WorldWideScience

Sample records for random order results

  1. Ordered random variables theory and applications

    CERN Document Server

    Shahbaz, Muhammad Qaiser; Hanif Shahbaz, Saman; Al-Zahrani, Bander M

    2016-01-01

    Ordered Random Variables have attracted several authors. The basic building block of Ordered Random Variables is Order Statistics which has several applications in extreme value theory and ordered estimation. The general model for ordered random variables, known as Generalized Order Statistics has been introduced relatively recently by Kamps (1995).

  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. 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.

  4. 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; Ko, Young-Chai; Alouini, Mohamed-Slim

    2017-01-01

    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

  5. Recent results for random networks of automata

    International Nuclear Information System (INIS)

    Flyvbjerg, H.

    1987-05-01

    After a very brief historical and contextual introduction to random networks of automata we review recent numerical and analytical results. Open questions and unsolved problems are pointed out and discussed. One such question is also answered: it is shown that the size of the stable core can be used as order parameter for a transition between phases of frozen and chaotic network behavior. A mean-field-like but exact selfconsistency equation for the size of the stable core is given. A new derivation of critical parameter values follows from it. (orig.)

  6. Random matrix ensembles with random interactions: Results for ...

    Indian Academy of Sciences (India)

    ... Public Lectures · Lecture Workshops · Refresher Courses · Symposia · Live Streaming. Home; Journals; Pramana – Journal of Physics; Volume 73; Issue 3. Random matrix ensembles with random interactions: Results for EGUE(2)-(4). Manan Vyas Manan Vyas. Volume 73 Issue 3 September 2009 pp 521-531 ...

  7. Ordering statistics of four random walkers on a line

    Science.gov (United States)

    Helenbrook, Brian; ben-Avraham, Daniel

    2018-05-01

    We study the ordering statistics of four random walkers on the line, obtaining a much improved estimate for the long-time decay exponent of the probability that a particle leads to time t , Plead(t ) ˜t-0.91287850 , and that a particle lags to time t (never assumes the lead), Plag(t ) ˜t-0.30763604 . Exponents of several other ordering statistics for N =4 walkers are obtained to eight-digit accuracy as well. The subtle correlations between n walkers that lag jointly, out of a field of N , are discussed: for N =3 there are no correlations and Plead(t ) ˜Plag(t) 2 . In contrast, our results rule out the possibility that Plead(t ) ˜Plag(t) 3 for N =4 , although the correlations in this borderline case are tiny.

  8. Long range order and giant components of quantum random graphs

    CERN Document Server

    Ioffe, D

    2006-01-01

    Mean field quantum random graphs give a natural generalization of classical Erd\\H{o}s-R\\'{e}nyi percolation model on complete graph $G_N$ with $p =\\beta /N$. Quantum case incorporates an additional parameter $\\lambda\\geq 0$, and the short-long range order transition should be studied in the $(\\beta ,\\lambda)$-quarter plane. In this work we explicitly compute the corresponding critical curve $\\gamma_c$, and derive results on two-point functions and sizes of connected components in both short and long range order regions. In this way the classical case corresponds to the limiting point $(\\beta_c ,0) = (1,0)$ on $\\gamma_c$.

  9. Magnetic and superconducting order in some random pseudobinary compounds

    International Nuclear Information System (INIS)

    Dongen, J.C.M. van.

    1982-01-01

    This thesis presents the results of a study on the magnetic and superconducting ordering phenomena in some random pseudobinary compounds. In the investigations ternary systems are utilised in which two of the elements form a binary intermetallic compound, e.g. PdH, GdCu and YCo 2 . A third element is then randomly substituted into one of the sublattices without changing the basic intermetallic compound structure. In chapter II a study is presented on the Kondo effect and spin-glass freezing of the magnetic impurities Cr, Mn, and Fe in superconducting palladium hydride. Chapter III contains a study on crystal structure transformations and magnetic ordering phenomena in GdCusub(1-x)Gasub(x) and related pseudobinary compounds. In Chapter IV experiments on the magnetic properties and the electrical resistivity of the transition metal Laves phase compounds Y(Cosub(1-x)Fesub(x)) 2 , Y(Irsub(1-x)Fesub(x)) 2 and Hf(Cosub(1-x)Fesub(x)) 2 are described. (Auth.)

  10. On mean square displacement behaviors of anomalous diffusions with variable and random orders

    International Nuclear Information System (INIS)

    Sun Hongguang; Chen Wen; Sheng Hu; Chen Yangquan

    2010-01-01

    Mean square displacement (MSD) is used to characterize anomalous diffusion. Recently, models of anomalous diffusion with variable-order and random-order were proposed, but no MSD analysis has been given so far. The purpose of this Letter is to offer a concise derivation of MSD functions for the variable-order model and the random-order model. Numerical results are presented to illustrate the analytical results. In addition, we show how to establish a variable-random-order model for a given MSD function which has clear application potentials.

  11. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  12. Quantitative measure of randomness and order for complete genomes

    Science.gov (United States)

    Kong, Sing-Guan; Fan, Wen-Lang; Chen, Hong-Da; Wigger, Jan; Torda, Andrew E.; Lee, H. C.

    2009-06-01

    We propose an order index, ϕ , which gives a quantitative measure of randomness and order of complete genomic sequences. It maps genomes to a number from 0 (random and of infinite length) to 1 (fully ordered) and applies regardless of sequence length. The 786 complete genomic sequences in GenBank were found to have ϕ values in a very narrow range, ϕg=0.031-0.015+0.028 . We show this implies that genomes are halfway toward being completely random, or, at the “edge of chaos.” We further show that artificial “genomes” converted from literary classics have ϕ ’s that almost exactly coincide with ϕg , but sequences of low information content do not. We infer that ϕg represents a high information-capacity “fixed point” in sequence space, and that genomes are driven to it by the dynamics of a robust growth and evolution process. We show that a growth process characterized by random segmental duplication can robustly drive genomes to the fixed point.

  13. Qualitatively Assessing Randomness in SVD Results

    Science.gov (United States)

    Lamb, K. W.; Miller, W. P.; Kalra, A.; Anderson, S.; Rodriguez, A.

    2012-12-01

    Singular Value Decomposition (SVD) is a powerful tool for identifying regions of significant co-variability between two spatially distributed datasets. SVD has been widely used in atmospheric research to define relationships between sea surface temperatures, geopotential height, wind, precipitation and streamflow data for myriad regions across the globe. A typical application for SVD is to identify leading climate drivers (as observed in the wind or pressure data) for a particular hydrologic response variable such as precipitation, streamflow, or soil moisture. One can also investigate the lagged relationship between a climate variable and the hydrologic response variable using SVD. When performing these studies it is important to limit the spatial bounds of the climate variable to reduce the chance of random co-variance relationships being identified. On the other hand, a climate region that is too small may ignore climate signals which have more than a statistical relationship to a hydrologic response variable. The proposed research seeks to identify a qualitative method of identifying random co-variability relationships between two data sets. The research identifies the heterogeneous correlation maps from several past results and compares these results with correlation maps produced using purely random and quasi-random climate data. The comparison identifies a methodology to determine if a particular region on a correlation map may be explained by a physical mechanism or is simply statistical chance.

  14. Order-based representation in random networks of cortical neurons.

    Directory of Open Access Journals (Sweden)

    Goded Shahaf

    2008-11-01

    Full Text Available The wide range of time scales involved in neural excitability and synaptic transmission might lead to ongoing change in the temporal structure of responses to recurring stimulus presentations on a trial-to-trial basis. This is probably the most severe biophysical constraint on putative time-based primitives of stimulus representation in neuronal networks. Here we show that in spontaneously developing large-scale random networks of cortical neurons in vitro the order in which neurons are recruited following each stimulus is a naturally emerging representation primitive that is invariant to significant temporal changes in spike times. With a relatively small number of randomly sampled neurons, the information about stimulus position is fully retrievable from the recruitment order. The effective connectivity that makes order-based representation invariant to time warping is characterized by the existence of stations through which activity is required to pass in order to propagate further into the network. This study uncovers a simple invariant in a noisy biological network in vitro; its applicability under in vivo constraints remains to be seen.

  15. Fuzzy Random Walkers with Second Order Bounds: An Asymmetric Analysis

    Directory of Open Access Journals (Sweden)

    Georgios Drakopoulos

    2017-03-01

    Full Text Available Edge-fuzzy graphs constitute an essential modeling paradigm across a broad spectrum of domains ranging from artificial intelligence to computational neuroscience and social network analysis. Under this model, fundamental graph properties such as edge length and graph diameter become stochastic and as such they are consequently expressed in probabilistic terms. Thus, algorithms for fuzzy graph analysis must rely on non-deterministic design principles. One such principle is Random Walker, which is based on a virtual entity and selects either edges or, like in this case, vertices of a fuzzy graph to visit. This allows the estimation of global graph properties through a long sequence of local decisions, making it a viable strategy candidate for graph processing software relying on native graph databases such as Neo4j. As a concrete example, Chebyshev Walktrap, a heuristic fuzzy community discovery algorithm relying on second order statistics and on the teleportation of the Random Walker, is proposed and its performance, expressed in terms of community coherence and number of vertex visits, is compared to the previously proposed algorithms of Markov Walktrap, Fuzzy Walktrap, and Fuzzy Newman–Girvan. In order to facilitate this comparison, a metric based on the asymmetric metrics of Tversky index and Kullback–Leibler divergence is used.

  16. Order out of Randomness: Self-Organization Processes in Astrophysics

    Science.gov (United States)

    Aschwanden, Markus J.; Scholkmann, Felix; Béthune, William; Schmutz, Werner; Abramenko, Valentina; Cheung, Mark C. M.; Müller, Daniel; Benz, Arnold; Chernov, Guennadi; Kritsuk, Alexei G.; Scargle, Jeffrey D.; Melatos, Andrew; Wagoner, Robert V.; Trimble, Virginia; Green, William H.

    2018-03-01

    Self-organization is a property of dissipative nonlinear processes that are governed by a global driving force and a local positive feedback mechanism, which creates regular geometric and/or temporal patterns, and decreases the entropy locally, in contrast to random processes. Here we investigate for the first time a comprehensive number of (17) self-organization processes that operate in planetary physics, solar physics, stellar physics, galactic physics, and cosmology. Self-organizing systems create spontaneous " order out of randomness", during the evolution from an initially disordered system to an ordered quasi-stationary system, mostly by quasi-periodic limit-cycle dynamics, but also by harmonic (mechanical or gyromagnetic) resonances. The global driving force can be due to gravity, electromagnetic forces, mechanical forces (e.g., rotation or differential rotation), thermal pressure, or acceleration of nonthermal particles, while the positive feedback mechanism is often an instability, such as the magneto-rotational (Balbus-Hawley) instability, the convective (Rayleigh-Bénard) instability, turbulence, vortex attraction, magnetic reconnection, plasma condensation, or a loss-cone instability. Physical models of astrophysical self-organization processes require hydrodynamic, magneto-hydrodynamic (MHD), plasma, or N-body simulations. Analytical formulations of self-organizing systems generally involve coupled differential equations with limit-cycle solutions of the Lotka-Volterra or Hopf-bifurcation type.

  17. Effects of randomness on chaos and order of coupled logistic maps

    International Nuclear Information System (INIS)

    Savi, Marcelo A.

    2007-01-01

    Natural systems are essentially nonlinear being neither completely ordered nor completely random. These nonlinearities are responsible for a great variety of possibilities that includes chaos. On this basis, the effect of randomness on chaos and order of nonlinear dynamical systems is an important feature to be understood. This Letter considers randomness as fluctuations and uncertainties due to noise and investigates its influence in the nonlinear dynamical behavior of coupled logistic maps. The noise effect is included by adding random variations either to parameters or to state variables. Besides, the coupling uncertainty is investigated by assuming tinny values for the connection parameters, representing the idea that all Nature is, in some sense, weakly connected. Results from numerical simulations show situations where noise alters the system nonlinear dynamics

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

    Directory of Open Access Journals (Sweden)

    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.

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

    International Nuclear Information System (INIS)

    Luque, Bartolo; Ballesteros, Fernando J; Fernandez, Manuel

    2005-01-01

    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

  20. 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.

  1. 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.

  2. An AES chip with DPA resistance using hardware-based random order execution

    International Nuclear Information System (INIS)

    Yu Bo; Li Xiangyu; Chen Cong; Sun Yihe; Wu Liji; Zhang Xiangmin

    2012-01-01

    This paper presents an AES (advanced encryption standard) chip that combats differential power analysis (DPA) side-channel attack through hardware-based random order execution. Both decryption and encryption procedures of an AES are implemented on the chip. A fine-grained dataflow architecture is proposed, which dynamically exploits intrinsic byte-level independence in the algorithm. A novel circuit called an HMF (Hold-Match-Fetch) unit is proposed for random control, which randomly sets execution orders for concurrent operations. The AES chip was manufactured in SMIC 0.18 μm technology. The average energy for encrypting one group of plain texts (128 bits secrete keys) is 19 nJ. The core area is 0.43 mm 2 . A sophisticated experimental setup was built to test the DPA resistance. Measurement-based experimental results show that one byte of a secret key cannot be disclosed from our chip under random mode after 64000 power traces were used in the DPA attack. Compared with the corresponding fixed order execution, the hardware based random order execution is improved by at least 21 times the DPA resistance. (semiconductor integrated circuits)

  3. An AES chip with DPA resistance using hardware-based random order execution

    Science.gov (United States)

    Bo, Yu; Xiangyu, Li; Cong, Chen; Yihe, Sun; Liji, Wu; Xiangmin, Zhang

    2012-06-01

    This paper presents an AES (advanced encryption standard) chip that combats differential power analysis (DPA) side-channel attack through hardware-based random order execution. Both decryption and encryption procedures of an AES are implemented on the chip. A fine-grained dataflow architecture is proposed, which dynamically exploits intrinsic byte-level independence in the algorithm. A novel circuit called an HMF (Hold-Match-Fetch) unit is proposed for random control, which randomly sets execution orders for concurrent operations. The AES chip was manufactured in SMIC 0.18 μm technology. The average energy for encrypting one group of plain texts (128 bits secrete keys) is 19 nJ. The core area is 0.43 mm2. A sophisticated experimental setup was built to test the DPA resistance. Measurement-based experimental results show that one byte of a secret key cannot be disclosed from our chip under random mode after 64000 power traces were used in the DPA attack. Compared with the corresponding fixed order execution, the hardware based random order execution is improved by at least 21 times the DPA resistance.

  4. Diversity Order Results for MIMO Optical Wireless Communications

    KAUST Repository

    Sapenov, Yerzhan; Chaaban, Anas; Rezki, Zouheir; Abdallah, Mohamed; Qaraqe, Khalid; Alouini, Mohamed-Slim

    2017-01-01

    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.

  5. 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.

  6. Magnetic ordering at low temperatures in some random superconducting and insulating compounds

    International Nuclear Information System (INIS)

    Hueser, D.

    1985-01-01

    This thesis presents the results of some investigations on the magnetic ordering phenomena in some random superconducting and insulating materials. The results are described of an investigation of the coexistence of superconductivity and random magnetic freezing in (Th,Nd)Ru 2 . On the basis of various measurements as function of temperature and external magnetic field the author found that spin glass-like freezing can occur far below the superconductivity and even that a sample may re-enter the superconducting state below a freezing temperature. Associated with the isothermal remanent magnetization of a random magnetic material he observed strong anomalies in the critical field versus temperature curves. Also a magnetic field memory effect has been found. (Auth.)

  7. 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 ...... for the ordered alloys are in good agreement with experimental data. For all the alloys the calculated ordering energy and the equilibrium lattices parameters are found to be almost exact quadratic functions of the long-range-order parameter....... and the partially ordered alloys are included in the screened impurity model. The prefactor in the Madelung energy is determined by the requirement that the total energy obtained in direct SS CPA calculations should equal the total energy given by the Connolly-Williams expansion based on Green’s function...

  8. Neutron Transport in Spatially Random Media: An Assessment of the Accuracy of First Order Smoothing

    International Nuclear Information System (INIS)

    Williams, M.M.R.

    2000-01-01

    A formalism has been developed for studying the transmission of neutrons through a spatially stochastic medium. The stochastic components are represented by absorbing plates of randomly varying strength and random position. This type of geometry enables the Feinberg-Galanin-Horning method to be employed and leads to the solution of a coupled set of linear equations for the flux at the plate positions. The matrix of the coefficients contains members that are random and these are solved by simulation. That is, the strength and plate positions are sampled from uniform distributions and the equations solved many times (in this case 10 5 simulations are carried out). Probability distributions for the plate transmission and reflection factors are constructed from which the mean and variance can be computed.These essentially exact solutions enable closure approximations to be assessed for accuracy. To this end, we have compared the mean and variance obtained from the first order smoothing approximation of Keller with the exact results and have found excellent agreement for the mean values but note deviations of up to 40% for the variance. Nevertheless, for the problems considered here, first order smoothing appears to be of practical value and is very efficient numerically in comparison with simulation

  9. Piecewise linearisation of the first order loss function for families of arbitrarily distributed random variables

    NARCIS (Netherlands)

    Rossi, R.; Hendrix, E.M.T.

    2014-01-01

    We discuss the problem of computing optimal linearisation parameters for the first order loss function of a family of arbitrarily distributed random variable. We demonstrate that, in contrast to the problem in which parameters must be determined for the loss function of a single random variable,

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

    KAUST Repository

    Motamed, Mohammad; Nobile, Fabio; Tempone, Raul

    2012-01-01

    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

  11. Digital Fractional Order Controllers Realized by PIC Microprocessor: Experimental Results

    OpenAIRE

    Petras, I.; Grega, S.; Dorcak, L.

    2003-01-01

    This paper deals with the fractional-order controllers and their possible hardware realization based on PIC microprocessor and numerical algorithm coded in PIC Basic. The mathematical description of the digital fractional -order controllers and approximation in the discrete domain are presented. An example of realization of the particular case of digital fractional-order PID controller is shown and described.

  12. 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.

  13. 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.

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

    OpenAIRE

    Fengjiao Wu; Guitao Zhang; Zhengzhong Wang

    2016-01-01

    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. ...

  15. Experiments in order to reproduce cold fusion results

    International Nuclear Information System (INIS)

    Bimbot, R.; Blain, G.; Boureau, G.; Cieur, M.

    1989-01-01

    Three experiments have been performed in order to try and reproduce the cold fusion experiments reported by FLEISCHMANN and PONS (D 2 O electrolysis) and by the Frascati Group (D 2 absorption in Ti at liquid nitrogen temperature). In the two electrolysis experiments, a Pd cathode was used together with a Pt anode and a Pd (D 2 ) reference electrode, in acid and basic media. The electrolysis cell was surrounded by four neutron counters filled with an organic scintillator (NE213). The electronics made it possible to discriminate neutrons from gamma rays. The global efficiency for neutron detection was 20%, and the detection threshold was equal to 1 neutron/s/4π. A germanium detector (efficiency 70%) and a NaI crystal were used to record gamma ray spectra. In one of the experiments, tritium was measured in the solution before and after electrolysis. None of the two experiments showed neutron, gamma, or tritium production above background. In the third experiment, deuterium was absorbed in titanium by cooling at liquid nitrogen temperature, and desorbed by warming up at room temperature; both neutron and gamma emissions were recorded during these operations. The results of this experiment were also negative [fr

  16. First-order corrections to random-phase approximation GW calculations in silicon and diamond

    NARCIS (Netherlands)

    Ummels, R.T.M.; Bobbert, P.A.; van Haeringen, W.

    1998-01-01

    We report on ab initio calculations of the first-order corrections in the screened interaction W to the random-phase approximation polarizability and to the GW self-energy, using a noninteracting Green's function, for silicon and diamond. It is found that the first-order vertex and self-consistency

  17. 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.

  18. The sink strengths of voids and the expected swelling for both random and ordered void distributions

    International Nuclear Information System (INIS)

    Quigley, T.M.; Murphy, S.M.; Bullough, R.; Wood, M.H.

    1981-10-01

    The sink strength of a void has been obtained when the void is a member of a random or ordered distribution of voids. The former sink strength derivation has employed the embedding model and the latter the cellular model. In each case the spatially varying size-effect interaction between the intrinsic point defects and the voids has been included together with the presence of other sink types in addition to the voids. The results are compared with previously published sink strengths that have made use of an approximate representation for the size-effect interactions, and indicate the importance of using the exact form of the interaction. In particular the bias for interstitials compared with vacancies of small voids is now much reduced and contamination of the surfaces of such voids no longer appears essential to facilitate the nucleation and growth of the voids. These new sink strengths have been used, in conjunction with recently published dislocation sink strengths, to calculate the expected swelling of materials containing network dislocations and voids. Results are presented for both the random and the void lattice situations. (author)

  19. First-order reversal curves of single domain particles: diluted random assemblages and chains

    Science.gov (United States)

    Egli, R.

    2009-04-01

    Exact magnetic models can be used to calculate first-order reversal curves (FORC) of single domain (SD) particle assemblages, as shown by Newell [2005] for the case of isolated Stoner-Wohlfarth particles. After overcoming experimental difficulties, a FORC diagram sharing many similarities to Newell's model has been measured on a lake sediment sample (see A.P. Chen et al., "Quantification of magnetofossils using first-order reversal curves", EGU General Assembly 2009, Abstracts Vol. 11, EGU2009-10719). This sample contains abundant magnetofossils, as shown by coercivity analysis and electron microscopy, therefore suggesting that well dispersed, intact magnetosome chains are the main SD carriers. Subtle differences between the reversible and the irreversible contributions of the measured FORC distribution suggest that magnetosome chains might not be correctly described by the Stoner-Wohlfarth model. To better understand the hysteresis properties of such chains, a simple magnetic model has been implemented, taking dipole-dipole interactions between particles within the same chain into account. The model results depend on the magnetosome elongation, the number of magnetosomes in a chain, and the gap between them. If the chain axis is subparallel to the applied field, the magnetic moment reverses by a pseudo-fanning mode, which is replaced by a pseudo-coherent rotation mode at greater angles. These reversal modes are intrinsically different from coherent rotation assumed Stoner-Wohlfarth model, resulting in FORC diagrams with a smaller reversible component. On the other hand, isolated authigenic SD particles can precipitate in the sediment matrix, as it might occur for pedogenic magnetite. In this case, an assembly of randomly located particles provides a possible model for the resulting FORC diagram. If the concentration of the particles is small, each particle is affected by a random interaction field whose statistical distribution can be calculated from first

  20. Modular Transformations, Order-Chaos Transitions and Pseudo-Random Number Generation

    Science.gov (United States)

    Bonelli, Antonio; Ruffo, Stefano

    Successive pairs of pseudo-random numbers generated by standard linear congruential transformations display ordered patterns of parallel lines. We study the "ordered" and "chaotic" distribution of such pairs by solving the eigenvalue problem for two-dimensional modular transformations over integers. We conjecture that the optimal uniformity for pair distribution is obtained when the slope of linear modular eigenspaces takes the value n opt =maxint (p/√ {p-1}), where p is a prime number. We then propose a new generator of pairs of independent pseudo-random numbers, which realizes an optimal uniform distribution (in the "statistical" sense) of points on the unit square (0, 1] × (0, 1]. The method can be easily generalized to the generation of k-tuples of random numbers (with k>2).

  1. Simulation-based production planning for engineer-to-order systems with random yield

    NARCIS (Netherlands)

    Akcay, Alp; Martagan, Tugce

    2018-01-01

    We consider an engineer-to-order production system with unknown yield. We model the yield as a random variable which represents the percentage output obtained from one unit of production quantity. We develop a beta-regression model in which the mean value of the yield depends on the unique

  2. 76 FR 2336 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Final Results of...

    Science.gov (United States)

    2011-01-13

    ... Semiconductors From the Republic of Korea: Final Results of Countervailing Duty Administrative Review AGENCY... administrative review of the countervailing duty order on dynamic random access memory semiconductors from the... to a change in the net subsidy rate. The final net subsidy rate for Hynix Semiconductor, Inc. is...

  3. 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, …

  4. Anisotropy of the monomer random walk in a polymer melt: local-order and connectivity effects

    International Nuclear Information System (INIS)

    Bernini, S; Leporini, D

    2016-01-01

    The random walk of a bonded monomer in a polymer melt is anisotropic due to local order and bond connectivity. We investigate both effects by molecular-dynamics simulations on melts of fully-flexible linear chains ranging from dimers (M  =  2) up to entangled polymers (M  =  200). The corresponding atomic liquid is also considered a reference system. To disentangle the influence of the local geometry and the bond arrangements, and to reveal their interplay, we define suitable measures of the anisotropy emphasising either the former or the latter aspect. Connectivity anisotropy, as measured by the correlation between the initial bond orientation and the direction of the subsequent monomer displacement, shows a slight enhancement due to the local order at times shorter than the structural relaxation time. At intermediate times—when the monomer displacement is comparable to the bond length—a pronounced peak and then decays slowly as t −1/2 , becoming negligible when the displacement is as large as about five bond lengths, i.e. about four monomer diameters or three Kuhn lengths. Local-geometry anisotropy, as measured by the correlation between the initial orientation of a characteristic axis of the Voronoi cell and the subsequent monomer dynamics, is affected at shorter times than the structural relaxation time by the cage shape with antagonistic disturbance by the connectivity. Differently, at longer times, the connectivity favours the persistence of the local-geometry anisotropy, which vanishes when the monomer displacement exceeds the bond length. Our results strongly suggest that the sole consideration of the local order is not enough to understand the microscopic origin of the rattling amplitude of the trapped monomer in the cage of the neighbours. (paper)

  5. Single order soft X-ray diffraction with quasi-random radius pinhole array spectroscopic photon sieves

    International Nuclear Information System (INIS)

    Zhang Qiang-Qiang; Wei Lai; Yang Zu-Hua; Qian Feng; Fan Quan-Ping; Zhang Bo; Gu Yu-Qiu; Cao Lei-Feng

    2014-01-01

    A novel single order diffraction grating in the soft X-ray region, called quasi-random radius pinhole array spectroscopic photon sieves (QRSPS), is proposed in this paper. This new grating is composed of pinholes on a substrate, whose radii are quasi-random, while their centers are regular. Analysis proves that its transmittance function across the grating bar is similar to that of sinusoidal transmission gratings. Simulation results show that the QRSPS can suppress higher-order diffraction effectively. And the QRSPS would still retain its characteristic of single order diffraction when we take the effect of X-ray penetration into account. These properties indicate that the QRSPS can be used in the soft X-ray spectra measurement. (electromagnetism, optics, acoustics, heat transfer, classical mechanics, and fluid dynamics)

  6. Analytic results for asymmetric random walk with exponential transition probabilities

    International Nuclear Information System (INIS)

    Gutkowicz-Krusin, D.; Procaccia, I.; Ross, J.

    1978-01-01

    We present here exact analytic results for a random walk on a one-dimensional lattice with asymmetric, exponentially distributed jump probabilities. We derive the generating functions of such a walk for a perfect lattice and for a lattice with absorbing boundaries. We obtain solutions for some interesting moment properties, such as mean first passage time, drift velocity, dispersion, and branching ratio for absorption. The symmetric exponential walk is solved as a special case. The scaling of the mean first passage time with the size of the system for the exponentially distributed walk is determined by the symmetry and is independent of the range

  7. The Schwinger Dyson equations and the algebra of constraints of random tensor models at all orders

    International Nuclear Information System (INIS)

    Gurau, Razvan

    2012-01-01

    Random tensor models for a generic complex tensor generalize matrix models in arbitrary dimensions and yield a theory of random geometries. They support a 1/N expansion dominated by graphs of spherical topology. Their Schwinger Dyson equations, generalizing the loop equations of matrix models, translate into constraints satisfied by the partition function. The constraints have been shown, in the large N limit, to close a Lie algebra indexed by colored rooted D-ary trees yielding a first generalization of the Virasoro algebra in arbitrary dimensions. In this paper we complete the Schwinger Dyson equations and the associated algebra at all orders in 1/N. The full algebra of constraints is indexed by D-colored graphs, and the leading order D-ary tree algebra is a Lie subalgebra of the full constraints algebra.

  8. Random textures of the order parameter of superfluid sup 3 He-B in aerogel

    CERN Document Server

    Fomin, Yu A

    2002-01-01

    The scheme for describing the properties of the superfluid sup 3 He in the aerogel is proposed in accordance with the Ginzburg and Landau theory. The aerogel effect on the order parameter is described by the random tensor field. This field exerts desorientation effect on the order parameter in the sup 3 He A-phase, but it does not influence the order parameter orientation in the B-phase, if there is no magnetic field. The change in the order parameter texture, originating in the B-phase in the aerogel in the magnetic field, is considered. Fluctuations of the sup 3 He-B anisotropy axis direction are correlated on the length, inversely proportional to the field intensity and having the macroscopic scale

  9. Defining Higher-Order Turbulent Moment Closures with an Artificial Neural Network and Random Forest

    Science.gov (United States)

    McGibbon, J.; Bretherton, C. S.

    2017-12-01

    Unresolved turbulent advection and clouds must be parameterized in atmospheric models. Modern higher-order closure schemes depend on analytic moment closure assumptions that diagnose higher-order moments in terms of lower-order ones. These are then tested against Large-Eddy Simulation (LES) higher-order moment relations. However, these relations may not be neatly analytic in nature. Rather than rely on an analytic higher-order moment closure, can we use machine learning on LES data itself to define a higher-order moment closure?We assess the ability of a deep artificial neural network (NN) and random forest (RF) to perform this task using a set of observationally-based LES runs from the MAGIC field campaign. By training on a subset of 12 simulations and testing on remaining simulations, we avoid over-fitting the training data.Performance of the NN and RF will be assessed and compared to the Analytic Double Gaussian 1 (ADG1) closure assumed by Cloudy Layers Unified By Binormals (CLUBB), a higher-order turbulence closure currently used in the Community Atmosphere Model (CAM). We will show that the RF outperforms the NN and the ADG1 closure for the MAGIC cases within this diagnostic framework. Progress and challenges in using a diagnostic machine learning closure within a prognostic cloud and turbulence parameterization will also be discussed.

  10. SOERP, Statistics and 2. Order Error Propagation for Function of Random Variables

    International Nuclear Information System (INIS)

    Cox, N. D.; Miller, C. F.

    1985-01-01

    1 - Description of problem or function: SOERP computes second-order error propagation equations for the first four moments of a function of independently distributed random variables. SOERP was written for a rigorous second-order error propagation of any function which may be expanded in a multivariable Taylor series, the input variables being independently distributed. The required input consists of numbers directly related to the partial derivatives of the function, evaluated at the nominal values of the input variables and the central moments of the input variables from the second through the eighth. 2 - Method of solution: The development of equations for computing the propagation of errors begins by expressing the function of random variables in a multivariable Taylor series expansion. The Taylor series expansion is then truncated, and statistical operations are applied to the series in order to obtain equations for the moments (about the origin) of the distribution of the computed value. If the Taylor series is truncated after powers of two, the procedure produces second-order error propagation equations. 3 - Restrictions on the complexity of the problem: The maximum number of component variables allowed is 30. The IBM version will only process one set of input data per run

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

    KAUST Repository

    Nam, Sungsik; Alouini, Mohamed-Slim; Yang, Hongchuan

    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

  12. 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.

  13. Numerical solution of second-order stochastic differential equations with Gaussian random parameters

    Directory of Open Access Journals (Sweden)

    Rahman Farnoosh

    2014-07-01

    Full Text Available In this paper, we present the numerical solution of ordinary differential equations (or SDEs, from each orderespecially second-order with time-varying and Gaussian random coefficients. We indicate a complete analysisfor second-order equations in specially case of scalar linear second-order equations (damped harmonicoscillators with additive or multiplicative noises. Making stochastic differential equations system from thisequation, it could be approximated or solved numerically by different numerical methods. In the case oflinear stochastic differential equations system by Computing fundamental matrix of this system, it could becalculated based on the exact solution of this system. Finally, this stochastic equation is solved by numericallymethod like E.M. and Milstein. Also its Asymptotic stability and statistical concepts like expectationand variance of solutions are discussed.

  14. Strong result for real zeros of random algebraic polynomials

    Directory of Open Access Journals (Sweden)

    T. Uno

    2001-01-01

    Full Text Available An estimate is given for the lower bound of real zeros of random algebraic polynomials whose coefficients are non-identically distributed dependent Gaussian random variables. Moreover, our estimated measure of the exceptional set, which is independent of the degree of the polynomials, tends to zero as the degree of the polynomial tends to infinity.

  15. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  16. Measurement model choice influenced randomized controlled trial results.

    Science.gov (United States)

    Gorter, Rosalie; Fox, Jean-Paul; Apeldoorn, Adri; Twisk, Jos

    2016-11-01

    In randomized controlled trials (RCTs), outcome variables are often patient-reported outcomes measured with questionnaires. Ideally, all available item information is used for score construction, which requires an item response theory (IRT) measurement model. However, in practice, the classical test theory measurement model (sum scores) is mostly used, and differences between response patterns leading to the same sum score are ignored. The enhanced differentiation between scores with IRT enables more precise estimation of individual trajectories over time and group effects. The objective of this study was to show the advantages of using IRT scores instead of sum scores when analyzing RCTs. Two studies are presented, a real-life RCT, and a simulation study. Both IRT and sum scores are used to measure the construct and are subsequently used as outcomes for effect calculation. The bias in RCT results is conditional on the measurement model that was used to construct the scores. A bias in estimated trend of around one standard deviation was found when sum scores were used, where IRT showed negligible bias. Accurate statistical inferences are made from an RCT study when using IRT to estimate construct measurements. The use of sum scores leads to incorrect RCT results. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Radiation-induced segregation behavior in random and ordered face-centered cubic materials

    International Nuclear Information System (INIS)

    Bui, T.X.; Robertson, I.M.; Klatt, J.L.; Averback, R.S.; Kirk, M.A.

    1993-01-01

    Radiation-induced segregation has been studied in random solid solution alloys Ni-10%Al and Ni-6%Si, and in the ordered (L1 2 structure) intermetallics Ni 3 Si and Ni 3 Al. These materials were irradiated with 2 MeV He + ions at a temperature between 0.45 and 0.55T m and at an ion dose rate of approximately 1x10 -4 dpa per second. Subsequent Auger Electron Spectroscopy analysis showed that silicon segregated to the surface in the Ni-6% Si and Ni 3 Si alloys, and aluminum segregated away from the near surface region in the Ni-10% Al alloy. The Ni 3 Al samples exhibited no detectable segregation with respect to depth from the sample surface. The mechanisms that may give rise to this resistance to radiation induced segregation will be examined in terms of the mobility of the alloying constituents, ordering energies and atomic sizes. (orig.)

  18. 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.

  19. Measuring order in disordered systems and disorder in ordered systems: Random matrix theory for isotropic and nematic liquid crystals and its perspective on pseudo-nematic domains

    Science.gov (United States)

    Zhao, Yan; Stratt, Richard M.

    2018-05-01

    Surprisingly long-ranged intermolecular correlations begin to appear in isotropic (orientationally disordered) phases of liquid crystal forming molecules when the temperature or density starts to close in on the boundary with the nematic (ordered) phase. Indeed, the presence of slowly relaxing, strongly orientationally correlated, sets of molecules under putatively disordered conditions ("pseudo-nematic domains") has been apparent for some time from light-scattering and optical-Kerr experiments. Still, a fully microscopic characterization of these domains has been lacking. We illustrate in this paper how pseudo-nematic domains can be studied in even relatively small computer simulations by looking for order-parameter tensor fluctuations much larger than one would expect from random matrix theory. To develop this idea, we show that random matrix theory offers an exact description of how the probability distribution for liquid-crystal order parameter tensors converges to its macroscopic-system limit. We then illustrate how domain properties can be inferred from finite-size-induced deviations from these random matrix predictions. A straightforward generalization of time-independent random matrix theory also allows us to prove that the analogous random matrix predictions for the time dependence of the order-parameter tensor are similarly exact in the macroscopic limit, and that relaxation behavior of the domains can be seen in the breakdown of the finite-size scaling required by that random-matrix theory.

  20. Theoretical and empirical convergence results for additive congruential random number generators

    Science.gov (United States)

    Wikramaratna, Roy S.

    2010-03-01

    Additive Congruential Random Number (ACORN) generators represent an approach to generating uniformly distributed pseudo-random numbers that is straightforward to implement efficiently for arbitrarily large order and modulus; if it is implemented using integer arithmetic, it becomes possible to generate identical sequences on any machine. This paper briefly reviews existing results concerning ACORN generators and relevant theory concerning sequences that are well distributed mod 1 in k dimensions. It then demonstrates some new theoretical results for ACORN generators implemented in integer arithmetic with modulus M=2[mu] showing that they are a family of generators that converge (in a sense that is defined in the paper) to being well distributed mod 1 in k dimensions, as [mu]=log2M tends to infinity. By increasing k, it is possible to increase without limit the number of dimensions in which the resulting sequences approximate to well distributed. The paper concludes by applying the standard TestU01 test suite to ACORN generators for selected values of the modulus (between 260 and 2150), the order (between 4 and 30) and various odd seed values. On the basis of these and earlier results, it is recommended that an order of at least 9 be used together with an odd seed and modulus equal to 230p, for a small integer value of p. While a choice of p=2 should be adequate for most typical applications, increasing p to 3 or 4 gives a sequence that will consistently pass all the tests in the TestU01 test suite, giving additional confidence in more demanding applications. The results demonstrate that the ACORN generators are a reliable source of uniformly distributed pseudo-random numbers, and that in practice (as suggested by the theoretical convergence results) the quality of the ACORN sequences increases with increasing modulus and order.

  1. 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.

  2. Does quasi-long-range order in the two-dimensional XY model really survive weak random phase fluctuations?

    International Nuclear Information System (INIS)

    Mudry, Christopher; Wen Xiaogang

    1999-01-01

    Effective theories for random critical points are usually non-unitary, and thus may contain relevant operators with negative scaling dimensions. To study the consequences of the existence of negative-dimensional operators, we consider the random-bond XY model. It has been argued that the XY model on a square lattice, when weakly perturbed by random phases, has a quasi-long-range ordered phase (the random spin wave phase) at sufficiently low temperatures. We show that infinitely many relevant perturbations to the proposed critical action for the random spin wave phase were omitted in all previous treatments. The physical origin of these perturbations is intimately related to the existence of broadly distributed correlation functions. We find that those relevant perturbations do enter the Renormalization Group equations, and affect critical behavior. This raises the possibility that the random XY model has no quasi-long-range ordered phase and no Kosterlitz-Thouless (KT) phase transition

  3. 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

    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.......Within the broad area of probabilistic modelling of individual discrete choice, we develop three strands of discussion. First, we outline a theoretical framework for the modelling of individual discrete choice under risk, distinguishing between three specific sources of randomness; in preference...... 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...

  4. Some Limit Properties of Random Transition Probability for Second-Order Nonhomogeneous Markov Chains Indexed by a Tree

    Directory of Open Access Journals (Sweden)

    Shi Zhiyan

    2009-01-01

    Full Text Available We study some limit properties of the harmonic mean of random transition probability for a second-order nonhomogeneous Markov chain and a nonhomogeneous Markov chain indexed by a tree. As corollary, we obtain the property of the harmonic mean of random transition probability for a nonhomogeneous Markov chain.

  5. IRFK2D: a computer program for simulating intrinsic random functions of order k

    Science.gov (United States)

    Pardo-Igúzquiza, Eulogio; Dowd, Peter A.

    2003-07-01

    IRFK2D is an ANSI Fortran-77 program that generates realizations of an intrinsic function of order k (with k equal to 0, 1 or 2) with a permissible polynomial generalized covariance model. The realizations may be non-conditional or conditioned to the experimental data. The turning bands method is used to generate realizations in 2D and 3D from simulations of an intrinsic random function of order k along lines that span the 2D or 3D space. The program generates two output files, the first containing the simulated values and the second containing the theoretical generalized variogram for different directions together with the theoretical model. The experimental variogram is calculated from the simulated values while the theoretical variogram is the specified generalized covariance model. The generalized variogram is used to assess the quality of the simulation as measured by the extent to which the generalized covariance is reproduced by the simulation. The examples given in this paper indicate that IRFK2D is an efficient implementation of the methodology.

  6. Application of random coherence order selection in gradient-enhanced multidimensional NMR

    International Nuclear Information System (INIS)

    Bostock, Mark J.; Nietlispach, Daniel

    2016-01-01

    Development of multidimensional NMR is essential to many applications, for example in high resolution structural studies of biomolecules. Multidimensional techniques enable separation of NMR signals over several dimensions, improving signal resolution, whilst also allowing identification of new connectivities. However, these advantages come at a significant cost. The Fourier transform theorem requires acquisition of a grid of regularly spaced points to satisfy the Nyquist criterion, while frequency discrimination and acquisition of a pure phase spectrum require acquisition of both quadrature components for each time point in every indirect (non-acquisition) dimension, adding a factor of 2 N -1 to the number of free- induction decays which must be acquired, where N is the number of dimensions. Compressed sensing (CS) ℓ 1 -norm minimisation in combination with non-uniform sampling (NUS) has been shown to be extremely successful in overcoming the Nyquist criterion. Previously, maximum entropy reconstruction has also been used to overcome the limitation of frequency discrimination, processing data acquired with only one quadrature component at a given time interval, known as random phase detection (RPD), allowing a factor of two reduction in the number of points for each indirect dimension (Maciejewski et al. 2011 PNAS 108 16640). However, whilst this approach can be easily applied in situations where the quadrature components are acquired as amplitude modulated data, the same principle is not easily extended to phase modulated (P-/N-type) experiments where data is acquired in the form exp (iωt) or exp (-iωt), and which make up many of the multidimensional experiments used in modern NMR. Here we demonstrate a modification of the CS ℓ 1 -norm approach to allow random coherence order selection (RCS) for phase modulated experiments; we generalise the nomenclature for RCS and RPD as random quadrature detection (RQD). With this method, the power of RQD can be extended

  7. Mixed results in the safety performance of computerized physician order entry.

    Science.gov (United States)

    Metzger, Jane; Welebob, Emily; Bates, David W; Lipsitz, Stuart; Classen, David C

    2010-04-01

    Computerized physician order entry is a required feature for hospitals seeking to demonstrate meaningful use of electronic medical record systems and qualify for federal financial incentives. A national sample of sixty-two hospitals voluntarily used a simulation tool designed to assess how well safety decision support worked when applied to medication orders in computerized order entry. The simulation detected only 53 percent of the medication orders that would have resulted in fatalities and 10-82 percent of the test orders that would have caused serious adverse drug events. It is important to ascertain whether actual implementations of computerized physician order entry are achieving goals such as improved patient safety.

  8. Synthesis of results of randomized controlled trials of contrast media

    International Nuclear Information System (INIS)

    Kinnison, M.L.; Powe, N.R.; Steinberg, E.P.

