WorldWideScience

Sample records for random order results

  1. 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...

  2. New Closed-Form Results on Ordered Statistics of Partial Sums of Gamma Random Variables and its Application to Performance Evaluation in the Presence of Nakagami Fading

    KAUST Repository

    Nam, Sung Sik

    2017-06-19

    Complex wireless transmission systems require multi-dimensional joint statistical techniques for performance evaluation. Here, we first present the exact closed-form results on order statistics of any arbitrary partial sums of Gamma random variables with the closedform results of core functions specialized for independent and identically distributed Nakagami-m fading channels based on a moment generating function-based unified analytical framework. These both exact closed-form results have never been published in the literature. In addition, as a feasible application example in which our new offered derived closed-form results can be applied is presented. In particular, we analyze the outage performance of the finger replacement schemes over Nakagami fading channels as an application of our method. Note that these analysis results are directly applicable to several applications, such as millimeter-wave communication systems in which an antenna diversity scheme operates using an finger replacement schemes-like combining scheme, and other fading scenarios. Note also that the statistical results can provide potential solutions for ordered statistics in any other research topics based on Gamma distributions or other advanced wireless communications research topics in the presence of Nakagami fading.

  3. Ramsey-type results for ordered hypergraphs

    OpenAIRE

    Balko, Martin

    2017-01-01

    Ramsey-type results for ordered hypergraphs Martin Balko Abstract We introduce ordered Ramsey numbers, which are an analogue of Ramsey numbers for graphs with a linear ordering on their vertices. We study the growth rate of ordered Ramsey numbers of ordered graphs with respect to the number of vertices. We find ordered match- ings whose ordered Ramsey numbers grow superpolynomially. We show that ordered Ramsey numbers of ordered graphs with bounded degeneracy and interval chromatic number are...

  4. Cloud Macroscopic Organization: Order Emerging from Randomness

    Science.gov (United States)

    Yuan, Tianle

    2011-01-01

    Clouds play a central role in many aspects of the climate system and their forms and shapes are remarkably diverse. Appropriate representation of clouds in climate models is a major challenge because cloud processes span at least eight orders of magnitude in spatial scales. Here we show that there exists order in cloud size distribution of low-level clouds, and that it follows a power-law distribution with exponent gamma close to 2. gamma is insensitive to yearly variations in environmental conditions, but has regional variations and land-ocean contrasts. More importantly, we demonstrate this self-organizing behavior of clouds emerges naturally from a complex network model with simple, physical organizing principles: random clumping and merging. We also demonstrate symmetry between clear and cloudy skies in terms of macroscopic organization because of similar fundamental underlying organizing principles. The order in the apparently complex cloud-clear field thus has its root in random local interactions. Studying cloud organization with complex network models is an attractive new approach that has wide applications in climate science. We also propose a concept of cloud statistic mechanics approach. This approach is fully complementary to deterministic models, and the two approaches provide a powerful framework to meet the challenge of representing clouds in our climate models when working in tandem.

  5. Periodic boundary value problems of second order random differential equations

    Directory of Open Access Journals (Sweden)

    Bapurao Dhage

    2009-04-01

    Full Text Available In this paper, an existence and the existence of extremal random solutions are proved for a periodic boundary value problem of second order ordinary random differential equations. Our investigations have been placed in the space of real-valued functions defined and continuous on closed and bounded intervals of real line together with the applications of the random version of a nonlinear alternative of Leray-Schauder type and an algebraic random fixed point theorem of Dhage. An example is also indicated for demonstrating the realizations of the abstract theory developed in this paper.

  6. 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

  7. Ordering and phase transitions in random-field Ising systems

    Science.gov (United States)

    Maritan, Amos; Swift, Michael R.; Cieplak, Marek; Chan, Moses H. W.; Cole, Milton W.; Banavar, Jayanth R.

    1991-01-01

    An exact analysis of the Ising model with infinite-range interactions in a random field and a local mean-field theory in three dimensions is carried out leading to a phase diagram with several coexistence surfaces and lines of critical points. The results show that the phase diagram depends crucially on whether the distribution of random fields is symmetric or not. Thus, Ising-like phase transitions in a porous medium (the asymmetric case) are in a different universality class from the conventional random-field model (symmetric case).

  8. Quantum Chaos and Random Matrix Theory Some New Results

    CERN Document Server

    Smilansky, U

    1996-01-01

    New insight into the correspondence between Quantum Chaos and Random Matrix Theory is gained by developing a semiclassical theory for the autocorrelation function of spectral determinants. We study in particular the unitary operators which are the quantum versions of area preserving maps. The relevant Random Matrix ensembles are the Circular ensembles. The resulting semiclassical expressions depend on the symmetry of the system with respect to time reversal, and on a classical parameter $\\mu = tr U -1$ where U is the classical 1-step evolution operator. For system without time reversal symmetry, we are able to reproduce the exact Random Matrix predictions in the limit $\\mu \\to 0$. For systems with time reversal symmetry we can reproduce only some of the features of Random Matrix Theory. For both classes we obtain the leading corrections in $\\mu$. The semiclassical theory for integrable systems is also developed, resulting in expressions which reproduce the theory for the Poissonian ensemble to leading order i...

  9. Study on the Business Cycle Model with Fractional-Order Time Delay under Random Excitation

    Directory of Open Access Journals (Sweden)

    Zifei Lin

    2017-07-01

    Full Text Available Time delay of economic policy and memory property in a real economy system is omnipresent and inevitable. In this paper, a business cycle model with fractional-order time delay which describes the delay and memory property of economic control is investigated. Stochastic averaging method is applied to obtain the approximate analytical solution. Numerical simulations are done to verify the method. The effects of the fractional order, time delay, economic control and random excitation on the amplitude of the economy system are investigated. The results show that time delay, fractional order and intensity of random excitation can all magnify the amplitude and increase the volatility of the economy system.

  10. Presic-Boyd-Wong Type Results in Ordered Metric Spaces

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    Satish Shukla

    2014-04-01

    Full Text Available The purpose of this paper is to prove some Presic-Boyd-Wong type fixed point theorems in ordered metric spaces. The results of this paper generalize the famous results of Presic and Boyd-Wong in ordered metric spaces. We also initiate the homotopy result in product spaces. Some examples are provided which illustrate the results proved herein.

  11. Introducing Randomness into First-Order and Second-Order Deterministic Differential Equations

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    John F. Moxnes

    2010-01-01

    Full Text Available We incorporate randomness into deterministic theories and compare analytically and numerically some well-known stochastic theories: the Liouville process, the Ornstein-Uhlenbeck process, and a process that is Gaussian and exponentially time correlated (Ornstein-Uhlenbeck noise. Different methods of achieving the marginal densities for correlated and uncorrelated noise are discussed. Analytical results are presented for a deterministic linear friction force and a stochastic force that is uncorrelated or exponentially correlated.

  12. Ground-state properties of ordered, partially ordered, and random Cu-Au and Ni-Pt alloys

    DEFF Research Database (Denmark)

    Ruban, Andrei; Abrikosov, I. A.; Skriver, Hans Lomholt

    1995-01-01

    We have studied the ground-state properties of ordered, partially ordered, and random Cu-Au and Ni-Pt alloys at the stoichiometric 1/4, 1/2, and 3/4 compositions in the framework of the multisublattice single-site (SS) coherent potential approximation (CPA). Charge-transfer effects in the random...

  13. Ordering of random walks: the leader and the laggard

    Energy Technology Data Exchange (ETDEWEB)

    Ben-Avraham, D [Department of Physics, Clarkson University, Potsdam, NY 13699-5820, USA (United States); Johnson, B M [Department of Physics, Clarkson University, Potsdam, NY 13699-5820, USA (United States); Monaco, C A [Department of Physics, Clarkson University, Potsdam, NY 13699-5820, USA (United States); Krapivsky, P L [Center for BioDynamics, Center for Polymer Studies, and Department of Physics, Boston University, Boston, MA 02215, USA (United States); Redner, S [Center for BioDynamics, Center for Polymer Studies, and Department of Physics, Boston University, Boston, MA 02215, USA (United States)

    2003-02-21

    We investigate two complementary problems related to maintaining the relative positions of N random walks on the line: (i) the leader problem, that is, the probability L{sub N}(t) that the leftmost particle remains the leftmost as a function of time and (ii) the laggard problem, the probability R{sub N}(t) that the rightmost particle never becomes the leftmost. We map these ordering problems onto an equivalent (N - 1)-dimensional electrostatic problem. From this construction we obtain a very accurate estimate for L{sub N}(t) for N = 4, the first case that is not exactly solvable: L{sub 4}(t) {proportional_to} t{sup -{beta}{sub 4}}, with {beta}{sub 4} = 0.91342(8). The probability of being the laggard also decays algebraically, R{sub N}(t) {proportional_to} t{sup -{gamma}{sub N}}; we derive {gamma}{sub 2} = 1/2, {gamma}{sub 3} = 3/8, and argue that {gamma}{sub N} {yields} N{sup -1} ln N as N {yields} {infinity}.

  14. Variances as order parameter and complexity measure for random Boolean networks

    Energy Technology Data Exchange (ETDEWEB)

    Luque, Bartolo [Departamento de Matematica Aplicada y EstadIstica, Escuela Superior de Ingenieros Aeronauticos, Universidad Politecnica de Madrid, Plaza Cardenal Cisneros 3, Madrid 28040 (Spain); Ballesteros, Fernando J [Observatori Astronomic, Universitat de Valencia, Ed. Instituts d' Investigacio, Pol. La Coma s/n, E-46980 Paterna, Valencia (Spain); Fernandez, Manuel [Departamento de Matematica Aplicada y EstadIstica, Escuela Superior de Ingenieros Aeronauticos, Universidad Politecnica de Madrid, Plaza Cardenal Cisneros 3, Madrid 28040 (Spain)

    2005-02-04

    Several order parameters have been considered to predict and characterize the transition between ordered and disordered phases in random Boolean networks, such as the Hamming distance between replicas or the stable core, which have been successfully used. In this work, we propose a natural and clear new order parameter: the temporal variance. We compute its value analytically and compare it with the results of numerical experiments. Finally, we propose a complexity measure based on the compromise between temporal and spatial variances. This new order parameter and its related complexity measure can be easily applied to other complex systems.

  15. Residual and Past Entropy for Concomitants of Ordered Random Variables of Morgenstern Family

    Directory of Open Access Journals (Sweden)

    M. M. Mohie EL-Din

    2015-01-01

    Full Text Available For a system, which is observed at time t, the residual and past entropies measure the uncertainty about the remaining and the past life of the distribution, respectively. In this paper, we have presented the residual and past entropy of Morgenstern family based on the concomitants of the different types of generalized order statistics (gos and give the linear transformation of such model. Characterization results for these dynamic entropies for concomitants of ordered random variables have been considered.

  16. The Effect of Interference on Temporal Order Memory for Random and Fixed Sequences in Nondemented Older Adults

    Science.gov (United States)

    Tolentino, Jerlyn C.; Pirogovsky, Eva; Luu, Trinh; Toner, Chelsea K.; Gilbert, Paul E.

    2012-01-01

    Two experiments tested the effect of temporal interference on order memory for fixed and random sequences in young adults and nondemented older adults. The results demonstrate that temporal order memory for fixed and random sequences is impaired in nondemented older adults, particularly when temporal interference is high. However, temporal order…

  17. Diversity Order Results for MIMO Optical Wireless Communications

    KAUST Repository

    Sapenov, Yerzhan

    2017-09-21

    An optical wireless multiple-input multiple-output (MIMO) communication system employing intensity-modulation direct-detection (IM/DD) is considered. The maximal diversity order of the channel is characterized by studying the outage probability. Then, spatial repetition coding (RC) is shown to be diversity-optimal as it achieves the channel’s maximal diversity order. This diversity order is given by a simple expression which is suitable for any channel statistics of practical interest. The results are specialized to some practical channel statistics, and numerical results are provided to verify the results.

  18. Stationary and nonstationary random vibrations of laminated composite plates via a higher order theory

    Science.gov (United States)

    Elishakoff, Isaac; Librescu, Liviu; Cederbaum, Gabriel

    1990-01-01

    Higher order shear deformation theory is utilized to study he weakly stationary and nonstationary random vibrations of cross-ply laminated plates. Normal mode method, in conjunction with the biorthogonality condition, for the nonsymmetric differential equations is applied. Detailed derivation is given for the governing equations, biorthogonality condition, the generalized mass and the generalized forces. Results are listed for a plate which is simply supported at all the edges, and subjected to a point load which is either timewise stationary or nonstationary random process.

  19. A novel single-order diffraction grating: Random position rectangle grating

    Science.gov (United States)

    Zuhua, Yang; Qiangqiang, Zhang; Jing, Wang; Quanping, Fan; Yuwei, Liu; Lai, Wei; Leifeng, Cao

    2016-05-01

    Spectral diagnosis of radiation from laser plasma interaction and monochromation of radiation source are hot and important topics recently. Grating is one of the primary optical elements to do this job. Although easy to fabricate, traditional diffraction grating suffers from multi-order diffraction contamination. On the other hand, sinusoidal amplitude grating has the nonharmonic diffraction property, but it is too difficult to fabricate, especially for x-ray application. A novel nonharmonic diffraction grating named random position rectangle grating (RPRG) is proposed in this paper. Theoretical analysis and experiment results show that the RPRG is both higher order diffraction suppressing and not difficult to fabricate. Additionally, it is highly efficient; its first order absolute theoretical diffraction efficiency reaches 4.1%. Our result shows that RPRG is a novel tool for radiation diagnosis and monochromation. Project supported by the National Natural Science Foundation of China (Grant No. 11375160) and the National Science Instruments Major Project of China (Grant No. 2012YQ130125).

  20. Permutation Test Approach for Ordered Alternatives in Randomized Complete Block Design: A Comparative Study

    OpenAIRE

    GOKPINAR, Esra; GUL, Hasan; GOKPINAR, Fikri; BAYRAK, Hülya; OZONUR, Deniz

    2013-01-01

    Randomized complete block design is one of the most used experimental designs in statistical analysis. For testing ordered alternatives in randomized complete block design, parametric tests are used if random sample are drawn from Normal distribution. If normality assumption is not provide, nonparametric methods are used. In this study, we are interested nonparametric tests and we introduce briefly the nonparametric tests, such as Page, Modified Page and Hollander tests. We also give Permutat...

  1. Will electrical cyber-physical interdependent networks undergo first-order transition under random attacks?

    Science.gov (United States)

    Ji, Xingpei; Wang, Bo; Liu, Dichen; Dong, Zhaoyang; Chen, Guo; Zhu, Zhenshan; Zhu, Xuedong; Wang, Xunting

    2016-10-01

    Whether the realistic electrical cyber-physical interdependent networks will undergo first-order transition under random failures still remains a question. To reflect the reality of Chinese electrical cyber-physical system, the "partial one-to-one correspondence" interdependent networks model is proposed and the connectivity vulnerabilities of three realistic electrical cyber-physical interdependent networks are analyzed. The simulation results show that due to the service demands of power system the topologies of power grid and its cyber network are highly inter-similar which can effectively avoid the first-order transition. By comparing the vulnerability curves between electrical cyber-physical interdependent networks and its single-layer network, we find that complex network theory is still useful in the vulnerability analysis of electrical cyber-physical interdependent networks.

  2. Exponential ratio-product type estimators under second order approximation in stratified random sampling

    OpenAIRE

    Singh, Rajesh; Sharma, Prayas; Smarandache, Florentin

    2014-01-01

    Singh et al (20009) introduced a family of exponential ratio and product type estimators in stratified random sampling. Under stratified random sampling without replacement scheme, the expressions of bias and mean square error (MSE) of Singh et al (2009) and some other estimators, up to the first- and second-order approximations are derived. Also, the theoretical findings are supported by a numerical example.

  3. The Continuous Spin Random Field Model : Ferromagnetic Ordering in d ≥ 3

    NARCIS (Netherlands)

    Külske, Christof

    1999-01-01

    We investigate the Gibbs-measures of ferromagnetically coupled continuous spins in double-well potentials subjected to a random field (our specific example being the φ4 theory), showing ferromagnetic ordering in d ≥ 3 dimensions for weak disorder and large energy barriers. We map the random

  4. Robust Fuzzy Control for Fractional-Order Uncertain Hydroturbine Regulating System with Random Disturbances

    Directory of Open Access Journals (Sweden)

    Fengjiao Wu

    2016-01-01

    Full Text Available The robust fuzzy control for fractional-order hydroturbine regulating system is studied in this paper. First, the more practical fractional-order hydroturbine regulating system with uncertain parameters and random disturbances is presented. Then, on the basis of interval matrix theory and fractional-order stability theorem, a fuzzy control method is proposed for fractional-order hydroturbine regulating system, and the stability condition is expressed as a group of linear matrix inequalities. Furthermore, the proposed method has good robustness which can process external random disturbances and uncertain parameters. Finally, the validity and superiority are proved by the numerical simulations.

  5. Randomized and quantum algorithms for solving initial-value problems in ordinary differential equations of order k

    Directory of Open Access Journals (Sweden)

    Maciej Goćwin

    2008-01-01

    Full Text Available The complexity of initial-value problems is well studied for systems of equations of first order. In this paper, we study the \\(\\varepsilon\\-complexity for initial-value problems for scalar equations of higher order. We consider two models of computation, the randomized model and the quantum model. We construct almost optimal algorithms adjusted to scalar equations of higher order, without passing to systems of first order equations. The analysis of these algorithms allows us to establish upper complexity bounds. We also show (almost matching lower complexity bounds. The \\(\\varepsilon\\-complexity in the randomized and quantum setting depends on the regularity of the right-hand side function, but is independent of the order of equation. Comparing the obtained bounds with results known in the deterministic case, we see that randomized algorithms give us a speed-up by \\(1/2\\, and quantum algorithms by \\(1\\ in the exponent. Hence, the speed-up does not depend on the order of equation, and is the same as for the systems of equations of first order. We also include results of some numerical experiments which confirm theoretical results.

  6. Protein Ordered Sequences are Formed by Random Joining of Amino Acids in Protein 0th-Order Structure, Followed by Evolutionary Process

    Science.gov (United States)

    Ikehara, Kenji

    2014-12-01

    Only random processes should occur on the primitive Earth. In contrast, many ordered sequences are synthesized according to genetic information on the present Earth. In this communication, I have proposed an idea that protein 0th-order structures or specific amino acid compositions would mediate the transfer from random process to formation of ordered sequences, after formation of double-stranded genes.

  7. Some new results on Brownian Directed Polymers in Random Environment

    CERN Document Server

    Comets, F

    2004-01-01

    We prove some new results on Brownian directed polymers in random environment recently introduced by the authors. The directed polymer in this model is a $d$-dimensional Brownian motion (up to finite time $t$) viewed under a Gibbs measure which is built up with a Poisson random measure on $\\R_+ \\times \\R^d$ (=time $\\times$ space). Here, the Poisson random measure plays the role of the random environment which is independent both in time and in space. We prove that (i) For $d \\ge 3$ and the inverse temperature $\\beta$ smaller than a certain positive value $\\beta_0$, the central limit theorem for the directed polymer holds almost surely with respect to the environment. (ii) If $d=1$ and $\\beta \

  8. A higher order conditional random field model for simultaneous classification of land cover and land use

    Science.gov (United States)

    Albert, Lena; Rottensteiner, Franz; Heipke, Christian

    2017-08-01

    We propose a new approach for the simultaneous classification of land cover and land use considering spatial as well as semantic context. We apply a Conditional Random Fields (CRF) consisting of a land cover and a land use layer. In the land cover layer of the CRF, the nodes represent super-pixels; in the land use layer, the nodes correspond to objects from a geospatial database. Intra-layer edges of the CRF model spatial dependencies between neighbouring image sites. All spatially overlapping sites in both layers are connected by inter-layer edges, which leads to higher order cliques modelling the semantic relation between all land cover and land use sites in the clique. A generic formulation of the higher order potential is proposed. In order to enable efficient inference in the two-layer higher order CRF, we propose an iterative inference procedure in which the two classification tasks mutually influence each other. We integrate contextual relations between land cover and land use in the classification process by using contextual features describing the complex dependencies of all nodes in a higher order clique. These features are incorporated in a discriminative classifier, which approximates the higher order potentials during the inference procedure. The approach is designed for input data based on aerial images. Experiments are carried out on two test sites to evaluate the performance of the proposed method. The experiments show that the classification results are improved compared to the results of a non-contextual classifier. For land cover classification, the result is much more homogeneous and the delineation of land cover segments is improved. For the land use classification, an improvement is mainly achieved for land use objects showing non-typical characteristics or similarities to other land use classes. Furthermore, we have shown that the size of the super-pixels has an influence on the level of detail of the classification result, but also on the

  9. Firm-Related Training Tracks: A Random Effects Ordered Probit Model

    Science.gov (United States)

    Groot, Wim; van den Brink, Henriette Maassen

    2003-01-01

    A random effects ordered response model of training is estimated to analyze the existence of training tracks and time varying coefficients in training frequency. Two waves of a Dutch panel survey of workers are used covering the period 1992-1996. The amount of training received by workers increased during the period 1994-1996 compared to…

  10. Non-Parametric Inference for Ordered Alternatives in a Randomized Block Design

    Science.gov (United States)

    Hettmansperger, Thomas P.

    1975-01-01

    Treats the problem of testing an ordered hypothesis based on the ranks of the data. Statistical procedures for the randomized block design with more than one observation per cell are derived. Multiple comparisions and estimation procedures are included. (Author/RC)

  11. A generalized Jonckheere test against ordered alternatives for repeated measures in randomized blocks.

    Science.gov (United States)

    Zhang, Ying; Cabilio, Paul

    2013-05-10

    Focusing on statistical methods in patient-reported outcomes, we propose and develop a generalized Jonckheere test against ordered alternatives for repeated measures in a randomized block design. We derive its asymptotic null distribution properties and describe methods for estimating the null distribution for testing the hypothesis. We present a numerical example to illustrate the test procedure. Copyright © 2012 John Wiley & Sons, Ltd.

  12. REGULAR METHOD FOR SYNTHESIS OF BASIC BENT-SQUARES OF RANDOM ORDER

    Directory of Open Access Journals (Sweden)

    A. V. Sokolov

    2016-01-01

    Full Text Available The paper is devoted to the class construction of the most non-linear Boolean bent-functions of any length N = 2k (k = 2, 4, 6…, on the basis of their spectral representation – Agievich bent squares. These perfect algebraic constructions are used as a basis to build many new cryptographic primitives, such as generators of pseudo-random key sequences, crypto graphic S-boxes, etc. Bent-functions also find their application in the construction of C-codes in the systems with code division multiple access (CDMA to provide the lowest possible value of Peak-to-Average Power Ratio (PAPR k = 1, as well as for the construction of error-correcting codes and systems of orthogonal biphasic signals. All the numerous applications of bent-functions relate to the theory of their synthesis. However, regular methods for complete class synthesis of bent-functions of any length N = 2k are currently unknown. The paper proposes a regular synthesis method for the basic Agievich bent squares of any order n, based on a regular operator of dyadic shift. Classification for a complete set of spectral vectors of lengths (l = 8, 16, … based on a criterion of the maximum absolute value and set of absolute values of spectral components has been carried out in the paper. It has been shown that any spectral vector can be a basis for building bent squares. Results of the synthesis for the Agievich bent squares of order n = 8 have been generalized and it has been revealed that there are only 3 basic bent squares for this order, while the other 5 can be obtained with help the operation of step-cyclic shift. All the basic bent squares of order n = 16 have been synthesized that allows to construct the bent-functions of length N = 256. The obtained basic bent squares can be used either for direct synthesis of bent-functions and their practical application or for further research in order to synthesize new structures of bent squares of orders n = 16, 32, 64, …

  13. Primary care physicians' challenges in ordering clinical laboratory tests and interpreting results.

    Science.gov (United States)

    Hickner, John; Thompson, Pamela J; Wilkinson, Tom; Epner, Paul; Sheehan, Meghan; Pollock, Anne M; Lee, Jim; Duke, Christopher C; Jackson, Brian R; Taylor, Julie R

    2014-01-01

    The number and complexity of clinical laboratory tests is rapidly expanding, presenting primary care physicians with challenges in accurately, efficiently, and safely ordering and interpreting diagnostic tests. The objective of this study was to identify challenges primary care physicians face related to diagnostic laboratory testing and solutions they believe are helpful and available to them. In this study, sponsored by the Centers for Disease Control and Prevention, a random sample of general internal medicine and family medicine physicians from the American Medical Association Masterfile were surveyed in 2011. 1768 physicians (5.6%) responded to the survey. Physicians reported ordering diagnostic laboratory tests for an average of 31.4% of patient encounters per week. They reported uncertainty about ordering tests in 14.7% and uncertainty in interpreting results in 8.3% of these diagnostic encounters. The most common problematic challenges in ordering tests were related to the cost to patients and insurance coverage restrictions. Other challenges included different names for the same test, tests not available except as part of a test panel, and different tests included in panels with the same names. The most common problematic challenges in interpreting and using test results were not receiving the results and confusing report formats. Respondents endorsed a variety of information technology and decision support solutions to improve test selection and results interpretation, but these solutions were not widely available at the time of the survey. Physicians infrequently sought assistance or consultation from laboratory professionals but valued these consultations when they occurred. Primary care physicians routinely experience uncertainty and challenges in ordering and interpreting diagnostic laboratory tests. With more than 500 million primary care patient visits per year, the level of uncertainty reported in this study potentially affects 23 million patients

  14. Random walker in temporally deforming higher-order potential forces observed in a financial crisis.

    Science.gov (United States)

    Watanabe, Kota; Takayasu, Hideki; Takayasu, Misako

    2009-11-01

    Basic peculiarities of market price fluctuations are known to be well described by a recently developed random-walk model in a temporally deforming quadratic potential force whose center is given by a moving average of past price traces [M. Takayasu, T. Mizuno, and H. Takayasu, Physica A 370, 91 (2006)]. By analyzing high-frequency financial time series of exceptional events, such as bubbles and crashes, we confirm the appearance of higher-order potential force in the markets. We show statistical significance of its existence by applying the information criterion. This time series analysis is expected to be applied widely for detecting a nonstationary symptom in random phenomena.

  15. Random walker in temporally deforming higher-order potential forces observed in a financial crisis

    Science.gov (United States)

    Watanabe, Kota; Takayasu, Hideki; Takayasu, Misako

    2009-11-01

    Basic peculiarities of market price fluctuations are known to be well described by a recently developed random-walk model in a temporally deforming quadratic potential force whose center is given by a moving average of past price traces [M. Takayasu, T. Mizuno, and H. Takayasu, Physica A 370, 91 (2006)]. By analyzing high-frequency financial time series of exceptional events, such as bubbles and crashes, we confirm the appearance of higher-order potential force in the markets. We show statistical significance of its existence by applying the information criterion. This time series analysis is expected to be applied widely for detecting a nonstationary symptom in random phenomena.

  16. Monadic structures over an ordered universal random graph and finite automata

    Energy Technology Data Exchange (ETDEWEB)

    Dudakov, Sergey M [Tver' State University, Tver' (Russian Federation)

    2011-10-31

    We continue the investigation of the expressive power of the language of predicate logic for finite algebraic systems embedded in infinite systems. This investigation stems from papers of M. A. Taitslin, M. Benedikt and L. Libkin, among others. We study the properties of a finite monadic system which can be expressed by formulae if such a system is embedded in a random graph that is totally ordered in an arbitrary way. The Buechi representation is used to connect monadic structures and formal languages. It is shown that, if one restricts attention to formulae that are <-invariant in totally ordered random graphs, then these formulae correspond to finite automata. We show that =-invariant formulae expressing the properties of the embedded system itself can express only Boolean combinations of properties of the form 'the cardinality of an intersection of one-place predicates belongs to one of finitely many fixed finite or infinite arithmetic progressions'.

  17. Transmission performance improvement using random DFB laser based Raman amplification and bidirectional second-order pumping

    OpenAIRE

    Tan, M.; Rosa, P; Le, S.T.; Iqbal, Md A.; Phillips, I.D.; Harper, P.

    2016-01-01

    We demonstrate that a distributed Raman amplification scheme based on random distributed feedback (DFB) fiber laser enables bidirectional second-order Raman pumping without increasing relative intensity noise (RIN) of the signal. This extends the reach of 10 × 116 Gb/s DP-QPSK WDM transmission up to 7915 km, compared with conventional Raman amplification schemes. Moreover, this scheme gives the longest maximum transmission distance among all the Raman amplification schemes presented in this p...

  18. Orders on Intervals Over Partially Ordered Sets: Extending Allen's Algebra and Interval Graph Results

    Energy Technology Data Exchange (ETDEWEB)

    Zapata, Francisco; Kreinovich, Vladik; Joslyn, Cliff A.; Hogan, Emilie A.

    2013-08-01

    To make a decision, we need to compare the values of quantities. In many practical situations, we know the values with interval uncertainty. In such situations, we need to compare intervals. Allen’s algebra describes all possible relations between intervals on the real line, and ordering relations between such intervals are well studied. In this paper, we extend this description to intervals in an arbitrary partially ordered set (poset). In particular, we explicitly describe ordering relations between intervals that generalize relation between points. As auxiliary results, we provide a logical interpretation of the relation between intervals, and extend the results about interval graphs to intervals over posets.

  19. Is the order of the New Testament books in the canon random?

    Directory of Open Access Journals (Sweden)

    Paweł Marek Mucha

    2007-10-01

    Full Text Available Decretum de canonicis Scripturis (Council of Trent gives the following list of the canonical books of the New Testament: Matthew, Mark, Luke, John, Acts of the Apostles, Pauline Epistles, Catholic Epistles, Revelation. This order is based on many manuscripts, but is not the only one known. The Apostolic Fathers cite the books of the New Testament, but never give their titles. The books were only given titles in the late second century. The Muratorian fragment is the oldest document (the second half of the 2nd century which enumerates canonical books in an appropriate order. The important fact is that this list was prepared in the Roman Church and the order is in accordance with our canon. The Muratorian fragment presents the list of books in the reverse alphabetical order (from Z to A. It is a consequence of the tendency to order books alphabetically (not only in codices. Due to the fact that the oldest list of canonical books enlists them in the same order as we do in our canon and this order is not random, the order in our canon seems to be authentic.

  20. Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial.

    Science.gov (United States)

    Sajobi, Tolulope T; Singh, Gurbakhshash; Lowerison, Mark W; Engbers, Jordan; Menon, Bijoy K; Demchuk, Andrew M; Goyal, Mayank; Hill, Michael D

    2017-11-02

    We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the "Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times" (ESCAPE) trial. The ESCAPE trial is a prospective, multicenter, randomized clinical trial that enrolled subjects with the following main inclusion criteria: less than 12 h from symptom onset, age 18 years or older, baseline NIHSS score > 5, ASPECTS score > 5 and computed tomography angiography (CTA) evidence of carotid T/L or M1-segment middle cerebral artery (MCA) occlusion, and at least moderate collaterals by CTA. Patients were randomized using a real-time, dynamic, Internet-based, minimal sufficient balance randomization method that balanced the study arms with respect to baseline covariates including age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS score and treatment with intravenously administered alteplase. Permutation-based tests of group differences confirmed group balance across several baseline covariates including sex (p = 1.00), baseline NIHSS score (p = 0.95), site of arterial occlusion (p = 1.00), baseline ASPECTS score (p = 0.28), treatment with intravenously administered alteplase (p = 0.31), and age (p = 0.67). Results from the ESCAPE trial demonstrate the feasibility and the benefit of this covariate adaptive randomization scheme in small-sample trials and for data monitoring endeavors. ESCAPE trial - NCT01778335 - at www.clinicaltrials.gov . Registered on 29 January 2013.

  1. Universality of Wigner random matrices: a survey of recent results

    Energy Technology Data Exchange (ETDEWEB)

    Erdos, Laszlo [Ludwig-Maximilians-University of Munich (Germany)

    2011-06-30

    This is a study of the universality of spectral statistics for large random matrices. Considered are NxN symmetric, Hermitian, or quaternion self-dual random matrices with independent identically distributed entries (Wigner matrices), where the probability distribution of each matrix element is given by a measure {nu} with zero expectation and with subexponential decay. The main result is that the correlation functions of the local eigenvalue statistics in the bulk of the spectrum coincide with those of the Gaussian Orthogonal Ensemble (GOE), the Gaussian Unitary Ensemble (GUE), and the Gaussian Symplectic Ensemble (GSE), respectively, in the limit as N {yields} {infinity}. This approach is based on a study of the Dyson Brownian motion via a related new dynamics, the local relaxation flow. As a main input, it is established that the density of the eigenvalues converges to the Wigner semicircle law, and this holds even down to the smallest possible scale. Moreover, it is shown that the eigenvectors are completely delocalized. These results hold even without the condition that the matrix elements are identically distributed: only independence is used. In fact, for the matrix elements of the Green function strong estimates are given that imply that the local statistics of any two ensembles in the bulk are identical if the first four moments of the matrix elements match. Universality at the spectral edges requires matching only two moments. A Wigner-type estimate is also proved, and it is shown that the eigenvalues repel each other on arbitrarily small scales. Bibliography: 108 titles.

  2. An MGF-based Unified Framework to Determine the Joint Statistics of Partial Sums of Ordered Random Variables

    CERN Document Server

    Nam, Sung Sik; Yang, Hong-Chuan

    2010-01-01

    Order statistics find applications in various areas of communications and signal processing. In this paper, we introduce an unified analytical framework to determine the joint statistics of partial sums of ordered random variables (RVs). With the proposed approach, we can systematically derive the joint statistics of any partial sums of ordered statistics, in terms of the moment generating function (MGF) and the probability density function (PDF). Our MGF-based approach applies not only when all the K ordered RVs are involved but also when only the Ks (Ks < K) best RVs are considered. In addition, we present the closed-form expressions for the exponential RV special case. These results apply to the performance analysis of various wireless communication systems over fading channels.

  3. An MGF-based unified framework to determine the joint statistics of partial sums of ordered random variables

    KAUST Repository

    Nam, Sungsik

    2010-11-01

    Order statistics find applications in various areas of communications and signal processing. In this paper, we introduce an unified analytical framework to determine the joint statistics of partial sums of ordered random variables (RVs). With the proposed approach, we can systematically derive the joint statistics of any partial sums of ordered statistics, in terms of the moment generating function (MGF) and the probability density function (PDF). Our MGF-based approach applies not only when all the K ordered RVs are involved but also when only the Ks(Ks < K) best RVs are considered. In addition, we present the closed-form expressions for the exponential RV special case. These results apply to the performance analysis of various wireless communication systems over fading channels. © 2006 IEEE.

  4. Randomization techniques for assessing the significance of gene periodicity results

    Directory of Open Access Journals (Sweden)

    Vuokko Niko

    2011-08-01

    Full Text Available Abstract Background Modern high-throughput measurement technologies such as DNA microarrays and next generation sequencers produce extensive datasets. With large datasets the emphasis has been moving from traditional statistical tests to new data mining methods that are capable of detecting complex patterns, such as clusters, regulatory networks, or time series periodicity. Study of periodic gene expression is an interesting research question that also is a good example of challenges involved in the analysis of high-throughput data in general. Unlike for classical statistical tests, the distribution of test statistic for data mining methods cannot be derived analytically. Results We describe the randomization based approach to significance testing, and show how it can be applied to detect periodically expressed genes. We present four randomization methods, three of which have previously been used for gene cycle data. We propose a new method for testing significance of periodicity in gene expression short time series data, such as from gene cycle and circadian clock studies. We argue that the underlying assumptions behind existing significance testing approaches are problematic and some of them unrealistic. We analyze the theoretical properties of the existing and proposed methods, showing how our method can be robustly used to detect genes with exceptionally high periodicity. We also demonstrate the large differences in the number of significant results depending on the chosen randomization methods and parameters of the testing framework. By reanalyzing gene cycle data from various sources, we show how previous estimates on the number of gene cycle controlled genes are not supported by the data. Our randomization approach combined with widely adopted Benjamini-Hochberg multiple testing method yields better predictive power and produces more accurate null distributions than previous methods. Conclusions Existing methods for testing significance

  5. Statistical mechanics of random geometric graphs: Geometry-induced first-order phase transition.

    Science.gov (United States)

    Ostilli, Massimo; Bianconi, Ginestra

    2015-04-01

    Random geometric graphs (RGGs) can be formalized as hidden-variables models where the hidden variables are the coordinates of the nodes. Here we develop a general approach to extract the typical configurations of a generic hidden-variables model and apply the resulting equations to RGGs. For any RGG, defined through a rigid or a soft geometric rule, the method reduces to a nontrivial satisfaction problem: Given N nodes, a domain D, and a desired average connectivity 〈k〉, find, if any, the distribution of nodes having support in D and average connectivity 〈k〉. We find out that, in the thermodynamic limit, nodes are either uniformly distributed or highly condensed in a small region, the two regimes being separated by a first-order phase transition characterized by a O(N) jump of 〈k〉. Other intermediate values of 〈k〉 correspond to very rare graph realizations. The phase transition is observed as a function of a parameter a∈[0,1] that tunes the underlying geometry. In particular, a=1 indicates a rigid geometry where only close nodes are connected, while a=0 indicates a rigid antigeometry where only distant nodes are connected. Consistently, when a=1/2 there is no geometry and no phase transition. After discussing the numerical analysis, we provide a combinatorial argument to fully explain the mechanism inducing this phase transition and recognize it as an easy-hard-easy transition. Our result shows that, in general, ad hoc optimized networks can hardly be designed, unless to rely to specific heterogeneous constructions, not necessarily scale free.

  6. Reduced-Order Monte Carlo Modeling of Radiation Transport in Random Media

    Science.gov (United States)

    Olson, Aaron

    The ability to perform radiation transport computations in stochastic media is essential for predictive capabilities in applications such as weather modeling, radiation shielding involving non-homogeneous materials, atmospheric radiation transport computations, and transport in plasma-air structures. Due to the random nature of such media, it is often not clear how to model or otherwise compute on many forms of stochastic media. Several approaches to evaluation of transport quantities for some stochastic media exist, though such approaches often either yield considerable error or are quite computationally expensive. We model stochastic media using the Karhunen-Loeve (KL) expansion, seek to improve efficiency through use of stochastic collocation (SC), and provide higher-order information of output values using the polynomial chaos expansion (PCE). We study and demonstrate method convergence and apply the new methods to both spatially continuous and spatially discontinuous stochastic media. New methods are shown to produce accurate solutions for reasonable computational cost for several problem when compared with existing solution methods. Spatially random media are modeled using transformations of the Gaussian-distributed KL expansion-continuous random media with a lognormal transformation and discontinuous random media with a Nataf transformation. Each transformation preserves second-order statistics for the quantity-atom density or material index, respectively-being modeled. The Nystrom method facilitates numerical solution of the KL eigenvalues and eigenvectors, and a variety of methods are investigated for sampling KL eigenfunctions as a function of solved eigenvectors. The infinite KL expansion is truncated to a finite number of terms each containing a random variable, and material realizations are created by either randomly or deterministically sampling from the random variables. Deterministic sampling is performed with either isotropic or anisotropic

  7. A model for a correlated random walk based on the ordered extension of pseudopodia.

    Directory of Open Access Journals (Sweden)

    Peter J M Van Haastert

    Full Text Available Cell migration in the absence of external cues is well described by a correlated random walk. Most single cells move by extending protrusions called pseudopodia. To deduce how cells walk, we have analyzed the formation of pseudopodia by Dictyostelium cells. We have observed that the formation of pseudopodia is highly ordered with two types of pseudopodia: First, de novo formation of pseudopodia at random positions on the cell body, and therefore in random directions. Second, pseudopod splitting near the tip of the current pseudopod in alternating right/left directions, leading to a persistent zig-zag trajectory. Here we analyzed the probability frequency distributions of the angles between pseudopodia and used this information to design a stochastic model for cell movement. Monte Carlo simulations show that the critical elements are the ratio of persistent splitting pseudopodia relative to random de novo pseudopodia, the Left/Right alternation, the angle between pseudopodia and the variance of this angle. Experiments confirm predictions of the model, showing reduced persistence in mutants that are defective in pseudopod splitting and in mutants with an irregular cell surface.

  8. Random responding from participants is a threat to the validity of social science research results

    Directory of Open Access Journals (Sweden)

    Jason W Osborne

    2011-01-01

    Full Text Available Research in the social sciences often relies upon the motivation and goodwill of research participants (e.g., teachers, students, minimally-compensated volunteers to do their best on low stakes assessments of the effects of interventions. Research participants who are unmotivated to perform well can engage in random responding on outcome measures, which can cause substantial mis-estimation of results, biasing results toward the null hypothesis. Data from a recent educational intervention study served as a clear example of this problem: participants identified as random responders showed substantially lower scores than other participants on tests during the study, and failed to show growth in scores from pre- to posttest, while those not engaging in random responding showed much higher scores and significant growth over time. This served to mask the hypothesized group differences across instructional method when random responders were retained in the sample (anticipated group differences were significant when these random responders were removed. We remind researchers to screen their data for random responding (and other response biases in their critical outcome measures in order to improve the odds of detecting effects of their interventions.

  9. First-order system least-squares for second-order elliptic problems with discontinuous coefficients: Further results

    Energy Technology Data Exchange (ETDEWEB)

    Bloechle, B.; Manteuffel, T.; McCormick, S.; Starke, G.

    1996-12-31

    Many physical phenomena are modeled as scalar second-order elliptic boundary value problems with discontinuous coefficients. The first-order system least-squares (FOSLS) methodology is an alternative to standard mixed finite element methods for such problems. The occurrence of singularities at interface corners and cross-points requires that care be taken when implementing the least-squares finite element method in the FOSLS context. We introduce two methods of handling the challenges resulting from singularities. The first method is based on a weighted least-squares functional and results in non-conforming finite elements. The second method is based on the use of singular basis functions and results in conforming finite elements. We also share numerical results comparing the two approaches.

  10. Transmission performance improvement using random DFB laser based Raman amplification and bidirectional second-order pumping.

    Science.gov (United States)

    Tan, M; Rosa, P; Le, S T; Iqbal, Md A; Phillips, I D; Harper, P

    2016-02-08

    We demonstrate that a distributed Raman amplification scheme based on random distributed feedback (DFB) fiber laser enables bidirectional second-order Raman pumping without increasing relative intensity noise (RIN) of the signal. This extends the reach of 10 × 116 Gb/s DP-QPSK WDM transmission up to 7915 km, compared with conventional Raman amplification schemes. Moreover, this scheme gives the longest maximum transmission distance among all the Raman amplification schemes presented in this paper, whilst maintaining relatively uniform and symmetric signal power distribution, and is also adjustable in order to be highly compatible with different nonlinearity compensation techniques, including mid-link optical phase conjugation (OPC) and nonlinear Fourier transform (NFT).

  11. A Randomized Trial of Displaying Paid Price Information on Imaging Study and Procedure Ordering Rates.

    Science.gov (United States)

    Chien, Alyna T; Lehmann, Lisa Soleymani; Hatfield, Laura A; Koplan, Kate E; Petty, Carter R; Sinaiko, Anna D; Rosenthal, Meredith B; Sequist, Thomas D

    2017-04-01

    Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy. To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO). Block randomized controlled trial for 1 year. A total of 1205 fully licensed clinicians (728 primary care, 477 specialists). Starting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO's services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers. Ordering rates (orders per 100 face-to-face encounters with adult patients): overall, designated to be completed internally within the ACO, considered "inappropriate" (e.g., MRI for simple headache), and thought to be "appropriate" (e.g., screening colonoscopy). We found no significant difference in overall ordering rates across the Control, Single Median Price, or Paired Internal/External Median Prices study arms. For every 100 encounters, clinicians in the Control arm ordered 15.0 (SD 31.1) tests, those in the Single Median Price arm ordered 15.0 (SD 16.2) tests, and those in the Paired Prices arms ordered 15.7 (SD 20.5) tests (one-way ANOVA p-value 0.88). There was no difference in ordering rates for tests designated to be completed internally or considered to be inappropriate or appropriate. Displaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO. Those with a particular interest in removing waste from the health care system may want to

  12. A stochastic collocation method for the second order wave equation with a discontinuous random speed

    KAUST Repository

    Motamed, Mohammad

    2012-08-31

    In this paper we propose and analyze a stochastic collocation method for solving the second order wave equation with a random wave speed and subjected to deterministic boundary and initial conditions. The speed is piecewise smooth in the physical space and depends on a finite number of random variables. The numerical scheme consists of a finite difference or finite element method in the physical space and a collocation in the zeros of suitable tensor product orthogonal polynomials (Gauss points) in the probability space. This approach leads to the solution of uncoupled deterministic problems as in the Monte Carlo method. We consider both full and sparse tensor product spaces of orthogonal polynomials. We provide a rigorous convergence analysis and demonstrate different types of convergence of the probability error with respect to the number of collocation points for full and sparse tensor product spaces and under some regularity assumptions on the data. In particular, we show that, unlike in elliptic and parabolic problems, the solution to hyperbolic problems is not in general analytic with respect to the random variables. Therefore, the rate of convergence may only be algebraic. An exponential/fast rate of convergence is still possible for some quantities of interest and for the wave solution with particular types of data. We present numerical examples, which confirm the analysis and show that the collocation method is a valid alternative to the more traditional Monte Carlo method for this class of problems. © 2012 Springer-Verlag.

  13. Comparing cost effects of two quality strategies to improve test ordering in primary care: a randomized trial.

    NARCIS (Netherlands)

    Verstappen, W.H.; Merode, F. van; Grimshaw, J.; Dubois, W.; Grol, R.P.T.M.; Weijden, T. van der

    2004-01-01

    OBJECTIVE: To determine the costs and cost reductions of an innovative strategy aimed at improving test ordering routines of primary care physicians, compared with a traditional strategy. DESIGN: Multicenter randomized controlled trial with randomization at the local primary care physicians group

  14. On solving large-scale polynomial convex problems by randomized first order algorithms

    NARCIS (Netherlands)

    Ben-Tal, A.; Nemirovski, A.

    2015-01-01

    One of the most attractive recent approaches to processing well-structured large-scale convex optimization problems is based on smooth convex-concave saddle point reformulation of the problem of interest and solving the resulting problem by a fast first order saddle point method utilizing smoothness

  15. Order-to-chaos transition in the hardness of random Boolean satisfiability problems

    Science.gov (United States)

    Varga, Melinda; Sumi, Róbert; Toroczkai, Zoltán; Ercsey-Ravasz, Mária

    2016-05-01

    Transient chaos is a ubiquitous phenomenon characterizing the dynamics of phase-space trajectories evolving towards a steady-state attractor in physical systems as diverse as fluids, chemical reactions, and condensed matter systems. Here we show that transient chaos also appears in the dynamics of certain efficient algorithms searching for solutions of constraint satisfaction problems that include scheduling, circuit design, routing, database problems, and even Sudoku. In particular, we present a study of the emergence of hardness in Boolean satisfiability (k -SAT), a canonical class of constraint satisfaction problems, by using an analog deterministic algorithm based on a system of ordinary differential equations. Problem hardness is defined through the escape rate κ , an invariant measure of transient chaos of the dynamical system corresponding to the analog algorithm, and it expresses the rate at which the trajectory approaches a solution. We show that for a given density of constraints and fixed number of Boolean variables N , the hardness of formulas in random k -SAT ensembles has a wide variation, approximable by a lognormal distribution. We also show that when increasing the density of constraints α , hardness appears through a second-order phase transition at αχ in the random 3-SAT ensemble where dynamical trajectories become transiently chaotic. A similar behavior is found in 4-SAT as well, however, such a transition does not occur for 2-SAT. This behavior also implies a novel type of transient chaos in which the escape rate has an exponential-algebraic dependence on the critical parameter κ ˜NB |α - αχ|1-γ with 0 <γ <1 . We demonstrate that the transition is generated by the appearance of metastable basins in the solution space as the density of constraints α is increased.

  16. 78 FR 78694 - Orders: Supplemental Orders on Reporting by Regulated Entities of Stress Testing Results as of...

    Science.gov (United States)

    2013-12-27

    ... AGENCY 12 CFR Part 1238 Orders: Supplemental Orders on Reporting by Regulated Entities of Stress Testing... Analysis, Modeling and Simulations, (202) 649-3140, [email protected] ; Stefan Szilagyi, Examination... additional appendices of scenario assumptions to be used for stress testing. II. Orders For the convenience...

  17. Higher-order singular value decomposition-based discrete fractional random transform for simultaneous compression and encryption of video images

    Science.gov (United States)

    Wang, Qingzhu; Chen, Xiaoming; Zhu, Yihai

    2017-09-01

    Existing image compression and encryption methods have several shortcomings: they have low reconstruction accuracy and are unsuitable for three-dimensional (3D) images. To overcome these limitations, this paper proposes a tensor-based approach adopting tensor compressive sensing and tensor discrete fractional random transform (TDFRT). The source video images are measured by three key-controlled sensing matrices. Subsequently, the resulting tensor image is further encrypted using 3D cat map and the proposed TDFRT, which is based on higher-order singular value decomposition. A multiway projection algorithm is designed to reconstruct the video images. The proposed algorithm can greatly reduce the data volume and improve the efficiency of the data transmission and key distribution. The simulation results validate the good compression performance, efficiency, and security of the proposed algorithm.

  18. Loss of long-range magnetic order in a nanoparticle assembly due to random anisotropy

    Science.gov (United States)

    Binns, C.; Howes, P. B.; Baker, S. H.; Marchetto, H.; Potenza, A.; Steadman, P.; Dhesi, S. S.; Roy, M.; Everard, M. J.; Rushforth, A.

    2008-02-01

    We have used soft x-ray photoemission electron microscopy (XPEEM) combined with x-ray magnetic circular dichroism (XMCD) and DC SQUID (superconducting quantum interference device) magnetometry to probe the magnetic ground state in Fe thin films produced by depositing size-selected gas-phase Fe nanoparticles with a diameter of 1.7 nm (~200 atoms) onto Si substrates. The depositions were carried out in ultrahigh vacuum conditions and thicknesses of the deposited film in the range 5-50 nm were studied. The magnetometry data are consistent with the film forming a correlated super-spin glass with a magnetic correlation length ~5 nm. The XPEEM magnetic maps from the cluster-assembled films were compared to those for a conventional thin Fe film with a thickness of 20 nm produced by a molecular beam epitaxy (MBE) source. Whereas a normal magnetic domain structure is observed in the conventional MBE thin film, no domain structure could be observed in any of the nanoparticle films down to the resolution limit of the XMCD based XPEEM (100 nm) confirming the ground state indicated by the magnetometry measurements. This observation is consistent with the theoretical prediction that an arbitrarily weak random anisotropy field will destroy long-range magnetic order.

  19. Higher-order cognitive training effects on processing speed-related neural activity: a randomized trial.

    Science.gov (United States)

    Motes, Michael A; Yezhuvath, Uma S; Aslan, Sina; Spence, Jeffrey S; Rypma, Bart; Chapman, Sandra B

    2017-10-12

    Higher-order cognitive training has shown to enhance performance in older adults, but the neural mechanisms underlying performance enhancement have yet to be fully disambiguated. This randomized trial examined changes in processing speed and processing speed-related neural activity in older participants (57-71 years of age) who underwent cognitive training (CT, N = 12) compared with wait-listed (WLC, N = 15) or exercise-training active (AC, N = 14) controls. The cognitive training taught cognitive control functions of strategic attention, integrative reasoning, and innovation over 12 weeks. All 3 groups worked through a functional magnetic resonance imaging processing speed task during 3 sessions (baseline, mid-training, and post-training). Although all groups showed faster reaction times (RTs) across sessions, the CT group showed a significant increase, and the WLC and AC groups showed significant decreases across sessions in the association between RT and BOLD signal change within the left prefrontal cortex (PFC). Thus, cognitive training led to a change in processing speed-related neural activity where faster processing speed was associated with reduced PFC activation, fitting previously identified neural efficiency profiles. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  20. An Authenticated Key Agreement Scheme Based on Cyclic Automorphism Subgroups of Random Orders

    Directory of Open Access Journals (Sweden)

    Yang Jun

    2017-01-01

    Full Text Available Group-based cryptography is viewed as a modern cryptographic candidate solution to blocking quantum computer attacks, and key exchange protocols on the Internet are one of the primitives to ensure the security of communication. In 2016 Habeeb et al proposed a “textbook” key exchange protocol based on the semidirect product of two groups, which is insecure for use in real-world applications. In this paper, after discarding the unnecessary disguising notion of semidirect product in the protocol, we establish a simplified yet enhanced authenticated key agreement scheme based on cyclic automorphism subgroups of random orders by making hybrid use of certificates and symmetric-key encryption as challenge-and-responses in the public-key setting. Its passive security is formally analyzed, which is relative to the cryptographic hardness assumption of a computational number-theoretic problem. Cryptanalysis of this scheme shows that it is secure against the intruder-in-the-middle attack even in the worst case of compromising the signatures, and provides explicit key confirmation to both parties.

  1. Loss of long-range magnetic order in a nanoparticle assembly due to random anisotropy

    Energy Technology Data Exchange (ETDEWEB)

    Binns, C [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Howes, P B [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Baker, S H [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Marchetto, H [Diamond Light Source Ltd, Harwell Science and Innovation Campus, Diamond House, Chilton, Didcot, Oxfordshire OX11 0DE (United Kingdom); Potenza, A [Diamond Light Source Ltd, Harwell Science and Innovation Campus, Diamond House, Chilton, Didcot, Oxfordshire OX11 0DE (United Kingdom); Steadman, P [Diamond Light Source Ltd, Harwell Science and Innovation Campus, Diamond House, Chilton, Didcot, Oxfordshire OX11 0DE (United Kingdom); Dhesi, S S [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Roy, M [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Everard, M J [Department of Physics and Astronomy, University of Leicester, Leicester LE1 7RH (United Kingdom); Rushforth, A [School of Physics and Astronomy, University of Nottingham, Nottingham NG7 2RD (United Kingdom)

    2008-02-06

    We have used soft x-ray photoemission electron microscopy (XPEEM) combined with x-ray magnetic circular dichroism (XMCD) and DC SQUID (superconducting quantum interference device) magnetometry to probe the magnetic ground state in Fe thin films produced by depositing size-selected gas-phase Fe nanoparticles with a diameter of 1.7 nm ({approx}200 atoms) onto Si substrates. The depositions were carried out in ultrahigh vacuum conditions and thicknesses of the deposited film in the range 5-50 nm were studied. The magnetometry data are consistent with the film forming a correlated super-spin glass with a magnetic correlation length {approx}5 nm. The XPEEM magnetic maps from the cluster-assembled films were compared to those for a conventional thin Fe film with a thickness of 20 nm produced by a molecular beam epitaxy (MBE) source. Whereas a normal magnetic domain structure is observed in the conventional MBE thin film, no domain structure could be observed in any of the nanoparticle films down to the resolution limit of the XMCD based XPEEM (100 nm) confirming the ground state indicated by the magnetometry measurements. This observation is consistent with the theoretical prediction that an arbitrarily weak random anisotropy field will destroy long-range magnetic order.

  2. 75 FR 55764 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Preliminary Results of...

    Science.gov (United States)

    2010-09-14

    ... memory, such as video graphics adapter boards and cards, are not included in the scope. The order also..., video random access memory and synchronous graphics random access memory, as well as various types of... for Foreign Technicians (Article 18 of RSTA) G. Reduction of Tax Regarding the Movement of a Factory...

  3. Multiplicity Result of Positive Solutions for Nonlinear Differential Equation of Fractional Order

    Directory of Open Access Journals (Sweden)

    Yang Liu

    2012-01-01

    Full Text Available We investigate the existence of multiple positive solutions for a class of boundary value problems of nonlinear differential equation with Caputo’s fractional order derivative. The existence results are obtained by means of the Avery-Peterson fixed point theorem. It should be point out that this is the first time that this fixed point theorem is used to deal with the boundary value problem of differential equations with fractional order derivative.

  4. Fixed point results for generalized Chatterjea type contractive conditions in partially ordered G-metric spaces.

    Science.gov (United States)

    Khan, Safeer Hussain; Abbas, Mujahid; Nazir, Talat

    2014-01-01

    In the framework of ordered G-metric spaces, fixed points of maps that satisfy the generalized (ψ, φ)-Chatterjea type contractive conditions are obtained. The results presented in the paper generalize and extend several well known comparable results in the literature.

  5. Higher order moments of a sum of random variables: remarks and applications.

    Directory of Open Access Journals (Sweden)

    Luisa Tibiletti

    1996-02-01

    Full Text Available The moments of a sum of random variables depend on both the pure moments of each random addendum and on the addendum mixed moments. In this note we introduce a simple measure to evaluate the relative impedance to attach to the latter. Once the pure moments are fixed, the functional relation between the random addenda leading to the extreme values is also provided. Applications to Finance, Decision Theory and Actuarial Sciences are also suggested.

  6. Effect of a dilute random field on a continuous-symmetry order parameter

    Science.gov (United States)

    Proctor, T. C.; Chudnovsky, E. M.

    2015-04-01

    X Y and Heisenberg spins, subjected to strong random fields acting at a few points in space with a concentration cr≪1 , are studied numerically on three-dimensional lattices containing over 4 ×106 sites. Glassy behavior with a strong dependence on initial conditions is found. Beginning with a random initial orientation of spins, the system evolves into ferromagnetic domains inversely proportional to cr in size. The area of the hysteresis loop m (H ) scales as cr2. These findings are explained by mapping the effect of a strong dilute random field onto the effect of a weak continuous random field. Our theory applies directly to ferromagnets with magnetic impurities, and is conceptually relevant to strongly pinned vortex lattices in superconductors and pinned charge-density waves.

  7. Iterative oscillation results for second-order differential equations with advanced argument

    Directory of Open Access Journals (Sweden)

    Irena Jadlovska

    2017-07-01

    Full Text Available This article concerns the oscillation of solutions to a linear second-order differential equation with advanced argument. Sufficient oscillation conditions involving limit inferior are given which essentially improve known results. We base our technique on the iterative construction of solution estimates and some of the recent ideas developed for first-order advanced differential equations. We demonstrate the advantage of our results on Euler-type advanced equation. Using MATLAB software, a comparison of the effectiveness of newly obtained criteria as well as the necessary iteration length in particular cases are discussed.

  8. Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering

    NARCIS (Netherlands)

    Verstappen, Wim H. J. M.; van der Weijden, Trudy; ter Riet, Gerben; Grimshaw, Jeremy; Winkens, Ron; Grol, Richard P. T. M.

    2004-01-01

    Background and Objective: To evaluate the value of balanced incomplete block designs in quality improvement research, and their capacity to control for the Hawthorne effect. Methods: General practitioners teams were randomized into three arms and received an intervention on test ordering, relating

  9. Block design allowed for control of the Hawthorne effect in a randomized controlled trial of test ordering.

    NARCIS (Netherlands)

    Verstappen, W.H.; Weijden, T. van der; Riet, G. ter; Grimshaw, J.; Winkens, R.; Grol, R.P.T.M.

    2004-01-01

    BACKGROUND AND OBJECTIVE: To evaluate the value of balanced incomplete block designs in quality improvement research, and their capacity to control for the Hawthorne effect. METHODS: General practitioners teams were randomized into three arms and received an intervention on test ordering, relating

  10. Order acceptance in food processing systems with random raw material requirements

    NARCIS (Netherlands)

    Kilic, Onur A.; van Donk, Dirk Pieter; Wijngaard, Jacob; Tarim, S. Armagan

    This study considers a food production system that processes a single perishable raw material into several products having stochastic demands. In order to process an order, the amount of raw material delivery from storage needs to meet the raw material requirement of the order. However, the amount

  11. Fixed point results of locally contractive mappings in ordered quasi-partial metric spaces.

    Science.gov (United States)

    Shoaib, Abdullah; Arshad, Muhammad; Ahmad, Jamshaid

    2013-01-01

    Fixed point results for a self-map satisfying locally contractive conditions on a closed ball in an ordered 0-complete quasi-partial metric space have been established. Instead of monotone mapping, the notion of dominated mappings is applied. We have used weaker metric, weaker contractive conditions, and weaker restrictions to obtain unique fixed points. An example is given which shows that how this result can be used when the corresponding results cannot. Our results generalize, extend, and improve several well-known conventional results.

  12. Oscillation results on meromorphic solutions of second order differential equations in the complex plane

    Directory of Open Access Journals (Sweden)

    Ting-Bin Cao

    2010-11-01

    Full Text Available The main purpose of this paper is to consider the oscillation theory on meromorphic solutions of second order linear differential equations of the form $f^{''}+A(zf=0$ where $A$ is meromorphic in the complex plane. We improve and extend some oscillation results due to Bank and Laine, Kinnunen, Liang and Liu, and others.

  13. Transient modeling of non-Fickian transport and first-order reaction using continuous time random walk

    Science.gov (United States)

    Burnell, Daniel K.; Hansen, Scott K.; Xu, Jie

    2017-09-01

    Contaminants in groundwater may experience a broad spectrum of velocities and multiple rates of mass transfer between mobile and immobile zones during transport. These conditions may lead to non-Fickian plume evolution which is not well described by the advection-dispersion equation (ADE). Simultaneously, many groundwater contaminants are degraded by processes that may be modeled as first-order decay. It is now known that non-Fickian transport and reaction are intimately coupled, with reaction affecting the transport operator. However, closed-form solutions for these important scenarios have not been published for use in applications. In this paper, we present four new Green's function analytic solutions in the uncoupled, uncorrelated continuous time random walk (CTRW) framework for reactive non-Fickian transport, corresponding to the quartet of conservative tracer solutions presented by Kreft and Zuber (1978) for Fickian transport. These consider pulse injection for both resident and flux concentration combined with detection in both resident and flux concentration. A pair of solutions for resident concentration temporal pulses with detection in both flux and resident concentration is also presented. We also derive the relationship between flux and resident concentration for non-Fickian transport with first-order reaction for this CTRW formulation. An explicit discussion of employment of the new solutions to model transport with arbitrary upgradient boundary conditions as well as mobile-immobile mass transfer is then presented. Using the new solutions, we show that first-order reaction has no effect on the anomalous spatial spreading rate of concentration profiles, but produces breakthrough curves at fixed locations that appear to have been generated by Fickian transport. Under the assumption of a Pareto CTRW transition distribution, we present a variety of numerical simulations including results showing coherence of our analytic solutions and CTRW particle

  14. Results on the effect of orderings on SSOR and ILU preconditionings

    Energy Technology Data Exchange (ETDEWEB)

    Joubert, W.; Knill, E.

    1998-12-31

    It is known that for SSOR and ILU preconditionings for solving systems of linear equations, orderings can have an enormous impact on robustness, convergence rate and parallelism. Unfortunately, it has been observed that there is an inverse relation between the convergence rate and the parallelism of typical orderings used in practice. This paper presents some numerical experiments with simple matrices to illustrate this behavior as well as a new theoretical result which sheds some light on this phenomenon and also gives an upper bound on the convergence rate of a number of preconditioners in popular use.

