size consisted of mean difference (MD and 95% CI between the outcomes of intervention and the control groups using the generic inverse-variance random effects model. Results: The meta-analysis of the 14 studies testing the acute effects of WG foods showed significant reductions of the post-prandial values of the glucose iAUC (0–120 min by −29.71 mmol min/L (95% CI: −43.57, −15.85 mmol min/L, the insulin iAUC (0–120 min by −2.01 nmol min/L (95% CI: −2.88, −1.14 nmol min/L, and the maximal glucose and insulin response. In 16 medium- and long-term RCTs, effects of WG foods on fasting glucose and insulin and homeostatic model assessment-insulin resistance values were not significant. Conclusions: The consumption of WG foods is able to improve acutely the postprandial glucose and insulin homeostasis compared to similar refined foods in healthy subjects. Further research is needed to better understand the long-term effects and the biological mechanisms.

  1. Active classifier selection for RGB-D object categorization using a Markov random field ensemble method

    Science.gov (United States)

    Durner, Maximilian; Márton, Zoltán.; Hillenbrand, Ulrich; Ali, Haider; Kleinsteuber, Martin

    2017-03-01

    In this work, a new ensemble method for the task of category recognition in different environments is presented. The focus is on service robotic perception in an open environment, where the robot's task is to recognize previously unseen objects of predefined categories, based on training on a public dataset. We propose an ensemble learning approach to be able to flexibly combine complementary sources of information (different state-of-the-art descriptors computed on color and depth images), based on a Markov Random Field (MRF). By exploiting its specific characteristics, the MRF ensemble method can also be executed as a Dynamic Classifier Selection (DCS) system. In the experiments, the committee- and topology-dependent performance boost of our ensemble is shown. Despite reduced computational costs and using less information, our strategy performs on the same level as common ensemble approaches. Finally, the impact of large differences between datasets is analyzed.

  2. Implications of structural genomics target selection strategies: Pfam5000, whole genome, and random approaches

    Energy Technology Data Exchange (ETDEWEB)

    Chandonia, John-Marc; Brenner, Steven E.

    2004-07-14

    The structural genomics project is an international effort to determine the three-dimensional shapes of all important biological macromolecules, with a primary focus on proteins. Target proteins should be selected according to a strategy which is medically and biologically relevant, of good value, and tractable. As an option to consider, we present the Pfam5000 strategy, which involves selecting the 5000 most important families from the Pfam database as sources for targets. We compare the Pfam5000 strategy to several other proposed strategies that would require similar numbers of targets. These include including complete solution of several small to moderately sized bacterial proteomes, partial coverage of the human proteome, and random selection of approximately 5000 targets from sequenced genomes. We measure the impact that successful implementation of these strategies would have upon structural interpretation of the proteins in Swiss-Prot, TrEMBL, and 131 complete proteomes (including 10 of eukaryotes) from the Proteome Analysis database at EBI. Solving the structures of proteins from the 5000 largest Pfam families would allow accurate fold assignment for approximately 68 percent of all prokaryotic proteins (covering 59 percent of residues) and 61 percent of eukaryotic proteins (40 percent of residues). More fine-grained coverage which would allow accurate modeling of these proteins would require an order of magnitude more targets. The Pfam5000 strategy may be modified in several ways, for example to focus on larger families, bacterial sequences, or eukaryotic sequences; as long as secondary consideration is given to large families within Pfam, coverage results vary only slightly. In contrast, focusing structural genomics on a single tractable genome would have only a limited impact in structural knowledge of other proteomes: a significant fraction (about 30-40 percent of the proteins, and 40-60 percent of the residues) of each proteome is classified in small

  3. Clinical outcome of intracytoplasmic injection of spermatozoa morphologically selected under high magnification: a prospective randomized study.

    Science.gov (United States)

    Balaban, Basak; Yakin, Kayhan; Alatas, Cengiz; Oktem, Ozgur; Isiklar, Aycan; Urman, Bulent

    2011-05-01

    Recent evidence shows that the selection of spermatozoa based on the analysis of morphology under high magnification (×6000) may have a positive impact on embryo development in cases with severe male factor infertility and/or previous implantation failures. The objective of this prospective randomized study was to compare the clinical outcome of 87 intracytoplasmic morphologically selected sperm injection (IMSI) cycles with 81 conventional intracytoplasmic sperm injection (ICSI) cycles in an unselected infertile population. IMSI did not provide a significant improvement in the clinical outcome compared with ICSI although there were trends for higher implantation (28.9% versus 19.5%), clinical pregnancy (54.0% versus 44.4%) and live birth rates (43.7% versus 38.3%) in the IMSI group. However, severe male factor patients benefited from the IMSI procedure as shown by significantly higher implantation rates compared with their counterparts in the ICSI group (29.6% versus 15.2%, P=0.01). These results suggest that IMSI may improve IVF success rates in a selected group of patients with male factor infertility. New technological developments enable the real time examination of motile spermatozoa with an inverted light microscope equipped with high-power differential interference contrast optics, enhanced by digital imaging. High magnification (over ×6000) provides the identification of spermatozoa with a normal nucleus and nuclear content. Intracytoplasmic injection of spermatozoa selected according to fine nuclear morphology under high magnification may improve the clinical outcome in cases with severe male factor infertility. Copyright © 2010 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

  4. Radiographic methods used before removal of mandibular third molars among randomly selected general dental clinics.

    Science.gov (United States)

    Matzen, Louise H; Petersen, Lars B; Wenzel, Ann

    2016-01-01

    To assess radiographic methods and diagnostically sufficient images used before removal of mandibular third molars among randomly selected general dental clinics. Furthermore, to assess factors predisposing for an additional radiographic examination. 2 observers visited 18 randomly selected clinics in Denmark and studied patient files, including radiographs of patients who had their mandibular third molar(s) removed. The radiographic unit and type of receptor were registered. A diagnostically sufficient image was defined as the whole tooth and mandibular canal were displayed in the radiograph (yes/no). Overprojection between the tooth and mandibular canal (yes/no) and patient-reported inferior alveolar nerve sensory disturbances (yes/no) were recorded. Regression analyses tested if overprojection between the third molar and the mandibular canal and an insufficient intraoral image predisposed for additional radiographic examination(s). 1500 mandibular third molars had been removed; 1090 had intraoral, 468 had panoramic and 67 had CBCT examination. 1000 teeth were removed after an intraoral examination alone, 433 after panoramic examination and 67 after CBCT examination. 90 teeth had an additional examination after intraoral. Overprojection between the tooth and mandibular canal was a significant factor (p < 0.001, odds ratio = 3.56) for an additional examination. 63.7% of the intraoral images were sufficient and 36.3% were insufficient, with no significant difference between images performed with phosphor plates and solid-state sensors (p = 0.6). An insufficient image predisposed for an additional examination (p = 0.008, odds ratio = 1.8) but was only performed in 11% of the cases. Most mandibular third molars were removed based on an intraoral examination although 36.3% were insufficient.

  5. Robustness of parameter and standard error estimates against ignoring a contextual effect of a subject level covariate in cluster randomized trials

    NARCIS (Netherlands)

    Korendijk, E.J.H.; Hox, J.; Moerbeek, M.

    2011-01-01

    In experimental research, it is not uncommon to assign clusters to conditions.When analysing the data of such cluster-randomized trials, a multilevel analysis should be applied in order to take into account the dependency of firstlevel units (i.e., subjects) within a second-level unit (i.e., a

  6. Using Exponential Random Graph Models to Analyze the Character of Peer Relationship Networks and Their Effects on the Subjective Well-being of Adolescents.

    Science.gov (United States)

    Jiao, Can; Wang, Ting; Liu, Jianxin; Wu, Huanjie; Cui, Fang; Peng, Xiaozhe

    2017-01-01

    The influences of peer relationships on adolescent subjective well-being were investigated within the framework of social network analysis, using exponential random graph models as a methodological tool. The participants in the study were 1,279 students (678 boys and 601 girls) from nine junior middle schools in Shenzhen, China. The initial stage of the research used a peer nomination questionnaire and a subjective well-being scale (used in previous studies) to collect data on the peer relationship networks and the subjective well-being of the students. Exponential random graph models were then used to explore the relationships between students with the aim of clarifying the character of the peer relationship networks and the influence of peer relationships on subjective well being. The results showed that all the adolescent peer relationship networks in our investigation had positive reciprocal effects, positive transitivity effects and negative expansiveness effects. However, none of the relationship networks had obvious receiver effects or leaders. The adolescents in partial peer relationship networks presented similar levels of subjective well-being on three dimensions (satisfaction with life, positive affects and negative affects) though not all network friends presented these similarities. The study shows that peer networks can affect an individual's subjective well-being. However, whether similarities among adolescents are the result of social influences or social choices needs further exploration, including longitudinal studies that investigate the potential processes of subjective well-being similarities among adolescents.

  7. Imaging gastric structuring of lipid emulsions and its effect on gastrointestinal function: a randomized trial in healthy subjects.

    Science.gov (United States)

    Steingoetter, Andreas; Radovic, Tijana; Buetikofer, Simon; Curcic, Jelena; Menne, Dieter; Fried, Michael; Schwizer, Werner; Wooster, Tim J

    2015-04-01

    Efficient fat digestion requires fat processing within the stomach and fat sensing in the intestine. Both processes also control gastric emptying and gastrointestinal secretions. We aimed to visualize the influence of the intragastric stability of fat emulsions on their dynamics of gastric processing and structuring and to assess the effect this has on gastrointestinal motor and secretory functions. Eighteen healthy subjects with normal body mass index (BMI) were studied on 4 separate occasions in a double-blind, randomized, crossover design. Magnetic resonance imaging (MRI) data of the gastrointestinal tract and blood triglycerides were recorded before and for 240 min after the consumption of the following 4 different fat emulsions: lipid emulsion 1 (LE1; acid stable, 0.33 μm), lipid emulsion 2 (LE2; acid stable, 52 μm), lipid emulsion 3 (LE3; acid unstable, solid fat, 0.32 μm), and lipid emulsion 4 (LE4; acid unstable, liquid fat, 0.38 μm). Intragastric emulsion instability was associated with a change in gastric emptying. Acid-unstable emulsions exhibited biphasic and faster emptying profiles than did the 2 acid-stable emulsions (P ≤ 0.0001). When combined with solid fat (LE3), different dynamics of postprandial gallbladder volume were induced (P ≤ 0.001). For acid-stable emulsions, a reduction of droplet size by 2 orders of magnitude [LE1 (0.33 μm) compared with LE2 (52 μm)] delayed gastric emptying by 38 min. Although acid-stable (LE1 and LE2) and redispersible (LE4) emulsions caused a constant increase in blood triglycerides, no increase was detectable for LE3 (P emulsions. The acute effects of lipid emulsions on gastric emptying, gallbladder volume, and triglyceride absorption are dependent on microstructural changes undergone during consumption. Gastric peristalsis and secretion were effective at redispersing pools of liquid fat in the stomach. This trial was registered at clinicaltrials.gov as NCT01253005. © 2015 American Society for Nutrition.

  8. The adverse effect of selective cyclooxygenase-2 inhibitor on random skin flap survival in rats.

    Directory of Open Access Journals (Sweden)

    Haiyong Ren

    Full Text Available BACKGROUND: Cyclooxygenase-2(COX-2 inhibitors provide desired analgesic effects after injury or surgery, but evidences suggested they also attenuate wound healing. The study is to investigate the effect of COX-2 inhibitor on random skin flap survival. METHODS: The McFarlane flap model was established in 40 rats and evaluated within two groups, each group gave the same volume of Parecoxib and saline injection for 7 days. The necrotic area of the flap was measured, the specimens of the flap were stained with haematoxylin-eosin(HE for histologic analysis. Immunohistochemical staining was performed to analyse the level of VEGF and COX-2 . RESULTS: 7 days after operation, the flap necrotic area ratio in study group (66.65 ± 2.81% was significantly enlarged than that of the control group(48.81 ± 2.33%(P <0.01. Histological analysis demonstrated angiogenesis with mean vessel density per mm(2 being lower in study group (15.4 ± 4.4 than in control group (27.2 ± 4.1 (P <0.05. To evaluate the expression of COX-2 and VEGF protein in the intermediate area II in the two groups by immunohistochemistry test .The expression of COX-2 in study group was (1022.45 ± 153.1, and in control group was (2638.05 ± 132.2 (P <0.01. The expression of VEGF in the study and control groups were (2779.45 ± 472.0 vs (4938.05 ± 123.6(P <0.01.In the COX-2 inhibitor group, the expressions of COX-2 and VEGF protein were remarkably down-regulated as compared with the control group. CONCLUSION: Selective COX-2 inhibitor had adverse effect on random skin flap survival. Suppression of neovascularization induced by low level of VEGF was supposed to be the biological mechanism.

  9. Rapid selection of accessible and cleavable sites in RNA by Escherichia coli RNase P and random external guide sequences

    OpenAIRE

    Lundblad, Eirik W.; Xiao, Gaoping; Ko, Jae-hyeong; Altman, Sidney

    2008-01-01

    A method of inhibiting the expression of particular genes by using external guide sequences (EGSs) has been improved in its rapidity and specificity. Random EGSs that have 14-nt random sequences are used in the selection procedure for an EGS that attacks the mRNA for a gene in a particular location. A mixture of the random EGSs, the particular target RNA, and RNase P is used in the diagnostic procedure, which, after completion, is analyzed in a gel with suitable control lanes. Within a few ho...

  10. Effects of progressive muscle relaxation on state anxiety and subjective well-being in people with schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Vancampfort, Davy; De Hert, Marc; Knapen, Jan; Maurissen, Katrien; Raepsaet, Julie; Deckx, Seppe; Remans, Sander; Probst, Michel

    2011-06-01

    To examine the efficacy of a single progressive muscle relaxation session compared with a control condition on state anxiety, psychological stress, fatigue and subjective well-being in patients with schizophrenia. Randomized controlled trial. An acute inpatient care unit of an University Psychiatric Centre. Sixty-four out of 88 eligible patients with schizophrenia. Patients were randomly assigned to either a single progressive muscle relaxation session during 25 minutes or a resting control condition with the opportunity to read for an equal amount of time. Before and after the single interventions the State anxiety inventory and the Subjective exercise experiences scale were completed. Effect sizes were calculated. Only within progressive muscle relaxation, participants (n=27) showed decreased state anxiety, psychological stress and fatigue and increased subjective well-being. Between-group differences in post scores were found for state anxiety, subjective well-being and psychological stress, but not for fatigue. The effect size favouring progressive muscle relaxation was 1.26 for subjective well-being and -1.25 and -1.02 for respectively state anxiety and psychological stress. Progressive muscle relaxation is highly effective in reducing acute feelings of stress and anxiety in patients with schizophrenia. A reduction in stress and state anxiety is associated with an increase in subjective well-being.

  11. Gait assessment during the initial fitting of customized selective laser sintering ankle foot orthoses in subjects with drop foot.

    Science.gov (United States)

    Creylman, Veerle; Muraru, Luiza; Pallari, Jari; Vertommen, Helga; Peeraer, Louis

    2013-04-01

    Recently, additive fabrication has been proposed as a feasible engineering method for manufacturing of customized ankle foot orthoses (AFOs). Consequently, studies on safety, comfort and effectiveness are now carried out to assess the performance of such devices. Evaluate the clinical performance of customized (selective laser sintering) SLS-AFOs on eight subjects with unilateral drop foot gait and compare to clinically accepted (polypropylene) PP-AFOs. Active control trial. For each subject two customized AFOs were fabricated: one SLS-AFO manufactured following an additive fabrication framework and one thermoplastic PP-AFO manufactured according to the traditional handcraft method. Clinical performance of both AFOs was evaluated during gait analysis. A significant beneficial effect of both custom-moulded PP-AFO and customized SLS-AFO in terms of spatial temporal gait parameters and ankle kinematic parameters compared to barefoot gait of adults with drop foot gait are observed. No statistically significant difference between the effect of PP-AFO and of SLS-AFO was found in terms of spatial temporal gait parameters and ankle kinematic parameters. AFOs manufactured through the SLS technique show performances that are at least equivalent to the handcrafted PP-AFOs commonly prescribed in current clinical practice. Clinical relevance Manufacturing personalized AFOs with selective laser sintering (SLS) in an automated production process results in decreased production time and guarantees the consistency of shape and functional characteristics over different production time points compared to the traditional manufacturing process. Moreover, it reduces the dependency of the appliance on the experience and craftsmanship of the orthopaedic technician.

  12. Random genetic drift, natural selection, and noise in human cranial evolution.

    Science.gov (United States)

    Roseman, Charles C

    2016-08-01

    This study assesses the extent to which relationships among groups complicate comparative studies of adaptation in recent human cranial variation and the extent to which departures from neutral additive models of evolution hinder the reconstruction of population relationships among groups using cranial morphology. Using a maximum likelihood evolutionary model fitting approach and a mixed population genomic and cranial data set, I evaluate the relative fits of several widely used models of human cranial evolution. Moreover, I compare the goodness of fit of models of cranial evolution constrained by genomic variation to test hypotheses about population specific departures from neutrality. Models from population genomics are much better fits to cranial variation than are traditional models from comparative human biology. There is not enough evolutionary information in the cranium to reconstruct much of recent human evolution but the influence of population history on cranial variation is strong enough to cause comparative studies of adaptation serious difficulties. Deviations from a model of random genetic drift along a tree-like population history show the importance of environmental effects, gene flow, and/or natural selection on human cranial variation. Moreover, there is a strong signal of the effect of natural selection or an environmental factor on a group of humans from Siberia. The evolution of the human cranium is complex and no one evolutionary process has prevailed at the expense of all others. A holistic unification of phenome, genome, and environmental context, gives us a strong point of purchase on these problems, which is unavailable to any one traditional approach alone. Am J Phys Anthropol 160:582-592, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. Data on the recurrence of breast tumors fit a model in which dormant cells are subject to slow attrition but can randomly awaken to become malignant

    DEFF Research Database (Denmark)

    Stein, Wilfred D; Litman, Thomas

    2006-01-01

    by the body's immune system, or by random apoptosis or senescence. (iv) Recurrence suppressor mechanisms exist. (v) When such genes are disabled by random mutations, the dormant metastatic cell is activated, and will develop to a cancer recurrence. The model was also fitted to data on the survival......We successfully modeled the recurrence of tumors in breast cancer patients, assuming that: (i) A breast cancer patient is likely to have some circulating metastatic cells, even after initial surgery. (ii) These metastatic cells are dormant. (iii) The dormant cells are subject to attrition...

  14. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

    Directory of Open Access Journals (Sweden)

    Jastreboff Pawel J

    2011-01-01

    Full Text Available Abstract Background Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. Methods A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12. Results Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane, but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of Conclusions This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. Trial Registration ClinicalTrials.gov NCT00405886

  15. CURE-SMOTE algorithm and hybrid algorithm for feature selection and parameter optimization based on random forests.

    Science.gov (United States)

    Ma, Li; Fan, Suohai

    2017-03-14

    The random forests algorithm is a type of classifier with prominent universality, a wide application range, and robustness for avoiding overfitting. But there are still some drawbacks to random forests. Therefore, to improve the performance of random forests, this paper seeks to improve imbalanced data processing, feature selection and parameter optimization. We propose the CURE-SMOTE algorithm for the imbalanced data classification problem. Experiments on imbalanced UCI data reveal that the combination of Clustering Using Representatives (CURE) enhances the original synthetic minority oversampling technique (SMOTE) algorithms effectively compared with the classification results on the original data using random sampling, Borderline-SMOTE1, safe-level SMOTE, C-SMOTE, and k-means-SMOTE. Additionally, the hybrid RF (random forests) algorithm has been proposed for feature selection and parameter optimization, which uses the minimum out of bag (OOB) data error as its objective function. Simulation results on binary and higher-dimensional data indicate that the proposed hybrid RF algorithms, hybrid genetic-random forests algorithm, hybrid particle swarm-random forests algorithm and hybrid fish swarm-random forests algorithm can achieve the minimum OOB error and show the best generalization ability. The training set produced from the proposed CURE-SMOTE algorithm is closer to the original data distribution because it contains minimal noise. Thus, better classification results are produced from this feasible and effective algorithm. Moreover, the hybrid algorithm's F-value, G-mean, AUC and OOB scores demonstrate that they surpass the performance of the original RF algorithm. Hence, this hybrid algorithm provides a new way to perform feature selection and parameter optimization.

  16. Responses to high-fat challenges varying in fat type in subjects with different metabolic risk phenotypes: a randomized trial

    NARCIS (Netherlands)

    Dijk, van S.J.; Mensink, M.R.; Esser, D.; Feskens, E.J.M.; Muller, M.R.; Afman, L.A.

    2012-01-01

    Background The ability of subjects to respond to nutritional challenges can reflect the flexibility of their biological system. Nutritional challenge tests could be used as an indicator of health status but more knowledge on metabolic and immune responses of different subjects to nutritional

  17. Modeling Slotted Aloha as a Stochastic Game with Random Discrete Power Selection Algorithms

    Directory of Open Access Journals (Sweden)

    Rachid El-Azouzi

    2009-01-01

    Full Text Available We consider the uplink case of a cellular system where bufferless mobiles transmit over a common channel to a base station, using the slotted aloha medium access protocol. We study the performance of this system under several power differentiation schemes. Indeed, we consider a random set of selectable transmission powers and further study the impact of priorities given either to new arrival packets or to the backlogged ones. Later, we address a general capture model where a mobile transmits successfully a packet if its instantaneous SINR (signal to interferences plus noise ratio is lager than some fixed threshold. Under this capture model, we analyze both the cooperative team in which a common goal is jointly optimized as well as the noncooperative game problem where mobiles reach to optimize their own objectives. Furthermore, we derive the throughput and the expected delay and use them as the objectives to optimize and provide a stability analysis as alternative study. Exhaustive performance evaluations were carried out, we show that schemes with power differentiation improve significantly the individual as well as global performances, and could eliminate in some cases the bi-stable nature of slotted aloha.

  18. The prevalence of symptoms associated with pulmonary tuberculosis in randomly selected children from a high burden community

    OpenAIRE

    Marais, B.; Obihara, C; Gie, R.; Schaaf, H; Hesseling, A.; Lombard, C.; Enarson, D; Bateman, E; Beyers, N

    2005-01-01

    Background: Diagnosis of childhood tuberculosis is problematic and symptom based diagnostic approaches are often promoted in high burden settings. This study aimed (i) to document the prevalence of symptoms associated with tuberculosis among randomly selected children living in a high burden community, and (ii) to compare the prevalence of these symptoms in children without tuberculosis to those in children with newly diagnosed tuberculosis.

  19. Low-dose ticagrelor yields an antiplatelet efficacy similar to that of standard-dose ticagrelor in healthy subjects: an open-label randomized controlled trial

    OpenAIRE

    Pan Li; Ying Gu; Yawei Yang; Lizhi Chen; Junmei Liu; Lihong Gao; Yongwen Qin; Quancai Cai; Xianxian Zhao; Zhuo Wang; Liping Ma

    2016-01-01

    Ticagrelor has a greater antiplatelet efficacy than clopidogrel but may be accompanied by an increased risk of bleeding. This study evaluated the antiplatelet effect and pharmacokinetic profile of low-dose ticagrelor in healthy Chinese volunteers. Thirty healthy subjects were randomized to receive standard-dose ticagrelor (180-mg loading dose, 90-mg twice daily [bid] [n?=?10]), low-dose ticagrelor (90-mg loading dose, 45-mg bid [n?=?10]), or clopidogrel (600-mg loading dose, 75-mg once daily ...

  20. Approximate Forward Difference Equations for the Lower Order Non-Stationary Statistics of Geometrically Non-Linear Systems subject to Random Excitation

    DEFF Research Database (Denmark)

    Köylüoglu, H. U.; Nielsen, Søren R. K.; Cakmak, A. S.

    Geometrically non-linear multi-degree-of-freedom (MDOF) systems subject to random excitation are considered. New semi-analytical approximate forward difference equations for the lower order non-stationary statistical moments of the response are derived from the stochastic differential equations...... of motion, and, the accuracy of these equations is numerically investigated. For stationary excitations, the proposed method computes the stationary statistical moments of the response from the solution of non-linear algebraic equations....

  1. The Mulligan ankle taping does not affect balance performance in healthy subjects: a prospective, randomized blinded trial.

    Science.gov (United States)

    de-la-Morena, Jose Maria Delfa; Alguacil-Diego, Isabel Maria; Molina-Rueda, Francisco; Ramiro-González, Maria; Villafañe, Jorge Hugo; Fernández-Carnero, Josué

    2015-05-01

    [Purpose] The aim of this study was to evaluate the immediate effects of Mulligan fibular taping on static and dynamic postural balance in healthy subjects using computerized dynamic posturography (CDP). [Subjects and Methods] Forty-four volunteers (26 males and 18 females) aged 21 ±2 years participated in the study. The Mulligan tape was applied by a specialist in this technique. The placebo group received a treatment with a similar tape but with several cuts to avoid the fibular repositioning effect produced by Mulligan tape. The Sensory Organization Test (SOT) and the Motor Control Test (MCT) were performed by each subject at baseline and after the interventions. Outcome measures included equilibrium and strategy scores from each trial and condition of the SOT, and speed of reaction (latency period) from the MCT. [Results] Mulligan ankle taping did not have an impact on postural control during static and dynamic balance in subjects with healthy ankles when compared with placebo taping. [Conclusion] There was no difference in, equilibrium and strategy (SOT) and speed of reaction (MCT) in any of the subjects in this study. Therefore, this study suggests that Mulligan ankle taping does not have an impact on balance in healthy subjects.

  2. Rapid selection of accessible and cleavable sites in RNA by Escherichia coli RNase P and random external guide sequences.

    Science.gov (United States)

    Lundblad, Eirik W; Xiao, Gaoping; Ko, Jae-Hyeong; Altman, Sidney

    2008-02-19

    A method of inhibiting the expression of particular genes by using external guide sequences (EGSs) has been improved in its rapidity and specificity. Random EGSs that have 14-nt random sequences are used in the selection procedure for an EGS that attacks the mRNA for a gene in a particular location. A mixture of the random EGSs, the particular target RNA, and RNase P is used in the diagnostic procedure, which, after completion, is analyzed in a gel with suitable control lanes. Within a few hours, the procedure is complete. The action of EGSs designed by an older method is compared with EGSs designed by the random EGS method on mRNAs from two bacterial pathogens.

  3. Differential privacy-based evaporative cooling feature selection and classification with relief-F and random forests.

    Science.gov (United States)

    Le, Trang T; Simmons, W Kyle; Misaki, Masaya; Bodurka, Jerzy; White, Bill C; Savitz, Jonathan; McKinney, Brett A

    2017-09-15

    Classification of individuals into disease or clinical categories from high-dimensional biological data with low prediction error is an important challenge of statistical learning in bioinformatics. Feature selection can improve classification accuracy but must be incorporated carefully into cross-validation to avoid overfitting. Recently, feature selection methods based on differential privacy, such as differentially private random forests and reusable holdout sets, have been proposed. However, for domains such as bioinformatics, where the number of features is much larger than the number of observations p≫n , these differential privacy methods are susceptible to overfitting. We introduce private Evaporative Cooling, a stochastic privacy-preserving machine learning algorithm that uses Relief-F for feature selection and random forest for privacy preserving classification that also prevents overfitting. We relate the privacy-preserving threshold mechanism to a thermodynamic Maxwell-Boltzmann distribution, where the temperature represents the privacy threshold. We use the thermal statistical physics concept of Evaporative Cooling of atomic gases to perform backward stepwise privacy-preserving feature selection. On simulated data with main effects and statistical interactions, we compare accuracies on holdout and validation sets for three privacy-preserving methods: the reusable holdout, reusable holdout with random forest, and private Evaporative Cooling, which uses Relief-F feature selection and random forest classification. In simulations where interactions exist between attributes, private Evaporative Cooling provides higher classification accuracy without overfitting based on an independent validation set. In simulations without interactions, thresholdout with random forest and private Evaporative Cooling give comparable accuracies. We also apply these privacy methods to human brain resting-state fMRI data from a study of major depressive disorder. Code

  4. Fourier power, subjective distance and object categories all provide plausible models of BOLD responses in scene-selective visual areas

    Directory of Open Access Journals (Sweden)

    Mark Daniel Lescroart

    2015-11-01

    Full Text Available Perception of natural visual scenes activates several functional areas in the human brain, including the Parahippocampal Place Area (PPA, Retrosplenial Complex (RSC, and the Occipital Place Area (OPA. It is currently unclear what specific scene-related features are represented in these areas. Previous studies have suggested that PPA, RSC, and/or OPA might represent at least three qualitatively different classes of features: (1 2D features related to Fourier power; (2 3D spatial features such as the distance to objects in a scene; or (3 abstract features such as the categories of objects in a scene. To determine which of these hypotheses best describes the visual representation in scene-selective areas, we applied voxel-wise modeling (VM to BOLD fMRI responses elicited by a set of 1,386 images of natural scenes. VM provides an efficient method for testing competing hypotheses by comparing predictions of brain activity based on encoding models that instantiate each hypothesis. Here we evaluated three different encoding models that instantiate each of the three hypotheses listed above. We used linear regression to fit each encoding model to the fMRI data recorded from each voxel, and we evaluated each fit model by estimating the amount of variance it predicted in a withheld portion of the data set. We found that voxel-wise models based on Fourier power or the subjective distance to objects in each scene predicted much of the variance predicted by a model based on object categories. Furthermore, the response variance explained by these three models is largely shared, and the individual models explain little unique variance in responses. Based on an evaluation of previous studies and the data we present here, we conclude that there is currently no good basis to favor any one of the three alternative hypotheses about visual representation in scene-selective areas. We offer suggestions for further studies that may help resolve this issue.

  5. Fourier power, subjective distance, and object categories all provide plausible models of BOLD responses in scene-selective visual areas

    Science.gov (United States)

    Lescroart, Mark D.; Stansbury, Dustin E.; Gallant, Jack L.

    2015-01-01

    Perception of natural visual scenes activates several functional areas in the human brain, including the Parahippocampal Place Area (PPA), Retrosplenial Complex (RSC), and the Occipital Place Area (OPA). It is currently unclear what specific scene-related features are represented in these areas. Previous studies have suggested that PPA, RSC, and/or OPA might represent at least three qualitatively different classes of features: (1) 2D features related to Fourier power; (2) 3D spatial features such as the distance to objects in a scene; or (3) abstract features such as the categories of objects in a scene. To determine which of these hypotheses best describes the visual representation in scene-selective areas, we applied voxel-wise modeling (VM) to BOLD fMRI responses elicited by a set of 1386 images of natural scenes. VM provides an efficient method for testing competing hypotheses by comparing predictions of brain activity based on encoding models that instantiate each hypothesis. Here we evaluated three different encoding models that instantiate each of the three hypotheses listed above. We used linear regression to fit each encoding model to the fMRI data recorded from each voxel, and we evaluated each fit model by estimating the amount of variance it predicted in a withheld portion of the data set. We found that voxel-wise models based on Fourier power or the subjective distance to objects in each scene predicted much of the variance predicted by a model based on object categories. Furthermore, the response variance explained by these three models is largely shared, and the individual models explain little unique variance in responses. Based on an evaluation of previous studies and the data we present here, we conclude that there is currently no good basis to favor any one of the three alternative hypotheses about visual representation in scene-selective areas. We offer suggestions for further studies that may help resolve this issue. PMID:26594164

  6. Using ArcMap, Google Earth, and Global Positioning Systems to select and locate random households in rural Haiti

    Directory of Open Access Journals (Sweden)

    Wampler Peter J

    2013-01-01

    Full Text Available Abstract Background A remote sensing technique was developed which combines a Geographic Information System (GIS; Google Earth, and Microsoft Excel to identify home locations for a random sample of households in rural Haiti. The method was used to select homes for ethnographic and water quality research in a region of rural Haiti located within 9 km of a local hospital and source of health education in Deschapelles, Haiti. The technique does not require access to governmental records or ground based surveys to collect household location data and can be performed in a rapid, cost-effective manner. Methods The random selection of households and the location of these households during field surveys were accomplished using GIS, Google Earth, Microsoft Excel, and handheld Garmin GPSmap 76CSx GPS units. Homes were identified and mapped in Google Earth, exported to ArcMap 10.0, and a random list of homes was generated using Microsoft Excel which was then loaded onto handheld GPS units for field location. The development and use of a remote sensing method was essential to the selection and location of random households. Results A total of 537 homes initially were mapped and a randomized subset of 96 was identified as potential survey locations. Over 96% of the homes mapped using Google Earth imagery were correctly identified as occupied dwellings. Only 3.6% of the occupants of mapped homes visited declined to be interviewed. 16.4% of the homes visited were not occupied at the time of the visit due to work away from the home or market days. A total of 55 households were located using this method during the 10 days of fieldwork in May and June of 2012. Conclusions The method used to generate and field locate random homes for surveys and water sampling was an effective means of selecting random households in a rural environment lacking geolocation infrastructure. The success rate for locating households using a handheld GPS was excellent and only

  7. Using ArcMap, Google Earth, and Global Positioning Systems to select and locate random households in rural Haiti.

    Science.gov (United States)

    Wampler, Peter J; Rediske, Richard R; Molla, Azizur R

    2013-01-18

    A remote sensing technique was developed which combines a Geographic Information System (GIS); Google Earth, and Microsoft Excel to identify home locations for a random sample of households in rural Haiti. The method was used to select homes for ethnographic and water quality research in a region of rural Haiti located within 9 km of a local hospital and source of health education in Deschapelles, Haiti. The technique does not require access to governmental records or ground based surveys to collect household location data and can be performed in a rapid, cost-effective manner. The random selection of households and the location of these households during field surveys were accomplished using GIS, Google Earth, Microsoft Excel, and handheld Garmin GPSmap 76CSx GPS units. Homes were identified and mapped in Google Earth, exported to ArcMap 10.0, and a random list of homes was generated using Microsoft Excel which was then loaded onto handheld GPS units for field location. The development and use of a remote sensing method was essential to the selection and location of random households. A total of 537 homes initially were mapped and a randomized subset of 96 was identified as potential survey locations. Over 96% of the homes mapped using Google Earth imagery were correctly identified as occupied dwellings. Only 3.6% of the occupants of mapped homes visited declined to be interviewed. 16.4% of the homes visited were not occupied at the time of the visit due to work away from the home or market days. A total of 55 households were located using this method during the 10 days of fieldwork in May and June of 2012. The method used to generate and field locate random homes for surveys and water sampling was an effective means of selecting random households in a rural environment lacking geolocation infrastructure. The success rate for locating households using a handheld GPS was excellent and only rarely was local knowledge required to identify and locate households. This

  8. Effect of Oral Coadministration of Ascorbic Acid with Ling Zhi Preparation on Pharmacokinetics of Ganoderic Acid A in Healthy Male Subjects: A Randomized Crossover Study

    Science.gov (United States)

    Tawasri, Patcharanee; Ampasavate, Chadarat; Tharatha, Somsak

    2016-01-01

    The objective of this randomized, open-label, single-dose, two-phase crossover study was to determine the effect of ascorbic acid on pharmacokinetics of ganoderic acid A, an important biologically active triterpenoid compound with anticancer activities, following oral administration of water extract of fruiting bodies of Ling Zhi in 12 healthy male subjects. Each subject was randomized to receive either one of the two regimens: (1) a single dose of 3,000 mg of the Ling Zhi preparation or (2) a single dose of 3,000 mg of the Ling Zhi preparation in combination with 2,500 mg of ascorbic acid. After a washout period of at least two weeks, subjects were switched to receive the alternate regimen. Blood samples were collected in each phase immediately before dosing and at specific time points for 8 hours after dosing. Plasma ganoderic acid A concentrations were quantified using liquid chromatography-mass spectrometry (LC-MS). The pharmacokinetic parameters analyzed were maximal plasma concentration (C max), time to reach peak concentration (T max), area under the plasma concentration-time curve (AUC), and half-life (t 1/2). An oral coadministration of ascorbic acid with Ling Zhi preparation did not significantly alter the pharmacokinetic parameters of ganoderic acid A in healthy male subjects. PMID:27747224

  9. Effects of oral α-lipoic acid administration on body weight in overweight or obese subjects: a crossover randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Li, Nong; Yan, Weili; Hu, Xiaojuan; Huang, Yongdi; Wang, Fugang; Zhang, Weiguo; Wang, Qian; Wang, Xiaoling; Sun, Kehong

    2017-05-01

    Alpha-lipoic acid (ALA) has shown beneficial properties on diabetes and obesity. The aim of this study was to examine the effects of oral ALA on body weight in subjects with overweight or obese. Single-centre, randomized, double-blind, crossover controlled study. A total of 166 subjects of Chinese Han ethnicity with a BMI ≥25 kg/m2 were screened and 103 subjects fulfilled the study requirements, in terms of informed consent and participation to the study. The subjects were randomized (1:1) to receive either ALA (1200 mg/day) or placebo treatment in a crossover design for 8 weeks. The primary end-point was the change in body weight. The secondary end-points were the changes in waist circumference, BMI, lipid profile, plasma leptin levels and the adverse events that occurred following ALA treatment. The changes in the body weight and waist circumference noted in the ALA group were significantly different compared to the placebo group as demonstrated by mixed model statistical analysis (both P weight reduction was seen in the ALA group, and no significant differences were noted as regards cholesterol levels, triglyceride levels, high-density lipoprotein cholesterol levels and adverse events between the two groups. The administration of ALA was well tolerated, and no serious adverse events were noted. Oral administration of ALA (1200 mg/day) for 8 weeks induced mild weight loss accompanied by a reduction in waist circumference. © 2017 John Wiley & Sons Ltd.

  10. Randomized, multi-center trial of two hypo-energetic diets in obese subjects: high- versus low-fat content

    DEFF Research Database (Denmark)

    Petersen, M; Taylor, M A; Saris, W H M

    2006-01-01

    OBJECTIVE: To investigate whether a hypo-energetic low-fat diet is superior to a hypo-energetic high-fat diet for the treatment of obesity. DESIGN: Open-label, 10-week dietary intervention comparing two hypo-energetic (-600 kcal/day) diets with a fat energy percent of 20-25 or 40-45.Subjects......:Obese (BMI >or=30 kg/m(2)) adult subjects (n = 771), from eight European centers. MEASUREMENTS: Body weight loss, dropout rates, proportion of subjects who lost more than 10% of initial body weight, blood lipid profile, insulin and glucose. RESULTS: The dietary fat energy percent was 25% in the low-fat group...

  11. A randomized crossover study to evaluate LDL-cholesterol lowering effect of a generic product of simvastatin (Unison Company) compared to simvastatin (Zocor) in hypercholesterolemic subjects.

    Science.gov (United States)

    Assawawitoontip, Surin; Wiwanitkit, Viroj

    2002-06-01

    It is agreed that people with a high blood LDL-cholesterol level will have a higher risk of coronary heart disease (CAD) than those with low blood LDL-cholesterol level. Because of the present National Drug Strategy of Thailand, the promotion of "in-country production" of a generic drug has been established. Simvastatin is one of the drugs in this strategy. In this, the primary report of a randomized crossover study with washout period for a cholesterol lowering effect in a generic product of simvastatin (Unison company) which was compared to the original simvastatin (Zocor) hypercholesterolemic to the subjects were presented. Simvastatin used in this study were derived from two sources. The first group was the original product (Zocor), dosage 10 mg, Lot No IC4/36(N) from Merck Sharp & Dohme Company and the second group was a generic product, dosage 10 mg, Lot No T05/080 and T06/109 from Unison Company. All simvastatin tablets from the first and second sources were inserted into closed capsule of the same shape and called drug A and drug B, respectively. Both the physician in-charge and the subjects in this study were blinded for the content inside the capsule (Double blind). Thirty drug capsules were put into a sachet and distributed to the subject at each visit. The interval between each visit was 4 weeks. All subjects were asked to bring back the residual capsule within the sachet to the researcher at each visit in order to evaluate the subject's compliance. All subjects had physical examination and blood tests at each visit. Furthermore, all subjects were advised to practice diet control and regular in-take of the drug capsule daily after their evening meal. All 48 subjects were randomly allocated into 2 groups. This study was run as a randomized crossover study. After taking the drugs for the first 8 weeks, no statistically significant difference of blood LDL-cholesterol between the first and second group was detected. After a 4 week washout period, crossover

  12. Objective and subjective evaluation of the performance of medical contact lenses fitted using a contact lens selection algorithm.

    Science.gov (United States)

    Visser, Esther-Simone; Wisse, Robert P L; Soeters, Nienke; Imhof, Saskia M; Van der Lelij, Allegonda

    2016-08-01

    To evaluate the performance of medical contact lenses (CLs) for a wide range of clinical indications. Prospective cross-sectional study. A total of 281 eyes were evaluated in 281 consecutive patients (≥18 years of age; CL use ≥3 months) who visited the contact lens service in a tertiary academic clinic for a scheduled follow-up visit. The main outcome measured were clinical indications for CL wear; CL type; change in corrected distance visual acuity (CDVA) with CL use; CL wearing duration; CL wearing time; subjective performance measured using a visual analog scale (VAS) questionnaire (score range: 0-100); and effectiveness of the lens-selection algorithm. Wearing CLs significantly improved CDVA compared to wearing spectacles (median change: -0.15 logMAR, range: 1.00 to -2.10; Plenses and users of soft lenses. These results underscore the importance of prescribing scleral lenses and the need for tertiary eye clinics to offer patients a variety of CL types. Copyright © 2016 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

  13. Practice-based randomized controlled-comparison clinical trial of chiropractic adjustments and brief massage treatment at sites of subluxation in subjects with essential hypertension: pilot study.

    Science.gov (United States)

    Plaugher, Gregory; Long, Cynthia R; Alcantara, Joel; Silveus, Alyssa D; Wood, Herbert; Lotun, Kapildeo; Menke, J Michael; Meeker, William C; Rowe, Stephen H

    2002-05-01

    To determine the feasibility of conducting a randomized clinical trial in the private practice setting examining short- and long-term effects of chiropractic adjustments for subjects with essential hypertension compared with a brief soft tissue massage, as well as a nontreatment control group. Randomized controlled-comparison trial with 3 parallel groups. Private practice outpatient chiropractic clinic. Twenty-three subjects, aged 24 to 50 years with systolic or diastolic essential hypertension. Two months of full-spine chiropractic care (ie, Gonstead) consisting primarily of specific-contact, short-lever-arm adjustments delivered at motion segments exhibiting signs of subluxation. The massage group had a brief effleurage procedure delivered at localized regions of the spine believed to be exhibiting signs of subluxation. The nontreatment control group rested alone for a period of approximately 5 minutes in an adjustment room. Cost per enrolled subject, as well as systolic and diastolic blood pressure (BP) measured with a random-0 sphygmomanometer and patient reported health status (SF-36). Pilot study outcome measures also included an assessment of cooperation of subjects to randomization procedures and drop-out rates, recruitment effectiveness, analysis of temporal stability of BPs at the beginning of care, and the effects of inclusion/exclusion criteria on the subject pool. Thirty subjects enrolled, yielding a cost of $161 per enrolled subject. One subject was later determined to be ineligible, and 6 others dropped out. In both the chiropractic and massage therapy groups, all subjects were classified as either overweight or obese; in the control group there were only 2 classified as such. SF-36 profiles for the groups were similar to that of a normal population. The mean change in diastolic BP was -4 (95% confidence interval [CI]: -8.6, 0.5) in the chiropractic care group, 0.5 (95% CI: -3.5, 4.5) in the brief massage treatment group, and -4.9 (95% CI: -9.7, -0

  14. Pharmacodynamics and pharmacokinetics of AMG 531, a thrombopoiesis-stimulating peptibody, in healthy Japanese subjects: a randomized, placebo-controlled study.