    1988-01-01

    The authors review 100 randomized controlled trials (RCTs) that examine the safety or efficacy of new low-osmolality contrast media (LOM) and focus on the 43 RCTs judged to be of the highest quality. These RCTs showed no consistent differences in nephrotoxicity between high- and low-osmolality contrast media. Certain cardiovascular parameters were altered less with low-osmolality agents during intracardiac injection, but the clinical significance of these differences in unclear. Heat and pain sensations occurred less often with low-osmolality contrast media. No differences were noted in the incidence of nausea, vomiting, urticaria, or bronchospasm. Even with numerous RCTs comparing these media, physicians still must make economically significant choices about contrast media without sufficient data about their relative safety

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

    International Nuclear Information System (INIS)

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

    2008-01-01

    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

  10. 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.

  11. Global Attractivity Results for Mixed-Monotone Mappings in Partially Ordered Complete Metric Spaces

    Directory of Open Access Journals (Sweden)

    Kalabušić S

    2009-01-01

    Full Text Available We prove fixed point theorems for mixed-monotone mappings in partially ordered complete metric spaces which satisfy a weaker contraction condition than the classical Banach contraction condition for all points that are related by given ordering. We also give a global attractivity result for all solutions of the difference equation , where satisfies mixed-monotone conditions with respect to the given ordering.

  12. 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.

  13. 78 FR 78694 - Orders: Supplemental Orders on Reporting by Regulated Entities of Stress Testing Results as of...

    Science.gov (United States)

    2013-12-27

    ... reporting under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd... testing. II. Orders For the convenience of the affected parties, the text of the Supplemental Orders... Reform and Consumer Protection Act (``Dodd-Frank Act'') requires certain financial companies with total...

  14. 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

  15. Controllability Results For First Order Impulsive Stochastic Functional Differential Systems with State-Dependent Delay

    Directory of Open Access Journals (Sweden)

    C. Parthasarathy

    2013-03-01

    Full Text Available In this paper, we study the controllability results of first order impulsive stochastic differential and neutral differential systems with state-dependent delay by using semigroup theory. The controllability results are derived by the means of Leray-SchauderAlternative fixed point theorem. An example is provided to illustrate the theory.

  16. Reverse transcription using random pentadecamer primers increases yield and quality of resulting cDNA

    DEFF Research Database (Denmark)

    Stangegaard, Michael; Dufva, I.H.; Dufva, Hans Martin

    2006-01-01

    oligonucleotides (pentadecamers) consistently, yielded at least 2 fold as much cDNA as did random hexamers using either-poly(A) RNA or an amplified version of messenger RNA (aRNA) as a template. The cDNA generated using pentadecamers did not differ in size distribution or the amount of incorporated label compared...... with cDNA generated with random hexamers. The increased efficiency of priming using random pentadecamers resulted in reverse transcription of > 80% of the template aRNA, while random hexamers induced reverse transcription of only 40% of the template aRNA. This suggests a better coverage...... that random pentadecamers can replace random hexamers in reverse transcription reactions on both poly(A) RNA and amplified RNA, resulting in higher cDNA yields and quality....

  17. 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

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

    International Nuclear Information System (INIS)

    Jumarie, Guy

    2009-01-01

    A probability distribution of fractional (or fractal) order is defined by the measure μ{dx} = p(x)(dx) α , 0 α (D x α h α )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.

  19. Competing order parameters in quenched random alloys: Fe/sub 1-x/Co/sub x/Cl2

    International Nuclear Information System (INIS)

    Wong, P.; Horn, P.M.; Birgeneau, R.J.; Safinya, C.R.; Shirane, G.

    1980-01-01

    A study is reported of the magnetic properties of the random alloy Fe/sub 1-x/Co/sub x/Cl 2 , which represents an archetypal example of a system with competing orthogonal spin anisotropies. Behavior similar to previous experiments and theoretical predictions is found, but with important qualitative and quantitative differences; in particular the phase transition in one variable is drastically altered by the existence of long-range order in the other variable. It is hypothesized that this is due to microscopic random-field effects

  20. Order parameter fluctuations at a critical point - an exact result about percolation -

    International Nuclear Information System (INIS)

    Botet, Robert

    2011-01-01

    The order parameter of the system in the critical state, is expected to undergo large non-Gaussian fluctuations. However, almost nothing is known about the mathematical forms of the possible probability distributions of the order parameter. A remarkable exception is the site-percolation on the Bethe lattice, for which the complete order-parameter distribution has been recently derived at the critical point. Surprisingly, it appears to be the Kolmogorov-Smirnov distribution, well known in very different areas of mathematical statistics. In the present paper, we explain first how this special distribution could appear naturally in the context of the critical systems, under the assumption (still virtually unstudied) of the exponential distribution of the number of domains of a given size. In a second part, we present for the first time the complete derivation of the order-parameter distribution for the critical percolation model on the Bethe lattice, thus completing a recent publication announcing this result.

  1. 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.

  2. Multidimensional coincidence point results for generalized $(\\psi ,\\theta ,\\varphi$-contraction on ordered metric spaces

    Directory of Open Access Journals (Sweden)

    Bhavana Deshpande

    2017-11-01

    Full Text Available The main objective of this research article is to establish some coincidence point theorem for $g$-non-decreasing mappings under generalized $(\\psi ,\\theta ,\\varphi $-contraction on a partially ordered metric space. Furthermore, we show how multidimensional results can be seen as a simple consequences of our unidimensional coincidence point theorem. Our results modify, improve, sharpen, enrich and generalize various known results.

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

    International Nuclear Information System (INIS)

    Tarantola, S.; Gatelli, D.; Mara, T.A.

    2006-01-01

    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

  4. 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.

  5. Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial

    International Nuclear Information System (INIS)

    Martenson, James A.; Hyland, Glenn; Moertel, Charles G.; Mailliard, James A.; O'Fallon, Judith R.; Collins, Roger T.; Morton, Roscoe F.; Tewfik, Hamed H.; Moore, Randy L.; Frank, Albert R.; Urias, Rodolfo E.; Deming, Richard L.

    1996-01-01

    Purpose: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. Methods and Materials: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. Results: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). Conclusion: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy

  6. 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

  7. Using computerized provider order entry to enforce documentation of tests with pending results at hospital discharge.

    Science.gov (United States)

    Cadwallader, J; Asirwa, C; Li, X; Kesterson, J; Tierney, W M; Were, M C

    2012-01-01

    Small numbers of tests with pending results are documented in hospital discharge summaries leading to breakdown in communication and medical errors due to inadequate followup. Evaluate effect of using a computerized provider order entry (CPOE) system to enforce documentation of tests with pending results into hospital discharge summaries. We assessed the percent of all tests with pending results and those with actionable results that were documented before (n = 182 discharges) and after (n = 203 discharges) implementing the CPOE-enforcement tool. We also surveyed providers (n = 52) about the enforcement functionality. Documentation of all tests with pending results improved from 12% (87/701 tests) before to 22% (178/812 tests) (p = 0.02) after implementation. Documentation of tests with eventual actionable results increased from 0% (0/24) to 50% (14/28)(ppending results into discharge summaries significantly increased documentation rates, especially of actionable tests. However, gaps in documentation still exist.

  8. 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.

  9. A unified model for transfer alignment at random misalignment angles based on second-order EKF

    International Nuclear Information System (INIS)

    Cui, Xiao; Qin, Yongyuan; Yan, Gongmin; Liu, Zhenbo; Mei, Chunbo

    2017-01-01

    In the transfer alignment process of inertial navigation systems (INSs), the conventional linear error model based on the small misalignment angle assumption cannot be applied to large misalignment situations. Furthermore, the nonlinear model based on the large misalignment angle suffers from redundant computation with nonlinear filters. This paper presents a unified model for transfer alignment suitable for arbitrary misalignment angles. The alignment problem is transformed into an estimation of the relative attitude between the master INS (MINS) and the slave INS (SINS), by decomposing the attitude matrix of the latter. Based on the Rodriguez parameters, a unified alignment model in the inertial frame with the linear state-space equation and a second order nonlinear measurement equation are established, without making any assumptions about the misalignment angles. Furthermore, we employ the Taylor series expansions on the second-order nonlinear measurement equation to implement the second-order extended Kalman filter (EKF2). Monte-Carlo simulations demonstrate that the initial alignment can be fulfilled within 10 s, with higher accuracy and much smaller computational cost compared with the traditional unscented Kalman filter (UKF) at large misalignment angles. (paper)

  10. A unified model for transfer alignment at random misalignment angles based on second-order EKF

    Science.gov (United States)

    Cui, Xiao; Mei, Chunbo; Qin, Yongyuan; Yan, Gongmin; Liu, Zhenbo

    2017-04-01

    In the transfer alignment process of inertial navigation systems (INSs), the conventional linear error model based on the small misalignment angle assumption cannot be applied to large misalignment situations. Furthermore, the nonlinear model based on the large misalignment angle suffers from redundant computation with nonlinear filters. This paper presents a unified model for transfer alignment suitable for arbitrary misalignment angles. The alignment problem is transformed into an estimation of the relative attitude between the master INS (MINS) and the slave INS (SINS), by decomposing the attitude matrix of the latter. Based on the Rodriguez parameters, a unified alignment model in the inertial frame with the linear state-space equation and a second order nonlinear measurement equation are established, without making any assumptions about the misalignment angles. Furthermore, we employ the Taylor series expansions on the second-order nonlinear measurement equation to implement the second-order extended Kalman filter (EKF2). Monte-Carlo simulations demonstrate that the initial alignment can be fulfilled within 10 s, with higher accuracy and much smaller computational cost compared with the traditional unscented Kalman filter (UKF) at large misalignment angles.

  11. Multi-instantons and exact results II: specific cases, higher-order effects, and numerical calculations

    International Nuclear Information System (INIS)

    Zinn-Justin, Jean; Jentschura, Ulrich D.

    2004-01-01

    In this second part of the treatment of instantons in quantum mechanics, the focus is on specific calculations related to a number of quantum mechanical potentials with degenerate minima. We calculate the leading multi-instanton contributions to the partition function, using the formalism introduced in the first part of the treatise [Ann. Phys. (N. Y.) (previous issue) (2004)]. The following potentials are considered: (i) asymmetric potentials with degenerate minima, (ii) the periodic cosine potential, (iii) anharmonic oscillators with radial symmetry, and (iv) a specific potential which bears an analogy with the Fokker-Planck equation. The latter potential has the peculiar property that the perturbation series for the ground-state energy vanishes to all orders and is thus formally convergent (the ground-state energy, however, is non-zero and positive). For the potentials (ii), (iii), and (iv), we calculate the perturbative B-function as well as the instanton A-function to fourth order in g. We also consider the double-well potential in detail, and present some higher-order analytic as well as numerical calculations to verify explicitly the related conjectures up to the order of three instantons. Strategies analogous to those outlined here could result in new conjectures for problems where our present understanding is more limited

  12. Ordering molecular genetic tests and reporting results: practices in laboratory and clinical settings.

    Science.gov (United States)

    Lubin, Ira M; Caggana, Michele; Constantin, Carolyn; Gross, Susan J; Lyon, Elaine; Pagon, Roberta A; Trotter, Tracy L; Wilson, Jean Amos; McGovern, Margaret M

    2008-09-01

    Previous studies have suggested that patient care may be compromised as a consequence of poor communication between clinicians and laboratory professionals in cases in which molecular genetic test results are reported. To understand better the contributing factors to such compromised care, we investigated both pre- and postanalytical processes using cystic fibrosis mutation analysis as our model. We found that although the majority of test requisition forms requested patient/family information that was necessary for the proper interpretation of test results, in many cases, these data were not provided by the individuals filling out the forms. We found instances in which result reports for simulated diagnostic testing described individuals as carriers where only a single mutation was found with no comment pertaining to a diagnosis of cystic fibrosis. Similarly, reports based on simulated scenarios for carrier testing were problematic when no mutations were identified, and the patient's race/ethnicity and family history were not discussed in reference to residual risk of disease. Remarkably, a pilot survey of obstetrician-gynecologists revealed that office staff, including secretaries, often helped order genetic tests and reported test results to patients, raising questions about what efforts are undertaken to ensure personnel competency. These findings are reviewed in light of what efforts should be taken to improve the quality of test-ordering and result-reporting practices.

  13. Active control on high-order coherence and statistic characterization on random phase fluctuation of two classical point sources.

    Science.gov (United States)

    Hong, Peilong; Li, Liming; Liu, Jianji; Zhang, Guoquan

    2016-03-29

    Young's double-slit or two-beam interference is of fundamental importance to understand various interference effects, in which the stationary phase difference between two beams plays the key role in the first-order coherence. Different from the case of first-order coherence, in the high-order optical coherence the statistic behavior of the optical phase will play the key role. In this article, by employing a fundamental interfering configuration with two classical point sources, we showed that the high- order optical coherence between two classical point sources can be actively designed by controlling the statistic behavior of the relative phase difference between two point sources. Synchronous position Nth-order subwavelength interference with an effective wavelength of λ/M was demonstrated, in which λ is the wavelength of point sources and M is an integer not larger than N. Interestingly, we found that the synchronous position Nth-order interference fringe fingerprints the statistic trace of random phase fluctuation of two classical point sources, therefore, it provides an effective way to characterize the statistic properties of phase fluctuation for incoherent light sources.

  14. Effect of order of draw of blood samples during phlebotomy on routine biochemistry results.

    Science.gov (United States)

    Sulaiman, Raashda A; Cornes, Michael P; Whitehead, Simon J; Othonos, Nadia; Ford, Clare; Gama, Rousseau

    2011-11-01

    To investigate whether incorrect order of draw of blood samples during phlebotomy causes in vitro potassium ethylenediaminetetraacetic acid EDTA (kEDTA) contamination of blood samples. Serum kEDTA, potassium, calcium, magnesium, alkaline phosphatase, zinc and iron concentrations were measured in blood samples drawn before and after collecting blood into kEDTA containing sample tubes by an experienced phlebotomist using the Sarstedt Safety Monovette system. EDTA was undetectable in all samples. The concentrations of other analytes were similar in blood samples drawn before and after collection of the EDTA blood sample. Order of draw of blood samples using the Sarstedt Safety Monovette system has no effect on serum biochemistry results, when samples are taken by an experienced phlebotomist.

  15. 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.

  16. 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.

  17. The Relationship of Dynamical Heterogeneity to the Adam-Gibbs and Random First-Order Transition Theories of Glass Formation

    OpenAIRE

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

    2013-01-01

    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 stri...

  18. 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.

  19. 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].

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

    KAUST Repository

    Soury, Hamza; Alouini, Mohamed-Slim

    2016-01-01

    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 [1].

  1. Optimal Order of Successive Office Hysteroscopy and Endometrial Biopsy for the Evaluation of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

    Science.gov (United States)

    Sarkar, Papri; Mikhail, Emad; Schickler, Robyn; Plosker, Shayne; Imudia, Anthony N

    2017-09-01

    To estimate the optimal order of office hysteroscopy and endometrial biopsy when performed successively for evaluation of abnormal uterine bleeding. Patients undergoing successive office hysteroscopy and endometrial biopsy were included in a single-blind, prospective, randomized trial. The primary outcome was to evaluate the effect of order of procedures on patients' pain score. Prespecified secondary outcomes include procedure duration, hysteroscopic visualization of the uterine cavity, endometrial sample adequacy, and number of attempts at biopsy. Pain scores were assessed using a visual analog scale from 0 to 10 and endometrial sample adequacy was determined from the histopathology report. Hysteroscopy images were recorded. Sample size of 34 per group (n=68) was determined to be adequate to detect a difference of 20% in visual analog scale score between hysteroscopy first (group A) and biopsy first (group B) at α of 0.05 and 80% power. Between October 2015 and January 2017, 78 women were randomized to group A (n=40) and group B (n=38). There was no difference in global pain perception [7 (0-10) vs 7 (0-10); P=.57, 95% CI 5.8-7.1]. Procedure duration [3 (1-9) vs 3 (2-10), P=.32, 95% CI 3.3-4.1] and endometrial sample adequacy (78.9% vs 75.7%, P=.74) were similar in both groups. Group A patients had better endometrial visualization (Pabnormal uterine bleeding, the global pain perception, and time required are independent of the order in which procedures are performed. Performing hysteroscopy first ensures better image, whereas biopsy first yields adequate tissue sample with fewer attempts. ClinicalTrials.gov, NCT02472184.

  2. 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…

  3. The Results of a Randomized Control Trial Evaluation of the SPARK Literacy Program

    Science.gov (United States)

    Jones, Curtis J.; Christian, Michael; Rice, Andrew

    2016-01-01

    The purpose of this report is to present the results of a two-year randomized control trial evaluation of the SPARK literacy program. SPARK is an early grade literacy program developed by Boys & Girls Clubs of Greater Milwaukee. In 2010, SPARK was awarded an Investing in Innovation (i3) Department of Education grant to further develop the…

  4. Random Schroedinger operators and the theory of disordered systems: some rigorous results

    International Nuclear Information System (INIS)

    Kunz, H.; Souillard, B.

    1981-01-01

    The authors report results on a class of finite difference Schroedinger operators with stochastic potentials. The Hamiltonian is then H(V)=-Δ+V; where Δ is the discretized Laplacian and the potential V acts as a multiplication operator. The potential V is random. (Auth.)

  5. Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

    Science.gov (United States)

    Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

    2014-01-01

    For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

  6. Methods and optical fibers that decrease pulse degradation resulting from random chromatic dispersion

    Science.gov (United States)

    Chertkov, Michael; Gabitov, Ildar

    2004-03-02

    The present invention provides methods and optical fibers for periodically pinning an actual (random) accumulated chromatic dispersion of an optical fiber to a predicted accumulated dispersion of the fiber through relatively simple modifications of fiber-optic manufacturing methods or retrofitting of existing fibers. If the pinning occurs with sufficient frequency (at a distance less than or are equal to a correlation scale), pulse degradation resulting from random chromatic dispersion is minimized. Alternatively, pinning may occur quasi-periodically, i.e., the pinning distance is distributed between approximately zero and approximately two to three times the correlation scale.

  7. 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...

  8. 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...

  9. 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...

  10. Further results on global state feedback stabilization of nonlinear high-order feedforward systems.

    Science.gov (United States)

    Xie, Xue-Jun; Zhang, Xing-Hui

    2014-03-01

    In this paper, by introducing a combined method of sign function, homogeneous domination and adding a power integrator, and overcoming several troublesome obstacles in the design and analysis, the problem of state feedback control for a class of nonlinear high-order feedforward systems with the nonlinearity's order being relaxed to an interval rather than a fixed point is solved. Copyright © 2013 ISA. Published by Elsevier Ltd. All rights reserved.

  11. Pre-ordering lunch at work. Results of the what to eat for lunch study.

    Science.gov (United States)

    Stites, Shana D; Singletary, S Brook; Menasha, Adeena; Cooblall, Clarissa; Hantula, Donald; Axelrod, Saul; Figueredo, Vincent M; Phipps, Etienne J

    2015-01-01

    The objective of this study was to evaluate an intervention that combined mindful eating and online pre-ordering to promote healthier lunch purchases at work. The study took place at an urban hospital with 26 employees who were overweight or obese. The design included a contemporaneous comparison with delayed-treatment control and a three-phase prospective study. A minimum 4-week baseline period preceded a 4-week full-intervention, in which participants received mindful eating training, pre-ordered their lunches, and received price discounts toward lunch purchases. In a 4-week reduced intervention phase, participants pre-ordered lunches without price discounts. Participant lunch purchases were tracked electronically at the point of purchase. The primary outcome measures were the amounts of kilocalories and fat grams in purchased lunches. In contemporaneous comparisons, the treatment group purchased lunches with an average of 144.6 fewer kilocalories (p = 0.01) and 8.9 fewer grams of fat (p = 0.005) compared to controls. In multivariable longitudinal analyses, participants decreased the average number of calories in their meals by 114.6 kcal per lunch and the average grams of fat by 5.4 per lunch during the partial-intervention compared to the baseline (p ordering system if offered in the future. Combined mindful eating training and online pre-ordering appears a feasible and useful worksite intervention to improve food choices by employees. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

    OpenAIRE

    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-res...

  13. Value Distribution and Uniqueness Results of Zero-Order Meromorphic Functions to Their q-Shift

    Directory of Open Access Journals (Sweden)

    Haiwa Guan

    2012-01-01

    Full Text Available We investigate value distribution and uniqueness problems of meromorphic functions with their q-shift. We obtain that if f is a transcendental meromorphic (or entire function of zero order, and Q(z is a polynomial, then afn(qz+f(z−Q(z has infinitely many zeros, where q∈ℂ∖{0}, a is nonzero constant, and n≥5 (or n≥3. We also obtain that zero-order meromorphic function share is three distinct values IM with its q-difference polynomial P(f, and if limsup r→∞(N(r,f/T(r,f<1, then f≡P(f.

  14. Adjuvant Hormone Therapy May Improve Survival in Epithelial Ovarian Cancer: Results of the AHT Randomized Trial.

    Science.gov (United States)

    Eeles, Rosalind A; Morden, James P; Gore, Martin; Mansi, Janine; Glees, John; Wenczl, Miklos; Williams, Christopher; Kitchener, Henry; Osborne, Richard; Guthrie, David; Harper, Peter; Bliss, Judith M

    2015-12-10

    To assess the effects of adjuvant hormone therapy (AHT) on survival and disease outcome in women with epithelial ovarian cancer. Participants were premenopausal and postmenopausal women who had been diagnosed with epithelial ovarian cancer (any International Federation of Gynecology and Obstetrics stage) 9 or fewer months previously. Ineligible patients included those with deliberately preserved ovarian function, with a history of a hormone-dependent malignancy, or with any contraindications to hormone-replacement therapy. Patients were centrally randomly assigned in a 1:1 ratio to either AHT for 5 years after random assignment or no AHT (control). Main outcome measures were overall survival (OS), defined as time from random assignment to death (any cause), and relapse-free survival, defined as time from random assignment to relapse or death (any cause). Patients who continued, alive and relapse free, were censored at their last known follow-up. A total of 150 patients (n = 75, AHT; n = 75, control) were randomly assigned from 1990 to 1995 from 19 centers in the United Kingdom, Spain, and Hungary; all patients were included in intention-to-treat analyses. The median follow-up in alive patients is currently 19.1 years. Of the 75 patients with AHT, 53 (71%) have died compared with 68 (91%) of 75 patients in the control group. OS was significantly improved in patients who were receiving AHT (hazard ratio, 0.63; 95% CI, 0.44 to 0.90; P = .011). A similar effect was seen for relapse-free survival (hazard ratio, 0.67; 95% CI, 0.47 to 0.97; P = .032). Effects remained after adjustment for known prognostic factors. These results show that women who have severe menopausal symptoms after ovarian cancer treatment can safely take hormone-replacement therapy, and this may, in fact, infer benefits in terms of OS in addition to known advantages in terms of quality of life. © 2015 by American Society of Clinical Oncology.

  15. 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.

  16. 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

  17. 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.

  18. Effects of a randomized intervention promoting healthy children's meals on children's ordering and dietary intake in a quick-service restaurant.

    Science.gov (United States)

    Anzman-Frasca, Stephanie; Braun, Abbey C; Ehrenberg, Sarah; Epstein, Leonard H; Gampp, April; Leone, Lucia A; Singh, Anita; Tauriello, Sara

    2018-08-01

    Children's consumption of restaurant foods is associated with higher energy intake and lower nutritional quality compared to foods prepared at home. The aim of this pilot study was to test whether an in-restaurant intervention promoting healthy children's meals (i.e. two meals that met nutrition recommendations and were thus healthier than typical children's meal offerings across leading restaurants) affected children's meal selection and intake. Families with 4-to-8-year-old children were recruited from one location of Anderson's Frozen Custard, a regional quick-service restaurant chain. Families were randomly assigned to return to the restaurant during an intervention or control period and were blinded to group assignment. All families received free meals. During the intervention period families also received placemats featuring two healthy "Kids' Meals of the Day" upon restaurant entry. After families finished dining, researchers recorded children's orders and collected leftovers for quantifying dietary intake via weighed plate waste. Poisson regression and chi-square tests were used to compare children's orders between study groups, and t-tests were used to test for differences in dietary intake among children ordering a promoted healthy entrée (main dish) versus those who did not. Fifty-eight families participated. Children who were exposed to the study placemats prior to ordering ordered a significantly greater number of healthy food components compared to controls (p = 0.03). Overall, in the intervention group, 21% of children ordered a healthy entrée or side dish, versus 7% of controls. Children who ordered one of the promoted healthy entrées consumed less saturated fat across the total meal compared to those who did not (p = 0.04). Manipulating the prominence of healthy choices in restaurants may shift children's meal selections. Future research should build on these initial promising results, aiming to increase the potency of the intervention

  19. 77 FR 15101 - Results From Inert Ingredient Test Orders Issued Under EPA's Endocrine Disruptor Screening...

    Science.gov (United States)

    2012-03-14

    ... the selection criteria for endocrine testing under the Safe Drinking Water Act (SDWA). EPA has no...) because the chemicals meet the selection criteria. EPA has no plans to issue further test orders for the... Screening Program (EDSP) and the Federal Food, Drug, and Cosmetic Act (FFDCA). In response to the test...

  20. Fixed point results for contractions involving generalized altering distances in ordered metric spaces

    Directory of Open Access Journals (Sweden)

    Samet Bessem

    2011-01-01

    Full Text Available Abstract In this article, we establish coincidence point and common fixed point theorems for mappings satisfying a contractive inequality which involves two generalized altering distance functions in ordered complete metric spaces. As application, we study the existence of a common solution to a system of integral equations. 2000 Mathematics subject classification. Primary 47H10, Secondary 54H25

  1. Existence results for a fourth order partial differential equation arising in condensed matter physics

    Czech Academy of Sciences Publication Activity Database

    Escudero, C.; Gazzola, F.; Hakl, Robert; Torres, P.J.

    2015-01-01

    Roč. 140, č. 4 (2015), s. 385-393 ISSN 0862-7959 Institutional support: RVO:67985840 Keywords : higher order parabolic equation * existence of solution * blow-up in finite time Subject RIV: BA - General Mathematics http://hdl.handle.net/10338.dmlcz/144457

  2. 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 (p<0.0001), and meeting exercise guidelines (p<0.0001) were associated with fewer calories 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.

  3. Hierarchical random additive process and logarithmic scaling of generalized high order, two-point correlations in turbulent boundary layer flow

    Science.gov (United States)

    Yang, X. I. A.; Marusic, I.; Meneveau, C.

    2016-06-01

    Townsend [Townsend, The Structure of Turbulent Shear Flow (Cambridge University Press, Cambridge, UK, 1976)] hypothesized that the logarithmic region in high-Reynolds-number wall-bounded flows consists of space-filling, self-similar attached eddies. Invoking this hypothesis, we express streamwise velocity fluctuations in the inertial layer in high-Reynolds-number wall-bounded flows as a hierarchical random additive process (HRAP): uz+=∑i=1Nzai . Here u is the streamwise velocity fluctuation, + indicates normalization in wall units, z is the wall normal distance, and ai's are independently, identically distributed random additives, each of which is associated with an attached eddy in the wall-attached hierarchy. The number of random additives is Nz˜ln(δ /z ) where δ is the boundary layer thickness and ln is natural log. Due to its simplified structure, such a process leads to predictions of the scaling behaviors for various turbulence statistics in the logarithmic layer. Besides reproducing known logarithmic scaling of moments, structure functions, and correlation function [" close="]3/2 uz(x ) uz(x +r ) >, new logarithmic laws in two-point statistics such as uz4(x ) > 1 /2, 1/3, etc. can be derived using the HRAP formalism. Supporting empirical evidence for the logarithmic scaling in such statistics is found from the Melbourne High Reynolds Number Boundary Layer Wind Tunnel measurements. We also show that, at high Reynolds numbers, the above mentioned new logarithmic laws can be derived by assuming the arrival of an attached eddy at a generic point in the flow field to be a Poisson process [Woodcock and Marusic, Phys. Fluids 27, 015104 (2015), 10.1063/1.4905301]. Taken together, the results provide new evidence supporting the essential ingredients of the attached eddy hypothesis to describe streamwise velocity fluctuations of large, momentum transporting eddies in wall-bounded turbulence, while observed deviations suggest the need for further extensions of the

  4. Asymptotic results for the semi-Markovian random walk with delay

    International Nuclear Information System (INIS)

    Khaniyev, T.A.; Aliyev, R.T.

    2006-12-01

    In this study, the semi-Markovian random walk with a discrete interference of chance (X(t) ) is considered and under some weak assumptions the ergodicity of this process is discussed. Characteristic function of the ergodic distribution of X(t) is expressed by means of the probability characteristics of the boundary functionals (N,S N ). Some exact formulas for first and second moments of ergodic distribution of the process X(t) are obtained when the random variable ζ 1 - s, which is describing a discrete interference of chance, has Gamma distribution on the interval [0, ∞) with parameter (α,λ) . Based on these results, the asymptotic expansions with three terms for the first two moments of the ergodic distribution of the process X(t) are obtained, as λ → 0. (author)

  5. In Her Own Words: Women Describe Their Use of Force Resulting in Court-Ordered Intervention.

    Science.gov (United States)

    Larance, Lisa Young; Miller, Susan L

    2016-09-13

    Although researchers and practitioners have established that men and women use force in their intimate heterosexual relationships for very different reasons, there is a dearth of information regarding the events surrounds women's arrests and subsequent court orders to anti-violence intervention programming. This information is fundamental to improving Criminal Legal System (CLS) and community-partner understanding of and response to intimate partner violence (IPV). The authors meet this need by analyzing 208 women's descriptions of their arrests and subsequent court order to intervention programs for using force. From these, the authors frame nine categorical descriptions of women's actions. The descriptions and categories highlight areas for CLS and community-partners' growing understanding of this complex issue. © The Author(s) 2016.

  6. E-learning in order to improve drug prescription for hospitalized older patients: a cluster-randomized controlled study.

    Science.gov (United States)

    Franchi, Carlotta; Tettamanti, Mauro; Djade, Codjo Dgnefa; Pasina, Luca; Mannucci, Pier Mannuccio; Onder, Graziano; Gussoni, Gualberto; Manfellotto, Dario; Bonassi, Stefano; Salerno, Francesco; Nobili, Alessandro

    2016-07-01

    The aim of the study was to evaluate the effect of an e-learning educational program meant to foster the quality of drug prescription in hospitalized elderly patients. Twenty geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control (basic geriatric pharmacology notions). Logistic regression analysis was used in order to assess the effect of the intervention on the use of potentially inappropriate medication (PIM, primary outcome) at hospital discharge. Secondary outcomes were a reduced prevalence of at least one potential drug-drug interaction (DDI) and potentially severe DDI at discharge. Mortality rate and incidence of re-hospitalizations were other secondary outcomes assessed at the 12-month follow-up. A total of 697 patients (347 in the intervention and 350 in the control arms) were enrolled. No difference in the prevalence of PIM at discharge was found between arms (OR 1.29 95%CI 0.87-1.91). We also found no decrease in the prevalence of DDI (OR 0.67 95%CI 0.34-1.28) and potentially severe DDI (OR 0.86 95%CI 0.63-1.15) at discharge, nor in mortality rates and incidence of re-hospitalization at 12-month follow-up. This e-learning educational program had no clear effect on the quality of drug prescription and clinical outcomes in hospitalized elderly patients. Given the high prevalence of PIMs and potential DDIs recorded in the frame of this study, other approaches should be developed in order to improve the quality of drug prescription in this population. © 2016 The British Pharmacological Society.

  7. 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.

  8. Some existence results for a fourth order equation involving critical exponent

    CERN Document Server

    Ben-Ayed, M; Hammami, M

    2003-01-01

    In this paper a fourth order equation involving critical growth is considered under the Navier boundary condition: DELTA sup 2 u = Ku sup p , u > 0 in OMEGA, u = DELTA u = 0 on partial deriv OMEGA, where K is a positive function, OMEGA is a bounded smooth domain in R sup n , n >= 5 and p + 1 2n/(n - 4) is the critical Sobolev exponent. We give some topological conditions on K to ensure the existence of solutions. Our methods involve the study of the critical points at infinity and their contribution to the topology of the level sets of the associated Euler Lagrange functional.

  9. 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.

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

    International Nuclear Information System (INIS)

    Adam, R.; Ade, P. A. R.; Aghanim, N.; Arnaud, M.; Ashdown, M.

    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 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 study 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. Finally, angular cross-power spectra using data sets that are decorrelated in time are immune to the main systematic effects.

  11. 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

  12. Mean Abnormal Result Rate: Proof of Concept of a New Metric for Benchmarking Selectivity in Laboratory Test Ordering.

    Science.gov (United States)

    Naugler, Christopher T; Guo, Maggie

    2016-04-01

    There is a need to develop and validate new metrics to access the appropriateness of laboratory test requests. The mean abnormal result rate (MARR) is a proposed measure of ordering selectivity, the premise being that higher mean abnormal rates represent more selective test ordering. As a validation of this metric, we compared the abnormal rate of lab tests with the number of tests ordered on the same requisition. We hypothesized that requisitions with larger numbers of requested tests represent less selective test ordering and therefore would have a lower overall abnormal rate. We examined 3,864,083 tests ordered on 451,895 requisitions and found that the MARR decreased from about 25% if one test was ordered to about 7% if nine or more tests were ordered, consistent with less selectivity when more tests were ordered. We then examined the MARR for community-based testing for 1,340 family physicians and found both a wide variation in MARR as well as an inverse relationship between the total tests ordered per year per physician and the physician-specific MARR. The proposed metric represents a new utilization metric for benchmarking relative selectivity of test orders among physicians. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  13. Squeezing resulting from a fourth-order interaction in a degenerate parametric amplifier with absorption losses

    Science.gov (United States)

    Garca Fernández, P.; Colet, P.; Toral, R.; San Miguel, M.; Bermejo, F. J.

    1991-05-01

    The squeezing properties of a model of a degenerate parametric amplifier with absorption losses and an added fourth-order nonlinearity have been analyzed. The approach used consists of obtaining the Langevin equation for the optical field from the Heisenberg equation provided that a linearization procedure is valid. The steady states of the deterministic equations have been obtained and their local stability has been analyzed. The stationary covariance matrix has been calculated below and above threshold. Below threshold, a squeezed vacuum state is obtained and the nonlinear effects in the fluctuations have been taken into account by a Gaussian decoupling. In the case above threshold, a phase-squeezed coherent state is obtained and numerical simulations allowed to compute the time interval, depending on the loss parameter, on which the system jumps from one stable state to the other. Finally, the variances numerically determined have been compared with those obtained from the linearized theory and the limits of validity of the linear theory have been analyzed. It has become clear that the nonlinear contribution may perhaps be profitably used for the construction of above-threshold squeezing devices.

  14. 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.

  15. Examination of Cognitive Function During Six Months of Calorie Restriction: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Martin, Corby K.; Anton, Stephen D.; Han, Hongmei; York-Crowe, Emily; Redman, Leanne M.; Ravussin, Eric; Williamson, Donald A.

    2009-01-01

    Background Calorie restriction increases longevity in many organisms, and calorie restriction or its mimetic might increase longevity in humans. It is unclear if calorie restriction/dieting contributes to cognitive impairment. During this randomized controlled trial, the effect of 6 months of calorie restriction on cognitive functioning was tested. Methods Participants (n = 48) were randomized to one of four groups: (1) control (weight maintenance), (2) calorie restriction (CR; 25% restriction), (3) CR plus structured exercise (CR + EX, 12.5% restriction plus 12.5% increased energy expenditure via exercise), or (4) low-calorie diet (LCD; 890 kcal/d diet until 15% weight loss, followed by weight maintenance). Cognitive tests (verbal memory, visual memory, attention/concentration) were conducted at baseline and months 3 and 6. Mixed linear models tested if cognitive function changed significantly from baseline to months 3 and 6, and if this change differed by group. Correlation analysis was used to determine if average daily energy deficit (quantified from change in body energy stores) was associated with change in cognitive test performance for the three dieting groups combined. Results No consistent pattern of verbal memory, visual retention/memory, or attention/concentration deficits emerged during the trial. Daily energy deficit was not significantly associated with change in cognitive test performance. Conclusions This randomized controlled trial suggests that calorie restriction/dieting was not associated with a consistent pattern of cognitive impairment. These conclusions must be interpreted in the context of study limitations, namely small sample size and limited statistical power. Previous reports of cognitive impairment might reflect sampling biases or information processing biases. PMID:17518698

  16. Some results on convergence rates for probabilities of moderate deviations for sums of random variables

    Directory of Open Access Journals (Sweden)

    Deli Li

    1992-01-01

    Full Text Available Let X, Xn, n≥1 be a sequence of iid real random variables, and Sn=∑k=1nXk, n≥1. Convergence rates of moderate deviations are derived, i.e., the rate of convergence to zero of certain tail probabilities of the partial sums are determined. For example, we obtain equivalent conditions for the convergence of series ∑n≥1(ψ2(n/nP(|Sn|≥nφ(n only under the assumptions convergence that EX=0 and EX2=1, where φ and ψ are taken from a broad class of functions. These results generalize and improve some recent results of Li (1991 and Gafurov (1982 and some previous work of Davis (1968. For b∈[0,1] and ϵ>0, letλϵ,b=∑n≥3((loglognb/nI(|Sn|≥(2+ϵnloglogn.The behaviour of Eλϵ,b as ϵ↓0 is also studied.

  17. MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

    Science.gov (United States)

    Staats, Peter S; Benyamin, Ramsin M

    2016-02-01

    Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

  18. 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.

  19. 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.

  20. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available 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 mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  1. Exploring the pullback attractors of a low-order quasigeostrophic ocean model subject to deterministic and random forcing

    Science.gov (United States)

    Ghil, M.; Pierini, S.; Chekroun, M.

    2017-12-01

    A low-order quasigeostrophic model [1] captures several key features of intrinsic low-frequency variability of the oceans' wind-driven circulation. This double-gyre model is used here as a prototype of an unstable and nonlinear dynamical system with time-dependent forcing to explore basic features of climate change in the presence of natural variability. The studies rely on the theoretical framework of nonautonomous dynamical systems and of their pullback attractors (PBAs), namely the time-dependent invariant sets that attract all trajectories initialized in the remote past [2,3]. Ensemble simulations help us explore these PBAs. The chaotic PBAs of the periodically forced model [4] are found to be cyclo-stationary and cyclo-ergodic. Two parameters are then introduced to analyze the topological structure of the PBAs as a function of the forcing period; their joint use allows one to identify four distinct forms of sensitivity to initial state that correspond to distinct types of system behavior. The model's response to periodic forcing turns out to be, in most cases, very sensitive to the initial state. The system is then forced by a synthetic aperiodic forcing [5]. The existence of a global PBA is rigorously demonstrated. We then assess the convergence of trajectories to this PBA by computing the probability density function (PDF) of trajectory localization in the model's phase space. A sensitivity analysis with respect to forcing amplitude shows that the global PBA experiences large modifications if the underlying autonomous system is dominated by small-amplitude limit cycles, while the changes are less dramatic in a regime characterized by large-amplitude relaxation oscillations. The dependence of the attracting sets on the choice of the ensemble of initial states is analyzed in detail. The extension to random dynamical systems is described and connected to the model's autonomous and periodically forced behavior. [1] Pierini, S., 2011. J. Phys. Oceanogr., 41, 1585

  2. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease.

    Science.gov (United States)

    Kinlock, Timothy W; Gordon, Michael S; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E

    2009-10-01

    This study examined the impact of prison-initiated methadone maintenance at 12 months postrelease. Males with pre-incarceration heroin dependence (N = 204) were randomly assigned to (a) Counseling Only: counseling in prison, with passive referral to treatment upon release; (b) Counseling + Transfer: counseling in prison with transfer to methadone maintenance treatment upon release; and (c) 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 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.

  3. [Stimulation of wound healing by tetrachlordecaoxide. Results of a randomized double-blind study].

    Science.gov (United States)

    Hinz, J; Hautzinger, H; Helling, J; Schirren, G; Sell, G; Stahl, K W; Kühne, F W

    1984-05-10

    In 38 patients with chronic therapeutically resistant wounds, which, in 25 cases, had been existing for more than one year, Tetrachlorodecaoxide ( TCDO ) in a water solution containing glycerin was analyzed for its capacity to induce wound healing and compared in this respect to the standard in moist wound treatment, physiological sodium chloride. The results of the clinical trial demonstrate that the TCDO solution is significantly superior to physiological saline in local wound treatment regarding the degree of wound smear reduction, the formation of wound granulation tissue, the stimulation of epithelisation on the wound borders and the shrinking of the wound surface. The differences in therapeutic efficiency are so large that, in spite of the relatively small patient samples (21 + 17) it was possible to verify the superiority of a method for wound treatment in a randomized double blind clinical trial.

  4. Partner-Assisted Emotional Disclosure for Patients with GI Cancer: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Porter, Laura S.; Keefe, Francis J.; Baucom, Donald H.; Hurwitz, Herbert; Moser, Barry; Patterson, Emily; Kim, Hong Jin

    2009-01-01

    Background For patients with cancer who are married or in an intimate relationship, their relationships with their partners play a critical role in their adaptation to their illness. However, cancer patients and their partners often have difficulty in talking with each other about their cancer-related concerns. Difficulties in communication may ultimately compromise both the patient-partner relationship and the patient's psychological adjustment. The present study tested the efficacy of a novel partner-assisted emotional disclosure intervention in a sample of patients with gastrointestinal (GI) cancer. Methods 130 patients with GI cancer and their partners were randomly assigned to receive four sessions of either partner-assisted emotional disclosure or a couples cancer education/support intervention. Patients and partners completed measures of relationship quality, intimacy with their partner, and psychological distress before randomization and at the end of the intervention sessions. Data were analyzed using multilevel modeling. Results Compared to an education/support condition, the partner-assisted emotional disclosure condition led to improvements in relationship quality and intimacy for couples in which the patient initially reported higher levels of holding back from discussing cancer-related concerns. Conclusions Partner-assisted emotional disclosure is a novel intervention that builds on both the private emotional disclosure and the cognitive-behavioral marital literature. The results of this study suggest that this intervention may be beneficial for couples in which the patient tends to hold back from discussing concerns. Future research on methods of enhancing the effects of partner-assisted emotional disclosure is warranted. PMID:19731357

  5. Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial.