  15. A whale better adjusts the biosonar to ordered rather than to random changes in the echo parameters.

    Science.gov (United States)

    Supin, Alexander Ya; Nachtigall, Paul E; Breese, Marlee

    2012-09-01

    A false killer whale's (Pseudorca crassidens) sonar clicks and auditory evoked potentials (AEPs) were recorded during echolocation with simulated echoes in two series of experiments. In the first, both the echo delay and transfer factor (which is the dB-ratio of the echo sound-pressure level to emitted pulse source level) were varied randomly from trial to trial until enough data were collected (random presentation). In the second, a combination of the echo delay and transfer factor was kept constant until enough data were collected (ordered presentation). The mean click level decreased with shortening the delay and increasing the transfer factor, more at the ordered presentation rather than at the random presentation. AEPs to the self-heard emitted clicks decreased with shortening the delay and increasing the echo level equally in both series. AEPs to echoes increased with increasing the echo level, little dependent on the echo delay at random presentations but much more dependent on delay with ordered presentations. So some adjustment of the whale's biosonar was possible without prior information about the echo parameters; however, the availability of prior information about echoes provided additional whale capabilities to adjust both the transmitting and receiving parts of the biosonar.

  16. Nudging physician prescription decisions by partitioning the order set: results of a vignette-based study.

    Science.gov (United States)

    Tannenbaum, David; Doctor, Jason N; Persell, Stephen D; Friedberg, Mark W; Meeker, Daniella; Friesema, Elisha M; Goldstein, Noah J; Linder, Jeffrey A; Fox, Craig R

    2015-03-01

    Healthcare professionals are rapidly adopting electronic health records (EHRs). Within EHRs, seemingly innocuous menu design configurations can influence provider decisions for better or worse. The purpose of this study was to examine whether the grouping of menu items systematically affects prescribing practices among primary care providers. We surveyed 166 primary care providers in a research network of practices in the greater Chicago area, of whom 84 responded (51% response rate). Respondents and non-respondents were similar on all observable dimensions except that respondents were more likely to work in an academic setting. The questionnaire consisted of seven clinical vignettes. Each vignette described typical signs and symptoms for acute respiratory infections, and providers chose treatments from a menu of options. For each vignette, providers were randomly assigned to one of two menu partitions. For antibiotic-inappropriate vignettes, the treatment menu either listed over-the-counter (OTC) medications individually while grouping prescriptions together, or displayed the reverse partition. For antibiotic-appropriate vignettes, the treatment menu either listed narrow-spectrum antibiotics individually while grouping broad-spectrum antibiotics, or displayed the reverse partition. The main outcome was provider treatment choice. For antibiotic-inappropriate vignettes, we categorized responses as prescription drugs or OTC-only options. For antibiotic-appropriate vignettes, we categorized responses as broad- or narrow-spectrum antibiotics. Across vignettes, there was an 11.5 percentage point reduction in choosing aggressive treatment options (e.g., broad-spectrum antibiotics) when aggressive options were grouped compared to when those same options were listed individually (95% CI: 2.9 to 20.1%; p = .008). Provider treatment choice appears to be influenced by the grouping of menu options, suggesting that the layout of EHR order sets is not an arbitrary exercise

  17. Danish randomized trial comparing breast-preserving therapy with mastectomy in mammary carcinoma. Preliminary results

    Energy Technology Data Exchange (ETDEWEB)

    Blichert-Toft, M.; Brincker, H.; Andersen, J.A.; Andersen, K.W.; Axelsson, C.K.; Mouridsen, H.T.; Dombernowsky, P.; Overgaard, M.; Gadeberg, C.; Knudsen, G.

    1988-01-01

    The present study comprises 847 women operated upon for invasive breast carcinoma at 19 surgical departments and enrolled in protocol DBCG-82TM from January 1983 to November 1987. Among them 662 (78%) were allocated for breast-preserving therapy or mastectomy by randomization, while 185 patients (22%) did not accept randomization. Within the randomized group 6% could not be entered into adjuvant protocols, i.e. subsequent programmes of postoperative therapy and follow-up. This left 619 evaluable patients. In the non-randomized series 26% did not fulfil the demands for entrance into the adjuvant protocols, leaving 136 evaluable patients, 60 of whom had chosen a breast-preserving operation and 76 mastectomy. In the randomized series the patients in the two treatment arms were comparable in age, menopausal status, site of tumour, pathoanatomical diameter of the tumour, number of removed axillary lymph nodes, number of metastatic axillary lymph nodes, and distribution on adjuvant regimens. Ninety per cent of the patients in the randomized group accepted the method offered, whereas 10% declined and wanted the alternate form of operation. The median follow-up period was approximately 1.75 years. The cumulative recurrence rate in the randomized group was 13% and in the non-randomized group 7%. These results are preliminary. Life-table analyses have not so far demonstrated differences in recurrence-free survival either in the randomized or the non-randomized series.

  18. All-order results for infrared and collinear singularities in massless gauge theories

    Energy Technology Data Exchange (ETDEWEB)

    Dixon, Lance J.; /SLAC; Gardi, Einan; /Edinburgh U.; Magnea, Lorenzo; /CERN

    2010-05-26

    We review recent results concerning the all-order structure of infrared and collinear divergences in massless gauge theory amplitudes. While the exponentiation of these divergences for nonabelian gauge theories has been understood for a long time, in the past couple of years we have begun to unravel the all-order structure of the anomalous dimensions that build up the perturbative exponent. In the large-N{sub c} limit, all infrared and collinear divergences are determined by just three functions; one of them, the cusp anomalous dimension, plays a key role also for non-planar contributions. Indeed, all infrared and collinear divergences of massless gauge theory amplitudes with any number of hard partonsmay be captured by a surprisingly simple expression constructed as a sum over color dipoles. Potential corrections to this expression, correlating four or more hard partons at three loops or beyond, are tightly constrained and are currently under study.

  19. All-order results for infrared and collinear singularities in massless gauge theories

    CERN Document Server

    Dixon, Lance J; Magnea, Lorenzo

    2010-01-01

    We review recent results concerning the all-order structure of infrared and collinear divergences in massless gauge theory amplitudes. While the exponentiation of these divergences for nonabelian gauge theories has been understood for a long time, in the past couple of years we have begun to unravel the all-order structure of the anomalous dimensions that build up the perturbative exponent. In the large-Nc limit, all infrared and collinear divergences are determined by just three functions; one of them, the cusp anomalous dimension, plays a key role also for non-planar contributions. Indeed, all infrared and collinear divergences of massless gauge theory amplitudes with any number of hard partons may be captured by a surprisingly simple expression constructed as a sum over color dipoles. Potential corrections to this expression, correlating four or more hard partons at three loops or beyond, are tightly constrained and are currently under study.

  20. Random balance designs for the estimation of first order global sensitivity indices

    Energy Technology Data Exchange (ETDEWEB)

    Tarantola, S. [Joint Research Centre, European Commission, Institute of the Protection and Security of the Citizen, TP 361, Via E. Fermi 1, 21020 Ispra (Vatican City State, Holy See,) (Italy)]. E-mail: stefano.tarantola@jrc.it; Gatelli, D. [Joint Research Centre, European Commission, Institute of the Protection and Security of the Citizen, TP 361, Via E. Fermi 1, 21020 Ispra (VA) (Italy); Mara, T.A. [Laboratory of Industrial engineering, University of Reunion Island, BP 7151, 15 avenue Rene Cassin, 97 715 Saint-Denis (France)

    2006-06-15

    We present two methods for the estimation of main effects in global sensitivity analysis. The methods adopt Satterthwaite's application of random balance designs in regression problems, and extend it to sensitivity analysis of model output for non-linear, non-additive models. Finite as well as infinite ranges for model input factors are allowed. The methods are easier to implement than any other method available for global sensitivity analysis, and reduce significantly the computational cost of the analysis. We test their performance on different test cases, including an international benchmark on safety assessment for nuclear waste disposal originally carried out by OECD/NEA.

  1. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  2. Finding Order in Randomness: Single-Molecule Studies Reveal Stochastic RNA Processing | Center for Cancer Research

    Science.gov (United States)

    Producing a functional eukaryotic messenger RNA (mRNA) requires the coordinated activity of several large protein complexes to initiate transcription, elongate nascent transcripts, splice together exons, and cleave and polyadenylate the 3’ end. Kinetic competition between these various processes has been proposed to regulate mRNA maturation, but this model could lead to multiple, randomly determined, or stochastic, pathways or outcomes. Regulatory checkpoints have been suggested as a means of ensuring quality control. However, current methods have been unable to tease apart the contributions of these processes at a single gene or on a time scale that could provide mechanistic insight. To begin to investigate the kinetic relationship between transcription and splicing, Daniel Larson, Ph.D., of CCR’s Laboratory of Receptor Biology and Gene Expression, and his colleagues employed a single-molecule RNA imaging approach to monitor production and processing of a human β-globin reporter gene in living cells.

  3. On the temporal order of first-passage times in one-dimensional lattice random walks

    Science.gov (United States)

    Sanders, J. B.; Temme, N. M.

    2005-10-01

    A random walk problem with particles on discrete double infinite linear grids is discussed. The model is based on the work of Montroll and others. A probability connected with the problem is given in the form of integrals containing modified Bessel functions of the first kind. By using several transformations, simpler integrals are obtained from which for two and three particles asymptotic approximations are derived for large values of the parameters. Expressions of the probability for n particles are also derived.I returned and saw under the sun, that the race is not to the swift, nor the battle to the strong, neither yet bread to the wise, nor yet riches to men of understanding, nor yet favour to men of skill; but time and chance happeneth to them all. George Orwell, Politics and the English Language, Selected Essays, Penguin Books, 1957. (The citation is from Ecclesiastes 9:11.)

  4. Evaluation of dysprosia aerogels as drug delivery systems: a comparative study with random and ordered mesoporous silicas.

    Science.gov (United States)

    Bang, Abhishek; Sadekar, Anand G; Buback, Clayton; Curtin, Brice; Acar, Selin; Kolasinac, Damir; Yin, Wei; Rubenstein, David A; Lu, Hongbing; Leventis, Nicholas; Sotiriou-Leventis, Chariklia

    2014-04-09

    Biocompatible dysprosia aerogels were synthesized from DyCl3·6H2O and were reinforced mechanically with a conformal nano-thin-polyurea coating applied over their skeletal framework. The random mesoporous space of dysprosia aerogels was filled up to about 30% v/v with paracetamol, indomethacin, or insulin, and the drug release rate was monitored spectrophotometrically in phosphate buffer (pH = 7.4) or 0.1 M aqueous HCl. The drug uptake and release study was conducted comparatively with polyurea-crosslinked random silica aerogels, as well as with as-prepared (native) and polyurea-crosslinked mesoporous silica perforated with ordered 7 nm tubes in hexagonal packing. Drug uptake from random nanostructures (silica or dysprosia) was higher (30-35% w/w) and the release rate was slower (typically >20 h) relative to ordered silica (19-21% w/w, Drug release data from dysprosia aerogels were fitted with a flux equation consisting of three additive terms that correspond to drug stored successively in three hierarchical pore sites on the skeletal framework. The high drug uptake and slow release from dysprosia aerogels, in combination with their low toxicity, strong paramagnetism, and the possibility for neutron activation render those materials attractive multifunctional vehicles for site-specific drug delivery.

  5. Sequential sampling model for multiattribute choice alternatives with random attention time and processing order.

    Science.gov (United States)

    Diederich, Adele; Oswald, Peter

    2014-01-01

    A sequential sampling model for multiattribute binary choice options, called multiattribute attention switching (MAAS) model, assumes a separate sampling process for each attribute. During the deliberation process attention switches from one attribute consideration to the next. The order in which attributes are considered as well for how long each attribute is considered-the attention time-influences the predicted choice probabilities and choice response times. Several probability distributions for the attention time with different variances are investigated. Depending on the time and order schedule the model predicts a rich choice probability/choice response time pattern including preference reversals and fast errors. Furthermore, the difference between finite and infinite decision horizons for the attribute considered last is investigated. For the former case the model predicts a probability p 0 > 0 of not deciding within the available time. The underlying stochastic process for each attribute is an Ornstein-Uhlenbeck process approximated by a discrete birth-death process. All predictions are also true for the widely applied Wiener process.

  6. Sequential sampling model for multiattribute choice alternatives with random attention time and processing order

    Directory of Open Access Journals (Sweden)

    Adele eDiederich

    2014-09-01

    Full Text Available A sequential sampling model for multiattribute binary choice options, called Multiattribute attention switching (MAAS model, assumes a separate sampling process for each attribute. During the deliberation process attention switches from one attribute consideration to the next. The order in which attributes are considered as well for how long each attribute is considered - the attention time - influences the predicted choice probabilities and choice response times. Several probability distributions for the attention time including deterministic, Poisson, binomial, geometric, and uniform with different variances are investigated. Depending on the time and order schedule the model predicts a rich choice probability/choice response time pattern including preference reversals and fast errors. Furthermore, the difference between a finite and infinite decision horizons for the attribute considered last is investigated. For the former case the model predicts a probability $p_0> 0$ of not deciding within the available time. The underlying stochastic process for each attribute is an Ornstein-Uhlenbeck process approximated by a discrete birth-death process. All predictions are also true for the widely applied Wiener process.

  7. Randomness in preference orderings, outcomes and attribute tastes: An application to journey time risk

    DEFF Research Database (Denmark)

    Batley, Richard; Ibáñez Rivas, Juan Nicolás

    2012-01-01

    orderings, in outcomes, and in attribute tastes. Second, we apply this theoretical modelling framework to the domain of journey time risk (or ‘reliability’), a subject which has acquired prominence in the transportation policies of many countries. Third, we apply the modelling framework empirically, based...... upon a Stated Preference experiment of 2395 rail travellers choosing between alternative journeys embodying different levels of journey time risk. Across the sample of travellers, we estimate a mean value of scheduled journey time of 25.62pence/min, against a median of 18.55pence/min. We further...... estimate a mean ‘reliability ratio’ (ratio of the value of standard deviation of journey time to the value of scheduled journey time) of 2.07, against a median of 0.85. The properties of the distribution of the reliability ratio suggest a predominant behaviour of aversion to journey time risk....

  8. Waiting time analysis for MX/G/1 priority queues with/without vacations under random order of service discipline

    Directory of Open Access Journals (Sweden)

    Norikazu Kawasaki

    2000-01-01

    Full Text Available We study MX/G/1 nonpreemptive and preemptive-resume priority queues with/without vacations under random order of service (ROS discipline within each class. By considering the conditional waiting times given the states of the system, which an arbitrary message observes upon arrival, we derive the Laplace-Stieltjes transforms of the waiting time distributions and explicitly obtain the first two moments. The relationship for the second moments under ROS and first-come first-served disciplines extends the one found previously by Takacs and Fuhrmann for non-priority single arrival queues.

  9. New Results on the Sum of Two Generalized Gaussian Random Variables

    KAUST Repository

    Soury, Hamza

    2016-01-06

    We propose in this paper a new method to compute the characteristic function (CF) of generalized Gaussian (GG) random variable in terms of the Fox H function. The CF of the sum of two independent GG random variables is then deduced. Based on this results, the probability density function (PDF) and the cumulative distribution function (CDF) of the sum distribution are obtained. These functions are expressed in terms of the bivariate Fox H function. Next, the statistics of the distribution of the sum, such as the moments, the cumulant, and the kurtosis, are analyzed and computed. Due to the complexity of bivariate Fox H function, a solution to reduce such complexity is to approximate the sum of two independent GG random variables by one GG random variable with suitable shape factor. The approximation method depends on the utility of the system so three methods of estimate the shape factor are studied and presented [1].

  10. New Results On the Sum of Two Generalized Gaussian Random Variables

    KAUST Repository

    Soury, Hamza

    2015-01-01

    We propose in this paper a new method to compute the characteristic function (CF) of generalized Gaussian (GG) random variable in terms of the Fox H function. The CF of the sum of two independent GG random variables is then deduced. Based on this results, the probability density function (PDF) and the cumulative distribution function (CDF) of the sum distribution are obtained. These functions are expressed in terms of the bivariate Fox H function. Next, the statistics of the distribution of the sum, such as the moments, the cumulant, and the kurtosis, are analyzed and computed. Due to the complexity of bivariate Fox H function, a solution to reduce such complexity is to approximate the sum of two independent GG random variables by one GG random variable with suitable shape factor. The approximation method depends on the utility of the system so three methods of estimate the shape factor are studied and presented.

  11. Orderings of weakly correlated random variables, and prime number races with many contestants

    OpenAIRE

    Harper, Adam; Lamzouri, Youness

    2017-01-01

    We investigate the race between prime numbers in many residue classes modulo $q$, assuming the standard conjectures GRH and LI. Among our results we exhibit, for the first time, prime races modulo $q$ with $n$ competitor classes where the biases do not dissolve when $n, q\\to \\infty$. We also study the leaders in the prime number race, obtaining asymptotic formulae for logarithmic densities when the number of competitors can be as large as a power of $q$, whereas previous methods could only al...

  12. Planck 2015 results: VII. High Frequency Instrument data processing: Time-ordered information and beams

    DEFF Research Database (Denmark)

    Adam, R.; Ade, P. A R; Aghanim, N.

    2016-01-01

    The Planck High Frequency Instrument (HFI) has observed the full sky at six frequencies (100, 143, 217, 353, 545, and 857 GHz) in intensity and at four frequencies in linear polarization (100, 143, 217, and 353 GHz). In order to obtain sky maps, the time-ordered information (TOI) containing the d...

  13. 77 FR 15101 - Results From Inert Ingredient Test Orders Issued Under EPA's Endocrine Disruptor Screening...

    Science.gov (United States)

    2012-03-14

    ... orders (Data Call-Ins) to companies that manufacture or import any of the following nine chemicals...). In response to the test orders, companies have agreed to develop data and have asserted data... their use as inert ingredients in pesticide products. EPA is, however, offering an opportunity for...

  14. Ordered Non-Archimedean Fuzzy Metric Spaces and Some Fixed Point Results

    Directory of Open Access Journals (Sweden)

    Miheţ Dorel

    2010-01-01

    Full Text Available In the present paper we provide two different kinds of fixed point theorems on ordered nonArchimedean fuzzy metric spaces. First, two fixed point theorems are proved for fuzzy order -contractive type mappings. Then a common fixed point theorem is given for noncontractive type mappings. Kirk's problem on an extension of Caristi's theorem is also discussed.

  15. Ordered Non-Archimedean Fuzzy Metric Spaces and Some Fixed Point Results

    Directory of Open Access Journals (Sweden)

    Dorel Miheţ

    2010-01-01

    Full Text Available In the present paper we provide two different kinds of fixed point theorems on ordered nonArchimedean fuzzy metric spaces. First, two fixed point theorems are proved for fuzzy order ψ-contractive type mappings. Then a common fixed point theorem is given for noncontractive type mappings. Kirk's problem on an extension of Caristi's theorem is also discussed.

  16. Reporting of positive results in randomized controlled trials of mindfulness-based mental health interventions

    NARCIS (Netherlands)

    Coronado-Montoya, S.; Levis, A.W.; Kwakkenbos, C.M.C.; Steele, R.J.; Turner, E.H.; Thombs, B.D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of

  17. [Evidence-based medicine: can we trust the results of well-designed randomized trials?].

    Science.gov (United States)

    Maturana, A; Benaglio, C

    2014-10-01

    Evidence based medicine assists in clinical decision-making by integrating critically appraised information with patient's values and preferences within an existing clinical context. A fundamental concept in this paradigm is the hierarchy of information. The randomized clinical trial is recognized as one of the designs that is less prone to bias and therefore of higher methodological quality. Clinical guidelines are one of the principal tools that evidence based medicine uses to transfer scientific information to clinical practice and many of their recommendations are based on these type of studies. In this review we present some of the limitations that the results can have, in even well designed and executed randomized clinical trials. We also discuss why valid results in these types of studies could not necessarily be extrapolated to the general population. Although the randomized clinical trial continues to be one of the best methodological designs, we suggest that the reader be careful when interpreting its results.

  18. Existence Results for Higher-Order Boundary Value Problems on Time Scales

    OpenAIRE

    Sang Yanbin; Liu Jian

    2009-01-01

    By using the fixed-point index theorem, we consider the existence of positive solutions for the following nonlinear higher-order four-point singular boundary value problem on time scales , ; , ; , ; , , where , , , , , , , and is rd-continuous.

  19. Probability calculus of fractional order and fractional Taylor's series application to Fokker-Planck equation and information of non-random functions

    Energy Technology Data Exchange (ETDEWEB)

    Jumarie, Guy [Department of Mathematics, University of Quebec at Montreal, P.O. Box 8888, Downtown Station, Montreal, Qc, H3C 3P8 (Canada)], E-mail: jumarie.guy@uqam.ca

    2009-05-15

    A probability distribution of fractional (or fractal) order is defined by the measure {mu}{l_brace}dx{r_brace} = p(x)(dx){sup {alpha}}, 0 < {alpha} < 1. Combining this definition with the fractional Taylor's series f(x+h)=E{sub {alpha}}(D{sub x}{sup {alpha}}h{sup {alpha}})f(x) provided by the modified Riemann Liouville definition, one can expand a probability calculus parallel to the standard one. A Fourier's transform of fractional order using the Mittag-Leffler function is introduced, together with its inversion formula; and it provides a suitable generalization of the characteristic function of fractal random variables. It appears that the state moments of fractional order are more especially relevant. The main properties of this fractional probability calculus are outlined, it is shown that it provides a sound approach to Fokker-Planck equation which are fractional in both space and time, and it provides new results in the information theory of non-random functions.

  20. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  1. On the statistical implications of certain Random permutations in Markovian Arrival Processes (MAPs) and second order self-similar processes

    DEFF Research Database (Denmark)

    Andersen, Allan T.; Nielsen, Bo Friis

    2000-01-01

    . The implications for the correlation structure when shuffling an exactly second-order self-similar process are examined. We apply the Markovian arrival process (MAP) as a tool to investigate whether general conclusions can be made with regard to the statistical implications of the shuffling experiments......In this paper, we examine the implications of certain random permutations in an arrival process that have gained considerable interest in recent literature. The so-called internal and external shuffling have been used to explain phenomena observed in traffic traces from LANs. Loosely, the internal...... shuffling can be viewed as a way of performing local permutations in the arrival stream, while the external shuffling is a way of performing global permutations. We derive formulas for the correlation structures of the shuffled processes in terms of the original arrival process in great generality...

  2. Response-Order Effects in Survey Methods: A Randomized Controlled Crossover Study in the Context of Sport Injury Prevention.

    Science.gov (United States)

    Chan, Derwin K; Ivarsson, Andreas; Stenling, Andreas; Yang, Sophie X; Chatzisarantis, Nikos L; Hagger, Martin S

    2015-12-01

    Consistency tendency is characterized by the propensity for participants responding to subsequent items in a survey consistent with their responses to previous items. This method effect might contaminate the results of sport psychology surveys using cross-sectional design. We present a randomized controlled crossover study examining the effect of consistency tendency on the motivational pathway (i.e., autonomy support → autonomous motivation → intention) of self-determination theory in the context of sport injury prevention. Athletes from Sweden (N = 341) responded to the survey printed in either low interitem distance (IID; consistency tendency likely) or high IID (consistency tendency suppressed) on two separate occasions, with a one-week interim period. Participants were randomly allocated into two groups, and they received the survey of different IID at each occasion. Bayesian structural equation modeling showed that low IID condition had stronger parameter estimates than high IID condition, but the differences were not statistically significant.

  3. The effect of a test ordering software intervention on the prescription of unnecessary laboratory tests - a randomized controlled trial.

    Science.gov (United States)

    Martins, Carlos Manuel Silva; da Costa Teixeira, Andreia Sofia; de Azevedo, Luís Filipe Ribeiro; Sá, Luísa Maria Barbosa; Santos, Paulo Alexandre Azevedo Pereira; do Couto, Maria Luciana Gomes Domingues; da Costa Pereira, Altamiro Manuel Rodrigues; Hespanhol, Alberto Augusto Oliveira Pinto; da Costa Santos, Cristina Maria Nogueira

    2017-02-20

    The way software for electronic health records and laboratory tests ordering systems are designed may influence physicians' prescription. A randomised controlled trial was performed to measure the impact of a diagnostic and laboratory tests ordering system software modification. Participants were family physicians working and prescribing diagnostic and laboratory tests. The intervention group had a modified software with a basic shortcut menu changes, where some tests were withdrawn or added, and with the implementation of an evidence-based decision support based on United States Preventive Services Task Force (USPSTF) recommendations. This intervention group was compared with usual software (control group). The outcomes were the number of tests prescribed from those: withdrawn from the basic menu; added to the basic menu; marked with green dots (USPSTF's grade A and B); and marked with red dots (USPSTF's grade D). Comparing the monthly average number of tests prescribed before and after the software modification, from those tests that were withdrawn from the basic menu, the control group prescribed 33.8 tests per 100 consultations before and 30.8 after (p = 0075); the intervention group prescribed 31.3 before and 13.9 after (p menu, the intervention group prescribed a monthly average of 14.0 vs. 29.3 tests per 100 consultations in the control group (p menu of the diagnosis and laboratory tests ordering system had a significant impact and reduced unnecessary prescription of tests. The fact that it was not possible to perform the randomization at the family physicians' level, but only of the computer servers is a limitation of our study. Future research should assess the impact of different tests ordering systems during longer periods. ISRCTN45427977 , May 1st 2014 (retrospectively registered).

  4. Improving the Management Style of School Principals: Results from a Randomized Trial

    Science.gov (United States)

    Lassibille, Gérard

    2016-01-01

    Using information from a randomized experiment carried out over the course of two school years in Madagascar, this paper evaluates the impact of specific actions designed to streamline and tighten the work processes of public primary school directors. The results show that interventions at the school level, reinforced by interventions at the…

  5. Learning Communities for Developmental Education Students: Early Results from Randomized Experiments at Three Community Colleges

    Science.gov (United States)

    Weiss, Michael J.; Visher, Mary; Weissman, Evan

    2011-01-01

    This paper presents results from a rigorous random assignment study of Learning Communities programs operated at three of six community colleges participating in the National Center for Postsecondary Research's (NCPR) Learning Communities Demonstration. The demonstration's focus is on determining whether Learning Communities are an effective…

  6. Incentive Pay Programs Do Not Affect Teacher Motivation or Reported Practices: Results from Three Randomized Studies

    Science.gov (United States)

    Yuan, Kun; Le, Vi-Nhuan; McCaffrey, Daniel F.; Marsh, Julie A.; Hamilton, Laura S.; Stecher, Brian M.; Springer, Matthew G.

    2013-01-01

    This study drew on teacher survey responses from randomized experiments exploring three different pay-for-performance programs to examine the extent to which these programs motivated teachers to improve student achievement and the impact of such programs on teachers' instruction, number of hours worked, job stress, and collegiality. Results showed…

  7. A multi-tier higher order Conditional Random Field for land cover classification of multi-temporal multi-spectral Landsat imagery

    CSIR Research Space (South Africa)

    Salmon, BP

    2015-07-01

    Full Text Available In this paper the authors present a 2-tier higher order Conditional Random Field which is used for land cover classification. The Conditional Random Field is based on probabilistic messages being passed along a graph to compute efficiently...

  8. Nonparametric Polytomous IRT Models for Invariant Item Ordering, with Results for Parametric Models.

    Science.gov (United States)

    Sijtsma, Klaas; Hemker, Bas T.

    1998-01-01

    The absence of the invariant item ordering (IIO) property in two nonparametric polytomous item response theory (IRT) models is discussed, and two nonparametric models are discussed that imply an IIO. Only two parametric polytomous IRT models are found to imply an IIO. A method is proposed to investigate whether an IIO is implied with empirical…

  9. Multiplicity Results for Variable-Coefficient Singular Third-Order Differential Equation with a Parameter

    Directory of Open Access Journals (Sweden)

    Zhibo Cheng

    2014-01-01

    Full Text Available We investigate a class of variable coefficients singular third-order differential equation with superlinearity or sublinearity assumptions at infinity for an appropriately chosen parameter. By applications of Green’s function and the Krasnoselskii fixed point theorem, sufficient conditions for the existence of positive periodic solutions are established.

  10. Second-order advantage obtained from standard addition first-order instrumental data and multivariate curve resolution-alternating least squares. Calculation of the feasible bands of results.

    Science.gov (United States)

    Mohseni, Naimeh; Bahram, Morteza; Olivieri, Alejandro C

    2014-03-25

    In order to achieve the second-order advantage, second-order data per sample is usually required, e.g., kinetic-spectrophotometric data. In this study, instead of monitoring the time evolution of spectra (and collecting the kinetic-spectrophotometric data) replicate spectra are used to build a virtual second order data. This data matrix (replicate mode×λ) is rank deficient. Augmentation of these data with standard addition data [or standard sample(s)] will break the rank deficiency, making the quantification of the analyte of interest possible. The MCR-ALS algorithm was applied for the resolution and quantitation of the analyte in both simulated and experimental data sets. In order to evaluate the rotational ambiguity in the retrieved solutions, the MCR-BANDS algorithm was employed. It has been shown that the reliability of the quantitative results significantly depends on the amount of spectral overlap in the spectral region of occurrence of the compound of interest and the remaining constituent(s). Copyright © 2013 Elsevier B.V. All rights reserved.

  11. The fragility of significant results underscores the need of larger randomized controlled trials in nephrology.

    Science.gov (United States)

    Shochet, Lani R; Kerr, Peter G; Polkinghorne, Kevan R

    2017-07-26

    The Fragility Index is a tool for testing robustness of randomized controlled trial results for dichotomous outcomes. It describes the minimum number of individuals in whom changing an event status would render a statistically significant result nonsignificant. Here we identified all randomized controlled trials in five nephrology and five general journals from 2005-2014. A total of 127 randomized controlled trials reporting at least one dichotomous statistically significant outcome (p less than 0.05) were included and the Fragility Index was calculated. Twenty randomized controlled trials had a Fragility Index of zero and were excluded from further analysis. Linear regression was performed to assess factors associated with Fragility Indexes stratified by primary or secondary outcomes. The median sample size was 134 (range 2211506) with 36 (range 5-2743) total number of events. The median Fragility Index was three (range 1-166), indicating that in half the trials the addition of three events to the treatment with the lowest number of events rendered the result nonsignificant. For primary outcome studies a doubling in total event number and sample size significantly increased the geometric mean Fragility Index by 52% and 42%, respectively. Compared to a reported p value of 0.05 to 0.01, those reporting 0.01 to 0.001 or less than 0.001 had a significant 57% and 472% increase in the median Fragility Index, respectively. Forty-one percent had a Fragility Index less than the total loss to follow-up, indicating a potential to change a trial result had all individuals been accounted for. Thus, our study highlights the need for larger randomized controlled trials with accurate accounting for loss to follow-up to adequately guide evidence-based practice. Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

  12. Proteus: a random forest classifier to predict disorder-to-order transitioning binding regions in intrinsically disordered proteins

    Science.gov (United States)

    Basu, Sankar; Söderquist, Fredrik; Wallner, Björn

    2017-05-01

    The focus of the computational structural biology community has taken a dramatic shift over the past one-and-a-half decades from the classical protein structure prediction problem to the possible understanding of intrinsically disordered proteins (IDP) or proteins containing regions of disorder (IDPR). The current interest lies in the unraveling of a disorder-to-order transitioning code embedded in the amino acid sequences of IDPs/IDPRs. Disordered proteins are characterized by an enormous amount of structural plasticity which makes them promiscuous in binding to different partners, multi-functional in cellular activity and atypical in folding energy landscapes resembling partially folded molten globules. Also, their involvement in several deadly human diseases (e.g. cancer, cardiovascular and neurodegenerative diseases) makes them attractive drug targets, and important for a biochemical understanding of the disease(s). The study of the structural ensemble of IDPs is rather difficult, in particular for transient interactions. When bound to a structured partner, an IDPR adapts an ordered conformation in the complex. The residues that undergo this disorder-to-order transition are called protean residues, generally found in short contiguous stretches and the first step in understanding the modus operandi of an IDP/IDPR would be to predict these residues. There are a few available methods which predict these protean segments from their amino acid sequences; however, their performance reported in the literature leaves clear room for improvement. With this background, the current study presents `Proteus', a random forest classifier that predicts the likelihood of a residue undergoing a disorder-to-order transition upon binding to a potential partner protein. The prediction is based on features that can be calculated using the amino acid sequence alone. Proteus compares favorably with existing methods predicting twice as many true positives as the second best method (55

  13. Effect of calorie or exercise labels on menus on calories and macronutrients ordered and calories from specific foods in Hispanic participants: a randomized study.

    Science.gov (United States)

    Shah, Meena; Bouza, Brooke; Adams-Huet, Beverley; Jaffery, Manall; Esposito, Phil; Dart, Lyn

    2016-12-01

    The effect of menu labels on food choices is unknown in Hispanics. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics. 372 Hispanics (18-65 years) were randomly assigned to menus with no labels (NL) (n=127), rank-ordered calorie labels plus a statement on energy needs per meal (CL) (n=123), or rank-ordered exercise labels showing minutes of brisk walking necessary to burn the food calories (EL) (n=122). The menus had identical food choices. Participants were instructed to select foods from the assigned menu as if having lunch in a fast food restaurant. One-way analysis of variance found no difference in calories ordered (median (25th and 75th centiles)) by menu condition (NL: 785.0 (465.0, 1010.0) kcal; CL: 790.0 (510.0, 1020.0) kcal; EL: 752.5 (520.0, 1033.8) kcal; p=0.75). Calories from specific foods and macronutrient intake were not different by menu condition. Menu label use was 26.8% in the CL and 25.4% in the EL condition. Calories ordered were not different between those who used and those who did not use the labels. Regression analysis showed that perception of being overweight (p=0.02), selecting foods based on health value (pcalories ordered. Logistic regression showed that selecting foods based on health value (p=0.01) was associated with higher food label use. Menu labels did not affect food choices in Hispanic participants. Future studies should determine if nutrition, exercise, and weight perception counseling prior to menu labels intervention would result in better food choices. NCT02804503; post-results. Copyright © 2016 American Federation for Medical Research.

  14. Scattering of electromagnetic waves from 3D multilayer random rough surfaces based on the second-order small perturbation method: energy conservation, reflectivity, and emissivity.

    Science.gov (United States)

    Sanamzadeh, Mohammadreza; Tsang, Leung; Johnson, Joel T; Burkholder, Robert J; Tan, Shurun

    2017-03-01

    A theoretical investigation of energy conservation, reflectivity, and emissivity in the scattering of electromagnetic waves from 3D multilayer media with random rough interfaces using the second-order small perturbation method (SPM2) is presented. The approach is based on the extinction theorem and develops integral equations for surface fields in the spectral domain. Using the SPM2, we calculate the scattered and transmitted coherent fields and incoherent fields. Reflected and transmitted powers are then found in the form of 2D integrations over wavenumber in the spectral domain. In the integrand, there is a summation over the spectral densities of each of the rough interfaces with each weighted by a corresponding kernel function. We show in this paper that there exists a "strong" condition of energy conservation in that the kernel functions multiplying the spectral density of each interface obey energy conservation exactly. This means that energy is conserved independent of the roughness spectral densities of the rough surfaces. Results of this strong condition are illustrated numerically for up to 50 rough interfaces without requiring specification of surface roughness properties. Two examples are illustrated. One is a multilayer configuration having weak contrasts between adjacent layers, random layer thicknesses, and randomly generated permittivity profiles. The second example is a photonic crystal of periodically alternating permittivities of larger dielectric contrast. The methodology is applied to study the effect of roughness on the brightness temperatures of the Antarctic ice sheet, which is characterized by layers of ice with permittivity fluctuations in addition to random rough interfaces. The results show that the influence of roughness can significantly increase horizontally polarized thermal emission while leaving vertically polarized emissions relatively unaffected.

  15. Planck 2015 results. VII. High Frequency Instrument data processing: Time-ordered information and beams

    Science.gov (United States)

    Planck Collaboration; Adam, R.; Ade, P. A. R.; Aghanim, N.; Arnaud, M.; Ashdown, M.; Aumont, J.; Baccigalupi, C.; Banday, A. J.; Barreiro, R. B.; Bartolo, N.; Battaner, E.; Benabed, K.; Benoît, A.; Benoit-Lévy, A.; Bernard, J.-P.; Bersanelli, M.; Bertincourt, B.; Bielewicz, P.; Bock, J. J.; Bonavera, L.; Bond, J. R.; Borrill, J.; Bouchet, F. R.; Boulanger, F.; Bucher, M.; Burigana, C.; Calabrese, E.; Cardoso, J.-F.; Catalano, A.; Challinor, A.; Chamballu, A.; Chary, R.-R.; Chiang, H. C.; Christensen, P. R.; Clements, D. L.; Colombi, S.; Colombo, L. P. L.; Combet, C.; Couchot, F.; Coulais, A.; Crill, B. P.; Curto, A.; Cuttaia, F.; Danese, L.; Davies, R. D.; Davis, R. J.; de Bernardis, P.; de Rosa, A.; de Zotti, G.; Delabrouille, J.; Delouis, J.-M.; Désert, F.-X.; Diego, J. M.; Dole, H.; Donzelli, S.; Doré, O.; Douspis, M.; Ducout, A.; Dupac, X.; Efstathiou, G.; Elsner, F.; Enßlin, T. A.; Eriksen, H. K.; Falgarone, E.; Fergusson, J.; Finelli, F.; Forni, O.; Frailis, M.; Fraisse, A. A.; Franceschi, E.; Frejsel, A.; Galeotta, S.; Galli, S.; Ganga, K.; Ghosh, T.; Giard, M.; Giraud-Héraud, Y.; Gjerløw, E.; González-Nuevo, J.; Górski, K. M.; Gratton, S.; Gruppuso, A.; Gudmundsson, J. E.; Hansen, F. K.; Hanson, D.; Harrison, D. L.; Henrot-Versillé, S.; Herranz, D.; Hildebrandt, S. R.; Hivon, E.; Hobson, M.; Holmes, W. A.; Hornstrup, A.; Hovest, W.; Huffenberger, K. M.; Hurier, G.; Jaffe, A. H.; Jaffe, T. R.; Jones, W. C.; Juvela, M.; Keihänen, E.; Keskitalo, R.; Kisner, T. S.; Kneissl, R.; Knoche, J.; Kunz, M.; Kurki-Suonio, H.; Lagache, G.; Lamarre, J.-M.; Lasenby, A.; Lattanzi, M.; Lawrence, C. R.; Le Jeune, M.; Leahy, J. P.; Lellouch, E.; Leonardi, R.; Lesgourgues, J.; Levrier, F.; Liguori, M.; Lilje, P. B.; Linden-Vørnle, M.; López-Caniego, M.; Lubin, P. M.; Macías-Pérez, J. F.; Maggio, G.; Maino, D.; Mandolesi, N.; Mangilli, A.; Maris, M.; Martin, P. G.; Martínez-González, E.; Masi, S.; Matarrese, S.; McGehee, P.; Melchiorri, A.; Mendes, L.; Mennella, A.; Migliaccio, M.; Mitra, S.; Miville-Deschênes, M.-A.; Moneti, A.; Montier, L.; Moreno, R.; Morgante, G.; Mortlock, D.; Moss, A.; Mottet, S.; Munshi, D.; Murphy, J. A.; Naselsky, P.; Nati, F.; Natoli, P.; Netterfield, C. B.; Nørgaard-Nielsen, H. U.; Noviello, F.; Novikov, D.; Novikov, I.; Oxborrow, C. A.; Paci, F.; Pagano, L.; Pajot, F.; Paoletti, D.; Pasian, F.; Patanchon, G.; Pearson, T. J.; Perdereau, O.; Perotto, L.; Perrotta, F.; Pettorino, V.; Piacentini, F.; Piat, M.; Pierpaoli, E.; Pietrobon, D.; Plaszczynski, S.; Pointecouteau, E.; Polenta, G.; Pratt, G. W.; Prézeau, G.; Prunet, S.; Puget, J.-L.; Rachen, J. P.; Reinecke, M.; Remazeilles, M.; Renault, C.; Renzi, A.; Ristorcelli, I.; Rocha, G.; Rosset, C.; Rossetti, M.; Roudier, G.; Rowan-Robinson, M.; Rusholme, B.; Sandri, M.; Santos, D.; Sauvé, A.; Savelainen, M.; Savini, G.; Scott, D.; Seiffert, M. D.; Shellard, E. P. S.; Spencer, L. D.; Stolyarov, V.; Stompor, R.; Sudiwala, R.; Sutton, D.; Suur-Uski, A.-S.; Sygnet, J.-F.; Tauber, J. A.; Terenzi, L.; Toffolatti, L.; Tomasi, M.; Tristram, M.; Tucci, M.; Tuovinen, J.; Valenziano, L.; Valiviita, J.; Van Tent, B.; Vibert, L.; Vielva, P.; Villa, F.; Wade, L. A.; Wandelt, B. D.; Watson, R.; Wehus, I. K.; Yvon, D.; Zacchei, A.; Zonca, A.

    2016-09-01

    The Planck High Frequency Instrument (HFI) has observed the full sky at six frequencies (100, 143, 217, 353, 545, and 857 GHz) in intensity and at four frequencies in linear polarization (100, 143, 217, and 353 GHz). In order to obtain sky maps, the time-ordered information (TOI) containing the detector and pointing samples must be processed and the angular response must be assessed. The full mission TOI is included in the Planck 2015 release. This paper describes the HFI TOI and beam processing for the 2015 release. HFI calibration and map making are described in a companion paper. The main pipeline has been modified since the last release (2013 nominal mission in intensity only), by including a correction for the nonlinearity of the warm readout and by improving the model of the bolometer time response. The beam processing is an essential tool that derives the angular response used in all the Planck science papers and we report an improvement in the effective beam window function uncertainty of more than a factor of 10 relative to the2013 release. Noise correlations introduced by pipeline filtering function are assessed using dedicated simulations. Angular cross-power spectra using data sets that are decorrelated in time are immune to the main systematic effects.

  16. Corneal Densitometry and Higher Order Aberrations After Bowman Layer Transplantation: 1-Year Results.

    Science.gov (United States)

    Luceri, Salvatore; Parker, Jack; Dapena, Isabel; Baydoun, Lamis; Oellerich, Silke; van Dijk, Korine; Melles, Gerrit R J

    2016-07-01

    To evaluate corneal densitometry and higher order aberrations (HOAs) up to 1 year after Bowman layer (BL) transplantation. This was a retrospective study carried out at a tertiary referral center. Fifteen eyes of 14 patients who underwent BL transplantation for advanced keratoconus and had at least 1 year of follow-up were examined before BL transplantation and postoperatively at 1 day, 1 week, and 1, 3, 6, and 12 months. Corrected distance visual acuity (CDVA) with spectacles and contact lenses, anterior and posterior HOAs, and corneal densitometry were analyzed. One year after surgery, average logarithm of the minimum angle of resolution of spectacle-CDVA changed from 1.35 (±0.46) preoperatively to 0.96 (±0.32, P cornea, with a peak 1 month after surgery (P transplantation, whereas corneal backscattering increased, mostly in the central and posterior layers, where the graft has been placed. Changes in HOAs and corneal backscattering did not correlate with CDVA.

  17. Mailed outreach and facilitated test ordering to promote cholesterol screening in community health centers: A randomized trial.

    Science.gov (United States)

    Persell, Stephen D; Brown, Tiffany; Lee, Ji Young; Henley, Eric; Long, Timothy; Sanchez, Thomas; Knight, Regina

    2017-06-01

    Lipid screening is central to cardiovascular risk assessment. We sought to determine whether a simple mailed outreach message and facilitated test ordering increase cholesterol screening among federally qualified community health center patients with no recent cholesterol screening test performed. Using a patient-randomized controlled trial, we examined the effects of delivering a simple mailed outreach intervention promoting cholesterol testing and facilitated test ordering (without requiring an office visit). Participants were adult patients 50 to 75 years old, with no diagnosed cardiovascular disease or diabetes, and no cholesterol test within 5 years who had received care from community health centers in Illinois and Arizona. The intervention took place in 2014 and was powered to detect a 10% increase in screening due to the intervention. Participants' (n = 480) mean age was 57.5 years, 51.0% were male, and 43.8% were smokers. There was no significant difference between groups in the primary study outcome-completion of total cholesterol and high-density lipoprotein cholesterol tests or complete lipid panel within 3 months; 32 participants (13.3%) in intervention group versus 26 (10.8%) in control group met the primary outcome, with absolute difference of 2.5 percentage points (95% confidence interval -6.6 to 11.6). This outreach intervention promoting cholesterol screening was ineffective. Interventions that attempt to minimize barriers to cholesterol screening on multiple fronts and that are more compelling to patients are needed. © 2016 John Wiley & Sons, Ltd.

  18. Random Mutagenesis of the Aspergillus oryzae Genome Results in Fungal Antibacterial Activity

    Science.gov (United States)

    Leonard, Cory A.; Brown, Stacy D.; Hayman, J. Russell

    2013-01-01

    Multidrug-resistant bacteria cause severe infections in hospitals and communities. Development of new drugs to combat resistant microorganisms is needed. Natural products of microbial origin are the source of most currently available antibiotics. We hypothesized that random mutagenesis of Aspergillus oryzae would result in secretion of antibacterial compounds. To address this hypothesis, we developed a screen to identify individual A. oryzae mutants that inhibit the growth of Methicillin-resistant Staphylococcus aureus (MRSA) in vitro. To randomly generate A. oryzae mutant strains, spores were treated with ethyl methanesulfonate (EMS). Over 3000 EMS-treated A. oryzae cultures were tested in the screen, and one isolate, CAL220, exhibited altered morphology and antibacterial activity. Culture supernatant from this isolate showed antibacterial activity against Methicillin-sensitive Staphylococcus aureus, MRSA, and Pseudomonas aeruginosa, but not Klebsiella pneumonia or Proteus vulgaris. The results of this study support our hypothesis and suggest that the screen used is sufficient and appropriate to detect secreted antibacterial fungal compounds resulting from mutagenesis of A. oryzae. Because the genome of A. oryzae has been sequenced and systems are available for genetic transformation of this organism, targeted as well as random mutations may be introduced to facilitate the discovery of novel antibacterial compounds using this system. PMID:23983696

  19. Random Mutagenesis of the Aspergillus oryzae Genome Results in Fungal Antibacterial Activity

    Directory of Open Access Journals (Sweden)

    Cory A. Leonard

    2013-01-01

    Full Text Available Multidrug-resistant bacteria cause severe infections in hospitals and communities. Development of new drugs to combat resistant microorganisms is needed. Natural products of microbial origin are the source of most currently available antibiotics. We hypothesized that random mutagenesis of Aspergillus oryzae would result in secretion of antibacterial compounds. To address this hypothesis, we developed a screen to identify individual A. oryzae mutants that inhibit the growth of Methicillin-resistant Staphylococcus aureus (MRSA in vitro. To randomly generate A. oryzae mutant strains, spores were treated with ethyl methanesulfonate (EMS. Over 3000 EMS-treated A. oryzae cultures were tested in the screen, and one isolate, CAL220, exhibited altered morphology and antibacterial activity. Culture supernatant from this isolate showed antibacterial activity against Methicillin-sensitive Staphylococcus aureus, MRSA, and Pseudomonas aeruginosa, but not Klebsiella pneumonia or Proteus vulgaris. The results of this study support our hypothesis and suggest that the screen used is sufficient and appropriate to detect secreted antibacterial fungal compounds resulting from mutagenesis of A. oryzae. Because the genome of A. oryzae has been sequenced and systems are available for genetic transformation of this organism, targeted as well as random mutations may be introduced to facilitate the discovery of novel antibacterial compounds using this system.

  20. Existence Results for a Michaud Fractional, Nonlocal, and Randomly Position Structured Fragmentation Model

    Directory of Open Access Journals (Sweden)

    Emile Franc Doungmo Goufo

    2014-01-01

    Full Text Available Until now, classical models of clusters’ fission remain unable to fully explain strange phenomena like the phenomenon of shattering (Ziff and McGrady, 1987 and the sudden appearance of infinitely many particles in some systems having initial finite number of particles. That is why there is a need to extend classical models to models with fractional derivative order and use new and various techniques to analyze them. In this paper, we prove the existence of strongly continuous solution operators for nonlocal fragmentation models with Michaud time derivative of fractional order (Samko et al., 1993. We focus on the case where the splitting rate is dependent on size and position and where new particles generating from fragmentation are distributed in space randomly according to some probability density. In the analysis, we make use of the substochastic semigroup theory, the subordination principle for differential equations of fractional order (Prüss, 1993, Bazhlekova, 2000, the analogy of Hille-Yosida theorem for fractional model (Prüss, 1993, and useful properties of Mittag-Leffler relaxation function (Berberan-Santos, 2005. We are then able to show that the solution operator to the full model is positive and contractive.

  1. Metal Vacancy Ordering in an Antiperovskite Resulting in Two Modifications of Fe2 SeO.

    Science.gov (United States)

    Valldor, Martin; Wright, Taylor; Fitch, Andrew; Prots, Yurii

    2016-08-01

    Small, red Fe2 SeO single crystals in two modifications were obtained from a CsCl flux. The metastable α-phase is pseudo-tetragonal (Cmce, a=16.4492(8) Å, b=11.1392(4) Å, c=11.1392(4) Å), whereas the β-phase is trigonal (P31 , a=9.8349(4) Å, c=6.9591(4) Å)) and thermodynamically stable within a narrow temperature range. Both crystal structures were solved from twinned specimens. The enantiomers of the β-phase appear as racemic mixtures. Selenium and oxygen form two individual interpenetrating primitive cubic lattices, giving a bcc packing. A quasi-octahedrally coordinated iron atom is found close to the center of each surface of the selenium sublattice. The difference between the α- and β-phases is the distribution of iron at 2/3 of the surfaces. α- and β-Fe2 SeO are comparable with metal-vacancy-ordered antiperovskites. Each Fe/O lattice can also be described in terms of vertex-sharing OFe4 tetrahedra, with a crystal structure similar to that of an antisilicate. Iron is divalent and has a high-spin d(6) (S=2) configuration. The β-phase exhibits magnetoelectric coupling. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  2. Housing first reduces re-offending among formerly homeless adults with mental disorders: results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Julian M Somers

    Full Text Available BACKGROUND: Homelessness and mental illness have a strong association with public disorder and criminality. Experimental evidence indicates that Housing First (HF increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders. HF is also associated with lower residential costs than common alternative approaches. Few studies have examined the effect of HF on criminal behavior. METHODS: Individuals meeting criteria for homelessness and a current mental disorder were randomized to one of three conditions treatment as usual (reference; scattered site HF; and congregate HF. Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following randomization for up to two years. RESULTS: The majority of the sample (67% was involved with the justice system, with a mean of 8.07 convictions per person in the ten years prior to recruitment. The most common category of crime was "property offences" (mean=4.09. Following randomization, the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual (Adjusted IRR=0.29; 95% CI 0.12-0.72. Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual (Adjusted IRR=0.55; 95% CI: 0.26-1.14. CONCLUSIONS: This study is the first randomized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime. Our sample was frequently involved with the justice system, with great personal and societal costs. Further implementation of HF is strongly indicated, particularly in the scattered site format. Research examining interdependencies between housing, health, and the justice system is indicated. TRIAL REGISTRATION: ISRCTN57595077.

  3. The relationship of dynamical heterogeneity to the Adam-Gibbs and random first-order transition theories of glass formation.

    Science.gov (United States)

    Starr, Francis W; Douglas, Jack F; Sastry, Srikanth

    2013-03-28

    We carefully examine common measures of dynamical heterogeneity for a model polymer melt and test how these scales compare with those hypothesized by the Adam and Gibbs (AG) and random first-order transition (RFOT) theories of relaxation in glass-forming liquids. To this end, we first analyze clusters of highly mobile particles, the string-like collective motion of these mobile particles, and clusters of relative low mobility. We show that the time scale of the high-mobility clusters and strings is associated with a diffusive time scale, while the low-mobility particles' time scale relates to a structural relaxation time. The difference of the characteristic times for the high- and low-mobility particles naturally explains the well-known decoupling of diffusion and structural relaxation time scales. Despite the inherent difference of dynamics between high- and low-mobility particles, we find a high degree of similarity in the geometrical structure of these particle clusters. In particular, we show that the fractal dimensions of these clusters are consistent with those of swollen branched polymers or branched polymers with screened excluded-volume interactions, corresponding to lattice animals and percolation clusters, respectively. In contrast, the fractal dimension of the strings crosses over from that of self-avoiding walks for small strings, to simple random walks for longer, more strongly interacting, strings, corresponding to flexible polymers with screened excluded-volume interactions. We examine the appropriateness of identifying the size scales of either mobile particle clusters or strings with the size of cooperatively rearranging regions (CRR) in the AG and RFOT theories. We find that the string size appears to be the most consistent measure of CRR for both the AG and RFOT models. Identifying strings or clusters with the "mosaic" length of the RFOT model relaxes the conventional assumption that the "entropic droplets" are compact. We also confirm the

  4. A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at One-Month Post- Release

    Science.gov (United States)

    Gordon, Michael S.; Schwartz, Robert P.; O’Grady, Kevin; Fitzgerald, Terrence T.; Wilson, Monique

    2008-01-01

    Background Despite its effectiveness, methadone maintenance is rarely provided in American correctional facilities. This study is the first randomized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction. Methods A three-group randomized controlled trial was conducted between September 2003 and June 2005. Two hundred-eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study. Participants were randomly assigned to the following: Counseling Only: counseling in prison, with passive referral to treatment upon release (n = 70); Counseling + Transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and Counseling + Methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Results Two hundred participants were located for follow-up interviews and included in the current analysis. The percentages of participants in each condition that entered community-based treatment were, respectively, Counseling Only 7.8%, Counseling + Transfer 50.0%, and Counseling + Methadone 68.6%, p prison appears to have beneficial short-term impact on community treatment entry and heroin use. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories. PMID:17628351

  5. Investigation of factors affecting the injury severity of single-vehicle rollover crashes: A random-effects generalized ordered probit model.

    Science.gov (United States)

    Anarkooli, Alireza Jafari; Hosseinpour, Mehdi; Kardar, Adele

    2017-09-01

    Rollover crashes are responsible for a notable number of serious injuries and fatalities; hence, they are of great concern to transportation officials and safety researchers. However, only few published studies have analyzed the factors associated with severity outcomes of rollover crashes. This research has two objectives. The first objective is to investigate the effects of various factors, of which some have been rarely reported in the existing studies, on the injury severities of single-vehicle (SV) rollover crashes based on six-year crash data collected on the Malaysian federal roads. A random-effects generalized ordered probit (REGOP) model is employed in this study to analyze injury severity patterns caused by rollover crashes. The second objective is to examine the performance of the proposed approach, REGOP, for modeling rollover injury severity outcomes. To this end, a mixed logit (MXL) model is also fitted in this study because of its popularity in injury severity modeling. Regarding the effects of the explanatory variables on the injury severity of rollover crashes, the results reveal that factors including dark without supplemental lighting, rainy weather condition, light truck vehicles (e.g., sport utility vehicles, vans), heavy vehicles (e.g., bus, truck), improper overtaking, vehicle age, traffic volume and composition, number of travel lanes, speed limit, undulating terrain, presence of central median, and unsafe roadside conditions are positively associated with more severe SV rollover crashes. On the other hand, unpaved shoulder width, area type, driver occupation, and number of access points are found as the significant variables decreasing the probability of being killed or severely injured (i.e., KSI) in rollover crashes. Land use and side friction are significant and positively associated only with slight injury category. These findings provide valuable insights into the causes and factors affecting the injury severity patterns of rollover

  6. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits. Copyright © 2016, American Association for the Advancement of Science.

  7. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  8. Results from the PALM-3000 high-order adaptive optics system

    Science.gov (United States)

    Roberts, Jennifer E.; Dekany, Richard G.; Burruss, Rick S.; Baranec, Christoph; Bouchez, Antonin; Croner, Ernest E.; Guiwits, Stephen R.; Hale, David D. S.; Henning, John R.; Palmer, Dean L.; Troy, Mitchell; Truong, Tuan N.; Zolkower, Jeffry

    2012-07-01

    The first of a new generation of high actuator density AO systems developed for large telescopes, PALM-3000 is optimized for high-contrast exoplanet science but will support operation with natural guide stars as faint as V ~ 18. PALM-3000 began commissioning in June 2011 on the Palomar 200" telescope and has to date over 60 nights of observing. The AO system consists of two Xinetics deformable mirrors, one with 66 by 66 actuators and another with 21 by 21 actuators, a Shack-Hartman WFS with four pupil sampling modes (ranging from 64 to 8 samples across the pupil), and a full vector matrix multiply real-time system capable of running at 2KHz frame rates. We present the details of the completed system, and initial results. Operating at 2 kHz with 8.3cm pupil sampling on-sky, we have achieved a K-band Strehl ratio as high as 84% in ~1.0 arcsecond visible seeing.

  9. Results from an online computer-tailored weight management intervention for overweight adults: randomized controlled trial.

    Science.gov (United States)

    van Genugten, Lenneke; van Empelen, Pepijn; Boon, Brigitte; Borsboom, Gerard; Visscher, Tommy; Oenema, Anke

    2012-03-14

    Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the study, but there were no differences

  10. Correlations in two-dimensional electron gas: Random-phase approximation with exchange and ladder results

    Science.gov (United States)

    Pederiva, F.; Lipparini, E.; Takayanagi, K.

    1997-12-01

    We have evaluated the density-density response of the two-dimensional electron gas at zero temperature by solving the Dyson equation for the particle-hole Green's function, including exchange Coulomb matrix elements and short-range contributions in the ladder approximation. We study the effect of these correlations on the total energy, compressibility per particle, local field factor G(q), static structure factor and pair-correlation function. Results are compared with the normal random-phase approximation, local field theories and quantum Monte Carlo calculations.

  11. Third-Order Differential Subordination and Superordination Results for Meromorphically Multivalent Functions Associated with the Liu-Srivastava Operator

    Directory of Open Access Journals (Sweden)

    Huo Tang

    2014-01-01

    Full Text Available There are many articles in the literature dealing with the first-order and the second-order differential subordination and superordination problems for analytic functions in the unit disk, but only a few articles are dealing with the above problems in the third-order case (see, e.g., Antonino and Miller (2011 and Ponnusamy et al. (1992. The concept of the third-order differential subordination in the unit disk was introduced by Antonino and Miller in (2011. Let Ω be a set in the complex plane C. Also let p be analytic in the unit disk U=z:z∈C  and  z<1 and suppose that ψ:C4×U→C. In this paper, we investigate the problem of determining properties of functions p(z that satisfy the following third-order differential superordination: Ω⊂ψpz,zp′z,z2p′′z,z3p′′′z;z:z∈U. As applications, we derive some third-order differential subordination and superordination results for meromorphically multivalent functions, which are defined by a family of convolution operators involving the Liu-Srivastava operator. The results are obtained by considering suitable classes of admissible functions.

  12. [Increase in orders for specific IgE tests and more positive results in children in 1985-2003].

    Science.gov (United States)

    Baatenburg de Jong, A; Dikkeschei, L D; Brand, P L P

    2008-08-09

    To describe changes over time in the number of allergy tests for specific IgE ordered and outcomes in children, to help address the question whether the increase in allergies is due to an actual increase in sensitisation or an increase in diagnostic awareness of allergies among physicians. Retrospective and descriptive. We reviewed the results of all specific IgE tests performed in our hospital's laboratory for children 0-18 years of age in the period 1985-2003. This included tests ordered by both general practitioners and hospital-based specialists. We analysed trends over time in the number of tests ordered (as an indicator ofdiagnostic awareness) and test results (as an indicator ofsensitisation). Between 1989 and 1995, the annual number of tests ordered increased from 1 per 10,000 children to 95 per 10,000 children and remained stable thereafter. Before 1990, more than 90% of tests were ordered by hospital-based specialists; after 1990, approximately 70% of the tests were ordered by general practitioners (p < 0.001). The proportion of positive tests remained stable at approximately 27% until 1991, after which it increased to more than 45% (p < 0.001). The increase in the proportion of positive tests suggests an increase in atopic sensitization between 1985 and 2000 which has stabilized since.

  13. Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.

    Science.gov (United States)

    Bulian, Dirk Rolf; Knuth, Jurgen; Cerasani, Nicola; Lange, Jonas; Ströhlein, Michael Alfred; Sauerwald, Axel; Heiss, Markus Maria

    2014-08-01

    For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2-3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy. To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains "satisfaction" and "pain" of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months. Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P = 0.004 and P < 0.001). There were no postoperative pathological gynecological findings. Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.

  14. Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

    Science.gov (United States)

    Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

    2016-04-01

    The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

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

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

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

  16. Early Childhood Mental Health Consultation: Results of a Statewide Random-Controlled Evaluation.

    Science.gov (United States)

    Gilliam, Walter S; Maupin, Angela N; Reyes, Chin R

    2016-09-01

    Despite recent federal recommendations calling for increased funding for early childhood mental health consultation (ECMHC) as a means to decrease preschool expulsions, no randomized-controlled evaluations of this form of intervention have been reported in the scientific literature. This study is the first attempt to isolate the effects of ECMHC for enhancing classroom quality, decreasing teacher-rated behavior problems, and decreasing the likelihood of expulsion in targeted children in early childhood classrooms. The sample consisted of 176 target children (3-4 years old) and 88 preschool classrooms and teachers randomly assigned to receive ECMHC through Connecticut's statewide Early Childhood Consultation Partnership (ECCP) or waitlist control treatment. Before randomization, teachers selected 2 target children in each classroom whose behaviors most prompted the request for ECCP. Evaluation measurements were collected before and after treatment, and child behavior and social skills and overall quality of the childcare environment were assessed. Hierarchical linear modeling was used to evaluate the effectiveness of ECCP and to account for the nested structure of the study design. Children who received ECCP had significantly lower ratings of hyperactivity, restlessness, externalizing behaviors, problem behaviors, and total problems compared with children in the control group even after controlling for gender and pretest scores. No effects were found on likelihood of expulsion and quality of childcare environment. ECCP resulted in significant decreases across several domains of teacher-rated externalizing and problem behaviors and is a viable and potentially cost-effective means for infusing mental health services into early childhood settings. Clinical and policy implications for ECMHC are discussed. Copyright © 2016 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  17. Method for evaluating prediction models that apply the results of randomized trials to individual patients

    Directory of Open Access Journals (Sweden)

    Kattan Michael W

    2007-06-01

    Full Text Available Abstract Introduction The clinical significance of a treatment effect demonstrated in a randomized trial is typically assessed by reference to differences in event rates at the group level. An alternative is to make individualized predictions for each patient based on a prediction model. This approach is growing in popularity, particularly for cancer. Despite its intuitive advantages, it remains plausible that some prediction models may do more harm than good. Here we present a novel method for determining whether predictions from a model should be used to apply the results of a randomized trial to individual patients, as opposed to using group level results. Methods We propose applying the prediction model to a data set from a randomized trial and examining the results of patients for whom the treatment arm recommended by a prediction model is congruent with allocation. These results are compared with the strategy of treating all patients through use of a net benefit function that incorporates both the number of patients treated and the outcome. We examined models developed using data sets regarding adjuvant chemotherapy for colorectal cancer and Dutasteride for benign prostatic hypertrophy. Results For adjuvant chemotherapy, we found that patients who would opt for chemotherapy even for small risk reductions, and, conversely, those who would require a very large risk reduction, would on average be harmed by using a prediction model; those with intermediate preferences would on average benefit by allowing such information to help their decision making. Use of prediction could, at worst, lead to the equivalent of an additional death or recurrence per 143 patients; at best it could lead to the equivalent of a reduction in the number of treatments of 25% without an increase in event rates. In the Dutasteride case, where the average benefit of treatment is more modest, there is a small benefit of prediction modelling, equivalent to a reduction of

  18. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  19. Cerebral activation related to skills practice in a double serial reaction time task : striatal involvement in random-order sequence learning

    NARCIS (Netherlands)

    van der Graaf, FHCE; de Jong, BM; Maguire, RP; Meiners, LC; Leenders, KL

    We used functional Magnetic Resonance Imaging (fMRI) to examine the distribution of cerebral activation related to prolonged skill practice. In a bimanual variant of the Serial Reaction Time Task (SRT), simultaneous finger movements of the two hands were made in response to randomly ordered pairs of

  20. Novel asymptotic results on the high-order statistics of the channel capacity over generalized fading channels

    KAUST Repository

    Yilmaz, Ferkan

    2012-06-01

    The exact analysis of the higher-order statistics of the channel capacity (i.e., higher-order ergodic capacity) often leads to complicated expressions involving advanced special functions. In this paper, we provide a generic framework for the computation of the higher-order statistics of the channel capacity over generalized fading channels. As such, this novel framework for the higher-order statistics results in simple, closed-form expressions which are shown to be asymptotically tight bounds in the high signal-to-noise ratio (SNR) regime of a variety of fading environment. In addition, it reveals the existence of differences (i.e., constant capacity gaps in log-domain) among different fading environments. By asymptotically tight bound we mean that the high SNR limit of the difference between the actual higher-order statistics of the channel capacity and its asymptotic bound (i.e., lower bound) tends to zero. The mathematical formalism is illustrated with some selected numerical examples that validate the correctness of our newly derived results. © 2012 IEEE.