    Science.gov (United States)

    Kumagai, Yuji; Fujita, Tomoe; Ozaki, Machiko; Sahashi, Kunihiko; Ohkura, Masayuki; Ohtsu, Tomoko; Arai, Yoshihiro; Sonehara, Yusuke; Nichol, Janet L

    2007-12-01

    AMG 531 is a novel thrombopoiesis-stimulating peptibody being investigated for the treatment of chronic immune thrombocytopenic purpura. This double-blind, phase I study evaluated the safety, pharmacodynamics, and pharmacokinetics of AMG 531 in healthy Japanese men. Thirty subjects were randomly assigned 4:1 (AMG 531/placebo) to receive 1 dose of AMG 531 (0.3, 1, or 2 microg/kg) or placebo by subcutaneous injection; subjects were evaluated for 6 weeks. AMG 531 was generally well tolerated, with adverse events similar to placebo. Treatment-related adverse events (headache, "feeling hot," malaise) were reported for 5 of 24 AMG 531-treated subjects. Platelets generated after exposure to AMG 531 functioned normally. Four of 8 subjects receiving 1 microg/kg and 7 of 8 receiving 2 microg/kg had platelet count increases > or =1.5-fold over baseline, an effect similar to that seen in non-Japanese subjects. Serum AMG 531 concentrations were below the lower limit of quantification in all but 2 subjects receiving 2 microg/kg.

  15. Subjective Well-Being and the Family: Results from an Ordered Probit Model with Multiple Random Effects

    OpenAIRE

    Winkelmann, Rainer

    2004-01-01

    The previous literature on the determinants of individual well-being has failed to fully account for the interdependencies in well-being at the family level. This paper develops an ordered probit model with multiple random effects that allows to identify the intrafamily correlation in well-being. The parameters of the model can be estimated with panel data using Maximum Marginal Likelihood. The approach is illustrated in an application using panel data for the period 1984-1997 from the German...

  16. Generation of Aptamers from A Primer-Free Randomized ssDNA Library Using Magnetic-Assisted Rapid Aptamer Selection

    Science.gov (United States)

    Tsao, Shih-Ming; Lai, Ji-Ching; Horng, Horng-Er; Liu, Tu-Chen; Hong, Chin-Yih

    2017-04-01

    Aptamers are oligonucleotides that can bind to specific target molecules. Most aptamers are generated using random libraries in the standard systematic evolution of ligands by exponential enrichment (SELEX). Each random library contains oligonucleotides with a randomized central region and two fixed primer regions at both ends. The fixed primer regions are necessary for amplifying target-bound sequences by PCR. However, these extra-sequences may cause non-specific bindings, which potentially interfere with good binding for random sequences. The Magnetic-Assisted Rapid Aptamer Selection (MARAS) is a newly developed protocol for generating single-strand DNA aptamers. No repeat selection cycle is required in the protocol. This study proposes and demonstrates a method to isolate aptamers for C-reactive proteins (CRP) from a randomized ssDNA library containing no fixed sequences at 5‧ and 3‧ termini using the MARAS platform. Furthermore, the isolated primer-free aptamer was sequenced and binding affinity for CRP was analyzed. The specificity of the obtained aptamer was validated using blind serum samples. The result was consistent with monoclonal antibody-based nephelometry analysis, which indicated that a primer-free aptamer has high specificity toward targets. MARAS is a feasible platform for efficiently generating primer-free aptamers for clinical diagnoses.

  17. Resveratrol as Add-on Therapy in Subjects With Well-Controlled Type 2 Diabetes: A Randomized Controlled Trial.

    NARCIS (Netherlands)

    Timmers, S.; Ligt, M. de; Phielix, E.; Weijer, T. van de; Hansen, J.; Moonen-Kornips, E.; Schaart, G.; Kunz, I.; Hesselink, M.K.; Schrauwen-Hinderling, V.B.; Schrauwen, P.

    2016-01-01

    OBJECTIVE: To determine whether resveratrol supplementation can improve insulin sensitivity and promote overall metabolic health on top of standard diabetes care. RESEARCH DESIGN AND METHODS: Seventeen subjects with well-controlled type 2 diabetes (T2D) were treated with placebo and 150 mg/day

  18. A randomized controlled trial: the effect of inulin on weight management and ectopic fat in subjects with prediabetes

    OpenAIRE

    Guess, ND; Dornhorst, A; Oliver, N; Bell, JD; Thomas, EL; Frost, GS

    2015-01-01

    Background Fat infiltration of the liver, muscle and pancreas is associated with insulin resistance and risk of diabetes. Weight loss reduces ectopic fat deposition and risk of diabetes, but is difficult to sustain to due to compensatory increases in appetite. Fermentable carbohydrates have been shown to decrease appetite and food intake, and promote weight loss in overweight subjects. In animal studies, fermentable carbohydrate reduces ectopic fat independent of weight loss. We aimed to inve...

  19. Effect of neuroscience education on subjects with chronic knee pain related to osteoarthritis: a randomized controlled trial

    OpenAIRE

    Lluch Girbés, Enrique Juan

    2017-01-01

    In this PhD study, the evidence for the role of central pain mechanisms in people with OA was investigated by means of a narrative and a systematic review of the existent literature. In addition, clinical criteria for recognizing central sensitization in subjects with knee OA are discussed as well as the rationale for a comprehensive integrative treatment program including pain neuroscience education and manual therapy for this population. Clinicians may find some practical problems when comb...

  20. An integrated production inventory model of deteriorating items subject to random machine breakdown with a stochastic repair time

    Directory of Open Access Journals (Sweden)

    Huynh Trung Luong

    2016-11-01

    Full Text Available In a continuous manufacturing environment where production and consumption occur simultaneously, one of the biggest challenges is the efficient management of production and inventory system. In order to manage the integrated production inventory system economically it is necessary to identify the optimal production time and the optimal production reorder point that either maximize the profit or minimize the cost. In addition, during production the process has to go through some natural phenomena like random breakdown of machine, deterioration of product over time, uncertainty in repair time that eventually create the possibility of shortage. In this situation, efficient management of inventory & production is crucial. This paper addresses the situation where a perishable (deteriorated product is manufactured and consumed simultaneously, the demand of this product is stable over the time, machine that produce the product also face random failure and the time to repair this machine is also uncertain. In order to describe this scenario more appropriately, the continuously reviewed Economic Production Quantity (EPQ model is considered in this research work. The main goal is to identify the optimal production uptime and the production reorder point that ultimately minimize the expected value of total cost consisting of machine setup, deterioration, inventory holding, shortage and corrective maintenance cost.

  1. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease.

    Science.gov (United States)

    Ananthasubramaniam, Karthik; Weiss, Robert; McNutt, Bruce; Klauke, Barbara; Feaheny, Kathleen; Bukofzer, Stan

    2012-04-01

    The safety and tolerability of regadenoson, a pharmacologic stress agent that is excreted primarily by the kidneys, were examined in subjects with chronic kidney disease (CKD). This multicenter, double-blind, randomized, placebo-controlled study involved men and women, ≥18 years of age, with stage 3 or 4 [estimated glomerular filtration rate (eGFR) 30-59 mL/minute/1.73 m(2) and 15-29 mL/minute/1.73 m(2), respectively] CKD and known or suspected coronary artery disease. Subjects were randomized 2:1 to receive one 10-second intravenous injection of regadenoson 0.4 mg or placebo. The primary outcome measure was the frequency of serious adverse events over 24-h post-dose. The study included 432 subjects with stage 3 (regadenoson n = 287; placebo n = 145) and 72 with stage 4 (regadenoson n = 47; placebo n = 25) CKD. No serious adverse events or deaths were reported over 24-h post-dose. The overall adverse event incidence was higher with regadenoson than placebo (62.6% vs 21.2%; P regadenoson, headache (24.9% vs 7.1%), dyspnea (19.2% vs 0.6%), chest discomfort (14.7% vs 0.6%), nausea (14.7% vs 1.2%), flushing (12.0% vs 1.8%), and dizziness (9.6% vs 0.6%) occurred significantly more often (P regadenoson than placebo. There were no trends for clinically meaningful changes in eGFR from baseline to 24-h post-dose in subjects with stage 3 or 4 CKD. Regadenoson was not associated with any serious or unexpected adverse events in subjects with stage 3 or 4 CKD.

  2. Selected elements of socio-demographic status and lifestyle as factors determining subjective assessment of life in women after mastectomy.

    Science.gov (United States)

    Skrzypczak, Magdalena; Czerniak, Urszula; Laski, Piotr

    2012-01-01

    The main objective of the study is to specify whether socio-demographic factors and physical activity result in differences in subjective assessment of life in women diagnosed with breast cancer. The study group consisted of 145 women who had been diagnosed with breast cancer. The women had undergone radical surgery, chemotherapy and radiotherapy. The participants filled in an anonymous questionnaire which contained a number of detailed questions relating to their socio-demographic standing, life style, condition and the current self-assessment of life after breast cancer. In order to assess the differences between groups made on the basis of socio-economic variables, the Kruskal-Wallis rank test was used. For a comprehensive assessment of relations, multiple correspondence analysis on the basis of Burt tables was used. Their mean age at the time of the study was 57.1 years. The analysis of the effect of education and marital status on differences in the assessment of quality of life showed that these variables resulted in differences in the sphere related to social contacts (better educated women more often avoided social contacts) and in feeling of fatigue and exhaustion (the participants who were in a relationship indicated less fatigue and exhaustion). Mastectomy caused by breast cancer in women and related chemotherapy and radiotherapy negatively affect the physical and emotional condition of patients involving mental stress. Selected socio-demographic factors and elements of life style co-exist with each other, interpenetrating; thus the assessment of quality of life should comprise a set of factors and take into consideration their mutual interrelations.

  3. Use of hyaluronan in the selection of sperm for intracytoplasmic sperm injection (ICSI): significant improvement in clinical outcomes--multicenter, double-blinded and randomized controlled trial.

    Science.gov (United States)

    Worrilow, K C; Eid, S; Woodhouse, D; Perloe, M; Smith, S; Witmyer, J; Ivani, K; Khoury, C; Ball, G D; Elliot, T; Lieberman, J

    2013-02-01

    and 247 participants were randomized to the NP group. Of the 318 patients stratified to the I-HB ≤ 65% arm, 164 participants were randomized to the control group and 154 participants were randomized to the HYAL group. HYAL patients with an F-HB score ≤ 65% demonstrated an IR of 37.4% compared with 30.7% for control [n = 63, 58, P > 0.05, (95% CI of the difference -7.7 to 21.3)]. In addition, the CPR associated with patients randomized to the HYAL group was 50.8% when compared with 37.9% for those randomized to the control group (n = 63, 58, P > 0.05). The 12.9% difference was associated with a risk ratio (RR) of 1.340 (RR 95% CI 0.89-2.0). HYAL patients with I-HB and F-HB scores ≤ 65% revealed a statistically significant reduction in their PLR (I-HB: 3.3 versus 15.1%, n = 73, 60, P = 0.021, RR of 0.22 (RR 95% CI 0.05-0.96) (F-HB: 0.0%, 18.5%, n = 27, 32, P = 0.016, RR not applicable due to 0.0% value) over control patients. The study was originally planned to have 200 participants per arm providing 86.1% power to detect an increase in CPR from 35 to 50% at α = 0.05 but was stopped early for financial reasons. As a pilot study had demonstrated that sperm preparation protocols may increase the HB score, the design of the current study incorporated a priori collection and analysis of the data by both the I-HB and the F-HB scores. Analysis by both the I-HB and F-HB score acknowledged the potential impact of sperm preparation protocols. Selection bias was controlled by randomization. Geographic and seasonal bias was controlled by recruiting from 10 geographically unique sites and by sampling over a 2-year period. The potential for population effect was controlled by adjusting for higher prevalence rates of >65% I-HB that naturally occur by adding the NP arm and to concurrently recruit >65% and ≤ 65% I-HB subjects. Monitoring and site audits occurred regularly to ensure standardization of data collection, adherence to the study protocol and subject recruitment

  4. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study.

    Science.gov (United States)

    Rodriguez-Blanco, Cleofás; Cocera-Morata, Francisco Miguel; Heredia-Rizo, Alberto Marcos; Ricard, François; Almazán-Campos, Ginés; Oliva-Pascual-Vaca, Ángel

    2015-08-01

    To assess the immediate effects on vertical mouth opening, orofacial mechanosensitivity, and lumbar and suboccipital mobility after adding a myofascial induction technique to a multimodal protocol in subjects with temporomandibular disorders (TMD). A randomized and double-blind controlled trial was carried out. University-based physical therapy research clinic. Sixty subjects (35±11.22 years) with TMD, and restricted mobility of the mandibular condyles and the first cervical vertebrae, were recruited and randomized to either a control group (CG) (n=30) or an experimental group (EG) (n=30). The CG underwent a neuromuscular technique over the masseter muscles and passive hamstring muscle stretching. A suboccipital muscle inhibition technique was added to this protocol in the EG. Primary measurements were made of vertical mouth opening and pressure pain threshold of the masseter muscles. Secondary outcome measures included pressure algometry of the trigeminal nerve, suboccipital range of motion, and lumbar spine mobility, assessed with the sit-and-reach (SAR) test and lumbar forward bending. All evaluations were collected at baseline and immediately after intervention. In the intragroup comparison, the EG observed an increase in suboccipital flexion (p0.05). The inclusion of a myofascial induction maneuver in a protocol combining local (neuromuscular treatment) and distal techniques (hamstring stretching) in subjects with TMD has no impact on improving mouth opening, suboccipital and lumbar mobility, and orofacial sensitivity to mechanical pressure.

  5. Effects of Kinesio® Tape in low back muscle fatigue: randomized, controlled, doubled-blinded clinical trial on healthy subjects.

    Science.gov (United States)

    Álvarez-Álvarez, S; José, F García-Muro San; Rodríguez-Fernández, A L; Güeita-Rodríguez, J; Waller, B J

    2014-01-01

    Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain (LBP). The underlying physiology of fatigue is complex and not fully understood. The Kinesio® Taping (KT) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception. The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects. A randomized, controlled, doubled-blinded clinical trial was conducted. Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio® Tape (KT), placebo (P) and control (C). Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test. Subjects and researchers were blinded to the intervention. Time achieved (seconds) was compared between groups with one-way ANOVA with confidence intervals of 95%. There were significant differences between the time achieved in the KT group versus the control group (p < 0.05). The placebo group performed better than the control group but worse than the KT group, these were not significant in either case. KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test. These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP.

  6. The basic science and mathematics of random mutation and natural selection.

    Science.gov (United States)

    Kleinman, Alan

    2014-12-20

    The mutation and natural selection phenomenon can and often does cause the failure of antimicrobial, herbicidal, pesticide and cancer treatments selection pressures. This phenomenon operates in a mathematically predictable behavior, which when understood leads to approaches to reduce and prevent the failure of the use of these selection pressures. The mathematical behavior of mutation and selection is derived using the principles given by probability theory. The derivation of the equations describing the mutation and selection phenomenon is carried out in the context of an empirical example. Copyright © 2014 John Wiley & Sons, Ltd.

  7. Effects of different segmental spinal stabilization exercise protocols on postural stability in asymptomatic subjects: randomized controlled trial.

    Science.gov (United States)

    Kaya, Derya Ozer; Ergun, Nevin; Hayran, Mutlu

    2012-01-01

    The aim was to assess and compare the postural stability effects of the "Progressive Dynamic Spine Stabilization Exercise Protocols" (PDSSEP) which were designed for different spinal segments. The asymptomatic, sedentary, and female volunteers (21.26 ± 1.30 years old) were allocated randomly into Cervical (n=22), Lumbar (n=21), Thoracic (n=20), Combined (n=20), and Control (n=21) Groups. All training groups participated into the related PDSSEP for six weeks, 3 days/week. The assessments were carried out at the baseline, after 6(th) week, and on the 12(th) week. "Tetrax Interactive Posturography and Balance System" (Tetrax System, Ramat Gan, Israel) was used to assess the overall postural stability (SI), weight distribution (WDI) and somatosensory reactions. "Kruskal Wallis Test" for the differences of the pre-6th weeks, pre-12(th) weeks within the groups, "Mann-Whitney U Test" for control and inter-group comparisons were used. The differences were observed for eyes closed SI, and WDI in head right rotated position (p< 0.05) between the baseline and after completing the programs. Eyes closed SI in solid surface was shown statistically different in Thoracic group in comparison to controls (p< 0.02). SI on soft surface, SI head left rotated position and somatosensory reactions with head flexed position improved in Thoracic Group at the 12(th) week (p< 0.01). WDI significantly improved in Cervical Group (p< 0.01). Thoracic spine can be considered as a hidden source for improving overall postural stability. It may be appropriate to focus on thoracic region in the kinetic chain for the treatment or training. A prospective randomized controlled trial, Level 1.

  8. Are blood pressure and diabetes additive or synergistic risk factors? outcome in 8494 subjects randomly recruited from 10 populations

    DEFF Research Database (Denmark)

    Sehestedt, Thomas; Hansen, Tine W; Li, Yan

    2011-01-01

    It remains unknown whether diabetes and high blood pressure (BP) are simply additive risk factors for cardiovascular outcome or whether they act synergistically and potentiate one another. We performed 24-h ambulatory BP monitoring in 8494 subjects (mean age, 54.6 years; 47.0% women; 6.9% diabetic...... as the reference group, the adjusted hazard ratios for the cardiovascular endpoint were 1.35 (95% confidence interval (CI), 0.87-2.11) for white-coat hypertension, 1.78 (95% CI, 1.22-2.60) for masked hypertension and 2.44 (95% CI, 1.92-3.11) for sustained hypertension. The hazard ratios for non-diabetic subjects...... were not different from those of diabetic patients (P-values for interaction, 0.09¿P¿0.72). In conclusion, in a large international population-based database, both diabetes mellitus and BP contributed equally to the risk of cardiovascular complications without evidence for a synergistic effect.Hypertension...

  9. Tissue Damage Markers after a Spinal Manipulation in Healthy Subjects: A Preliminary Report of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    A. Achalandabaso

    2014-01-01

    Full Text Available Spinal manipulation (SM is a manual therapy technique frequently applied to treat musculoskeletal disorders because of its analgesic effects. It is defined by a manual procedure involving a directed impulse to move a joint past its physiologic range of movement (ROM. In this sense, to exceed the physiologic ROM of a joint could trigger tissue damage, which might represent an adverse effect associated with spinal manipulation. The present work tries to explore the presence of tissue damage associated with SM through the damage markers analysis. Thirty healthy subjects recruited at the University of Jaén were submitted to a placebo SM (control group; n=10, a single lower cervical manipulation (cervical group; n=10, and a thoracic manipulation (n=10. Before the intervention, blood samples were extracted and centrifuged to obtain plasma and serum. The procedure was repeated right after the intervention and two hours after the intervention. Tissue damage markers creatine phosphokinase (CPK, lactate dehydrogenase (LDH, C-reactive protein (CRP, troponin-I, myoglobin, neuron-specific enolase (NSE, and aldolase were determined in samples. Statistical analysis was performed through a 3×3 mixed-model ANOVA. Neither cervical manipulation nor thoracic manipulation did produce significant changes in the CPK, LDH, CRP, troponin-I, myoglobin, NSE, or aldolase blood levels. Our data suggest that the mechanical strain produced by SM seems to be innocuous to the joints and surrounding tissues in healthy subjects.

  10. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo.

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    T N A van den Berg

    Full Text Available In patients with myocardial infarction, ticagrelor reduces cardiovascular and sepsis-related mortality, and can cause dyspnea. It is suggested that this is caused by adenosine receptor stimulation, because in preclinical studies, ticagrelor blocks the nucleoside transporter and increases cellular ATP release. We now investigated the effects of ticagrelor on the adenosine system in humans in vivo.In a double-blinded, placebo-controlled cross-over trial in 14 healthy subjects, we have tested whether ticagrelor (180 mg affects adenosine- and dipyridamole-induced forearm vasodilation, as surrogates of nucleoside uptake inhibition and adenosine formation, respectively. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was measured. Primary endpoint was adenosine-induced vasodilation.Ticagrelor did not affect adenosine- or dipyridamole-induced forearm vasodilation. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was not affected by ticagrelor. In vitro, ticagrelor dose-dependently inhibited nucleoside uptake, but only at supra-physiological concentrations.In conclusion, at relevant plasma concentration, ticagrelor does not affect adenosine transport, nor adenosine formation in healthy subjects. Therefore, it is unlikely that this mechanism is a relevant pleiotropic effect of ticagrelor.ClinicalTrials.gov NCT01996735.

  11. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo

    Science.gov (United States)

    Rongen, G. A.; van den Broek, P. H. H.; Bilos, A.; Donders, A. R. T.; Gomes, M. E.; Riksen, N. P.

    2015-01-01

    Background and Purpose In patients with myocardial infarction, ticagrelor reduces cardiovascular and sepsis-related mortality, and can cause dyspnea. It is suggested that this is caused by adenosine receptor stimulation, because in preclinical studies, ticagrelor blocks the nucleoside transporter and increases cellular ATP release. We now investigated the effects of ticagrelor on the adenosine system in humans in vivo. Experimental Approach In a double-blinded, placebo-controlled cross-over trial in 14 healthy subjects, we have tested whether ticagrelor (180 mg) affects adenosine- and dipyridamole-induced forearm vasodilation, as surrogates of nucleoside uptake inhibition and adenosine formation, respectively. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was measured. Primary endpoint was adenosine-induced vasodilation. Key Results Ticagrelor did not affect adenosine- or dipyridamole-induced forearm vasodilation. Also, ex vivo uptake of adenosine and uridine in isolated red blood cells was not affected by ticagrelor. In vitro, ticagrelor dose-dependently inhibited nucleoside uptake, but only at supra-physiological concentrations. Conclusion and Implications In conclusion, at relevant plasma concentration, ticagrelor does not affect adenosine transport, nor adenosine formation in healthy subjects. Therefore, it is unlikely that this mechanism is a relevant pleiotropic effect of ticagrelor. Trial Registration ClinicalTrials.gov NCT01996735 PMID:26509673

  12. Metabolic Effects of Replacing Sugar-Sweetened Beverages with Artificially-Sweetened Beverages in Overweight Subjects with or without Hepatic Steatosis: A Randomized Control Clinical Trial

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    Vanessa Campos

    2017-02-01

    Full Text Available Objective: Addition of fructose to the diet of normal weight and overweight subjects can increase postprandial plasma triglyceride and uric acid concentration. We, therefore, assessed whether replacing sugar-sweetened beverages (SSB with artificially-sweetened beverages (ASB in the diet of overweight and obese subjects would decrease these parameters. Methods: Twenty-six participants of the REDUCS study, which assessed the effects of replacing SSB by ASB over 12 weeks on intra-hepatocellular lipid concentration, were included in this sub-analysis. All were studied after a four-week run-in period during which they consumed their usual diet and SSBs, and after a 12-week intervention in which they were randomly assigned to replace their SSBs with ASBs (ASB arm or to continue their usual diet and SSBs (control arm, CTRL. At the end of run-in (week 4 and again at the end of intervention (week 16, they took part in an 8.5 h metabolic investigation during which their plasma glucose, insulin, glucagon, lactate, triglyceride (TG, non-esterified fatty acids (NEFA, and uric acid concentrations were measured over a 30 min fasting period (−30–0 min, then every 2 h over 480 min. with ingestion of standard breakfast at time 0 min and a standard lunch at time 240 min. Breakfast and lunch were consumed together with a 3.3 dL SSB at week 4 and with either an ASB (ASB arm or a SSB (CTRL arm at week 16. After analyzing the whole group, a secondary analysis was performed on 14 subjects with hepatic steatosis (seven randomized to ASB, seven to CTRL and 12 subjects without hepatic steatosis (six randomized to ASB and six to CTRL. Results: Ingestion of meals increased plasma glucose, insulin, glucagon, lactate, and TG concentrations and decreased NEFA concentrations, but with no significant difference of integrated postprandial responses between week 4 and week 16 in both ASB and CTRL, except for a slightly decreased glucagon response in ASB. There was, however, no

  13. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial.

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  14. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nuria eRuffini

    2015-08-01

    Full Text Available Context: Heart Rate Variability (HRV indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT on ANS activity through changes of High Frequency, a heart rate variability index indicating the parasympathetic activity, in healthy subjects, compared with sham therapy and control group.Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults, both smokers and non-smokers and not on medications. At enrollment subjects were randomized in 3 groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920.Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 minutes.Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency rate (p<0.001, and decrease of sympathetic activity, as revealed by Low Frequency rate (p<0.01; results also showed a reduction of Low Frequency/High Frequency ratio (p<0.001 and Detrended fluctuation scaling exponent (p<0.05. Conclusions: Findings suggested that OMT can influence ANS activity increasing parasympathetic function and decreasing sympathetic activity, compared to sham therapy and control group.

  15. Novel random peptide libraries displayed on AAV serotype 9 for selection of endothelial cell-directed gene transfer vectors.

    Science.gov (United States)

    Varadi, K; Michelfelder, S; Korff, T; Hecker, M; Trepel, M; Katus, H A; Kleinschmidt, J A; Müller, O J

    2012-08-01

    We have demonstrated the potential of random peptide libraries displayed on adeno-associated virus (AAV)2 to select for AAV2 vectors with improved efficiency for cell type-directed gene transfer. AAV9, however, may have advantages over AAV2 because of a lower prevalence of neutralizing antibodies in humans and more efficient gene transfer in vivo. Here we provide evidence that random peptide libraries can be displayed on AAV9 and can be utilized to select for AAV9 capsids redirected to the cell type of interest. We generated an AAV9 peptide display library, which ensures that the displayed peptides correspond to the packaged genomes and performed four consecutive selection rounds on human coronary artery endothelial cells in vitro. This screening yielded AAV9 library capsids with distinct peptide motifs enabling up to 40-fold improved transduction efficiencies compared with wild-type (wt) AAV9 vectors. Incorporating sequences selected from AAV9 libraries into AAV2 capsids could not increase transduction as efficiently as in the AAV9 context. To analyze the potential on endothelial cells in the intact natural vascular context, human umbilical veins were incubated with the selected AAV in situ and endothelial cells were isolated. Fluorescence-activated cell sorting analysis revealed a 200-fold improved transduction efficiency compared with wt AAV9 vectors. Furthermore, AAV9 vectors with targeting sequences selected from AAV9 libraries revealed an increased transduction efficiency in the presence of human intravenous immunoglobulins, suggesting a reduced immunogenicity. We conclude that our novel AAV9 peptide library is functional and can be used to select for vectors for future preclinical and clinical gene transfer applications.

  16. Modulation of protein fermentation does not affect fecal water toxicity: a randomized cross-over study in healthy subjects.

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    Karen Windey

    Full Text Available Protein fermentation results in production of metabolites such as ammonia, amines and indolic, phenolic and sulfur-containing compounds. In vitro studies suggest that these metabolites might be toxic. However, human and animal studies do not consistently support these findings. We modified protein fermentation in healthy subjects to assess the effects on colonic metabolism and parameters of gut health, and to identify metabolites associated with toxicity.After a 2-week run-in period with normal protein intake (NP, 20 healthy subjects followed an isocaloric high protein (HP and low protein (LP diet for 2 weeks in a cross-over design. Protein fermentation was estimated from urinary p-cresol excretion. Fecal metabolite profiles were analyzed using GC-MS and compared using cluster analysis. DGGE was used to analyze microbiota composition. Fecal water genotoxicity and cytotoxicity were determined using the Comet assay and the WST-1-assay, respectively, and were related to the metabolite profiles.Dietary protein intake was significantly higher during the HP diet compared to the NP and LP diet. Urinary p-cresol excretion correlated positively with protein intake. Fecal water cytotoxicity correlated negatively with protein fermentation, while fecal water genotoxicity was not correlated with protein fermentation. Heptanal, 3-methyl-2-butanone, dimethyl disulfide and 2-propenyl ester of acetic acid are associated with genotoxicity and indole, 1-octanol, heptanal, 2,4-dithiapentane, allyl-isothiocyanate, 1-methyl-4-(1-methylethenyl-benzene, propionic acid, octanoic acid, nonanoic acid and decanoic acid with cytotoxicity.This study does not support a role of protein fermentation in gut toxicity. The identified metabolites can provide new insight into colonic health.ClinicalTrial.gov NCT01280513.

  17. The effect of a high-fat breakfast on the pharmacokinetics of moxidectin in healthy male subjects: a randomized phase I trial.

    Science.gov (United States)

    Korth-Bradley, Joan M; Parks, Virginia; Chalon, Stephan; Gourley, Ian; Matschke, Kyle; Cailleux, Karine; Fitoussi, Serge; Fleckenstein, Lawrence

    2012-01-01

    The objective of this study was to assess the effect of a high-fat meal on the pharmacokinetics of moxidectin. Healthy male subjects were randomized to receive single oral 8 mg doses of moxidectin after an overnight fast or high-fat breakfast. In fasted subjects (N = 27), mean [SD] parameters were C(max): 58.9 [12.5] ng/mL; t(max): 3.7 [1.5] h; area under concentration-time curve (AUC): 3,387 [1,328] ng/h/mL; Vλ(z)/F: 2,829 [1,267] L; CL/F: 2.76 [1.28] L/h; and t(1/2): 784 [347] h. Compared with fasted subjects, fed subjects (N = 27) exhibited a 34% increase in C(max), delay in t(max) to 5.3 [2.1] h, 44% increase in AUC, 40% decrease in Vλ(z)/F, and a 35% decrease in CL/F. There was no significant change in t(1/2). The changes are consistent with an increase in moxidectin bioavailability following administration with food. There were no clinically relevant changes in vital signs, laboratory tests, or electrocardiograms.

  18. Ensemble of random forests One vs. Rest classifiers for MCI and AD prediction using ANOVA cortical and subcortical feature selection and partial least squares.

    Science.gov (United States)

    Ramírez, J; Górriz, J M; Ortiz, A; Martínez-Murcia, F J; Segovia, F; Salas-Gonzalez, D; Castillo-Barnes, D; Illán, I A; Puntonet, C G

    2017-12-11

    Alzheimer's disease (AD) is the most common cause of dementia in the elderly and affects approximately 30 million individuals worldwide. Mild cognitive impairment (MCI) is very frequently a prodromal phase of AD, and existing studies have suggested that people with MCI tend to progress to AD at a rate of about 10-15% per year. However, the ability of clinicians and machine learning systems to predict AD based on MRI biomarkers at an early stage is still a challenging problem that can have a great impact in improving treatments. The proposed system, developed by the SiPBA-UGR team for this challenge, is based on feature standardization, ANOVA feature selection, partial least squares feature dimension reduction and an ensemble of One vs. Rest random forest classifiers. With the aim of improving its performance when discriminating healthy controls (HC) from MCI, a second binary classification level was introduced that reconsiders the HC and MCI predictions of the first level. The system was trained and evaluated on an ADNI datasets that consist of T1-weighted MRI morphological measurements from HC, stable MCI, converter MCI and AD subjects. The proposed system yields a 56.25% classification score on the test subset which consists of 160 real subjects. The classifier yielded the best performance when compared to: (i) One vs. One (OvO), One vs. Rest (OvR) and error correcting output codes (ECOC) as strategies for reducing the multiclass classification task to multiple binary classification problems, (ii) support vector machines, gradient boosting classifier and random forest as base binary classifiers, and (iii) bagging ensemble learning. A robust method has been proposed for the international challenge on MCI prediction based on MRI data. The system yielded the second best performance during the competition with an accuracy rate of 56.25% when evaluated on the real subjects of the test set. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Selective Endothelin-1 Receptor type-A Inhibition in Cardiac Surgery Subjects with Pre-Existing LV Dysfunction: Influence on Early Post-Operative Hemodynamics

    Science.gov (United States)

    Toole, John M.; Ikonomidis, John S.; Szeto, Wilson Y.; Zellner, James L.; Mulcahy, John; Deardorff, Rachael L.; Spinale, Francis G.

    2010-01-01

    Background and Objective A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor LV function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF. Methods and Results Patients (n=29; 66±2 yrs) with a reduced LVEF (37±2%) were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus; n=9, 10 respectively) or vehicle (saline; n=10). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB. Baseline plasma ET (4.0±0.3 fmol/mL) was identical across all 3 groups, but when compared to pre-operative, baseline values obtained from age matched subjects with a normal LVEF (n=37;LVEF>50%), were significantly increased (2.9±0.2 fmol/mL, pTime 0, SVR changed in an equivalent fashion in the post-CPB period, but a significant ET-ARA effect was observed for PVR (ANOVA; p<0.05). For example at 24 hrs post-CPB, PVR increased by 40 d.scm-5 in the vehicle group, but directionally decreased by over 40 d·s·cm-5 in the 2 mg/kg ETARA group (p<0.05). Total adverse events were equivalently distributed across the ET-ARA/placebo groups. Conclusions These unique findings demonstrated that infusion of an ET-ARA in high risk cardiac surgery patients was not associated with significant hemodynamic compromise. Moreover, ET-ARA favorably affected PVR in the

  20. The Jackprot Simulation Couples Mutation Rate with Natural Selection to Illustrate How Protein Evolution Is Not Random

    Science.gov (United States)

    Espinosa, Avelina; Bai, Chunyan Y.

    2016-01-01

    Protein evolution is not a random process. Views which attribute randomness to molecular change, deleterious nature to single-gene mutations, insufficient geological time, or population size for molecular improvements to occur, or invoke “design creationism” to account for complexity in molecular structures and biological processes, are unfounded. Scientific evidence suggests that natural selection tinkers with molecular improvements by retaining adaptive peptide sequence. We used slot-machine probabilities and ion channels to show biological directionality on molecular change. Because ion channels reside in the lipid bilayer of cell membranes, their residue location must be in balance with the membrane's hydrophobic/philic nature; a selective “pore” for ion passage is located within the hydrophobic region. We contrasted the random generation of DNA sequence for KcsA, a bacterial two-transmembrane-domain (2TM) potassium channel, from Streptomyces lividans, with an under-selection scenario, the “jackprot,” which predicted much faster evolution than by chance. We wrote a computer program in JAVA APPLET version 1.0 and designed an online interface, The Jackprot Simulation http://faculty.rwu.edu/cbai/JackprotSimulation.htm, to model a numerical interaction between mutation rate and natural selection during a scenario of polypeptide evolution. Winning the “jackprot,” or highest-fitness complete-peptide sequence, required cumulative smaller “wins” (rewarded by selection) at the first, second, and third positions in each of the 161 KcsA codons (“jackdons” that led to “jackacids” that led to the “jackprot”). The “jackprot” is a didactic tool to demonstrate how mutation rate coupled with natural selection suffices to explain the evolution of specialized proteins, such as the complex six-transmembrane (6TM) domain potassium, sodium, or calcium channels. Ancestral DNA sequences coding for 2TM-like proteins underwent nucleotide

  1. The Jackprot Simulation Couples Mutation Rate with Natural Selection to Illustrate How Protein Evolution Is Not Random.

    Science.gov (United States)

    Paz-Y-Miño C, Guillermo; Espinosa, Avelina; Bai, Chunyan Y

    2011-09-01

    Protein evolution is not a random process. Views which attribute randomness to molecular change, deleterious nature to single-gene mutations, insufficient geological time, or population size for molecular improvements to occur, or invoke "design creationism" to account for complexity in molecular structures and biological processes, are unfounded. Scientific evidence suggests that natural selection tinkers with molecular improvements by retaining adaptive peptide sequence. We used slot-machine probabilities and ion channels to show biological directionality on molecular change. Because ion channels reside in the lipid bilayer of cell membranes, their residue location must be in balance with the membrane's hydrophobic/philic nature; a selective "pore" for ion passage is located within the hydrophobic region. We contrasted the random generation of DNA sequence for KcsA, a bacterial two-transmembrane-domain (2TM) potassium channel, from Streptomyces lividans, with an under-selection scenario, the "jackprot," which predicted much faster evolution than by chance. We wrote a computer program in JAVA APPLET version 1.0 and designed an online interface, The Jackprot Simulation http://faculty.rwu.edu/cbai/JackprotSimulation.htm, to model a numerical interaction between mutation rate and natural selection during a scenario of polypeptide evolution. Winning the "jackprot," or highest-fitness complete-peptide sequence, required cumulative smaller "wins" (rewarded by selection) at the first, second, and third positions in each of the 161 KcsA codons ("jackdons" that led to "jackacids" that led to the "jackprot"). The "jackprot" is a didactic tool to demonstrate how mutation rate coupled with natural selection suffices to explain the evolution of specialized proteins, such as the complex six-transmembrane (6TM) domain potassium, sodium, or calcium channels. Ancestral DNA sequences coding for 2TM-like proteins underwent nucleotide "edition" and gene duplications to generate the 6

  2. Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias.

    NARCIS (Netherlands)

    Borm, G.F.; Melis, R.J.F.; Teerenstra, S.; Peer, P.G.M.

    2005-01-01

    In some clinical trials, treatment allocation on a patient level is not feasible, and whole groups or clusters of patients are allocated to the same treatment. If, for example, a clinical trial is investigating the efficacy of various patient coaching methods and randomization is done on a patient

  3. Exploring the Relationship between Secondary Science Teachers' Subject Matter Knowledge and Knowledge of Student Conceptions While Teaching Evolution by Natural Selection

    Science.gov (United States)

    Lucero, Margaret M.; Petrosino, Anthony J.; Delgado, Cesar

    2017-01-01

    The fundamental scientific concept of evolution occurring by natural selection is home to many deeply held alternative conceptions and considered difficult to teach. Science teachers' subject matter knowledge (SMK) and the pedagogical content knowledge (PCK) component of knowledge of students' conceptions (KOSC) can be valuable resources for…

  4. Effects of a Recruitment Workshop on Selected Urban High School Students' Self-Efficacy and Attitudes toward Agriculture as a Subject, College Major, and Career

    Science.gov (United States)

    Fraze, Lacee Brianne; Wingenbach, Gary; Rutherford, Tracy; Wolfskill, Lawrence A.

    2011-01-01

    The purpose of this study was to determine if selected high school students' participation in a summer agricultural communications workshop affected their self-efficacy and attitudes toward agriculture as a subject, college major, and/or as a career. Data were gathered from an accessible population (N = 145), from which a purposive sample (n = 94)…

  5. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial.

    Science.gov (United States)

    Heinitz, Sascha; Reinhardt, Martin; Piaggi, Paolo; Weise, Christopher M; Diaz, Enrique; Stinson, Emma J; Venti, Colleen; Votruba, Susanne B; Wassermann, Eric M; Alonso-Alonso, Miguel; Krakoff, Jonathan; Gluck, Marci E

    2017-12-01

    Background: Obesity is associated with reduced activation in the left dorsolateral prefrontal cortex (DLPFC), a region of the brain that plays a key role in the support of self-regulatory aspects of eating behavior and inhibitory control. Transcranial direct current stimulation (tDCS) is a noninvasive technique used to modulate brain activity. Objectives: We tested whether repeated anodal tDCS targeted at the left DLPFC (compared with sham tDCS) has an immediate effect on eating behavior during ad libitum food intake, resulting in weight change, and whether it might influence longer-term food intake-related appetite ratings in individuals with obesity. Design: In a randomized parallel-design study combining inpatient and outpatient assessments over 31 d, 23 individuals with obesity [12 men; mean ± SD body mass index (BMI; in kg/m 2 ): 39.3 ± 8.42] received 15 sessions of anodal (i.e., enhancing cortical activity) or sham tDCS aimed at the left DLPFC. Ad libitum food intake was assessed through the use of a vending machine paradigm and snack food taste tests (SFTTs). Appetite was evaluated with a visual analog scale (VAS). Body weight was measured. We examined the effect of short-term (i.e., 3 sessions) and long-term (i.e., 15 sessions) tDCS on these variables. Results: Relative to sham tDCS, short-term anodal tDCS did not influence ad libitum intake of food from the vending machines. Accordingly, no effect on short-term or 4-wk weight change was observed. In the anodal tDCS group, compared with the sham group, VAS ratings for hunger and the urge to eat declined significantly more ( P = 0.01 and P = 0.05, respectively), and total energy intake during an SFTT was relatively lower in satiated individuals ( P = 0.01), after long-term tDCS. Conclusions: Short-term anodal tDCS of the left DLPFC did not have an immediate effect on ad libitum food intake or thereby weight change, relative to sham tDCS. Hunger and snack food intake were reduced only after a longer period

  6. Analysis of 2-Week Data from Two Randomized, Controlled Trials Conducted in Subjects with Frequent Heartburn Treated with Esomeprazole 20 mg.

    Science.gov (United States)

    Katz, Philip O; Le Moigne, Anne; Pollack, Charles

    2017-05-01

    These secondary analyses used data from 2 similarly designed studies in subjects experiencing frequent heartburn to evaluate the efficacy of esomeprazole 20 mg once daily for 2 weeks, which reflects the approved over-the-counter dosage and duration. Subjects without endoscopically identified erosive esophagitis who were experiencing heartburn for ≥6 months and ≥4 of 7 days prior to baseline (study 1, N = 368; study 2, N = 349) were randomly assigned to receive double-blind treatment with esomeprazole 40 or 20 mg (administered as esomeprazole magnesium trihydrate 44.5 and 22.3 mg, respectively) or placebo once daily for 4 weeks. Subjects recorded the severity of heartburn in a daily diary, and investigators assessed subjects at each study visit. Two-week assessments were the primary end points of interest in these analyses and included the percentage of subjects with complete heartburn resolution (no episodes during 7 consecutive days), time to sustained complete heartburn resolution (the first of 7 consecutive episode-free days), and heartburn relief (no episodes other than ≤1 mild episode during 7 consecutive days). At week 2, the percentages of subjects who experienced complete heartburn resolution were significantly greater with esomeprazole 40 mg (study 1, 26.1%; study 2, 35.3%) and 20 mg (study 1, 25.2%; study 2, 35.7%) compared with placebo (study 1, 9.0%; study 2, 3.4%) (all, P ≤ 0.001). Beginning on day 1, the percentages of subjects who experienced sustained heartburn resolution was significantly greater in the groups treated with esomeprazole 40 mg (study 1, 19%; study 2, 19%; P esomeprazole 40 mg (study 1, 35.3%; study 2, 40.5%) and 20 mg (study 1, 34.5%; study 2, 46.4%) compared with placebo (study 1, 16.5%; study 2, 8.6%) (all, P ≤ 0.001). The results of this study demonstrate that once-daily treatment with esomeprazole 20 mg for 2 weeks effectively resolved subjects׳ heartburn compared with placebo, beginning on day 1. Studies precede FDA

  7. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Simmons PA

    2015-04-01

    Full Text Available Peter A Simmons, Haixia Liu, Cindy Carlisle-Wilcox, Joseph G Vehige Allergan Clinical Research, Allergan, Inc., Irvine, CA, USA Purpose: To evaluate and compare the efficacy and safety of two investigational artificial tear formulations (CHO-1 and CHO-2 containing carmellose sodium, hyaluronic acid at different concentrations, and osmoprotectants, with a standard carmellose sodium-containing formulation (Refresh Tears [RT] in the treatment of dry eye disease. Subjects and methods: In this 3-month, double-masked, multicenter study, subjects (n=305 were randomized 1:1:1 to receive CHO-1, CHO-2, or RT, used as needed but at least twice daily. The primary endpoint was change in ocular surface disease index (OSDI score from baseline to day 90. Other key outcomes included symptoms evaluated on a visual analog scale, corneal and conjunctival staining, and adverse events. Results: OSDI scores and dry eye symptoms showed a rapid and sustained reduction from baseline in each group. Both CHO-1 and CHO-2 met the primary efficacy endpoint of noninferiority to RT in day 90 OSDI score change from baseline. OSDI ocular symptoms subscale improved more with CHO-1 than CHO-2 (P=0.048. In subjects with clinically relevant baseline ocular surface staining (>14 total score of a maximum of 55, day 90 improvements were greater with CHO-1 and CHO-2 than RT (P≤0.044. Day 90 improvements in OSDI ocular symptoms subscale scores were also greater with CHO-1 than RT (P<0.007 in subjects with clinically relevant ocular staining. All treatments were well tolerated.Conclusion: Both combination artificial tear formulations were efficacious and well tolerated in subjects with dry eye. CHO-1 demonstrated the best performance in improving ocular symptoms and reducing ocular staining in this heterogeneous study population. Keywords: dry eye syndromes, ophthalmic solutions, carmellose, hyaluronic acid

  8. Effects of Food on the Pharmacokinetics of Omega-3-Carboxylic Acids in Healthy Japanese Male Subjects: A Phase I, Randomized, Open-label, Three-period, Crossover Trial.