    Science.gov (United States)

    Denny, Lynette; Kuhn, Louise; Hu, Chih-Chi; Tsai, Wei-Yann; Wright, Thomas C

    2010-10-20

    Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial. A total of 6637 unscreened South African women aged 35-65 years who were tested for the presence of high-risk human papillomavirus (HPV) DNA in cervical samples underwent visual inspection of the cervix using acetic acid staining and HIV serotesting. Of these, 6555 were randomly assigned to three study arms: 1) HPV-and-treat, in which all women with a positive HPV DNA test result underwent cryotherapy; 2) visual inspection-and-treat, in which all women with a positive visual inspection test result underwent cryotherapy; or 3) control, in which further evaluation or treatment was delayed for 6 months. All women underwent colposcopy with biopsy at 6 months. All women who were HPV DNA- or visual inspection-positive at enrollment, and a subset of all other women had extended follow-up to 36 months (n = 3639) with yearly colposcopy. The endpoint-cervical intraepithelial neoplasia grade 2 or worse (CIN2+)-was analyzed using actuarial life-table methods. All statistical tests were two-sided. After 36 months, there was a sustained statistically significant decrease in the cumulative detection of CIN2+ in the HPV-and-treat arm compared with the control arm (1.5% vs 5.6%, difference = 4.1%, 95% confidence interval [CI] = 2.8% to 5.3%, P cryotherapy.

  6. Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

    Science.gov (United States)

    Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

    2018-05-05

    The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

  7. 75 FR 55764 - Dynamic Random Access Memory Semiconductors From the Republic of Korea: Preliminary Results of...

    Science.gov (United States)

    2010-09-14

    ... Kuhbach, Director, Office 1, ``Sixth Countervailing Duty Administrative Review: Dynamic Random Access... ``Purchases at Prices that Constitute `More than Adequate Remuneration,' '' (``Uranium from France'') (citing...

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

    Science.gov (United States)

    Ruers, Theo; 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

    2017-09-01

    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. 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. 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. This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases. © The Author 2017. Published by Oxford University Press.

  9. Partner-assisted emotional disclosure for patients with gastrointestinal cancer: results from a randomized controlled trial.

    Science.gov (United States)

    Porter, Laura S; Keefe, Francis J; Baucom, Donald H; Hurwitz, Herbert; Moser, Barry; Patterson, Emily; Kim, Hong Jin

    2009-09-15

    For patients with cancer who are married or in an intimate relationship, their relationships with their partners play a critical role in their adaptation to illness. However, cancer patients and their partners often have difficulty in talking with each other about their cancer-related concerns. Difficulties in communication ultimately may compromise both the patient-partner relationship and the patient's psychological adjustment. The current study tested the efficacy of a novel partner-assisted emotional disclosure intervention in a sample of patients with gastrointestinal (GI) cancer. One hundred thirty patients with GI cancer and their partners were assigned randomly to receive 4 sessions of either partner-assisted emotional disclosure or a couples cancer education/support intervention. Patients and partners completed measures of relationship quality, intimacy with their partner, and psychological distress before randomization and at the end of the intervention sessions. Data were analyzed using multilevel modeling. Compared with an education/support condition, the partner-assisted emotional disclosure condition led to improvements in relationship quality and intimacy for couples in which the patient initially reported higher levels of holding back from discussing cancer-related concerns. Partner-assisted emotional disclosure is a novel intervention that builds on both the private emotional disclosure and the cognitive-behavioral marital literature. The results of this study suggested that this intervention may be beneficial for couples in which the patient tends to hold back from discussing concerns. The authors concluded that future research on methods of enhancing the effects of partner-assisted emotional disclosure is warranted. Copyright (c) 2009 American Cancer Society.

  10. Pion radiation for high grade astrocytoma: results of a randomized study

    International Nuclear Information System (INIS)

    Pickles, Tom; Goodman, George B.; Rheaume, Dorianne E.; Duncan, Graeme G.; Fryer, Chris J.; Bhimji, Shamim; Ludgate, Charles; Syndikus, Isabel; Graham, Peter; Dimitrov, Mario; Bowen, Julie

    1997-01-01

    Purpose: This study attempted to compare within a randomized study the outcome of pion radiation therapy vs. conventional photon irradiation for the treatment of high-grade astrocytomas. Methods and Materials: Eighty-four patients were randomized to pion therapy (33-34.5 Gyπ), or conventional photon irradiation (60 Gy). Entry criteria included astrocytoma (modified Kernohan high Grade 3 or Grade 4), age 18-70, Karnofsky performance status (KPS) ≥50, ability to start irradiation within 30 days of surgery, unifocal tumor, and treatment volume < 850 cc. The high-dose volume in both arms was computed tomography enhancement plus a 2-cm margin. The study was designed with the power to detect a twofold difference between arms. Results: Eighty-one eligible patients were equally balanced for all known prognostic variables. Pion patients started radiation 7 days earlier on average than photon patients, but other treatment-related variables did not differ. There were no significant differences for either early or late radiation toxicity between treatment arms. Actuarial survival analysis shows no differences in terms of time to local recurrence or overall survival where median survival was 10 months in both arms (p = 0.22). The physician-assessed KPS and patient-assessed quality of life (QOL) measurements were generally maintained within 10 percentage points until shortly before tumor recurrence. There was no apparent difference in the serial KPS or QOL scores between treatment arms. Conclusion: In contrast to high linear energy transfer (LET) therapy for central nervous system tumors, such as neutron or neon therapy, the safety of pion therapy, which is of intermediate LET, has been reaffirmed. However, this study has demonstrated no therapeutic gain for pion therapy of glioblastoma

  11. Tamibarotene as maintenance therapy for acute promyelocytic leukemia: results from a randomized controlled trial.

    Science.gov (United States)

    Shinagawa, Katsuji; Yanada, Masamitsu; Sakura, Toru; Ueda, Yasunori; Sawa, Masashi; Miyatake, Junichi; Dobashi, Nobuaki; Kojima, Minoru; Hatta, Yoshihiro; Emi, Nobuhiko; Tamaki, Shigehisa; Gomyo, Hiroshi; Yamazaki, Etsuko; Fujimaki, Katsumichi; Asou, Norio; Matsuo, Keitaro; Ohtake, Shigeki; Miyazaki, Yasushi; Ohnishi, Kazunori; Kobayashi, Yukio; Naoe, Tomoki

    2014-11-20

    The introduction of all-trans-retinoic acid (ATRA) has significantly improved outcomes for acute promyelocytic leukemia (APL), although a subset of patients still suffer relapse. The purpose of this study was to evaluate the role of maintenance therapy with the synthetic retinoid tamibarotene in APL. Patients with newly diagnosed APL in molecular remission at the end of consolidation therapy were randomly assigned to receive ATRA or tamibarotene, both orally, for 14 days every 3 months for up to 2 years. A total of 347 patients were enrolled. Of the 344 eligible patients, 319 (93%) achieved complete remission. After completing three courses of consolidation therapy, 269 patients underwent maintenance random assignment. The relapse-free survival (RFS) rate at 4 years was 84% for the ATRA arm and 91% for the tamibarotene arm (hazard ratio [HR], 0.54; 95% CI, 0.26 to 1.13). When the analysis was restricted to 52 high-risk patients with an initial WBC count ≥ 10.0 × 10(9)/L, the intergroup difference was statistically significant, with 4-year RFS rates of 58% for the ATRA arm and 87% for the tamibarotene arm (HR, 0.26; 95% CI, 0.07 to 0.95). For patients with non-high-risk disease, the HR was 0.82 (95% CI, 0.32 to 2.01). The test for interaction between treatment effects and these subgroups resulted in P = .075. Both treatments were generally well tolerated. In this trial, no difference was detected between ATRA and tamibarotene for maintenance therapy. In an exploratory analysis, there was a suggestion of improved efficacy of tamibarotene in high-risk patients, but this requires further study. © 2014 by American Society of Clinical Oncology.

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

    Directory of Open Access Journals (Sweden)

    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.

  13. Prosthetic above-knee femoropopliteal bypass grafting: five-year results of a randomized trial.

    Science.gov (United States)

    Green, R M; Abbott, W M; Matsumoto, T; Wheeler, J R; Miller, N; Veith, F J; Money, S; Garrett, H E

    2000-03-01

    This trial was designed to identify factors affecting patency rates of primary prosthetic above-knee femoropopliteal bypass grafts at 5 years. A multi-institutional, prospective trial randomized 240 patients to compare patency rates of Gore-tex and Hemashield above-knee femoropopliteal bypass grafts at 5 years. Univariate comparisons of patency between levels of each prognostic variable were made with the Kaplan-Meier method. Variables that had a univariate P value less than.25 or those known to be important were submitted to a Cox regression analysis. The patient survival rate at 5 years was 59.4%. There were no differences in primary or secondary patency rates at 5 years between the two graft materials (primary, 45% vs 43% and secondary, 68% vs 68%). The risk for graft occlusion was significantly increased for patients younger than 65 years (2.1; P =.001) and for grafts with a diameter less than 7 mm (1.65; P =.0219). Variables with no apparent independent effect on patency rates were smoking status, runoff, diabetes mellitus, sex, presenting symptoms, and postoperative treatment with aspirin or Coumadin. Noninvasive test results were not predictive of subsequent graft function. Although the type of prosthetic used for above-knee femoropopliteal bypass grafts does not affect 5-year patency rates, age and graft size do influence results. These factors should be considered before a prosthetic bypass grafting procedure. Furthermore, these data should serve as a contemporary standard, with which evolving and conventional procedures can be compared.

  14. 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.

  15. Improving predictions for collider observables by consistently combining fixed order calculations with resummed results in perturbation theory

    International Nuclear Information System (INIS)

    Schoenherr, Marek

    2011-01-01

    With the constantly increasing precision of experimental data acquired at the current collider experiments Tevatron and LHC the theoretical uncertainty on the prediction of multiparticle final states has to decrease accordingly in order to have meaningful tests of the underlying theories such as the Standard Model. A pure leading order calculation, defined in the perturbative expansion of said theory in the interaction constant, represents the classical limit to such a quantum field theory and was already found to be insufficient at past collider experiments, e.g. LEP or HERA. Such a leading order calculation can be systematically improved in various limits. If the typical scales of a process are large and the respective coupling constants are small, the inclusion of fixed-order higher-order corrections then yields quickly converging predictions with much reduced uncertainties. In certain regions of the phase space, still well within the perturbative regime of the underlying theory, a clear hierarchy of the inherent scales, however, leads to large logarithms occurring at every order in perturbation theory. In many cases these logarithms are universal and can be resummed to all orders leading to precise predictions in these limits. Multiparticle final states now exhibit both small and large scales, necessitating a description using both resummed and fixed-order results. This thesis presents the consistent combination of two such resummation schemes with fixed-order results. The main objective therefor is to identify and properly treat terms that are present in both formulations in a process and observable independent manner. In the first part the resummation scheme introduced by Yennie, Frautschi and Suura (YFS), resumming large logarithms associated with the emission of soft photons in massive QED, is combined with fixed-order next-to-leading matrix elements. The implementation of a universal algorithm is detailed and results are studied for various precision

  16. Existence and controllability results for damped second order impulsive functional differential systems with state-dependent delay

    Directory of Open Access Journals (Sweden)

    M. Mallika Arjunan

    2014-01-01

    Full Text Available In this paper, we investigate the existence and controllability of mild solutions for a damped second order impulsive functional differential equation with state-dependent delay in Banach spaces. The results are obtained by using Sadovskii's fixed point theorem combined with the theories of a strongly continuous cosine family of bounded linear operators. Finally, an example is provided to illustrate the main results.

  17. 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.

  18. Values-based action in fibromyalgia: results from a randomized pilot of acceptance and commitment therapy

    Directory of Open Access Journals (Sweden)

    Jennifer L. Steiner

    2013-09-01

    Full Text Available Fibromyalgia Syndrome (FMS is a chronic pain condition characterized by pain, fatigue, and nonrestorative sleep. The disruptive symptoms of FMS are associated with reductions in quality of life related to family, intimate relationships, and work. The present study was part of a randomized pilot study of an 8-week Acceptance and Commitment Therapy (ACT intervention compared to education in a sample of 28 women with FMS. The Chronic Pain Values Inventory was administered at baseline, postintervention, and 12 week follow-up. Both groups showed significant improvements in family success, which were maintained at follow-up. Groups showed a differential pattern of success in work. The ACT group demonstrated significant, maintained improvements in success in intimate relationships, while the education group reported no changes over time. Findings suggest that both interventions may lead to improvements in valued living; however different interventions may be best suited for certain valued domains. The results of this study indicate that FMS patients are able to improve their success in family and intimate relationships and losses in these areas are not necessarily permanent.

  19. 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

  20. Land surface temperature downscaling using random forest regression: primary result and sensitivity analysis

    Science.gov (United States)

    Pan, Xin; Cao, Chen; Yang, Yingbao; Li, Xiaolong; Shan, Liangliang; Zhu, Xi

    2018-04-01

    The land surface temperature (LST) derived from thermal infrared satellite images is a meaningful variable in many remote sensing applications. However, at present, the spatial resolution of the satellite thermal infrared remote sensing sensor is coarser, which cannot meet the needs. In this study, LST image was downscaled by a random forest model between LST and multiple predictors in an arid region with an oasis-desert ecotone. The proposed downscaling approach was evaluated using LST derived from the MODIS LST product of Zhangye City in Heihe Basin. The primary result of LST downscaling has been shown that the distribution of downscaled LST matched with that of the ecosystem of oasis and desert. By the way of sensitivity analysis, the most sensitive factors to LST downscaling were modified normalized difference water index (MNDWI)/normalized multi-band drought index (NMDI), soil adjusted vegetation index (SAVI)/ shortwave infrared reflectance (SWIR)/normalized difference vegetation index (NDVI), normalized difference building index (NDBI)/SAVI and SWIR/NDBI/MNDWI/NDWI for the region of water, vegetation, building and desert, with LST variation (at most) of 0.20/-0.22 K, 0.92/0.62/0.46 K, 0.28/-0.29 K and 3.87/-1.53/-0.64/-0.25 K in the situation of +/-0.02 predictor perturbances, respectively.

  1. EXERCISE IMPROVES SEXUAL FUNCTION IN WOMEN TAKING ANTIDEPRESSANTS: RESULTS FROM A RANDOMIZED CROSSOVER TRIAL

    Science.gov (United States)

    Lorenz, Tierney Ahrold; Meston, Cindy May

    2014-01-01

    Background In laboratory studies, exercise immediately before sexual stimuli improved sexual arousal of women taking antidepressants [1]. We evaluated if exercise improves sexual desire, orgasm, and global sexual functioning in women experiencing antidepressant-induced sexual side effects. Methods Fifty-two women who were reporting antidepressant sexual side effects were followed for 3 weeks of sexual activity only. They were randomized to complete either three weeks of exercise immediately before sexual activity (3×/week) or 3 weeks of exercise separate from sexual activity (3×/week). At the end of the first exercise arm, participants crossed to the other. We measured sexual functioning, sexual satisfaction, depression, and physical health. Results Exercise immediately prior to sexual activity significantly improved sexual desire and, for women with sexual dysfunction at baseline, global sexual function. Scheduling regular sexual activity significantly improved orgasm function; exercise did not increase this benefit. Neither regular sexual activity nor exercise significantly changed sexual satisfaction. Conclusions Scheduling regular sexual activity and exercise may be an effective tool for the behavioral management of sexual side effects of antidepressants. PMID:24754044

  2. Results of a Community-Based Randomized Trial to Increase Colorectal Cancer Screening Among Filipino Americans

    Science.gov (United States)

    Bastani, Roshan; Danao, Leda L.; Antonio, Cynthia; Garcia, Gabriel M.; Crespi, Catherine M.

    2010-01-01

    Objectives. We conducted 1 of the first community-based trials to develop a multicomponent intervention that would increase colorectal cancer screening among an Asian American population. Methods. Filipino Americans (n = 548) nonadherent to colorectal cancer (CRC) screening guidelines were randomized into an intervention group that received an education session on CRC screening and free fecal occult blood test (FOBT) kits; a second intervention group that received an education session but no free FOBT kits; and a control group that received an education session on the health benefits of physical activity. Results. Self-reported CRC screening rates during the 6-month follow-up period were 30%, 25%, and 9% for participants assigned to intervention with FOBT kit, intervention without the kit, and control group, respectively. Participants in either of the 2 intervention groups were significantly more likely to report screening at follow-up than were participants in the control group. Conclusions. A multicomponent intervention that includes an educational group session in a community setting can significantly increase CRC screening among Filipino Americans, even when no free FOBT kits are distributed. PMID:20864724

  3. Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials.

    Science.gov (United States)

    Rozental, Alexander; Shafran, Roz; Wade, Tracey D; Kothari, Radha; Egan, Sarah J; Ekberg, Linda; Wiss, Maria; Carlbring, Per; Andersson, Gerhard

    2018-04-26

    Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). The results are promising for the use of

  4. Prosthodontic maintenance of overdentures on zirconia implants: 1-year results of a randomized controlled trial.

    Science.gov (United States)

    Osman, Reham B; Ma, Sunyoung

    2014-01-01

    The purpose of this study was to determine the prosthodontic outcomes of one-piece zirconia implants and their attachment systems in edentulous participants with maxillary and mandibular overdentures after 1 year of a randomized controlled trial. Random allocation of 24 edentulous participants (age range: 45 to 86 years) into titanium (control) or zirconia (test) groups using onepiece implants and a planned unsplinted prosthodontic design was performed. Four maxillary implants (one midpalatal; three anterior crestal) and three mandibular implants (one midsymphyseal; two bilateral distal) were conventionally loaded with the overdentures. Similar attachment systems were used throughout: ball abutment-type patrices (diameter: 2.25 to 3.1 mm as part of the one-piece implants) and custommade plastic matrices (with or without metal housings depending on the patrix size). Prosthodontic outcomes were documented during the first year of the clinical trial. Following three deaths and two dropouts, there were 19 participants who were available at the 1-year recall. Of these participants, 3 had early maxillary implant failure and had to be converted to conventional maxillary complete dentures opposing mandibular implant overdentures. There were 79 maintenance events, 34 in the titanium (control) group and 45 in the zirconia (test) group. Patrix loss occurred as a result of three zirconia implant fractures (one mandibular and two crestal maxillary implants). Maintenance events were principally the replacement of matrices and overdenture fracture. Although relines and replacement overdentures also occurred, overall there were no significant differences in prosthodontic maintenance between the control and test groups. A six-field prosthodontic-success analysis table showed no statistically significant difference between the two groups; however, 50% of participants in each group were allocated to the retreatment (repair) field, which produced a low prosthodontic success rate

  5. 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.

  6. Much of the variation in breast pathology quality assurance data in the UK can be explained by the random order in which cases arrive at individual centres, but some true outliers do exist.

    Science.gov (United States)

    Cross, Simon S; Stephenson, Timothy J; Harrison, Robert F

    2011-10-01

    To investigate the role of random temporal order of patient arrival at screening centres in the variability seen in rates of node positivity and breast cancer grade between centres in the NHS Breast Screening Programme. Computer simulations were performed of the variation in node positivity and breast cancer grade with the random temporal arrival of patients at screening centres based on national UK audit data. Cumulative mean graphs of these data were plotted. Confidence intervals for the parameters were generated, using the binomial distribution. UK audit data were plotted on these control limit graphs. The results showed that much of the variability in the audit data could be accounted for by the effects of random order of arrival of cases at the screening centres. Confidence intervals of 99.7% identified true outliers in the data. Much of the variation in breast pathology quality assurance data in the UK can be explained by the random order in which cases arrive at individual centres. Control charts with confidence intervals of 99.7% plotted against the number of reported cases are useful tools for identification of true outliers. 2011 Blackwell Publishing Limited.

  7. 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.

  8. 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

  9. 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....

  10. 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.

  11. 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)...

  12. RIght VErsus Left Apical transvenous pacing for bradycardia: Results of the RIVELA randomized study

    Directory of Open Access Journals (Sweden)

    Haran Burri

    2017-11-01

    Full Text Available Aims: To compare cardiac function when pacing from the right or left ventricular apex in patients with preserved left ventricular systolic function, at 1-year follow-up. Methods: Prospective, multicentre centre randomizing conventional right ventricular apical (RVA versus left ventricular apical (LVA pacing using a coronary sinus lead in patients requiring ventricular pacing for bradycardia. Follow-up was performed using 3D-echocardiography at 6 and 12 months. Results: A total of 36 patients (age 75.4 ± 8.7 years, 21 males were enrolled (17 patients in the RVA group and 19 patients in the LVA group. A right ventricular lead was implanted in 8 patients in the LVA group, mainly because of high capture thresholds. There were no differences in the primary endpoint of LVEF at 1 year (60.4 ± 7.1% vs 62.1 ± 7.2% for the RVA and LVA groups respectively, P = 0.26 nor in any of the secondary endpoints (left ventricular dimensions, left ventricular diastolic function, right ventricular systolic function and tricuspid/mitral insufficiency. LVEF did not change significantly over follow-up in either group. Capture thresholds were significantly higher in the LVA group, and two patients had unexpected loss of capture of the coronary sinus lead during follow-up. Conclusions: Left univentricular pacing seems to be comparable to conventional RVA pacing in terms of ventricular function at up to 1 year follow-up, and is an option to consider in selected patients (e.g. those with a tricuspid valve prosthesis. Keywords: Ventricular pacing, Right ventricle, Left ventricle, Coronary sinus, Ventricular function

  13. 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.

  14. A Monotonicity Result for the Range of a Perturbed Random Walk

    OpenAIRE

    Chen, Lung-Chi; Sun, Rongfeng

    2012-01-01

    We consider a discrete time simple symmetric random walk on Z^d, d>=1, where the path of the walk is perturbed by inserting deterministic jumps. We show that for any time n and any deterministic jumps that we insert, the expected number of sites visited by the perturbed random walk up to time n is always larger than or equal to that for the unperturbed walk. This intriguing problem arises from the study of a particle among a Poisson system of moving traps with sub-diffusive trap motion. In pa...

  15. 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 second-order nonlinear water kinematics is developed based on a Gram Charlier series expansion using the first four stochasticmoments of thewave process. Thewave surface velocities and accelerations are expressed using a Taylor series expansion about themean sea level, which satisfies to the second...

  16. Motivational Interviewing for Workers with Disabling Musculoskeletal Disorders: Results of a Cluster Randomized Control Trial.

    Science.gov (United States)

    Park, Joanne; Esmail, Shaniff; Rayani, Fahreen; Norris, Colleen M; Gross, Douglas P

    2018-06-01

    Purpose Although functional restoration programs appear effective in assisting injured workers to return-to-work (RTW) after a work related musculoskeletal (MSK) disorder, the addition of Motivational Interviewing (MI) to these programs may result in higher RTW. Methods We conducted a cluster randomized controlled trial with claimants attending an occupational rehabilitation facility from November 17, 2014 to June 30, 2015. Six clinicians provided MI in addition to the standard functional restoration program and formed an intervention group. Six clinicians continued to provide the standard functional restoration program based on graded activity, therapeutic exercise, and workplace accommodations. Independent t tests and chi square analysis were used to compare groups. Multivariable logistic regression was used to obtain the odds ratio of claimants' confirmed RTW status at time of program discharge. Results 728 workers' compensation claimants with MSK disorders were entered into 1 of 12 therapist clusters (MI group = 367, control group = 361). Claimants were predominantly employed (72.7%), males (63.2%), with moderate levels of pain and disability (mean pain VAS = 5.0/10 and mean Pain Disability Index = 48/70). Claimants were stratified based on job attachment status. The proportion of successful RTW at program discharge was 12.1% higher for unemployed workers in the intervention group (intervention group 21.6 vs. 9.5% in control, p = 0.03) and 3.0% higher for job attached workers compared to the control group (intervention group 97.1 vs. 94.1% in control, p = 0.10). Adherence to MI was mixed, but RTW was significantly higher among MI-adherent clinicians. The odds ratio for unemployed claimants was 2.64 (0.69-10.14) and 2.50 (0.68-9.14) for employed claimants after adjusting for age, sex, pain intensity, perceived disability, and therapist cluster. Conclusion MI in addition to routine functional restoration is more effective than routine

  17. 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

  18. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Meredith, Ruby; Salter, Merle; Kim, Robert; Spencer, Sharon; Weppelmann, Burkhard; Rodu, Brad; Smith, Judy; Lee, Jeanette

    1997-01-01

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of antacid, diphenhydramine, and viscous lidocaine alone. Methods and Materials: A double-blind study was conducted in which nurses and pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of antacid, diphenhydramine, and viscous lidocaine vs. the same solution plus sucralfate. Eligible patients were those receiving >40 Gy at 1.8 Gy/fraction, one fraction/day, five fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. The observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective nonstudy agents was not allowed. The ability to eat various consistency of foods was graded 0-5, with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + SD for food and soreness scores, paired t-test, and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 111 patients were entered. Because some withdrew and others did not require medication, results are presented for evaluable patients in each category. Mild adverse effects from the medication solution (usually mouth discomfort) were reported by <10% of patients in each treatment group among 106 patients evaluable for toxicity. There was a comparable incidence of mild-moderate mucositis for the two treatment groups. Severe mucositis was noted in two patients of the standard medication group and none among patients receiving sucralfate. The groups were comparable

  19. 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

  20. 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,

  1. Survival after relapse in patients with 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

    Objective. The aim of this study was to determine the rates of local control and survival after relapse in patients with stage I endometrial cancer treated in the multicenter randomized PORTEC trial. Methods, The PORTEC trial included 715 patients with stage I endometrial cancer, either grade I or 2

  2. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  3. Assessing the Promise of Standards-Based Performance Evaluation for Principals: Results from a Randomized Trial

    Science.gov (United States)

    Kimball, Steven Miller; Milanowski, Anthony; McKinney, Sarah A.

    2009-01-01

    Principals (N = 76) in a large western U.S. school district were randomly assigned to be evaluated using either a new standards-based system or to continue with the old system. It was hypothesized that principals evaluated with the new system would report clearer performance expectations, better feedback, greater fairness and system satisfaction,…

  4. The effects of a digital formative assessment tool on spelling achievement : Results of a randomized experiment

    NARCIS (Netherlands)

    Faber, Janke M.; Visscher, Adrie J.

    2018-01-01

    In this study, a randomized experimental design was used to examine the effects of a digital formative assessment tool on spelling achievement of third grade students (eight-to nine-years-olds). The sample consisted of 30 experimental schools (n = 619) and 39 control schools (n = 986). Experimental

  5. Averaging Principle for the Higher Order Nonlinear Schrödinger Equation with a Random Fast Oscillation

    Science.gov (United States)

    Gao, Peng

    2018-04-01

    This work concerns the problem associated with averaging principle for a higher order nonlinear Schrödinger equation perturbed by a oscillating term arising as the solution of a stochastic reaction-diffusion equation evolving with respect to the fast time. This model can be translated into a multiscale stochastic partial differential equations. Stochastic averaging principle is a powerful tool for studying qualitative analysis of stochastic dynamical systems with different time-scales. To be more precise, under suitable conditions, we prove that there is a limit process in which the fast varying process is averaged out and the limit process which takes the form of the higher order nonlinear Schrödinger equation is an average with respect to the stationary measure of the fast varying process. Finally, by using the Khasminskii technique we can obtain the rate of strong convergence for the slow component towards the solution of the averaged equation, and as a consequence, the system can be reduced to a single higher order nonlinear Schrödinger equation with a modified coefficient.

  6. Averaging Principle for the Higher Order Nonlinear Schrödinger Equation with a Random Fast Oscillation

    Science.gov (United States)

    Gao, Peng

    2018-06-01

    This work concerns the problem associated with averaging principle for a higher order nonlinear Schrödinger equation perturbed by a oscillating term arising as the solution of a stochastic reaction-diffusion equation evolving with respect to the fast time. This model can be translated into a multiscale stochastic partial differential equations. Stochastic averaging principle is a powerful tool for studying qualitative analysis of stochastic dynamical systems with different time-scales. To be more precise, under suitable conditions, we prove that there is a limit process in which the fast varying process is averaged out and the limit process which takes the form of the higher order nonlinear Schrödinger equation is an average with respect to the stationary measure of the fast varying process. Finally, by using the Khasminskii technique we can obtain the rate of strong convergence for the slow component towards the solution of the averaged equation, and as a consequence, the system can be reduced to a single higher order nonlinear Schrödinger equation with a modified coefficient.

  7. The Effects of the Bali Yoga Program for Breast Cancer Patients on Chemotherapy-Induced Nausea and Vomiting: Results of a Partially Randomized and Blinded Controlled Trial.

    Science.gov (United States)

    Anestin, Annélie S; Dupuis, Gilles; Lanctôt, Dominique; Bali, Madan

    2017-10-01

    Complementary and alternative medicine has been shown to be beneficial in reducing chemotherapy-induced nausea and vomiting. However, conclusive results are lacking in order to confirm its usefulness. The purpose of this study was to determine whether a standardized yoga intervention could reduce these adverse symptoms. This was a partially randomized and blinded controlled trial comparing a standardized yoga intervention with standard care. Eligible patients were adults diagnosed with stages I to III breast cancer receiving chemotherapy. Patients randomized to the experimental group participated in an 8-week yoga program. There was no significant difference between the experimental and control groups on chemotherapy-induced nausea and vomiting after 8 weeks. Results suggest the yoga program is not beneficial in managing these adverse symptoms. However, considering preliminary evidence suggesting yoga's beneficial impact in cancer symptom management, methodological limitations should be explored and additional studies should be conducted.

  8. Steps to Health employee weight management randomized control trial: short-term follow-up results.

    Science.gov (United States)

    Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

    2015-02-01

    To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

  9. 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.

  10. Interferon versus methotrexate in intermediate uveitis with macular edema: results of a randomized controlled clinical trial.

    Science.gov (United States)

    Mackensen, Friederike; Jakob, Eva; Springer, Christina; Dobner, Bianca C; Wiehler, Ute; Weimer, Petra; Rohrschneider, Klaus; Fiehn, Christoph; Max, Regina; Storch-Hagenlocher, Brigitte; Becker, Matthias D

    2013-09-01

    To compare interferon (IFN) beta with methotrexate (MTX) in the treatment of intermediate uveitis with macular edema. Monocentric, prospective, randomized, controlled clinical trial. Specialized uveitis center at the University of Heidelberg. PATIENT OR STUDY POPULATION: Patients with either primary intermediate uveitis or uveitis associated with multiple sclerosis. MAIN INCLUSION CRITERIA: Visual acuity of 20/30 or worse (0.2 logarithm of the minimal angle of resolution) and macular edema of more than 250 μm (central 1-mm in optical coherence tomography; Stratus). Randomization into either IFN beta 44 μg subcutaneously 3 times weekly or 20 mg MTX subcutaneously once weekly. At 3 months, the primary outcome parameter of mean change in visual acuity was evaluated and efficacy was determined. Secondary parameters were macular edema by optical coherence tomography, inflammatory activity, and retinal sensitivity by microperimetry (MP-1; Nidek). In case of treatment failure, switching to the other treatment arm was possible. Nineteen patients were included. Ten were randomized to MTX, and 9 were randomized to IFN beta. At 3 months, visual acuity improved a mean 0.31 logarithm of the minimal angle of resolution (range, -0.02 to -0.96, 15.6 letters on the Early Treatment Diabetic Retinopathy Study chart) in the IFN beta group versus a mean 0.09 logarithm of the minimal angle of resolution (range, 0.12 to -0.38, 4.7 letters) in the MTX arm (P = .0435, Mann-Whitney U test). Macular thickness decreased by a mean of 206 μm (range, -41 to -416 μm) in the IFN arm, but increased by 47 μm (range, 108 to -28 μm) in the MTX group (P treatment of macular edema in the setting of intermediate uveitis. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Computer-Based Cognitive Training for Mild Cognitive Impairment: Results from a Pilot Randomized, Controlled Trial

    OpenAIRE

    Barnes, Deborah E.; Yaffe, Kristine; Belfor, Nataliya; Jagust, William J.; DeCarli, Charles; Reed, Bruce R.; Kramer, Joel H.

    2009-01-01

    We performed a pilot randomized, controlled trial of intensive, computer-based cognitive training in 47 subjects with mild cognitive impairment (MCI). The intervention group performed exercises specifically designed to improve auditory processing speed and accuracy for 100 minutes/day, 5 days/week for 6 weeks; the control group performed more passive computer activities (reading, listening, visuospatial game) for similar amounts of time. Subjects had a mean age of 74 years and 60% were men; 7...

  12. Results of a prospective randomized controlled trial of early ambulation for patients with lower extremity autografts.

    Science.gov (United States)

    Lorello, David John; Peck, Michael; Albrecht, Marlene; Richey, Karen J; Pressman, Melissa A

    2014-01-01

    It is common practice to keep those patients with lower extremity autografts immobile until post-operative day (POD) 5. There is however inherent risks associated with even short periods of immobility. As of now there are no randomized controlled trials looking at early ambulation of patients with lower extremity autografts in the burn community.The objective of this study was to show that patients who begin ambulation within 24 hours of lower extremity autografting will have no increased risk of graft failure than those patients who remain immobile until POD 5. Thirty-one subjects who received autografts to the lower extremity were randomized after surgery into either the early ambulation group (EAG;17 subjects) or the standard treatment group (STG;14 subjects). Those subjects randomized to the EAG began ambulating with physical therapy on POD 1. Subjects in the STG maintained bed rest until POD 5. There was no difference in the number of patients with graft loss in either the EAG or STG on POD 5, and during any of the follow-up visits. No subjects required regrafting. There was a significant difference in the mean minutes of ambulation, with the EAG ambulating longer than the STG (EAG 23.4 minutes [SD 12.03], STG 14.1 [SD 9.00], P=.0235) on POD 5. Burn patients with lower extremity autografts can safely ambulate on POD 1 without fear of graft failure compared with those patients that remain on bed rest for 5 days.

  13. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Meredith, R.; Salter, M.; Kim, R.; Spencer, S.; Weppelmann, B.; Rodu, B.; Smith, J.; Lee, J.

    1995-01-01

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of Maalox, diphenhyrdramine and viscous lidocaine alone. Methods: A double-blind study was conducted in which nurses/pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of Maalox, diphenhydramime and viscous lidocaine verses the same solution plus sucralfate. Eligible patients were those receiving > 40 Gy at 1.8 Gy/fraction, 1 fraction/day, 5 fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. Baseline information regarding use of tobacco, alcohol, and food intake was obtained prior to symptomatic mucositis. This was compared with similar information obtained weekly once symptoms occurred. The patients subjected evaluation of throat soreness and relief with medication was elicited as well as physician observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective non-study agents was not allowed. Subjective soreness was graded on a scale of 0-20 with 0 indicating no soreness and 20 designating severe soreness that compromised ability to swallow secretions. The ability to eat various consistency of foods was graded 0-5 with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + S.D. for food and soreness scores, paired t-test and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 110 patients were entered. Since some withdrew and others did not require medication, results are presented for

  14. "Big Bang" as a result result of the curvature-driven first-order phase transition in the early cold Universe

    Science.gov (United States)

    Pashitskii, E. A.; Pentegov, V. I.

    We suggest that the "Big Bang" may be a result of the first-order phase transition driven by changing scalar curvature of the 4D space-time in the expanding cold Universe, filled with nonlinear scalar field φ and neutral matter with equation of state p = vɛ (where p and ɛ are pressure and energy density of matter). We consider a Lagrangian for scalar field in curved space-time with nonlinearity φ, which along with the quadratic term -ΣR|φ|2 (where Σ is interaction constant and R is scalar curvature) contains a term ΣR(φ +φ+) linear in φ. Due to this term the condition for the extrema of the potential energy of the scalar field is given by a cubic equation. Provided v > 1/3 the scalar curvature R = [κ(3v-1)ɛ - 4Γ (where κ and Γ are Einstein's gravitational and cosmological constants) decreases along with decreasing " in the process of the Universe's expansion, and at some critical value Rc < 0 a first-order phase transition occurs, driven by an "external field" parameter proportional to R. Given certain conditions the critical radius of the early Universe at the point of the first-order phase transition may reach arbitrary large values, so this scenario of unrestricted "inflation" of the Universe may be called "hyperinflation". Beyond the point of phase transition the system is rolling down into the potential minimum releasing the potential energy of scalar field with subsequent powerful heating of the Universe playing the role of "Big Bang".

  15. 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

  16. Random Fields

    Science.gov (United States)

    Vanmarcke, Erik

    1983-03-01

    Random variation over space and time is one of the few attributes that might safely be predicted as characterizing almost any given complex system. Random fields or "distributed disorder systems" confront astronomers, physicists, geologists, meteorologists, biologists, and other natural scientists. They appear in the artifacts developed by electrical, mechanical, civil, and other engineers. They even underlie the processes of social and economic change. The purpose of this book is to bring together existing and new methodologies of random field theory and indicate how they can be applied to these diverse areas where a "deterministic treatment is inefficient and conventional statistics insufficient." Many new results and methods are included. After outlining the extent and characteristics of the random field approach, the book reviews the classical theory of multidimensional random processes and introduces basic probability concepts and methods in the random field context. It next gives a concise amount of the second-order analysis of homogeneous random fields, in both the space-time domain and the wave number-frequency domain. This is followed by a chapter on spectral moments and related measures of disorder and on level excursions and extremes of Gaussian and related random fields. After developing a new framework of analysis based on local averages of one-, two-, and n-dimensional processes, the book concludes with a chapter discussing ramifications in the important areas of estimation, prediction, and control. The mathematical prerequisite has been held to basic college-level calculus.

  17. 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

  18. 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.

  19. Sample size adjustments for varying cluster sizes in cluster randomized trials with binary outcomes analyzed with second-order PQL mixed logistic regression.

    Science.gov (United States)

    Candel, Math J J M; Van Breukelen, Gerard J P

    2010-06-30

    Adjustments of sample size formulas are given for varying cluster sizes in cluster randomized trials with a binary outcome when testing the treatment effect with mixed effects logistic regression using second-order penalized quasi-likelihood estimation (PQL). Starting from first-order marginal quasi-likelihood (MQL) estimation of the treatment effect, the asymptotic relative efficiency of unequal versus equal cluster sizes is derived. A Monte Carlo simulation study shows this asymptotic relative efficiency to be rather accurate for realistic sample sizes, when employing second-order PQL. An approximate, simpler formula is presented to estimate the efficiency loss due to varying cluster sizes when planning a trial. In many cases sampling 14 per cent more clusters is sufficient to repair the efficiency loss due to varying cluster sizes. Since current closed-form formulas for sample size calculation are based on first-order MQL, planning a trial also requires a conversion factor to obtain the variance of the second-order PQL estimator. In a second Monte Carlo study, this conversion factor turned out to be 1.25 at most. (c) 2010 John Wiley & Sons, Ltd.

  20. Tangential breast irradiation with or without internal mammary chain irradiation: results of a randomized trial

    International Nuclear Information System (INIS)

    Kaija, Holli; Maunu, Pitkaenen

    1995-01-01

    A prospective randomized study was made of 270 patients with unilateral stage I or II invasive breast cancer treated by segmental resection, axillary dissection and radiation at the University Hospital of Tampere, Finland, between 1989 and 1991. The aim of the study was to determine whether there is any advantage or disadvantage if the internal mammary chains (IMC) are included in the radiation target volume. The medial and lateral two-field technique was used and the target volumes were determined randomly either to include the internal mammary chain (IMC-RT) or not (no-IMC-RT). The prevalence of radiation pneumonitis was 16% and there was no significant difference between the IMC- and no-IMC-groups (18 vs. 14%). Skin reactions were equal in both groups. Lung fibrosis was more common in the IMC-RT group. In conclusion: radiation of internal mammary chain after conservative surgery does not lead to an increase in clinically important skin or pulmonary complications. Whether it prevents recurrences or new primaries of the opposite breast is too early to say because of the short follow-up time

  1. Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial.

    Science.gov (United States)

    Marissen, Marlies A E; Franken, Ingmar H A; Blanken, Peter; van den Brink, Wim; Hendriks, Vincent M

    2007-01-01

    Persistent cue reactivity to drug-related stimuli is a well-known phenomenon among abstinent drug users and has been found to be a predictor of relapse. Cue exposure therapy (CET) aims to reduce this cue reactivity by exposing abstinent drug users to conditioned drug-related stimuli while preventing their habitual response, i.e. drug use. 127 abstinent heroin-dependent Dutch inpatients were randomized to CET (n = 65; 55 completers) and placebo psychotherapy treatment (PPT) (n = 62; 59 completers). It was examined whether CET would lead to a decrease in drug-related cue reactivity (using mixed-design ANOVA) and subsequently to lower dropout and relapse rates (using logistic regression) compared to PPT. Both groups responded with a similar decrease in self-reported cue reactivity (craving, mood). The CET group did show a significant decrease in physiological reactivity (skin conductance) compared to PPT. However, dropout and relapse rates were, contrary to our expectations, significantly higher in the CET group. This is the first randomized controlled trial showing that CET, compared to a non-specific psychotherapy, might increase dropout and relapse rates among abstinent heroin-dependent clients in a drug-free setting. Caution is warranted when applying CET in this specific context. Copyright 2007 S. Karger AG, Basel.

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

    Science.gov (United States)

    Akhtari-Zavare, Mehrnoosh; Juni, Muhamad Hanafiah; Said, Salmiah Md; Ismail, Irmi Zarina; Latiff, Latiffah A; Ataollahi Eshkoor, Sima

    2016-08-08

    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. 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. Mean scores of knowledge on breast cancer (pMalaysia. The ANZCTR clinical trial registry ( ACTRN12616000831482 ), retrospectively registered on Jun 23, 2016 in ANZCTR.org.au.

  3. Supply and Demand for Improved Sanitation: Results from Randomized Pricing Experiments in Rural Tanzania.

    Science.gov (United States)

    Peletz, Rachel; Cock-Esteb, Alicea; Ysenburg, Dorothea; Haji, Salim; Khush, Ranjiv; Dupas, Pascaline

    2017-06-20

    Improving access to sanitation is a global public health priority. Sufficient consumer demand is required for sanitation coverage to expand through private provision. To measure consumer demand for hygienic latrine platform products in rural Tanzania, we conducted a randomized, voucher-based real-money sales trial with 1638 households with unimproved latrines. We also evaluated multiple supply chain options to determine the costs of supplying latrine platform products to rural households. For concrete latrine SanPlats, 60% of households were willing to pay US$0.48 and 10% of households were willing to pay US$4.05, yet the average cost of supplying the SanPlat to households was US$7.51. Similarly, for plastic sanitary platforms, willingness-to-pay (WTP) dropped from almost 60% at a price of US$1.43 to 5% at a price of US$12.29, compared to an average supply cost of US$23.28. WTP was not significantly different between villages that had participated in the National Sanitation Campaign and those that had not. Randomized informational interventions, including hygiene data-sharing and peer-based exposure to latrine platform products, had minimal effects on WTP. In conclusion, current household demand for latrine platform products is too low to achieve national goals for improved sanitation coverage through fully commercial distribution.

  4. 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.

  5. 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

    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...

  6. 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

  7. 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

  8. A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

    Science.gov (United States)

    Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

    2016-03-01

    Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

  9. 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.

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

    KAUST Repository

    Yilmaz, Ferkan; Alouini, Mohamed-Slim

    2012-01-01

    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

  11. 78 FR 78165 - Orders: Reporting by Regulated Entities of Stress Testing Results as of September 30, 2013...