  1. Mitigation of Systemic Oxidative Stress by Curcuminoids in Osteoarthritis: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Panahi, Yunes; Alishiri, Gholam Hossein; Parvin, Shahram; Sahebkar, Amirhossein

    2016-01-01

    Oxidative stress is implicated in the pathogenesis of osteoarthritis. Curcuminoids are natural polyphenols with strong antioxidant capacity and may thus be helpful in the treatment of osteoarthritis. The present randomized double-blind placebo-controlled trial investigated the efficacy of curcuminoids in reducing systemic oxidative burden in patients suffering from knee osteoarthritis. Forty patients with mild-to-moderate primary knee osteoarthritis were given curcuminoid capsules (1500 mg/day in 3 divided doses; n = 19) or matched placebo capsules (n = 21) for a period of 6 weeks. Curcuminoids were co-administered with piperine (15 mg/day) in order to improve the bioavailability. Serum activities of superoxide dismutase (SOD) and concentrations of reduced glutathione (GSH) and malonedialdehyde (MDA) were determined spectrophotometrically at baseline and at the end of the treatment period in both groups. Serum activities of SOD as well as GSH and MDA concentrations were comparable between the study groups at baseline (p > 0.05). There was a significant elevation in serum SOD activities (mean change: 2.94 ± 3.73 vs. -0.38 ± 1.33; p osteoarthritis. These antioxidant effects may account for the reported therapeutic effects of curcuminoids in relieving osteoarthritis symptoms.

  2. Survival of two post systems--five-year results of a randomized clinical trial.

    Science.gov (United States)

    Schmitter, Marc; Hamadi, Khaled; Rammelsberg, Peter

    2011-01-01

    To assess the survival rate of two different post systems after 5 years of service with a prospective randomized controlled trial. One hundred patients in need of a post were studied. Half of the patients received long glass fiber-reinforced posts, while the other half received long metal screw posts. The posts were assigned randomly. After at least 5 years (mean, 61.37 months), follow-ups were established. When a complication occurred prior to this recall, the type and time of the complication was documented. Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis. Additionally, a Cox regression was performed to analyze risk factors. The survival rate of fiber-reinforced posts was 71.8%. In the metal screw post group, the survival rate was significantly lower, 50.0% (log-rank test, P = .026). Metal posts resulted more often in more unfavorable complications (eg, root fractures); consequently, more teeth (n = 17) had to be extracted. The Cox regression identified the following risk factors: position of the tooth (anterior vs posterior teeth), degree of coronal tooth destruction, and the post system (fiber-reinforced post vs metal screw post). Fiber-reinforced restorations loosened in several patients; in some of these cases (n = 6), patients did not notice this, leading to the extraction of teeth. Long metal screw posts should be used with great care in endodontically treated teeth. Besides the selection of the post system, other factors influence the survival of the restoration.

  3. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    Directory of Open Access Journals (Sweden)

    Cătălin Pleșea Condratovici

    2016-01-01

    Full Text Available Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS. Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls were included (n=18/group. Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P=0.027. At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.

  4. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Science.gov (United States)

    Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

    2015-01-01

    Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

  5. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

    Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

  6. A randomized comparison of permanent septal versus apical right ventricular pacing: short-term results.

    Science.gov (United States)

    Victor, Frederic; Mabo, Philippe; Mansour, Hassan; Pavin, Dominique; Kabalu, Guillaume; de Place, Christian; Leclercq, Christophe; Daubert, J Claude

    2006-03-01

    This study compared chronic right ventricular (RV) pacing at the septum versus apex. Chronic RV apical pacing may be detrimental to ventricular function. This randomized, pilot study examined whether, compared with apical, permanent septal pacing preserves cardiac function. Ablation of the atrioventricular junction for permanent AF, followed by implantation of a DDDR pacemaker connected to two ventricular leads was performed in 28 patients. One lead screwed into the septum and another placed at the apex were connected to the atrial and ventricular port, respectively. Septum or apex was paced by programming AAIR or VVIR modes, respectively. Patients were randomly assigned, 4 months later, to pacing at one site for 3 months, and crossed over to the other for 3 months. New York Heart Association class, QRS width and axis, left ventricular ejection fraction (LVEF), exercise duration, and peak oxygen uptake were measured. Results in patients with LVEF > 45% and < or = 45% were compared. Septal pacing was associated with shorter QRS (145 +/- 4 msec vs 170 +/- 4 msec, P < 0.01) and normal axis (40 degrees +/- 10 degrees vs -71 +/- 4 degrees , P < 0.01). At 3 months, among patients with baseline LVEF < or = 45%, LVEF was 42 +/- 5% after septal pacing versus 37 +/- 4% after apical pacing (P < 0.001). In contrast to RV apical pacing, chronic RV septal pacing preserved LVEF in patients with baseline LVEF < or = 45%.

  7. Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Caroline Maltepe

    2013-01-01

    Full Text Available Objectives. To determine whether the initiation of treatment (preemptive treatment before the symptoms of nausea and vomiting of pregnancy (NVP versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047. In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13% in the first 3 weeks of NVP (P=0.05. In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50% (P<0.002. Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

  8. Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial

    Science.gov (United States)

    Van Coevorden, Frits; Punt, Cornelis J. A.; Pierie, Jean-Pierre E. N.; Borel-Rinkes, Inne; Ledermann, Jonathan A.; Poston, Graeme; Bechstein, Wolf; Lentz, Marie-Ange; Mauer, Murielle; Folprecht, Gunnar; Van Cutsem, Eric; Ducreux, Michel; Nordlinger, Bernard

    2017-01-01

    Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n  38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. PMID:28376151

  9. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial

    Science.gov (United States)

    Motzer, Robert J.; Rini, Brian I.; McDermott, David F.; Redman, Bruce G.; Kuzel, Timothy M.; Harrison, Michael R.; Vaishampayan, Ulka N.; Drabkin, Harry A.; George, Saby; Logan, Theodore F.; Margolin, Kim A.; Plimack, Elizabeth R.; Lambert, Alexandre M.; Waxman, Ian M.; Hammers, Hans J.

    2015-01-01

    Purpose Nivolumab is a fully human immunoglobulin G4 programmed death–1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC). Patients and Methods Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety. Results A total of 168 patients were randomly assigned to the nivolumab 0.3- (n = 60), 2- (n = 54), and 10-mg/kg (n = 54) cohorts. One hundred eighteen patients (70%) had received more than one prior systemic regimen. Median PFS was 2.7, 4.0, and 4.2 months, respectively (P = .9). Respective ORRs were 20%, 22%, and 20%. Median OS was 18.2 months (80% CI, 16.2 to 24.0 months), 25.5 months (80% CI, 19.8 to 28.8 months), and 24.7 months (80% CI, 15.3 to 26.0 months), respectively. The most common treatment-related adverse event (AE) was fatigue (24%, 22%, and 35%, respectively). Nineteen patients (11%) experienced grade 3 to 4 treatment-related AEs. Conclusion Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in mRCC. No dose-response relationship was detected as measured by PFS. These efficacy and safety results in mRCC support study in the phase III setting. PMID:25452452

  10. Restoring Body Image After Cancer (ReBIC): Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Esplen, Mary Jane; Wong, Jiahui; Warner, Ellen; Toner, Brenda

    2018-01-22

    Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Methods A prospective, randomized controlled trial was conducted to assess the efficacy of an 8-week group intervention in women after BC treatment. The manual-based intervention combined two powerful ingredients: expressive guided-imagery exercises integrated within a model of group-therapy principles. The intervention facilitates exploration of identity, the development of new self-schemas, and personal growth. In addition, the intervention included an educational component on the social and cultural factors affecting women's self-esteem and BI. The control condition included standard care plus educational reading materials. One hundred ninety-four BC survivors who had expressed concerns about negative BI and/or difficulties with sexual functioning participated in the study; 131 were randomly assigned to the intervention, and 63 were assigned to the control condition. Participants were followed for 1 year. Results Women in the intervention group reported significantly less concern/distress about body appearance ( P < .01), decreased body stigma ( P < .01), and lower level of BC-related concerns ( P < .01), compared with women in the control group. BC-related quality of life was also better in the intervention group compared with the control group at the 1-year follow-up ( P < .01). There was no statistically significant group difference in sexual functioning. Conclusion Restoring Body Image After Cancer (ReBIC), a group intervention using guided imagery within a group-therapy approach, is an effective method for addressing BI-related concerns and quality of life post-BC. The manual-based intervention can be easily adapted to both cancer centers and primary care settings.

  11. Dialectical Behavior Therapy for Adolescents with Bipolar Disorder: Results from a Pilot Randomized Trial

    Science.gov (United States)

    Fersch-Podrat, Rachael K.; Rivera, Maribel; Axelson, David A.; Merranko, John; Yu, Haifeng; Brent, David A.; Birmaher, Boris

    2015-01-01

    Abstract Objective: The purpose of this study was to conduct a pilot randomized trial of dialectical behavior therapy (DBT) versus psychosocial treatment as usual (TAU) for adolescents diagnosed with bipolar disorder (BP). Methods: We recruited participants 12–18 years of age with a primary BP diagnosis (I, II, or operationalized not otherwise specified [NOS] criteria) from a pediatric specialty clinic. Eligible patients were assigned using a 2:1 randomization structure to either DBT (n=14) or psychosocial TAU (n=6). All patients received medication management from a study-affiliated psychiatrist. DBT included 36 sessions (18 individual, 18 family skills training) over 1 year. TAU was an eclectic psychotherapy approach consisting of psychoeducational, supportive, and cognitive behavioral techniques. An independent evaluator, blind to treatment condition, assessed outcomes including affective symptoms, suicidal ideation and behavior, nonsuicidal self-injurious behavior, and emotional dysregulation, quarterly over 1 year. Results: Adolescents receiving DBT attended significantly more therapy sessions over 1 year than did adolescents receiving TAU, possibly reflecting greater engagement and retention; both treatments were rated as highly acceptable by adolescents and parents. As compared with adolescents receiving TAU, adolescents receiving DBT demonstrated significantly less severe depressive symptoms over follow-up, and were nearly three times more likely to demonstrate improvement in suicidal ideation. Models indicate a large effect size, for more weeks being euthymic, over follow-up among adolescents receiving DBT. Although there were no between-group differences in manic symptoms or emotional dysregulation with treatment, adolescents receiving DBT, but not those receiving TAU, evidenced improvement from pre- to posttreatment in both manic symptoms and emotional dysregulation. Conclusions: DBT may offer promise as an adjunct to pharmacotherapy in the treatment

  12. The dissemination of motivational interviewing in Swedish county councils: Results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Maria Beckman

    Full Text Available A significant number of Swedish practitioners are offered workshop trainings in motivational interviewing through community-based implementation programs. The objective of this randomized controlled trial was to evaluate to what extent the practitioners acquire and retain skills from additional supervision consisting of feedback based on monitoring of practice.A total of 174 practitioners in five county councils across Sweden were randomized to one of the study's two groups: 1 Regular county council workshop training, 2 Regular county council workshop training followed by six sessions of supervision. The participant's mean age was 43.3 years, and the majority were females (88.1%.Recruiting participants proved difficult, which may have led to a biased sample of practitioners highly motivated to learn the method. Although slightly different in form and content, all the workshop trainings increased the participants' skills to the same level. Also, consistent with previous research, the additional supervision group showed larger gains in proficiency compared to the group who received workshop training only at the six-month follow-up. However, analyses showed generally maintained levels of skills for all the participants at the follow-up assessment, and the majority of participants did not attain beginning proficiency levels at either post-workshop or follow-up.The results of this study address the real-life implications of dissemination of evidence-based practices. The maintained level of elevated skills for all participants is a promising finding. However, the low interest for obtaining additional supervision among the Swedish practitioners is problematic. In addition, neither the workshop trainings nor the additional supervision, although improving skills, were sufficient for most of the participants to reach beginning proficiency levels. This raises questions regarding the most efficient form of training to attain and sustain adequate practice

  13. Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial.

    Science.gov (United States)

    Papadaki, Angeliki; Martínez-González, Miguel Ángel; Alonso-Gómez, Angel; Rekondo, Javier; Salas-Salvadó, Jordi; Corella, Dolores; Ros, Emilio; Fitó, Montse; Estruch, Ramon; Lapetra, José; García-Rodriguez, Antonio; Fiol, Miquel; Serra-Majem, Lluís; Pintó, Xavier; Ruiz-Canela, Miguel; Bulló, Monica; Serra-Mir, Mercè; Sorlí, Jose V; Arós, Fernando

    2017-09-01

    The aim of this study was to evaluate the effect of the Mediterranean diet (MedDiet) on the incidence of heart failure (HF), a pre-specified secondary outcome in the PREDIMED (PREvención con DIeta MEDiterránea) primary nutrition-intervention prevention trial. Participants at high risk of cardiovascular disease were randomly assigned to one of three diets: MedDiet supplemented with extra-virgin olive oil (EVOO), MedDiet supplemented with nuts, or a low-fat control diet. Incident HF was ascertained by a Committee for Adjudication of events blinded to group allocation. Among 7403 participants without prevalent HF followed for a median of 4.8 years, we observed 29 new HF cases in the MedDiet with EVOO group, 33 in the MedDiet with nuts group, and 32 in the control group. No significant association with HF incidence was found for the MedDiet with EVOO and MedDiet with nuts, compared with the control group [hazard ratio (HR) 0.68; 95% confidence interval (CI) 0.41-1.13, and HR 0.92; 95% CI 0.56-1.49, respectively]. In this sample of adults at high cardiovascular risk, the MedDiet did not result in lower HF incidence. However, this pre-specified secondary analysis may have been underpowered to provide valid conclusions. Further randomized controlled trials with HF as a primary outcome are needed to better assess the effect of the MedDiet on HF risk. ISRCTN35739639. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  14. Result of randomized control trial to increase breast health awareness among young females in Malaysia

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    Mehrnoosh Akhtari-Zavare

    2016-08-01

    Full Text Available Abstract Background Breast cancer is the most common cancer and the second principal cause of cancer deaths in women worldwide as well as in Malaysia. Breast self-examination (BSE has a role in raising breast cancer awareness among women and educational programs play an important role in breast cancer preventive behavior. The aim of this study is to develop, implement and evaluate the effectiveness of Breast Health Awareness program based on health belief model on knowledge of breast cancer and breast-selfexamination and BSE practice among female students in Malaysia. Methods A single-blind randomized controlled trial was carried out among 370 female undergraduate students from January 2011 to April 2012 in two selected public universities in Malaysia. Participants were randomized to either the intervention group or the control group. The educational program was delivered to the intervention group. The outcome measures were assessed at baseline, 6, and 12 months after implementing the health educational program. Chi-square, independent samples t-test and two-way repeated measures ANOVA (GLM were conducted in the course of the data analyses. Results Mean scores of knowledge on breast cancer (p<0.003, knowledge on breast self examination (p<0.001, benefits of BSE (p<0.00, barrier of BSE (0.01 and confidence of BSE practice (p<0.00 in the intervention group had significant differences in comparison with those of the control group 6 and 12 months after the intervention. Also, among those who never practiced BSE at baseline, frequency of BSE practice increased 6 and 12 months after the intervention (p<0.05. Conclusion The Breast Health Awareness program based on health the belief model had a positive effect on knowledge of breast cancer and breast self-examination and practice of BSE among females in Malaysia. Trial registration The ANZCTR clinical trial registry ( ACTRN12616000831482 , retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.

  15. Improving educational quality through enhancing community participation: results from a randomized field experiment in Indonesia

    NARCIS (Netherlands)

    Pradhan, M.; Suryadarma, D.; Beatty, A.; Wong, M.; Alishjabana, A.; Gaduh, A.

    2011-01-01

    This study evaluates the effect of four randomized interventions aimed at strengthening school committees, and subsequently improving learning outcomes, in public primary schools in Indonesia. All study schools were randomly allocated to either a control group receiving no intervention, or to

  16. Systematic instruction for individuals with acquired brain injury: Results of a randomized controlled trial

    Science.gov (United States)

    Powell, Laurie Ehlhardt; Glang, Ann; Ettel, Deborah; Todis, Bonnie; Sohlberg, McKay; Albin, Richard

    2012-01-01

    The goal of this study was to experimentally evaluate systematic instruction compared with trial-and-error learning (conventional instruction) applied to assistive technology for cognition (ATC), in a double blind, pretest-posttest, randomized controlled trial. Twenty-nine persons with moderate-severe cognitive impairments due to acquired brain injury (15 in systematic instruction group; 14 in conventional instruction) completed the study. Both groups received 12, 45-minute individual training sessions targeting selected skills on the Palm Tungsten E2 personal digital assistant (PDA). A criterion-based assessment of PDA skills was used to evaluate accuracy, fluency/efficiency, maintenance, and generalization of skills. There were no significant differences between groups at immediate posttest with regard to accuracy and fluency. However, significant differences emerged at 30-day follow-up in favor of systematic instruction. Furthermore, systematic instruction participants performed significantly better at immediate posttest generalizing trained PDA skills when interacting with people other than the instructor. These results demonstrate that systematic instruction applied to ATC results in better skill maintenance and generalization than trial-and-error learning for individuals with moderate-severe cognitive impairments due to acquired brain injury. Implications, study limitations, and directions for future research are discussed. PMID:22264146

  17. Randomization in laboratory procedure is key to obtaining reproducible microarray results.

    Directory of Open Access Journals (Sweden)

    Hyuna Yang

    Full Text Available The quality of gene expression microarray data has improved dramatically since the first arrays were introduced in the late 1990s. However, the reproducibility of data generated at multiple laboratory sites remains a matter of concern, especially for scientists who are attempting to combine and analyze data from public repositories. We have carried out a study in which a common set of RNA samples was assayed five times in four different laboratories using Affymetrix GeneChip arrays. We observed dramatic differences in the results across laboratories and identified batch effects in array processing as one of the primary causes for these differences. When batch processing of samples is confounded with experimental factors of interest it is not possible to separate their effects, and lists of differentially expressed genes may include many artifacts. This study demonstrates the substantial impact of sample processing on microarray analysis results and underscores the need for randomization in the laboratory as a means to avoid confounding of biological factors with procedural effects.

  18. Impact of Laboratory Charge Display Within the Electronic Health Record Across an Entire Academic Medical Center: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Schmidt, Robert L; Colbert-Getz, Jorie M; Milne, Caroline K; Vargo, Daniel J; Hussong, Jerry W; Hoidal, John R; Markewitz, Boaz A; Walker, Brandon S; Kawamoto, Kensaku

    2017-11-20

    To determine the impact of systemwide charge display on laboratory utilization. This was a randomized controlled trial with a baseline period and an intervention period. Tests were randomized to a control arm or an active arm. The maximum allowable Medicare reimbursement rate was displayed for tests in the active arm during the intervention period. Total volume of tests in the active arm was compared with those in the control arm. Residents were surveyed before and after the intervention to assess charge awareness. Charge display had no effect on order behavior. This result held for patient type (inpatient vs outpatient) and for insurance category (commercial, government, self-pay). Residents overestimated the charges of tests both before and after the intervention. Many residents failed to notice the charge display in the computerized order entry system. The impact of charge display depends on context. Charge display is not always effective.

  19. Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial.

    Science.gov (United States)

    Bhandari, Mohit; Jin, Ling; See, Kyoungah; Burge, Russel; Gilchrist, Nigel; Witvrouw, Richard; Krohn, Kelly D; Warner, Margaret R; Ahmad, Qasim I; Mitlak, Bruce

    2016-05-01

    There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo(®)/ Forsteo(®), recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing. We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 μg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally expected treatment effect but had approximately 80% power to detect a larger difference of 12% between treatment groups for risk of revision surgery. The proportion of

  20. Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and US Department of Agriculture Database Information: A Multisite Randomized Study

    Science.gov (United States)

    Urban, Lorien E.; Weber, Judith L.; Heyman, Melvin B.; Schichtl, Rachel L.; Verstraete, Sofia; Lowery, Nina S.; Das, Sai Krupa; Schleicher, Molly M.; Rogers, Gail; Economos, Christina; Masters, William A.; Roberts, Susan B.

    2017-01-01

    Background Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ~50% of US restaurants are individual or small-chain (non–chain) establishments that do not provide nutrition information. Objective To measure the energy content of frequently ordered meals in non–chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. Design A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non–chain restaurants, together with equivalent meals from large-chain restaurants. Setting Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Main outcome measures Meal energy content determined by bomb calorimetry. Statistical analysis performed Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non–chain and chain meals, human energy requirements, and food database values. Results Meals from non–chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non–chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Conclusions Non–chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized

  1. Aspirin Reduces Plasma Concentrations of the Oncometabolite 2-Hydroxyglutarate: Results of a Randomized, Double-Blind, Crossover Trial

    Science.gov (United States)

    Liesenfeld, David B.; Botma, Akke; Habermann, Nina; Toth, Reka; Weigel, Christoph; Popanda, Odilia; Klika, Karel D.; Potter, John D.; Lampe, Johanna W.; Ulrich, Cornelia M.

    2015-01-01

    Background Aspirin use is an effective strategy for the chemoprevention of colorectal cancer, even at low doses. However, in order to implement aspirin interventions, risk–benefit balances and biological mechanisms need to be better defined; to further this aim, we used a metabolomics approach. Methods We metabolically profiled 40 healthy, non-smoking men and women aged 20–45 years enrolled in a randomized, double-blind, crossover trial of 325 mg aspirin/d over 60 days. Gas and liquid chromatography–mass spectrometry were used to comprehensively profile participants’ plasma samples after aspirin and placebo interventions. Results A total of 363 metabolites, covering most human biochemical pathways, were measured. Compared to placebo-treated participants, plasma concentrations of the oncometabolite 2-hydroxyglutarate (R+S) decreased after aspirin treatment in both men and women (p = 0.005). This signal proved robust during 20-fold random splitting of the data using 80% of the samples in each split. We subsequently performed functional follow-up studies using targeted, enantiospecific detection in human colorectal cancer cell lines and observed an aspirin-induced reduction of (R)-2-hydroxyglutarate. We further showed that salicylate, the primary aspirin metabolite, inhibits the hydroxyacid–oxoacid transhydrogenase (HOT) mediated production of (R)-2-hydroxyglutarate, thereby providing mechanistic evidence for the clinically observed effects of aspirin on total-2-hydroxyglutarate. Conclusion Using a metabolomics approach with functional follow-up, we propose that a decrease in the oncometabolite (R)-2-hydroxyglutarate may identify an additional mechanism for aspirin or its metabolites in cancer prevention. Impact Reduction of the oncometabolite (R)-2-hydroxyglutarate identifies a novel, non-COX-inhibition-mediated mechanism of aspirin. PMID:26585118

  2. Burns in Baghdad from 2003–2014: results of a randomized household cluster survey

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Shatari, Sahar A Esa Al; Cherewick, Megan; Burnham, Gilbert; Hagopian, Amy; Galway, Lindsay P; Kushner, Adam L

    2015-01-01

    Purpose Civilians living amid conflict are at high-risk of burns. However, the epidemiology of burns among this vulnerable group is poorly understood, yet vital for health policy and relief planning. To address this gap, we aimed to determine the death and disability, healthcare needs and household financial consequences of burns in post-invasion Baghdad. Methods A two-stage, cluster randomized, community-based household survey was performed in May of 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about cause of household member death, households were interviewed regarding burn specifics, healthcare required, disability, relationship to conflict and resultant financial hardship. Results Nine-hundred households, totaling 5,148 individuals, were interviewed. There were 55 burns, which were 10% of all injuries reported. There were an estimated 2,340 serious burn injures (39 per 100,000 persons) in Baghdad in 2003. The frequency of serious burn injuries generally increased post-invasion to 8,780 burns in 2013 (117 per 100,000 persons). Eight burns (15%) were the direct result of conflict. Individuals aged over 45 years had more than twice the odds of burn injury than children aged less than 13 years (aOR 2.42; 95%CI 1.08 – 5.44). Nineteen burns (35%) involved ≥20% body surface area. Death (16% of burn injuries), disability (40%), household financial hardship (48%) and food insecurity (50%) were common after burn injury. Conclusion Civilian burn injury in Baghdad is epidemic, increasing in frequency and associated with household financial hardship. Challenges of healthcare provision during prolonged conflict were evidenced by a high mortality rate and likelihood of disability after burn injury. Ongoing conflict will directly and indirectly generate more burns, which mandates planning for burn prevention and care within local capacity development initiatives, as well as humanitarian assistance. PMID:26526376

  3. A memory and organizational aid improves AD research consent capacity: Results of a randomized, controlled trial

    Science.gov (United States)

    Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

    2010-01-01

    Objectives AD patients' early and progressive cognitive impairments hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, we tested whether a memory and organizational aid improves AD patient performance on measures of capacity and competency to give informed consent. Design, Setting, and Participants AD patients randomly assigned to standard consent, or standard plus a memory and organizational aid. Intervention Memory and organizational aid summarized at a 6th grade reading level the content of information mandated under the Common Rule's informed consent disclosure requirements. Measurements Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison to cognitively normal older adult norms. Results AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on measures of appreciation or reasoning. Conclusions A consent process that addresses an AD patients' deficits in memory and attention can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. PMID:20808101

  4. THERAPEUTIC EQUIVALENCE OF ORIGINAL CLOPIDOGREL (PLAVIX AND ITS GENERIC (EGITROMB. RESULTS OF COMPARATIVE RANDOMIZED CROSS-OVER BLIND STUDY

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2011-01-01

    Full Text Available Aim. To study therapeutic equivalence (efficacy, safety and tolerability of original clopidogrel (Plavix and its generic (Egitromb in patients of high cardiovascular risk. Material and methods. Thirty one patients with coronary heart disease and indications for clopidogrel therapy were involved into the randomized cross-over blind study. Half of the patients received original clopidogrel (75 mg daily during the first 2 weeks and then they received generic clopidogrel in the same dose during next 2 weeks. Another half of the patients received the drugs in reverse order. Antiplatelet activity of Plavix and Egitromb was estimated by effects on ADP-induced platelet aggregation initially and after 2 weeks of treatment with each drug. Study blinding was provided by the following approach: doctors of cardiology clinic performed clinical monitoring and drug distribution; coded blood samples for platelet aggregation assessment were studied in independent laboratory of thrombosis; statistical data analysis was performed by biostatistics expert in other research center. Results. 2-week therapy with each drug led to a significant decrease of ADP-induced platelet aggregation which remained low after switching from original drug to generic and vice versa. Aggregation dynamics did not depend on the first administered drug. There were no significant differences between aggregation changes as a result of treatment with original or generic drug. No one adverse event was observed in association with both drugs therapy. Conclusion. Generic drug Egitromb (Egis, Hungary and original clopidogrel Plavix (Sanofi-Aventis, France have equivalent antiplatelet effect.

  5. 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....

  6. Resveratrol supplementation did not improves cognition in patients with schizophrenia: results from a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    KARINE ZORTEA

    2016-09-01

    Full Text Available Background: Schizophrenia is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related with neuroprotective action but there are no studies evaluating resveratrol in schizophrenia. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with schizophrenia. Methods: This is a 1-month randomized, double-blind controlled trial (NCT 02062190, in which 19 men with diagnosis of schizophrenia, aged 18 to 65 years, were assigned to a resveratrol supplement group (200mg or placebo group (200mg, with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, Weschler Adult Intelligence Scale and Brief Psychiatric Rating Scale assessed psychopathology severity. Results: There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility and psychopathology severity after 1-month of resveratrol supplementation (p>0.05. Conclusion: In conclusion, we have shown that 1-month of a resveratrol supplementation (200 mg/day did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention and mental flexibility as compared with placebo in patients with schizophrenia.

  7. A web application for moderation training: initial results of a randomized clinical trial.

    Science.gov (United States)

    Hester, Reid K; Delaney, Harold D; Campbell, William; Handmaker, Nancy

    2009-10-01

    Eighty-four heavy drinkers who responded to a newspaper recruitment advertisement were randomly assigned to receive either (a) training in a Moderate Drinking protocol via an Internet-based program (www.moderatedrinking.com) and use of the online resources of Moderation Management (MM; www.moderation.org) or (b) use of the online resources of MM alone. Follow-ups are being conducted at 3, 6, and 12 months. Results of the recently completed 3-month follow-up (86% follow-up) indicated both groups significantly reduced their drinking based on these variables: standard drinks per week, percent days abstinent, and mean estimated blood alcohol concentration (BAC) per drinking day. Both groups also significantly reduced their alcohol-related problems. Relative to the control group, the experimental group had better outcomes on percent days abstinent and log drinks per drinking day. These short-term outcome data provide evidence for the effectiveness of both the Moderate Drinking Web application and of the resources available online at MM in helping heavy drinkers reduce their drinking and alcohol-related problems.

  8. A web application for moderation training: Initial results of a randomized clinical trial1

    Science.gov (United States)

    Hester, Reid K.; Delaney, Harold D.; Campbell, William; Handmaker, Nancy

    2009-01-01

    Eighty four heavy drinkers who responded to a newspaper recruitment ad were randomly assigned to receive either: a) training in a moderate drinking protocol via an Internet-based program (www.moderatedrinking.com) and use of the online resources of Moderation Management (MM) (www.moderation.org) or b) use of the online resources of MM alone. Follow-ups are being conducted at 3, 6, and 12 months. Results of the recently completed 3 month follow-up (86% follow-up) indicated both groups significantly reduced their drinking based on these variables: standard drinks per week; percent days abstinent; and mean BAC per drinking day. Both groups also significantly reduced their alcohol-related problems. Relative to the control group the experimental group had better outcomes on percent days abstinent and log Drinks per Drinking Day. These short-term outcome data provide evidence for the effectiveness of both the moderate drinking web application and of the resources available online at MM in helping heavy drinkers reduce their drinking and alcohol-related problems. PMID:19339137

  9. How to configure blended problem based learning-results of a randomized trial.

    Science.gov (United States)

    Moeller, Stefan; Spitzer, Klaus; Spreckelsen, Cord

    2010-01-01

    Problem based learning (PBL) may be successfully complemented by Blended Learning approaches. However, the precise effect of combining different eLearning components in PBL-courses is yet unclear. This study aims at comparing the effects of the different combinations of three interactive components (Wiki, Chat, and, Interactive Diagnostic Context - a diagnostic related link collection to expert sources) on learning, aspects of group process, and individual learner satisfaction. A mixed-method study addressed all possible combinations of the three components. Tests and controls were assigned by group randomization. Hypotheses were tested by the Friedman- and the Mann-Whitney U test. The results prove Wiki to positively influence the ratings given by students to the course, whereas no evidence supports the expected advantages of Chat. The Interactive Diagnostic Context led to only few significant effects concerning the diagnostic approach and general score. Blended PBL (bPBL) profits best from supporting asynchronous communication (i.e. Wiki). Synchronous communication components and hypothesis-driven information retrieval do not yield further improvements. Thus, bPBL should concentrate on technically fostering the group process and avoid overloading the course configuration by other eLearning components.

  10. Relation of Depression to Perceived Social Support: Results from a Randomized Adolescent Depression Prevention Trial

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff; Ochner, Chris

    2012-01-01

    Theorists posit that certain behaviors exhibited by depressed individuals (e.g., negative self-statements, dependency, reassurance seeking, inappropriate or premature disclosures, passivity, social withdrawal) reduce social support, yet there have been few experimental tests of this hypothesis. Using data from a randomized depression prevention trial (N = 253) involving adolescents (M age = 15.5, SD = 1.2), we tested whether a cognitive behavioral group intervention that significantly reduced depressive symptoms relative to bibliotherapy and educational brochure control conditions through 2-year follow-up produced improvements in perceived parental and friend social support and whether change in depressive symptoms mediated the effect on change in social support. Cognitive behavioral group participants showed significantly greater increases in perceived friend social support through 1-year follow-up relative to bibliotherapy and brochure controls, but there were no significant effects for perceived parental support. Further, change in depressive symptoms appeared to mediate the effects of the intervention on change in perceived friend support. Results provide experimental support for the theory that depressive symptoms are inversely related to perceived social support, but imply that this effect may be specific to friend versus parental support for adolescents. PMID:21439551

  11. Training pediatric health care providers in prevention of dental decay: results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zeldin Leslie P

    2007-11-01

    Full Text Available Abstract Background Physicians report willingness to provide preventive dental care, but optimal methods for their training and support in such procedures are not known. This study aimed to evaluate the effect of three forms of continuing medical education (CME on provision of preventive dental services to Medicaid-enrolled children by medical personnel in primary care physician offices. Methods Practice-based, randomized controlled trial. Setting: 1,400 pediatric and family physician practices in North Carolina providing care to an estimated 240,000 Medicaid-eligible children aged 0–3 years. Interventions: Group A practices (n = 39 received didactic training and course materials in oral health screening, referral, counseling and application of fluoride varnish. Group B practices (n = 41 received the same as Group A and were offered weekly conference calls providing advice and support. Group C practices (n = 41 received the same as Group B and were offered in-office visit providing hands-on advice and support. In all groups, physicians were reimbursed $38–$43 per preventive dental visit. Outcome measures were computed from reimbursement claims submitted to NC Division of Medical Assistance. Primary outcome measure: rate of preventive dental services provision per 100 well-child visits. Secondary outcome measure: % of practices providing 20 or more preventive dental visits. Results 121 practices were randomized, and 107 provided data for analysis. Only one half of Group B and C practices took part in conference calls or in-office visits. Using intention-to-treat analysis, rates of preventive dental visits did not differ significantly among CME groups: GroupA = 9.4, GroupB = 12.9 and GroupC = 8.5 (P = 0.32. Twenty or more preventive dental visits were provided by 38–49% of practices in the three study groups (P = 0.64. Conclusion A relatively high proportion of medical practices appear capable of adopting these preventive dental services

  12. Epilepsy surgery and meaningful improvements in quality of life: results from a randomized controlled trial.

    Science.gov (United States)

    Fiest, Kirsten M; Sajobi, Tolulope T; Wiebe, Samuel

    2014-06-01

    We examine improvement and worsening in quality of life (QOL) in terms of proportions achieving minimum clinically important change (MCID), and factors related to MCID, in patients with temporal lobe epilepsy randomized to medical or surgical treatment. Eighty patients with temporal lobe epilepsy randomized to surgical (n(1) = 40) or medical (n(2) = 40) therapy were followed for 12 months, reporting QOL at baseline, and at 6 and 12 months. Previously established thresholds for MCID across various general and epilepsy-specific QOL instruments were used to determine meaningful improvement (positive MCID) or worsening (negative MCID). Generalized linear mixed-effects models were used to compare MCID in both groups. At 6 months, 56.0% of patients in the surgical group achieved positive MCID on the Quality of Life in Epilepsy (QOLIE)-89, as compared to 11.0% of those in the medical group (p MCID (p < 0.001). Substantially more medically treated patients exhibited clinically significant worsening in QOL, as compared with those surgically treated. The respective medical versus surgical proportions with worsening were 36.67% versus 13.8% in QOLIE31, 20% versus 15% in Health Utility Index-III (HUI-III), and 30% versus 19% in Short Form-36 (SF-36) Mental Composite Score (MCS). The number of patients who need to undergo surgery for one additional person to have a meaningful improvement in the QOLIE-31 is two (number needed to treat = 2). The results also favored surgery using the generic HUI-III instrument, but not with the mental of physical function subscales of the SF-36. Significantly more patients in the surgical group achieved meaningful improvement in epilepsy-specific measures of QOL at 6 and 12 months compared to those in the medical group. Substantially more patients in the medical therapy group exhibited clinically significant worsening in their QOL assessed with epilepsy-specific and generic instruments. A PowerPoint slide summarizing this article is available for

  13. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial

  14. An MGF-based unified framework to determine the joint statistics of partial sums of ordered i.n.d. random variables

    KAUST Repository

    Nam, Sungsik

    2014-08-01

    The joint statistics of partial sums of ordered random variables (RVs) are often needed for the accurate performance characterization of a wide variety of wireless communication systems. A unified analytical framework to determine the joint statistics of partial sums of ordered independent and identically distributed (i.i.d.) random variables was recently presented. However, the identical distribution assumption may not be valid in several real-world applications. With this motivation in mind, we consider in this paper the more general case in which the random variables are independent but not necessarily identically distributed (i.n.d.). More specifically, we extend the previous analysis and introduce a new more general unified analytical framework to determine the joint statistics of partial sums of ordered i.n.d. RVs. Our mathematical formalism is illustrated with an application on the exact performance analysis of the capture probability of generalized selection combining (GSC)-based RAKE receivers operating over frequency-selective fading channels with a non-uniform power delay profile. © 1991-2012 IEEE.

  15. Some new results on stability and synchronization for delayed inertial neural networks based on non-reduced order method.

    Science.gov (United States)

    Li, Xuanying; Li, Xiaotong; Hu, Cheng

    2017-12-01

    In this paper, without transforming the second order inertial neural networks into the first order differential systems by some variable substitutions, asymptotic stability and synchronization for a class of delayed inertial neural networks are investigated. Firstly, a new Lyapunov functional is constructed to directly propose the asymptotic stability of the inertial neural networks, and some new stability criteria are derived by means of Barbalat Lemma. Additionally, by designing a new feedback control strategy, the asymptotic synchronization of the addressed inertial networks is studied and some effective conditions are obtained. To reduce the control cost, an adaptive control scheme is designed to realize the asymptotic synchronization. It is noted that the dynamical behaviors of inertial neural networks are directly analyzed in this paper by constructing some new Lyapunov functionals, this is totally different from the traditional reduced-order variable substitution method. Finally, some numerical simulations are given to demonstrate the effectiveness of the derived theoretical results. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Results of the first order leveling surveys in the Mexicali Valley and at the Cerro Prieto field

    Energy Technology Data Exchange (ETDEWEB)

    de la Pena L, A.

    1981-01-01

    The results obtained from the third leveling survey carried out by the Direccion General de Geografia del Territorio Nacional (previously DETENAL) during November and December 1979 are presented. Calculations of the changes in field elevation and plots showing comparisons of the 1977, 1978, and 1979 surveys are also presented. Results from a second order leveling survey performed to ascertain the extent of ground motion resulting from the 8 June 1980 earthquake are presented. This magnitude ML = 6.7 earthquake with epicenter located 15 km southeast of the Guadalupe Victoria village, caused fissures on the surface, the formation of small sand volcanos, and the ejection of ground water in the vicinity of the Cerro Prieto field. This leveling survey was carried out between benchmark BN-10067 at the intersection of the Solfatara canal and the Sonora-Baja California railroad, and benchmark BN-10055 located at the Delta station.

  17. Burns in Baghdad from 2003 to 2014: Results of a randomized household cluster survey.

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Esa Al Shatari, Sahar A; Cherewick, Megan; Burnham, Gilbert; Hagopian, Amy; Galway, Lindsay P; Kushner, Adam L

    2016-02-01

    Civilians living amid conflict are at high-risk of burns. However, the epidemiology of burns among this vulnerable group is poorly understood, yet vital for health policy and relief planning. To address this gap, we aimed to determine the death and disability, healthcare needs and household financial consequences of burns in post-invasion Baghdad. A two-stage, cluster randomized, community-based household survey was performed in May 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about cause of household member death, households were interviewed regarding burn specifics, healthcare required, disability, relationship to conflict and resultant financial hardship. Nine-hundred households, totaling 5148 individuals, were interviewed. There were 55 burns, which were 10% of all injuries reported. There were an estimated 2340 serious burns (39 per 100,000 persons) in Baghdad in 2003. The frequency of serious burns generally increased post-invasion to 8780 burns in 2013 (117 per 100,000 persons). Eight burns (15%) were the direct result of conflict. Individuals aged over 45 years had more than twice the odds of burn than children aged less than 13 years (aOR 2.42; 95%CI 1.08-5.44). Nineteen burns (35%) involved ≥ 20% body surface area. Death (16% of burns), disability (40%), household financial hardship (48%) and food insecurity (50%) were common after burn. Civilian burn in Baghdad is epidemic, increasing in frequency and associated with household financial hardship. Challenges of healthcare provision during prolonged conflict were evidenced by a high mortality rate and likelihood of disability after burn. Ongoing conflict will directly and indirectly generates more burns, which mandates planning for burn prevention and care within local capacity development initiatives, as well as humanitarian assistance. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  18. Enhancing Congruence between Implicit Motives and Explicit Goal Commitments: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ramona M. Roch

    2017-09-01

    Full Text Available Objective: Theory and research suggest that the pursuit of personal goals that do not fit a person's affect-based implicit motives results in impaired emotional well-being, including increased symptoms of depression. The aim of this study was to evaluate an intervention designed to enhance motive-goal congruence and study its impact on well-being.Method: Seventy-four German students (mean age = 22.91, SD = 3.68; 64.9% female without current psychopathology, randomly allocated to three groups: motivational feedback (FB; n = 25; participants learned about the fit between their implicit motives and explicit goals, FB + congruence-enhancement training (CET; n = 22; participants also engaged in exercises to increase the fit between their implicit motives and goals, and a no-intervention control group (n = 27, were administered measures of implicit motives, personal goal commitments, happiness, depressive symptoms, and life satisfaction 3 weeks before (T1 and 6 weeks after (T2 treatment.Results: On two types of congruence measures derived from motive and goal assessments, treated participants showed increases in agentic (power and achievement congruence, with improvements being most consistent in the FB+CET group. Treated participants also showed a trend-level depressive symptom reduction, but no changes on other well-being measures. Although increases in overall and agentic motivational congruence were associated with increases in affective well-being, treatment-based reduction of depressive symptoms was not mediated by treatment-based agentic congruence changes.Conclusion: These findings document that motivational congruence can be effectively enhanced, that changes in motivational congruence are associated with changes in affective well-being, and they suggest that individuals' implicit motives should be considered when personal goals are discussed in the therapeutic process.

  19. Enhancing Congruence between Implicit Motives and Explicit Goal Commitments: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Roch, Ramona M; Rösch, Andreas G; Schultheiss, Oliver C

    2017-01-01

    Objective: Theory and research suggest that the pursuit of personal goals that do not fit a person's affect-based implicit motives results in impaired emotional well-being, including increased symptoms of depression. The aim of this study was to evaluate an intervention designed to enhance motive-goal congruence and study its impact on well-being. Method: Seventy-four German students (mean age = 22.91, SD = 3.68; 64.9% female) without current psychopathology, randomly allocated to three groups: motivational feedback (FB; n = 25; participants learned about the fit between their implicit motives and explicit goals), FB + congruence-enhancement training (CET; n = 22; participants also engaged in exercises to increase the fit between their implicit motives and goals), and a no-intervention control group (n = 27), were administered measures of implicit motives, personal goal commitments, happiness, depressive symptoms, and life satisfaction 3 weeks before (T1) and 6 weeks after (T2) treatment. Results: On two types of congruence measures derived from motive and goal assessments, treated participants showed increases in agentic (power and achievement) congruence, with improvements being most consistent in the FB+CET group. Treated participants also showed a trend-level depressive symptom reduction, but no changes on other well-being measures. Although increases in overall and agentic motivational congruence were associated with increases in affective well-being, treatment-based reduction of depressive symptoms was not mediated by treatment-based agentic congruence changes. Conclusion: These findings document that motivational congruence can be effectively enhanced, that changes in motivational congruence are associated with changes in affective well-being, and they suggest that individuals' implicit motives should be considered when personal goals are discussed in the therapeutic process.

  20. Influence of second-order random wave kinematics on the design loads of offshore wind turbine support structures

    DEFF Research Database (Denmark)

    Natarajan, Anand

    2014-01-01

    The impact of wave model nonlinearities on the design loads of wind turbine monopile foundations is delineated based on a second-order nonlinear randomwave model that satisfies the boundary conditions at the free surface and by including the effects of convective acceleration in the inertial load...

  1. Fall injuries in Baghdad from 2003 to 2014: results of a randomized household cluster survey

    Science.gov (United States)

    Stewart, Barclay T; Lafta, Riyadh; Shatari, Sahar A Esa Al; Cherewick, Megan; Flaxman, Abraham; Hagopian, Amy; Burnham, Gilbert; Kushner, Adam L

    2015-01-01

    Introduction Falls incur nearly 35 million disability-adjusted life-years annually; 75% of which occur in low- and middle-income countries. The epidemiology of civilian injuries during conflict is relatively unknown, yet important for planning prevention initiatives, health policy and humanitarian assistance. This study aimed to determine the death and disability and household consequences of fall injuries in post-invasion Baghdad. Methods A two-stage, cluster randomized, community-based household survey was performed in May of 2014 to determine the civilian burden of injury from 2003 to 2014 in Baghdad. In addition to questions about household member death, households were interviewed regarding injury specifics, healthcare required, disability, relatedness to conflict and resultant financial hardship. Results Nine hundred households totaling 5,148 individuals were interviewed. There were 138 fall injuries (25% of all injuries reported); fall was the most common mechanism of civilian injury in Baghdad. The rate of serious fall injuries increased from 78 to 466 per 100,000 persons in 2003 and 2013, respectively. Fall was the most common mechanism among the injured elderly (i.e. ≥65 years; 15/24 elderly unintentional injuries; 63%). However, 46 fall injuries were children aged injuries) and 77 were respondents aged 15 - 64 years (36%). Respondents who spent significant time within the home (i.e. unemployed, retired, homemaker) had three times greater odds of having suffered a fall injury than student referents (aOR 3.34; 95%CI 1.30 – 8.60). Almost 80% of fall injured were left with life-limiting disability. Affected households often borrowed substantial sums of money (34 households; 30% of affected households) and/or suffered food insecurity after a family member's fall (52; 46%). Conclusion Falls were the most common cause of civilian injury in Baghdad. In part due to the effect of prolonged insecurity on a fragile health system, many injuries resulted in life

  2. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  3. Multimedia learning tools for teaching undergraduate ophthalmology: results of a randomized clinical study.

    Science.gov (United States)

    Steedman, Michael; Abouammoh, Marwan; Sharma, Sanjay

    2012-02-01

    To evaluate the effectiveness of a novel multimedia learning tool (MMLT) for teaching a method of approaching common ophthalmologic presentations. Randomized clinical study. 25 second-year medical students at Queen's University. We evaluated 2 MMLTs pertaining to common ophthalmologic presentations--acute visual loss and cataract--through the use of a randomized clinical study. Subjects were randomized either to watch a short-form video or to read a textbook excerpt for both cataract and acute visual loss. If randomized to one MMLT for the first module, the subject was allocated to the other modality for the second module. The main outcomes of interest were knowledge retention as measured by a short multiple-choice questionnaire, efficiency, and user preference. A trend was noted whereby subjects randomized to an MMLT had higher composite scores on multiple-choice questionnaires (mean score MMLT = 75.2% vs text = 67.5%; t test = 1.535; df = 22; p value = 0.139). Additionally, those who watched an MMLT spent 72% less time reviewing the education content (29 min vs 8 min; t test = 3.955, p value = 0.0003). Of the sample, 87% preferred the MMLT over the text. MMLTs can significantly reduce learning time without sacrificing knowledge retention in undergraduate students of ophthalmology. Copyright © 2012 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  4. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  5. Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study.

    Science.gov (United States)

    Bates, Debbie; Bolwell, Brian; Majhail, Navneet S; Rybicki, Lisa; Yurch, Melissa; Abounader, Donna; Kohuth, Joseph; Jarancik, Shannon; Koniarczyk, Heather; McLellan, Linda; Dabney, Jane; Lawrence, Christine; Gallagher, Lisa; Kalaycio, Matt; Sobecks, Ronald; Dean, Robert; Hill, Brian; Pohlman, Brad; Hamilton, Betty K; Gerds, Aaron T; Jagadeesh, Deepa; Liu, Hien D

    2017-09-01

    High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is frequently performed in patients with hematologic malignancies. ASCT can result in significant nausea, pain, and discomfort. Supportive care has improved, and pharmacologic therapies are frequently used, but with limitations. Music has been demonstrated to improve nausea and pain in patients undergoing chemotherapy, but little data are available regarding the effects of music therapy in the transplantation setting. In a prospective study, patients with lymphoma or multiple myeloma undergoing ASCT were randomized to receive either interactive music therapy with a board-certified music therapist or no music therapy. The music therapy arm received 2 music therapy sessions on days +1 and +5. Primary outcomes were perception of pain and nausea measured on a visual analog scale. Secondary outcomes were narcotic pain medication use from day -1 to day +5 and impact of ASCT on patient mood as assessed by Profile of Mood States (POMS) on day +5. Eighty-two patients were enrolled, with 37 in the music therapy arm and 45 in the no music therapy arm. Patients who received MT had slightly increased nausea by day +7 compared with the no music therapy patients. The music therapy and no music therapy patients had similar pain scores; however, the patients who received music therapy used significantly less narcotic pain medication (median, 24 mg versus 73 mg; P = .038). Music therapy may be a viable nonpharmacologic method of pain management for patients undergoing ASCT; the music therapy patients required significantly fewer morphine equivalent doses compared with the no music therapy patients. Additional research is needed to better understand the effects of music therapy on patient-perceived symptoms, such as pain and nausea. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  6. Enhanced Fidelity to a Psychosocial Treatment for Bipolar Disorder: Results from a Randomized Controlled Implementation Trial

    Science.gov (United States)

    Waxmonsky, Jeanette; Kilbourne, Amy M.; Goodrich, David E.; Nord, Kristina M.; Laird, Christina; Lai, Zongshan; Clogston, Julia; Kim, Hyungjin Myra; Miller, Christopher J.; Bauer, Mark S.

    2014-01-01

    Background We determined whether application of a novel implementation intervention (Enhanced Replicating Effective Programs-REP) versus its standard, dissemination-focused version (REP) improved fidelity to bipolar disorder treatment (Life Goals Collaborative Care- LGCC). Methods Five community practices from Michigan and Colorado were randomized to receive LGCC using Enhanced or standard REP. One provider at each practice implemented LGCC which included patient self-management support (4 group sessions focused on symptoms and behavior goals), guideline dissemination to providers, and ongoing phone care management focused on maintaining behavior goals and provider engagement. Standard REP included intervention packaging (i.e., translation of LGCC core components into user-friendly language), training, and as-needed technical assistance. Enhanced REP added customization of LGCC and ongoing, proactive technical assistance through an internal and external facilitator that focused on enhancing provider buy-in and uptake. Multiple and logistic regression analyses determined the impact on patient-level LGCC fidelity between Enhanced versus standard REP. Results Participants (N=384; mean age = 42 years, 67% women, 29% nonwhite) averaged 3.0 out of 4 LGCC group sessions and had 4.0 care management contacts. Enhanced REP implementation was associated with 2.6 (pmanagement contacts, after adjusting for patient factors. Women and those with a history of homelessness received fewer sessions. Conclusions Enhanced REP implementation was associated with improved LGCC fidelity, primarily for care management contacts. Additional customization of interventions such as LGCC may be needed to ensure adequate treatment fidelity for key vulnerable populations. PMID:24129806

  7. Enhanced Motivational Interviewing versus Brief Advice for Adolescent Smoking Cessation: Results from a Randomized Clinical Trial

    Science.gov (United States)

    Colby, Suzanne M.; Nargiso, Jessica; Tevyaw, Tracy O’Leary; Barnett, Nancy P.; Metrik, Jane; Lewander, William; Woolard, Robert H.; Rohsenow, Damaris J.; Monti, Peter M.

    2012-01-01

    Background Motivational interviewing (MI) is widely used for adolescent smoking cessation but empirical support for this approach is mixed. Methods Adolescent cigarette smokers 14–18 years old (N = 162) were recruited from medical, school, and community settings and randomly assigned to enhanced MI or brief advice (BA) for smoking cessation. MI comprised an in-person individual session, a telephone booster session one week later, and a brief telephone-based parent intervention. BA consisted of standardized brief advice to quit smoking. Assessments occurred at baseline, post-treatment and at 1-, 3-, and 6-month follow ups. Results Biochemically-confirmed 7-day point prevalence abstinence rates were low (e.g., 4.5% for MI; 1.4% for BA at 1 month) and did not differ significantly by group at any follow up. Only those in MI reported significant decreases in cigarettes smoked per day (CPD) from baseline to 1 month. At 3 and 6 months, smokers in both groups reported significantly reduced CPD with no differences between groups. MI reduced perceived norms regarding peer and adult smoking rates, while BA had no effect on normative perceptions. No group differences emerged for self-reported motivation or self-efficacy to quit smoking. Conclusions Findings support the efficacy of MI for addressing normative misperceptions regarding peer and adult smoking and for modestly reducing CPD in the short-term; however, these effects did not translate to greater smoking abstinence. MI may have more promise as a prelude to more intensive smoking intervention with adolescents than as a stand-alone intervention. PMID:22472523

  8. EFFICIENCY OF DYNAMIC ELECTRONEUROSTIMULATION IN KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    O. M. Lesnyak

    2015-01-01

    Full Text Available Dynamic electroneurostimulation (DENS is a type of percutaneous electroneurostimulation with a differentiation approach to choosing exposure areas and to optimizing electrocutaneous therapeutic action on the reflexogenic areas and acupuncture points for analgesia and for the treatment of functional disorders.Objective: to study the clinical efficiency and safety of therapy using a DiaDENS-PC apparatus in the treatment of knee osteoarthritis (OA.Subjects and methods. A multicenter randomized double-blind placebo-controlled study was conducted in 132 knee OA patients with pain value above 40 mm on visual analogue scale (VAS and Lequesne’s index of 4–12. In a study group (n = 66, DENS was carried outwith a DiaDENS-PC apparatus using a trailing electrode applicator to the knee target in a Therapy stimulation mode at a frequency 77 Hz, a power of 15 units. In the placebo group, the similar procedure was performed with a switched-on placebo apparatus that did not differ in appearance from the working apparatus; but produced no electrical pulses. The treatment cycle consisted of 10 sessions lasting 30 min. Changes in Lequesne’s algofunctional index were primary end point. The results of the Get-Up to Go test (in seconds and changes pain on VAS and WOMAC were used as secondary end points.Results and discussion. Both groups showed a statistically significant reduction of painand improvement of Get-Up and to Go test results by the end of the treatment course (p < 0.0001. Therewas a statistically significant difference in pain in the compared groups after a treatment session during the first (p = 0.037 and second (p = 0.010 visits. The analgesic effect of therapy was observed to persist in the DENS group 2 weeks (p = 0.006 and 1 month (p = 0.070 after treatment termination. After 10 sessions, there was a statistically significant difference between the groups in the Get-Up and Go test (p = 0.033 and Lequesne’s index (p = 0.022. Both

  9. Fragility of Results in Ophthalmology Randomized Controlled Trials: A Systematic Review.

    Science.gov (United States)

    Shen, Carl; Shamsudeen, Isabel; Farrokhyar, Forough; Sabri, Kourosh

    2017-12-11

    Evidence-based medicine is guided by our interpretation of randomized controlled trials (RCTs) that address important clinical questions. Evaluation of the robustness of statistically significant outcomes adds a crucial element to the global assessment of trial findings. The purpose of this systematic review was to determine the robustness of ophthalmology RCTs through application of the Fragility Index (FI), a novel metric of the robustness of statistically significant outcomes. Systematic review. A literature search (MEDLINE) was performed for all RCTs published in top ophthalmology journals and ophthalmology-related RCTs published in high-impact journals in the past 10 years. Two reviewers independently screened 1811 identified articles for inclusion if they (1) were a human ophthalmology-related trial, (2) had a 1:1 prospective study design, and (3) reported a statistically significant dichotomous outcome in the abstract. All relevant data, including outcome, P value, number of patients in each group, number of events in each group, number of patients lost to follow-up, and trial characteristics, were extracted. The FI of each RCT was calculated and multivariate regression applied to determine predictive factors. The 156 trials had a median sample size of 91.5 (range, 13-2593) patients/eyes, and a median of 28 (range, 4-2217) events. The median FI of the included trials was 2 (range, 0-48), meaning that if 2 non-events were switched to events in the treatment group, the result would lose its statistical significance. A quarter of all trials had an FI of 1 or less, and 75% of trials had an FI of 6 or less. The FI was less than the number of missing data points in 52.6% of trials. Predictive factors for FI by multivariate regression included smaller P value (P < 0.001), larger sample size (P = 0.001), larger number of events (P = 0.011), and journal impact factor (P = 0.029). In ophthalmology trials, statistically significant dichotomous results are often

  10. Remarks on a dynamical higher-order theory of laminated plates and its application in random vibration response

    Science.gov (United States)

    Cederbaum, G.; Librescu, L.; Elishakoff, I.

    1989-01-01

    This paper presents an analysis of the equations governing the dynamics of shear-deformable composite plates, without recourse to a variational procedure. It is noted that the operator associated with the governing equations is nonsymmetric; using a first-order perturbation technique, it is shown to be positive-definite. In addition, using the biorthogonality condition, the dynamic response of the plate is formulated.

  11. Variances in the projections, resulting from CLIMEX, Boosted Regression Trees and Random Forests techniques

    Science.gov (United States)

    Shabani, Farzin; Kumar, Lalit; Solhjouy-fard, Samaneh

    2017-08-01

    The aim of this study was to have a comparative investigation and evaluation of the capabilities of correlative and mechanistic modeling processes, applied to the projection of future distributions of date palm in novel environments and to establish a method of minimizing uncertainty in the projections of differing techniques. The location of this study on a global scale is in Middle Eastern Countries. We compared the mechanistic model CLIMEX (CL) with the correlative models MaxEnt (MX), Boosted Regression Trees (BRT), and Random Forests (RF) to project current and future distributions of date palm ( Phoenix dactylifera L.). The Global Climate Model (GCM), the CSIRO-Mk3.0 (CS) using the A2 emissions scenario, was selected for making projections. Both indigenous and alien distribution data of the species were utilized in the modeling process. The common areas predicted by MX, BRT, RF, and CL from the CS GCM were extracted and compared to ascertain projection uncertainty levels of each individual technique. The common areas identified by all four modeling techniques were used to produce a map indicating suitable and unsuitable areas for date palm cultivation for Middle Eastern countries, for the present and the year 2100. The four different modeling approaches predict fairly different distributions. Projections from CL were more conservative than from MX. The BRT and RF were the most conservative methods in terms of projections for the current time. The combination of the final CL and MX projections for the present and 2100 provide higher certainty concerning those areas that will become highly suitable for future date palm cultivation. According to the four models, cold, hot, and wet stress, with differences on a regional basis, appears to be the major restrictions on future date palm distribution. The results demonstrate variances in the projections, resulting from different techniques. The assessment and interpretation of model projections requires reservations

  12. Hypospadias repair using laser tissue soldering (LTS): preliminary results of a prospective randomized study

    Science.gov (United States)

    Kirsch, Andrew J.; Cooper, Christopher S.; Canning, Douglas A.; Snyder, Howard M., III; Zderic, Stephen A.

    1998-07-01

    Purpose: The purpose of this study was to evaluate laser tissue soldering using an 808 nm diode laser and wavelength- matched human albumin solder for urethral surgery in children. Methods: Currently, 30 boys, ages 3 months to 8 years were randomized to standard suturing (n equals 22) or 'sutureless' laser hypospadias repair (n equals 18). Laser soldering was performed with a human albumin solder doped with indocyanine green dye (2.5 mg/ml) using a laser power output of 0.5 W, pulse duration of 0.5 sec, and interval of 0.1 sec. Power density was approximately 16 W/cm2. In the laser group, sutures were used for tissue alignment only. At the time of surgery, neourethral and penile lengths, operative time for urethral repair, and number of sutures/throws were measured. Postoperatively, patients were examined for complications of wound healing, stricture, or fistula formation. Results: Mean age, severity of urethral defect, type of repair, and neourethra length were equivalent between the two groups. Operative time was significantly faster for laser soldering in both simple (1.6 plus or minus 0.21 min, p less than 0.001) and complex (5.4 plus or minus 0.28 min, p less than 0.0001) hypospadias repairs compared to controls (10.6 plus or minus 1.4 min and 27.8 plus or minus 2.9 min, respectively). The mean number of sutures used in the laser group for simple and complex repairs (3.3 plus or minus 0.3 and 8.1 plus or minus 0.64, respectively) were significantly (p less than 0.0001) less than for controls (8.2 plus or minus 0.84 and 20 plus or minus 2.3, respectively). Followup was between 3 months and 14 months. The overall complication rate in the laser group (11%) was lower than the controls (23%). However, statistical significance (p less than 0.05) was achieved only for the subgroup of patients undergoing simple repairs (LTS, 100% success versus suturing, 69% success). Conclusions: These preliminary results indicate that laser tissue soldering for hypospadias repair

  13. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial.