    Science.gov (United States)

    Shimada, Hitoshi; Nilsson, Catarina; Noda, Yoshinori; Kim, Hyosung; Lundström, Torbjörn; Yajima, Toshitaka

    2017-09-01

    Omega-3-carboxylic acids (OM3-CA) contain omega-3 free fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as carboxylic acids. Food intake is known to affect the bioavailability of ethyl ester fatty acid formulations. We conducted a phase I study to investigate the effects of the timing of OM3-CA administration relative to food intake on the pharmacokinetics of EPA and DHA. In this randomized, open-label, three-period crossover study, Japanese healthy male subjects were administered 4×1 g OM3-CA capsules with continued fasting, before a meal, or after a meal. All subjects fasted for ≥10 h prior to drug/meal administration. The primary objective was to examine the effect of meal timing on the pharmacokinetics of EPA and DHA after OM3-CA administration. The secondary objectives were to examine the safety and tolerability of OM3-CA. A total of 42 Japanese subjects was enrolled in the study. The baseline-adjusted maximum concentration and area under the concentration-time curve from 0 to 72 h for EPA, DHA, and EPA +DHA were lower in the fasting and before meal conditions than in the after meal condition. The maximum total EPA, total DHA, and total EPA+DHA concentrations were reached later when administered in fasting conditions than in fed conditions, indicating slower absorption in fasting conditions. Diarrhea was reported by five, six, and no subjects in the fasting, before meal, and after meal conditions, respectively. The timing of OM3-CA administration relative to food intake influences the systemic bioavailability of EPA and DHA in healthy Japanese male subjects. NCT02372344.

  9. The effect of dry needling on the radiating pain in subjects with discogenic low-back pain: A randomized control trial.

    Science.gov (United States)

    Mahmoudzadeh, Ashraf; Rezaeian, Zahra Sadat; Karimi, Abdolkarim; Dommerholt, Jan

    2016-01-01

    Disk herniation is the most common cause of radiating low back pain (LBP) in subjects under 60 years of age. The present study aims to compare the effect of dry needling (DN) and a standard conservative approach on the pain and function in subjects with discogenic radiating LBP. Fifty-eight subjects with discogenic radicular LBP were screened and randomized into control (Standard physical therapy, n = 29) and experimental group (Standard physical therapy and DN, n = 29). Radiating pain intensity and disability were measured using visual analog scale (VAS) and Oswestry Disability indices at baseline, at the end of treatment and 2 months after the last intervention session. The changes in pain intensity and disability were studied using a 3 × 2 repeated measures analysis of variance considering time as the within-subject factor and group as the between-subject. Pain intensity and disability scores decreased significantly in both experimental and control groups (experimental group: VAS = 37.24, Oswestry Disability Index [ODI] =28.48, control group: VAS = 45.5, ODI = 32.96), following the intervention. The change continued during the follow-up period (P < 0.001 for all comparisons). Pain and disability improvement, however, were more significant in experimental group, both in post intervention (experimental group: VAS = 25.17, ODI = 22.17, control group: VAS = 42.4, ODI = 30.27) (P = 0.05 and P = 0.03, respectively) and follow-up measures (P = 0.006 and P = 0.002, respectively). Both intervention strategies seem to significantly improve pain and disability immediately following intervention, where the improvement continued during 2 months after the last active intervention. Therefore, supplementary DN application may enhance the effect of the standard intervention considerably.

  10. The effect of dry needling on the radiating pain in subjects with discogenic low-back pain: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Ashraf Mahmoudzadeh

    2016-01-01

    Full Text Available Background: Disk herniation is the most common cause of radiating low back pain (LBP in subjects under 60 years of age. The present study aims to compare the effect of dry needling (DN and a standard conservative approach on the pain and function in subjects with discogenic radiating LBP. Materials and Methods: Fifty-eight subjects with discogenic radicular LBP were screened and randomized into control (Standard physical therapy, n = 29 and experimental group (Standard physical therapy and DN, n = 29. Radiating pain intensity and disability were measured using visual analog scale (VAS and Oswestry Disability indices at baseline, at the end of treatment and 2 months after the last intervention session. The changes in pain intensity and disability were studied using a 3 × 2 repeated measures analysis of variance considering time as the within-subject factor and group as the between-subject. Results: Pain intensity and disability scores decreased significantly in both experimental and control groups (experimental group: VAS = 37.24, Oswestry Disability Index [ODI] =28.48, control group: VAS = 45.5, ODI = 32.96, following the intervention. The change continued during the follow-up period (P < 0.001 for all comparisons. Pain and disability improvement, however, were more significant in experimental group, both in post intervention (experimental group: VAS = 25.17, ODI = 22.17, control group: VAS = 42.4, ODI = 30.27 (P = 0.05 and P = 0.03, respectively and follow-up measures (P = 0.006 and P = 0.002, respectively. Conclusion: Both intervention strategies seem to significantly improve pain and disability immediately following intervention, where the improvement continued during 2 months after the last active intervention. Therefore, supplementary DN application may enhance the effect of the standard intervention considerably.

  11. Efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with disorders of the spinal cord: A randomized double-blind controlled trial.

    Science.gov (United States)

    Taly, Arun B; Sivaraman Nair, Krishan P; Murali, Thyloth; John, Archana

    2004-10-01

    To study the efficacy of multiwavelength light therapy in the treatment of pressure ulcers in subjects with spinal cord disorders. Randomized controlled trial. Neurologic rehabilitation ward of a referral center in India. Thirty-five subjects with spinal cord injury, with 64 pressure ulcers (stage 2, n=55; stage 3, n=8; stage 4, n=1), were randomized into treatment and control groups. One subject refused consent. Mean duration of ulcers in the treatment group was 34.2+/-45.5 days and in the control group, 57.1+/-43.5 days. Treatment group received 14 sessions of multiwavelength light therapy, with 46 probes of different wavelengths from a gallium-aluminum-arsenide laser source, 3 times a week. Energy used was 4.5 J/cm(2). Ulcers in the control group received sham treatment. Healing of the ulcer, defined as the complete closure of the wound with healthy scar tissue, time taken for the ulcer to heal, and stage of the ulcer and Pressure Sore Status Tool score 14 days after last treatment. There was no significant difference in healing between the treatment and control groups. Eighteen ulcers in treatment group and 14 in control group healed completely ( P =.802). Mean time taken by the ulcers to heal was 2.45+/-2.06 weeks in the treatment group and 1.78+/-2.13 weeks in the control group ( P =.330). Time taken for stage 3 and 4 ulcers to reach stage 2 was 2.25+/-0.5 weeks in treatment group and 4.33+/-1.53 weeks in control group ( P =.047). Multiwavelength light therapy from a gallium-aluminum-arsenide laser source did not influence overall healing pressure ulcers. Limited evidence suggested that it improved healing of stage 3 and 4 pressure ulcers.

  12. Black tea consumption improves postprandial glycemic control in normal and pre-diabetic subjects: a randomized, double-blind, placebo-controlled crossover study.

    Science.gov (United States)

    Butacnum, Arisa; Chongsuwat, Rewadee; Bumrungpert, Akkarach

    2017-01-01

    Postprandial glycemic control is important for prevention of diabetes. Black tea consumption may improve postprandial glycemic control. The major bioactive compounds are polyphenols, black tea polymerized polyphenol (BTPP).This study examined the effect of black tea consumption on postprandial blood glucose and insulin response following sucrose loading in normal and pre-diabetes subjects. This study was a randomized, double-blind, placebo-controlled crossover study. Twenty-four subjects, male and female aged 20-60 years, normal and pre-diabetic, randomly ingested a sucrose solution with a low dose (110 mg BTPP), a high dose (220 mg BTPP) of black tea drink or a placebo drink (0 mg BTPP). Blood samples were collected at 0, 30, 60, 90, and 120 min from commencement of drink ingestion to measure blood glucose and insulin levels. The drink containing low dose and high dose BTPP significantly decreased incremental blood glucose area under the curve (AUC) after sucrose intake compared with placebo in the normal (T0-60 min 3,232±356 vs 3,295±312 vs 3,652±454 mg.min/dL; p=0.016) and pre-diabetic subjects (T0-60 min 2,554±395 vs 2,472±280 vs 2,888±502 mg.min/dL; p=0.048). There was no statistically significant difference of changes in insulin levels between the placebo and black tea groups (p>0.05). No significant differences in adverse effects were observed with the placebo, low dose and high dose of BTPP groups. Black tea consumption can decrease postprandial blood glucose after sucrose intake.

  13. The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

    Science.gov (United States)

    Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Jim, Heather S; Ramesar, Sophia; Alinat, Carissa B; Budhrani, Pinky H; Farias, Jerrica R; Shelton, Melissa M; Moscoso, Manolete S; Park, Jong Y; Kip, Kevin E

    2015-04-01

    The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p < 0.01). Small nonsignificant improvements were found in SSP in the MBSR(BC) group from baseline to 6 weeks (PSQI total score, p = 0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS. Copyright © 2014 John Wiley & Sons, Ltd.

  14. Small Amounts of Gluten in Subjects With Suspected Nonceliac Gluten Sensitivity: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial.

    Science.gov (United States)

    Di Sabatino, Antonio; Volta, Umberto; Salvatore, Chiara; Biancheri, Paolo; Caio, Giacomo; De Giorgio, Roberto; Di Stefano, Michele; Corazza, Gino R

    2015-09-01

    There is debate over the existence of nonceliac gluten sensitivity (NCGS) intestinal and extraintestinal symptoms in response to ingestion of gluten-containing foods by people without celiac disease or wheat allergy. We performed a randomized, double-blind, placebo-controlled, cross-over trial to determine the effects of administration of low doses of gluten to subjects with suspected NCGS. We enrolled 61 adults without celiac disease or a wheat allergy who believed ingestion of gluten-containing food to be the cause of their intestinal and extraintestinal symptoms. Participants were assigned randomly to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastrosoluble capsules. After a 1-week gluten-free diet, participants crossed over to the other group. The primary outcome was the change in overall (intestinal and extraintestinal) symptoms, determined by established scoring systems, between gluten and placebo intake. A secondary outcome was the change in individual symptom scores between gluten vs placebo. According to the per-protocol analysis of data from the 59 patients who completed the trial, intake of gluten significantly increased overall symptoms compared with placebo (P = .034). Abdominal bloating (P = .040) and pain (P = .047), among the intestinal symptoms, and foggy mind (P = .019), depression (P = .020), and aphthous stomatitis (P = .025), among the extraintestinal symptoms, were significantly more severe when subjects received gluten than placebo. In a cross-over trial of subjects with suspected NCGS, the severity of overall symptoms increased significantly during 1 week of intake of small amounts of gluten, compared with placebo. Clinical trial no: ISRCTN72857280. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

  15. The Effects of Mindfulness-Based Stress Reduction (MBSR(BC)) on Objective and Subjective Sleep Parameters in Women with Breast Cancer: A Randomized Controlled Trial

    Science.gov (United States)

    Lengacher, Cecile A.; Reich, Richard R.; Paterson, Carly L.; Jim, Heather S.; Ramesar, Sophia; Alinat, Carissa B.; Budhrani, Pinky H.; Farias, Jerrica R.; Shelton, Melissa M.; Moscoso, Manolete S.; Park, Jong Y.; Kip, Kevin E.

    2014-01-01

    Objective The purpose of this study was to investigate the effects of MBSR(BC) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). Methods Data were collected using a two-armed randomized controlled design among BCS enrolled in either a six week MBSR(BC) program or a Usual Care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) six week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburg Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, six weeks and 12 weeks after completing the MBSR(BC) or UC program. Results Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group vs. 74.6% UC group, p=0.04), percent of sleep time (81.0% MBSR(BC) vs. 77.4% UC, p=0.02) and less number waking bouts (93.5 in MBSR(BC) vs. 118.6 in the UC group, pMBSR(BC) group from baseline to 6 weeks (PSQI total score, p=0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. Conclusions These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS. PMID:24943918

  16. Presence of psychoactive substances in oral fluid from randomly selected drivers in Denmark

    DEFF Research Database (Denmark)

    Simonsen, K. Wiese; Steentoft, A.; Hels, Tove

    2012-01-01

    This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme stratified by time, season...... of narcotic drugs. It can be concluded that driving under the influence of drugs is as serious a road safety problem as drunk driving.......This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme stratified by time, season...

  17. Presence of psychoactive substances in oral fluid from randomly selected drivers in Denmark

    DEFF Research Database (Denmark)

    Simonsen, Kirsten Wiese; Steentoft, Anni; Hels, Tove

    2012-01-01

    This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme stratified by time, season....... It can be concluded that driving under the influence of drugs is as serious a road safety problem as drunk driving.......This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme stratified by time, season...

  18. Feature selection and classification of mechanical fault of an induction motor using random forest classifier

    Directory of Open Access Journals (Sweden)

    Raj Kumar Patel

    2016-09-01

    Full Text Available Fault detection and diagnosis is the most important technology in condition-based maintenance (CBM system for rotating machinery. This paper experimentally explores the development of a random forest (RF classifier, a recently emerged machine learning technique, for multi-class mechanical fault diagnosis in bearing of an induction motor. Firstly, the vibration signals are collected from the bearing using accelerometer sensor. Parameters from the vibration signal are extracted in the form of statistical features and used as input feature for the classification problem. These features are classified through RF classifiers for four class problems. The prime objective of this paper is to evaluate effectiveness of random forest classifier on bearing fault diagnosis. The obtained results compared with the existing artificial intelligence techniques, neural network. The analysis of results shows the better performance and higher accuracy than the well existing techniques.

  19. Acetyl-coenzyme A carboxylase inhibition reduces de novo lipogenesis in overweight male subjects: A randomized, double-blind, crossover study.

    Science.gov (United States)

    Stiede, Kathryn; Miao, Wenyan; Blanchette, Heather S; Beysen, Carine; Harriman, Geraldine; Harwood, H James; Kelley, Heather; Kapeller, Rosana; Schmalbach, Tess; Westlin, William F

    2017-08-01

    NDI-010976, an allosteric inhibitor of acetyl-coenzyme A carboxylases (ACC) ACC1 and ACC2, reduces hepatic de novo lipogenesis (DNL) and favorably affects steatosis, inflammation, and fibrosis in animal models of fatty liver disease. This study was a randomized, double-blind, placebo-controlled, crossover trial evaluating the pharmacodynamic effects of a single oral dose of NDI-010976 on hepatic DNL in overweight and/or obese but otherwise healthy adult male subjects. Subjects were randomized to receive either NDI-010976 (20, 50, or 200 mg) or matching placebo in period 1, followed by the alternate treatment in period 2; and hepatic lipogenesis was stimulated with oral fructose administration. Fractional DNL was quantified by infusing a stable isotope tracer, [1-13 C]acetate, and monitoring 13 C incorporation into palmitate of circulating very low-density lipoprotein triglyceride. Single-dose administration of NDI-010976 was well tolerated at doses up to and including 200 mg. Fructose administration over a 10-hour period stimulated hepatic fractional DNL an average of 30.9 ± 6.7% (mean ± standard deviation) above fasting DNL values in placebo-treated subjects. Subjects administered single doses of NDI-010976 at 20, 50, or 200 mg had significant inhibition of DNL compared to placebo (mean inhibition relative to placebo was 70%, 85%, and 104%, respectively). An inverse relationship between fractional DNL and NDI-010976 exposure was observed with >90% inhibition of fractional DNL associated with plasma concentrations of NDI-010976 >4 ng/mL. ACC inhibition with a single dose of NDI-010976 is well tolerated and results in a profound dose-dependent inhibition of hepatic DNL in overweight adult male subjects. Therefore, NDI-010976 could contribute considerable value to the treatment algorithm of metabolic disorders characterized by dysregulated fatty acid metabolism, including nonalcoholic steatohepatitis. (Hepatology 2017;66:324-334). © 2017 Nimbus Discovery, Inc

  20. Efficacy and tolerability of Meratrim for weight management: a randomized, double-blind, placebo-controlled study in healthy overweight human subjects.

    Science.gov (United States)

    Kudiganti, Venkateshwarlu; Kodur, Raveendra Ramamurthy; Kodur, Sushma Raveendra; Halemane, Manjunath; Deep, Dheeraj Kumar

    2016-08-24

    Meratrim is a blend of two plant extracts obtained from Sphaeranthus indicus flower heads and Garcinia mangostana fruit rinds. Previous studies have demonstrated that Meratrim is effective for weight management in obese individuals. The objective of this study was to assess the efficacy and tolerability of Meratrim in managing body weight in healthy overweight subjects. Sixty participants with a mean BMI of 28.3 kg/m(2) were randomized into two groups receiving either 400 mg of Meratrim twice daily or two identical placebo capsules for a period of 16 weeks. Subjects were asked to consume about 2,000 kcal/day throughout the study period and walk 5 days a week for 30 min daily. The primary endpoint was defined as the change in body weight from baseline to end of week 16 for the Meratrim group versus placebo. Fifty seven subjects completed the trial. At study conclusion, statistically significant reductions in body weight (5.09 vs. 1.1 kg; p 38 vs. 5.11 cm; p nic.in.

  1. Persistent effects of cognitive-behavioral stress management on cortisol responses to acute stress in healthy subjects--a randomized controlled trial.

    Science.gov (United States)

    Hammerfald, K; Eberle, C; Grau, M; Kinsperger, A; Zimmermann, A; Ehlert, U; Gaab, J

    2006-04-01

    Psychosocial stress leads to a release of cortisol. While this psychoneuroendocrine response helps to maintain physiological as well as psychological equilibrium under stress, exaggerated secretion of cortisol has been shown to have negative effects on somatic health and cognitive functioning. The study set out to examine the long-term effects of cognitive-behavioral stress management training on cortisol stress responses in healthy men and women. Eighty-three healthy subjects were randomly assigned to cognitive-behavioral stress management (CBSM) training or a control condition. Four months after the CBSM, 76 subjects underwent a standardized psychosocial stress test. Salivary cortisol responses were assessed repeatedly before and after the stress test. Subjects in the CBSM group showed significantly reduced cortisol stress responses. With regard to gender, this effect was observed in both men and women. However, the magnitude of the CBSM effect on cortisol responses was smaller in women than in men. Use of oral contraceptives in women influenced the cortisol response, but did not have an impact on the CBSM effect on cortisol. The results show that the previously reported attenuation of cortisol stress responses through CBSM persists and are observable in both men and women. Since stress-induced alterations of hypothalamus pituitary adrenal axis functioning are discussed to be involved in the onset and maintenance of both somatic and psychiatric conditions, similar interventions could be used for prevention and therapy of these detrimental stress effects.

  2. Effects of 8-Week Hatha Yoga Training on Metabolic and Inflammatory Markers in Healthy, Female Chinese Subjects: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Neng Chen

    2016-01-01

    Full Text Available We aimed to determine the effects of an 8 wk Hatha yoga training on blood glucose, insulin, lipid profiles, endothelial microparticles (EMPs, and inflammatory status in healthy, lean, and female Chinese subjects. A total of 30 healthy, female Chinese subjects were recruited and randomized into control or yoga practice group. The yoga practice included 8 wks of yoga practice (2 times/wk for a total of 16 times. Fasting blood samples were collected before and after yoga training. Plasma was isolated for the measurement of lipid profiles, glucose, insulin, EMPs, and inflammatory cytokines. Whole blood was cultured ex vivo and stimulated with lipopolysaccharide (LPS and Pam3Cys-SK4. Peripheral blood mononuclear cells (PBMCs were isolated for the measurement of TLR2 and TLR4 protein expression. Yoga practice significantly reduced plasma cholesterol, LDL-cholesterol, insulin levels, and CD31+/CD42b− EMPs. Cultured whole blood from the yoga group has reduced proinflammatory cytokines secretion both at unstimulated condition and when stimulated with Pam3Cys-SK4; this might be associated with reduced TLR2 protein expression in PBMCs after yoga training. Hatha yoga practice in healthy Chinese female subjects could improve hallmarks related to MetS; thus it can be considered as an ancillary intervention in the primary MetS prevention for the healthy population. This trial is registered with ChiCTR-IOR-14005747.

  3. Selective nerve root blocks vs. caudal epidural injection for single level prolapsed lumbar intervertebral disc - A prospective randomized study.

    Science.gov (United States)

    Singh, Sudhir; Kumar, Sanjiv; Chahal, Gaurav; Verma, Reetu

    2017-01-01

    Chronic lumbar radiculopathy has a lifetime prevalence of 5.3% in men and 3.7% in women. It usually resolves spontaneously, but up to 30% cases will have pronounced symptoms even after one year. A prospective randomized single-blind study was conducted to compare the efficacy of caudal epidural steroid injection and selective nerve root block in management of pain and disability in cases of lumbar disc herniation. Eighty patients with confirmed single-level lumbar disc herniation were equally divided in two groups: (a) caudal epidural and (b) selective nerve root block group, by a computer-generated random allocation method. The caudal group received three injections of steroid mixed with local anesthetics while selective nerve root block group received single injection of steroid mixed with local anesthetic agent. Patients were assessed for pain relief and reduction in disability. In SNRB group, pain reduced by more than 50% up till 6 months, while in caudal group more than 50% reduction of pain was maintained till 1 year. The reduction in ODI in SNRB group was 52.8% till 3 months, 48.6% till 6 months, and 46.7% at 1 year, while in caudal group the improvement was 59.6%, 64.6%, 65.1%, and 65.4% at corresponding follow-up periods, respectively. Caudal epidural block is an easy and safe method with better pain relief and improvement in functional disability than selective nerve root block. Selective nerve root block injection is technically more demanding and has to be given by a skilled anesthetist.

  4. A comparison of the effects of random and selective mass extinctions on erosion of evolutionary history in communities of digital organisms.

    Directory of Open Access Journals (Sweden)

    Gabriel Yedid

    Full Text Available The effect of mass extinctions on phylogenetic diversity and branching history of clades remains poorly understood in paleobiology. We examined the phylogenies of communities of digital organisms undergoing open-ended evolution as we subjected them to instantaneous "pulse" extinctions, choosing survivors at random, and to prolonged "press" extinctions involving a period of low resource availability. We measured age of the phylogenetic root and tree stemminess, and evaluated how branching history of the phylogenetic trees was affected by the extinction treatments. We found that strong random (pulse and strong selective extinction (press both left clear long-term signatures in root age distribution and tree stemminess, and eroded deep branching history to a greater degree than did weak extinction and control treatments. The widely-used Pybus-Harvey gamma statistic showed a clear short-term response to extinction and recovery, but differences between treatments diminished over time and did not show a long-term signature. The characteristics of post-extinction phylogenies were often affected as much by the recovery interval as by the extinction episode itself.

  5. Inference of selection and random effects in the house mouse hybrid zone

    Czech Academy of Sciences Publication Activity Database

    Dufková, Petra; Macholán, Miloš; Piálek, Jaroslav

    2011-01-01

    Roč. 65, č. 4 (2011), s. 993-1010 ISSN 0014-3820 R&D Projects: GA ČR GA206/08/0640; GA AV ČR IAA600930506; GA MŠk LC06073 Institutional research plan: CEZ:AV0Z60930519; CEZ:AV0Z50450515 Keywords : cline analysis * Mus musculus * reproductive isolation * speciation * X chromosome Subject RIV: EG - Zoology Impact factor: 5.146, year: 2011

  6. Why School Students Choose and Reject Science: A Study of the Factors That Students Consider When Selecting Subjects

    Science.gov (United States)

    Palmer, Tracey-Ann; Burke, Paul F.; Aubusson, Peter

    2017-01-01

    Student study of science at school has been linked to the need to provide a scientifically capable workforce and a scientifically literate society. Educators, scientists, and policymakers are concerned that too few students are choosing science for study in their final years of school. How and why students choose and reject certain subjects,…

  7. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole.

    Science.gov (United States)

    Belhocine, Kafia; Vavasseur, Fabienne; Volteau, Christelle; Flet, Laurent; Touchefeu, Yann; Bruley des Varannes, Stanislas

    2014-07-15

    Obesity is associated with a risk of gastroesophageal reflux disease. The pharmacodynamic efficacy of proton pump inhibitors has not been specifically evaluated in obese subjects. The aim of this study was to compare the antisecretory response to a single oral dose of 20 mg rabeprazole, 20 mg omeprazole and placebo in obese subjects. Gastric pH was monitored for 24 hours on three separate occasions in eighteen H. pylori-negative, asymptomatic obese subjects. Subjects were given omeprazole, rabeprazole or placebo in a randomized order and in a double-blind fashion. The main analysis criterion was 24-h percent of time post dose with intragastric pH above 3; secondary criteria were percentage of time above pH 4, median pH, [H+] concentrations and nocturnal acid breakthrough (NAB). Results were analyzed using linear mixed models and Wilks test comparing variances. 24-h median [IQ] percentages of time with gastric pH above 3 and 4 were higher with rabeprazole than omeprazole (46 [37-55] vs. 30 [15-55] %, 9 [5-11] % for placebo) but the differences did not reach statistical significance (p = 0.11 and 0.24, respectively). Median acid concentrations were significantly lower with rabeprazole than with omeprazole and placebo (22 [14-53] vs. 54 [19-130] and 95 [73-170] mmoles/l, p omeprazole (median 1 [1,2] vs. 2 [1-3], p = 0.04). Variances of 24-h data (pH above 3 and 4, median pH, [H+] concentrations) were significantly lower with rabeprazole than with omeprazole (p omeprazole was strong and not significantly different between drugs despite a significantly more homogeneous response with rabeprazole. ClinicalTrial.gov: NCT01136317.

  8. The effects of morphine-neostigmine and secretin provocation on pancreaticobiliary morphology in healthy subjects: a randomized, double-blind crossover study using serial MRCP.

    Science.gov (United States)

    Chowdhury, Abeed H; Humes, David J; Pritchard, Susan E; Marciani, Luca; Gowland, Penny A; Simpson, John; Lobo, Dileep N

    2011-09-01

    Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP) is used for the diagnosis of sphincter of Oddi dysfunction (SOD), but it does not correlate well with sphincter of Oddi manometry. Serial MRCP following morphine-neostigmine provocation may be of value in the assessment of SOD, but the effects of these pharmacological agents on pancreaticobiliary morphology in healthy subjects have not been studied. The aim of the present study was to use serial MRCP to characterize the effects of morphine-neostigmine and secretin provocation on serum pancreatic enzyme responses and pancreaticobiliary ductal morphology in healthy subjects. Following a baseline scan and serum lipase and amylase assays, 10 healthy subjects were randomized in a double-blind manner to receive morphine (10 mg intramuscularly [IM]), neostigmine (1 mg IM) and saline (intravenously [IV]); OR saline (IM), saline (IM) and secretin (1 U/kg IV). A MRCP study was performed at 5, 30, 60, 90, 120, 150, and 180 min thereafter, with blood samples taken every 60 min for 4 h. Pancreatic duct (PD) diameter, visible PD length, common bile duct (CBD) diameter, and gallbladder volume were recorded. Crossover studies were performed 10 days later. Serum pancreatic enzyme concentrations were significantly greater (amylase, P = 0.003; lipase, P = 0.04) after morphine-neostigmine than after secretin. Following morphine-neostigmine and secretin provocation, the mean (SEM) percentage increase in PD diameter was 28.7 (7.2) versus 12.9 (3.3); P < 0.0001, and visible PD length was 49.4 (11.5) versus 28.1 (8.2); P < 0.0001, respectively. The effects of morphine-neostigmine were more pronounced than those of secretin in healthy subjects. The diagnostic utility of morphine-neostigmine stimulated serial MRCP for SOD merits further evaluation.

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

    Directory of Open Access Journals (Sweden)

    Nicholas Brown

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

  10. Specific and selective probes for Staphylococcus aureus from phage-displayed random peptide libraries.

    Science.gov (United States)

    De Plano, Laura M; Carnazza, Santina; Messina, Grazia M L; Rizzo, Maria Giovanna; Marletta, Giovanni; Guglielmino, Salvatore P P

    2017-09-01

    Staphylococcus aureus is a major human pathogen causing health care-associated and community-associated infections. Early diagnosis is essential to prevent disease progression and to reduce complications that can be serious. In this study, we selected, from a 9-mer phage peptide library, a phage clone displaying peptide capable of specific binding to S. aureus cell surface, namely St.au9IVS5 (sequence peptide RVRSAPSSS).The ability of the isolated phage clone to interact specifically with S. aureus and the efficacy of its bacteria-binding properties were established by using enzyme linked immune-sorbent assay (ELISA). We also demonstrated by Western blot analysis that the most reactive and selective phage peptide binds a 78KDa protein on the bacterial cell surface. Furthermore, we observed selectivity of phage-bacteria-binding allowing to identify clinical isolates of S. aureus in comparison with a panel of other bacterial species. In order to explore the possibility of realizing a selective bacteria biosensor device, based on immobilization of affinity-selected phage, we have studied the physisorbed phage deposition onto a mica surface. Atomic Force Microscopy (AFM) was used to determine the organization of phage on mica surface and then the binding performance of mica-physisorbed phage to bacterial target was evaluated during the time by fluorescent microscopy. The system is able to bind specifically about 50% of S. aureus cells after 15' and 90% after one hour. Due to specificity and rapidness, this biosensing strategy paves the way to the further development of new cheap biosensors to be used in developing countries, as lab-on-chip (LOC) to detect bacterial agents in clinical diagnostics applications. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Selection of locations of knots for linear splines in random regression test-day models.

    Science.gov (United States)

    Jamrozik, J; Bohmanova, J; Schaeffer, L R

    2010-04-01

    Using spline functions (segmented polynomials) in regression models requires the knowledge of the location of the knots. Knots are the points at which independent linear segments are connected. Optimal positions of knots for linear splines of different orders were determined in this study for different scenarios, using existing estimates of covariance functions and an optimization algorithm. The traits considered were test-day milk, fat and protein yields, and somatic cell score (SCS) in the first three lactations of Canadian Holsteins. Two ranges of days in milk (from 5 to 305 and from 5 to 365) were taken into account. In addition, four different populations of Holstein cows, from Australia, Canada, Italy and New Zealand, were examined with respect to first lactation (305 days) milk only. The estimates of genetic and permanent environmental covariance functions were based on single- and multiple-trait test-day models, with Legendre polynomials of order 4 as random regressions. A differential evolution algorithm was applied to find the best location of knots for splines of orders 4 to 7 and the criterion for optimization was the goodness-of-fit of the spline covariance function. Results indicated that the optimal position of knots for linear splines differed between genetic and permanent environmental effects, as well as between traits and lactations. Different populations also exhibited different patterns of optimal knot locations. With linear splines, different positions of knots should therefore be used for different effects and traits in random regression test-day models when analysing milk production traits.

  12. Reversal of apixaban anticoagulation by four-factor prothrombin complex concentrates in healthy subjects: a randomized three-period crossover study.

    Science.gov (United States)

    Song, Y; Wang, Z; Perlstein, I; Wang, J; LaCreta, F; Frost, R J A; Frost, C

    2017-11-01

    Essentials Prothrombin complex concentrates (PCCs) may reverse the effect of factor Xa (FXa) inhibitors. We conducted an open-label, randomized, placebo-controlled, three-period crossover study in 15 subjects. Both PCCs rapidly reversed apixaban-mediated decreases in mean endogenous thrombin potential. Four-factor PCC administration had no effect on apixaban pharmacokinetics or anti-FXa activity. Background Currently, there is no approved reversal agent for direct activated factor Xa (FXa) inhibitors; however, several agents are under investigation, including prothrombin complex concentrates (PCCs). Objective This open-label, randomized, placebo-controlled, three-period crossover study assessed the effect of two four-factor PCCs on apixaban pharmacodynamics and pharmacokinetics in 15 healthy subjects. Methods Subjects received apixaban 10 mg twice daily for 3 days. On day 4, 3 h after apixaban, subjects received a 30-min infusion of 50 IU kg-1 Cofact, Beriplex P/N (Beriplex), or saline. Change in endogenous thrombin potential (ETP), measured with a thrombin generation assay (TGA), was the primary endpoint. Secondary endpoints included changes in other TGA parameters, prothrombin time (PT), International Normalized Ratio (INR), activated partial thromboplastin time, anti-FXa activity, apixaban pharmacokinetics, and safety. Results Apixaban-related changes in ETP and several other pharmacodynamic measures occurred following apixaban administration. Both PCCs reversed apixaban's effect on ETP; the differences in adjusted mean change from pre-PCC baseline to end of infusion were 425 nm min (95% confidence interval [CI] 219.8-630.7 nm min; P 0.05) for Beriplex. Both PCCs returned ETP to pre-apixaban baseline levels 4 h after PCC infusion, versus 45 h for placebo. For both PCCs, mean ETP peaked 21 h after PCC initiation, and then slowly decreased over the following 48 h. Both PCCs reversed apixaban's effect on TGA peak height, PT, and INR. Apixaban pharmacokinetic and

  13. Outcomes are not different for patient-matched vs. non-matched treatment in subjects with chronic, recurrent low back pain: a randomized clinical trial

    Science.gov (United States)

    Henry, Sharon M.; Van Dillen, Linda; Ouellette-Morton, Rebecca H.; Hitt, Juvena R.; Lomond, Karen V.; DeSarno, Michael J.; Bunn, Janice Y.

    2014-01-01

    Background Classification schemas for low back pain (LBP), such as the Treatment Based Classification and the Movement System Impairment schemas, use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes. Purpose To assess if providing matched treatments based on patient specific clinical features led to superior treatment outcomes compared to an unmatched treatment for subjects with chronic, recurrent LBP. Study Design A randomized controlled trial. Patient Sample Subjects (n=124) with LBP (≥ 12 months) with or without recurrences underwent a standardized clinical exam to group them into one of 2 strata: (1) ineligible or (2) eligible for stabilization exercises based on the Treatment Based Classification schema. Subjects underwent additional clinical tests to assign them to one of the 5 possible Movement System Impairment categories. Outcome Measures Questionnaires were collected electronically at: Week 0, prior to treatment; Week 7 (following the 6 weekly, one hour treatment sessions); and 12 months. Using the Oswestry Disability Index (0-100) and the Numeric Pain Rating Scale (0-10), the primary analysis was performed using the intention-to-treat principle. Secondary outcomes included fear-avoidance beliefs as well as psychosocial, work related and general health status. Methods After subjects were categorized based on their particular clinical features using both the Treatment Based Classification and Movement System Impairment schemas, they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments. The treatments were (1) trunk stabilization exercise, or (2) Movement System Impairment-directed exercises. The study was funded by National Institutes of Health (NCMRR/R01HD040909; $1,485,000). There are no study specific conflicts of interest to report. Results Of the patients allocated to treatment for this study, 76 received a matched treatment and 25 received an unmatched

  14. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    Science.gov (United States)

    Ruffini, Nuria; D'Alessandro, Giandomenico; Mariani, Nicolò; Pollastrelli, Alberto; Cardinali, Lucia; Cerritelli, Francesco

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-armed randomized placebo controlled within subject cross-over single blinded study. Participants were asymptomatic adults (26.7 ± 8.4 y, 51% male, BMI 18.5 ± 4.8), both smokers and non-smokers and not on medications. At enrollment subjects were randomized in three groups: A, B, C. Standardized structural evaluation followed by a patient need-based osteopathic treatment was performed in the first session of group A and in the second session of group B. Standardized evaluation followed by a protocoled sham treatment was provided in the second session of group A and in the first session of group B. No intervention was performed in the two sessions of group C, acting as a time-control. The trial was registered on clinicaltrials.gov identifier: NCT01908920. Main Outcomes Measures: HRV was calculated from electrocardiography before, during and after the intervention, for a total amount time of 25 min and considering frequency domain as well as linear and non-linear methods as outcome measures. Results: OMT engendered a statistically significant increase of parasympathetic activity, as shown by High Frequency power (p < 0.001), expressed in normalized and absolute unit, and possibly decrease of sympathetic activity, as revealed by Low Frequency power (p < 0.01); results also showed a reduction of Low Frequency/High Frequency ratio (p < 0.001) and Detrended fluctuation scaling exponent (p < 0.05). Conclusions: Findings suggested that OMT can influence ANS activity increasing

  15. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: a randomized controlled trial.

    Science.gov (United States)

    Albornoz-Cabello, Manuel; Maya-Martín, Julián; Domínguez-Maldonado, Gabriel; Espejo-Antúnez, Luis; Heredia-Rizo, Alberto Marcos

    2017-02-01

    To assess the short-term efficacy of transregional interferential current therapy on pain perception and disability level in chronic non-specific low back pain. A randomized, single-blinded (the assessor collecting the outcome data was blinded), controlled trial. A private physiotherapy research clinic. A total of 64 individuals, 20 men and 44 women, mean (SD) age was 51 years (11.93), with low back pain of more than three months, with or without pain radiating to the lower extremities above the knee, were distributed into a control ( n = 20) or an experimental group ( n = 44). A 2:1 randomization ratio was used in favour of the latter. A transregional interferential current electrotherapy protocol was performed for participants in the experimental group, while the control group underwent a 'usual care' treatment (massage, mobilization and soft-tissue techniques). All subjects received up to 10 treatment sessions of 25 minutes over a two-week period, and completed the intervention and follow-up evaluations. Self-perceived pain was assessed with a Visual Analogue Scale. Secondary measure included the Oswestry Low Back Disability Index. Evaluations were collected at baseline and after the intervention protocol. Significant between-group differences were found for interferential current therapy on pain perception ( p = 0.032) and disability level ( p = 0.002). The observed differences in the between-group mean changes were of 11.34 mm (1.77/20.91) and 13.38 points (4.97/21.78), respectively. A two-week transregional interferential current treatment has shown significant short-term efficacy, when compared with a 'usual care' protocol, on self-perceived pain and functionality in subjects with chronic low back pain.

  16. A randomized, controlled study of specific immunotherapy in monosensitized subjects with seasonal rhinitis: effect on bronchial hyperresponsiveness, sputum inflammatory markers and development of asthma symptoms.

    Science.gov (United States)

    Crimi, Nunzio; Li Gotti, Fabrizio; Mangano, Giuseppe; Paolino, Giuseppina; Mastruzzo, Claudio; Vancheri, Carlo; Lisitano, Natalina; Polosa, Riccardo

    2004-01-01

    Allergic rhinitis is often associated with bronchial hyperresponsiveness (BHR) and airway inflammation, and it seems to be an important risk factor for the development of asthma. Specific immunotherapy (SIT) reduces symptoms and medication requirements in subjects with allergic rhinitis, but the mechanisms by which SIT promotes these beneficial effects are less clear. We have investigated the effects of Parietaria-SIT on rhinitis symptoms, BHR to inhaled methacholine, eosinophilic inflammation and cytokine production (interferon gamma and interleukin-4) in the sputum. The effect on asthma progression was also examined. Thirty non-asthmatic subjects with seasonal rhinitis and monosensitized to Parietaria judaica participated in a randomized, double-blind, placebo-controlled, parallel group study. Participants were randomly assigned to receive injections of a Parietaria pollen vaccine (n = 15) or matched placebo injections (n = 15) in a rapid updosing cluster regimen for 7 weeks, followed by monthly injections for 34 months. Throughout the 3-year study we collected data on symptoms and medication score, airway responsiveness to methacholine, eosinophilia and soluble cytokines in sputum, followed by a complete evaluation of the clinical course of atopy. Hay fever symptom and medication scores were well controlled by SIT. By the end of the study, in the placebo group, symptom and medication scores significantly increased by a median (interquartile range) of 121% (15-280%) and 263% (0-4400%) respectively (p Parietaria-SIT is effective in controlling hay fever symptoms and rescue medications, but no changes in the BHR to methacholine or sputum eosinophilia were observed. Moreover, Parietaria-SIT appears to prevent the natural progression of allergic rhinitis to asthma, suggesting that SIT should be considered earlier in the management of this condition.

  17. Short-term effect of spinal manipulation on pain perception, spinal mobility, and full height recovery in male subjects with degenerative disk disease: a randomized controlled trial.

    Science.gov (United States)

    Vieira-Pellenz, Felipe; Oliva-Pascual-Vaca, Angel; Rodriguez-Blanco, Cleofás; Heredia-Rizo, Alberto Marcos; Ricard, François; Almazán-Campos, Ginés

    2014-09-01

    To evaluate the short-term effect on spinal mobility, pain perception, neural mechanosensitivity, and full height recovery after high-velocity, low-amplitude (HVLA) spinal manipulation (SM) in the lumbosacral joint (L5-S1). Randomized, double-blind, controlled clinical trial with evaluations at baseline and after intervention. University-based physical therapy research clinic. Men (N=40; mean age ± SD, 38 ± 9.14 y) with diagnosed degenerative lumbar disease at L5-S1 were randomly divided into 2 groups: a treatment group (TG) (n=20; mean age ± SD, 39 ± 9.12 y) and a control group (CG) (n=20; mean age ± SD, 37 ± 9.31 y). All participants completed the intervention and follow-up evaluations. A single L5-S1 SM technique (pull-move) was performed in the TG, whereas the CG received a single placebo intervention. Measures included assessing the subject's height using a stadiometer. The secondary outcome measures included perceived low back pain, evaluated using a visual analog scale; neural mechanosensitivity, as assessed using the passive straight-leg raise (SLR) test; and amount of spinal mobility in flexion, as measured using the finger-to-floor distance (FFD) test. The intragroup comparison indicated a significant improvement in all variables in the TG (Pperceived pain, spinal mobility in flexion, hip flexion during the passive SLR test, and subjects' full height. Future studies should include women and should evaluate the long-term results. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  18. Effect of phytosterols and inulin-enriched soymilk on LDL-cholesterol in Thai subjects: a double-blinded randomized controlled trial.