    Science.gov (United States)

    2013-12-26

    ... Instructions and Guidance AGENCY: Federal Housing Finance Agency. ACTION: Orders. SUMMARY: In this document... is amending the Summary Instructions and Guidance, which accompanied the Orders. DATES: Each Order is effective November 26, 2013. FOR FURTHER INFORMATION CONTACT: Naa Awaa Tagoe, Senior Associate Director...

  12. Dialectical behavior therapy for adolescents with bipolar disorder: results from a pilot randomized trial.

    Science.gov (United States)

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

    2015-03-01

    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). 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. 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. DBT may offer promise as an adjunct to pharmacotherapy in the treatment of depressive symptoms and suicidal ideation for

  13. 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 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 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

  14. 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.

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

    Science.gov (United States)

    Scheltens, Philip; Twisk, Jos W R; Blesa, Rafael; Scarpini, Elio; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Swinkels, Sophie H N; Stam, Cornelis J; de Waal, Hanneke; Wurtman, Richard J; Wieggers, Rico L; Vellas, Bruno; Kamphuis, Patrick 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, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with mild AD. Patients were randomized 1:1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p = 0.023; Cohen's d = 0.21; 95% confidence interval [-0.06]-[0.49]). A trend for an effect was observed on the NTB total composite z-score (p = 0.053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.

  16. 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.

  17. 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 < 0.05). Waist circumference was significantly associated with calorie, vitamin E, glutamic acid, and selenium intake. A year-long dietary intervention was effective at reducing caloric intake in pediatric ALL patients receiving steroid-based chemotherapy, indicating that this is a modality that can be built upon for obesity prevention and management. © 2016 Wiley Periodicals, Inc.

  18. 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.)

  19. Effects of Housing First on Employment and Income of Homeless Individuals: Results of a Randomized Trial.

    Science.gov (United States)

    Poremski, Daniel; Stergiopoulos, Vicky; Braithwaite, Erika; Distasio, Jino; Nisenbaum, Rosane; Latimer, Eric

    2016-06-01

    Housing First is emerging as an evidence-based practice for housing and supporting people who are homeless and have a mental illness. The objective of this study was to determine whether Housing First increases the odds of obtaining competitive employment in this population and affects income, including income from informal and illegal sources. A total of 2,148 people with a mental illness were recruited from five Canadian cities while they were homeless, classified as having moderate or high needs, and randomly assigned to Housing First or usual care. Housing First participants with high needs received assertive community treatment (ACT), and those with moderate needs received intensive case management (ICM). Every three months, participants were interviewed about employment and earnings in the previous months (median follow-up=745 days). Regression models were estimated via generalized estimating equations. ICM recipients had lower odds of obtaining employment compared with the control group with moderate needs. The odds of obtaining employment among ICM recipients increased but their employment rate never exceeded that of the control group. For ACT recipients, the odds of obtaining employment were not significantly different from those of the control group. Among Housing First participants, persons employed at baseline, men, and younger participants had greater odds of employment compared with control participants. Housing First did not appear to significantly increase income. This was the first large-scale randomized controlled study of Housing First's effects on employment. Further research is needed to determine how Housing First may be enhanced to increase odds of obtaining employment.

  20. 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.

  1. A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

    Science.gov (United States)

    Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

    2014-02-01

    Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

  2. 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

  3. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial.

    Science.gov (United States)

    Cheng, Ann-Lii; Kang, Yoon-Koo; Lin, Deng-Yn; Park, Joong-Won; Kudo, Masatoshi; Qin, Shukui; Chung, Hyun-Cheol; Song, Xiangqun; Xu, Jianming; Poggi, Guido; Omata, Masao; Pitman Lowenthal, Susan; Lanzalone, Silvana; Yang, Liqiang; Lechuga, Maria Jose; Raymond, Eric

    2013-11-10

    Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. Primary end point was overall survival (OS). Early trial termination occurred for futility and safety reasons. A total of 1,074 patients were randomly assigned to the study (sunitinib arm, n = 530; sorafenib arm, n = 544). For sunitinib and sorafenib, respectively, median OS was 7.9 versus 10.2 months (hazard ratio [HR], 1.30; one-sided P = .9990; two-sided P = .0014); median progression-free survival (PFS; 3.6 v 3.0 months; HR, 1.13; one-sided P = .8785; two-sided P = .2286) and time to progression (TTP; 4.1 v 3.8 months; HR, 1.13; one-sided P = .8312; two-sided P = .3082) were comparable. Median OS was similar among Asian (7.7 v 8.8 months; HR, 1.21; one-sided P = .9829) and hepatitis B-infected patients (7.6 v 8.0 months; HR, 1.10; one-sided P = .8286), but was shorter with sunitinib in hepatitis C-infected patients (9.2 v 17.6 months; HR, 1.52; one-sided P = .9835). Sunitinib was associated with more frequent and severe adverse events (AEs) than sorafenib. Common grade 3/4 AEs were thrombocytopenia (29.7%) and neutropenia (25.7%) for sunitinib; hand-foot syndrome (21.2%) for sorafenib. Discontinuations owing to AEs were similar (sunitinib, 13.3%; sorafenib, 12.7%). OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib. OS was comparable in Asian and hepatitis B-infected patients. OS was superior in hepatitis C-infected patients who received sorafenib. Sunitinib-treated patients reported more frequent and severe toxicity.

  4. The AOLI low-order non-linear curvature wavefront sensor: laboratory and on-sky results

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    Crass, Jonathan; King, David; MacKay, Craig

    2014-08-01

    Many adaptive optics (AO) systems in use today require the use of bright reference objects to determine the effects of atmospheric distortions. Typically these systems use Shack-Hartmann Wavefront sensors (SHWFS) to distribute incoming light from a reference object between a large number of sub-apertures. Guyon et al. evaluated the sensitivity of several different wavefront sensing techniques and proposed the non-linear Curvature Wavefront Sensor (nlCWFS) offering improved sensitivity across a range of orders of distortion. On large ground-based telescopes this can provide nearly 100% sky coverage using natural guide stars. We present work being undertaken on the nlCWFS development for the Adaptive Optics Lucky Imager (AOLI) project. The wavefront sensor is being developed as part of a low-order adaptive optics system for use in a dedicated instrument providing an AO corrected beam to a Lucky Imaging based science detector. The nlCWFS provides a total of four reference images on two photon-counting EMCCDs for use in the wavefront reconstruction process. We present results from both laboratory work using a calibration system and the first on-sky data obtained with the nlCWFS at the 4.2 metre William Herschel Telescope, La Palma. In addition, we describe the updated optical design of the wavefront sensor, strategies for minimising intrinsic effects and methods to maximise sensitivity using photon-counting detectors. We discuss on-going work to develop the high speed reconstruction algorithm required for the nlCWFS technique. This includes strategies to implement the technique on graphics processing units (GPUs) and to minimise computing overheads to obtain a prior for a rapid convergence of the wavefront reconstruction. Finally we evaluate the sensitivity of the wavefront sensor based upon both data and low-photon count strategies.

  5. RESEARCH ON CUSTOMER SATISFACTION DEGREE AT THE STORE MOBEXPERT PITEŞTI, IN ORDER TO IMPROVE THE SALES RESULTS

    Directory of Open Access Journals (Sweden)

    BRUTU MĂDĂLINA

    2015-07-01

    Full Text Available This paper presents a detailed research of customer satisfaction at the store Mobexpert Pitesti, in order to identify the main causes that led to their possible dissatisfaction. Starting from these results, the paper also aims at identifying a range of solutions designed to improve sales activity. Therefore we defined the research purpose and objectives, designed the questionnaire, defined the variables and established the research hypotheses. The sample of research consisted of the customers of the store Mobexpert Pitesti, men and women aged between 18 and over 55, with middle, high and very high incomes. A single operator collected the data inside Mobexpert Piteşti for two days, using a 3 minute questionnaire. Analyzing the research results, we conclude that there is a high degree of customer satisfaction for the store Mobexpert Piteşti, that it can be further increased by applying the following improvement directions: increasing service quality, better customer understanding, training the sales force through e-learning, motivating the sales force more effectively through a satisfactory system of salaries and bonuses and, not least, increasing the impact of marketing actions.

  6. Exploring and reducing stress in young restaurant workers: results of a randomized field trial.

    Science.gov (United States)

    Petree, Robyn D; Broome, Kirk M; Bennett, Joel B

    2012-01-01

    Young adult restaurant workers face the dual stressors of work adjustment and managing personal responsibilities. We assessed a new psychosocial/health promotion training designed to reduce these stressors in the context of restaurant work. DESIGN . A cluster-randomized trial of a training program, with surveys administered approximately 2 weeks before training and both 6 and 12 months after training. A national restaurant chain. A total of 947 restaurant workers in 28 restaurants. Personal stress, exposure to problem coworkers, and personal and job characteristics. Team Resilience (TR) is an interactive program for stress management, teamwork, and work-life balance. TR focuses on "five Cs" of resilience: compassion, commitment, centering, community, and confidence. ANALYSIS . Mixed-model (multilevel) analysis of covariances. Compared with workers in control stores, workers in TR-trained stores showed significant reductions over time in exposure to problem coworkers (F[2, 80.60]  =  4.48; p  =  .01) and in personal stress (F[2, 75.28]  =  6.12; p  =  .003). The TR program may help young workers who face the challenges of emerging adulthood and work-life balance.

  7. Evaluation of the efficacy of a nonlatex condom: results from a randomized, controlled clinical trial.

    Science.gov (United States)

    Walsh, Terri L; Frezieres, Ron G; Peacock, Karen; Nelson, Anita L; Clark, Virginia A; Bernstein, Leslie

    2003-01-01

    To reduce unintended pregnancy and HIV infection, it is critical to develop reliable male condoms that will attract consumers who reject conventional latex condoms. In a prospective clinical trial conducted in 1998-2000, 830 monogamous couples were randomized in equal numbers to use either a nonlatex condom or a commercial natural latex condom for six months as their only method of birth control. Couples completed detailed reports for the first five condom uses and recorded intercourse and condom use in coital diaries. Pregnancy rates associated with typical and consistent condom use were calculated using life-table analysis. Rates of clinical failure (condom breakage or slippage) were determined for the first five condom uses. During the first five uses, the nonlatex condom had a higher frequency of breakage or slippage during intercourse or withdrawal (4.0%) than latex condoms (1.3%); the breakage rate for the nonlatex condom was about eight times that of latex condoms. The six-cycle typical-use pregnancy rate did not differ significantly between users of nonlatex (10.8%) and latex condoms (6.4%). The six-cycle consistent-use pregnancy rate was higher for nonlatex condom users than for latex condom users (4.9% vs. 1.0%). The data present strong indirect support for public health messages that promote the use of latex condoms and, for individuals who cannot or are unwilling to use latex condoms, the use of nonlatex condoms for prevention of pregnancy and disease.

  8. Irisin and exercise training in humans - results from a randomized controlled training trial.

    Science.gov (United States)

    Hecksteden, Anne; Wegmann, Melissa; Steffen, Anke; Kraushaar, Jochen; Morsch, Arne; Ruppenthal, Sandra; Kaestner, Lars; Meyer, Tim

    2013-11-05

    The recent discovery of a new myokine (irisin) potentially involved in health-related training effects has gained great attention, but evidence for a training-induced increase in irisin remains preliminary. Therefore, the present study aimed to determine whether irisin concentration is increased after regular exercise training in humans. In a randomized controlled design, two guideline conforming training interventions were studied. Inclusion criteria were age 30 to 60 years, Physical performance provided positive control for the overall efficacy of training. Differences between groups were tested for significance using analysis of variance. For post hoc comparisons with the control group, Dunnett's test was used. Maximum performance increased significantly in the training groups compared with controls (controls: ±0.0 ± 0.7 km/h; AET: 1.1 ± 0.6 km/h, P error probability = 0.7). The general upward trend was mainly accounted for by a negative association of irisin concentration with the storage duration of frozen serum samples (P storage of samples from initial tests.

  9. Efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose: Results of a randomized controlled trial.

    Science.gov (United States)

    Göke, R; Eschenbach, P; Dütting, E D

    2015-06-01

    This study compared the efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose (FPG) as single-pill combinations (SPCs) with metformin. The randomized crossover, open-label, active-controlled study design assessed the FPG-lowering abilities of a vildagliptin/metformin (50/1000 mg twice daily) SPC compared with a sitagliptin/metformin (50/1000 mg twice daily) SPC after 2 weeks of treatment in 99 type 2 diabetes patients uncontrolled by stable metformin therapy (1000-2000 mg/day). The change in FPG from baseline to day 14 was significantly greater (P vildagliptin [-21.9 mg/dL (SD 27.0)] than with sitagliptin [-14.5 mg/dL (SD 23.0)]. After 14 days of treatment, the mean FPG was 137.8 mg/dL (SD 28.5) with vildagliptin and 140.1mg/dL (SD 26.5) with sitagliptin (P vildagliptin produced a significantly greater reduction in FPG vs baseline compared with sitagliptin, which may translate into clinical relevance. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  10. Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

    Science.gov (United States)

    Madsen, Kristine; Linchey, Jennifer; Gerstein, Dana; Ross, Michelle; Myers, Esther; Brown, Katie; Crawford, Patricia

    2015-08-01

    Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; pchildren's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

  11. Results of a large-scale randomized behavior change intervention on road safety in Kenya.

    Science.gov (United States)

    Habyarimana, James; Jack, William

    2015-08-25

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1-2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved.

  12. 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.

  13. 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

  14. Use of crisis management interventions among suicidal patients: Results of a randomized controlled trial.

    Science.gov (United States)

    Bryan, Craig J; May, Alexis M; Rozek, David C; Williams, Sean R; Clemans, Tracy A; Mintz, Jim; Leeson, Bruce; Burch, T Scott

    2018-05-10

    Previous research supports the efficacy of the crisis response plan (CRP) for the reduction of suicidal behaviors as compared to treatment as usual (TAU). Patient perspectives and use of the CRP, and their relationship to later suicidal thoughts, remain unknown. A secondary analysis of a randomized clinical trial comparing a standard CRP (S-CRP), a CRP enhanced with reasons for living (E-CRP), and TAU in a sample of 97 active-duty U.S. Army personnel was conducted. Participants were asked about their use, perceptions, and recall of each intervention. Generalized estimating equations were used to test the conditional effects of intervention use, perceptions, and recall on severity of suicide ideation during follow-up. Across all treatment groups, over 80% of participants retained their written CRP up to 6 months later, but less than 25% had the written plan in their physical possession at the time of each assessment. Participants in S-CRP and E-CRP were more likely to recall self-management strategies and sources of social support. Participants in TAU were more likely to recall use of professional healthcare services and crisis management services. All three interventions were rated as highly useful. More frequent use of the E-CRP and recall of its components were associated with significantly reduced suicide ideation as compared to TAU. Both CRPs have high acceptability ratings. The effect of both CRPs on reduced suicide ideation is associated with patient recall of components. More frequent use of the E-CRP is associated with larger reductions in suicide ideation. © 2018 Wiley Periodicals, Inc.

  15. Clinical effectiveness of cognitive therapy v. interpersonal psychotherapy for depression: results of a randomized controlled trial.

    Science.gov (United States)

    Lemmens, L H J M; Arntz, A; Peeters, F; Hollon, S D; Roefs, A; Huibers, M J H

    2015-07-01

    Although both cognitive therapy (CT) and interpersonal psychotherapy (IPT) have been shown to be effective treatments for major depressive disorder (MDD), it is not clear yet whether one therapy outperforms the other with regard to severity and course of the disorder. This study examined the clinical effectiveness of CT v. IPT in a large sample of depressed patients seeking treatment in a Dutch outpatient mental health clinic. We tested whether one of the treatments was superior to the other at post-treatment and at 5 months follow-up. Furthermore, we tested whether active treatment was superior to no treatment. We also assessed whether initial depression severity moderated the effect of time and condition and tested for therapist differences. Depressed adults (n = 182) were randomized to either CT (n = 76), IPT (n = 75) or a 2-month waiting list control (WLC) condition (n = 31). Main outcome was depression severity, measured with the Beck Depression Inventory - II (BDI-II), assessed at baseline, 2, 3, and 7 months (treatment phase) and monthly up to 5 months follow-up (8-12 months). No differential effects between CT and IPT were found. Both treatments exceeded response in the WLC condition, and led to considerable improvement in depression severity that was sustained up to 1 year. Baseline depression severity did not moderate the effect of time and condition. Within our power and time ranges, CT and IPT appeared not to differ in the treatment of depression in the acute phase and beyond.

  16. High-dose estradiol improves cognition for women with AD: results of a randomized study.

    Science.gov (United States)

    Asthana, S; Baker, L D; Craft, S; Stanczyk, F Z; Veith, R C; Raskind, M A; Plymate, S R

    2001-08-28

    To characterize the cognitive and neuroendocrine response to treatment with a high dose of estrogen for postmenopausal women with AD. Twenty postmenopausal women with AD were randomized to receive either 0.10 mg/day of 17 beta-estradiol by skin patch or a placebo patch for 8 weeks. Subjects were evaluated at baseline, at weeks 3, 5, and 8 during treatment, and again 8 weeks after treatment termination. During each visit, cognition was assessed with a battery of neuropsychological tests, and blood samples were collected to measure plasma estradiol as well as several other neuroendocrine markers of interest. Significant effects of estrogen treatment were observed on attention (Stroop Color Word Interference Test), verbal memory (Buschke Selective Reminding Test), and visual memory (Figure Copy/Memory). In addition, women treated with estrogen demonstrated improved performance on a test of semantic memory (Boston Naming Test) compared with subjects who received a placebo. Estrogen appeared to have a suppressive effect on the insulin-like growth factor (IGF) system such that plasma concentration of IGF binding protein-3 was significantly reduced and plasma levels of estradiol and IGF-I were negatively correlated during estrogen treatment. Administration of a higher dose of estrogen may enhance attention and memory for postmenopausal women with AD. Although these findings provide further clinical evidence to support a cognitive benefit of estrogen for women with AD, studies evaluating the effect of estradiol administration, in particular, using larger sample sizes and for longer treatment durations are warranted before the therapeutic potential of estrogen replacement for women with AD can be firmly established.

  17. 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.

  18. Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial

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    Diana Brasil Pedral-Sampaio

    Full Text Available It has been postulated that deficient or incomplete clinical and/or microbiological response to tuberculosis treatment is associated with cell-mediated immunological dysfunction involving monocytes and macrophages. A phase 2 safety trial was conducted by treating patients with either recombinant human granulocyte-macrophage colony-stimulating factor (rhu-GM-CSF or a placebo, both in combination with anti-tuberculosis chemotherapy. Thirty-one patients with documented pulmonary tuberculosis were treated with rifampin/isoniazid for six months, plus pyrazinamide for the first two months. At the beginning of treatment, rhu-GM-CSF (125µg/M² was randomly assigned to 16 patients and injected subcutaneously twice weekly for four weeks; the other 15 patients received a placebo. The patients were accompanied in the hospital for two weeks, then monthly on an out patient basis, for 12 months. Clinical outcomes were similar in both groups, with no difference in acid-fast bacilli (AFB clearance in sputum at the end of the fourth week of treatment. Nevertheless, a trend to faster conversion to negative was observed in the rhu-GM-CSF group until the eighth week of treatment (p=0.07, after which all patients converted to AFB negative. Adverse events in the rhu-GM-CSF group were local skin inflammation and an increase in the leukocyte count after each injection, returning to normal 72 hours after rhu-GM-CSF injection. Three patients developed SGOP and SGPT > 2.5 times the normal values. All patients included in the GM-CSF group were culture negative at six months, except one who had primary TB resistance. None of the patients had to discontinue the treatment in either group. We conclude that rhu-GM-CSF adjuvant immunotherapy could be safely explored in a phase 3 trial with patients who have active tuberculosis.

  19. Use of rhu-GM-CSF in pulmonary tuberculosis patients: results of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Pedral-Sampaio Diana Brasil

    2003-01-01

    Full Text Available It has been postulated that deficient or incomplete clinical and/or microbiological response to tuberculosis treatment is associated with cell-mediated immunological dysfunction involving monocytes and macrophages. A phase 2 safety trial was conducted by treating patients with either recombinant human granulocyte-macrophage colony-stimulating factor (rhu-GM-CSF or a placebo, both in combination with anti-tuberculosis chemotherapy. Thirty-one patients with documented pulmonary tuberculosis were treated with rifampin/isoniazid for six months, plus pyrazinamide for the first two months. At the beginning of treatment, rhu-GM-CSF (125µg/M² was randomly assigned to 16 patients and injected subcutaneously twice weekly for four weeks; the other 15 patients received a placebo. The patients were accompanied in the hospital for two weeks, then monthly on an out patient basis, for 12 months. Clinical outcomes were similar in both groups, with no difference in acid-fast bacilli (AFB clearance in sputum at the end of the fourth week of treatment. Nevertheless, a trend to faster conversion to negative was observed in the rhu-GM-CSF group until the eighth week of treatment (p=0.07, after which all patients converted to AFB negative. Adverse events in the rhu-GM-CSF group were local skin inflammation and an increase in the leukocyte count after each injection, returning to normal 72 hours after rhu-GM-CSF injection. Three patients developed SGOP and SGPT > 2.5 times the normal values. All patients included in the GM-CSF group were culture negative at six months, except one who had primary TB resistance. None of the patients had to discontinue the treatment in either group. We conclude that rhu-GM-CSF adjuvant immunotherapy could be safely explored in a phase 3 trial with patients who have active tuberculosis.

  20. When Help Becomes Hindrance: Unexpected Errors of Omission and Commission in Eyewitness Memory Resulting from Change Temporal Order at Retrieval?

    Science.gov (United States)

    Dando, Coral J.; Ormerod, Thomas C.; Wilcock, Rachel; Milne, Rebecca

    2011-01-01

    An experimental mock eyewitness study is reported that compared Free and reverse order recall of an empirically informed scripted crime event. Proponents of reverse order recall suggest it facilitates recovery of script incidental information and increases the total amount of information recalled. However, compared with free recall it was found to…

  1. 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).

  2. Preliminary results of an attempt to provide soil moisture datasets in order to verify numerical weather prediction models

    International Nuclear Information System (INIS)

    Cassardo, C.; Loglisci, N.

    2005-01-01

    In the recent years, there has been a significant growth in the recognition of the soil moisture importance in large-scale hydrology and climate modelling. Soil moisture is a lower boundary condition, which rules the partitioning of energy in terms of sensible and latent heat flux. Wrong estimations of soil moisture lead to wrong simulation of the surface layer evolution and hence precipitations and cloud cover forecasts could be consequently affected. This is true for large scale medium-range weather forecasts as well as for local-scale short range weather forecasts, particularly in those situations in which local convection is well developed. Unfortunately; despite the importance of this physical parameter there are only few soil moisture data sets sparse in time and in space around in the world. Due to this scarcity of soil moisture observations, we developed an alternative method to provide soil moisture datasets in order to verify numerical weather prediction models. In this paper are presented the preliminary results of an attempt to verify soil moisture fields predicted by a mesoscale model. The data for the comparison were provided by the simulations of the diagnostic land surface scheme LSPM (Land Surface Process Model), widely used at the Piedmont Regional Weather Service for agro-meteorological purposes. To this end, LSPM was initialized and driven by Synop observations, while the surface (vegetation and soil) parameter values were initialized by ECOCLIMAP global dataset at 1km 2 resolution

  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

    2018-03-01

    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 2018, 11: 519-530. © 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

  4. 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

  5. Randomized controlled trial of perioperative antimicrobial therapy based on the results of preoperative bile cultures in patients undergoing biliary reconstruction.

    Science.gov (United States)

    Okamura, Kunishige; Tanaka, Kimitaka; Miura, Takumi; Nakanishi, Yoshitsugu; Noji, Takehiro; Nakamura, Toru; Tsuchikawa, Takahiro; Okamura, Keisuke; Shichinohe, Toshiaki; Hirano, Satoshi

    2017-07-01

    The high frequency of surgical site infections (SSIs) after hepato-pancreato-biliary (HPB) surgery is a problem that needs to be addressed. This prospective, randomized, controlled study examined whether perioperative prophylactic use of antibiotics based on preoperative bile culture results in HPB surgery could decrease SSI. Participants comprised 126 patients who underwent HPB (bile duct, gallbladder, ampullary, or pancreatic) cancer surgery with biliary reconstruction at Hokkaido University Hospital between August 2008 and March 2013 (UMIN Clinical Trial Registry #00001278). Before surgery, subjects were randomly allocated to a targeted group administered antibiotics based on bile culture results or a standard group administered cefmetazole. The primary endpoint was SSI rates within 30 days after surgery. Secondary endpoint was SSI rates for each operative procedure. Of the 126 patients, 124 were randomly allocated (targeted group, n = 62; standard group, n = 62). Frequency of SSI after surgery was significantly lower in the targeted group (27 patients, 43.5%) than in the standard group (44 patients, 71.0%; P = 0.002). Among patients who underwent pancreaticoduodenectomy and hepatectomy, SSI occurred significantly less frequently in the targeted group (P = 0.001 and P = 0.025, respectively). This study demonstrated that preoperative bile culture-targeted administration of prophylactic antibiotics decreased SSIs following HBP surgery with biliary reconstruction. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  6. Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial

    DEFF Research Database (Denmark)

    Obling, Sine Roelsgaard; Wilson, Benedicte Vibjerg; Pfeiffer, Per

    2018-01-01

    , the primary endpoint being fat free mass (FFM) and secondary: muscle function, quality of life and overall survival. Design and methods: In a single centre open-label randomised controlled trial, patients with incurable gastrointestinal cancer, nutritionally at risk, were randomly assigned to either; a) best...... FFM. Secondary outcomes were muscle strength, quality of life and survival. Results: Eligible for inclusion were 234 patients, 47 of these accepted enrolment; 25 were randomized to non-sHPN and 22 to sHPN according to performance status, age and diagnoses. Median age was 66.9 (41.5-88.2), BMI 21.3 (14.......8-35.7) and (91%) were receiving palliative chemotherapy. Median FFM and fat free mass index increased in the sHPN group. At 12 weeks a significant difference (p FFM. Handgrip strength increased in both groups...

  7. Models of disordered media: some new results, including some new connections between composite-media, fluid-state, and random-flight theories

    International Nuclear Information System (INIS)

    Stell, G.

    1983-01-01

    Some new theoretical results on the microstructure of models of two-phase disordered media are given, as well as the new quantitative bounds on the thermal conductivity that follows for one such model (randomly centered spherical inclusions). A second set of results is then given for random flights, including random flights with hit expectancy prescribed in a unit hall around the flight origin. Finally, some interesting correspondences are demonstrated, via the Ornstein-Zernike equation, between random-flight results, liquid-state results and percolation-theory results. 27 references, 6 figures, 4 tables

  8. Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

    Science.gov (United States)

    Schiff, Gordon D; Reyes Nieva, Harry; Griswold, Paula; Leydon, Nicholas; Ling, Judy; Federico, Frank; Keohane, Carol; Ellis, Bonnie R; Foskett, Cathy; Orav, E John; Yoon, Catherine; Goldmann, Don; Weissman, Joel S; Bates, David W; Biondolillo, Madeleine; Singer, Sara J

    2017-08-01

    Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all Pcoaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

  9. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  10. The effects of radiation therapy on quality of life in women with breast cancer: Results of a randomized trial

    International Nuclear Information System (INIS)

    Whelan, T.; Levine, M.; Julian, J.; Skingley, P.; Kirkbride, P.; Clark, R.; Lipa, M.; Wilkinson, R.

    1997-01-01

    Purpose/Objective: The effects of radiation therapy on quality of life of women with breast cancer are not well known. The purpose of this study was to evaluate the effect of breast irradiation on quality of life including cosmetic outcome in the context of a randomized controlled trial. Methods: Between 1984 and 1989 a randomized trial was conducted in Ontario in which women with node-negative breast cancer who had undergone lumpectomy and axillary section were randomized either to postoperative radiation (4000 cGy in 16 fractions to the whole breast, followed by a boost of 1250 cGy in five fractions to the primary site) or no further treatment (J Natl Cancer Inst 1996; 88:1659). A modified version of the breast cancer chemotherapy questionnaire (J Clin Oncol 1988; 6:1798) containing 17 items was administered to women at baseline, one month and two months postrandomization. Each item was scored on a Likert scale from ''1'' All of the Time to ''7'' None of the Time. Patient assessments of breast pain and cosmetic outcome were also evaluated every three months for the first two years of the study. Results: Of 837 patients, 416 were randomly allocated to radiation therapy and 421 to no further treatment. The groups were comparable in terms of baseline characteristics. Factor analysis identified three different domains of the quality of life instrument: emotional/social, fatigue, and physical/inconvenience. There was a significant difference in the physical/inconvenience and fatigue domain scores between the radiation and control groups over time. The differences in scores between groups at two months post randomization were 0.97, p = 0.0001; 0.33, p=0.0001; and 0.03, p=0.62 for the physical/inconvenience, fatigue and emotional/social domains respectively. The percentage of patients who were troubled by breast pain differed between radiation and control groups up to one year (33.3% vs 19.9%, p = 0.001 at 6 months). Beyond one year, no difference was detected. The

  11. Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

    Science.gov (United States)

    Van Hamersveld, Koen T; Marang-Van De Mheen, Perla J; Nelissen, Rob G H H; Toksvig-Larsen, Sören

    2018-05-09

    Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

  12. Off-label use of recombinant factor VIIa for treatment of haemorrhage: results from randomized clinical trials

    DEFF Research Database (Denmark)

    Johansson, Per Ingemar

    2008-01-01

    ) for evidence of such an approach. Methods In October 2007, a review of RCT involving rFVIIa for non-haemophilic indications was performed. The effect of rFVIIa on blood loss and transfusion requirements was recorded. Results Seventeen RCTs were identified concerning different bleeding conditions, for example......, secondary to surgery, infection and stem cell transplantation. Three pilot studies reported a significant reduction in transfusion requirements and/or blood loss in the rFVIIa-treated groups, but these have not been confirmed in large randomized trials. No difference in thromboembolic complications between...

  13. 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 fr...... 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....

  14. Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

    1984-01-01

    The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

  15. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

    Science.gov (United States)

    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  16. Effect of oxygen therapy on chest pain in patients with ST elevation myocardial infarction: results from the randomized SOCCER trial.

    Science.gov (United States)

    Khoshnood, Ardavan; Akbarzadeh, Mahin; Carlsson, Marcus; Sparv, David; Bhiladvala, Pallonji; Mokhtari, Arash; Erlinge, David; Ekelund, Ulf

    2018-04-01

    Oxygen (O 2 ) have been a cornerstone in the treatment of acute myocardial infarction. Studies have been inconclusive regarding the cardiovascular and analgesic effects of oxygen in these patients. In the SOCCER trial, we compared the effects of oxygen treatment versus room air in patients with ST-elevation myocardial infarction (STEMI). There was no difference in myocardial salvage index or infarct size assessed with cardiac magnetic resonance imaging. In the present subanalysis, we wanted to evaluate the effect of O 2 on chest pain in patients with STEMI. Normoxic patients with first time STEMI were randomized in the ambulance to standard care with 10 l/min O 2 or room air until the end of the percutaneous coronary intervention (PCI). The ambulance personnel noted the patients´ chest pain on a visual analog scale (VAS; 1-10) before randomization and after the transport but before the start of the PCI, and also registered the amount of morphine given. 160 patients were randomized to O 2 (n = 85) or room air (n = 75). The O 2 group had a higher median VAS at randomization than the air group (7.0 ± 2.3 vs 6.0 ± 2.9; p = .02) and also received a higher median total dose of morphine (5.0 mg ± 4.4 vs 4.0 mg ± 3.7; p = .02). There was no difference between the O 2 and air groups in VAS at the start of the PCI (4.0 ± 2.4 vs 3.0 ± 2.5; p = .05) or in the median VAS decrease from randomization to the start of the PCI (-2.0 ± 2.2 vs -1.0 ± 2.9; p = .18). Taken together with previously published data, these results do not support a significant analgesic effect of oxygen in patients with STEMI. European Clinical Trials Database (EudraCT): 2011-001452-11. ClinicalTrials.gov Identifier: NCT01423929.

  17. Some results of the spectra of random Schroedinger operators and their application to random point interaction models in one and three dimensions

    International Nuclear Information System (INIS)

    Kirsch, W.; Martinelli, F.

    1981-01-01

    After the derivation of weak conditions under which the potential for the Schroedinger operator is well defined the authers state an ergodicity assumption of this potential which ensures that the spectrum of this operator is a fixed non random set. Then random point interaction Hamiltonians are considered in this framework. Finally the authors consider a model where for sufficiently small fluctuations around the equilibrium positions a finite number of gaps appears. (HSI)

  18. Determinants of translation speed are randomly distributed across transcripts resulting in a universal scaling of protein synthesis times

    Science.gov (United States)

    Sharma, Ajeet K.; Ahmed, Nabeel; O'Brien, Edward P.

    2018-02-01

    Ribosome profiling experiments have found greater than 100-fold variation in ribosome density along mRNA transcripts, indicating that individual codon elongation rates can vary to a similar degree. This wide range of elongation times, coupled with differences in codon usage between transcripts, suggests that the average codon translation-rate per gene can vary widely. Yet, ribosome run-off experiments have found that the average codon translation rate for different groups of transcripts in mouse stem cells is constant at 5.6 AA/s. How these seemingly contradictory results can be reconciled is the focus of this study. Here, we combine knowledge of the molecular factors shown to influence translation speed with genomic information from Escherichia coli, Saccharomyces cerevisiae and Homo sapiens to simulate the synthesis of cytosolic proteins in these organisms. The model recapitulates a near constant average translation rate, which we demonstrate arises because the molecular determinants of translation speed are distributed nearly randomly amongst most of the transcripts. Consequently, codon translation rates are also randomly distributed and fast-translating segments of a transcript are likely to be offset by equally probable slow-translating segments, resulting in similar average elongation rates for most transcripts. We also show that the codon usage bias does not significantly affect the near random distribution of codon translation rates because only about 10 % of the total transcripts in an organism have high codon usage bias while the rest have little to no bias. Analysis of Ribo-Seq data and an in vivo fluorescent assay supports these conclusions.

  19. 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

  20. Comparison of results using second-order moments with and without width correction to solve the advection equation

    International Nuclear Information System (INIS)

    Pepper, D.W.; Long, P.E.

    1978-01-01

    The method of moments is used with and without a a width-correction technique to solve the advection of a passive scalar. The method of moments is free of numerical dispersion but suffers from numerical diffusion (damping). In order to assess the effect of the width-correction procedure on reducing numerical diffusion, both versions are used to advect a passive scalar in straight-line and rotational wind fields. Although the width-correction procedure reduces numerical diffusion under some circumstances, the unmodified version of the second-moment procedure is better suited as a general method

  1. Breast-conserving therapy with partial or whole breast irradiation: Ten-year results of the Budapest randomized trial

    International Nuclear Information System (INIS)

    Polgár, Csaba; Fodor, János; Major, Tibor; Sulyok, Zoltán; Kásler, Miklós

    2013-01-01

    Background and purpose: To report the long-term results of a single-institution randomized study comparing the results of breast-conserving treatment with partial breast irradiation (PBI) or conventional whole breast irradiation (WBI). Patients and methods: Between 1998 and 2004, 258 selected women with pT1 pN0-1mi M0, grade 1–2, non-lobular breast cancer without the presence of extensive intraductal component and resected with negative margins were randomized after BCS to receive 50 Gy WBI (n = 130) or PBI (n = 128). The latter consisted of either 7 × 5.2 Gy high-dose-rate (HDR) multi-catheter brachytherapy (BT; n = 88) or 50 Gy electron beam (EB) irradiation (n = 40). Primary endpoint was local recurrence (LR) as a first event. Secondary endpoints were overall survival (OS), cancer-specific survival (CSS), disease-free survival (DFS), and cosmetic results. Results: After a median follow up of 10.2 years, the ten-year actuarial rate of LR was 5.9% and 5.1% in PBI and WBI arms, respectively (p = 0.77). There was no significant difference in the ten-year probability of OS (80% vs 82%), CSS (94% vs 92%), and DFS (85% vs 84%), either. The rate of excellent-good cosmetic result was 81% in the PBI, and 63% in the control group (p < 0.01). Conclusions: Partial breast irradiation delivered by interstitial HDR BT or EB for a selected group of early-stage breast cancer patients produces similar ten-year results to those achieved with conventional WBI. Significantly better cosmetic outcome can be achieved with HDR BT implants compared with the outcome after WBI

  2. [Work-Related Medical Rehabilitation in Cancer Rehabilitation - Short-Term Results from a Cluster-Randomized Multicenter-Trial].

    Science.gov (United States)

    Wienert, Julian; Bethge, Matthias

    2018-05-25

    Rehabilitation programs that support return to work become increasingly relevant for cancer survivors. In Germany, such programs were established as work-related medical rehabilitation (WMR). The study investigated whether WMR leads to better results compared to medical rehabilitation (MR). We report effects on secondary outcomes when the rehabilitation program was completed. Clusters of participants were randomly assigned to WMR or MR. Patients of working age and an elevated risk of not returning to work were included. The grade of implementation was assessed by dose delivered and dose received. Study outcomes were assessed using scales measuring functioning and symptoms, coping with illness as well as self-reported work ability. Treatment effects were estimated using mixed linear models. From 232 planned randomized intervention groups, 165 (71%) were realized. In total, 476 patients were included. Mean age of participants was 50.7 years (SD=7.3). Most frequent primary diagnoses were malignant neoplasms of the breast. Participants in the WMR program reported significantly better outcomes regarding quality of life (SMD=0.17-0.25), fatigue (SMD=0.18-0.27), coping with illness (SMD=0.17-0.22), and self-reported work-ability (SMD=0.16) compared to participants in MR program (all p<0.05). The results indicate a positive effect in favor of WMR for cancer patients with an elevated risk of not returning to work at the end of their treatment. © Georg Thieme Verlag KG Stuttgart · New York.

  3. 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

  4. Symptomatic treatment (ibuprofen or antibiotics (ciprofloxacin for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Wegscheider Karl

    2010-05-01

    Full Text Available Abstract Background Uncomplicated lower urinary tract infections (UTI are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options. This pilot study was set out 1 to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2 to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. Methods We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg (+1 placebo oral, both for three days. Intensity of main symptoms - dysuria, frequency, low abdominal pain - was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none to 4 (very strong. The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms, symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. Results Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39. On Day 4, 21/36 (58.3% of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5% in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42 than ciprofloxacin patients (1,3; SD 1,9, difference -0,33 (95% CI (-1,13 to +0,47, PP (per protocol analysis. During Days 0 and 9, 12/36 (33% of patients

  5. A Dietary Intervention in Urban African Americans: Results of the "Five Plus Nuts and Beans" Randomized Trial.

    Science.gov (United States)

    Miller, Edgar R; Cooper, Lisa A; Carson, Kathryn A; Wang, Nae-Yuh; Appel, Lawrence J; Gayles, Debra; Charleston, Jeanne; White, Karen; You, Na; Weng, Yingjie; Martin-Daniels, Michelle; Bates-Hopkins, Barbara; Robb, Inez; Franz, Whitney K; Brown, Emily L; Halbert, Jennifer P; Albert, Michael C; Dalcin, Arlene T; Yeh, Hsin-Chieh

    2016-01-01

    Unhealthy diets, often low in potassium, likely contribute to racial disparities in blood pressure. We tested the effectiveness of providing weekly dietary advice, assistance with selection of higher potassium grocery items, and a $30 per week food allowance on blood pressure and other outcomes in African American adults with hypertension. We conducted an 8-week RCT with two parallel arms between May 2012 and November 2013. We randomized 123 African Americans with controlled hypertension from an urban primary care clinic in Baltimore, Maryland, and implemented the trial in partnership with a community supermarket and the Baltimore City Health Department. Mean (SD) age was 58.6 (9.5) years; 71% were female; blood pressure was 131.3 (14.7)/77.2 (10.5) mmHg; BMI was 34.5 (8.2); and 28% had diabetes. Participants randomized to the active intervention group (Dietary Approaches to Stop Hypertension [DASH]-Plus) received coach-directed dietary advice and assistance with weekly online ordering and purchasing of high-potassium foods ($30/week) delivered by a community supermarket to a neighborhood library. Participants in the control group received a printed DASH diet brochure along with a debit account of equivalent value to that of the DASH-Plus group. The primary outcome was blood pressure change. Analyses were conducted in January to October 2014. Compared with the control group, the DASH-Plus group increased self-reported consumption of fruits and vegetables (mean=1.4, 95% CI=0.7, 2.1 servings/day); estimated intake of potassium (mean=0.4, 95% CI=0.1, 0.7 grams/day); and urine potassium excretion (mean=19%, 95% CI=1%, 38%). There was no significant effect on blood pressure. A program providing dietary advice, assistance with grocery ordering, and $30/week of high-potassium foods in African American patients with controlled hypertension in a community-based clinic did not reduce BP. However, the intervention increased consumption of fruits, vegetables, and urinary

  6. Recruitment to and pilot results of the PACES randomized trial of physical exercise during adjuvant chemotherapy for colon cancer.

    Science.gov (United States)

    van Waart, Hanna; Stuiver, Martijn M; van Harten, Wim H; Geleijn, Edwin; de Maaker-Berkhof, Marianne; Schrama, Jolanda; Geenen, Maud M; Meerum Terwogt, Jetske M; van den Heiligenberg, Simone M; Hellendoorn-van Vreeswijk, Jeannette A J H; Sonke, Gabe S; Aaronson, Neil K

    2018-01-01

    We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy. Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up. Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up. Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial. Netherlands Trial Register - NTR2159.

  7. 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.

  8. Results of vardenafil mediated power Doppler ultrasound, contrast enhanced ultrasound and systematic random biopsies to detect prostate cancer.

    Science.gov (United States)

    Morelli, Girolamo; Pagni, Riccardo; Mariani, Chiara; Minervini, Riccardo; Morelli, Andrea; Gori, Francesco; Ferdeghini, Ezio Maria; Paterni, Marco; Mauro, Eva; Guidi, Elisa; Armillotta, Nicola; Canale, Domenico; Vitti, Paolo; Caramella, Davide; Minervini, Andrea

    2011-06-01

    We evaluated the ability of the phosphodiesterase-5 inhibitor vardenafil to increase prostate microcirculation during power Doppler ultrasound. We also evaluated the results of contrast and vardenafil enhanced targeted biopsies compared to those of standard 12-core random biopsies to detect cancer. Between May 2008 and January 2010, 150 consecutive patients with prostate specific antigen more than 4 ng/ml at first diagnosis with negative digital rectal examination and transrectal ultrasound, and no clinical history of prostatitis underwent contrast enhanced power Doppler ultrasound (bolus injection of 2.4 ml SonoVue® contrast agent), followed by vardenafil enhanced power Doppler ultrasound (1 hour after oral administration of vardenafil 20 mg). All patients underwent standard 12-core transrectal ultrasound guided random prostate biopsy plus 1 further sampling from each suspected hypervascular lesion detected by contrast and vardenafil enhanced power Doppler ultrasound. Prostate cancer was detected in 44 patients (29.3%). Contrast and vardenafil enhanced power Doppler ultrasound detected suspicious, contrast enhanced and vardenafil enhanced areas in 112 (74.6%) and 110 patients (73.3%), and was diagnostic for cancer in 32 (28.5%) and 42 (38%), respectively. Analysis of standard technique, and contrast and vardenafil enhanced power Doppler ultrasound findings by biopsy core showed significantly higher detection using vardenafil vs contrast enhanced power Doppler ultrasound and standard technique (41.2% vs 22.7% and 8.1%, p power Doppler ultrasound was 10% and 11.7% (p not significant). Vardenafil enhanced power Doppler ultrasound enables excellent visualization of the microvasculature associated with cancer and can improve the detection rate compared to contrast enhanced power Doppler ultrasound and the random technique. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  9. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial.