    Science.gov (United States)

    Cortes, Jorge E; Gambacorti-Passerini, Carlo; Deininger, Michael W; Mauro, Michael J; Chuah, Charles; Kim, Dong-Wook; Dyagil, Irina; Glushko, Nataliia; Milojkovic, Dragana; le Coutre, Philipp; Garcia-Gutierrez, Valentin; Reilly, Laurence; Jeynes-Ellis, Allison; Leip, Eric; Bardy-Bouxin, Nathalie; Hochhaus, Andreas; Brümmendorf, Tim H

    2018-01-20

    Purpose Bosutinib is a potent dual SRC/ABL kinase inhibitor approved for adults with Philadelphia chromosome-positive chronic myeloid leukemia (CML) resistant and /or intolerant to prior therapy. We assessed the efficacy and safety of bosutinib versus imatinib for first-line treatment of chronic-phase CML. Methods In this ongoing, multinational, phase III study, 536 patients with newly diagnosed chronic-phase CML were randomly assigned 1:1 to receive 400 mg of bosutinib once daily (n = 268) or imatinib (n = 268). Per protocol, efficacy was assessed in patients who were Philadelphia chromosome-positive with typical (e13a2/e14a2) transcripts (bosutinib, n = 246; imatinib, n = 241). Patients with Philadelphia chromosome-negative-/ BCR-ABL1-positive status and those with unknown Philadelphia chromosome status and/or atypical BCR-ABL1 transcript type were excluded from this population. Results The major molecular response (MMR) rate at 12 months (primary end point) was significantly higher with bosutinib versus imatinib (47.2% v 36.9%, respectively; P = .02), as was complete cytogenetic response (CCyR) rate by 12 months (77.2% v 66.4%, respectively; P = .0075). Cumulative incidence was favorable with bosutinib (MMR: hazard ratio, 1.34; P = .0173; CCyR: hazard ratio, 1.38; P bosutinib and six patients (2.5%) receiving imatinib experienced disease progression to accelerated/blast phase. Among treated patients, 22.0% of patients receiving bosutinib and 26.8% of patients receiving imatinib discontinued treatment, most commonly for drug-related toxicity (12.7% and 8.7%, respectively). Grade ≥ 3 diarrhea (7.8% v 0.8%) and increased ALT (19.0% v 1.5%) and AST (9.7% v 1.9%) levels were more common with bosutinib. Cardiac and vascular toxicities were uncommon. Conclusion Patients who received bosutinib had significantly higher rates of MMR and CCyR and achieved responses faster than those who received imatinib. Consistent with the known safety profile, GI events and

  14. Establishing optimal selenium status: results of a randomized, double-blind, placebo-controlled trial1234

    Science.gov (United States)

    Armah, Charlotte N; Dainty, Jack R; Hart, Dave J; Teucher, Birgit; Goldson, Andrew J; Broadley, Martin R; Motley, Amy K; Fairweather-Tait, Susan J

    2010-01-01

    Background: Dietary recommendations for selenium differ between countries, mainly because of uncertainties over the definition of optimal selenium status. Objective: The objective was to examine the dose-response relations for different forms of selenium. Design: A randomized, double-blind, placebo-controlled dietary intervention was carried out in 119 healthy men and women aged 50–64 y living in the United Kingdom. Daily placebo or selenium-enriched yeast tablets containing 50, 100, or 200 μg Se (≈60% selenomethionine), selenium-enriched onion meals (≈66% γ-glutamyl-methylselenocysteine, providing the equivalent of 50 μg Se/d), or unenriched onion meals were consumed for 12 wk. Changes in platelet glutathione peroxidase activity and in plasma selenium and selenoprotein P concentrations were measured. Results: The mean baseline plasma selenium concentration for all subjects was 95.7 ± 11.5 ng/mL, which increased significantly by 10 wk to steady state concentrations of 118.3 ± 13.1, 152.0 ± 24.3, and 177.4 ± 26.3 ng/mL in those who consumed 50, 100, or 200 μg Se-yeast/d, respectively. Platelet glutathione peroxidase activity did not change significantly in response to either dose or form of selenium. Selenoprotein P increased significantly in all selenium intervention groups from an overall baseline mean of 4.99 ± 0.80 μg/mL to 6.17 ± 0.85, 6.73 ± 1.01, 6.59 ± 0.64, and 5.72 ± 0.75 μg/mL in those who consumed 50, 100, or 200 μg Se-yeast/d and 50 μg Se-enriched onions/d, respectively. Conclusions: Plasma selenoprotein P is a useful biomarker of status in populations with relatively low selenium intakes because it responds to different dietary forms of selenium. To optimize the plasma selenoprotein P concentration in this study, 50 μg Se/d was required in addition to the habitual intake of ≈55 μg/d. In the context of established relations between plasma selenium and risk of cancer and mortality, and recognizing the important functions of

  15. Caries management strategies for primary molars: 1-yr randomized control trial results.

    Science.gov (United States)

    Santamaria, R M; Innes, N P T; Machiulskiene, V; Evans, D J P; Splieth, C H

    2014-11-01

    Minimal invasive approaches to managing caries, such as partial caries removal techniques, are showing increasing evidence of improved outcomes over the conventional complete caries removal. There is also increasing interest in techniques where no caries is removed. We present the 1-yr results of clinical efficacy for 3 caries management options for occlusoproximal cavitated lesions in primary molars: conventional restorations (CR; complete caries removal and compomer restoration), Hall technique (HT; no caries removal, sealing in with stainless steel crowns), and nonrestorative caries treatment (NRCT; no caries removal, opening up the cavity, teaching brushing and fluoride application). In sum, 169 children (3-8 yr old; mean, 5.56 ± 1.45 yr) were enrolled in this secondary care-based, 3-arm, parallel-group, randomized clinical trial. Treatments were carried out by specialist pediatric dentists or postgraduate trainees. One lesion per child received CR, HT, or NRCT. Outcome measures were clinical failure rates, grouped as minor failure (restoration loss/need for replacement, reversible pulpitis, caries progression, etc.) and major failure (irreversible pulpitis, abscess, etc.). There were 148 children (87.6%) with a minimum follow-up of 11 mo (mean, 12.23 ± 0.98 mo). Twenty teeth were recorded as having at least 1 minor failure: NRCT, n = 8 (5%); CR, n = 11 (7%); HT, n = 1 (1%) (p = .002, 95% CI = 0.001 to 0.003). Only the comparison between NRCT and CR showed no significant difference (p = .79, 95% CI = 0.78 to 0.80). Nine (6%) experienced at least 1 major failure: NRCT, n = 4 (2%); CR, n = 5 (3%); HT, n = 0 (0%) (p = .002, 95% CI = 0.001 to 0.003). Individual comparison of NRCT and CR showed no statistically significant difference in major failures (p = .75, 95% CI = 0.73 to 0.76). Success and failure rates were not significantly affected by pediatric dentists' level of experience (p = .13, 95% CI = 0.12 to 0.14). The HT was significantly more successful

  16. Blast-cooling of beef-in-sauce catering meals: numerical results based on a dynamic zero-order model

    Directory of Open Access Journals (Sweden)

    Jose A. Rabi

    2014-10-01

    Full Text Available Beef-in-sauce catering meals under blast-cooling have been investigated in a research project which aims at quantitative HACCP (hazard analysis critical control point. In view of its prospective coupling to a predictive microbiology model proposed in the project, zero-order spatial dependence has proved to suitably predict meal temperatures in response to temperature variations in the cooling air. This approach has modelled heat transfer rates via the a priori unknown convective coefficient hc which is allowed to vary due to uncertainty and variability in the actual modus operandi of the chosen case study hospital kitchen. Implemented in MS Excel®, the numerical procedure has successfully combined the 4th order Runge-Kutta method, to solve the governing equation, with non-linear optimization, via the built-in Solver, to determine the coefficient hc. In this work, the coefficient hc was assessed for 119 distinct recently-cooked meal samples whose temperature-time profiles were recorded in situ after 17 technical visits to the hospital kitchen over a year. The average value and standard deviation results were hc = 12.0 ± 4.1 W m-2 K-1, whilst the lowest values (associated with the worst cooling scenarios were about hc » 6.0 W m-2 K-1.

  17. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Meisel, S.F.; Beeken, R.J.; Jaarsveld, C.H.M. van; Wardle, J.

    2015-01-01

    OBJECTIVE: To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. METHODS: Individually randomized controlled trial comparing the effect of: (i) simple weight

  18. Results of artificial insemination at home by the partner with cryopreserved donor semen: a randomized study

    NARCIS (Netherlands)

    Hogerzeil, H. V.; Hamerlynck, J. V.; van Amstel, N.; Nagelkerke, N. J.; Lammes, F. B.

    1988-01-01

    The use of cryopreserved semen offers the possibility of home insemination by the instructed partner. A comparative study was designed whereby participants were randomly allocated to use home or clinic insemination for six cycles. If no pregnancy had occurred after six cycles, the site of

  19. Mass Azithromycin and Malaria Parasitemia in Niger: Results from a Community-Randomized Trial.

    Science.gov (United States)

    O'Brien, Kieran S; Cotter, Sun Y; Amza, Abdou; Kadri, Boubacar; Nassirou, Baido; Stoller, Nicole E; Zhou, Zhaoxia; Cotter, Chris; West, Sheila K; Bailey, Robin L; Rosenthal, Philip J; Gaynor, Bruce D; Porco, Travis C; Lietman, Thomas M

    2017-09-01

    Studies designed to determine the effects of mass administration of azithromycin on trachoma have suggested that mass azithromycin distributions may also reduce the prevalence of malaria. These studies have typically examined the impact of a small number of treatments over short durations. In this prespecified substudy of a cluster-randomized trial for trachoma, we compared malaria parasitemia prevalence in 24 communities in Niger randomized to receive either annual or biannual mass azithromycin distributions over 3 years. The 12 communities randomized to annual azithromycin received three treatments during the high-transmission season, and the 12 communities randomized to biannual azithromycin received a total of six treatments: three during the high-transmission season and three during the low-transmission season. Blood samples were taken to assess malariometric indices among children in all study communities at a single time point during the high-transmission season after 3 years of the intervention. No significant differences were identified in malaria parasitemia, parasite density, or hemoglobin concentration between the annual and biannual treatment arms. When compared with annual mass azithromycin alone, additional mass azithromycin distributions given during the low-transmission season did not significantly reduce the subsequent prevalence of malaria parasitemia or parasite density after 3 years, as measured during the high-transmission season.

  20. Enhancing Attachment Organization among Maltreated Children: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Bernard, Kristin; Dozier, Mary; Bick, Johanna; Lewis-Morrarty, Erin; Lindhiem, Oliver; Carlson, Elizabeth

    2012-01-01

    Young children who have experienced early adversity are at risk for developing disorganized attachments. The efficacy of Attachment and Biobehavioral Catch-up (ABC), an intervention targeting nurturing care among parents identified as being at risk for neglecting their young children, was evaluated through a randomized clinical trial. Attachment…

  1. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    Science.gov (United States)

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  2. Pharmacokinetics of oral hydrocortisone : Results and implications from a randomized controlled trial

    NARCIS (Netherlands)

    Werumeus Buning, Jorien; Touw, Daan J; Brummelman, Pauline; Dullaart, Robin P F; van den Berg, Gerrit; van der Klauw, Melanie M; Kamp, Jasper; Wolffenbuttel, Bruce H R; van Beek, André P

    CONTEXT AND OBJECTIVE: This study aimed at comparing pharmacokinetics of two different doses of hydrocortisone (HC) in patients with secondary adrenal insufficiency (SAI). DESIGN, SETTING AND PATIENTS: Forty-six patients with SAI participated in this randomized double-blind crossover study.

  3. Recidivism among Child Sexual Abusers: Initial Results of a 13-Year Longitudinal Random Sample

    Science.gov (United States)

    Patrick, Steven; Marsh, Robert

    2009-01-01

    In the initial analysis of data from a random sample of all those charged with child sexual abuse in Idaho over a 13-year period, only one predictive variable was found that related to recidivism of those convicted. Variables such as ethnicity, relationship, gender, and age differences did not show a significant or even large association with…

  4. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial

    NARCIS (Netherlands)

    Scheltens, P.; Twisk, J.W.; Blesa, R.; Scarpini, E.; von Arnim, C.A.F.; Bongers, A.; Harrison, J.; Swinkels, S.H.N.; Stam, C.J.; de Waal, H.; Wurtman, R.J.; Wieggers, R.L.; Vellas, B.; Kamphuis, P.J.G.H.

    2012-01-01

    Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind,

  5. Preferred mesh-based inguinal hernia repair in a teaching setting: results of a randomized study.

    NARCIS (Netherlands)

    Nienhuijs, S.W.; Kortmann, B.B.M.; Boerma, M.; Strobbe, L.J.; Rosman, C.

    2004-01-01

    HYPOTHESIS: Surgeons' preferences for any of 3 methods of inguinal hernia repair are comparable in terms of operating time, incision length, perceived difficulty, and surgeon's satisfaction. DESIGN: Randomized patient-blinded study. SETTING: Teaching hospital. PATIENTS: A total of 334 patients

  6. Laboratory test ordering and results management systems: a qualitative study of safety risks identified by administrators in general practice.

    Science.gov (United States)

    Bowie, Paul; Halley, Lyn; McKay, John

    2014-02-06

    To explore experiences and perceptions of frontline administrators involved in the systems-based management of laboratory test ordering and results handling in general medical practice. Qualitative using focus group interviews. West of Scotland general medical practices in three National Health Service (NHS) territorial board areas. Convenience samples of administrators (receptionists, healthcare assistants and phlebotomists). Transcript data were subjected to content analysis. A total of 40 administrative staff were recruited. Four key themes emerged: (1) system variations and weaknesses (eg, lack of a tracking process is a known risk that needs to be addressed). (2) Doctor to administrator communication (eg, unclear information can lead to emotional impacts and additional workload). (3) Informing patients of test results (eg, levels of anxiety and uncertainty are experienced by administrators influenced by experience and test result outcome) and (4) patient follow-up and confidentiality (eg, maintaining confidentiality in a busy reception area can be challenging). The key findings were explained in terms of sociotechnical systems theory. The study further confirms the safety-related problems associated with results handling systems and adds to our knowledge of the communication and psychosocial issues that can affect the health and well-being of staff and patients alike. However, opportunities exist for practices to identify barriers to safe care, and plan and implement system improvements to accommodate or mitigate the potential for human error in this complex area.

  7. Midpalatal implants vs headgear for orthodontic anchorage - a randomized clinical trial: Cephalometric results\\ud

    OpenAIRE

    Benson, P.E.; Tinsley, D.; O'Dwyer, J.J; Majumdar, A.; Doyle, P.; Sandler, P.J.

    2007-01-01

    OBJECTIVE: To compare the clinical effectiveness of the mid-palatal implant as a method of reinforcing anchorage during orthodontic treatment with that of conventional extra-oral anchorage.\\ud \\ud DESIGN: A prospective, randomized, clinical trial\\ud Setting: Chesterfield and North Derbyshire Royal Hospital NHS Trust and the Charles Clifford Dental Hospital, Sheffield.\\ud \\ud SUBJECTS AND METHODS: 51 orthodontic patients between the ages of 12 and 39, with a class II division 1 malocclusion an...

  8. Social Cognitive Mediators of Adolescent Smoking Cessation: Results from a Large Randomized Intervention Trial

    OpenAIRE

    Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.

    2010-01-01

    Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervent...

  9. Two-year results of microcatheter-assisted trabeculotomy in paediatric glaucoma: a randomized controlled study.

    Science.gov (United States)

    El Sayed, Yasmine; Gawdat, Ghada

    2017-12-01

    To compare the outcomes of microcatheter-assisted circumferential trabeculotomy to standard rigid probe trabeculotomy in childhood glaucomas. Eyes of children requiring trabeculotomy for primary congenital or secondary paediatric glaucoma were randomized to undergo either trabeculotomy using the Glaucolight illuminated microcatheter, or a rigid probe trabeculotomy. Complete success was defined as an intraocular pressure (IOP) of glaucoma. The need for reoperation for glaucoma was significantly lower in the microcatheter group. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  10. Cost-effectiveness of family psychoeducation to prevent relapse in major depression: Results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shimodera Shinji

    2012-05-01

    Full Text Available Abstract Background Family psychoeducation is a relatively simple and straightforward intervention whose prophylactic effectiveness and cost-effectiveness is well-established for schizophrenia. We have recently demonstrated its effectiveness for unipolar depression, but its cost-effectiveness has never been examined. We hereby report a cost-effectiveness analysis alongside a randomized controlled trial in order to assess its cost-effectiveness for preventing relapse/recurrence in depression. Methods Fifty-seven patients diagnosed with major depression and undergoing its maintenance treatment, and their primary family members were randomized to treatment as usual (TAU only or to TAU plus family psychoeducation, which consisted of four 2-hour multiple-family sessions consisting of didactic lectures about depression (30 minutes and group discussion and problem solving (60–90 minutes. The economic analyses were undertaken from the perspective of the National Health Insurance (NHI, assuming the most reasonable price of US$50 per psychoeducation session per patient. The main outcome measures included relapse-free days and direct costs to the NHI. Results The intervention group enjoyed 272 (SD: 7.1 relapse-free days, while the control group spent 214 (SD: 90.8 relapse-free days (Cox proportional hazard ratio = 0.17, 95%CI: 0.04 to 0.75, p = 0.002. Cost-effectiveness acceptability curves suggested that the family psychoeducation has 90% or more chances of being cost-effective if the decision-maker is prepared to pay US$20 for one additional relapse-free day. This cost-effectiveness finding was robust when the price for family psychoeducation ranged between 50% to 150% of the baseline scenario in sensitivity analyses. If a relapse-free day is considered to be worth $30 or more, all the pricing scenarios have a close to 100% probability of being cost-effective. Conclusion Family psychoeducation is effective in the relapse prevention of

  11. Higher order optical aberrations and visual acuity in a randomized controlled trial comparing transepithelial versus epithelium-off corneal crosslinking for progressive keratoconus

    Directory of Open Access Journals (Sweden)

    Godefrooij DA

    2017-10-01

    Full Text Available Daniel A Godefrooij, Mustapha El Kandoussi, Nienke Soeters, Robert PL Wisse Utrecht Cornea Research Group, Department of Ophthalmology, University Medical Center Utrecht, Utrecht, the Netherlands Purpose: The purpose of this study was to compare the effects of transepithelial crosslinking (trans-CXL versus epithelium-off crosslinking (epi-off CXL for progressive keratoconus with respect to the development of higher order aberrations (HOAs and their effects on visual acuity.Materials and methods: A total of 61 patients were randomized and examined preoperatively and 1, 3, 6, and 12 months postoperatively in an academic referral center. Total corneal HOAs were compared between the two treatment groups using mixed linear modeling. Types of HOAs (coma, trefoil, and spherical aberration that differed between groups were entered in a multivariable analysis to test their effect on uncorrected distance visual acuity (UDVA and corrected distance visual acuity (CDVA.Results: The epi-off CXL group had more flattening in maximal keratometry compared to the trans-CXL group (P=0.02. UDVA did not differ significantly between the groups (P=0.59; however, CDVA was significantly more improved in the trans-CXL group (P=0.02. Horizontal trefoil improved more in the epi-off group compared to the trans-CXL group (P=0.04, whereas the other HOAs were virtually unchanged in both groups. Differences in changes in HOAs between the two groups had no effect on either UCVA (P=0.76 or CDVA (P=0.96.Conclusion: Although HOAs are clinically relevant determinants of vision quality in keratoconus patients, the change in total HOAs post treatment did not differ between the trans-CXL and epi-off CXL groups. Only horizontal trefoil differed significantly post treatment between the trans-CXL and epi-off CXL groups. However, this difference did not independently affect either UDVA or CDVA. Trans-CXL provides no benefit over epi-off CXL regarding visual relevant HOAs. Keywords

  12. Order-parameter fluctuations (OPF) in spin glasses: Monte Carlo simulations and exact results for small sizes

    Science.gov (United States)

    Picco, M.; Ritort, F.; Sales, M.

    The use of parameters measuring order-parameter fluctuations (OPF) has been encouraged by the recent results reported in referenece [2,3] which show that two of these parameters, G and Gc, take universal values in the . In this paper we present a detailed study of parameters measuring OPF for two mean-field models with and without time-reversal symmetry which exhibit different patterns of replica symmetry breaking below the transition: the Sherrington-Kirkpatrick model with and without a field and the Ising p-spin glass (p = 3). We give numerical results and analyze the consequences which replica equivalence imposes on these models in the infinite volume limit. We give evidence for the transition in each system and discuss the character of finite-size effects. Furthermore, a comparative study between this new family of parameters and the usual Binder cumulant analysis shows what kind of new information can be extracted from the finite T behavior of these quantities. The two main outcomes of this work are: 1) Parameters measuring OPF give better estimates than the Binder cumulant for Tc and even for very small systems they give evidence for the transition. 2) For systems with no time-reversal symmetry, parameters defined in terms of connected quantities are the proper ones to look at.

  13. Statin Effects on Aggression: Results from the UCSD Statin Study, a Randomized Control Trial

    Science.gov (United States)

    Golomb, Beatrice A.; Dimsdale, Joel E.; Koslik, Hayley J.; Evans, Marcella A.; Lu, Xun; Rossi, Steven; Mills, Paul J.; Criqui, Michael H.

    2015-01-01

    Background Low/ered cholesterol is linked to aggression in some study designs. Cases/series have reported reproducible aggression increases on statins, but statins also bear mechanisms that could reduce aggression. Usual statin effects on aggression have not been characterized. Methods 1016 adults (692 men, 324 postmenopausal women) underwent double-blind sex-stratified randomization to placebo, simvastatin 20mg, or pravastatin 40mg (6 months). The Overt-Aggression-Scale-Modified–Aggression-Subscale (OASMa) assessed behavioral aggression. A significant sex-statin interaction was deemed to dictate sex-stratified analysis. Exploratory analyses assessed the influence of baseline-aggression, testosterone-change (men), sleep and age. Results The sex-statin interaction was significant (P=0.008). In men, statins tended to decrease aggression, significantly so on pravastatin: difference=-1.0(SE=0.49)P=0.038. Three marked outliers (OASMa-change ≥40 points) offset otherwise strong significance-vs-placebo: statins:-1.3(SE=0.38)P=0.0007; simvastatin:-1.4(SE=0.43)P=0.0011; pravastatin:-1.2(SE=0.45)P=0.0083. Age≤40 predicted greater aggression-decline on statins: difference=-1.4(SE=0.64)P=0.026. Aggression-protection was emphasized in those with low baseline aggression: ageaggression (N=40) statin-difference-vs-placebo=-2.4(SE=0.71)P=0.0016. Statins (especially simvastatin) lowered testosterone, and increased sleep problems. Testosterone-drop on statins predicted aggression-decline: β=0.64(SE=0.30)P=0.034, particularly on simvastatin: β=1.29(SE=0.49)P=0.009. Sleep-worsening on statins significantly predicted aggression-increase: β=2.2(SE=0.55)Paggression-increase on statins became significant with exclusion of one younger, surgically-menopausal woman (N=310) β=0.70(SE=0.34)P=0.039. The increase was significant, without exclusions, for women of more typical postmenopausal age (≥45): (N=304) β=0.68(SE=0.34)P=0.048 – retaining significance with modified age

  14. A cluster randomized controlled trial aimed at implementation of local quality improvement collaboratives to improve prescribing and test ordering performance of general practitioners: Study Protocol

    Directory of Open Access Journals (Sweden)

    Winkens Ron

    2009-02-01

    Full Text Available Abstract Background The use of guidelines in general practice is not optimal. Although evidence-based methods to improve guideline adherence are available, variation in physician adherence to general practice guidelines remains relatively high. The objective for this study is to transfer a quality improvement strategy based on audit, feedback, educational materials, and peer group discussion moderated by local opinion leaders to the field. The research questions are: is the multifaceted strategy implemented on a large scale as planned?; what is the effect on general practitioners' (GPs test ordering and prescribing behaviour?; and what are the costs of implementing the strategy? Methods In order to evaluate the effects, costs and feasibility of this new strategy we plan a multi-centre cluster randomized controlled trial (RCT with a balanced incomplete block design. Local GP groups in the south of the Netherlands already taking part in pharmacotherapeutic audit meeting groups, will be recruited by regional health officers. Approximately 50 groups of GPs will be randomly allocated to two arms. These GPs will be offered two different balanced sets of clinical topics. Each GP within a group will receive comparative feedback on test ordering and prescribing performance. The feedback will be discussed in the group and working agreements will be created after discussion of the guidelines and barriers to change. The data for the feedback will be collected from existing and newly formed databases, both at baseline and after one year. Discussion We are not aware of published studies on successes and failures of attempts to transfer to the stakeholders in the field a multifaceted strategy aimed at GPs' test ordering and prescribing behaviour. This pragmatic study will focus on compatibility with existing infrastructure, while permitting a certain degree of adaptation to local needs and routines. Trial registration Nederlands Trial Register ISRCTN40008171

  15. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    Full Text Available Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS. We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74 vs. active control (n = 61 training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30, despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006. This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction.Clinicaltrials.gov NCT02141386.

  16. Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial.

    Science.gov (United States)

    Charvet, Leigh E; Yang, Jie; Shaw, Michael T; Sherman, Kathleen; Haider, Lamia; Xu, Jianjin; Krupp, Lauren B

    2017-01-01

    Cognitive impairment affects more than half of all individuals living with multiple sclerosis (MS). We hypothesized that training at home with an adaptive online cognitive training program would have greater cognitive benefit than ordinary computer games in cognitively-impaired adults with MS. This was a double-blind, randomized, active-placebo-controlled trial. Participants with MS were recruited through Stony Brook Medicine and randomly assigned to either the adaptive cognitive remediation (ACR) program or active control of ordinary computer games for 60 hours over 12 weeks. Training was remotely-supervised and delivered through a study-provided laptop computer. A computer generated, blocked stratification table prepared by statistician provided the randomization schedule and condition was assigned by a study technician. The primary outcome, administered by study psychometrician, was measured by change in a neuropsychological composite measure from baseline to study end. An intent-to-treat analysis was employed and missing primary outcome values were imputed via Markov Chain Monte Carlo method. Participants in the ACR (n = 74) vs. active control (n = 61) training program had significantly greater improvement in the primary outcome of cognitive functioning (mean change in composite z score±SD: 0·25±0·45 vs. 0·09±0·37, p = 0·03, estimated difference = 0·16 with 95% CI: 0·02-0·30), despite greater training time in the active control condition (mean±SD:56·9 ± 34·6 vs. 37·7 ±23 ·8 hours played, p = 0·006). This study provides Class I evidence that adaptive, computer-based cognitive remediation accessed from home can improve cognitive functioning in MS. This telerehabilitation approach allowed for rapid recruitment and high compliance, and can be readily applied to other neurological conditions associated with cognitive dysfunction. Clinicaltrials.gov NCT02141386.

  17. Decreasing Divorce in Army Couples: Results from a Randomized Controlled Trial using PREP for Strong Bonds.

    Science.gov (United States)

    Stanley, Scott M; Allen, Elizabeth S; Markman, Howard J; Rhoades, Galena K; Prentice, Donnella L

    2010-04-01

    Findings from a large, randomized controlled trial of couple education are presented in this brief report. Married Army couples were assigned to either PREP for Strong Bonds (n = 248) delivered by Army chaplains or to a no-treatment control group (n = 228). One year after the intervention, couples who received PREP for Strong Bonds had 1/3 the rate of divorce of the control group. Specifically, 6.20% of the control group divorced while 2.03% of the intervention group divorced. These findings suggest that couple education can reduce the risk of divorce, at least in the short run with military couples.

  18. Decreasing Divorce in Army Couples: Results from a Randomized Controlled Trial using PREP for Strong Bonds

    Science.gov (United States)

    Stanley, Scott M.; Allen, Elizabeth S.; Markman, Howard J.; Rhoades, Galena K.; Prentice, Donnella L.

    2010-01-01

    Findings from a large, randomized controlled trial of couple education are presented in this brief report. Married Army couples were assigned to either PREP for Strong Bonds (n = 248) delivered by Army chaplains or to a no-treatment control group (n = 228). One year after the intervention, couples who received PREP for Strong Bonds had 1/3 the rate of divorce of the control group. Specifically, 6.20% of the control group divorced while 2.03% of the intervention group divorced. These findings suggest that couple education can reduce the risk of divorce, at least in the short run with military couples. PMID:20634994

  19. Week 96 results of the randomized, multicentre Maraviroc Switch (MARCH) study.

    Science.gov (United States)

    Pett, S L; Amin, J; Horban, A; Andrade-Villanueva, J; Losso, M; Porteiro, N; Madero, J S; Belloso, W; Tu, E; Silk, D; Kelleher, A; Harrigan, R; Clark, A; Sugiura, W; Wolff, M; Gill, J; Gatell, J; Clarke, A; Ruxrungtham, K; Prazuck, T; Kaiser, R; Woolley, I; Alberto Arnaiz, J; Cooper, D; Rockstroh, J K; Mallon, P; Emery, S

    2018-01-01

    The Maraviroc Switch (MARCH) study week 48 data demonstrated that maraviroc, a chemokine receptor-5 (CCR5) inhibitor, was a safe and effective switch for the ritonavir-boosted protease inhibitor (PI/r) component of a two nucleos(t)ide reverse transcriptase inhibitor [N(t)RTI] plus PI/r-based antiretroviral regimen in patients with R5-tropic virus. Here we report the durability of this finding. MARCH, an international, multicentre, randomized, 96-week open-label switch study, enrolled HIV-1-infected adults with R5-tropic virus who were stable (> 24 weeks) and virologically suppressed [plasma viral load (pVL) < 50 HIV-1 RNA copies/mL]. Participants were randomized to continue their current PI/r-based regimen (PI/r) or to switch to MVC plus two N(t)RTIs (MVC) (1:2 randomization). The primary endpoint was the difference in the proportion with pVL < 200 copies/mL at 96 weeks. The switch arm was defined as noninferior if the lower limit of the 95% confidence interval (CI) for the difference was < -12% in the intention-to-treat (ITT) population. Safety endpoints (the difference in the mean change from baseline or a comparison of proportions) were analysed as key secondary endpoints. Eighty-two (PI/r) and 156 (MVC) participants were randomized and included in the ITT analysis; 71 (87%) and 130 (83%) were in follow-up and on therapy at week 96. At week 96, 89.0% and 90.4% in the PI/r and MVC arms, respectively, had pVL < 50 copies/mL (95% CI -6.6, 10.2). Moreover, in those switching away from PI/r, there were significant reductions in mean total cholesterol (differences 0.31 mmol/L; P = 0.02) and triglycerides (difference 0.44 mmol/L; P < 0.001). Changes in CD4 T-cell count, renal function, and serious and nonserious adverse events were similar in the two arms. MVC as a switch for a PI/r is safe and effective at maintaining virological suppression while having significant lipid benefits over 96 weeks. © 2017 British HIV Association.

  20. Efficacy of an internet-based problem-solving training for teachers: results of a randomized controlled trial

    NARCIS (Netherlands)

    Ebert, D.D.; Lehr, D.; BoB, L.; Riper, H.; Cuijpers, P.; Andersson, G.; Thiart, H.; Heber, E.; Berking, M.

    2014-01-01

    Objective The primary purpose of this randomized controlled trial (RCT) was to evaluate the efficacy of internet-based problem-solving training (iPST) for employees in the educational sector (teachers) with depressive symptoms. The results of training were compared to those of a waitlist control

  1. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial.

    NARCIS (Netherlands)

    Hartgrink, H.H.; Velde, C.J. van de; Putter, H.; Bonenkamp, J.J.; Meershoek-Klein Kranenbarg, E.; Songun, I.; Welvaart, K.; Krieken, J.H.J.M. van; Meijer, S.; Plukker, J.T.; Elk, P.J. van; Obertop, H.; Gouma, D.J.; Lanschot, J.J.B. van; Taat, C.W.; Graaf, P.W. de; Meyenfeldt, M.F. von; Tilanus, H.W.; Sasako, M.

    2004-01-01

    PURPOSE: The extent of lymph node dissection appropriate for gastric cancer is still under debate. We have conducted a randomized trial to compare the results of a limited (D1) and extended (D2) lymph node dissection in terms of morbidity, mortality, long-term survival and cumulative risk of

  2. Extended lymph node dissection for gastric cancer : Who may benefit? Final results of the randomized Dutch Gastric Cancer Group Trial

    NARCIS (Netherlands)

    Hartgrink, HH; van de Velde, CJH; Putter, H; Bonenkamp, JJ; Kranenbarg, EK; Songun, [No Value; Welvaart, K; van Krieken, JHJM; Meijer, S; Plukker, JTM; van Elk, PJ; Obertop, H; Gouma, DJ; van Lanschot, JJB; Taat, CW; de Graaf, PW; von Meyenfeldt, MF; Tilanus, H; Sasako, M

    2004-01-01

    Purpose. The extent of lymph node dissection appropriate for gastric cancer is still under debate. We have conducted a randomized trial to compare the results of a limited (D1) and extended (D2) lymph node dissection in terms of morbidity, mortality, long-term survival and cumulative risk of

  3. Yoga of Awareness program for menopausal symptoms in breast cancer survivors: results from a randomized trial.

    Science.gov (United States)

    Carson, James W; Carson, Kimberly M; Porter, Laura S; Keefe, Francis J; Seewaldt, Victoria L

    2009-10-01

    Breast cancer survivors have limited options for the treatment of hot flashes and related symptoms. Further, therapies widely used to prevent recurrence in survivors, such as tamoxifen, tend to induce or exacerbate menopausal symptoms. The aim of this preliminary, randomized controlled trial was to evaluate the effects of a yoga intervention on menopausal symptoms in a sample of survivors of early-stage breast cancer (stages IA-IIB). Thirty-seven disease-free women experiencing hot flashes were randomized to the 8-week Yoga of Awareness program (gentle yoga poses, meditation, and breathing exercises) or to wait-list control. The primary outcome was daily reports of hot flashes collected at baseline, posttreatment, and 3 months after treatment via an interactive telephone system. Data were analyzed by intention to treat. At posttreatment, women who received the yoga program showed significantly greater improvements relative to the control condition in hot-flash frequency, severity, and total scores and in levels of joint pain, fatigue, sleep disturbance, symptom-related bother, and vigor. At 3 months follow-up, patients maintained their treatment gains in hot flashes, joint pain, fatigue, symptom-related bother, and vigor and showed additional significant gains in negative mood, relaxation, and acceptance. This pilot study provides promising support for the beneficial effects of a comprehensive yoga program for hot flashes and other menopausal symptoms in early-stage breast cancer survivors.

  4. A randomized clinical trial on the sealing of occlusal carious lesions: 3–4-year results

    Directory of Open Access Journals (Sweden)

    Luana Severo ALVES

    2017-06-01

    Full Text Available Abstract This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8–43 years (median: 19 years. The inclusion criteria comprised the presence of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28 or restorative treatment (n = 26. Clinical and radiographic examinations were performed after 1 year and after 3–4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1 needed repair, and 1 showed caries progression, totaling 4 failures in the sealant group. In the restoration group, 1 failure was observed (in need of repair. The success rates were 76% and 94% in the sealant and the restoration groups, respectively (p > 0.05. The sealing of occlusal carious lesions in permanent teeth succeeded in controlling caries over a 3–4-year period. However, sealed carious lesions require patient compliance in attending regular follow-ups to control the occurrence of clinical failures of the sealants.

  5. Apathy in nursing home residents with dementia: results from a cluster-randomized controlled trial.

    Science.gov (United States)

    Treusch, Y; Majic, T; Page, J; Gutzmann, H; Heinz, A; Rapp, M A

    2015-02-01

    Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy. A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n=117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months. We found significant group differences with respect to apathy during the 10 month intervention period (F2,82=7.79, Papathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P=0.55). Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  6. TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial.

    Science.gov (United States)

    Valpas, A; Ala-Nissilä, S; Tomas, E; Nilsson, C G

    2015-01-01

    Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the "gold standard" procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM). A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score. Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %). By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

  7. Virtual reality training improves operating room performance: results of a randomized, double-blinded study.

    Science.gov (United States)

    Seymour, Neal E; Gallagher, Anthony G; Roman, Sanziana A; O'Brien, Michael K; Bansal, Vipin K; Andersen, Dana K; Satava, Richard M

    2002-10-01

    To demonstrate that virtual reality (VR) training transfers technical skills to the operating room (OR) environment. The use of VR surgical simulation to train skills and reduce error risk in the OR has never been demonstrated in a prospective, randomized, blinded study. Sixteen surgical residents (PGY 1-4) had baseline psychomotor abilities assessed, then were randomized to either VR training (MIST VR simulator diathermy task) until expert criterion levels established by experienced laparoscopists were achieved (n = 8), or control non-VR-trained (n = 8). All subjects performed laparoscopic cholecystectomy with an attending surgeon blinded to training status. Videotapes of gallbladder dissection were reviewed independently by two investigators blinded to subject identity and training, and scored for eight predefined errors for each procedure minute (interrater reliability of error assessment r > 0.80). No differences in baseline assessments were found between groups. Gallbladder dissection was 29% faster for VR-trained residents. Non-VR-trained residents were nine times more likely to transiently fail to make progress (P trained group (1.19 vs. 7.38 errors per case; P training skills from VR to OR sets the stage for more sophisticated uses of VR in assessment, training, error reduction, and certification of surgeons.

  8. Midpalatal implants vs headgear for orthodontic anchorage--a randomized clinical trial: cephalometric results.

    Science.gov (United States)

    Benson, Philip E; Tinsley, David; O'Dwyer, Jonathan J; Majumdar, Arun; Doyle, Peter; Sandler, P Jonathan

    2007-11-01

    The purpose of this study was to compare the clinical effectiveness of the midpalatal implant as a method of reinforcing anchorage during orthodontic treatment with that of conventional extraoral anchorage. This was a prospective, randomized, clinical trial at Chesterfield and North Derbyshire Royal Hospital NHS Trust and the Charles Clifford Dental Hospital, Sheffield, in the United Kingdom. Fifty-one orthodontic patients between the ages of 12 and 39, with Class II Division 1 malocclusion and absolute anchorage requirements, were randomly allocated to receive either a midpalatal implant or headgear to reinforce orthodontic anchorage. The main outcome was to compare the mesial movement of the molars and the incisors of the 2 treatment groups between the start and the end of anchorage reinforcement as measured from cephalometric radiographs. The reproducibility of the measuring technique was acceptable. There were significant differences between T1 and T2 in the implant group for the positions of the maxillary central incisor (P mandibular molar (P mandibular central incisor (P mandibular molar (P skeletal and dental points moved mesially more in the headgear group during treatment than in the implant group. These ranged from an average of 0.5 mm more mesially for the mandibular permanent molar to 1.5 mm more mesially for the maxillary molar and the mandibular base. No treatment changes between the groups were statistically significant. Midpalatal implants are an acceptable technique for reinforcing anchorage in orthodontic patients.

  9. Results of an Active Neurodynamic Mobilization Program in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Torres, Janet Rodríguez; Martos, Irene Cabrera; Sánchez, Irene Torres; Rubio, Araceli Ortíz; Pelegrina, Ana Díaz; Valenza, Marie Carmen

    2015-10-01

    To examine the effects of an active neurodynamic mobilization program on pain, neurodynamics, perceived health state, and fatigue in patients with fibromyalgia syndrome (FMS). Randomized controlled trial. Local fibromyalgia association. Patients with FMS (N=48). Patients were randomly allocated to an active neurodynamic mobilization program or a control group. The intervention was performed twice a week. Pain was assessed with the Brief Pain Inventory and Pain Catastrophizing Scale; neurodynamics were evaluated using neurodynamic tests for upper and lower limbs. The functional state was evaluated with the Health Assessment Questionnaire Disability Index, and perceived fatigue was evaluated with the Fatigue Severity Scale. Significant (Pneurodynamics, functional state, and fatigue. Also, significant pre- to postintervention within-group differences were found in the intervention group, whereas no significant changes were found in the control group. A neurodynamic mobilization program is effective in improving pain, neurodynamics, functional status, and fatigue in patients with FMS. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. Adolescents' impressions of antismoking media literacy education: qualitative results from a randomized controlled trial.

    Science.gov (United States)

    Primack, Brian A; Fine, Danielle; Yang, Christopher K; Wickett, Dustin; Zickmund, Susan

    2009-08-01

    Although media literacy represents an innovative venue for school-based antismoking programming, studies have not systematically compared student impressions of these and traditional programs. This study utilized data from a randomized trial comparing these two types of programs. After each program, students responded to three open-ended questions related to their assigned curriculum. Two coders, blinded to student assignments, independently coded these data. Coders had strong inter-rater agreement (kappa = 0.77). Our primary measures were spontaneously noted overall assessment, enjoyment/interest and the likelihood of changing smoking behavior. Of the 531 participants, 255 (48.0%) were randomized to the intervention (media literacy) group. Intervention participants had more net positive responses [rate ratio (RR) = 1.27, 95% confidence interval (CI) = 1.05, 1.54], more responses rating the program as compelling (RR = 1.63, 95% CI = 1.16, 2.29) and fewer responses rating the program as non-compelling (RR = 0.62, 95% CI = 0.39, 0.97). However, the intervention group was not more likely to suggest that the curriculum was likely to change behavior positively (RR = 0.57, 95% CI = 0.30, 1.06). Findings suggest that although media literacy provides a compelling format for the delivery of anti-tobacco programming, integration of components of traditional programming may help media literacy programs achieve maximal efficacy.

  11. A randomized nutrition counseling intervention in pediatric leukemia patients receiving steroids results in reduced caloric intake.

    Science.gov (United States)

    Li, Rhea; Donnella, Hayley; Knouse, Phillip; Raber, Margaret; Crawford, Karla; Swartz, Maria C; Wu, Jimin; Liu, Diane; Chandra, Joya

    2017-02-01

    Quality of life in survivors of pediatric acute lymphocytic leukemia (ALL) can be compromised by chronic diseases including increased risk of second cancers, cardiovascular disease, and diabetes. Overweight or obesity further increases these risks. Steroids are a component of chemotherapy for ALL, and weight gain is a common side effect. To impact behaviors associated with weight gain, we conducted a randomized nutrition counseling intervention in ALL patients on treatment. ALL patients on a steroid-based treatment regimen at the MD Anderson Children's Cancer Hospital were recruited and randomized into control or intervention groups. The control group received standard care and nutrition education materials. The intervention group received monthly one-on-one nutrition counseling sessions, consisting of a baseline and 12 follow-up visits. Anthropometrics, dietary intake (3-day 24-hr dietary recalls) and oxidative stress measures were collected at baseline, 6 months, and postintervention. Dietary recall data were analyzed using the Nutrition Data System for Research. Twenty-two patients (median age 11.5 years), all in the maintenance phase of treatment, were recruited. The intervention group (n = 12) reported significantly lower calorie intake from baseline to 12-month follow-up and significant changes in glutamic acid and selenium intake (P prevention and management. © 2016 Wiley Periodicals, Inc.

  12. Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial.

    Science.gov (United States)

    Sedrak, Mina S; Myers, Jennifer S; Small, Dylan S; Nachamkin, Irving; Ziemba, Justin B; Murray, Dana; Kurtzman, Gregory W; Zhu, Jingsan; Wang, Wenli; Mincarelli, Deborah; Danoski, Daniel; Wells, Brian P; Berns, Jeffrey S; Brennan, Patrick J; Hanson, C William; Dine, C Jessica; Patel, Mitesh S

    2017-07-01

    Many health systems are considering increasing price transparency at the time of order entry. However, evidence of its impact on clinician ordering behavior is inconsistent and limited to single-site evaluations of shorter duration. To test the effect of displaying Medicare allowable fees for inpatient laboratory tests on clinician ordering behavior over 1 year. The Pragmatic Randomized Introduction of Cost data through the electronic health record (PRICE) trial was a randomized clinical trial comparing a 1-year intervention to a 1-year preintervention period, and adjusting for time trends and patient characteristics. The trial took place at 3 hospitals in Philadelphia between April 2014 and April 2016 and included 98 529 patients comprising 142 921 hospital admissions. Inpatient laboratory test groups were randomly assigned to display Medicare allowable fees (30 in intervention) or not (30 in control) in the electronic health record. Primary outcome was the number of tests ordered per patient-day. Secondary outcomes were tests performed per patient-day and Medicare associated fees. The sample included 142 921 hospital admissions representing patients who were 51.9% white (74 165), 38.9% black (55 526), and 56.9% female (81 291) with a mean (SD) age of 54.7 (19.0) years. Preintervention trends of order rates among the intervention and control groups were similar. In adjusted analyses of the intervention group compared with the control group over time, there were no significant changes in overall test ordering behavior (0.05 tests ordered per patient-day; 95% CI, -0.002 to 0.09; P = .06) or associated fees ($0.24 per patient-day; 95% CI, -$0.42 to $0.91; P = .47). Exploratory subset analyses found small but significant differences in tests ordered per patient-day based on patient intensive care unit (ICU) stay (patients with ICU stay: -0.16; 95% CI, -0.31 to -0.01; P = .04; patients without ICU stay: 0.13; 95% CI, 0.08-0.17; P < .001) and the

  13. Occupation Time of a Randomly Accelerated Particle on the Positive Half Axis: Results for the First Five Moments

    Science.gov (United States)

    Burkhardt, Theodore W.

    2017-11-01

    In the random acceleration process a point particle is accelerated by Gaussian white noise with zero mean. Although several fundamental statistical properties of the motion have been analyzed in detail, the statistics of occupation times is still not well understood. We consider the occupation or residence time T_+ on the positive x axis of a particle which is randomly accelerated on the unbounded x axis for a time t. The first two moments of T_+ were recently derived by Ouandji Boutcheng et al. (J Stat Mech 053213:1-10, 2016). With an alternate approach utilizing basis functions which have proved useful in other studies of randomly accelerated motion, results for the first five moments are obtained in this paper.

  14. Occupation Time of a Randomly Accelerated Particle on the Positive Half Axis: Results for the First Five Moments

    Science.gov (United States)

    Burkhardt, Theodore W.

    2017-10-01

    In the random acceleration process a point particle is accelerated by Gaussian white noise with zero mean. Although several fundamental statistical properties of the motion have been analyzed in detail, the statistics of occupation times is still not well understood. We consider the occupation or residence time T_+ on the positive x axis of a particle which is randomly accelerated on the unbounded x axis for a time t. The first two moments of T_+ were recently derived by Ouandji Boutcheng et al. (J Stat Mech 053213:1-10, 2016). With an alternate approach utilizing basis functions which have proved useful in other studies of randomly accelerated motion, results for the first five moments are obtained in this paper.

  15. Patient education videos for elective colorectal surgery: results of a randomized controlled trial.

    Science.gov (United States)

    Ihedioha, U; Vaughan, S; Mastermann, J; Singh, B; Chaudhri, S

    2013-11-01

    Recent advances in surgery have focused on peri-operative care and interventions to improve outcome following surgery. Psychological preparation has a positive impact on recovery and incorporates a range of strategies with dissemination of information as one of the key elements. Information can be given verbally, through printed information or through use of a video. Traditionally, reliance has been on the use of written material as an adjunct to patient education in clinic. The current study is a randomized trial on the use of video education in patients undergoing elective colorectal resection within an enhanced recovery programme. Sixty-five eligible patients undergoing elective colorectal surgery were identified and 61 were randomized between August 2010 and August 2011 to either video and information leaflets or information leaflets alone. A fast track protocol was established for all the patients. Clinicians in charge of postoperative recovery were blinded. Standard discharge criteria were employed for all patients. Of 61 patients randomized, one dropped out and outcomes on 60 were analysed. There was no difference in baseline characteristics between the groups (age, P = 0.964; body mass index, P = 0.829). Twenty-eight (91%) patients in the video group had left sided resections while two (6%) had right sided resections. Nineteen (66%) in the non-video group had left sided resections while nine (31%) had right sided resections. One (3%) patient in the non-video group and one (3%) in the video group had a total colectomy. Fourteen (45%) patients in the video group and 12 (41%) in the non-video group had surgery completed laparoscopically. There was no difference in the primary (median hospital stay 5 vs 5 days; P = 0.239) or the secondary outcome measures (pain score on movement, P = 0.338; pain score at rest, P = 0.989; nausea score, P = 0.74; epidural use, P = 0.984; paracetamol use, P = 0.44; voltarol use, P = 0.506) between the groups. Use of video

  16. Modeling and predicting the Spanish Bachillerato academic results over the next few years using a random network model

    Science.gov (United States)

    Cortés, J.-C.; Colmenar, J.-M.; Hidalgo, J.-I.; Sánchez-Sánchez, A.; Santonja, F.-J.; Villanueva, R.-J.

    2016-01-01

    Academic performance is a concern of paramount importance in Spain, where around of 30 % of the students in the last two courses in high school, before to access to the labor market or to the university, do not achieve the minimum knowledge required according to the Spanish educational law in force. In order to analyze this problem, we propose a random network model to study the dynamics of the academic performance in Spain. Our approach is based on the idea that both, good and bad study habits, are a mixture of personal decisions and influence of classmates. Moreover, in order to consider the uncertainty in the estimation of model parameters, we perform a lot of simulations taking as the model parameters the ones that best fit data returned by the Differential Evolution algorithm. This technique permits to forecast model trends in the next few years using confidence intervals.

  17. 76 FR 7150 - Notice of Final Results of Expedited Sunset Review of the Antidumping Duty Order: Glycine From...

    Science.gov (United States)

    2011-02-09

    ... specified in 19 CFR 351.218(d)(1)(I). See Letter from David M. Schwartz, to Secretary Gary Locke, titled... from David M. Schwartz, to Secretary Gary Locke, titled ``Sunset Review of the Antidumping Order on...

  18. Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial.

    Science.gov (United States)

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-09-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61). Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Moderators of dialectical behavior therapy for binge eating disorder: results from a randomized controlled trial.

    Science.gov (United States)

    Robinson, Athena Hagler; Safer, Debra L

    2012-05-01

    Investigate moderators of a randomized clinical trial of group Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED) compared to an active comparison group control (ACGT) on the post-treatment outcome of binge frequency after twenty 2-h weekly sessions. Moderation analyses. Participants were 101 adults with BED [mean (SD) age, 52.2 (10.6) years and BMI, 36.4 (8.6)]. Analyses identified two moderators of post-treatment outcome. Participants with (1) Avoidant Personality Disorder or (2) an earlier onset of overweight and dieting (DBT-BED. Participants with certain indicators of higher baseline pathology respond better to DBT-BED than ACGT at post-treatment. Copyright © 2011 Wiley Periodicals, Inc.

  20. Social Cognitive Mediators of Adolescent Smoking Cessation: Results from a Large Randomized Intervention Trial

    Science.gov (United States)

    Bricker, Jonathan B.; Liu, Jingmin; Comstock, Bryan A.; Peterson, Arthur V.; Kealey, Kathleen A.; Marek, Patrick M.

    2010-01-01

    Only one prior study has examined why adolescent smoking cessation interventions are effective. To address this understudied and important issue, this study examined whether a large adolescent smoking cessation intervention trial’s outcomes were mediated by Social Cognitive Theory processes. In a randomized trial (N = 2,151), counselors proactively delivered a telephone intervention to senior year high school smokers. Mediators and smoking status were self-reported at 12 months post-intervention-eligibility (88.8% retention). At-least-6-months abstinence was the outcome. Among all enrolled smokers, increased self-efficacy to resist smoking in (a) social & (b) stressful situations together statistically mediated 55.6% of the intervention’s effect on smoking cessation (p smoking in stressful situations statistically mediated 56.9% of the intervention’s effect (p smoking is a possible mediator of the intervention’s effect on smoking cessation. PMID:20853929

  1. Sealing caries in primary molars: randomized control trial, 5-year results.

    Science.gov (United States)

    Innes, N P T; Evans, D J P; Stirrups, D R

    2011-12-01

    The Hall Technique (HT) is a method for managing carious primary molars. Decay is sealed under pre-formed metal crowns without any caries removal, tooth preparation, or local anesthesia. The aim of this study was to compare HT clinical/radiographic failure rates with General Dental Practitioners' (GDPs) standard (control) restorations. We conducted a split-mouth, randomized control trial (132 children, aged 3-10 yrs, GDPs n = 17) in Scotland. There were 264 study teeth with initial lesions, 42% of which were radiographically > half-way into dentin, and 67% of which had Class II restorations. Teeth were randomized to HT (intervention) or GDPs' usual treatment (control). Annual clinical/radiographic follow-up data were recorded. Ninety-one patients (69%) had 48 months' minimum follow-up. At 60 months, 'Major' failures (irreversible pulpitis, loss of vitality, abscess, or unrestorable tooth) were recorded: HT, 3 (3%); control restorations, 15 (16.5%) (p = 0.000488; NNT 8); and 'Minor' failures (reversible pulpitis, restoration loss/wear/fracture; or secondary caries): HT, 4 (5%); control restorations, 38 (42%) (p < 0.000001; NNT 3). Overall, there were follow-up data for 130 patients (2-60 mos): 'Major' failures: HT, 3 (2%); control restorations, 22 (17%) (p = 0.000004; NNT 7); and 'Minor' failures, HT, 7 (5%); control restorations, 60 (46%) (p < 0.000001; NNT 3). Sealing in caries by the Hall Technique statistically, and clinically, significantly outperformed GDPs' standard restorations in the long term (Trial registration no. ISRCTN 47267892).

  2. Sugars, obesity, and cardiovascular disease: results from recent randomized control trials.

    Science.gov (United States)

    Rippe, James M; Angelopoulos, Theodore J

    2016-11-01

    The relationship between sugar consumption and various health-related sequelas is controversial. Some investigators have argued that excessive sugar consumption is associated with increased risk of obesity, coronary heart disease, diabetes (T2D), metabolic syndrome, non-alcoholic fatty liver disease, and stimulation of reward pathways in the brain potentially causing excessive caloric consumption. These concerns have influenced organizations such as the World Health Organization, the Scientific Advisory Committee on Nutrition in England not to exceed 5 % of total energy and the Dietary Guidelines for Americans Advisory Committee 2015 to recommend upper limits of sugar consumption not to exceed 10 % of calories. Data from many randomized control trials (RCTs) do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects. Fructose and glucose are typically consumed together in roughly equal proportions from high-fructose corn syrup (also known as isoglucose in Europe) or sucrose. The purpose of this review is to present data from recent RCTs and findings from recent systematic reviews and meta-analyses related to sugar consumption and its putative health effects. This review evaluates findings from recent randomized controlled trials, systematic reviews and meta-analyses into the relationship of sugar consumption and a range of health-related issues including energy-regulating hormones, obesity, cardiovascular disease, diabetes, and accumulation of liver fat and neurologic responses. Data from these sources do not support linkages between sugar consumption at normal levels within the human diet and various adverse metabolic and health-related effects.

  3. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

    Science.gov (United States)

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-11-01

    Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Prospective, randomized, placebo-controlled, double-masked clinical trial conducted at the University of Minnesota. Forty-five subjects with albinism. Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side-effects were recorded with a symptom survey. Blood was drawn for genotyping. Side-effects and best-corrected visual acuity 20 weeks after enrolment. All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow up was 100% and compliance was good. Minor side-effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

  4. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial.

    Science.gov (United States)

    Politi, Mary C; Kuzemchak, Marie D; Kaphingst, Kimberly A; Perkins, Hannah; Liu, Jingxia; Byrne, Margaret M

    2016-12-01

    Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. ©AlphaMed Press.

  5. Efficacy of the epilepsy nurse: Results of a randomized controlled study.

    Science.gov (United States)

    Pfäfflin, Margarete; Schmitz, Bettina; May, Theodor W

    2016-07-01

    We investigated the efficacy of epilepsy nurses on satisfaction with counseling about epilepsy in a randomized, controlled, prospective trial. Patients with epilepsy treated by neurologists in outpatient clinics were consecutively enrolled and randomly allocated to either the epilepsy nurse (EN) group (n = 92) or the control group (n = 95). Patients in the EN group were advised according to their needs by epilepsy nurses. The control group received routine care without additional counseling. The EN group completed the questionnaires before the first consultation (T1) and 6 months later (T2); the control group completed the questionnaires twice with an interval of 6 months. Primary outcome measure was satisfaction of patients with information and support. Secondary outcome measures were satisfaction with patient-doctor relationship, organization of treatment, epilepsy knowledge, coping, and restrictions in daily life. Anxiety and depression (Hospital Anxiety and Depression Scale) and global Quality of Life (item from QOLIE-31) were also assessed. Statistical analysis included generalized estimating equation (GEE) and nonparametric tests. Satisfaction with information and support improved significantly in the EN group compared to the control group (GEE, interaction group × time, p = 0.001). In addition, Epilepsy Knowledge (p = 0.014) and Coping (subscale Information Seeking) (p = 0.023) improved. Increase in satisfaction with counseling was dependent on patients' needs for information and on the amount of received information (Jonckheere-Terpstra test, p < 0.001). No differences between the groups were observed on other epilepsy-specific scales. A reliable questionnaire for satisfaction with epilepsy care has been developed. Epilepsy nurses improve the satisfaction of patients with counseling and information about epilepsy and concomitant problems. Wiley Periodicals, Inc. © 2016 International League Against Epilepsy.

  6. A family-school intervention for children with ADHD: results of a randomized clinical trial.

    Science.gov (United States)

    Power, Thomas J; Mautone, Jennifer A; Soffer, Stephen L; Clarke, Angela T; Marshall, Stephen A; Sharman, Jaclyn; Blum, Nathan J; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F

    2012-08-01

    Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with attention-deficit/hyperactivity disorder (ADHD) that target the family and school, as well as the intersection of family and school. This study evaluated the effectiveness of a family-school intervention, Family-School Success (FSS), designed to improve the family and educational functioning of students in Grades 2-6 who meet criteria for ADHD combined and inattentive types. Key components of FSS were conjoint behavioral consultation, daily report cards, and behavioral homework interventions. FSS was provided over 12 weekly sessions, which included 6 group sessions, 4 individualized family sessions, and 2 school-based consultations. Participating families were given the choice of placing their children on medication; 43% of children were on medication at the time of random assignment. Children (n = 199) were randomly assigned to FSS or a comparison group controlling for non-specific treatment effects (Coping With ADHD Through Relationships and Education [CARE]). Outcomes were assessed at post-intervention and 3-month follow-up. The analyses controlled for child medication status. FSS had a significant effect on the quality of the family-school relationship, homework performance, and parenting behavior. The superiority of FSS was demonstrated even though about 40% of the participants in FSS and CARE were on an optimal dose of medication and there were significant time effects on each measure. This relatively brief intervention produced effect sizes comparable to those of the more intensive Multimodal Treatment Study of Children With ADHD (MTA) behavioral intervention. © 2012 American Psychological Association

  7. Discoloration of teeth after avulsion and replantation: results from a multicenter randomized controlled trial.

    Science.gov (United States)

    Day, Peter F; Duggal, Monty S; High, Alec S; Robertson, Angus; Gregg, Terry A; Ashley, Paul F; Welbury, Richard R; Cole, Ben O; Westland, Stephen

    2011-08-01

    There is evidence to suggest that Ledermix, placed as an intervisit root canal dressing, might improve periodontal healing after replantation of avulsed teeth. As a part of a multicenter randomized controlled trial, we aimed to compare the effect of 2 root canal medicaments, Ledermix and Ultracal XS, on the discoloration of replanted teeth. Discoloration was investigated by using 3 methods: patient satisfaction with the color of replanted teeth, clinical photographs taken at baseline and 12-month reviews, and estimation of color change by using CIELAB scores for baseline and 12-month photographs. Twenty-two patients (27 teeth) were recruited. Ten patients (12 teeth) were randomized to the Ledermix group and 12 patients (15 teeth) to the Ultracal XS group. At 12 months, 8 patients were concerned with the discoloration of their teeth. Seven came from the Ledermix group and 1 from the Ultracal XS group. This difference was significant (Fisher exact test, P = .009). Standardized photographs were taken for the patients recruited at one center only (17 patients). There was significant discoloration of teeth from baseline with Ledermix, causing a darkening and gray-brown discoloration (mean change from baseline to 12 months, L∗ = -5.1, a∗ = 0.3, b∗ = -1.2, and ΔE = 8.1) and Ultracal XS, causing a yellowing and lightening of teeth (L∗ = 1.9, a∗ = 0.3, b∗ = 3.3, and ΔE = 5.4). There was a significant difference for the L∗ and b∗ variables (independent t test) between the 2 groups. Both root canal medicaments cause discoloration, with Ledermix proving less acceptable to patients. Copyright © 2011 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  8. Biologic vs synthetic inguinal hernia repair: 1-year results of a randomized double-blinded trial.

    Science.gov (United States)

    Bochicchio, Grant V; Jain, Ajay; McGonigal, Kelly; Turner, Douglas; Ilahi, Obeid; Reese, Stacey; Bochicchio, Kelly

    2014-04-01

    Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications. Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique. A prospective, randomized, double-blinded, single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix (IHM; Cook Medical) compared with polypropylene (PP) mesh using Lichtenstein's inguinal hernia repair in a 3-year outcomes study. Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks, 3 months, 6 months, and 1 year post procedure. Patient demographics, including comorbidities and nutrition status, were recorded. Intraoperative information including hernia type and location, procedure time, level of difficulty, degree of surgeon frustration, and surgical experience were collected. One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion. There were no significant differences in degree of difficulty and level of frustration between the 2 groups. At 1-year follow-up, 3 recurrences were diagnosed in the IHM group as compared with none in the PP group (p = 0.11). Persistent pain trended higher in the PP group (6% vs 4%). All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training (3 different attendings). No recurrences occurred in patients operated on by more senior surgeons. The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications. Surgeon experience appears to be a major factor affecting successful outcomes. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  9. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  10. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer: Results of an RTOG Randomized Study

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, George E. [Washington U.; Krall, John M. [Unlisted, PA; Thomas, Frank J. [Unlisted, OH; Griffin, Thomas W. [Washington U.; Maor, Moshe H. [Unlisted, TX; Hendrickson, Frank R. [Fermilab

    1985-01-01

    Between June 1977 and April 1983, the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized study investigating fast neutron radiation therapy in the treatment of patients with locally advanced (Stage C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation therapy or fast neutron irradiation used in a mixed-beam treatment schedule (neutron/photon). A total of 91 analyzable patients were entered in the study; 78 of them were treated without major protocol deviations. The two treatment groups were balanced in regard to all major prognostic variables. Actuarial curves for "overall" survival, "determinantal" survival and local/regional control are presented both for the entire group of 91 patients and the 78 patients treated within protocol guidelines. The overall local/regional tumor recurrence rate is 7% for the mixed-beam treated group of patients and is 22% for the photon (X ray) treated group of patients. The difference is statistically significant at the p = 0.05 level. For the entire group of 91 evaluable patients, the 5-year "overall" survival rate is 62% for the mixed-beam-treated group and 35% for the photon-treated group. This difference is also statistically significant (p less than 0.05). However, this statistical significance is lost when the smaller number of patients treated strictly within protocol guidelines is considered. The significance is regained (p less than 0.02) when one looks at "determinantal" survival, which uses active cancer at time of death as the failure endpoint. This study demonstrates that a regional treatment modality, in this case mixed-beam irradiation, can influence both local/regional tumor control and survival in patients with locally-advanced adenocarcinoma of the prostate gland.