    Science.gov (United States)

    Kietsiriroje, Noppadol; Kwankaew, Jirateep; Kitpakornsanti, Sunita; Leelawattana, Rattana

    2015-11-09

    Hypercholesterolemia, particularly high LDL-c and non-HDL-c levels, is a traditional risk for cardiovascular disease. Ingestion of diets containing phytosterols and inulin can reduce plasma LDL-c and triglyceride levels, respectively. Phytosterols and inulin-enriched soymilk may be an alternative for a supplemental diet to improve both LDL-c and non-HDL-c to reduce the risk of cardiovascular disease. Two hundred and forty subjects who were 18 years old or older and had a baseline LDL-c of 130 mg/dl or higher were enrolled into the double-blinded randomized controlled trial study. Subjects were randomly assigned into the study group that received 2 g/day of phytosterols and 10 g/day of inulin-enriched soymilk or into the control group that received standard soymilk. The lipid profile was measured every 2 weeks for 8 weeks. Primary outcomes were 1) to determine the LDL-c reduction after consumption of phytosterols and inulin-enriched soymilk for 8 weeks and 2) to compare the difference of the LDL-c levels between the study and control groups. The secondary outcomes were to compare the difference of TC, TG and HDL-c between the study and control groups. At the end of the study, the median LDL-c levels decreased significantly from 165 (132, 254) mg/dl to 150 (105, 263) mg/dl in the study group (p inulin reduced TC and LDL-c better than standard soymilk. It had no effect on TG and HDL-c levels compared to standard soymilk. Both soymilk products were comparably safe. Thai Clinical Trial Registry: TCTR20150417001 date: April 17, 2015.

  19. Glucosamine-containing supplement improves locomotor functions in subjects with knee pain a randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Kanzaki N

    2015-10-01

    Full Text Available Noriyuki Kanzaki,1 Yoshiko Ono,1 Hiroshi Shibata,1 Toshio Moritani2 1Institute for Health Care Science, Suntory Wellness Ltd, Seika-cho, Soraku-gun, 2Graduate School of Human and Environmental Studies, Kyoto University, Sakyo-ku, Kyoto, Japan Background: The aim of this study was to investigate the ability of a glucosamine-containing supplement to improve locomotor functions in subjects with knee pain.Methods: A randomized, double-blind, placebo-controlled, parallel-group comparative study was conducted for 16 weeks in 100 Japanese subjects (age, 51.8±0.8 years with knee pain. Subjects were randomly assigned to one of the two supplements containing 1 1,200 mg of glucosamine hydrochloride, 60 mg of chondroitin sulfate, 45 mg of type II collagen peptides, 90 mg of quercetin glycosides, 10 mg of imidazole peptides, and 5 µg of vitamin D per day (GCQID group, n=50 or 2 a placebo (placebo group, n=50. Japanese Knee Osteoarthritis Measure, visual analog scale score, normal walking speed, and knee-extensor strength were measured to evaluate the effects of the supplement on knee-joint functions and locomotor functions.Results: In subjects eligible for efficacy assessment, there was no significant group × time interaction, and there were improvements in knee-joint functions and locomotor functions in both groups, but there was no significant difference between the groups. In subjects with mild-to-severe knee pain at baseline, knee-extensor strength at week 8 (104.6±5.0% body weight vs 92.3±5.5% body weight, P=0.030 and the change in normal walking speed at week 16 (0.11±0.03 m/s vs 0.05±0.02 m/s, P=0.038 were significantly greater in the GCQID group than in the placebo group. Further subgroup analysis based on Kellgren–Lawrence (K–L grade showed that normal walking speed at week 16 (1.36±0.05 m/s vs 1.21±0.02 m/s, P<0.05 was significantly greater in the GCQID group than in the placebo group in subjects with K–L grade I. No

  20. Effects of a program to prevent social isolation on loneliness, depression, and subjective well-being of older adults: a randomized trial among older migrants in Japan.

    Science.gov (United States)

    Saito, Tami; Kai, Ichiro; Takizawa, Ayako

    2012-01-01

    Social isolation among the elderly is a concern in developed countries. Using a randomized trial, this study examined the effect of a social isolation prevention program on loneliness, depression, and subjective well-being of the elderly in Japan. Among the elderly people who relocated to suburban Tokyo, 63 who responded to a pre-test were randomized and assessed 1 and 6 months after the program. Four sessions of a group-based program were designed to prevent social isolation by improving community knowledge and networking with other participants and community "gatekeepers." The Life Satisfaction Index A (LSI-A), Geriatric Depression Scale (GDS), Ando-Osada-Kodama (AOK) loneliness scale, social support, and other variables were used as outcomes of this study. A linear mixed model was used to compare 20 of the 21 people in the intervention group to 40 of the 42 in the control group, and showed that the intervention program had a significant positive effect on LSI-A, social support, and familiarity with services scores and a significant negative effect on AOK over the study period. The program had no significant effect on depression. The findings of this study suggest that programs aimed at preventing social isolation are effective when they utilize existing community resources, are tailor-made based on the specific needs of the individual, and target people who can share similar experiences. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. The effect of nano-curcumin on HbA1c, fasting blood glucose, and lipid profile in diabetic subjects: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hamid Reza Rahimi

    2016-08-01

    Full Text Available Objective: Diabetes mellitus is defined as a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both or insulin resistance. Curcumin inhibits NF-κB signaling pathway. The aim of this study is evaluation of the effect of Nano-curcumin on HbA1C, fast blood glucose and lipid profile in diabetic patients. Materials and Methods: Seventy type-2 diabetic patients (fasting blood glucose (FBG ≥ 126 mg/dL or 2-hr postprandial blood glucose ≥200 mg/dl randomly receivedeither Curcumin (as nano-micelle 80 mg/day or placebo for 3 months in a double blind randomized clinical trial. Fasting blood glucose, HbA1C, and lipids profile were checked before and after the intervention. Data analyses, including parametric and nonparametric tests were done using the SPSS 11.5 software. A p value < 0.05 was regarded as statistically significant. (RCT registration code: IRCT2013081114330N1 Results: Mean age, BMI, FBG, total cholesterol (TC, triglyceride (TG, LDL, HDL, HbA1c , and  sex and had no significant difference at the baseline between the groups. In Nano-curcumin group, a significant decrease was found in HbA1C, FBG, TG, and BMI comparing results of each subject before and after the treatment (p

  2. A randomized, double-blind, placebo-controlled study evaluating the effects of quercetin-rich onion on cognitive function in elderly subjects

    Directory of Open Access Journals (Sweden)

    Mie Nishimura

    2017-05-01

    Full Text Available Background: Quercetin, a phenolic compound, exhibits various functional effectsthat includeanti-oxidant, anti-dyslipidemic, and anti-dysglycemic activities, in addition tobeneficial effects on cognitive function. We evaluated the effects of a powder made from quercetin-rich onions (‘Quergold’ and ‘Sarasara-gold’ on cognitive function.Methods:In this randomized, double-blind, placebo-controlled study, we randomized 50 adults (25 males and 25 females, aged 65–84 years and made them consume products made from quercetin-rich (active test food group or quercetin-free(placebo food group onions. Cognitive function,hematological, and biological examinations were performed at the beginning (week 0 of the study and at weeks 12 and 24 after the start of the study. Results:There were no differences in the Mini-Mental State Examination (MMSE and cognitive impairment rating scale scores between the two groups. However, in younger subjects, the MMSE scores were significantly higher in the active test food group than in the placebo food group at week 24 (p = 0.019. Conclusion: These results suggest that the ingestion of quercetin-rich onions improves cognitive function and reduce cognitive declinein elderly people.

  3. Selected elements of socio-demographic status and lifestyle as factors determining subjective assessment of life in women after mastectomy

    OpenAIRE

    Skrzypczak, Magdalena; Czerniak, Urszula; ?aski, Piotr

    2013-01-01

    Aim of the study The main objective of the study is to specify whether socio-demographic factors and physical activity result in differences in subjective assessment of life in women diagnosed with breast cancer. Material and methods The study group consisted of 145 women who had been diagnosed with breast cancer. The women had undergone radical surgery, chemotherapy and radiotherapy. The participants filled in an anonymous questionnaire which contained a number of detailed questions relating...

  4. Electronic Grey Literature in Accelerator Science and Its Allied Subjects : Selected Web Resources for Scientists and Engineers

    CERN Document Server

    Rajendiran, P

    2006-01-01

    Grey literature Web resources in the field of accelerator science and its allied subjects are collected for the scientists and engineers of RRCAT (Raja Ramanna Centre for Advanced Technology). For definition purposes the different types of grey literature are described. The Web resources collected and compiled in this article (with an overview and link for each) specifically focus on technical reports, preprints or e-prints, which meet the main information needs of RRCAT users.

  5. Selected Gauteng secondary school learners’ lived experiences of Life Orientation and the fulfilment of its outcomes as a school subject

    OpenAIRE

    2013-01-01

    D.Ed. (Educational Psychology) Through quality education for all, learners will be able to reach their full potential and will be able to “meaningfully contribute to and participate in that society throughout their lives” (Department of Education, 1997, p.11). To facilitate this process, Life Orientation (LO) has been introduced as a compulsory subject in grades 8 to 12 and, according to the National Curriculum Statement, it will be “guiding learners to develop their full potential in all ...

  6. Subject-specific abnormal region detection in traumatic brain injury using sparse model selection on high dimensional diffusion data.

    Science.gov (United States)

    Shaker, Matineh; Erdogmus, Deniz; Dy, Jennifer; Bouix, Sylvain

    2017-04-01

    We present a method to estimate a multivariate Gaussian distribution of diffusion tensor features in a set of brain regions based on a small sample of healthy individuals, and use this distribution to identify imaging abnormalities in subjects with mild traumatic brain injury. The multivariate model receives apriori knowledge in the form of a neighborhood graph imposed on the precision matrix, which models brain region interactions, and an additional L1 sparsity constraint. The model is then estimated using the graphical LASSO algorithm and the Mahalanobis distance of healthy and TBI subjects to the distribution mean is used to evaluate the discriminatory power of the model. Our experiments show that the addition of the apriori neighborhood graph results in significant improvements in classification performance compared to a model which does not take into account the brain region interactions or one which uses a fully connected prior graph. In addition, we describe a method, using our model, to detect the regions that contribute the most to the overall abnormality of the DTI profile of a subject's brain. Copyright © 2017 Elsevier B.V. All rights reserved.

  7. Generational association studies of dopaminergic genes in reward deficiency syndrome (RDS) subjects: selecting appropriate phenotypes for reward dependence behaviors.

    Science.gov (United States)

    Blum, Kenneth; Chen, Amanda L C; Oscar-Berman, Marlene; Chen, Thomas J H; Lubar, Joel; White, Nancy; Lubar, Judith; Bowirrat, Abdalla; Braverman, Eric; Schoolfield, John; Waite, Roger L; Downs, Bernard W; Madigan, Margaret; Comings, David E; Davis, Caroline; Kerner, Mallory M; Knopf, Jennifer; Palomo, Tomas; Giordano, John J; Morse, Siobhan A; Fornari, Frank; Barh, Debmalya; Femino, John; Bailey, John A

    2011-12-01

    Abnormal behaviors involving dopaminergic gene polymorphisms often reflect an insufficiency of usual feelings of satisfaction, or Reward Deficiency Syndrome (RDS). RDS results from a dysfunction in the "brain reward cascade," a complex interaction among neurotransmitters (primarily dopaminergic and opioidergic). Individuals with a family history of alcoholism or other addictions may be born with a deficiency in the ability to produce or use these neurotransmitters. Exposure to prolonged periods of stress and alcohol or other substances also can lead to a corruption of the brain reward cascade function. We evaluated the potential association of four variants of dopaminergic candidate genes in RDS (dopamine D1 receptor gene [DRD1]; dopamine D2 receptor gene [DRD2]; dopamine transporter gene [DAT1]; dopamine beta-hydroxylase gene [DBH]). We genotyped an experimental group of 55 subjects derived from up to five generations of two independent multiple-affected families compared to rigorously screened control subjects (e.g., N = 30 super controls for DRD2 gene polymorphisms). Data related to RDS behaviors were collected on these subjects plus 13 deceased family members. Among the genotyped family members, the DRD2 Taq1 and the DAT1 10/10 alleles were significantly (at least p spurious results. Utilization of a nonspecific "reward" phenotype may be a paradigm shift in future association and linkage studies involving dopaminergic polymorphisms and other neurotransmitter gene candidates.

  8. A Randomized Controlled Trial of Cognitive Debiasing Improves Assessment and Treatment Selection for Pediatric Bipolar Disorder

    Science.gov (United States)

    Jenkins, Melissa M.; Youngstrom, Eric A.

    2015-01-01

    Objective This study examined the efficacy of a new cognitive debiasing intervention in reducing decision-making errors in the assessment of pediatric bipolar disorder (PBD). Method The study was a randomized controlled trial using case vignette methodology. Participants were 137 mental health professionals working in different regions of the US (M=8.6±7.5 years of experience). Participants were randomly assigned to a (1) brief overview of PBD (control condition), or (2) the same brief overview plus a cognitive debiasing intervention (treatment condition) that educated participants about common cognitive pitfalls (e.g., base-rate neglect; search satisficing) and taught corrective strategies (e.g., mnemonics, Bayesian tools). Both groups evaluated four identical case vignettes. Primary outcome measures were clinicians’ diagnoses and treatment decisions. The vignette characters’ race/ethnicity was experimentally manipulated. Results Participants in the treatment group showed better overall judgment accuracy, p < .001, and committed significantly fewer decision-making errors, p < .001. Inaccurate and somewhat accurate diagnostic decisions were significantly associated with different treatment and clinical recommendations, particularly in cases where participants missed comorbid conditions, failed to detect the possibility of hypomania or mania in depressed youths, and misdiagnosed classic manic symptoms. In contrast, effects of patient race were negligible. Conclusions The cognitive debiasing intervention outperformed the control condition. Examining specific heuristics in cases of PBD may identify especially problematic mismatches between typical habits of thought and characteristics of the disorder. The debiasing intervention was brief and delivered via the Web; it has the potential to generalize and extend to other diagnoses as well as to various practice and training settings. PMID:26727411

  9. NPY mRNA Expression in the Prefrontal Cortex: Selective Reduction in the Superficial White Matter of Subjects with Schizoaffective Disorder

    Science.gov (United States)

    Morris, Harvey M.; Stopczynski, Rachelle E.; Lewis, David A.

    2009-01-01

    Background Alterations in the inhibitory circuitry of the dorsolateral prefrontal cortex (DLPFC) in schizophrenia include reduced expression of the messenger RNA (mRNA) for somatostatin (SST), a neuropeptide present in a subpopulation of γ-aminobutyric acid (GABA) neurons. Neuropeptide Y (NPY) is expressed in a subset of SST-containing interneurons and lower levels of NPY mRNA have also been reported in schizophrenia spectrum disorders. However, whether the alterations in these two transcripts identify the same, particularly vulnerable, subset of GABA neurons has not been examined. Methods We used in situ hybridization to quantify NPY mRNA levels in DLPFC gray and white matter from 23 pairs of subjects with schizophrenia or schizoaffective disorder and matched normal control subjects; results were compared to those from a previous study of SST mRNA expression in the same subjects. Results In contrast to SST mRNA, NPY mRNA levels were not significantly lower in the gray matter of subjects with schizophrenia or schizoaffective disorder. However, NPY, but not SST, mRNA expression was significantly lower in the superficial white matter of subjects with schizoaffective disorder. Conclusion These findings suggest that the alterations in SST-containing interneurons in schizophrenia and schizoaffective disorder are selective for the subset that do not express NPY mRNA, and that lower NPY mRNA expression in the superficial white matter may distinguish subjects with schizoaffective disorder from those with schizophrenia. PMID:19804960

  10. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Arce Roger M

    2011-02-01

    Full Text Available Abstract Background Periodontal disease (PD is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group or supragingival plaque removal only (control group. A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98 and all patients will be followed-up for secondary outcomes and will be monitored

  11. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial

    Science.gov (United States)

    2011-01-01

    Background Periodontal disease (PD) is an infectious clinical entity characterized by the destruction of supporting tissues of the teeth as the result of a chronic inflammatory response in a susceptible host. It has been proposed that PD as subclinical infection may contribute to the etiology and to the pathogenesis of several systemic diseases including Atherosclerosis. A number of epidemiological studies link periodontal disease/edentulism as independent risk factor for acute myocardial infarction, peripheral vascular disease, and cerebrovascular disease. Moreover, new randomized controlled clinical trials have shown an improvement on cardiovascular surrogate markers (endothelial function, sICAM, hsPCR level, fibrinogen) after periodontal treatment. Nonetheless, such trials are still limited in terms of external validity, periodontal treatment strategies, CONSORT-based design and results consistency/extrapolation. The current study is designed to evaluate if periodontal treatment with scaling and root planning plus local delivered chlorhexidine improves endothelial function and other biomarkers of cardiovascular disease in subjects with moderate to severe periodontitis. Methods/Design This randomized, single-blind clinical trial will be performed at two health centers and will include two periodontal treatment strategies. After medical/periodontal screening, a baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) and other systemic surrogate markers will be obtained from all recruited subjects. Patients then will be randomized to receive either supragingival/subgingival plaque cleaning and calculus removal plus chlorhexidine (treatment group) or supragingival plaque removal only (control group). A second and third FMD will be obtained after 24 hours and 12 weeks in both treatment arms. Each group will consist of 49 patients (n = 98) and all patients will be followed-up for secondary outcomes and will be monitored through a coordinating

  12. Camelina Sativa Oil, but not Fatty Fish or Lean Fish Improved Serum Lipid Profile in Subjects with Impaired Glucose Metabolism - a Randomized Controlled Trial.

    Science.gov (United States)

    Schwab, Ursula S; Lankinen, Maria A; de Mello, Vanessa D; Manninen, Suvi M; Kurl, Sudhir; Pulkki, Kari J; Laaksonen, David E; Erkkilä, Arja T

    2017-12-22

    The aim of the study was to examine whether lean fish (LF), fatty fish (FF) and camelina sativa oil (CSO), a plant-based source of alpha-linolenic acid (ALA), differ in their metabolic effects in subjects with impaired glucose metabolism. Altogether 79 volunteers with impaired fasting glucose, BMI 25-36 kg/m2 , age 43-72 years, participated in a 12-week randomized controlled trial with four parallel groups, i.e. the FF (4 fish meals/week), LF (4 fish meals/week), CSO (10 g/day ALA) and control (limited intakes of fish and source of ALA) groups. The proportions of EPA and DHA increased in plasma lipids in the FF group, and the proportion of ALA increased in the CSO group (P < 0.0001 for all). In the CSO group total and LDL-cholesterol (C) concentrations decreased compared with the FF and LF groups, LDL-C/HDL-C and ApoB/ApoA-I ratios decreased compared with the LF group. There were no significant changes in glucose metabolism or markers of low-grade inflammation. A diet enriched in CSO improves serum lipid profile as compared with a diet enriched in FF or LF in subjects with impaired fasting glucose, with no differences in glucose metabolism or concentrations of inflammatory markers. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  13. Absence of a significant pharmacokinetic interaction between atorvastatin and fenofibrate: A randomized, crossover, study of a fixed-dose formulation in healthy Mexican subjects

    Directory of Open Access Journals (Sweden)

    Omar ePatiño-Rodríguez

    2015-01-01

    Full Text Available Several clinical trials have substantiated the efficacy of the co-administration of statins like atorvastatin and fibrates. Without information currently available about the interaction between the two drugs, a pharmacokinetic study was conducted to investigate the effect when both drugs were co-administered. The purpose of this study was to investigate the pharmacokinetic profile of tablets containing atorvastatin 20 mg, or the combination of atorvastatin 20 mg with fenofibrate 160 mg administered to healthy Mexican volunteers. This was a randomized, two-period, two-sequence, crossover study; 36 eligible subjects aged between 20 to 50 years were included. Blood samples were collected up to 96 h after dosing, and pharmacokinetic parameters were obtained by non-compartmental analysis. Adverse events were evaluated based on subject interviews and physical examinations. Area under the concentration-time curve (AUC and maximum plasma drug concentration (Cmax were measured for atorvastatin as the reference and atorvastatin and fenofibrate as the test product for bioequivalence design. The estimation computed (90% confidence intervals for atorvastatin and fenofibrate combination versus atorvastatin for Cmax, AUC0-t and AUC0-∞, were 102,09, 125,95 and 120,97% respectively. These results suggest that atorvastatin and fenofibrate have no relevant clinical-pharmacokinetic drug interaction.

  14. Acute and chronic effects of flavanol-rich cocoa on vascular function in subjects with coronary artery disease: a randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Farouque, H M Omar; Leung, Michael; Hope, Sarah A; Baldi, Mauro; Schechter, Clyde; Cameron, James D; Meredith, Ian T

    2006-07-01

    Evidence suggests that flavonoid-containing diets reduce cardiovascular risk, but the mechanisms responsible are unclear. In the present study, we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD (coronary artery disease). Forty subjects (61+/-8 years; 30 male) with CAD were recruited to a 6-week randomized double-blind placebo-controlled study. Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily (total flavanols, 444 mg/day) or matching isocaloric placebos daily (total flavanols, 19.6 mg/day) for 6 weeks. Brachial artery FMD (flow-mediated dilation) and SAC (systemic arterial compliance) were assessed at baseline, 90 min following the first beverage and after 3 and 6 weeks of daily consumption. Soluble cellular adhesion molecules and FBF (forearm blood flow) responses to ACh (acetylcholine chloride; 3-30 microg/min) and SNP (sodium nitroprusside; 0.3-3 microg/min) infusions, forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks. FMD, SAC and FBF responses did not differ between groups at baseline. No acute or chronic changes in FMD or SAC were seen in either group. No difference in soluble cellular adhesion molecules, FBF responses to ischaemia, exercise, SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks. These data suggest that over a 6-week period, flavanol-rich cocoa does not modify vascular function in patients with established CAD.

  15. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

    Science.gov (United States)

    Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee

    2017-08-01

    This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC0-∞). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.

  16. The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jingfen Zhu

    2016-01-01

    Full Text Available Subjective memory complaints (SMCs are common in older adults that can often predict further cognitive impairment. No proven effective agents are available for SMCs. The effect of BrainPower Advanced, a dietary supplement consisting of herbal extracts, nutrients, and vitamins, was evaluated in 98 volunteers with SMCs, averaging 67 years of age (47–88, in a randomized, double-blind, placebo-controlled trial. Subjective hypomnesis/memory loss (SML and attention/concentration deficits (SAD were evaluated before and after 12-week supplementation of BrainPower Advanced capsules (n=47 or placebo (n=51, using a 5-point memory questionnaire (1 = no/slight, 5 = severe. Objective memory function was evaluated using 3 subtests of visual/audio memory, abstraction, and memory recall that gave a combined total score. The BrainPower Advanced group had more cases of severe SML (severity ⩾ 3 (44/47 and severe SAD (43/47 than the placebo group (39/51 and 37/51, < 0.05, < 0.05, resp. before the treatment. BrainPower Advanced intervention, however, improved a greater proportion of the severe SML (29.5%(13/44 (P<0.01 and SAD (34.9%(15/43(P<0.01 than placebo (5.1% (2/39 and 13.5% (5/37, resp.. Thus, 3-month BrainPower Advanced supplementation appears to be beneficial to older adults with SMCs.

  17. Efficacy of a novel herbal composition licorice flavonoid oil in subject with metabolic syndrome: a randomized double-blind placebo-controlled clinical study

    Directory of Open Access Journals (Sweden)

    Kaku Nakagawa

    2017-03-01

    Full Text Available Background:In order toevaluate the effects of licorice flavonoid oil (LFOon abdominalwaist circumference, blood pressure, body weight, body mass index (BMI, lipid profile, body fat composition,and fasting blood glucose in patients with metabolic syndrome, a 12 week randomized double-blind placebo-controlledstudywas conducted. Methods: Fiftypatientswith metabolic syndrome agedbetween 18-75 years were assigned toeither the LFO or placebo group. Abdominal waist circumference, blood pressure, body weight,and BMI were assessed atbaseline, week 4, week 8,and week 12. Clinical laboratory examinations, fat composition,andfasting blood glucose level wereassessed at baseline (week 0 and final visit(week 12.Results: Atotal of 50 subjects (25 subjects in each groupcompleted the 12-weekstudy. Significant difference inchangesfrom the baseline wasobserved in body weight, waist circumference,and BMI in the LFOgroup compared to the placebo group from week 4or week 8 onwards. No adverse events were noted throughout the study. Conclusion: The present study suggeststhat LFOisa promising dietary nutrient forimproving metabolic syndrome, particularlythroughits beneficial effect of normalizingbody weight, BMI,and possibly the amount of visceral fatand HDL cholesterol.

  18. Genome-wide association data classification and SNPs selection using two-stage quality-based Random Forests.

    Science.gov (United States)

    Nguyen, Thanh-Tung; Huang, Joshua; Wu, Qingyao; Nguyen, Thuy; Li, Mark

    2015-01-01

    Single-nucleotide polymorphisms (SNPs) selection and identification are the most important tasks in Genome-wide association data analysis. The problem is difficult because genome-wide association data is very high dimensional and a large portion of SNPs in the data is irrelevant to the disease. Advanced machine learning methods have been successfully used in Genome-wide association studies (GWAS) for identification of genetic variants that have relatively big effects in some common, complex diseases. Among them, the most successful one is Random Forests (RF). Despite of performing well in terms of prediction accuracy in some data sets with moderate size, RF still suffers from working in GWAS for selecting informative SNPs and building accurate prediction models. In this paper, we propose to use a new two-stage quality-based sampling method in random forests, named ts-RF, for SNP subspace selection for GWAS. The method first applies p-value assessment to find a cut-off point that separates informative and irrelevant SNPs in two groups. The informative SNPs group is further divided into two sub-groups: highly informative and weak informative SNPs. When sampling the SNP subspace for building trees for the forest, only those SNPs from the two sub-groups are taken into account. The feature subspaces always contain highly informative SNPs when used to split a node at a tree. This approach enables one to generate more accurate trees with a lower prediction error, meanwhile possibly avoiding overfitting. It allows one to detect interactions of multiple SNPs with the diseases, and to reduce the dimensionality and the amount of Genome-wide association data needed for learning the RF model. Extensive experiments on two genome-wide SNP data sets (Parkinson case-control data comprised of 408,803 SNPs and Alzheimer case-control data comprised of 380,157 SNPs) and 10 gene data sets have demonstrated that the proposed model significantly reduced prediction errors and outperformed

  19. Asthma and Rhinitis Induced by Selective Immediate Reactions to Paracetamol and Non-steroidal Anti-inflammatory Drugs in Aspirin Tolerant Subjects.

    Science.gov (United States)

    Pérez-Alzate, Diana; Blanca-López, Natalia; Doña, Inmaculada; Agúndez, José A; García-Martín, Elena; Cornejo-García, José A; Perkins, James R; Blanca, Miguel; Canto, Gabriela

    2016-01-01

    In subjects with non-steroidal anti-inflammatory drugs (NSAIDs)- exacerbated respiratory disease (NERD) symptoms are triggered by acetyl salicylic acid (ASA) and other strong COX-1 inhibitors, and in some cases by weak COX-1 or by selective COX-2 inhibitors. The mechanism involved is related to prostaglandin pathway inhibition and leukotriene release. Subjects who react to a single NSAID and tolerate others are considered selective responders, and often present urticaria and/or angioedema and anaphylaxis (SNIUAA). An immunological mechanism is implicated in these reactions. However, anecdotal evidence suggests that selective responders who present respiratory airway symptoms may also exist. Our objective was to determine if subjects might develop selective responses to NSAIDs/paracetamol that manifest as upper/lower airways respiratory symptoms. For this purpose, we studied patients reporting asthma and/or rhinitis induced by paracetamol or a single NSAID that tolerated ASA. An allergological evaluation plus controlled challenge with ASA was carried out. If ASA tolerance was found, we proceeded with an oral challenge with the culprit drug. The appearance of symptoms was monitored by a clinical questionnaire and by measuring FEV1 and/or nasal airways volume changes pre and post challenge. From a total of 21 initial cases, we confirmed the appearance of nasal and/or bronchial manifestations in ten, characterized by a significant decrease in FEV1% and/or a decrease in nasal volume cavity after drug administration. All cases tolerated ASA. This shows that ASA tolerant subjects with asthma and/or rhinitis induced by paracetamol or a single NSAID without skin/systemic manifestations exist. Whether these patients represent a new clinical phenotype to be included within the current classification of hypersensitivity reactions to NSAIDs requires further investigation.

  20. Well-being, problematic alcohol consumption and acute subjective drug effects in past-year ayahuasca users: a large, international, self-selecting online survey

    OpenAIRE

    Lawn, W.; Hallak, J. E.; Crippa, J. A.; Dos Santos, R.; Porffy, L.; Barratt, M. J.; Ferris, J. A.; Winstock, A. R.; Morgan, C. J. A.

    2017-01-01

    Ayahuasca is a natural psychedelic brew, which contains dimethyltryptamine (DMT). Its potential as a psychiatric medicine has recently been demonstrated and its non-medical use around the world appears to be growing. We aimed to investigate well-being and problematic alcohol use in ayahuasca users, and ayahuasca's subjective effects. An online, self-selecting, global survey examining patterns of drug use was conducted in 2015 and 2016 (n = 96,901). Questions were asked about: use of ayahuasca...

  1. The Vermont Diabetes Information System (VDIS): Study Design and Subject Recruitment for a Cluster Randomized Trial of a Decision Support System in a Regional Sample of Primary Care Practices

    Science.gov (United States)

    MacLean, Charles D.; Littenberg, Benjamin; Gagnon, Michael; Reardon, Mimi; Turner, Paul D.; Jordan, Cy

    2008-01-01

    Background Despite evidence that optimal care for diabetes can result in reduced complications and improved economic outcomes, such care is often not achieved. The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. Purpose To develop and evaluate a regional decision support system for patients with diabetes. Methods Randomized trial of an information system with clustering at the practice level. Ten percent random sub sample of patients selected for a home interview. Subject and setting includes 10 hospitals, 121 primary care providers, and 7,348 patients in 55 Vermont and New York primary care practices. Results We report on the study design and baseline characteristics of the population. Patients have a mean age of 63 years and a mean glycosolated hemoglobin A1C of 7.1%. Sixty percent of the population has excellent glycemic control (A1C<7%); 45% have excellent lipid control (serum LDL-cholesterol < 100mg/dl and serum triglycerides < 400mg/dl). Twenty-five percent have excellent blood pressure control (<130/80 mm Hg). These results compare favorably to recent national reports. However, only 8% are in optimal control for all three of hyperglycemia, lipids and blood pressure. Conclusions Our experience to date indicates that a low cost decision support and information system based on the chronic care model is feasible in primary care practices that lack sophisticated electronic information systems. VDIS is well accepted by patients, providers, and laboratory staff. If proven beneficial in a rigorous, randomized, controlled evaluation, the intervention could be widely disseminated to practices across America and the world with a substantial impact on the outcomes and costs of diabetes. It could also be adapted to other chronic conditions. We anticipate the results of the study will be available in 2006. PMID

  2. Role of selective V2-receptor-antagonism in septic shock: a randomized, controlled, experimental study

    OpenAIRE

    Rehberg, Sebastian; Ertmer, Christian; Lange, Matthias; Morelli, Andrea; Whorton, Elbert; Strohhäcker, Anne-Katrin; Dünser, Martin Wolfgang; Lipke, Erik; Kampmeier, Tim G; Aken, Hugo; Traber, Daniel L; Westphal, Martin

    2010-01-01

    ABSTRACT : INTRODUCTION : V2-receptor (V2R) stimulation potentially aggravates sepsis-induced vasodilation, fluid accumulation and microvascular thrombosis. Therefore, the present study was performed to determine the effects of a first-line therapy with the selective V2R-antagonist (Propionyl1-D-Tyr(Et)2-Val4-Abu6-Arg8,9)-Vasopressin on cardiopulmonary hemodynamics and organ function vs. the mixed V1aR/V2R-agonist arginine vasopressin (AVP) or placebo in an established ovine model of septic s...

  3. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.

    Directory of Open Access Journals (Sweden)

    Chaoying Hu

    Full Text Available Inhaled umeclidinium (UMEC and the combination of inhaled UMEC with vilanterol (UMEC/VI are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This was a randomized, open-label, three-period crossover, single- and repeat-dose study to assess the pharmacokinetics (PK, safety, and tolerability of inhaled UMEC/VI 62.5/25 μg (delivering 55/22 μg and UMEC/VI 125/25 μg (delivering 113/22 μg compared with their monotherapy components (UMEC 62.5 μg, UMEC 125 μg and, VI 25 μg [delivering 55, 113, and 22 μg, respectively] in healthy Chinese subjects (n=20. UMEC and VI were rapidly absorbed following single and repeat dosing (time to maximum plasma concentration [tmax]: UMEC = 5 min; VI = 5 min. The median tlast was 2–4 h for UMEC and 1–2 h for VI following single doses of UMEC/VI and UMEC monotherapy (both doses. UMEC reached steady-state prior to Day 10; steady-state for VI could not be assessed. UMEC accumulation following repeat dosing was 11–34% based on Cmax and 19–59% based on area under the concentration-time curve from time zero to 2 h (AUC(0-2. VI accumulation following repeat dosing was 25–66% based on Cmax and 17–43% based on AUC(0-2. The evidence was not sufficient to suggest that systemic exposure was substantially different between UMEC/VI combination therapy and the constituent monotherapies following single or repeat dosing. Following both single- and repeat-dose administration, the inter-subject coefficient of variation for all UMEC PK parameter estimates ranged from 12% to 165% for all treatments, indicating a wide range of variability in inhaled PK parameters. Twelve subjects experienced ≥1 adverse event (AE. Six subjects experienced ≥1 treatment-related AE; the most commonly reported treatment-related AE was chest discomfort (n=3 [15%]. No clinically important changes in vital signs or electrocardiogram parameters were reported. These data suggest that single- and repeat

  4. Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.

    Science.gov (United States)

    Hu, Chaoying; Jia, Jingying; Dong, Kelly; Luo, Linda; Wu, Kai; Mehta, Rashmi; Peng, Jack; Ren, Yan; Gross, Annette; Yu, Hui

    2015-01-01

    Inhaled umeclidinium (UMEC) and the combination of inhaled UMEC with vilanterol (UMEC/VI) are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This was a randomized, open-label, three-period crossover, single- and repeat-dose study to assess the pharmacokinetics (PK), safety, and tolerability of inhaled UMEC/VI 62.5/25 μg (delivering 55/22 μg) and UMEC/VI 125/25 μg (delivering 113/22 μg) compared with their monotherapy components (UMEC 62.5 μg, UMEC 125 μg and, VI 25 μg [delivering 55, 113, and 22 μg, respectively]) in healthy Chinese subjects (n=20). UMEC and VI were rapidly absorbed following single and repeat dosing (time to maximum plasma concentration [tmax]: UMEC = 5 min; VI = 5 min). The median tlast was 2–4 h for UMEC and 1–2 h for VI following single doses of UMEC/VI and UMEC monotherapy (both doses). UMEC reached steady-state prior to Day 10; steady-state for VI could not be assessed. UMEC accumulation following repeat dosing was 11–34% based on Cmax and 19–59% based on area under the concentration-time curve from time zero to 2 h (AUC(0-2)). VI accumulation following repeat dosing was 25–66% based on Cmax and 17–43% based on AUC(0-2). The evidence was not sufficient to suggest that systemic exposure was substantially different between UMEC/VI combination therapy and the constituent monotherapies following single or repeat dosing. Following both single- and repeat-dose administration, the inter-subject coefficient of variation for all UMEC PK parameter estimates ranged from 12% to 165% for all treatments, indicating a wide range of variability in inhaled PK parameters. Twelve subjects experienced ≥1 adverse event (AE). Six subjects experienced ≥1 treatment-related AE; the most commonly reported treatment-related AE was chest discomfort (n=3 [15%]). No clinically important changes in vital signs or electrocardiogram parameters were reported. These data suggest that single- and repeat

  5. A randomized, double-blind, placebo-controlled phase 3 skin cancer prevention study of DFMO in subjects with previous history of skin cancer

    Science.gov (United States)

    Bailey, HH; Kim, K; Verma, A; Sielaff, K; Larson, PO; Snow, S; Lenaghan, T; Viner, JL; Douglass, J; Dreckschmidt, N; Hamielec, M; Pomplun, M; Sharata, HH; Puchalsky, D; Berg, ER; Havighurst, T; Carbone, PP

    2009-01-01

    Preclinical studies have shown the inhibition of ornithine decarboxylase (ODC) by α-difluoromethylornithine (DFMO) and resultant decreases in tissue concentrations of polyamines (putrescine & spermidine) prevents neoplastic developments in many tissue types. Clinical studies of oral DFMO at 500 mg/m2/day revealed it to be safe and tolerable and resulted in significant inhibition of phorbol ester-induced skin ODC activity. Two hundred and ninety-one participants (mean 61 y.o., 60% male) with a history of prior non-melanoma skin cancer (mean 4.5 skin cancers) were randomized to oral DFMO (500 mg/m2/day) or placebo for 4–5 years. There was a trend toward a history of more prior skin cancers in subjects randomized to placebo, but all other characteristics including sunscreen and NSAID use were evenly distributed. Evaluation of 1200-person years of follow-up revealed a new non-melanoma skin cancer (NMSC) rate of 0.5 events/person/year. The primary endpoint, new NMSC’s, was not significantly different between subjects taking DFMO and placebo (260 vs. 363 cancers, p=0.069, two-sample t test). Evaluation of basal cell (BCC) and squamous cell (SCC) cancers separately revealed very little difference in SCC between treatment groups but a significant difference in new BCC (DFMO 163 cancers; Placebo 243 cancers; expressed as event rate 0.28 BCC/person/year vs. 0.40 BCC/person/year, p=0.03). Compliance with DFMO was >90% and it appeared to be well tolerated with evidence of mild ototoxicity as measured by serial audiometric examination when compared to placebo subjects. Analysis of normal skin biopsies revealed a significant (pskin cancer taking daily DFMO had an insignificant reduction (p=0.069), in new NMSC that was predominantly due to a marked reduction in new BCC. Based on these data, the potential of DFMO, alone or in combination, to prevent skin cancers should be explored further. PMID:20051371

  6. Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies.

    Science.gov (United States)

    Goldwater, Ronald; Hussaini, Azra; Bosch, Bill; Nemeth, Paul

    2017-07-01

    Abiraterone acetate is approved for the treatment of metastatic castration-resistant prostate cancer. The originator abiraterone acetate (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in abiraterone exposure. Abiraterone acetate fine particle (AAFP) is a proprietary formulation (using SoluMatrix Fine Particle Technology™) designed to increase the oral bioavailability of abiraterone acetate. Here, we report on two phase I studies in healthy male subjects aged 18-50 years. In Study 101, 20 subjects were randomized in a crossover design to single doses of AAFP 100, 200, or 400 mg or OAA 1000 mg taken orally under fasting conditions. Results suggested that AAFP 500 mg would be bioequivalent to OAA 1000 mg in the fasted state. To confirm the bioequivalence hypothesis and to further expand the AAFP dose range, in Study 102, 36 subjects were randomized in a crossover design to single doses of AAFP 125, 500, or 625 mg or OAA 1000 mg. Both studies included a 7-day washout period between administrations. Dose-dependent increases in the area under the plasma concentration-time curve and maximum plasma concentration with AAFP were observed in both studies. The AAFP 500-mg bioavailability relative to OAA 1000 mg measured by the geometric mean ratio for area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration was 93.4% (90% confidence interval 85.3-102.4), area under the plasma concentration-time curve from time zero to infinity was 91.0% (90% confidence interval 83.3-99.4), and maximum plasma concentration was 99.8% (90% confidence interval 86.3-115.5). Dose proportionality was seen across all AAFP dose levels (100-625 mg). Abiraterone acetate fine particle was found to be safe and well tolerated in this study. Abiraterone acetate fine particle 500 mg was demonstrated to be bioequivalent to OAA 1000 mg in healthy volunteers under fasted conditions.

  7. A randomized, double-blind, placebo-controlled, dose-response study to assess the pharmacokinetics, efficacy, and safety of gabapentin enacarbil in subjects with restless legs syndrome.

    Science.gov (United States)

    Lal, Ritu; Ellenbogen, Aaron; Chen, Dan; Zomorodi, Katie; Atluri, Harisha; Luo, Wendy; Tovera, James; Hurt, Janet; Bonzo, Daniel; Lassauzet, Marie-Liesse; Vu, Amanda; Cundy, Kenneth C

    2012-01-01

    The objective of this study was to determine steady-state gabapentin exposures and corresponding relief of symptoms and safety profile produced by 4 dose levels of gabapentin enacarbil (GEn) in subjects with restless legs syndrome (RLS). Subjects with RLS (n = 217) were randomized to receive once-daily, orally administered GEn 600 (n = 48), 1200 (n = 45), 1800 (n = 38), or 2400 mg (n = 45) or placebo (n = 41) in this 12-week, double-blind, multicenter study (NCT01332305). Clinic visits were at screening, baseline, and weeks 1, 2, 3, 4, 6, 8, 10, and 12; plasma gabapentin concentrations were measured by a validated liquid chromatography-mass spectrometry/mass spectrometry method at weeks 4 and 12. Exposure to gabapentin was proportional to GEn dose. Time to maximum plasma concentration was 7 to 9 hours, and elimination half-life was ~6 hours. The mean reduction from baseline to week 12 in International Restless Legs Syndrome Rating Scale total score and proportions of subjects with "much improved"/"very much improved" Clinical Global Impression-Improvement scores (investigator and patient ratings) ranged from -12.9 to -13.9 for GEn treatment groups versus -9.3 for placebo. The 2 most commonly reported adverse events were somnolence and dizziness. Gabapentin exposure was approximately proportional to GEn dose. Efficacy data showed that a once-daily dose of GEn 600 to 2400 mg provides greater relief of RLS symptoms than placebo; GEn was generally well tolerated with an adverse event profile consistent with gabapentin.

  8. Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study.