    Science.gov (United States)

    Polgár, Csaba; Fodor, János; Major, Tibor; Sulyok, Zoltán; Kásler, Miklós

    2013-08-01

    To report the long-term results of a single-institution randomized study comparing the results of breast-conserving treatment with partial breast irradiation (PBI) or conventional whole breast irradiation (WBI). Between 1998 and 2004, 258 selected women with pT1 pN0-1mi M0, grade 1-2, non-lobular breast cancer without the presence of extensive intraductal component and resected with negative margins were randomized after BCS to receive 50 Gy WBI (n=130) or PBI (n=128). The latter consisted of either 7 × 5.2 Gy high-dose-rate (HDR) multi-catheter brachytherapy (BT; n=88) or 50 Gy electron beam (EB) irradiation (n=40). Primary endpoint was local recurrence (LR) as a first event. Secondary endpoints were overall survival (OS), cancer-specific survival (CSS), disease-free survival (DFS), and cosmetic results. After a median follow up of 10.2 years, the ten-year actuarial rate of LR was 5.9% and 5.1% in PBI and WBI arms, respectively (p=0.77). There was no significant difference in the ten-year probability of OS (80% vs 82%), CSS (94% vs 92%), and DFS (85% vs 84%), either. The rate of excellent-good cosmetic result was 81% in the PBI, and 63% in the control group (p<0.01). Partial breast irradiation delivered by interstitial HDR BT or EB for a selected group of early-stage breast cancer patients produces similar ten-year results to those achieved with conventional WBI. Significantly better cosmetic outcome can be achieved with HDR BT implants compared with the outcome after WBI. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  10. 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.

  11. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials

    International Nuclear Information System (INIS)

    Vernon, Clare C.; Hand, Jeffrey W.; Field, Stanley B.; Machin, David; Whaley, Jill B.; Zee, Jacoba van der; Putten, Wim L.J. van; Rhoon, Gerard C. van; Dijk, Jan D.P. van; Gonzalez, Dionisio Gonzalez; Liu, F.-F.; Goodman, Phyllis; Sherar, Michael

    1996-01-01

    Purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that

  12. 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.

  13. ATG-Fresenius treatment and low-dose tacrolimus: results of a randomized controlled trial in liver transplantation.

    Science.gov (United States)

    Benítez, C E; Puig-Pey, I; López, M; Martínez-Llordella, M; Lozano, J J; Bohne, F; Londoño, M C; García-Valdecasas, J C; Bruguera, M; Navasa, M; Rimola, A; Sánchez-Fueyo, A

    2010-10-01

    We report the results of a prospective randomized controlled trial in liver transplantation assessing the efficacy and safety of antithymocyte globulin (ATG-Fresenius) plus tacrolimus monotherapy at gradually decreasing doses. Patients were randomized to either: (a) standard-dose tacrolimus plus steroids;or (b) peritransplant ATG-Fresenius plus reduced-dose tacrolimus monotherapy followed by weaning of tacrolimus starting 3 months after transplantation. The primary end-point was the achievement of very low-dose tacrolimus (every-other-day or once daily dose with Fresenius group but no benefits in terms of improved renal function, lower metabolic complications or increased prevalence of tolerance-related biomarkers were observed. In conclusion, the use of ATG-Fresenius and tacrolimus at gradually decreasing doses was associated with a high rate of rejection, did not allow for the administration of very low doses of tacrolimus and failed to provide detectable clinical benefits. ClinicalTrials.gov identifier: NCT00436722. © 2010 The Authors Journal compilation © 2010 The American Society of Transplantation and the American Society of Transplant Surgeons.

  14. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  15. Effects of a price increase on purchases of sugar sweetened beverages. Results from a randomized controlled trial.

    Science.gov (United States)

    Waterlander, Wilma Elzeline; Ni Mhurchu, Cliona; Steenhuis, Ingrid H M

    2014-07-01

    Sugar sweetened beverage (SSB) taxes are receiving increased political interest. However, there have been no experimental studies of the effects of price increases on SSBs or the effects on close substitutes such as diet drinks, alcohol or sugary snacks. Therefore, the aim of this study was to examine the effects of a price increase on SSBs on beverage and snack purchases using a randomized controlled design within a three-dimensional web-based supermarket. The trial contained two conditions: experimental condition with a 19% tax on SSBs (to reflect an increase in Dutch value added tax from 6% to 19%); and a control condition with regular prices. N = 102 participants were randomized and purchased groceries on a single occasion at a three-dimensional Virtual Supermarket. Data were analysed using independent t-tests and regression analysis. Results showed that participants in the price increase condition purchased significantly less SSBs than the control group (B = -.90; 95% CI = -1.70 to -.10 L per household per week). There were no significant effects on purchases in other beverage or snack food categories. This means that the higher VAT rate was effective in reducing SSB purchases and had no negative side-effects. Copyright © 2014. Published by Elsevier Ltd.

  16. 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).

  17. 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.

  18. Potent corticosteroid cream (mometasone furoate) significantly reduces acute radiation dermatitis: results from a double-blind, randomized study

    International Nuclear Information System (INIS)

    Bostroem, Aasa; Lindman, Henrik; Swartling, Carl; Berne, Berit; Bergh, Jonas

    2001-01-01

    Purpose: Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study. Material and methods: The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions. Results: MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups. Conclusions: Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis

  19. 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 (operational limitations, the majority of recipients had relatively well-controlled diseases at the time of enrollment.

  20. Results of a lay health education intervention to increase colorectal cancer screening among Filipino Americans: A cluster randomized controlled trial.

    Science.gov (United States)

    Cuaresma, Charlene F; Sy, Angela U; Nguyen, Tung T; Ho, Reginald C S; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Tong, Elisa K; Kagawa-Singer, Marjorie; Stewart, Susan L

    2018-04-01

    Filipino colorectal cancer (CRC) screening rates fall below Healthy People 2020 goals. In this study, the authors explore whether a lay health educator (LHE) approach can increase CRC screening among Filipino Americans ages 50 to 75 years in Hawai'i. A cluster randomized controlled trial from 2012 through 2015 compared an intervention, which consisted of LHEs delivering 2 education sessions and 2 telephone follow-up calls on CRC screening plus a CRC brochure versus an attention control, in which 2 lectures and 2 follow-up calls on nutrition and physical activity plus a CRC brochure were provided. The primary outcome was change in self-reported ever receipt of CRC screening at 6 months. Among 304 participants (77% women, 86% had > 10 years of residence in the United States), the proportion of participants who reported ever having received CRC screening increased significantly in the intervention group (from 80% to 89%; P = .0003), but not in the control group (from 73% to 74%; P = .60). After covariate adjustment, there was a significant intervention effect (odds ratio, 1.9; 95% confidence interval, 1.0-3.5). There was no intervention effect on up-to-date screening. This first randomized controlled trial for CRC screening among Hawai'i's Filipinos used an LHE intervention with mixed, but promising, results. Cancer 2018;124:1535-42. © 2018 American Cancer Society. © 2018 American Cancer Society.

  1. Comparison of Higher Order Aberrations after Wavefront-guided LASIK and PRK: One Year Follow-Up Results.

    Science.gov (United States)

    Jahadi Hosseini, Seyed Hamid Reza; Abtahi, Seyed Mohammad Bagher; Khalili, Mohammad Reza

    2016-01-01

    To evaluate the changes and predictability of higher order aberrations (HOAs) after personalized laser in situ keratomileusis (LASIK) and personalized photorefractive keratectomy (PRK) for simple myopia and compound myopic astigmatism. In this prospective cross-sectional study, 100 eyes were included. A total of 50 eyes underwent personalized LASIK and 50 eyes underwent personalized PRK. Preoperative and postoperative wavefront data were compared between the two groups. The influential factors and predictability of HOAs were also assessed. Total HOA increased in the amount of 0.01 ± 0.14 μm for the 5 mm pupil ( P = 0.55) and 0.08 ± 0.22 μm for the 6 mm pupil ( P = 0.02) after PRK; however after LASIK the corresponding values for the 5 and 6 mm pupil sizes were 0.05 ± 0.12 and 0.15 ± 0.18 μm, respectively ( P PRK and LASIK groups for both 5 and 6 mm pupil sizes ( P = 0.21 and P = 0.13, respectively). Spherical aberration increased following LASIK more than following PRK ( P PRK and LASIK with no significant difference between the two groups. Change of the total HOA RMS was influenced by the preoperative values. The known influencing factors could predict nearly 50% of the changes in total HOA.

  2. Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

    Science.gov (United States)

    Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2016-01-01

    Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

  3. 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

  4. 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

  5. Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

    Science.gov (United States)

    Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

    2015-06-01

    The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

  6. 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

  7. Prevention of heterotopic ossification about the hip using perioperative radiotherapy: Results of two randomized trials in 410 patients

    International Nuclear Information System (INIS)

    Seegenschmiedt, M. Heinrich; Keiholz, Ludwig; Martus, Peter; Woelfel, Rainer; Henning, Friedrich; Sauer, Rolf

    1996-01-01

    BACKGROUND: In-vivo data (Kantorowitz et al., 1991) indicate the efficacy of pre- and postoperative radiotherapy (RT) in suppressing development of heterotopic ossification (HO) after hip surgery. Since 1987 two prospective randomized trials were initiated at our institution to assess the comparative efficacy of 'high-dose RT' versus 'low-dose RT' (HOP study 1) and 'preoperative RT' versus 'postoperative RT' (HOP study 2). A control arm without radiotherapy (RT) was avoided, as only those patients (pts) were entered, who had a very high risk to develop HO after hip arthroplasty. PATIENTS and METHODS: In HOP study 1 (accrual: June 1987 - June 1992), 249 pts were randomized between the following postoperative RT schedules: 'low-dose RT' with 5 x 2 Gy, 10 Gy total RT dose (N = 129) versus 'high dose RT' with 5 x 3.5 Gy, 17.5 Gy total RT dose (N = 121); RT was applied with daily fractionation starting at postoperative day 1 - 4. In HOP study 2 (accrual : July 1992 - July 1995), 161 pts were randomized between 'preoperative RT' using a single dose of 7 Gy (N = 80 pts) and postoperative RT with 5 x 3.5 Gy (N = 51 pts). In both studies only patients were includes with one or multiple of the following risk factors for HO: ipsi- (55%) or contralateral HO (33%), hypertrophic osteoarthritis (48%), repeated hip surgery, acetabular fracture or severe hip trauma (43%); 62% of all pts had at least two risk factors. The structure of the relevant and possibly confounding patient and disease parameters and risk factors was similar in each of the treatment arms within the two randomized studies. - The assessment of 'treatment failures' was based upon the comparison of the amount of HO seen on the immediately postoperative radiograph as compared to radiographs obtained at least 6 months after surgery (Brooker Score). Any progression of HO by Brooker score was regarded as treatment failure. RESULTS: At last FU, in January 1996 both studies 369 of 410 pts (90%) had received an effective

  8. Anesthesiologic Effects of Transperitoneal Versus Extraperitoneal Approach During Robot-Assisted Radical Prostatectomy: Results of a Prospective Randomized Study

    Directory of Open Access Journals (Sweden)

    Fabrizio Dal Moro

    2015-06-01

    Full Text Available ABSTRACTObjectives:To compare the effects of CO2 insufflation on hemodynamics and oxygen levels and on acid-base level during Robot-Assisted Radical Prostatectomy (RARP with transperitoneal (TP versus extra-peritoneal (EP accesses.Materials and Methods:Sixty-two patients were randomly assigned to TP (32 and EP (30 to RARP. Pre-operation data were collected for all patients. Hemodynamic, respiratory and blood acid-base parameters were measured at the moment of induction of anesthesia (T0, after starting CO2 insuffation (T1, and at 60 (T2 and 120 minutes (T3 after insufflation. In all cases, the abdominal pressure was set at 15 mmHg. Complications were reported according to the Clavien-Dindo classification. Student's two–t-test, with a significance level set at pResults:The demographic characteristics of the patients in both groups were statistically comparable. Analysis of intra-operative anesthesiologic parameters showed that partial CO2 pressure during EP was significantly higher than during TP, with a consequent decrease in arterial pH. Other parameters analysed were similar in the two groups. Postoperative complications were comparable between groups. The most important limitations of this study were the small size of the patient groups and the impossibility of maintaining standard abdominal pressure throughout the operational phases, despite attempts to regulate it.Conclusions:This prospective randomized study demonstrates that, from the anesthesiologic viewpoint, during RARP the TP approach is preferable to EP, because of lower CO2 reabsorption and risk of acidosis.

  9. 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

  10. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.

    Science.gov (United States)

    Wells, John A; Glassman, Adam R; Ayala, Allison R; Jampol, Lee M; Bressler, Neil M; Bressler, Susan B; Brucker, Alexander J; Ferris, Frederick L; Hampton, G Robert; Jhaveri, Chirag; Melia, Michele; Beck, Roy W

    2016-06-01

    To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. Copyright © 2016 American Academy of Ophthalmology. All rights

  11. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results.

    Science.gov (United States)

    Rebecchi, Fabrizio; Giaccone, Claudio; Farinella, Eleonora; Campaci, Roberto; Morino, Mario

    2008-12-01

    To compare in a prospective, randomized trial the long-term results of laparoscopic Heller myotomy plus Dor fundoplication versus laparoscopic Heller myotomy plus floppy-Nissen for achalasia. Anterior fundoplication is usually performed after Heller myotomy to control GER; however, the incidence of postoperative GER ranges between 10% and 30%. Total fundoplication may aid in reducing GER rates. From December 1993 to September 2002, 153 patients with achalasia underwent Heller laparoscopic myotomy plus antireflux fundoplication. Of these, 9 were excluded from the study. The remaining 144 patients were randomly assigned to 2 treatment groups: Heller laparoscopic myotomy plus anterior fundoplication (Dor procedure) or Heller laparoscopic myotomy plus total fundoplication (floppy-Nissen procedure). The primary end point was incidence of clinical and instrumental GER after a minimum of 60 months follow-up. The secondary end point was recurrence of dysphagia. Follow-up clinical assessments were performed at 1, 3, 12, and 60 months using a modified DeMeester Symptom Scoring System (MDSS). Esophageal manometry and 24-hour pH monitoring were performed at 3, 12, and 60 months postoperative. Of the 144 patients originally included in the study, 138 were available for long-term analysis: 71 (51%) underwent antireflux fundoplication plus a Dor procedure (H + D group) and 67 (49%) antireflux fundoplication plus a Nissen procedure (H + N group). No mortality was observed. The mean follow-up period was 125 months. No statistically significant differences in clinical (5.6% vs. 0%) or instrumental GER (2.8% vs. 0%) were found between the 2 groups; however, a statistically significant difference in dysphagia rates was noted (2.8% vs. 15%; P Heller myotomy.

  12. Efficacy and causal mechanism of an online social media intervention to increase physical activity: Results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jingwen Zhang

    2015-01-01

    Full Text Available Objective: To identify what features of social media – promotional messaging or peer networks – can increase physical activity. Method: A 13-week social media-based exercise program was conducted at a large Northeastern university in Philadelphia, PA. In a randomized controlled trial, 217 graduate students from the University were randomized to three conditions: a control condition with a basic online program for enrolling in weekly exercise classes led by instructors of the University for 13 weeks, a media condition that supplemented the basic program with weekly online promotional media messages that encourage physical activity, and a social condition that replaced the media content with an online network of four to six anonymous peers composed of other participants of the program, in which each participant was able to see their peers' progress in enrolling in classes. The primary outcome was the number of enrollments in exercise classes, and the secondary outcomes were self-reported physical activities. Data were collected in 2014. Results: Participants enrolled in 5.5 classes on average. Compared with enrollment in the control condition (mean = 4.5, promotional messages moderately increased enrollment (mean = 5.7, p = 0.08, while anonymous social networks significantly increased enrollment (mean = 6.3, p = 0.02. By the end of the program, participants in the social condition reported exercising moderately for an additional 1.6 days each week compared with the baseline, which was significantly more than an additional 0.8 days in the control condition. Conclusion: Social influence from anonymous online peers was more successful than promotional messages for improving physical activity. Clinical Trial Registration: ClinicalTrials.gov: NCT02267369.

  13. A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study.

    Science.gov (United States)

    Wild, Beate; Hünnemeyer, Katharina; Sauer, Helene; Hain, Bernhard; Mack, Isabelle; Schellberg, Dieter; Müller-Stich, Beat Peter; Weiner, Rudolf; Meile, Tobias; Rudofsky, Gottfried; Königsrainer, Alfred; Zipfel, Stephan; Herzog, Wolfgang; Teufel, Martin

    2015-01-01

    For severely obese patients, bariatric surgery has been recommended as an effective therapy. The Bariataric Surgery and Education (BaSE) study aimed to assess the efficacy of a videoconferencing-based psychoeducational group intervention in patients after bariatric surgery. The BaSE study is a randomized, controlled multicenter clinical trial involving 117 patients undergoing bariatric surgery (mean preoperative body mass index [BMI] 49.9 kg/m(2), SD 6.4). Patients were enrolled between May 2009 and November 2012 and were randomly assigned to receive either conventional postsurgical visits or, in addition, a videoconferencing-based 1-year group program. Primary outcome measures were weight in kilograms, health-related quality of life (HRQOL), and general self-efficacy (GSE). Secondary outcome measures were depression symptoms and eating behavior. 94% of the patients completed the study. Mean weight loss for all patients was 45.9 kg (SD 16.4) 1 year after surgery (mean excess weight loss [EWL] 63%). Intention-to-treat analyses revealed no differences in weight loss, EWL, HRQOL, or self-efficacy between study groups at 1 year after surgery. However, patients with clinically significant depression symptoms (CSD) at baseline assigned to the intervention group (n = 29) had a significantly better HRQOL (P = .03), lower depression scores (P = .02), and a trend for a better EWL (.06) 1 year after surgery compared with the control group (n = 20). We could not prove the efficacy of the group program for the whole study sample. However, results indicate that the intervention is effective for the important subgroup of patients with CSD. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  14. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study].

    Science.gov (United States)

    Walther, C; Mende, M; Gaede, L; Müller, U; Machalica, K; Schuler, G

    2011-11-01

    It was the aim of this study to measure the effects over two years of daily sport activity during the school-day on their physical fitness (primary endpoint), motor coordination and blood pressure (secondary endpoints). A total of 232 children from eleven different 6 (th) grade classes were enrolled after informed parental consent. Their mean age was 11.1  ±  0.6 years. Six classes were randomly assigned for intervention (n=141), five as control (n=91). Those of the intervention cohort undertook, for five days weekly during the school year one hour of regulated sport exercise, including 15 min of endurance training. The pupils of the control group undertook customary sport activity (two hours a week). Anthropometric data were recorded and maximal oxygen uptake measured in each pupil, as well as blood pressure and motor coordination at the beginning and at the end of each of the two years of the study. The data were analyzed using the cluster randomization method. Maximal oxygen uptake (VO (2)max) had improved among the intervention group after two years, compared with the controls (3.12 m/kg/min, 95% confindence interval [CI] 0.06-6.19), while improvement in motor coordination just failed to reach statistical significance (3.06, 95% CI -0.17-6.29). There was no significant difference in systolic and diastolic blood pressure, but a downward trend in the prevalence of overweight and obesity from 12.1% to 7.8% in the intervention group. The results indicate that daily physical exercise during school hours should be given greater importance. But it will require a long-term trial to determine whether promotion of increased physical activity at school influences the prevalence of cardiovascular risk factors when the pupils reach adulthood. © Georg Thieme Verlag KG Stuttgart · New York.

  15. Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study

    Science.gov (United States)

    Ohtsu, Atsushi; Ajani, Jaffer A.; Bai, Yu-Xian; Bang, Yung-Jue; Chung, Hyun-Cheol; Pan, Hong-Ming; Sahmoud, Tarek; Shen, Lin; Yeh, Kun-Huei; Chin, Keisho; Muro, Kei; Kim, Yeul Hong; Ferry, David; Tebbutt, Niall C.; Al-Batran, Salah-Eddin; Smith, Heind; Costantini, Chiara; Rizvi, Syed; Lebwohl, David; Van Cutsem, Eric

    2013-01-01

    Purpose The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. Patients and Methods Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. Results Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW. Conclusion Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers. PMID:24043745

  16. Ten-Year Survival Results of a Randomized Trial of Irradiation of Internal Mammary Nodes After Mastectomy

    International Nuclear Information System (INIS)

    Hennequin, Christophe; Bossard, Nadine; Servagi-Vernat, Stéphanie; Maingon, Philippe; Dubois, Jean-Bernard; Datchary, Jean; Carrie, Christian; Roullet, Bernard; Suchaud, Jean-Philippe; Teissier, Eric; Lucardi, Audrey; Gerard, Jean-Pierre; Belot, Aurélien

    2013-01-01

    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

  17. 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.

  18. Efficacy and safety of fasudil in patients with subarachnoid hemorrhage. Final results of a randomized trial of fasudil versus nimodipine

    International Nuclear Information System (INIS)

    Zhao Jizong; Zhou Dingbiao; Guo Jing

    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. (author)

  19. 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.; Beek, A.J. van der

    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

  20. 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

  1. 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

  2. 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

    2018-03-01

    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;

  3. 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.

  4. Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood.

    Science.gov (United States)

    Kohn, Julia E; Simons, Hannah R; Della Badia, Lisa; Draper, Elissa; Morfesis, Johanna; Talmont, Elizabeth; Beasley, Anitra; McDonald, Melanie; Westhoff, Carolyn L

    2018-03-01

    Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. We randomized 401 females ages 15-44 requesting DMPA at clinics in Texas and New Jersey to self-administration or clinic administration in a 1:1 allocation. Clinic staff taught participants randomized to self-administration to self-inject and observed the first injection; participants received instructions, a sharps container, and three doses for home use. Participants randomized to clinic administration received usual care. All participants received DMPA-sc at no cost and injection reminders via text message or email. We conducted follow-up surveys at six and 12 months. Three hundred thirty-six participants (84%) completed the 12-month survey; 316 completed both follow-up surveys (an 80% response rate excluding eight withdrawals). Participants ranged in age from 16-44. One-year DMPA continuous use was 69% in the self-administration group and 54% in the clinic group (p=.005). There were three self-reported pregnancies during the study period, all occurred in the clinic group; all three women had discontinued DMPA and one reported her pregnancy as intended. Among the self-administration group, 97% reported that self-administration was very or somewhat easy; 87% would recommend self-administration of DMPA-sc to a friend. Among the clinic group, 52% reported interest in self-administration in the future. Satisfaction was similar between groups. No serious adverse events were reported. DMPA self-administration improves contraceptive continuation and is a feasible and acceptable option for women and adolescents. Self-administration of subcutaneous DMPA can improve contraceptive access, autonomy, and continuation, and is a feasible and acceptable option for women and adolescents. It should be made widely available

  5. 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.

  6. Low-fat dietary pattern and cardiovascular disease: results from the Women's Health Initiative randomized controlled trial.

    Science.gov (United States)

    Prentice, Ross L; Aragaki, Aaron K; Van Horn, Linda; Thomson, Cynthia A; Beresford, Shirley Aa; Robinson, Jennifer; Snetselaar, Linda; Anderson, Garnet L; Manson, JoAnn E; Allison, Matthew A; Rossouw, Jacques E; Howard, Barbara V

    2017-07-01

    Background: The influence of a low-fat dietary pattern on the cardiovascular health of postmenopausal women continues to be of public health interest. Objective: This report evaluates low-fat dietary pattern influences on cardiovascular disease (CVD) incidence and mortality during the intervention and postintervention phases of the Women's Health Initiative Dietary Modification Trial. Design: Participants comprised 48,835 postmenopausal women aged 50-79 y; 40% were randomly assigned to a low-fat dietary pattern intervention (target of 20% of energy from fat), and 60% were randomly assigned to a usual diet comparison group. The 8.3-y intervention period ended in March 2005, after which >80% of surviving participants consented to additional active follow-up through September 2010; all participants were followed for mortality through 2013. Breast and colorectal cancer were the primary trial outcomes, and coronary heart disease (CHD) and overall CVD were additional designated outcomes. Results: Incidence rates for CHD and total CVD did not differ between the intervention and comparison groups in either the intervention or postintervention period. However, CHD HRs comparing these groups varied strongly with baseline CVD and hypertension status. Participants without prior CVD had an intervention period CHD HR of 0.70 (95% CI: 0.56, 0.87) or 1.04 (95% CI: 0.90, 1.19) if they were normotensive or hypertensive, respectively ( P -interaction = 0.003). The CHD benefit among healthy normotensive women was partially offset by an increase in ischemic stroke risk. Corresponding HRs in the postintervention period were close to null. Participants with CVD at baseline (3.4%) had CHD HRs of 1.47 (95% CI: 1.12, 1.93) and 1.61 (95% CI: 1.02, 2.55) in the intervention and postintervention periods, respectively. However, various lines of evidence suggest that results in women with CVD or hypertension at baseline are confounded by postrandomization use of cholesterol-lowering medications

  7. Long-Term Results of a Randomized Trial in Locally Advanced Rectal Cancer: No Benefit From Adding a Brachytherapy Boost

    International Nuclear Information System (INIS)

    Appelt, Ane L.; Vogelius, Ivan R.; Pløen, John; Rafaelsen, Søren R.; Lindebjerg, Jan; Havelund, Birgitte M.; Bentzen, Søren M.; Jakobsen, Anders

    2014-01-01

    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

  8. 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.

  9. 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

  10. 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

  11. Random glucose is useful for individual prediction of type 2 diabetes: results of the Study of Health in Pomerania (SHIP).

    Science.gov (United States)

    Kowall, Bernd; Rathmann, Wolfgang; Giani, Guido; Schipf, Sabine; Baumeister, Sebastian; Wallaschofski, Henri; Nauck, Matthias; Völzke, Henry

    2013-04-01

    Random glucose is widely used in routine clinical practice. We investigated whether this non-standardized glycemic measure is useful for individual diabetes prediction. The Study of Health in Pomerania (SHIP), a population-based cohort study in north-east Germany, included 3107 diabetes-free persons aged 31-81 years at baseline in 1997-2001. 2475 persons participated at 5-year follow-up and gave self-reports of incident diabetes. For the total sample and for subjects aged ≥50 years, statistical properties of prediction models with and without random glucose were compared. A basic model (including age, sex, diabetes of parents, hypertension and waist circumference) and a comprehensive model (additionally including various lifestyle variables and blood parameters, but not HbA1c) performed statistically significantly better after adding random glucose (e.g., the area under the receiver-operating curve (AROC) increased from 0.824 to 0.856 after adding random glucose to the comprehensive model in the total sample). Likewise, adding random glucose to prediction models which included HbA1c led to significant improvements of predictive ability (e.g., for subjects ≥50 years, AROC increased from 0.824 to 0.849 after adding random glucose to the comprehensive model+HbA1c). Random glucose is useful for individual diabetes prediction, and improves prediction models including HbA1c. Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  12. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation

    International Nuclear Information System (INIS)

    Fisher, B.; Redmond, C.; Fisher, E.R.

    1985-01-01

    In 1971 a randomized trial was begun to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative auxillary nodes, with respect to disease-free survival, distant-disease-free survival, or overall survival (about 57%) at 10 years. The patients were treated by radical mastectomy, total (simple) mastectomy without auxillary dissection but with regional irradiation, or total mastectomy without irradiation plus auxillary dissection only if nodes were subsequently positive. Similarly, no differences, were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without auxillary dissection but with regional irradiation. Survival at 10 years was about 38% in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. It was concluded that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer. 25 references, 6 figures, 1 table

  13. Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Aasmul, Irene; Husebo, Bettina Sandgathe; Flo, Elisabeth

    2016-12-01

    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. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n = 175) or control group (27 NH units; n = 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n = 138) used the Neuropsychiatric Inventory-NH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (Mini-Mental State Examination). Using hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P pain treatment reduced staff distress in the intervention group compared to control group especially in regard to agitation-related symptoms and apathy. Furthermore, our results indicated a multifactorial model of staff distress, in which enhanced knowledge and understanding of NPSs and pain in people with advanced dementia may play an important role. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  14. 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.

  15. 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.

  16. Acceptance-based versus standard behavioral treatment for obesity: Results from the mind your health randomized controlled trial.

    Science.gov (United States)

    Forman, Evan M; Butryn, Meghan L; Manasse, Stephanie M; Crosby, Ross D; Goldstein, Stephanie P; Wyckoff, Emily P; Thomas, J Graham

    2016-10-01

    To evaluate the efficacy, as well as potential moderators and mediators, of a revised acceptance-based behavioral treatment (ABT) for obesity, relative to standard behavioral treatment (SBT). Participants with overweight and obesity (n = 190) were randomized to 25 sessions of ABT or SBT over 1 year. Primary outcome (weight), mediator, and moderator measurements were taken at baseline, 6 months, and/or 12 months, and weight was also measured every session. Participants assigned to ABT attained a significantly greater 12-month weight loss (13.3% ± 0.83%) than did those assigned to SBT (9.8% ± 0.87%; P = 0.005). A condition by quadratic time effect on session-by-session weights (P = 0.01) indicated that SBT had a shallower trajectory of weight loss followed by an upward deflection. ABT participants were also more likely to maintain a 10% weight loss at 12 months (64.0% vs. 48.9%; P = 0.04). No evidence of moderation was found. Results supported the mediating role of autonomous motivation and psychological acceptance of food-related urges. Behavioral weight loss outcomes can be improved by integrating self-regulation skills that are reflected in acceptance-based treatment, i.e., tolerating discomfort and reduction in pleasure, enacting commitment to valued behavior, and being mindfully aware during moments of decision-making. © 2016 The Obesity Society.

  17. Results of a randomized controlled pilot trial of intravascular renal denervation for management of treatment-resistant hypertension.

    Science.gov (United States)

    Jacobs, Lotte; Persu, Alexandre; Huang, Qi-Fang; Lengelé, Jean-Philippe; Thijs, Lutgarde; Hammer, Frank; Yang, Wen-Yi; Zhang, Zhen-Yu; Renkin, Jean; Sinnaeve, Peter; Wei, Fang-Fei; Pasquet, Agnès; Fadl Elmula, Fadl Elmula M; Carlier, Marc; Elvan, Arif; Wunder, Cora; Kjeldsen, Sverre E; Toennes, Stefan W; Janssens, Stefan; Verhamme, Peter; Staessen, Jan A

    2017-12-01

    Previous trials of catheter-based renal-artery denervation (RDN) as treatment modality in resistant hypertension (rHT) generated unconvincing results. In the Investigator-Steered Project on Intravascular Denervation for Management of Treatment-Resistant Hypertension (INSPiRED; NCT01505010), we optimized selection and management of rHT patients. With ethical clearance to randomize 18 patients, three Belgian hypertension centers screened 29 rHT patients on treatment with ≥3 drugs, of whom 17 after optimization of treatment (age efficacy endpoint, and 2.5 mL/min/1.73 m 2 (+1.5 vs. -1.1 mL/min/1.73 m 2 ; P = .86) for eGFR, the primary safety endpoint. At 6 month, ECG voltages and the number of prescribed drugs (P ≤ .036) were lower in RDN patients, but quality of life and adherence, captured by questionnaire and urine analysis were similar in both groups. Changes in BP and adherence were unrelated. No major complications occurred. The INSPiRED pilot suggests that RDN with the EnligHTN ™ system is effective and safe and generated insights useful for the design of future RDN trials.

  18. 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

  19. The effect of a prenatal lifestyle intervention on glucose metabolism: results of the Norwegian Fit for Delivery randomized controlled trial.

    Science.gov (United States)

    Sagedal, Linda R; Vistad, Ingvild; Øverby, Nina C; Bere, Elling; Torstveit, Monica K; Lohne-Seiler, Hilde; Hillesund, Elisabet R; Pripp, Are; Henriksen, Tore

    2017-06-02

    The effectiveness of prenatal lifestyle intervention to prevent gestational diabetes and improve maternal glucose metabolism remains to be established. The Norwegian Fit for Delivery (NFFD) randomized, controlled trial studied the effect of a combined lifestyle intervention provided to a general population, and found significantly lower gestational weight gain among intervention participants but no improvement in obstetrical outcomes or the proportion of large infants. The aim of the present study is to examine the effect of the NFFD intervention on glucose metabolism, including an assessment of the subgroups of normal-weight and overweight/obese participants. Healthy, non-diabetic women expecting their first child, with pre-pregnancy body mass index (BMI) ≥19 kg/m 2 , age ≥ 18 years and a singleton pregnancy of ≤20 gestational-weeks were enrolled from healthcare clinics in southern Norway. Gestational weight gain was the primary endpoint. Participants (n = 606) were individually randomized to intervention (two dietary consultations and access to twice-weekly exercise groups) or control group (routine prenatal care). The effect of intervention on glucose metabolism was a secondary endpoint, measuring glucose (fasting and 2-h following 75-g glucose load), insulin, homeostatic assessment of insulin resistance (HOMA-IR) and leptin levels at gestational-week 30. Blood samples from 557 (91.9%) women were analyzed. For the total group, intervention resulted in reduced insulin (adj. Mean diff -0.91 mU/l, p = 0.045) and leptin levels (adj. Mean diff -207 pmol/l, p = 0.021) compared to routine care, while glucose levels were unchanged. However, the effect of intervention on both fasting and 2-h glucose was modified by pre-pregnancy BMI (interaction p = 0.030 and p = 0.039, respectively). For overweight/obese women (n = 158), intervention was associated with increased risk of at least one glucose measurement exceeding International Association of

  20. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2012-01-01

    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.)

  1. Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

    Science.gov (United States)

    Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

    2017-03-01

    OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant

  2. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study – a randomized controlled trial

    Science.gov (United States)

    Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

    2016-01-01

    Objective: Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. Methods: A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Results: Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were −17.9 mmHg (95%CI −30.9 to −4.9); P = 0.010 and −6.6 mmHg (95%CI −12.9 to −0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were −12.1 mmHg (95%CI −29.1 to 5.1); P = 0.158 and of −5.3 mmHg (95%CI −16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was −10.7 ml/min per 1.73 m2 (95%CI −20.1 to −1.4); P = 0.027. Conclusion: We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated’ in all patients with resistant hypertension before considering RDN. PMID:27327441

  3. 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

  4. No benefit of intraoperative whole blood sequestration and autotransfusion during coronary artery bypass grafting : results of a randomized clinical trial

    NARCIS (Netherlands)

    Ramnath, A N; Naber, H R; de Boer, A; Leusink, J A

    OBJECTIVES: In a randomized clinical trial of patients undergoing elective coronary artery bypass grafting, we evaluated the effect of intraoperative whole blood sequestration and autotransfusion on postoperative blood loss and the use of allogeneic blood products. METHODS: Male patients were

  5. Effect of a tailored physical activity intervention delivered in general practice settings: results of a randomized controlled trial

    NARCIS (Netherlands)

    Sluijs, van E.M.F.; Poppel - Bruinvels, van M.N.M.; Twisk, J.W.R.; Paw, M.J.M. Chin A; Calfas, K.J.; Mechelen, van 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

  6. 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

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

    NARCIS (Netherlands)

    Acarturk, C.; Konuk, E.; Cetinkaya, M.; Senay, I.; Sijbrandij, M.; Cuijpers, P.; Aker, T.

    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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. Midterm Clinical and First Reproductive Results of a Randomized Controlled Trial Comparing Uterine Fibroid Embolization and Myomectomy

    International Nuclear Information System (INIS)

    Mara, Michal; Maskova, Jana; Fucikova, Zuzana; Kuzel, David; Belsan, Tomas; Sosna, Ondrej

    2008-01-01

    The purpose of this study was to compare the midterm results of a radiological and surgical approach to uterine fibroids. One hundred twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4 cm were randomly selected for either uterine artery embolization (UAE) or myomectomy. We compared the efficacy and safety of the two procedures and their impact on patient fertility. Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. We conclude that UAE is less invasive and as symptomatically effective and safe as myomectomy, but myomectomy appears to have superior reproductive outcomes in the first 2 years after treatment

  13. 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.

  14. Neutron scattering study of unstable magnetic long-range order in the random two-dimensional Ising antiferromagnets Rb/sub 2/Cosub(c)Mgsub(1-c)F/sub 4/

    Energy Technology Data Exchange (ETDEWEB)

    Ikeda, H; Suzuki, M [Ochanomizu Univ., Tokyo (Japan). Dept. of Physics; Hutchings, M T [UKAEA Atomic Energy Research Establishment, Harwell. Materials Physics Div.

    1979-01-01

    The spin correlation between two-dimensionally (2D) ordered antiferromagnetic layers in the random antiferromagnets Rb/sub 2/Cosub(c)Mgsub(1-c)F/sub 4/ depends strongly on the rate at which the sample is cooled through the Neel point Tsub(N) and decreases markedly with decreasing Co/sup 2 +/ ion concentration c. Preliminary data are presented which indicate that the order below sub(N) is metastable and relaxes to a fully correlated 3D ordered state on a finite, measurable, time-scale.

  15. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation.

    Science.gov (United States)

    Jackson, James C; Ely, E Wesley; Morey, Miriam C; Anderson, Venice M; Denne, Laural B; Clune, Jennifer; Siebert, Carol S; Archer, Kristin R; Torres, Renee; Janz, David; Schiro, Elena; Jones, Julie; Shintani, Ayumi K; Levine, Brian; Pun, Brenda T; Thompson, Jennifer; Brummel, Nathan E; Hoenig, Helen

    2012-04-01

    Millions of patients who survive medical and surgical general intensive care unit care every year experience newly acquired long-term cognitive impairment and profound physical and functional disabilities. To overcome the current reality in which patients receive inadequate rehabilitation, we devised a multifaceted, in-home, telerehabilitation program implemented using social workers and psychology technicians with the goal of improving cognitive and functional outcomes. This was a single-site, feasibility, pilot, randomized trial of 21 general medical/surgical intensive care unit survivors (8 controls and 13 intervention patients) with either cognitive or functional impairment at hospital discharge. After discharge, study controls received usual care (sporadic rehabilitation), whereas intervention patients received a combination of in-home cognitive, physical, and functional rehabilitation over a 3-month period via a social worker or master's level psychology technician utilizing telemedicine to allow specialized multidisciplinary treatment. Interventions over 12 wks included six in-person visits for cognitive rehabilitation and six televisits for physical/functional rehabilitation. Outcomes were measured at the completion of the rehabilitation program (i.e., at 3 months), with cognitive functioning as the primary outcome. Analyses were conducted using linear regression to examine differences in 3-month outcomes between treatment groups while adjusting for baseline scores. Patients tolerated the program with only one adverse event reported. At baseline both groups were well-matched. At 3-month follow-up, intervention group patients demonstrated significantly improved cognitive executive functioning on the widely used and well-normed Tower test (for planning and strategic thinking) vs. controls (median [interquartile range], 13.0 [11.5-14.0] vs. 7.5 [4.0-8.5]; adjusted p improving cognitive performance and functional outcomes in just 3 months. Future investigations

  16. Moxifloxacin in Pediatric Patients with Complicated Intra-Abdominal Infections: Results of the MOXIPEDIA Randomized Controlled Study.

    Science.gov (United States)

    Wirth, Stefan; Emil, Sherif G S; Engelis, Arnis; Digtyar, Valeri; Criollo, Margarita; DiCasoli, Carl; Stass, Heino; Willmann, Stefan; Nkulikiyinka, Richard; Grossmann, Ulrike

    2018-01-18

    This study was designed to evaluate primarily the safety and also the efficacy of moxifloxacin (MXF) in children with complicated intra-abdominal infections (cIAIs). In this multicenter, randomized, double-blind, controlled study, 451 pediatric patients aged 3 months to 17 years with cIAIs were treated with intravenous/oral MXF (N = 301) or comparator (COMP, intravenous ertapenem followed by oral amoxicillin/clavulanate; N = 150) for 5 to 14 days. Doses of MXF were selected based on the results of a Phase 1 study in pediatric patients (NCT01049022). The primary endpoint was safety, with particular focus on cardiac and musculoskeletal safety; clinical and bacteriological efficacy at test of cure were also investigated. The proportion of patients with adverse events (AEs) was comparable between the two treatment arms (MXF: 58.1% and COMP: 54.7%). The incidence of drug-related AEs was higher in the MXF arm than the COMP arm (14.3% and 6.7%, respectively). No cases of QTc interval prolongation-related morbidity or mortality were observed. The proportion of patients with musculoskeletal AEs was comparable between treatment arms; no drug-related events were reported. Clinical cure rates were 84.6% and 95.5% in the MXF and COMP arms, respectively, in patients with confirmed pathogen(s) at baseline. MXF treatment was well tolerated in children with cIAIs. However, a lower clinical cure rate was observed with MXF treatment compared with COMP. This study does not support a recommendation of MXF for children with cIAIs when alternative more efficacious antibiotics with better safety profile are available.