  11. Voriconazole therapeutic drug monitoring: results of a prematurely discontinued randomized multicenter trial.

    Science.gov (United States)

    Neofytos, D; Ostrander, D; Shoham, S; Laverdiere, M; Hiemenz, J; Nguyen, H; Clarke, W; Brass, L; Lu, N; Marr, K A

    2015-12-01

    Voriconazole (VOR) levels are highly variable, with potential implications to both efficacy and safety. We hypothesized that VOR therapeutic drug monitoring (TDM) will decrease the incidence of treatment failures and adverse events (AEs). We initiated a prospective, randomized, non-blinded multicenter study to compare clinical outcomes in adult patients randomized to standard dosing (clinician-driven) vs. TDM (doses adjusted based on levels). VOR trough levels were obtained on day 5, 14, 28, and 42 (or at completion of drug; ± 3 days). Real-time dose adjustments were made to maintain a range between 1-5 μg/mL on the TDM-arm, while levels were assessed retrospectively in the standard-arm. Patient questionnaires were administered to assess subjective AEs. The study was discontinued prematurely, after 29 patients were enrolled. Seventeen (58.6%) patients experienced 38 AEs: visual changes (22/38, 57.9%), neurological symptoms (13/38, 34.2%), and liver abnormalities (3/38, 7.9%). VOR was discontinued in 7 (25%) patients because of an AE (4 standard-arm, 3 TDM-arm). VOR levels were frequently out of range in the standard-arm (8 tests >5 μg/mL; 9 tests <1 μg/mL). Three dose changes occurred in the TDM-arm for VOR levels <1 μg/mL. Levels decreased over time in the standard-arm, with mean VOR levels lower at end of therapy compared to TDM (1.3 vs. 4.6 μg/mL, P = 0.008). VOR TDM has become widespread clinical practice, based on known variability in drug levels, which impaired accrual in this study. Although comparative conclusions are limited, observations of variability and waning levels over time support TDM. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Science.gov (United States)

    Mhalu, Grace; Hella, Jerry; Doulla, Basra; Mhimbira, Francis; Mtutu, Hawa; Hiza, Helen; Sasamalo, Mohamed; Rutaihwa, Liliana; Rieder, Hans L; Seimon, Tamsyn; Mutayoba, Beatrice; Weiss, Mitchell G; Fenner, Lukas

    2015-01-01

    We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video. Randomized controlled trial. We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania). They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100) or standard of care (control group, n = 100). Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups. Median age was 39.1 years (interquartile range 37.0-50.0); 94 (47%) were females, 106 (53%) were males, and 49 (24.5%) were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%). Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%). Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum samples. If confirmed in larger studies, instructional videos may have a substantial effect on the case yield using sputum microscopy and also molecular tests. This low-cost strategy should be considered as part of the efforts to control TB in resource-limited settings. Pan African Clinical Trials Registry PACTR201504001098231.

  13. HIV incidence among people who inject drugs (PWID) in Ukraine: results from a clustered randomized trial

    Science.gov (United States)

    Davis, Jonathan M.; Dvoryak, Sergey; Brewster, John T.; Lisovska, Oksana; Strathdee, Steffanie A.; Latkin, Carl A.

    2016-01-01

    Summary Background In this study, we sought to assess whether a social network intervention was superior to HIV testing and counseling in impacting HIV incidence among PWID. Although this was not a primary study aim, it is associated with reducing drug and sex risk behaviors, which were primary aims. Methods PWID were recruited from street settings in Odessa, Donetsk, and Nikolayev, Ukraine for a clustered randomized clinical trial (RCT). “Index” or peer leaders, along with two of their network members, were randomly assigned to testing and counseling block (N=589) or testing and counseling plus a social network intervention block (N=611). Participants in the network intervention received 5-sessions to train their network members in risk reduction. Those assigned testing and counseling received no further intervention following counseling. Employing an intent to treat analyses, the primary outcome was HIV sero-conversion using Cox regression and incorporating a gamma frailty term to account for clustering. No stratification or minimization was utilized. The trail was registered with ClinicalTrial.gov, NCT01159704. Findings Between July 12, 2010 and November 23, 2012, 2,304 PWID were recruited, 1,200 of whom were HIV negative and included in the present study. At baseline, there were no significant differences between groups. Of the 1,200 HIV negative participants, 1,085 (90.4%) were retained at 12 months. Incidence density revealed 18.45 (95% CI 14.87 – 22.03, 102 events in 553.0 py) per 100 person years (py) for those in the intervention group and 31.78 (95% CI 26.83–36.74, 158 events in 497.1 py) per 100 py among control arm participants. This corresponded to a reduced hazard in the intervention group, HR= 0.53 (95% CI 0.38, 0.76, p =0.0003). There were no study-related adverse events. Interpretation These data provide strong support for integrating peer education into comprehensive HIV prevention programs for PWID and suggest the value in developing and

  14. Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study.

    Science.gov (United States)

    Agarwal, Brij B; Nanavati, Juhil D; Agarwal, Nayan; Sharma, Naveen; Agarwal, Krishna A; Manish, Kumar; Saluja, Satish; Agarwal, Sneh

    2016-05-01

    Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC). This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a p value of biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (p values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (p < 0.05), whereas in the non-ED group, IL-6 showed significant fall (p = 0.004) and TNF-α showed no significant change (p = 0.063). Both the groups showed H4-H24 elevation of HS-CRP (p = 0.000). Energized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels. Clinical Trials Registry, India (REF/2014/06/007153).

  15. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial.

    Science.gov (United States)

    Evans, Abigail T; Peters, Ellen; Strasser, Andrew A; Emery, Lydia F; Sheerin, Kaitlin M; Romer, Daniel

    2015-01-01

    Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge. Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7), did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text. Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only) caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention). Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention). Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later. In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings in encouraging

  16. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Abigail T Evans

    Full Text Available Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge.Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7, did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text.Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention. Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention. Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later.In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings

  17. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Grace Mhalu

    Full Text Available We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB, and evaluated the acceptance of the video.Randomized controlled trial.We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania. They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100 or standard of care (control group, n = 100. Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups.Median age was 39.1 years (interquartile range 37.0-50.0; 94 (47% were females, 106 (53% were males, and 49 (24.5% were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p <0.0001, an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6-85.7%, versus 45%, 95% CI 35.0-55.3%, p <0.0001, and specimens less likely to be salivary (14%, 95% CI 7.9-22.4%, versus 39%, 95% CI 29.4-49.3%, p = 0.0001. Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%. Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%.Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum

  18. The empirical antibiotic treatment of nosocomial spontaneous bacterial peritonitis: Results of a randomized, controlled clinical trial.

    Science.gov (United States)

    Piano, Salvatore; Fasolato, Silvano; Salinas, Freddy; Romano, Antonietta; Tonon, Marta; Morando, Filippo; Cavallin, Marta; Gola, Elisabetta; Sticca, Antonietta; Loregian, Arianna; Palù, Giorgio; Zanus, Giacomo; Senzolo, Marco; Burra, Patrizia; Cillo, Umberto; Angeli, Paolo

    2016-04-01

    Spontaneous bacterial peritonitis (SBP) is a common, life-threatening complication of liver cirrhosis. Third-generation cephalosporins have been considered the first-line treatment of SBP. In 2014, a panel of experts suggested a broader spectrum antibiotic regimen for nosocomial SBP, according to the high rate of bacteria resistant to third-generation cephalosporins found in these patients. However, a broader-spectrum antibiotic regimen has never been compared to third-generation cephalosporins in the treatment of nosocomial SBP. The aim of our study was to compare meropenem plus daptomycin versus ceftazidime in the treatment of nosocomial SBP. Patients with cirrhosis and nosocomial SBP were randomized to receive meropenem (1 g/8 hours) plus daptomycin (6 mg/kg/day) or ceftazidime (2 g/8 hours). A paracentesis was performed after 48 hours of treatment. A reduction in ascitic fluid neutrophil count <25% of pretreatment value was considered a treatment failure. The primary outcome was the efficacy of treatment defined by the resolution of SBP after 7 days of treatment. Thirty-two patients were randomized and 31 were analyzed. The combination of meropenem plus daptomycin was significantly more effective than ceftazidime in the treatment of nosocomial SBP (86.7 vs. 25%; P < 0.001). Ninety-day transplant-free survival (TFS) was not significantly different between the two groups. In the multivariate analysis, ineffective response to first-line treatment (hazard ratio [HR]: 20.6; P = 0.01), development of acute kidney injury during hospitalization (HR: 23.2; P = 0.01), and baseline mean arterial pressure (HR: 0.92; P = 0.01) were found to be independent predictors of 90-day TFS. The combination of meropenem plus daptomycin is more effective than ceftazidime as empirical antibiotic treatment of nosocomial SBP. Efficacy of the empirical antibiotic treatment is a strong predictor of 90-day survival in patients with nosocomial SBP. © 2015 by the American

  19. Order patterns and chaos

    Energy Technology Data Exchange (ETDEWEB)

    Amigo, Jose M. [Centro de Investigacion Operativa, Universidad Miguel Hernandez, E-03202 Elche (Spain)]. E-mail: jm.amigo@umh.es; Kocarev, Ljupco [Institute for Nonlinear Science, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093-0402 (United States); Szczepanski, Janusz [Institute for Fundamental Technological Research, Polish Academy of Sciences, Swietokrzyska 21, PL-00-049 Warsaw (Poland)

    2006-06-19

    Chaotic maps can mimic random behavior in a quite impressive way. In particular, those possessing a generating partition can produce any symbolic sequence by properly choosing the initial state. We study in this Letter the ability of chaotic maps to generate order patterns and come to the conclusion that their performance in this respect falls short of expectations. This result reveals some basic limitation of a deterministic dynamic as compared to a random one. This being the case, we propose a non-statistical test based on 'forbidden' order patterns to discriminate chaotic from truly random time series with, in principle, arbitrarily high probability. Some relations with discrete chaos and chaotic cryptography are also discussed.

  20. Organ donation video messaging in motor vehicle offices: results of a randomized trial.

    Science.gov (United States)

    Rodrigue, James R; Fleishman, Aaron; Fitzpatrick, Sean; Boger, Matthew

    2015-12-01

    Since nearly all registered organ donors in the United States signed up via a driver's license transaction, motor vehicle (MV) offices represent an important venue for organ donation education. To evaluate the impact of organ donation video messaging in MV offices. A 2-group (usual care vs usual care+video messaging) randomized trial with baseline, intervention, and follow-up assessment phases. Twenty-eight MV offices in Massachusetts. Usual care comprised education of MV clerks, display of organ donation print materials (ie, posters, brochures, signing mats), and a volunteer ambassador program. The intervention included video messaging with silent (subtitled) segments highlighting individuals affected by donation, playing on a recursive loop on monitors in MV waiting rooms. Aggregate monthly donor designation rates at MV offices (primary) and percentage of MV customers who registered as donors after viewing the video (secondary). Controlling for baseline donor designation rate, analysis of covariance showed a significant group effect for intervention phase (F=7.3, P=.01). The usual-care group had a significantly higher aggregate monthly donor designation rate than the intervention group had. In the logistic regression model of customer surveys (n=912), prior donor designation (β=-1.29, odds ratio [OR]=0.27 [95% CI=0.20-0.37], Pcustomers most likely contributed to the negative trial finding.

  1. Tailored health messaging improves contraceptive continuation and adherence: results from a randomized controlled trial.

    Science.gov (United States)

    Garbers, Samantha; Meserve, Allison; Kottke, Melissa; Hatcher, Robert; Chiasson, Mary Ann

    2012-11-01

    Discontinuation and incorrect use of contraceptive methods may contribute to as many as 1 million unintended pregnancies annually in the United States. Interventions to improve contraceptive method continuation and adherence are needed. A three-arm randomized controlled trial was conducted at two family planning sites testing the efficacy of a computer-based contraceptive assessment module in increasing the proportion of patients who continued use of their chosen contraceptive method 4 months after the family planning visit (n=224). In analyses adjusting for clinical site of recruitment, family planning patients who used the module and received individually tailored health materials (n=78), compared to those in the control group (n=70), were significantly more likely to continue use of their chosen contraceptive method [95% compared to 77%; odds ratio (OR)=5.48; 95% confidence interval (CI): 1.72-17.42] and to adhere to their method (86% compared to 69%; OR=2.74; 95% CI: 1.21-6.21). No significant differences in these outcomes were found for participants who used the module but did not receive tailored materials (n=76), compared to the control group. Tailored health materials significantly improved contraceptive method continuation and adherence. Additional research on the impact of the intervention on continuation and adherence in a larger sample and over a longer follow-up period is merited. Copyright © 2012 Elsevier Inc. All rights reserved.

  2. Resveratrol Supplementation Did Not Improve Cognition in Patients with Schizophrenia: Results from a Randomized Clinical Trial.

    Science.gov (United States)

    Zortea, Karine; Franco, Viviane C; Guimarães, Paula; Belmonte-de-Abreu, Paulo S

    2016-01-01

    Schizophrenia (SZ) is associated with psychotic experiences and cognitive deficits. Therefore, cognitive function is one of the most critical determinants of quality of life in this pathology. Resveratrol has been related to neuroprotective action, but there are no studies evaluating resveratrol in SZ. The objective of this study was to determine the efficacy of resveratrol supplementation on cognition in individuals with SZ. This is a 1-month randomized, double-blind, and controlled trial (NCT 02062190), in which 19 men with diagnosis of SZ, aged 18-65 years, were assigned to a resveratrol supplementation group (200 mg) or placebo group (200 mg), with a 1-month follow-up. Applying a series of cognitive tests assessed neuropsychology performance (Hopkins Verbal Learning Test, Stroop Color and Word Test, and Weschler Adult Intelligence Scale) and Brief Psychiatric Rating Scale assessed psychopathology severity. There were no significant improvement in neuropsychology performance (episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility) and psychopathology severity after 1 month of resveratrol supplementation (P > 0.05). In conclusion, we have shown that 1 month of a resveratrol supplementation (200 mg/day) did not improve episodic memory, working memory, attention and concentration capacity, inhibitory control, interference measures, selective attention, and mental flexibility as compared with placebo in patients with SZ.

  3. The intrastromal corneal ring in penetrating keratoplasty-long-term results of a prospective randomized study.

    Science.gov (United States)

    Birnbaum, Florian; Schwartzkopff, Johannes; Böhringer, Daniel; Reinhard, Thomas

    2011-07-01

    Postoperative astigmatism after penetrating keratoplasty is a major problem in corneal transplantation. The purpose of this prospective randomized study was to evaluate the efficacy and safety of an intrastromal corneal ring after penetrating keratoplasty. Twenty patients were included, 10 of whom received an intracorneal ring (group 1) and 10 who did not (group 2, control group). Astigmatism in Orbscan corneal topography, occurrence of immune reactions, and occurrence of side effects were this study's main outcome criteria. Mean follow-up time was 27.6 ± 5.3 months. Mean astigmatism (Orbscan) was 4.4 diopters in group 1 and 4.4 diopters in group 2 (P = 0.695). Spontaneous suture rupture occurred in 5 patients with corneal ring but in none of those in the control group. We observed 3 immune reactions in 3 patients with corneal ring, whereas group 2 experienced no rejection (P keratoplasty caused no reduction in postoperative astigmatism. However, its use was statistically significantly associated with adverse events.

  4. A randomized trial comparing TVT with TVT-O: 12-month results.

    Science.gov (United States)

    Rinne, Kirsi; Laurikainen, Eija; Kivelä, Arre; Aukee, Pauliina; Takala, Teuvo; Valpas, Antti; Nilsson, Carl Gustaf

    2008-08-01

    The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

  5. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil.

    Science.gov (United States)

    Alvarez, X Antón; Cacabelos, R; Sampedro, C; Couceiro, V; Aleixandre, M; Vargas, M; Linares, C; Granizo, E; García-Fantini, M; Baurecht, W; Doppler, E; Moessler, H

    2011-08-01

    Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimer's disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinician's Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.

  6. The results of a 2-year randomized trial of a worksite weight management intervention.

    Science.gov (United States)

    Williams, Andrew E; Stevens, Victor J; Albright, Cheryl L; Nigg, Claudio R; Meenan, Richard T; Vogt, Thomas M

    2014-01-01

    We assessed the effectiveness of a worksite management intervention (the 3W program) for overweight and obese hotel employees. The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals. All participating hotels were on Oahu, Hawaii. The intervention was implemented within hotel worksites. Participants were included in the analysis if they had an initial body mass index (BMI) ≥ 25, were assessed at least twice, were not missing other data needed for the analysis, and did not switch to employment at a hotel in a different experimental condition. Of the 6519 employees we assessed, data from 1207 individuals (intervention: 598; control: 610) met these criteria and contributed to the analysis. The intervention had two components: (1) group meetings and (2) a workplace environment intervention. Weight and waist to height ratio (WHtR) were measured at three annual assessments. The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters. The effects on change in BMI and WHtR were in the expected direction but were not statistically significant. The 3W program was not effective. The low intensity of the intervention may have contributed to its ineffectiveness.

  7. Exposure to suicide and identification as survivor. Results from a random-digit dial survey.

    Science.gov (United States)

    Cerel, Julie; Maple, Myfanwy; Aldrich, Rosalie; van de Venne, Judy

    2013-01-01

    There is little empirical evidence regarding lifetime exposure to suicide or identification of those impacted by suicide deaths. Studies previously conducted used only convenience samples. To determine the prevalence of suicide exposure in the community and those affected by suicide deaths. A random digit dial sample of 302 adults. 64% of the sample knew someone who had attempted or died by suicide, and 40% knew someone who died by suicide. No demographic variables differentiated exposed versus unexposed, indicating that exposure to suicide cuts across demographics. Almost 20% said they were a "survivor" and had been significantly affected by a suicide death. Demographic variables did not differentiate groups. The relationship to the decedent was not related to self-identified survivor status; what did differentiate those individuals impacted by the death from those who did not was their perception of their relationship with the decedent. Kinship proximity and relationship category to the deceased appeared to be unrelated to survivor status, but perceived psychological closeness to the deceased showed a robust association with self-identified survivor status. We need an expanded definition of "suicide survivor" to account for the profound impact of suicide in the community.

  8. 76 FR 33243 - Sulfanilic Acid From India; Final Results of Expedited Sunset Review of Countervailing Duty Order

    Science.gov (United States)

    2011-06-08

    ... order would be likely to lead to continuation or recurrence of a countervailable subsidy at the level... production of optical brighteners, food colors, specialty dyes, and concrete additives. The principal... materials present in the sulfanilic acid. All grades are available as dry free flowing powders. Technical...

  9. Brief Strategic Family Therapy Versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    Science.gov (United States)

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, José

    2012-01-01

    Objective To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to TAU with a multiethnic sample of adolescents (213 Hispanic, 148 White, and 110 Black) referred for drug abuse treatment at 8 community treatment agencies nationwide. Randomization encompassed both adolescents’ families (n = 480) and the agency therapists (n = 49) who provided either TAU or BSFT services. The primary outcome was adolescent drug use, assessed monthly via adolescent self-report and urinalysis for up to 1 year post randomization. Secondary outcomes included treatment engagement (≥2 sessions), retention (≥8 sessions), and participants’ reports of family functioning 4, 8, and 12 months following randomization. Results No overall differences between conditions were observed in the trajectories of self-reports of adolescent drug use. However, the median number of days of self-reported drug use was significantly higher, χ2(1) = 5.40, p family members in treatment and in improving parent reports of family functioning, χ2(2) = 9.10, p < .011. Conclusions We discuss challenges in treatment implementation in community settings and provide recommendations for further research. PMID:21967492

  10. Impact of quality circles for improvement of asthma care: results of a randomized controlled trial.

    Science.gov (United States)

    Schneider, Antonius; Wensing, Michel; Biessecker, Kathrin; Quinzler, Renate; Kaufmann-Kolle, Petra; Szecsenyi, Joachim

    2008-04-01

    Quality circles (QCs) are well established as a means of aiding doctors. New quality improvement strategies include benchmarking activities. The aim of this paper was to evaluate the efficacy of QCs for asthma care working either with general feedback or with an open benchmark. Twelve QCs, involving 96 general practitioners, were organized in a randomized controlled trial. Six worked with traditional anonymous feedback and six with an open benchmark; both had guided discussion from a trained moderator. Forty-three primary care practices agreed to give out questionnaires to patients to evaluate the efficacy of QCs. A total of 256 patients participated in the survey, of whom 185 (72.3%) responded to the follow-up 1 year later. Use of inhaled steroids at baseline was high (69%) and self-management low (asthma education 27%, individual emergency plan 8%, and peak flow meter at home 21%). Guideline adherence in drug treatment increased (P = 0.19), and asthma steps improved (P = 0.02). Delivery of individual emergency plans increased (P = 0.008), and unscheduled emergency visits decreased (P = 0.064). There was no change in asthma education and peak flow meter usage. High medication guideline adherence was associated with reduced emergency visits (OR 0.24; 95% CI 0.07-0.89). Use of theophylline was associated with hospitalization (OR 7.1; 95% CI 1.5-34.3) and emergency visits (OR 4.9; 95% CI 1.6-14.7). There was no difference between traditional and benchmarking QCs. Quality circles working with individualized feedback are effective at improving asthma care. The trial may have been underpowered to detect specific benchmarking effects. Further research is necessary to evaluate strategies for improving the self-management of asthma patients.

  11. Bridging emergency contraceptive pill users to regular contraception: results from a randomized trial in Jamaica.

    Science.gov (United States)

    Chin-Quee, Dawn S; Wedderburn, Maxine; Otterness, Conrad; Janowitz, Barbara; Chen-Mok, Mario

    2010-02-01

    Emergency contraception research has shifted from examining the public health effects of increasing access to emergency contraceptive pills (ECPs) to bridging ECP users to a regular contraceptive method as a way of decreasing unintended pregnancies. In a randomized controlled trial in Jamaica, we tested a discount coupon for oral contraceptive pills (OCPs) among pharmacy-based ECP purchasers as an incentive to adopt (i.e., use for at least 2 months) this and other regular contraceptive methods. Women in the intervention and control arms were followed up at 3 and 6 months after ECP purchase to determine whether they adopted the OCP or any other contraceptive method. Condom use was recorded but was not considered a regular contraceptive due to its inconsistent use. There was no significant difference in the proportion of women who adopted the OCP, injectable or intrauterine device in the control group or the intervention group (p=.39), and only 14.6% of the sample (mostly OCP adopters) used one of these three methods. Condom use was high (44.0%), demonstrating that ECP users were largely a condom-using group. The discount coupon intervention was not successful. Although a small proportion of ECP users did bridge, the coupon did not affect the decision to adopt a regular contraceptive method. The study highlighted the need for bridging strategies to consider women's reproductive and sexual behaviors, as well as their context. However, in countries like Jamaica where HIV/AIDS is of concern and condom use is appropriately high, bridging may not be an optimal strategy.

  12. Effect of prenatal DHA supplementation on the infant epigenome: results from a randomized controlled trial.

    Science.gov (United States)

    van Dijk, Susan J; Zhou, Jing; Peters, Timothy J; Buckley, Michael; Sutcliffe, Brodie; Oytam, Yalchin; Gibson, Robert A; McPhee, Andrew; Yelland, Lisa N; Makrides, Maria; Molloy, Peter L; Muhlhausler, Beverly S

    2016-01-01

    Evidence is accumulating that nutritional exposures in utero can influence health outcomes in later life. Animal studies and human epidemiological studies have implicated epigenetic modifications as playing a key role in this process, but there are limited data from large well-controlled human intervention trials. This study utilized a large double-blind randomized placebo-controlled trial to test whether a defined nutritional exposure in utero, in this case docosahexaenoic acid (DHA), could alter the infant epigenome. Pregnant mothers consumed DHA-rich fish oil (800 mg DHA/day) or placebo supplements from 20 weeks' gestation to delivery. Blood spots were collected from the children at birth (n = 991) and blood leukocytes at 5 years (n = 667). Global DNA methylation was measured in all samples, and Illumina HumanMethylation450K BeadChip arrays were used for genome-wide methylation profiling in a subset of 369 children at birth and 65 children at 5 years. There were no differences in global DNA methylation levels between the DHA and control group either at birth or at 5 years, but we identified 21 differentially methylated regions (DMRs) at birth, showing small DNA methylation differences (DHA supplementation during the second half of pregnancy had small effects on DNA methylation of infants. While the potential functional significance of these changes remains to be determined, these findings further support the role of epigenetic modifications in developmental programming in humans and point the way for future studies. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12605000569606 and ACTRN12611001127998.

  13. Diabetes Nurse Case Management in a Canadian Tertiary Care Setting: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Li, Danni; Elliott, Tom; Klein, Gerri; Ur, Ehud; Tang, Tricia S

    2017-06-01

    To examine the effects of a 6-month nurse case manager (NCM) intervention compared to standard care (SC) on glycemic control and diabetes distress in a Canadian tertiary-care setting. We recruited 140 adults with type 2 diabetes and glycated hemoglobin (A1C) levels >8% (64 mmol/mol) from 2 tertiary care facilities and randomized them to: 1) a 6-month NCM intervention in addition to SC or 2) SC by the primary endocrinologists. Assessments were conducted at baseline and at 6 months. Primary outcomes included A1C levels and diabetes distress scores (DDS). Secondary outcomes included body mass index, blood pressure, diabetes-related behaviour measures, depressive symptoms, self-motivation and perception of support. At the 6-month follow up, the NCM group experienced larger reductions in A1C levels of -0.73% compared to the SC group (p=0.027; n=134). The NCM group also showed an additional reduction of -0.40 (26% reduction) in DDS compared to those in the SC group (p=0.001; n=134). The NCM group had lower blood pressure, ate more fruit and vegetables, exercised more, checked their feet more frequently, were more motivated, were less depressed and perceived more support. There were no changes and no group differences in terms of body mass index, medication compliance or frequency of testing. Compared to SC, NCM intervention was more effective in improving glycemic control and reducing diabetes distress. It is, therefore, a viable adjunct to standard diabetes care in the tertiary care setting, particularly for patients at high risk and with poor control. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  14. Methionyl human growth hormone and oxandrolone in Turner syndrome: preliminary results of a prospective randomized trial.

    Science.gov (United States)

    Rosenfeld, R G; Hintz, R L; Johanson, A J; Brasel, J A; Burstein, S; Chernausek, S D; Clabots, T; Frane, J; Gotlin, R W; Kuntze, J

    1986-12-01

    Seventy girls with Turner syndrome, 4 to 12 years of age, were randomly assigned to receive either no treatment (control) or methionyl human growth hormone (0.125 mg/kg three times per week), oxandrolone (0.125 mg/kg/day), or combination hGH plus oxandrolone therapy. Baseline growth rates averaged 4.3 cm/yr, and all were within 2 SD of mean growth velocity for age in girls with Turner syndrome. Sixty-seven girls remained in the study for a minimum of 1 year. Growth rates and growth velocity (in standard deviations for age in girls with Turner syndrome) were control 3.8 cm/yr (-0.1 SD), hGH 6.6 cm/yr (+2.3 SD), oxandrolone 7.9 cm/yr (+3.7 SD), and combination therapy 9.8 cm/yr (+5.4 SD). Mean bone ages advanced 1.0 years (hGH), 1.3 years (oxandrolone), and 1.6 years (combination). However, median increments in height age/bone age (delta HA/delta BA) ratios ranged from 1.0 to 1.1 for treatment groups, compared with 0.8 for the controls. Predicted adult height by the method of Bayley-Pinneau increased 2.5 cm for hGH or oxandrolone alone, and 3.2 cm for combination treatment. These data indicate that both hGH and oxandrolone can significantly stimulate short-term skeletal growth in patients with Turner syndrome, and potentially increase final adult height.

  15. Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas.

    Science.gov (United States)

    Thompson, Beti; Carosso, Elizabeth A; Jhingan, Esther; Wang, Lei; Holte, Sarah E; Byrd, Theresa L; Benavides, Maria C; Lopez, Cathy; Martinez-Gutierrez, Javiera; Ibarra, Genoveva; Gonzalez, Virginia J; Gonzalez, Nora E; Duggan, Catherine R

    2017-02-15

    Latinas have the highest rates of cervical cancer in the United States and the second highest rate of cervical cancer mortality. One factor in the disparity is the relatively low rate of screening for cervical cancer in this population. Eligible women who were out of adherence with cervical cancer screening (>3 years since their last Papanicolaou [Pap] test) were identified via medical record review by a federally qualified local health center. The effects of a low-intensity intervention (video delivered to participants' homes; n = 150) and a high-intensity intervention (video plus a home-based educational session; n = 146) on cervical cancer screening uptake in comparison with a control arm (usual care; n = 147) were investigated. A cost-effectiveness analysis of the interventions was conducted: all intervention costs were calculated, and the incremental cost-effectiveness ratio was computed. Finally, women with positive Pap tests were provided navigation by a community health educator to ensure that they received follow-up care. A total of 443 Latinas participated. Seven months after randomization, significantly more women in the high-intensity arm received a Pap test (53.4%) in comparison with the low-intensity arm (38.7%; P cancer; these women received navigation for follow-up care. A culturally appropriate, in-home, promotora-led educational intervention was successful in increasing cervical cancer screening among Latinas. Cancer 2017;123:666-674. © 2016 American Cancer Society. © 2016 American Cancer Society.

  16. Levothyroxine Treatment of Euthyroid Children with Autoimmune Hashimoto Thyroiditis: Results of a Multicenter, Randomized, Controlled Trial.

    Science.gov (United States)

    Dörr, Helmuth G; Bettendorf, Markus; Binder, Gerhard; Karges, Beate; Kneppo, Carolin; Schmidt, Heinrich; Voss, Egbert; Wabitsch, Martin; Dötsch, Jörg

    2015-01-01

    Levothyroxine (L-T4) treatment of euthyroid children with Hashimoto thyroiditis (HT) is a controversial issue. We conducted a prospective, randomized, controlled clinical trial. Out of 79 identified euthyroid patients, 59 started the study; 25 patients (21 female, 4 male; age: 11.8 ± 2.3 years) received L-T4 at a mean dose of 1.6 µg/kg (SD, 0.8) daily, and 34 (27 female, 7 male; age: 12.6 ± 1.2 years) were not treated. Patients developing subclinical hypothyroidism during follow-up (n = 13) were treated with L-T4 and removed from the observation group. As the main outcome measures, thyroid gland volume (determined by ultrasound) as well as serum levels of TSH, free T4, and antibodies against thyroid peroxidase and thyroglobulin were assessed every 6 months for 36 months. At the start, the mean thyroid volume (standard deviation score, SDS) was 2.5 in the treatment group and 1.6 in the observation group. There was a constant decline in mean thyroid volume (SDS) from 2.13 (month 12) to 1.12 (month 30) in the treated group, with a delta thyroid volume of -1.01 SDS. In the observation group, the mean delta thyroid volume increased to +0.27 SDS. The change of the delta thyroid volume was statistically significantly different between both groups during the 12- and 30-month time points (p thyroid function and serum thyroid antibodies. L-T4 treatment can decrease the thyroid volume in euthyroid children with HT, but the effect is limited to a definite time period. © 2015 S. Karger AG, Basel.

  17. Remote ischemic preconditioning in aortic valve surgery: Results of a randomized controlled study.

    Science.gov (United States)

    Pinaud, Frédéric; Corbeau, Jean-Jacques; Baufreton, Christophe; Binuani, Jean-Patrice; De Brux, Jean-Louis; Fouquet, Olivier; Angoulvant, Denis; Furber, Alain; Prunier, Fabrice

    2016-01-01

    Although remote ischemic preconditioning (RIPC) has emerged as an attractive strategy to reduce cardiac injury in patients undergoing diverse cardiac surgical procedures, it is unclear whether RIPC has protective effects in patients undergoing aortic valve replacement surgery without coronary artery bypass grafting (CABG). Hence, 100 adult patients undergoing elective aortic valve replacement for aortic valve stenosis, without combined surgery with CABG, were prospectively randomly assigned in a 1:1 ratio to either the RIPC group or the control group. The RIPC group underwent three cycles of 5-min inflation to 200mmHg and 5-min deflation of an automated upper-arm cuff inflator after induction of anesthesia. The control group had a deflated cuff placed on upper arm for 30min. The primary endpoint was 72-h area under curve (AUC) for troponin I (cTnI). Secondary endpoints were 72-h AUC for creatine kinase-MB isoenzyme (CK-MB) release, incidence of acute kidney injury, extubation time, length of stay in intensive care unit, and simplified acute physiology score (SAPS II). There were no significant differences in cTnI AUC [195±190 arbitrary units (a.u.) in RIPC group vs. 169±117 a.u. in the control group; p=0.41] and CK-MB AUC between groups. None of the other secondary endpoints differed between groups. Acute kidney injury occurred in 12 patients (24.5%) in the control group and in 13 (26.0%) in the RIPC group (p=0.86). RIPC did not exhibit significant cardiac or kidney protective effects in patients undergoing aortic valve replacement surgery without CABG. Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  18. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

    Science.gov (United States)

    Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

    2014-01-01

    Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), pemail notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

  19. [Pilot results of using tamsulone-FS in patients with prostatic adenoma according to the results of a randomized multicenter comparative trial].

    Science.gov (United States)

    Lopatkin, N A; Petrov, S B; Sivkov, A V; Markov, A V; Oshchepkov, N N; Bolokhanov, Iu N

    2006-01-01

    Tamsulone-FS--a novel Russian alpha1A/D-adrenoblocker (Farm-Syntez)--was studied in a randomized multicenter comparative trial in patients with prostatic adenoma. Pilot results agreed with other trials published in the literature and demonstrated tamsulone-FS efficacy and safety for management of lower urinary tract symptoms caused by prostatic adenoma. The efficacy and safety of tamsulone-FS was comparable to those of omnik. This drug can be recommended for wide clinical practice in prostatic adenoma. It is registered by Roszdravnadzor (certificate N LC-000859 of 03.11.2005) and allowed for production and sale.

  20. Vitamin D supplementation and growth in urban Mongol school children: Results from two randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Davaasambuu Ganmaa

    Full Text Available Symptomatic vitamin D deficiency is associated with slowed growth in children. It is unknown whether vitamin D repletion in children with asymptomatic serum vitamin D deficiency can restore normal growth.We tested the impact of vitamin D-supplementation on serum concentrations of 25-hydroxyvitamin D [25(OHD] and short-term growth in Mongol children, with very low serum vitamin D levels in winter.We conducted two randomized, double-blind, placebo-controlled trials in urban school age children without clinical signs of rickets. The Supplementation Study was a 6-month intervention with an 800 IU vitamin D3 supplement daily, compared with placebo, in 113 children aged 12-15 years. A second study, the Fortification Study, was a 7-week intervention with 710 ml of whole milk fortified with 300 IU vitamin D3 daily, compared with unfortified milk, in 235 children aged 9-11 years.At winter baseline, children had low vitamin D levels, with a mean (±SD serum 25-hydroxyvitamin D [25(OHD] concentration of 7.3 (±3.9 ng/ml in the Supplementation Study and 7.5 (±3.8 ng/ml in the Fortification Study. The serum levels increased in both vitamin D groups-by 19.8 (±5.1 ng/ml in the Supplementation Study, and 19.7 (±6.1 ng/ml in the Fortification Study. Multivariable analysis showed a 0.9 (±0.3 SE cm greater increase in height in the vitamin-D treated children, compared to placebo treated children, in the 6-month Supplementation Study (p = 0.003. Although the children in the 7-week Fortification Study intervention arm grew 0.2 (±0.1 cm more, on average, than placebo children this difference was not statistically significant (p = 0.2. There were no significant effects of vitamin D supplements on differences in changes in weight or body mass index in either trial. For the Fortification Study, girls gained more weight than boys while taking vitamin D 3 (p-value for interaction = 0.03, but sex was not an effect modifier of the relationship between vitamin D3 and

  1. Vitamin D supplementation and growth in urban Mongol school children: Results from two randomized clinical trials.

    Science.gov (United States)

    Ganmaa, Davaasambuu; Stuart, Jennifer J; Sumberzul, Nyamjav; Ninjin, Boldbaatar; Giovannucci, Edward; Kleinman, Ken; Holick, Michael F; Willett, Walter C; Frazier, Lindsay A; Rich-Edwards, Janet W

    2017-01-01

    Symptomatic vitamin D deficiency is associated with slowed growth in children. It is unknown whether vitamin D repletion in children with asymptomatic serum vitamin D deficiency can restore normal growth. We tested the impact of vitamin D-supplementation on serum concentrations of 25-hydroxyvitamin D [25(OH)D] and short-term growth in Mongol children, with very low serum vitamin D levels in winter. We conducted two randomized, double-blind, placebo-controlled trials in urban school age children without clinical signs of rickets. The Supplementation Study was a 6-month intervention with an 800 IU vitamin D3 supplement daily, compared with placebo, in 113 children aged 12-15 years. A second study, the Fortification Study, was a 7-week intervention with 710 ml of whole milk fortified with 300 IU vitamin D3 daily, compared with unfortified milk, in 235 children aged 9-11 years. At winter baseline, children had low vitamin D levels, with a mean (±SD) serum 25-hydroxyvitamin D [25(OH)D] concentration of 7.3 (±3.9) ng/ml in the Supplementation Study and 7.5 (±3.8) ng/ml in the Fortification Study. The serum levels increased in both vitamin D groups-by 19.8 (±5.1) ng/ml in the Supplementation Study, and 19.7 (±6.1) ng/ml in the Fortification Study. Multivariable analysis showed a 0.9 (±0.3 SE) cm greater increase in height in the vitamin-D treated children, compared to placebo treated children, in the 6-month Supplementation Study (p = 0.003). Although the children in the 7-week Fortification Study intervention arm grew 0.2 (±0.1) cm more, on average, than placebo children this difference was not statistically significant (p = 0.2). There were no significant effects of vitamin D supplements on differences in changes in weight or body mass index in either trial. For the Fortification Study, girls gained more weight than boys while taking vitamin D 3 (p-value for interaction = 0.03), but sex was not an effect modifier of the relationship between vitamin D3 and change

  2. Hip-Hop to Health Jr. Randomized Effectiveness Trial: 1-Year Follow-up Results.

    Science.gov (United States)

    Kong, Angela; Buscemi, Joanna; Stolley, Melinda R; Schiffer, Linda A; Kim, Yoonsang; Braunschweig, Carol L; Gomez-Perez, Sandra L; Blumstein, Lara B; Van Horn, Linda; Dyer, Alan R; Fitzgibbon, Marian L

    2016-02-01

    The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child's life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. RCT. Primarily African American children (aged 3-5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Eighteen preschools were randomly assigned in 2007-2008 to receive either (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors or (2) a 14-week teacher-delivered general health curriculum (control group). The primary outcome, BMI, was measured at baseline, postintervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively. This study is registered at www.clinicaltrials.gov NCT00241878. Copyright © 2016 American Journal of

  3. Cognitive enhancement therapy for adult autism spectrum disorder: Results of an 18-month randomized clinical trial.

    Science.gov (United States)

    Eack, Shaun M; Hogarty, Susan S; Greenwald, Deborah P; Litschge, Maralee Y; Porton, Shannondora A; Mazefsky, Carla A; Minshew, Nancy J

    2017-12-29

    Cognitive remediation is a promising approach to treating core cognitive deficits in adults with autism, but rigorously controlled trials of comprehensive interventions that target both social and non-social cognition over a sufficient period of time to impact functioning are lacking. This study examined the efficacy of cognitive enhancement therapy (CET) for improving core cognitive and employment outcomes in adult autism. Verbal adult outpatients with autism spectrum disorder (N = 54) were randomized to an 18-month, single-blind trial of CET, a cognitive remediation approach that integrates computer-based neurocognitive training with group-based training in social cognition, or an active enriched supportive therapy (EST) comparison focused on psychoeducation and condition management. Primary outcomes were composite indexes of neurocognitive and social-cognitive change. Competitive employment was a secondary outcome. Intent-to-treat analyses indicated that CET produced significant differential increases in neurocognitive function relative to EST (d = .46, P = .013). Both CET and EST were associated with large social-cognitive improvements, with CET demonstrating an advantage at 9 (d = .58, P = 0.020), but not 18 months (d = .27, P = 0.298). Effects on employment indicated that participants treated with CET were significantly more likely to gain competitive employment than those in EST, OR = 6.21, P = 0.023, which was mediated by cognitive improvement. CET is a feasible and potentially effective treatment for core cognitive deficits in adult autism spectrum disorder. The treatment of cognitive impairments in this population can contribute to meaningful improvements in adult outcomes. Autism Res 2017. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. Cognitive enhancement therapy (CET), an 18-month cognitive remediation intervention designed to improve thinking and social understanding, was found to be

  4. Blast-cooling of beef-in-sauce catering meals: numerical results based on a dynamic zero-order model

    OpenAIRE

    Jose A. Rabi; Evelyne Derens-Bertheau; Elisabeth Morelli; Isabelle Trezzani-Harbelot

    2014-01-01

    Beef-in-sauce catering meals under blast-cooling have been investigated in a research project which aims at quantitative HACCP (hazard analysis critical control point). In view of its prospective coupling to a predictive microbiology model proposed in the project, zero-order spatial dependence has proved to suitably predict meal temperatures in response to temperature variations in the cooling air. This approach has modelled heat transfer rates via the a priori unknown convective coefficient ...

  5. Search Result Clustering via Randomized Partitioning of Query-Induced Subgraphs

    Directory of Open Access Journals (Sweden)

    A. Bradic

    2009-06-01

    Full Text Available In this paper, we present an approach to search result clustering, using partitioning of underlying link graph. We define the notion of "query-induced subgraph" and formulate the problem of search result clustering as a problem of efficient partitioning of a given subgraph into topic-related clusters. Also, we propose a novel algorithm for approximative partitioning of such a graph, which results in a cluster quality comparable to the one obtained by deterministic algorithms, while operating in a more efficient computation time, suitable for practical implementations. Finally, we present a practical clustering search engine developed as a part of this research and use it to get results about real-world performance of proposed concepts.

  6. Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - Results from the randomized DAHANCA 5 and 7 trials

    DEFF Research Database (Denmark)

    Hoff, Camilla Molich; Lassen, Pernille; Eriksen, Jesper Grau

    2011-01-01

    Abstract Background. Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect...... of transfusion by the results from the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients. Material and methods....... Patients were randomized to treatment in the DAHANCA 5 and 7 study (nimorazole vs. placebo and five fx/week vs. six fx/week), and in addition, patients with "low" pre-irradiation hemoglobin values (females...

  7. Botulinum toxin type A-a novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study

    DEFF Research Database (Denmark)

    Petersen, Christina Damsted; Giraldi, Annamaria; Lundvall, Lene

    2009-01-01

    INTRODUCTION: Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. AIM: This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. METHODS: Sixty-four women were randomized...... to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. MAIN OUTCOME MEASURES: Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured...... using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). RESULTS: Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly...

  8. Effect of Educational Intervention on the Rate of Rarely Appropriate Outpatient Echocardiograms Ordered by Attending Academic Cardiologists: A Randomized Clinical Trial.

    Science.gov (United States)

    Dudzinski, David M; Bhatia, R Sacha; Mi, Michael Y; Isselbacher, Eric M; Picard, Michael H; Weiner, Rory B

    2016-10-01

    Appropriate use criteria-based educational initiatives have been shown to improve transthoracic echocardiography (TTE) ordering practices of physicians in training. Whether such an intervention is successful with attending cardiologists remains unknown. To prospectively investigate the effect of an appropriate use criteria-based educational intervention on ordering of outpatient TTEs by attending academic cardiologists. We conducted a prospective, randomized clinical trial of an educational intervention designed to reduce the number of outpatient TTEs that were deemed to be rarely appropriate by published appropriate use criteria. Investigators classifying TTEs were blinded to participant groupings. The study was conducted within the cardiology division at the Massachusetts General Hospital, an academic quaternary care hospital. Staff members of the cardiology division were included; 66 cardiologists were randomized. The study was conducted from November 19, 2013, to June 1, 2014. An analysis of the evaluable population was performed. The appropriate use criteria-based educational intervention consisted of a review lecture and electronic information card, as well as monthly individual physician feedback via email. The email described the percentage of rarely appropriate TTEs as well as the appropriate use criteria rationale for classifying studies as rarely appropriate. We hypothesized a priori that the educational intervention would reduce the number of rarely appropriate TTEs. The primary outcome was the rate of rarely appropriate TTEs. Of the 66 cardiologists enrolled in the study, 65 were included in the analysis (1 intervention cardiologist retired from practice during the study). The participants' mean (SD) age was 50.6 (10.5) years; 48 (73%) were men. Following intervention, the proportion of rarely appropriate TTEs was significantly lower in the intervention vs control group (143 of 1359 [10.5%] vs 285 of 1728 [16.5%]; odds ratio [OR], 0.59 [95% CI, 0

  9. Exit times for a class of random walks: exact distribution results

    DEFF Research Database (Denmark)

    Jacobsen, Martin

    2011-01-01

    the exit possible has a Laplace transform which is a rational function. The expected exit time is also determined and the paper concludes with exact distribution results concerning exits from bounded intervals. The proofs use simple martingale techniques together with some classical expansions...

  10. Anandron (RU 23908) associated with orchiectomy in stage D prostate cancer. Preliminary results of a randomized, double-blind study.

    Science.gov (United States)

    Namer, M; Amiel, J; Toubol, J

    1988-01-01

    A randomized, double-blind, multicenter trial was performed comparing the association of orchiectomy plus the nonsteroid antiandrogen Anandron (300 mg daily) to orchiectomy plus placebo in the treatment of patients with stage C or D prostate cancer. The results for 98 evaluable stage D patients with a median follow-up of 23.4 +/- 8.9 months are given. Although there was no statistically significant difference between the two treatments with regard to any parameter (subjective response, best objective response according to NPCP criteria, and progression-free interval and survival), the results were invariably in favor of the combined treatment, as already reported in other trials on Anandron.

  11. Endodontic surgery using 2 different magnification devices: preliminary results of a randomized controlled study.

    Science.gov (United States)

    Taschieri, Silvio; Del Fabbro, Massimo; Testori, Tiziano; Francetti, Luca; Weinstein, Roberto

    2006-02-01

    The introduction of microsurgical instruments and magnification devices has brought advantages in root-end management and the application of root-end filling materials. The main purpose of this prospective clinical study was to monitor the outcome of ultrasonic root-end preparation using magnification loupes or an endoscope. Tooth location and the presence of post restoration were also examined as potentially affecting the outcome. Teeth treated surgically showed a periradicular lesion of strictly endodontic origin. A total of 59 patients were included in the study, according to specific selection criteria. Following the reflection of a full mucoperiosteal tissue flap, residual soft tissues were curetted, root ends were resected, and root-end cavities were prepared ultrasonically with a zirconium nitrate tip, and zinc oxide EBA-reinforced cement root-end fillings were placed. Thirty-two root-end management procedures were performed using magnification loupes and 39 using an endoscope. All cases followed for a period of 1 year were classified into 3 groups (success, uncertain healing, and failure) according to radiographic and clinical criteria. Of the 71 teeth evaluated at 1-year follow-up, 67 teeth (92.95%) successfully healed, 3 teeth had uncertain healing, and 2 failed. In the group using endoscopy, 94.9% of successful healing was achieved, while for the other group, 90.6% was recorded. We found no statistically significant differences in treatment results related to the arch (P = .20), post restoration (P = .21), or type of magnification device (P = .08). In the present study, adherence to a strict endodontic surgical protocol and the use of modern surgical endodontic procedures, together with visual magnifications, resulted in an overall high success rate.

  12. Transvaginal/Transumbilical Hybrid—NOTES—Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial

    Science.gov (United States)

    Knuth, Jürgen; Cerasani, Nicola; Sauerwald, Axel; Lefering, Rolf; Heiss, Markus Maria

    2015-01-01

    Objective: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Background: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. Methods: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Results: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Conclusions: Although comparable in terms of

  13. Increasing Pap Smear Utilization Among Samoan Women: Results from a Community Based Participatory Randomized Trial

    Science.gov (United States)

    Mishra, Shiraz I.; Luce, Pat H.; Baquet, Claudia R.

    2013-01-01

    Background We tested the effectiveness of a theory-guided, culturally tailored cervical cancer education program designed to increase Pap smear use among Samoan women residing in the U.S. Territory of American Samoa. Methods We used a two-group, pretest-posttest design. The sample comprised 398 Samoan women age 20 and older who we recruited from Samoan churches. Women in the intervention group received a culturally tailored cervical cancer education program in three weekly sessions. The primary outcome was self-reported receipt of a Pap smear. Results Overall, there was a significant intervention effect, with intervention compared with control group women twice (adjusted odds ratio = 2.0, 95% confidence interval = 1.3–3.2, pPap smear use at the posttest. Conclusions The findings support the efficacy of the multifaceted, theory-guided, culturally tailored community-based participatory cervical cancer education program for Samoan women in effecting positive changes in Pap smear use and cervical cancer related knowledge and attitudes. PMID:19711495

  14. Implementing a Pilot Trial of an Infection Control Program in Nursing Homes: Results of a Matched Cluster Randomized Trial.

    Science.gov (United States)

    McConeghy, Kevin W; Baier, Rosa; McGrath, Kevin P; Baer, Christof J; Mor, Vincent

    2017-08-01

    Hand hygiene is the single-most important nursing home (NH) infection control measure. We piloted a multifaceted hand-washing/surface cleaning intervention in 5 NHs. Our aims were to assess the feasibility of implementing this intervention by assessing staff participation, satisfaction, hand-washing compliance, and whether the intervention was associated with reductions in infection rates, new antimicrobial orders, or overall hospitalization rates. We conducted a randomized, pair-matched pilot intervention in 10 Colorado NHs to reduce infections for all NH residents from October 1, 2015 through May 31, 2016. To evaluate process, we determined online education participation rates, recorded intervention fidelity through weekly reporting measures on microbial surface counts, hand-washing, and infection reporting, and conducted a survey of participating employees. To evaluate potential impacts on clinical outcomes, we collected information on monthly infection log data, new antibiotic orders, and hospitalizations. Three of 5 sites had education participation rates >90%, the other 2 were poor (13% and 23%). The majority of participation survey respondents (58%) were promoters of the intervention. Directors of nursing reported hygiene hand-washing data for 19.6/24 (81.8%) weeks and microbial surface count data for 20.4/24 (85.1%) weeks. For the first 4 weeks of the study, the bacterial counts averaged 351.4 ± 497.5 relative light units, the mean value for the last 4 weeks was 127.7 ± 85.1 (P value = .12). The number of hand-washing occasions per NH resident was steady over time but differed by treatment facility (P = .03). We observed nonsignificant reductions for total infections (6.7%) and lower respiratory tract infections (19.9%) vs control NHs. There were no significant differences in antimicrobial orders or hospitalization rates pre-post intervention. This multifaceted hand-washing and surface cleaning intervention was designed to reduce infection rates

  15. Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Craig R. Cohen

    2012-01-01

    Full Text Available Background. Bacterial vaginosis (BV has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial. Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10 were compared to those with intermediate (score 4–6 and normal flora (score 0–3. During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup. Results. 528 participants were enrolled; 213 (40% had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56 but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94 or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27 at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16% were reported using anything else but water to cleanse the vagina over the course of the trial. Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

  16. Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and U.S. Department of Agriculture Database Information: A Multisite Randomized Study.

    Science.gov (United States)

    Urban, Lorien E; Weber, Judith L; Heyman, Melvin B; Schichtl, Rachel L; Verstraete, Sofia; Lowery, Nina S; Das, Sai Krupa; Schleicher, Molly M; Rogers, Gail; Economos, Christina; Masters, William A; Roberts, Susan B

    2016-04-01

    Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ∼50% of US restaurants are individual or small-chain (non-chain) establishments that do not provide nutrition information. To measure the energy content of frequently ordered meals in non-chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non-chain restaurants, together with equivalent meals from large-chain restaurants. Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Meal energy content determined by bomb calorimetry. Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non-chain and chain meals, human energy requirements, and food database values. Meals from non-chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non-chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Non-chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized for providing excess energy. Restaurants in general, rather than specific categories of restaurant, expose patrons to

  17. Transvaginal/transumbilical hybrid--NOTES--versus 3-trocar needlescopic cholecystectomy: short-term results of a randomized clinical trial.

    Science.gov (United States)

    Bulian, Dirk Rolf; Knuth, Jürgen; Cerasani, Nicola; Sauerwald, Axel; Lefering, Rolf; Heiss, Markus Maria

    2015-03-01

    For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Although comparable in terms of safety, TVC caused less pain, increased satisfaction

  18. Does transfusion improve the outcome for HNSCC patients treated with radiotherapy? - results from the randomized DAHANCA 5 and 7 trials

    DEFF Research Database (Denmark)

    Hoff, Camilla; Lassen, Pernille; Eriksen, Jesper Grau

    2011-01-01

    Patients with head and neck squamous cell carcinoma (HNSCC) and a low level of hemoglobin often have a poor response to radiation that may be related to hypoxia-induced radioresistance. We have previously published the importance of hemoglobin level and the effect of transfusion by the results from...... the randomized DAHANCA 5 trial, including 414 patients in the analysis. Aim of the current analysis was to gain additional power by adding patients from the continued subrandomization in the DAHANCA 7 trial, now including a total of almost 1200 patients....

  19. 78 FR 78165 - Orders: Reporting by Regulated Entities of Stress Testing Results as of September 30, 2013...

    Science.gov (United States)

    2013-12-26

    ... 30, 2013; Revision and Amendments to Summary Instructions and Guidance AGENCY: Federal Housing...-FHLMC-2 Reporting by Regulated Entities of Stress Testing Results as of September 30, 2013 Whereas...'') requires certain financial companies with total consolidated assets of more than $10 billion, and which are...

  20. Ordering blood tests for patients with unexplained fatigue in general practice: what does it yield? Results of the VAMPIRE trial.

    NARCIS (Netherlands)

    Koch, H.; Bokhoven, M.A. van; Riet, G. ter; Alphen-Jager, J.T. van; Weijden, T.T. van der; Dinant, G.J.; Bindels, P.J.

    2009-01-01

    BACKGROUND: Unexplained fatigue is frequently encountered in general practice. Because of the low prior probability of underlying somatic pathology, the positive predictive value of abnormal (blood) test results is limited in such patients. AIM: The study objectives were to investigate the

  1. Ordering blood tests for patients with unexplained fatigue in general practice: what does it yield? Results of the VAMPIRE trial

    NARCIS (Netherlands)

    Koch, Hèlen; van Bokhoven, Marloes A.; ter Riet, Gerben; van Alphen-Jager, Jm Tineke; van der Weijden, Trudy; Dinant, Geert-Jan; Bindels, Patrick Je

    2009-01-01

    Background Unexplained fatigue is frequently encountered in general practice. Because of the low prior probability of underlying somatic pathology, the positive predictive value of abnormal (blood) test results is limited in such patients. Aim The study objectives were to investigate the

  2. Effects of phlebotomy-induced reduction of body iron stores on metabolic syndrome: results from a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Houschyar Khosrow S

    2012-05-01

    Full Text Available Abstract Background Metabolic syndrome (METS is an increasingly prevalent but poorly understood clinical condition characterized by insulin resistance, glucose intolerance, dyslipidemia, hypertension, and obesity. Increased oxidative stress catalyzed by accumulation of iron in excess of physiologic requirements has been implicated in the pathogenesis of METS, but the relationships between cause and effect remain uncertain. We tested the hypothesis that phlebotomy-induced reduction of body iron stores would alter the clinical presentation of METS, using a randomized trial. Methods In a randomized, controlled, single-blind clinical trial, 64 patients with METS were randomly assigned to iron reduction by phlebotomy (n = 33 or to a control group (n = 31, which was offered phlebotomy at the end of the study (waiting-list design. The iron-reduction patients had 300 ml of blood removed at entry and between 250 and 500 ml removed after 4 weeks, depending on ferritin levels at study entry. Primary outcomes were change in systolic blood pressure (SBP and insulin sensitivity as measured by Homeostatic Model Assessment (HOMA index after 6 weeks. Secondary outcomes included HbA1c, plasma glucose, blood lipids, and heart rate (HR. Results SBP decreased from 148.5 ± 12.3 mmHg to 130.5 ± 11.8 mmHg in the phlebotomy group, and from 144.7 ± 14.4 mmHg to 143.8 ± 11.9 mmHg in the control group (difference -16.6 mmHg; 95% CI -20.7 to -12.5; P Conclusions In patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control. Blood donation may have beneficial effects for blood donors with METS. Trial registration ClinicalTrials.gov: NCT01328210 Please see related article: http://www.biomedcentral.com/1741-7015/10/53

  3. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial

    Science.gov (United States)

    Kropff, Martin; Baylon, Honorata Giongco; Hillengass, Jens; Robak, Tadeusz; Hajek, Roman; Liebisch, Peter; Goranov, Stefan; Hulin, Cyrille; Bladé, Joan; Caravita, Tommaso; Avet-Loiseau, Herve; Moehler, Thomas M.; Pattou, Claire; Lucy, Lela; Kueenburg, Elisabeth; Glasmacher, Axel; Zerbib, Robert; Facon, Thierry

    2012-01-01

    Background Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. Design and Methods We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. Results In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. Conclusions Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. (Clinical trial registration number: NCT00452569) PMID:22133776

  4. Pharmacokinetics of lacosamide and omeprazole coadministration in healthy volunteers: results from a phase I, randomized, crossover trial.

    Science.gov (United States)

    Cawello, Willi; Mueller-Voessing, Christa; Fichtner, Andreas

    2014-05-01

    The antiepileptic drug lacosamide has a low potential for drug-drug interactions, but is a substrate and moderate inhibitor of the cytochrome P450 (CYP) enzyme CYP2C19. This phase I, randomized, open-label, two-way crossover trial evaluated the pharmacokinetic effects of lacosamide and omeprazole coadministration. Healthy, White, male volunteers (n = 36) who were not poor metabolizers of CYP2C19 were randomized to treatment A (single-dose 40 mg omeprazole on days 1 and 8 together with 6 days of multiple-dose lacosamide [200-600 mg/day] on days 3-8) and treatment B (single doses of 300 mg lacosamide on days 1 and 8 with 7 days of 40 mg/day omeprazole on days 3-9) in pseudorandom order, separated by a ≥ 7-day washout period. Area under the concentration-time curve (AUC) and peak concentration (C(max)) were the primary pharmacokinetic parameters measured for lacosamide or omeprazole administered alone (reference) or in combination (test). Bioequivalence was determined if the 90 % confidence interval (CI) of the ratio (test/reference) fell within the acceptance range of 0.8-1.25. The point estimates (90 % CI) of the ratio of omeprazole + lacosamide coadministered versus omeprazole alone for AUC (1.098 [0.996-1.209]) and C(max) (1.105 [0.979-1.247]) fell within the acceptance range for bioequivalence. The point estimates (90 % CI) of the ratio of lacosamide + omeprazole coadministration versus lacosamide alone also fell within the acceptance range for bioequivalence (AUC 1.133 [1.102-1.165]); C(max) 0.996 (0.947-1.047). Steady-state lacosamide did not influence omeprazole single-dose pharmacokinetics, and multiple-dose omeprazole did not influence lacosamide single-dose pharmacokinetics.

  5. Strengths of early physical rehabilitation programs in surgical breast cancer patients: results of a randomized controlled study.

    Science.gov (United States)

    Testa, A; Iannace, C; Di Libero, L

    2014-06-01

    In the immediate postoperative period surgical breast cancer patients can face many problems including functional limitation of the shoulder, edema, pain and depression. Although those symptoms can alleviate during the stages of the therapeutic route, most of the time concur significantly to the everyday life discomforts decreasing sharply the quality of life. Therefore, is essential to pay attention to the functional problems of breast cancer patients in order to ensure a quick and complete physical and psychosocial recovery. Aim of this study, comparing 2 groups of patients, one that underwent to early physical rehabilitation program (EPRP) and one as a control group, is to evaluate: functional improvements of the glenohumeral joint mobility, antalgic effect of EPRP, improvements and/or worsening of quality of life. Randomized controlled study. Inpatient and outpatient clinic, Breast Unit, "San Giuseppe Moscati" Hospital, Avellino, Italy. Seventy women planned for Madden's modified radical mastectomy or for segmental mastectomy with axillary dissection in the period from March 2010 to February 2011. Patients were randomly assigned to treated and control group. All participants were evaluated before surgery and postoperatively at fifth day, first, sixth and twelfth month. Patients of the treated group, underwent first, to assisted cautious mobilization of hand, wrist and elbow and after drainage removal, to twenty physiotherapy sessions under the guide of a physiotherapist. Within group statistical analysis evidenced that TG regained normal function at 1 year after surgery while CG was unable to do so for flexion, abduction and internal rotation movements. TG manifested general and statistically significative improvements in QoL. Improvements in the grade of pain perceived were observed starting from the first postoperative month. Postoperative early physical rehabilitation programme in surgical breast cancer patients surgically treated significantly improves

  6. Comorbidity and temporal ordering of alcohol use disorders and other psychiatric disorders: results from a Danish register-based study

    DEFF Research Database (Denmark)

    Flensborg-Madsen, Trine; Mortensen, Erik Lykke; Knop, Joachim

    2009-01-01

    BACKGROUND: Understanding the comorbidity of alcohol use disorders (AUD) and other psychiatric disorders may have important implications for treatment and preventive interventions. However, information on the epidemiology of this comorbidity is lacking. The objective of this study was to present...... results on lifetime psychiatric comorbidity of AUD in a large Danish community population. METHODS: A prospective cohort study was used, comprising 3 updated measures of sets of lifestyle covariates and 26 years of follow-up data on 18,146 individuals from the Copenhagen City Heart Study, Denmark....... The study population was linked to national Danish hospital registers and a greater Copenhagen alcohol unit treatment register to detect registrations with AUD and other psychiatric disorders. RESULTS: Of the individuals invited to the study, 7.6% were registered with AUD, and among these, 50.3% had...

  7. Effects of the Resident Assessment Instrument in home care settings: results of a cluster randomized controlled trial.

    Science.gov (United States)

    Stolle, C; Wolter, A; Roth, G; Rothgang, H

    2012-06-01

    Deficits in quality, a lack of professional process management and, most importantly, neglect of outcome quality are criticized in long-term care. A cluster randomized, controlled trial was conducted to assess whether the Resident Assessment Instrument (RAI) can help to improve or stabilize functional abilities (ADL, IADL) and cognitive skills (MMST), improve quality of life (EQ-5D), and reduce institutionalization, thereby, increasing outcome quality. A total of 69 home care services throughout Germany were included and randomized. The treatment group (n = 36) received training in RAI and was supported by the research team during the study (13 months). Comparison of mean differences between the treatment and control groups (n = 33) showed no significant effect. Although the multilevel regression results show that clients in the treatment group fared better in terms of ADLs and IADLs (smaller decline) and were less likely to move to nursing homes and be hospitalized, none of these effects is significant. The lack of significance might result from the small number of clients included in the study. Moreover, RAI was not fully implemented and even partial implementation required more time than expected.