    Science.gov (United States)

    Gunawardhana, Lhanoo; McLean, Lachy; Punzi, Henry A; Hunt, Barbara; Palmer, Robert N; Whelton, Andrew; Feig, Daniel I

    2017-11-04

    Hyperuricemia is associated with hypertension, with elevated serum uric acid levels postulated to have a causal role in the development of hypertension. Consequently, serum uric acid reduction may help lower blood pressure (BP). A Phase 2, double-blind, placebo-controlled trial was conducted to assess the potential BP-lowering effects of the xanthine oxidase inhibitor febuxostat in subjects with hypertension and hyperuricemia (serum uric acid ≥0.42 mmol/L [≥7.0 mg/dL]). Subjects (n=121) were randomized 1:1 to febuxostat 80 mg once daily or to placebo. The primary end point was change from baseline to Week 6 in 24-hour mean ambulatory systolic BP (SBP). Additional end points included the following: change from baseline to Week 3 in 24-hour mean SBP and changes from baseline to Weeks 3 and 6 in 24-hour mean ambulatory diastolic BP, serum uric acid, mean daytime and nighttime ambulatory SBP/diastolic BP, and clinic SBP/diastolic BP. For the overall study population, there were no significant differences between febuxostat and placebo for changes from baseline to Weeks 3 or 6 in ambulatory, daytime or nighttime, or clinic SBP or diastolic BP. However, in a preplanned subgroup analysis, there was a significant decrease in SBP from baseline to Week 6 in subjects with normal renal function (estimated glomerular filtration rate ≥90 mL/min) treated with febuxostat versus placebo; least squares mean difference, -6.7; 95% confidence interval -13.3 to -0.0; P=0.049. This study suggests that febuxostat may lower BP in hyperuricemic patients with hypertension and normal renal function; further studies should be conducted to confirm this finding. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01496469. © 2017 The Authors and Takeda Pharmaceuticals. Published on behalf of the American Heart Association, Inc., by Wiley.

  9. Generational Association Studies of Dopaminergic Genes in Reward Deficiency Syndrome (RDS Subjects: Selecting Appropriate Phenotypes for Reward Dependence Behaviors

    Directory of Open Access Journals (Sweden)

    Frank Fornari

    2011-11-01

    Full Text Available Abnormal behaviors involving dopaminergic gene polymorphisms often reflect an insufficiency of usual feelings of satisfaction, or Reward Deficiency Syndrome (RDS. RDS results from a dysfunction in the “brain reward cascade,” a complex interaction among neurotransmitters (primarily dopaminergic and opioidergic. Individuals with a family history of alcoholism or other addictions may be born with a deficiency in the ability to produce or use these neurotransmitters. Exposure to prolonged periods of stress and alcohol or other substances also can lead to a corruption of the brain reward cascade function. We evaluated the potential association of four variants of dopaminergic candidate genes in RDS (dopamine D1 receptor gene [DRD1]; dopamine D2 receptor gene [DRD2]; dopamine transporter gene [DAT1]; dopamine beta-hydroxylase gene [DBH]. Methodology: We genotyped an experimental group of 55 subjects derived from up to five generations of two independent multiple-affected families compared to rigorously screened control subjects (e.g., N = 30 super controls for DRD2 gene polymorphisms. Data related to RDS behaviors were collected on these subjects plus 13 deceased family members. Results: Among the genotyped family members, the DRD2 Taq1 and the DAT1 10/10 alleles were significantly (at least p < 0.015 more often found in the RDS families vs. controls. The TaqA1 allele occurred in 100% of Family A individuals (N = 32 and 47.8% of Family B subjects (11 of 23. No significant differences were found between the experimental and control positive rates for the other variants. Conclusions: Although our sample size was limited, and linkage analysis is necessary, the results support the putative role of dopaminergic polymorphisms in RDS behaviors. This study shows the importance of a nonspecific RDS phenotype and informs an understanding of how evaluating single subset behaviors of RDS may lead to spurious results. Utilization of a nonspecific

  10. Conflicts of Interest, Selective Inertia, and Research Malpractice in Randomized Clinical Trials: An Unholy Trinity.

    Science.gov (United States)

    Berger, Vance W

    2015-08-01

    Recently a great deal of attention has been paid to conflicts of interest in medical research, and the Institute of Medicine has called for more research into this important area. One research question that has not received sufficient attention concerns the mechanisms of action by which conflicts of interest can result in biased and/or flawed research. What discretion do conflicted researchers have to sway the results one way or the other? We address this issue from the perspective of selective inertia, or an unnatural selection of research methods based on which are most likely to establish the preferred conclusions, rather than on which are most valid. In many cases it is abundantly clear that a method that is not being used in practice is superior to the one that is being used in practice, at least from the perspective of validity, and that it is only inertia, as opposed to any serious suggestion that the incumbent method is superior (or even comparable), that keeps the inferior procedure in use, to the exclusion of the superior one. By focusing on these flawed research methods we can go beyond statements of potential harm from real conflicts of interest, and can more directly assess actual (not potential) harm.

  11. Bioavailability of two oral suspension and two oral tablet formulations of acyclovir 400 mg: two single-dose, open-label, randomized, two-period crossover comparisons in healthy Mexican adult subjects.

    Science.gov (United States)

    Palma-Aguirre, Jose Antonio; Absalón-Reyes, Jose Antonio; Novoa-Heckel, Germán; de Lago, Alberto; Oliva, Iván; Rodríguez, Zulema; González-de la Parra, Mario; Burke-Fraga, Victoria; Namur, Salvador

    2007-06-01

    Acyclovir is an important antiviral drug, used extensively for treatment of herpes simplex and varicella zoster. Six oral generic formulations of acyclovir are available in Mexico; however, a literature search failed to identify data information concerning the bioavailability of these formulations in the Mexican population. The aim of these 2 studies was to compare the bioavailability of 4 oral formulations of acyclovir 400 mg--2 tablet formulations and 2 suspension formulations--with their corresponding listed drug references in Mexico (a list issued by Mexican Health Authorities). Two separate, single-dose, open-label, randomized, 2-period crossover studies were conducted at the Centro de Estudios Científicos y Clínicos Pharma, S.A. de C.V. (clinical unit), Mexico City, Mexico. For each study, a different set of eligible subjects were selected. They included healthy Mexican volunteers of either sex. For each study, subjects were randomly assigned to receive 1 test formulation of acyclovir 400 mg followed by the reference formulation, or vice versa, with a 1-week washout period between doses. After a 12-hour (overnight) fast, subjects received a single 400-mg dose (tablet or 10-mL suspension) of the corresponding formulation. For the analysis of pharmacokinetic properties, including C(max), AUC from time 0 (baseline) to time t (AUC(0-t)), and AUC from baseline to infinity (AUC(0-infinity)), blood samples were drawn at baseline, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, and 24 hours after dosing. The formulations were considered bioequivalent if the natural logarithm (ln)-transformed ratios of Cmax and AUC were within the predetermined equivalence range of 80% to 125% and if P healthy subjects, single, 400-mg doses of the test brand of acyclovir administered either in tablet or suspension form, appeared to be bioequivalent to the reference brand based on the rate and extent of absorption in accordance with the definition of the US Food and Drug

  12. Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

    Science.gov (United States)

    Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

    2017-03-01

    To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

  13. Effect of a Counseling Session Bolstered by Text Messaging on Self-Selected Health Behaviors in College Students: A Preliminary Randomized Controlled Trial.

    Science.gov (United States)

    Sandrick, Janice; Tracy, Doreen; Eliasson, Arn; Roth, Ashley; Bartel, Jeffrey; Simko, Melanie; Bowman, Tracy; Harouse-Bell, Karen; Kashani, Mariam; Vernalis, Marina

    2017-05-17

    The college experience is often the first time when young adults live independently and make their own lifestyle choices. These choices affect dietary behaviors, exercise habits, techniques to deal with stress, and decisions on sleep time, all of which direct the trajectory of future health. There is a need for effective strategies that will encourage healthy lifestyle choices in young adults attending college. This preliminary randomized controlled trial tested the effect of coaching and text messages (short message service, SMS) on self-selected health behaviors in the domains of diet, exercise, stress, and sleep. A second analysis measured the ripple effect of the intervention on health behaviors not specifically selected as a goal by participants. Full-time students aged 18-30 years were recruited by word of mouth and campuswide advertisements (flyers, posters, mailings, university website) at a small university in western Pennsylvania from January to May 2015. Exclusions included pregnancy, eating disorders, chronic medical diagnoses, and prescription medications other than birth control. Of 60 participants, 30 were randomized to receive a single face-to-face meeting with a health coach to review results of behavioral questionnaires and to set a health behavior goal for the 8-week study period. The face-to-face meeting was followed by SMS text messages designed to encourage achievement of the behavioral goal. A total of 30 control subjects underwent the same health and behavioral assessments at intake and program end but did not receive coaching or SMS text messages. The texting app showed that 87.31% (2187/2505) of messages were viewed by intervention participants. Furthermore, 28 of the 30 intervention participants and all 30 control participants provided outcome data. Among intervention participants, 22 of 30 (73%) showed improvement in health behavior goal attainment, with the whole group (n=30) showing a mean improvement of 88% (95% CI 39-136). Mean

  14. Selective endothelin-1 receptor type A inhibition in subjects undergoing cardiac surgery with preexisting left ventricular dysfunction: Influence on early postoperative hemodynamics.

    Science.gov (United States)

    Toole, John M; Ikonomidis, John S; Szeto, Wilson Y; Zellner, James L; Mulcahy, John; Deardorff, Rachael L; Spinale, Francis G

    2010-03-01

    A robust release of endothelin-1 with subsequent endothelin-A subtype receptor activation occurs in patients after cardiac surgery requiring cardiopulmonary bypass. Increased endothelin-A subtype receptor activation has been identified in patients with poor left ventricular function (reduced ejection fraction). Accordingly, this study tested the hypothesis that a selective endothelin-A subtype receptor antagonist administered perioperatively would favorably affect post-cardiopulmonary bypass hemodynamic profiles in patients with a preexisting poor left ventricular ejection fraction. Patients (n = 29; 66 +/- 2 years) with a reduced left ventricular ejection fraction (37% +/- 2%) were prospectively randomized in a blinded fashion, at the time of elective coronary revascularization or valve replacement requiring cardiopulmonary bypass, to infusion of the highly selective and potent endothelin-A subtype receptor antagonist sitaxsentan at 1 or 2 mg/kg (intravenous bolus; n = 9, 10 respectively) or vehicle (saline; n = 10). Infusion of the endothelin-A subtype receptor antagonist/vehicle was performed immediately before separation from cardiopulmonary bypass and again at 12 hours after cardiopulmonary bypass. Endothelin and hemodynamic measurements were performed at baseline, at separation from cardiopulmonary bypass (time 0), and at 0.5, 6, 12, and 24 hours after cardiopulmonary bypass. Baseline plasma endothelin (4.0 +/- 0.3 fmol/mL) was identical across all 3 groups, but when compared with preoperative values, baseline values obtained from age-matched subjects with a normal left ventricular ejection fraction (n = 37; left ventricular ejection fraction > 50%) were significantly increased (2.9 +/- 0.2 fmol/mL, P time 0, systemic vascular resistance changed in an equivalent fashion in the post-cardiopulmonary bypass period, but a significant endothelin-A subtype receptor antagonist effect was observed for pulmonary vascular resistance (analysis of variance; P < .05). For

  15. Content analysis of a stratified random selection of JVME articles: 1974-2004.

    Science.gov (United States)

    Olson, Lynne E

    2011-01-01

    A content analysis was performed on a random sample (N = 168) of 25% of the articles published in the Journal of Veterinary Medical Education (JVME) per year from 1974 through 2004. Over time, there were increased numbers of authors per paper, more cross-institutional collaborations, greater prevalence of references or endnotes, and lengthier articles, which could indicate a trend toward publications describing more complex or complete work. The number of first authors that could be identified as female was greatest for the most recent time period studied (2000-2004). Two different categorization schemes were created to assess the content of the publications. The first categorization scheme identified the most frequently published topics as admissions, descriptions of courses, the effect of changing teaching methods, issues facing the profession, and examples of uses of technology. The second categorization scheme identified the subset of articles that described medical education research on the basis of the purpose of the research, which represented only 14% of the sample articles (24 of 168). Of that group, only three of 24, or 12%, represented studies based on a firm conceptual framework that could be confirmed or refuted by the study's results. The results indicate that JVME is meeting its broadly based mission and that publications in the veterinary medical education literature have features common to publications in medicine and medical education.

  16. Capturing the Flatness of a peer-to-peer lending network through random and selected perturbations

    Science.gov (United States)

    Karampourniotis, Panagiotis D.; Singh, Pramesh; Uparna, Jayaram; Horvat, Emoke-Agnes; Szymanski, Boleslaw K.; Korniss, Gyorgy; Bakdash, Jonathan Z.; Uzzi, Brian

    Null models are established tools that have been used in network analysis to uncover various structural patterns. They quantify the deviance of an observed network measure to that given by the null model. We construct a null model for weighted, directed networks to identify biased links (carrying significantly different weights than expected according to the null model) and thus quantify the flatness of the system. Using this model, we study the flatness of Kiva, a large international crownfinancing network of borrowers and lenders, aggregated to the country level. The dataset spans the years from 2006 to 2013. Our longitudinal analysis shows that flatness of the system is reducing over time, meaning the proportion of biased inter-country links is growing. We extend our analysis by testing the robustness of the flatness of the network in perturbations on the links' weights or the nodes themselves. Examples of such perturbations are event shocks (e.g. erecting walls) or regulatory shocks (e.g. Brexit). We find that flatness is unaffected by random shocks, but changes after shocks target links with a large weight or bias. The methods we use to capture the flatness are based on analytics, simulations, and numerical computations using Shannon's maximum entropy. Supported by ARL NS-CTA.

  17. The Relationships between Belief, Attitude, Subjective Norm, and Behavior Towards Infant Food Formula Selection: The Views of the Malaysian Mothers

    Directory of Open Access Journals (Sweden)

    T. Ramayah

    2004-09-01

    Full Text Available The purpose of the study is to determine the relationships between belief, attitude, subjective norm, intention, and behavior towards the choice of infant food based on the Theory of Reasoned Action (TRA. An analysis on a sample of 108 mothers indicates that the TRA could be used in predicting choice decision of infant food formulas by explaining 57 percent of the variance in the behavioral intention. The subjective norm component had a higher predictive power than the attitudinal component. Of this normative component, parents or relatives and doctors were found to be more influential. Intention to choose an infant formula was also influenced by family income. The belief outcomes in evaluating a premium infant formula and economic infant formula were found to be different. For premium infant formula, brand trusted, closest to breast milk and nutrients content were identified as the dominant attributes. In contrast, availability, affordable, and nutrients content were identified as the prime beliefs in evaluating economic infant formula. Implications of the findings are discussed.

  18. Risk-Informed Safety Margin Characterization Case Study: Selection of Electrical Equipment to Be Subjected to Environmental Qualification

    Energy Technology Data Exchange (ETDEWEB)

    D. P. Blanchard; R. W. Youngblood

    2014-06-01

    The Risk-Informed Safety Margin Characterization (RISMC) pathway of the DOE’s Light Water Reactor Sustainability (LWRS) program focuses on advancing the state of the art in safety analysis and risk assessment to support decision-making on nuclear power plant operation well beyond the originally designed lifetime of the plants (i.e., beyond 60 years). Among the issues being addressed in RISMC is the significance of SSC aging and how confident we are about our understanding of its impact on the margin between the loads SSCs are expected to see during normal operation and accident conditions, and the SSC capacities (their ability to resist those loads) as the SSCs age. In this paper, a summary is provided of a case study that examines SSC aging from an environmental qualification (EQ) perspective. The case study illustrates how the state of knowledge regarding SSC margin can be characterized given the overall integrated plant design, and was developed to demonstrate a method for deciding on which cables to focus, which cables are not so important from an environmental qualification margin standpoint, and what plant design features or operating characteristics determine the role that environmental qualification plays in establishing a safety case on which decisions regarding margin can be made. The selection of cables for which demonstration of margin with respect to aging and environmental challenges uses a technique known as Prevention Analysis. Prevention Analysis is a Boolean method for optimal selection of SSCs (that is, those combinations of SSCs both necessary and sufficient to meet a predetermined selection criterion) in a manner that allows demonstration that plant-level safety can be demonstrated by the collection of selected SSCs alone. Choosing the set of SSCs that is necessary and sufficient to satisfy the safety objectives, and demonstrating that the safety objectives can be met effectively, determines where resources are best allocated to assure SSC

  19. The Effect of Cumin cyminum L. Plus Lime Administration on Weight Loss and Metabolic Status in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Abedi, Fatemeh; Sharifi, Nasrin; Karamali, Fatemeh; Fakhrieh Kashan, Zohreh; Asemi, Zatollah

    2016-08-01

    Limited data are available regarding the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight subjects. The current study aimed to assess the effects of combined administration of Cumin cyminum L. and lime on weight loss and metabolic profiles among subjects with overweight. This randomized double-blind placebo-controlled clinical trial was conducted on 72 subjects with overweight, aged 18 - 50 years old. Participants were randomly divided into three groups: Group A received high-dose Cumin cyminum L. and lime capsules (75 mg each, n = 24), group B low-dose Cumin cyminum L. and lime capsules (25 mg each, n = 24) and group C placebos (n = 24) twice daily for eight weeks. After eight weeks of intervention, compared with low-dose C. cyminum L. plus lime and placebo, taking high-dose C. cyminum L. plus lime resulted in significant weight loss (in the high-dose group: -2.1 ± 1.7 vs. in the low-dose group: -1.2 ± 1.5 and in the placebo group: + 0.2 ± 1.3 kg, respectively; P < 0.001) and body mass index (-0.8 ± 0.6 vs. -0.5 ± 0.5 and +0.1 ± 0.5 kg/m(2), respectively; P < 0.001). In addition, administration of high-dose C. cyminum L. plus lime compared with low-dose C. cyminum L. plus lime and placebo, led to a significant reduction in fasting plasma glucose (FPG) (P < 0.001) and a significant rise in quantitative insulin sensitivity check index (QUICKI) (+ 0.02 ± 0.02 vs. + 0.01 ± 0.02 and 0.01 ± 0.01, respectively; P = 0.01). Moreover, a significant decrease in serum triglycerides (-14.1 ± 56.2 vs. +13.9 ± 36.8 and + 10.6 ± 25.1 mg/dL; respectively; P = 0.03), total-cholesterol (-18.4 ± 28.6 vs. +8.6 ± 28.5 and -1.0 ± 24.8 mg/dL; respectively; P = 0.004) and low density lipoproteins- (LDL)-cholesterol levels (-11.8 ± 20.7 vs. +6.5 ± 23.2 and -2.9 ± 20.4 mg/dL, respectively; P = 0.01) was observed following the consumption of high-dose C. cyminum L. plus lime compared with

  20. The Hamburg selection procedure for dental students - introduction of the HAM-Nat as subject-specific test for study aptitude.

    Science.gov (United States)

    Kothe, Christian; Hissbach, Johanna; Hampe, Wolfgang

    2013-01-01

    The present study examines the question whether the selection of dental students should be based solely on average school-leaving grades (GPA) or whether it could be improved by using a subject-specific aptitude test. The HAM-Nat Natural Sciences Test was piloted with freshmen during their first study week in 2006 and 2007. In 2009 and 2010 it was used in the dental student selection process. The sample size in the regression models varies between 32 and 55 students. Used as a supplement to the German GPA, the HAM-Nat test explained up to 12% of the variance in preclinical examination performance. We confirmed the prognostic validity of GPA reported in earlier studies in some, but not all of the individual preclinical examination results. The HAM-Nat test is a reliable selection tool for dental students. Use of the HAM-Nat yielded a significant improvement in prediction of preclinical academic success in dentistry.

  1. A Permutation Importance-Based Feature Selection Method for Short-Term Electricity Load Forecasting Using Random Forest

    Directory of Open Access Journals (Sweden)

    Nantian Huang

    2016-09-01

    Full Text Available The prediction accuracy of short-term load forecast (STLF depends on prediction model choice and feature selection result. In this paper, a novel random forest (RF-based feature selection method for STLF is proposed. First, 243 related features were extracted from historical load data and the time information of prediction points to form the original feature set. Subsequently, the original feature set was used to train an RF as the original model. After the training process, the prediction error of the original model on the test set was recorded and the permutation importance (PI value of each feature was obtained. Then, an improved sequential backward search method was used to select the optimal forecasting feature subset based on the PI value of each feature. Finally, the optimal forecasting feature subset was used to train a new RF model as the final prediction model. Experiments showed that the prediction accuracy of RF trained by the optimal forecasting feature subset was higher than that of the original model and comparative models based on support vector regression and artificial neural network.

  2. Effectiveness of a selective, personality-targeted prevention program for adolescent alcohol use and misuse: a cluster randomized controlled trial.

    Science.gov (United States)

    Conrod, Patricia J; O'Leary-Barrett, Maeve; Newton, Nicola; Topper, Lauren; Castellanos-Ryan, Natalie; Mackie, Clare; Girard, Alain

    2013-03-01

    Selective school-based alcohol prevention programs targeting youth with personality risk factors for addiction and mental health problems have been found to reduce substance use and misuse in those with elevated personality profiles. To report 24-month outcomes of the Teacher-Delivered Personality-Targeted Interventions for Substance Misuse Trial (Adventure trial) in which school staff were trained to provide interventions to students with 1 of 4 high-risk (HR) profiles: anxiety sensitivity, hopelessness, impulsivity, and sensation seeking and to examine the indirect herd effects of this program on the broader low-risk (LR) population of students who were not selected for intervention. Cluster randomized controlled trial. Secondary schools in London, United Kingdom. A total of 1210 HR and 1433 LR students in the ninth grade (mean [SD] age, 13.7 [0.33] years). Schools were randomized to provide brief personality-targeted interventions to HR youth or treatment as usual (statutory drug education in class). Participants were assessed for drinking, binge drinking, and problem drinking before randomization and at 6-monthly intervals for 2 years. Two-part latent growth models indicated long-term effects of the intervention on drinking rates (β = -0.320, SE = 0.145, P = .03) and binge drinking rates (β = -0.400, SE = 0.179, P = .03) and growth in binge drinking (β = -0.716, SE = 0.274, P = .009) and problem drinking (β = -0.452, SE = 0.193, P = .02) for HR youth. The HR youth were also found to benefit from the interventions during the 24-month follow-up on drinking quantity (β = -0.098, SE = 0.047, P = .04), growth in drinking quantity (β = -0.176, SE = 0.073, P = .02), and growth in binge drinking frequency (β = -0.183, SE = 0.092, P = .047). Some herd effects in LR youth were observed, specifically on drinking rates (β = -0.259, SE = 0.132, P = .049) and growth of binge drinking (β = -0.244, SE = 0.073, P = .001), during the 24-month follow-up. Findings further

  3. A double-blind, randomized, Phase III, multicenter study in 358 pediatric subjects receiving isotretinoin therapy demonstrates no effect on pediatric bone mineral density.

    Science.gov (United States)

    Hoover, K B; Miller, C G; Galante, N C; Langman, C B

    2015-10-01

    This study compared the effects of pediatric acne treatment with two isotretinoin formulations on bone mineral density. We demonstrated no difference in the effect of the two formulations. No effect on pediatric bone mineral density was identified for either formulation. Isotretinoin (13-cis-retinoic acid) is a treatment for recalcitrant nodular acne with a purported effect on bone mineral density (BMD). The side effects of isotretinoin on vertebral bone were evaluated to assess the safety of a new FDA-approved isotretinoin formulation: Lidose-isotretinoin (Cip-Iso). This double-blind, randomized, phase III, active control, parallel-group, multicenter study compared the safety, efficacy, and non-inferiority of CIP-Iso to a marketed reference product, Accutane®, in severe recalcitrant nodular acne subjects. Three hundred fifty-eight pediatric male and female subjects aged between 12 and 17 years underwent 20 weeks of treatment with PA lumbar spine dual X-ray absorptiometry (DXA) measurements obtained for bone mineral density (BMD) and Z-scores, 5.5 months apart on visits 1 and 8. One hundred sixty-eight of 358 subjects had height adjusted Z-scores (HAZ) calculated. There was no difference in the least squares (LS) mean Z-score or HAZ of the two drugs at visit 1 or 8. The mean and LS mean Z-score and HAZ were greater than zero at visits 1 and 8 for both drugs. The change in the LS mean spine Z-score, but not HAZ, between visits, was statistically significant for both drugs. There was a mean increase in BMD (g/cm(2)) for both products between visits. There is no difference in the effect of two formulations of isotretinoin on spine bone density after 6 months of treatment. BMD increased and the small change in spine Z-score over treatment disappeared after height adjustment. Mean positive Z-scores and HAZ in the study were likely due to the exclusion of low and inclusion of high Z-score subjects.

  4. Analgesic effect of cathodal transcranial current stimulation over right dorsolateral prefrontal cortex in subjects with muscular temporomandibular disorders: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Brandão Filho, Rivail Almeida; Baptista, Abrahão Fontes; Brandão, Renata de Assis Fonseca Santos; Meneses, Francisco Monteiro; Okeson, Jeffrey; de Sena, Eduardo Pondé

    2015-09-17

    Temporomandibular disorders are a group of orofacial pain conditions that are commonly identified in the general population. Like many other chronic pain conditions, they can be associated with anxiety/depression, which can be related to changes in the activity of the dorsolateral prefrontal cortex. Some studies have demonstrated clinical improvement in subjects with chronic pain who are given therapeutic neuromodulation. Transcranial direct current stimulation is a noninvasive brain stimulation technique that allows the modulation of neuronal membranes. This therapy can enhance or inhibit action potential generation in cortical neurons. In some instances, medications acting in the central nervous system may be helpful despite their adverse side effects. It is important to determine if cathodal transcranial direct current stimulation over the dorsolateral prefrontal cortex, an area that modulates emotion and motor cortex excitability, has an analgesic effect on chronic temporomandibular disorders pain. The investigators will run a randomized, controlled crossover double blind study with 15 chronic muscular temporomandibular disorder subjects. Each subject will undergo active (1 mA and 2 mA) and sham transcranial direct current stimulation. Inclusion criteria will be determined by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire, with subjects who have a pain visual analogic scale score of greater than 4/10 and whose pain has been present for the previous 6 months, and with a State-Trait Anxiety Inventory score of more than 42. The influence of transcranial direct current stimulation will be assessed through a visual analogic scale, quantitative sensory testing, quantitative electroencephalogram, and the State-Trait Anxiety Inventory score. Some studies have demonstrated a strong association between anxiety/depression and chronic pain, where one may be the cause of the other. This is especially true in chronic temporomandibular

  5. Effect of commercial breakfast fibre cereals compared with corn flakes on postprandial blood glucose, gastric emptying and satiety in healthy subjects: a randomized blinded crossover trial

    Directory of Open Access Journals (Sweden)

    Almér Lars-Olof

    2007-09-01

    Full Text Available Abstract Background Dietary fibre food intake is related to a reduced risk of developing diabetes mellitus. However, the mechanism of this effect is still not clear. The aim of this study was to evaluate the effect of commercial fibre cereals on the rate of gastric emptying, postprandial glucose response and satiety in healthy subjects. Methods Gastric emptying rate (GER was measured by standardized real time ultrasonography. Twelve healthy subjects were assessed using a randomized crossover blinded trial. The subjects were examined after an 8 hour fast and after assessment of normal fasting blood glucose level. Satiety scores were estimated and blood glucose measurements were taken before and at 0, 20, 30, 40, 60, 80, 100 and 120 min after the end of the meal. GER was calculated as the percentage change in the antral cross-sectional area 15 and 90 min after ingestion of sour milk with corn flakes (GER1, cereal bran flakes (GER2 or wholemeal oat flakes (GER3. Results The median value was, respectively, 42% for GER1, 33 % for GER2 and 51% for GER3. The difference between the GER after ingestion of bran flakes compared to wholemeal oat flakes was statistically significant (p = 0.023. The postprandial delta blood glucose level was statistically significantly lower at 40 min (p = 0.045 and 120 min (p = 0.023 after the cereal bran flakes meal. There was no statistical significance between the areas under the curve (AUCs of the cereals as far as blood glucose and satiety were concerned. Conclusion The result of this study demonstrates that the intake of either bran flakes or wholemeal oat flakes has no effect on the total postprandial blood glucose response or satiety when compared to corn flakes. However, the study does show that the intake of cereal bran flakes slows the GER when compared to oat flakes and corn flakes, probably due to a higher fibre content. Since these products do not differ in terms of glucose response and satiety on healthy

  6. [Correlation of subjective and objective assessment of vaginal prolapse surgery - secondary analysis of randomized controlled study in patients with pelvic floor injury treated with vaginal mesh or with sacrospinous ligament fixation].

    Science.gov (United States)

    Švabík, K; El Haddad, R; Mašata, J; Hubka, P; Martan, A

    2015-10-01

    We had provided secondary analysis of our randomized controlled study comparing vaginal mesh with sacrospinous fixation for vaginal prolapse. We correlated data from subjective and objective assessment. Secondly we had provided correlations results of subjective and objective assessment between patient with anatomical failure and those without. The aim of this analysis was to provide correlation between objective and subjective outcome measures. Subanalysis of randomized controlled study. Obstetric Gynecology Department, First Faculty of Medicine of Charles University and General University Hospital in Prague. This is secondary analysis of single center randomized controlled study comparing two standard procedures for vaginal prolapse after hysterectomy in patients with levator avulsion injury. We had analyzed pre- and postoperative subjective POPDI score (Pelvic Organ Prolapse Distress Inventory) and correlated this score with most prolapsed portion of vaginal wall. We had compared all vaginal compartments using POPQ (Pelvic Organ Prolapse Quantification): anterior wall with point Ba, apical with point C, and posterior with point Bp. Subsequently we compared subjective POPDI score in group of patients with anatomical failure and those without. We had included in randomized study 70 women. Mean preoperative POPDI score was 65.25 (3.57-200). We didnt found any correlation between subjective score and objective assessment in preoperative data: POPDI vs. Ba (p = 0.75) POPDI vs. C (p = 0.57) a POPDI vs. Bp (p = 0.22) and no correlation in postoperative assessment. Postoperative POPDI score decreased to 26.1, but there was no difference in POPDI score in woman with anatomical failure and no failure - 17.4 vs. 23.3 (p = 0.64)CONCLUSION: Secondary analysis of randomized controlled study had shown that objective and subjective assessment have poor correlation. We didnt found any correlation between degree of prolapse and intensity of complains. The large inter

  7. Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

    Science.gov (United States)

    Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

    2017-01-01

    Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing

  8. A randomized controlled trial of two simple mind-body programs, Kirtan Kriya meditation and music listening, for adults with subjective cognitive decline: Feasibility and acceptability.

    Science.gov (United States)

    Innes, Kim E; Selfe, Terry Kit; Khalsa, Dharma Singh; Kandati, Sahiti

    2016-06-01

    In this randomized controlled trial (RCT), we assessed the feasibility and acceptability of two simple home-based relaxation programs in adults experiencing subjective cognitive decline, a strong predictor of Alzheimer's disease. Sixty participants were randomized to a beginner Kirtan Kriya meditation (KK) program or a music listening (ML) program. Participants were asked to practice 12min daily for the first 12 weeks, then as often as they liked for the following 3 months. Participants underwent assessments at baseline, 12 weeks, and 6 months to evaluate changes in key outcomes. Feasibility and acceptability were evaluated by measuring recruitment and retention rates, assessment visit attendance, practice adherence, and treatment expectancy; exit questionnaires completed at 12 weeks and 6 months provided additional data regarding participant experience with the study, perceived barriers to and facilitators of practice, reasons for drop-out, and views regarding the assigned intervention. Fifty-three participants (88%) completed the 6 month study. Adherence in both groups was excellent, with participants completing 93% (91% KK, 94% ML) of sessions on average in the first 12 weeks, and 71% (68% KK, 74% ML) during the 3 month, practice-optional, follow-up period. At week 12, over 80% of participants indicated they were likely to continue practicing following study completion. Responses to both structured and open-ended exit questionnaire items also suggested high satisfaction with both programs. Findings of this RCT of a beginner meditation practice and a simple ML program suggest that both programs were well accepted and the practices are feasible in adults with early memory loss. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Both resistance training and aerobic training reduce hepatic fat content in type 2 diabetic subjects with nonalcoholic fatty liver disease (the RAED2 Randomized Trial).

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    Bacchi, Elisabetta; Negri, Carlo; Targher, Giovanni; Faccioli, Niccolò; Lanza, Massimo; Zoppini, Giacomo; Zanolin, Elisabetta; Schena, Federico; Bonora, Enzo; Moghetti, Paolo

    2013-10-01

    Although lifestyle interventions are considered the first-line therapy for nonalcoholic fatty liver disease (NAFLD), which is extremely common in people with type 2 diabetes, no intervention studies have compared the effects of aerobic (AER) or resistance (RES) training on hepatic fat content in type 2 diabetic subjects with NAFLD. In this randomized controlled trial, we compared the 4-month effects of either AER or RES training on insulin sensitivity (by hyperinsulinemic euglycemic clamp), body composition (by dual-energy X-ray absorptiometry), as well as hepatic fat content and visceral (VAT), superficial (SSAT), and deep (DSAT) subcutaneous abdominal adipose tissue (all quantified by an in-opposed-phase magnetic resonance imaging technique) in 31 sedentary adults with type 2 diabetes and NAFLD. After training, hepatic fat content was markedly reduced (P AER and the RES training groups (mean relative reduction from baseline [95% confidence interval] -32.8% [-58.20 to -7.52] versus -25.9% [-50.92 to -0.94], respectively). Additionally, hepatic steatosis (defined as hepatic fat content >5.56%) disappeared in about one-quarter of the patients in each intervention group (23.1% in the AER group and 23.5% in the RES group). Insulin sensitivity during euglycemic clamp was increased, whereas total body fat mass, VAT, SSAT, and hemoglobin A1c were reduced comparably in both intervention groups. This is the first randomized controlled study to demonstrate that resistance training and aerobic training are equally effective in reducing hepatic fat content among type 2 diabetic patients with NAFLD. Copyright © 2013 by the American Association for the Study of Liver Diseases.

  10. Acute effect of oatmeal on subjective measures of appetite and satiety compared to a ready-to-eat breakfast cereal: a randomized crossover trial.

    Science.gov (United States)

    Rebello, Candida J; Johnson, William D; Martin, Corby K; Xie, Wenting; O'Shea, Marianne; Kurilich, Anne; Bordenave, Nicolas; Andler, Stephanie; van Klinken, B Jan Willem; Chu, Yi-Fang; Greenway, Frank L

    2013-01-01

    The physicochemical properties of soluble oat fiber (β-glucan) affect viscosity-dependent mechanisms that influence satiety. The objective of this study was to compare the satiety impact of oatmeal with the most widely sold ready-to-eat breakfast cereal (RTEC) when either was consumed as a breakfast meal. Forty-eight healthy individuals ≥18 years of age were enrolled in a randomized crossover trial. Following an overnight fast, subjects consumed either oatmeal or RTEC in random order at least a week apart. The breakfasts were isocaloric and contained 363 kcal (250 kcal cereal, 113 kcal milk). Visual analogue scales measuring appetite and satiety were completed before breakfast and throughout the morning. The content and physicochemical properties of oat β-glucan were determined. Appetite and satiety responses were analyzed by area under the curve (AUC). Physicochemical properties were analyzed using t tests. Oatmeal, higher in fiber and protein but lower in sugar than the RTEC, resulted in greater increase in fullness (AUC: p = 0.005 [120 minute: p = 0.0408, 180 minute: p = 0.0061, 240 minute: p = 0.0102]) and greater reduction in hunger (AUC: p = 0.0009 [120 minute: p = 0.0197, 180 minute: p = 0.0003, 240 minute: p = 0.0036]), desire to eat (AUC: p = 0.0002 [120 minute: p = 0.0168, 180 minute: p Oatmeal had higher β-glucan content, higher molecular weight (p Oatmeal improves appetite control and increases satiety. The effects may be attributed to the viscosity and hydration properties of its β-glucan content.

  11. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine.

    Science.gov (United States)

    de Hoon, Jan; Van Hecken, Anne; Vandermeulen, Corinne; Yan, Lucy; Smith, Brian; Chen, Jiyun Sunny; Bautista, Edgar; Hamilton, Lisa; Waksman, Javier; Vu, Thuy; Vargas, Gabriel

    2017-07-24

    Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) signaling are being explored as prophylactic treatments for migraine. Erenumab (AMG 334) is the first potent, selective, and competitive human mAb antagonist of the CGRP receptor. We report the data from two phase I studies assessing the safety, pharmacokinetics (PK), and pharmacodynamics of single and multiple administrations of erenumab in healthy subjects and patients with migraine. The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin G2 antibodies. Single doses of erenumab resulted in >75% inhibition of capsaicin-induced dermal blood flow, with no apparent dose-dependency for erenumab ≥21 mg. Erenumab was generally well tolerated, with an acceptable safety profile, supporting further clinical development of erenumab for migraine prevention. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  12. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Science.gov (United States)

    Jonsdottir, Johanna; Thorsen, Rune; Aprile, Irene; Galeri, Silvia; Spannocchi, Giovanna; Beghi, Ettore; Bianchi, Elisa; Montesano, Angelo; Ferrarin, Maurizio

    2017-01-01

    Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Multicenter randomized controlled trial. Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of

  13. Aceneuramic Acid Extended Release Administration Maintains Upper Limb Muscle Strength in a 48-week Study of Subjects with GNE Myopathy: Results from a Phase 2, Randomized, Controlled Study

    Science.gov (United States)

    Argov, Zohar; Caraco, Yoseph; Lau, Heather; Pestronk, Alan; Shieh, Perry B.; Skrinar, Alison; Koutsoukos, Tony; Ahmed, Ruhi; Martinisi, Julia; Kakkis, Emil

    2016-01-01

    Background: GNE Myopathy (GNEM) is a progressive adult-onset myopathy likely caused by deficiency of sialic acid (SA) biosynthesis. Objective: Evaluate the safety and efficacy of SA (delivered by aceneuramic acid extended-release [Ace-ER]) as treatment for GNEM. Methods: A Phase 2, randomized, double-blind, placebo-controlled study evaluating Ace-ER 3 g/day or 6 g/day versus placebo was conducted in GNEM subjects (n = 47). After the first 24 weeks, placebo subjects crossed over to 3 g/day or 6 g/day for 24 additional weeks (dose pre-assigned during initial randomization). Assessments included serum SA, muscle strength by dynamometry, functional assessments, clinician- and patient-reported outcomes, and safety. Results: Dose-dependent increases in serum SA levels were observed. Supplementation with Ace-ER resulted in maintenance of muscle strength in an upper extremity composite (UEC) score at 6 g/day compared with placebo at Week 24 (LS mean difference +2.33 kg, p = 0.040), and larger in a pre-specified subgroup able to walk ≥200 m at Screening (+3.10 kg, p = 0.040). After cross-over, a combined 6 g/day group showed significantly better UEC strength than a combined 3 g/day group (+3.46 kg, p = 0.0031). A similar dose-dependent response was demonstrated within the lower extremity composite score, but was not significant (+1.06 kg, p = 0.61). The GNEM-Functional Activity Scale demonstrated a trend improvement in UE function and mobility in a combined 6 g/day group compared with a combined 3 g/day group. Patients receiving Ace-ER tablets had predominantly mild-to-moderate AEs and no serious adverse events. Conclusions: This is the first clinical study to provide evidence that supplementation with SA delivered by Ace-ER may stabilize muscle strength in individuals with GNEM and initiating treatment earlier in the disease course may lead to better outcomes. PMID:27854209

  14. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

    Directory of Open Access Journals (Sweden)

    Johanna Jonsdottir

    Full Text Available Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT. Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible.Multicenter randomized controlled trial.Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT or conventional rehabilitation care including TOT (C-TOT. Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT, Upper Extremity Fugl-Meyer Assessment (FMA-UE scores and Disability of the Arm Shoulder and Hand questionnaire.Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1 of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0 and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5. Considering subacute subjects (time since stroke < 6 months, there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9% than in the C-TOT group (33.2% (difference in proportion improved 24.7%; 95% CI -4.0; 48.6, though the study did not meet the planned sample size.This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery

  15. Resveratrol does not influence metabolic risk markers related to cardiovascular health in overweight and slightly obese subjects: a randomized, placebo-controlled crossover trial.

    Directory of Open Access Journals (Sweden)

    Sanne M van der Made

    Full Text Available In vitro and animal studies have shown positive effects of resveratrol on lipid and lipoprotein metabolism, but human studies specifically designed to examine these effects are lacking.The primary outcome parameter of this study in overweight and slightly obese subjects was the effect of resveratrol on apoA-I concentrations. Secondary outcome parameters were effects on other markers of lipid and lipoprotein metabolism, glucose metabolism, and markers for inflammation and endothelial function.This randomized, placebo-controlled crossover study was conducted in 45 overweight and slightly obese men (n = 25 and women (n = 20 with a mean age of 61 ± 7 years. Subjects received in random order resveratrol (150 mg per day or placebo capsules for 4 weeks, separated by a 4-week wash-out period. Fasting blood samples were collected at baseline and at the end of each intervention period.Compliance was excellent as indicated by capsule count and changes in resveratrol and dihydroresveratrol concentrations. No difference between resveratrol and placebo was found in any of the fasting serum or plasma metabolic risk markers (mean ± SD for differences between day 28 values of resveratrol vs. placebo: apoA-I; 0.00 ± 0.12 g/L (P = 0.791, apoB100; -0.01 ± 0.11 g/L (P = 0.545, HDL cholesterol; 0.00 ± 0.09 mmol/L (P = 0.721, LDL cholesterol -0.03 ± 0.57 mmol/L (P = 0.718, triacylglycerol; 0.10 ± 0.54 mmol/L (P = 0.687, glucose; -0.08 ± 0.28 mmol/L (P = 0.064, insulin; -0.3 ± 2.5 mU/L (P = 0.516. Also, no effects on plasma markers for inflammation and endothelial function were observed. No adverse events related to resveratrol intake were observed.150 mg of daily resveratrol intake for 4 weeks does not change metabolic risk markers related to cardiovascular health in overweight and slightly obese men and women. Effects on glucose metabolism warrant further study.ClinicalTrials.gov NCT01364961.

  16. Single-chain lipopeptide vaccines for the induction of virus-specific cytotoxic T cell responses in randomly selected populations.

    Science.gov (United States)

    Gras-Masse, H

    2001-12-01

    Effective vaccine development is now taking advantage of the rapidly accumulating information concerning the molecular basis of a protective immune response. Analysts and medicinal chemists have joined forces with immunologists and taken up the clear challenge of identifying immunologically active structural elements and synthesizing them in pure, reproducible forms. Current literature reveals the growing interest for extremely reductionist approaches aiming at producing totally synthetic vaccines that would be fully defined at the molecular level and particularly safe. The sequential information contained in these formulations tends to be minimized to those epitopes which elicit neutralizing antibodies, or cell-mediated responses. In the following review, we describe some of our results in developing fully synthetic, clinically acceptable lipopeptide vaccines for inducing cytotoxic T lymphocytes (CTL) responses in randomly selected populations.