  17. Radiotherapy and chemotherapy in the treatment of head and neck cancer: results after five years of a randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Santarelli, M.; Raffetto, N.; Torcia, P.; Vitturini, A.; Tombolini, V.; Maurizi Enrici, R. [Istituto di radiologia Universita Roma ' ' La Sapienza' ' , Rome (Italy)

    1999-11-01

    Purpose: this study was undertaken to evaluate the efficacy of two regimens of chemoradiotherapy in the treatment of locally advanced head and neck cancer. Methods: from 1992 to 1997, 127 patients with locally advanced head and neck cancer (stage III-IV) were randomized. Sixty-six patients (group a), 42 male and 24 female, with a median age of 48 years (range 40-72) received during radiotherapy two courses (1.-6. week) of chemotherapy with carbo-platin (300 mg/m{sup 2} day 1) and etoposide (60 mg/m{sup 2} days 1 to 3). Sixty-one patients (group b), 40 male and 21 female, with a median age of 51 years (range 42-69) received two cycles of chemotherapy with 5 FU (750 mg/m{sup 2} days 1 to 5) and MIT C ( 10 mg/m{sup 2} day 1). The median dose of radiotherapy was 60 Gy (range 55-66 Gy) 180 cGy /d 5w. Results: the actuarial five-year survival rate(Kaplan-Meier) was 38 % for group a (CBDCA+etoposide+RT) and 25 % for group b (5FU+MIT C+RT). The difference was statistically significant (p = 0.036). Toxicity group a: mucositis G III in 41 patients and G IV in 16; dysphagia G III in 46 patients and IV in 5; leukopenia in 24 patients; 28 patients required nutritional therapy. Toxicity group b: mucositis G III in 38 patients and G IV in 17; dysphagia G III in 48 patients and G IV in 3; leukopenia in 23 patients; 25 patients needed nutritional therapy. Conclusions: the data of the actuarial survival five-year rate suggest that concomitant chemotherapy in group a (CBDCA+etoposide+RT) is better than the concomitant chemotherapy in group b (5FU+MIT C+RT). (author)

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

    Science.gov (United States)

    Ebert, David Daniel; Lehr, Dirk; Boß, Leif; Riper, Heleen; Cuijpers, Pim; Andersson, Gerhard; Thiart, Hanne; Heber, Elena; Berking, Matthias

    2014-11-01

    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 group (WLC). One-hundred and fifty teachers with elevated depressive symptoms (Center for Epidemiologic Studies Depression Scale, CES-D ≥16) were assigned to either the iPST or WLC group. The iPST consisted of five lessons, including problem-solving and rumination techniques. Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks, three months, and six months. The primary outcome was depressive symptom severity (CES-D). Secondary outcomes included general and work-specific self-efficacy, perceived stress, pathological worries, burnout symptoms, general physical and mental health, and absenteeism. iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention (d=0.59, 95% CI 0.26-0.92), after three months (d=0.37, 95% CI 0.05-0.70) and after six months (d=0.38, 95% CI 0.05-0.70) compared to the control group. The iPST participants also displayed significantly higher improvements in secondary outcomes. However, workplace absenteeism was not significantly affected. iPST is effective in reducing symptoms of depression among teachers. Disseminated on a large scale, iPST could contribute to reducing the burden of stress-related mental health problems among teachers. Future studies should evaluate iPST approaches for use in other working populations.

  19. 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.

  20. Burnout syndrome in the practice of oncology: results of a random survey of 1,000 oncologists.

    Science.gov (United States)

    Whippen, D A; Canellos, G P

    1991-10-01

    Burnout, the end result of stress, can occur in any profession. We set out to determine the extent of burnout among a representative group of American oncologists. A questionnaire with 12 specific points was designed and prepared by the authors. It was mailed to 1,000 randomly selected physician subscribers to the Journal of Clinical Oncology. Five hundred ninety-eight completed surveys (60%) were returned before the cut-off date and included in the analysis. Overall, 56% of the respondents reported experiencing burnout in their professional life. No significance was found between the incidence of burnout and specialty within oncology, year medical training ended, or practice location. Significance was found, however, between type of practice and the incidence of burnout; institution- or university-based oncologists reported a lower incidence of burnout (47%) versus all other types of practice (66% burnout rate for oncology plus internal medicine, 63% for private adult oncology only, 39% for pediatric oncologists [there were too few pediatric oncologists for this rate to be significant], and 64% for others; P = .0003). Frustration or a sense of failure was the most frequently chosen (56%) description of burnout, and insufficient personal and/or vacation time was the most frequent reason (57%) chosen to explain the existence of burnout. To alleviate burnout, the majority (69%) of respondents indicated the need for more vacation or personal time. Administering palliative or terminal care, reimbursement issues, and a heavy work load were identified as contributing factors to burnout. Given the high response to the questionnaire and a 56% incidence of burnout in the surveyed population, it is concluded that further research on this issue is required.

  1. 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).

  2. Couple-Based Psychosexual Support Following Prostate Cancer Surgery: Results of a Feasibility Pilot Randomized Control Trial.

    Science.gov (United States)

    Robertson, Jane; McNamee, Phillip; Molloy, Gerry; Hubbard, Gill; McNeill, Alan; Bollina, Prasad; Kelly, Daniel; Forbat, Liz

    2016-08-01

    Surgery for prostate cancer can result in distressing side effects such as sexual difficulties, which are associated with lower levels of dyadic functioning. The study developed and tested an intervention to address sexual, relational, and emotional aspects of the relationship after prostate cancer by incorporating elements of family systems theory and sex therapy. To develop and test the feasibility and acceptability of relational psychosexual treatment for couples with prostate cancer, determine whether a relational-psychosexual intervention is feasible and acceptable for couples affected by prostate cancer, and determine the parameters for a full-scale trial. Forty-three couples were recruited for this pilot randomized controlled trial and received a six-session manual-based psychosexual intervention or usual care. Outcomes were measured before, after, and 6 months after the intervention. Acceptability and feasibility were established from recruitment and retention rates and adherence to the manual. The primary outcome measurement was the sexual bother subdomain of the Expanded Prostate Cancer Index Composite. The Hospital Anxiety and Depression Scale and the 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) were used to measure emotional and relational functioning, respectively. The intervention was feasible and acceptable. The trial achieved adequate recruitment (38%) and retention (74%) rates. The intervention had a clinically and statistically significant effect on sexual bother immediately after the intervention. Small decreases in anxiety and depression were observed for the intervention couples, although these were not statistically significant. Practitioners reported high levels of adherence to the manual. The clinically significant impact on sexual bother and positive feedback on the study's feasibility and acceptability indicate that the intervention should be tested in a multicenter trial. The SCORE-15 lacked specificity for this

  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 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. Sex Differences in Civilian Injury in Baghdad From 2003 to 2014: Results of a Randomized Household Cluster Survey.

    Science.gov (United States)

    Shaak, Kyle; Lafta, Riyadh; Stewart, Barclay T; Fowler, Thomas R; Al-Shatari, Sahar A Esa; Burnham, Gilbert; Cherewick, Megan; Wren, Sherry M; Groen, Reinou S; Kushner, Adam L

    2018-06-01

    To examine sex differences in injury mechanisms, injury-related death, injury-related disability, and associated financial consequences in Baghdad since the 2003 invasion of Iraq to inform prevention initiatives, health policy, and relief planning. Reliable estimates of injury burden among civilians during conflict are lacking, particularly among vulnerable subpopulations, such as women. A 2-stage, cluster randomized, community-based household survey was conducted in May 2014 to determine the civilian burden of injury in Baghdad since 2003. Households were surveyed regarding injury mechanisms, healthcare required, disability, deaths, connection to conflict, and resultant financial hardship. We surveyed 900 households (5148 individuals), reporting 553 injuries, 162 (29%) of which were injuries among women. The mean age of injury was higher among women compared with men (34 ± 21.3 vs 27 ± 16.5 years; P < 0.001). More women than men were injured while in the home [104 (64%) vs 82 (21%); P < 0.001]. Fewer women than men died from injuries [11 (6.8%) vs 77 (20%); P < 0.001]; however, women were more likely than men to live with reduced function [101 (63%) vs 192 (49%); P = 0.005]. Of intentional injuries, women had higher rates of injury by shell fragments (41% vs 26%); more men were injured by gunshots [76 (41%) vs 6 (17.6%); P = .011). Women experienced fewer injuries than men in postinvasion Baghdad, but were more likely to suffer disability after injury. Efforts to improve conditions for injured women should focus on mitigating financial and provisional hardships, providing counseling services, and ensuring access to rehabilitation services.

  5. 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.

    2015-01-01

    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 PMID:26069291

  6. Radiotherapy and chemotherapy in the treatment of head and neck cancer: results after five years of a randomized study

    International Nuclear Information System (INIS)

    Santarelli, M.; Raffetto, N.; Torcia, P.; Vitturini, A.; Tombolini, V.; Maurizi Enrici, R.

    1999-01-01

    Purpose: this study was undertaken to evaluate the efficacy of two regimens of chemoradiotherapy in the treatment of locally advanced head and neck cancer. Methods: from 1992 to 1997, 127 patients with locally advanced head and neck cancer (stage III-IV) were randomized. Sixty-six patients (group a), 42 male and 24 female, with a median age of 48 years (range 40-72) received during radiotherapy two courses (1.-6. week) of chemotherapy with carbo-platin (300 mg/m 2 day 1) and etoposide (60 mg/m 2 days 1 to 3). Sixty-one patients (group b), 40 male and 21 female, with a median age of 51 years (range 42-69) received two cycles of chemotherapy with 5 FU (750 mg/m 2 days 1 to 5) and MIT C ( 10 mg/m 2 day 1). The median dose of radiotherapy was 60 Gy (range 55-66 Gy) 180 cGy /d 5w. Results: the actuarial five-year survival rate (Kaplan-Meier) was 38 % for group a (CBDCA+etoposide+RT) and 25 % for group b (5FU+MIT C+RT). The difference was statistically significant (p = 0.036). Toxicity group a: mucositis G III in 41 patients and G IV in 16; dysphagia G III in 46 patients and IV in 5; leukopenia in 24 patients; 28 patients required nutritional therapy. Toxicity group b: mucositis G III in 38 patients and G IV in 17; dysphagia G III in 48 patients and G IV in 3; leukopenia in 23 patients; 25 patients needed nutritional therapy. Conclusions: the data of the actuarial survival five-year rate suggest that concomitant chemotherapy in group a (CBDCA+etoposide+RT) is better than the concomitant chemotherapy in group b (5FU+MIT C+RT). (author)

  7. Probiotics are effective in alleviating infantile colic; results of a randomized controlled trial held at benazir bhutto hospital rawalpindi, pakistan

    International Nuclear Information System (INIS)

    Ashraf, M.W.; Ayaz, S.B.; Ashraf, M.N.

    2015-01-01

    Objectives: This study aimed to assess the role of probiotics in alleviating infantile colic (IC) while targeting local population. In case of a positive outcome, its use could be suggested in pediatric health care facilities. Methodology: It was a non-blinded randomized control trial conducted at the department of pediatrics, Benazir Bhutto Hospital, Rawalpindi from 4th October 2012 to 3rd April 2013. Through non-probability consecutive sampling we included breast-fed infants of either sex of age 3 weeks (21 days) to 3 months (90 days) diagnosed with IC based on Wessel description. We divided them into two groups i.e. group-A and B who were given probiotics containing Lactobacillus reuteri and simethicone respectively. Results: Of 90 children, 45 children were in each group. Group-A had a mean age 48 ± 17 days and group-B had a mean age 50 ± 17 days. Maximum infants were in sub-group 21 - 45 days (55.6% and 51.1% respectively) in both the groups. The male gender dominated both groups (64.4% and 57.7% respectively). Significantly large percentage (p<0.001) of infants in group-A (86.7%) reached the landmark set for the efficacy confirmation than group-B (51.1%). The mean crying time for the group-A (39 ± 53 minutes) at the end of treatment was significantly shorter (p<0.001) than that of group-B (113 ± 54 minutes). No side effect was reported in the whole sample. Conclusion: Probiotics containing Lactobacillus reuteri significantly improved symptoms in managing IC than simethicaone with no side effects. (author)

  8. Telomere disruption results in non-random formation of de novo dicentric chromosomes involving acrocentric human chromosomes.

    Directory of Open Access Journals (Sweden)

    Kaitlin M Stimpson

    2010-08-01

    Full Text Available Genome rearrangement often produces chromosomes with two centromeres (dicentrics that are inherently unstable because of bridge formation and breakage during cell division. However, mammalian dicentrics, and particularly those in humans, can be quite stable, usually because one centromere is functionally silenced. Molecular mechanisms of centromere inactivation are poorly understood since there are few systems to experimentally create dicentric human chromosomes. Here, we describe a human cell culture model that enriches for de novo dicentrics. We demonstrate that transient disruption of human telomere structure non-randomly produces dicentric fusions involving acrocentric chromosomes. The induced dicentrics vary in structure near fusion breakpoints and like naturally-occurring dicentrics, exhibit various inter-centromeric distances. Many functional dicentrics persist for months after formation. Even those with distantly spaced centromeres remain functionally dicentric for 20 cell generations. Other dicentrics within the population reflect centromere inactivation. In some cases, centromere inactivation occurs by an apparently epigenetic mechanism. In other dicentrics, the size of the alpha-satellite DNA array associated with CENP-A is reduced compared to the same array before dicentric formation. Extra-chromosomal fragments that contained CENP-A often appear in the same cells as dicentrics. Some of these fragments are derived from the same alpha-satellite DNA array as inactivated centromeres. Our results indicate that dicentric human chromosomes undergo alternative fates after formation. Many retain two active centromeres and are stable through multiple cell divisions. Others undergo centromere inactivation. This event occurs within a broad temporal window and can involve deletion of chromatin that marks the locus as a site for CENP-A maintenance/replenishment.

  9. Physical activity within a CBT intervention improves coping with pain in traumatized refugees: results of a randomized controlled design.

    Science.gov (United States)

    Liedl, Alexandra; Müller, Julia; Morina, Naser; Karl, Anke; Denke, Claudia; Knaevelsrud, Christine

    2011-02-01

    Many traumatized refugees experience both posttraumatic stress disorder and chronic pain. Based on Mutual Maintenance Theory and the Perpetual Avoidance Model, this study examined the additional effect of physical activity within a biofeedback-based cognitive behavioral therapy (CBT-BF) for traumatized refugees. In a controlled design, 36 patients were randomized into one of three conditions (CBT-BF, CBT-BF with physical activity [CBT-BF+active], and a waiting list control group [WL]). Thirty patients (n=10 in each group) completed the treatment and a follow-up assessment 3 months later. Participants' coping strategies, pain and mental health status, and physiological reactivity were assessed before and after the intervention and at 3-month follow-up. Treatment effects were analyzed using analyses of variance with baseline scores as covariates (ANCOVAs) and the Reliable Change Index. The CBT-BF and CBT-BF+active groups showed improvements in all outcome measures relative to the WL group. The effect sizes for the main outcome measures were higher in the CBT-BF+active group than in the CBT-BF group. Repeated measures analyses of covariance showed significant group effects for coping strategies--in particular, for the "cognitive restructuring" and "counter-activities" subscales as well as a marginally significant group effect for "perceived self-competence"--with the CBT-BF+active group showing more favorable outcomes than the CBT-BF group. Moreover, 60% of participants in the CBT-BF+active group showed clinically reliable intraindividual change in at least one subscale of the pain coping strategies questionnaire, compared with just 30% of participants in the CBT-BF group. Findings of improved coping strategies, larger effect sizes, and higher rates of clinical improvement in the CBT-BF+active group suggest that physical activity adds value to pain management interventions for traumatized refugees. Given the small sample size, however, these preliminary results need

  10. 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

  11. Melatonin increases anagen hair rate in women with androgenetic alopecia or diffuse alopecia: results of a pilot randomized controlled trial.

    Science.gov (United States)

    Fischer, T W; Burmeister, G; Schmidt, H W; Elsner, P

    2004-02-01

    In addition to the well-known hormonal influences of testosterone and dihydrotestosterone on the hair cycle, melatonin has been reported to have a beneficial effect on hair growth in animals. The effect of melatonin on hair growth in humans has not been investigated so far. To examine whether topically applied melatonin influences anagen and telogen hair rate in women with androgenetic or diffuse hair loss. A double-blind, randomized, placebo-controlled study was conducted in 40 women suffering from diffuse alopecia or androgenetic alopecia. A 0.1% melatonin or a placebo solution was applied on the scalp once daily for 6 months and trichograms were performed to assess anagen and telogen hair rate. To monitor effects of treatment on physiological melatonin levels, blood samples were taken over the whole study period. Melatonin led to a significantly increased anagen hair rate in occipital hair in women with androgenetic hair loss compared with placebo (n=12; P=0.012). For frontal hair, melatonin gave a significant increase in the group with diffuse alopecia (n=28; P=0.046). The occipital hair samples of patients with diffuse alopecia and the frontal hair counts of those with androgenetic alopecia also showed an increase of anagen hair, but differences were not significant. Plasma melatonin levels increased under treatment with melatonin, but did not exceed the physiological night peak. To the authors' knowledge, this pilot study is the first to show that topically applied melatonin might influence hair growth in humans in vivo. The mode of action is not known, but the effect might result from an induction of anagen phase.

  12. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.

    Science.gov (United States)

    Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio

    2005-08-01

    An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.

  13. Random-field effects on the order in the diluted weakly anisotropic antiferromagnet K2NixZn1-xF4

    DEFF Research Database (Denmark)

    Dikken, B. J.; Arts, A. F. M.; Wijn, H. W. de

    1984-01-01

    With the use of neutron diffraction, the effects of random fields are studied in the diluted quadratic-layer antiferromagnet K2NixZn1-xF4 for x=0.96, 0.85, and 0.75. Upon cooling in external fields as small as H∼0.1 T, the systems quench into a nonequilibrium domain state characterized...

  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. 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

  16. results

    Directory of Open Access Journals (Sweden)

    Salabura Piotr

    2017-01-01

    Full Text Available HADES experiment at GSI is the only high precision experiment probing nuclear matter in the beam energy range of a few AGeV. Pion, proton and ion beams are used to study rare dielectron and strangeness probes to diagnose properties of strongly interacting matter in this energy regime. Selected results from p + A and A + A collisions are presented and discussed.

  17. 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…

  18. 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

  19. Lactotripeptides Show No Effect on Human Blood Pressure: Results from a double-blind randomized controlled trial

    NARCIS (Netherlands)

    Engberink, M.F.; Schouten, E.G.; Kok, F.J.; Mierlo, van L.A.J.; Brouwer, I.A.; Geleijnse, J.M.

    2008-01-01

    Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and

  20. 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…

  1. 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.

  2. Relative Cost-Effectiveness of Treatments for Adolescent Depression: 36-Week Results from the TADS Randomized Trial

    Science.gov (United States)

    Domino, Marisa Elena; Foster, E. Michael; Vitiello, Benedetto; Kratochvil, Christopher J.; Burns, Barbara J.; Silva, Susan G.; Reinecke, Mark A.; March, John S.

    2009-01-01

    Randomized controlled trials that involve 327 participants aged 12 to 18 who were diagnosed with major depression were given either fluoxetine alone, cognitive-behavioral therapy, or a combination of both. Cost-effectiveness acceptability curves suggest that combination treatment is highly likely to be the most cost-effective treatment than…

  3. 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…

  4. 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.

  5. 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…

  6. 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

  7. 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…

  8. Research on random service system efficiency of sorted storage manual order picking manners%分类存储人工拣选随机服务系统效率研究

    Institute of Scientific and Technical Information of China (English)

    朱杰; 周丽; 郭键

    2012-01-01

    The manual order picking system with order arrival as Poisson flow, and single picking servicer can be considered as M/G/l random service system. This paper studies the efficiency optimization problem of manual order picking system. We also analyze the stochastic characteristics of arrived orders goods categories and items number. The paper establishes picker route stochastic models under sorted storage return-type and S-type picking for logistics distribution center to deduce corresponding picking time distribution functions. Experiment results show that the two models approximate all approach simulation better under permitted error conditions. Compare the two picking manners with five kinds of goods order frequency and storage assignment, and then get application situations. This paper provides reference for estimation picking time and waiting time of traditional rectangular logistic distribution center, and provides basis for choosing storage strategy.%可以把订单服从泊松输入、单个拣选人员提供服务的人工拣选作业系统看作M/G/1随机服务系统,研究此随机服务系统的效率优化问题.分析订单到达的物品种类与件数随机特性,建立分类存储返回型与S型拣选距离随机模型,分别推导相应的拣选时间分布.仿真结果表明,两个模型的结果能在误差允许条件下较好地与仿真逼近.比较5种物品订购频率和货位分配情况下的返回型和S型拣选方式,得出两种拣选方式各自适用的情况.研究结论可以为传统矩形配送中心的订单拣选时间、等待时间估计提供参考,可为拣选路径方式选择提供依据.

  9. Ocular iontophoresis of EGP-437 (dexamethasone phosphate in dry eye patients: results of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Patane MA

    2011-05-01

    Full Text Available Michael A Patane¹, Amy Cohen¹, Stephen From¹, Gail Torkildsen², Donna Welch³, George W Ousler III³¹Eyegate Pharmaceuticals, Inc, Waltham, MA, USA; ²Andover Eye Associates, Andover, MA, USA; ³Ora, Inc, Andover, MA, USAPurpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP] in dry eye patients.Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE. Patients (n = 103 with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.5 mA-min at 2.5 mA (DP 7.5, n = 41; 10.5 mA-min at 3.5 mA (DP 10.5, n = 37; or 10.5 mA-min at 3.5 mA (placebo, n = 25. Three CAE visits and 4 follow-up visits occurred over 3 weeks. Patients meeting enrollment criteria received iontophoresis in both eyes after the second CAE exposure (visit 3 and before the third CAE exposure (visit 5. Primary efficacy endpoints were corneal staining and ocular discomfort. Secondary endpoints included tear film break-up time, ocular protection index (OPI, and symptomatology.Results: The DP 7.5 and DP 10.5 treatment groups showed statistically significant improvements in signs and symptoms of dry eye at various time points; however, the primary endpoints were not achieved. The DP 7.5 treatment group exhibited statistically significant improvements in corneal staining (when comparing the differences between study entry and exit, 3 weeks, P = 0.039, OPI (immediately following the second treatment, P = 0.048 and ocular discomfort at follow-up visits (a week after the first treatment, P = 0.032; 24 hours after the second treatment, P = 0.0032. Treatment-emergent adverse events (AEs were experienced by 87% of patients and were consistent across all treatment groups. Most AEs were mild and no severe AEs were observed.Conclusion: Ocular iontophoresis of EGP-437 demonstrated statistically and clinically significant improvements in

  10. 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 < .05) and in AUC analysis (P < .001). 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

  11. Technology-enhanced writing therapy for people with aphasia: results of a quasi-randomized waitlist controlled study.

    Science.gov (United States)

    Marshall, Jane; Caute, Anna; Chadd, Katie; Cruice, Madeline; Monnelly, Katie; Wilson, Stephanie; Woolf, Celia

    2018-05-10

    Acquired writing impairment, or dysgraphia, is common in aphasia. It affects both handwriting and typing, and may recover less well than other aphasic symptoms. Dysgraphia is an increasing priority for intervention, particularly for those wishing to participate in online written communication. Effective dysgraphia treatment studies have been reported, but many did not target, or did not achieve, improvements in functional writing. Functional outcomes might be promoted by therapies that exploit digital technologies, such as voice recognition and word prediction software. This study evaluated the benefits of technology-enhanced writing therapy for people with acquired dysgraphia. It aimed to explore the impact of therapy on a functional writing activity, and to examine whether treatment remediated or compensated for the writing impairment. The primary question was: Does therapy improve performance on a functional assessment of writing; and, if so, do gains occur only when writing is assisted by technology? Secondary measures examined whether therapy improved unassisted written naming, functional communication, mood and quality of life. The study employed a quasi-randomized waitlist controlled design. A total of 21 people with dysgraphia received 12 h of writing therapy either immediately or after a 6-week delay. The primary outcome measure was a functional assessment of writing, which was administered in handwriting and on a computer with assistive technology enabled. Secondary measures were: The Boston Naming Test (written version), Communication Activities of Daily Living-2, Visual Analogue Mood Scales (Sad question), and the Assessment of Living with Aphasia. Analyses of variance (ANOVA) were used to examine change on the outcome measures over two time points, between which the immediate group had received therapy but the delayed group had not. Pre-therapy, post-therapy and follow-up scores on the measures were also examined for all participants. Time × group

  12. Side-to-end vs. straight stapled colorectal anastomosis after low anterior resection: results of randomized clinical trial.

    Science.gov (United States)

    Rybakov, E G; Pikunov, D Yu; Fomenko, O Yu; Chernyshov, S V; Shelygin, Yu A

    2016-08-01

    The aim of this study is to compare surgical, functional, physiologic outcomes and QOL after low anterior resection (LAR) with andside-to-end or straight colorectal anastomosis. Between 2012 and 2015, 86 patients with mid and low rectal tumors were enrolled into randomized trial. Wexner score, number of defecations, use of antidiarrheal medicine or laxatives, enemas, pads, episodes of nocturnal incontinence, and urgency were recorded. The Fecal Incontinence Quality of Life (FIQL) scale was used for assessment of QOL. Anal manometry and volumetric examination were performed. Six patients were excluded from the study. There was no mortality. The morbidity rate was 6 (14.6 %) for side-to-end vs. 8 (20.0 %) for straight anastomosis (p = 0.57). The median Wexner score was 5 vs. 6 (p = 0.033), 4 vs. 5 (p = 0.006), and 2 vs. 3 (p = 0.1) at 1, 3, and 6 months after stoma reversal, respectively. Side-to-end anastomosis resulted in a fewer mean numbers of bowel movements per day at the same check points of follow-up: 5.8 ± 0.14 vs. 6.4 ± 0.15 (p = 0.006), 3.7 ± 0.1 vs. 4.2 ± 0.1 (p = 0.003), and 2.5 ± 0.1 vs. 3.0 ± 0.10 (p = 0.0002), correspondingly. Maximal tolerated volume was higher for side-to-end anastomosis at 3 and 6 months of follow-up: 152.0 vs. 137.8 cm(3) (p = 0.002) and 180.5 vs. 167.0 cm(3) (p = 0.006), respectively. Better FIQL score was found at 1 and 3 months in the side-to-end group. Better functional outcomes and QOL were observed in a short period after stoma closure, but at 6 months of follow-up, the only benefit of side-to-end anastomosis was a lower number of bowel movements.

  13. 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

  14. Effectiveness of skin protection creams in the prevention of occupational dermatitis: results of a randomized, controlled trial.

    Science.gov (United States)

    Winker, Robert; Salameh, Bayda; Stolkovich, Sabine; Nikl, Michael; Barth, Alfred; Ponocny, Elisabeth; Drexler, Hans; Tappeiner, Gerhard

    2009-04-01

    The aim of the trial was to investigate whether the publicized effects of skin protection creams can be replicated in a real occupational setting during activities that expose the skin. A prospective, randomized, four-tailed controlled pilot trial was performed to compare the effect of skin protection and skin care alone or in combination with cleansing against a control group (only cleansing). Two branches were selected for the investigation: the building industry and the timber industry. A total of 1,006 workers from these two branches were recruited, and out of these 485 workers were examined longitudinally for at least three time points over 1 year (lost for follow-up: 430 workers, exclusion: 91 workers). At each time point, as a primary outcome measure, we assessed the condition of the skin at both hands in a blinded manner and the individual was assigned to one of the following categories: no eczema, mild, moderate and severe eczema. As a secondary outcome measure, the worker's transepidermal water loss (TEWL) was measured under standardized conditions at the back of both hands. In addition, the workers were asked to evaluate their skin condition during the study. With regard to differences in the occurrence of eczemas, we found only in workers in building industry without application of skin protection or skin care creams a statistical significant increase in the incidence between the first and the second visit and a statistical significant decrease in the incidence between the second and third visit. When evaluating the secondary outcome-measurement changes in the TEWL values, an improvement was found for the group skin protection and skin care in combination and by skin care alone. Females in the timber industry started with better TEWL values than males, which may be due to better overall skin care. In this group we found an improvement for the group skin protection and skin care in combination and by skin protection alone. For skin protection alone, we

  15. Long-term results of a randomized controlled trial evaluating preoperative chemotherapy in resectable non-small cell lung cancer

    Directory of Open Access Journals (Sweden)

    Chen ZW

    2013-06-01

    Full Text Available Zhiwei Chen,* Qingquan Luo,* Hong Jian, Zhen Zhou, Baijun Cheng, Shun Lu, Meilin LiaoShanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China *These authors contributed equallyObjective: We aimed to evaluate whether preoperative chemotherapy provides benefits in the survival and prognosis of patients with non-small cell lung cancer (NSCLC in resectable stages I to IIIA, except T1N0. Methods: In this randomized, controlled trial, 356 patients with stage I (except for T1N0, II and IIIA NSCLC were assigned to either the preoperative chemotherapy plus surgery arm (179 patients or the primary surgery arm (177 patients. Both treatments were followed by adjuvant chemotherapy. The end point of this study included overall survival (OS, progression-free survival (PFS, and survival rate associated with clinical remission. Results: Statistical survival difference was found between the preoperative chemotherapy plus surgery arm and the surgery-alone arm. However, the median survival time (MST in the preoperative chemotherapy arm was lower than that of surgery-alone arm (MST, 45.42 months vs 57.59 months (P = 0.016. When comparing the effect of preoperative chemotherapy at each stage of NSCLC, a statistical survival difference was found in stage II NSCLC but not in stage I and IIIA (MST 40.86 months vs 80.81 months (P = 0.044. However, no statistically significant difference in PFS was noticed between the two arms, except for stage I NSCLC (hazard radio [HR] = 0.87; 95% CI, 0.561−1.629; P = 0.027. The survival rate was higher for patients who had clinical remission after preoperative chemotherapy, but the differences did not reach statistical significance (MST 42.10 months vs 35.33 months (P = 0.630. Conclusion: Preoperative chemotherapy did not show benefits in OS and PFS for stage I-IIIA NSCLC patients. Keywords: NSCLC, neoadjuvent, mitomycin, cisplatin, vindesine

  16. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

    Science.gov (United States)

    Gass, Jonathon D; Misra, Anamika; Yadav, Mahendra Nath Singh; Sana, Fatima; Singh, Chetna; Mankar, Anup; Neal, Brandon J; Fisher-Bowman, Jennifer; Maisonneuve, Jenny; Delaney, Megan Marx; Kumar, Krishan; Singh, Vinay Pratap; Sharma, Narender; Gawande, Atul; Semrau, Katherine; Hirschhorn, Lisa R

    2017-09-07

    There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial. We designed the Data Quality Monitoring and Improvement System (DQMIS) to reinforce six dimensions of data quality: accuracy, reliability, timeliness, completeness, precision, and integrity. The DQMIS was comprised of five functional components: 1) a monitoring and evaluation team to support the system; 2) a DQA protocol, including data collection audits and targets, rapid data feedback, and supportive supervision; 3) training; 4) standard operating procedures for data collection; and 5) an electronic data collection and reporting system. Routine audits by supervisors included double data entry, simultaneous delivery observations, and review of recorded calls to patients. Data feedback reports identified errors automatically, facilitating supportive supervision through a continuous quality improvement model. The five functional components of the DQMIS successfully reinforced data reliability, timeliness, completeness, precision, and integrity. The DQMIS also resulted in 98.33% accuracy across all data collection activities in the trial. All data collection activities demonstrated improvement in accuracy throughout implementation. Data collectors demonstrated a statistically significant (p = 0.0004) increase in accuracy throughout

  17. E-cigarettes May Support Smokers With High Smoking-Related Risk Awareness to Stop Smoking in the Short Run: Preliminary Results by Randomized Controlled Trial.

    Science.gov (United States)

    Masiero, Marianna; Lucchiari, Claudio; Mazzocco, Ketti; Veronesi, Giulia; Maisonneuve, Patrick; Jemos, Costantino; Salè, Emanuela Omodeo; Spina, Stefania; Bertolotti, Raffaella; Pravettoni, Gabriella

    2018-04-11

    E-cigarettes may be positively used in tobacco cessation treatments. However, neither the World Health Organization nor the American Food and Drug Administration has recognized them as effective cessation aids. Data about the efficacy and safety of e-cigarettes are still limited and controversial. This was a double-blind randomized controlled study. The main aim was to assess the efficacy of the use of e-cigarettes in a tobacco cessation program with a group of chronic smokers voluntarily involved in long-term lung cancer screening. Participants were randomized into three arms: e-cigarettes (Arm 1), placebo (Arm 2), and control (Arm 3). All subjects also received a low-intensity counseling. About 25% of participants who followed a cessation program based on the use of e-cigarettes (Arm 1 and Arm 2) were abstinent after 3 months. Conversely, only about 10% of smokers in Arm 3 stopped. Participants in Arm 1 also reported a higher reduction rate (M = -11.6441, SD = 7.574) than participants in Arm 2 (M = -10.7636, SD = 8.156) and Arm 3 (M = -9.1379, SD = 8.8127). Our findings support the efficacy and safety of e-cigarettes in a short-term period. E-cigarettes use led to a higher cessation rate. Furthermore, although all participants reported a significant reduction of daily cigarette consumption compared to the baseline, the use of e-cigarettes (including those without nicotine) allowed smokers to achieve better results. E-cigarettes increased the stopping rate as well as the reduction of daily cigarettes in participants who continued smoking. In fact, although all participants reported a significant reduction of tobacco consumption compared to the baseline, the use of e-cigarettes allowed smokers to achieve a better result. It could be worthwhile to associate this device with new ICT-driven models of self-management support in order to enable people to better handle behavioral changes and side effects. This is true for ready-to-quit smokers (such as our participants

  18. Oral pilocarpine for radiation-induced xerostomia: integrated efficacy and safety results from two prospective randomized clinical trials

    International Nuclear Information System (INIS)

    Rieke, John W.; Hafermann, Mark D.; Johnson, Jonas T.; LeVeque, Francis G.; Iwamoto, Ryan; Steiger, Barry W.; Muscoplat, Charles; Gallagher, Susan C.

    1995-01-01

    Purpose: Pilocarpine hydrochloride administered in either a fixed-dose or in a dose-titration protocol three times a day for 12 weeks was evaluated for its ability to relieve symptoms of postradiation xerostomia and to improve saliva production. The studies were randomized, double-blind, placebo-controlled, multicenter clinical trials. A total of 369 patients who had received at least 40 Gy of radiation to the head and neck with clinically significant xerostomia were enrolled in the two studies. In the dose-titration study, 162 patients were enrolled and they received a thrice daily regimen of 2.5 mg tablets for first 4 weeks, 5.0 mg tablets for the second 4 weeks, and 10.0 mg tablets for last 4 weeks of a 12-week study. Patients in the titration study were allowed to down titrate following at least one dose escalation to alleviate bothersome side effects, if any. In the fixed dose study, 207 patients received either placebo, 5.0 mg, or 10.0 mg tablets t.i.d. for 12 weeks. Methods and Materials: Patients were evaluated for symptomatic relief by responding to questionnaires using visual analog scales and categorical questions; and, for saliva production by sialometry. Questionnaires measured relief of intraoral dryness, improvement in overall condition (global response), oral discomfort, difficulty in speaking, chewing and swallowing, denture wearing, and usage of artificial saliva. Evaluations were conducted at baseline, and weeks 4, 8, and 12. Results: There were statistically significant improvements in salivary flow in pilocarpine treatment groups vs. placebo. There was a significant improvement in the overall 'global' condition of xerostomia associated with the use of pilocarpine in both studies. In the fixed-dose study, there were significant improvements in oral dryness, mouth comfort, ability to speak, and reduction in the use of oral comfort agents. The dose-titration study showed improvements in dryness that approached significance (p = 0.057) and a

  19. Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost

    DEFF Research Database (Denmark)

    Appelt, Ane L; Vogelius, Ivan R; Pløen, John

    2014-01-01

    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...... 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...

  20. The Kubo-Greenwood formula as a result of the random phase approximation for the electrons of the metal

    Science.gov (United States)

    Ivliev, S. V.

    2017-12-01

    For calculation of short laser pulse absorption in metal the imaginary part of permittivity, which is simply related to the conductivity, is required. Currently to find the static and dynamic conductivity the Kubo-Greenwood formula is most commonly used. It describes the electromagnetic energy absorption in the one-electron approach. In the present study, this formula is derived directly from the expression for the permittivity expression in the random phase approximation, which in fact is equivalent to the method of the mean field. The detailed analysis of the role of electron-electron interaction in the calculation of the matrix elements of the velocity operator is given. It is shown that in the one-electron random phase approximation the single-particle conductive electron wave functions in the field of fixed ions should be used. The possibility of considering the exchange and correlation effects by means of an amendment to a local function field is discussed.

  1. The medical food Souvenaid affects brain phospholipid metabolism in mild Alzheimer's disease: results from a randomized controlled trial

    OpenAIRE

    Rijpma, A.; Graaf, M. van der; Lansbergen, M.M.; Meulenbroek, O.V.; Cetinyurek-Yavuz, A.; Sijben, J.W.; Heerschap, A.; Olde Rikkert, M.G.M.

    2017-01-01

    Background Synaptic dysfunction contributes to cognitive impairment in Alzheimer?s disease and may be countered by increased intake of nutrients that target brain phospholipid metabolism. In this study, we explored whether the medical food Souvenaid affects brain phospholipid metabolism in patients with Alzheimer?s disease. Methods Thirty-four drug-naive patients with mild Alzheimer?s disease (Mini Mental State Examination score ?20) were enrolled in this exploratory, double-blind, randomized...

  2. 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.

  3. A facility specialist model for improving retention of nursing home staff: results from a randomized, controlled study.

    Science.gov (United States)

    Pillemer, Karl; Meador, Rhoda; Henderson, Charles; Robison, Julie; Hegeman, Carol; Graham, Edwin; Schultz, Leslie

    2008-07-01

    This article reports on a randomized, controlled intervention study designed to reduce employee turnover by creating a retention specialist position in nursing homes. We collected data three times over a 1-year period in 30 nursing homes, sampled in stratified random manner from facilities in New York State and Connecticut and randomly assigned to treatment and control conditions. Staff outcomes were measured through certified nursing assistant interviews, and turnover rates were measured over the course of the year. In the intervention condition, a staff member was selected to be the facility retention specialist, who would advocate for and implement programs to improve staff retention and commitment throughout the facility. Retention specialists received an intensive 3-day training in retention leadership and in a number of evidence-based retention programs. Ongoing support was provided throughout the project. Treatment facilities experienced significant declines in turnover rates compared to control facilities. As predicted, we found positive effects on certified nursing assistant assessments of the quality of retention efforts and of care provided in the facility; we did not find effects for job satisfaction or stress. The study provides evidence for the effectiveness of the retention specialist model. Findings from a detailed process evaluation suggest modifications of the program that may increase program effects.

  4. Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

    Science.gov (United States)

    Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

    2014-10-01

    An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

  5. The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

    Science.gov (United States)

    Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

    2018-03-01

    Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

  6. Detailed computational fluid dynamics calculations in order to assess respective safety issues regarding existing nuclear power plant. Interpretation and presentation of results

    International Nuclear Information System (INIS)

    2014-11-01

    The results of analysis showed that in case of injection of cold water to loops water temperature stratification in the pipes will occur if all the RCPs (Reactor Coolant Pump) are stopped. This water temperature stratification can lead to temperature misreading by sensors if they are located improperly, and may lead to wrong operation of PTS (Pressurized Thermal Shock) protection system. Therefore, results of current analysis can be used to choose the correct locations for temperature sensors to be installed in order to determine whether PTS protection system should be activated

  7. 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

  8. Fractional Brownian motions via random walk in the complex plane and via fractional derivative. Comparison and further results on their Fokker-Planck equations

    International Nuclear Information System (INIS)

    Jumarie, Guy

    2004-01-01

    There are presently two different models of fractional Brownian motions available in the literature: the Riemann-Liouville fractional derivative of white noise on the one hand, and the complex-valued Brownian motion of order n defined by using a random walk in the complex plane, on the other hand. The paper provides a comparison between these two approaches, and in addition, takes this opportunity to contribute some complements. These two models are more or less equivalent on the theoretical standpoint for fractional order between 0 and 1/2, but their practical significances are quite different. Otherwise, for order larger than 1/2, the fractional derivative model has no counterpart in the complex plane. These differences are illustrated by an example drawn from mathematical finance. Taylor expansion of fractional order provides the expression of fractional difference in terms of finite difference, and this allows us to improve the derivation of Fokker-Planck equation and Kramers-Moyal expansion, and to get more insight in their relation with stochastic differential equations of fractional order. In the case of multi-fractal systems, the Fokker-Planck equation can be solved by using path integrals, and the fractional dynamic equations of the state moments of the stochastic system can be easily obtained. By combining fractional derivative and complex white noise of order n, one obtains a family of complex-valued fractional Brownian motions which exhibits long-range dependence. The conclusion outlines suggestions for further research, mainly regarding Lorentz transformation of fractional noises

  9. Comparison of outcomes among patients randomized to warfarin therapy according to anticoagulant control: results from SPORTIF III and V

    DEFF Research Database (Denmark)

    White, Harvey D; Gruber, Michael; Feyzi, Jan

    2007-01-01

    BACKGROUND: Warfarin sodium reduces stroke risk in patients with atrial fibrillation, but international normalized ratio (INR) monitoring is required. Target INRs are frequently not achieved, and the risk of death, bleeding, myocardial infarction (MI), and stroke or systemic embolism event (SEE......) may be related to INR control. METHODS: We analyzed the relationship between INR control and the rates of death, bleeding, MI, and stroke or SEE among 3587 patients with atrial fibrillation randomized to receive warfarin treatment in the SPORTIF (Stroke Prevention Using an Oral Thrombin Inhibitor...... control group (1.69% and 1.58%, respectively) (Pwarfarin, the risks of death...

  10. Controls/CFD Interdisciplinary Research Software Generates Low-Order Linear Models for Control Design From Steady-State CFD Results

    Science.gov (United States)

    Melcher, Kevin J.

    1997-01-01

    The NASA Lewis Research Center is developing analytical methods and software tools to create a bridge between the controls and computational fluid dynamics (CFD) disciplines. Traditionally, control design engineers have used coarse nonlinear simulations to generate information for the design of new propulsion system controls. However, such traditional methods are not adequate for modeling the propulsion systems of complex, high-speed vehicles like the High Speed Civil Transport. To properly model the relevant flow physics of high-speed propulsion systems, one must use simulations based on CFD methods. Such CFD simulations have become useful tools for engineers that are designing propulsion system components. The analysis techniques and software being developed as part of this effort are an attempt to evolve CFD into a useful tool for control design as well. One major aspect of this research is the generation of linear models from steady-state CFD results. CFD simulations, often used during the design of high-speed inlets, yield high resolution operating point data. Under a NASA grant, the University of Akron has developed analytical techniques and software tools that use these data to generate linear models for control design. The resulting linear models have the same number of states as the original CFD simulation, so they are still very large and computationally cumbersome. Model reduction techniques have been successfully applied to reduce these large linear models by several orders of magnitude without significantly changing the dynamic response. The result is an accurate, easy to use, low-order linear model that takes less time to generate than those generated by traditional means. The development of methods for generating low-order linear models from steady-state CFD is most complete at the one-dimensional level, where software is available to generate models with different kinds of input and output variables. One-dimensional methods have been extended

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

    KAUST Repository

    Nam, Sungsik; Yang, Hongchuan; Alouini, Mohamed-Slim; Kim, Dongin

    2014-01-01

    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

  12. Efficacy of a medical food on cognition in Alzheimer's disease: results from secondary analyses of a randomized, controlled trial.