  8. Botulinum Toxin to Improve Results in Cleft Lip Repair: A Double-Blinded, Randomized, Vehicle-Controlled Clinical Trial

    Science.gov (United States)

    Chang, Chun-Shin; Wallace, Christopher Glenn; Hsiao, Yen-Chang; Chang, Chee-Jen; Chen, Philip Kuo-Ting

    2014-01-01

    Background Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. Methods In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR) surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30) or vehicle (normal saline; n = 30) injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS), Visual Analogue Scale (VAS) and photographic plus ultrasound measurements of scar widths. Results 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. Conclusion Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. Trial Registration ClinicalTrials.gov NCT01429402 PMID:25541942

  9. Improving classroom learning environments by Cultivating Awareness and Resilience in Education (CARE): results of a randomized controlled trial.

    Science.gov (United States)

    Jennings, Patricia A; Frank, Jennifer L; Snowberg, Karin E; Coccia, Michael A; Greenberg, Mark T

    2013-12-01

    Cultivating Awareness and Resilience in Education (CARE for Teachers) is a mindfulness-based professional development program designed to reduce stress and improve teachers' performance and classroom learning environments. A randomized controlled trial examined program efficacy and acceptability among a sample of 50 teachers randomly assigned to CARE or waitlist control condition. Participants completed a battery of self-report measures at pre- and postintervention to assess the impact of the CARE program on general well-being, efficacy, burnout/time pressure, and mindfulness. Participants in the CARE group completed an evaluation of the program after completing the intervention. ANCOVAs were computed between the CARE group and control group for each outcome, and the pretest scores served as a covariate. Participation in the CARE program resulted in significant improvements in teacher well-being, efficacy, burnout/time-related stress, and mindfulness compared with controls. Evaluation data showed that teachers viewed CARE as a feasible, acceptable, and effective method for reducing stress and improving performance. Results suggest that the CARE program has promise to support teachers working in challenging settings and consequently improve classroom environments. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  10. Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Bush, David A., E-mail: dbush@llu.edu [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Smith, Jason C. [Department of Diagnostic Radiology, Loma Linda University Medical Center, Loma Linda, California (United States); Slater, Jerry D. [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Volk, Michael L. [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Reeves, Mark E. [VA Loma Linda Health Care System, Loma Linda, California (United States); Cheng, Jason [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Grove, Roger [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Vera, Michael E. de [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States)

    2016-05-01

    Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are

  11. Implementation of Treat-to-Target in Rheumatoid Arthritis Through a Learning Collaborative: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Solomon, Daniel H; Losina, Elena; Lu, Bing; Zak, Agnes; Corrigan, Cassandra; Lee, Sara B; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie R; Pincus, Theodore; Radner, Helga; Yu, Zhi; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N

    2017-07-01

    Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. © 2017, American College of Rheumatology.

  12. Long-term results of a randomized clinical trial comparing Roux-en-Y gastric bypass with vertical banded gastroplasty.

    Science.gov (United States)

    Werling, M; Fändriks, L; Björklund, P; Maleckas, A; Brandberg, J; Lönroth, H; le Roux, C W; Olbers, T

    2013-01-01

    The long-term results of Roux-en-$\\hbox{Y}$ gastric bypass (gastric bypass) and vertical banded gastroplasty (VBG) from randomized studies have not been described in detail. Patients were randomized to gastric bypass or VBG. Body mass index (BMI), body composition, eating habits and gastrointestinal hormones were reviewed after 6 years. The frequency of reoperation was assessed up to 10 years after surgery. Sixty-six (80 per cent) of the 82 subjects randomized were assessed for weight and BMI 6 years after surgery, 30 (81 per cent) in the gastric bypass group and 36 (80 per cent) in the VBG group. Intention-to-treat analysis demonstrated greater weight loss after gastric bypass compared with VBG, 6 years after surgery: BMI reduced from 41·8 (95 per cent confidence interval 41·3 to 42·3) to 30·3 (28·6 to 32·0) kg/m(2) for gastric bypass and from 42·3 (42·8 to 44·8) to 32·9 (31·3 to 34·5) kg/m(2) for VBG (P = 0·036). Gastric bypass caused a larger loss of fat mass (P = 0·026) and better preservation of lean tissue (P = 0·009). Patients having a gastric bypass had greater postprandial responses to the satiety hormones glucagon-like peptide 1 and peptide YY (P = 0·003 and P = 0·004 respectively). Ghrelin levels did not differ between the groups. Patients with a gastric bypass maintained a lower intake of fat compared with those having VBG (P = 0·013). Some 89 per cent of patients who initially had VBG had undergone, or were scheduled for, conversion to gastric bypass at latest follow-up. Gastric bypass was superior to VBG regarding weight loss, body composition, dietary composition and postprandial satiety hormone responses. Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  13. Intensive Psychosocial Intervention Enhances Functioning in Patients With Bipolar Depression: Results From a 9-Month Randomized Controlled Trial

    Science.gov (United States)

    Miklowitz, David J.; Otto, Michael W.; Frank, Ellen; Reilly-Harrington, Noreen A.; Kogan, Jane N.; Sachs, Gary S.; Thase, Michael E.; Calabrese, Joseph R.; Marangell, Lauren B.; Ostacher, Michael J.; Patel, Jayendra; Thomas, Marshall R.; Araga, Mako; Gonzalez, Jodi M.; Wisniewski, Stephen R.

    2013-01-01

    Objective Psychosocial interventions are effective adjuncts to pharmacotherapy in delaying recurrences of bipolar disorder; however, to date their effects on life functioning have been given little attention. In a randomized trial, the authors examined the impact of intensive psychosocial treatment plus pharmacotherapy on the functional outcomes of patients with bipolar disorder over the 9 months following a depressive episode. Method Participants were 152 depressed outpatients with bipolar I or bipolar II disorder in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study. All patients received pharmacotherapy. Eighty-four patients were randomly assigned to intensive psychosocial intervention (30 sessions over 9 months of interpersonal and social rhythm therapy, cognitive behavior therapy [CBT], or family-focused therapy), and 68 patients were randomly assigned to collaborative care (a 3-session psychoeducational treatment). Independent evaluators rated the four subscales of the Longitudinal Interval Follow-Up Evaluation–Range of Impaired Functioning Tool (LIFE-RIFT) (relationships, satisfaction with activities, work/role functioning, and recreational activities) through structured interviews given at baseline and every 3 months over a 9-month period. Results Patients in intensive psychotherapy had better total functioning, relationship functioning, and life satisfaction scores over 9 months than patients in collaborative care, even after pretreatment functioning and concurrent depression scores were covaried. No effects of psychosocial intervention were observed on work/role functioning or recreation scores during this 9-month period. Conclusions Intensive psychosocial treatment enhances relationship functioning and life satisfaction among patients with bipolar disorder. Alternate interventions focused on the specific cognitive deficits of individuals with bipolar disorder may be necessary to enhance vocational functioning

  14. Physicians' knowledge and attitude towards adverse event reporting system and result to intervention--randomized nested trial among Bulgarian physicians.

    Science.gov (United States)

    Stoynova, Veselina; Getov, Ilko N; Naseva, Emilia K; Lebanova, Hristina V; Grigorov, Evgeni E

    2013-08-01

    To identify the factors that influence physicians' under-reporting in Bulgaria and their attitude towards adverse event reporting system and to estimate the role of self-education by providing educational materials. A randomized nested trial among physicians-general practitioners and specialists in Bulgaria was conducted by a validated questionnaire in order to evaluate their knowledge and attitude towards adverse event reporting system. One month after the intervention the participants were re-visited and were asked to answer the same questions again in order to estimate the change in their knowledge and attitude towards pharmacovigilance system and to obtain their evaluation for the materials provided. The response rate was 91. Fifty seven (46.3%) physicians were not familiar with the pharmacovigilance system. The most common reason for non-reporting adverse drug reactions (ADRs) was uncertainty concerning the relationship between the suspected drug and ADRs, the ADRs were already known and the fact that the physician was not aware where they should report. Although 103 (83.7%) respondents in the entry survey and by 102 (82.9%) of those participating in the exit survey consider ADRs reporting as their obligation (p more than 0.05), only 50 (40.7%) and 31 (25.2%), respectively answered that they had ever reported ADRs; 109 (88.6%) of the surveyed physicians assessed the provided educational materials as useful for them. The physicians in Bulgaria have poor knowledge for the pharmacovigilance system; however self-education leads to a better knowledge and positive attitude towards ADRs reporting system. National drug regulatory authority should play a more active role in improving physicians' adherence to the ADRs reporting systems and the developed educational pack can be used in nationwide campaign.

  15. Media Use and Source Trust among Muslims in Seven Countries: Results of a Large Random Sample Survey

    Directory of Open Access Journals (Sweden)

    Steven R. Corman

    2013-12-01

    Full Text Available Despite the perceived importance of media in the spread of and resistance against Islamist extremism, little is known about how Muslims use different kinds of media to get information about religious issues, and what sources they trust when doing so. This paper reports the results of a large, random sample survey among Muslims in seven countries Southeast Asia, West Africa and Western Europe, which helps fill this gap. Results show a diverse set of profiles of media use and source trust that differ by country, with overall low trust in mediated sources of information. Based on these findings, we conclude that mass media is still the most common source of religious information for Muslims, but that trust in mediated information is low overall. This suggests that media are probably best used to persuade opinion leaders, who will then carry anti-extremist messages through more personal means.

  16. Randomized controlled clinical pilot trial of titanium vs. glass fiber prefabricated posts: preliminary results after up to 3 years.

    Science.gov (United States)

    Naumann, Michael; Sterzenbac, Guido; Alexandra, Franke; Dietrich, Thomas

    2007-01-01

    This randomized parallel-group clinical pilot study aimed to compare the clinical outcome of prefabricated rigid titanium to glass fiber endodontic posts when luted with self-adhesive universal resin cement. Ninety-eight patients in need of postendodontic restoration were assessed for eligibility. Ninety-one patients met the selection criteria and were randomized and allocated to 2 intervention groups. Forty-five participants were treated using a titanium post and 46 participants received a glass fiber post, each in combination with composite core buildups for postendodontic restoration. All posts had a diameter of 1.4 mm and a length of 13 mm and were cemented 8 mm within the root canal with self-adhesive universal resin cement. A circumferential ferrule of 2 mm was always provided. Surgical crown lengthening was necessary in 13 cases. Patients were observed in intervals of 3, 6, 12, 24, and 36 months after post placement. After 24 to 36 months (mean +/- SD: 27.9 +/- 5.6) of observation following post placement, 1 tooth was extracted because of changes of the prosthetic treatment plan. No failures were observed among the 88 patients with follow-up data. Both titanium and glass fiber reinforced composite posts result in successful treatment outcomes after 2 years. The material combination used seems to be appropriate in the short term for cementing endodontic posts, irrespective of the post material.

  17. 10-year results of a new low-monomer cement: follow-up of a randomized RSA study.

    Science.gov (United States)

    Söderlund, Per; Dahl, Jon; Röhrl, Stephan; Nivbrant, Bo; Nilsson, Kjell G

    2012-12-01

    The properties and performance of a new low-monomer cement were examined in this prospective randomized, controlled RSA study. 5-year data have already been published, showing no statistically significant differences compared to controls. In the present paper we present the 10-year results. 44 patients were originally randomized to receive total hip replacement with a Lubinus SPII titanium-aluminum-vanadium stem cemented either with the new Cemex Rx bone cement or with control bone cement, Palacos R. Patients were examined using RSA, Harris hip score, and conventional radiographs. At 10 years, 33 hips could be evaluated clinically and 30 hips could be evaluated with RSA (16 Cemex and 14 Palacos). 9 patients had died and 4 patients were too old or infirm to be investigated. Except for 1 hip that was revised for infection after less than 5 years, no further hips were revised before the 10-year follow-up. There were no statistically significant clinical differences between the groups. The Cemex cement had magnitudes of migration similar to or sometimes lower than those of Palacos cement. In both groups, most hips showed extensive radiolucent lines, probably due to the use of titanium alloy stems. At 10 years, the Cemex bone cement tested performed just as well as the control (Palacos bone cement).

  18. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Chun-Shin Chang

    Full Text Available Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds.In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30 or vehicle (normal saline; n = 30 injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS, Visual Analogue Scale (VAS and photographic plus ultrasound measurements of scar widths.58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group.Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing.ClinicalTrials.gov NCT01429402.

  19. Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

    Science.gov (United States)

    Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

    2012-06-01

    To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

  20. INTERACTIVE WORKSHOPS TO PROMOTE GENDER EQUITY AND FAMILY PLANNING IN RURAL COMMUNITIES OF GUATEMALA: RESULTS OF A COMMUNITY RANDOMIZED STUDY.

    Science.gov (United States)

    Schuler, Sidney Ruth; Nanda, Geeta; Ramírez, Luis F; Chen, Mario

    2015-09-01

    In Guatemala, especially in rural areas, gender norms contribute to high fertility and closely spaced births by discouraging contraceptive use and constraining women from making decisions regarding the timing of their pregnancies and the size of their families. Community workshops for men, women and couples were conducted in 30 rural communities in Guatemala to test the hypothesis that the promotion of gender equity in the context of reproductive health will contribute to gender-equitable attitudes and strengthen the practice of family planning. Communities were randomly assigned to intervention and control groups. Pre/post surveys were conducted. Odds ratios estimated with mixed effect models to account for community-level randomization and repeated measures per participant were compared. The analyses showed statistically significant effects of the intervention on two of the three outcomes examined: gender attitudes and contraceptive knowledge. Findings regarding contraceptive use were suggestive but not significant. The results suggest that it is possible to influence both inequitable gender norms and reproductive health knowledge and, potentially, behaviours in a short span of time using appropriately designed communications interventions that engage communities in re-thinking the inequitable gender norms that act as barriers to health.

  1. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial.

    Science.gov (United States)

    Weinhold, Jan; Hunger, Christina; Bornhäuser, Annette; Link, Leoni; Rochon, Justine; Wild, Beate; Schweitzer, Jochen

    2013-10-01

    The study examined the efficacy of nonrecurring family constellation seminars on psychological health. We conducted a monocentric, single-blind, stratified, and balanced randomized controlled trial (RCT). After choosing their roles for participating in a family constellation seminar as either active participant (AP) or observing participant (OP), 208 adults (M = 48 years, SD = 10; 79% women) from the general population were randomly allocated to the intervention group (IG; 3-day family constellation seminar; 64 AP, 40 OP) or a wait-list control group (WLG; 64 AP, 40 OP). It was predicted that family constellation seminars would improve psychological functioning (Outcome Questionnaire OQ-45.2) at 2-week and 4-month follow-ups. In addition, we assessed the impact of family constellation seminars on psychological distress and motivational incongruence. The IG showed significantly improved psychological functioning (d = 0.45 at 2-week follow-up, p = .003; d = 0.46 at 4-month follow-up, p = .003). Results were confirmed for psychological distress and motivational incongruence. No adverse events were reported. This RCT provides evidence for the efficacy of family constellation in a nonclinical population. The implications of the findings are discussed.

  2. C-class functions with new approach on coincidence point results for generalized [Formula: see text]-weakly contractions in ordered b-metric spaces.

    Science.gov (United States)

    Mustafa, Zead; Jaradat, Mohammed M M; Ansari, Arslan Hojat; Popović, Branislav Z; Jaradat, Husein M

    2016-01-01

    In this paper, by using the C-class functions and a new approach we present some coincidence point results for four mappings satisfying generalized [Formula: see text]-weakly contractive condition in the setting of ordered b-metric spaces. Also, an application and example are given to support our results.

  3. A Result on Order Statistics

    OpenAIRE

    Wang, Jianqi; Love, David J.; Zoltowski, Michael D.

    2007-01-01

    This work was supported in part by the Department of Defense (administered by the United States Air Force Office of Scientific Research) under Grant No. AFOSR F49620-03-1-0149, the SBC Foundation, and the National Science Foundation under Grant CCF-0513916.

  4. 1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass.

    Science.gov (United States)

    Reijnen, Michel M P J; van Walraven, Laurens A; Fritschy, Wilbert M; Lensvelt, Mare M A; Zeebregts, Clark J; Lemson, M Suzanna; Wikkeling, Otmar R M; Smeets, Luuk; Holewijn, Suzanne

    2017-11-27

    This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates. Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion. A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner. A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed

  5. Imagine HEALTH: results from a randomized pilot lifestyle intervention for obese Latino adolescents using Interactive Guided ImagerySM.

    Science.gov (United States)

    Weigensberg, Marc J; Lane, Christianne J; Ávila, Quintilia; Konersman, Kati; Ventura, Emily; Adam, Tanja; Shoar, Zohreh; Goran, Michael I; Spruijt-Metz, Donna

    2014-01-17

    There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type 2 diabetes and cardiovascular disease risk in obese Latino adolescents. Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents. Our objectives were: 1) To pilot test a new 12-wk lifestyle intervention using a randomized trial design in obese Latino adolescents, in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM (IGI), over and above those of a didactic lifestyle education, on insulin resistance, eating and physical activity behaviors, stress and stress biomarkers; and 2) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes, particularly insulin resistance. Obese (BMI > 95th percentile), Latino adolescents (n = 35, age 14-17) were randomized to receive either 12 weekly sessions of a lifestyle education plus guided imagery program (GI), or lifestyle education plus a digital storytelling computer program (DS). Between-group differences in behavioral, biological, and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the 29 subjects who completed the intervention. The GI group demonstrated significant reductions in leisure sedentary behavior (p < .05) and increases in moderate physical activity (p < .05) compared to DS group, and a trend toward reduced caloric intake in GI vs DS (p = .09). Salivary cortisol was acutely reduced by stress-reduction guided imagery (p < .01). There were no group differences in adiposity, insulin resistance, perceived stress, or stress biomarkers across the 12-week intervention, though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity (p = .03) independent of intervention group and

  6. Effect of individualized communication skills training on physicians' discussion of clinical trials in oncology: results from a randomized controlled trial.

    Science.gov (United States)

    Wuensch, Alexander; Goelz, Tanja; Ihorst, Gabriele; Terris, Darcey D; Bertz, Hartmut; Bengel, Juergen; Wirsching, Michael; Fritzsche, Kurt

    2017-04-13

    Discussing randomized clinical trials (RCTs) with cancer patients is one of the most challenging communication tasks a physician faces. Only two prior Communication Skills Trainings (CSTs) focused on RCTs in oncology have been reported. Their results demonstrated the need for further improvement. We developed and evaluated an enhanced, individually-tailored CST focused on improving physicians' communication during discussions of RCTs. The CST focused on personal learning goals derived from video pre-assessment that were addressed in a 1.5-day group workshop and one-on-one coaching sessions. Forty physicians were recruited and randomly assigned to intervention and control groups. Video-recorded standardized consultations with actor-patients were utilized. As a primary outcome (1), training success was evaluated by blinded raters using a previously developed checklist. Change in checklist items was evaluated between pre- and post-training assessment and compared against control group results. As a secondary outcome (2), the physicians' feeling of confidence was assessed by a questionnaire. (1) Significant improvements in the intervention group were observed for the score on all items (p = 0.03), for the subgroup of content-specific items (p = 0.02), and for the global rating of communication competence (p = 0.04). The improvement observed for the subgroup of general communication skill items did not achieve significance (p = 0.20). (2) The feeling of confidence improved in nine out of ten domains. While the individually-tailored CST program significantly improved the physicians' discussions of RCTs, specifically related to discussion content, what remains unknown is the influence of such programs in practice on participant recruitment rates. The study was registered retrospectively in 2010/07/22 under DRKS-ID: DRKS00000492 .

  7. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial

    Science.gov (United States)

    Reich, Richard R.; Paterson, Carly L.; Ramesar, Sophia; Park, Jong Y.; Alinat, Carissa; Johnson-Mallard, Versie; Moscoso, Manolete; Budhrani-Shani, Pinky; Miladinovic, Branko; Jacobsen, Paul B.; Cox, Charles E.; Goodman, Matthew; Kip, Kevin E.

    2016-01-01

    Purpose The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. Patients and Methods A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. Results Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). Conclusion The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes. PMID:27247219

  8. HealthWorks: results of a multi-component group-randomized worksite environmental intervention trial for weight gain prevention

    Directory of Open Access Journals (Sweden)

    Linde Jennifer A

    2012-02-01

    Full Text Available Abstract Background U.S. adults are at unprecedented risk of becoming overweight or obese, and most scientists believe the primary cause is an obesogenic environment. Worksites provide an opportunity to shape the environments of adults to reduce obesity risk. The goal of this group-randomized trial was to implement a four-component environmental intervention at the worksite level to positively influence weight gain among employees over a two-year period. Environmental components focused on food availability and price, physical activity promotion, scale access, and media enhancements. Methods Six worksites in a U.S. metropolitan area were recruited and randomized in pairs at the worksite level to either a two-year intervention or a no-contact control. Evaluations at baseline and two years included: 1 measured height and weight; 2 online surveys of individual dietary intake and physical activity behaviors; and 3 detailed worksite environment assessment. Results Mean participant age was 42.9 years (range 18-75, 62.6% were women, 68.5% were married or cohabiting, 88.6% were white, 2.1% Hispanic. Mean baseline BMI was 28.5 kg/m2 (range 16.9-61.2 kg/m2. A majority of intervention components were successfully implemented. However, there were no differences between sites in the key outcome of weight change over the two-year study period (p = .36. Conclusions Body mass was not significantly affected by environmental changes implemented for the trial. Results raise questions about whether environmental change at worksites is sufficient for population weight gain prevention. Trial Registration ClinicalTrials.gov: NCT00708461

  9. Radial Access Reduces Mortality in Patients With Acute Coronary Syndromes: Results From an Updated Trial Sequential Analysis of Randomized Trials.

    Science.gov (United States)

    Andò, Giuseppe; Capodanno, Davide

    2016-04-11

    The authors sought to investigate whether the cumulative evidence coming from randomized studies has reached the necessary power to consider radial access as a bleeding avoidance strategy that reduces mortality and ischemic endpoints in patients with acute coronary syndromes (ACS). Studies in ACS patients have reached conflicting conclusions about the impact of radial access in improving ischemic outcomes in addition to the established bleeding benefit. English-language publications and abstracts of major cardiovascular meetings until October 2015 were scrutinized. Study quality, patient characteristics, procedural data, and outcomes were extracted. Data were pooled in random effects meta-analyses with classic and trial sequential techniques. Trial sequential analysis combines the a priori information size calculation needed to allow for clinically meaningful statistical inference with the adjustment of thresholds for which results are considered significant. Seventeen studies, encompassing data from 19,328 patients, were pooled. Radial access was found to reduce mortality (relative risk [RR]: 0.73; 95% confidence interval [CI]: 0.60 to 0.88; p = 0.001), major adverse cardiovascular events (RR: 0.86; 95% CI: 0.77 to 0.95; p = 0.005), and major bleeding (RR: 0.60; 95% CI: 0.48 to 0.76; p < 0.001). Multiple sensitivity analyses showed consistent results, and trial sequential analysis suggested firm evidence for a meaningful reduction in mortality with radial access. Radial access reduces mortality compared with femoral access in ACS patients undergoing invasive management. This benefit is paralleled by consistent reductions in major adverse cardiovascular events and major bleeding, supporting radial access as the default strategy for cardiac catheterization in patients with ACS. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Yoga decreases kyphosis in senior women and men with adult onset hyperkyphosis: results of a randomized controlled trial

    Science.gov (United States)

    Greendale, Gail A.; Huang, Mei-Hua; Karlamangla, Arun S.; Seeger, Leanne; Crawford, Sybil

    2013-01-01

    Objective To assess whether a specifically designed Yoga intervention can reduce hyperkyphosis. Design A 6-month, 2 group, randomized, controlled, single masked trial. Setting Community research unit. Participants 118 women and men aged >60 years with kyphosis angle >40 degrees. Major exclusions were: serious medical comorbidity; use of assistive device; unable to hear or see adequately for participation; or unable to pass a physical safety screen. Intervention The active treatment group attended hour-long Yoga classes, 3 days per week, for 24 weeks. The control group attended a monthly luncheon/seminar and received mailings. Measurements Primary outcomes were change (baseline to 6 months) in Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach and walking speed. Secondary outcomes were change in: kyphosis index, flexicurve kyphosis angle, the Rancho Bernardo Blocks posture assessment and health-related quality of life (HRQOL). Results Compared to control participants, those randomized to Yoga experienced a 4.4% improvement in flexicurve kyphosis angle (p=0.006) and a 5% improvement in kyphosis index (p=0.004). The intervention did not result in statistically significant improvement in Debrunner kyphometer angle, measured physical performance or in self-assessed HRQOL (each p>0.1). Conclusion The decrease in flexicurve kyphosis angle in the Yoga treatment group shows that hyperkyphosis is remediable, a critical first step in the pathway to treating or preventing this condition. Larger, more definitive studies of Yoga or other interventions for hyperkyphosis should be considered. Targeting individuals with more malleable spines and using longitudinally precise measures of kyphosis could strengthen the treatment effect. PMID:19682114

  11. The treatment of disc herniation-induced sciatica with infliximab - Results of a randomized, controlled, 3-month follow-up study

    NARCIS (Netherlands)

    Korhonen, T; Karppinen, J; Paimela, L; Malmivaara, A; Lindgren, KA; Jarvinen, S; Niinimaki, J; Veeger, N; Seitsalo, S; Hurri, H

    2005-01-01

    Study Design. A randomized controlled trial. Objectives. To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. Summary of Background Data. Recently, we obtained encouraging results in an open-label study of

  12. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial.

    Science.gov (United States)

    Macías-Rodríguez, Ricardo U; Ilarraza-Lomelí, Hermes; Ruiz-Margáin, Astrid; Ponce-de-León-Rosales, Sergio; Vargas-Vorácková, Florencia; García-Flores, Octavio; Torre, Aldo; Duarte-Rojo, Andrés

    2016-07-14

    Exercise has been scarcely studied in patients with cirrhosis, and prior evidence showed hepatic venous pressure gradient (HVPG) to be increased in response to exercise. The aim of this study was to investigate the effects of a supervised physical exercise program (PEP) in patients with cirrhosis. In an open-label, pilot clinical trial, patients with cirrhosis were randomized to PEP (cycloergometry/kinesiotherapy plus nutritional therapy, n=14) or control (nutritional therapy, n=15); for 14 weeks. Primary outcomes were: the effect of PEP in HVPG, and quality of life (chronic liver disease questionnaire, CLDQ). As secondary outcomes we investigated changes in physical fitness (cardiopulmonary exercise testing), nutritional status (phase angle-bioelectrical impedance), ammonia levels, and safety. Twenty-two patients completed the study (11 each). HVPG decreased in subjects allocated to PEP (-2.5 mm Hg (interquartile range: -5.25 to 2); P=0.05), and increased in controls (4 mm Hg (0-5); P=0.039), with a significant between-groups difference (P=0.009). No major changes were noted in CLDQ in both groups. There was significant improvement in ventilatory efficiency (VE/VCO2) in PEP group (-1.9 (-3.12 to -0.1); P=0.033), but not in controls (-0.4 (-5.7 to 1.4); P=0.467). Phase angle improvement and a less-pronounced exercise-induced hyperammonemia were noted only in PEP group. No episodes of variceal bleeding or hepatic encephalopathy were observed. A supervised PEP in patients with cirrhosis decreases the HVPG and improves nutritional status with no changes in quality of life. Further studies evaluating physical training in cirrhosis are eagerly awaited in order to better define the benefits of sustained exercise. ClinicalTrials.gov:NCT00517738.

  13. No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Fleckenstein, Johannes; Niederer, Daniel; Auerbach, Kerstin; Bernhörster, Marcus; Hübscher, Markus; Vogt, Lutz; Banzer, Winfried

    2016-11-01

    Delayed-onset muscle soreness (DOMS) is a common symptom in people participating in exercise, sport, or recreational physical activities. Several remedies have been proposed to prevent and alleviate DOMS. A five-arm randomized controlled study was conducted to examine the effects of acupuncture on eccentric exercise-induced DOMS of the biceps brachii muscle. Participants were recruited through convenience sampling of students and general public. Participants were randomly allocated to needle, laser, sham needle, sham laser acupuncture, and no intervention. Outcome measures included pressure pain threshold (PPT), pain intensity (visual analog scale), and maximum isometric voluntary force. Delayed-onset muscle soreness was induced in 60 participants (22 females, age 23.6 ± 2.8 years, weight 66.1 ± 9.6 kg, and height 171.6 ± 7.9 cm). Neither verum nor sham interventions significantly improved outcomes within 72 hours when compared with no treatment control (P > 0.05). Acupuncture was not effective in the treatment of DOMS. From a mechanistic point of view, these results have implications for further studies: (1) considering the high-threshold mechanosensitive nociceptors of the muscle, the cutoff for PPT (5 kg/cm) chosen to avoid bruising might have led to ceiling effects; (2) the traditional acupuncture regimen, targeting muscle pain, might have been inappropriate as the DOMS mechanisms seem limited to the muscular unit and its innervation. Therefore, a regionally based regimen including an intensified intramuscular needling (dry needling) should be tested in future studies, using a higher cutoff for PPT to avoid ceiling effects.

  14. Effects of music therapy on pain among female breast cancer patients after radical mastectomy: results from a randomized controlled trial.

    Science.gov (United States)

    Li, Xiao-Mei; Yan, Hong; Zhou, Kai-Na; Dang, Shao-Nong; Wang, Duo-Lao; Zhang, Yin-Ping

    2011-07-01

    Music therapy has been used in multiple health care settings to reduce patient pain, anxiety, and stress. However, few available studies have investigated its effect on pain among breast cancer patients after radical mastectomy. The aim of this study was to explore the effects of music therapy on pain reduction in patients with breast cancer after radical mastectomy. This randomized controlled trial was conducted at the Surgical Department of Oncology Center, First Affiliated Hospital of Xi'an Jiaotong University from March to November 2009. A total of 120 breast cancer patients who received Personal Controlled Analgesia (PCA) following surgery (mastectomy) were randomly allocated to two groups, an intervention group and a control group (60 patients in each group). The intervention group accepted music therapy from the first day after radical mastectomy to the third admission to hospital for chemotherapy in addition to the routine nursing care, while the control group received only routine nursing care. Pain scores were measured at baseline and three post-tests using the General Questionnaire and Chinese version of Short-Form of McGill Pain Questionnaire. The primary endpoint was the change in the Pain Rating Index (PRI-total) score from baseline. Music therapy was found to reduce the PRI-total score in the intervention group significantly compared with the control group with a mean difference (95% CI) of -2.38 (-2.80, -1.95), -2.41 (-2.85, -1.96), and -1.87 (-2.33, -1.42) for the 1st, 2nd, and 3rd post-tests, respectively. Similar results were found for Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) scores. The findings of the study provide some evidence that music therapy has both short- and long-term positive effects on alleviating pain in breast cancer patients following radical mastectomy.

  15. Examination of Broad Symptom Improvement Resulting From Mindfulness-Based Stress Reduction in Breast Cancer Survivors: A Randomized Controlled Trial.

    Science.gov (United States)

    Lengacher, Cecile A; Reich, Richard R; Paterson, Carly L; Ramesar, Sophia; Park, Jong Y; Alinat, Carissa; Johnson-Mallard, Versie; Moscoso, Manolete; Budhrani-Shani, Pinky; Miladinovic, Branko; Jacobsen, Paul B; Cox, Charles E; Goodman, Matthew; Kip, Kevin E

    2016-08-20

    The purpose of this randomized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program in improving psychological and physical symptoms and quality of life among breast cancer survivors (BCSs) who completed treatment. Outcomes were assessed immediately after 6 weeks of MBSR(BC) training and 6 weeks later to test efficacy over an extended timeframe. A total of 322 BCSs were randomly assigned to either a 6-week MBSR(BC) program (n = 155) or a usual care group (n = 167). Psychological (depression, anxiety, stress, and fear of recurrence) and physical symptoms (fatigue and pain) and quality of life (as related to health) were assessed at baseline and at 6 and 12 weeks. Linear mixed models were used to assess MBSR(BC) effects over time, and participant characteristics at baseline were also tested as moderators of MBSR(BC) effects. Results demonstrated extended improvement for the MBSR(BC) group compared with usual care in both psychological symptoms of anxiety, fear of recurrence overall, and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference (P < .01). Overall effect sizes were largest for fear of recurrence problems (d = 0.35) and fatigue severity (d = 0.27). Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC). The MBSR(BC) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC) training, with generally small to moderate overall effect sizes. © 2016 by American Society of Clinical Oncology.

  16. Effects of Cognitive Leisure Activity on Cognition in Mild Cognitive Impairment: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Doi, Takehiko; Verghese, Joe; Makizako, Hyuma; Tsutsumimoto, Kota; Hotta, Ryo; Nakakubo, Sho; Suzuki, Takao; Shimada, Hiroyuki

    2017-08-01

    To test the hypothesis that a long-term, structured cognitive leisure activity program is more effective than a health education program at reducing the risk of further cognitive decline in older adults with mild cognitive impairment syndrome (MCI), a high risk for dementia. A 3-arm, single-blind randomized controlled trial. Community. A total of 201 Japanese adults with MCI (mean age: 76.0 years, 52% women). Participants were randomized into 1 of 2 cognitive leisure activity programs (60 minutes weekly for 40 weeks): dance (n = 67) and playing musical instruments (n = 67), or a health education control group (n = 67). Primary outcomes were memory function changes at 40 weeks. Secondary outcomes included changes in Mini-Mental State Examination and nonmemory domain (Trail Making Tests A and B) scores. At 40 weeks, the dance group showed improved memory recall scores compared with controls [mean change (SD): dance group 0.73 (1.9) vs controls 0.01 (1.9); P = .011], whereas the music group did not show an improvement compared with controls (P = .123). Both dance [mean change (SD): 0.29 (2.6); P = .026] and music groups [mean change (SD): 0.46 (2.1); P = .008] showed improved Mini-Mental State Examination scores compared with controls [mean change (SD): -0.36 (2.3)]. No difference in the nonmemory cognitive tests was observed. Long-term cognitive leisure activity programs involving dance or playing musical instruments resulted in improvements in memory and general cognitive function compared with a health education program in older adults with MCI. UMIN-CTR UMIN000014261. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  17. Ten-Year Survival Results of a Randomized Trial of Irradiation of Internal Mammary Nodes After Mastectomy

    Energy Technology Data Exchange (ETDEWEB)

    Hennequin, Christophe, E-mail: christophe.hennequin@sls.aphp.fr [Hôpital Saint-Louis, AP-HP et Université de Paris VII (France); Bossard, Nadine [Hospices Civils de Lyon, Service de Biostatistique, Université Lyon 1, Lyon, and CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biotatistique-Santé, Villeurbanne (France); Servagi-Vernat, Stéphanie [Centre hospitalier Universitaire de Besançon (France); Maingon, Philippe [Centre François Leclerc, Dijon (France); Dubois, Jean-Bernard [Centre Val d' Aurelle, Montpellier (France); Datchary, Jean [Centre Hospitalier d' Annecy (France); Carrie, Christian [Centre Léon Bérard, Lyon (France); Roullet, Bernard [Centre Hospitalier Universitaire de Limoges (France); Suchaud, Jean-Philippe [Centre Hospitalier de Roanne (France); Teissier, Eric [Centre de Radiothérapie de Mougins (France); Lucardi, Audrey [Hospices Civils de Lyon (France); Gerard, Jean-Pierre [Centre Antoine Lacassagne, Nice (France); Belot, Aurélien [Hospices Civils de Lyon, Service de Biostatistique, Université Lyon 1, Lyon, and CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biotatistique-Santé, Villeurbanne (France); Institut de Veille Sanitaire, Département des Maladies Chroniques et des Traumatismes, Saint-Maurice (France); and others

    2013-08-01

    Purpose: To evaluate the efficacy of irradiation of internal mammary nodes (IMN) on 10-year overall survival in breast cancer patients after mastectomy. Methods and Patients: This multicenter phase 3 study enrolled patients with positive axillary nodes (pN+) or central/medial tumors with or without pN+. Other inclusion criteria were age <75 and a Karnofsky index ≥70. All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were randomly assigned to receive IMN irradiation or not. Randomization was stratified by tumor location (medial/central or lateral), axillary lymph node status, and adjuvant therapy (chemotherapy vs no chemotherapy). The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent. The first 5 intercostal spaces were included in the IMN target volume, and two-thirds of the dose (31.5 Gy) was given by electrons. The primary outcome was overall survival at 10 years. Disease-free survival and toxicity were secondary outcomes. Results: T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors. No benefit of IMN irradiation on the overall survival could be demonstrated: the 10-year overall survival was 59.3% in the IMN-nonirradiated group versus 62.6% in the IMN-irradiated group (P=.8). According to stratification factors, we defined 6 subgroups (medial/central or lateral tumor, pN0 [only for medial/central] or pN+, and chemotherapy or not). In all these subgroups, IMN irradiation did not significantly improve overall survival. Conclusions: In patients treated with 2-dimensional techniques, we failed to demonstrate a survival benefit for IMN irradiation. This study cannot rule out a moderate benefit, especially with more modern, conformal techniques applied to a higher risk population.

  18. Financial Incentives for Chronic Disease Management: Results and Limitations of 2 Randomized Clinical Trials With New York Medicaid Patients.

    Science.gov (United States)

    VanEpps, Eric M; Troxel, Andrea B; Villamil, Elizabeth; Saulsgiver, Kathryn A; Zhu, Jingsan; Chin, Jo-Yu; Matson, Jacqueline; Anarella, Joseph; Roohan, Patrick; Gesten, Foster; Volpp, Kevin G

    2018-01-01

    To identify whether financial incentives promote improved disease management in Medicaid recipients diagnosed with hypertension or diabetes, respectively. Four-group, multicenter, randomized clinical trials. Between 2013 and 2016, New York State Medicaid managed care members diagnosed with hypertension (N = 920) or with diabetes (N = 959). Participants in each 6-month trial were randomly assigned to 1 of 4 arms: (1) process incentives-earned by attending primary care visits and/or receiving prescription medication refills, (2) outcome incentives-earned by reducing systolic blood pressure (hypertension) or hemoglobin A 1c (HbA 1c ; diabetes) levels, (3) combined process and outcome incentives, and (4) control (no incentives). Systolic blood pressure (hypertension) and HbA 1c (diabetes) levels, primary care visits, and medication prescription refills. Analysis and Results: At 6 months, there were no statistically significant differences between intervention arms and the control arm in the change in systolic blood pressure, P = .531. Similarly, there were no significant differences in blood glucose control (HbA 1c ) between the intervention arms and control after 6 months, P = .939. The majority of participants had acceptable systolic blood pressure (<140 mm Hg) or blood glucose (<8.0%) levels at baseline and throughout the study. Financial incentives-regardless of whether they were delivered based on disease-relevant outcomes, process activities, or a combination of the two-have a negligible impact on health outcomes for Medicaid recipients diagnosed with either hypertension or diabetes in 2 studies in which, among other design and operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.

  19. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  20. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial.

    Science.gov (United States)

    Busch, Andrew M; Tooley, Erin M; Dunsiger, Shira; Chattillion, Elizabeth A; Srour, John Fani; Pagoto, Sherry L; Kahler, Christopher W; Borrelli, Belinda

    2017-04-17

    Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS) significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC). Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Fifty-nine participants (28 BAT-CS, 31 SC) were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41-3.93) for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42-3.82) for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03). At 24-weeks, effect sizes for mood and stress outcomes ranged from η(2)partial of.07-.11, with significant between treatment effects for positive affect, negative affect, and stress. The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  1. Effect of Testosterone Administration on Liver Fat in Older Men With Mobility Limitation: Results From a Randomized Controlled Trial

    Science.gov (United States)

    2013-01-01

    Background. Androgen receptor (AR) knockout male mice display hepatic steatosis, suggesting that AR signaling may regulate hepatic fat. However, the effects of testosterone replacement on hepatic fat in men are unknown. The aim of this study was to determine the effects of testosterone administration on hepatic fat in older men with mobility limitation and low testosterone levels who were participating in a randomized trial (the Testosterone in Older Men trial). Methods. Two hundred and nine men with mobility limitation and low total or free testosterone were randomized in the parent trial to either placebo or 10-g testosterone gel daily for 6 months. Hepatic fat was determined by magnetic resonance imaging in 73 men (36 in placebo and 37 in testosterone group) using the volumetric method. Insulin sensitivity (homeostatic model assessment–insulin resistance) was derived from fasting glucose and insulin. Results. Baseline characteristics were similar between the two groups, including liver volumes (1583±363 in the testosterone group vs 1522±271mL in the placebo group, p = .42). Testosterone concentrations increased from 250±72 to 632±363ng/dL in testosterone group but did not change in placebo group. Changes in liver volume during intervention did not differ significantly between groups (p = .5) and were not related to on-treatment testosterone concentrations. The change in homeostatic model assessment–insulin resistance also did not differ significantly between groups and was not related to either baseline or change in liver fat. Conclusion. Testosterone administration in older men with mobility limitation and low testosterone levels was not associated with a reduction in hepatic fat. Larger trials are needed to determine whether testosterone replacement improves liver fat in men with nonalcoholic hepatic steatosis. PMID:23292288

  2. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders.

    Science.gov (United States)

    Bamelis, Lotte L M; Evers, Silvia M A A; Spinhoven, Philip; Arntz, Arnoud

    2014-03-01

    The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. A multicenter randomized controlled trial, with a single-blind parallel design, was conducted between 2006 and 2011 in 12 Dutch mental health institutes. A total of 323 patients with personality disorders were randomly assigned (schema therapy, N=147; treatment as usual, N=135; clarification-oriented psychotherapy, N=41). There were two cohorts of schema therapy therapists, with the first trained primarily with lectures and the second primarily with exercises. The primary outcome was recovery from personality disorder 3 years after treatment started (assessed by blinded interviewers). Secondary outcomes were dropout rates and measures of personality disorder traits, depressive and anxiety disorders, general psychological complaints, general and social functioning, self-ideal discrepancy, and quality of life. A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy. Second-cohort schema therapists had better results than first-cohort therapists. Clarification-oriented psychotherapy and treatment as usual did not differ. Findings did not vary with specific personality disorder diagnosis. Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions. All treatments showed improvements on secondary outcomes. Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up. While interview-based measures demonstrated significant differences between treatments, differences were not found with self-report measures. Schema therapy was superior to treatment as usual on recovery, other interview-based outcomes, and dropout. Exercise-based schema therapy training was superior to

  3. Diabetes nurse case management and motivational interviewing for change (DYNAMIC): results of a 2-year randomized controlled pragmatic trial.

    Science.gov (United States)

    Gabbay, Robert A; Añel-Tiangco, Raquel M; Dellasega, Cheryl; Mauger, David T; Adelman, Alan; Van Horn, Deborah H A

    2013-09-01

    The aim of the present study was to determine whether the addition of nurse case managers (NCMs) trained in motivational interviewing (MI) to usual care would result in improved outcomes in high-risk type 2 diabetes patients. A 2-year randomized controlled pragmatic trial randomized 545 patients to usual care control (n=313) or those who received the intervention (n=232) with additional practice-embedded NCM care, including MI-guided behavior change counseling. The NCMs received intensive MI training with ongoing fidelity assessment. Systolic blood pressure (SBP) was better in the intervention than usual care group (131 ± 15 vs. 135 ± 18 mmHg, respectively; P<0.05). Improvements were seen in both the control and intervention groups in terms of HbA1c (from 9.1% to 8.0% and from 8.8% to 7.8%, respectively), low-density lipoprotein (LDL; from 127 to 100 mg/dL and from 128 to 102 mg/dL, respectively), and diastolic blood pressure (from 78 to 74 mmHg and from 80 to 74 mmHg, respectively). Depression symptom scores were better in the intervention group. The reduction in diabetes-related distress approached statistical significance. The NCMs and MI improved SBP and complications screening. The large decrease in HbA1C and LDL in the control group may have obscured any further intervention effect. Although nurses prompted providers for medication titration, strategies to reduce provider clinical inertia may also be needed. © 2013 Wiley Publishing Asia Pty Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

  4. Reducing smoking in adolescents: cost-effectiveness results from the cluster randomized ASSIST (A Stop Smoking In Schools Trial).

    Science.gov (United States)

    Hollingworth, William; Cohen, David; Hawkins, James; Hughes, Rachael A; Moore, Laurence A R; Holliday, Jo C; Audrey, Suzanne; Starkey, Fenella; Campbell, Rona

    2012-02-01

    School-based smoking prevention programmes can be effective, but evidence on cost-effectiveness is lacking. We conducted a cost-effectiveness analysis of a school-based "peer-led" intervention. We evaluated the ASSIST (A Stop Smoking In Schools Trial) programme in a cluster randomized controlled trial. The ASSIST programme trained students to act as peer supporters during informal interactions to encourage their peers not to smoke. Fifty-nine secondary schools in England and Wales were randomized to receive the ASSIST programme or usual smoking education. Ten thousand seven hundred and thirty students aged 12-13 years attended participating schools. Previous work has demonstrated that the ASSIST programme achieved a 2.1% (95% CI = 0%-4.2%) reduction in smoking prevalence. We evaluated the public sector cost, prevalence of weekly smoking, and cost per additional student not smoking at 24 months. The ASSIST programme cost of £32 (95% CI = £29.70-£33.80) per student. The incremental cost per student not smoking at 2 years was £1,500 (95% CI = £669-£9,947). Students in intervention schools were less likely to believe that they would be a smoker at age 16 years (odds ratio [OR] = 0.80; 95% CI = 0.66-0.96). A peer-led intervention reduced smoking among adolescents at a modest cost. The intervention is cost-effective under realistic assumptions regarding the extent to which reductions in adolescent smoking lead to lower smoking prevalence and/or earlier smoking cessation in adulthood. The annual cost of extending the intervention to Year 8 students in all U.K. schools would be in the region of £38 million and could result in 20,400 fewer adolescent smokers.

  5. Yoga decreases kyphosis in senior women and men with adult-onset hyperkyphosis: results of a randomized controlled trial.

    Science.gov (United States)

    Greendale, Gail A; Huang, Mei-Hua; Karlamangla, Arun S; Seeger, Leanne; Crawford, Sybil

    2009-09-01

    To assess whether a specifically designed yoga intervention can reduce hyperkyphosis. A 6-month, two-group, randomized, controlled, single-masked trial. Community research unit. One hundred eighteen women and men aged 60 and older with a kyphosis angle of 40 degrees or greater. Major exclusions were serious medical comorbidity, use of assistive device, inability to hear or see adequately for participation, and inability to pass a physical safety screen. The active treatment group attended hour-long yoga classes 3 days per week for 24 weeks. The control group attended a monthly luncheon and seminar and received mailings. Primary outcomes were change (baseline to 6 months) in Debrunner kyphometer-assessed kyphosis angle, standing height, timed chair stands, functional reach, and walking speed. Secondary outcomes were change in kyphosis index, flexicurve kyphosis angle, Rancho Bernardo Blocks posture assessment, and health-related quality of life (HRQOL). Compared with control participants, participants randomized to yoga experienced a 4.4% improvement in flexicurve kyphosis angle (P=.006) and a 5% improvement in kyphosis index (P=.004). The intervention did not result in statistically significant improvement in Debrunner kyphometer angle, measured physical performance, or self-assessed HRQOL (each P>.1). The decrease in flexicurve kyphosis angle in the yoga treatment group shows that hyperkyphosis is remediable, a critical first step in the pathway to treating or preventing this condition. Larger, more-definitive studies of yoga or other interventions for hyperkyphosis should be considered. Targeting individuals with more-malleable spines and using longitudinally precise measures of kyphosis could strengthen the treatment effect.

  6. Efficacy and safety of fasudil in patients with subarachnoid hemorrhage: final results of a randomized trial of fasudil versus nimodipine.

    Science.gov (United States)

    Zhao, Jizong; Zhou, Dingbiao; Guo, Jing; Ren, Zuyuan; Zhou, Liangfu; Wang, Shuo; Zhang, Yan; Xu, Bainan; Zhao, Kuiming; Wang, Renzhi; Mao, Ying; Xu, Bin; Zhang, Xiaolin

    2011-01-01

    Fasudil is believed to be at least equally effective as nimodipine for the prevention of cerebral vasospasm and subsequent ischemic injury in patients undergoing surgery for subarachnoid hemorrhage (SAH). We report the final results of a randomized, open trial to compare the efficacy and safety of fasudil with nimodipine. A total of 63 patients undergoing surgery for SAH received fasudil and 66 received nimodipine between 1998 and 2004. Symptomatic vasospasm, low density areas on computed tomography (CT), clinical outcomes, and adverse events were all recorded, and the results were compared between the fasudil and nimodipine groups. Absence of symptomatic vasospasm, occurrence of low density areas associated with vasospasm on CT, and occurrence of adverse events were similar between the two groups. The clinical outcomes were more favorable in the fasudil group than in the nimodipine group (p = 0.040). The proportion of patients with good clinical outcome was 74.5% (41/55) in the fasudil group and 61.7% (37/60) in the nimodipine group. There were no serious adverse events reported in the fasudil group. The present results suggest that fasudil is equally or more effective than nimodipine for the prevention of cerebral vasospasm and subsequent ischemic injury in patients undergoing surgery for SAH.

  7. Web Platform vs In-Person Genetic Counselor for Return of Carrier Results From Exome Sequencing: A Randomized Clinical Trial.

    Science.gov (United States)

    Biesecker, Barbara B; Lewis, Katie L; Umstead, Kendall L; Johnston, Jennifer J; Turbitt, Erin; Fishler, Kristen P; Patton, John H; Miller, Ilana M; Heidlebaugh, Alexis R; Biesecker, Leslie G

    2018-01-22

    A critical bottleneck in clinical genomics is the mismatch between large volumes of results and the availability of knowledgeable professionals to return them. To test whether a web-based platform is noninferior to a genetic counselor for educating patients about their carrier results from exome sequencing. A randomized noninferiority trial conducted in a longitudinal sequencing cohort at the National Institutes of Health from February 5, 2014, to December 16, 2016, was used to compare the web-based platform with a genetic counselor. Among the 571 eligible participants, 1 to 7 heterozygous variants were identified in genes that cause a phenotype that is recessively inherited. Surveys were administered after cohort enrollment, immediately following trial education, and 1 month and 6 months later to primarily healthy postreproductive participants who expressed interest in learning their carrier results. Both intention-to-treat and per-protocol analyses were applied. A web-based platform that integrated education on carrier results with personal test results was designed to directly parallel disclosure education by a genetic counselor. The sessions took a mean (SD) time of 21 (10.6), and 27 (9.3) minutes, respectively. The primary outcomes and noninferiority margins (δNI) were knowledge (0 to 8, δNI = -1), test-specific distress (0 to 30, δNI = +1), and decisional conflict (15 to 75, δNI = +6). After 462 participants (80.9%) provided consent and were randomized, all but 3 participants (n = 459) completed surveys following education and counseling; 398 (86.1%) completed 1-month surveys and 392 (84.8%) completed 6-month surveys. Participants were predominantly well-educated, non-Hispanic white, married parents; mean (SD) age was 63 (63.1) years and 246 (53.6%) were men. The web platform was noninferior to the genetic counselor on outcomes assessed at 1 and 6 months: knowledge (mean group difference, -0.18; lower limit of 97.5% CI, -0.63;

  8. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial

    NARCIS (Netherlands)

    Eadie, J.; van de Water, A.T.; Lonsdale, C.; Tully, M.A.; van Mechelen, W.; Boreham, C.A.; Daly, L.; McDonough, S.M.; Hurley, D.A.

    2013-01-01

    Objective: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). Design: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. Setting: Outpatient

  9. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; van der Beek, A.J.

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no

  10. Early conversion from calcineurin inhibitor- to everolimus-based therapy following kidney transplantation : Results of the randomized ELEVATE trial

    NARCIS (Netherlands)

    de Fijter, Johan W; Holdaas, Hallvard; Øyen, Ole; Sanders, Jan Stephan; Sundar, Sankaran; Bemelman, Frederike J; Sommerer, Claudia; Pascual, Julio; Avihingsanon, Yingyos; Pongskul, Cholatip; Oppenheimer, Frederic; Toselli, Lorenzo; Russ, Graeme; Wang, Zailong; Lopez, Patricia; Kochuparampil, Jossy; Cruzado, Josep M; van der Giet, Markus

    In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n=359) or remain on standard calcineurin inhibitor (CNI) therapy (n=356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and

  11. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    Science.gov (United States)

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  12. Cost-effectiveness of internet-based cognitive behavior therapy for irritable bowel syndrome: results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Paxling Björn

    2011-04-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is highly prevalent and is associated with a substantial economic burden. Cognitive behavior therapy (CBT has been shown to be effective in treating IBS. The aim of this study was to evaluate the cost-effectiveness of a new treatment alternative, internet-delivered CBT based on exposure and mindfulness exercises. Methods Participants (N = 85 with IBS were recruited through self-referral and were assessed via a telephone interview and self-report measures on the internet. Participants were randomized to internet-delivered CBT or to a discussion forum. Economic data was assessed at pre-, post- and at 3-month and 1 year follow-up. Results Significant cost reductions were found for the treatment group at $16,806 per successfully treated case. The cost reductions were mainly driven by reduced work loss in the treatment group. Results were sustained at 3-month and 1 year follow-up. Conclusions Internet-delivered CBT appears to generate health gains in IBS treatment and is associated with cost-savings from a societal perspective.

  13. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Mohamed, Rachid; Hilsden, Robert J; Dube, Catherine; Rostom, Alaa

    2016-01-01

    Background. The efficacy of colonoscopy in detecting abnormalities within the colon is highly dependent on the adequacy of the bowel preparation. The objective of this study was to compare the efficacy, safety, and tolerability of PEG lavage and split-dose PEG lavage with specific emphasis on the cleanliness of the right colon. Methods. The study was a prospective, randomized, two-arm, controlled trial of 237 patients. Patients between the age of 50 and 75 years were referred to an outpatient university screening clinic for colonoscopy. Patients were allocated to receive either a single 4 L PEG lavage or a split-dose PEG lavage. Results. Overall, the bowel preparation was superior in the split-dose group compared with the single-dose group (mean Ottawa score 3.50 ± 2.89 versus 5.96 ± 3.53; P < 0.05) and resulted in less overall fluid in the colon. This effect was observed across all segments of the colon assessed. Conclusions. The current study supports use of a split-dose PEG lavage over a single large volume lavage for superior bowel cleanliness, which may improve polyp detection. This trial is registered with ClinicalTrials.gov identifier NCT01610856.

  14. Split-Dose Polyethylene Glycol Is Superior to Single Dose for Colonoscopy Preparation: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Rachid Mohamed

    2016-01-01

    Full Text Available Background. The efficacy of colonoscopy in detecting abnormalities within the colon is highly dependent on the adequacy of the bowel preparation. The objective of this study was to compare the efficacy, safety, and tolerability of PEG lavage and split-dose PEG lavage with specific emphasis on the cleanliness of the right colon. Methods. The study was a prospective, randomized, two-arm, controlled trial of 237 patients. Patients between the age of 50 and 75 years were referred to an outpatient university screening clinic for colonoscopy. Patients were allocated to receive either a single 4 L PEG lavage or a split-dose PEG lavage. Results. Overall, the bowel preparation was superior in the split-dose group compared with the single-dose group (mean Ottawa score 3.50 ± 2.89 versus 5.96 ± 3.53; P<0.05 and resulted in less overall fluid in the colon. This effect was observed across all segments of the colon assessed. Conclusions. The current study supports use of a split-dose PEG lavage over a single large volume lavage for superior bowel cleanliness, which may improve polyp detection. This trial is registered with ClinicalTrials.gov identifier NCT01610856.

  15. Can dialectical behavior therapy be learned in highly structured learning environments? Results from a randomized controlled dissemination trial.

    Science.gov (United States)

    Dimeff, Linda A; Woodcock, Eric A; Harned, Melanie S; Beadnell, Blair

    2011-06-01

    This study evaluated the efficacy of methods of training community mental health providers (N=132) in dialectical behavior therapy (DBT) distress tolerance skills, including (a) Linehan's (1993a) Skills Training Manual for Borderline Personality Disorder (Manual), (b) a multimedia e-Learning course covering the same content (e-DBT), and (c) a placebo control e-Learning course (e-Control). Participants were randomized to a condition, and the training took place in a highly structured and controlled learning environment. Assessments were completed at baseline, post-training, and 2, 7, 11, and 15 weeks following training. The results indicate that one or both of the active DBT conditions outperformed the control condition on all outcomes except motivation to learn and use the treatment. While clinicians preferred e-DBT over the Manual and found it more helpful and engaging, the active DBT conditions generally did not differ on the primary outcomes of knowledge and self-efficacy, with the exception that e-DBT significantly outperformed the Manual on knowledge at the 15-week follow-up. E-DBT also produced the highest rate of applying and teaching the newly learned skills in clinical practice. Overall, results from this study support the efficacy of e-Learning in disseminating knowledge of empirically supported treatments to clinicians, while also indicating that treatment manuals can be effective training tools. Copyright © 2011. Published by Elsevier Ltd.

  16. On being grateful and kind: results of two randomized controlled trials on study-related emotions and academic engagement.

    Science.gov (United States)

    Ouweneel, Else; Le Blanc, Pascale M; Schaufeli, Wilmar B

    2014-01-01

    Despite the large amount of research attention to engagement as well as positive psychology in a general context, there have been few attempts to increase academic well-being by means of positive psychological interventions. This article tests the potential of positive psychological interventions to enhance study-related positive emotions and academic engagement, and to reduce study-related negative emotions among university students. We modified two existing positive interventions that are aimed at increasing general happiness for use in an academic context. These interventions focused on "thoughts of gratitude" and "acts of kindness," respectively. The present study consisted of two randomized controlled trials with experimental (thoughts of gratitude or acts of kindness) and control conditions in which participants were monitored on a daily basis during the one-week intervention, and additional pre-, post-, and follow-up assessments were carried out. Results revealed that the gratitude intervention had a significant positive effect on daily positive emotions only. The kindness intervention had a positive influence on both positive emotions and academic engagement, though not in the long run. The results showed no effects on negative emotions in either of the two interventions. Positive psychological interventions seem to foster positive emotions and academic engagement, but do not decrease negative emotions.

  17. Medical Exercise Therapy for Treating Musculoskeletal Pain: A Narrative Review of Results from Randomized Controlled Trials with a Theoretical Perspective.

    Science.gov (United States)

    Lorås, H; Østerås, B; Torstensen, T A; Østerås, H

    2015-09-01

    The purpose of this narrative review is to present an overview and theoretical rationale of medical exercise therapy (MET) as a physiotherapeutic rehabilitation treatment for musculoskeletal pain conditions. Results from randomized controlled trials (RCTs) conducted on MET are also presented. Computerized searches for any RCTs were conducted on the MET concept in the databases PubMed, Medline, Embase and ISI Web of science up to 2013. Overall findings from five included MET RCTs are long-term (≥1 year) reductions in pain and improved physical and functional capabilities. These results are interpreted in the context of the biopsychosocial model, advancing the view of a dynamic interaction among physiologic, psychological and social factors that influence pain modulation. MET is a biopsychosocial treatment that reduces pain and improves activities of daily living in patients with a musculoskeletal pain condition. Pain modulation is a key feature of MET, and an important area for further research is to elucidate the specific mechanisms behind the treatment effects. Copyright © 2015 John Wiley & Sons, Ltd.

  18. Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial

    National Research Council Canada - National Science Library

    Ronco, Guglielmo; Segnan, Nereo; Giorgi-Rossi, Paolo; Zappa, Marco; Casadei, Gian Piero; Carozzi, Francesca; Dalla Palma, Paolo; Del Mistro, Annarosa; Folicaldi, Stefania; Gillio-Tos, Anna; Nardo, Gaetano; Naldoni, Carlo; Schincaglia, Patrizia; Zorzi, Manuel; Confortini, Massimo; Cuzick, Jack

    2006-01-01

    ...), studies comparing conventional and liquid-based cytology have had conflicting results. In the first phase of a two-phase multicenter randomized controlled trial, women aged 35-60 years in the conventional arm (n = 16,658...

  19. Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

    NARCIS (Netherlands)

    Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

    2016-01-01

    Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

  20. An integral topical gel for cellulite reduction: results from a double-blind, randomized, placebo-controlled evaluation of efficacy

    Directory of Open Access Journals (Sweden)

    Dupont E

    2014-02-01

    Full Text Available Eric Dupont,1 Michel Journet,2 Marie-Laure Oula,3 Juan Gomez,1 Claude Léveillé,4 Estelle Loing,5 Diane Bilodeau6 1Immanence IDC Inc, Québec, QC, Canada; 2Clinique de Dermatologie St-Joseph, Montréal, QC, Canada; 3Evalulab Inc, Mont-Royal, QC, Canada; 4Clinique de Chirurgie Esthétique du Québec Métropolitain, Lévis, QC, Canada; 5Lucas Meyer Cosmetics, Québec, QC, Canada; 6CosmeConsult, Québec, QC, Canada Background: Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. Objective: To assess the clinical efficacy of a complex integral anti-cellulite gel. Methods: This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25–55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. Results: At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined. At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (P<0.05 over placebo, on all studied areas. Skin tonicity improved on average by +41% for buttocks, +35% for hips, and +31% for thighs. Orange peel appearance was reduced on average by -25% for buttocks, -22% for hips, and -22% for thighs. Stubborn cellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (P<0.05 over placebo

  1. Long-Term Results of a Randomized Trial in Locally Advanced Rectal Cancer: No Benefit From Adding a Brachytherapy Boost

    Energy Technology Data Exchange (ETDEWEB)

    Appelt, Ane L., E-mail: ane.lindegaard.appelt@rsyd.dk [Department of Oncology, Vejle Hospital, Vejle (Denmark); Faculty of Health Sciences, University of Southern Denmark, Odense (Denmark); Vogelius, Ivan R. [Department of Radiation Oncology, Rigshospitalet, University of Copenhagen, Copenhagen (Denmark); Pløen, John; Rafaelsen, Søren R.; Lindebjerg, Jan; Havelund, Birgitte M. [Danish Colorectal Cancer Group South, Vejle Hospital, Vejle (Denmark); Bentzen, Søren M. [Division of Biostatistics and Bioinformatics, University of Maryland Greenebaum Cancer Center, and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland (United States); Jakobsen, Anders [Faculty of Health Sciences, University of Southern Denmark, Odense (Denmark); Danish Colorectal Cancer Group South, Vejle Hospital, Vejle (Denmark)

    2014-09-01

    Purpose/Objective(s): Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy (CRT) for locally advanced rectal cancer. Methods and Materials: Between March 2005 and November 2008, 248 patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4 Gy in 28 fractions, per oral tegafur-uracil and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10 Gy in 2 fractions). The primary trial endpoint was pathologic complete response (pCR) at the time of surgery; secondary endpoints included overall survival (OS), progression-free survival (PFS), and freedom from locoregional failure. Results: Results for the primary endpoint have previously been reported. This analysis presents survival data for the 224 patients in the Danish part of the trial. In all, 221 patients (111 control arm, 110 brachytherapy boost arm) had data available for analysis, with a median follow-up time of 5.4 years. Despite a significant increase in tumor response at the time of surgery, no differences in 5-year OS (70.6% vs 63.6%, hazard ratio [HR] = 1.24, P=.34) and PFS (63.9% vs 52.0%, HR=1.22, P=.32) were observed. Freedom from locoregional failure at 5 years were 93.9% and 85.7% (HR=2.60, P=.06) in the standard and in the brachytherapy arms, respectively. There was no difference in the prevalence of stoma. Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration. Conclusions: Despite increased pathologic tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery.