  17. Selecting Optimal Random Forest Predictive Models: A Case Study on Predicting the Spatial Distribution of Seabed Hardness

    Science.gov (United States)

    Li, Jin; Tran, Maggie; Siwabessy, Justy

    2016-01-01

    Spatially continuous predictions of seabed hardness are important baseline environmental information for sustainable management of Australia’s marine jurisdiction. Seabed hardness is often inferred from multibeam backscatter data with unknown accuracy and can be inferred from underwater video footage at limited locations. In this study, we classified the seabed into four classes based on two new seabed hardness classification schemes (i.e., hard90 and hard70). We developed optimal predictive models to predict seabed hardness using random forest (RF) based on the point data of hardness classes and spatially continuous multibeam data. Five feature selection (FS) methods that are variable importance (VI), averaged variable importance (AVI), knowledge informed AVI (KIAVI), Boruta and regularized RF (RRF) were tested based on predictive accuracy. Effects of highly correlated, important and unimportant predictors on the accuracy of RF predictive models were examined. Finally, spatial predictions generated using the most accurate models were visually examined and analysed. This study confirmed that: 1) hard90 and hard70 are effective seabed hardness classification schemes; 2) seabed hardness of four classes can be predicted with a high degree of accuracy; 3) the typical approach used to pre-select predictive variables by excluding highly correlated variables needs to be re-examined; 4) the identification of the important and unimportant predictors provides useful guidelines for further improving predictive models; 5) FS methods select the most accurate predictive model(s) instead of the most parsimonious ones, and AVI and Boruta are recommended for future studies; and 6) RF is an effective modelling method with high predictive accuracy for multi-level categorical data and can be applied to ‘small p and large n’ problems in environmental sciences. Additionally, automated computational programs for AVI need to be developed to increase its computational efficiency and

  18. Selecting Optimal Random Forest Predictive Models: A Case Study on Predicting the Spatial Distribution of Seabed Hardness.

    Directory of Open Access Journals (Sweden)

    Jin Li

    Full Text Available Spatially continuous predictions of seabed hardness are important baseline environmental information for sustainable management of Australia's marine jurisdiction. Seabed hardness is often inferred from multibeam backscatter data with unknown accuracy and can be inferred from underwater video footage at limited locations. In this study, we classified the seabed into four classes based on two new seabed hardness classification schemes (i.e., hard90 and hard70. We developed optimal predictive models to predict seabed hardness using random forest (RF based on the point data of hardness classes and spatially continuous multibeam data. Five feature selection (FS methods that are variable importance (VI, averaged variable importance (AVI, knowledge informed AVI (KIAVI, Boruta and regularized RF (RRF were tested based on predictive accuracy. Effects of highly correlated, important and unimportant predictors on the accuracy of RF predictive models were examined. Finally, spatial predictions generated using the most accurate models were visually examined and analysed. This study confirmed that: 1 hard90 and hard70 are effective seabed hardness classification schemes; 2 seabed hardness of four classes can be predicted with a high degree of accuracy; 3 the typical approach used to pre-select predictive variables by excluding highly correlated variables needs to be re-examined; 4 the identification of the important and unimportant predictors provides useful guidelines for further improving predictive models; 5 FS methods select the most accurate predictive model(s instead of the most parsimonious ones, and AVI and Boruta are recommended for future studies; and 6 RF is an effective modelling method with high predictive accuracy for multi-level categorical data and can be applied to 'small p and large n' problems in environmental sciences. Additionally, automated computational programs for AVI need to be developed to increase its computational efficiency and

  19. Pharmacokinetics, Pharmacodynamics, Tolerability, and Food Effect of Cenerimod, a Selective S1P1 Receptor Modulator in Healthy Subjects

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    Pierre-Eric Juif

    2017-12-01

    Full Text Available The pharmacokinetics, pharmacodynamics, tolerability, and food effect of cenerimod, a potent sphingosine-1-phosphate subtype 1 receptor modulator, were investigated in three sub-studies. Two double-blind, placebo-controlled, randomised studies in healthy male subjects were performed. Cenerimod was administered either as single dose (1, 3, 10 or 25 mg; Study 1 or once daily for 35 days (0.5, 1, 2 or 4 mg; Study 2. A two-period cross-over, open-label study was performed to assess the food effect (1 mg, Study 3. The pharmacokinetic profile of cenerimod was characterised by a tmax of 5.0–6.2 h. Terminal half-life after single and multiple doses ranged from 170 to 199 h and 283 to 539 h, respectively. Food had no relevant effect on the pharmacokinetics of cenerimod. A dose-dependent decrease in lymphocyte count was observed after initiation of cenerimod and reached a plateau (maximum change from baseline: −64% after 20–23 days of treatment. Lymphocyte counts returned to baseline values at end-of-study examination. One serious adverse event of circulatory collapse (25 mg dose group, maximum tolerated dose: 10 mg and adverse events of mild-to-moderate intensity were reported. Treatment initiation was associated with transient decreases in heart rate and blood pressure at doses >1 and ≥10 mg, respectively.

  20. Effect of time of administration on cholesterol-lowering by psyllium: a randomized cross-over study in normocholesterolemic or slightly hypercholesterolemic subjects

    Directory of Open Access Journals (Sweden)

    Edwards Alun L

    2004-09-01

    Full Text Available Abstract Background Reports of the use of psyllium, largely in hypercholesterolemic men, have suggested that it lowers serum cholesterol as a result of the binding of bile acids in the intestinal lumen. Widespread advertisements have claimed an association between the use of soluble fibre from psyllium seed husk and a reduced risk of coronary heart disease. Given the purported mechanism of cholesterol-lowering by psyllium, we hypothesized that there would be a greater effect when psyllium is taken with breakfast than when taken at bedtime. Secondarily, we expected to confirm a cholesterol-lowering effect of psyllium in subjects with "average" cholesterol levels. Methods Sixteen men and 47 women ranging in age from 18 to 77 years [mean 53 +/- 13] with LDL cholesterol levels that were normal or slightly elevated but acceptable for subjects at low risk of coronary artery disease were recruited from general gastroenterology and low risk lipid clinics. Following a one month dietary stabilization period, they received an average daily dose of 12.7 g of psyllium hydrophilic mucilloid, in randomized order, for 8 weeks in the morning and 8 weeks in the evening. Change from baseline was determined for serum total cholesterol, LDL, HDL and triglycerides. Results Total cholesterol for the "AM first" group at baseline, 8 and 16 weeks was 5.76, 5.77 and 5.80 mmol/L and for the "PM first" group the corresponding values were 5.47, 5.61 and 5.57 mmol/L. No effect on any lipid parameter was demonstrated for the group as a whole or in any sub-group analysis. Conclusion The timing of psyllium administration had no effect on cholesterol-lowering and, in fact, no cholesterol-lowering was observed. Conclusions regarding the effectiveness of psyllium for the prevention of heart disease in the population at large may be premature.

  1. Low-dose ticagrelor yields an antiplatelet efficacy similar to that of standard-dose ticagrelor in healthy subjects: an open-label randomized controlled trial.

    Science.gov (United States)

    Li, Pan; Gu, Ying; Yang, Yawei; Chen, Lizhi; Liu, Junmei; Gao, Lihong; Qin, Yongwen; Cai, Quancai; Zhao, Xianxian; Wang, Zhuo; Ma, Liping

    2016-08-24

    Ticagrelor has a greater antiplatelet efficacy than clopidogrel but may be accompanied by an increased risk of bleeding. This study evaluated the antiplatelet effect and pharmacokinetic profile of low-dose ticagrelor in healthy Chinese volunteers. Thirty healthy subjects were randomized to receive standard-dose ticagrelor (180-mg loading dose, 90-mg twice daily [bid] [n = 10]), low-dose ticagrelor (90-mg loading dose, 45-mg bid [n = 10]), or clopidogrel (600-mg loading dose, 75-mg once daily [n = 10]). Platelet reactivity was assessed by using the VerifyNow P2Y12 assay at baseline and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours post-dosing. The ticagrelor and AR-C124910XX concentrations were measured for pharmacokinetic analysis. The percentage inhibition of P2Y12 reaction units was higher in the low-dose and standard-dose ticagrelor group than in the clopidogrel group at 0.5, 1, 2, 4, 8, and 48 hours post-dosing (P ticagrelor doses at any time-point (P > 0.05). The plasma ticagrelor and ARC124910XX concentrations were approximately 2-fold higher with standard-dose versus low-dose ticagrelor. No serious adverse events were reported. In conclusion, low-dose ticagrelor achieved faster and higher inhibition of platelet functions in healthy Chinese subjects than did clopidogrel, with an antiplatelet efficacy similar to that of standard-dose ticagrelor.

  2. Immediate effect of ultrasound and ischemic compression techniques for the treatment of trapezius latent myofascial trigger points in healthy subjects: a randomized controlled study.

    Science.gov (United States)

    Aguilera, F Javier Montañez; Martín, Daniel Pecos; Masanet, Rosana Arnau; Botella, Ana Camps; Soler, Lorena Borja; Morell, Francisco Bosch

    2009-09-01

    The purpose of this study was to determine immediate effects of ischemic compression (IC) and ultrasound (US) for the treatment of myofascial trigger points (MTrPs) in the trapezius muscle. Sixty-six volunteers, all CEU-Cardenal Herrera University, Valencia, Spain, personnel, participated in this study. Subjects were healthy individuals, diagnosed with latent MTrPs in the trapezius muscle. Subjects were randomly placed into 3 groups: G1, which received IC treatment for MTrPs; G2, which received US; and G3 (control), which received sham US. The following data were recorded before and after each treatment: active range of motion (AROM) of cervical rachis measured with a cervical range of motion instrument, basal electrical activity (BEA) of muscle trapezius measured with surface electromyography, and pressure tolerance of MTrP measured with visual analogue scale assessing local pain evoked by the application of 2.5 kg/cm(2) of pressure using a pressure analog algometer. The results showed an immediate decrease in BEA of the trapezius muscle and a reduction of MTrP sensitivity after treatment with both therapeutic modalities. In the case of IC, an improvement of AROM of cervical rachis was also been obtained. In this group of participants, both treatments were shown to have an immediate effect on latent MTrPs. The results show a relation among AROM of cervical rachis, BEA of the trapezius muscle, and MTrP sensitivity of the trapezius muscle gaining short-term positive effects with use of IC.

  3. Bioavailability of fatty acids from krill oil, krill meal and fish oil in healthy subjects--a randomized, single-dose, cross-over trial.

    Science.gov (United States)

    Köhler, Anton; Sarkkinen, Essi; Tapola, Niina; Niskanen, Tarja; Bruheim, Inge

    2015-03-15

    Krill contains two marine omega-3 polyunsaturated fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), mainly bound in phospholipids. Typical products from krill are krill oil and krill meal. Fish oils contain EPA and DHA predominantly bound in triglycerides. The difference in the chemical binding of EPA and DHA has been suggested to affect their bioavailability, but little is known on bioavailability of EPA and DHA in krill meal. This study was undertaken to compare the acute bioavailability of two krill products, krill oil and krill meal, with fish oil in healthy subjects. A randomized, single-dose, single-blind, cross-over, active-reference trial was conducted in 15 subjects, who ingested krill oil, krill meal and fish oil, each containing approx. 1 700 mg EPA and DHA. Fatty acid compositions of plasma triglycerides and phospholipids were measured repeatedly for 72 hours. The primary efficacy analysis was based on the 72 hour incremental area under the curve (iAUC) of EPA and DHA in plasma phospholipid fatty acids. A larger iAUC for EPA and DHA in plasma phospholipid fatty acids was detected after krill oil (mean 89.08±33.36%×h) than after krill meal (mean 44.97±18.07%xh, poil (mean 59.15±22.22%×h, p=0.003). Mean iAUC's after krill meal and after fish oil were not different. A large inter-individual variability in response was observed. EPA and DHA in krill oil had a higher 72-hour bioavailability than in krill meal or fish oil. Our finding that bioavailabilities of EPA and DHA in krill meal and fish oil were not different argues against the interpretation that phospholipids are better absorbed than triglycerides. Longer-term studies using a parameter reflecting tissue fatty acid composition, like erythrocyte EPA plus DHA are needed. NCT02089165.

  4. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects.

    Science.gov (United States)

    Hanes, Vladimir; Chow, Vincent; Zhang, Nan; Markus, Richard

    2017-05-01

    This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 980 and trastuzumab in healthy males. In this single-blind study, 157 healthy males were randomized 1:1:1 to a single 6 mg/kg intravenous infusion of ABP 980, FDA-licensed trastuzumab [trastuzumab (US)], or EU-authorized trastuzumab [trastuzumab (EU)]. Primary endpoints were area under the serum concentration-time curve from time 0 to infinity (AUCinf) and maximum observed serum concentration (C max). To establish equivalence, the geometric mean ratio (GMR) and 90% confidence interval (CI) for C max and AUCinf had to be within the equivalence criteria of 0.80-1.25. The GMRs and 90% CIs for C max and AUCinf, respectively, were: 1.04 (0.99-1.08) and 1.06 (1.00-1.12) for ABP 980 versus trastuzumab (US); 0.99 (0.95-1.03) and 1.00 (0.95-1.06) for ABP 980 versus trastuzumab (EU); and 0.96 (0.92-1.00) and 0.95 (0.90-1.01) for trastuzumab (US) versus trastuzumab (EU). All comparisons were within the equivalence criteria of 0.80-1.25. Treatment-emergent adverse events (TEAEs) were reported in 84.0, 75.0, and 78.2 of subjects in the ABP 980, trastuzumab (US), and trastuzumab (EU) groups, respectively. There were no deaths or TEAEs leading to study discontinuation and no binding or neutralizing anti-drug anti-bodies were detected. This study demonstrated the PK similarity of ABP 980 to both trastuzumab (US) and trastuzumab (EU), and of trastuzumab (US) to trastuzumab (EU). No differences in safety and tolerability between treatments were noted; no subject tested positive for binding anti-bodies.

  5. Prevention of overuse injuries by a concurrent exercise program in subjects exposed to an increase in training load: a randomized controlled trial of 1020 army recruits.

    Science.gov (United States)

    Brushøj, Christoffer; Larsen, Klaus; Albrecht-Beste, Elisabeth; Nielsen, Michael Bachmann; Løye, Finn; Hölmich, Per

    2008-04-01

    It is unknown whether an exercise program can prevent overuse injuries in the lower extremity. An often encountered and important risk factor for the development of lower extremity overuse injuries is an abrupt increase in activity level. A preventive training program based on a literature review of intrinsic risk factors, and performed concurrent with an increase in physical activity, can reduce the incidence of overuse knee injuries and medial tibial stress syndrome, as well as increase running distance. Randomized controlled trial; Level of evidence, 1. A total of 1020 soldiers aged 20.9 years (range, 19-26 years) undergoing 3 months of basic military training consecutively enrolled from December 2004 to December 2005. The prevention program consisted of an exercise program of 15 minutes' duration 3 times a week, including 5 exercises for strength, flexibility, and coordination; the placebo program consisted of 5 exercises for the upper body. During the observation period, 223 subjects sustained an injury, with 50 and 48 of these fulfilling the study criteria for overuse knee injuries or medial tibial stress syndrome, respectively. There were no significant differences in incidence of injury between the prevention group and the placebo group (incidence, 0.22 vs 0.19; P = .162; relative risk = 1.05 [range, 0.98-1.11]). The soldiers in the prevention group had the greater improvement in running distance in 12-minute run tests (82 vs 43 m; P = .037). An exercise program with an emphasis on muscular strengthening, coordination, and flexibility based on intrinsic risk factors identified through a literature review did not influence the risk of developing overuse knee injuries or medial tibial stress syndrome in subjects undergoing an increase in physical activity. The program increased maximal running distance in a 12-minute test.

  6. Well-being, problematic alcohol consumption and acute subjective drug effects in past-year ayahuasca users: a large, international, self-selecting online survey.

    Science.gov (United States)

    Lawn, Will; Hallak, Jaime E; Crippa, Jose A; Dos Santos, Rafael; Porffy, Lilla; Barratt, Monica J; Ferris, Jason A; Winstock, Adam R; Morgan, Celia J A

    2017-11-09

    Ayahuasca is a natural psychedelic brew, which contains dimethyltryptamine (DMT). Its potential as a psychiatric medicine has recently been demonstrated and its non-medical use around the world appears to be growing. We aimed to investigate well-being and problematic alcohol use in ayahuasca users, and ayahuasca's subjective effects. An online, self-selecting, global survey examining patterns of drug use was conducted in 2015 and 2016 (n = 96,901). Questions were asked about: use of ayahuasca, lysergic acid diethylamide (LSD) and magic mushrooms; demographics, current well-being and past-year problematic alcohol use of past-year ayahuasca users and comparison drug users; and subjective effects of ayahuasca and comparison drugs. Ayahuasca users (n = 527) reported greater well-being than both classic psychedelic users (n = 18,138) and non-psychedelic drug-using respondents (n = 78,236). Ayahuasca users reported less problematic drinking than classic psychedelic users, although both groups reported greater problematic drinking than the other respondents. Ayahuasca's acute subjective effects usually lasted for six hours and were most strongly felt one hour after consumption. Within our online, self-selecting survey, ayahuasca users reported better well-being than comparison groups and less problematic drinking than classic psychedelic users. Future longitudinal studies of international samples and randomised controlled trials are needed to dissect the effects of ayahuasca on these outcomes.

  7. Assessing blood brain barrier dynamics or identifying or measuring selected substances, including ethanol or toxins, in a subject by analyzing Raman spectrum signals

    Science.gov (United States)

    Lambert, James L. (Inventor); Borchert, Mark S. (Inventor)

    2008-01-01

    A non-invasive method for analyzing the blood-brain barrier includes obtaining a Raman spectrum of a selected portion of the eye and monitoring the Raman spectrum to ascertain a change to the dynamics of the blood brain barrier.Also, non-invasive methods for determining the brain or blood level of an analyte of interest, such as glucose, drugs, alcohol, poisons, and the like, comprises: generating an excitation laser beam at a selected wavelength (e.g., at a wavelength of about 400 to 900 nanometers); focusing the excitation laser beam into the anterior chamber of an eye of the subject so that aqueous humor, vitreous humor, or one or more conjunctiva vessels in the eye is illuminated; detecting (preferably confocally detecting) a Raman spectrum from the illuminated portion of the eye; and then determining the blood level or brain level (intracranial or cerebral spinal fluid level) of an analyte of interest for the subject from the Raman spectrum. In certain embodiments, the detecting step may be followed by the step of subtracting a confounding fluorescence spectrum from the Raman spectrum to produce a difference spectrum; and determining the blood level and/or brain level of the analyte of interest for the subject from that difference spectrum, preferably using linear or nonlinear multivariate analysis such as partial least squares analysis. Apparatus for carrying out the foregoing methods are also disclosed.

  8. White Grape Juice Elicits a Lower Breath Hydrogen Response Compared with Apple Juice in Healthy Human Subjects: A Randomized Controlled Trial.

    Science.gov (United States)

    Erickson, Jennifer; Wang, Qi; Slavin, Joanne

    2017-06-01

    Diets low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS) are used to manage symptoms in individuals with irritable bowel syndrome. Although effective at reducing symptoms, the diet can be complex and restrictive. In addition, there are still large gaps in the literature and many foods with unclear effects in the gastrointestinal (GI) tract, like fruit juice. Although many fruits are allowable on a low-FODMAP diet, consumption of all fruit juice is generally cautioned due to the large fructose load contained in juice, regardless of the glucose concentration. Very little research exists regarding the importance of limiting fructose load during a low-FODMAP diet; therefore, individuals following a low-FODMAP diet may be unnecessarily restricting their diets. To determine whether there is a difference in GI tolerance between juice from a high-FODMAP fruit (apple juice) and juice from a low-FODMAP fruit (white grape juice) in healthy human subjects. The goal is to provide insight into the role of juice in a low-FODMAP diet. A double-blind, randomized, controlled crossover study was conducted with 40 healthy adults. Fasted subjects consumed 12 oz of either apple juice or white grape juice. Breath hydrogen measures were taken at baseline, 1, 2, and 3 hours. Subjective GI tolerance surveys were completed at the same time intervals and at 12 and 24 hours. Breath hydrogen and GI symptoms were assessed with area under the curve analysis. Significance was determined with a two-sided t test with a P value hydrogen area under the curve at 23.3 ppm/hour (95% CI 13.0 to 33.6) compared with white grape juice at 5.8 ppm/hour (95% CI -4.6 to 16.1) (Phydrogen, which may suggest excluding foods only because of the high fructose load could be unnecessarily restrictive. The results of this study suggest that the fructose-to-glucose ratio is likely more important than the total fructose load of the food when considering the acceptability of a food

  9. In a randomized trial, the live attenuated tetravalent dengue vaccine TV003 is well-tolerated and highly immunogenic in subjects with flavivirus exposure prior to vaccination

    Science.gov (United States)

    Whitehead, Stephen S.; Durbin, Anna P.; Pierce, Kristen K.; Elwood, Dan; McElvany, Benjamin D.; Fraser, Ellen A.; Carmolli, Marya P.; Tibery, Cecilia M.; Hynes, Noreen A.; Jo, Matthew; Lovchik, Janece M.; Larsson, Catherine J.; Doty, Elena A.; Dickson, Dorothy M.; Luke, Catherine J.; Subbarao, Kanta; Kirkpatrick, Beth D.

    2017-01-01

    Infection caused by the four serotypes of dengue virus (DENV-1-4) is a leading cause of mosquito-borne disease. Clinically-severe dengue disease is more common when secondary dengue infection occurs following prior infection with a heterologous dengue serotype. Other flaviviruses such as yellow fever virus, Japanese encephalitis virus, and Zika virus, can also elicit antibodies which are cross-reactive to DENV. As candidate dengue vaccines become available in endemic settings and for individuals who have received other flavivirus vaccines, it is important to examine vaccine safety and immunogenicity in these flavivirus-experienced populations. We performed a randomized, controlled trial of the National Institutes of Health live attenuated tetravalent dengue vaccine candidate (TV003) in fifty-eight individuals with prior exposure to flavivirus infection or vaccine. As in prior studies of this vaccine in flavivirus-naive volunteers, flavivirus-experienced subjects received two doses of vaccine six months apart and were followed closely for clinical events, laboratory changes, viremia, and neutralizing antibody titers. TV003 was well tolerated with few adverse events other than rash, which was predominately mild. Following one dose, 87% of vaccinees had an antibody response to all four serotypes (tetravalent response), suggesting a robust immune response. In addition, 76% of vaccinees were viremic; mean peak titers ranged from 0.68–1.1 log10 PFU/mL and did not differ by serotype. The second dose of TV003 was not associated with viremia, rash, or a sustained boost in antibody titers indicating that a single dose of the vaccine is likely sufficient to prevent viral replication and thus protect against disease. In comparison to the viremia and neutralizing antibody response elicited by TV003 in flavivirus-naïve subjects from prior studies, we found that subjects who were flavivirus-exposed prior to vaccination exhibited slightly higher DENV-3 viremia, higher

  10. Twelve-week physical and leisure activity programme improved cognitive function in community-dwelling elderly subjects: a randomized controlled trial.

    Science.gov (United States)

    Kamegaya, Tadahiko; Araki, Yumi; Kigure, Hanami; Yamaguchi, Haruyasu

    2014-03-01

    Japan is one of the most rapidly ageing societies in the world. A number of municipalities have started services for the prevention of cognitive decline for community-dwelling elderly individuals, but the effectiveness of these services is currently insufficient. Our study explored the efficacy of a comprehensive intervention programme consisting of physical and leisure activities to prevent cognitive decline in community-dwelling elderly subjects. We administered a 12-week intervention programme consisting of physical and leisure activities aimed at enhancing participants' motivation to participate and support one another by providing a pleasant atmosphere, empathetic communication, praise, and errorless support. This programme for the prevention of cognitive decline was conducted as a service by the city of Maebashi. All participants underwent the Five-Cog test, which evaluated the cognitive domains of attention, memory, visuospatial function, language, and reasoning. Executive function was evaluated by the Wechsler Digit Symbol Substitution Test and Yamaguchi Kanji-Symbol Substitution Test. Subjective health status, level of social support, functional capacity, subjective quality of life, and depressive symptoms were assessed with a questionnaire. Grip strength test, timed up-and-go test, 5-m maximum walking times test, and functional reach test were performed to evaluate physical function. Fifty-two participants were randomly allocated to intervention (n = 26) and control (n = 26) groups. Twenty-six participants, aged between 65-87 years, received intervention once a week at a community centre. The programme was conducted by health-care professionals, with the help of senior citizen volunteers. The intervention group (n = 19) showed significant improvement on the analogy task of the Five-Cog test (F(1,38) = 4.242, P = 0.046) and improved quality of life (F(1,38) = 4.773, P = 0.035) as compared to the control group (n = 24). A community-based 12-week

  11. Regular consumption of vitamin D-fortified yogurt drink (Doogh improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Shab-Bidar Sakineh

    2011-11-01

    Full Text Available Abstract Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D. In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Methods Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50 or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50 twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP-9 were evaluated at the beginning and after the 12-week intervention period. Results The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI, glycated hemoglobin (HbA1c, triacylglycerols, high-density lipoprotein cholesterol (HDL-C, endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P P = 0.009 and P = 0.005, respectively but disappeared for E-selectin (P = 0.092. On the contrary, after controlling for serum 25(OHD, the differences disappeared for endothelin-1(P = 0.066 and MMP-9 (P = 0.277 but still remained significant for E-selectin (P = 0.011. Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status, lipid profile and endothelial biomarkers in T2D subjects. Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers. Trial registration

  12. Regular consumption of vitamin D-fortified yogurt drink (Doogh) improved endothelial biomarkers in subjects with type 2 diabetes: a randomized double-blind clinical trial.

    Science.gov (United States)

    Shab-Bidar, Sakineh; Neyestani, Tirang R; Djazayery, Abolghassem; Eshraghian, Mohammad-Reza; Houshiarrad, Anahita; Gharavi, A'azam; Kalayi, Ali; Shariatzadeh, Nastaran; Zahedirad, Malihe; Khalaji, Niloufar; Haidari, Homa

    2011-11-24

    Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease, the major cause of death in diabetes. We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes (T2D). In this study, the effects of improvement of vitamin D status on glycemic status, lipid profile and endothelial biomarkers in T2D subjects were investigated. Subjects with T2D were randomly allocated to one of the two groups to receive either plain yogurt drink (PYD; containing 170 mg calcium and no vitamin D/250 mL, n1 = 50) or vitamin D3-fortified yogurt drink (FYD; containing 170 mg calcium and 500 IU/250 mL, n2 = 50) twice a day for 12 weeks. Anthropometric measures, glycemic status, lipid profile, body fat mass (FM) and endothelial biomarkers including serum endothelin-1, E-selectin and matrix metalloproteinase (MMP)-9 were evaluated at the beginning and after the 12-week intervention period. The intervention resulted in a significant improvement in fasting glucose, the Quantitative Insulin Check Index (QUICKI), glycated hemoglobin (HbA1c), triacylglycerols, high-density lipoprotein cholesterol (HDL-C), endothelin-1, E-selectin and MMP-9 in FYD compared to PYD (P < 0.05, for all). Interestingly, difference in changes of endothelin-1, E-selectin and MMP-9 concentrations in FYD compared to PYD (-0.35 ± 0.63 versus -0.03 ± 0.55, P = 0.028; -3.8 ± 7.3 versus 0.95 ± 8.3, P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL, respectively, P < 0.05 for all), even after controlling for changes of QUICKI, FM and waist circumference, remained significant for endothelin-1 and MMP-9 (P = 0.009 and P = 0.005, respectively) but disappeared for E-selectin (P = 0.092). On the contrary, after controlling for serum 25(OH)D, the differences disappeared for endothelin-1(P = 0.066) and MMP-9 (P = 0.277) but still remained significant for E-selectin (P = 0

  13. Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.

    Science.gov (United States)

    Mehta, Rashmi; Green, Michelle; Patel, Bela; Wagg, Jonathan

    2016-04-01

    The long-acting muscarinic antagonist umeclidinium (UMEC) is approved as a once-daily monotherapy and in combination with the long-acting β2 agonist vilanterol (VI) for chronic obstructive pulmonary disease. The objective of this analysis was to assess the relationship between observed plasma UMEC and/or VI concentrations and QT interval corrected using Fridericia's correction (QTcF). 103 subjects were enrolled and 86 (83 %) completed the study. Subjects were randomized to 4 of 5 repeat-dose treatments (days 1-10: n = 77 subjects received placebo, n = 76 UMEC 500 µg, n = 78 UMEC/VI 125/25 µg, or n = 76 UMEC/VI 500/100 µg; day 10: n = 74 oral tablet moxifloxacin 400 mg [positive control]). The concentration-QTcF interval relationship was examined using nonlinear mixed-effects methods. For UMEC, predicted QTcF interval prolongation (at observed geometric mean of maximum plasma concentrations) was -2.38 ms (90 % prediction interval [PI] -3.82, -0.85) with UMEC 500 µg and -0.50 ms (90 % PI -0.80, -0.18) and -2.01 ms (90 % PI -3.22, -0.72) with UMEC/VI 125/25 µg and 500/100 µg, respectively. For VI, estimates were 5.89 ms (90 % PI 4.89, 6.91) and 7.23 ms (90 % PI 5.88, 8.55) with UMEC/VI 125/25 µg and 500/100 µg, respectively. Combined additive mean effects were estimated for UMEC/VI 125/25 µg (5.39 ms [90 % PI 4.40, 6.47]) and 500/100 µg (5.22 ms [90 % PI 3.72, 6.80]). The model-predicted decrease with UMEC and increase with UMEC/VI combination in QTcF interval suggest that the QT effect is likely attributable to VI. These model-predicted results support those of previously-published traditional statistical analyses.

  14. The Effect of a Vegetarian vs Conventional Hypocaloric Diabetic Diet on Thigh Adipose Tissue Distribution in Subjects with Type 2 Diabetes: A Randomized Study.

    Science.gov (United States)

    Kahleova, Hana; Klementova, Marta; Herynek, Vit; Skoch, Antonin; Herynek, Stepan; Hill, Martin; Mari, Andrea; Pelikanova, Terezie

    2017-07-01

    The aim of our study was to compare the effects of a vegetarian and a conventional diet on thigh adipose tissue distribution in subjects with type 2 diabetes (T2D). Seventy-four subjects with T2D were randomly assigned to either follow a vegetarian diet (V, n = 37) or a control group who followed an isocaloric conventional anti-diabetic diet (C, n = 37). Both diets were calorie restricted (-500 kcal/day). To measure insulin sensitivity, the hyperinsulinemic (1 mU.kg(-1).min(-1)) isoglycemic clamp was conducted. β-Cell function was assessed using a mathematical model after a test meal. Magnetic resonance imaging of the thigh was performed. All subjects were examined at 0, 3, and 6 months. Statistical analyses were performed using repeated measures analysis of variance and a multivariate regression model. Greater reduction was observed in total leg area in V (-13.6 cm(2) [95% confidence interval [CI], -14.2 to -12.9] in V vs -9.9 cm(2) [95% CI, -10.6 to -9.2] in C; Gxt p vegetarian diet (-0.82 [95% CI, -1.13 to -0.55] cm(2) in V vs -0.44 [95% CI, -0.78 to +0.02] cm(2) in C; Gxt, p = 0.04). The reduction in intramuscular fat tended to be greater in response to a vegetarian diet (-1.78 [95% CI, -2.26 to -1.27] cm(2) in V vs -0.57 [95% CI, -1.06 to -0.09] cm(2) in C; Gxt, p = 0.12). Changes in subcutaneous and subfascial fat correlated with changes in glycated hemoglobin (HbA1c), fasting plasma glucose, and β-cell insulin sensitivity. After adjustment for changes in body mass index (BMI), correlations remained significant for changes in fasting plasma glucose and β-cell insulin sensitivity and with changes in triglycerides. Our data indicate the importance of both subcutaneous and subfascial fat in relationship to glucose and lipid metabolism. BMI , body mass index; C , control group; FPG , fasting plasma glucose; Gxt , interaction between group and time; HbA1c , glycated hemoglobin; MCR , metabolic clearance rate of glucose; OPLS , orthogonal projections to

  15. Repetitive Intermittent Hypoxia and Locomotor Training Enhances Walking Function in Incomplete Spinal Cord Injury Subjects: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    Navarrete-Opazo, Angela; Alcayaga, Julio; Sepúlveda, Oscar; Rojas, Enrique; Astudillo, Carolina

    2017-05-01

    Incomplete spinal cord injuries (iSCI) leave spared synaptic pathways below the level of injury. Intermittent hypoxia (IH) elicits plasticity in the spinal cord and strengthens spared synaptic pathways, expressed as respiratory and somatic functional recovery in experimental animals and humans with iSCI. This study is a randomized, triple-blind, two-arm parallel clinical trial performed in Santiago, Chile. We compared the effects of a 4-week protocol of IH combined with body weight-supported treadmill training (BWSTT), with continuous normoxia (Nx) and BWSTT on 10-meter walk test (10MWT), 6-minute walk test (6MWT), and timed up and go (TUG) test in American Spinal Injury Association C and D individuals with iSCI. Subjects received daily IH (cycling 9%/21% O 2 every 1.5 min, 15 cycles/day) or continuous Nx (21% O 2 ) combined with 45 min BWSTT for 5 consecutive days, followed by IH/Nx 3 × per week (3 × wIH/Nx) for 3 additional weeks. Subjects were assessed at day 5, weekly from weeks 2-4, and at a 2-week follow-up. Daily IH plus BWSTT enhanced walking speed, expressed as decreased 10MWT time at day 5 versus baseline (IH: -10.2 ± 3.0 vs. Nx: -1.7 ± 1.7 sec, p = 0.006), and walking endurance expressed as increased 6MWT distance at day 5 versus baseline (IH: 43.0 ± 10.7 vs. Nx: 6.1 ± 3.4 m, p = 0.012), but not TUG time. Further, 3 × wIH maintained the daily IH-induced walking speed, and enhanced the daily IH-induced walking endurance, which is maintained up to the 2-week follow-up. We conclude that daily IH enhances walking recovery in subjects with iSCI, confirming previous findings. Moreover, 3 × wIH prolonged or enhanced daily IH-induced walking speed and endurance improvements, respectively, up to 5 weeks post-daily IH. Repetitive IH may be a safe and effective therapeutic alternative for persons with iSCI.

  16. Effects of a healthy Nordic diet on plasma 25-hydroxyvitamin D concentration in subjects with metabolic syndrome: a randomized, [corrected] controlled trial (SYSDIET).

    Science.gov (United States)

    Brader, Lea; Rejnmark, Lars; Carlberg, Carsten; Schwab, Ursula; Kolehmainen, Marjukka; Rosqvist, Fredrik; Cloetens, Lieselotte; Landin-Olsson, Mona; Gunnarsdottir, Ingibjorg; Poutanen, Kaisa S; Herzig, Karl-Heinz; Risérus, Ulf; Savolainen, Markku J; Thorsdottir, Inga; Uusitupa, Matti; Hermansen, Kjeld

    2014-06-01

    At northern latitudes, vitamin D is not synthesized endogenously during winter, causing low plasma 25-hydroxyvitamin D (25(OH)D) concentrations. Therefore, we evaluated the effects of a healthy Nordic diet based on Nordic nutrition recommendations (NNR) on plasma 25(OH)D and explored its dietary predictors. In a Nordic multi-centre trial, subjects (n = 213) with metabolic syndrome were randomized to a control or a healthy Nordic diet favouring fish (≥300 g/week, including ≥200 g/week fatty fish), whole-grain products, berries, fruits, vegetables, rapeseed oil and low-fat dairy products. Plasma 25(OH)D and parathyroid hormone were analysed before and after 18- to 24-week intervention. At baseline, 45 % had vitamin D inadequacy (hormone (P = 0.207) were not altered by the healthy Nordic diet. Predictors for 25(OH)D were intake of vitamin D, eicosapentaenoic acids (EPA), docosahexaenoic acids (DHA), vitamin D supplement, plasma EPA and plasma DHA. Nevertheless, only vitamin D intake and season predicted the 25(OH)D changes. Consuming a healthy Nordic diet based on NNR increased vitamin D intake but not plasma 25(OH)D concentration. The reason why fish consumption did not improve vitamin D status might be that many fish are farmed and might contain little vitamin D or that frying fish may result in vitamin D extraction. Additional ways to improve vitamin D status in Nordic countries may be needed.

  17. Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial.

    Science.gov (United States)

    Malinvaud, D; Londero, A; Niarra, R; Peignard, Ph; Warusfel, O; Viaud-Delmon, I; Chatellier, G; Bonfils, P

    2016-03-01

    Subjective tinnitus (ST) is a frequent audiologic condition that still requires effective treatment. This study aimed at evaluating two therapeutic approaches: Virtual Reality (VR) immersion in auditory and visual 3D environments and Cognitive Behaviour Therapy (CBT). This open, randomized and therapeutic equivalence trial used bilateral testing of VR versus CBT. Adult patients displaying unilateral or predominantly unilateral ST, and fulfilling inclusion criteria were included after giving their written informed consent. We measured the different therapeutic effect by comparing the mean scores of validated questionnaires and visual analog scales, pre and post protocol. Equivalence was established if both strategies did not differ for more than a predetermined limit. We used univariate and multivariate analysis adjusted on baseline values to assess treatment efficacy. In addition of this trial, purely exploratory comparison to a waiting list group (WL) was provided. Between August, 2009 and November, 2011, 148 of 162 screened patients were enrolled (VR n = 61, CBT n = 58, WL n = 29). These groups did not differ at baseline for demographic data. Three month after the end of the treatment, we didn't find any difference between VR and CBT groups either for tinnitus severity (p = 0.99) or tinnitus handicap (p = 0.36). VR appears to be at least as effective as CBT in unilateral ST patients. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Pharmacodynamic consequences of administration of VLA-4 antagonist CDP323 to multiple sclerosis subjects: a randomized, double-blind phase 1/2 study.

    Directory of Open Access Journals (Sweden)

    Christian Wolf

    Full Text Available Lymphocyte inhibition by antagonism of α4 integrins is a validated therapeutic approach for relapsing multiple sclerosis (RMS.Investigate the effect of CDP323, an oral α4-integrin inhibitor, on lymphocyte biomarkers in RMS.Seventy-one RMS subjects aged 18-65 years with Expanded Disability Status Scale scores ≤6.5 were randomized to 28-day treatment with CDP323 100 mg twice daily (bid, 500 mg bid, 1000 mg once daily (qd, 1000 mg bid, or placebo.Relative to placebo, all dosages of CDP323 significantly decreased the capacity of lymphocytes to bind vascular adhesion molecule-1 (VCAM-1 and the expression of α4-integrin on VCAM-1-binding cells. All but the 100-mg bid dosage significantly increased total lymphocytes and naive B cells, memory B cells, and T cells in peripheral blood compared with placebo, and the dose-response relationship was shown to be linear. Marked increases were also observed in natural killer cells and hematopoietic progenitor cells, but only with the 500-mg bid and 1000-mg bid dosages. There were no significant changes in monocytes. The number of samples for regulator and inflammatory T cells was too small to draw any definitive conclusions.CDP323 at daily doses of 1000 or 2000 mg induced significant increases in total lymphocyte count and suppressed VCAM-1 binding by reducing unbound very late antigen-4 expression on lymphocytes.ClinicalTrials.gov NCT00726648.

  19. Comparative bioavailability and pharmacokinetics of two oral formulations of flurbiprofen: a single-dose, randomized, open-label, two-period, crossover study in Pakistani subjects.

    Science.gov (United States)

    Qayyum, Aisha; Najmi, Muzammil Hasan; Abbas, Mateen

    2013-11-01

    Comparative bioavailability studies are conducted to establish the bioequivalence of generic formulation with that of branded reference formulation, providing confidence to clinicians to use these products interchangeably. This study was carried out to compare a locally manufactured formulation of flurbiprofen with that of a branded product. Twenty two healthy male adults received a single dose of flurbiprofen (100mg) either generic or branded product according to randomization scheme on each of 2 periods. Blood samples were collected and plasma flurbiprofen concentration was determined by a validated HPLC method. Pharmacokinetic parameters like AUC(0-t), AUC(0-oo), Cmax, Tmax, t½, Vd and clearance were determined. The 90% CI for the ratio of geometric means of test to reference product's pharmacokinetic variables was calculated. Pharmacokinetic parameters for two formulations were comparable. Ratio of means of AUC(0-24), AUC(0-oo) and Cmax for test to reference products and 90% CI for these ratios were within the acceptable range. The p-values calculated by TOST were much less than the specified value (p-0.05). ANOVA gave p-values which were more than the specified value (p-0.05) for sequence, subject, period and formulation. Test formulation of flurbiprofen (tablet Flurso) was found to meet the criteria for bioequivalence to branded product (tablet Ansaid) based on pharmacokinetic parameters.

  20. Effectiveness of Kinesio Taping for Hand on Grip Strength and Upper Limb Function in Subjects with Cervical Radiculopathy: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Shruti Prabhu

    2017-08-01

    Full Text Available Cervical radiculopathy is common condition seen today. It is found to associate with upper limb dysfunction which in turn hinders daily activity due to muscular weakness. Grip strength is found to be reduced in cervical radiculopathy and is taken to be a good measure of upper limb function. Treatment of cervical radiculopathy is mainly concentrated over neck region and very less has been done to improve upper limb function. Kinesio taping is found to improve muscle activity and can be used to improve grip strength and function in cervical radiculopathy. Method: 32 subjects with unilateral cervical radiculopathy were randomly divided into 2 groups, experimental and conventional group (n=16. The conventional group was given intermittent cervical traction, hot moist pack, TENS and exercises and experimental group was given conventional treatment along with kinesio taping to extensor aspect of forearm. Preand post-values for grip and pinch strength and NDI and DASH were assessed and analysed. Result: There was marked improvement seen both groups, but there was significant improvement in grip and pinch strength seen in experimental group while there was improvement seen functional outcomes namely NDI and DASH. This suggests that kinesio taping does not play a role in improving grip strength but can improve upper limb function.

  1. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Micka, Antje; Siepelmeyer, Anne; Holz, Anja; Theis, Stephan; Schön, Christiane

    2017-02-01

    Constipation is among the most common health impairments in Western countries. This study aimed to determine the effect of the chicory-derived fermentable dietary fiber Orafti ® Inulin on stool frequency in healthy subjects with constipation. The study was conducted according to recent guidance documents for investigating bowel function and used a randomized, double-blind, placebo-controlled, cross-over design with a 2-week wash-out phase. Each study period comprised a run-in phase followed by 4 weeks daily intake of 3 × 4g inulin or maltodextrin (placebo). Forty-four healthy volunteers with constipation documented stool frequency and consistency, gastrointestinal characteristics and quality of life. Consumption of Orafti ® Inulin significantly increased stool frequency compared to placebo (median 4.0 [IQR 2.5-4.5] versus 3.0 [IQR 2.5-4.0] stools/week, p = 0.038). This was accompanied by a softening of stools and trend toward higher satisfaction versus placebo (p = 0.059). In conclusion, Orafti ® Inulin was effective in volunteers with chronic constipation and significantly improved bowel function. This trial was registered at clinicaltrials.gov as NCT02548247.