    Science.gov (United States)

    Kamphuis, P J G H; Verhey, F R J; Olde Rikkert, M G M; Twisk, J W R; Swinkels, S H N; Scheltens, P

    2011-08-01

    To investigate the extent that baseline cognitive impairment and intake adherence affected the 13-item Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) intervention response of a medical food in Alzheimer's Disease (AD) patients. DESIGN/SETTING/PARTICIPANTS /INTERVENTION/MEASUREMENTS: This analysis was performed on data from a proof-of-concept study, consisting of a 12-week, double-blind, randomized, controlled, multicenter trial, followed by a similarly designed 12-week extension study. Patients with mild AD (Mini-Mental State Examination [MMSE] score of 20-26) were randomized to receive active or control product as a 125 ml daily drink. One of the co-primary outcome measures was the 13-item ADAS-cog. In this analysis, the study population was divided into two subgroups: patients with 'low' baseline ADAS-cog scores (Souvenaid intervention on ADAS-cog outcome. A higher intake of active study product was also associated with greater cognitive benefit. These findings highlight the potential benefits of Souvenaid in AD patients and warrant confirmation in larger, controlled studies.

  13. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  14. Dissemination of evidence-based cancer control interventions among Catholic faith-based organizations: results from the CRUZA randomized trial.

    Science.gov (United States)

    Allen, Jennifer D; Torres, Maria Idalí; Tom, Laura S; Leyva, Bryan; Galeas, Ana V; Ospino, Hosffman

    2016-05-18

    The CRUZA randomized trial tested the efficacy of an organizational-level intervention to increase the capacity of Catholic faith-based organizations (FBOs) serving Latinos to implement evidence-based strategies (EBS) for cancer control. Thirty-one Catholic parishes were enrolled. Twenty were randomized to a "capacity enhancement" (CE) intervention and 11 to a "standard dissemination" (SD) condition. Each received a Program Implementation Manual and Toolkit of materials culturally adapted for FBOs with Latino audiences for five types of EBS recommended by the US Preventive Services Community Guide. CE parishes were offered a menu of capacity-building activities over a 3-month period, while SD parishes were provided a one-time consultation by an Intervention Specialist. Baseline and follow-up surveys compared the number and types of EBS offered. At baseline, only one parish had offered any cancer-related program in the prior year, yet a third (36 %) had offered some other type of health program or service. At post-intervention follow-up, all parishes offered a greater number of EBS. The only statistically significant difference between CE and SD groups was the number of parishes offering small media interventions (90 % in CE, 64 % in SD; p support to carry out programming. Further research is needed to examine the extent to which program offerings continued after the period of grant funding. Clinicaltrials.gov NCT01740219 .

  15. An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results.

    Science.gov (United States)

    Boezeman, Edwin J; Nieuwenhuijsen, Karen; Sluiter, Judith K

    2018-06-01

    The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress.

  16. Policing behaviors, safe injection self-efficacy, and intervening on injection risks: Moderated mediation results from a randomized trial.

    Science.gov (United States)

    Pitpitan, Eileen V; Patterson, Thomas L; Abramovitz, Daniela; Vera, Alicia; Martinez, Gustavo; Staines, Hugo; Strathdee, Steffanie A

    2016-01-01

    We aim to use conditional or moderated mediation to simultaneously test how and for whom an injection risk intervention was efficacious at reducing receptive needle sharing among female sex workers who inject drugs (FSWs-IDUs) in Mexico. Secondary analysis of data from a randomized trial. A total of 300 FSW-IDUs participated in Mujer Mas Segura in Ciudad Juarez, Mexico, and were randomized to an interactive injection risk intervention or a didactic injection risk intervention. We measured safe injection self-efficacy as the hypothesized mediator and policing behaviors (being arrested and syringe confiscation) as hypothesized moderators. In total, 213 women provided complete data for the current analyses. Conditional (moderated) mediation showed that the intervention affected receptive needle sharing through safe injection self-efficacy among women who experienced syringe confiscation. On average, police syringe confiscation was associated with lower safe injection self-efficacy (p = .04). Among those who experienced syringe confiscation, those who received the interactive (vs. didactic) intervention reported higher self-efficacy, which in turn predicted lower receptive needle sharing (p = .04). Whereas syringe confiscation by the police negatively affected safe injection self-efficacy and ultimately injection risk behavior, our interactive intervention helped to "buffer" this negative impact of police behavior on risky injection practices. The theory-based, active skills building elements included in the interactive condition, which were absent from the didactic condition, helped participants' self-efficacy for safer injection in the face of syringe confiscation. (c) 2015 APA, all rights reserved).

  17. The Effect of Changes in Physical Activity on Sedentary Behavior: Results From a Randomized Lifestyle Intervention Trial.

    Science.gov (United States)

    Siddique, Juned; de Chavez, Peter John; Craft, Lynette L; Freedson, Patty; Spring, Bonnie

    2017-07-01

    To investigate whether changes in physical activity (PA) have an impact on sedentary behavior (SB) during a lifestyle intervention. Study design was a randomized trial. Participants (n = 204) were individuals with low PA and high sedentary leisure screen time from the Chicago area. Participants were randomized to either increase PA (iPA) or decrease sedentary leisure (dSED). The intervention consisted of decision support, coaching, and financial incentives. For iPA participants, the goal was at least 60 min/d of self-reported moderate-tovigorous-intensity PA (MVPA). For dSED participants the goal was less than 90 min/d of sedentary leisure screen time. Daily accelerometer-based measures of SB and bout-corrected MVPA were obtained. Linear mixed-effects models were fit to estimate the effect of the intervention on MVPA and total SB and to estimate the effect of daily changes in MVPA on daily SB. The iPA participants increased their bout-corrected MVPA by 14 min/d (p much of this time by reducing their SB.

  18. 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

  19. 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

  20. Improving temporal bone dissection using self-directed virtual reality simulation: results of a randomized blinded control trial.

    Science.gov (United States)

    Zhao, Yi Chen; Kennedy, Gregor; Yukawa, Kumiko; Pyman, Brian; O'Leary, Stephen

    2011-03-01

    A significant benefit of virtual reality (VR) simulation is the ability to provide self-direct learning for trainees. This study aims to determine whether there are any differences in performance of cadaver temporal bone dissections between novices who received traditional teaching methods and those who received unsupervised self-directed learning in a VR temporal bone simulator. Randomized blinded control trial. Royal Victorian Eye and Ear Hospital. Twenty novice trainees. After receiving an hour lecture, participants were randomized into 2 groups to receive an additional 2 hours of training via traditional teaching methods or self-directed learning using a VR simulator with automated guidance. The simulation environment presented participants with structured training tasks, which were accompanied by real-time computer-generated feedback as well as real operative videos and photos. After the training, trainees were asked to perform a cortical mastoidectomy on a cadaveric temporal bone. The dissection was videotaped and assessed by 3 otologists blinded to participants' teaching group. The overall performance scores of the simulator-based training group were significantly higher than those of the traditional training group (67% vs 29%; P < .001), with an intraclass correlation coefficient of 0.93, indicating excellent interrater reliability. Using other assessments of performance, such as injury size, the VR simulator-based training group also performed better than the traditional group. This study indicates that self-directed learning on VR simulators can be used to improve performance on cadaver dissection in novice trainees compared with traditional teaching methods alone.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Impact of platform switching on inter-proximal bone levels around 8.5 mm implants in the posterior region; 5-year results from a randomized clinical trial

    NARCIS (Netherlands)

    Telleman, Gerdien; Raghoebar, Gerry M.; Vissink, Arjan; Meijer, Henny J. A.

    Aim: To assess the medium- term results of 8.5 mm implants supplied with a conventional platform- matched implant- abutment connection or a platform- switched design. Materials and Methods: Eighty patients with one or more missing teeth in the maxillary or mandibular posterior zone were randomly

  7. 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…

  8. Internet-Based Guided Self-Help for Vaginal Penetration Difficulties: Results of a Randomized Controlled Pilot Trial.

    Science.gov (United States)

    Zarski, Anna-Carlotta; Berking, Matthias; Fackiner, Christina; Rosenau, Christian; Ebert, David Daniel

    2017-02-01

    Difficulties with vaginal penetration can severely affect a woman's desire to have sexual intercourse, her sexual and general well-being, or her partnership. However, treatment opportunities for vaginismus are scarce. To evaluate the efficacy of an internet-based guided self-help intervention for vaginismus in a randomized controlled pilot trial. Seventy-seven women with vaginismus (primary inclusion criterion = no intercourse ≥ 6 months) were randomly assigned to an intervention group (IG) and a waitlist control group (WCG). The intervention consisted of 10 sessions involving psychoeducation, relaxation exercises, sensate focus, and gradual exposure with dilators. Participants received written feedback on completed sessions from an eCoach. The primary outcome was successful sexual intercourse. Secondary outcomes were non-intercourse penetration, fear of coitus, sexual functioning, and dyadic coping. Self-reported assessments were scheduled at baseline, 10 weeks, and 6 months. More participants (10 of 40, 34.48%) in the IG had intercourse compared with those in the WCG (6 of 37, 20.69%) at least once at 10 weeks or 6 months (odds ratio = 2.02). The difference was not significant (χ 2 1  = 1.38, P = .38), but in the IG, there was a significant increase in intercourse penetration from baseline to 6 months (d = 0.65). No such increase was found in the WCG (d = 0.21). There were significant between-group effects concerning non-intercourse penetration (self-insertion of a finger or dilator or insertion by the partner) in favor of the IG. Fear of coitus and dyadic coping significantly decreased in the IG. Overall satisfaction with the training was high. This randomized controlled trial showed promising effects of an internet-based intervention by increasing participants' ability to have intercourse and non-intercourse penetration while experiencing high treatment satisfaction. The WCG also showed improvement, although participants had vaginismus for an average

  9. Serelaxin as a potential treatment for renal dysfunction in cirrhosis: Preclinical evaluation and results of a randomized phase 2 trial.

    Directory of Open Access Journals (Sweden)

    Victoria K Snowdon

    2017-02-01

    Full Text Available Chronic liver scarring from any cause leads to cirrhosis, portal hypertension, and a progressive decline in renal blood flow and renal function. Extreme renal vasoconstriction characterizes hepatorenal syndrome, a functional and potentially reversible form of acute kidney injury in patients with advanced cirrhosis, but current therapy with systemic vasoconstrictors is ineffective in a substantial proportion of patients and is limited by ischemic adverse events. Serelaxin (recombinant human relaxin-2 is a peptide molecule with anti-fibrotic and vasoprotective properties that binds to relaxin family peptide receptor-1 (RXFP1 and has been shown to increase renal perfusion in healthy human volunteers. We hypothesized that serelaxin could ameliorate renal vasoconstriction and renal dysfunction in patients with cirrhosis and portal hypertension.To establish preclinical proof of concept, we developed two independent rat models of cirrhosis that were characterized by progressive reduction in renal blood flow and glomerular filtration rate and showed evidence of renal endothelial dysfunction. We then set out to further explore and validate our hypothesis in a phase 2 randomized open-label parallel-group study in male and female patients with alcohol-related cirrhosis and portal hypertension. Forty patients were randomized 1:1 to treatment with serelaxin intravenous (i.v. infusion (for 60 min at 80 μg/kg/d and then 60 min at 30 μg/kg/d or terlipressin (single 2-mg i.v. bolus, and the regional hemodynamic effects were quantified by phase contrast magnetic resonance angiography at baseline and after 120 min. The primary endpoint was the change from baseline in total renal artery blood flow. Therapeutic targeting of renal vasoconstriction with serelaxin in the rat models increased kidney perfusion, oxygenation, and function through reduction in renal vascular resistance, reversal of endothelial dysfunction, and increased activation of the AKT

  10. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial.

    Science.gov (United States)

    Richardson, Caroline R; Buis, Lorraine R; Janney, Adrienne W; Goodrich, David E; Sen, Ananda; Hess, Michael L; Mehari, Kathleen S; Fortlage, Laurie A; Resnick, Paul J; Zikmund-Fisher, Brian J; Strecher, Victor J; Piette, John D

    2010-12-17

    Approximately half of American adults do not meet recommended physical activity guidelines. Face-to-face lifestyle interventions improve health outcomes but are unlikely to yield population-level improvements because they can be difficult to disseminate, expensive to maintain, and inconvenient for the recipient. In contrast, Internet-based behavior change interventions can be disseminated widely at a lower cost. However, the impact of some Internet-mediated programs is limited by high attrition rates. Online communities that allow participants to communicate with each other by posting and reading messages may decrease participant attrition. Our objective was to measure the impact of adding online community features to an Internet-mediated walking program on participant attrition and average daily step counts. This randomized controlled trial included sedentary, ambulatory adults who used email regularly and had at least 1 of the following: overweight (body mass index [BMI] ≥ 25), type 2 diabetes, or coronary artery disease. All participants (n = 324) wore enhanced pedometers throughout the 16-week intervention and uploaded step-count data to the study server. Participants could log in to the study website to view graphs of their walking progress, individually-tailored motivational messages, and weekly calculated goals. Participants were randomized to 1 of 2 versions of a Web-based walking program. Those randomized to the "online community" arm could post and read messages with other participants while those randomized to the "no online community" arm could not read or post messages. The main outcome measures were participant attrition and average daily step counts over 16 weeks. Multiple regression analyses assessed the effect of the online community access controlling for age, sex, disease status, BMI, and baseline step counts. Both arms significantly increased their average daily steps between baseline and the end of the intervention period, but there were no

  11. Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

    Science.gov (United States)

    Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

    2009-01-01

    Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

  12. Mental skills training effectively minimizes operative performance deterioration under stressful conditions: Results of a randomized controlled study.

    Science.gov (United States)

    Anton, N E; Beane, J; Yurco, A M; Howley, L D; Bean, E; Myers, E M; Stefanidis, D

    2018-02-01

    Stress can negatively impact surgical performance, but mental skills may help. We hypothesized that a comprehensive mental skills curriculum (MSC) would minimize resident performance deterioration under stress. Twenty-four residents were stratified then randomized to receive mental skills and FLS training (MSC group), or only FLS training (control group). Laparoscopic suturing skill was assessed on a live porcine model with and without external stressors. Outcomes were compared with t-tests. Twenty-three residents completed the study. The groups were similar at baseline. There were no differences in suturing at posttest or transfer test under normal conditions. Both groups experienced significantly decreased performance when stress was applied, but the MSC group significantly outperformed controls under stress. This MSC enabled residents to perform significantly better than controls in the simulated OR under unexpected stressful conditions. These findings support the use of psychological skills as an integral part of a surgical resident training. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

    2015-07-01

    Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  14. Efficacy and causal mechanism of an online social media intervention to increase physical activity: Results of a randomized controlled trial.

    Science.gov (United States)

    Zhang, Jingwen; Brackbill, Devon; Yang, Sijia; Centola, Damon

    2015-01-01

    To identify what features of social media - promotional messaging or peer networks - can increase physical activity. A 13-week social media-based exercise program was conducted at a large Northeastern university in Philadelphia, PA. In a randomized controlled trial, 217 graduate students from the University were randomized to three conditions: a control condition with a basic online program for enrolling in weekly exercise classes led by instructors of the University for 13 weeks, a media condition that supplemented the basic program with weekly online promotional media messages that encourage physical activity, and a social condition that replaced the media content with an online network of four to six anonymous peers composed of other participants of the program, in which each participant was able to see their peers' progress in enrolling in classes. The primary outcome was the number of enrollments in exercise classes, and the secondary outcomes were self-reported physical activities. Data were collected in 2014. Participants enrolled in 5.5 classes on average. Compared with enrollment in the control condition (mean = 4.5), promotional messages moderately increased enrollment (mean = 5.7, p = 0.08), while anonymous social networks significantly increased enrollment (mean = 6.3, p = 0.02). By the end of the program, participants in the social condition reported exercising moderately for an additional 1.6 days each week compared with the baseline, which was significantly more than an additional 0.8 days in the control condition. Social influence from anonymous online peers was more successful than promotional messages for improving physical activity. ClinicalTrials.gov: NCT02267369.

  15. Does Bacopa monnieri improve memory performance in older persons? Results of a randomized, placebo-controlled, double-blind trial.

    Science.gov (United States)

    Morgan, Annette; Stevens, John

    2010-07-01

    The objective of this study was to investigate the effectiveness of Bacopa monnieri Linn. for improvement of memory performance in healthy older persons. This was a randomized, double-blind, placebo-controlled trial. The trial took place in Lismore, NSW, Australia between February and July 2005. Ninety-eight (98) healthy participants over 55 years of age were recruited from the general population. Participants were randomized to receive an extract of Bacopa monnieri called BacoMind(TM) (Natural Remedies Pvt. Ltd.), 300 mg/day, or an identical placebo. Following screening, neuropsychologic and subjective memory assessments were performed at baseline and at 12 weeks. Audioverbal and visual memory performance were measured by the Rey Auditory Verbal Learning Test (AVLT), the Rey-Osterrieth Complex Figure Test (CFT), and the Reitan Trail Making Test (TMT). Subjective memory performance was measured by the Memory Complaint Questionnaire (MAC-Q). One hundred and thirty-six (136) subjects volunteered; 103 met entry criteria, 98 commenced, and 81 completed the trial. Bacopa significantly improved verbal learning, memory acquisition, and delayed recall as measured by the AVLT: trial a4 (p = 0.000), trial a5 (p = 0.016); trial a6 (p = 0.000); trial a7 (delayed recall) (p = 0.001); total learning (p = 0.011); and retroactive interference (p = 0.048). CFT, MAC-Q, and TMT scores improved but group differences were not significant. Bacopa versus placebo caused gastrointestinal tract (GIT) side-effects. Bacopa significantly improved memory acquisition and retention in healthy older Australians. This concurs with previous findings and traditional use. Bacopa caused GIT side-effects of increased stool frequency, abdominal cramps, and nausea.

  16. Adjuvant therapy in stage I and stage II epithelial ovarian cancer. Results of two prospective randomized trials

    International Nuclear Information System (INIS)

    Young, R.C.; Walton, L.A.; Ellenberg, S.S.; Homesley, H.D.; Wilbanks, G.D.; Decker, D.G.; Miller, A.; Park, R.; Major, F. Jr.

    1990-01-01

    About a third of patients with ovarian cancer present with localized disease; despite surgical resection, up to half the tumors recur. Since it has not been established whether adjuvant treatment can benefit such patients, we conducted two prospective, randomized national cooperative trials of adjuvant therapy in patients with localized ovarian carcinoma. All patients underwent surgical resection plus comprehensive staging and, 18 months later, surgical re-exploration. In the first trial, 81 patients with well-differentiated or moderately well differentiated cancers confined to the ovaries (Stages Iai and Ibi) were assigned to receive either no chemotherapy or melphalan (0.2 mg per kilogram of body weight per day for five days, repeated every four to six weeks for up to 12 cycles). After a median follow-up of more than six years, there were no significant differences between the patients given no chemotherapy and those treated with melphalan with respect to either five-year disease-free survival or overall survival. In the second trial, 141 patients with poorly differentiated Stage I tumors or with cancer outside the ovaries but limited to the pelvis (Stage II) were randomly assigned to treatment with either melphalan (in the same regimen as above) or a single intraperitoneal dose of 32P (15 mCi) at the time of surgery. In this trial (median follow-up, greater than 6 years) the outcomes for the two treatment groups were similar with respect to five-year disease-free survival (80 percent in both groups) and overall survival (81 percent with melphalan vs. 78 percent with 32P; P = 0.48). We conclude that in patients with localized ovarian cancer, comprehensive staging at the time of surgical resection can serve to identify those patients (as defined by the first trial) who can be followed without adjuvant chemotherapy

  17. Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C

    2015-12-01

    The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

  18. Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial.

    Science.gov (United States)

    Campbell-Yeo, Marsha L; Johnston, C Celeste; Joseph, K S; Feeley, Nancy; Chambers, Christine T; Barrington, Keith J; Walker, Claire-Dominique

    2014-07-01

    To examine the effect of co-bedding between preterm twins on stress response after heel lance. Using a multisite randomized controlled trial design, stable preterm twins (67 sets, N=134 infants) between 28 and 36 completed weeks' gestational age, stratified by gestational age (≤ and >32 weeks) and site, were randomly assigned to a co-bedding group, cared for continuously in the same incubator or crib or a standard care group, cared for in a separate incubator or crib, and underwent a medically indicated heel lance after at least 24 hours and no greater than 10 days of group allocation. The reported outcome was cortisol from saliva samples from 89 twins (n=49 co-bedding, n=40 standard care) collected immediately before the heel lance (baseline levels) and 113 twins (n=58 co-bedding, n=55 standard care) collected 20 minutes after heel lance (stress levels) as an index of stress response. No group differences were noted in baseline salivary cortisol levels: 0.36 μg/dL (SD 0.25) in the co-bedding group and 0.43 μg/dL (SD 0.50) in the standard care group. Twenty minutes after lance, levels were significantly lower in the co-bedding group, 0.28 μg/dL (SD 0.25) versus 0.50 μg/dL (SD 0.73) in the standard group (P=0.04). Similarly, the mean of paired changes in salivary cortisol from baseline was lower in the co-bedding group (-0.06 μg/dL) compared with the standard care group (0.14 μg/dL, Plance. clinicaltrials.gov Identifier: NCT009176.

  19. Topical Minocycline Foam for the Treatment of Impetigo in Children: Results of a Randomized, Double-Blind, Phase 2 Study.

    Science.gov (United States)

    Chamny, Shlomo; Miron, Dan; Lumelsky, Nadia; Shalev, Hana; Gazal, Elana; Keynan, Rita; Shemer, Avner; Tamarkin, Dov

    2016-10-01

    Currently available treatment options for impetigo are limited by either systemic side effects (for oral therapy) or lack of ease of use (for topical ointment). A novel foam formulation of minocycline for topical use may improve convenience and treatment utilization for pediatric patients with impetigo. To evaluate the safety and efficacy of topically applied minocycline foam (FMX-102 1% and 4%) in the treatment of impetigo and to determine the optimal therapeutic active ingredient concentration. In this randomized, parallel-group, double-blind, comparative clinical trial, 32 subjects aged ≥2 years with a clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo were randomized to treatment with FMX-102 1% or 4%, twice daily for 7 days. Subjects were followed for up to 7 days post-treatment. Clinical cure, defined as ≥80% cured lesions (fully recovered lesions, visually determined by investigators), was achieved by 57.1% and 50.0% of FMX-102 1% and 4% subjects, respectively, at the end of treatment (visit 3). Clinical success, defined as the absence of lesions, or the drying or improvement of treated lesions (decrease in size of affected area, lesion number, or both), was demonstrated in 81.3% and 78.6% of FMX-102 1% and 4% subjects, respectively, following 3 days of treatment (visit 2), in 92.3% and 100% of the respective subjects at the end of treatment, and in 100% in both groups at follow-up (visit 4). Bacteriologic success rates at the end of treatment, defined as complete pathogen eradication, were 85% and 74% in the FMX-102 1% and 4% groups, respectively. The bacteriologic success rate for MRSA infections was 100% (11/11), with no recurrences. Both FMX-102 1% and 4% were considered well tolerated and safe. Topical minocycline foam may be a safe and effective new treatment option for impetigo in children, including those with MRSA. J Drugs Dermatol. 2016;15(10):1238-1243.

  20. Cognitive behavioral therapy positively affects fatigue in patients with multiple sclerosis: Results of a randomized controlled trial.

    Science.gov (United States)

    van den Akker, Lizanne E; Beckerman, Heleen; Collette, Emma H; Twisk, Jos Wr; Bleijenberg, Gijs; Dekker, Joost; Knoop, Hans; de Groot, Vincent

    2017-10-01

    Fatigue is a common symptom in multiple sclerosis (MS) and often restricts societal participation. Cognitive behavioral therapy (CBT) may alleviate MS-related fatigue, but evidence in literature is inconclusive. To evaluate the effectiveness of CBT to improve MS-related fatigue and participation. In a multi-center, assessor-masked, randomized controlled trial, participants with severe MS-related fatigue were assigned to CBT or control treatment. CBT consisted of 12 individual sessions with a psychologist trained in CBT, the control treatment consisted of three consultations with a MS nurse, both delivered over 16 weeks. Assessments were at baseline, 8, 16 (i.e. post-intervention), 26, and 52 weeks post-baseline. Primary outcomes were the Checklist Individual Strength-fatigue subscale (CIS20r fatigue) and the Impact on Participation and Autonomy questionnaire (IPA). Data were analyzed according to the intention-to-treat principle, using mixed-model analysis. Between 2011 and 2014, 91 patients were randomized (CBT: n = 44; control: n = 47). Between-group analysis showed a positive post-intervention effect for CBT on CIS20r fatigue (T16: -6.7 (95% confidence interval (CI) = -10.7; -2.7) points) that diminished during follow-up (T52: 0.5 (95% CI = -3.6; 4.4)). No clinically relevant effects were found on societal participation. Severe MS-related fatigue can be reduced effectively with CBT in the short term. More research is needed on how to maintain this effect over the long term.

  1. The effect of solifenacin on postvoid dribbling in women: results of a randomized, double-blind placebo-controlled trial.

    Science.gov (United States)

    Ablove, Tova; Bell, Lauren N; Liang, Hong; Chappell, Richard J; Toklu, Hale Z; Yale, Steven H

    2018-03-24

    To determine the effectiveness of the muscarinic receptor antagonist solifenacin (VESIcare®) in the treatment of postvoid dribbling (PVD). We carried out a multicenter, 12-week, double-blind, randomized, placebo-controlled, parallel design study. Between 2012 and 2015, a total of 118 women (age 18-89 years) with PVD at least twice/weekly, were randomized to receive solifenacin (5 mg; n = 58) or placebo (n = 60) once daily. The primary outcome was the percentage reduction in PVD episodes. Secondary outcomes included the percentage of patients with ≥50% reduction in PVD episodes and changes in quality of life. There were no differences in either the primary or secondary outcome variables. Subgroup analysis, based on those with more severe disease (>10 PVD episodes/week), showed a greater and significant percentage reduction in the frequency of PVD episodes per day (60.3% vs 32.1%; p = 0.035) and a higher percentage of patients showing ≥50% reduction in the frequency of PVD episodes with solifenacin (68.1% vs 45.8%; p = 0.0476). A significant solifenacin effect occurred at week 2 and continued through week 12 for the subgroup. For solifenacin, PVD reduction was the same for the entire cohort and subgroup, whereas for placebo, it was 10% lower in the subgroup, declining from 42% to 32%. There were no differences in PVD outcomes between the solifenacin and placebo groups. Solifenacin may play a role in treating women with the most severe symptoms. Because of the powerful placebo response seen in this study, behavior-based interventions may be useful for treating PVD.

  2. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    Science.gov (United States)

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  3. Hypnotherapy is more effective than nicotine replacement therapy for smoking cessation: results of a randomized controlled trial.

    Science.gov (United States)

    Hasan, Faysal M; Zagarins, Sofija E; Pischke, Karen M; Saiyed, Shamila; Bettencourt, Ann Marie; Beal, Laura; Macys, Diane; Aurora, Sanjay; McCleary, Nancy

    2014-02-01

    The efficacy of pharmacotherapy for smoking cessation is well documented. However, due to relapse rates and side effects, hypnotherapy is gaining attention as an alternative treatment option. The aim of this one-center randomized study was to compare the efficacy of hypnotherapy alone, as well as hypnotherapy with nicotine replacement therapy (NRT), to conventional NRT in patients hospitalized with a cardiac or pulmonary illness. We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization. Patients (n=164) were randomized into one of three counseling-based treatment groups: NRT for 30 days (NRT; n=41), a 90-min hypnotherapy session (H; n=39), and NRT with hypnotherapy (HNRT; n=37). Treatment groups were compared to a "self-quit" group of 35 patients who refused intervention. Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks (43.9% vs. 28.2%; p=0.14) and 26 weeks after hospitalization (36.6% vs. 18.0%; p=0.06). Smoking abstinence rates in the HNRT group were similar to the H group. There was no difference in smoking abstinence rates at 26 weeks between "self quit" and participants in any of the treatment groups. In multivariable regression analysis adjusting for diagnosis and demographic characteristics, H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge (RR=3.6; p=0.03 and RR=3.2; p=0.04, respectively). Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness, and could be an asset to post-discharge smoking cessation programs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

    2017-01-01

    Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

  6. Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial.

    Science.gov (United States)

    Gerke, Alicia K; Pezzulo, Alejandro A; Tang, Fan; Cavanaugh, Joseph E; Bair, Thomas B; Phillips, Emily; Powers, Linda S; Monick, Martha M

    2014-03-26

    Vitamin D deficiency has been implicated as a factor in a number of infectious and inflammatory lung diseases. In the lung, alveolar macrophages play a key role in inflammation and defense of infection, but there are little data exploring the immunomodulatory effects of vitamin D on innate lung immunity in humans. The objective of this study was to determine the effects of vitamin D supplementation on gene expression of alveolar macrophages. We performed a parallel, double-blind, placebo-controlled, randomized trial to determine the effects of vitamin D on alveolar macrophage gene expression. Vitamin D3 (1000 international units/day) or placebo was administered to adults for three months. Bronchoscopy was performed pre- and post-intervention to obtain alveolar macrophages. Messenger RNA was isolated from the macrophages and subjected to whole genome exon array analysis. The primary outcome was differential gene expression of the alveolar macrophage in response to vitamin D supplementation. Specific genes underwent validation by polymerase chain reaction methods. Fifty-eight subjects were randomized to vitamin D (n = 28) or placebo (n = 30). There was a marginal overall difference between treatment group and placebo group in the change of 25-hydroxyvitaminD levels (4.43 ng/ml vs. 0.2 ng/ml, p = 0.10). Whole genome exon array analysis revealed differential gene expression associated with change in serum vitamin D levels in the treated group. CCL8/MCP-2 was the top-regulated cytokine gene and was further validated. Although only a non-significant increased trend was seen in serum vitamin D levels, subjects treated with vitamin D supplementation had immune-related differential gene expression in alveolar macrophages. ClinicalTrials.org: NCT01967628.

  7. Prophylactic Acetaminophen or Ibuprofen Results in Equivalent Acute Mountain Sickness Incidence at High Altitude: A Prospective Randomized Trial.

    Science.gov (United States)

    Kanaan, Nicholas C; Peterson, Alicia L; Pun, Matiram; Holck, Peter S; Starling, Jennifer; Basyal, Bikash; Freeman, Thomas F; Gehner, Jessica R; Keyes, Linda; Levin, Dana R; O'Leary, Catherine J; Stuart, Katherine E; Thapa, Ghan B; Tiwari, Aditya; Velgersdyk, Jared L; Zafren, Ken; Basnyat, Buddha

    2017-06-01

    Recent trials have demonstrated the usefulness of ibuprofen in the prevention of acute mountain sickness (AMS), yet the proposed anti-inflammatory mechanism remains unconfirmed. Acetaminophen and ibuprofen were tested for AMS prevention. We hypothesized that a greater clinical effect would be seen from ibuprofen due to its anti-inflammatory effects compared with acetaminophen's mechanism of possible symptom reduction by predominantly mediating nociception in the brain. A double-blind, randomized trial was conducted testing acetaminophen vs ibuprofen for the prevention of AMS. A total of 332 non-Nepali participants were recruited at Pheriche (4371 m) and Dingboche (4410 m) on the Everest Base Camp trek. The participants were randomized to either acetaminophen 1000 mg or ibuprofen 600 mg 3 times a day until they reached Lobuche (4940 m), where they were reassessed. The primary outcome was AMS incidence measured by the Lake Louise Questionnaire score. Data from 225 participants who met inclusion criteria were analyzed. Twenty-five participants (22.1%) in the acetaminophen group and 18 (16.1%) in the ibuprofen group developed AMS (P = .235). The combined AMS incidence was 19.1% (43 participants), 14 percentage points lower than the expected AMS incidence of untreated trekkers in prior studies at this location, suggesting that both interventions reduced the incidence of AMS. We found little evidence of any difference between acetaminophen and ibuprofen groups in AMS incidence. This suggests that AMS prevention may be multifactorial, affected by anti-inflammatory inhibition of the arachidonic-acid pathway as well as other analgesic mechanisms that mediate nociception. Additional study is needed. Copyright © 2017 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  8. Randomized clinical trial of implant-supported ceramic-ceramic and metal-ceramic fixed dental prostheses: preliminary results.

    Science.gov (United States)

    Esquivel-Upshaw, Josephine F; Clark, Arthur E; Shuster, Jonathan J; Anusavice, Kenneth J

    2014-02-01

    The aim of this study was to determine the survival rates over time of implant-supported ceramic-ceramic and metal-ceramic prostheses as a function of core-veneer thickness ratio, gingival connector embrasure design, and connector height. An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study involving 55 patients missing three teeth in either one or two posterior areas. These patients (34 women; 21 men; age range 52-75 years) were recruited for the study to receive a three-unit implant-supported fixed dental prosthesis (FDP). Two implants were placed for each of the 72 FDPs in the study. The implants (Osseospeed, Astra Tech), which were made of titanium, were grit blasted. A gold-shaded, custom-milled titanium abutment (Atlantis, Astra Tech), was secured to each implant body. Each of the 72 FDPs in 55 patients were randomly assigned based on one of the following options: (1) A. ceramic-ceramic (Yttria-stabilized zirconia core, pressable fluorapatite glass-ceramic, IPS e.max ZirCAD, and ZirPress, Ivoclar Vivadent) B. metal-ceramic (palladium-based noble alloy, Capricorn, Ivoclar Vivadent, with press-on leucite-reinforced glass-ceramic veneer, IPS InLine POM, Ivoclar Vivadent); (2) occlusal veneer thickness (0.5, 1.0, and 1.5 mm); (3) curvature of gingival embrasure (0.25, 0.5, and 0.75 mm diameter); and (4) connector height (3, 4, and 5 mm). FDPs were fabricated and cemented with dual-cure resin cement (RelyX, Universal Cement, 3M ESPE). Patients were recalled at 6 months, 1 year, and 2 years. FDPs were examined for cracks, fracture, and general surface quality. Recall exams of 72 prostheses revealed 10 chipping fractures. No fractures occurred within the connector or embrasure areas. Two-sided Fisher's exact tests showed no significant correlation between fractures and type of material system (p = 0.51), veneer thickness (p = 0.75), radius of curvature of gingival embrasure (p = 0.68), and connector height (p = 0

  9. Community risk factors for ocular Chlamydia infection in Niger: pre-treatment results from a cluster-randomized trachoma trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    Full Text Available Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection.This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies. Univariate and multivariate associations were tested using linear regression and Bayes model averaging.There were a total of 24,536 participants (4,484 children aged 0-5 years in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system was 26.0% (95% CI: 21.9% to 30.0% and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9% in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P = 0.03, presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P = 0.001, and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P = 0.03 were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P = 0.03 and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P = 0.02 were associated risk factors for ocular chlamydial infection.We have found that the presence of facial flies and years of education of the head

  10. Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mahamadou A Thera

    2010-02-01

    Full Text Available The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02(A in children exposed to seasonal falciparum malaria.A Phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02(A is a recombinant protein (FMP2.1 based on apical membrane antigen 1 (AMA1 from the 3D7 clone of P. falciparum, formulated in the Adjuvant System AS02(A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert. One hundred healthy Malian children aged 1-6 years were recruited into 3 cohorts and randomized to receive either 10 microg FMP2.1 in 0.1 mL AS02(A, or 25 microg FMP2.1 in 0.25 mL AS02(A, or 50 microg FMP2.1 50 microg in 0.5 mL AS02(A, or rabies vaccine. Three doses of vaccine were given at 0, 1 and 2 months, and children were followed for 1 year. Solicited symptoms were assessed for 7 days and unsolicited symptoms for 30 days after each vaccination. Serious adverse events were assessed throughout the study. Transient local pain and swelling were common and more frequent in all malaria vaccine dosage groups than in the comparator group, but were acceptable to parents of participants. Levels of anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared to baseline in all 3 malaria vaccine groups, and remained high during the year of follow up.The FMP2.1/AS02(A vaccine had a good safety profile, was well-tolerated, and induced high and sustained antibody levels in malaria-exposed children. This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site.ClinicalTrials.gov NCT00358332 [NCT00358332].

  11. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mahamadou A Thera

    2008-01-01

    Full Text Available The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1 based on apical membrane antigen-1 (AMA-1 from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert. Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.

  12. Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial.

    Science.gov (United States)

    Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

    2016-09-01

    Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9 mmHg (95%CI -30.9 to -4.9); P = 0.010 and -6.6 mmHg (95%CI -12.9 to -0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1 mmHg (95%CI -29.1 to 5.1); P = 0.158 and of -5.3 mmHg (95%CI -16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7 ml/min per 1.73 m (95%CI -20.1 to -1.4); P = 0.027. We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.

  13. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.

    Science.gov (United States)

    Cutolo, Maurizio; Myerson, Gary E; Fleischmann, Roy M; Lioté, Frédéric; Díaz-González, Federico; Van den Bosch, Filip; Marzo-Ortega, Helena; Feist, Eugen; Shah, Kamal; Hu, ChiaChi; Stevens, Randall M; Poder, Airi

    2016-09-01

    Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy. Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16. In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient. Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

  14. Impact of a brief intervention on patient communication and barriers to pain management: results from a randomized controlled trial.

    Science.gov (United States)

    Smith, Meredith Y; DuHamel, Katherine N; Egert, Jennifer; Winkel, Gary

    2010-10-01

    This study examined the impact of a brief pain communication/education intervention on patient outcomes in breast cancer. We hypothesized that our intervention would improve patient communication and reduce misconceptions ("Barriers") concerning pain management, and that patients with lower Barriers, or who perceived their physician as being more facilitative and receptive, would report better outcomes. Female breast cancer patients with persistent pain (n=89) were randomly assigned to either a 30-min in-person pain education/communication intervention or control condition and followed for 12 weeks. Intervention group patients reported a significant decrease in pain Barriers but not in other outcomes. Overall, patients with lower barrier scores reported less distress and better emotional well-being. Patients who scored higher in active communication (e.g., asking questions, giving information) reported fewer Barriers and better pain relief. Individuals who perceived their physicians as being more receptive reported better pain management while those who perceived their physicians as being both more receptive and facilitative were more satisfied with their health care. A brief education/communication intervention reduced patients' Barriers to pain management but did not impact other patient outcomes. Pain outcomes may be improved by addressing patients' pain misconceptions and emphasizing a receptive and responsive communication style. (c) 2009 Elsevier Ireland Ltd. All rights reserved.

  15. A brief facial morphing intervention to reduce skin cancer risk behaviors: Results from a randomized controlled trial.

    Science.gov (United States)

    Blashill, Aaron J; Rooney, Benjamin M; Luberto, Christina M; Gonzales, Manuel; Grogan, Sarah

    2018-04-20

    The current study was designed to test the efficacy of an appearance-based facial morphing program to reduce intentional UV exposure among individuals at risk for skin cancer. A three-arm randomized controlled trial was employed (N = 219) comparing facial morphing + health information to: (1) mindfulness + health information; and (2) health information only. Participants were young adults with a history of recent intentional tanning and future intentions to tan. Primary outcomes were indoor and outdoor tanning frequency and tanning intentions, with secondary outcomes of tanning attitudes, body image, and affect. Facial morphing participants reported less frequent tanning, compared to mindfulness and control participants at 1-month follow-up. Facial morphing participants also generally reported lower intentions to tan at immediate follow-up, although the magnitude of these effects weakened at 1-month follow-up. Facial morphing programs may offer a brief, efficacious, and scalable augmentation to standard of care in reducing intentional UV exposure. This trial is registered with clinicaltrials.gov (NCT03237013). Copyright © 2018 Elsevier Ltd. All rights reserved.

  16. Maxillary overdentures supported by four or six implants in the anterior region: 5-year results from a randomized controlled trial.

    Science.gov (United States)

    Slot, Wim; Raghoebar, Gerry M; Cune, Marco S; Vissink, Arjan; Meijer, Henny J A

    2016-12-01

    To compare a four- and six-implant maxillary overdenture after an observation period of 5 years. Fifty subjects with functional problems concerning their maxillary denture, who had ample bone volume in the anterior region to place four or six implants, were included and randomly assigned to either group. Implant and overdenture survival, clinical performance, marginal bone loss and patient satisfaction were assessed. Forty-six patients completed the 5-year follow-up. One implant failed in the six implants group (99.2% survival) and none in the four implants group (100% survival). No overdentures had to be replaced during the observation period and the number of complications was limited. Clinical function was good, with no difference in clinical parameters between the groups. Mean marginal bone resorption was 0.50 ± 0.37 and 0.52 ± 0.43 mm in the four and six implant group respectively. In patients with functional complaints of their maxillary denture, bar-supported overdentures on four implants in the anterior maxillary region were not inferior to overdentures supported by six implants after 5 years of function. Implant survival and patient satisfaction were high, clinical parameters favourable, bone loss and complications to the denture were minor in both groups (Clinical trial registration number: NTR2969). © 2016 The Authors. Journal of Clinical Periodontology Published by John Wiley & Sons Ltd.

  17. Treatment of age-related subfoveal neovascular membranes by teletherapy. Results of a non-randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Subasi, M.; Akmansu, M.; Or, M. [Gazi Univ., Ankara (Turkey). Medical Faculty

    1999-03-01

    This investigation was designed to determine whether low-dose radiation to the macular region could influence the natural course of age-related subfoveal neovascularization. Thirty-one patients with subfoveal membranes due to age-related macular degeneration (ARMD) were treated with 12 Gy of 6 MV X-rays, and 72 patients who were untreated served as a control group. Both groups were followed-up. At six months of follow-up visual acuity was maintained in 54.8% and improved 25.8% of patients treated by radiotherapy. In the control group, visual acuity showed deterioration in 55.5%. There was a significant difference between the treated and untreated groups (p<0.01). Significant neovascular membrane regression or stabilization was recorded in 61.3% of treated patients at six months post-radiation, whereas the membranes in all. 72 control patients showed progressive enlargement. This non-randomized study suggested that low doses of radiation may be an alternative treatment for ARMD without an immediate drop in visual acuity or significant radiation morbidity. (author)

  18. Fast neutron therapy for squamous cell carcinoma in the head and neck region: results of a randomized trial

    International Nuclear Information System (INIS)

    Duncan, W.; Orr, J.A.; Arnott, S.J.; Jack, W.J.; Kerr, G.R.; Williams, J.R.

    1987-01-01

    A randomized trial of fast neuron therapy compared with 4MV photons for patients with head and neck cancer is reported. One hundred and sixty-eight patients were recruited between 1977 and 1984. The minimum follow-up is 2 years. Three patients were withdrawn before treatment began. Eighty-five were allocated to neutron therapy and 80 to receive photon therapy. All patients had squamous cell cancers in one of four primary sites: oral cavity, oropharynx, larynx, and hypopharynx. Local tumor control was similar in both groups: 44.7% after neutrons and 45.0% after photons. Salvage surgery was performed on 18 patients in each treatment group for residual or recurrent cancer. Acute radiation reactions of the mucous membranes were significantly more severe after photons. The number of patients with serious late reactions was greater after neutron therapy but the difference was not statistically significant. There were six deaths related to late morbidity after neutron therapy but none after photon therapy. Survival was better after photon therapy but the difference compared with the neutron group failed to reach statistical significance. When intercurrent deaths are excluded, the difference is less marked. Photon therapy was clearly better in terms of disease-free survival giving a 2-year local disease-free rate of 41.3% (s.e. 5.5%) compared with 29.4% (s.e. 4.9%) after neutrons

  19. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial.