  2. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Andrew M. Busch

    2017-04-01

    Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  3. Change in Parental Depressive Symptoms in Trauma-Focused Cognitive-Behavioral Therapy: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    Tutus, Dunja; Keller, Ferdinand; Sachser, Cedric; Pfeiffer, Elisa; Goldbeck, Lutz

    2017-03-01

    Depressive symptoms are frequently described in parents whose children have been exposed to traumatic events. Hence, including nonoffending parents in trauma-focused cognitive-behavioral therapy (TF-CBT) for children and adolescents may help both children and their parents to cope with the trauma. Up to now, three randomized controlled trials have investigated parental depressive symptoms after TF-CBT. Given the ambiguous results, further effectiveness trials are needed to investigate parental benefit from TF-CBT. The aim of this study is to determine whether TF-CBT is superior to waitlist (WL) regarding change in parental depressive symptoms. Parents, N = 84, whose children (age 6-17 years) were randomly assigned to either 12 sessions of TF-CBT (n = 40) or to WL condition (n = 44) completed the Beck Depression Inventory-Second Edition (BDI-II) for pre-post comparison. The group difference was tested through repeated-measures analyses of variance (ANOVA). The change in parental depressive symptoms was additionally categorized using the reliable change index. Repeated-measures ANOVA indicated a significant time effect F(1, 82) = 2.55, p = 0.02, and no significant time-group interaction F(1, 82) = 1.09, p = 0.30, suggesting a similar reduction in parental depressive symptoms in both groups. Across both conditions, most of the parents remained unchanged (n = 62), some of them improved (n = 17), and a few deteriorated (n = 5). There was no significant difference between the conditions (χ(2)(2) = 1.74; p = 0.42). Contrary to findings of several previous studies, our results suggest no superiority of TF-CBT in comparison with WL regarding change in depressive symptoms in parents. This might be due to different types of the child's trauma. Parental benefit from TF-CBT was found in samples of sexually abused, but not in children and adolescents exposed to diverse trauma types.

  4. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.

    Science.gov (United States)

    Bianchi-Ferraro, Ana Maria H M; Jarmy-DiBella, Zsuzsanna I K; de Aquino Castro, Rodrigo; Bortolini, Maria Augusta T; Sartori, Marair G F; Girão, Manoel J B C

    2014-10-01

    The aim was to compare the efficacy and safety of single-incision sling TVT-Secur (TVT-S) and transobturator midurethral sling (TVT-O) for the treatment of stress urinary incontinence (SUI) over 2 years' follow-up. This is a randomized controlled trial in which women with SUI were randomly assigned to have either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria included: voiding dysfunction, detrusor overactivity, and pelvic organ prolapse beyond the hymen. The primary outcomes were objective and subjective cure rates at a follow-up visit at 24 months, defined as a negative stress test and pad test as well as absence of self-reported SUI symptoms. Secondary endpoints included quality of life assessment using the King's Health Questionnaire (KHQ), and complication and reoperation rates. Analysis was performed using intention to treat, and statistical significance was fixed at 5% (p TVT-S and TVT-O groups were 77.3% and 83.6%, while subjective cure rates were 75.7% and 80.3% respectively, with no statistically significant differences between the techniques. There was a significant improvement in all KHQ domains in both groups (p TVT-O, while the long-term one was tape exposure observed in 5.3% of TVT-O and in 7.5% of TVT-S cases. The efficacy of the TVT-S was similar to that of the TVT-O after 2 years' assessment. This cohort will continue to be followed in order to maintain commitment to contributing data on long-term results.

  5. Effects of Home Access to Active Videogames on Child Self-Esteem, Enjoyment of Physical Activity, and Anxiety Related to Electronic Games: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    Abbott, Rebecca A; Smith, Anne J; Howie, Erin K; Pollock, Clare; Straker, Leon

    2014-08-01

    Active-input videogames could provide a useful conduit for increasing physical activity by improving a child's self-confidence, physical activity enjoyment, and reducing anxiety. Therefore this study evaluated the impact of (a) the removal of home access to traditional electronic games or (b) their replacement with active-input videogames, on child self-perception, enjoyment of physical activity, and electronic game use anxiety. This was a crossover, randomized controlled trial, conducted over a 6-month period in participants' family homes in metropolitan Perth, Australia, from 2007 to 2010. Children 10-12 years old were recruited through school and community media. Of 210 children who were eligible, 74 met inclusion criteria, and 8 withdrew, leaving 66 children (33 girls) for analysis. A counterbalanced randomized order of three conditions sustained for 8 weeks each: No home access to electronic games, home access to traditional electronic games, and home access to active-input electronic games. Perception of self-esteem (Harter's Self Perception Profile for Children), enjoyment of physical activity (Physical Activity Enjoyment Scale questionnaire), and anxiety toward electronic game use (modified Loyd and Gressard Computer Anxiety Subscale) were assessed. Compared with home access to traditional electronic games, neither removal of all electronic games nor replacement with active-input games resulted in any significant change to child self-esteem, enjoyment of physical activity, or anxiety related to electronic games. Although active-input videogames have been shown to be enjoyable in the short term, their ability to impact on psychological outcomes is yet to be established.

  6. 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....

  7. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years.

    Science.gov (United States)

    Gilling, Peter J; Wilson, Liam C; King, Colleen J; Westenberg, Andre M; Frampton, Christopher M; Fraundorfer, Mark R

    2012-02-01

    To assess the durability of holmium laser enucleation of prostate in comparison to transurethral resection of the prostate (TURP). Patients were enrolled in the present study between June 1997 and December 2000 and followed per protocol. All patients were urodynamically obstructed with a prostate volume of between 40 and 200 mL. At long-term follow-up, variables assessed included Benign Prostatic Hyperplasia Impact Index (BPHII), International Continence Society Short Form Male questionnaire (ICSmale-SF) and the International Index of Erectile Function (IIEF). Adverse events, including the need for retreatment, were specifically assessed. Thirty-one (14 holmium laser enucleation of the prostate [HoLEP] and 17 TURP) of the initial 61 patients were available, with 12 deceased and 18 lost to follow-up. The mean (range) follow-up was 7.6 (5.9-10.0) years and the mean (±sd) age at follow-up was 79.8 (±6.2) years. The mean (±sd) values (HoLEP vs TURP) were as follows: maximum urinary flow rate (Q(max)), 22.09 ± 15.47 vs 17.83 ± 8.61 mL/s; American Urological Association (AUA) symptom score, 8.0 ± 5.2 vs 10.3 ± 7.42; quality of life (QOL) score 1.47 ± 1.31 vs 1.31 ± 0.85; BPHII, 1.53 ± 2.9 vs 0.58 ± 0.79; IIEF-EF (erectile function), 11.6 ± 7.46 vs 9.21 ± 7.17; ICSmale Voiding Score (VS), 4.2 ± 3.76 vs 3.0 ± 2.41; ICSmale Incontinence Score (IS), 3.07 ± 3.3 vs 1.17 ± 1.4. There were no significant differences in any variable between the two groups beyond the first year. Of the assessable patients, none required re-operation for recurrent BPH in the HoLEP arm and three (of 17) required re-operation in the TURP arm . The results of this randomized trial confirm that HoLEP is at least equivalent to TURP in the long term with fewer re-operations being necessary. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

  8. Six-year results of a randomized, prospective trial of human growth hormone and oxandrolone in Turner syndrome.

    Science.gov (United States)

    Rosenfeld, R G; Frane, J; Attie, K M; Brasel, J A; Burstein, S; Cara, J F; Chernausek, S; Gotlin, R W; Kuntze, J; Lippe, B M

    1992-07-01

    Seventy girls with Turner syndrome, verified by karyotype, were randomly assigned to observation or treatment with human growth hormone (hGH), oxandrolone, or a combination of hGH plus oxandrolone for a period of 12 to 24 months, to assess the effect of treatment on growth velocity and adult height. Subsequently, all subjects received either hGH alone or hGH plus oxandrolone. Data are presented for 62 subjects treated for a period of 3 to 6 years. When compared with the anticipated growth rate in untreated patients, the growth rate after treatment with hGH, both alone and in combination with oxandrolone, showed a sustained increase for at least 6 years. Treatment is continuing in over half of the subjects; at present, 14 (82%) of 17 girls receiving hGH alone and 41 (91%) of 45 girls receiving combination therapy exceeded their expected adult heights. Thirty girls have completed treatment; mean height for these 30 patients is 151.9 cm, compared with their mean original projected adult height of 143.8 cm. We conclude that therapy with hGH, alone and in combination with oxandrolone, can result in a sustained increase in growth rate and a significant increase in adult height for most prepubertal girls with Turner syndrome.

  9. A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at Twelve-Months Post-Release

    Science.gov (United States)

    Kinlock, Timothy W.; Gordon, Michael S.; Schwartz, Robert P.; Fitzgerald, Terrence T.; O’Grady, Kevin E.

    2009-01-01

    This study examined the impact of prison-initiated methadone maintenance at 12-months post-release. Males with pre-incarceration heroin dependence (n=204) were randomly assigned to: 1) Counseling Only: counseling in prison, with passive referral to treatment upon release; 2) Counseling+Transfer: counseling in prison with transfer to methadone maintenance treatment upon release; and 3) Counseling+Methadone: counseling and methadone maintenance in prison, continued in the community upon release. The mean number of days in community-based drug abuse treatment were, respectively, Counseling Only 23.1, Counseling+Transfer 91.3, and Counseling+Methadone 166.0, p <.01; all pairwise comparisons were statistically significant (all ps < .01). Counseling+Methadone participants were also significantly less likely than participants in each of the other two groups to be opioid-positive or cocaine-positive according to urine drug testing. These results support the effectiveness of prison-initiated methadone for males in the United States. Further study is required to confirm the findings for women. PMID:19339140

  10. A School Support Intervention and Educational Outcomes Among Orphaned Adolescents: Results of a Cluster Randomized Controlled Trial in Kenya.

    Science.gov (United States)

    Cho, Hyunsan; Catherine Ryberg, Renee; Hwang, Karam; Pearce, Lisa D; Iritani, Bonita J

    2017-11-01

    Globally, significant progress has been made in primary school enrollment. However, there are millions of adolescents-including orphans in sub-Saharan Africa-who still experience barriers to remaining in school. We conducted a 4-year cluster randomized controlled trial (cRCT) (N = 835) in a high HIV prevalence area in western Kenya to test whether providing orphaned adolescents with a school support intervention improves their educational outcomes. The school support intervention consisted of directly paying tuition, exam fees, and uniform costs to primary and secondary schools for those students who remained enrolled. In addition, research staff monitored intervention participants' school attendance and helped to address barriers to staying in school. This school support intervention had significant positive impacts on educational outcomes for orphaned adolescents. Over the course of the study, school absence remained stable for intervention group participants but increased in frequency for control group participants. Intervention group participants were less likely to drop out of school compared to the control group. Furthermore, the intervention participants were more likely to make age-appropriate progression in grade, matriculate into secondary school, and achieve higher levels of education by the end of the study. The intervention also increased students' expectations of graduating from college in the future. However, we found no significant intervention impact on primary and secondary school test scores. Results from this cRCT suggest that directly covering school-related expenses for male and female orphaned adolescents in western Kenya can improve their educational outcomes.

  11. Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results.

    Science.gov (United States)

    Sabbagh, J; Dagher, S; El Osta, N; Souhaid, P

    2017-01-01

    Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow (p value > 0.05). The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system.

  12. Randomized Clinical Trial of a Self-Adhering Flowable Composite for Class I Restorations: 2-Year Results

    Directory of Open Access Journals (Sweden)

    J. Sabbagh

    2017-01-01

    Full Text Available Objectives. To compare the clinical performances of a self-adhering resin composite and a conventional flowable composite with a self-etch bonding system on permanent molars. The influence of using rubber dam versus cotton roll isolation was also investigated. Materials and Methods. Patients aged between 6 and 12 years and presenting at least two permanent molars in need of small class I restorations were selected. Thirty-four pairs of restorations were randomly placed by the same operator. Fifteen patients were treated under rubber dam and nineteen using cotton rolls isolation and saliva ejector. They were evaluated according to the modified USPHS criteria at baseline, 6 months, and 1 and 2 years by two independent evaluators. Results. All patients attended the two-year recall. For all measured variables, there was no significant difference between rubber dam and cotton after 2 years of restoration with Premise Flowable or Vertise Flow (p value > 0.05. The percentage of restorations scored alpha decreased significantly over time with Premise Flowable and Vertise Flow for marginal adaptation and surface texture as well as marginal discoloration while it did not vary significantly for color matching. After 2 years, Vertise Flow showed a similar behaviour to the Premise Flowable used with a self-adhesive resin system.

  13. A 20-week program of resistance or concurrent exercise improves symptoms of schizophrenia: results of a blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bruna Andrade e Silva

    2015-01-01

    Full Text Available Objective:To evaluate the effects of 20 weeks of resistance and concurrent training on psychotic and depressive symptoms, quality of life outcomes, and serum IGF-1, IGFBP-3, and brain-derived neurotrophic factor (BDNF concentrations in patients with schizophrenia.Methods:In this blind, randomized controlled clinical trial, 34 patients with schizophrenia were assigned to one of three groups: control (CTRL, n=13, resistance exercise (RESEX, n=12, or concurrent exercise (CONCEX, n=9. Symptoms, quality of life, strength, and other variables were assessed.Results:A significant time-by-group interaction was found for the RESEX and CONCEX groups on the Positive and Negative Syndrome Scale (PANSS total score for disease symptoms (p = 0.007, positive symptoms (p = 0.003, and on the arm extension one-repetition maximum (1RM test (p = 0.016. In addition, significant improvements on negative symptoms (p = 0.027, on the role-physical domain of the Short Form-36 Health Survey (p = 0.019, and on the chest press 1RM test (p = 0.040 were observed in the RESEX group. No changes were observed for the other variables investigated.Conclusions:In this sample of patients with schizophrenia, 20 weeks of resistance or concurrent exercise program improved disease symptoms, strength, and quality of life. ClinicalTrials.gov: NCT01674543.

  14. Improving Nutrition and Physical Activity Policies in Afterschool Programs: Results from a Group-Randomized Controlled Trial

    Science.gov (United States)

    Kenney, Erica L.; Giles, Catherine M.; deBlois, Madeleine E.; Gortmaker, Steven L.; Chinfatt, Sherene; Cradock, Angie L.

    2017-01-01

    OBJECTIVE Afterschool programs can be health-promoting environments for children. Written policies positively influence nutrition and physical activity (PA) environments, but effective strategies for building staff capacity to write such policies have not been evaluated. This study measures the comprehensiveness of written nutrition, PA, and screen time policies in afterschool programs and assesses impact of the Out of School Nutrition and Physical Activity (OSNAP) intervention on key policies. METHODS Twenty afterschool programs in Boston, MA participated in a group-randomized, controlled trial from September 2010 to June 2011. Intervention program staff attended learning collaboratives focused on practice and policy change. The Out-of-School Time (OST) Policy Assessment Index evaluated written policies. Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed. RESULTS The measure demonstrated moderate to excellent inter-rater reliability (Spearman’s r=0.53 to 0.97) and construct validity. OSNAP was associated with significant increases in standards-based policy statements surrounding snacks (+2.6, p=0.003), beverages (+2.3, p=0.008), screen time (+0.8, p=0.046), family communication (+2.2, p=0.002), and a summary index of OSNAP goals (+3.3, p=0.02). CONCLUSIONS OSNAP demonstrated success in building staff capacity to write health-promoting policy statements. Future research should focus on determining policy change impact on practices. PMID:24941286

  15. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Department of Radiation Oncology

    2012-12-15

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 {+-} 23.7 and 53.2 {+-} 21.8 (p = 0.158), 38.2 {+-} 26.1 and 34.0 {+-} 24.5 (p = 0.189), and 33.0 {+-} 27.2 and 23.7 {+-} 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 {+-} 3.0 and 9.5 {+-} 2.7 (p = 0.309), 6.1 {+-} 3.6 and 5.4 {+-} 3.6 (p = 0.096), 5.3 {+-} 3.7 and 4.1 {+-} 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  16. Cost-Effectiveness of Group and Internet Cognitive Behavioral Therapy for Insomnia in Adolescents: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    De Bruin, Eduard J; van Steensel, Francisca J A; Meijer, Anne Marie

    2016-08-01

    To investigate cost-effectiveness of adolescent cognitive behavioral therapy for insomnia (CBTI) in group- and Internet-delivered formats, from a societal perspective with a time horizon of 1 y. Costs and effects data up to 1-y follow-up were obtained from a randomized controlled trial (RCT) comparing Internet CBTI to face-to-face group CBTI. The study was conducted at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam, and the academic youth mental health care center UvAMinds in Amsterdam. Sixty-two participants meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria for insomnia were randomized to face-to-face group CBTI (GT; n = 31, age = 15.6 y ± 1.8, 71.0% girls) or individual Internet CBTI (IT; n = 31, age = 15.4 y ± 1.5, 83.9% girls). The intervention consisted of six weekly sessions and a 2-mo follow up booster-session of CBTI, consisting of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT sessions were held in groups of six to eight adolescents guided by two trained sleep therapists. IT consisted of individual Internet therapy with preprogrammed content similar to GT, and guided by trained sleep therapists. Outcome measures were subjective sleep efficiency (SE) ≥ 85%, and quality-adjusted life-years (QALY). Analyses were conducted from a societal perspective. Incremental cost-effectiveness ratios (ICERs) were calculated using bootstrap sampling, and presented in cost-effectiveness planes. Primary analysis showed costs over 1 y were higher for GT but effects were similar for IT and GT. Bootstrapped ICERs demonstrated there is a high probability of IT being cost-effective compared to GT. Secondary analyses confirmed robustness of results. Internet CBTI is a cost-effective treatment compared to group CBTI for adolescents, although effects were largely similar for both formats

  17. Testing two different doses of tiotropium Respimat® in cystic fibrosis: phase 2 randomized trial results.

    Directory of Open Access Journals (Sweden)

    Judy M Bradley

    Full Text Available Tiotropium is a once-daily, long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis. Our objective was to evaluate the efficacy and safety of 2.5 and 5 µg once-daily tiotropium delivered via the Respimat Soft Mist Inhaler vs. placebo in people with cystic fibrosis.This phase 2, 12-week, randomized, double-blind, placebo-controlled parallel-group study of tiotropium Respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in 1 second (FEV1 ≥ 25% predicted. Co-primary efficacy end points were change from baseline in percent-predicted FEV1 area under the curve from 0 to 4 hours (FEV1 AUC0-4h, and trough FEV1 at the end of week 12.A total of 510 subjects with cystic fibrosis aged 5-69 years were randomized. Both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week 12 (change from baseline in percent-predicted FEV1 AUC0-4h: 2.5 µg: 2.94%, 95% confidence interval 1.19-4.70, p = 0.001; 5 µg: 3.39%, 95% confidence interval 1.67-5.12, p = 0.0001; in percent-predicted trough FEV1 ∶ 2.5 µg: 2.24%, p = 0.2; 5 µg: 2.22%, p = 0.02. There was a greater benefit with tiotropium 5 vs. 2.5 µg. No treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium.Tiotropium significantly improved lung function in people with cystic fibrosis. The improvement was greater with the higher dose than the lower dose, with no difference in adverse events.ClinicalTrials.gov NCT00737100 EudraCT 2008-001156-43.

  18. Health economic evaluation of acupuncture along meridians for treating migraine in China: results from a randomized controlled trial.

    Science.gov (United States)

    Deng, Zhu-qing; Zheng, Hui; Zhao, Ling; Zhou, Si-yuan; Li, Ying; Liang, Fan-rong

    2012-06-14

    To evaluate different types of acupuncture treatment for migraine in China from the perspective of health economics, particularly the comparison between treatment of specific acupoints in Shaoyang meridians and penetrating sham acupoints treatment. Data were obtained from a multicenter, randomized controlled trial of acupuncture treatment in patients with migraine. Four-hundred eighty migraineurs were randomly assigned to 3 arms of treatment with genuine acupoints and 1 arm of penetrating sham acupoints. The primary outcome measurement was the cost-effectiveness ratio (C/E), expressed as cost per 1 day reduction of headache days from baseline to week 16. Cost-comparison analyses, differences in the migraine-specific quality of life questionnaire (MSQ), and the incremental cost-effectiveness ratio were taken as secondary outcome measurements. In addition, a sensitivity analysis was conducted. The total cost per patient was ¥1273.2 (95% CI 1171.3-1375.1) in the Shaoyang specific group, ¥1427.7 (95% CI 1311.8-1543.6) in the Shaoyang non-specific group, ¥1490.8 (95% CI 1327.1-1654.6) in the Yangming specific group, and ¥1470.1 (95% CI 1358.8-1581.3) in the sham acupuncture group. The reduced days with migraine were 3.972 ± 2.7, 3.555 ± 2.8, 3.793 ± 3.6, and 2.155 ± 3.7 in these 4 groups (P vs the sham group), respectively, at week 16. The C/Es of the 4 groups were 320.5, 401.6, 393.1, and 682.2, respectively. Results of the sensitivity analysis were consistent with that of the cost-effectiveness analysis. The Shaoyang specific group significantly improved in all 3 MSQ domains compared with the sham acupuncture group. Treatment of specific acupoints in Shaoyang meridians is more cost-effective than that of non-acupoints, representing a dramatic improvement in the quality of life of people with migraine and a significant reduction in cost. Compared with the other 3 groups, Shaoyang-specific acupuncture is a relatively cost-effective treatment for migraine

  19. Health economic evaluation of acupuncture along meridians for treating migraine in China: results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Deng Zhu-qing

    2012-06-01

    Full Text Available Abstract Background To evaluate different types of acupuncture treatment for migraine in China from the perspective of health economics, particularly the comparison between treatment of specific acupoints in Shaoyang meridians and penetrating sham acupoints treatment. Methods Data were obtained from a multicenter, randomized controlled trial of acupuncture treatment in patients with migraine. Four-hundred eighty migraineurs were randomly assigned to 3 arms of treatment with genuine acupoints and 1 arm of penetrating sham acupoints. The primary outcome measurement was the cost-effectiveness ratio (C/E, expressed as cost per 1 day reduction of headache days from baseline to week 16. Cost-comparison analyses, differences in the migraine-specific quality of life questionnaire (MSQ, and the incremental cost-effectiveness ratio were taken as secondary outcome measurements. In addition, a sensitivity analysis was conducted. Results The total cost per patient was ¥1273.2 (95% CI 1171.3-1375.1 in the Shaoyang specific group, ¥1427.7 (95% CI 1311.8-1543.6 in the Shaoyang non-specific group, ¥1490.8 (95% CI 1327.1-1654.6 in the Yangming specific group, and ¥1470.1 (95% CI 1358.8-1581.3 in the sham acupuncture group. The reduced days with migraine were 3.972 ± 2.7, 3.555 ± 2.8, 3.793 ± 3.6, and 2.155 ± 3.7 in these 4 groups (P  Conclusions Treatment of specific acupoints in Shaoyang meridians is more cost-effective than that of non-acupoints, representing a dramatic improvement in the quality of life of people with migraine and a significant reduction in cost. Compared with the other 3 groups, Shaoyang-specific acupuncture is a relatively cost-effective treatment for migraine prophylaxis in China. Trial registration Clinical Trials.gov NCT00599586

  20. Does Stepwise Voltage Ramping Protect the Kidney from Injury During Extracorporeal Shockwave Lithotripsy? Results of a Prospective Randomized Trial.

    Science.gov (United States)

    Skuginna, Veronika; Nguyen, Daniel P; Seiler, Roland; Kiss, Bernhard; Thalmann, George N; Roth, Beat

    2016-02-01

    Renal damage is more frequent with new-generation lithotripters. However, animal studies suggest that voltage ramping minimizes the risk of complications following extracorporeal shock wave lithotripsy (SWL). In the clinical setting, the optimal voltage strategy remains unclear. To evaluate whether stepwise voltage ramping can protect the kidney from damage during SWL. A total of 418 patients with solitary or multiple unilateral kidney stones were randomized to receive SWL using a Modulith SLX-F2 lithotripter with either stepwise voltage ramping (n=213) or a fixed maximal voltage (n=205). SWL. The primary outcome was sonographic evidence of renal hematomas. Secondary outcomes included levels of urinary markers of renal damage, stone disintegration, stone-free rate, and rates of secondary interventions within 3 mo of SWL. Descriptive statistics were used to compare clinical outcomes between the two groups. A logistic regression model was generated to assess predictors of hematomas. Significantly fewer hematomas occurred in the ramping group(12/213, 5.6%) than in the fixed group (27/205, 13%; p=0.008). There was some evidence that the fixed group had higher urinary β2-microglobulin levels after SWL compared to the ramping group (p=0.06). Urinary microalbumin levels, stone disintegration, stone-free rate, and rates of secondary interventions did not significantly differ between the groups. The logistic regression model showed a significantly higher risk of renal hematomas in older patients (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.00-1.05; p=0.04). Stepwise voltage ramping was associated with a lower risk of hematomas (OR 0.39, 95% CI 0.19-0.80; p=0.01). The study was limited by the use of ultrasound to detect hematomas. In this prospective randomized study, stepwise voltage ramping during SWL was associated with a lower risk of renal damage compared to a fixed maximal voltage without compromising treatment effectiveness. Lithotripsy is a noninvasive

  1. A mobile phone intervention increases physical activity in people with cardiovascular disease: Results from the HEART randomized controlled trial.

    Science.gov (United States)

    Maddison, Ralph; Pfaeffli, Leila; Whittaker, Robyn; Stewart, Ralph; Kerr, Andrew; Jiang, Yannan; Kira, Geoffrey; Leung, William; Dalleck, Lance; Carter, Karen; Rawstorn, Jonathan

    2015-06-01

    To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease (IHD). In this single-blind, parallel, two-arm, randomized controlled trial adults (n = 171) with IHD were randomized to receive a mobile phone delivered intervention (HEART; n = 85) plus usual care, or usual care alone (n = 86). Adult participants aged 18 years or more, with a diagnosis of IHD, were clinically stable as outpatients, able to perform exercise, able to understand and write English, and had access to the Internet. The HEART (Heart Exercise And Remote Technologies) intervention involved a personalized, automated package of text messages and a secure website with video messages aimed at increasing exercise behaviour, delivered over 24 weeks. All participants were able to access usual community-based cardiac rehabilitation, which involves encouragement of physical activity and an offer to join a local cardiac support club. All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake (PVO2; primary outcome), self-reported physical activity, health-related quality of life, self-efficacy and motivation (secondary outcomes). Results showed no differences in PVO2 between the two groups (difference -0.21 ml kg(-1)min(-1), 95% CI: -1.1, 0.7; p = 0.65) at 24 weeks. However significant treatment effects were observed for selected secondary outcomes, including leisure time physical activity (difference 110.2 min/week, 95% CI: -0.8, 221.3; p = 0.05) and walking (difference 151.4 min/week, 95% CI: 27.6, 275.2; p = 0.02). There were also significant improvements in self-efficacy to be active (difference 6.2%, 95% CI: 0.2, 12.2; p = 0.04) and the general health domain of the SF36 (difference 2.1, 95% CI: 0.1, 4.1; p = 0.03) at 24 weeks. The HEART programme was considered likely to be cost-effective for leisure time activity and walking. A mobile phone intervention

  2. Treating adolescents with cannabis use disorder with Multidimensional Family Therapy (MDFT): Main results of a Randomized Controlled Trial (RCT)

    NARCIS (Netherlands)

    P. Tossmann (Peter); B. Jonas (Benjamin); H. Rigter (Henk); A. Gantner (Andreas)

    2012-01-01

    textabstractAims: To determine the effectiveness of Multidimensional Family Therapy (MDFT) among adolescents with cannabis use disorder in Germany. Methods: In a randomized controlled trial (RCT), MDFT was compared with Youth Psychotherapy (JUP), an individual intervention including Cognitive

  3. Effect of a tailored physical activity intervention delivered in general practice settings: results of a randomized controlled trial

    NARCIS (Netherlands)

    van Sluijs, E.M.F.; van Poppel-Bruinvels, M.N.M.; Twisk, J.W.R.; Chin A Paw, M.J.M.; Calfas, K.J.; van Mechelen, W.

    2005-01-01

    Objectives. We evaluated the effectiveness of a minimal intervention physical activity strategy (physician-based assessment and counseling for exercise [PACE]) applied in general practice settings in the Netherlands. Methods. Randomization took place at the general practice level. Participants were

  4. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    Bamelis, L.L.M.; Evers, S.M.A.A.; Spinhoven, P.; Arntz, A.

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  5. Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

    OpenAIRE

    Toledo, Estefanía; Hu, F. B.; Estruch Riba, Ramon; Buil-Cosiales, P.; Corella Piquer, Dolores; Salas Salvadó, Jordi; Covas Planells, María Isabel; Arós, Fernando; Gómez-Gracia, E.; Fiol Sala, Miguel; Lapetra, José; Serra Majem, Lluís; Pintó Sala, Xavier; Lamuela Raventós, Rosa Ma.; Sáez Tormo, Guillermo

    2013-01-01

    BACKGROUND: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. METHODS: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for car...

  6. Extreme Attributions Predict the Course of Bipolar Depression: Results from the STEP-BD Randomized Controlled Trial of Psychosocial Treatment

    Science.gov (United States)

    Stange, Jonathan P.; Sylvia, Louisa G.; da Silva Magalhães, Pedro Vieira; Miklowitz, David J.; Otto, Michael W.; Frank, Ellen; Berk, Michael; Nierenberg, Andrew A.; Deckersbach, Thilo

    2013-01-01

    Objective Little is known about predictors of recovery from bipolar depression or moderators of treatment response. In the present study we investigated attributional style (a cognitive pattern of explaining the causes of life events) as a predictor of recovery from episodes of bipolar depression and as a moderator of response to psychotherapy for bipolar depression. Method 106 depressed outpatients with DSM-IV bipolar I or II disorder enrolled in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) were randomized to intensive psychotherapy for depression (n=62), or collaborative care (n=44), a minimal psychoeducational intervention. The primary outcome was recovery status at each study visit as measured by the Clinical Monitoring Form. Attributional style was measured at baseline using the Attributional Style Questionnaire. Data were collected between 1998 and 2005. Results All analyses were by intention to treat. Extreme attributions predicted a lower likelihood of recovery (p=.01, OR=0.93, 95% CI=.88-.98) and longer time until recovery (p<.01, OR=0.96, 95% CI=.93-.99), independent of the effects of initial depression severity. Among individuals with more pessimistic attributional styles, initial depression severity predicted a lower likelihood of recovery (p=.01, OR=0.64, 95% CI=.45-.91) and longer time until recovery (p<.001, OR=0.76, 95% CI=.66-.88). There was no difference in recovery rates between intensive psychotherapy and collaborative care (OR=0.90, 95% CI=0.40-2.01) in the full sample. Conclusions These results suggest that extreme, rigid attributions may be associated with a more severe course of depression, and that evaluating attributional style may help clinicians to identify patients who are at risk for experiencing a more severe course of depression. PMID:23561230

  7. Differentiating intraprofessional attitudes toward paradigms in health care delivery among chiropractic factions: results from a randomly sampled survey

    Science.gov (United States)

    2014-01-01

    Background As health care has increased in complexity and health care teams have been offered as a solution, so too is there an increased need for stronger interprofessional collaboration. However the intraprofessional factions that exist within every profession challenge interprofessional communication through contrary paradigms. As a contender in the conservative spinal health care market, factions within chiropractic that result in unorthodox practice behaviours may compromise interprofessional relations and that profession’s progress toward institutionalization. The purpose of this investigation was to quantify the professional stratification among Canadian chiropractic practitioners and evaluate the practice perceptions of those factions. Methods A stratified random sample of 740 Canadian chiropractors was surveyed to determine faction membership and how professional stratification could be related to views that could be considered unorthodox to current evidence-based care and guidelines. Stratification in practice behaviours is a stated concern of mainstream medicine when considering interprofessional referrals. Results Of 740 deliverable questionnaires, 503 were returned for a response rate of 68%. Less than 20% of chiropractors (18.8%) were aligned with a predefined unorthodox perspective of the conditions they treat. Prediction models suggest that unorthodox perceptions of health practice related to treatment choices, x-ray use and vaccinations were strongly associated with unorthodox group membership (X2 =13.4, p = 0.0002). Conclusion Chiropractors holding unorthodox views may be identified based on response to specific beliefs that appear to align with unorthodox health practices. Despite continued concerns by mainstream medicine, only a minority of the profession has retained a perspective in contrast to current scientific paradigms. Understanding the profession’s factions is important to the anticipation of care delivery when considering

  8. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment.

    Science.gov (United States)

    Bausback, Yvonne; Willfort-Ehringer, Andrea; Sievert, Horst; Geist, Volker; Lichtenberg, Michael; Del Giudice, Costantino; Sauguet, Antoine; Diaz-Cartelle, Juan; Marx, Claudia; Ströbel, Armin; Schult, Ingolf; Scheinert, Dierk

    2017-08-01

    To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.

  9. Response to Instruction in Preschool: Results of Two Randomized Studies with Children At Significant Risk of Reading Difficulties

    Science.gov (United States)

    Lonigan, Christopher J.; Phillips, Beth M.

    2015-01-01

    Although response-to-instruction (RTI) approaches have received increased attention, few studies have evaluated the potential impacts of RTI approaches with preschool populations. This manuscript presents results of two studies examining impacts of Tier II instruction with preschool children. Participating children were identified as substantially delayed in the acquisition of early literacy skills despite exposure to high-quality, evidence-based classroom instruction. Study 1 included 93 children (M age = 58.2 months; SD = 3.62) attending 12 Title I preschools. Study 2 included 184 children (M age = 58.2 months; SD = 3.38) attending 19 Title I preschools. The majority of children were Black/African American, and about 60% were male. In both studies, eligible children were randomized to receive either 11 weeks of need-aligned, small-group instruction or just Tier I. Tier II instruction in Study 1 included variations of activities for code- and language-focused domains with prior evidence of efficacy in non-RTI contexts. Tier II instruction in Study 2 included instructional activities narrower in scope, more intensive, and delivered to smaller groups of children. Impacts of Tier II instruction in Study 1 were minimal; however, there were significant and moderate-to-large impacts in Study 2. These results identify effective Tier II instruction but indicate that the context in which children are identified may alter the nature of Tier II instruction that is required. Children identified as eligible for Tier II in an RTI framework likely require more intensive and more narrowly focused instruction than do children at general risk of later academic difficulties. PMID:26869730

  10. A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial.

    Science.gov (United States)

    Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

    2010-12-01

    Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent. Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid. Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level. Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms. AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning. A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.

  11. No Benefit After THA Performed With Computer-assisted Cup Placement: 10-year Results of a Randomized Controlled Study.

    Science.gov (United States)

    Parratte, Sebastien; Ollivier, Matthieu; Lunebourg, Alexandre; Flecher, Xavier; Argenson, Jean-Noel A

    2016-10-01

    Computer-assisted surgery (CAS) for cup placement has been developed to improve the functional results and to reduce the dislocation rate and wear after total hip arthroplasty (THA). Previously published studies demonstrated radiographic benefits of CAS in terms of implant position, but whether these improvements result in clinically important differences that patients might perceive remains largely unknown. We hypothesized that THA performed with CAS would improve 10-year patient-reported outcomes measured by validated scoring tools, reduce acetabular polyethylene wear as measured using a validated radiological method, and increase survivorship. Sixty patients operated on for a THA between April 2004 and April 2005 were randomized into two groups using either the CAS technique or a conventional technique for cup placement. All patient candidates for a THA with the diagnosis of primary arthritis or avascular necrosis were eligible for the CAS procedure and randomly assigned to the CAS group by the Hospital Informatics Department with use of a systematic sampling method. The patients assigned to the freehand cup placement group were matched for sex, age within 5 years, pathological condition, operatively treated side, and body mass index within 3 points. All patients were operated on through an anterolateral approach (patient in the supine position) using cementless implants. In the CAS group, a specific surgical procedure using an imageless cup positioning computer-based navigation system was performed. There were 16 men and 14 women in each group; mean age was 62 years (range, 24-80 years), and mean body mass index was 25 ± 3 kg/m(2). No patient was lost to followup at 10 years, but five patients have died (two in the CAS group and three in the control group). At the 10-year followup, an independent observer blinded to the type of technique performed patients' evaluation. Cup positioning was evaluated postoperatively using a CT scan in the two groups with results

  12. Updated Results and Patterns of Failure in a Randomized Hypofractionation Trial for High-risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Arcangeli, Stefano [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia [Laboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome (Italy); Gomellini, Sara; Saracino, Biancamaria; Petrongari, Maria Grazia; Pinnaro, Paola; Pinzi, Valentina [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Arcangeli, Giorgio, E-mail: arcangeli.gio@tiscali.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2012-12-01

    Purpose: To report long-term results and patterns of failure after conventional and hypofractionated radiation therapy in high-risk prostate cancer. Methods and Materials: This randomized phase III trial compared conventional fractionation (80 Gy at 2 Gy per fraction in 8 weeks) vs hypofractionation (62 Gy at 3.1 Gy per fraction in 5 weeks) in combination with 9-month androgen deprivation therapy in 168 patients with high-risk prostate cancer. Freedom from biochemical failure (FFBF), freedom from local failure (FFLF), and freedom from distant failure (FFDF) were analyzed. Results: In a median follow-up of 70 months, biochemical failure (BF) occurred in 35 of the 168 patients (21%) in the study. Among these 35 patients, local failure (LF) only was detected in 11 (31%), distant failure (DF) only in 16 (46%), and both LF and DF in 6 (17%). In 2 patients (6%) BF has not yet been clinically detected. The risk reduction by hypofractionation was significant in BF (10.3%) but not in LF and DF. We found that hypofractionation, with respect to conventional fractionation, determined only an insignificant increase in the actuarial FFBF but no difference in FFLF and FFDF, when considering the entire group of patients. However, an increase in the 5-year rates in all 3 endpoints-FFBF, FFLF, and FFDF-was observed in the subgroup of patients with a pretreatment prostate-specific antigen (iPSA) level of 20 ng/mL or less. On multivariate analysis, the type of fractionation, iPSA level, Gleason score of 4+3 or higher, and T stage of 2c or higher have been confirmed as independent prognostic factors for BF. High iPSA levels and Gleason score of 4+3 or higher were also significantly associated with an increased risk of DF, whereas T stage of 2c or higher was the only independent variable for LF. Conclusion: Our results confirm the isoeffectiveness of the 2 fractionation schedules used in this study, although a benefit in favor of hypofractionation cannot be excluded in the subgroup of

  13. A Parent-Mediated Intervention That Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

    OpenAIRE

    Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

    2014-01-01

    The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in J Autism Dev Disord 43:540–555, 2013a). The current analyses focus on children’s attachment related outcomes. Results revealed that children who were randomly assigned to FPI showed bigger ...

  14. Effective photoprotection of human skin against infrared A radiation by topically applied antioxidants: results from a vehicle controlled, double-blind, randomized study.

    Science.gov (United States)

    Grether-Beck, Susanne; Marini, Alessandra; Jaenicke, Thomas; Krutmann, Jean

    2015-01-01

    Infrared A radiation (IRA) from solar sunlight contributes to photoaging of human skin, e.g. by upregulating MMP-1 expression in dermal fibroblasts, indicating the need for photoprotection of human skin against IRA. Up to now, however, there has been no controlled study to show that effective protection of human skin against IRA radiation is possible. Here, we have conducted a randomized, controlled, double-blinded prospective study in 30 healthy volunteers to assess the capacity of an SPF 30 sunscreen versus the same sunscreen supplemented with an antioxidant cocktail containing grape seed extract, vitamin E, ubiquinone and vitamin C to protect human skin against IRA radiation-induced MMP-1 upregulation. As expected, exposure to IRA radiation significantly upregulated MMP-1 expression, as compared to unirradiated skin, and this response was significantly reduced, if the SPF30 sunscreen plus the antioxidant cocktail had been applied prior to IRA radiation. In contrast, treatment of human skin with the SPF30 sunscreen alone did not provide significant protection. These results indicate that topically applied antioxidants effectively protect human skin against IRA radiation and that regular sunscreens need to be supplemented with specific antioxidants in order to achieve IRA photoprotection. © 2014 The American Society of Photobiology.

  15. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial.

    Science.gov (United States)

    Ford, Jessica; Rosman, Lindsey; Wuensch, Karl; Irvine, Jane; Sears, Samuel F

    2016-08-01

    Approximately 20% of patients with implantable cardioverter defibrillators (ICDs) suffer from posttraumatic stress disorder (PTSD) due to a history of cardiac arrest, device implantation, and ICD shock. There has been very little examination of treatment of PTSD symptoms in these patients. This study evaluated the effect of a specific cognitive-behavioral therapy (CBT) intervention for ICD patients with high levels of PTSD symptoms: a manualized program consisting of 8 telephone sessions with a trained counselor, a patient education book, and a stress management procedure on compact disc. Participants were 193 ICD patients, who were randomized to CBT or usual cardiac care (UCC) who completed self-report surveys at the time of recruitment and 6 and 12 months after initial measurement. Previous publication on the primary research evaluation questions reported that the CBT condition resulted in greater improvement on PTSD and depression symptoms than the UCC for the general population of ICD patients, but did not evaluate the effect on those with elevated symptoms of PTSD. The authors conducted secondary analyses of the effect of treatment on high and low PTSD symptom groups based on a cutoff for the Impact of Event Scale-Revised (Weiss & Marmar, 1997). Participants in the CBT group who had high symptoms experienced significantly greater symptom reduction from baseline to 12 months (d = 2.44, p = .021) than the UCC group (d = 1.12). Participants with low symptoms had small reductions regardless of group assignment (d = 0.16, p = .031). ICD-focused CBT was sufficient to produce a large, statistically significant reduction in PTSD symptoms in ICD patients with indications for treatment. Copyright © 2016 International Society for Traumatic Stress Studies.

  16. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial.

    Science.gov (United States)

    Schackman, Bruce R; Metsch, Lisa R; Colfax, Grant N; Leff, Jared A; Wong, Angela; Scott, Callie A; Feaster, Daniel J; Gooden, Lauren; Matheson, Tim; Haynes, Louise F; Paltiel, A David; Walensky, Rochelle P

    2013-02-01

    The President's National HIV/AIDS Strategy calls for coupling HIV screening and prevention services with substance abuse treatment programs. Fewer than half of US community-based substance abuse treatment programs make HIV testing available on-site or through referral. We measured the cost-effectiveness of three HIV testing strategies evaluated in a randomized trial conducted in 12 community-based substance abuse treatment programs in 2009: off-site testing referral, on-site rapid testing with information only, on-site rapid testing with risk-reduction counseling. Data from the trial included patient demographics, prior testing history, test acceptance and receipt of results, undiagnosed HIV prevalence (0.4%) and program costs. The Cost-Effectiveness of Preventing AIDS Complications (CEPAC) computer simulation model was used to project life expectancy, lifetime costs, and quality-adjusted life years (QALYs) for HIV-infected individuals. Incremental cost-effectiveness ratios (2009 US $/QALY) were calculated after adding costs of testing HIV-uninfected individuals; costs and QALYs were discounted at 3% annually. Referral for off-site testing is less efficient (dominated) compared to offering on-site testing with information only. The cost-effectiveness ratio for on-site testing with information is $60,300/QALY in the base case, or $76,300/QALY with 0.1% undiagnosed HIV prevalence. HIV risk-reduction counseling costs $36 per person more without additional benefit. A strategy of on-site rapid HIV testing offer with information only in substance abuse treatment programs increases life expectancy at a cost-effectiveness ratio substance abuse treatment leaders should seek funding to implement on-site rapid HIV testing in substance abuse treatment programs for those not recently tested. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  17. Effect of a high intake of cheese on cholesterol and metabolic syndrome: results of a randomized trial

    Science.gov (United States)

    Nilsen, Rita; Høstmark, Arne Torbjørn; Haug, Anna; Skeie, Siv

    2015-01-01

    Background Cheese is generally rich in saturated fat, which is associated with increased risk for cardiovascular diseases. Nevertheless, recent reports suggest that cheese may be antiatherogenic. Objective The goal of this study was to assess whether intake of two types of Norwegian cheese, with widely varying fat and calcium content, might influence factors of the metabolic syndrome and serum cholesterol levels differently. Design A total of 153 participants were randomized to one of three groups: Gamalost®, a traditional fat- and salt-free Norwegian cheese (50 g/day), Gouda-type cheese with 27% fat (80 g/day), and a control group with a limited cheese intake. Blood samples, anthropometric measurements, blood pressure, and questionnaires about lifestyle and diet were obtained at inclusion and end. Results At baseline, there were no differences between the groups in relevant baseline characteristics, mean age 43, 52.3% female. After 8 weeks’ intervention, there were no changes in any of the metabolic syndrome factors between the intervention groups compared with the control group. There were no increases in total- or LDL cholesterol in the cheese groups compared with the control. Stratified analysis showed that those in the Gouda group with metabolic syndrome at baseline had significant reductions in total cholesterol at the end of the trial compared with control (−0.70 mmol/L, p=0.013), and a significantly higher reduction in mean triglycerides. In the Gamalost group, those who had high total cholesterol at baseline had a significant reduction in total cholesterol compared with control (−0.40 mmol/L, p=0.035). Conclusions In conclusion, cholesterol levels did not increase after high intake of 27% fat Gouda-type cheese over 8 weeks’ intervention, and stratified analysis showed that participants with metabolic syndrome had reduced cholesterol at the end of the trial. PMID:26294049

  18. Cost-effectiveness of a pragmatic exercise intervention for women with breast cancer: results from a randomized controlled trial.

    Science.gov (United States)

    Gordon, Louisa G; DiSipio, Tracey; Battistutta, Diana; Yates, Patsy; Bashford, John; Pyke, Chris; Eakin, Elizabeth; Hayes, Sandra C

    2017-05-01

    To report on the cost-effectiveness of the Exercise for Health trial, comparing an exercise intervention with usual care during and following treatment for women with breast cancer. Women with breast cancer were randomized to an 8-month exercise intervention (involving regular contact with an exercise physiologist over the phone, n = 67, or home delivered face to face, n = 67) or usual care (n = 60) group and were assessed pre-intervention (5 weeks post-surgery), mid-intervention (6 months post-surgery), and 10 weeks post-intervention (12 months post-surgery). The benefit measures were "number of improvers" in quality of life (FACT-B+4) and quality-adjusted life years (QALYs). Data on provider, patient, and government costs were used to consider 2 cost scenarios: (1) a service provider model and (2) a private model. There were 69 improvers in the intervention group compared with 21 in the usual care group (odds ratio 2.09, 95% confidence interval 1.08, 4.01; P = .033). The incremental cost per improver was A$2282 to A$2644. Quality-adjusted life years gain for the intervention group versus the usual care group was 0.009, with incremental cost per QALY gain for models 1 and 2 being A$105 231 and A$90 842, respectively. However, sensitivity analyses indicate that incremental cost per QALY gained was volatile to EuroQol-5D-3L weights. Findings suggest that a pragmatic exercise intervention yields more women with markedly improved quality of life after breast cancer than usual care and may be cost-effective. The results are less certain in terms of incremental cost per quality-adjusted life years; however, this may be an inappropriate measure for reflecting exercise benefit for women with breast cancer. Copyright © 2016 John Wiley & Sons, Ltd.

  19. Treating Anxiety Disorders in Inner City Schools: Results from a Pilot Randomized Controlled Trial Comparing CBT and Usual Care

    Science.gov (United States)

    Becker, Kimberly D.; Drazdowski, Tess K.; Tein, Jenn-Yun

    2012-01-01

    Background The effectiveness of cognitive-behavioral treatment (CBT) in inner city schools, when delivered by novice CBT clinicians, and compared to usual care (UC), is unknown. Objective This pilot study addressed this issue by comparing a modular CBT for anxiety disorders to UC in a sample of 32 volunteer youth (mean age 10.28 years, 63% female, 84% African American) seen in school-based mental health programs. Methods Youth were randomly assigned to CBT (n = 17) or UC (n = 15); independent evaluators conducted diagnostic interviews with children and parents at pre- and post-intervention, and at a one-month follow-up. Results Based on intent-to-treat analyses, no differences were found in response rates between groups with 50 and 42% of the children in CBT, compared to 46 and 57% in UC no longer meeting criteria for an anxiety disorder at post-treatment and follow-up respectively. Similar improvements in global functioning were also found in both treatment groups. Baseline predictors of a positive treatment response included lower anxiety, fewer maladaptive thoughts, less exposure to urban hassles, and lower levels of parenting stress. Therapist use of more CBT session structure elements and greater competence in implementing these elements was also related to a positive treatment response. Conclusions Findings from this small pilot failed to show that CBT was superior to UC when delivered by school-based clinicians. Large scale comparative effectiveness trials are needed to determine whether CBT leads to superior clinical outcomes prior to dissemination. PMID:22701295

  20. Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis.

    Directory of Open Access Journals (Sweden)

    James D Berry

    Full Text Available Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing.In Stage 1, 66 subjects at ten clinical sites were enrolled and randomized equally into three study groups receiving intravenous placebo, ceftriaxone 2 grams daily or ceftriaxone 4 grams daily divided BID. Participants provided serum and cerebrospinal fluid for pharmacokinetic analysis on study day 7. Participants continued their assigned treatment in Stage 2. The Data and Safety Monitoring Board (DSMB reviewed the data after the last participants completed 20 weeks on study drug.Stage 1 analysis revealed linear pharmacokinetics, and CSF trough levels for both dosage levels exceeding the pre-specified target trough level of 1 µM (0.55 µg/mL. Tolerability (Stages 1 and 2 results showed that ceftriaxone at dosages up to 4 grams/day was well tolerated at 20 weeks. Biliary adverse events were more common with ceftriaxone but not dose-dependent and improved with ursodeoxycholic (ursodiol therapy.The goals of Stages 1 and 2 of the ceftriaxone trial were successfully achieved. Based on the pre-specified decision rules, the DSMB recommended the use of ceftriaxone 4 g/d (divided BID for Stage 3, which recently closed.ClinicalTrials.gov NCT00349622.

  1. Striatal functional connectivity changes following specific balance training in elderly people: MRI results of a randomized controlled pilot study.

    Science.gov (United States)

    Magon, Stefano; Donath, Lars; Gaetano, Laura; Thoeni, Alain; Radue, Ernst-Wilhelm; Faude, Oliver; Sprenger, Till

    2016-09-01

    Practice-induced effects of specific balance training on brain structure and activity in elderly people are largely unknown. In the present study, we investigated morphological and functional brain changes following slacking training (balancing over nylon ribbons) in a group of elderly people. Twenty-eight healthy volunteers were recruited and randomly assigned to the intervention (mean age: 62.3±5.4years) or control group (mean age: 61.8±5.3years). The intervention group completed six-weeks of slackline training. Brain morphological changes were investigated using voxel-based morphometry and functional connectivity changes were computed via independent component analysis and seed-based analyses. All analyses were applied to the whole sample and to a subgroup of participants who improved in slackline performance. The repeated measures analysis of variance showed a significant interaction effect between groups and sessions. Specifically, the Tukey post-hoc analysis revealed a significantly improved slackline standing performance after training for the left leg stance time (pre: 4.5±3.6s vs. 26.0±30.0s, pfunctional connectivity differences before or after the training between the intervention and control groups (whole sample). However, subsequent analysis in subjects with improved slackline performance showed a decrease of connectivity between the striatum and other brain areas during the training period. These preliminary results suggest that improved balance performance with slackline training goes along with an increased efficiency of the striatal network. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Piloting relationship education for female same-sex couples: Results of a small randomized waitlist-control trial.

    Science.gov (United States)

    Whitton, Sarah W; Scott, Shelby B; Dyar, Christina; Weitbrecht, Eliza M; Hutsell, David W; Kuryluk, Amanda D

    2017-10-01

    Relationship education represents a promising, nonstigmatizing approach to promoting the health and stability of same-sex couples. A new culturally sensitive adaptation of relationship education was developed specifically for female same-sex couples (The Strengthening Same-Sex Relationships Program, Female version; SSSR-F). SSSR-F includes adaptations of evidence-based strategies to build core relationship skills (e.g., communication skills training) as well as new content to address unique challenges faced by this population (e.g., discrimination; low social support). A small randomized waitlist-control trial (N = 37 couples) was conducted to evaluate program feasibility, acceptability, and efficacy. Three proximal outcomes targeted by SSSR-F (communication, perceived stress, social support) and 3 distal outcomes (global relationship satisfaction, instability, and confidence) were assessed at pre- and posttreatment and 3-month follow-up. Results of multilevel models accounting for nonindependence in dyadic data indicated statistically significant program effects on positive and negative couple communication, relationship satisfaction, and relationship confidence and small, nonsignificant program effects on stress, social support, and relationship instability. Analyses of follow-up data suggest maintenance of effects on the proximal but not the distal outcomes. Ratings of program satisfaction were high. Overall, findings support the feasibility, acceptability, and initial efficacy of SSSR-F, highlighting the potential value of culturally sensitive relationship education for same-sex couples. Continued efforts are needed to increase sustainability of program effects on global relationship quality over time. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial.

    Science.gov (United States)

    Asgary, Saeed; Eghbal, Mohammad Jafar; Ghoddusi, Jamileh

    2014-01-01

    Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis. In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed. Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P irreversible pulpitis. Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.

  4. Effectiveness of public deliberation methods for gathering input on issues in healthcare: Results from a randomized trial.

    Science.gov (United States)

    Carman, Kristin L; Mallery, Coretta; Maurer, Maureen; Wang, Grace; Garfinkel, Steve; Yang, Manshu; Gilmore, Dierdre; Windham, Amy; Ginsburg, Marjorie; Sofaer, Shoshanna; Gold, Marthe; Pathak-Sen, Ela; Davies, Todd; Siegel, Joanna; Mangrum, Rikki; Fernandez, Jessica; Richmond, Jennifer; Fishkin, James; Siu Chao, Alice

    2015-05-01

    Public deliberation elicits informed perspectives on complex issues that are values-laden and lack technical solutions. This Deliberative Methods Demonstration examined the effectiveness of public deliberation for obtaining informed public input regarding the role of medical evidence in U.S. healthcare. We conducted a 5-arm randomized controlled trial, assigning participants to one of four deliberative methods or to a reading materials only (RMO) control group. The four deliberative methods reflected important differences in implementation, including length of the deliberative process and mode of interaction. The project convened 76 groups between August and November 2012 in four U.S. Chicago, IL; Sacramento, CA; Silver Spring, MD; and Durham, NC, capturing a sociodemographically diverse sample with specific attention to ensuring inclusion of Hispanic, African-American, and elderly participants. Of 1774 people recruited, 75% participated: 961 took part in a deliberative method and 377 participants comprised the RMO control group. To assess effectiveness of the deliberative methods overall and of individual methods, we evaluated whether mean pre-post changes on a knowledge and attitude survey were statistically different from the RMO control using ANCOVA. In addition, we calculated mean scores capturing participant views of the impact and value of deliberation. Participating in deliberation increased participants' knowledge of evidence and comparative effectiveness research and shifted participants' attitudes regarding the role of evidence in decision-making. When comparing each deliberative method to the RMO control group, all four deliberative methods resulted in statistically significant change on at least one knowledge or attitude measure. These findings were underscored by self-reports that the experience affected participants' opinions. Public deliberation offers unique potential for those seeking informed input on complex, values-laden topics affecting broad

  5. Evaluating indoor residual spray for reducing malaria infection prevalence in Eritrea: results from a community randomized control trial.

    Science.gov (United States)

    Keating, Joseph; Locatelli, Andrea; Gebremichael, Andemariam; Ghebremeskel, Tewolde; Mufunda, Jacob; Mihreteab, Selam; Berhane, Daniel; Carneiro, Pedro

    2011-08-01

    This paper examines the relationship between indoor residual spray (IRS) and malaria parasite infection in Gash Barka Zone, Eritrea, an area with near universal coverage of insecticide treated bednets (ITN) and already low malaria parasite prevalence. A community randomized control trial was conducted in 2009. Malaria parasite infection prevalence was 0.5% [95% confidence interval (CI): 0.37-0.78%], with no significant difference detected between treatment and control areas. ITN possession remains high, with over 70% of households reporting ITN ownership [95% CI: 68.4-72.9]. ITN use among individuals within ITN-owning households was just under half [46.7% (95% CI: 45.4-48.0)]. Slight differences in ITN possession and use were detected between treatment and control areas. There was no significant difference in malaria parasite infection prevalence among individuals in households with ≥1 ITN compared to those in households without ITNs, nor among individuals reporting ITN use. Among individuals in ITN-owning households, sleeping under an ITN offered no statistically significant protection from malaria parasite infection. Community participation in environmental and larval habitat management activities was low: 17.9% (95% CI: 16.0-19.7). It is likely that IRS, larval habitat management and ITN distribution alone may be insufficient to interrupt transmission without corresponding high ITN use, sustained IRS application in areas where infections are clustered, and promptly seeking laboratory diagnosis and treatment of all fevers. Eritrea is ready for elimination, irrespective of inconclusive impact evaluation results. Copyright © 2011 Elsevier B.V. All rights reserved.

  6. Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial.

    Science.gov (United States)

    García-Sanz, Ramón; Oriol, Albert; Moreno, María J; de la Rubia, Javier; Payer, Angel R; Hernández, Miguel T; Palomera, Luis; Teruel, Ana I; Blanchard, María J; Gironella, Mercedes; Ribas, Paz; Bargay, Joan; Abellá, Eugenia; Granell, Miquel; Ocio, Enrique M; Ribera, Josep M; San Miguel, Jesús F; Mateos, María V

    2015-09-01

    This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse. One hundred patients were randomized to receive either zoledronic acid (4 mg iv/4 weeks, 12 doses) (n=51) or not (n=49). Experimental and control groups were well balanced for disease and prognostic features. Zoledronic acid did not show an antitumor effect according to changes in M-component. However, there were fewer symptomatic progressions in the experimental group than in the control group (34 versus 41, respectively; P=0.05) resulting in a median time to symptoms of 16 versus 10 months (P=0.161). The median time to next therapy was also slightly longer for the treated group than the untreated, control group (13.4 versus 10.1 months), although the difference was not statistically significant (P=0.360). The pattern of relapses was different for treated versus control patients: progressive bone disease (8 versus 20), anemia (24 versus 18), renal dysfunction (1 versus 2), and plasmacytomas (1 versus 1, respectively). This concurred with fewer skeletal-related events in the treated group than in the control group (2 versus 14), with a projected 4-year event proportion of 6% versus 40% (P<0.001). In summary, zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma, but does reduce the risk of progression with symptomatic bone disease and skeletal complications. This trial was registered in the ClinicalTrials.gov database with code NCT01087008. Copyright© Ferrata Storti Foundation.

  7. Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Kheirandish-Gozal, Leila; Bandla, Hari P R; Gozal, David

    2016-10-01

    Obstructive sleep apnea (OSA) is highly prevalent in children and is usually treated by adenotonsillectomy. Nonsurgical therapies for OSA consist primarily of antiinflammatory approaches and have gained popularity, but their efficacy remains to be critically examined. To determine the effect of montelukast on pediatric OSA. A prospective randomized double-blind controlled trial of polysomnographically diagnosed OSA in children ages 2-10 years who were treated with either oral montelukast (4 or 5 mg daily) or placebo for 16 weeks. Adherence to the medication was ascertained using automated timed pill dispensers along with weekly telephonic reminders. Ninety-two children diagnosed with OSA were approached, and 64 (69.6%) agreed to participate. Of these, 57 (89.0%) completed the 16-week trial, 28 in the montelukast group and 29 in the placebo group. Age, sex, and percentage of obesity were similar in the two groups, as were initial apnea-hypopnea index (AHI) scores. Overall, intention-to-treat analyses revealed that beneficial effects occurred in 20 children receiving montelukast (71.4%), whereas only 2 (6.9%) of the children receiving placebo showed reductions in AHI score (P montelukast-treated children, whereas in children receiving placebo, the AHI did not change (from 8.2 ± 5.0/h TST before to 8.7 ± 4.9/h TST at completion of the trial). When compared with placebo, montelukast for 16 weeks effectively reduced the severity of obstructive sleep apnea in children 2-10 years of age. These results support a therapeutic role for leukotriene modifiers in pediatric OSA provided that long-term trials confirm current findings. Clinical trial registered with www.clinicaltrials.gov (NCT 00599534).

  8. Effect of a high intake of cheese on cholesterol and metabolic syndrome: results of a randomized trial

    Directory of Open Access Journals (Sweden)

    Rita Nilsen

    2015-08-01

    Full Text Available Background: Cheese is generally rich in saturated fat, which is associated with increased risk for cardiovascular diseases. Nevertheless, recent reports suggest that cheese may be antiatherogenic. Objective: The goal of this study was to assess whether intake of two types of Norwegian cheese, with widely varying fat and calcium content, might influence factors of the metabolic syndrome and serum cholesterol levels differently. Design: A total of 153 participants were randomized to one of three groups: Gamalost®, a traditional fat- and salt-free Norwegian cheese (50 g/day, Gouda-type cheese with 27% fat (80 g/day, and a control group with a limited cheese intake. Blood samples, anthropometric measurements, blood pressure, and questionnaires about lifestyle and diet were obtained at inclusion and end. Results: At baseline, there were no differences between the groups in relevant baseline characteristics, mean age 43, 52.3% female. After 8 weeks’ intervention, there were no changes in any of the metabolic syndrome factors between the intervention groups compared with the control group. There were no increases in total- or LDL cholesterol in the cheese groups compared with the control. Stratified analysis showed that those in the Gouda group with metabolic syndrome at baseline had significant reductions in total cholesterol at the end of the trial compared with control (−0.70 mmol/L, p=0.013, and a significantly higher reduction in mean triglycerides. In the Gamalost group, those who had high total cholesterol at baseline had a significant reduction in total cholesterol compared with control (−0.40 mmol/L, p=0.035. Conclusions: In conclusion, cholesterol levels did not increase after high intake of 27% fat Gouda-type cheese over 8 weeks’ intervention, and stratified analysis showed that participants with metabolic syndrome had reduced cholesterol at the end of the trial.