  2. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

    Science.gov (United States)

    Vahdatpour, Babak; Sajadieh, Sepideh; Bateni, Vahid; Karami, Mehdi; Sajjadieh, Hamidreza

    2012-01-01

    Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT) in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm2) in 3 sessions at weekly intervals) or sham therapy (n = 20 in each group). Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients’ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results: The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy. PMID:23826009

  3. A phase 1, randomized ascending single-dose study of antagonist anti-human CD40 ASKP1240 in healthy subjects.

    Science.gov (United States)

    Goldwater, R; Keirns, J; Blahunka, P; First, R; Sawamoto, T; Zhang, W; Kowalski, D; Kaibara, A; Holman, J

    2013-04-01

    This first-in-human, phase I study evaluated the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ASKP1240 in healthy subjects. Twelve sequential groups (each 6 active and 3 placebo) were randomly assigned to placebo or single ascending doses of intravenous ASKP1240 (0.00003-10 mg/kg). ASKP1240 exhibited nonlinear pharmacokinetics, with mean maximal serum concentrations and area under the serum concentration-time curves ranging from 0.7 to 251.6 μg/mL and 6.5 to 55409.6 h·μg/mL following doses 0.1 mg/kg-10 mg/kg, respectively. CD40 receptor occupancy by ASKP1240, which was dose-dependent, reached a maximum at doses above 0.01 mg/kg. ASKP1240 was well tolerated, with no evidence of cytokine release syndrome or thromboembolic events. Treatment emergent antibodies to ASKP1240 were detected in 5/70 (7.1%) ASKP1240 recipients. In conclusion, antagonism of the CD40/CD154 interaction with ASKP1240 was safe and well tolerated at the doses tested. © Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.

  4. Beneficial Effects of Pterocarpan-High Soybean Leaf Extract on Metabolic Syndrome in Overweight and Obese Korean Subjects: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ri Ryu

    2016-11-01

    Full Text Available Pterocarpans are known to have antifungal and anti-inflammatory properties. However, little is known about the changes in transcriptional profiles in response to a pterocarpan-high soybean leaf extract (PT. Therefore, this study investigated the effects of PT on blood glucose and lipid levels, as well as on the inflammation-related gene expression based on a peripheral blood mononuclear cells (PBMCs mRNA sequencing analysis in Korean overweight and obese subjects with mild metabolic syndrome. The participants were randomly assigned to two groups and were administered either placebo (starch, 3 g/day or PT (2 g/day for 12 weeks. The PT intervention did not change body weight, body fat percentage and body mass index (BMI. However, PT significantly decreased the glycosylated hemoglobin (HbA1c, plasma glucose, free fatty acid, total cholesterol, and non-HDL cholesterol levels after 12 weeks. Furthermore, PT supplementation significantly lowered the homeostatic index of insulin resistance, as well as the plasma levels of inflammatory markers. Finally, the mRNA sequencing analysis revealed that PT downregulated genes related to immune responses. PT supplementation is beneficial for the improvement of metabolic syndrome by altering the fasting blood and plasma glucose, HbA1c, plasma lipid levels and inflammation-related gene expression in PBMCs.

  5. Beneficial Effects of Pterocarpan-High Soybean Leaf Extract on Metabolic Syndrome in Overweight and Obese Korean Subjects: Randomized Controlled Trial.

    Science.gov (United States)

    Ryu, Ri; Jeong, Tae-Sook; Kim, Ye Jin; Choi, Ji-Young; Cho, Su-Jung; Kwon, Eun-Young; Jung, Un Ju; Ji, Hyeon-Seon; Shin, Dong-Ha; Choi, Myung-Sook

    2016-11-18

    Pterocarpans are known to have antifungal and anti-inflammatory properties. However, little is known about the changes in transcriptional profiles in response to a pterocarpan-high soybean leaf extract (PT). Therefore, this study investigated the effects of PT on blood glucose and lipid levels, as well as on the inflammation-related gene expression based on a peripheral blood mononuclear cells (PBMCs) mRNA sequencing analysis in Korean overweight and obese subjects with mild metabolic syndrome. The participants were randomly assigned to two groups and were administered either placebo (starch, 3 g/day) or PT (2 g/day) for 12 weeks. The PT intervention did not change body weight, body fat percentage and body mass index (BMI). However, PT significantly decreased the glycosylated hemoglobin (HbA1c), plasma glucose, free fatty acid, total cholesterol, and non-HDL cholesterol levels after 12 weeks. Furthermore, PT supplementation significantly lowered the homeostatic index of insulin resistance, as well as the plasma levels of inflammatory markers. Finally, the mRNA sequencing analysis revealed that PT downregulated genes related to immune responses. PT supplementation is beneficial for the improvement of metabolic syndrome by altering the fasting blood and plasma glucose, HbA1c, plasma lipid levels and inflammation-related gene expression in PBMCs.

  6. Reproducibility and seasonal variation of ambulatory short-term heart rate variability in healthy subjects during a self-selected rest period and during sleep.

    Science.gov (United States)

    Kristiansen, Jesper; Olsen, Annemarie; Skotte, Jørgen H; Garde, Anne Helene

    2009-01-01

    Although ambulatory measurements of heart rate variability (HRV) are widely used, the reproducibility and seasonal variation of ambulatory sampled short-term HRV measurements in healthy participants has not been investigated before. In the present study we collected ambulatory ECGs from 19 healthy participants monthly for 12 months, and for a sub-group of 12 participants weekly for one month. Frequency-domain HRV-metrics were calculated for 5 min ECG segments during (i) a 15-min self-selected rest period (awake period), and (ii) a 30-min sleep period starting 45 min after estimated sleep onset. Total, within- and between-subject coefficient of variation (CV) and seasonal variation were estimated for ln (TP), ln (LFP), ln (HFP), ln (LF/HF), LFnu, HFnu, the mean heart period and the ECG derived respiratory frequency.The within- and between-subject CV varied considerably between different variables, from 100% for ln (LF/HF). Within- and between-subject CV of ln (HFP), LFnu and HFnu were 10-40%. A weak, but significant, seasonal variation was found for ln (TP) (p = 0.05), ln (LFP) (p<0.05) and the respiratory frequency (p<0.01), but the seasonal variation did not affect the within-subject CV. Furthermore, sample size calculations demonstrated that the reproducibility was sufficient for ambulatory HRV measurements to be used to study autonomic cardiac regulation in healthy populations.

  7. T cell activation and proliferation following acute exercise in human subjects is altered by storage conditions and mitogen selection.

    Science.gov (United States)

    Siedlik, Jacob A; Deckert, Jake A; Benedict, Stephen H; Bhatta, Anuja; Dunbar, Amanda J; Vardiman, John P; Gallagher, Philip M

    2017-07-01

    Recent work investigating exercise induced changes in immunocompetence suggests that some of the ambiguity in the literature is resultant from different cell isolation protocols and mitogen selection. To understand this effect, we compared post-exercise measures of T cell activation and proliferation using two different stimulation methods (costimulation through CD28 or stimulation with phytohaemagglutinin [PHA]). Further, we investigated whether exercise induced changes are maintained when T cell isolation from whole blood is delayed overnight in either a room temperature or chilled (4°C) environment. As expected, an increased proliferation response was observed post-exercise in T cells isolated from whole blood of previously trained individuals immediately after blood collection. Also, cells stimulated with PHA after resting overnight in whole blood were not adversely impacted by the storage conditions. In contrast, allowing cells to rest overnight in whole blood prior to stimulation through CD28, lessened the proliferation observed by cells following exercise rendering both the room temperature and chilled samples closer to the results seen in the control condition. Changes in early markers of activation (CD25), followed a similar pattern, with activation in PHA stimulated cells remaining fairly robust after overnight storage; whereas cell activation following stimulation through CD3+CD28 was disproportionately decreased by the influence of overnight storage. These findings indicate that decisions regarding cell stimulation methods need to be paired with the timeline for T cell isolation from whole blood. These considerations will be especially important for field based studies of immunocompetence where there is a delay in getting whole blood samples to a lab for processing as well as clinical applications where a failure to isolate T cells in a timely manner may result in loss of the response of interest. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib

    DEFF Research Database (Denmark)

    Macdonald, Thomas M; Hawkey, Chris J; Ford, Ian

    2017-01-01

    BACKGROUND: Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting....... METHOD: Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial...... expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient...

  9. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.

    Directory of Open Access Journals (Sweden)

    James A Tumlin

    Full Text Available Acute kidney injury (AKI is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU.A randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT alone and 65 received SCD therapy.No significant difference in 60-day mortality was observed between the treated (27/69; 39% and control patients (21/59; 36%, with six patients lost to follow up in the intention to treat (ITT analysis. Of the 19 SCD subjects (CRRT+SCD and 31 control subjects (CRRT alone who maintained a post-filter ionized calcium (iCa level in the protocol's recommended range (≤ 0.4 mmol/L for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19 in the SCD group compared to 41% (11/27 in the CRRT alone group (p = 0.11. Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16 and 25% (4/16, respectively (P = 0.10. When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01. The incidence of serious adverse events did not differ between the treated (45/69; 65% and control groups (40/65; 63%; p = 0·86.SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

  10. Well-being, problematic alcohol consumption and acute subjective drug effects in past-year ayahuasca users: a large, international, self-selecting online survey

    OpenAIRE

    Lawn, Will; Hallak, Jaime E.; Crippa, Jose A.; Dos Santos, Rafael; Porffy, Lilla; Barratt, Monica J.; Ferris, Jason A.; Winstock, Adam R.; Morgan, Celia J. A.

    2017-01-01

    Ayahuasca is a natural psychedelic brew, which contains dimethyltryptamine (DMT). Its potential as a psychiatric medicine has recently been demonstrated and its non-medical use around the world appears to be growing. We aimed to investigate well-being and problematic alcohol use in ayahuasca users, and ayahuasca’s subjective effects. An online, self-selecting, global survey examining patterns of drug use was conducted in 2015 and 2016 (n = 96,901). Questions were asked about: use of ayahuasca...

  11. K-Ras(G12D)-selective inhibitory peptides generated by random peptide T7 phage display technology.

    Science.gov (United States)

    Sakamoto, Kotaro; Kamada, Yusuke; Sameshima, Tomoya; Yaguchi, Masahiro; Niida, Ayumu; Sasaki, Shigekazu; Miwa, Masanori; Ohkubo, Shoichi; Sakamoto, Jun-Ichi; Kamaura, Masahiro; Cho, Nobuo; Tani, Akiyoshi

    2017-03-11

    Amino-acid mutations of Gly 12 (e.g. G12D, G12V, G12C) of V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-Ras), the most promising drug target in cancer therapy, are major growth drivers in various cancers. Although over 30 years have passed since the discovery of these mutations in most cancer patients, effective mutated K-Ras inhibitors have not been marketed. Here, we report novel and selective inhibitory peptides to K-Ras(G12D). We screened random peptide libraries displayed on T7 phage against purified recombinant K-Ras(G12D), with thorough subtraction of phages bound to wild-type K-Ras, and obtained KRpep-2 (Ac-RRCPLYISYDPVCRR-NH 2 ) as a consensus sequence. KRpep-2 showed more than 10-fold binding- and inhibition-selectivity to K-Ras(G12D), both in SPR analysis and GDP/GTP exchange enzyme assay. K D and IC 50 values were 51 and 8.9 nM, respectively. After subsequent sequence optimization, we successfully generated KRpep-2d (Ac-RRRRCPLYISYDPVCRRRR-NH 2 ) that inhibited enzyme activity of K-Ras(G12D) with IC 50  = 1.6 nM and significantly suppressed ERK-phosphorylation, downstream of K-Ras(G12D), along with A427 cancer cell proliferation at 30 μM peptide concentration. To our knowledge, this is the first report of a K-Ras(G12D)-selective inhibitor, contributing to the development and study of K-Ras(G12D)-targeting drugs. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. A randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.

    Science.gov (United States)

    Kelleher, Dennis; Tombs, Lee; Preece, Andrew; Brealey, Noushin; Mehta, Rashmi

    2014-10-01

    The long-acting muscarinic antagonist umeclidinium (UMEC) and the combination of UMEC with the long-acting beta2 agonist vilanterol (VI) are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU. This study investigated the effect of UMEC and UMEC/VI on the QT interval corrected using Fridericia's correction (QTcF) following a 10-day treatment period. Randomized, placebo- and moxifloxacin-controlled, 4-period incomplete block crossover study of healthy non-smokers (n = 103). All treatments were double blind, except for moxifloxacin/moxifloxacin placebo controls which were single blinded. Subjects were randomized to a treatment sequence which consisted of 4 of 5 regimens. Each regimen consisted of once-daily doses on Days 1-10 via the ELLIPTA™ dry powder inhaler and a single tablet on Day 10 of the following: placebo + placebo; placebo + moxifloxacin; UMEC 500 μg + placebo; UMEC/VI 125/25 μg (delivered dose: 113/22 μg) + placebo; UMEC/VI 500/100 μg + placebo. QT interval, additional cardiac parameters, pharmacokinetics, pharmacodynamics and safety were assessed. No clinically significant changes from baseline in QTcF occurred with UMEC 500 μg and UMEC/VI 125/25 μg compared with placebo, however, there was a change in QTcF from baseline of 6.4 ms (90% confidence interval [CI]: 4.3, 8.5) at 10 min and 8.2 ms (90%: 6.2, 10.2) at 30 min post dose following UMEC/VI 500/100 μg compared with placebo. On Day 10, categorical analysis demonstrated absolute QTcF values >450-480 ms for UMEC/VI 125/25 μg (1 subject) and moxifloxacin (3 subjects), and a change from baseline QTcF of >30-60 ms for UMEC/VI 125/25 μg, UMEC 500/100 μg and placebo (1 subject each) and moxifloxacin (2 subjects). On Day 10, the mean change from baseline in heart rate was increased with UMEC/VI 125/25 μg and UMEC 500/100 μg compared with placebo with the maximum increase occurring at 10 min post dose (8.4 bpm [90% CI: 7.0, 9

  13. Evaluation of Clinical Effectiveness and Subjective Satisfaction of a New Toothbrush for Postsurgical Hygiene Care: A Randomized Split-Mouth Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Marco Montevecchi

    2015-01-01

    Full Text Available The aim of this RCT was to evaluate plaque control and gingival health promotion effectiveness of a new toothbrush with extra-soft filaments in postsurgical sets. Ten consecutive patients with at least two scheduled symmetrical periodontal surgeries were selected. Following the first periodontal surgery, a test (TB1 or control (TB2 toothbrush was randomly assigned. After the second surgery, the remaining toothbrush was given. Patients were asked to gently wipe the surgical area from days 3 to 7 postoperatively and to gently brush using a roll technique from day 7 till the end of the study. Baseline evaluation took place on the day of surgery and follow-ups were performed at days 7, 14, and 30 postoperatively. A more evident PI reduction was recorded for test toothbrush where a regular decrease was observed till day 14; then, this parameter tended to stabilize, remaining however lower than that recorded for the control toothbrush. There were no statistical differences in the GI between test and control toothbrushes. All patients introduced the test toothbrush at surgical site at third day; the control toothbrush was introduced within a mean of 9 days. The introduction of the test toothbrush 3 days after periodontal surgery may be recommended.

  14. Effect of self-selected music on adults' anxiety and subjective experiences during initial radiotherapy treatment: a randomised controlled trial and qualitative research.

    Science.gov (United States)

    O'Callaghan, Clare; Sproston, Michael; Wilkinson, Kate; Willis, David; Milner, Alvin; Grocke, Denise; Wheeler, Greg

    2012-08-01

    Patients may experience radiotherapy as anxiety provoking, especially during unfamiliar initial treatment. This study examines whether patients' use of self-selected music while undergoing first radiotherapy treatment reduces anxiety, and how patients describe their first radiotherapy experience with or without self-selected music. Using quantitative and qualitative methods, 100 participants preparing to commence radiotherapy were assigned to the initial radiotherapy session either with self-selected music or without music. In both participant groups, the Spielberger State Anxiety Inventory measured pre- and post-radiotherapy levels, music preference questions examined future music desires during treatment and a semistructured questionnaire examined additional subjective experiences. Overall, participants were not highly anxious pre-radiotherapy, anxiety decreased in both music and control groups following radiotherapy (P = 0.008) and this change was not different between groups (P = 0.35). However, music group participants were significantly more likely to want music in future radiotherapy sessions (P = 0.007). Some reported a benefit from the music in terms of feeling supported, distracted or that treatment time seemed faster. Participants in both groups often commended helpful staff. Negative reactions were only occasional. Although preferred music does not reduce anxiety, it can support some patients undergoing initial radiotherapy and departmental staff should invite patients to bring music to radiotherapy, provide music libraries and offer to play patient selected music during treatments. © 2012 The Authors. Journal of Medical Imaging and Radiation Oncology © 2012 The Royal Australian and New Zealand College of Radiologists.

  15. Resolution of sleepiness and fatigue: a comparison of bupropion and selective serotonin reuptake inhibitors in subjects with major depressive disorder achieving remission at doses approved in the European Union.

    Science.gov (United States)

    Cooper, James A; Tucker, Vivian L; Papakostas, George I

    2014-02-01

    Unlike selective serotonin reuptake inhibitors (SSRIs), bupropion may be classified as a dual noradrenaline and dopamine reuptake inhibitor, a difference with potential implications for the treatment of residual sleepiness and fatigue in major depressive disorder (MDD). Post-hoc analysis of subjects with remitted MDD was performed on data pooled from six double-blind, randomized trials comparing the European Union (EU)-approved dose of ≤300 mg/day bupropion with SSRIs (sertraline, paroxetine or escitalopram) for the resolution of sleepiness and fatigue. Hypersomnia score was defined as the sum of scores of the Hamilton Depression Rating Scale (HDRS) items 22, 23, and 24; fatigue score as HDRS item 13 score; and remission as HDRS-17≤7. Similar proportions of bupropion- and SSRI-treated subjects achieved remission at study endpoint (169/343, 49.3% vs 324/656, 49.4%; last observation carried forward (LOCF), p=0.45). Fewer bupropion-treated remitters had residual symptoms of sleepiness (32/169, 18.9% vs 104/324, 32.1%; pBupropion-treated remitters also showed greater improvement (mean change from baseline) in sleepiness (pBupropion treatment at the EU-approved dose of ≤300 mg/day may offer advantages over SSRIs in the resolution of sleepiness and fatigue in remitted MDD patients.

  16. "Open mesh" or "strictly selected population" recruitment? The experience of the randomized controlled MeMeMe trial

    Directory of Open Access Journals (Sweden)

    Cortellini M

    2017-07-01

    Full Text Available Mauro Cortellini, Franco Berrino, Patrizia Pasanisi Department of Preventive & Predictive Medicine, Foundation IRCCS National Cancer Institute of Milan, Milan, Italy Abstract: Among randomized controlled trials (RCTs, trials for primary prevention require large samples and long follow-up to obtain a high-quality outcome; therefore the recruitment process and the drop-out rates largely dictate the adequacy of the results. We are conducting a Phase III trial on persons with metabolic syndrome to test the hypothesis that comprehensive lifestyle changes and/or metformin treatment prevents age-related chronic diseases (the MeMeMe trial, EudraCT number: 2012-005427-32, also registered on ClinicalTrials.gov [NCT02960711]. Here, we briefly analyze and discuss the reasons which may lead to participants dropping out from trials. In our experience, participants may back out of a trial for different reasons. Drug-induced side effects are certainly the most compelling reason. But what are the other reasons, relating to the participants’ perception of the progress of the trial which led them to withdraw after randomization? What about the time-dependent drop-out rate in primary prevention trials? The primary outcome of this analysis is the point of drop-out from trial, defined as the time from the randomization date to the withdrawal date. Survival functions were non-parametrically estimated using the product-limit estimator. The curves were statistically compared using the log-rank test (P=0.64, not significant. Researchers involved in primary prevention RCTs seem to have to deal with the paradox of the proverbial “short blanket syndrome”. Recruiting only highly motivated candidates might be useful for the smooth progress of the trial but it may lead to a very low enrollment rate. On the other hand, what about enrolling all the eligible subjects without considering their motivation? This might boost the enrollment rate, but it can lead to biased

  17. Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs.

    Science.gov (United States)

    Hammami, Muhammad M; De Padua, Sophia J S; Hussein, Rajaa; Al Gaai, Eman; Khodr, Nesrine A; Al-Swayeh, Reem; Alvi, Syed N; Binhashim, Nada

    2017-12-08

    The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale. We assessed bioequivalence of 42 generic products of 14 immediate-release oral drugs with the highest number of generic products on the Saudi market. We conducted 14 four-sequence, randomized, crossover studies on the reference and three randomly-selected generic products of amlodipine, amoxicillin, atenolol, cephalexin, ciprofloxacin, clarithromycin, diclofenac, ibuprofen, fluconazole, metformin, metronidazole, paracetamol, omeprazole, and ranitidine. Geometric mean ratios of maximum concentration (Cmax) and area-under-the-concentration-time-curve, to last measured concentration (AUCT), extrapolated to infinity (AUCI), or truncated to Cmax time of reference product (AUCReftmax) were calculated using non-compartmental method and their 90% confidence intervals (CI) were compared to the 80.00%-125.00% bioequivalence range. Percentages of individual ratios falling outside the ±25% range were also determined. Mean (SD) age and body-mass-index of 700 healthy volunteers (28-80/study) were 32.2 (6.2) years and 24.4 (3.2) kg/m2, respectively. In 42 generic-reference comparisons, 100% of AUCT and AUCI CIs showed bioequivalence, 9.5% of Cmax CIs barely failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 21.4% of Cmax CIs failed to show bioequivalence. In 42 generic-generic comparisons, 2.4% of AUCT, AUCI, and Cmax CIs failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 14.3% of Cmax CIs failed to show bioequivalence. Average geometric mean ratio deviation from 100% was ≤3.2 and ≤5.4 percentage points for AUCI and Cmax, respectively, in both generic

  18. Pilates-based therapeutic exercise: effect on subjects with nonspecific chronic low back pain and functional disability: a randomized controlled trial.

    Science.gov (United States)

    Rydeard, Rochenda; Leger, Andrew; Smith, Drew

    2006-07-01

    A randomized controlled trial, prestest-posttest design, with a 3-, 6-, and 12-month follow-up. To investigate the efficacy of a therapeutic exercise approach in a population with chronic low back pain (LBP). Therapeutic approaches developed from the Pilates method are becoming increasingly popular; however, there have been no reports on their efficacy. Thirty-nine physically active subjects between 20 and 55 years old with chronic LBP were randomly assigned to 1 of 2 groups. The specific-exercise-training group participated in a 4-week program consisting of training on specialized (Pilates) exercise equipment, while the control group received the usual care, defined as consultation with a physician and other specialists and healthcare professionals, as necessary. Treatment sessions were designed to train the activation of specific muscles thought to stabilize the lumbar-pelvic region. Functional disability outcomes were measured with The Roland Morris Disability Questionnaire (RMQ/RMDQ-HK) and average pain intensity using a 101-point numerical rating scale. There was a significantly lower level of functional disability (P = .023) and average pain intensity (P = .002) in the specific-exercise-training group than in the control group following the treatment intervention period. The posttest adjusted mean in functional disability level in the specific-exercise-training group was 2.0 (95% CI, 1.3 to 2.7) RMQ/RMDQ-HK points compared to a posttest adjusted mean in the control group of 3.2 (95% CI, 2.5 to 4.0) RMQ/RMDQ-HK points. The posttest adjusted mean in pain intensity in the specific-exercise-training group was 18.3 (95% CI, 11.8 to 24.8), as compared to 33.9 (95% CI, 26.9 to 41.0) in the control group. Improved disability scores in the specific-exercise-training group were maintained for up to 12 months following treatment intervention. The individuals in the specific-exercise-training group reported a significant decrease in LBP and disability, which was

  19. A Phase II, Randomized, Double-Blind, Placebo Controlled, Dose-Response Trial of the Melatonin Effect on the Pain Threshold of Healthy Subjects.

    Directory of Open Access Journals (Sweden)

    Luciana Cadore Stefani

    Full Text Available Previous studies have suggested that melatonin may produce antinociception through peripheral and central mechanisms. Based on the preliminary encouraging results of studies of the effects of melatonin on pain modulation, the important question has been raised of whether there is a dose relationship in humans of melatonin on pain modulation.The objective was to evaluate the analgesic dose response of the effects of melatonin on pressure and heat pain threshold and tolerance and the sedative effects.Sixty-one healthy subjects aged 19 to 47 y were randomized into one of four groups: placebo, 0.05 mg/kg sublingual melatonin, 0.15 mg/kg sublingual melatonin or 0.25 mg/kg sublingual melatonin. We determine the pressure pain threshold (PPT and the pressure pain tolerance (PPTo. Quantitative sensory testing (QST was used to measure the heat pain threshold (HPT and the heat pain tolerance (HPTo. Sedation was assessed with a visual analogue scale and bispectral analysis.Serum plasma melatonin levels were directly proportional to the melatonin doses given to each subject. We observed a significant effect associated with dose group. Post hoc analysis indicated significant differences between the placebo vs. the intermediate (0.15 mg/kg and the highest (0.25 mg/kg melatonin doses for all pain threshold and sedation level tests. A linear regression model indicated a significant association between the serum melatonin concentrations and changes in pain threshold and pain tolerance (R(2  = 0.492 for HPT, R(2  = 0.538 for PPT, R(2  = 0.558 for HPTo and R(2  = 0.584 for PPTo.The present data indicate that sublingual melatonin exerts well-defined dose-dependent antinociceptive activity. There is a correlation between the plasma melatonin drug concentration and acute changes in the pain threshold. These results provide additional support for the investigation of melatonin as an analgesic agent. Brazilian Clinical Trials Registry (ReBec: (U1111

  20. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects.

    Directory of Open Access Journals (Sweden)

    Jonna C Sandberg

    Full Text Available Whole grain has shown potential to prevent obesity, cardiovascular disease and type 2 diabetes. Possible mechanism could be related to colonic fermentation of specific indigestible carbohydrates, i.e. dietary fiber (DF. The aim of this study was to investigate effects on cardiometabolic risk factors and appetite regulation the next day when ingesting rye kernel bread rich in DF as an evening meal.Whole grain rye kernel test bread (RKB or a white wheat flour based bread (reference product, WWB was provided as late evening meals to healthy young adults in a randomized cross-over design. The test products RKB and WWB were provided in two priming settings: as a single evening meal or as three consecutive evening meals prior to the experimental days. Test variables were measured in the morning, 10.5-13.5 hours after ingestion of RKB or WWB. The postprandial phase was analyzed for measures of glucose metabolism, inflammatory markers, appetite regulating hormones and short chain fatty acids (SCFA in blood, hydrogen excretion in breath and subjective appetite ratings.With the exception of serum CRP, no significant differences in test variables were observed depending on length of priming (P>0.05. The RKB evening meal increased plasma concentrations of PYY (0-120 min, P<0.001, GLP-1 (0-90 min, P<0.05 and fasting SCFA (acetate and butyrate, P<0.05, propionate, P = 0.05, compared to WWB. Moreover, RKB decreased blood glucose (0-120 min, P = 0.001, serum insulin response (0-120 min, P<0.05 and fasting FFA concentrations (P<0.05. Additionally, RKB improved subjective appetite ratings during the whole experimental period (P<0.05, and increased breath hydrogen excretion (P<0.001, indicating increased colonic fermentation activity.The results indicate that RKB evening meal has an anti-diabetic potential and that the increased release of satiety hormones and improvements of appetite sensation could be beneficial in preventing obesity. These effects could

  1. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib

    DEFF Research Database (Denmark)

    Macdonald, Thomas M; Hawkey, Chris J; Ford, Ian

    2017-01-01

    infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). RESULTS: In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than......-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two......NSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib....

  2. Assessment of subjective and hemodynamic tolerance of different high- and low-flux dialysis membranes in patients undergoing chronic intermittent hemodialysis: a randomized controlled trial.

    Science.gov (United States)

    Bianchi, Giorgia; Salvadé, Vanja; Lucchini, Barbara; Schätti-Stählin, Sibylle; Salvadé, Igor; Burnier, Michel; Gabutti, Luca

    2014-10-01

    Clinical experience and experimental data suggest that intradialytic hemodynamic profiles could be influenced by the characteristics of the dialysis membranes. Even within the worldwide used polysulfone family, intolerance to specific membranes was occasionally evoked. The aim of this study was to compare hemodynamically some of the commonly used polysulfone dialyzers in Switzerland. We performed an open-label, randomized, cross-over trial, including 25 hemodialysis patients. Four polysulfone dialyzers, A (Revaclear high-flux, Gambro, Stockholm, Sweden), B (Helixone high-flux, Fresenius), C (Xevonta high-flux, BBraun, Melsungen, Germany), and D (Helixone low-flux, Fresenius, Bad Homburg vor der Höhe, Germany), were compared. The hemodynamic profile was assessed and patients were asked to provide tolerance feedback. The mean score (±SD) subjectively assigned to dialysis quality on a 1-10 scale was A 8.4 ± 1.3, B 8.6 ± 1.3, C 8.5 ± 1.6, D 8.5 ± 1.5. Kt/V was A 1.58 ± 0.30, B 1.67 ± 0.33, C 1.62 ± 0.32, D 1.45 ± 0.31. The low- compared with the high-flux membranes, correlated to higher systolic (128.1 ± 13.1 vs. 125.6 ± 12.1 mmHg, P 20 mmHg) were 70 with A, 87 with B, 73 with C, and 75 with D (P Hemodialysis.

  3. Adverse effects on insulin secretion of replacing saturated fat with refined carbohydrate but not with monounsaturated fat: A randomized controlled trial in centrally obese subjects.

    Science.gov (United States)

    Chang, Lin F; Vethakkan, Shireene R; Nesaretnam, Kalanithi; Sanders, Thomas A B; Teng, Kim-Tiu

    Current dietary guidelines recommend the replacement of saturated fatty acids (SAFAs) with carbohydrates or monounsaturated fatty acids (MUFAs) based on evidence on lipid profile alone, the chronic effects of the mentioned replacements on insulin secretion and insulin sensitivity are however unclear. To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects. Using a crossover design, randomized controlled trial in abdominally overweight men and women, we compared the effects of substitution of 7% energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each. Fasting and postprandial blood samples in response to corresponding SAFA, carbohydrate, or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes. As expected, postprandial nonesterified fatty acid suppression and elevation of C-peptide, insulin and glucose secretion were the greatest with high-carbohydrate (CARB) meal. Interestingly, CARB meal attenuated postprandial insulin secretion corrected for glucose response; however, the insulin sensitivity and disposition index were not affected. SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations, which increased after MUFA but not SAFA when compared with CARB. In conclusion, a 6-week lower-fat/higher-carbohydrate (increased by 7% refined carbohydrate) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets. In contrast, exchanging MUFA for SAFA at 7% energy had no appreciable adverse impact on insulin secretion. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  4. Extracorporeal shock wave therapy in patients with plantar fasciitis. A randomized, placebo-controlled trial with ultrasonographic and subjective outcome assessments

    Directory of Open Access Journals (Sweden)

    Babak Vahdatpour

    2012-01-01

    Full Text Available Background and Aim: Results of previous studies have been conflicting on the efficacy of extracorporeal shock wave therapy (ESWT in the treatment of plantar fasciitis. We evaluated the effects of ESWT on plantar fasciitis in terms of ultrasonographic and subjective evaluations. Materials and Methods: In this randomized placebo-controlled trial, patients with plantar fasciitis were assigned to receive ESWT (4000 shock waves/session of 0.2 mJ/mm 2 in 3 sessions at weekly intervals or sham therapy (n = 20 in each group. Outcomes were documented by the ultrasonographic appearance of the aponeurosis and by patients′ pain scores, performed at baseline and 12 weeks after completion of the therapy. Results : The two groups were similar in baseline characteristics. Over the study period, plantar fascia thickness significantly reduced in the ESWT group (4.1 ± 1.3 to 3.6 ± 1.2 mm, P < 0.001, but slightly increased in the sham group (4.1 ± 0.8 to 4.5 ± 0.9 mm, P = 0.03. Both groups showed significant pain improvement over the course of the study (P < 0.001, though pain scores were significantly more reduced in the ESWT than the sham group (-4.2 ± 2.9 vs. -2.7 ± 1.8, P = 0.049. Conclusions: Extracorporeal shock wave therapy contributes to healing and pain reduction in plantar fasciitis and ultrasound imaging is able to depict the morphologic changes related to plantar fasciitis as a result of this therapy.

  5. Selectivity of Chemoresistive Sensors Made of Chemically Functionalized Carbon Nanotube Random Networks for Volatile Organic Compounds (VOC

    Directory of Open Access Journals (Sweden)

    Jean-François Feller

    2014-01-01

    Full Text Available Different grades of chemically functionalized carbon nanotubes (CNT have been processed by spraying layer-by-layer (sLbL to obtain an array of chemoresistive transducers for volatile organic compound (VOC detection. The sLbL process led to random networks of CNT less conductive, but more sensitive to vapors than filtration under vacuum (bucky papers. Shorter CNT were also found to be more sensitive due to the less entangled and more easily disconnectable conducting networks they are making. Chemical functionalization of the CNT’ surface is changing their selectivity towards VOC, which makes it possible to easily discriminate methanol, chloroform and tetrahydrofuran (THF from toluene vapors after the assembly of CNT transducers into an array to make an e-nose. Interestingly, the amplitude of the CNT transducers’ responses can be enhanced by a factor of five (methanol to 100 (chloroform by dispersing them into a polymer matrix, such as poly(styrene (PS, poly(carbonate (PC or poly(methyl methacrylate (PMMA. COOH functionalization of CNT was found to penalize their dispersion in polymers and to decrease the sensors’ sensitivity. The resulting conductive polymer nanocomposites (CPCs not only allow for a more easy tuning of the sensors’ selectivity by changing the chemical nature of the matrix, but they also allow them to adjust their sensitivity by changing the average gap between CNT (acting on quantum tunneling in the CNT network. Quantum resistive sensors (QRSs appear promising for environmental monitoring and anticipated disease diagnostics that are both based on VOC analysis.

  6. Short term non-invasive ventilation post-surgery improves arterial blood-gases in obese subjects compared to supplemental oxygen delivery - a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zoremba Norbert

    2011-05-01

    Full Text Available Abstract Background In the immediate postoperative period, obese patients are more likely to exhibit hypoxaemia due to atelectasis and impaired respiratory mechanics, changes which can be attenuated by non-invasive ventilation (NIV. The aim of the study was to evaluate the duration of any effects of early initiation of short term pressure support NIV vs. traditional oxygen delivery via venturi mask in obese patients during their stay in the PACU. Methods After ethics committee approval and informed consent, we prospectively studied 60 obese patients (BMI 30-45 undergoing minor peripheral surgery. Half were randomly assigned to receive short term NIV during their PACU stay, while the others received routine treatment (supplemental oxygen via venturi mask. Premedication, general anaesthesia and respiratory settings were standardized. We measured arterial oxygen saturation by pulse oximetry and blood gas analysis on air breathing. Inspiratory and expiratory lung function was measured preoperatively (baseline and at 10 min, 1 h, 2 h, 6 h and 24 h after extubation, with the patient supine, in a 30 degrees head-up position. The two groups were compared using repeated-measure analysis of variance (ANOVA and t-test analysis. Statistical significance was considered to be P Results There were no differences at the first assessment. During the PACU stay, pulmonary function in the NIV group was significantly better than in the controls (p Conclusion Early initiation of short term NIV during in the PACU promotes more rapid recovery of postoperative lung function and oxygenation in the obese. The effect lasted 24 hours after discontinuation of NIV. Patient selection is necessary in order to establish clinically relevant improvements. Trial Registration# DRKS00000751; http://www.germanctr.de

  7. Optimal Subset Selection of Time-Series MODIS Images and Sample Data Transfer with Random Forests for Supervised Classification Modelling

    Directory of Open Access Journals (Sweden)

    Fuqun Zhou

    2016-10-01

    Full Text Available Nowadays, various time-series Earth Observation data with multiple bands are freely available, such as Moderate Resolution Imaging Spectroradiometer (MODIS datasets including 8-day composites from NASA, and 10-day composites from the Canada Centre for Remote Sensing (CCRS. It is challenging to efficiently use these time-series MODIS datasets for long-term environmental monitoring due to their vast volume and information redundancy. This challenge will be greater when Sentinel 2–3 data become available. Another challenge that researchers face is the lack of in-situ data for supervised modelling, especially for time-series data analysis. In this study, we attempt to tackle the two important issues with a case study of land cover mapping using CCRS 10-day MODIS composites with the help of Random Forests’ features: variable importance, outlier identification. The variable importance feature is used to analyze and select optimal subsets of time-series MODIS imagery for efficient land cover mapping, and the outlier identification feature is utilized for transferring sample data available from one year to an adjacent year for supervised classification modelling. The results of the case study of agricultural land cover classification at a regional scale show that using only about a half of the variables we can achieve land cover classification accuracy close to that generated using the full dataset. The proposed simple but effective solution of sample transferring could make supervised modelling possible for applications lacking sample data.

  8. Biased random key genetic algorithm with insertion and gender selection for capacitated vehicle routing problem with time windows

    Science.gov (United States)

    Rochman, Auliya Noor; Prasetyo, Hari; Nugroho, Munajat Tri

    2017-06-01

    Vehicle Routing Problem (VRP) often occurs when the manufacturers need to distribute their product to some customers/outlets. The distribution process is typically restricted by the capacity of the vehicle and the working hours at the distributor. This type of VRP is also known as Capacitated Vehicle Routing Problem with Time Windows (CVRPTW). A Biased Random Key Genetic Algorithm (BRKGA) was designed and coded in MATLAB to solve the CVRPTW case of soft drink distribution. The standard BRKGA was then modified by applying chromosome insertion into the initial population and defining chromosome gender for parent undergoing crossover operation. The performance of the established algorithms was then compared to a heuristic procedure for solving a soft drink distribution. Some findings are revealed (1) the total distribution cost of BRKGA with insertion (BRKGA-I) results in a cost saving of 39% compared to the total cost of heuristic method, (2) BRKGA with the gender selection (BRKGA-GS) could further improve the performance of the heuristic method. However, the BRKGA-GS tends to yield worse results compared to that obtained from the standard BRKGA.

  9. Sequence-Based Prediction of RNA-Binding Proteins Using Random Forest with Minimum Redundancy Maximum Relevance Feature Selection

    Directory of Open Access Journals (Sweden)

    Xin Ma

    2015-01-01

    Full Text Available The prediction of RNA-binding proteins is one of the most challenging problems in computation biology. Although some studies have investigated this problem, the accuracy of prediction is still not sufficient. In this study, a highly accurate method was developed to predict RNA-binding proteins from amino acid sequences using random forests with the minimum redundancy maximum relevance (mRMR method, followed by incremental feature selection (IFS. We incorporated features of conjoint triad features and three novel features: binding propensity (BP, nonbinding propensity (NBP, and evolutionary information combined with physicochemical properties (EIPP. The results showed that these novel features have important roles in improving the performance of the predictor. Using the mRMR-IFS method, our predictor achieved the best performance (86.62% accuracy and 0.737 Matthews correlation coefficient. High prediction accuracy and successful prediction performance suggested that our method can be a useful approach to identify RNA-binding proteins from sequence information.

  10. A preliminary investigation of the jack-bean urease inhibition by randomly selected traditionally used herbal medicine.

    Science.gov (United States)

    Biglar, Mahmood; Soltani, Khadijeh; Nabati, Farzaneh; Bazl, Roya; Mojab, Faraz; Amanlou, Massoud

    2012-01-01

    Helicobacter pylori (H. pylori) infection leads to different clinical and pathological outcomes in humans, including chronic gastritis, peptic ulcer disease and gastric neoplasia and even gastric cancer and its eradiation dependst upon multi-drug therapy. The most effective therapy is still unknown and prompts people to make great efforts to find better and more modern natural or synthetic anti-H. pylori agents. In this report 21 randomly selected herbal methanolic extracts were evaluated for their effect on inhibition of Jack-bean urease using the indophenol method as described by Weatherburn. The inhibition potency was measured by UV spectroscopy technique at 630 nm which attributes to released ammonium. Among these extracts, five showed potent inhibitory activities with IC50 ranges of 18-35 μg/mL. These plants are Matricaria disciforme (IC50:35 μg/mL), Nasturtium officinale (IC50:18 μg/mL), Punica granatum (IC50:30 μg/mL), Camelia sinensis (IC50:35 μg/mL), Citrus aurantifolia (IC50:28 μg/mL).

  11. A brief, web-based personalized feedback selective intervention for college student marijuana use: a randomized clinical trial.

    Science.gov (United States)

    Lee, Christine M; Neighbors, Clayton; Kilmer, Jason R; Larimer, Mary E

    2010-06-01

    Despite clear need, brief web-based interventions for marijuana-using college students have not been evaluated in the literature. The current study was designed to evaluate a brief, web-based personalized feedback intervention for at-risk marijuana users transitioning to college. All entering first-year students were invited to complete a brief questionnaire. Participants meeting criteria completed a baseline assessment (N = 341) and were randomly assigned to web-based personalized feedback or assessment-only control conditions. Participants completed 3-month (95.0%) and 6-month (94.4%) follow-up assessments. Results indicated that although there was no overall intervention effect, moderator analyses found promising effects for those with a family history of drug problems and, to a smaller extent, students who were higher in contemplation of changing marijuana use at baseline. Implications of these findings for selective intervention of college marijuana use and web-based interventions in general are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

  12. Optimal Subset Selection of Time-Series MODIS Images and Sample Data Transfer with Random Forests for Supervised Classification Modelling.

    Science.gov (United States)

    Zhou, Fuqun; Zhang, Aining

    2016-10-25

    Nowadays, various time-series Earth Observation data with multiple bands are freely available, such as Moderate Resolution Imaging Spectroradiometer (MODIS) datasets including 8-day composites from NASA, and 10-day composites from the Canada Centre for Remote Sensing (CCRS). It is challenging to efficiently use these time-series MODIS datasets for long-term environmental monitoring due to their vast volume and information redundancy. This challenge will be greater when Sentinel 2-3 data become available. Another challenge that researchers face is the lack of in-situ data for supervised modelling, especially for time-series data analysis. In this study, we attempt to tackle the two important issues with a case study of land cover mapping using CCRS 10-day MODIS composites with the help of Random Forests' features: variable importance, outlier identification. The variable importance feature is used to analyze and select optimal subsets of time-series MODIS imagery for efficient land cover mapping, and the outlier identification feature is utilized for transferring sample data available from one year to an adjacent year for supervised classification modelling. The results of the case study of agricultural land cover classification at a regional scale show that using only about a half of the variables we can achieve land cover classification accuracy close to that generated using the full dataset. The proposed simple but effective solution of sample transferring could make supervised modelling possible for applications lacking sample data.

  13. Enumeration of Escherichia coli cells on chicken carcasses as a potential measure of microbial process control in a random selection of slaughter establishments in the United States

    Science.gov (United States)

    The purpose of this study was to evaluate whether the measurement of Escherichia coli levels at two points during the chicken slaughter process has utility as a measure of quality control. A one year long survey was conducted during 2004 and 2005 in 20 randomly selected United States chicken slaught...