    Science.gov (United States)

    Olds, David L; Robinson, JoAnn; Pettitt, Lisa; Luckey, Dennis W; Holmberg, John; Ng, Rosanna K; Isacks, Kathy; Sheff, Karen; Henderson, Charles R

    2004-12-01

    To examine the effects of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through age 4 years. We conducted, in public and private care settings in Denver, Colorado, a randomized, controlled trial with 3 arms, ie, control, paraprofessional visits, and nurse visits. Home visits were provided from pregnancy through child age 2 years. We invited 1178 consecutive, low-income, pregnant women with no previous live births to participate, and we randomized 735; 85% were unmarried, 47% Mexican American, 35% white non-Mexican American, 15% black, and 3% American Indian/Asian. Outcomes consisted of maternal reports of subsequent pregnancies, participation in education and work, use of welfare, marriage, cohabitation, experience of domestic violence, mental health, substance use, and sense of mastery; observations of mother-child interaction and the home environment; tests of children's language and executive functioning; and mothers' reports of children's externalizing behavior problems. Two years after the program ended, women who were visited by paraprofessionals, compared with control subjects, were less likely to be married (32.2% vs 44.0%) and to live with the biological father of the child (32.7% vs 43.1%) but worked more (15.13 months vs 13.38 months) and reported a greater sense of mastery and better mental health (standardized scores [mean = 100, SD = 10] of 101.25 vs 99.31 and 101.21 vs 99.16, respectively). Paraprofessional-visited women had fewer subsequent miscarriages (6.6% vs 12.3%) and low birth weight newborns (2.8% vs 7.7%). Mothers and children who were visited by paraprofessionals, compared with control subjects, displayed greater sensitivity and responsiveness toward one another (standardized score [mean = 100, SD = 10] of 100.92 vs 98.66) and, in cases in which the mothers had low levels of psychologic resources at registration, had home environments that were more supportive of children's early learning (score of

  20. Effectiveness of a worksite lifestyle intervention on vitality, work engagement, productivity, and sick leave: results of a randomized controlled trial.

    Science.gov (United States)

    Strijk, Jorien E; Proper, Karin I; van Mechelen, Willem; van der Beek, Allard J

    2013-01-01

    A worksite lifestyle intervention aiming to improve lifestyle behaviors could be an effective tool to keep older workers vital, and thereby prolong their labor participation. Therefore, this study evaluates the effectiveness of such an intervention on vitality, work engagement, productivity and sick leave. In a randomized controlled trial design, 367 workers (control group: N=363) received a 6-month intervention, which included two weekly guided group sessions: one yoga and one workout, as well as one weekly session of aerobic exercising, without face-to-face instruction, and three individual coach visits aimed at changing workers' lifestyle behavior by goal setting, feedback, and problem-solving strategies. Furthermore, free fruit was provided at the guided sessions. Data on work-related vitality (UWES vitality scale), general vitality (RAND-36 vitality scale), work engagement (UWES), productivity (single item scoring 0-10), and sick leave (yes/no past 3 months) were collected using questionnaires at baseline (N=730), and at 6- (N=575) and 12-months (N=500) follow-up. Effects were analyzed according to the intention-to-treat principle with complete cases (N=500) and imputed data (N=730). There were no significant differences in vitality, work engagement, productivity, and sick leave between the intervention and control group workers after either 6- and 12-months follow-up. Yoga and workout subgroup analyses showed a 12-month favorable effect on work-related vitality [β=0.14, 95% confidence interval (95% CI) 0.04-0.28] and general vitality (β=2.9, 95% CI 0.02-5.9) among high yoga compliers. For high workout compliers, this positive trend was also seen, but it was not statistically significant. Implementation of worksite yoga facilities could be a useful strategy to promote vitality-related work outcomes, but only if high compliance can be maximized. Therefore, impeding factors for participation should be investigated in more detail in future research.

  1. The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease.

    Science.gov (United States)

    Shah, Raj C; Kamphuis, Patrick J; Leurgans, Sue; Swinkels, Sophie H; Sadowsky, Carl H; Bongers, Anke; Rappaport, Stephen A; Quinn, Joseph F; Wieggers, Rico L; Scheltens, Philip; Bennett, David A

    2013-01-01

    Souvenaid® containing Fortasyn® Connect is a medical food designed to support synapse synthesis in persons with Alzheimer's disease (AD). Fortasyn Connect includes precursors (uridine monophosphate; choline; phospholipids; eicosapentaenoic acid; docosahexaenoic acid) and cofactors (vitamins E, C, B12, and B6; folic acid; selenium) for the formation of neuronal membranes. Whether Souvenaid slows cognitive decline in treated persons with mild-to-moderate AD has not been addressed. In a 24-week, double-masked clinical trial at 48 clinical centers, 527 participants taking AD medications [52% women, mean age 76.7 years (Standard Deviation, SD = 8.2), and mean Mini-Mental State Examination score 19.5 (SD = 3.1, range 14-24)] were randomized 1:1 to daily, 125-mL (125 kcal), oral intake of the active product (Souvenaid) or an iso-caloric control. The primary outcome of cognition was assessed by the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). Compliance was calculated from daily diary recordings of product intake. Statistical analyses were performed using mixed models for repeated measures. Cognitive performance as assessed by ADAS-cog showed decline over time in both control and active study groups, with no significant difference between study groups (difference =0.37 points, Standard Error, SE = 0.57, p = 0.513). No group differences in adverse event rates were found and no clinically relevant differences in blood safety parameters were noted. Overall compliance was high (94.1% [active] and 94.5% [control]), which was confirmed by significant changes in blood (nutritional) biomarkers. Add-on intake of Souvenaid during 24 weeks did not slow cognitive decline in persons treated for mild-to-moderate AD. Souvenaid was well tolerated in combination with standard care AD medications. DUTCH TRIAL REGISTER NUMBER: NTR1683.

  2. The medical food Souvenaid affects brain phospholipid metabolism in mild Alzheimer's disease: results from a randomized controlled trial.

    Science.gov (United States)

    Rijpma, Anne; van der Graaf, Marinette; Lansbergen, Marieke M; Meulenbroek, Olga; Cetinyurek-Yavuz, Aysun; Sijben, John W; Heerschap, Arend; Olde Rikkert, Marcel G M

    2017-07-26

    Synaptic dysfunction contributes to cognitive impairment in Alzheimer's disease and may be countered by increased intake of nutrients that target brain phospholipid metabolism. In this study, we explored whether the medical food Souvenaid affects brain phospholipid metabolism in patients with Alzheimer's disease. Thirty-four drug-naive patients with mild Alzheimer's disease (Mini Mental State Examination score ≥20) were enrolled in this exploratory, double-blind, randomized controlled study. Before and after 4-week intervention with Souvenaid or an isocaloric control product, phosphorus and proton magnetic resonance spectroscopy (MRS) was performed to assess surrogate measures of phospholipid synthesis and breakdown (phosphomonoesters [PME] and phosphodiesters [PDEs]), neural integrity (N-acetyl aspartate), gliosis (myo-inositol), and choline metabolism (choline-containing compounds [tCho]). The main outcome parameters were PME and PDE signal intensities and the PME/PDE ratio. MRS data from 33 patients (60-86 years old; 42% males; Souvenaid arm n = 16; control arm n = 17) were analyzed. PME/PDE and tCho were higher after 4 weeks of Souvenaid compared with control (PME/PDE least squares [LS] mean difference [95% CI] 0.18 [0.06-0.30], p = 0.005; tCho LS mean difference [95% CI] 0.01 [0.00-0.02], p = 0.019). No significant differences were observed in the other MRS outcome parameters. MRS reveals that Souvenaid affects brain phospholipid metabolism in mild Alzheimer's disease, in line with findings in preclinical studies. Netherlands Trial Register, NTR3346 . Registered on 13 March 2012.

  3. Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers.

    Science.gov (United States)

    Burns, Olivia; Zhu, John; Manyak, Michael J; Ravindranath, Ramiya; Koosha, Fariba; Haque, Nazneen; Chung, Sally

    2018-05-01

    The relative bioavailabilities of dutasteride/tamsulosin hydrochloride 0.5 mg/0.2 mg fixed-dose combination (FDC) capsules compared with coadministered reference products (1 dutasteride 0.5-mg capsule [Avodart ® ] + 1 tamsulosin hydrochloride 0.2-mg orally disintegrating tablet [Harnal D ® ]) were investigated in 2 clinical trials under fasted and fed conditions (ClinicalTrials.gov NCT02184585 and NCT02509104). Both trials were open-label, randomized, single-dose, crossover studies in healthy male adults aged 18-65 years. Trial 1 evaluated 2 formulations (FDC1 and FDC2), and trial 2 evaluated a third formulation (FDC3). The primary end points were dutasteride area under the concentration-time curve from time 0 to t (AUC (0-t) ) and peak plasma concentration (C max ) and tamsulosin AUC (0-∞) , AUC (0-t) , and C max . The formulations were considered to be bioequivalent if the 90%CIs for the geometric mean ratios for each end point were within the range of 0.80-1.25. For FDC1 in trial 1, bioequivalence criteria were not met for dutasteride C max or AUC in the fasted state or for tamsulosin C max in the fasted or fed states. For FDC2 in trial 1, all bioequivalence criteria were met except for tamsulosin C max in the fasted state. For FDC3 in trial 2, bioequivalence criteria were met for all dutasteride and tamsulosin end points in both the fed and fasted states. Safety profiles were similar for all FDC formulations and combination treatments. © 2017, The American College of Clinical Pharmacology.

  4. Plasmodium falciparum malaria challenge by the bite of aseptic Anopheles stephensi mosquitoes: results of a randomized infectivity trial.

    Directory of Open Access Journals (Sweden)

    Kirsten E Lyke

    2010-10-01

    Full Text Available Experimental infection of malaria-naïve volunteers by the bite of Plasmodium falciparum-infected mosquitoes is a preferred means to test the protective effect of malaria vaccines and drugs. The standard model relies on the bite of five infected mosquitoes to induce malaria. We examined the efficacy of malaria transmission using mosquitoes raised aseptically in compliance with current Good Manufacturing Practices (cGMPs.Eighteen adults aged 18-40 years were randomized to receive 1, 3 or 5 bites of Anopheles stephensi mosquitoes infected with the chloroquine-sensitive NF54 strain of P. falciparum. Seventeen participants developed malaria; fourteen occurring on Day 11. The mean prepatent period was 10.9 days (9-12 days. The geometric mean parasitemia was 15.7 parasites/µL (range: 4-70 by microscopy. Polymerase chain reaction (PCR detected parasites 3.1 (range: 0-4 days prior to microscopy. The geometric mean sporozoite load was 16,753 sporozoites per infected mosquito (range: 1,000-57,500. A 1-bite participant withdrew from the study on Day 13 post-challenge and was PCR and smear negative.The use of aseptic, cGMP-compliant P. falciparum-infected mosquitoes is safe, is associated with a precise prepatent period compared to the standard model and appears more efficient than the standard approach, as it led to infection in 100% (6/6 of volunteers exposed to three mosquito bites and 83% (5/6 of volunteers exposed to one mosquito bite.ClinicalTrials.gov NCT00744133.

  5. Effect of Mud-Bath Therapy on Serum Biomarkers in Patients with Knee Osteoarthritis: Results from a Randomized Controlled Trial.

    Science.gov (United States)

    Pascarelli, Nicola A; Cheleschi, Sara; Bacaro, Giovanni; Guidelli, Giacomo M; Galeazzi, Mauro; Fioravanti, Antonella

    2016-01-01

    Balneotherapy is one of the most commonly used non-pharmacological approaches for osteoarthritis (OA). Recent data indicate that some biomarkers could be useful to predict OA progression and to assess therapeutic response. To evaluate the effects of mud-bath therapy on serum biomarkers in patients with knee OA. The study group comprised 103 patients with primary symptomatic bilateral knee OA who were randomly assigned to receive a cycle of mud-bath therapy over a period of 2 weeks or to continue their standard therapy alone. Clinical and biochemical parameters were assessed at baseline and after 2 weeks. Clinical assessments included global pain score on a visual analogue scale (VAS) and the Western Ontario and McMaster Universities Index (WOMAC) subscores for knee OA. Cartilage oligomeric matrix protein (COMP), C-terminal cross-linked telopeptide type II collagen (CTX-II), myeloperoxidase (MPO) and high sensitivity C-reactive protein (hsCRP) serum levels were assessed by ELISA. At the end of mud-bath therapy we observed a statistically significant improvement in VAS and WOMAC subscores. Serum levels of COMP, MPO and hsCRP did not show any significant modification in either group, while a significant increase (P mud-bath group after the treatment. A cycle of mud-bath therapy added to the usual treatment had a beneficial effect on pain and function in patients with knee OA. The evaluation of serum biomarkers showed a significant increase of CTX-II only, perhaps due to an increase of cartilage turnover induced by thermal stress.

  6. PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2): Results of a Randomized, Double-Blind Placebo-Controlled Clinical Trial.

    Science.gov (United States)

    de Ridder, Inger R; den Hertog, Heleen M; van Gemert, H Maarten A; Schreuder, A H C M L Tobien; Ruitenberg, Annemieke; Maasland, E Lisette; Saxena, Ritu; van Tuijl, Jordie H; Jansen, Ben P W; Van den Berg-Vos, Renske M; Vermeij, Frederique; Koudstaal, Peter J; Kappelle, L Jaap; Algra, Ale; van der Worp, H Bart; Dippel, Diederik W J

    2017-04-01

    Subfebrile body temperature and fever in the first days after stroke are strongly associated with unfavorable outcome. A subgroup analysis of a previous trial suggested that early treatment with paracetamol may improve functional outcome in patients with acute stroke and a body temperature of ≥36.5°C. In the present trial, we aimed to confirm this finding. PAIS 2 (Paracetamol [Acetaminophen] in Stroke 2) was a multicenter, randomized, double-blind, placebo-controlled clinical trial. We aimed to include 1500 patients with acute ischemic stroke or intracerebral hemorrhage within 12 hours of symptom onset. Patients were treated with paracetamol in a daily dose of 6 g or matching placebo for 3 consecutive days. The primary outcome was functional outcome at 3 months, assessed with the modified Rankin Scale and analyzed with multivariable ordinal logistic regression. Because of slow recruitment and lack of funding, the study was stopped prematurely. Between December 2011 and October 2015, we included 256 patients, of whom 136 (53%) were allocated to paracetamol. In this small sample, paracetamol had no effect on functional outcome (adjusted common odds ratio, 1.15; 95% confidence interval, 0.74-1.79). There was no difference in the number of serious adverse events (paracetamol n=35 [26%] versus placebo n=28 [24%]). Treatment with high-dose paracetamol seemed to be safe. The effect of high-dose paracetamol on functional outcome remains uncertain. Therefore, a large trial of early treatment with high-dose paracetamol is still needed. URL: http://www.trialregister.nl. Unique identifier: NTR2365. © 2017 American Heart Association, Inc.

  7. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    Directory of Open Access Journals (Sweden)

    Craig R Cohen

    Full Text Available To determine if integration of family planning (FP and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices and decreased pregnancy rates.Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration sites and oversaw integrated services at the original intervention (early integration sites.Eighteen health facilities in Kenya.Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2."One-stop shop" approach to integrating FP and HIV services.Use of more effective contraceptive methods and incident pregnancy across two years of follow-up.Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR = 1.39 (1.19-1.63. Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%. Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87.Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model.ClinicalTrials.gov NCT01001507.

  8. Efficacy of Psychoeducational Intervention on Allograft Function in Kidney Transplant Patients: 10-Year Results of a Prospective Randomized Study.

    Science.gov (United States)

    Breu-Dejean, Nathalie; Driot, Damien; Dupouy, Julie; Lapeyre-Mestre, Maryse; Rostaing, Lionel

    2016-02-01

    Improving treatment adherence to immunosuppressive agents could have positive effects on the morbidity and mortality of kidney transplant recipients. Our objective was to determine whether psychoeducational intervention aimed at improving treatment adherence also could improve 10-year kidney allograft survival rates. A randomized open-label study compared a group who received psychoeducational intervention (n = 55) with a control group (n = 55), with all patients being kidney transplant recipients in the Department of Nephrology and Organ Transplantation (University Hospital, Toulouse, France). Psychoeducational intervention comprised 8 weekly sessions provided by multidisciplinary teams. Patients were included between 2002 and 2003. The primary endpoint was allograft survival at 10 years (ie, by 2012). A failed allograft or death with a functioning allograft was considered an event. Mean overall allograft survival rate at 10 years was 78.2% (95% confidence interval, 70.5-25.3). In the control group, 48 patients (43.6%) still had a functioning graft at 10 years versus 38 patients (34.5%) in the psychoeducational intervention group (P = .02). However, a log-rank test did not find any significant difference in allograft survival between the groups (P = .06). In multivariate analyses (Cox model), no factor was significantly associated with allograft survival at 10 years. After an initial 6-month observational adherence survey, there was no benefit to kidney allograft survival at 10 years after the psychoeducational intervention, which had aimed to improve patient adherence to treatment with immunosuppressive agents. This might be related to the fact that booster interventions are needed (eg, on a yearly basis).

  9. Caloric restriction alters the metabolic response to a mixed-meal: results from a randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Kim M Huffman

    Full Text Available To determine if caloric restriction (CR would cause changes in plasma metabolic intermediates in response to a mixed meal, suggestive of changes in the capacity to adapt fuel oxidation to fuel availability or metabolic flexibility, and to determine how any such changes relate to insulin sensitivity (S(I.Forty-six volunteers were randomized to a weight maintenance diet (Control, 25% CR, or 12.5% CR plus 12.5% energy deficit from structured aerobic exercise (CR+EX, or a liquid calorie diet (890 kcal/d until 15% reduction in body weightfor six months. Fasting and postprandial plasma samples were obtained at baseline, three, and six months. A targeted mass spectrometry-based platform was used to measure concentrations of individual free fatty acids (FFA, amino acids (AA, and acylcarnitines (AC. S(I was measured with an intravenous glucose tolerance test.Over three and six months, there were significantly larger differences in fasting-to-postprandial (FPP concentrations of medium and long chain AC (byproducts of FA oxidation in the CR relative to Control and a tendency for the same in CR+EX (CR-3 month P = 0.02; CR-6 month P = 0.002; CR+EX-3 month P = 0.09; CR+EX-6 month P = 0.08. After three months of CR, there was a trend towards a larger difference in FPP FFA concentrations (P = 0.07; CR-3 month P = 0.08. Time-varying differences in FPP concentrations of AC and AA were independently related to time-varying S(I (P<0.05 for both.Based on changes in intermediates of FA oxidation following a food challenge, CR imparted improvements in metabolic flexibility that correlated with improvements in S(I.ClinicalTrials.gov NCT00099151.

  10. Results of a randomized clinical trial of external beam radiation to prevent restenosis after superficial femoral artery stenting.

    Science.gov (United States)

    Therasse, Eric; Donath, David; Elkouri, Stéphane; Lespérance, Jacques; Giroux, Marie-France; Oliva, Vincent L; Guertin, Marie-Claude; Bouchard, Louis; Perreault, Pierre; Gilbert, Patrick; Soulez, Gilles

    2016-06-01

    The objective of this study was to evaluate the safety and efficacy of external beam radiation (EBR) in preventing restenosis after superficial femoral artery (SFA) stenting in comparison with a control group treated with SFA stenting only. In this Institutional Review Board-approved study, patients who provided written informed consent were randomly assigned to 0 Gy or 14 Gy of EBR to the stent site 24 hours after SFA stenting. The primary end point was the angiographic binary restenosis rate 2 years after stenting. Categorical and continuous end points were respectively analyzed using logistic regression models and Wilcoxon tests. End points expressed as time to event were analyzed using a log-rank test. The study included 155 patients, 46 women and 109 men (mean age, 66 years; range, 45-85 years). In the 0 and 14 Gy groups, binary restenosis was present, respectively, in 44% (34/77) and 68% (52/76; P = .003) 2 years after stenting. Stent thrombosis occurred in 13% (10/78) of the 0 Gy group and in 33% (25/77) of the 14 Gy group (P = .003). Target lesion revascularization at 2 years was 26% (25/78) in the 0 Gy group and 30% (23/77) in the 14 Gy group (P = .56). There were no significant differences in total walking distances change from baseline to 2 years (46 ± 100 and 26 ± 79 m, respectively, in the 0 Gy and 14 Gy group; P = .25). There were no procedure-related deaths and no major amputations. A single 14 Gy dose of EBR to the SFA stenting site did not prevent in-stent restenosis. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  11. Treatment of Sarcopenia with Bimagrumab: Results from a Phase II, Randomized, Controlled, Proof-of-Concept Study.

    Science.gov (United States)

    Rooks, Daniel; Praestgaard, Jens; Hariry, Sam; Laurent, Didier; Petricoul, Olivier; Perry, Robert G; Lach-Trifilieff, Estelle; Roubenoff, Ronenn

    2017-09-01

    To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations. A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study. Five centers in the United States. Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m 2 or less for men and 5.67 kg/m 2 or less for women. Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21). Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD). Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs -0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs -1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study. Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  12. Pace-capture-guided ablation after contact-force-guided pulmonary vein isolation: results of the randomized controlled DRAGON trial.

    Science.gov (United States)

    Masuda, Masaharu; Fujita, Masashi; Iida, Osamu; Okamoto, Shin; Ishihara, Takayuki; Nanto, Kiyonori; Kanda, Takashi; Sunaga, Akihiro; Tsujimura, Takuya; Matsuda, Yasuhiro; Ohashi, Takuya; Uematsu, Masaaki

    2017-11-17

    Before the discovery of contact-force guidance, eliminating pacing capture along the pulmonary vein (PV) isolation line had been reported to improve PV isolation durability and rhythm outcomes. DRAGON (UMIN-CTR, UMIN000015332) aimed to elucidate the efficacy of pace-capture-guided ablation following contact-force-guided PV isolation ablation in paroxysmal atrial fibrillation (AF) patients. A total of 156 paroxysmal AF patients with AF-trigger ectopies from any of the four PVs induced by isoproterenol were randomly assigned to undergo pace-capture-guided ablation along a contact-force-guided isolation line around AF-trigger PVs (PC group, n = 76) or contact-force-guided PV isolation ablation alone (control group, n = 80). Follow-up of at least 1 year commenced with serial 24 h Holter and symptom-triggered ambulatory monitoring. There was no significant difference in acute PV reconnection rates during a 20 min waiting period after the last ablation or adenosine infusion testing between the PC and the control groups (per patient, 21% vs. 27%, P = 0.27; per AF-trigger PV, 5.9% vs. 7.3%, P = 0.70; and per non-AF-trigger PV, 7.1% vs. 7.4%, P = 0.92). Atrial tachyarrhythmia-free survival rates off antiarrhythmic drugs after the initial session were comparable at 19.3 ± 6.2 months between the two groups (82% vs. 80%, P = 0.80). Among 22 patients who required a second ablation procedure, there was no difference between the PC and the control groups in the PV reconnection rates at both previously AF-trigger (29% vs. 43%, P = 0.70) and non-AF-trigger PVs (18% vs. 19%, P = 0.88). Pace-capture-guided ablation performed after contact-force-guided PV isolation demonstrated no improvement in PV isolation durability or rhythm outcome. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  13. Corneal power, thickness, and stiffness: results of a prospective randomized controlled trial of PRK and LASIK for myopia.

    Science.gov (United States)

    Hjortdal, Jesper Ø; Møller-Pedersen, Torben; Ivarsen, Anders; Ehlers, Niels

    2005-01-01

    To compare the short-, medium-, and long-term changes in corneal optical power and corneal aberrations, central corneal thickness, and corneal "stiffness" assessed by pneumotonometry readings in patients having laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) for myopia. Department of Ophthalmology, Arhus University Hospital, Arhus, Denmark. One eye of each of 45 patients with myopia ranging from -6.00 to -8.00 diopters (D) (spherical equivalent spectacle refraction [SER]) was randomized to LASIK (n=25; mean SER -7.12 D +/- 0.57 [SD]) or PRK (n=20; mean SER -6.91 +/- 0.57 D). Data were collected prospectively before and 1, 3, 6, 12, and 36 months after surgery. Measurements included corneal topography (TMS-1, Tomey), corneal thickness (ultrasound pachymetry), and apparent intraocular pressure (IOP) (pneumotonometry). Retreatments were not performed during the first year, and retreated eyes were excluded from the 3-year follow-up. Changes in corneal power and aberrations, thickness, and apparent IOP were calculated in a pair-wise manner for 3 time periods: short term (preoperative to 1 month after surgery), medium term (1 to 12 months after surgery), and long term (1 to 3 years after surgery). In the short term, corneal power decreased equally in LASIK and PRK eyes. Spherical aberrations and coma-like aberrations increased equally, while corneal thickness decreased significantly less in LASIK eyes than in PRK eyes. The apparent IOP decreased more in LASIK eyes than in PRK eyes. In the medium term, corneal power increased significantly in both groups. Spherical aberrations decreased significantly in PRK eyes but not in LASIK eyes. From 1 to 12 months, corneal thickness increased more in PRK eyes than in LASIK eyes. During this period, the apparent IOP increased significantly in LASIK eyes. In the long term, corneal power and corneal aberrations did not change significantly in either group. Corneal thickness increased slightly but

  14. Combining Internet-Based and Postal Survey Methods in a Survey among Gynecologists: Results of a Randomized Trial.

    Science.gov (United States)

    Ernst, Sinja Alexandra; Brand, Tilman; Lhachimi, Stefan K; Zeeb, Hajo

    2018-04-01

    To assess whether a combination of Internet-based and postal survey methods (mixed-mode) compared to postal-only survey methods (postal-only) leads to improved response rates in a physician survey, and to compare the cost implications of the different recruitment strategies. All primary care gynecologists in Bremen and Lower Saxony, Germany, were invited to participate in a cross-sectional survey from January to July 2014. The sample was divided into two strata (A; B) depending on availability of an email address. Within each stratum, potential participants were randomly assigned to mixed-mode or postal-only group. In Stratum A, the mixed-mode group had a lower response rate compared to the postal-only group (12.5 vs. 20.2 percent; RR = 0.61, 95 percent CI: 0.44-0.87). In stratum B, no significant differences were found (15.6 vs. 16.2 percent; RR = 0.95, 95 percent CI: 0.62-1.44). Total costs (in €) per valid questionnaire returned (Stratum A: 399.72 vs. 248.85; Stratum B: 496.37 vs. 455.15) and per percentage point of response (Stratum A: 1,379.02 vs. 861.02; Stratum B 1,116.82 vs. 1,024.09) were higher, whereas variable costs were lower in mixed-mode compared to the respective postal-only groups (Stratum A cost ratio: 0.47, Stratum B cost ratio: 0.71). In this study, primary care gynecologists were more likely to participate by traditional postal-only than by mixed-mode survey methods that first offered an Internet option. However, the lower response rate for the mixed-mode method may be partly due to the older age structure of the responding gynecologists. Variable costs per returned questionnaire were substantially lower in mixed-mode groups and indicate the potential for cost savings if the sample population is sufficiently large. © Health Research and Educational Trust.

  15. A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results.

    Science.gov (United States)

    Saccà, Francesco; Quarantelli, Mario; Rinaldi, Carlo; Tucci, Tecla; Piro, Raffaele; Perrotta, Gaetano; Carotenuto, Barbara; Marsili, Angela; Palma, Vincenzo; De Michele, Giuseppe; Brunetti, Arturo; Brescia Morra, Vincenzo; Filla, Alessandro; Salvatore, Marco

    2012-01-01

    Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≤3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p deficit, with higher levels in the bulbar-onset group. During follow-up, patients showed progressive increase in HOMA-IR and decrease in IGFBP-3 levels.

  16. Personal child and mother carbon monoxide exposures and kitchen levels: methods and results from a randomized trial of woodfired chimney cookstoves in Guatemala (RESPIRE).

    Science.gov (United States)

    Smith, Kirk R; McCracken, John P; Thompson, Lisa; Edwards, Rufus; Shields, Kyra N; Canuz, Eduardo; Bruce, Nigel

    2010-07-01

    During the first randomized intervention trial (RESPIRE: Randomized Exposure Study of Pollution Indoors and Respiratory Effects) in air pollution epidemiology, we pioneered application of passive carbon monoxide (CO) diffusion tubes to measure long-term personal exposures to woodsmoke. Here we report on the protocols and validations of the method, trends in personal exposure for mothers and their young children, and the efficacy of the introduced improved chimney stove in reducing personal exposures and kitchen concentrations. Passive diffusion tubes originally developed for industrial hygiene applications were deployed on a quarterly basis to measure 48-hour integrated personal carbon monoxide exposures among 515 children 0-18 months of age and 532 mothers aged 15-55 years and area samples in a subsample of 77 kitchens, in households randomized into control and intervention groups. Instrument comparisons among types of passive diffusion tubes and against a continuous electrochemical CO monitor indicated that tubes responded nonlinearly to CO, and regression calibration was used to reduce this bias. Before stove introduction, the baseline arithmetic (geometric) mean 48-h child (n=270), mother (n=529) and kitchen (n=65) levels were, respectively, 3.4 (2.8), 3.4 (2.8) and 10.2 (8.4) p.p.m. The between-group analysis of the 3355 post-baseline measurements found CO levels to be significantly lower among the intervention group during the trial period: kitchen levels: -90%; mothers: -61%; and children: -52% in geometric means. No significant deterioration in stove effect was observed over the 18 months of surveillance. The reliability of these findings is strengthened by the large sample size made feasible by these unobtrusive and inexpensive tubes, measurement error reduction through instrument calibration, and a randomized, longitudinal study design. These results from the first randomized trial of improved household energy technology in a developing country and

  17. A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

    Science.gov (United States)

    Modi, Riddhi A; Mugavero, Michael J; Amico, Rivet K; Keruly, Jeanne; Quinlivan, Evelyn Byrd; Crane, Heidi M; Guzman, Alfredo; Zinski, Anne; Montue, Solange; Roytburd, Katya; Church, Anna; Willig, James H

    2017-06-16

    Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user

  18. Nutritional profile and obesity: results from a random-sample population-based study in Córdoba, Argentina.

    Science.gov (United States)

    Aballay, Laura R; Osella, Alberto R; De La Quintana, Ana G; Diaz, María Del Pilar

    2016-03-01

    Obesity is a chronic, heterogeneous, multifactorial disease, which has sharply increased in prevalence in both developed and developing countries. This study aimed to estimate the prevalence of obesity and to identify socio-demographic risk factors associated with it, with special emphasis on diet. Nutritional status, demographic characteristics, lifestyle habits, and food consumption patterns derived from a Food Frequency Questionnaire were investigated. Exhaustive exploratory analyses were performed in order to describe dietary patterns, and logistic regression models were used for odds ratio estimation. The study included 4328 subjects, over 18 years old and resident in Cordoba city. The prevalence of overweight and obesity was 34 and 17 %, respectively, with 60 % in men and 45 % in women of BMI ≥ 25. Obesity risk factors were high intake of sodium, refined grains, starchy vegetables, and snacks. A lower risk of overweight and obesity was associated with an adequate, moderate intake of meats, eggs, alcoholic beverages, sugar and sweets, milk, yogurt, and pulses. A high intake of snacks, refined grains, starchy vegetables and sodium and low intake of yogurt, milk, pulses, and whole grains seem to be associated with the emergence and high prevalence of obesity in Cordoba, Argentina.

  19. Conflicting results between randomized trials and observational studies on the impact of proton pump inhibitors on cardiovascular events when coadministered with dual antiplatelet therapy: systematic review.

    Science.gov (United States)

    Melloni, Chiara; Washam, Jeffrey B; Jones, W Schuyler; Halim, Sharif A; Hasselblad, Victor; Mayer, Stephanie B; Heidenfelder, Brooke L; Dolor, Rowena J

    2015-01-01

    Discordant results have been reported on the effects of concomitant use of proton pump inhibitors (PPIs) and dual antiplatelet therapy (DAPT) for cardiovascular outcomes. We conducted a systematic review comparing the effectiveness and safety of concomitant use of PPIs and DAPT in the postdischarge treatment of unstable angina/non-ST-segment-elevation myocardial infarction patients. We searched for clinical studies in MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews, from 1995 to 2012. Reviewers screened and extracted data, assessed applicability and quality, and graded the strength of evidence. We performed meta-analyses of direct comparisons when outcomes and follow-up periods were comparable. Thirty-five studies were eligible. Five (4 randomized controlled trials and 1 observational) assessed the effect of omeprazole when added to DAPT; the other 30 (observational) assessed the effect of PPIs as a class when compared with no PPIs. Random-effects meta-analyses of the studies assessing PPIs as a class consistently reported higher event rates in patients receiving PPIs for various clinical outcomes at 1 year (composite ischemic end points, all-cause mortality, nonfatal MI, stroke, revascularization, and stent thrombosis). However, the results from randomized controlled trials evaluating omeprazole compared with placebo showed no difference in ischemic outcomes, despite a reduction in upper gastrointestinal bleeding with omeprazole. Large, well-conducted observational studies of PPIs and randomized controlled trials of omeprazole seem to provide conflicting results for the effect of PPIs on cardiovascular outcomes when coadministered with DAPT. Prospective trials that directly compare pharmacodynamic parameters and clinical events among specific PPI agents in patients with unstable angina/non-ST-segment-elevation myocardial infarction treated with DAPT are warranted. © 2015 American Heart Association, Inc.

  20. LapTrain: multi-modality training curriculum for laparoscopic cholecystectomy-results of a randomized controlled trial.

    Science.gov (United States)

    Kowalewski, K F; Garrow, C R; Proctor, T; Preukschas, A A; Friedrich, M; Müller, P C; Kenngott, H G; Fischer, L; Müller-Stich, B P; Nickel, F

    2018-02-12

    Multiple training modalities for laparoscopy have different advantages, but little research has been conducted on the benefit of a training program that includes multiple different training methods compared to one method only. This study aimed to evaluate benefits of a combined multi-modality training program for surgical residents. Laparoscopic cholecystectomy (LC) was performed on a porcine liver as the pre-test. Randomization was stratified for experience to the multi-modality Training group (12 h of training on Virtual Reality (VR) and box trainer) or Control group (no training). The post-test consisted of a VR LC and porcine LC. Performance was rated with the Global Operative Assessment of Laparoscopic Skills (GOALS) score by blinded experts. Training (n = 33) and Control (n = 31) were similar in the pre-test (GOALS: 13.7 ± 3.4 vs. 14.7 ± 2.6; p = 0.198; operation time 57.0 ± 18.1 vs. 63.4 ± 17.5 min; p = 0.191). In the post-test porcine LC, Training had improved GOALS scores (+ 2.84 ± 2.85 points, p < 0.001), while Control did not (+ 0.55 ± 2.34 points, p = 0.154). Operation time in the post-test was shorter for Training vs. Control (40.0 ± 17.0 vs. 55.0 ± 22.2 min; p = 0.012). Junior residents improved GOALS scores to the level of senior residents (pre-test: 13.7 ± 2.7 vs. 18.3 ± 2.9; p = 0.010; post-test: 15.5 ± 3.4 vs. 18.8 ± 3.8; p = 0.120) but senior residents remained faster (50.1 ± 20.6 vs. 25.0 ± 1.9 min; p < 0.001). No differences were found between groups on the post-test VR trainer. Structured multi-modality training is beneficial for novices to improve basics and overcome the initial learning curve in laparoscopy as well as to decrease operation time for LCs in different stages of experience. Future studies should evaluate multi-modality training in comparison with single modalities. German Clinical Trials Register DRKS00011040.

  1. Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial.

    Science.gov (United States)

    Himelhoch, Seth; Medoff, Deborah; Maxfield, Jennifer; Dihmes, Sarah; Dixon, Lisa; Robinson, Charles; Potts, Wendy; Mohr, David C

    2013-10-01

    This pilot randomized controlled trial evaluated a previously developed manualized telephone based cognitive behavioral therapy (T-CBT) intervention compared to face-to-face (f2f) therapy among low-income, urban dwelling HIV infected depressed individuals. The primary outcome was the reduction of depressive symptoms as measured by the Hamliton rating scale for depression scale. The secondary outcome was adherence to HAART as measured by random telephone based pill counts. Outcome measures were collected by trained research assistants masked to treatment allocation. Analysis was based on intention-to-treat. Thirty-four participants met eligibility criteria and were randomly assigned to receive T-CBT (n = 16) or f2f (n = 18). There was no statistically significant difference in depression treatment outcomes comparing f2f to T-CBT. Within group evaluation demonstrated that both the T-CBT and the f2f psychotherapy groups resulted in significant reductions in depressive symptoms. Those who received the T-CBT were significantly more likely to maintain their adherence to antiretroviral medication compared to the f2f treatment. None of the participants discontinued treatment due to adverse events. T-CBT can be delivered to low-income, urban dwelling HIV infected depressed individuals resulting in significant reductions in depression symptoms and improved adherence to antiretroviral medication. Clinical Trial.gov identifier: NCT01055158.

  2. Pilot Randomized Trial Comparing Intersession Scheduling of Biofeedback Results to Individuals with Chronic Pain: Influence on Psychologic Function and Pain Intensity.

    Science.gov (United States)

    Weeks, Douglas L; Whitney, Anthony A; Tindall, Angelique G; Carter, Gregory T

    2015-10-01

    The objective of this study was to compare the effectiveness of two biofeedback schedules on long-term improvement in physical and psychologic reactivity to chronic nonmalignant pain. This study is a prospective, randomized pilot trial. Twenty adults with chronic pain engaged in heart rate variability (HRV) biofeedback training for nine sessions with HRV presented visually. Two groups, formed by random assignment, were compared: The faded feedback group received concurrent visual HRV biofeedback in session 1, with the amount of biofeedback systematically reduced for ensuing sessions so that, by session 9, the participants were controlling HRV without external feedback. The full feedback group received visual HRV biofeedback continuously across all sessions. Outcome measures assessed at baseline, immediately after the program, and 3 mos after the program included pain intensity, fear-avoidance beliefs, and self-report physical functioning. Use of biofeedback skills was also assessed 3 mos after the program. Nominal variables were analyzed with χ. Continuous measures were analyzed with repeated-measures analyses of variance. The faded feedback schedule resulted in greater use of biofeedback skills at 3 mos and improved pain intensity and fear-avoidance beliefs after the program and at 3 mos. Physical functioning did not differ between groups. Systematically reducing the frequency of external visual feedback during HRV biofeedback training was associated with reduced reactivity to chronic pain. Results of this pilot study should be confirmed with a larger randomized study.

  3. High-field magnetization curve of random-anisotropy amorphous magnet: Observation of a crossover and link to structural short-range order

    Science.gov (United States)

    Filippi, J.; Amaral, V. S.; Barbara, B.

    1991-08-01

    High-field magnetization curves of the series of amorphous alloys DyxGd1-xNi have been measured up to 15 tesla and interpreted in the framework of the theory of Chudnovsky et al. The results show several features (high-field crossovers, correlation volume of local-anisotropy directions, ferromagnetic correlation length) all consistent with each other and in agreement with theoretical predictions.

  4. High-field magnetization curve of random-anisotropy amorphous magnet: Observation of a crossover and link to structural short-range order

    International Nuclear Information System (INIS)

    Filippi, J.; Amaral, V.S.; Barbara, B.

    1991-01-01

    High-field magnetization curves of the series of amorphous alloys Dy x Gd 1-x Ni have been measured up to 15 tesla and interpreted in the framework of the theory of Chudnovsky et al. The results show several features (high-field crossovers, correlation volume of local-anisotropy directions, ferromagnetic correlation length) all consistent with each other and in agreement with theoretical predictions

  5. On the limit distribution of lower extreme generalized order statistics

    Indian Academy of Sciences (India)

    Abstract. In a wide subclass of generalized order statistics (gOs), which contains most of the known and important models of ordered random variables, weak conver- gence of lower extremes are developed. A recent result of extreme value theory of m−gOs (as well as the classical extreme value theory of ordinary order ...

  6. On the Limit Distribution of Lower Extreme Generalized Order Statistics

    Indian Academy of Sciences (India)

    In a wide subclass of generalized order statistics ( g O s ) , which contains most of the known and important models of ordered random variables, weak convergence of lower extremes are developed. A recent result of extreme value theory of m − g O s (as well as the classical extreme value theory of ordinary order statistics) ...

  7. Staple Line Reinforcement During Laparoscopic Sleeve Gastrectomy: Absorbable Monofilament, Barbed Suture, Fibrin Glue, or Nothing? Results of a Prospective Randomized Study.

    Science.gov (United States)

    Carandina, S; Tabbara, M; Bossi, M; Valenti, A; Polliand, C; Genser, L; Barrat, Christophe

    2016-02-01

    Laparoscopic sleeve gastrectomy (LSG) is associated with serious complications, such as staple line (SL) leaks and bleeding. In order to prevent the occurrence of these complications, surgeons have advocated the need to strengthen the staple line. The aim of this randomized controlled study was to compare the efficacy of three different ways of strengthening of the SL in LSG in preventing surgical post-operative complications. Between April 2012 and December 2014, 600 patients (pts) scheduled for LSG were prospectively randomized into groups without SL reinforcement (group A) or with SL reinforcement including fibrin glue coverage (group B), or oversewn SL with imbricating absorbable (Monocryl™; group C) or barbed (V lock®) running suture (group D). Primary endpoints were post-operative leaks, bleeding, and stenosis, while secondary outcomes consisted of the time to perform the staple line reinforcement (SLR) and total operative time. Mean SLR operative time was lower for group B (3.4 ± 1.3 min) compared with that for groups C (26.8 ± 8.5 min) and D (21.1 ± 8.4 min) (p running suture or with fibrin glue, is an unrewarding surgical act with the sole effect of prolonging the operative time.

  8. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  9. Effects of formative assessments to develop self-regulation among sixth grade students: Results from a randomized controlled intervention

    NARCIS (Netherlands)

    Meusen-Beekman, Kelly; Joosten-ten Brinke, Desirée; Boshuizen, Els

    2018-01-01

    This article presents the results of a formative assessment intervention in writing assignments in sixth grade. We examined whether formative assessments would improve self-regulation, motivation and self-efficacy among sixth graders, and whether differential effects exist between formative

  10. Randomized random walk on a random walk

    International Nuclear Information System (INIS)

    Lee, P.A.

    1983-06-01

    This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

  11. Staggered chiral random matrix theory

    International Nuclear Information System (INIS)

    Osborn, James C.

    2011-01-01

    We present a random matrix theory for the staggered lattice QCD Dirac operator. The staggered random matrix theory is equivalent to the zero-momentum limit of the staggered chiral Lagrangian and includes all taste breaking terms at their leading order. This is an extension of previous work which only included s