  9. Galantamine versus donepezil in Chinese patients with Alzheimer’s disease: results from a randomized, double-blind study

    Directory of Open Access Journals (Sweden)

    Zhang Z

    2012-12-01

    Full Text Available Zhenxin Zhang,1 Lu Yu,2 Maren Gaudig,3 Barbara Schäuble,4 Ute Richarz51Department of Neurology of Peking Union Medical College Hospital, 2Xi’an Janssen Pharmaceutical Ltd, Beijing, China; 3Health Economics and Reimbursement, Janssen-Cilag EMEA, Neuss, Germany; 4Formerly of EMEA Medical Affairs, Janssen-Cilag EMEA, Neuss, Germany; 5Global Medical Affairs, Janssen Global Services LLC, Janssen-Cilag AG, Baar, SwitzerlandBackground: Acetylcholinesterase inhibitors are considered standard of care for Alzheimer’s disease in many countries. Galantamine is an acetylcholinesterase inhibitor that may also act via allosteric modulation of nicotinic acetylcholine receptors. Therefore, it may provide benefits compared with other acetylcholinesterase inhibitors. The present study compared galantamine (n = 116 with donepezil (n = 117 in a double-blind trial at nine hospitals in China.Methods: After washout of any previous acetylcholinesterase inhibitors, subjects with mild to moderate Alzheimer’s disease received galantamine or donepezil for 16 weeks.Results: Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog/11 scores improved significantly from baseline in both treatment arms, with a significant difference in favor of galantamine on the “language” functional area (P = 0.035. Significantly more galantamine-treated patients responded to treatment (defined as a reduction in ADAS-cog/11 score of >4, >7, or >10 points; all P < 0.05, and had an ADAS-cog/11 score < 20 at end point (P = 0.015. Both treatments were well tolerated, although fewer galantamine-treated patients experienced gastrointestinal adverse events compared with donepezil (30% versus 48%.Conclusion: Cognitive function improved significantly in subjects with mild to moderate Alzheimer’s disease treated with galantamine or donepezil, and both treatments were generally well tolerated. Significant benefits for galantamine over donepezil were observed for language and

  10. Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.

    Science.gov (United States)

    Ruscica, Massimiliano; Gomaraschi, Monica; Mombelli, Giuliana; Macchi, Chiara; Bosisio, Raffaella; Pazzucconi, Franco; Pavanello, Chiara; Calabresi, Laura; Arnoldi, Anna; Sirtori, Cesare R; Magni, Paolo

    2014-01-01

    Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals. The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment. Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol. Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged. These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate. Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.

  11. Early results of low-level laser application for masticatory muscle pain: a double-blind randomized clinical study.

    Science.gov (United States)

    Sancakli, Erkan; Gökçen-Röhlıg, Bilge; Balık, Ali; Öngül, Değer; Kıpırdı, Selin; Keskın, Haluk

    2015-10-23

    To evaluate the effect of Low Level Laser (LLL) application at the points of greatest pain in patients with chronic masticatory muscle pain. A total number of 30 (21 women, 9 men, with a mean age of 39.2) were selected after the diagnosis of MPDS according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD). The patients were randomly divided into three groups; laser group I (n = 10); patients received the LLL at the point of greatest pain, laser group II (n = 10); patients received LLL at pre-established points in the effected muscles and placebo group (n = 10). LLL and placebo were applied three times per week, for a total of 12 sessions. Mandibular mobility was examined, masticator muscles tenderness were assessed and PPT values were obtained. Subjective pain levels were evaluated using VAS. The measurements performed before the treatment and after the completion of the therapy. Descriptive statistics (mean, standard deviation, and frequency) Student's t-test, Mann-Whitney U-test and paired-sample t-tests were used for analysis. In both laser groups, there was a statically significant reduction in PPT values of the muscles, number of muscles without any pain on palpation increased significantly, mandibular movements' ranges were improved. Laser group I demonstrated statistically better results than the Laser group II in all of the measured values. Plasebo group did not show any statistically difference in any of the measured values. LLLT can be accepted as an alternative treatment modality in the management of masticatory muscle pain and direct irradiation seems to effect better. Current Controlled Trials ISRCTN31085 , Date of registration 28/08/20145.

  12. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cichocki M

    2015-05-01

    Full Text Available Martin Cichocki,1 Viktoria Quehenberger,1 Michael Zeiler,1 Tanja Adamcik,1 Matthias Manousek,1 Tanja Stamm,2 Karl Krajic1 1Ludwig Boltzmann Institute Health Promotion Research, 2Medical University of Vienna & University of Applied Sciences FH Campus, Wien, Vienna, Austria Purpose: Research on effectiveness of low-threshold mobility interventions that are viable for users of residential aged care is scarce. Low-threshold is defined as keeping demands on organizations (staff skills, costs and participants (health status, discipline rather low. The study explored the effectiveness of a multi-faceted, low-threshold physical activity program in three residential aged-care facilities in Austria. Main goals were enhancement of mobility by conducting a multi-faceted training program to foster occupational performance and thus improve different aspects of health-related quality of life (QoL.Participants and methods: The program consisted of a weekly session of 60 minutes over a period of 20 weeks. A standardized assessment of mobility status and health-related QoL was applied before and after the intervention. A total of 222 of 276 participants completed the randomized controlled trial study (intervention group n=104, control group n=118; average age 84 years, 88% female.Results: Subjective health status (EuroQoL-5 dimensions: P=0.001, d=0.36 improved significantly in the intervention group, and there were also positive trends in occupational performance (Canadian Occupational Performance Measure. No clear effects were found concerning the functional and cognitive measures applied.Conclusion: Thus, the low-threshold approach turned out to be effective primarily on subjective health-related QoL. This outcome could be a useful asset for organizations offering low-threshold physical activity interventions. Keywords: physical activity, intervention, residential aged care, effectiveness, aged

  13. Exit-site infection of peritoneal catheter is reduced by the use of polyhexanide. results of a prospective randomized trial.

    Science.gov (United States)

    Núñez-Moral, M; Sánchez-Álvarez, E; González-Díaz, I; Peláez-Requejo, B; Fernández-Viña, A; Quintana-Fernández, A; Rodríguez-Suárez, C

    2014-05-01

    One of the most common and severe complications affecting peritoneal dialysis (PD) patients is exit-site infection of the peritoneal catheter; it is therefore of vital importance to prevent it. This complication has a negative impact on the success of the technique. In spite of this, there are no clear guidelines concerning how to take care of the exit site. The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period. We designed a single-center, prospective, open-labeled, randomized controlled clinical trial with parallel groups. Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study. Patients were randomized to be daily cured as follows: Group A: traditional care with saline serum and povidone-iodine; and Group B: polyhexanide solution. Exit sites were evaluated at baseline and every four to six weeks or if any event occurred, according to the Twardowski criteria. Of the 60 included patients, 46 completed the 12-month follow-up period. Six underwent transplantation, five died and three were transferred to hemodialysis (HD). The treatment was well tolerated, with no side effects nor abandonments due to such effects. Throughout the study period, six patients (20%) undergoing traditional care and only two (6,7%) receiving polyhexanide developed an exit-site infection (p = 0.032). There were a total number of 12 infections; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide (p = 0.037). The germs responsible for the infections were: S. aureus (six cases), Corynebacterium jeikeium (two cases) and P. aeruginosa (one case) in the saline serum and povidone-iodine group and P. aeruginosa (three cases) in the

  14. SMALL-DOSE CYTOKINES IN COMBINATION WITH 5-FLUOROURACIL IN OLISSEMINATED RENAL CELL CARCINOMA: FINAL RESULTS OF A RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    L. V. Demidov

    2009-01-01

    Full Text Available Background: High and intermediate IL-2 regimens are difficult to recommend because of great toxicity and efficacy is not sufficient. We suggest that a combination of very low-dose cytokines is effective and safe in metastatic renal cell carcinoma (MRCC patients (pts. A prospective randomized study was started in 2003. The primary end-point was a response rate. Methods: The eligibility criteria included histopathologically confirmed MRCC, ECOG PS 0-2, no autoimmune diseases, no brain metastases, and normal organ function. All pts were randomized in three arms: IL-2 alone, 1.5 MIU, iv, t.i.w., weeks 1—3 or IL-2 1.0 MIU, iv, t.i.w., weeks 1—3 plus IFN 5 MIU, sc, t.i.w, weeks 1—3 or biochemotherapy group 5-FU, 500 mg/m2, iv, once a week, weeks 1—3 plus IL-2 1.0 MIU, iv, t.i.w., weeks 1—3 plus IFN 5 MIU, sc, t.i.w., weeks 1—3. Courses were repeated every three weeks. A response was assessed according to the RECIST every 2 courses.Results: 64 pts were enrolled, of whom 63 were analyzed. Their median age was 55.4 years (range 16—74. 42.9% of the patients had pre- viously received chemo- or immunotherapy. 55.6 percent of the pts had poor prognosis (according to Motzer et al., 2002. Bone metastases were present in 52.4% of the pts. Sixteen patients treated with IL-2 alone showed no CR, PR, 2 SD, or 14 PD. Of 23 patients in the IL-2+IFN group, there were 5 PR, 8 SD, and 10 PD, with a response rate of 21.7%. Amongst 24 patients in the 5-FU+IL-2+IFN group, there were 1 CR, 3 PR, 10 SD, and 10 PD, with a response rate of 16.7%. One-year survival was 20.0%, 81.3% and 81.0%, respectively. The influenza-like syndrome was the most common side effect in the pts who received IFN (89.1%, grade 1, CTC. Hypotension associated with IL-2 (all groups was seen in 56.3% (50%, grade 1 and 6.3%, grade 2. The other adverse reactions were 12.7% grade 1 neutropenia and vomiting in 4.7% pts (Group 3.Conclusion: All regimens are well tolerated. Small-dose IL-2

  15. Immediate vs. early loading of SLA implants in the posterior mandible: 5-year results of randomized controlled clinical trial.

    Science.gov (United States)

    Kokovic, Vladimir; Jung, Ronald; Feloutzis, Andreas; Todorovic, Vladimir S; Jurisic, Milan; Hämmerle, Christoph H F

    2014-02-01

    The aim of this study was to compare clinical results of immediate and early loading (EL) self-tapping implants placed in posterior mandibles. Twelve patients with bilateral edentulous posterior mandibular were randomly assigned to treatment either with immediate (test) or early loaded implants (control). Seventy-two self-tapping implants with SLA surface (Ø 4, 1/4, 8 mm; length 8 and 10 mm) were analyzed in this study. Test implants (36) were loaded on the day of surgery and control implants 6 weeks later. The measuring of implant stability quotient (ISQ) was performed on 0, 6th, 12th, and 52nd week after implant insertion. The bone resorption, modified plaque, and bleeding index were notified at 1 and 5 years later. After 5 years, survival in the both groups was 100%. The mean value of primary implant stability was 76.92 ± 0.79 ISQ. In the first 6 weeks, ISQ values significantly increased in the test group (77.92 ± 1.16 vs. 79.61 ± 0.90) as well as in the control group (7.92 ± 1.05 vs. 77.55 ± 0.99). A significant longitudinal increase in ISQ value was recorded in test and control group. The differences between immediate and early loaded implants were statistically insignificant (P > 0.05). At the 5 years, no statistically significant differences were found between immediate and early loaded implants with respect to mean crestal bone loss measurements (0.4 ± 0.24 vs. 0.8 ± 0.15 mm), mean bleeding index (0.22 ± 0.11 vs. 0.25 ± 0.11), and mean plaque index (0.17 ± 0.15 vs. 0.19 ± 0.20). Based on these results, the self-tapping implants inserted in posterior mandible can provide adequate primary stability value as the main factor for immediate and EL protocol. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  16. Prospective, randomized, fellow eye comparison of WaveLight® Allegretto Wave® Eye-Q versus VISX CustomVueTM STAR S4 IRTM in photorefractive keratectomy: analysis of visual outcomes and higher-order aberrations

    Directory of Open Access Journals (Sweden)

    Sikder S

    2011-08-01

    Full Text Available Majid Moshirfar1, Daniel S Churgin2, Brent S Betts3, Maylon Hsu1, Shameema Sikder4, Marcus Neuffer1, Dane Church5, Mark D Mifflin11University of Utah, John A Moran Eye Center, Department of Ophthalmology and Visual Sciences, Salt Lake City, UT, USA; 2University of Arizona College of Medicine, Phoenix, AZ; 3Temple University School of Medicine, Philadelphia, PA, USA; 4Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA; 5Virginia Commonwealth University School of Medicine, Richmond, VA, USABackground: The purpose of this study was to compare differences in visual outcomes, higher-order aberrations, contrast sensitivity, and dry eye in patients undergoing photorefractive keratectomy using wavefront-guided VISX CustomVue™ and wavefront-optimized WaveLight® Allegretto platforms.Methods: In this randomized, prospective, single-masked, fellow-eye study, photorefractive keratectomy was performed on 46 eyes from 23 patients, with one eye randomized to WaveLight Allegretto, and the fellow eye receiving VISX CustomVue. Three-month postoperative outcome measures included uncorrected distance visual acuity, corrected distance visual acuity, refractive error, root mean square of total and grouped higher-order aberrations, contrast sensitivity, and Schirmer’s testing.Results: Mean values for uncorrected distance visual acuity (logMAR were —0.03 ± 0.07 and —0.06 ± 0.09 in the wavefront-optimized and wavefront-guided groups, respectively (P = 0.121. Uncorrected distance visual acuity of 20/20 or better was achieved in 91% of eyes receiving wavefront-guided photorefractive keratectomy, and 87% of eyes receiving wavefront-optimized photorefractive keratectomy, whereas uncorrected distance visual acuity of 20/15 was achieved in 35% of the wavefront-optimized group and 64% of the wavefront-guided group (P ≥ 0.296. While root mean square of total higher-order aberration, coma, and trefoil tended to increase in the wavefront

  17. Effect of audit and feedback with peer review on general practitioners' prescribing and test ordering performance: a cluster-randomized controlled trial

    National Research Council Canada - National Science Library

    Trietsch, J; Steenkiste, B. van; Grol, R.P; Winkens, B; Ulenkate, H; Metsemakers, J; Weijden, T.T. van der

    2017-01-01

    .... In this study a large-scale implementation of a peer review strategy was tested on both test ordering and prescribing behaviour in primary care in the normal quality improvement setting. METHODS...

  18. Comparison of visual results and higher-order aberrations after small incision lenticule extraction (SMILE): high myopia vs. mild to moderate myopia.

    Science.gov (United States)

    Jin, Hong-Ying; Wan, Ting; Wu, Fang; Yao, Ke

    2017-07-06

    To compare the refractive results and higher-order aberrations (HOAs) after small incision lenticule extraction (SMILE) in high myopia and mild to moderate myopia patients. This prospective study included 165 eyes (86 patients) undergoing SMILE. According to the preoperative spherical equivalent (SE), treated eyes were divided into two groups: the high myopia group (more than -6.0 D, group-H) and the mild to moderate group (less than -6.0 D, group-M). Follow-up intervals were at 1 day, 10 days, 1 month and 3 months postoperatively. We obtained the following parameters: uncorrected (UDVA) and corrected distance visual acuity (CDVA), SE, efficacy and safety index, and HOAs. Preoperative SE was -7.16 ± 0.93 D in group-H and -4.34 ± 0.97 D in group-M. At 3 months postoperatively, the SE in group-H and group-M was -0.20 ± 0.37 D and 0.01 ± 0.19 D (t = - 4.11, P 0.05), respectively. There were significant increases in total HOAs, 3rd-order coma, and 4th-order spherical aberrations. SMILE is an effective and safe surgery for correcting myopia. But the target correction amount in high myopia patients should be adjusted to avoid undercorrection and acquired more satisfaction. SMILE induced increases of HOAs. ChiTrial registration number: ChiCTR-OON-16009164 . Retrospectively registered: 06.September.2016.

  19. Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

    Science.gov (United States)

    Lindfors, Perjohan; Unge, Peter; Arvidsson, Patrik; Nyhlin, Henry; Björnsson, Einar; Abrahamsson, Hasse; Simrén, Magnus

    2012-02-01

    Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (Phypnotherapy group than in the control group (Phypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.

  20. Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial

    NARCIS (Netherlands)

    Rhodes, Lesley E.; de Rie, Menno; Enström, Ylva; Groves, Richard; Morken, Tore; Goulden, Victoria; Wong, Gavin A. E.; Grob, Jean-Jacques; Varma, Sandeep; Wolf, Peter

    2004-01-01

    Photodynamic therapy (PDT) is increasingly used as a noninvasive treatment for nodular basal cell carcinoma (BCC), without a sound evidence base. To compare topical PDT, with the use of the sensitizer methyl aminolevulinate, and standard excision surgery in nodular BCC. Prospective, randomized

  1. Alpha-galactosylceramide in chronic hepatitis B infection: results from a randomized placebo-controlled Phase I/II trial.

    NARCIS (Netherlands)

    Woltman, A.M.; Borg, M.J. Ter; Binda, R.S.; Sprengers, D.; Blomberg, B.M.E. von; Scheper, R.J.; Hayashi, K.; Nishi, N.; Boonstra, A.; Molen, R.G. van der; Janssen, H.L.

    2009-01-01

    BACKGROUND: The glycosphingolipid alpha-galactosylceramide (alpha-GalCer) is known to stimulate invariant natural killer T-cells (iNKTs) and is able to induce powerful antiviral immune responses. The present dose-escalating randomized placebo-controlled Phase I/II trial aimed to investigate

  2. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  3. Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    Science.gov (United States)

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

    2011-01-01

    Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

  4. Effectiveness of proactive quitline counselling for smoking parents recruited through primary schools: results of a randomized controlled trial

    NARCIS (Netherlands)

    Schuck, K.; Bricker, J.B.; Otten, R.; Kleinjan, M.; Brandon, T.H.; Engels, R.C.M.E.

    2014-01-01

    Aims To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Design Two-arm randomized controlled trial with 3- and 12-month follow-up. Setting Proactive telephone counselling was

  5. Reducing HIV-Risk Behavior Among Adults Receiving Outpatient Psychiatric Treatment: Results From a Randomized Controlled Trial

    Science.gov (United States)

    Carey, Michael P.; Carey, Kate B.; Maisto, Stephen A.; Gordon, Christopher M.; Schroder, Kerstin E. E.; Vanable, Peter A.

    2004-01-01

    This study investigated the efficacy of a 10-session, HIV-risk-reduction intervention with 221 women and 187 men receiving outpatient psychiatric care for a mental illness. Patients were randomly assigned to the HIV intervention, a structurally equivalent substance use reduction (SUR) intervention, or standard care; they were assessed pre- and…

  6. Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

    2009-01-01

    The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

  7. Sustainable effect of skin stretching for burn scar excision: Long-term results of a multicenter randomized controlled trial

    NARCIS (Netherlands)

    Verhaegen, P.D.H.M.; van der Wal, M.B.A.; Bloemen, M.C.T.; Dokter, J.; Melis, P.; Middelkoop, E.; van Zuijlen, P.P.M.

    2011-01-01

    Purpose: Primary wound closure of large defects after burn scar excision may be facilitated by intraoperative stretching of the adjacent skin. In a randomized controlled trial (RCT), the effect of skin stretching for wound closure after scar excision (SS) was compared to scar excision without

  8. Cognitive Behavioral Treatment of PTSD in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Johnson, Dawn M.; Zlotnick, Caron; Perez, Sara

    2011-01-01

    Objective: This study was designed to explore the acceptability, feasibility, and initial efficacy of a new shelter-based treatment for victims of intimate partner violence (IPV; i.e., Helping to Overcome PTSD through Empowerment [HOPE]). Method: A Phase I randomized clinical trial comparing HOPE (n = 35) with standard shelter services (SSS) (n =…

  9. Mindfulness Training and Reductions in Teacher Stress and Burnout: Results from Two Randomized, Waitlist-Control Field Trials

    Science.gov (United States)

    Roeser, Robert W.; Schonert-Reichl, Kimberly A.; Jha, Amishi; Cullen, Margaret; Wallace, Linda; Wilensky, Rona; Oberle, Eva; Thomson, Kimberly; Taylor, Cynthia; Harrison, Jessica

    2013-01-01

    The effects of randomization to mindfulness training (MT) or to a waitlist-control condition on psychological and physiological indicators of teachers' occupational stress and burnout were examined in 2 field trials. The sample included 113 elementary and secondary school teachers (89% female) from Canada and the United States. Measures were…

  10. Parent training in foster families with children with behavior problems : Follow-up results from a randomized controlled trial

    NARCIS (Netherlands)

    Maaskant, A.M.; van Rooij, F.B.; Overbeek, G.J.; Oort, F.J.; Hermanns, J.M.A.

    2016-01-01

    The present randomized controlled trial examined the four months follow-up effectiveness of Parent Management Training Oregon (PMTO) for parents with foster children (aged 4–12) with severe externalizing behavior problems in long-term foster care arrangements. The aim of PMTO, a relative long and

  11. Reducing Aggressive Behavior in Boys With a Social Cognitive Group Treatment: Results of a Randomized, Controlled Trial.

    NARCIS (Netherlands)

    van Manen, T.G.; Prins, P.J.M.; Emmelkamp, P.M.G.

    2004-01-01

    Objective: To evaluate the effectiveness of a social cognitive intervention program for Dutch aggressive boys and to compare it with a social skills training and a waitlist control group. Method: A randomized, controlled treatment outcome study with 97 aggressive boys (aged 9-13 years) was

  12. The effects of a digital formative assessment tool on mathematics achievement and student motivation: Results of a randomized experiment

    NARCIS (Netherlands)

    Faber, Janke; Luyten, Johannes W.; Visscher, Arend J.

    2017-01-01

    In this study a randomized experimental design was used to examine the effects of a digital formative assessment tool on mathematics achievement and motivation in grade three primary education (n schools = 79, n students = 1808). Experimental schools used a digital formative assessment tool whereas

  13. Transfer Incentives for High-Performing Teachers: Final Results from a Multisite Randomized Experiment. Executive Summary. NCEE 2014-4004

    Science.gov (United States)

    Glazerman, Steven; Protik, Ali; Teh, Bing-ru; Bruch, Julie; Max, Jeffrey

    2013-01-01

    One way to improve struggling schools' access to effective teachers is to use selective transfer incentives. Such incentives offer bonuses for the highest-performing teachers to move into schools serving the most disadvantaged students. In this report, we provide evidence from a randomized experiment that tested whether such a policy intervention…

  14. Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

    Science.gov (United States)

    Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

    2018-01-01

    To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

  15. Assessing Fun Items' Effectiveness in Increasing Learning of College Introductory Statistics Students: Results of a Randomized Experiment

    Science.gov (United States)

    Lesser, Lawrence M.; Pearl, Dennis K.; Weber, John J., III

    2016-01-01

    There has been a recent emergence of scholarship on the use of fun in the college statistics classroom, with at least 20 modalities identified. While there have been randomized experiments that suggest that fun can enhance student achievement or attitudes in statistics, these studies have generally been limited to one particular fun modality or…

  16. Does Written Emotional Disclosure about Stress Improve College Students' Academic Performance? Results from Three Randomized, Controlled Studies

    Science.gov (United States)

    Radcliffe, Alison M.; Stevenson, Jennifer K.; Lumley, Mark A.; D'Souza, Pamela J.; Kraft, Christina A.

    2011-01-01

    Several early studies and subsequent reviews suggested that written emotional disclosure (WED)--writing repeatedly about personal stressful experiences--leads to improved academic performance of college students. A critical review of available studies casts some doubt on this conclusion, so we conducted three randomized, controlled experiments of…

  17. Implementing Mother Tongue Instruction in the Real World: Results from a Medium-Scale Randomized Controlled Trial in Kenya

    Science.gov (United States)

    Piper, Benjamin; Zuilkowski, Stephanie S.; Ong'ele, Salome

    2016-01-01

    Research in sub-Saharan Africa investigating the effect of mother tongue (MT) literacy instruction at medium scale is limited. A randomized controlled trial of MT literacy instruction was implemented in 2013 and 2014 as part of the Primary Math and Reading (PRIMR) Initiative in Kenya. We compare the effect of two treatment groups--the base PRIMR…

  18. Pharmacokinetic and pharmacodynamic studies of two different rabbit antithymocyte globulin dosing regimens: results of a randomized trial.

    Science.gov (United States)

    Büchler, Matthias; Longuet, Hélène; Lemoine, Roxane; Herr, Florence; Gatault, Philippe; Thibault, Gilles; Ternant, David; Foulon, Christine; Pilorge, Bernadette; Lemay, Djamila; Sung, Crystal; Halimi, Jean-Michel; Baron, Christophe; Lebranchu, Yvon

    2013-03-01

    Rabbit antithymocyte globulin (rATG; Thymoglobulin(®)) is currently used to prevent acute rejection in kidney transplantation. The dose and regimen of rATG have not been optimized. Moreover, the impact of different treatment regimens on T-cell phenotype reconstitution remains unknown. We conducted a prospective randomized study of 17 renal transplant patients to determine the pharmacokinetics of total and active (bound to human cells) rATG and T-cell phenotype reconstitution after rATG administration. Patients received rATG at a total dose of 6mg/kg, administered either as 1.5mg/kg/day on days 0-3 (Group 1, n=8) or 3mg/kg on days 0 and 3 (Group 2, n=9). All patients received tacrolimus, mycophenolate mofetil and steroids. Blood samples were assayed for total rATG by enzyme linked immunosorbent assay and active rATG by flow cytometry. Maximum concentrations and terminal half-lives were similar between the two groups but at month 3 Group 1 had significantly lower values for total rATG (concentration was 6.2±1.1μg/mL versus 10.2±2.9μg/mL in Group 2, p=0.027) and total rATG dose-normalized AUC (374±83dayg/mL versus 508±149dayg/mL in Group 2, p=0.046). Time to sub-therapeutic levels (memory CD4(+) T-cells increased to a similar extent in both groups (Group 1: 38±18% at baseline, 74±23% at one year, p=0.009; Group 2: 32±14% at baseline, 65±14% at one year, p=0.001). In conclusion, our results suggest that the dosing regimen for rATG induction influences pharmacokinetic parameters without affecting the quality of immune reconstitution. Copyright © 2013 Elsevier B.V. All rights reserved.

  19. Chest pain control with kinesiology taping after lobectomy for lung cancer: initial results of a randomized placebo-controlled study.

    Science.gov (United States)

    Imperatori, Andrea; Grande, Annamaria; Castiglioni, Massimo; Gasperini, Laura; Faini, Agnese; Spampatti, Sebastiano; Nardecchia, Elisa; Terzaghi, Lorena; Dominioni, Lorenzo; Rotolo, Nicola

    2016-08-01

    Kinesiology taping (KT) is a rehabilitative technique performed by the cutaneous application of a special elastic tape. We tested the safety and efficacy of KT in reducing postoperative chest pain after lung lobectomy. One-hundred and seventeen consecutive patients, both genders, age 18-85, undergoing lobectomy for lung cancer between January 2013 and July 2015 were initially considered. Lobectomies were performed by the same surgical team, with thoracotomy or video-assisted thoracoscopic surgery (VATS) access. Exclusion criteria (n = 25 patients) were: previous KT exposure, recent trauma, pre-existing chest pain, lack of informed consent, >24-h postoperative intensive care unit treatment. After surgery, the 92 eligible patients were randomized to KT experimental group (n = 46) or placebo control group (n = 46). Standard postoperative analgesia was administered in both groups (paracetamol/non-steroidal anti-inflammatory drugs, epidural analgesia including opioids), with supplemental analgesia boluses at patient request. On postoperative day 1 in addition, in experimental group patients a specialized physiotherapist applied KT, with standardized tape length, tension and shape, over three defined skin areas: at the chest access site pain trigger point; over the ipsilateral deltoid/trapezius; lower anterior chest. In control group, usual dressing tape mimicking KT was applied over the same areas, as placebo. Thoracic pain severity score [visual analogue scale (VAS) ranging 0-10] was self-assessed by all patients on postoperative days 1, 2, 5, 8, 9 and 30. The KT group and the control group had similar demographics, lung cancer clinico-pathological features and thoracotomy/VATS ratio. Postoperatively, the two groups also resulted similar in supplemental analgesia, complication rate, mean duration of chest drainage and length of stay. There were no adverse events with KT application. After tape application, KT patients reported overall less thoracic pain than the

  20. Pretreatment fasting plasma glucose and insulin modify dietary weight loss success: results from 3 randomized clinical trials.

    Science.gov (United States)

    Hjorth, Mads F; Ritz, Christian; Blaak, Ellen E; Saris, Wim Hm; Langin, Dominique; Poulsen, Sanne Kellebjerg; Larsen, Thomas Meinert; Sørensen, Thorkild Ia; Zohar, Yishai; Astrup, Arne

    2017-08-01

    Background: Which diet is optimal for weight loss and maintenance remains controversial and implies that no diet fits all patients.Objective: We studied concentrations of fasting plasma glucose (FPG) and fasting insulin (FI) as prognostic markers for successful weight loss and maintenance through diets with different glycemic loads or different fiber and whole-grain content, assessed in 3 randomized trials of overweight participants.Design: After an 8-wk weight loss, participants in the DiOGenes (Diet, Obesity, and Genes) trial consumed ad libitum for 26 wk a diet with either a high or a low glycemic load. Participants in the Optimal well-being, development and health for Danish children through a healthy New Nordic Diet (OPUS) Supermarket intervention (SHOPUS) trial consumed ad libitum for 26 wk the New Nordic Diet, which is high in fiber and whole grains, or a control diet. Participants in the NUGENOB (Nutrient-Gene Interactions in Human Obesity) trial consumed a hypocaloric low-fat and high-carbohydrate or a high-fat and low-carbohydrate diet for 10 wk. On the basis of FPG before treatment, participants were categorized as normoglycemic (FPG diabetic (FPG ≥7.0 mmol/L). Modifications of the dietary effects of FPG and FI before treatment were examined with linear mixed models.Results: In the DiOGenes trial, prediabetic individuals regained a mean of 5.83 kg (95% CI: 3.34, 8.32 kg; P diabetic individuals lost a mean of 2.04 kg (95% CI: -0.20, 4.28 kg; P = 0.07) more on the high-fat and low-carbohydrate diet than on the low-fat and high-carbohydrate diet, whereas normoglycemic individuals lost a mean of 0.43 kg (95% CI: 0.03, 0.83 kg; P = 0.03) more on the low-fat and high-carbohydrate diet [mean group difference: 2.47 kg (95% CI: 0.20, 4.75 kg); P = 0.03]. The addition of FI strengthened these associations.Conclusion: Elevated FPG before treatment indicates success with dietary weight loss and maintenance among overweight patients consuming diets with a low

  1. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial.

    Science.gov (United States)

    Bertrand, Helene; Kyriazis, Marylene; Reeves, K Dean; Lyftogt, John; Rabago, David

    2015-11-01

    Capsaicin specifically activates, and then gradually exhausts, the transient receptor potential vanilloid type 1 (TRPV1) receptor, a key receptor in neuropathic pain. Activation of the TRPV-1 receptor is accompanied by burning pain. A natural substance or medication that can reduce the burning pain resulting from capsaicin application may have therapeutic potential in neuropathic pain. To assess the pain-relieving effects of a mannitol-containing cream in a capsaicin-based pain model. Randomized, placebo-controlled, double-blind clinical trial. Outpatient pain clinic. Twenty-five adults with pain-free lips. Capsaicin .075% cream was applied to both halves of each participant's upper lip, inducing pain via stimulation of the transient receptor potential vanilloid 1 (TRPV1, capsaicin) receptor, then removed after 5 minutes or when participants reported a burning pain of 8/10, whichever came first. A cream containing mannitol and the same cream without mannitol (control) were then immediately applied, 1 on each side of the lip, in an allocation-masked manner. Participants self-recorded a numeric rating scale (NRS, 0-10) pain score for each side of the lip per minute for 10 minutes. A t-test was performed to evaluate the pain score change from baseline between each side of the lip at each recording. Area under the curve (AUC) analysis was used to determine the overall difference between groups. Participants reached a capsaicin-induced pain level of 7.8 ± 1.0 points in 3.3 ± 1.6 minutes that was equal on both sides of the lip. Both groups reported progressive diminution of pain over the 10-minute study period. However, participants reported significantly reduced pain scores on the mannitol cream half-lip compared to control at 3 through 10 minutes (P Mannitol cream reduced self-reported pain scores in a capsaicin pain model more rapidly than a control cream, potentially via a TRPV1 receptor effect. Copyright © 2015 American Academy of Physical Medicine and

  2. The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van den Berg N

    2017-03-01

    Full Text Available Neeltje van den Berg,1,2 Sabina Ulbricht,2,3 Thea Schwaneberg,1,2 Kerstin Weitmann,1,2 Franziska Weymar,1–3 Stefan Groß,2,4 Marcus Dörr,2,4 Wolfgang Hoffmann1,2 1Institute for Community Medicine, University Medicine Greifswald, 2German Centre for Cardiovascular Research (DZHK, Partner Site Greifswald, 3Institute of Social Medicine and Prevention, University Medicine Greifswald, 4Department of Internal Medicine B, University Medicine Greifswald, Greifswald, Germany Background: Physical activity (PA can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs on adherence was examined. Methods: A randomized study with four groups was conducted in the context of a health examination program among participants aged 40–75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance. The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme “day and night” or “day only” and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days. A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. Results: Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males. The mean wearing time was 84.04 hours (SD 20.75. Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005. SPCs had no additional effect on adherence (IRR 0.80; P=0.168. Conclusion: To assess PA, the wearing scheme day and night provides the best possible

  3. Use of the Mean Abnormal Result Rate (MARR) to Gauge Changes in Family Physicians' Selectivity of Laboratory Test Ordering, 2010-2015.

    Science.gov (United States)

    Brack, Andrew P; Guo, Maggie; Ma, Irene; Naugler, Christopher

    2017-11-02

    The mean abnormal result rate (MARR) has recently been advanced as a metric of laboratory test appropriateness. We used the MARR metric to examine patterns of change in family physician test requisitions over time. We accessed the Laboratory Information System of Calgary Laboratory Services for family physician-ordered testing on outpatients to gather aggregate test and abnormal result counts from 2010 to 2015. Over the 6 years, there was an annual average of 3,401,553 tests for 411,295 distinct patients on their first test requisition for the year. The MARR increased from 8.1% to 9.0% through this period. The MARR for Calgary and surrounding area gives tentative evidence of a gradual increase in physician test selectivity in recent years. Further data from other catchment areas are needed before making assertions about broader trends in physician awareness of laboratory resource use.

  4. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial

    OpenAIRE

    Mac?as-Rodr?guez, Ricardo U; Ilarraza-Lomel?, Hermes; Ruiz-Marg?in, Astrid; Ponce-de-Le?n-Rosales, Sergio; Vargas-Vor?ckov?, Florencia; Garc?a-Flores, Octavio; Torre, Aldo; Duarte-Rojo, Andr?s

    2016-01-01

    OBJECTIVES: Exercise has been scarcely studied in patients with cirrhosis, and prior evidence showed hepatic venous pressure gradient (HVPG) to be increased in response to exercise. The aim of this study was to investigate the effects of a supervised physical exercise program (PEP) in patients with cirrhosis. METHODS: In an open-label, pilot clinical trial, patients with cirrhosis were randomized to PEP (cycloergometry/kinesiotherapy plus nutritional therapy, n=14) or control (nutritional the...

  5. Effect of a high intake of cheese on cholesterol and metabolic syndrome: results of a randomized trial

    OpenAIRE

    Nilsen, Rita; Høstmark, Arne Torbjørn; Haug, Anna; Skeie, Siv

    2015-01-01

    Background: Cheese is generally rich in saturated fat, which is associated with increased risk for cardiovascular diseases. Nevertheless, recent reports suggest that cheese may be antiatherogenic. Objective: The goal of this study was to assess whether intake of two types of Norwegian cheese, with widely varying fat and calcium content, might influence factors of the metabolic syndrome and serum cholesterol levels differently. Design: A total of 153 participants were randomized to one of thre...

  6. Staff distress improves by treating pain in nursing home patients with dementia: results from a cluster-randomized controlled trial

    OpenAIRE

    Aasmul, Irene; Husebo, Bettina Sandgathe; Flo, Elisabeth

    2016-01-01

    Context. Most people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden. Objectives. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Methods. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n ¼ 175) or control group (27 NH units; n &fr...

  7. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial.

    Science.gov (United States)

    Steinberg, William M; Buse, John B; Ghorbani, Marie Louise Muus; Ørsted, David D; Nauck, Michael A

    2017-07-01

    To evaluate serum amylase and lipase levels and the rate of acute pancreatitis in patients with type 2 diabetes and high cardiovascular risk randomized to liraglutide or placebo and observed for 3.5-5.0 years. A total of 9,340 patients with type 2 diabetes were randomized to either liraglutide or placebo (median observation time 3.84 years). Fasting serum lipase and amylase were monitored. Acute pancreatitis was adjudicated in a blinded manner. Compared with the placebo group, liraglutide-treated patients had increases in serum lipase and amylase of 28.0% and 7.0%, respectively. Levels were increased at 6 months and then remained stable. During the study, 18 (0.4% [1.1 events/1,000 patient-years of observation] [PYO]) liraglutide-treated and 23 (0.5% [1.7 events/1,000 PYO]) placebo patients had acute pancreatitis confirmed by adjudication. Most acute pancreatitis cases occurred ≥12 months after randomization. Liraglutide-treated patients with prior history of pancreatitis (n = 147) were not more likely to develop acute pancreatitis than similar patients in the placebo group (n = 120). Elevations of amylase and lipase levels did not predict future risk of acute pancreatitis (positive predictive value pancreatitis among liraglutide-treated patients (regardless of previous history of pancreatitis) compared with the placebo group. Liraglutide was associated with increases in serum lipase and amylase, which were not predictive of an event of subsequent acute pancreatitis. © 2017 by the American Diabetes Association.

  8. Laparoscopic versus open appendectomy: what is the real difference? Results of a prospective randomized double-blinded trial.

    Science.gov (United States)

    Ignacio, R C; Burke, R; Spencer, D; Bissell, C; Dorsainvil, C; Lucha, P A

    2004-02-01

    The comparison of laparoscopic to open appendectomy has been reviewed in many retrospective and prospective studies. Some report shorter hospital stays, less postoperative pain, and earlier return to work while others fail to demonstrate such differences. We performed a prospective, randomized double-blinded trial to evaluate this ongoing debate. Fifty-two consecutive men presenting with signs and symptoms suggestive of acute appendicitis were randomized to undergo either laparoscopic appendectomy or open appendectomy. Length of operative times, hospital stay, lost work days, visual analog pain scores, and operative costs were compared. Length of stay averaged 21.5 h for the laparoscopic group and was not statistically different when compared to the open group. Perceived postoperative pain on postoperative days 1 and 7 were not statistically different between the two groups. Mean time to return to work was 11 days, and there was no statistical difference between groups. Operative costs were >600 dollars greater for the laparoscopic approach. In this prospective randomized double-blinded trial, laparoscopic appendectomy appears to confer no significant advantage over open appendectomy for postoperative pain or lost work days. It does carry an increase in operating room costs and, contrary to other reports, hospital stay is not shortened. Further studies are needed to determine if specific populations, such as the obese or women, may benefit from a minimally invasive approach to appendicitis.

  9. Coping with stress in medical students: results of a randomized controlled trial using a mindfulness-based stress prevention training (MediMind) in Germany.

    Science.gov (United States)

    Kuhlmann, S M; Huss, M; Bürger, A; Hammerle, F

    2016-12-28

    High prevalence rates of psychological distress in medical training and later professional life indicate a need for prevention. Different types of intervention were shown to have good effects, but little is known about the relative efficacy of different types of stress management interventions, and methodological limitations have been reported. In order to overcome some of these limitations, the present study aimed at evaluating the effect of a specifically developed mindfulness-based stress prevention training for medical students (MediMind) on measures of distress, coping and psychological morbidity. We report on a prospective randomized controlled trial with three study conditions: experimental treatment (MediMind), standard treatment (Autogenic Training) and a control group without treatment. The sample consisted of medical or dental students in the second or eighth semester. They completed self-report questionnaires at baseline, after the training and at one year follow-up. Distress (Trier Inventory for the Assessment of Chronic Stress, TICS) was assessed as the primary outcome and coping (Brief COPE) as a co-primary outcome. Effects on the psychological morbidity (Brief Symptom Inventory, BSI) as a secondary outcome were expected one year after the trainings. Initially, N = 183 students were randomly allocated to the study groups. At one year follow-up N = 80 could be included into the per-protocol analysis: MediMind (n =31), Autogenic Training (n = 32) and control group (n = 17). A selective drop-out for students who suffered more often from psychological symptoms was detected (p = .020). MANCOVA's on TICS and Brief COPE revealed no significant interaction effects. On the BSI, a significant overall interaction effect became apparent (p = .002, η2partial = .382), but post hoc analyses were not significant. Means of the Global Severity Index (BSI) indicated that MediMind may contribute to a decrease in psychological morbidity. Due

  10. Tellurium speciation, connectivity, and chemical order in As(x)Te(100-x) glasses: results from two-dimensional 125Te NMR spectroscopy.

    Science.gov (United States)

    Kaseman, Derrick C; Hung, Ivan; Lee, Kathleen; Kovnir, Kirill; Gan, Zhehong; Aitken, Bruce; Sen, Sabyasachi

    2015-02-05

    The short-range structure, connectivity, and chemical order in As(x)Te(100-x) (25 ≤ x ≤ 65) glasses are studied using high-resolution two-dimensional projection magic-angle-turning (pjMAT) (125)Te nuclear magnetic resonance (NMR) spectroscopy. The (125)Te pjMAT NMR results indicate that the coordination of Te atoms obeys the 8-N coordination rule over the entire composition range. However, in strong contrast with the analogous glass-forming As-S and As-Se chalcogenides, significant violation of chemical order is observed in As-Te glasses over the entire composition range in the form of homopolar As-As (Te-Te) bonds, even in severely As (Te)-deficient glasses. The speciation of the Te coordination environments can be explained with the dissociation reaction model As2Te3 → 2As + 3Te(II), characterized by a dissociation constant that is independent of glass composition. These structural characteristics can be attributed to the high metallicity of Te and the strong energetic similarity between the Te-Te, Te-As, and As-As bonds, and they are consistent with the monotonic and often nearly linear variation of physical properties observed in telluride glasses as a function of the Te content.

  11. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial.

    Science.gov (United States)

    Berger, T; Urech, A; Krieger, T; Stolz, T; Schulz, A; Vincent, A; Moser, C T; Moritz, S; Meyer, B

    2017-01-01

    Internet-based cognitive-behavioural treatment (ICBT) for anxiety disorders has shown some promise, but no study has yet examined unguided ICBT in primary care. This randomized controlled trial (RCT) investigated whether a transdiagnostic, unguided ICBT programme for anxiety disorders is effective in primary care settings, after a face-to-face consultation with a physician (MD). We hypothesized that care as usual (CAU) plus unguided ICBT would be superior to CAU in reducing anxiety and related symptoms among patients with social anxiety disorder (SAD), panic disorder with or without agoraphobia (PDA) and/or generalized anxiety disorder (GAD). Adults (n = 139) with at least one of these anxiety disorders, as reported by their MD and confirmed by a structured diagnostic interview, were randomized. Unguided ICBT was provided by a novel transdiagnostic ICBT programme ('velibra'). Primary outcomes were generic measures, such as anxiety and depression symptom severity, and diagnostic status at post-treatment (9 weeks). Secondary outcomes included anxiety disorder-specific measures, quality of life, treatment adherence, satisfaction, and general psychiatric symptomatology at follow-up (6 months after randomization). CAU plus unguided ICBT was more effective than CAU at post-treatment, with small to medium between-group effect sizes on primary (Cohen's d = 0.41-0.47) and secondary (Cohen's d = 0.16-0.61) outcomes. Treatment gains were maintained at follow-up. In the treatment group, 28.2% of those with a SAD diagnosis, 38.3% with a PDA diagnosis, and 44.8% with a GAD diagnosis at pretreatment no longer fulfilled diagnostic criteria at post-treatment. The unguided ICBT intervention examined is effective for anxiety disorders when delivered in primary care.

  12. Results of Mujeres Felices por ser Saludables: a dietary/breast health randomized clinical trial for Latino women.

    Science.gov (United States)

    Fitzgibbon, Marian L; Gapstur, Susan M; Knight, Sara J

    2004-10-01

    Data are limited on the efficacy of health-focused interventions for young, low-acculturated Latino women. Because breast cancer is the most commonly diagnosed cancer and the most common cause of cancer mortality in this population, combined interventions that address both early detection and dietary patterns could help reduce both morbidity and mortality associated with breast cancer in this underserved population. Mujeres Felices por ser Saludables was randomized intervention study designed to assess the efficacy of an 8-month combined dietary and breast health intervention to reduce fat and increase fiber intake as well as to increase the frequency and proficiency of breast self-examination (BSE) and reduce anxiety related to BSE among Latinas. Blocked randomization in blocks of 6 was used to randomize 256 20- to 40-year-old Latinas to the intervention (n = 127) or control group (n = 129). The intervention group attended an 8-month multicomponent education program designed specifically for low-acculturated Latinas. The control group received mailed health education material on a schedule comparable to the intervention. A total of 195 women (76.2%) completed both the baseline and 8-month follow-up interviews. The intervention and control groups were similar on baseline sociodemographic characteristics. At the 8-month follow up, the intervention group reported lower dietary fat (P < .001) and higher fiber intake (p = .06); a higher proportion reported practicing BSE at the recommended interval (p < .001) and showed improved BSE proficiency (p < .001) compared to the control group. BSE-related anxiety was low for both groups at baseline, and no difference in reduction was observed. This project provides a successful model for achieving dietary change and improving breast health behavior in young, low-acculturated Latinas.

  13. Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Gregory M Lucas

    Full Text Available Data regarding the efficacy of directly administered antiretroviral therapy (DAART are mixed. Opioid treatment programs (OTPs provide a convenient framework for DAART. In a randomized controlled trial, we compared DAART and self-administered therapy (SAT among HIV-infected subjects attending five OTPs in Baltimore, MD.HIV-infected individuals attending OTPs were eligible if they were not taking antiretroviral therapy (ART or were virologically failing ART at last clinical assessment. In subjects assigned to DAART, we observed one ART dose per weekday at the OTP for up to 12 months. SAT subjects administered ART at home. The primary efficacy comparison was the between-arm difference in the average proportions with HIV RNA <50 copies/mL during the intervention phase (3-, 6-, and 12-month study visits, using a logistic regression model accounting for intra-person correlation due to repeated observations. Adherence was measured with electronic monitors in both arms.We randomized 55 and 52 subjects from five Baltimore OTPs to DAART and SAT, respectively. The average proportions with HIV RNA <50 copies/mL during the intervention phase were 0.51 in DAART and 0.40 in SAT (difference 0.11, 95% CI: -0.020 to 0.24. There were no significant differences between arms in electronically-measured adherence, average CD4 cell increase from baseline, average change in log10 HIV RNA from baseline, opportunistic conditions, hospitalizations, mortality, or the development of new drug resistance mutations.In this randomized trial, we found little evidence that DAART provided clinical benefits compared to SAT among HIV-infected subjects attending OTPs.ClinicalTrials.gov NCT00279110 NCT00279110?term = NCT00279110&rank = 1.

  14. Exercise and quality of life during and after treatment for breast cancer: results of two randomized controlled trials.

    Science.gov (United States)

    Cadmus, Lisa A; Salovey, Peter; Yu, Herbert; Chung, Gina; Kasl, Stanislav; Irwin, Melinda L

    2009-04-01

    To determine the effect of exercise on quality of life in (a) a randomized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and (b) a similar trial among post-treatment survivors. Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and randomized to a 6-month, home-based exercise program (n=25) or a usual care group (n=25). In a separate trial, 75 post-treatment survivors were randomized to a 6-month, supervised exercise intervention (n=37) or to usual care (n=38). Participants in both studies completed measures of happiness, depressive symptoms, anxiety, stress, self-esteem, and quality of life at baseline and 6 months. Forty-five participants completed the trial for newly diagnosed survivors and 67 completed the trial for post-treatment survivors. Good adherence was observed in both studies. Baseline quality of life was similar for both studies on most measures. Exercise was not associated with quality of life benefits in the full sample of either study; however exercise was associated with improved social functioning among post-treatment survivors who reported low social functioning at baseline (p<0.05). Exercise did not affect quality of life in either recently diagnosed or post-treatment breast cancer survivors; however this may be due in part to relatively high baseline functioning among participants in both studies. Strategies for future research include limiting enrollment to survivors who report reduced quality of life on screening questionnaires and targeting survivor subgroups known to be at particular risk for quality of life impairment. (c) 2009 John Wiley & Sons, Ltd.

  15. A further result on consensus problems of second-order multi-agent systems with directed graphs, a moving mode and multiple delays.

    Science.gov (United States)

    Li, Xue; Gao, Kai; Lin, Peng; Mo, Lipo

    2017-07-03

    This paper considers a consensus problem of a class of second-order multi-agent systems with a moving mode and multiple delays on directed graphs. Using local information, a distributed algorithm is adopted to make all agents reach a consensus while moving together with a constant velocity in the presence of delays. To study the effects of the coexistence of the moving mode and delays on the consensus convergence, a frequency domain approach is employed through analyzing the relationship between the components of the eigenvector associated with the eigenvalue on imaginary axis. Then based on the continuity of the system function, an upper bound for the delays is given to ensure the consensus convergence of the system. A numerical example is included to illustrate the obtained theoretical results. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  16. Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception.

    Science.gov (United States)

    Hubacher, David; Spector, Hannah; Monteith, Charles; Chen, Pai-Lien; Hart, Catherine

    2015-03-01

    Most published contraceptive continuation rates have scientific limitations and cannot be compared; this is particularly true for dissimilar contraceptives. This study uses a new approach to determine if high continuation rates of long-acting reversible contraception (LARC) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC. We are conducting a partially randomized patient preference trial (PRPPT) to compare continuation rates of short-acting reversible contraception (SARC) and LARC. Only women seeking SARC were invited to participate. Participants chose to be in the preference cohort (self-selected method use) or opted to be randomized to SARC or LARC; only those in the randomized cohort received free product. We compared participant characteristics, reasons for not trying LARC previously and the contraceptive choices that were made. We enrolled 917 eligible women; 57% chose to be in the preference cohort and 43% opted for the randomized trial. The preference and randomized cohorts were similar on most factors. However, the randomized cohort was more likely than the preference cohort to be uninsured (48% versus 36%, respectively) and to cite cost as a reason for not trying LARC previously (50% versus 10%) (pcontraceptive continuation rates and unintended pregnancy in this ongoing trial. The choices participants made were associated with numerous factors; lack of insurance was associated with participation in the randomized trial. This PRPPT will provide new estimates of contraceptive continuation rates, such that any benefits of LARC will be more easily attributable to the technology and not the user. Combined with measuring level of satisfaction with LARC, the results will help project the potential role and benefits of expanding voluntary use of LARC. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. The treatment of disc herniation-induced sciatica with infliximab - One-year follow-up results of FIRST II, a randomized controlled trial

    NARCIS (Netherlands)

    Korhonen, Timo; Karppinen, Jaro; Paimela, Leena; Malmivaara, Antti; Lindgren, Karl-August; Bowman, Chris; Hammond, Anthony; Kirkham, Bruce; Jarvinen, Simo; Niinimaki, Jaakko; Veeger, Nic; Haapea, Marianne; Torkki, Markus; Tervonen, Osmo; Seitsalo, Seppo; Hurri, Heikki

    2006-01-01

    Study Design. A randomized controlled trial. Objectives. To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc. Summary of Background Data. The results of

  18. Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma

    NARCIS (Netherlands)

    A.M.M. Eggermont (Alexander); S. Suciu (Stefan); A. Testori (Alessandro); M. Santinami (Mario); W.H.J. Kruit (Wim); J. Marsden (Jeremy); C.J.A. Punt (Cornelis); F. Salès (François); R. Dummer (Reinhard); C. Robert (Caroline); D. Schadendorf (Dirk); P. Patel (Poulam); G. de Schaetzen (Gaetan); A. Spatz (Alan); U. Keilholz (Ulrich)

    2012-01-01

    textabstractPurpose: Adjuvant pegylated interferon alfa-2b (PEG-IFN-α-2b) was approved for treatment of resected stage III melanoma in 2011. Here, we present long-term follow-up results of this pivotal trial. Patients and Methods: In all, 1,256 patients with resected stage III melanoma were randomly

  19. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial

    NARCIS (Netherlands)

    Roncella, Adriana; Pristipino, Christian; Cianfrocca, Cinzia; Scorza, Silvia; Pasceri, Vincenzo; Pelliccia, Francesco; Denollet, J.; Pedersen, S.S.; Speciale, Giulio

    2013-01-01

    Background: Previous studies on cognitive and interpersonal interventions have yielded inconsistent results in ischemic heart disease patients. Methods: 101 patients aged ≤ 70 years, and enrolled one week after complete revascularization with urgent/emergent angioplasty for an AMI, were randomized

  20. Mindfulness-based cognitive therapy (MBCT) for multiple chemical sensitivity (MCS): Results from a randomized controlled trial with 1-year follow-up

    DEFF Research Database (Denmark)

    Hauge, Christian Riise; Rasmussen, Alice; Piet, Jacob

    2015-01-01

    the effects of mindfulness-based cognitive therapy (MBCT) for individuals with MCS. Methods The intention-to-treat sample (ITT) included 69 individuals who had been randomized to either MBCT or treatment as usual (TAU). The primary outcome measure was the Quick Environmental Exposure and Sensitivity Inventory...... emotional and cognitive representations. Possible explanations for these results are discussed....

  1. Correction to: Impact of an electronic monitoring device and behavioural feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial.

    Science.gov (United States)

    Yeh, E Ann; Grover, Stephanie A; Powell, Victoria E; Alper, Gulay; Banwell, Brenda L; Edwards, Kim; Gorman, Mark; Graves, Jennifer; Lotze, Timothy E; Mah, Jean K; Mednick, Lauren; Ness, Jayne; Obadia, Maya; Slater, Ruth; Waldman, Amy; Waubant, Emmanuelle; Schwartz, Carolyn E

    2017-12-23

    The clinicaltrials.gov identifying number for the article titled "Impact of an electronic monitoring device and behavioral feedback on adherence to multiple sclerosis therapies in youth: results of a randomized trial" is NCT02234713 (https://clinicaltrials.gov/ct2/show/NCT02234713).

  2. Evaluation of Oral Robenacoxib for the Treatment of Postoperative Pain and Inflammation in Cats: Results of a Randomized Clinical Trial

    Science.gov (United States)

    King, Stephen; Roberts, Elizabeth S.; Roycroft, Linda M.; King, Jonathan N.

    2012-01-01

    The efficacy and safety of robenacoxib were assessed for the control of postoperative pain and inflammation in cats. The study was a multicenter, prospective, randomized, blinded, and parallel group clinical trial. A total of 249 client-owned cats scheduled for forelimb onychectomy plus either ovariohysterectomy or castration surgeries were included. All cats received butorphanol prior to anesthesia and forelimb four-point regional nerve blocks with bupivacaine after induction of general anesthesia. Cats were randomized to receive daily oral tablet robenacoxib, at a mean (range) dosage of 1.84 (1.03–2.40) mg/kg (n = 167), or placebo (n = 82), once prior to surgery and for two days postoperatively. Significantly (P < 0.05) fewer robenacoxib cats received additional analgesia rescue therapy (16.5%) than placebo cats (46.3%). Pain elicited on palpation of the soft tissue incision site, behavior following social interaction, and posture assessed during the first 8 hours after extubation were significantly (P < 0.05) improved in cats receiving robenacoxib. Frequency of reported adverse clinical signs, hematology, serum chemistry and urinalysis variables, and body weight changes weresimilar between groups. In conclusion, robenacoxib was effective and well tolerated in the control of postoperative pain and inflammation in cats undergoing onychectomy with ovariohysterectomy or castration. PMID:23738129

  3. Results of a Pilates exercise program in patients with chronic non-specific low back pain: a randomized controlled trial.

    Science.gov (United States)

    Valenza, M C; Rodríguez-Torres, J; Cabrera-Martos, I; Díaz-Pelegrina, A; Aguilar-Ferrándiz, M E; Castellote-Caballero, Y

    2017-06-01

    To investigate the effects of a Pilates exercise program on disability, pain, lumbar mobility, flexibility and balance in patients with chronic non-specific low back pain. Randomized controlled trial. University laboratory. A total of 54 patients with chronic non-specific low back pain. Patients were randomly allocated to an experimental group ( n=27) included in a Pilates exercise program or to a control group ( n=27) receiving information in a form of a leaflet. Disability (Roland-Morris Disability Questionnaire and Oswestry Disability Index), current, average and pain at it least and at its worst (Visual Analogue Scales), lumbar mobility (modified Shober test), flexibility (finger-to-floor test) and balance (single limb stance test) were measured at baseline and after the intervention. A between-group analysis showed significant differences in the intervention group compared to the control group for both disability scores, the Rolland-Morris questionnaire (mean change±standard deviation of 5.31±3.37 and 2.40±6.78 respectively and between-groups mean difference of 3.2 ± 4.12, p=0.003) and the Oswestry Disability Index ( ppain ( p=0.002) and pain at it least ( p=0.033), flexibility (0.032) and balance (0.043). An 8-week Pilates exercise program is effective in improving disability, pain, flexibility and balance in patients with chronic non-specific low back pain.

  4. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  5. Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

    Science.gov (United States)

    Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

    2010-11-01

    The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

  6. Community-based educational intervention improved the diversity of complementary diets in western Kenya: results from a randomized controlled trial.

    Science.gov (United States)

    Waswa, Lydiah M; Jordan, Irmgard; Herrmann, Johannes; Krawinkel, Michael B; Keding, Gudrun B

    2015-12-01

    Lack of diversity is a major factor contributing to inadequate nutrient intakes among children during the complementary feeding period in many rural areas in developing countries. This has been attributed to inadequate feeding practices and nutrition knowledge among their caregivers. The aim of the present study was to assess the effect of an educational intervention on children's dietary diversity and nutrition knowledge of caregivers. Cluster randomization was applied and twenty matched village pairs were randomly assigned to the intervention or control group. The nutrition education intervention consisted of four sessions comprising of group trainings and cooking demonstrations that were conducted over a period of 5 months. Households in rural communities in Bondo and Teso South sub-counties, western Kenya. Caregivers with children aged 6-17 months receiving nutrition education. The children's dietary diversity scores (CDDS) and nutrition knowledge scores of the caregivers improved significantly in the intervention group at endline. The treatment effect on CDDS was positive and significant (P=0.001). The CDDS rate of the children in the intervention group was 27% larger than it would have been without the treatment effect. The intervention also had a significant effect on the caregivers' nutrition knowledge scores (incidence rate ratio=2.05; Pnutrition knowledge of the caregivers did not have a significant effect on CDDS (P=0.731). The nutrition education intervention led to improvements in children's dietary diversity and nutrition knowledge of the caregivers.

  7. Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial

    Science.gov (United States)

    Taveggia, Giovanni; Borboni, Alberto; Mulé, Chiara; Negrini, Stefano

    2016-01-01

    Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment. PMID:26512928

  8. An integral topical gel for cellulite reduction: results from a double-blind, randomized, placebo-controlled evaluation of efficacy.

    Science.gov (United States)

    Dupont, Eric; Journet, Michel; Oula, Marie-Laure; Gomez, Juan; Léveillé, Claude; Loing, Estelle; Bilodeau, Diane

    2014-01-01

    Cellulite is a serious cosmetic concern for most of the 90% of women affected by it. To assess the clinical efficacy of a complex integral anti-cellulite gel. This double-blind, randomized, placebo-controlled study involved 44 healthy women, aged 25-55 years. Subjects had a normal to slightly overweight body mass index and presented slight to moderate cellulite on their thighs, buttocks, and/or hips at baseline. Subjects were randomly assigned to either the treated or placebo group and accordingly applied the active product or placebo on their hips, stomach, buttocks, and thighs, twice daily for 3 months. Skin tonicity, orange-peel aspect, and stubborn cellulite were assessed at day 0, 28, 56, and 84. A self-evaluation questionnaire was completed by all volunteers. At the end of the study, an average of 81% of the subjects applying the active product presented improvement in their cellulite condition versus 32% for the placebo group (all descriptors and sites combined). At day 84, skin tonicity, orange-peel appearance, and stubborn cellulite were improved in a significant manner (Pcellulite was reduced on average by -19% for buttocks, -24% for hips, and -22% for thighs. Circumference measurements decreased in a significant manner (Pcellulite and reshape the silhouette.

  9. Brief intervention to preteens and adolescents to create smoke-free homes and cotinine results: a randomized trial.

    Science.gov (United States)

    Yilmaz, Gonca; Caylan, Nilgün; Karacan, Can Demir

    2013-10-01

    Little research has focused on brief and practical strategies for addressing environmental tobacco smoke exposure through interventions focused explicitly on creating a smoke-free home. We used a two-group (intervention and control groups) repeated-measures randomized controlled trial design. Families were randomized to the intervention (n = 176) or control (n = 176) condition after the baseline interview, with outcome assessments for reported and urine cotinine measures at 2 (post-intervention), 6 (follow-up) and 12 (follow-up) months. Baseline urinary cotinine levels of both groups were not statistically significantly different (P > 0.05); however, post-intervention urinary cotinine levels were significantly different at 2, 6 and 12 months after start of the study (P < 0.001). As a physician-based brief intervention, our intervention was effective. Clinical providers might offer feedback and brief interventions to preteens and adolescents. Because of the ease of intervention on delivery, this intervention has the potential to have significant impact if widely disseminated.

  10. High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties. © Hammill Institute on Disabilities 2014.

  11. Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial.

    Science.gov (United States)

    Taveggia, Giovanni; Borboni, Alberto; Mulé, Chiara; Villafañe, Jorge H; Negrini, Stefano

    2016-03-01

    Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (treatment according to the Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment.

  12. Does selenium supplementation affect thyroid function? Results from a randomized, controlled, double-blinded trial in a Danish population.

    Science.gov (United States)

    Winther, Kristian Hillert; Bonnema, Steen Joop; Cold, Frederik; Debrabant, Birgit; Nybo, Mads; Cold, Søren; Hegedüs, Laszlo

    2015-06-01

    Selenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism. The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function, under conditions of suboptimal dietary selenium intake. The Danish PREvention of Cancer by Intervention with SElenium pilot study (DK-PRECISE) is a randomized, double-blinded, placebo-controlled trial. A total of 491 males and females aged 60-74 years were randomized to 100 μg (n=124), 200 μg (n=122), or 300 μg (n=119) selenium-enriched yeast or matching yeast-based placebo tablets (n=126). A total of 361 participants, equally distributed across treatment groups, completed the 5-year intervention period. Plasma samples were analyzed for selenium and serum samples for TSH, free triiodothyronine (FT3), and free thyroxine (FT4) at baseline, and after 6 months, and 5 years of supplementation. Plasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium (Pselenium supplementation minutely and dose-dependently affects thyroid function, when compared with placebo, by decreasing serum TSH and FT4 concentrations. Based on these findings, selenium supplementation is not warranted under conditions of marginal selenium deficiency. However, a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved. © 2015 European Society of Endocrinology.

  13. The Effect of Wilderness Therapy on Adolescents' Cognitive Autonomy and Self-Efficacy: Results of a Non-Randomized Trial

    Science.gov (United States)

    Margalit, Daniella; Ben-Ari, Amichai

    2014-01-01

    Background: Adolescents participate in decision-making processes involving risky behaviors. Management of these important decisions may be promoted by enhancing adolescents' self-efficacy beliefs and cognitive autonomy. Objective: In order to elucidate the value of wilderness therapy to the successful management of decision making processes among…