  14. Impact of amoxicillin therapy on resistance selection in patients with community-acquired lower respiratory tract infections : A randomized, placebo-controlled study

    NARCIS (Netherlands)

    Malhotra-Kumar, Surbhi; Van Heirstraeten, Liesbet; Coenen, Samuel; Lammens, Christine; Adriaenssens, Niels; Kowalczyk, Anna; Godycki-Cwirko, Maciek; Bielicka, Zuzana; Hupkova, Helena; Lannering, Christina; Mölstad, Sigvard; Fernandez-Vandellos, Patricia; Torres, Antoni; Parizel, Maxim; Ieven, Margareta; Butler, Chris C.; Verheij, Theo; Little, Paul; Goossens, Hermanon; Frimodt-Møller, Niels; Bruno, Pascale; Hering, Iris; Lemiengre, Marieke; Loens, Katherine; Malmvall, Bo Eric; Muras, Magdalena; Romano, Nuria Sanchez; Prat, Matteu Serra; Svab, Igor; Swain, Jackie; Tarsia, Paolo; Leus, Frank; Veen, Robert; Worby, Tricia

    2016-01-01

    Objectives: To determine the effect of amoxicillin treatment on resistance selection in patients with community-acquired lower respiratory tract infections in a randomized, placebo-controlled trial. Methods: Patients were prescribed amoxicillin 1 g, three times daily (n = 52) or placebo (n = 50) for

  15. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

    2016-01-01

    Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

  16. Whole-grain wheat consumption reduces inflammation in a randomized controlled trial on overweight and obese subjects with unhealthy dietary and lifestyle behaviors: role of polyphenols bound to cereal dietary fiber.

    Science.gov (United States)

    Vitaglione, Paola; Mennella, Ilario; Ferracane, Rosalia; Rivellese, Angela A; Giacco, Rosalba; Ercolini, Danilo; Gibbons, Sean M; La Storia, Antonietta; Gilbert, Jack A; Jonnalagadda, Satya; Thielecke, Frank; Gallo, Maria A; Scalfi, Luca; Fogliano, Vincenzo

    2015-02-01

    Epidemiology associates whole-grain (WG) consumption with several health benefits. Mounting evidence suggests that WG wheat polyphenols play a role in mechanisms underlying health benefits. The objective was to assess circulating concentration, excretion, and the physiologic role of WG wheat polyphenols in subjects with suboptimal dietary and lifestyle behaviors. A placebo-controlled, parallel-group randomized trial with 80 healthy overweight/obese subjects with low intake of fruit and vegetables and sedentary lifestyle was performed. Participants replaced precise portions of refined wheat (RW) with a fixed amount of selected WG wheat or RW products for 8 wk. At baseline and every 4 wk, blood, urine, feces, and anthropometric and body composition measures were collected. Profiles of phenolic acids in biological samples, plasma markers of metabolic disease and inflammation, and fecal microbiota composition were assessed. WG consumption for 4-8 wk determined a 4-fold increase in serum dihydroferulic acid (DHFA) and a 2-fold increase in fecal ferulic acid (FA) compared with RW consumption (no changes). Similarly, urinary FA at 8 wk doubled the baseline concentration only in WG subjects. Concomitant reduction in plasma tumor necrosis factor-α (TNF-α) after 8 wk and increased interleukin (IL)-10 only after 4 wk with WG compared with RW (P = 0.04) were observed. No significant change in plasma metabolic disease markers over the study period was observed, but a trend toward lower plasma plasminogen activator inhibitor 1 with higher excretion of FA and DHFA in the WG group was found. Fecal FA was associated with baseline low Bifidobacteriales and Bacteroidetes abundances, whereas after WG consumption, it correlated with increased Bacteroidetes and Firmicutes but reduced Clostridium. TNF-α reduction correlated with increased Bacteroides and Lactobacillus. No effect of dietary interventions on anthropometric measurements and body composition was found. WG wheat

  17. A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

    Directory of Open Access Journals (Sweden)

    Rueda-Clausen Christian F

    2006-09-01

    Full Text Available Abstract Background The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has been previously associated with endothelial dysfunction, higher levels of inflammatory markers and increased risk of developing insulin resistance and cardiovascular events. Besides life-style changes, the blockade of the renin-angiotensin system has been proposed as a useful alternative intervention to improve insulin resistance and decrease the number of new type-2 diabetes cases. The aim of this clinical trial is to study the effect of the treatment with Candesartan, an angiotensin II receptor antagonist, on the insulin resistance, the plasma levels of adipoquines, oxidative stress and prothrombotic markers, in a group of non diabetic, non hypertensive, dysglycemic and obese subjects. Methods and design A randomized, double blind, cross-over, placebo-controlled, clinical trial was designed to assess the effects of Candesartan (up to 32 mg/day during 6 months on the Homeostasis Model Assessment (HOMA index, lipid profile, protrombotic state, oxidative stress and plasma levels of inflammatory markers. The participants will be recruited in the "Fundación Cardiovascular de Colombia". Subjects who fullfil selection criteria will receive permanent educational, nutritional and exercise support during their participation in the study. After a 15 days-run-in period with placebo and life-style recommendations, the patients who have a treatment compliance equal or greater than 80% will be randomlly assigned to one of the treatment groups. Group A will receive Candesartan during 6 months and placebo during 6 months. Group B will receive placebo during the first 6 months, and then, Candesartan during the last 6 months. Control visits will be programed monthly and all parameters of interest will be evaluated every 6 months

  18. ESSENS dyslipidemia: A placebo-controlled, randomized study of a nutritional supplement containing red yeast rice in subjects with newly diagnosed dyslipidemia.

    Science.gov (United States)

    Kasliwal, Ravi R; Bansal, Manish; Gupta, Rajeev; Shah, Siddharth; Dani, Sameer; Oomman, Abraham; Pai, Vikas; Prasad, Guru Mallapa; Singhvi, Sunil; Patel, Jitendra; Sivam, Sakthivel; Trehan, Naresh

    2016-01-01

    Evidence suggests prolonged exposure to lower levels of low-density lipoprotein cholesterol (LDL-C), starting at a younger age, substantially lowers cardiovascular (CV) risk. Accordingly, the CV pandemic affecting younger population in low- to low-middle-income countries, where statin usage is poor even in secondary prevention, may benefit from lipid-lowering nutritional products, as nutritional intervention is generally preferred in these cultures. However, the safety and efficacy of such preparations have not been systematically tested. In this multicenter, double-blind study, 191 statin-free subjects with newly-diagnosed hyperlipidemia (LDL-C >120 mg/dL, 3.11 mmol/L) and no evidence of CV disease were randomized to one capsule of a proprietary bioactive phytonutrient formulation containing red yeast rice, grape-seed, niacinamide, and folic acid (RYR-NS) or matched placebo twice daily, along with lifestyle modification, for 12 wk. Mean baseline LDL-C levels were 148.5 ± 24.0 mg/dL (3.85 ± 0.62 mmol/L) and 148.6 ± 21.9 mg/dL (3.85 ± 0.57 mmol/L) in the RYR-NS and placebo groups respectively. Compared with placebo, RYR-NS resulted in a significant reduction in LDL-C (-29.4% versus -3.5%, P < 0.0001) and non-high-density lipoprotein cholesterol (non-HDL-C; -29.8% versus -10.3%, P < 0.0001) at 12 wk. With RYR-NS, 43.4% individuals attained desirable LDL-C levels and 55.4% desirable non-HDL-C levels by week 12, compared to only 0% and 1.1%, respectively, at baseline. No safety issues were observed. This study demonstrates the efficacy and safety of RYR-NS in lowering LDL-C and non-HDL-C after 12 wk, with magnitude of LDL-C reduction being comparable to that seen with moderate-intensity statin therapy. Further long-term studies are required to determine the impact of RYR-NS on treatment adherence and clinical outcomes. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  19. Efficacy of agomelatine and escitalopram on depression, subjective sleep and emotional experiences in patients with major depressive disorder: a 24-wk randomized, controlled, double-blind trial.

    Science.gov (United States)

    Corruble, Emmanuelle; de Bodinat, Christian; Belaïdi, Carole; Goodwin, Guy M

    2013-11-01

    In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.9 and 54.4%; week 24: 69.6 and 63.1% respectively). Over the 12 and 24-wk treatment periods, the 'global satisfaction on sleep' scores increased in both treatment groups and did not differ between groups. Satisfaction with sleep-wake quality was high in both groups; the 'wellness feeling on waking' was more improved with agomelatine than with escitalopram (p = 0.02). In patients with pronounced sleep complaints, quality of sleep and feeling on waking were significantly more improved with agomelatine than with escitalopram (p = 0.016 and p = 0.009, respectively). Emotional blunting was less frequent on agomelatine than on escitalopram. Indeed, 28% of patients on agomelatine vs. 60% on escitalopram felt that their emotions lacked intensity and 16% of patients on agomelatine vs. 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). The tolerability profile of agomelatine was found to be superior to that of escitalopram and the incidence of patients with at least one emergent adverse event leading to treatment discontinuation was lower in the agomelatine group than in the escitalopram group (5.5 vs. 10.6%). The findings suggest that agomelatine displays additional long-term clinical benefits on sleep-wake quality and emotional experiences over

  20. Surveillance for cancer recurrence in long-term young breast cancer survivors randomly selected from a statewide cancer registry.

    Science.gov (United States)

    Jones, Tarsha; Duquette, Debra; Underhill, Meghan; Ming, Chang; Mendelsohn-Victor, Kari E; Anderson, Beth; Milliron, Kara J; Copeland, Glenn; Janz, Nancy K; Northouse, Laurel L; Duffy, Sonia M; Merajver, Sofia D; Katapodi, Maria C

    2018-01-20

    This study examined clinical breast exam (CBE) and mammography surveillance in long-term young breast cancer survivors (YBCS) and identified barriers and facilitators to cancer surveillance practices. Data collected with a self-administered survey from a statewide, randomly selected sample of YBCS diagnosed with invasive breast cancer or ductal carcinoma in situ younger than 45 years old, stratified by race (Black vs. White/Other). Multivariate logistic regression models identified predictors of annual CBEs and mammograms. Among 859 YBCS (n = 340 Black; n = 519 White/Other; mean age = 51.0 ± 5.9; diagnosed 11.0 ± 4.0 years ago), the majority (> 85%) reported an annual CBE and a mammogram. Black YBCS in the study were more likely to report lower rates of annual mammography and more barriers accessing care compared to White/Other YBCS. Having a routine source of care, confidence to use healthcare services, perceived expectations from family members and healthcare providers to engage in cancer surveillance, and motivation to comply with these expectations were significant predictors of having annual CBEs and annual mammograms. Cost-related lack of access to care was a significant barrier to annual mammograms. Routine source of post-treatment care facilitated breast cancer surveillance above national average rates. Persistent disparities regarding access to mammography surveillance were identified for Black YBCS, primarily due to lack of access to routine source of care and high out-of-pocket costs. Public health action targeting cancer surveillance in YBCS should ensure routine source of post-treatment care and address cost-related barriers. Clinical Trials Registration Number: NCT01612338.

  1. Evaluation of Randomly Selected Completed Medical Records Sheets in Teaching Hospitals of Jahrom University of Medical Sciences, 2009

    Directory of Open Access Journals (Sweden)

    Mohammad Parsa Mahjob

    2011-06-01

    Full Text Available Background and objective: Medical record documentation, often use to protect the patients legal rights, also providing information for medical researchers, general studies, education of health care staff and qualitative surveys is used. There is a need to control the amount of data entered in the medical record sheets of patients, considering the completion of these sheets is often carried out after completion of service delivery to the patients. Therefore, in this study the prevalence of completeness of medical history, operation reports, and physician order sheets by different documentaries in Jahrom teaching hospitals during year 2009 was analyzed. Methods and Materials: In this descriptive / retrospective study, the 400 medical record sheets of the patients from two teaching hospitals affiliated to Jahrom medical university was randomly selected. The tool of data collection was a checklist based on the content of medical history sheet, operation report and physician order sheets. The data were analyzed by SPSS (Version10 software and Microsoft Office Excel 2003. Results: Average of personal (Demography data entered in medical history, physician order and operation report sheets which is done by department's secretaries were 32.9, 35.8 and 40.18 percent. Average of clinical data entered by physician in medical history sheet is 38 percent. Surgical data entered by the surgeon in operation report sheet was 94.77 percent. Average of data entered by operation room's nurse in operation report sheet was 36.78 percent; Average of physician order data in physician order sheet entered by physician was 99.3 percent. Conclusion: According to this study, the rate of completed record papers reviewed by documentary in Jahrom teaching hospitals were not desirable and in some cases were very weak and incomplete. This deficiency was due to different reason such as medical record documentaries negligence, lack of adequate education for documentaries, High work

  2. Sexual selection has minimal impact on effective population sizes in species with high rates of random offspring mortality: An empirical demonstration using fitness distributions.

    Science.gov (United States)

    Pischedda, Alison; Friberg, Urban; Stewart, Andrew D; Miller, Paige M; Rice, William R

    2015-10-01

    The effective population size (N(e)) is a fundamental parameter in population genetics that influences the rate of loss of genetic diversity. Sexual selection has the potential to reduce N(e) by causing the sex-specific distributions of individuals that successfully reproduce to diverge. To empirically estimate the effect of sexual selection on N(e), we obtained fitness distributions for males and females from an outbred, laboratory-adapted population of Drosophila melanogaster. We observed strong sexual selection in this population (the variance in male reproductive success was ∼14 times higher than that for females), but found that sexual selection had only a modest effect on N(e), which was 75% of the census size. This occurs because the substantial random offspring mortality in this population diminishes the effects of sexual selection on N(e), a result that necessarily applies to other high fecundity species. The inclusion of this random offspring mortality creates a scaling effect that reduces the variance/mean ratios for male and female reproductive success and causes them to converge. Our results demonstrate that measuring reproductive success without considering offspring mortality can underestimate Ne and overestimate the genetic consequences of sexual selection. Similarly, comparing genetic diversity among different genomic components may fail to detect strong sexual selection. © 2015 The Author(s). Evolution © 2015 The Society for the Study of Evolution.

  3. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial.

    NARCIS (Netherlands)

    Rest, O. van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Olde Rikkert, M.G.M.; Beekman, A.T.; Groot, L.C. de

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  4. Effect of fish oil supplementation on quality of life in a general population of older Dutch subjects: a randomized, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.; Staveren, van W.A.; Olderikkert, M.G.M.; Beekman, A.T.F.; Groot, de L.C.P.G.M.

    2009-01-01

    OBJECTIVES: To investigate the effect of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) supplementation on quality of life (QOL). DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Independently living individuals from the general older Dutch population. PARTICIPANTS:

  5. Yeast (1,3)-(1,6)-beta-glucan helps to maintain the body?s defence against pathogens: a double-blind, randomized, placebo-controlled, multicentric study in healthy subjects

    OpenAIRE

    Auinger, Annegret; Riede, Linda; Bothe, Gordana; Busch, Regina; Gruenwald, Joerg

    2013-01-01

    Purpose The effect of brewers? yeast (1,3)-(1,6)-beta-d-glucan consumption on the number of common cold episodes in healthy subject was investigated. Methods In a placebo-controlled, double-blind, randomized, multicentric clinical trial, 162 healthy participants with recurring infections received 900?mg of either placebo (n?=?81) or an insoluble yeast (1,3)-(1,6)-beta-d-glucan preparation (n?=?81) per day over a course of 16?weeks. Subjects were instructed to document each occurring common co...

  6. Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study.

    Science.gov (United States)

    Goniewicz, Maciej L; Gawron, Michal; Smith, Danielle M; Peng, Margaret; Jacob, Peyton; Benowitz, Neal L

    2017-02-01

    Electronic cigarettes (e-cigarettes) are purported to deliver nicotine aerosol without any toxic combustion products present in tobacco smoke. In this longitudinal within-subjects observational study, we evaluated the effects of e-cigarettes on nicotine delivery and exposure to selected carcinogens and toxicants. We measured seven nicotine metabolites and 17 tobacco smoke exposure biomarkers in the urine samples of 20 smokers collected before and after switching to pen-style M201 e-cigarettes for 2 weeks. Biomarkers were metabolites of 13 major carcinogens and toxicants in cigarette smoke: one tobacco-specific nitrosamine (NNK), eight volatile organic compounds (1,3-butadiene, crotonaldehyde, acrolein, benzene, acrylamide, acrylonitrile, ethylene oxide, and propylene oxide), and four polycyclic aromatic hydrocarbons (naphthalene, fluorene, phenanthrene, and pyrene). Changes in urine biomarkers concentration were tested using repeated measures analysis of variance. In total, 45% of participants reported complete abstinence from cigarette smoking at 2 weeks, while 55% reported continued smoking. Levels of total nicotine and some polycyclic aromatic hydrocarbon metabolites did not change after switching from tobacco to e-cigarettes. All other biomarkers significantly decreased after 1 week of using e-cigarettes (p e-cigarettes, nicotine exposure remains unchanged, while exposure to selected carcinogens and toxicants is substantially reduced. To our knowledge, this is the first study that demonstrates that substituting tobacco cigarettes with an e-cigarette may reduce user exposure to numerous toxicants and carcinogens otherwise present in tobacco cigarettes. Data on reduced exposure to harmful constituents that are present in tobacco cigarettes and e-cigarettes can aid in evaluating e-cigarettes as a potential harm reduction device. © The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights

  7. Stand structure, composition and illegal logging in selectively logged production forests of Myanmar: Comparison of two compartments subject to different cutting frequency

    Directory of Open Access Journals (Sweden)

    Tual Cin Khai

    2016-07-01

    Full Text Available Appropriate cutting cycles and annual allowable cuts are crucial to ensure sustainability of tropical selective logging, but there have been limited field data to verify long-term effects of different cutting cycles. This study reveals some evidence of forest degradation in selectively logged production forests of Myanmar, which are subject to inappropriate cutting frequency. We compared stand structure, commercial species composition, and incidence of illegal logging between two compartments with low (LCF; 1 time and high (HCF; 5 times cutting frequency over a recent 18 years. Prior to the latest cutting, LCF had 176 trees ha−1 with an inverted-J shape distribution of diameter at breast height (DBH, including a substantial amount of teak (Tectona grandis and other commercially important species in each DBH class. HCF prior to the latest cut had only 41 trees ha−1 without many commercially important species. At HCF, nearly half the standing trees of various species and size were illegally cut following legal operations; this was for charcoal making in nearby kilns. At LCF, two species, teak and Xylia xylocarpa, were cut illegally and sawn for timber on the spot. More extensive and systematic surveys are needed to generalize the findings of forest degradation and illegal logging. However, our study calls for urgent reconsideration of logging practices with high cutting frequency, which can greatly degrade forests with accompanying illegal logging, and for rehabilitating strongly degraded, bamboo-dominated forests. To reduce illegal logging, it would be important to pay more attention on a MSS regulation stating that logging roads should be destroyed after logging operations.

  8. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial

    OpenAIRE

    Nuria eRuffini; Giandomenico eD'alessandro; Nicolò eMariani; Alberto ePollastrelli; Lucia eCardinali; Francesco eCerritelli

    2015-01-01

    Context: Heart Rate Variability (HRV) indicates how heart rate changes in response to inner and external stimuli. HRV is linked to health status and it is an indirect marker of the autonomic nervous system (ANS) function. Objective: To investigate the influence of osteopathic manipulative treatment (OMT) on cardiac autonomic modulation in healthy subjects, compared with sham therapy and control group. Methods: Sixty-six healthy subjects, both male and female, were included in the present 3-ar...

  9. Affinity selection of Nipah and Hendra virus-related vaccine candidates from a complex random peptide library displayed on bacteriophage virus-like particles

    Energy Technology Data Exchange (ETDEWEB)

    Peabody, David S.; Chackerian, Bryce; Ashley, Carlee; Carnes, Eric; Negrete, Oscar

    2017-01-24

    The invention relates to virus-like particles of bacteriophage MS2 (MS2 VLPs) displaying peptide epitopes or peptide mimics of epitopes of Nipah Virus envelope glycoprotein that elicit an immune response against Nipah Virus upon vaccination of humans or animals. Affinity selection on Nipah Virus-neutralizing monoclonal antibodies using random sequence peptide libraries on MS2 VLPs selected peptides with sequence similarity to peptide sequences found within the envelope glycoprotein of Nipah itself, thus identifying the epitopes the antibodies recognize. The selected peptide sequences themselves are not necessarily identical in all respects to a sequence within Nipah Virus glycoprotein, and therefore may be referred to as epitope mimics VLPs displaying these epitope mimics can serve as vaccine. On the other hand, display of the corresponding wild-type sequence derived from Nipah Virus and corresponding to the epitope mapped by affinity selection, may also be used as a vaccine.

  10. Pilot feasibility and safety study examining the effect of medium chain triglyceride supplementation in subjects with mild cognitive impairment: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Candida J. Rebello

    2015-06-01

    Conclusions: Consumption of 56 g/day of MCTs for 24 weeks increases serum ketone concentrations and appears to be a candidate for larger randomized control trials in the future that quantify the modulation of cognitive function through supplementation with ketone precursors, in patients with MCI.

  11. Effect of fish-oil supplementation on mental well-being in older subjects: a randomized, double-blind, placebo-controlled trial 1-3

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.J.; Staveren, van W.A.; Hoefnagels, W.H.; Beekman, A.T.F.; Groot, de C.P.G.M.

    2008-01-01

    Background: It is suggested that a low intake of fish and/or n¿3 PUFA is associated with depressed mood. However, results from epidemiologic studies are mixed, and randomized trials have mainly been performed in depressed patients, yielding conflicting results. Objective: We investigated the effect

  12. Scope and selection of structures subject to aging management review; Alcance y seleccion de estructuras sujetas a revision de gestion de envejecimiento

    Energy Technology Data Exchange (ETDEWEB)

    Mendoza, G.; Diaz, A.; Viais, J.; Carmona, M. [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico); Santander, L., E-mail: gonzalo.mendoza@inin.gob.mx [Comision Federal de Electricidad, Central Nucleoelectrica Laguna Verde, Carretera Cardel-Nautla Km. 42.5, Veracruz (Mexico)

    2014-10-15

    The purpose of this work is to determine the structures included within the scope of license renewal based on the performance of the functions and select those intended for aging management review; one purpose is to show the methodology used to establish the structure and structural components that are subject to a review of aging management, within the framework of license renewal rule. This is through the application of different types of structures and structural components related and unrelated to safety located in the rooms of the reactor building where there are components of the reactor core isolation cooling system (Rcic), these structures are poured concrete, concrete block, structural steel, shielding walls, attached metal, pile foundations, etc.; other non- security related , such as: 1) inherent characteristics not related to security that protect the equipment related to the safety of the missiles, that is, walls, low walls, dikes, doors, etc., which also provide flood barriers to structures, systems and components related to safety, 2 ) whipping restrictions on non- security, shields mitigation jet, vent panels , etc. that are designed and installed to protect equipment related with the safety of the effects of a broken line of high energy. Only rooms where there are components of the Rcic 68 structures within the scope were identified. (Author)

  13. Subjective and Cardiovascular Effects of Intravenous Methamphetamine during Perindopril Maintenance: A Randomized, Double-Blind, Placebo-Controlled Human Laboratory Study.

    Science.gov (United States)

    Verrico, Christopher D; Haile, Colin N; De La Garza, Richard; Grasing, Kenneth; Kosten, Thomas R; Newton, Thomas F

    2016-07-01

    Our pilot study suggested that the angiotensin-converting enzyme inhibitor perindopril might reduce some subjective effects produced by i.v. methamphetamine. We characterized the impact of a wider range of perindopril doses on methamphetamine-induced effects in a larger group of non-treatment-seeking, methamphetamine-using volunteers. Before treatment, participants received 30mg methamphetamine. After 5 to 7 days of perindopril treatment (0, 4, 8, or 16mg/d), participants received 15 and 30mg of methamphetamine on alternate days. Before and after treatment, participants rated subjective effects and cardiovascular measures were collected. Prior to treatment with perindopril, there were no significant differences between treatment groups on maximum or peak subjective ratings or on peak cardiovascular effects. Following perindopril treatment, there were significant main effects of treatment on peak subjective ratings of "anxious" and "stimulated"; compared to placebo treatment, treatment with 8mg perindopril significantly reduced peak ratings of both anxious (P=.0009) and stimulated (P=.0070). There were no significant posttreatment differences between groups on peak cardiovascular effects. Moderate doses of perindopril (8mg) significantly reduced peak subjective ratings of anxious and stimulated as well as attenuated many other subjective effects produced by methamphetamine, likely by inhibiting angiotensin II synthesis. Angiotensin II is known to facilitate the effects of norepinephrine, which contributes to methamphetamine's subjective effects. The lack of a classic dose-response function likely results from either nonspecific effects of perindopril or from between-group differences that were not accounted for in the current study (i.e., genetic variations and/or caffeine use). The current findings suggest that while angiotensin-converting enzyme inhibitors can reduce some effects produced by methamphetamine, more consistent treatment effects might be achieved by

  14. The relationship of music preferences and the selected risk-taking and autodestructive behaviour among teenage girls subject to inpatient stay due to mental condition – pilot study

    Directory of Open Access Journals (Sweden)

    Katarzyna Krajewska

    2017-03-01

    substances, nor the psychiatric diagnosis. Conclusions: Girls subject to inpatient stay at the mental ward most often preferred hip-hop. No significant relationship of the preference over a particular music genre and the number of autodestructive and risky behaviour was observed; only tendencies for more frequent selection of particular genres of music were visible.

  15. Power Calculations to Select Instruments for Clinical Trial Secondary Endpoints. A Case Study of Instrument Selection for Post-Traumatic Stress Symptoms in Subjects with Acute Respiratory Distress Syndrome.

    Science.gov (United States)

    Sjoding, Michael W; Schoenfeld, David A; Brown, Samuel M; Hough, Catherine L; Yealy, Donald M; Moss, Marc; Angus, Derek C; Iwashyna, Theodore J

    2017-01-01

    After the sample size of a randomized clinical trial (RCT) is set by the power requirement of its primary endpoint, investigators select secondary endpoints while unable to further adjust sample size. How the sensitivity and specificity of an instrument used to measure these outcomes, together with their expected underlying event rates, affect an RCT's power to measure significant differences in these outcomes is poorly understood. Motivated by the design of an RCT of neuromuscular blockade in acute respiratory distress syndrome, we examined how power to detect a difference in secondary endpoints varies with the sensitivity and specificity of the instrument used to measure such outcomes. We derived a general formula and Stata code for calculating an RCT's power to detect differences in binary outcomes when such outcomes are measured with imperfect sensitivity and specificity. The formula informed the choice of instrument for measuring post-traumatic stress-like symptoms in the Reevaluation of Systemic Early Neuromuscular Blockade RCT ( www.clinicaltrials.gov identifier NCT02509078). On the basis of published sensitivities and specificities, the Impact of Events Scale-Revised was predicted to measure a 36% symptom rate, whereas the Post-Traumatic Stress Symptoms instrument was predicted to measure a 23% rate, if the true underlying rate of post-traumatic stress symptoms were 25%. Despite its lower sensitivity, the briefer Post-Traumatic Stress Symptoms instrument provided superior power to detect a difference in rates between trial arms, owing to its higher specificity. Examining instruments' power to detect differences in outcomes may guide their selection when multiple instruments exist, each with different sensitivities and specificities.

  16. Zinc monotherapy increases serum brain-derived neurotrophic factor (BDNF) levels and decreases depressive symptoms in overweight or obese subjects: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Solati, Zahra; Jazayeri, Shima; Tehrani-Doost, Mehdi; Mahmoodianfard, Salma; Gohari, Mahmood Reza

    2015-05-01

    Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms. However, to our knowledge, no study has examined the effect of zinc monotherapy on mood. The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor (BDNF) levels in overweight or obese subjects. Fifty overweight or obese subjects were randomly assigned into two groups and received either 30 mg zinc or placebo daily for 12 weeks. At baseline and post-intervention, depression severity was assessed using Beck depression inventory II (BDI II), and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry, respectively. The trial was completed with 46 subjects. After a 12-week supplementation, serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group. BDI scores declined in both the groups at the end of the study, but reduction in the zinc-supplemented group was significantly higher than the placebo group. More analysis revealed that following supplementation, BDI scores decreased in subgroup of subjects with depressive symptoms (BDI ≥ 10) (n = 30), but did not change in the subgroup of non-depressed subjects (BDI BDNF levels and depression severity in all participants. Interestingly, a significant positive correlation was found between serum BDNF and zinc levels at baseline. Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels.

  17. Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial.

    Science.gov (United States)

    Liao, Hsien-Yin; Ho, Wen-Chao; Chen, Chun-Chung; Lin, Jaung-Geng; Chang, Chia-Chi; Chen, Liang-Yu; Lee, De-Chih; Lee, Yu-Chen

    2017-01-01

    Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS) score. Secondary outcome measures included changes in Barthel Index (BI), Instrumental Activities of Daily Living (IADL), Hamilton Depression Rating Scale (HAM-D), and Visual Analogue Scale (VAS) for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n = 28) or placebo (n = 24), 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04). There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

  18. Clinical Evaluation of Acupuncture as Treatment for Complications of Cerebrovascular Accidents: A Randomized, Sham-Controlled, Subject- and Assessor-Blind Trial

    Directory of Open Access Journals (Sweden)

    Hsien-Yin Liao

    2017-01-01

    Full Text Available Background and Purpose. The effect of acupuncture as treatment for poststroke complications is questionable. We performed a randomized, sham-controlled double-blind study to investigate it. Methods. Patients with first-time acute stroke were randomized to receive 24 sessions of either real or sham acupuncture during an eight-week period. The primary outcome measure was change in National Institute of Health Stroke Scale (NIHSS score. Secondary outcome measures included changes in Barthel Index (BI, Instrumental Activities of Daily Living (IADL, Hamilton Depression Rating Scale (HAM-D, and Visual Analogue Scale (VAS for pain scores. Results. Of the 52 patients who were randomized to receive acupuncture (n=28 or placebo (n=24, 10 patients in the acupuncture group and 9 patients in the placebo group failed to complete the treatment. In total, 18 patients in the acupuncture group and 15 patients in the control group completed the treatment course. Reduction in pain was significantly greater in the acupuncture group than in the control group (p value = 0.04. There were no significant differences in the other measures between the two groups. Conclusions. Acupuncture provided more effective poststroke pain relief than sham acupuncture treatment. However, acupuncture had no better effect on neurological, functional, and psychological improvement.

  19. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study

    Science.gov (United States)

    Maffei, L.; Picano, E.; Andreassi, M. G.; Angelucci, A.; Baldacci, F.; Baroncelli, L.; Begenisic, T.; Bellinvia, P. F.; Berardi, N.; Biagi, L.; Bonaccorsi, J.; Bonanni, E.; Bonuccelli, U.; Borghini, A.; Braschi, C.; Broccardi, M.; Bruno, R. M.; Caleo, M.; Carlesi, C.; Carnicelli, L.; Cartoni, G.; Cecchetti, L.; Cenni, M. C.; Ceravolo, R.; Chico, L.; Cintoli, S.; Cioni, G.; Coscia, M.; Costa, M.; D’Angelo, G.; D’Ascanio, P.; Nes, M. De; Turco, S. Del; Coscio, E. Di; Galante, M. Di; Lascio, N. di; Faita, F.; Falorni, I.; Faraguna, U.; Fenu, A.; Fortunato, L.; Franco, R.; Gargani, L.; Gargiulo, R.; Ghiadoni, L.; Giorgi, F. S.; Iannarella, R.; Iofrida, C.; Kusmic, C.; Limongi, F.; Maestri, M.; Maffei, M.; Maggi, S.; Mainardi, M.; Mammana, L.; Marabotti, A.; Mariotti, V.; Melissari, E.; Mercuri, A.; Micera, S.; Molinaro, S.; Narducci, R.; Navarra, T.; Noale, M.; Pagni, C.; Palumbo, S.; Pasquariello, R.; Pellegrini, S.; Pietrini, P.; Pizzorusso, T.; Poli, A.; Pratali, L.; Retico, A.; Ricciardi, E.; Rota, G.; Sale, A.; Sbrana, S.; Scabia, G.; Scali, M.; Scelfo, D.; Sicari, R.; Siciliano, G.; Stea, F.; Taddei, S.; Tognoni, G.; Tonacci, A.; Tosetti, M.; Turchi, S.; Volpi, L.

    2017-01-01

    Age-related cognitive impairment and dementia are an increasing societal burden. Epidemiological studies indicate that lifestyle factors, e.g. physical, cognitive and social activities, correlate with reduced dementia risk; moreover, positive effects on cognition of physical/cognitive training have been found in cognitively unimpaired elders. Less is known about effectiveness and action mechanisms of physical/cognitive training in elders already suffering from Mild Cognitive Impairment (MCI), a population at high risk for dementia. We assessed in 113 MCI subjects aged 65–89 years, the efficacy of combined physical-cognitive training on cognitive decline, Gray Matter (GM) volume loss and Cerebral Blood Flow (CBF) in hippocampus and parahippocampal areas, and on brain-blood-oxygenation-level-dependent (BOLD) activity elicited by a cognitive task, measured by ADAS-Cog scale, Magnetic Resonance Imaging (MRI), Arterial Spin Labeling (ASL) and fMRI, respectively, before and after 7 months of training vs. usual life. Cognitive status significantly decreased in MCI-no training and significantly increased in MCI-training subjects; training increased parahippocampal CBF, but no effect on GM volume loss was evident; BOLD activity increase, indicative of neural efficiency decline, was found only in MCI-no training subjects. These results show that a non pharmacological, multicomponent intervention improves cognitive status and indicators of brain health in MCI subjects. PMID:28045051

  20. Non-dipping pattern in ambulatory blood pressure monitoring is associated with metabolic abnormalities in a random sample of middle-aged subjects.

    Science.gov (United States)

    Ukkola, Olavi; Vasunta, Riitta-Liisa; Kesäniemi, Y Antero

    2009-11-01

    A reduction in the blood pressure decline at night (pattern') is associated with cardiovascular morbidity. Our aim was to evaluate whether ABPM characteristics are associated with metabolic abnormalities in subjects without known hypertension or type 2 diabetes mellitus (T2DM). This is a cross-sectional population-based study on middle-aged subjects (n=462). Two distinct definitions of metabolic syndrome (MetS) were used: National Cholesterol Education Program-Third Adult Treatment Panel (NCEP-ATPIII) and International Diabetes Federation (IDF) criteria. Results suggested that subjects characterized by non-dipping in 24 h ABPM were more obese (P=0.014). After adjustment for body mass index, age and sex, non-dippers had higher very-low-density lipoprotein (VLDL)-cholesterol (P=0.003), total (P=0.029)-and VLDL-triglycerides (P=0.026) and oral glucose tolerance test 2 h blood glucose (P=0.027) compared with dippers. Non-dipping status was more common among subjects with MetS (Ppattern. The percentage decline in blood pressure from day to night decreased with the number of metabolic abnormalities (P=0.012). In conclusion, ABPM non-dipping status is an independent predictor of glucose intolerance. It is also associated with several other metabolic abnormalities. Whether non-dipping pattern is causally related to these metabolic aberrations remains to be explored in a future prospective follow-up of this cohort.

  1. Randomized trial on the effects of a combined physical/cognitive training in aged MCI subjects: the Train the Brain study.

    Science.gov (United States)

    2017-01-03

    Age-related cognitive impairment and dementia are an increasing societal burden. Epidemiological studies indicate that lifestyle factors, e.g. physical, cognitive and social activities, correlate with reduced dementia risk; moreover, positive effects on cognition of physical/cognitive training have been found in cognitively unimpaired elders. Less is known about effectiveness and action mechanisms of physical/cognitive training in elders already suffering from Mild Cognitive Impairment (MCI), a population at high risk for dementia. We assessed in 113 MCI subjects aged 65-89 years, the efficacy of combined physical-cognitive training on cognitive decline, Gray Matter (GM) volume loss and Cerebral Blood Flow (CBF) in hippocampus and parahippocampal areas, and on brain-blood-oxygenation-level-dependent (BOLD) activity elicited by a cognitive task, measured by ADAS-Cog scale, Magnetic Resonance Imaging (MRI), Arterial Spin Labeling (ASL) and fMRI, respectively, before and after 7 months of training vs. usual life. Cognitive status significantly decreased in MCI-no training and significantly increased in MCI-training subjects; training increased parahippocampal CBF, but no effect on GM volume loss was evident; BOLD activity increase, indicative of neural efficiency decline, was found only in MCI-no training subjects. These results show that a non pharmacological, multicomponent intervention improves cognitive status and indicators of brain health in MCI subjects.

  2. Acute subjective effects after smoking joints containing up to 69 mg Δ9-tetrahydrocannabinol in recreational users : a randomized, crossover clinical trial

    NARCIS (Netherlands)

    Hunault, Claudine C.; Böcker, Koen B E; Stellato, R. K.; Kenemans, J. Leon; de Vries, Irma; Meulenbelt, Jan

    2014-01-01

    Rationale An increase in the potency of the cannabis cigarettes has been observed over the past three decades. Objectives In this study, we aimed to establish the impact of Δ9-tetrahydrocannabinol (THC) on the rating of subjective effects (intensity and duration of the effects), up to 23 % THC

  3. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    DEFF Research Database (Denmark)

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut

    2009-01-01

    between 1995 and 2000, in 168 individuals with impaired glucose tolerance (IGT) and body mass index above 27 at start. The intensive intervention group (n = 83) was subjected to a 1-month residential lifestyle programme. The usual care group (n = 85) participated in a health examination ending...

  4. A randomized control trial to evaluate the effect of adjuvant selective laser trabeculoplasty versus medication alone in primary open-angle glaucoma: preliminary results

    Directory of Open Access Journals (Sweden)

    Lee JWY

    2014-09-01

    Full Text Available Jacky WY Lee,1,2 Catherine WS Chan,2 Mandy OM Wong,3 Jonathan CH Chan,3 Qing Li,2 Jimmy SM Lai2 1The Department of Ophthalmology, Caritas Medical Centre, 2The Department of Ophthalmology, The University of Hong Kong, 3The Department of Ophthalmology, Queen Mary Hospital, Hong Kong Background: The objective of this study was to investigate the effects of adjuvant selective laser trabeculoplasty (SLT versus medication alone on intraocular pressure (IOP control, medication use, and quality of life in patients with primary open-angle glaucoma.Methods: This prospective, randomized control study recruited 41 consecutive primary open-angle glaucoma subjects with medically-controlled IOP ≤21 mmHg. The SLT group (n=22 received a single 360-degree SLT treatment. The medication-only group (n=19 continued with their usual treatment regimen. In both groups, medication was titrated to maintain a target IOP defined as a 25% reduction from baseline IOP without medication, or <18 mmHg, whichever was lower. Outcomes, which were measured at baseline and at 6 months, included the Glaucoma Quality of Life-15 (GQL-15 and Comparison of Ophthalmic Medications for Tolerability (COMTOL survey scores, IOP, and the number of antiglaucoma medicines. Results: The baseline IOP was 15.8±2.7 mmHg and 14.5±2.5 mmHg in the SLT and medication-only groups, respectively (P=0.04. Both groups had a comparable number of baseline medication (P=0.2, GQL-15 (P=0.3 and COMTOL scores (P=0.7. At 6 months, the SLT group had a lower IOP (P=0.03 and required fewer medications compared with both baseline (P<0.0001 and with the medication-only group (P=0.02. There was no statistically significant difference in the 6-month GQL-15 or COMTOL score as compared to baseline (P≥0.4 or between the two treatment groups (P≥0.2.Conclusion: A single session of adjuvant SLT provided further reductions in IOP and medication without substantial changes in quality of life or medication tolerability at 6

  5. Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins.

    Science.gov (United States)

    Dias, Clapton S; Shaywitz, Adam J; Wasserman, Scott M; Smith, Brian P; Gao, Bing; Stolman, Dina S; Crispino, Caroline P; Smirnakis, Karen V; Emery, Maurice G; Colbert, Alexander; Gibbs, John P; Retter, Marc W; Cooke, Blaire P; Uy, Stephen T; Matson, Mark; Stein, Evan A

    2012-11-06

    The aim of this study was to evaluate the safety, tolerability, and effects of AMG 145 on low-density lipoprotein cholesterol (LDL-C) in healthy and hypercholesterolemic subjects on statin therapy. Proprotein convertase subtilisin/kexin type 9 (PCSK9) down-regulates surface expression of the low-density lipoprotein receptor (LDL-R), increasing serum LDL-C. AMG 145, a fully human monoclonal antibody to PCSK9, prevents PCSK9/LDL-R interaction, restoring LDL-R recycling. Healthy adults (phase 1a) were randomized to 1 dose of AMG 145: 7, 21, 70, 210, or 420 mg SC; 21 or 420 mg IV; or matching placebo. Hypercholesterolemic adults (phase 1b) receiving low- to moderate-dose statins were randomized to multiple SC doses of AMG 145: 14 or 35 mg once weekly (QW) ×6, 140 or 280 mg every 2 weeks (Q2W) ×3, 420 mg every 4 weeks ×2, or matching placebo. Eleven subjects receiving high-dose statins and 6 subjects with heterozygous familial hypercholesterolemia were randomized to SC AMG 145 140 mg or placebo Q2W ×3. In the trials (AMG 145 n = 85, placebo n = 28), AMG 145 reduced LDL-C up to 64% (p AMG 145 versus placebo groups: 69% versus 71% (phase 1a); 65% versus 64% (phase 1b). In phase 1 studies, AMG 145 significantly reduced serum LDL-C in healthy and hypercholesterolemic statin-treated subjects, including those with heterozygous familial hypercholesterolemia or taking the highest doses of atorvastatin or rosuvastatin, with an overall AE profile similar to placebo. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Bias in the prediction of genetic gain due to mass and half-sib selection in random mating populations

    Directory of Open Access Journals (Sweden)

    José Marcelo Soriano Viana

    2009-01-01

    Full Text Available The prediction of gains from selection allows the comparison of breeding methods and selection strategies, although these estimates may be biased. The objective of this study was to investigate the extent of such bias in predicting genetic gain. For this, we simulated 10 cycles of a hypothetical breeding program that involved seven traits, three population classes, three experimental conditions and two breeding methods (mass and half-sib selection. Each combination of trait, population, heritability, method and cycle was repeated 10 times. The predicted gains were biased, even when the genetic parameters were estimated without error. Gain from selection in both genders is twice the gain from selection in a single gender only in the absence of dominance. The use of genotypic variance or broad sense heritability in the predictions represented an additional source of bias. Predictions based on additive variance and narrow sense heritability were equivalent, as were predictions based on genotypic variance and broad sense heritability. The predictions based on mass and family selection were suitable for comparing selection strategies, whereas those based on selection within progenies showed the largest bias and lower association with the realized gain.

  7. Expressed sequence tags of randomly selected cDNA clones from Eucalyptus globulus-Pisolithus tinctorius ectomycorrhiza.

    Science.gov (United States)

    Tagu, D; Martin, F

    1995-01-01

    Random sequencing of cDNA clones from Eucalyptus globulus-Pisolithus tinctorius ectomycorrhizal tissues was carried out to generate expressed sequence tags (ESTs). Database comparisons revealed that 42% of the cDNAs corresponded to previously sequenced genes. These ESTs represent efficient molecular markers to analyze changes in gene expression during the formation of the ectomycorrhizal symbiosis.

  8. Influence of the Lactotripeptides Isoleucine-Proline-Proline and Valine-Proline-Proline on Systolic Blood Pressure in Japanese Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Aurelie Chanson-Rolle

    Full Text Av